Vivactil
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Questions & Answers
Side Effects & Adverse Reactions
- Clinical Worsening and Suicide Risk
- Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents and young adults (aged 18 to 24) with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older.
- The pooled analysis of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders including a total of 24 short-term trials of 9 antidepressant drugs in over 4,400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1,000 patients treated) are provided in Table 1.
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Drug-Placebo Difference in Number of Cases of Suicidality
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Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Protriptyline hydrochloride tablets are indicated for the treatment of symptoms of mental depression in patients who are under close medical supervision. Its activating properties make it particularly suitable for withdrawn and anergic patients.
History
There is currently no drug history available for this drug.
Other Information
- Protriptyline hydrochloride, USP is N-methyl-5 H dibenzo[ a, d]-cycloheptene-5-propanamine hydrochloride. Its structural formula is:
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- C 19H 21N•HCl M.W. 299.84
- Protriptyline hydrochloride, USP, a dibenzocycloheptene derivative, is a white to yellowish powder that is freely soluble in water and soluble in dilute hydrochloride. Protriptyline hydrochloride, USP is supplied as 5 mg or 10 mg film-coated tablets. Inactive ingredients are anhydrous lactose, carnauba wax, corn starch, dibasic calcium phosphate, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, propylene glycol, sodium starch glycolate, titanium dioxide, and the 5 mg tablets contain FD&C Yellow #6 and FD&C Red #40; the 10 mg tablets contain D&C Yellow #10 and D&C Red #30.
Sources
Vivactil Manufacturers
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Teva Women’s Health, Inc.
![Vivactil (Protriptyline Hydrochloride) Tablet, Film Coated [Teva Women’s Health, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Vivactil | Teva Women's Health, Inc.
Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance. Usual Adult Dosage Fifteen to 40 mg a day divided into 3 or 4 doses. If necessary, dosage may be increased to 60 mg a day. Dosages above this amount are not recommended. Increases should be made in the morning dose. Adolescent and Elderly Patients In general, lower dosages are recommended for these patients. Five mg 3 times a day may be given initially, and increased gradually if necessary. In elderly patients, the cardiovascular system must be monitored closely if the daily dose exceeds 20 mg. When satisfactory improvement has been reached, dosage should be reduced to the smallest amount that will maintain relief of symptoms. Minor adverse reactions require reduction in dosage. Major adverse reactions or evidence of hypersensitivity require prompt discontinuation of the drug. The safety and effectiveness of protriptyline in pediatric patients have not been established.
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