RVP

Drug Catalog - Product Detail

AMITRIPTYLINE HCL TB 150MG 100

NDC Mfr Size Str Form
00378-2695-01 MYLAN 100 150MG TABLET
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Description
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: [Structural Formula] 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
How Supplied
HOW SUPPLIED 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 0378-2610-01 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 0378-2625-01 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 0378-2650-01 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 Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Indications & Usage
INDICATIONS AND USAGE For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.
Dosage and Administration
DOSAGE AND ADMINISTRATION Oral Dosage Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance. Initial Dosage for Adults For outpatients 75 mg of amitriptyline HCl a day in divided doses is usually satisfactory. If necessary, this may be increased to a total of 150 mg per day. Increases are made preferably in the late afternoon and/or bedtime doses. A sedative effect may be apparent before the antidepressant effect is noted, but an adequate therapeutic effect may take as long as 30 days to develop. An alternate method of initiating therapy in outpatients is to begin with 50 mg to 100 mg amitriptyline HCl at bedtime. This may be increased by 25 mg or 50 mg as necessary in the bedtime dose to a total of 150 mg per day. Hospitalized patients may require 100 mg a day initially. This can be increased gradually to 200 mg a day if necessary. A small number of hospitalized patients may need as much as 300 mg a day. Adolescent and Elderly Patients In general, lower dosages are recommended for these patients. 10 mg three times a day with 20 mg at bedtime may be satisfactory in adolescent and elderly patients who do not tolerate higher dosages. Maintenance The usual maintenance dosage of amitriptyline HCl is 50 mg to 100 mg per day. In some patients 40 mg per day is sufficient. For maintenance therapy the total daily dosage may be given in a single dose preferably at bedtime. When satisfactory improvement has been reached, dosage should be reduced to the lowest amount that will maintain a relief of symptoms. It is appropriate to continue maintenance therapy 3 months or longer, to lessen the possibility of relapse. Pediatric Use In view of the lack of experience with the use of this drug in pediatric patients, it is not recommended at the present time for patients under 12 years of age. Plasma Levels Because of the wide variation in the absorption and distribution of tricyclic antidepressants in body fluids, it is difficult to directly correlate plasma levels and therapeutic effect. However, determination of plasma levels may be useful in identifying patients who appear to have toxic effects and may have excessively high levels, or those in whom lack of absorption or noncompliance is suspected. Because of increased intestinal transit time and decreased hepatic metabolism in elderly patients, plasma levels are generally higher for a given oral dose of amitriptyline hydrochloride than in younger patients. Elderly patients should be monitored carefully and quantitative serum levels obtained as clinically appropriate. Adjustments in dosage should be made according to the patient’s clinical response and not on the basis of plasma levels.**