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amitriptyline hcl 25 mg tab

In stock Manufacturer ACCORD HEALTHCA 16729017217
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Dosage and Administration

Administration

Amitriptyline hydrochloride is given orally. Although amitriptyline has been administered in up to 4 divided doses throughout the day, it is long-acting and the entire oral daily dose may be administered at one time. Administration of the entire daily dose at bedtime may reduce daytime sedation.

In patients who were unwilling or unable to take amitriptyline orally, the drug also has been given IM. However, a parenteral dosage form is no longer commercially available in the US. Oral therapy should replace IM administration as soon as possible.

Dosage

There is a wide range of oral amitriptyline hydrochloride dosage requirements, and dosage must be carefully individualized.

Patients should be monitored for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustment.

Initial dosages should be low and generally range from 75-100 mg daily, depending on the severity of the condition being treated. Dosage may be gradually adjusted (preferably the late-afternoon and/or bedtime doses) to the level that produces maximal therapeutic effect with minimal toxicity and may range from 150-300 mg daily. Alternatively, the manufacturers recommend an initial amitriptyline hydrochloride dosage of 50-100 mg daily at bedtime. Dosage then can be increased by 25 or 50 mg as necessary to a suggested maximum of 150 mg daily. Hospitalized patients under close supervision may generally be given higher dosages than outpatients. Hospitalized patients generally may receive an initial amitriptyline dosage of 100 mg daily; dosage may be increased gradually to 200 mg daily as needed. Some patients may require dosages as high as 300 mg daily. Geriatric and adolescent patients should usually be given lower than average dosages. Manufacturers state that these patients may obtain satisfactory improvement with 10 mg of amitriptyline hydrochloride 3 times daily plus 20 mg at bedtime. Maximum antidepressant effects may not occur for 30 days after therapy is begun.

After symptoms are controlled, dosage should be gradually reduced to the lowest level that will maintain relief of symptoms. If maintenance therapy is necessary, the manufacturers recommend 50-100 mg of amitriptyline hydrochloride daily; however, 25-40 mg daily may be sufficient for some patients. During maintenance therapy, the total daily dosage may be administered as a single daily dose, preferably at bedtime. The manufacturers recommend that maintenance therapy be continued for at least 3 months to prevent relapse. To avoid the possibility of precipitating withdrawal symptoms, amitriptyline should not be terminated abruptly in patients who have received a high dosage for prolonged periods.

When amitriptyline is used in conjunction with a phenothiazine, commercially available fixed-ratio combination preparations should not be used initially. Dosage should first be adjusted by administering each drug separately. If it is determined that the optimum maintenance dosage corresponds to the ratio in a commercial combination, such a preparation may be used. However, whenever dosage adjustment is necessary, the drugs should be administered separately.

Cautions

Amitriptyline shares the pharmacologic actions, uses, and toxic potentials of the tricyclic antidepressants, and the usual precautions of tricyclic antidepressant administration should be observed. Patients should be fully advised about the risks, especially suicidal thinking and behavior (suicidality), associated with tricyclic antidepressant therapy. For a complete discussion,

Pediatric Precautions

Safety and efficacy of amitriptyline in children younger than 12 years of age have not been established. Therefore, the manufacturers state that the drug should not be used in this age group.

The US Food and Drug Administration (FDA) has determined that antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children and adolescents with major depressive disorder and other psychiatric disorders, However, the FDA also states that depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide. Anyone considering the use of amitriptyline in a child or adolescent for any clinical use must therefore balance the potential risk of therapy with the clinical need.

Pharmacokinetics

Absorption

Amitriptyline hydrochloride is rapidly absorbed from the GI tract and from parenteral sites. Peak plasma concentrations occur within 2-12 hours after oral or IM (a parenteral dosage form no longer is commercially available in the US) administration.

Distribution

Amitriptyline and its active metabolite, nortriptyline, are distributed into milk. Amitriptyline and nortriptyline concentrations in milk appear to be similar to or slightly greater than those present in maternal serum. It is estimated that a nursing infant would ingest less than 1% of the daily maternal dose of amitriptyline, and the drug was not detected in the serum of several nursing infants whose mothers were receiving 75-100 mg daily.

Elimination

The plasma half-life of amitriptyline ranges from 10-50 hours. Amitriptyline is metabolized via the same pathways as are other tricyclic antidepressants; nortriptyline, its N-monodemethylated metabolite, is pharmacologically active. Approximately 25-50% of a dose of amitriptyline is excreted in urine as inactive metabolites within 24 hours; small amounts are excreted in feces via biliary elimination.

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