Norflu 0.5 mg+10 mg Tablet

Norflu 0.5 mg+10 mg Tablet

DESCRIPTION

Norflu contains Nortriptyline and Fluphenazine.

Nortriptyline is a tricyclic antidepressant with more rapid activity and less sedation than the majority of the drugs of its class. Fluphenazine is a phenothiazine derivative of the piperazine type, its principal actions being those of tranquillization and anti-emesis. The pharmacokinetics and dose-response of both Nortriptyline and Fluphenazine are characterized by inter-individual variability. After oral administration, both Nortriptyline and Fluphenazine are well absorbed from the gastrointestinal tract and extensively metabolized during "first pass" metabolism of the liver. The plasma half-life of Nortriptyline ranges from approximately 18 to 93 hours and to that of Fluphenazine

HCl is approximately 15 hours.

COMPOSITION

Each film-coated tablet contains Nortriptyline 10 mg (as HCl) and Fluphenazine HCI BP 0.5 mg.

INDICATIONS

Mild to moderate anxiety, tension and/or agitation with or without co-existing depression.

Various forms of neuroses (anxiety, hysteria, depression, neurasthenia, hypochondria), disorders of sleep, transient situational disturbances, learning disturbances and involutional mechancholia.

DOSAGE AND ADMINISTRATION

The dosage of Norflu is flexible. The recommended daily dose is 3 tablets as a single dose in the evening or 1 tablet 3 times daily.

A children's dose has not been established, therefore it is not recommended for children.

A course of treatment with Norflu should be limited to 3 months. If the patient does not respond after 4 weeks an alternative treatment should be given.

OR AS DIRECTED BY THE PHYSICIAN.

SIDE EFFECTS

Dryness of mouth, drowsiness, faintness and constipation.

Occasionally tachycardia, nasal congestion, blurred vision

and excitement are seen.

CONTRAINDICATIONS

Norflu is contraindicated in patients with a history of hypersensitivity to Nortriptyline, Fluphenazine or any other dibenzazapines. Phenothiazines and tricyclic antidepressants have been shown to lower the threshold for electrically induced convulsions in animals; hence

Norflu is not recommended for patients with a history of epilepsy or brain damage. It is also contraindicated in patients with blood dyscrasias, severe cardiac insufficiency, renal or liver damage.

PRECAUTIONS

Norflu should be given with caution to patients with glaucoma and to those who have propensity for urinary retention. The use of this drug may impair alertness and abilities required for driving a car or operating machinery. Norflu should be used with caution in patients with cardiac failure, especially when there is evidence of rhythm disturbance, and in patients with recent myocardial infarction.

USE IN PREGNANCY

Norflu should not be used in pregnancy, especially in the first and last trimesters, unless there are compelling reasons. There is no evidence as to drug safety in human pregnancy nor are the results of animal studies conclusive.

USE IN LACTATION

Breast feeding is not recommended in women receiving Norflu.

USE IN ELDERLY

Elderly patients should be started on Norflu one tablet twice daily.

OVER DOSAGE

Symptoms of overdose may begin within several hours of ingestion. Overdosage should be treated symptomatically and supportively. If the patient is conscious, prompt gastric

lavage, dilution of the stomach contents to delay absorption, or stimulation of vomiting should be attempted.

An open airway should be maintained.

DRUG INTERACTIONS

Antacids : Concurrent administration may interfere with

Norflu absorption.

Monoamine oxidase inhibitors (MAOIs) : Concurrent administration should be avoided, as Norflu can both enhance the pressor response to adrenergic agents and antagonize the action of adrenaline and other sympathomimetics. ACE inhibitors : Hypotension may be aggravated. b-blockers : Plasma levels of Fluphenazine and the bblockers may be increased. The depression of myocardial contractility by Nortriptyline may be potentiated by bblockers. Conversely, the cardiovascular effects of bblockers may be reduced by Nortriptyline.

CNS depressants/alcohol/analgesics : The effect of these agents may be exaggerated while taking Norflu. Combined use with narcotic analgesics may cause hypotension as well as CNS or respiratory depression.

Supply

Each box contains 10 X 10 tablets in blister strips.