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Product Specialties - Psychotropic

Chlorpromazine HCl
LARACTYL®

Indications:

LARACTYL is a phenothiazine neuroleptic.

It is indicated in the following conditions:

• Schizophrenia and other psychoses (especillay paranoid); mania and hypomania.
• In axiety psychomotor agitation excitement, violent or dangerously impulsive bahvior. 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 hypothemia is facilitated by LARACTYL which prevents shivering and causes vasolidation.
• Childhood schizophrenia and autism.

Interactions of Penothiazine Neuroleptics:

The CNS depressant actions of LARACTYL and other neuroleptic agents may be intensified (additively) by alcohol, barbiturates and other sedatives. Respiratory depression may occur.

The hypotensive effect of most antihypertension drugs especially alpha-adrenoceptor blocking agents may be exaggerated by LARACTYL.

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

The action of some durgs may be opposed by LARACTYL; these include amphetamine, levodopa, clorindine, guanethidine, adrenaine.

Anticholinergic agents may reduce the antipsychotic effect of LARACTYL.

Some drugs interfered with absorption of neuroleptic agents: antacids, anti-Parkinson, lithium. Increases or decreases in the plasma concentration of a number of drugs, e.g., prophranolol, phnobarbitone have been observed but were not of clinical significance.

High doses of LARACTYL reduce the response of hypoglycaemic agents the dosage of which might have been raised.

Documented adverse clincially significant interactions occur with alcohol,guanethidine and hypoglycaemic agents. Adrenaline must not be used inpatients 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 a 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 jaudice and is associated with obstructions of the canaliculi by bile thrombi; the frequent presence of an accompanying eosipnophilia 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 volum depleted subjects are particularly susceptible; it is more likely to occur after intramuscular administration.

Extrapyramidal:

Acute dystonias of dyskinesias, usally 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 month of treatment. One or more of the following may be seen: tremor, rigidity, akinesia or other features of Parkinsonisms. Commonly just tremor.

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

Skin and Eyes:

Contact skin sensitisation is a serious but rare complication in those frequently handling preparations of LARACTYL: the greatest care 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.

Contraindication, 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 unless the physician considers it essential.

Precautions:

LARACTYL should be avoided in patients with liver or renal dysfunction, epilepsy. Parkinson's disease, hypothyrodism, cardiac failure, phaeochromocytoma, myasthenia gravis, prostate hypetrophy. 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-hypotenia).

Patients should be warned about drowsiness during the early days of treatment, and advised not to drive or operate machinery.

The elderly are particularly susceptibe to pustural hypotension.

Dosage & Administration:

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

Elderly of debilitated patients: Start with 1/3 to ½ the usual adult dose with a more gradual increase dosage.

Dosage should be low to beginwith the 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, Durgs, Devices and Cosmetics Act prohibits dispensing without prescription.

Availability:

Box of 100's of 50mg film coated tablets
Box of 100's of 100mg film coated tablets
Box of 100 of 200mg fil coated tablets

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