Largactil 50

Indications of Largactil 50

Chlorpromazine is indicated in the following conditions:

• Schizophrenia and other psychoses (especially paranoid), mania and hypomania.
• In anxiety psychomotor agitation excitement, violent or dangerously impulsive behaviour. Chlorpromazine is used as an adjunct in the short-term management of these conditions.
• Intractable hiccup.
• Nausea and vomiting of terminal illness (where other medicines have failed or are not available).
• Childhood schizophrenia and autism.

 

Pharmaceutical Name of Largactil 50

Sanofi Bangladesh ltd.

 

Pharmacology

Chlorpromazine is a neuroleptic that inhibits the release of hypothalamic and hypophyseal hormones by inhibiting the postsynaptic dopamine receptor in the mesolimbic dopaminergic pathway. It has antiemetic, serotonin-blocking, mild antihistaminic, and ganglion-blocking effects.

 

Dosage & Administration

Schizophrenia, Psychoses, Anxiety and Agitation

Oral-

• Adult: Initially 25 mg three times daily or 75 mg at bedtime increasing by daily amounts of 25 mg to an effective maintenance dose. This is usually in the range 75 to 300 mg daily, but some patients may require up to 1 g daily.
• Children: Under 1 Year: Do not use unless need is life saving. 1-5 Years: 0.5 mg/kg bodyweight every 4 - 6 hours to a maximum recommended dose of 40 mg daily. 6-12 Years: A third to half the adult dose, to a maximum recommended dose of 75 mg daily.
• Elderly: Start with a third to a half the usual adult dose with a more gradual increase in dosage.

Intramuscular-

• Adult: For acute relief of symptoms 25 - 50 mg every 6-8 hours.
• Children: Under 1 Year: Do not use unless need is life saving. 1-5 Years: 0.5 mg/kg bodyweight every 6 - 8 hours. Dosage is not advised to exceed 40 mg daily. 6-12 Years: 0.5 mg/kg bodyweight every 6-8 hours. Not to exceed 75 mg daily.
• Elderly: Doses in the lower range for adults should be sufficient to control symptoms, i.e. 25 mg, 8 hourly.

Intractable Hiccup (Adult)

• Oral: 25-50 mg three or four times daily.
• Intramuscular: 25-50 mg every 6-8 hours.
• Intravenous Infusion: If other routes of administration are inappropriate, give 25-50 mg in 500-1000 ml sodium chloride by slow intravenous infusion every 6-8 hours.

Nausea and Vomiting of Terminal Illness

Oral-

• Adults: 10-25 mg every 4-6 hours.
• Children: Under 1 Year: Do not use unless need is life saving. 1-5 Years: 0.5 mg/kg every 4 - 6 hours. Maximum daily dosage should not exceed 40 mg. 6-12 Years: 0.5 mg/kg every 4 - 6 hours. Maximum daily dosage should not exceed 75 mg.
• Elderly: Initially a third to half the adult dose. The physician should then use their clinical judgement to obtain control.

Intramuscular-

• Adults: 25 mg initially, then 25 - 50 mg every 3 - 4 hours until vomiting stops, then drug to be taken orally.
• Children: Under 1 Year: Do not use unless need is life saving. 1-5 Years: 0.5 mg/kg 6 - 8 hourly. It is advised that maximum daily dosage should not exceed 40 mg. 6-12 Years: 0.5 mg/kg every 6 - 8 hours. It is advised that maximum daily dosage should not exceed 75 mg.

May be taken with or without food. May be taken with meals to reduce GI discomfort.

 

Interaction of Largactil 50

Interactions that lead to lower levels of chlorpromazine: Food, alcohol, and phentropine can reduce the absorption of chlorpromazine. Antacids can slow down the absorption of chlorpromazine. Lithium and long-term use of barbiturates can lead to increased clearance of chlorpromazine.

Interactions that cause increased levels of chlorpromazine: Tricyclic antidepressants reduce the clearance of chlorpromazine and may lead to increased serum levels. Chlorpromazine combined with CYP1A2 inhibitors, especially strong (such as ciprofloxacin and fluvoxamine) or moderate (such as oral contraceptives and verofenib) inhibitors, will lead to the plasma concentration of chlorpromazine Increase. Therefore, patients may experience dose-dependent pharmacological adverse reactions of chlorpromazine.

 

Contraindications

Chlorpromazine should never be used in the following circumstances:

• Circulatory collapse.
• CNS depression, e.g. coma or drug intoxication.
• Previous history of a hypersensitivity reaction (e.g. jaundice or blood dyscrasia) to phenothiazines, especially chlorpromazine itself, or to any of the excipients contained in the tablets or injection.
• Bone marrow depression.
• Phaeochromocytoma.
• Hepatic failure or active hepatic disease.
• Chlorpromazine Injection contains sodium metabisulfite and sodium sulfite and may cause allergic-type reactions including anaphylactic symptoms and asthmatic episodes in susceptible people.

 

Side Effects of Largactil 50

The following adverse effects have been reported for chlorpromazine or phenothiazines in
general.

• Cardiovascular: Postural hypotension, ECG Changes.
• Dermatological
• Contact dermatitis, photosensitivity, urticarial, maculopapular, petechial or oedematous reactions.
• Endocrine: Elevated prolactin levels, impaired thermoregulation, hyperglycaemia, other hypothalamic effects.
• Gastrointestinal: Dry mouth, constipation.
• Immunological: Raised ANA titre, positive SLE cells.
• Genitourinary: Urinary retention.
• Haematological: Leucopenia, agranulocytosis, eosinophilia, hemolytic anaemia, aplastic anaemia, thrombocytopenic purpura and pancytopenia have been reported.

 

Pregnancy & Lactation

Pregnancy category C. Oral animal studies have shown reproductive toxicity (dose-related embryo-fetal toxicity: increased absorption and fetal death). A higher incidence of malformations was observed in mice, but only at doses that caused maternal death. There are insufficient data on the toxicity of parenteral chlorpromazine to animal reproduction. In humans, the teratogenic risk of chlorpromazine has not been assessed. Different prospective epidemiological studies using other phenothiazines have yielded conflicting results regarding the risk of teratogenicity. Chlorpromazine has been found to be excreted in human milk in varying amounts, so it is not recommended for breastfeeding mothers unless the expected benefits outweigh any potential risks.

 

Precautions & Warnings

Chlorpromazine generally should not be used in epilepsy, Parkinson’s disease, hypoparathyroidism, myasthenia gravis and prostatic hypertrophy.

 

Therapeutic Class

Anti-emetic drugs, Phenothiazine drugs, Phenothiazine related drugs

 

Storage Conditions

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

 

Generic of Largactil 50

Chlorpromazine Hydrochloride