DIETHYLPROPION HYDROCHLORIDE ER Extended-release tablet (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Lannett Company, Inc.

Λέξεις κλειδιά

0527-1477

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1. Description

Diethylpropion Hydrochloride Extended Release Tablets, 75 mg are available for oral administration as extended release tablets containing 75 mg diethylpropion hydrochloride, USP. The inactive ingredients ...

2. Clinical Pharmacology

Diethylpropion hydrochloride is a sympathomimetic amine with some pharmacologic activity similar to that of the prototype drugs of this class used in obesity, the amphetamines. Actions include some central ...

3. Indications and Usage

Diethylpropion hydrochloride extended release tablets, 75 mg are indicated in the management of exogenous obesity as a short-term adjunct (a few weeks) in a regimen of weight reduction based on caloric ...

4. Contraindications

Pulmonary hypertension, advanced arteriosclerosis, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma, severe hypertension (See PRECAUTIONS). Agitated states. ...

5. Warnings

Diethylpropion hydrochloride extended release tablets, 75 mg should not be used in combination with other anorectic agents, including prescribed drugs, over-the-counter preparations, and herbal products. ...

6.1. General

Caution is to be exercised in prescribing diethylpropion hydrochloride extended release tablets, 75 mg for patients with hypertension or with symptomatic cardiovascular disease, including arrhythmias. ...

6.2. Information for Patients

The patient should be cautioned about concomitant use of alcohol or other CNS-active drugs and diethylpropion hydrochloride extended release tablets, 75 mg (See WARNINGS). The patient should be advised ...

6.3. Laboratory Tests

None.

6.4. Drug Interactions

Because diethylpropion hydrochloride extended release tablets, 75 mg are monoamines, hypertension may result when either agent is used with monoamine oxidase (MAO) inhibitors (See CONTRAINDICATIONS). ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been done to evaluate diethylpropion hydrochloride for carcinogenicity. Mutagenicity studies have not been conducted. Animal reproduction studies have revealed no evidence ...

6.7. Pregnancy

Teratogenic Effects: Pregnancy Category B Reproduction studies have been performed in rats at doses up to 1.6 times the human dose (based on mg/m²) and have revealed no evidence of impaired fertility or ...

6.9. Nursing Mothers

Since diethylpropion hydrochloride and/or its metabolites have been shown to be excreted in human milk, caution should be exercised when diethylpropion hydrochloride extended release tablets, 75 mg are ...

6.10. Pediatric Use

Since safety and effectiveness in pediatric patients below the age of 16 have not been established, diethylpropion hydrochloride extended release tablets, 75 mg is <em>not</em> recommended for use in pediatric ...

6.11. Geriatric Use

Clinical studies of diethylpropion hydrochloride extended release tablets, 75 mg did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger ...

7. Adverse Reactions

<u>Cardiovascular:</u> Precordial pain, arrhythmia (including ventricular), ECG changes, tachycardia, elevation of blood pressure, palpitation and rare reports of pulmonary hypertension. Valvular heart ...

8. Drug Abuse and Dependence

Diethylpropion hydrochloride extended release tablets, 75 mg are schedule IV controlled substances. Diethylpropion hydrochloride has some chemical and pharmacologic similarities to the amphetamines and ...

9. Overdosage

Manifestations of acute overdosage include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states, and mydriasis. Fatigue and depression usually ...

10. Dosage and Administration

Diethylpropion Hydrochloride Extended Release Tablets, 75 mg: One extended-release 75 mg tablet daily, swallowed whole, in midmorning. Geriatric use This drug is known to be substantially excreted by the ...

11. How Supplied

Diethylpropion Hydrochloride Extended Release Tablets, 75 mg are supplied in bottles of 100 (NDC 0527-1477-01) and 250 (0527-1477-25). Each white to off-white capsule-shaped tablet is debossed LCI on one ...