Amitriptyline hydrochloride description

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Amitriptyline
AMITRIPTYLINE HYDROCHLORIDE®
FDA Package Insert
Indications and Usage
Dosage and Administration
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
How Supplied/Storage and Handling
Patient Counseling Information
Labels and Packages
Clinical Trials on Amitriptyline
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Description

Amitriptyline HCl is 3-(10, 11-dihydro-5H-dibenzo [a,d] cycloheptene-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride. Its molecular formula is C20H23N • HCl, and its structural formula is:

File:Ami04.png

Amitriptyline HCl, a dibenzocycloheptadiene derivative, has a molecular weight of 313.87. It is a white, odorless, crystalline compound which is freely soluble in water.

Each tablet for oral administration contains the following inactive ingredients: colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, sodium starch glycolate and titanium dioxide. In addition, the following product specific coloring agents are employed:

10 mg - calcium sulfate, talc 25 mg - FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake 50 mg - FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake 75 mg - FD&C Blue No. 2 Aluminum Lake 100 mg - D&C Red No. 30 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake 150 mg - D&C Red No. 30 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake[1]

References

  1. "AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]".

Adapted from the FDA Package Insert.