ZENZEDI Tablet (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Arbor Pharmaceuticals, Inc.

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

BOXED WARNING SECTION

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 ...

1. Description

Dextroamphetamine sulfate, USP is the dextro isomer of the compound d,l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine, ...

2. 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 ...

3. Indications and Usage

Zenzedi (dextroamphetamine sulfate tablets, USP) is indicated for: Narcolepsy. Attention Deficit Disorder with Hyperactivity: As an integral part of a total treatment program which typically includes other ...

4. Contraindications

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

5. 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 ...

6.1. General

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

6.2. 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 ...

6.4. 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 ...

6.5. 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.

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

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

6.7. Pregnancy

Teratogenic Effects 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 ...

6.9. Nursing Mothers

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

6.10. 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 ...

7. Adverse Reactions

Cardiovascular: Palpitations, tachycardia, elevation of blood pressure. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use. Central Nervous System: ...

8. Drug Abuse and Dependence

Zenzedi 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 ...

9. 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 ...

10. 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 ...

11. How Supplied

Zenzedi (dextroamphetamine sulfate tablets, USP) is supplied as follows: 2.5 mg: White, square tablet, debossed 2.5 on one side and MIA on the other side in bottles of 100 tablets, NDC 24338-850-10. ...

12. Storage and Handling

Store at 20° to 25°C (68° to 77°F); excursions permitted 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature] DEA Order Form Required. Pharmacist: Medication Guide to be dispensed to Patients. ...