Perphenazine and Amitriptyline Hydrochloride 10 mg/1
perphenazine and amitriptyline hydrochloride · TABLET, FILM COATED · Mylan Pharmaceuticals Inc.
Perphenazine and Amitriptyline Hydrochloride is a tablet, film coated containing perphenazine and amitriptyline hydrochloride at 10 mg/1, taken oral. Manufactured by Mylan Pharmaceuticals Inc..
Key Facts
- Brand Name
- Perphenazine and Amitriptyline Hydrochloride
- Generic Name
- perphenazine and amitriptyline hydrochloride
- NDC Code (Product)
0378-0330- Manufacturer
- Mylan Pharmaceuticals Inc.
- Strength
- 10 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA071443
- Drug Class
- Phenothiazine [EPC]
- Marketing Start
- 11/10/1988
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Perphenazine and amitriptyline hydrochloride tablets are recommended for treatment of (1) patients with moderate to severe anxiety and/or agitation and depressed mood, (2) patients with depression in whom anxiety and/or agitation are severe, and (3) patients with depression and anxiety in association with chronic physical disease. In many of these patients, anxiety masks the depressive state so that, although therapy with a tranquilizer appears to be indicated, the administration of a tranquilizer alone will not be adequate. Schizophrenic patients who have associated depressive symptoms should be considered for therapy with perphenazine and amitriptyline hydrochloride tablets.
Dosage & Administration
DOSAGE AND ADMINISTRATION Since dosage for children has not been established, this product is not recommended for use in children. The total daily dose of perphenazine and amitriptyline hydrochloride tablets should not exceed 16 mg of perphenazine and 200 mg of amitriptyline hydrochloride. Initial Dosage In psychoneurotic patients when anxiety and depression are of such a degree as to warrant combined therapy, one tablet of the 2 mg/25 mg or 4 mg/25 mg three or four times a day or one tablet of the 4 mg/50 mg combination twice a day is recommended. In more severely ill patients with schizophrenia , the 4 mg/25 mg combination is recommended in an initial dose of two tablets three times a day. If necessary, a fourth dose may be given at bedtime. In elderly patients and adolescents, and some other patients in whom anxiety tends to predominate, perphenazine and amitriptyline hydrochloride tablet 4 mg/10 mg combination may be administered three or four times a day initially, then adjusted as required for subsequent adequate therapy. Maintenance Dosage Depending on the condition being treated, therapeutic response may take from a few days to a few weeks or even longer. After a satisfacto…
Warnings
WARNINGS Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Perphenazine and amitriptyline hydrochloride is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING ). 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 …
Contraindications
CONTRAINDICATIONS Perphenazine and amitriptyline hydrochloride tablets are contraindicated in depression of the central nervous system from drugs (barbiturates, alcohol, narcotics, analgesics, antihistamines); in the presence of evidence of bone marrow depression; and in patients known to be hypersensitive to phenothiazines or amitriptyline. It should not be given concomitantly with monoamine oxidase inhibitors. Hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving tricyclic antidepressants and monoamine oxidase inhibitors simultaneously. When it is desired to replace a monoamine oxidase inhibitor with perphenazine and amitriptyline hydrochloride, a minimum of 14 days should be allowed to elapse after the former is discontinued. Perphenazine and amitriptyline hydrochloride should then be initiated cautiously with gradual increase in dosage until optimum response is achieved. Amitriptyline hydrochloride is not recommended for use during the acute recovery phase following myocardial infarction.
Drug Interactions
Drug Interactions Topiramate Some patients may experience a large increase in amitriptyline concentration in the presence of topiramate and any adjustments in amitriptyline dose should be made according to the patient’s clinical response and not on the basis of plasma levels. Drugs Metabolized by P450 2D6 The biochemical activity of the drug metabolizing isozyme cytochrome P450 2D6 (debrisoquin hydroxylase) is reduced in a subset of the Caucasian population (about 7% to 10% of Caucasians are so called "poor metabolizers"); reliable estimates of the prevalence of reduced P450 2D6 isozyme activity among Asian, African, and other populations are not yet available. Poor metabolizers have higher than expected plasma concentrations of tricyclic antidepressants (TCAs) when given usual doses. Depending on the fraction of drug metabolized by P450 2D6, the increase in plasma concentration may be small, or quite large (8-fold increase in plasma AUC of the TCA). In addition, certain drugs inhibit the activity of this isozyme and make normal metabolizers resemble poor metabolizers. An individual who is stable on a given dose of TCA may become abruptly toxic when given one of these inhibiting dr…
Adverse Reactions
ADVERSE REACTIONS To date, clinical evaluation of perphenazine has not revealed any adverse reactions peculiar to the combination. The adverse reactions that occurred were limited to those that have been reported previously for perphenazine and amitriptyline. Treatment with perphenazine and amitriptyline hydrochloride is commonly associated with sedation, hypertension, neurological impairments and dry mouth. Perphenazine The common acute neurological effects of neuroleptic drugs, including perphenazine, consist of dystonia, akathisia or motor restlessness, and pseudoparkinsonism. More chronic use of neuroleptics may be associated with the development of tardive dyskinesia. The salient features of this syndrome are described in the WARNINGS section and below. The following adverse reactions have been reported and, within each category, are listed in order of decreasing severity. Neurological Tardive Dyskinesia The syndrome is characterized by involuntary choreoathetoid movements which variously involve the tongue, face, mouth, lips, or jaw (e.g., protrusion of the tongue, puffing of cheeks, puckering of the mouth, chewing movements), trunk and extremities. The severity of the syndro…
Frequently Asked Questions
What is Perphenazine and Amitriptyline Hydrochloride used for?
Perphenazine and Amitriptyline Hydrochloride contains perphenazine and amitriptyline hydrochloride. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Perphenazine and Amitriptyline Hydrochloride a controlled substance?
Perphenazine and Amitriptyline Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Perphenazine and Amitriptyline Hydrochloride?
The generic name for Perphenazine and Amitriptyline Hydrochloride is perphenazine and amitriptyline hydrochloride. There are no other listed brand versions of perphenazine and amitriptyline hydrochloride.
What is the NDC code for Perphenazine and Amitriptyline Hydrochloride 10 mg/1?
The NDC (National Drug Code) for Perphenazine and Amitriptyline Hydrochloride 10 mg/1 is 0378-0330, listed by Mylan Pharmaceuticals Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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