Primox (Generic Nortriptyline Hydrochloride Tablets)

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Primox (Generic Nortriptyline Hydrochloride Tablets)

Generic Nortriptyline Hydrochloride Tablets

Clearsky Pharmacy

Primox (Generic Nortriptyline Hydrochloride Tablets) is used to treat the symptoms of depression. Generic Nortriptyline tablets are also used for the treatment of nicotine dependence as an aid to smoking cessation.

Primox Tablets

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Primox Tablets are manufactured by Sun Pharmaceutical Industries Ltd. (Website: www.sunpharma.com)

Nortriptyline Hydrochloride Tablets Brand Names

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Nortriptyline Hydrochloride tablets are available as Primox, Sensoval, Aventyl, Pamelor, Norpress, Allegron, Noritren, Sensival, and Nortrilen.

Active Ingredient

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The active ingredient contained in Primox tablets is Nortriptyline Hydrochloride. Each Primox tablet, for oral administration, contains Nortriptyline Hydrochloride, USP equivalent to 25 mg of Nortriptyline.

Chemical Structure

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The structure of Nortriptyline Hydrochloride is given below:

Uses of Generic Nortriptyline Tablets

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Generic Nortriptyline Hydrochloride Tablets (Primox) belong to a group of medicines called tricyclic antidepressants (TCAs) and are used to treat depression. Symptoms of depression can include feeling low in spirit, loss of interest in activities, being unable to enjoy life, poor appetite or overeating, disturbed sleep, often waking up early, loss of sex drive, lack of energy and feeling guilty over nothing.Generic Nortriptyline is also used as an aid to smoking cessation and may help you stop smoking.

Storage Instructions

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Generic Nortriptyline tablets (Primox) have to be stored at controlled room temperature i.e. from 20C to 25C (68F to 77F). Keep this as well as all other medicines away from children and pets.

Warnings

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Patients with major depressive disorder (MDD), both adult as well as pediatric, can experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, irrespective of whether they are taking antidepressant medications like Primox, and this risk may persist until significant remission occurs.

Primox Dosage

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Primox (Generic Nortriptyline Tablets) should be swallowed whole, and taken with a full glass of water. The recommended adult dose for the relief of symptoms of depression is 25 mg 3 or 4 times daily. Dosage should start at a low level and be increased as required.

Generic Nortriptyline doses above 100 mg per day are not recommended.

The dosage of Primox tablets (Generic Nortriptyline Hydrochloride) is given below:

Primox Dosage

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Start dosing prior to quit date at 25 mg/day and then increase to 75 to 100 mg when feasible over 10 days to 5 weeks. The recommended starting time is 10 to 28 days prior to the quit date and gradually increase to achieve a maintenance dose of 75 to100 mg/day when possible for a total of up to 12 weeks.

Although 12 weeks is the normal treatment duration, the doctor should have the discretion to use the medication for up to 6 months as a recent study shows some decrease in relapse to smoking with extended medication treatment.

The dosage of Primox (Generic Nortriptyline Hydrochloride Tablets) for smoking cessation is given below:

Primox Tablets

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Contraindications

Primox is contraindicated in patients with a hypersensitivity to Nortriptyline Hydrochloride or any other component of this medication. Generic Nortriptyline is contraindicated for the treatment of depression in patients 12 years of age and below.Generic Nortriptyline is contraindicated for the treatment of nocturnal enuresis.The concurrent use of Generic Nortriptyline Hydrochloride or other tricyclic antidepressants with a monoamine oxidase inhibitor (MAOI) is contraindicated.

Primox Tablets

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Contraindications

Cross-sensitivity between Nortriptyline (Primox) Hydrochloride and other dibenzazepines is a possibility.Primox (Generic Nortriptyline Tablets) is contraindicated during the acute recovery period after myocardial infarction.

Generic Nortriptyline Side Effects

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The most common Generic Nortriptyline side effects include dry mouth, sedation, constipation, and increased appetite, mild blurred vision, tinnitus, often euphoria and mania. An occasional side effect is a rapid or irregular heartbeat. Alcohol can increase some of its side effects.

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.

Generic Nortriptyline Side Effects

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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: Abrupt cessation of treatment after prolonged therapy may produce nausea, headache, and malaise.

Generic Nortriptyline Overdose

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Deaths may occur from overdosage with Primox (Generic Nortriptyline Tablets). Multiple drug ingestion (including alcohol) is common in deliberate tricyclic antidepressant overdose. Signs and symptoms of toxicity develop rapidly after tricyclic antidepressant overdose; therefore, hospital monitoring is required as soon as possible.

Generic Nortriptyline Overdose

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Symptoms of overdose include: cardiac dysrhythmias, severe hypotension, convulsions, and CNS depression, including coma. Changes in the electrocardiogram, particularly in QRS axis or width, are clinically significant indicators of tricyclic antidepressant toxicity.Other signs of Generic Nortriptyline overdose may include confusion, disturbed concentration, transient visual hallucinations, dilated pupils, agitation, hyperactive reflexes, stupor, drowsiness, muscle rigidity, vomiting, hypothermia, hyperpyrexia, or many of the symptoms listed under side effects.

Generic Nortriptyline Overdose

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Obtain an ECG and immediately start cardiac monitoring. Protect the patients airway, establish an intravenous line and initiate gastric decontamination. A bare minimum of six hours of observation with cardiac monitoring and observation for signs of CNS or respiratory depression, hypotension, cardiac dysrhythmias and/or conduction blocks, and seizures is necessary. In case signs of toxicity occur at any time during this period, extended monitoring is required.

Nortriptyline During Pregnancy

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Primox (Generic Nortriptyline Hydrochloride Tablets) has been classified by the AU TGA as Pregnancy Category C. US FDA pregnancy category: Not Assigned There are no controlled studies in pregnant women treated with Nortriptyline.Animal studies have shown reproductive toxicity.

Generic Nortriptyline Tablets

For more details on Primox Tablets click here

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Primox (Generic Nortriptyline Hydrochloride Tablets) by Sun Pharmaceutical Industries Ltd., India.