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Perphenazine and Amitriptyline Hydrochloride

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Overview

What is Perphenazine and Amitriptyline Hydrochloride?

Perphenazine and amitriptyline hydrochloride, a broad spectrum psychotherapeutic agent for the management of outpatients and hospitalized patients with psychoses or neuroses characterized by mixtures of anxiety or agitation with symptoms of depression, is a combination of perphenazine and amitriptyline hydrochloride. Since such mixed syndromes can occur in patients with various degrees of intensity of mental illness, perphenazine and amitriptyline hydrochloride tablets are provided in multiple combinations to afford dosage flexibility for optimum management.

Perphenazine is a phenothiazine derivative. The formula is 4-[3-(2-chloro-10-phenothiazin-10yl) propyl]-piperazineethanol. Perphenazine, USP is a white, odorless, bitter tasting powder that is insoluble in water. The molecular weight is 403.97. Its structural formula is:

Amitriptyline is a dibenzocycloheptadiene derivative. The formula is 10,11-dihydro-,-dimethyl-5-dibenzo[a,d]cycloheptene-∆,γ -propylamine hydrochloride. Amitriptyline hydrochloride, USP is a white, odorless, crystalline compound which is freely soluble in water. The molecular weight is 313.87. Its structural formula is:

Each tablet for oral administration contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (corn), sodium lauryl sulfate and titanium dioxide.

The following additional product specific inactive ingredients are employed:

2 mg/10 mg - hydroxypropyl cellulose2 mg/25 mg - hydroxypropyl cellulose4 mg/10 mg - polysorbate 804 mg/25 mg - hydroxypropyl cellulose4 mg/50 mg - hydroxypropyl cellulose

The following product specific coloring agents are employed:

2 mg/10 mg - calcium sulfate, talc2 mg/25 mg - D&C Red No. 7 Calcium Lake, FD&C Blue No. 1 Aluminum Lake4 mg/10 mg - FD&C Blue No. 1 Aluminum Lake4 mg/25 mg - FD&C Yellow No. 6 Aluminum Lake4 mg/50 mg - D&C Red No. 7 Calcium Lake, FD&C Blue No. 1 Aluminum Lake



What does Perphenazine and Amitriptyline Hydrochloride look like?



What are the available doses of Perphenazine and Amitriptyline Hydrochloride?

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What should I talk to my health care provider before I take Perphenazine and Amitriptyline Hydrochloride?

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How should I use Perphenazine and Amitriptyline Hydrochloride?

Perphenazine and amitriptyline hydrochloride tablets are recommended for treatment of (1) patients with(2) patients with and (3) patients with 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

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.


What interacts with Perphenazine and Amitriptyline Hydrochloride?

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.



What are the warnings of Perphenazine and Amitriptyline Hydrochloride?

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What are the precautions of Perphenazine and Amitriptyline Hydrochloride?

Leukopenia, Neutropenia, and Agranulocytosis

In clinical trial and postmarketing experience, events of leukopenia/neutropenia and agranulocytosis have been reported temporally related to antipsychotic agents.

Possible risk factors for leukopenia/neutropenia include preexisting low white blood cell count (WBC) and history of drug induced leukopenia/neutropenia. Patients with a preexisting low WBC or a history of drug induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and should discontinue perphenazine and amitriptyline hydrochloride tablets at the first sign of a decline in WBC in the absence of other causative factors.

Patients with neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur. Patients with severe neutropenia (absolute neutrophil count
General

The possibility of suicide in depressed patients remains during treatment and until significant remission occurs. Such patients should not have access to large quantities of this drug.

Perphenazine

As with all phenothiazine compounds, perphenazine should not be used indiscriminately. Caution should be observed in giving it to patients who have previously exhibited severe adverse reactions to other phenothiazines.

Some of the untoward actions of perphenazine tend to appear more frequently when high doses are used. However, as with other phenothiazine compounds, patients receiving perphenazine in any dosage should be kept under close supervision.

The antiemetic effect of perphenazine may obscure signs of toxicity due to overdosage of other drugs, or render more difficult the diagnosis of disorders such as brain tumors or intestinal obstruction.

A significant, not otherwise explained, rise in body temperature may suggest individual intolerance to perphenazine, in which case this product should be discontinued.

Neuroleptic drugs elevate prolactin levels; the elevation persists during chronic administration. Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin dependent a factor of potential importance if the prescription of these drugs is contemplated in a patient with a previously detected breast cancer. Although disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been reported, the clinical significance of elevated serum prolactin levels is unknown for most patients. An increase in mammary neoplasms has been found in rodents after chronic administration of neuroleptic drugs. Neither clinical studies nor epidemiologic studies conducted to date, however, have shown an association between chronic administration of these drugs and mammary tumorigenesis; the available evidence is considered too limited to be conclusive at this time.

Amitriptyline Hydrochloride

Depressed patients, particularly those with known manic depressive illness, may experience a shift to mania or hypomania. Patients with paranoid symptomatology may have an exaggeration of such symptoms. The tranquilizing effect of this product seems to reduce the likelihood of these effects.

Both elevation and lowering of blood sugar levels have been reported.

Amitriptyline hydrochloride should be used with caution in patients with impaired liver functions.

Information for Patients

While on therapy with perphenazine and amitriptyline hydrochloride, patients should be advised as to the possible impairment of mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle.

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with perphenazine and amitriptyline hydrochloride and should counsel them in its appropriate use. A patient Medication Guide about “Antidepressant Medicines, Depression and other Serious Mental Illnesses and Suicidal Thoughts or Actions” is available for perphenazine and amitriptyline hydrochloride. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.

Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking perphenazine and amitriptyline hydrochloride.

Patients should be advised that taking perphenazine and amitriptyline hydrochloride can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle-closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle-closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible.

Patients, their families and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day to day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication.

Drug Interactions

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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.

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Pediatric Use

Safety and effectiveness in the pediatric population have not been established (see and ). Anyone considering the use of perphenazine and amitriptyline hydrochloride in a child or adolescent must balance the potential risks with the clinical need.


What are the side effects of Perphenazine and Amitriptyline Hydrochloride?

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 section and below.

The following adverse reactions have been reported and, within each category, are listed in order of decreasing severity.

Neurological

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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 syndrome and the degree of impairment produced vary widely.

The syndrome may become clinically recognizable either during treatment, upon dosage reduction, or upon withdrawal of treatment. Movements may decrease in intensity and may disappear altogether if further treatment with neuroleptics is withheld. It is generally believed that reversibility is more likely after short rather than long term neuroleptic exposure. Consequently, early detection of tardive dyskinesia is important. To increase the likelihood of detecting the syndrome at the earliest possible time, the dosage of neuroleptic drug should be reduced periodically (if clinically possible) and the patient observed for signs of the disorder. It has been suggested that fine vermicular movements of the tongue may be an early sign of the syndrome, and that the full blown syndrome may not develop if medication is stopped when lingual vermiculation appears.

Cardiovascular

Hypotension, hypertension, tachycardia, peripheral edema, occasional change in pulse rate, ECG abnormalities (quinidine like effect), reversed epinephrine effect.

CNS and Neuromuscular

Extrapyramidal symptoms, including acute dyskinesia (see ), reactivation of psychoses and production of catatonic like states, paradoxical excitement, ataxia, muscle weakness, hypnotic effects, mild insomnia, lassitude, headache, hyperflexia, altered cerebrospinal fluid proteins.

Autonomic:

Allergic:

Hematologic:

Gastrointestinal:

Dermatologic:

Ophthalmic:

Endocrine:

Other:

Other adverse reactions that should be considered because they have been reported with various phenothiazine compounds, but not with perphenazine, include:

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Amitriptyline Hydrochloride

Within each category the following adverse reactions are listed in order of decreasing severity. Included in the listing which follows are a few adverse reactions which have not been reported with this specific drug. However, pharmacological similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when amitriptyline is administered.

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Withdrawal Symptoms

After prolonged administration, abrupt cessation of treatment may produce nausea, headache, and malaise. Gradual dosage reduction has been reported to produce, within 2 weeks, transient symptoms including irritability, restlessness, and dream and sleep disturbance. These symptoms are not indicative of addiction. Rare instances have been reported of mania or hypomania occurring within 2 to 7 days following cessation of chronic therapy with tricyclic antidepressants.


What should I look out for while using Perphenazine and Amitriptyline Hydrochloride?

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.


What might happen if I take too much Perphenazine and Amitriptyline Hydrochloride?

 Deaths may occur from overdosage with this class of drugs. Multiple drug ingestion (including alcohol) is common in deliberate overdose. As the management is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment. Signs and symptoms of toxicity develop rapidly after overdose, therefore, hospital monitoring is required as soon as possible.


How should I store and handle Perphenazine and Amitriptyline Hydrochloride?

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Freezing does not adversely affect the product, but exposure to elevated temperatures should be avoided. Protect from light. Store vials in carton until used.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Freezing does not adversely affect the product, but exposure to elevated temperatures should be avoided. Protect from light. Store vials in carton until used.Perphenazine and Amitriptyline Hydrochloride Tablets, USP are available in the following combinations:The 2 mg/10 mg combination tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0330-01bottles of 100 tabletsNDC 0378-0330-05bottles of 500 tabletsThe 2 mg/25 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0442-01bottles of 100 tabletsNDC 0378-0442-05bottles of 500 tabletsThe 4 mg/10 mg combination tablets are blue, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0042-01bottles of 100 tabletsThe 4 mg/25 mg combination tablets are orange, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0574-01bottles of 100 tabletsNDC 0378-0574-05bottles of 500 tabletsThe 4 mg/50 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0073-01bottles of 100 tabletsStore 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.PHARMACIST:* Topic: Antidepressants, Tricyclic. Micromedex Inc. Vol 85.Perphenazine and Amitriptyline Hydrochloride Tablets, USP are available in the following combinations:The 2 mg/10 mg combination tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0330-01bottles of 100 tabletsNDC 0378-0330-05bottles of 500 tabletsThe 2 mg/25 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0442-01bottles of 100 tabletsNDC 0378-0442-05bottles of 500 tabletsThe 4 mg/10 mg combination tablets are blue, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0042-01bottles of 100 tabletsThe 4 mg/25 mg combination tablets are orange, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0574-01bottles of 100 tabletsNDC 0378-0574-05bottles of 500 tabletsThe 4 mg/50 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0073-01bottles of 100 tabletsStore 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.PHARMACIST:* Topic: Antidepressants, Tricyclic. Micromedex Inc. Vol 85.Perphenazine and Amitriptyline Hydrochloride Tablets, USP are available in the following combinations:The 2 mg/10 mg combination tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0330-01bottles of 100 tabletsNDC 0378-0330-05bottles of 500 tabletsThe 2 mg/25 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0442-01bottles of 100 tabletsNDC 0378-0442-05bottles of 500 tabletsThe 4 mg/10 mg combination tablets are blue, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0042-01bottles of 100 tabletsThe 4 mg/25 mg combination tablets are orange, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0574-01bottles of 100 tabletsNDC 0378-0574-05bottles of 500 tabletsThe 4 mg/50 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0073-01bottles of 100 tabletsStore 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.PHARMACIST:* Topic: Antidepressants, Tricyclic. Micromedex Inc. Vol 85.Perphenazine and Amitriptyline Hydrochloride Tablets, USP are available in the following combinations:The 2 mg/10 mg combination tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0330-01bottles of 100 tabletsNDC 0378-0330-05bottles of 500 tabletsThe 2 mg/25 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0442-01bottles of 100 tabletsNDC 0378-0442-05bottles of 500 tabletsThe 4 mg/10 mg combination tablets are blue, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0042-01bottles of 100 tabletsThe 4 mg/25 mg combination tablets are orange, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0574-01bottles of 100 tabletsNDC 0378-0574-05bottles of 500 tabletsThe 4 mg/50 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0073-01bottles of 100 tabletsStore 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.PHARMACIST:* Topic: Antidepressants, Tricyclic. Micromedex Inc. Vol 85.Perphenazine and Amitriptyline Hydrochloride Tablets, USP are available in the following combinations:The 2 mg/10 mg combination tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0330-01bottles of 100 tabletsNDC 0378-0330-05bottles of 500 tabletsThe 2 mg/25 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0442-01bottles of 100 tabletsNDC 0378-0442-05bottles of 500 tabletsThe 4 mg/10 mg combination tablets are blue, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0042-01bottles of 100 tabletsThe 4 mg/25 mg combination tablets are orange, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0574-01bottles of 100 tabletsNDC 0378-0574-05bottles of 500 tabletsThe 4 mg/50 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0073-01bottles of 100 tabletsStore 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.PHARMACIST:* Topic: Antidepressants, Tricyclic. Micromedex Inc. Vol 85.Perphenazine and Amitriptyline Hydrochloride Tablets, USP are available in the following combinations:The 2 mg/10 mg combination tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0330-01bottles of 100 tabletsNDC 0378-0330-05bottles of 500 tabletsThe 2 mg/25 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0442-01bottles of 100 tabletsNDC 0378-0442-05bottles of 500 tabletsThe 4 mg/10 mg combination tablets are blue, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0042-01bottles of 100 tabletsThe 4 mg/25 mg combination tablets are orange, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0574-01bottles of 100 tabletsNDC 0378-0574-05bottles of 500 tabletsThe 4 mg/50 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0073-01bottles of 100 tabletsStore 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.PHARMACIST:* Topic: Antidepressants, Tricyclic. Micromedex Inc. Vol 85.Perphenazine and Amitriptyline Hydrochloride Tablets, USP are available in the following combinations:The 2 mg/10 mg combination tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0330-01bottles of 100 tabletsNDC 0378-0330-05bottles of 500 tabletsThe 2 mg/25 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0442-01bottles of 100 tabletsNDC 0378-0442-05bottles of 500 tabletsThe 4 mg/10 mg combination tablets are blue, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0042-01bottles of 100 tabletsThe 4 mg/25 mg combination tablets are orange, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0574-01bottles of 100 tabletsNDC 0378-0574-05bottles of 500 tabletsThe 4 mg/50 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0073-01bottles of 100 tabletsStore 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.PHARMACIST:* Topic: Antidepressants, Tricyclic. Micromedex Inc. Vol 85.Perphenazine and Amitriptyline Hydrochloride Tablets, USP are available in the following combinations:The 2 mg/10 mg combination tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0330-01bottles of 100 tabletsNDC 0378-0330-05bottles of 500 tabletsThe 2 mg/25 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0442-01bottles of 100 tabletsNDC 0378-0442-05bottles of 500 tabletsThe 4 mg/10 mg combination tablets are blue, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0042-01bottles of 100 tabletsThe 4 mg/25 mg combination tablets are orange, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0574-01bottles of 100 tabletsNDC 0378-0574-05bottles of 500 tabletsThe 4 mg/50 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0073-01bottles of 100 tabletsStore 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.PHARMACIST:* Topic: Antidepressants, Tricyclic. Micromedex Inc. Vol 85.Perphenazine and Amitriptyline Hydrochloride Tablets, USP are available in the following combinations:The 2 mg/10 mg combination tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0330-01bottles of 100 tabletsNDC 0378-0330-05bottles of 500 tabletsThe 2 mg/25 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0442-01bottles of 100 tabletsNDC 0378-0442-05bottles of 500 tabletsThe 4 mg/10 mg combination tablets are blue, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0042-01bottles of 100 tabletsThe 4 mg/25 mg combination tablets are orange, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0574-01bottles of 100 tabletsNDC 0378-0574-05bottles of 500 tabletsThe 4 mg/50 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0073-01bottles of 100 tabletsStore 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.PHARMACIST:* Topic: Antidepressants, Tricyclic. Micromedex Inc. Vol 85.Perphenazine and Amitriptyline Hydrochloride Tablets, USP are available in the following combinations:The 2 mg/10 mg combination tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0330-01bottles of 100 tabletsNDC 0378-0330-05bottles of 500 tabletsThe 2 mg/25 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0442-01bottles of 100 tabletsNDC 0378-0442-05bottles of 500 tabletsThe 4 mg/10 mg combination tablets are blue, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0042-01bottles of 100 tabletsThe 4 mg/25 mg combination tablets are orange, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0574-01bottles of 100 tabletsNDC 0378-0574-05bottles of 500 tabletsThe 4 mg/50 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0073-01bottles of 100 tabletsStore 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.PHARMACIST:* Topic: Antidepressants, Tricyclic. Micromedex Inc. Vol 85.Perphenazine and Amitriptyline Hydrochloride Tablets, USP are available in the following combinations:The 2 mg/10 mg combination tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0330-01bottles of 100 tabletsNDC 0378-0330-05bottles of 500 tabletsThe 2 mg/25 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0442-01bottles of 100 tabletsNDC 0378-0442-05bottles of 500 tabletsThe 4 mg/10 mg combination tablets are blue, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0042-01bottles of 100 tabletsThe 4 mg/25 mg combination tablets are orange, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0574-01bottles of 100 tabletsNDC 0378-0574-05bottles of 500 tabletsThe 4 mg/50 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0073-01bottles of 100 tabletsStore 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.PHARMACIST:* Topic: Antidepressants, Tricyclic. Micromedex Inc. Vol 85.Perphenazine and Amitriptyline Hydrochloride Tablets, USP are available in the following combinations:The 2 mg/10 mg combination tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0330-01bottles of 100 tabletsNDC 0378-0330-05bottles of 500 tabletsThe 2 mg/25 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0442-01bottles of 100 tabletsNDC 0378-0442-05bottles of 500 tabletsThe 4 mg/10 mg combination tablets are blue, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0042-01bottles of 100 tabletsThe 4 mg/25 mg combination tablets are orange, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0574-01bottles of 100 tabletsNDC 0378-0574-05bottles of 500 tabletsThe 4 mg/50 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0073-01bottles of 100 tabletsStore 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.PHARMACIST:* Topic: Antidepressants, Tricyclic. Micromedex Inc. Vol 85.Perphenazine and Amitriptyline Hydrochloride Tablets, USP are available in the following combinations:The 2 mg/10 mg combination tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0330-01bottles of 100 tabletsNDC 0378-0330-05bottles of 500 tabletsThe 2 mg/25 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0442-01bottles of 100 tabletsNDC 0378-0442-05bottles of 500 tabletsThe 4 mg/10 mg combination tablets are blue, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0042-01bottles of 100 tabletsThe 4 mg/25 mg combination tablets are orange, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0574-01bottles of 100 tabletsNDC 0378-0574-05bottles of 500 tabletsThe 4 mg/50 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0073-01bottles of 100 tabletsStore 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.PHARMACIST:* Topic: Antidepressants, Tricyclic. Micromedex Inc. Vol 85.Perphenazine and Amitriptyline Hydrochloride Tablets, USP are available in the following combinations:The 2 mg/10 mg combination tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0330-01bottles of 100 tabletsNDC 0378-0330-05bottles of 500 tabletsThe 2 mg/25 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0442-01bottles of 100 tabletsNDC 0378-0442-05bottles of 500 tabletsThe 4 mg/10 mg combination tablets are blue, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0042-01bottles of 100 tabletsThe 4 mg/25 mg combination tablets are orange, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0574-01bottles of 100 tabletsNDC 0378-0574-05bottles of 500 tabletsThe 4 mg/50 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0073-01bottles of 100 tabletsStore 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.PHARMACIST:* Topic: Antidepressants, Tricyclic. Micromedex Inc. Vol 85.Perphenazine and Amitriptyline Hydrochloride Tablets, USP are available in the following combinations:The 2 mg/10 mg combination tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0330-01bottles of 100 tabletsNDC 0378-0330-05bottles of 500 tabletsThe 2 mg/25 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0442-01bottles of 100 tabletsNDC 0378-0442-05bottles of 500 tabletsThe 4 mg/10 mg combination tablets are blue, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0042-01bottles of 100 tabletsThe 4 mg/25 mg combination tablets are orange, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0574-01bottles of 100 tabletsNDC 0378-0574-05bottles of 500 tabletsThe 4 mg/50 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0073-01bottles of 100 tabletsStore 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.PHARMACIST:* Topic: Antidepressants, Tricyclic. Micromedex Inc. Vol 85.Perphenazine and Amitriptyline Hydrochloride Tablets, USP are available in the following combinations:The 2 mg/10 mg combination tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0330-01bottles of 100 tabletsNDC 0378-0330-05bottles of 500 tabletsThe 2 mg/25 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0442-01bottles of 100 tabletsNDC 0378-0442-05bottles of 500 tabletsThe 4 mg/10 mg combination tablets are blue, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0042-01bottles of 100 tabletsThe 4 mg/25 mg combination tablets are orange, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0574-01bottles of 100 tabletsNDC 0378-0574-05bottles of 500 tabletsThe 4 mg/50 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0073-01bottles of 100 tabletsStore 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.PHARMACIST:* Topic: Antidepressants, Tricyclic. Micromedex Inc. Vol 85.Perphenazine and Amitriptyline Hydrochloride Tablets, USP are available in the following combinations:The 2 mg/10 mg combination tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0330-01bottles of 100 tabletsNDC 0378-0330-05bottles of 500 tabletsThe 2 mg/25 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0442-01bottles of 100 tabletsNDC 0378-0442-05bottles of 500 tabletsThe 4 mg/10 mg combination tablets are blue, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0042-01bottles of 100 tabletsThe 4 mg/25 mg combination tablets are orange, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0574-01bottles of 100 tabletsNDC 0378-0574-05bottles of 500 tabletsThe 4 mg/50 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0073-01bottles of 100 tabletsStore 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.PHARMACIST:* Topic: Antidepressants, Tricyclic. Micromedex Inc. Vol 85.Perphenazine and Amitriptyline Hydrochloride Tablets, USP are available in the following combinations:The 2 mg/10 mg combination tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0330-01bottles of 100 tabletsNDC 0378-0330-05bottles of 500 tabletsThe 2 mg/25 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0442-01bottles of 100 tabletsNDC 0378-0442-05bottles of 500 tabletsThe 4 mg/10 mg combination tablets are blue, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0042-01bottles of 100 tabletsThe 4 mg/25 mg combination tablets are orange, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0574-01bottles of 100 tabletsNDC 0378-0574-05bottles of 500 tabletsThe 4 mg/50 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0073-01bottles of 100 tabletsStore 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.PHARMACIST:* Topic: Antidepressants, Tricyclic. Micromedex Inc. Vol 85.Perphenazine and Amitriptyline Hydrochloride Tablets, USP are available in the following combinations:The 2 mg/10 mg combination tablets are white, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0330-01bottles of 100 tabletsNDC 0378-0330-05bottles of 500 tabletsThe 2 mg/25 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0442-01bottles of 100 tabletsNDC 0378-0442-05bottles of 500 tabletsThe 4 mg/10 mg combination tablets are blue, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0042-01bottles of 100 tabletsThe 4 mg/25 mg combination tablets are orange, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0574-01bottles of 100 tabletsNDC 0378-0574-05bottles of 500 tabletsThe 4 mg/50 mg combination tablets are purple, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-0073-01bottles of 100 tabletsStore 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.PHARMACIST:* Topic: Antidepressants, Tricyclic. Micromedex Inc. Vol 85.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

In common with all members of the piperazine group of phenothiazine derivatives, perphenazine has greater behavioral potency than phenothiazine derivatives of other groups without a corresponding increase in autonomic, hematologic, or hepatic side effects.

Extrapyramidal effects, however, may occur more frequently. These effects are interpreted as neuropharmacologic. They usually regress after discontinuation of the drug.

Perphenazine is a potent tranquilizer and also a potent antiemetic. Orally, its milligram potency is about 5 or 6 times that of chlorpromazine with respect to behavioral effects. It is capable of alleviating symptoms of anxiety, tension, psychomotor excitement, and other manifestations of emotional stress without apparent dulling of mental acuity.

Non-Clinical Toxicology
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.

In clinical trial and postmarketing experience, events of leukopenia/neutropenia and agranulocytosis have been reported temporally related to antipsychotic agents.

Possible risk factors for leukopenia/neutropenia include preexisting low white blood cell count (WBC) and history of drug induced leukopenia/neutropenia. Patients with a preexisting low WBC or a history of drug induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and should discontinue perphenazine and amitriptyline hydrochloride tablets at the first sign of a decline in WBC in the absence of other causative factors.

Patients with neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur. Patients with severe neutropenia (absolute neutrophil count
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.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).