Dextroamphetamine Extended-Release Capsules

Generic Name: dextroamphetamine sulfate

Dosage Form: capsule, extended release
DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES - CII

Revised SEPTEMBER 2007

11001275

Rx only

WARNING:

AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NON-THERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUGS SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY.

MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.

DESCRIPTION:

Dextroamphetamine sulfate is the dextro isomer of the compound d,l -amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of dextroamphetamine as the neutral sulfate. The structural formula is as follows:

(C9H13N)2 • H2SO4 Molecular Weight: 368.49

Each extended-release capsule is so prepared that an initial dose is released promptly and the remaining medication is released gradually over a prolonged period.

Each capsule contains dextroamphetamine sulfate, and has the following inactive ingredients: colloidal silicon dioxide, dibutyl sebacate, ethylcellulose aqueous dispersion, methylcellulose, povidone, propylene glycol, sugar spheres and talc.

The capsule shell ingredients in the 5 mg are D&C red no. 33, FD&C blue no. 1, FD&C yellow no. 6, gelatin, and titanium dioxide.

The capsule shell ingredients in the 10 mg are black iron oxide, gelatin, red iron oxide, titanium dioxide, and yellow iron oxide.

The capsule shell ingredients in the 15 mg are black iron oxide, gelatin, red iron oxide, titanium dioxide, and yellow iron oxide.

The imprinting ingredients are D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, pharmaceutical glaze, propylene glycol, and synthetic black iron oxide.

CLINICAL PHARMACOLOGY:

Amphetamines are non-catecholamine, sympathomimetic amines with CNS stimulant activity. Peripheral actions include elevations of systolic and diastolic blood pressures and weak bronchodilator and respiratory stimulant action.

There is neither specific evidence which clearly establishes the mechanism whereby amphetamines produce mental and behavioral effects in children, nor conclusive evidence regarding how these effects relate to the condition of the central nervous system.

Dextroamphetamine sulfate extended-release capsules are formulated to release the active drug substance in vivo in a more gradual fashion than the standard formulation, as demonstrated by blood levels. The formulation has not been shown superior in effectiveness over the same dosage of the standard, non-controlled-release formulations given in divided doses.

Pharmacokinetics:

The pharmacokinetics of the tablet and extended-release capsule was compared in 12 healthy subjects. The extent of bioavailability of the extended-release capsule was similar compared to the immediate release tablet. Following administration of three 5 mg tablets, average maximal dextroamphetamine plasma concentrations (Cmax) of 36.6 ng/mL were achieved at approximately 3 hours. Following administration of one 15 mg extended-release capsule, maximal dextroamphetamine plasma concentrations were obtained approximately 8 hours after dosing. The average Cmax was 23.5 ng/mL. The average plasma T1/2 was similar for both the tablet and extended-release capsule and was approximately 12 hours.

In 12 healthy subjects, the rate and extent of dextroamphetamine absorption were similar following administration of the extended-release capsule formulation in the fed (58 to 75 gm fat) and fasted state.

INDICATIONS AND USAGE:

Dextroamphetamine sulfate is indicated:

1. In Narcolepsy.

2. In Attention Deficit Disorder with Hyperactivity, as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 years to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.

CONTRAINDICATIONS:

Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma.

Agitated states.

Patients with a history of drug abuse.

During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result).

WARNINGS:

Serious Cardiovascular Events

Sudden Death in Patients with Pre-existing Structural Cardiac Abnormalities or Other Serious Heart Problems:

Children and Adolescents:  Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Although some serious heart problems alone carry an increased risk of sudden death, stimulant products generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.

Adults:  Sudden deaths, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Although the role of stimulants in these adult cases is also unknown, adults have a greater likelihood than children of having serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. Adults with such abnormalities should also generally not be treated with stimulant drugs (see CONTRAINDICATIONS).

Hypertension and Other Cardiovascular Conditions:

Stimulant medications cause a modest increase in average blood pressure (about 2-4 mmHg) and average heart rate (about 3-6 bpm), and individuals may have larger increases. While the mean changes alone would not be expected to have short-term consequences, all patients should be monitored for larger changes in heart rate and blood pressure. Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate, e.g., those with pre-existing hypertension, heart failure, recent myocardial infarction, or ventricular arrhythmia (see CONTRAINDICATIONS).

Assessing Cardiovascular Status in Patients Being Treated With Stimulant Medications:

Children, adolescents, or adults who are being considered for treatment with stimulant medications should have a careful history (including assessment for a family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac disease, and should receive further cardiac evaluation if findings suggest such disease (e.g., electrocardiogram and echocardiogram). Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation.

Psychiatric Adverse Events

Pre-Existing Psychosis:

Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.

Bipolar Illness:

Particular care should be taken in using stimulants to treat ADHD in patients with comorbid bipolar disorder because of concern for possible induction of a mixed/manic episode in such patients. Prior to initiating treatment with a stimulant, patients with comorbid depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.

Emergence of New Psychotic or Manic Symptoms:

Treatment emergent psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania in children and adolescents without a prior history of psychotic illness or mania can be caused by stimulants at usual doses. If such symptoms occur, consideration should be given to a possible causal role of the stimulant, and discontinuation of treatment may be appropriate. In a pooled analysis of multiple short-term, placebo-controlled studies, such symptoms occurred in about 0.1% (4 patients with events out of 3,482 exposed to methylphenidate or amphetamine for several weeks at usual doses) of stimulant-treated patients compared to 0 in placebo-treated patients.

Aggression:

Aggressive behavior or hostility is often observed in children and adolescents with ADHD, and has been reported in clinical trials and the postmarketing experience of some medications indicated for the treatment of ADHD. Although there is no systematic evidence that stimulants cause aggressive behavior or hostility, patients beginning treatment for ADHD should be monitored for the appearance of, or worsening of, aggressive behavior or hostility.

Long-Term Suppression of Growth:

Careful follow-up of weight and height in children ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated children over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated children (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development. Published data are inadequate to determine whether chronic use of amphetamines may cause a similar suppression of growth, however, it is anticipated that they likely have this effect as well. Therefore, growth should be monitored during treatment with stimulants, and patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.

Seizures:

There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued.

Visual Disturbance:

Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.

PRECAUTIONS:

General:

The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

Information for Patients:

Amphetamines may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or vehicles; the patient should therefore be cautioned accordingly.

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with dextroamphetamine and should counsel them in its appropriate use. A patient Medication Guide is available for Dextroamphetamine Sulfate Extended-Release Capsules.

The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.

Drug Interactions:

Acidifying agents:

Gastrointestinal acidifying agents (guanethidine, reserpine, glutamic acid HCl, ascorbic acid, fruit juices, etc.) lower absorption of amphetamines. Urinary acidifying agents (ammonium chloride, sodium acid phosphate, etc.) increase the concentration of the ionized species of the amphetamine molecule, thereby increasing urinary excretion. Both groups of agents lower blood levels and efficacy of amphetamines.

Adrenergic blockers:

Adrenergic blockers are inhibited by amphetamines.

Alkalinizing agents:

Gastrointestinal alkalinizing agents (sodium bicarbonate, etc.) increase absorption of amphetamines. Urinary alkalinizing agents (acetazolamide, some thiazides) increase the concentration of the non-ionized species of the amphetamine molecule, thereby decreasing urinary excretion. Both groups of agents increase blood levels and therefore potentiate the actions of amphetamines.

Antidepressants, tricyclic:

Amphetamines may enhance the activity of tricyclic or sympathomimetic agents; d-amphetamine with desipramine or protriptyline and possibly other tricyclics cause striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated.

MAO inhibitors:

MAOI antidepressants, as well as a metabolite of furazolidone, slow amphetamine metabolism. This slowing potentiates amphetamines, increasing their effect on the release of norepinephrine and other monoamines from adrenergic nerve endings; this can cause headaches and other signs of hypertensive crisis. A variety of neurological toxic effects and malignant hyperpyrexia can occur, sometimes with fatal results.

Antihistamines:

Amphetamines may counteract the sedative effect of antihistamines.

Antihypertensives:

Amphetamines may antagonize the hypotensive effects of antihypertensives.

Chlorpromazine:

Chlorpromazine blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamines, and can be used to treat amphetamine poisoning.

Ethosuximide:

Amphetamines may delay intestinal absorption of ethosuximide.

Haloperidol:

Haloperidol blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamines.

Lithium carbonate:

The stimulatory effects of amphetamines may be inhibited by lithium carbonate.

Meperidine:

Amphetamines potentiate the analgesic effect of meperidine.

Methenamine therapy:

Urinary excretion of amphetamines is increased, and efficacy is reduced, by acidifying agents used in methenamine therapy.

Norepinephrine:

Amphetamines enhance the adrenergic effect of norepinephrine.

Phenobarbital:

Amphetamines may delay intestinal absorption of phenobarbital; co-administration of phenobarbital may produce a synergistic anticonvulsant action.

Phenytoin:

Amphetamines may delay intestinal absorption of phenytoin; co-administration of phenytoin may produce a synergistic anticonvulsant action.

Propoxyphene:

In cases of propoxyphene overdosage, amphetamine CNS stimulation is potentiated and fatal convulsions can occur.

Veratrum Alkaloids:

Amphetamines inhibit the hypotensive effect of veratrum alkaloids.

Drug/Laboratory Test Interactions:

•  Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening.


•  Amphetamines may interfere with urinary steroid determinations.

Carcinogenesis/Mutagenesis:

Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of dextroamphetamine sulfate have not been performed.

Pregnancy-Teratogenic Effects:

Pregnancy Category C:

Dextroamphetamine sulfate has been shown to have embryotoxic and teratogenic effects when administered to A/Jax mice and C57BL mice in doses approximately 41 times the maximum human dose. Embryotoxic effects were not seen in New Zealand white rabbits given the drug in doses 7 times the human dose nor in rats given 12.5 times the maximum human dose. While there are no adequate and well-controlled studies in pregnant women, there has been one report of severe congenital bony deformity, tracheoesophageal fistula, and anal atresia (Vater association) in a baby born to a woman who took dextroamphetamine sulfate with lovastatin during the first trimester of pregnancy. Dextroamphetamine sulfate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects:

Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight. Also, these infants may experience symptoms of withdrawal as demonstrated by dysphoria, including agitation, and significant lassitude.

Nursing Mothers:

Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised to refrain from nursing.

Pediatric Use:

Long-term effects of amphetamines in pediatric patients have not been well established.

Amphetamines are not recommended for use in pediatric patients under 3 years of age with Attention Deficit Disorder with Hyperactivity described under INDICATIONS AND USAGE.

Clinical experience suggests that in psychotic children, administration of amphetamines may exacerbate symptoms of behavior disturbance and thought disorder.

Amphetamines have been reported to exacerbate motor and phonic tics and Tourette's syndrome. Therefore, clinical evaluation for tics and Tourette's syndrome in children and their families should precede use of stimulant medications.

Data are inadequate to determine whether chronic administration of amphetamines may be associated with growth inhibition; therefore, growth should be monitored during treatment.

Drug treatment is not indicated in all cases of Attention Deficit Disorder with Hyperactivity and should be considered only in light of the complete history and evaluation of the child. The decision to prescribe amphetamines should depend on the physician's assessment of the chronicity and severity of the child's symptoms and their appropriateness for his/her age. Prescription should not depend solely on the presence of one or more of the behavioral characteristics.

When these symptoms are associated with acute stress reactions, treatment with amphetamines is usually not indicated.

ADVERSE REACTIONS:

Cardiovascular:

Palpitations, tachycardia, elevation of blood pressure. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.

Central Nervous System:

Psychotic episodes at recommended doses (rare), overstimulation, restlessness, dizziness, insomnia, euphoria, dyskinesia, dysphoria, tremor, headache, exacerbation of motor and phonic tics and Tourette's syndrome.

Gastrointestinal:

Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects.

Allergic:

Urticaria.

Endocrine:

Impotence, changes in libido.

DRUG ABUSE AND DEPENDENCE:

Dextroamphetamine sulfate is a Schedule II controlled substance.

Amphetamines have been extensively abused. Tolerance, extreme psychological dependence and severe social disability have occurred. There are reports of patients who have increased the dosage to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG.

Manifestations of chronic intoxication with amphetamines include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. The most severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia. This is rare with oral amphetamines.

OVERDOSAGE:

Individual patient response to amphetamines varies widely. While toxic symptoms occasionally occur as an idiosyncrasy at doses as low as 2 mg, they are rare with doses of less than 15 mg; 30 mg can produce severe reactions, yet doses of 400 to 500 mg are not necessarily fatal.

In rats, the oral LD50 of dextroamphetamine sulfate is 96.8 mg/kg.

Manifestations of acute overdosage with amphetamines include restlessness, tremor, hyperreflexia, rhabdomyolysis, rapid respiration, hyperpyrexia, confusion, assaultiveness, hallucinations, panic states.

Fatigue and depression usually follow the central stimulation.

Cardiovascular effects include arrhythmias, hypertension or hypotension and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. Fatal poisoning is usually preceded by convulsions and coma.

Treatment:

Consult with a Certified Poison Control Center for up-to-date guidance and advice. Management of acute amphetamine intoxication is largely symptomatic and includes gastric lavage, administration of activated charcoal, administration of a cathartic, and sedation. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendation in this regard. Acidification of the urine increases amphetamine excretion, but is believed to increase risk of acute renal failure if myoglobinuria is present. If acute, severe hypertension complicates amphetamine overdosage, administration of intravenous phentolamine (Regitine®, CIBA) has been suggested. However, a gradual drop in blood pressure will usually result when sufficient sedation has been achieved.

Chlorpromazine antagonizes the central stimulant effects of amphetamines and can be used to treat amphetamine intoxication.

Since much of the extended-release capsule medication is coated for gradual release, therapy directed at reversing the effects of the ingested drug and at supporting the patient should be continued for as long as overdosage symptoms remain. Saline cathartics are useful for hastening the evacuation of pellets that have not already released medication.

DOSAGE AND ADMINISTRATION:

Amphetamines should be administered at the lowest effective dosage and dosage should be individually adjusted. Late evening doses - particularly with the extended-release capsule form - should be avoided because of the resulting insomnia.

Narcolepsy:

Usual dose 5 to 60 mg per day in divided doses, depending on the individual patient response. Narcolepsy seldom occurs in children under 12 years of age; however, when it does, dextroamphetamine sulfate may be used. The suggested initial dose for patients aged 6 to 12 is 5 mg daily; daily dose may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. In patients 12 years of age and older, start with 10 mg daily; daily dosage may be raised in increments of 10 mg at weekly intervals until optimal response is obtained. If bothersome adverse reactions appear (e.g., insomnia or anorexia), dosage should be reduced. Extended-release capsules may be used for once-a-day dosage wherever appropriate.

Attention Deficit Disorder with Hyperactivity:

Not recommended for pediatric patients under 3 years of age.

In pediatric patients 6 years of age and older, start with 5 mg once or twice daily; daily dosage may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. Only in rare cases will it be necessary to exceed a total of 40 mg per day.

Extended-release capsules may be used for once-a-day dosage wherever appropriate.

Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy.

HOW SUPPLIED:

Dextroamphetamine Sulfate Extended-Release Capsules are available as:

5 mg: Beige opaque cap and beige opaque body filled with white to off-white pellets. Imprinted in black ink barr 954. Available in bottles of:

30 Capsules NDC 0555-0954-01

100 Capsules NDC 0555-0954-02

10 mg: Brown opaque cap and colorless, clear body filled with white to off-white pellets. Imprinted in black ink barr 955. Available in bottles of:

30 Capsules NDC 0555-0955-01

100 Capsules NDC 0555-0955-02

15 mg: Dark brown opaque cap and colorless, clear body filled with white to off-white pellets. Imprinted in black ink barr 956. Available in bottles of:

30 Capsules NDC 0555-0956-01

100 Capsules NDC 0555-0956-02

Dispense in a tight, light-resistant container.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

MEDICATION GUIDE

DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES - CII

Read the Medication Guide that comes with Dextroamphetamine Sulfate Extended-Release Capsules before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about you or your child’s treatment with Dextroamphetamine Sulfate Extended-Release Capsules.

What is the most important information I should know about Dextroamphetamine Sulfate Extended-Release Capsules?

The following have been reported with use of Dextroamphetamine Sulfate Extended-Release Capsules and other stimulant medicines.

1. Heart-related problems:

• sudden death in patients who have heart problems or heart defects


• stroke and heart attack in adults


• increased blood pressure and heart rate

Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.

Your doctor should check you or your child carefully for heart problems before starting Dextroamphetamine Sulfate Extended-Release Capsules.

Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with Dextroamphetamine Sulfate Extended-Release Capsules.

Call your doctor right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Dextroamphetamine Sulfate Extended-Release Capsules.

2. Mental (Psychiatric) problems:

All Patients

• new or worse behavior and thought problems


• new or worse bipolar illness


• new or worse aggressive behavior or hostility

Children and Teenagers

• new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms

Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking Dextroamphetamine Sulfate Extended-Release Capsules, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

What are Dextroamphetamine Sulfate Extended-Release Capsules?

Dextroamphetamine Sulfate Extended-Release Capsules are a central nervous system stimulant  prescription medicine. It is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Dextroamphetamine Sulfate Extended-Release Capsules may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

Dextroamphetamine Sulfate Extended-Release Capsules should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

Dextroamphetamine Sulfate Extended-Release Capsules are also used in the treatment of a sleep disorder called narcolepsy.

Dextroamphetamine Sulfate is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Dextroamphetamine Sulfate Extended-Release Capsules in a safe place to prevent misuse and abuse. Selling or giving away Dextroamphetamine Sulfate Extended-Release Capsules may harm others, and is against the law.

Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.

Who should not take Dextroamphetamine Sulfate Extended-Release Capsules?

Dextroamphetamine Sulfate Extended-Release Capsules should not be taken if you or your child:

• have heart disease or hardening of the arteries


• have moderate to severe high blood pressure


• have hyperthyroidism


• have an eye problem called glaucoma


• are very anxious, tense, or agitated


• have a history of drug abuse


• are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.


• is sensitive to, allergic to, or had a reaction to other stimulant medicines

Dextroamphetamine Sulfate Extended-Release Capsules are not recommended for use in children less than 3 years old.

Dextroamphetamine Sulfate Extended-Release Capsules may not be right for you or your child. Before starting Dextroamphetamine Sulfate Extended-Release Capsules tell your or your child’s doctor about all health conditions (or a family history of) including:

• heart problems, heart defects, high blood pressure


• mental problems including psychosis, mania, bipolar illness, or depression


• tics or Tourette’s syndrome


• thyroid problems


• seizures or have had an abnormal brain wave test (EEG)

Tell your doctor if you are, or your child is pregnant, planning to become pregnant, or breastfeeding.

Can Dextroamphetamine Sulfate Extended-Release Capsules be taken with other medicines?

Tell your doctor about all of the medicines that you or your child takes including prescription and non-prescription medicines, vitamins, and herbal supplements.

Dextroamphetamine Sulfate Extended-Release Capsules and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking Dextroamphetamine Sulfate Extended-Release Capsules.

Your doctor will decide whether Dextroamphetamine Sulfate Extended-Release Capsules can be taken with other medicines.

Especially tell your doctor if you or your child take:

• anti-depression medicines including MAOIs


• blood pressure medicines


• antacids


• seizure medicines

Know the medicines that you or your child take. Keep a list of your medicines with you to show your doctor and pharmacist.

Do not start any new medicine while taking Dextroamphetamine Sulfate Extended-Release Capsules without talking to your doctor first.

How should Dextroamphetamine Sulfate Extended-Release Capsules be taken?

• Take Dextroamphetamine Sulfate Extended-Release Capsules exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.


• Dextroamphetamine Sulfate Extended-Release Capsules are usually taken once a day in the morning. Dextroamphetamine Sulfate Extended-Release Capsules is an extended release capsule. It releases medicine into your body throughout the day.


• From time to time, your doctor may stop Dextroamphetamine Sulfate Extended-Release Capsule treatment for a while to check ADHD symptoms.


• Your doctor may do regular checks of the blood, heart, and blood pressure while taking Dextroamphetamine Sulfate Extended-Release Capsules. Children should have their height and weight checked often while taking Dextroamphetamine Sulfate Extended-Release Capsules. Dextroamphetamine Sulfate Extended-Release Capsules treatment may be stopped if a problem is found during these check-ups.


• If you or your child take too much Dextroamphetamine Sulfate Extended-Release Capsules or overdoses, call your doctor or poison control center right away, or get emergency treatment.

What are possible side effects of Dextroamphetamine Sulfate Extended-Release Capsules?

See “What is the most important information I should know about Dextroamphetamine Sulfate Extended-Release Capsules?” for information on reported heart and mental problems.

Other serious side effects include:

• slowing of growth (height and weight) in children


• seizures, mainly in patients with a history of seizures


• eyesight changes or blurred vision

Common side effects include:

• fast heart beat


• headache


• stomach upset


• decreased appetite


• trouble sleeping


• weight loss


• tremors


• dizziness


• dry mouth

Dextroamphetamine Sulfate Extended-Release Capsules may affect your or your child’s ability to drive or do other dangerous activities.

Talk to your doctor if you or your child have side effects that are bothersome or do not go away.

This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information.

How should I store Dextroamphetamine Sulfate Extended-Release Capsules?

• Store Dextroamphetamine Sulfate Extended-Release Capsules in a safe place at room temperature, 20° to 25°C (68° to 77°F).


• Keep Dextroamphetamine Sulfate Extended-Release Capsules and all medicines out of the reach of children.

General information about Dextroamphetamine Sulfate Extended-Release Capsules

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Dextroamphetamine Sulfate Extended-Release Capsules  for a condition for which they were not prescribed. Do not give Dextroamphetamine Sulfate Extended-Release Capsules to other people, even if they have the same condition. It may harm them and it is against the law. This Medication Guide summarizes the most important information about Dextroamphetamine Sulfate Extended-Release Capsules. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Dextroamphetamine Sulfate Extended-Release Capsules that was written for healthcare professionals. For more in formation about Dextroamphetamine Sulfate Extended-Release Capsules, please contact Barr Laboratories, Inc. at 1-800-BARRLAB (227-7522).

What are the ingredients in Dextroamphetamine Sulfate Extended-Release Capsules?

Active Ingredients: dextroamphetamine sulfate

Inactive Ingredients: colloidal silicon dioxide, dibutyl sebacate, ethylcellulose aqueous dispersion, methylcellulose, povidone, propylene glycol, sugar spheres and talc. The capsule shell ingredients in the 5 mg are D&C red no. 33, FD&C blue no. 1, FD&C yellow no. 6, gelatin, and titanium dioxide. The capsule shell ingredients in the 10 mg are black iron oxide, gelatin, red iron oxide, titanium dioxide, and yellow iron oxide. The capsule shell ingredients in the 15 mg are black iron oxide, gelatin, red iron oxide, titanium dioxide, and yellow iron oxide. The imprinting ingredients are D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, pharmaceutical glaze, propylene glycol, and synthetic black iron oxide.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

BARR LABORATORIES, INC.

Pomona, NY 10970

Revised SEPTEMBER 2007

BR-0954, 0955, 0956

PRINCIPAL DISPLAY PANEL

Dextroamphetamine Sulfate Extended-Release Capsules 5 mg 30 Capsules Label Text

barr

Laboratories Inc.

CII

NDC 0555-0954-01

Dextroamphetamine

Sulfate

Extended-Release

Capsules

5 mg

Pharmacist: Dispense with

Medication Guide.

30 Capsules

Rx only

PRINCIPAL DISPLAY PANEL

Dextroamphetamine Sulfate Extended-Release Capsules 10 mg 30 Capsules Label Text

barr

Laboratories Inc.

CII

NDC 0555-0955-01

Dextroamphetamine

Sulfate

Extended-Release

Capsules

10 mg

Pharmacist: Dispense with

Medication Guide.

30 Capsules

Rx only

PRINCIPAL DISPLAY PANEL

Dextroamphetamine Sulfate Extended-Release Capsules 15 mg 30 Capsules Label Text

barr

Laboratories Inc.

CII

NDC 0555-0956-01

Dextroamphetamine

Sulfate

Extended-Release

Capsules

15 mg

Pharmacist: Dispense with

Medication Guide.

30 Capsules

Rx only

DEXTROAMPHETAMINE SULFATE  dextroamphetamine sulfate  capsule, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0555-0954 Route of Administration ORAL DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 5 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE   DIBUTYL SEBACATE   ETHYLCELLULOSES   METHYLCELLULOSE (15 CPS)   POVIDONE   PROPYLENE GLYCOL   SUCROSE   STARCH, CORN   TALC   D&C RED NO. 33   FD&C BLUE NO. 1   FD&C YELLOW NO. 6   GELATIN   TITANIUM DIOXIDE   D&C YELLOW NO. 10   FD&C BLUE NO. 2   FD&C RED NO. 40   ALUMINUM OXIDE   SHELLAC

Product Characteristics Color BROWN (beige) Score no score Shape CAPSULE Size 14mm Flavor Imprint Code barr;954 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0555-0954-01 30 CAPSULE In 1 BOTTLE None 2 0555-0954-02 100 CAPSULE In 1 BOTTLE None

Marketing Information

Marketing Category

Calcio Folinato Sandoz

Calcio Folinato Sandoz may be available in the countries listed below.

Ingredient matches for Calcio Folinato Sandoz

Calcium Folinate

Calcium Folinate pentahydrate (a derivative of Calcium Folinate) is reported as an ingredient of Calcio Folinato Sandoz in the following countries:

• Italy

International Drug Name Search

Metformin Lich

Metformin Lich may be available in the countries listed below.

Ingredient matches for Metformin Lich

Metformin

Metformin hydrochloride (a derivative of Metformin) is reported as an ingredient of Metformin Lich in the following countries:

• Germany

International Drug Name Search

Medivet Trio S

Medivet Trio S may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Medivet Trio S

Sulfadimidine

Sulfadimidine is reported as an ingredient of Medivet Trio S in the following countries:

• Switzerland

Sulfathiazole

Sulfathiazole is reported as an ingredient of Medivet Trio S in the following countries:

• Switzerland

Trimethoprim

Trimethoprim is reported as an ingredient of Medivet Trio S in the following countries:

• Switzerland

International Drug Name Search

Dermovate Scalp Application

Dermovate Scalp Application

clobetasol propionate

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 
  1 What Dermovate is and what it is used for


• 
  2 Before you use Dermovate


• 
  3 How to use Dermovate


• 
  4 Possible side effects


• 
  5 How to store Dermovate


• 
  6 Further information

What Dermovate is and what it is used for

Dermovate Scalp Application (called ‘Dermovate’ in this leaflet) contains a medicine called clobetasol propionate. It belongs to a group of medicines called steroids. It helps to reduce swelling and irritation.

Dermovate is used to help reduce the redness and itchiness of certain scalp problems. These include eczema and psoriasis that have not responded to milder steroid creams, ointments, lotions or scalp applications.

Before you use Dermovate

Do not use Dermovate:

• if you are allergic (hypersensitive) to clobetasol propionate or any of the other ingredients of Dermovate (listed in Section 6)


• if you have a skin infection on your scalp


• on a child under 1 year.

Do not use if any of the above apply to you.

If you are not sure, talk to your doctor or pharmacist before using Dermovate.

Take special care with Dermovate

Check with your doctor or pharmacist before using your medicine if:

• you are applying the liquid under an airtight dressing. These dressings make it easier for the active ingredient to pass through the skin. It is possible to accidentally end up using too much.


• you have psoriasis, your doctor will want to see you more often.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using this medicine.

Pregnancy and breast-feeding

Talk to your doctor or pharmacist before using this medicine if you are pregnant, might become pregnant or are breast-feeding.

How to use Dermovate

Always use Dermovate exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Using this medicine

• You usually put Dermovate on your scalp in the morning and at night. This may be reduced as your scalp problem begins to get better, or stopped when it is better.


• For use on your skin of your scalp only.


• Do not use it more often than prescribed or use it for a long time (such as every day for many weeks or months). If you need treatment for a long time, your doctor may decide you need to use a milder treatment.


• The germs that cause infections like warm and moist conditions under dressings so always clean the skin before a fresh dressing is put on.


• Be very careful not to get the liquid in your eyes. Do not touch your eyes until you have washed your hands.


• If you wash or shampoo your hair it should be dried before applying the liquid.


• If you are applying the scalp application on someone else make sure you wash your hands after use or wear disposable plastic
  gloves.


• 
  The liquid is flammable, you should keep it away from fire.
  


• 
  Do not dry your hair with a hairdryer or be near a fire.
  

Guidance on how to apply the liquid

• 
  1 Wash your hands.


• 
  2 Unscrew the bottle cap and place the nozzle directly on the scalp that needs treating.


• 
  3 Gently squeeze the bottle to cover the area with a thin and even layer of liquid.


• 
  4 You can rub this liquid in, but you don’t have to.


• 
  5 Your scalp will feel cool until the liquid has dried.


• 
  6 Wash your hands again.

If you use more Dermovate than you should

If, by mistake on a few occasions you use more than you should, do not worry. If you apply a lot or if a lot is accidentally swallowed, it could make you ill. Talk to your doctor or go to hospital as soon as possible.

If you forget to use Dermovate

If you forget to apply your scalp application, apply it as soon as you remember. If it is close to the time you are next meant to apply it, wait until this time.

If you stop using Dermovate

If you use Dermovate regularly make sure you talk to your doctor before you stop using it.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Dermovate can cause side effects, although not everybody gets them.

Stop using Dermovate and tell your doctor as soon as possible if:

• you find that your scalp problem gets worse or becomes swollen during treatment. You may be allergic to the scalp application, have an infection or need other treatment.

Other side effects you may notice when using Dermovate include:

• A feeling of burning, irritation or itching where the scalp application is applied.


• If you have psoriasis you may get raised bumps with pus under the skin. This can happen during or after the treatment and is known as pustular psoriasis.

Side effects if you use Dermovate for a long time, or you use a lot each time you apply it, or you apply it under an airtight dressing:

• Thinning of your skin that may also damage more easily.


• Weight gain, rounding of the face and high blood pressure. These are more likely to happen in infants and children.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Dermovate

• Keep out of the reach and sight of children.


• Do not use Dermovate after the expiry date on the bottle label or carton (Exp). The expiry date refers to the last day of that month.


• Do not store above 30°C.


• Keep away from naked flames, fires or artificial heat as the liquid is flammable.


• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Dermovate contains

• The active ingredient is clobetasol propionate. Each 10 ml contains 0.005 mg of clobetasol propionate (0.05% w/w).


• The other ingredients are carbomer, isopropyl alcohol, sodium hydroxide and purified water.

What Dermovate looks like and contents of the pack

Within each carton is a specially designed plastic bottle with a nozzle and cap that contains 30 or 100 ml of a sticky liquid.

Marketing Authorisation Holder and Manufacturer

Product licence held by

GlaxoSmithKline UK

Stockley Park West

Uxbridge

Middlesex

UB11 1BT

Manufactured by

Glaxo Wellcome GmbH & Co. KG

Bad Oldesloe

Germany

More Information

If you have any questions or are not sure about anything, ask your doctor or pharmacist who will advise you. Other sources of information are:

National Eczema Society

Hill House

Highgate Hill

London

N19 5NA

The Psoriasis Association

2 Queensbridge

Northampton

NN4 7BF

You may also be able to find out more from books in public libraries.

Other formats

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only)

Please be ready to give the following information:

Product name: Dermovate Scalp Application

Reference number: 10949/0046

This is a service provided by the Royal National Institute of Blind People.

Leaflet date: November 2007

Dermovate is a registered trademark of the GlaxoSmithKline group of companies

© 2007 GlaxoSmithKline group of companies

10000000051676

Trimétazidine Teva

Trimétazidine Teva may be available in the countries listed below.

Ingredient matches for Trimétazidine Teva

Trimetazidine

Trimetazidine dihydrochloride (a derivative of Trimetazidine) is reported as an ingredient of Trimétazidine Teva in the following countries:

• France

International Drug Name Search

Diazepam CF

Diazepam CF may be available in the countries listed below.

Ingredient matches for Diazepam CF

Diazepam

Diazepam is reported as an ingredient of Diazepam CF in the following countries:

• Netherlands

International Drug Name Search

Doctors Foster and Smith Dental Cleans Pad

Dosage Form: FOR ANIMAL USE ONLY

Drs. Foster and Smith Dental Cleans Pads help promote healthy teeth and gums through regular use. Also reduce bad breath and plaque build up. For Dogs and Cats.

DIRECTIONS FOR USE

Hold animal's head steady with one hand and gently wipe teeth and gums with pad. Use additional pads as needed until entire mouth has been cleaned.

ACTIVE INGREDIENT

0.1% Chlorhexidine Gluconate

OTHER INGREDIENTS

Water, Glycerin, Polysorbate 80, Peppermint Flavor, carmine Color.

Item# 8523

For Questions or to Reorder:

1-800-562-7169 or www.drsfostersmith.com

Doctors

Foster and smith

DentalClens

Pads

Cleans teeth and gums

Freshens breath

90 pads

Formulated by our veterinarians

DOCTORS FOSTER AND SMITH  chlorhexidine gluconate  cloth

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 65713-902 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chlorhexidine Gluconate (CHLORHEXIDINE) Chlorhexidine Gluconate 0.55 g  in 103.6 g

Inactive Ingredients Ingredient Name Strength WATER   GLYCERIN   POLYSORBATE 80

Product Characteristics Color brown (carmine color) Score      Shape Size Flavor PEPPERMINT (peppermint flavor) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65713-902-05 103.6 g In 1 JAR None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/23/2010

Labeler - Doctors Foster and Smith (122135148)

Registrant - United Pet Group (931135730)

Establishment
Name	Address	ID/FEI	Operations
JUNGLE LABORATORIES CORPORATION		032615270	manufacture

Revised: 02/2010Doctors Foster and Smith

Triatix

Triatix may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Triatix

Amitraz

Amitraz is reported as an ingredient of Triatix in the following countries:

• South Africa

Deltamethrin

Deltamethrin is reported as an ingredient of Triatix in the following countries:

• South Africa

Piperonyl Butoxide

Piperonyl Butoxide is reported as an ingredient of Triatix in the following countries:

• South Africa

International Drug Name Search

Dostinex

Generic Name: cabergoline (Oral route)

ka-BER-goe-leen

Commonly used brand name(s)

In the U.S.

• Dostinex

Available Dosage Forms:

• Tablet

Therapeutic Class: Prolactin Secretion Inhibitor

Pharmacologic Class: Dopamine Agonist

Uses For Dostinex

Cabergoline is used to treat different types of medical problems that occur when too much of the hormone prolactin is produced. It can be used to treat certain menstrual problems, fertility problems in men and women, and pituitary prolactinomas (tumors of the pituitary gland).

It works by stopping the brain from making and releasing the prolactin hormone from the pituitary gland. Cabergoline use is usually stopped when prolactin levels are normal for 6 months. It may be given again if symptoms of too much prolactin occur again.

This medicine is available only with your doctor's prescription.

Before Using Dostinex

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of cabergoline in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cabergoline in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving cabergoline.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Fibrotic disorders (scar-like tissues in the heart, lungs, or stomach), history of or


• Heart problems (e.g., heart valve disease), history of or


• Hypertension (high blood pressure), uncontrolled—Should not be used in patients with these conditions.

• Heart disease or


• Lung disease or other breathing problems—Use with caution. May make these conditions worse.

• High blood pressure, controlled or


• High blood pressure of pregnancy, or history of—Cabergoline usually decreases blood pressure but at times it may increase blood pressure and worsen these conditions.

• Liver disease—Use with caution. You may need a lower dose of this medicine.

Proper Use of Dostinex

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

You may take this medicine with or without food.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  
  • For disorders of high prolactin levels or pituitary tumors:
    
    • Adults—At first, 0.25 milligram (mg) two times a week. Your doctor may increase your dose every 4 weeks as needed, according to body prolactin levels, up to 1 mg two times a week.
    
    
    • Children—Use and dose must be determined by the doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

However, if it is almost time for your next dose, check with your doctor to see if you can double your dose.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Dostinex

It is important that your doctor check your progress at regular visits while you are taking this medicine to make sure that this medicine is working properly. Blood and other tests for the heart may be needed to check for unwanted effects.

Make sure your doctor knows if you are pregnant or planning to become pregnant. Tell your doctor right away if you think you might be pregnant at any time while you are using this medicine. If you are pregnant, make sure your doctor knows if you also have high blood pressure. You and your doctor should discuss whether you should continue to take this medicine during pregnancy.

This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help.

Check with your doctor right away if you have symptoms of fainting, hallucinations (seeing, hearing, or feeling things that are not there), lightheadedness, stuffy nose, or racing heartbeat.

This medicine may increase your risk of having serious heart, kidney, lung, or stomach problems. Check with your doctor right away if you have chest pain or tightness; extreme tiredness; lower back or side pain; lump or tenderness in the stomach; persistent cough; shortness of breath; troubled breathing; or swelling in your hands, ankles, lower legs, or feet.

Also tell your doctor if you have persistent cough along with shortness of breath or troubled breathing while you are using this medicine. This could be symptoms of a serious lung disorder called pulmonary fibrosis.

Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor if you start having problems with gambling or increased sex drive while using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Dostinex Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Bloating or swelling of the face, arms, hands, lower legs, or feet


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• chills


• cold sweats


• confusion


• dizziness, faintness, or lightheadedness when getting up from lying or sitting position


• fast, irregular, pounding, or racing heartbeat or pulse


• general feeling of discomfort or illness


• rapid weight gain


• swelling around the eyes


• tingling of the hands or feet


• unusual tiredness or weakness


• unusual weight gain or loss

Incidence not known

• Chest pain or tightness


• continuing loss of appetite


• continuing or severe abdominal or stomach pain


• continuing or severe nausea and vomiting


• cough


• decreased ability to exercise


• fever


• increased frequency of urination


• loss of appetite


• lower abdominal or stomach pain


• lower back pain


• nausea


• shortness of breath


• trouble with breathing


• vomiting


• weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Fainting


• seeing, hearing, or feeling things that are not there


• stuffy nose

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Difficulty having a bowel movement (stool)


• dizziness


• excess air or gas in the stomach or intestines


• full feeling


• headache


• lack or loss of strength


• passing gas

Less common

• Abdominal or stomach pain


• acid or sour stomach


• anxiety


• belching


• blemishes on the skin


• breast pain


• burning, itching, or stinging of the skin


• changes in vision


• cramps


• depression


• diarrhea


• difficulty with moving


• dry mouth or toothache


• feeling of constant movement of self or surroundings


• feeling of warmth


• gas


• heartburn


• heavy bleeding


• indigestion


• itching skin


• joint pain


• muscle aches and pains


• muscle stiffness


• pimples


• redness of the face, neck, arms, and occasionally, upper chest


• runny nose


• sensation of spinning


• shivering


• sleeplessness


• sleepiness or unusual drowsiness


• sneezing


• sore throat


• stomach discomfort or upset


• sudden sweating


• trouble with sleeping


• unable to sleep


• weight loss

Rare

• Bloody nose


• difficulty in concentrating


• increased in sexual ability, desire, drive, or performance


• increased interest in sexual intercourse

Incidence not known

• Attack, assault, or force


• feeling that others are watching you or controlling your behavior


• feeling that others can hear your thoughts


• hair loss or thinning of the hair


• pathological gambling


• severe mood or mental changes


• unusual behavior

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Dostinex side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Dostinex resources

• Dostinex Side Effects (in more detail)
• Dostinex Dosage
• Dostinex Use in Pregnancy & Breastfeeding
• Drug Images
• Dostinex Drug Interactions
• Dostinex Support Group
• 2 Reviews for Dostinex - Add your own review/rating

• Dostinex Prescribing Information (FDA)


• Dostinex MedFacts Consumer Leaflet (Wolters Kluwer)


• Dostinex Concise Consumer Information (Cerner Multum)


• Dostinex Monograph (AHFS DI)


• Cabergoline Prescribing Information (FDA)

Compare Dostinex with other medications

• Hyperprolactinemia

Begita

Begita may be available in the countries listed below.

Ingredient matches for Begita

Diclofenac

Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Begita in the following countries:

• Japan

International Drug Name Search

Doxycycline Monohydrate

Class: Tetracyclines
Note: This monograph also contains information on Doxycycline Calcium, Doxycycline Hyclate
VA Class: AM250
CAS Number: 24390-14-5
Brands: Doryx, Doxy 100, Monodox, Vibramycin, Vibra-Tabs

Introduction

Antibacterial; semisynthetic tetracycline antibiotic derived from oxytetracycline.^{103 111 113 114}

Uses for Doxycycline Monohydrate

Respiratory Tract Infections

Treatment of respiratory tract infections caused by Mycoplasma pneumoniae.^{111 113 114}

Treatment of respiratory tract infections caused by Haemophilus influenzae, Streptococcus pneumoniae, or Klebsiella.^{111 113 114} Should only be used for treatment of infections caused by these bacteria when in vitro susceptibility tests indicate the organism is susceptible.^{111 113 a}

Empiric treatment of community-acquired pneumonia (CAP) in conjunction with other anti-infectives.^a Tetracyclines provide coverage against C. pneumoniae, M. pneumoniae, H. influenzae, and Legionella, but S. pneumoniae may be resistant.^a Doxycycline is the preferred tetracycline for empiric treatment of CAP.^a

Alternative for treatment of infections caused by Legionella pneumophila†; ¹³⁷ used with or without rifampin.¹³⁷

Acne

Adjunctive treatment of moderate to severe inflammatory acne.^{111 a} Not indicated for treatment of noninflammatory acne.^a

Actinomycosis

Treatment of actinomycosis caused by Actinomyces israelii.^{111 113 137} Alternative to penicillin G;^{111 113 137} oral tetracyclines (usually doxycycline or tetracycline) also used as follow-up after initial parenteral penicillin G.¹⁰⁹

Amebiasis

Adjunct to amebicides for treatment of acute intestinal amebiasis.^{111 113} Tetracyclines not included in current recommendations for treatment of amebiasis caused by Entamoeba.^{109 122}

Anthrax

Postexposure prophylaxis to reduce the incidence or progression of disease following a suspected or confirmed exposure to aerosolized Bacillus anthracis spores (inhalational anthrax).^{102 111 113 141 147} Initial drug of choice for such prophylaxis is ciprofloxacin or doxycycline;^{102 141 147} doxycycline is the preferred tetracycline because of ease of administration and proven efficacy in monkey studies.¹⁰²

Treatment of inhalational anthrax.^{102 111 113 142 143 147 o} Monotherapy may be effective for anthrax that occurs as the result of natural or endemic exposures,^{109 o} but a multiple-drug parenteral regimen (ciprofloxacin or doxycycline and 1 or 2 other anti-infectives predicted to be effective) is recommended for inhalational anthrax that occurs as the result of exposure to anthrax spores in the context of biologic warfare or bioterrorism.^{102 143 147} Although tetracyclines not usually used in children <8 years of age or in pregnant women, the benefits of doxycycline outweigh the risks and CDC and others state doxycycline can be used when necessary for treatment of inhalational anthrax in these individuals.^{102 105 143 147}

Treatment of GI and oropharyngeal anthrax.^{102 143} If occurring in the context of biologic warfare or bioterrorism, use parenteral regimens recommended for inhalational anthrax.^{102 143}

Treatment of cutaneous anthrax.^{102 111 143 147 o} Multiple-drug regimen recommended for initial treatment when there are signs of systemic involvement, extensive edema, or lesions on the head or neck or when cutaneous anthrax occurs in children <2 years of age.^{102 105 143 147 o}

Bartonella Infections

Treatment of bartonellosis caused by Bartonella bacilliformis.^{111 113 160}

Treatment of infections caused by B. henselae† (e.g., cat scratch disease, bacillary angiomatosis, peliosis hepatitis).ⁱ Cat scratch disease generally is self-limited in immunocompetent individuals and may resolve spontaneously in 2–4 months; some clinicians suggest that anti-infective therapy be considered for acutely or severely ill patients with systemic symptoms, particularly those with hepatosplenomegaly or painful lymphadenopathy, and probably is indicated in immunocompromised patients.^{109 j k l} Anti-infectives also are indicated in patients with B. henselae infections who develop bacillary angiomatosis, neuroretinitis, or Parinaud’s oculoglandular syndrome.^{109 j k l} Optimum regimens have not been identified; some clinicians recommend erythromycin, azithromycin, doxycycline, ciprofloxacin, rifampin, co-trimoxazole, gentamicin, or third generation cephalosporins.^{109 i j k l}

Treatment of infections caused by B. quintana†.¹³⁷ Optimum anti-infective regimens have not been identified;^{e f g} various drugs have been used, including doxycycline, erythromycin, azithromycin, chloramphenicol, or cephalosporins.^{137 f g}

A drug of choice for treatment of bartonellosis in HIV-infected adults and adolescents, especially CNS bartonellosis.¹⁶⁰ USPHS/IDSA, CDC, and others suggest that long-term suppression with erythromycin or doxycycline should be considered to prevent recurrence of bartonellosis† in HIV-infected adults and adolescents with relapse or reinfection.^{160 h}

Brucellosis

Treatment of brucellosis;^{103 109 111 113 114 137 147 m} considered a drug of choice.^{109 147} Used in conjunction with other anti-infectives (e.g., streptomycin or gentamicin and/or rifampin),^{103 109 111 113 114 137 147 m} especially for severe infections or when there are complications (e.g., endocarditis, meningitis, osteomyelitis).^{109 147}

Postexposure prophylaxis following a high-risk exposure to Brucella†^{109 147} (e.g., needle-stick injury, inadvertent laboratory exposure, confirmed exposure in the context of biologic warfare or bioterrorism).¹⁴⁷ Postexposure prophylaxis not generally recommended after exposure to endemic brucellosis.^{109 147}

Burkholderia Infections

Treatment of melioidosis† caused by Burkholderia pseudomallei.^{137 147 gg} Although optimum regimens not identified, doxycycline monotherapy may be effective for mild, localized disease without toxicity, and doxycycline in conjunction with co-trimoxazole may be effective for localized disease with toxicity.¹⁴⁷ Severe illness requires an initial parenteral regimen of ceftazidime, imipenem, or meropenem (with or without concomitant co-trimoxazole or doxycycline), followed by a prolonged oral maintenance regimen of doxycycline (in conjunction with co-trimoxazole) or amoxicillin-clavulanate.^{147 gg}

Treatment of glanders† caused by B. mallei.¹³⁷ Experience is limited regarding treatment of human cases; optimum regimens not identified.^{147 gg} Some clinicians suggest streptomycin used in conjunction with tetracycline or chloramphenicol or imipenem monotherapy.¹³⁷ Others suggest that, pending results of in vitro susceptibility tests, regimens used for treatment of melioidosis can be used for initial empiric treatment of glanders.¹⁴⁷

The US Army Medical Research Institute of Infectious Diseases (USAMRIID) and European Commission’s Task Force on Biological and Chemical Agent Threats (BICHAT) state that the same treatment regimens recommended for naturally occurring melioidosis or glanders should be used if these Burkholderia infections occur in the context of biologic warfare or bioterrorism.^{147 gg} These experts suggest that postexposure prophylaxis with doxycycline or co-trimoxazole for ≥10 days can be attempted in such situations, but is of unproven benefit.^{147 gg}

Campylobacter Infections

Treatment of infections caused by Campylobacter fetus.^{103 111 114} Tetracyclines (usually doxycycline) are alternatives,¹⁰⁹ not drugs of choice for C. fetus.¹³⁷

Chancroid

Treatment of chancroid caused by Haemophilus ducreyi.^{103 111 113 114} Not included in CDC recommendations for treatment of chancroid.¹⁰⁷

Chlamydial Infections

Treatment of uncomplicated urethral, endocervical, or rectal infections caused by Chlamydia trachomatis.^{107 108 109 111 114 137} A drug of choice for presumptive treatment of chlamydial infections in patients with gonorrhea.^{107 108}

Treatment of trachoma and inclusion conjunctivitis caused by C. trachomatis.^{109 111 113 114} Consider that anti-infectives may not eliminate C. trachomatis in all cases of chronic trachoma.^{111 113 114}

Treatment of lymphogranuloma venereum (genital, inguinal, or anorectal infections) caused by C. trachomatis.^{103 107 108 111 113 114} Recommended as drug of choice by CDC and others.^{107 108}

Treatment of psittacosis (ornithosis) caused by C. psittaci.^{100 103 109 111 113 114} A drug of choice recommended by CDC.¹⁰⁰

Clostridium Infections

Treatment of infections caused by Clostridium.^{111 113} Tetracyclines are alternatives to metronidazole or penicillin G for adjunctive treatment of C. tetani infections.¹³⁷

Ehrlichiosis

Treatment of human granulocytotropic (or granulocytic) anaplasmosis† (HGA; formerly human granulocytic ehrlichiosis [HGE]) caused by Anaplasma phagocytophilum (formerly Ehrlichia phagocytophila, E. equi, agent of HGE); drug of choice.^{109 137 x z cc}

Treatment of human monocytotropic (or monocytic) ehrlichiosis† (HME) caused by E. chaffeensis; drug of choice.^{109 137 x cc}

Treatment of ehrlichiosis† caused by E. ewingii or E. canis; drug of choice.^{109 137 cc}

Enterobacteriaceae Infections

Treatment of infections caused by susceptible Escherichia coli, Enterobacter aerogenes, Klebsiella, or Shigella.^{111 113} Should only be used for treatment of infections caused by these common gram-negative bacteria when other appropriate anti-infectives are contraindicated or ineffective^a and when in vitro susceptibility tests indicate the organism is susceptible.^{111 113 a}

Fusobacterium Infections

Alternative to penicillin G for treatment of infections caused by Fusobacterium fusiforme (Vincent’s infection).^{111 113}

Gonorrhea and Associated Infections

Alternative for treatment of uncomplicated gonorrhea caused by susceptible Neisseria gonorrhoeae.^{111 113 114} However, tetracyclines are considered inadequate therapy and are not recommended by CDC for treatment of gonorrhea.^{107 b}

Empiric treatment of epididymitis most likely caused by N. gonorrhoeae or C. trachomatis; used in conjunction with IM ceftriaxone.^{107 108}

Granuloma Inguinale (Donovanosis)

Treatment of granuloma inguinale (donovanosis) caused by Calymmatobacterium granulomatis.^{107 111 113 114} CDC recommends doxycycline or co-trimoxazole as drugs of choice.¹⁰⁷

Leptospirosis

Alternative to penicillin G for treatment of leptosporosis†.^{109 137}

Prevention of leptosporosis† in travelers to areas where leptospirosis is endemic or epidemic who are at increased risk (e.g., those who engage in recreational water activities such as whitewater rafting, adventure racing, kayaking).^{123 153}

Can be used for combined prophylaxis in travelers at increased risk of leptospirosis who also require malaria chemoprophylaxis.¹²³

Listeria Infections

Alternative for treatment of listeriosis caused by Listeria monocytogenes.^{111 113} Not usually considered a drug of choice or alternative for these infections.^{109 137}

Lyme Disease

Treatment of early disseminated Lyme disease† associated with erythema migrans, in the absence of neurologic involvement or third-degree AV heart block.^{109 115 116 117 118 119 120 121 136 137 140} IDSA, AAP, and others recommend oral doxycycline or oral amoxicillin as first-line therapy for treatment of early localized or early disseminated Lyme disease when oral therapy is appropriate.^{109 115 116 117 118 119 120 121 136 137 140}

Treatment of uncomplicated Lyme arthritis† without objective evidence of neurologic involvement (e.g., meningitis or radiculopathy).^{109 115 116 117 121 136 140}

Alternative for treatment of neurologic manifestations of Lyme disease† when β-lactams (e.g., ceftriaxone, penicillin G) cannot be used.¹³⁶

Malaria

Prevention (prophylaxis) of malaria caused by Plasmodium falciparum, including chloroquine-resistant strains.^{111 122 123 139 153} Recommended by CDC and others as a drug of choice for prophylaxis in individuals traveling to areas where chloroquine-resistant P. falciparum malaria has been reported;^{122 123} recommended by CDC as an alternative in those traveling to areas where chloroquine-resistant P. falciparum has not been reported and who are unable to take chloroquine or hydroxychloroquine.¹²³

Treatment of uncomplicated malaria† caused by chloroquine-resistant Plasmodium falciparum or chloroquine-resistant P. vivax and when the plasmodial species has not been identified.^{122 158} Used in conjunction with quinine; not effective alone.^{122 158}

CDC and others state treatments of choice for uncomplicated chloroquine-resistant P. falciparum malaria are a regimen of oral quinine in conjunction with oral doxycycline, tetracycline, or clindamycin or a regimen of atovaquone and proguanil.^{122 158} A regimen of quinine and doxycycline (or tetracycline) generally preferred over quinine and clindamycin,¹⁵⁸ except for young children or pregnant women who should not receive tetracyclines.¹⁵⁸ Quinine in conjunction with tetracycline (or doxycycline) also a regimen of choice for chloroquine-resistant P. vivax malaria.^{122 158}

Treatment of severe malaria caused by P. falciparum†; used in conjunction with IV quinidine gluconate initially and then with oral quinine when an oral regimen is tolerated.¹⁵⁸

Presumptive self-treatment of malaria† in travelers who elect not to use prophylaxis, those who require or choose to use a prophylaxis regimen that may not have optimal efficacy, or for long-term travelers receiving effective prophylaxis but who plan to visit very remote areas; used in conjunction with quinine.¹²² Not recommended by CDC for presumptive self-treatment of malaria; CDC recommends the fixed combination of atovaquone and proguanil.¹²³

Active only against the asexual erythrocytic forms of Plasmodium (not exoerythrocytic stages) and cannot prevent delayed primary attacks or relapse of P. ovale or P. vivax malaria or provide a radical cure;^{122 123 158} primaquine usually also indicated to eradicate hypnozoites and prevent relapse in patients exposed to or being treated for P. ovale or P. vivax malaria.^{122 123 158}

Detailed recommendations regarding prevention of malaria available from CDC 24 hours a day from the voice information service (877-394-8747), fax information service (888-232-3299), or Internet at .¹²³

Assistance with diagnosis or treatment of malaria available from CDC Malaria Epidemiology Branch by contacting CDC Malaria Hotline at 770-488-7788 from 8:00 a.m. to 4:30 p.m. Eastern Standard Time or CDC Emergency Operation Center at 770-488-7100 after hours, on weekends, and holidays.¹⁵⁸

Mycobacterial Infections

Alternative for treatment of infections caused by Mycobacterium fortuitum†.¹³⁷

Treatment of cutaneous infections caused by M. marinum†;^{106 137} a drug of choice.¹⁰⁶

Nocardiosis

Alternative to co-trimoxazole for treatment of nocardiosis† caused by Nocardia.^{109 137 a}

Nongonococcal Urethritis

Treatment of nongonococcal urethritis (NGU) caused by Ureaplasma urealyticum, C. trachomatis, or Mycoplasma.^{107 108 111 114 b}

Consider that some cases of recurrent urethritis following doxycycline treatment may be caused by tetracycline-resistant U. urealyticum.¹⁰⁷

Pelvic Inflammatory Disease

Treatment of acute pelvic inflammatory disease (PID); used in conjunction with other anti-infectives.^{107 108} Doxycycline is included in PID regimens to provide coverage against Chlamydia.¹⁰⁷

When a parenteral regimen is indicated for PID, CDC and others recommend IV cefotetan (or cefoxitin) in conjunction with IV or oral doxycycline as a regimen of choice.^{107 108} A regimen of IV ampicillin and sulbactam and IV doxycycline is an alternative^{107 108} since it provides good coverage against C. trachomatis, N. gonorrhoeae, and anaerobes and is effective for tubo-ovarian abscess.¹⁰⁷ Doxycycline also used as follow-up after a parenteral regimen of clindamycin and gentamicin.¹⁰⁷

When an oral regimen is indicated, CDC and others recommend a single IM dose of ceftriaxone or cefoxitin (or other parenteral cephalosporin) followed by oral doxycycline (with or without oral metronidazole) as a regimen of choice.^{107 108} Although experience is limited, oral amoxicillin and clavulanate and oral doxycycline may be an alternative oral regimen.¹⁰⁷

Plague

Treatment of plague caused by Yersinia pestis,^{103 111 113 114 123 137 144 147} including naturally occurring or endemic bubonic, septicemic, or pneumonic plague and plague that occurs following exposure to Y. pestis in the context of biologic warfare or bioterrorism.^{137 144 147} Regimen of choice is streptomycin or gentamicin;^{137 144 147} alternatives are doxycycline, tetracycline, ciprofloxacin, or chloramphenicol.^{144 147} For plague meningitis, some experts recommend that treatment regimen include chloramphenicol.¹⁴⁷

Postexposure prophylaxis following a high-risk exposure to Y. pestis† (e.g., household, hospital, or other close contact with an individual who has pneumonic plague; laboratory exposure to viable Y. pestis; confirmed exposure to plague aerosol in the context of biologic warfare or bioterrorism).^{144 147} Doxycycline may be drug of choice;^{109 144 147} alternatives are tetracycline, ciprofloxacin, or chloramphenicol.¹⁴⁷ Prophylaxis not required for asymptomatic contacts of individuals with bubonic plague, but observe such contacts for 1 week and initiate treatment if symptoms occur.¹⁴⁷

Pleural Effusions

Management of pleural effusions† associated with metastatic tumors.^{126 127 128 132 134 151 152}

Rat-bite Fever

Treatment of rat-bite fever† caused by Streptobacillus moniliformis or Spirillum minus.^{109 137} Tetracyclines (usually doxycycline) are alternatives to penicillin G.^{109 137}

Relapsing Fever

Treatment of relapsing fever caused by Borrelia recurrentis.^{111 113 137} A drug of choice.¹³⁷

Rickettsial Infections

Treatment of rickettsial infections including Rocky Mountain spotted fever (RMSF), typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae.^{103 109 111 112 113 114 147 cc} Drug of choice for treatment of most rickettsial infections.^{109 112 147 a cc}

Syphilis

Alternative to penicillin G benzathine for treatment of primary, secondary, latent, or tertiary syphilis (not neurosyphilis) in nonpregnant adults and adolescents hypersensitive to penicillins, including HIV-infected patients.^{107 108 109 111 113 160} Use tetracyclines only if compliance and follow-up can be ensured since efficacy not well documented.^{107 160}

Tularemia

Treatment of tularemia caused by Francisella tularensis,^{103 111 113 114 137 145 147} including naturally occurring or endemic tularemia or tularemia that occurs following exposure to F. tularensis in the context of biologic warfare or bioterrorism.^{137 145 147} Drugs of choice are streptomycin or gentamicin; alternatives are tetracyclines (usually doxycycline), ciprofloxacin, or chloramphenicol.^{137 145 147} Risk of relapse and primary treatment failure may be higher with the alternatives.¹⁴⁵

Postexposure prophylaxis of tularemia† following a high-risk laboratory exposure to F. tularensis (e.g., spill, centrifuge accident, needlestick injury) or in individuals exposed to the organism in the context of biologic warfare or bioterrorism.^{145 147} Drugs of choice are doxycycline, tetracycline, or ciprofloxacin.^{145 147} Postexposure prophylaxis usually not recommended after exposure to natural or endemic tularemia (e.g., tick bite, rabbit or other animal exposure) and is unnecessary in close contacts of tularemia patients since human-to-human transmission does not occur.¹⁴⁷

Preexposure prophylaxis of tularemia†.¹⁴⁷ Based on results of in vitro susceptibility data, use of doxycycline or ciprofloxacin before exposure possibly may protect against tularemia in the context of biologic warfare or bioterrorism.¹⁴⁷

Vibrio Infections

Treatment of cholera caused by Vibrio cholerae.^{109 110 111 137 p} A drug of choice; used as an adjunct to fluid and electrolyte replacement in moderate to severe disease.^{109 110 137 p}

Treatment of severe V. parahaemolyticus† infection when anti-infective therapy is indicated in addition to supportive care.^p

Treatment of infections caused by V. vulnificus†.^{137 p p} Optimum anti-infective therapy has not been identified; a tetracycline or third generation cephalosporin (e.g., cefotaxime, ceftazidime) is recommended.^{137 p q} Because the case fatality rate associated with V. vulnificus is high, initiate anti-infective therapy promptly if indicated.^q

Yaws

Alternative to penicillin G for treatment of yaws caused by Treponema pertenue.^{111 137}

Yersinia Infections

Treatment of plague caused by Yersinia pestis.^{103 111 113 114 137 144 147} (See Plague under Uses.)

Treatment of GI infections caused by Yersinia enterocolitica† or Y. pseudotuberculosis†.^{110 p} These infections usually are self-limited, but IDSA, AAP, and others recommend anti-infectives for severe infections or when septicemia or other invasive disease occurs.^{109 110 p} Some suggest the role of oral anti-infectives in management of enterocolitis, pseudoappendicitis syndrome, or mesenteric adenitis caused by Yersinia needs further evaluation.¹⁰⁹

Prophylaxis in Sexual Assault Victims

Empiric anti-infective prophylaxis in sexual assault victims†; used in conjunction with a drug effective for gonorrhea (IM ceftriaxone) and a drug effective for bacterial vaginosis and trichomoniasis (oral metronidazole).^{107 108}

Doxycycline Monohydrate Dosage and Administration

Administration

Administer orally^{101 103 114 111} or by slow IV infusion.¹¹³ Also has been administered by intrapleural infusion.^{126 127 128 132 134 151 152}

Do not administer IM or sub-Q.¹¹³

IV route recommended only when oral therapy is not indicated or feasible; oral should replace IV as soon as possible.¹¹³ Prolonged IV administration may result in thrombophlebitis; avoid extravasation.¹¹³

Oral Administration

Administer capsules and tablets with adequate amounts of fluid to reduce the risk of esophageal irritation and ulceration.^{103 114 111 123} Probably should not be given at bedtime or to patients with esophageal obstruction or compression.^{123 b}

Administer with food or milk to minimize nausea and vomiting and if gastric irritation occurs;^{103 114 111} absorption not markedly influenced by simultaneous ingestion of food or milk.^{103 114 111 146 148 150}

When used for prevention of malaria, CDC recommends taking the drug in the evening (but not at bedtime), avoiding prolonged, direct exposure to the sun, and use of sunscreens that absorb long-wave UVA radiation to minimize the risk of photosensitivity.¹²³

Reconstitution

Reconstitute doxycycline monohydrate powder for oral suspension at the time of dispensing according to manufacturer’s directions to provide a suspension containing 25 mg/5 mL.¹¹¹

Doxycycline calcium oral suspension is administered as provided without further dilution and contains 50 mg/5 mL.¹¹¹

If necessary because the commercial powder for oral suspension and oral suspension are not available, doxycycline film-coated tablets can be ground and mixed with food or drinks.^{155 156} Ground doxycycline tablets are most palatable when mixed with chocolate pudding, regular or low-fat chocolate milk, simple syrup with sour apple flavor, apple juice with table sugar, or low-fat milk; the bitterness of the drug is not masked with grape or strawberry jellies or cherry yogurt.¹⁵⁵

IV Infusion

For solution and drug compatibility information, see Compatibility under Stability.

Reconstitution

Reconstitute vial containing 100 or 200 mg with 10 or 20 mL, respectively, of sterile water for injection or a compatible IV infusion solution (see Compatibility under Stability) to provide a solution containing 10 mg/mL.¹¹³

Dilution

Reconstituted solution must be further diluted prior to administration.¹¹³ Each 100 mg should be diluted in 100 mL to 1 L of compatible IV infusion solution (see Compatibility under Stability) to provide solutions containing approximately 0.1–1 mg/mL.¹¹³ Concentrations <0.1 mg/mL or >1 mg/mL are not recommended.¹¹³

Rate of Administration

Administer by slow IV infusion, usually over 1–4 hours (depending on the dose).¹¹³ The minimum recommended time to infuse 100 mg in a solution containing 0.5 mg/mL is 1 hour.¹¹³

Intrapleural Administration

Reconstitution and Dilution

Dilute 500 mg of doxycycline with 25–30 mL of 0.9% sodium chloride injection.^{126 127 128 132 134 151 152}

Intrapleural Administration Technique

Prior to intrapleural instillation of doxycycline solution, drain the pleural cavity by thoracentesis (needle aspiration) or via a thoracostomy tube by gravity or suction (i.e., closed chest tube drainage).^{127 128 130 131 133}

Efficacy of the procedure may be reduced if fluid drainage from the chest tube is >100 mL/24 hours when doxycycline is introduced into the pleural cavity.^{130 131 133}

Instill diluted doxycycline solution into the pleural space through a thoracostomy tube; clamp tube and subsequently remove the fluid.^{126 127 128 132 134 151 152}

Dosage

Available as doxycycline calcium,¹¹¹ doxycycline hyclate,^{103 111 113} and doxycycline monohydrate;^{111 114} dosage expressed in terms of doxycycline.^{103 111 113 114}

Pediatric Patients

General Pediatric Dosage

Oral

Children >8 years of age weighing ≤45 kg: 4.4 mg/kg in 2 divided doses on day 1 followed by 2.2 mg/kg daily in 1 or 2 divided doses.^{103 111 114} For severe infections, up to 4.4 mg/kg daily.^{103 111 114}

Children >8 years of age weighing >45 kg: 100 mg every 12 hours on day 1 followed by 100 mg daily in 1 or 2 divided doses.^{103 111 114} For more severe infections, 100 mg every 12 hours.^{103 111 114}

IV

Children >8 years of age weighing ≤45 kg: 4.4 mg/kg in 1 or 2 divided doses on day 1 followed by 2.2–4.4 mg/kg daily in 1 or 2 infusions.¹¹³

Children >8 years of age weighing >45 kg: 200 mg on day 1 in 1 or 2 infusions followed by 100–200 mg daily.¹¹³

Anthrax

Postexposure Prophylaxis Following Exposure in the Context of Biologic Warfare or Bioterrorism

Oral

Children ≤8 years of age† or weighing <45 kg: 2.2 mg/kg (up to 100 mg) twice daily given for ≥60 days.^{141 147 c} Because of concerns regarding long-term doxycycline use in infants and children, consider changing (after 10–14 days) to amoxicillin to complete the prophylaxis regimen if penicillin susceptibility is confirmed.^{102 104 141 147}

Children >8 years of age weighing ≥45 kg: 100 mg twice daily given for ≥60 days.^{104 141 147 c}

Optimum duration of postexposure prophylaxis after an inhalation exposure to B. anthracis spores is unclear,^{147 ff} but prolonged postexposure prophylaxis usually required.^{102 147} A duration of 60 days may be adequate for a low-dose exposure, but a duration >4 months may be necessary to reduce the risk following a high-dose exposure.^ff CDC and US Working Group on Civilian Biodefense recommend that postexposure prophylaxis following a confirmed exposure (including in laboratory workers with confirmed exposures to B. anthracis cultures) be continued for 60 days.^{102 147} The US Army Medical Research Institute of Infectious Diseases (USAMRIID) recommends that postexposure prophylaxis be continued for at least 60 days in individuals who are not fully immunized against anthrax and when anthrax vaccine is unavailable or cannot be used for postexposure vaccination.¹⁴⁷

Treatment of Inhalational, GI, or Oropharyngeal Anthrax

Oral

Children ≤8 years of age† or weighing <45 kg: 2.2 mg/kg twice daily (up to 200 mg daily).^{102 147 c}

Children >8 years of age weighing ≥45 kg: 100 mg twice daily.^{102 c} Some experts recommend an initial 200-mg dose, then 100 mg every 12 hours.¹⁴⁷

Initial parenteral regimen preferred; use oral regimen for initial treatment only when a parenteral regimen is not available (e.g., when there are supply or logistic problems because large numbers of individuals require treatment in a mass casualty setting).^{102 147} Continue for total duration of ≥60 days if inhalational anthrax occurred as the result of exposure to anthrax spores in the context of biologic warfare or bioterrorism.^{102 143 147} Because of concerns regarding long-term doxycycline use in infants and children, consider changing (after 10–14 days) to amoxicillin to complete the treatment regimen in children <8 years of age if penicillin susceptibility is confirmed.¹⁰⁵

IV, then Oral

Children ≤8 years of age† or weighing <45 kg: 2.2 mg/kg (up to 100 mg) twice daily.