Suphera

Generic Name: sulfacetamide sodium and sulfur topical (SUL fa SEET a mide SOE dee um and SUL fur TOP i kal)

Brand Names: Avar Cleanser, Avar Gel, Avar LS Cleanser, Avar-E, Avar-E Emollient, Avar-E Green, Avar-e LS, BP 10-Wash, Clarifoam EF, Clenia Emollient Cream, Clenia Foaming Wash, Plexion , Plexion Cleanser, Plexion Cleansing Cloths, Plexion SCT, Prascion, Prascion Cleanser, Prascion FC Cloths, Prascion RA, Rosac, Rosac Wash, Rosaderm Cleanser, Rosanil Cleanser, Rosula, SE 10-5 SS, Sulfacet-R, Sulfatol C, Sulfatol SS, SulZee Wash, Sumaxin, Sumaxin TS, Sumaxin Wash, Suphera, Topisulf, Zencia Wash, Zetacet

What is Suphera (sulfacetamide sodium and sulfur topical)?

Sulfacetamide sodium and sulfur are antibiotic that fight bacteria.

The combination of sulfacetamide sodium and sulfur topical (for the skin) is used to treat acne, rosacea, and seborrheic dermatitis (a red, flaking skin rash).

Sulfacetamide sodium and sulfur topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Suphera (sulfacetamide sodium and sulfur topical)?

You should not use this medication if you are allergy to sulfa drugs or if you have kidney disease. Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water.

Do not cover the treated skin area unless your doctor has told you to.

Avoid using other medications on the areas you treat with sulfacetamide sodium and sulfur topical unless you doctor tells you to.

What should I discuss with my healthcare provider before using Suphera (sulfacetamide sodium and sulfur topical)?

You should not use this medication if you are allergy to sulfa drugs or if you have kidney disease.

To make sure you can safely use this medication, tell your doctor about all of your medical conditions.

FDA pregnancy category C. It is not known whether sulfacetamide sodium and sulfur topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether sulfacetamide sodium and sulfur topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use Suphera (sulfacetamide sodium and sulfur topical)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Wash your hands before and after applying this medication.

Do not cover the treated skin area unless your doctor has told you to.

Use this medication regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Suphera (sulfacetamide sodium and sulfur topical)?

Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water. Do not use sulfacetamide sodium and sulfur topical on sunburned, windburned, dry, chapped, irritated, or broken skin.

Avoid using other medications on the areas you treat with sulfacetamide sodium and sulfur topical unless you doctor tells you to.

Suphera (sulfacetamide sodium and sulfur topical) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

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  new or worsening skin rash;

  
  


• 
  

  joint pain;

  
  


• 
  

  fever; or

  
  


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  mouth sores.

  
  

Less serious side effects may include redness, warmth, swelling, itching, stinging, burning, or irritation of treated skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Suphera (sulfacetamide sodium and sulfur topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied sulfacetamide sodium and sulfur. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Suphera resources

• Suphera Use in Pregnancy & Breastfeeding
• Suphera Drug Interactions
• Suphera Support Group
• 0 Reviews for Suphera - Add your own review/rating

• Avar LS Cleanser MedFacts Consumer Leaflet (Wolters Kluwer)


• Clarifoam EF Foam MedFacts Consumer Leaflet (Wolters Kluwer)


• Clarifoam EF Prescribing Information (FDA)


• Plexion Prescribing Information (FDA)


• Plexion Cleansing Cloths MedFacts Consumer Leaflet (Wolters Kluwer)


• Plexion SCT Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Plexion TS Emulsion MedFacts Consumer Leaflet (Wolters Kluwer)


• Prascion Cleanser Prescribing Information (FDA)


• Rosac Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Rosaderm Cleanser Prescribing Information (FDA)


• Rosanil Cleanser Prescribing Information (FDA)


• Rosula Foam MedFacts Consumer Leaflet (Wolters Kluwer)


• Rosula Prescribing Information (FDA)


• Rosula Cleanser Emulsion MedFacts Consumer Leaflet (Wolters Kluwer)


• Sumadan MedFacts Consumer Leaflet (Wolters Kluwer)


• Sumadan Wash Prescribing Information (FDA)


• Sumaxin Wash MedFacts Consumer Leaflet (Wolters Kluwer)


• Sumaxin Wash Prescribing Information (FDA)


• Zencia Wash Prescribing Information (FDA)

Compare Suphera with other medications

• Acne
• Rosacea
• Seborrheic Dermatitis

Where can I get more information?

• Your pharmacist can provide more information about sulfacetamide sodium and sulfur topical.

Dextroamphetamine

Generic Name: Dextroamphetamine sulfate

Dosage Form: tablet
Dextroamphetamine SULFATE TABLETS, USP, CII

Revised APRIL 2008

11001320

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 sulfate as the neutral sulfate. The structural formula is as follows:

(C9H13N)2∙H2SO4 Molecular Weight: 368.49

Inactive Ingredients:

Calcium sulfate, colloidal silicon dioxide, compressible sugar, magnesium stearate, microcrystalline cellulose, and starch.

The 5 mg also contains D&C yellow no. 10 aluminum lake and FD&C red no. 40 aluminum lake.

The 10 mg also contains FD&C red no. 40 aluminum lake and FD&C yellow no. 6 aluminum lake.

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.

Pharmacokinetics:

The pharmacokinetics of the tablet and sustained-release capsule were compared in 12 healthy subjects. The extent of bioavailability of the sustained-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 sustained-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 sustained-release capsule and was approximately 12 hours.

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

INDICATIONS AND USAGE:

Dextroamphetamine sulfate tablets are indicated for:

1. Narcolepsy.


2. 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 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. 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 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 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 pediatric patients, 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 pediatric patients 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 pediatric patient. The decision to prescribe amphetamines should depend on the physician's assessment of the chronicity and severity of the pediatric patient'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 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.

DOSAGE AND ADMINISTRATION:

Amphetamines should be administered at the lowest effective dosage and dosage should be individually adjusted. Late evening doses should be avoided because of the resulting insomnia.

Narcolepsy:

Usual dose is 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 an 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. Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.

Attention Deficit Disorder with Hyperactivity:

Not recommended for pediatric patients under 3 years of age.

In pediatric patients from 3 to 5 years of age, start with 2.5 mg daily; daily dosage may be raised in increments of 2.5 mg at weekly intervals until optimal response is obtained.

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.

Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.

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 Tablets, USP are available as:

5 mg: Peach, round, flat-faced, beveled-edge, scored tablet. Debossed with 952/5 on the scored side and stylized b on the other side. Available in bottles of:

100 NDC 0555-0952-02

10 mg: Pink, round, flat-faced, beveled-edge, scored tablet. Debossed with 953/10 on the scored side and stylized b on the other side. Available in bottles of:

100 NDC 0555-0953-02

Dispense in a tight, light-resistant container.

Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].

DEA Order Form Required.

MEDICATION GUIDE

Dextroamphetamine SULFATE TABLETS - CII

Read the Medication Guide that comes with Dextroamphetamine Sulfate Tablets 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 Tablets.

What is the most important information I should know about Dextroamphetamine Sulfate Tablets?

The following have been reported with use of Dextroamphetamine Sulfate Tablets 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 Tablets.

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

Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Dextroamphetamine Sulfate Tablets.

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 Tablets, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

What are Dextroamphetamine Sulfate Tablets?

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

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

Dextroamphetamine Sulfate Tablets 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 Tablets in a safe place to prevent misuse and abuse. Selling or giving away Dextroamphetamine Sulfate Tablets 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 Tablets?

Dextroamphetamine Sulfate Tablets 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 Tablets are not recommended for use in children less than 3 years old.

Dextroamphetamine Sulfate Tablets may not be right for you or your child. Before starting Dextroamphetamine Sulfate Tablets 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 or your child is pregnant, planning to become pregnant, or breastfeeding.

Can Dextroamphetamine Sulfate Tablets be taken with other medicines?

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

Dextroamphetamine Sulfate Tablets 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 Tablets.

Your doctor will decide whether Dextroamphetamine Sulfate Tablets 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 Tablets without talking to your doctor first.

How should Dextroamphetamine Sulfate Tablets be taken?

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


• Dextroamphetamine Sulfate Tablets are usually taken two or three times a day. The first dose is usually taken in the morning. One or two more doses may be taken during the day, 4 to 6 hours apart.


• From time to time, your doctor may stop Dextroamphetamine Sulfate Tablets 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 Tablets. Children should have their height and weight checked often while taking Dextroamphetamine Sulfate Tablets. Dextroamphetamine Sulfate Tablets treatment may be stopped if a problem is found during these check-ups.


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

What are possible side effects of Dextroamphetamine Sulfate Tablets?

See “What is the most important information I should know about Dextroamphetamine Sulfate Tablets?” 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


• decreased appetite


• tremors


• headache


• trouble sleeping


• dizziness


• stomach upset


• weight loss


• dry mouth

Dextroamphetamine Sulfate Tablets 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.

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

How should I store Dextroamphetamine Sulfate Tablets?

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


• Keep Dextroamphetamine Sulfate Tablets and all medicines out of the reach of children.

General information about Dextroamphetamine Sulfate Tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Dextroamphetamine Sulfate Tablets  for a condition for which they were not prescribed. Do not give Dextroamphetamine Sulfate Tablets 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 Tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Dextroamphetamine Sulfate Tablets that was written for healthcare professionals. For more in formation about Dextroamphetamine Sulfate Tablets, please contact Barr Laboratories, Inc. at 1-800-BARRLAB (227-7522).

What are the ingredients in Dextroamphetamine Sulfate Tablets?

Active Ingredients: Dextroamphetamine sulfate

Inactive Ingredients:

calcium sulfate, colloidal silicon dioxide, compressible sugar, magnesium stearate, microcrystalline cellulose, and starch.

The 5 mg also contains D&C yellow no. 10 aluminum lake and FD&C red no. 40 aluminum lake.

The 10 mg also contains FD&C red no. 40 aluminum lake and FD&C yellow no. 6 aluminum lake.

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

BARR LABORATORIES, INC.

Pomona, NY 10970

Revised APRIL 2008

BR-0952, 0953

PRINCIPAL DISPLAY PANEL

Dextroamphetamine Sulfate Tablets, USP 5 mg 100 Tablets Label Text

barr

CII

Dextroamphetamine

Sulfate

Tablets, USP

5 mg

Pharmacist: Dispense with

Medication Guide.

100 Tablets

Rx only

PRINCIPAL DISPLAY PANEL

Dextroamphetamine Sulfate Tablets, USP 10 mg 100 Tablets Label Text

barr

CII

Dextroamphetamine

Sulfate

Tablets, USP

10 mg

Pharmacist: Dispense with

Medication Guide.

100 Tablets

Rx only

Dextroamphetamine SULFATE  Dextroamphetamine sulfate  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0555-0952 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 CALCIUM SULFATE   SILICON DIOXIDE   MALTODEXTRIN   SUCROSE   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   STARCH, CORN   D&C YELLOW NO. 10   FD&C RED NO. 40   ALUMINUM OXIDE

Product Characteristics Color ORANGE (peach) Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code 952;5;b Contains

Packaging # NDC Package Description Multilevel Packaging 1 0555-0952-02 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040361	11/18/2010

Dextroamphetamine SULFATE  Dextroamphetamine sulfate  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0555-0953 Route of Administration ORAL DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dextroamphetamine SULFATE (Dextroamphetamine) Dextroamphetamine SULFATE 10 mg

Inactive Ingredients Ingredient Name Strength CALCIUM SULFATE   SILICON DIOXIDE   MALTODEXTRIN   SUCROSE   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   STARCH, CORN   FD&C RED NO. 40   FD&C YELLOW NO. 6   ALUMINUM OXIDE

Product Characteristics Color PINK Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code 953;10;b Contains

Packaging # NDC Package Description Multilevel Packaging 1 0555-0953-02 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040361	11/18/2010

Hyalur

Hyalur may be available in the countries listed below.

Ingredient matches for Hyalur

Hyaluronic Acid

Hyaluronic Acid sodium salt (a derivative of Hyaluronic Acid) is reported as an ingredient of Hyalur in the following countries:

• Switzerland

International Drug Name Search

Doxycycline Hyclate eent

Class: Antibacterials
Chemical Name: 4 - (Dimethylamino) - 1,4,4a,5,5a,6,11,12a - octahydro - 3,5,10,12,12a - pentahydroxy - 6 - methyl - 1,11 - dioxo - 2 - naphthacenecarboxamide monohydrochloride
Molecular Formula: (C₂₂H₂₄N₂O₈•HCl)₂
CAS Number: 24390-14-5
Brands: Atridox, Periostat

Introduction

Semisynthetic tetracycline antibiotic.¹

Uses for Doxycycline Hyclate

Periodontitis

Used orally as an adjunct to scaling and root planing to promote attachment-level gain and to reduce pocket depth in adults with periodontitis.^{14 15 16}

Used subgingivally in treatment of chronic periodontitis in adults to reduce pocket depth, gain clinical attachment level, and reduce bleeding associated with probing.^{1 2 3 4 5 7 10 11}

Doxycycline Hyclate Dosage and Administration

Administration

Oral Administration

Administered orally as 20-mg tablets for adjunctive treatment of periodontitis.¹⁴

Administer doses in the morning and evening and at least 1 hour prior to or 2 hours after meals.¹⁴

Give with adequate amounts of fluids to reduce risk of esophageal irritation and ulceration.¹⁴

Subgingival Administration

Administered subgingivally (as an extended-release preparation containing the drug incorporated into a bioresorbable polymer) into periodontal pockets by an oral health-care professional.^{1 4 10 11}

Each pair of syringes is intended for single use only.¹

Administration does not require local anesthesia.¹

Preparation does not have to be manually removed; preparation solidifies upon contact with gingival crevicular fluid and is bioabsorbed or expelled naturally.¹

Reconstitution

Mix contents of the 2 paired syringes (liquid polymeric delivery system [syringe A]; doxycycline hyclate powder [syringe B]) together prior to administration.¹ Remove syringes from the refrigerator at least 15 minutes prior to mixing.¹

Couple syringes together and inject contents of syringe A into syringe B and then back into syringe A to complete 1 mixing cycle.¹ Perform 100 mixing cycles (approximately 1 mixing cycle per second) prior to administration.¹

If not administered immediately, store coupled syringes in resealable pouch at room temperature for up to 3 days; an additional 10 mixing cycles is required just prior to administration.¹

After mixing, hold coupled syringes vertically with syringe A (indicated by a purple stripe) at the bottom.¹ Pull down on the plunger of syringe A and allow contents to flow down the barrel for several seconds into syringe A.¹ Uncouple syringes and attach the blunt cannula supplied in the package to syringe A prior to administration.¹ Bend cannula to resemble a periodontal probe.¹

Subgingival Administration Technique

Using the syringe with bent cannula, position tip of cannula near the base of the periodontal pocket and administer preparation into the pocket until the formulation reaches the top of the gingival margin.¹

After administration is completed, withdraw cannula from the pocket and cover pocket with periodontal dressing or dental adhesive.¹

Dosage

Available as doxycycline hyclate; dosage expressed in terms of doxycycline; 50 mg of doxycycline hyclate equivalent to 42.5 mg of doxycycline.¹

Adults

Periodontitis

Oral

20 mg every 12 hours.¹⁴

Safety of >12 months of treatment and efficacy of >9 months of treatment have not been established.¹⁴

Subgingival

Dosage varies depending on the size, shape, and number of periodontal pockets treated.¹ May repeat treatment 4 months after the initial treatment.¹

Cautions for Doxycycline Hyclate

Contraindications

• 
  

  Known hypersensitivity to doxycycline or other tetracyclines.^{1 14}

  
  

Warnings/Precautions

Warnings

Dental and Bone Effects

Avoid use during tooth development (e.g., the last half of pregnancy, infancy, childhood up to 8 years of age); potential for permanent tooth discoloration or enamel hypoplasia.^{1 14}

Tetracyclines form a stable calcium complex in any bone-forming tissue.¹⁴ Reversible decrease in fibula growth rate has occurred in premature infants receiving oral tetracycline.¹⁴

Sensitivity Reactions

Photosensitivity Reactions

Possible photosensitivity reactions (e.g., exaggerated sunburn reaction).^{1 14} Discontinue oral or subgingival therapy at the first sign of skin erythema.^{13 14}

General Precautions

Precautions Related to Subgingival Doxycycline

Not studied for use in the regeneration of alveolar bone, either in preparation for or in conjunction with placement of endosseous (dental) implants or in the treatment of failing implants.¹

Not studied in patients with extremely severe periodontal defects with little remaining periodontium.¹

Not studied in immunocompromised patients (e.g., those with diabetes or HIV infection, those receiving chemotherapy or radiation therapy).¹

Oral Candidiasis

Possible overgrowth of nonsusceptible organisms, including fungi.^{1 14} Use with caution in patients with a history of or predisposition to oral candidiasis.^{1 14} Safety and efficacy not established in patients with concomitant oral candidiasis.^{1 14}

Specific Populations

Pregnancy

Category D.^{1 14}

Lactation

Distributed into milk.^{1 14} Discontinue nursing or the drug.^{1 14}

Pediatric Use

Do not use oral doxycycline in children <8 years of age.¹⁴

Safety and efficacy of subgingival doxycycline not established in children <18 years of age.^{1 2 13}

Possible permanent tooth discoloration (see Dental and Bone Effects under Cautions).¹

Common Adverse Effects

Oral: Headache, common cold, flu symptoms, toothache, GI symptoms (diarrhea, nausea, dyspepsia), joint pain.¹⁴

Subgingival: Headache; common cold; gum discomfort, pain or soreness, loss of attachment, or increased pocket depth; toothache or pressure sensitivity; periodontal abscess, exudate, infection, drainage, extreme mobility, or suppuration; thermal tooth sensitivity.¹

Interactions for Doxycycline Hyclate

Drug interactions reported involve oral doxycycline.¹⁴ No formal drug interaction studies have been performed with doxycycline hyclate polymer for subgingival administration.¹

Specific Drugs

Drug	Interaction	Comments
Antacids (aluminum-, calcium-, or magnesium-containing)	Decreased doxycycline absorption14
Anticoagulants, oral	Possible decreased prothrombin activity14	Adjust anticoagulant dosage as needed14
Anticonvulsants (barbiturates, carbamazepine, phenytoin)	Possible decreased doxycycline half-life14
Bismuth subsalicylate	Possible decreased doxycycline absorption14
Hormonal contraceptives	Possible decreased effectiveness of oral contraceptives1 14
Iron-containing preparations	Possible decreased doxycycline absorption14
Methoxyflurane	Fatal renal toxicity reported with concomitant use of tetracycline and methoxyflurane14
Penicillins	Possible antagonism14	Avoid concomitant use14

Doxycycline Hyclate Pharmacokinetics

Absorption

Bioavailability

Oral: Doxycycline hyclate rapidly and almost completely absorbed from GI tract.¹⁴ In adults receiving 20-mg tablets of doxycycline hyclate, peak serum doxycycline concentrations attained within 1.4 hours after a single dose or within 2 hours of a dose at steady-state.¹⁴

Subgingival: Concentrations in gingival crevicular fluid (GCF) peaked 2 hours following administration and remained >1000 mcg/mL through 18 hours.¹ GCF concentrations then declined gradually but remained >MIC for periodontal pathogens (≤6 mcg/mL) through 7 days; serum concentrations remained ≤0.1 mcg/mL.¹

Stability

Storage

Oral

Tablets

15–30°C in tight, light-resistant container.¹⁴

Subgingival

For liquid, extended-release polymer

2–8°C.¹

Actions and SpectrumActions

• 
  

  Usually is bacteriostatic.¹

  
  


• 
  

  Inhibits protein synthesis in susceptible organisms.¹

  
  


• 
  

  Active in vitro at concentrations of ≤6 mcg/mL against Porphyromonas gingivalis, Prevotella intermedia, Campylobacter rectus, and Fusobacterium nucleatum.¹

  
  


• 
  

  No evidence of doxycycline or multidrug resistance in subgingival plaque or saliva in a clinical study of 6 months’ duration of subgingival doxycycline hyclate.^{1 6}

  
  

Advice to Patients

• 
  

  When taking doxycycline hyclate tablets, importance of drinking sufficient amounts of fluids to reduce the risk of esophageal irritation and ulceration.¹⁴

  
  


• 
  

  Doxycycline hyclate polymer for subgingival administration is not meant for self-administration; only qualified oral health-care professionals familiar with administration of the subgingival preparation should administer the drug.¹

  
  


• 
  

  Importance of not using mechanical oral hygiene procedures (i.e., brushing teeth, flossing) for 7 days following administration of the subgingival preparation.¹

  
  


• 
  

  Importance of avoiding exposure to direct sunlight or UV light while receiving oral or subgingival doxycycline hyclate; importance of notifying clinician and of discontinuing therapy at the first sign of skin erythema.^{1 13}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant diseases.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Doxycycline Hyclate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	20 mg (of doxycycline)	Periostat	CollaGenex
	Tablets, film-coated	20 mg (of doxycycline)*	Doxycycline Hyclate Tablets	Teva
Subgingival	For liquid, extended-release polymer	10% w/w (to deliver 42.5 mg [of doxycycline])	Atridox (available in a 2-syringe Atrigel Delivery System)	CollaGenex

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions June 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. CollaGenex Pharmaceuticals. Atridox (doxycycline hyclate 10%) prescribing information. Newtown, PA; 1998 Sep.

2. Wennström JL, Newman HN, MacNeill SR et al. Utilisation of locally delivered doxycycline in non-surgical treatment of chronic periodontitis. J Clin Periodontol. 2001; 28:753-761.

3. Garrett S, Adams DF, Bogle G et al. The effect of locally delivered controlled-release doxycycline or scaling and root planing on periodontal maintenance patients over 9 months. J Periodontol. 2000; 71:22-30. [PubMed 10695935]

4. Garrett S, Johnson L, Drisko CH et al. Two multi-center studies evaluating locally delivered doxycycline hyclate, placebo control, oral hygiene, and scaling and root planing in the treatment of periodontitis. J Periodontol. 1999; 70:490-503. [PubMed 10368053]

5. Drisko CH. The use of locally-delivered doxycycline in the treatment of periodontitis. Clinical results. J Clin Periodontol. 1998; 25:947-52. [PubMed 9839851]

6. Walker CB, Godowski KC, Borden L. The effects of sustained release doxycycline on anaerobic flora and antibiotic-resistant patterns in subgingival plaque and saliva. J Periodontol. 2000; 71:768-74. [PubMed 10872958]

7. Wolinsky LE, Camargo PM, Polson A et al. The significance of prior mechanical therapy for changes of periodontal status achieved by local delivery of a doxycycline-hyclate containing gel. J Clin Periodontol. 2001; 28:1115-20. [PubMed 11737508]

8. Stoller NH, Johnson LR, Trapnell S et al. The pharmacokinetic profile of a biodegradable controlled-release delivery system containing doxycycline compared to systemically delivered doxycycline in gingival crevicular fluid, saliva, and serum. J Periodontol. 1998; 69:1085-91. [PubMed 9802705]

9. Ryder MI, Pons B, Adams D et al. Effects of smoking on local delivery of controlled-release doxycycline as compared to scaling and root planing. J Clin Periodontol. 1999; 26:683-91. [PubMed 10522780]

10. Greenstein G, Tonetti M and the Research, Science, and Therapy Committee of the American Academy of Periodontology. Position Paper. The role of controlled drug delivery for periodontitis. J Periodontol. 2000; 71:125-40. [PubMed 10695948]

11. Greenstein G, Polson A. The role of local drug delivery in the management of periodontal diseases: a comprehensive review. J Periodontol. 1998; 69:507-520. [PubMed 9623893]

12. Garrett S. Local delivery of doxycycline for the treatment of periodontitis. Compendium. 1999; 20:437-46. [PubMed 10650359]

13. CollaGenex Pharmaceuticals, Inc. Newtown, PA; Personal communication.

14. CollaGenex Pharmaceuticals. Periostat (doxycycline hyclate) 20 mg tablets prescribing information. Newtown, PA; 2003 Oct.

15. Greenstein G. The role of Periostat in the management of adult periodontitis: a critical assessment. Compend Contin Educ Dent. 1999; 20:664,666-8,670,672,574,676-8. [PubMed 10650384]

16. Caton JG. Evaluation of Periostat for patient management. Compend Contin Educ Dent. 1999; 20:451-2,454-6,458-63. [PubMed 10650360]

More Doxycycline Hyclate eent resources

• Doxycycline Hyclate eent Use in Pregnancy & Breastfeeding
• Drug Images
• Doxycycline Hyclate eent Drug Interactions
• Doxycycline Hyclate eent Support Group
• 153 Reviews for Doxycycline Hyclate eent - Add your own review/rating

Compare Doxycycline Hyclate eent with other medications

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doxorubicin Intravenous

dox-oh-ROO-bi-sin

Intravenous route(Solution;Powder for Solution)

Severe local tissue necrosis will occur if there is extravasation during administration; do not administer by the intramuscular or subcutaneous route. Myocardial toxicity manifested in its most severe form by potentially fatal congestive heart failure (CHF) may occur either during therapy or months to years after termination of therapy. The risk of developing CHF increases rapidly with increasing total cumulative doses of doxorubicin in excess of 400 mg/m(2). Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) have been reported in patients treated with anthracyclines. Pediatric patients are also at risk for developing secondary AML. Reduce dosage in patients with impaired hepatic function. Severe myelosuppression may occur with therapy .

Commonly used brand name(s)

In the U.S.

• Adriamycin

Available Dosage Forms:

• Powder for Solution


• Solution

Therapeutic Class: Antineoplastic Agent

Chemical Class: Anthracycline

Uses For doxorubicin

Doxorubicin belongs to the general group of medicines known as antineoplastics. It is used to treat some kinds of cancers of the blood; lymph system; bladder; breast; stomach; lung; ovaries; thyroid; nerves; kidneys; bones; and soft tissues, including muscles and tendons. It may also be used to treat other kinds of cancer, as determined by your doctor.

Doxorubicin seems to interfere with the growth of cancer cells, which are then eventually destroyed by the body. Since the growth of normal body cells may also be affected by doxorubicin, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may not occur until months or years after the medicine is used.

Before you begin treatment with doxorubicin, you and your doctor should talk about the good doxorubicin will do as well as the risks of using it.

Doxorubicin is to be administered only by or under the supervision of your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, doxorubicin is used in certain patients with the following medical conditions:

• Autoimmune deficiency syndrome (AIDS)–associated Kaposi's sarcoma (a type of cancer of the skin and mucous membranes that is more common in patients with AIDS)


• Cancer of the adrenal cortex (the outside layer of the adrenal gland)


• Cancer of the cervix


• Cancer of the endometrium


• Cancer of the esophagus


• Cancers of the head and neck


• Cancer of the liver


• Cancer of the pancreas


• Cancer of the prostate


• Cancer of the thymus (a small organ found under the breast bone)


• Carcinoid tumors


• Chronic lymphocytic leukemia (a type of cancer of the blood and lymph system)


• Ewing's sarcoma (a type of cancer found in the bone)


• Gestational trophoblastic tumors (tumors in the uterus or womb)


• Hepatoblastoma (a certain type of liver cancer that occurs in children)


• Multiple myeloma (a certain type of cancer of the blood)


• Non–small cell lung cancer (a certain type of lung cancer usually associated with prior smoking, passive smoking, or radon exposure)


• Retinoblastoma (a type of eye cancer found primarily in children)


• Tumors in the ovaries

Before Using doxorubicin

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 doxorubicin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to doxorubicin 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

Heart problems are more likely to occur in children younger than 2 years of age, who are usually more sensitive to the effects of doxorubicin.

Geriatric

Heart problems are more likely to occur in the elderly, who are usually more sensitive to the effects of doxorubicin. The elderly may also be more likely to have blood problems.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using doxorubicin.

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. When you are receiving doxorubicin, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using doxorubicin with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Rotavirus Vaccine, Live

Using doxorubicin with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine Type 4, Live


• Adenovirus Vaccine Type 7, Live


• Bacillus of Calmette and Guerin Vaccine, Live


• Cisplatin


• Clozapine


• Docetaxel


• Glucosamine


• Influenza Virus Vaccine, Live


• Measles Virus Vaccine, Live


• Mumps Virus Vaccine, Live


• Paclitaxel


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Smallpox Vaccine


• Stavudine


• Trastuzumab


• Typhoid Vaccine


• Valspodar


• Varicella Virus Vaccine


• Warfarin


• Yellow Fever Vaccine


• Zidovudine

Using doxorubicin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cyclosporine


• Eltrombopag


• Phenytoin


• Sorafenib

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 doxorubicin. Make sure you tell your doctor if you have any other medical problems, especially:

• Chickenpox (including recent exposure) or


• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body

• Gout or


• Kidney stones—Doxorubicin may increase levels of uric acid in the body, which can cause gout or kidney stones

• Heart disease—Risk of heart problems caused by doxorubicin may be increased

• Liver disease—Effects of doxorubicin may be increased because of its slower removal from the body

Proper Use of doxorubicin

Doxorubicin is sometimes given together with certain other medicines. If you are receiving a combination of medicines, it is important that you receive each one at the proper time. If you are taking some of these medicines by mouth, ask your health care professional to help you plan a way to take them at the right times.

While you are using doxorubicin, your doctor may want you to drink extra fluids so that you will pass more urine. This will help prevent kidney problems and keep your kidneys working well.

Doxorubicin often causes nausea and vomiting. However, it is very important that you continue to receive the medication, even if you begin to feel ill. Ask your health care professional for ways to lessen these effects.

Dosing

The dose of doxorubicin 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 doxorubicin. 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.

Precautions While Using doxorubicin

It is very important that your doctor check your progress at regular visits to make sure that doxorubicin is working properly and to check for unwanted effects.

While you are being treated with doxorubicin, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Doxorubicin may lower your body's resistance, and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine, since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Doxorubicin can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.


• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.


• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.


• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.


• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.


• Avoid contact sports or other situations where bruising or injury could occur.

If doxorubicin accidentally seeps out of the vein into which it is injected, it may damage some tissues and cause scarring. Tell the doctor or nurse right away if you notice redness, pain, or swelling at the place of injection.

doxorubicin 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

• Fast or irregular heartbeat


• pain at place of injection


• shortness of breath


• swelling of feet and lower legs

Rare

• Black, tarry stools


• blood in urine


• pinpoint red spots on skin


• unusual bleeding or bruising


• wheezing

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Sores in mouth and on lips

Less common

• Cough or hoarseness accompanied by fever or chills


• darkening or redness of skin (if you recently had radiation treatment)


• fever or chills


• joint pain


• lower back or side pain accompanied by fever or chills


• painful or difficult urination accompanied by fever or chills


• red streaks along injected vein


• stomach pain

Rare

• Skin rash or itching

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

• Nausea and vomiting

Less common

• Darkening of soles, palms, or nails


• diarrhea

Doxorubicin causes the urine to turn reddish in color, which may stain clothes. This is not blood. It is to be expected and only lasts for 1 or 2 days after each dose is given.

doxorubicin often causes a temporary and total loss of hair. After treatment with doxorubicin has ended, normal hair growth should return.

After you stop using doxorubicin, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Fast or irregular heartbeat


• shortness of breath


• swelling of feet and lower legs

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.

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