AMITRIPTYLINE HYDROCHLORIDE tablet, film coated AMITRIPTYLINE HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMITRIPTYLINE HYDROCHLORIDE (UNII: 26LUD4JO9K) (AMITRIPTYLINE - UNII:1806D8D52K)

Available from:

Direct Rx

INN (International Name):

AMITRIPTYLINE HYDROCHLORIDE

Composition:

AMITRIPTYLINE HYDROCHLORIDE 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states. Amitriptyline hydrochloride tablets are contraindicated in patients who have shown prior hypersensitivity to it. It should not be given concomitantly with monoamine oxidase inhibitors. Hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving tricyclic antidepressant and monoamine oxidase inhibiting drugs simultaneously. When it is desired to replace a monoamine oxidase inhibitor with amitriptyline hydrochloride, a minimum of 14 days should be allowed to elapse after the former is discontinued. Amitriptyline hydrochloride should then be initiated cautiously with gradual increase in dosage until optimum response is achieved. Amitriptyline hydrochloride should not be given with cisapride due to the potential for increased QT interval and increased risk for arrhythmia. This drug is not recommended for use during the acute recovery phase following myocardi

Product summary:

Amitriptyline Hydrochloride Tablets, USP are available containing either 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 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 0378-2610-93 bottles of 30 tablets NDC 0378-2610-01 bottles of 100 tablets NDC 0378-2610-10 bottles of 1000 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 0378-2625-93 bottles of 30 tablets NDC 0378-2625-01 bottles of 100 tablets NDC 0378-2625-10 bottles of 1000 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 0378-2650-93 bottles of 30 tablets NDC 0378-2650-01 bottles of 100 tablets NDC 0378-2650-10 bottles of 1000 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 0378-2675-93 bottles of 30 tablets NDC 0378-2675-01 bottles of 100 tablets 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 0378-2685-93 bottles of 30 tablets NDC 0378-2685-01 bottles of 100 tablets The 150 mg tablets are flesh film-coated, capsule-shaped, unscored tablets debossed with M 39 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-2695-93 bottles of 30 tablets NDC 0378-2695-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMITRIPTYLINE HYDROCHLORIDE- AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM
COATED
AMITRIPTYLINE HYDROCHLORIDE- AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM
COATED
DIRECT RX
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AMITRIPTYLINE HYDROCHLORIDE
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:
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
CLINICAL PHARMACOLOGY
Amitriptyline hydrochloride is an antidepressant with sedative
effects. Its mechanism of action in man is
not known. It is not a monoamine oxidase inhibitor and it does not act
primarily by stimulation of the
central nervous system.
Amitriptyline inhibits the membrane pump mechanism responsible for
uptake of norepinephrine and
serotonin in adrenergic and serotonergic neurons. Pharmacologically
this action may potentiate or
prolong neuronal activity since reuptake of these biogenic amines is
important physiologically in
terminating transmitting activity. This interference with reuptake of
norepinephrine and/or serotonin is
believed by some to underli