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ISONIAZID + PYRIDOXINE HCl

Laractyl®



100 mg film coated tablet
200 mg film coated tablet

INDICATIONS:
Laractyl is a phenothiazine neuroleptic. It is indicated in the following conditions:

- Schizophrenia and other psychoses (especially paranoia); mania and hypomania.
- In anxiety psychomotor agitation excitement, violent or danger- ously impulsive behavior. It is used as an adjunct in the short term management of these conditions.
- Intractable hiccup.
- Nausea and vomiting of terminal illness (where other drugs have failed or are not available).
- Induction of hypothermia is facilitated by Laractyl which prevents
shivering and causes vasodilation.
- Childhood schizophrenia and autism.

Pharmacokinetics:
Laractyl is rapidly absorbed and widely distributed in the body. It is metabolized in the liver and excreted in the urine and bile. While plasma concentration of Laractyl itself rapidly declines, excretion of Laractyl metabolites are very slow. The drug is highly bound to plasma protein. It readily diffuses across the placenta. Small quantities have been detected in milk from treated women. Children require smaller dosage per kg than adults.

Interactions of phenothiazine neuroleptics: The CNS depressant actions of Laractyl and other neuroleptic agents may be intensified (additively) by an alcohol, barbiturates and other sedatives. Respiratory depression may occur.

The hypotensive effect of most antihypertensive drugs especially alpha-adrenoreceptor blocking agents may be exaggerated by Laractyl.

The mild anticholinergic effect of Laractyl may be enhanced by other anticholinergic drugs possibly leading to constipation, heat stroke, etc.

The action of some drugs may be opposed by Laractyl: these include amphetamine, levodopa, clonidine, guanethidine, adrenaline.

Anticholinergic agents may reduce the antipsychotic effect of Laractyl.

Some drugs interfere with absorption of neuleptic agents: antacids, anti-parkinson, lithium. Increases or decreases in the plasma concentration of a number of drugs, e.g. propranolol, phenobarbitone have been observed but were not of clinical significance.

High doses of Laractyl reduce the response to hypoglycemic agents the dosage of which might have been raised.

Documented adverse clinically significant interactions occur with alcohol, guanethidine and hypoglycemic agents. Adrenaline must not be used in patients overdose with Laractyl.

Simultaneous administration of desferrioxamine and prochlorperazine has been observed to induce a transient metabolic encephalopathy characterized by loss of consciousness for 48 - 72 hours. It is possible that this may occur with Laractyl since it shares many of the pharmacological activities of prochlorperazine.

Minor side effects: Nasal stuffiness, dry mouth, insomnia, agitation.

Adverse effects:
Liver function: Jaundice, usually transient, occurs in a very small percentage of patients taking Laractyl. A premonitory sign may be sudden onset of fever after one to three weeks of treatment followed by the development of jaundice. Laractyl jaundice has the biochemical and other characteristics of obstructive jaundice and is associated with obstructions of the canaliculi by bile thrombi; the frequent presence of an accompanying eosinophilia indicates the allergic nature of this phenomenon. Treatment should be withheld on the development of jaundice.

Cardio-respiratory:
Hypotension, usually postural, commonly occurs. Elderly or volume depleted subjects are particularly susceptible; it is more likely to occur after intramuscular administration.

Cardiac arrhythmias, including atrial arrhythmia, A-V block, venticulartachycardia and fibrillation have been reported during neurologic therapy, possibly related to dosage. Pre-existing cardiac disease, old age, hypokalaemia and concurrent tricyclic antidepressants may predispose. ECG changes, usually benign, include widened QT interval, ST depression, U-waves and T-waves changes.
v Respiratory depression is possible in susceptible patients.


Blood picture: A mild leucopenia occurs in up to 30% of patients on prolonged high dosage. Agranulocytosis may occur rarely; it is not dose related. The occurrence of unexplained infections or fever requires immediate haematological investigation.

Extrapyramidal: Acute dystonias or dyskinesias, usually transitory are more common in children and young adults, and usually occur within the first 4 days of treatment or after dosage increases.

Akathisia characteristically occurs after large initial doses.

Parkinsonism is more common in adults and the elderly. It usually develops after weeks or months of treatment. One or more of the following may be seen: tremor, rigidity, akinesia or other features of Parkinsonism. Commonly just tremor.

Tardive dyskinesia. If this occurs it is usually, but not necessarily, after prolonged or high dosage. It san even occur after treatment has been stopped. Dosage should be kept low whenever possible.

Skin and eyes: Contact skin sensitisationis a serious but rare complication in those frequently handling preparations of Laractyl: the greatest mare must be taken to avoid contact of the drug with the skin. Skin rashes of various kinds may also be seen in patients treated with the drug. Patients on high dosage should be warned that they may develop photosensitivity in sunny weather and should avoid exposure to direct sunlight.

Contraindications, Warnings: There is inadequate evidence of the safety of Laractyl in human pregnancy but it has been widely used for many years without apparent ill consequence. There is evidence of harmful effects in animals. Like other drugs it should be avoided in pregnancy unlessthe physician considers it essential.

It may occasionally prolong labour and at such a time should be withheld until the cervix is dilated 3 - 4 cm. Possible adverse effect on the neonate include lethargy or paradoxical hyperexcitability, tremor and low Apgar score. Laractyl being excreted in the milk, breastfeeding should be suspended during treatment.

Precautions: Laractyl should be avoided in patients with liver or renal dysfunction, epilepsy, Parkinson's disease, hypothyroidism, cardiac failure, phaeochromocytoma, myasthenia gravis, prostate hypertrophy. It should be avoided in patients known to be hypersensitive to phenothiazines or with a history of narrow angle glaucoma. It should be used with caution in the elderly, particularly during very hot or very cold weather (risk of hyper-hypothermia).

Patients should be warned about drowsiness during early days of treatment, and advised not to drive or operate machinery. The elderly are particularly susceptible to postural hypotension.

Dosage and administration:

Oral: Excessive anxiety tension and agitation (adult) - Initially 25 mg t.i.d. or 75 mg at bedtime increasing daily amounts of 25 mg to an effective maintenance dose. This is usually in the range of 75 - 300mg daily, but some patients may require 1 g daily.

Elderly or debilitated patients: Start with 1/3 to the usual adult dose with a more gradual increase in dosage.

Dosage should be low to begin with and gradually increased under close supervision until the optimum dosage within the recommended range for the individual is reached. Individuals vary considerably and the optimum dose may be affected by the formulation used.

Caution: Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.

Availability:
Box of 100's of 100 mg film coated tablets
Box of 100's of 200 mg film coated tablets

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