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Vivactil

Generic Name: Protriptyline HCl
Drug Category: Tricyclic Antidepressant
Litigation Alert Level: Medium
This drug has been approved for use by males and females over the age of 18 years old for a maximum duration of 1 year.

Approved Uses

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 Its activating properties make it particularly suitable for withdrawn and anergic patients.

It should be noted that protriptyline hydrochloride is not approved for use in treating bipolar depression.

This drug should not be used during the acute recovery phase following myocardial infarction.

When protriptyline is used to treat the depressive component of schizophrenia, psychotic symptoms may be aggravated. Likewise, in manic-depressive psychosis, depressed patients may experience a shift toward the manic phase if they are treated with an antidepressant drug. Paranoid delusions, with or without associated hostility, may be exaggerated.

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders.

Protriptyline should be used with caution in patients with a history of seizures, and, because of its autonomic activity, in patients with a tendency to urinary retention, or increased intraocular tension.

Tachycardia and postural hypotension may occur more frequently with protriptyline than with other antidepressant drugs. Protriptyline 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. Myocardial infarction and stroke have occurred with drugs of this class.

The pupillary dilation that occurs following use of many antidepressant drugs including protriptyline may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.

In patients who may use alcohol excessively, it should be borne in mind that the potentiation may increase the danger inherent in any suicide attempt or overdosage.

Vivactil should not be given concomitantly with a monoamine oxidase inhibiting compound. Hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving tricyclic antidepressant and monoamine oxidase inhibiting drugs simultaneously. When it is desired to substitute protriptyline for a monoamine oxidase inhibitor, a minimum of 14 days should be allowed to elapse after the latter is discontinued.

On rare occasions, hyperthyroid patients or those receiving thyroid medication may develop arrhythmias when this drug is given.

Vivactil is contraindicated in patients taking cisapride because of the possibility of adverse cardiac interactions including prolongation of the QT interval, cardiac arrhythmias and conduction system disturbances.

Protriptyline may block the antihypertensive effect of guanethidine or similarly acting compounds.

Tricyclic antidepressants may enhance the seizure risk in patients taking ULTRAM (tramadol hydrochloride).

Caution is indicated in the co-administration of TCAs with any of the SSRIs and also in switching from one class to the other.

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 co-therapy, an increased dose of tricyclic antidepressant may be required.

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).

Cimetidine is reported to reduce hepatic metabolism of certain tricyclic antidepressants, thereby delaying elimination and increasing steady-state concentrations of these drugs.

When protriptyline is given with anticholinergic agents or sympathomimetic drugs, including epinephrine combined with local anesthetics, close supervision and careful adjustment of dosages are required.

Hyperpyrexia has been reported when tricyclic antidepressants are administered with anticholinergic agents or with neuroleptic drugs, particularly during hot weather.

Tricyclic antidepressants may enhance the seizure risk in patients taking ULTRAM (tramadol-hydrochloride).

Protriptyline may enhance the response to alcohol and the effects of barbiturates and other CNS depressants.

Discontinue the drug several days before elective surgery, if possible.

Safe use in pregnancy and lactation has not been established.

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Off-label Uses

• Dosage greater than 60 mg a day. GoToSource

• Use in patients under the age of 18. GoToSource

• Chronic pain. GoToSource

• Attention-deficit hyperactivity disorder. GoToSource 

• Migraine prophylaxis. GoToSource 

• Chronic tension-type headaches and weight loss. GoToSource 

• Chronic obstructive pulmonary disease. GoToSource 

• Activating/stimulant medication in patients with head injury. GoToSource 

• Reversal of chronic diabetes insipidus. GoToSource 

• Obstructive sleep apnea. GoToSource

Adverse Events

Tinnitus. GoToSource 

Painful ejaculation. GoToSource 

Delirium. GoToSource

Hiatal herniation. GoToSource

Blurred vision, postural hypotension, cardiac arrhythmias and palpitations. GoToSource

Narrow-angle glaucoma, urinary retention, confusion, constipation, water retention, impaired sexual function and increased heart rate. GoToSource

Increased risk of preterm birth, low birth weight, respiratory distress, hypoglycemia, low apgar score and convulsions. GoToSource

Anxiety, agitation, weight gain, paralytic ileus, seizures, stroke and rash. GoToSource

Gynecomastia. GoToSource

Suicidal ideation and behavior. GoToSource

Litigation

Lawsuits filed for suicidal ideation and behavior. 

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

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Site Last Updated April 26, 2024