Notify your doctor if you develop chest pain,a rapid heart rate, difficulty urinating, nightmares, ringing in the ears, excessive sedation, uncoordinated movements or fainting.

Taking this medication at bedtime may help minimize side effects.

Talk to your doctor about this.

In the unlikely event you have an allergic reaction to this drug, seek medical attention immediately.

Symptoms of an allergic reaction include rash, itching, swelling, dizziness or trouble breathing. .

Precautions:

Before using this drug tell your doctor your medical history, especially of glaucoma, prostate problems, decreased urine output, thyroid disease, breathing problems, seizure problems, alcohol use, heart disease, mental/emotional problems, liver or kidney disease and of any drug allergies.

Use caution when engaging in tasks requiring alertness such as driving or operating machinery.

Limit alcohol consumption as it may increase the drowsiness and dizziness effects of this drug.

Limit exposure to hot weather as it may lead to heat stroke.

This drug should be used during pregnancy only if clearly needed.

Discuss the risks and benefits with your doctor.

This drug may be excreted into breast milk.

The effects on the infant are not known at this time.

Consult your doctor before breast-feeding.

Generic Name: Protriptyline HCl

Vivactil 10 mg Tablet - Prescription

Protriptyline HCl 10 mg Tablet - Prescription

Vivactil 5 mg Tablet - Prescription

Protriptyline HCl 5 mg Tablet - Prescription

425

http://erj.ersjournals.com/cgi/reprint/8/3/425.pdf

patients, protriptyline, Pao2, COPD, placebo, life, hypoxaemia, arterial blood gas, treatment, side-effects, exacerbations.

Effect of protriptyline, 10 mg daily, on chronic hypoxaemia in chronic obstructive pulmonary disease.

ABSTRACT: A daily dose of 20 mg of protriptyline can improve daytime arterial blood gas tensions in chronic obstructive pulmonary disease (COPD).

Twenty six patients were randomized to receive protriptyline or placebo in a double-blind parallel-group trial for 12 weeks, following a run-in period of 4 weeks, in order to assess the stability of hypoxaemia.

Laboratory evaluations There was no significant impact by protriptyline or placebo on routine laboratory evaluations.

Three patients in the protriptyline group and two patients in the placebo group experienced exacerbations of COPD during the trial (NS).

vivactil1200.pdf

http://www.citizen.org/eletter/labeling/vivactil1200.pdf

patients, drug, VIVACTIL, tricyclic antidepressant, inhibit, overdose, dosage, metabolizers, depression, dose, adverse reactions.

VIVACTIL* Tablets (Merck) (Protriptyline HCl) This product is marketed by Odyssey Pharmaceuticals, a subsidiary of Sidmak Labs.

VIVACTIL is indicated for the treatment of symptoms of mental depression in patients who are under close medical supervision.

Hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving tricyclic antidepressant and monoamine oxidase inhibiting drugs simultaneously.

VIVACTIL should be used with caution in elderly patients and patients with cardiovascular disorders; such patients should be observed closely because of the tendency of the drug to produce tachycardia, hypotension, arrhythmias, and prolongation of the conduction time.

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).

16012s38.pdf

http://www.fda.gov/cder/ogd/rld/16012s38.pdf

drug, patients, VIVACTIL, tablets, Supplement, HCI, tricyclic antidepressant, labeling, Agency, receiving, overdose.

This sentence is a repeat of information in PRECAUTIONS/ In formation for Patients and it reads: "It may impair mental and/or physical abilities required for the performance of hazardous tasks, such as operating machinery.

Supplement application S-046 provides revision of the OVERDOSAGE section of labeling in response to an Agency letter dated October 3, 1995, in order to describe current clinical toxicology recommendations on how to best manage overdoses with tricyclic antidepressants.

VIVACTIL* (Protriptyline HCI) is supplied as 5 mg and 10 mg film coated tablets.

Hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving tricyclic antidepressant and monoamine oxidase inhibiting drugs simultaneously.