DESOXYN

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Brooklyn ny 11217
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110 W End Ave
New York ny 10023
(212)362-0000

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5301 Broadway
West New York nj 07093
(201)520-9364

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New York ny 10013
(212)571-0027

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Woodside ny 11377
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125 18th St
Jersey City nj 07310
(201)418-0585

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139 Centre Street
New York ny 10013
(646)838-6388

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132 Allen St
New York ny 10002
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New York ny 10025
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(212)410-4410

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Astoria ny 11103
(718)777-8544

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Jersey City nj 07304
(201)451-4944

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126 Eighth Ave
New York ny 10011
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139 Flatbush Ave
Brooklyn ny 11217
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260 Broadway
Brooklyn ny 11211
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Secaucus nj 07094
(201)325-9275

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29 W 116th St
New York ny 10026
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400 Broadway
New York ny 10013
(646)744-0994

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154 9th Ave
New York ny 10011
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31 04 35th St
Astoria ny 11106
(718)932-8700

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55 Columbia St
New York ny 10002
(212)533-8120

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3510 Bergenline Ave
Union City nj 07087
(201)500-9366

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517 E 117th St
New York ny 10035
(212)896-5882

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1032 1st Ave
New York ny 10022
(212)755-4244

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534 Hudson Street
New York ny 10014
(646)486-1048

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1636 Madison Ave
New York ny 10029
(212)369-0700

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2325 1st Ave
New York ny 10035
(212)289-8839

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23 Flat Bush Ave
Brooklyn ny 11217
(718)596-7397

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2980 John F Kennedy Blvd
Jersey City nj 07306
(201)963-3617

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3519 31st Ave
Astoria ny 11106
(718)267-8063

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901 2nd Ave
New York ny 10017
(212)752-5151

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437 Central Ave
Jersey City nj 07307
(201)418-0009

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556 Grand St
Brooklyn ny 11211
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Pregnancy

Pregnancy Teratogenic effects: Pregnancy Category C. Methamphetamine has been shown to have teratogenic and embryocidal effects in mammals given high multiples of the human dose. There are no adequate and well-controlled studies in pregnant women. DESOXYN tablets should not be used during pregnancy unless 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.

Drug Interactions

Drug Interactions: Insulin requirements in diabetes mellitus may be altered in association with the use of methamphetamine and the concomitant dietary regimen. Methamphetamine may decrease the hypotensive effect of guanethidine. DESOXYN should not be used concurrently with monoamine oxidase inhibitors (see CONTRAINDICATIONS ). Concurrent administration of tricyclic antidepressants and indirect-acting sympathomimetic amines such as the amphetamines, should be closely supervised and dosage carefully adjusted. Phenothiazines are reported in the literature to antagonize the CNS stimulant action of the amphetamines.

Indications And Usage

INDICATIONS AND USAGE Attention Deficit Disorder with Hyperactivity: DESOXYN tablets are indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children over 6 years of age 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. Exogenous Obesity: as a short-term (i.e., a few weeks) adjunct in a regimen of weight reduction based on caloric restriction, for patients in whom obesity is refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs. The limited usefulness of DESOXYN tablets (see CLINICAL PHARMACOLOGY ) should be weighed against possible risks inherent in use of the drug, such as those described below.

Overdosage

OVERDOSAGE Manifestations of amphetamine overdose include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states, hyperpyrexia and rhabdomyolysis. Fatigue and depression usually follow the central nervous system stimulation. Serotonin syndrome has also been reported. 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.

Adverse Reactions

ADVERSE REACTIONS The following are adverse reactions in decreasing order of severity within each category that have been reported: Cardiovascular: Elevation of blood pressure, tachycardia and palpitation. Fatal cardiorespiratory arrest has been reported, mostly in the context of abuse/misuse. Central Nervous System: Psychotic episodes have been rarely reported at recommended doses. Dizziness, dysphoria, overstimulation, euphoria, insomnia, tremor, restlessness and headache. Exacerbation of motor and phonic tics and Tourette’s syndrome. Gastrointestinal: Diarrhea, constipation, dryness of mouth, unpleasant taste and other gastrointestinal disturbances. Hypersensitivity: Urticaria. Endocrine: Impotence and changes in libido; frequent or prolonged erections. Musculoskeletal: Rhabdomyolysis. Miscellaneous: Suppression of growth has been reported with the long-term use of stimulants in children (see WARNINGS ). Skin and Subcutaneous Tissue Disorders: Alopecia. To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1-888-575-8344 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Contraindications

CONTRAINDICATIONS In patients known to be hypersensitive to amphetamine, or other components of DESOXYN. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products (see ADVERSE REACTIONS ). Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis (see WARNINGS and DRUG INTERACTIONS ). It is also contraindicated in patients with glaucoma, advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism or known hypersensitivity or idiosyncrasy to sympathomimetic amines. Methamphetamine should not be given to patients who are in an agitated state or who have a history of drug abuse.