Amitriptyline hydrochloride how supplied storage and handling
| 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]
How Supplied
Amitriptyline Hydrochloride Tablets, USP are available containing either 10 mg, 25 mg, 50 mg, 75 mg or 100 mg of Amitriptyline Hydrochloride, USP.
The 10 mg tablets are white film-coated, round, unscored tablets debossed with M77 on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-131-20 - Unit dose blister packages of 100 (10 cards of 10 tablets each). NDC 51079-131-63 - Compliance Pack of 30 tablets.
The 25 mg tablets are light green film-coated, round, unscored tablets debossed with M over 51 on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-107-20 - Unit dose blister packages of 100 (10 cards of 10 tablets each). NDC 51079-107-19 - Robot Ready blister packages of 25 (25 cards of 1 tablet each). NDC 51079-107-63 - Compliance Pack of 30 tablets.
The 50 mg tablets are brown film-coated, round, unscored tablets debossed with M over 36 on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-133-20 - Unit dose blister packages of 100 (10 cards of 10 tablets each). NDC 51079-133-63 - Compliance Pack of 30 tablets.
The 75 mg tablets are blue film-coated, round, unscored tablets debossed with M over 37 on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-147-20 - Unit dose blister packages of 100 (10 cards of 10 tablets each).
The 100 mg tablets are orange film-coated, round, unscored tablets debossed with M over 38 on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-563-20 - Unit dose blister packages of 100 (10 cards of 10 tablets each).
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Protect from light.
PHARMACIST: Dispense a Medication Guide with each prescription.
Metabolism
Studies in man following oral administration of 14C-labeled drug indicated that amitriptyline is rapidly absorbed and metabolized. Radioactivity of the plasma was practically negligible, although significant amounts of radioactivity appeared in the urine by 4 to 6 hours and one-half to one-third of the drug was excreted within 24 hours.
Amitriptyline is metabolized by N-demethylation and bridge hydroxylation in man, rabbit, and rat. Virtually the entire dose is excreted as glucuronide or sulfate conjugate of metabolites, with little unchanged drug appearing in the urine. Other metabolic pathways may be involved.[1]
References
Adapted from the FDA Package Insert.