Nortriptyline Full Prescribing Information
Brand Name: Aventyl, Pamelor
Generic Name: Nortriptyline
Outside U.S., Brand Names also known as: Allegron; Allergron; Ateben; Aventyl; Kareon; Lisunim; Martimil; Noritren; Norline; Norpress; Nortrilen; Nortrix; Nortyline; Ortrip; Paxtibi; Sensaval; Sensibal; Sensival; Vividyl
Pamelor patient information (in plain English)
Nortriptyline (Aventyl, Pamelor) is a tricyclic antidepressant used to treat depression. It may also be used to treat chronic pain and other conditions as determined by your doctor.
The mechanism of mood elevation of tricyclic antidepressants is at present unknown. Nortriptyline is not an MAO inhibitor. It inhibits the activity of such diverse agents as histamine, 5-hydroxytryptamine, and acetylcholine. It increases the pressor effect of norepinephrine but blocks the pressor response of phenethylamine. Studies suggest that nortriptyline interferes with the transport, release, and storage of catecholamines.
Nortriptyline is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.
The use of Nortriptyline or other tricyclic antidepressants concurrently with a monoamine oxidase (MAO) inhibitor is contraindicated. Hyperpyretic crises, severe convulsions, and fatalities have occurred when similar tricyclic antidepressants were used in such combinations. It is advisable to have discontinued the MAO inhibitor for at least two weeks before treatment with Nortriptyline is started. Patients hypersensitive to Nortriptyline should not be given the drug.
Cross-sensitivity between Nortriptyline and other dibenzazepines is a possibility.
Nortriptyline is contraindicated during the acute recovery period after myocardial infarction.
Patients with cardiovascular disease should be given nortriptyline only under close supervision because of the tendency of the drug to produce sinus tachycardia and to prolong the conduction time. Myocardial infarction, arrhythmia, and strokes have occurred. The antihypertensive action of guanethidine and similar agents may be blocked. Because of its anticholinergic activity, use nortriptyline with great caution in patients with glaucoma or a history of urinary retention. Patients with a history of seizures should be followed closely when nortriptyline is administered because this drug is known to lower the convulsive threshold. Great care is required if nortriptyline is administered to hyperthyroid patients or those receiving thyroid medication, because cardiac arrhythmias may develop.
Nortriptyline may impair the mental and/or physical abilities required for the performance of hazardous tasks, such as operating machinery or driving a car; therefore, the patient should be warned accordingly.
Excessive consumption of alcohol in combination with nortriptyline therapy may have a potentiating effect, which may lead to the danger of increased suicidal attempts or overdosage, especially in patients with histories of emotional disturbances or suicidal ideation.
Usage in Pregnancy
Safe use of Nortriptyline during pregnancy and lactation has not been established; therefore, when the drug is administered to pregnant patients, nursing mothers, or women of childbearing potential, the potential benefits must be weighed against the possible hazards. Animal reproduction studies have yielded inconclusive results.
Usage in Children: This drug is not recommended for use in children, since safety and effectiveness in the pediatric age group have not been established.
The use of nortriptyline in schizophrenic patients may result in an exacerbation of the psychosis or may activate latent schizophrenic symptoms. If the drug is given to overactive or agitated patients, increased anxiety and agitation may occur. In manic depressive patients, nortriptyline may cause symptoms of the manic phase to emerge.
Troublesome patient hostility may be aroused by the use of nortriptyline. Epileptiform seizures may accompany its administration, as may happen with other drugs of its class.
Close supervision and careful adjustment of the dosage are required when nortriptyline is used with other anticholinergic drugs and sympathomimetic drugs.
When possible, the drug should be discontinued several days before elective surgery.
The possibility of a suicidal attempt by a depressed patient remains after the initiation of treatment; in this regard, it is important that the least possible quantity of drug be dispensed at any given time.
Both elevation and lowering of blood sugar levels have been reported.
Administration of reserpine during therapy with a tricyclic antidepressant has been shown to produce a "stimulating" effect in some depressed patients.
Close supervision and careful adjustment of the dosage are required when Nortriptyline is used with other anticholinergic drugs and sympathomimetic drugs.
Concurrent administration of cimetidine and tricyclic antidepressants can produce clinically significant increases in the plasma concentrations of the tricyclic antidepressant. The patient should be informed that the response to alcohol may be exaggerated.
A case of significant hypoglycemia has been reported in a type II diabetic patient maintained on chlorpropamide (250 mg/day), after the addition of nortriptyline (125 mg/day).
Amitriptyline may enhance the response to alcohol and the effects of barbiturates and other CNS depressants. Delirium has been reported with concurrent administration of amitriptyline and disulfiram.
BEFORE USING THIS MEDICINE: INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. This includes carbamazepine, cimetidine, dicumarol, clonidine, mibefradil, paroxetine, tramadol, other medicines for depression or emotional disorders, and medicines for seizures. Inform your doctor of any other medical conditions including heart conditions, allergies, pregnancy, or breast-feeding.
NOTE:: Some of the adverse reactions noted below have not been specifically reported with nortriptyline use. However, due to the close pharmacological similarities among the tricyclics, the reactions should be considered when prescribing nortriptyline. Within each category the following adverse reactions are listed in order of decreasing severity.
Cardiovascular: Hypotension, hypertension, tachycardia, palpitation, myocardial infarction, arrhythmias, heart block, stroke.
Psychiatric: Confusional states (especially in the elderly) with hallucinations, disorientation, delusions; anxiety, restlessness, agitation; insomnia, panic, nightmares; hypomania; exacerbation of psychosis.
Neurologic: Numbness, tingling, paresthesias of extremities; incoordination, ataxia, tremors; peripheral neuropathy; extrapyramidal symptoms; seizures, alteration in EEG patterns; tinnitus.
Anticholinergic: Dry mouth and, rarely, associated sublingual adenitis; blurred vision, disturbance of accommodation, mydriasis; constipation, paralytic ileus; urinary retention, delayed micturition, dilation of the urinary tract.
Allergic: Skin rash, petechiae, urticaria, itching, photosensitization (avoid excessive exposure to sunlight); edema (general or of face and tongue), drug fever, cross-sensitivity with other tricyclic drugs.
Hematologic: Bone marrow depression, including agranulocytosis; eosinophilia; purpura; thrombocytopenia.
Gastrointestinal: Nausea and vomiting, anorexia, epigastric distress, diarrhea, peculiar taste, stomatitis, abdominal cramps, blacktongue.
Endocrine: Gynecomastia in the male, breast enlargement and galactorrhea in the female; increased or decreased libido, impotence; testicular swelling; elevation or depression of blood sugar levels; syndrome of inappropriate ADH (antidiuretic hormone) secretion.
Other: Jaundice (simulating obstructive), altered liver function; weight gain or loss; perspiration; flushing; urinary frequency, nocturia; drowsiness, dizziness, weakness, fatigue; headache; parotid swelling; alopecia.
Withdrawal Symptoms: Though these are not indicative of addiction, abrupt cessation of treatment after prolonged therapy may produce nausea, headache, and malaise.
Toxic overdosage may result in confusion, restlessness, agitation, vomiting, hyperpyrexia, muscle rigidity, hyperactive reflexes, tachycardia, ECG evidence of impaired conduction, shock, congestive heart failure, stupor, coma, and CNS stimulation with convulsions followed by respiratory depression. Deaths have occurred following overdosage with drugs of this class.
If you or someone you know may have used more than the recommended dose of this medicine, contact your local poison control center or emergency room immediately.
No specific antidote is known. General supportive measures are indicated, with gastric lavage. Respiratory assistance is apparently the most effective measure when indicated. The use of CNS depressants may worsen the prognosis. The administration of barbiturates for control of convulsions alleviates an increase in the cardiac work load but should be undertaken with caution to avoid potentiation of respiratory depression. Intramuscular paraldehyde or diazepam provides anticonvulsant activity with less respiratory depression than do the barbiturates; diazepam seems to be preferred. The use of digitalis and/or physostigmine may be considered in case of serious cardiovascular abnormalities or cardiac failure. The value of dialysis has not been established.
After you start using this medicine, several weeks may pass before you feel the full benefit. If your symptoms do not improve after taking this medicine for 4 weeks, inform your doctor.
Do not exceed the recommended dosage or take this medicine for longer than prescribed. Do not stop taking this medicine without checking with your doctor.
- Follow the directions for using this medicine provided by your doctor.
- Store this medicine at room temperature, away from heat and light.
- If you miss a dose of this medicine, 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. If you take 1 dose daily at bedtime, do not take missed dose the next morning.
Additional Information:: Do not share this medicine with others for whom it was not prescribed. Do not use this medicine for other health conditions. Keep this medicine out of the reach of children.
IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.
Nortriptyline is not recommended for children.
Nortriptyline is administered orally in the form of capsules. Lower than usual dosages are recommended for elderly patients and adolescents. The use of lower dosages for outpatients is more important than for hospitalized patients who will be treated under close supervision. The physician should initiate dosages at a low level and increase it gradually, checking the clinical response carefully and noting any evidence of intolerance. Following remission, maintenance medication may be required for a long period of time at the lowest dose that will maintain remission. If a patient develops minor side effects, the dosage should be reduced. The drug should be discontinued promptly if adverse effects of a serious nature or allergic manifestations occur.
Usual Adult Dose: 25 mg three or four times daily; dosage should begin at a low level and be increased as required. As an alternate regimen, the total daily dosage may be given once a day. When doses above 100 mg daily are administered, plasma levels of nortriptyline should be monitored and maintained in the optimum range of 50-150 ng/ml. Doses above 150 mg/day are not recommended.
For outpatients 75 mg of amitriptyline a day in divided doses is usually satisfactory. If necessary, this may be increased to a total of 150 mg per day. Increases are made preferably in the late afternoon and/or bedtime doses. A sedative effect may be apparent before the antidepressant effect is noted, but an adequate therapeutic effect may take as long as 30 days to develop. An alternate method of initiating therapy in outpatients is to begin with 50 to 100 mg amitriptyline at bedtime. This may be increased by 25 or 50 mg as necessary in the bedtime dose to a total of 150 mg per day.
Adolescent and Elderly Patients: 30-50 mg/day, in divided doses, or the total daily dosage may be given once a day.
Tablets:: Each No. 3 Pulvule capsule with white, opaque body and yellow, opaque cap contains: Equivalent of 10 mg nortriptyline base. Each No. 1 Pulvule capsule with white, opaque body and yellow, opaque cap contains: Equivalent of 25 mg nortriptyline base. Tartrazine-free. Bottles of 100. Identi-Code: 10 mg (H 17), 25 mg (H 19). Store at controlled room temperature (15 to 30°C).
Last updated 03/2003
The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse. Last updated 3/03.
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