Pantrop

An anxiolytic benzodiazepine derivative with anticonvulsant, sedative, and amnesic properties. It has also been used in the symptomatic treatment of alcohol withdrawal.

Pantrop is indicated for the treatment of patients with moderate to severe depression associated with moderate to severe anxiety.

The therapeutic response to Pantrop occurs earlier and with fewer treatment failures than when either Pantrop or Chlordiazepoxide (Pantrop) is used alone.

Symptoms likely to respond in the first week of treatment include: insomnia, feelings of guilt or worthlessness, agitation, psychic and somatic anxiety, suicidal ideation and anorexia.

Pantrop is a tricyclic (try-SYE-klik) antidepressants. Pantrop affects chemicals in the brain that may become unbalanced.

Chlordiazepoxide (Pantrop) is in a group of drugs called benzodiazepines (ben-zoe-dye-AZE-eh-peens). Chlordiazepoxide (Pantrop) affects chemicals in the brain that may become unbalanced and cause anxiety.

The combination of Pantrop and Chlordiazepoxide (Pantrop) is used to treat depression and anxiety.

Pantrop and Chlordiazepoxide (Pantrop) may also be used for purposes not listed in this medication guide.

Optimum dosage varies with the severity of the symptoms and the response of the individual patient. When a satisfactory response is obtained, dosage should be reduced to the smallest amount needed to maintain the remission. The larger portion of the total daily dose may be taken at bedtime. In some patients, a single dose at bedtime may be sufficient. In general, lower dosages are recommended for elderly patients.

Pantrop (double strength) Tablets are recommended in an initial dosage of 3 or 4 tablets daily in divided doses; this may be increased to 6 tablets daily as required. Some patients respond to smaller doses and can be maintained on 2 tablets daily.

Pantrop Tablets in an initial dosage of 3 or 4 tablets daily in divided doses may be satisfactory in patients who do not tolerate higher doses.

How supplied

Pantrop (double strength) Tablets are available as white, film-coated, biconvex tablets containing 10 mg Chlordiazepoxide (Pantrop) and 25 mg Pantrop (as the hydrochloride salt) in bottles of 100 (NDC 0187-3806-10). Each tablet is engraved “V 3806” on one side.

Pantrop Tablets are available as blue, film-coated, biconvex tablets containing 5 mg Chlordiazepoxide (Pantrop) and 12.5 mg Pantrop (as the hydrochloride salt) in bottles of 100 (NDC 0187-3805-10). Each tablet is engraved “V 3805” on one side.

Store at 25°C (77°F); excursions permitted to 15°C – 30°C (59°F – 86°F). Store in a dry place.

Manufactured for: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724 1.866.901. Revised: Apr 2016

See also:
What is the most important information I should know about Pantrop?

Pantrop is contraindicated in patients with hypersensitivity to either benzodiazepines or tricyclic antidepressants. It should not be given concomitantly with a monoamine oxidase inhibitor. Hyperpyretic crises, severe convulsions and deaths have occurred in patients receiving a tricyclic antidepressant and a monoamine oxidase inhibitor simultaneously. When it is desired to replace a monoamine oxidase inhibitor with Pantrop, a minimum of 14 days should be allowed to elapse after the former is discontinued. Pantrop should then be initiated cautiously with gradual increase in dosage until optimum response is achieved.

This drug is contraindicated during the acute recovery phase following myocardial infarction.

Use Pantrop/Chlordiazepoxide (Pantrop) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Pantrop/Chlordiazepoxide (Pantrop) comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Pantrop/Chlordiazepoxide (Pantrop) refilled.
• Take Pantrop/Chlordiazepoxide (Pantrop) by mouth with or without food.
• Continue to use Pantrop/Chlordiazepoxide (Pantrop) even if you feel well. Do not miss any doses.
• Do not suddenly stop taking Pantrop/Chlordiazepoxide (Pantrop). Withdrawal symptoms may occur if you decrease your dose or suddenly stop taking it. Talk with your doctor about any changes to your dose.
• If you miss a dose of Pantrop/Chlordiazepoxide (Pantrop), take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pantrop/Chlordiazepoxide (Pantrop).

Use: Labeled Indications

Depression and anxiety: Treatment of moderate to severe depression associated with moderate to severe anxiety.

See also:
What other drugs will affect Pantrop?

Drug-Drug Interactions

Topiramate

Some patients may experience a large increase in Pantrop concentration in the presence of topiramate and any adjustments in Pantrop dose should be made according to the patient's clinical response and not on the basis of plasma levels.

Drug And Treatment Interactions

Because of its Pantrop component, Pantrop may block the antihypertensive action of guanethidine or compounds with a similar mechanism of action.

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 drugs as concomitant therapy. The drugs that inhibit cytochrome P450 2D6 include some that are not metabolized by the enzyme (quinidine; cimetidine) and many that are substrates for P450 2D6 (many other antidepressants, phenothiazines, and the type 1c antiarrhythmics propafenone and flecainide). While all the selective serotonin reuptake inhibitors (SSRIs), e.g., fluoxetine, sertraline and paroxetine, inhibit P450 2D6, they may vary in the extent of inhibition. The extent to which SSRI TCA interactions may pose clinical problems will depend on the degree of inhibition and the pharmacokinetics of the SSRI involved. Nevertheless, caution is indicated in the coadministration of TCAs with any of the SSRIs and also in switching from one class to the other. Of particular importance, sufficient time must elapse before initiating TCA treatment in a patient being withdrawn from fluoxetine, given the long half-life of the parent and active metabolite (at least 5 weeks may be necessary).

Concomitant use of tricyclic antidepressants with drugs that can inhibit cytochrome P450 2D6 may require lower doses than usually prescribed for either the tricyclic antidepressant or the other drug. Furthermore, whenever one of these other drugs is withdrawn from cotherapy, an increased dose of tricyclic antidepressant may be required. It is desirable to monitor TCA plasma levels whenever a TCA is going to be coadministered with another drug known to be an inhibitor of P450 2D6.

The effects of concomitant administration of Pantrop and other psychotropic drugs have not been evaluated. Sedative effects may be additive.

Cimetidine is reported to reduce hepatic metabolism of certain tricyclic antidepressants and benzodiazepines, thereby delaying elimination and increasing steady-state concentrations of these drugs. Clinically significant effects have been reported with the tricyclic antidepressants when used concomitantly with cimetidine (Tagamet).

The drug should be discontinued several days before elective surgery.

Concurrent administration of ECT and Pantrop should be limited to those patients for whom it is essential.

See also:
What are the possible side effects of Pantrop?

Adverse reactions to Pantrop are those associated with the use of either component alone. Most frequently reported were drowsiness, dry mouth, constipation, blurred vision, dizziness and bloating. Other side effects occurring less commonly included vivid dreams, impotence, tremor, confusion and nasal congestion. Many symptoms common to the depressive state, such as anorexia, fatigue, weakness, restlessness and lethargy, have been reported as side effects of treatment with both Pantrop and Pantrop.

Granulocytopenia, jaundice and hepatic dysfunction of uncertain etiology have also been observed rarely with Pantrop. When treatment with Pantrop is prolonged, periodic blood counts and liver function tests are advisable.

Note: Included in the listing which follows are adverse reactions which have not been reported with Pantrop. However, they are included because they have been reported during therapy with one or both of the components or closely related drugs.

Cardiovascular: Hypotension, hypertension, tachycardia, palpitations, myocardial infarction, arrhythmias, heart block, stroke.

Psychiatric: Euphoria, apprehension, poor concentration, delusions, hallucinations, hypomania and increased or decreased libido.

Neurologic: Incoordination, ataxia, numbness, tingling and paresthesias of the extremities, extrapyramidal symptoms, syncope, changes in EEG patterns.

Anticholinergic: Disturbance of accommodation, paralytic ileus, urinary retention, dilatation of urinary tract.

Allergic: Skin rash, urticaria, photosensitization, edema of face and tongue, pruritus.

Hematologic: Bone marrow depression including agranulocytosis, eosinophilia, purpura, thrombocytopenia.

Gastrointestinal: Nausea, epigastric distress, vomiting, anorexia, stomatitis, peculiar taste, diarrhea, black tongue.

Endocrine: Testicular swelling and gynecomastia in the male, breast enlargement, galactorrhea and minor menstrual irregularities in the female, elevation and lowering of blood sugar levels, and syndrome of inappropriate ADH (antidiuretic hormone) secretion.

Other: Headache, weight gain or loss, increased perspiration, urinary frequency, mydriasis, jaundice, alopecia, parotid swelling.