COGENTIN Solution for injection (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.)

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1. Description

Benztropine mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine. It is designated chemically as 8-azabicyclo[3.2.1] octane, 3-(diphenylmethoxy)-,endo ...

3. Indications and Usage

For use as an adjunct in the therapy of all forms of parkinsonism (see DOSAGE AND ADMINISTRATION). Useful also in the control of extrapyramidal disorders (except tardive dyskinesia – see PRECAUTIONS) ...

4. Contraindications

Hypersensitivity to any component of COGENTIN injection. Because of its atropine-like side effects, this drug is contraindicated in pediatric patients under three years of age, and should be used with ...

5. Warnings

Safe use in pregnancy has not been established. COGENTIN may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. ...

6.1. General

Since COGENTIN has cumulative action, continued supervision is advisable. Patients with a tendency to tachycardia and patients with prostatic hypertrophy should be observed closely during treatment. Dysuria ...

6.4. Drug Interactions

Antipsychotic drugs such as phenothiazines or haloperidol; tricyclic antidepressants (see WARNINGS).

6.10. Pediatric Use

Because of the atropine-like side effects, COGENTIN should be used with caution in pediatric patients over three years of age (see CONTRAINDICATIONS).

6.11. Geriatric Use

Clinical studies of COGENTIN did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has ...

7. Adverse Reactions

The adverse reactions below, most of which are anticholinergic in nature, have been reported and within each category are listed in order of decreasing severity. Cardiovascular: Tachycardia. ...

9. Overdosage

Manifestations May be any of those seen in atropine poisoning or antihistamine overdosage: CNS depression, preceded or followed by stimulation; confusion; nervousness; listlessness; intensification of ...

10. Dosage and Administration

Since there is no significant difference in onset of effect after intravenous or intramuscular injection, usually there is no need to use the intravenous route. The drug is quickly effective after either ...

11. How Supplied

Injection COGENTIN, 1 mg per mL, is a clear, colorless solution and is supplied as follows: NDC 76478-611-02 in boxes of 5 2 mL ampuls. AKORN: Distributed by: Akorn, Inc., Lake Forest, IL 60045 ...

12. Storage and Handling

Recommended Storage: Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature].