Arictin

Cyproheptadine Hydrochloride USP

Composition:

Arictin Tablet: Each tablet contains cyproheptadine hydrochloride USP 4mg

Clinical Pharmacology:

Cyproheptadine hydrochloride is a serotonin and histamine antagonist with anticholinergic and sedative effects. Antiserotonin and antihistamine drugs appear to compete with serotonin and histamine, respectively, for receptor sites.

Indications:

• Rash and pruritus in a variety of conditions
• Appetite stimulation
• Anorexia nervosa
• Cushing’s and nelson’s syndrome
• Carcinoid syndrome
• Acromegaly and hyperprolactinemia
• Migraine
• Antidepressant-induced inorgasmia.

Dosage & Administration:

Usual adult and adolescent dose:

Initially 4 mg every eight hours, the dosage being increased as needed. For most patients the therapeutic range is 4 - 20 mg a day. However, doses up to 32 mg a day have been used occasionally.

4 mg three times a day with meals (treatment period to promote weight gain should not exceed six months).

Initial: 4 mg at the start of the attack, repeated after thirty minutes if necessary.

Maintenance: 4 mg every four to six hours.

Usual paediatric dose:

125 mcg (0.125 mg) per kg of body weight or 4 mg per square meter of body surface, every eight to twelve hours as needed or for

Children 2 - 6 years of age: 2 mg every 8-12 hours as needed, not to exceed 12 mg per day.

Children 6 - 14 years of age: 4 mg every 8-12 hours as needed, not to exceed 16 mg per day.

Children 2 - 6 years of age: initially 2 mg 2-3 times a day with meals. The dosage may be increased, if necessary, but not to exceed 8 mg a day.

Children 6 - 14 years of age: initially 2 mg every 3-4 times a day with meals. The usual maintenance dose is 4 mg 2-3 times a day. The dosage may be increased, if necessary, but not to exceed 16 mg a day (treatment period to promote weight gain should not exceed 3 months).

Side-effects:

Prolonged therapy may cause blood dyscrasias. Anaphylactic reactions and hepatitis have been reported. Acute toxic effects mainly relate to the anticholinergic actions and include a variety of neurological and psychiatric disturbances, hypotension with palpitations and tachycardia, dry mouth and gastrointestinal upsets, difficulties with micturation and retention of urine, wheezing and nasal blockage. Nausea, fatigue, appetite increase and drowsiness have been reported.

Contraindications:

Cyproheptadine is contraindicated in-

• patients undergoing therapy for an acute asthmatic attack
• newborn or premature infants
• breast-feeding mothers
• patients with known sensitivity to cyproheptadine hydrochloride or drugs with similar chemical structure;
• concurrent use with monoamine oxidase inhibitors;
• glaucoma
• patients with pyloroduodenal obstruction, stenosing peptic ulcer, symptomatic prostatic hypertrophy, predisposition to urinary retention or bladder neck obstruction;
• elderly, debilitated patients.
  

Use in pregnancy:

Pregnancy Category B: Studies in pregnant women have not shown that cyproheptadine increase the risk of abnormalities when administered during the first, second and third trimesters of pregnancy. No teratogenic effects have been observed in any of the newborns. Nevertheless, because the studies in human cannot rule out the possibility of harm, cyproheptadine should be used during pregnancy only if clearly needed.

Use in nursing mothers:

It is not known whether this drug is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from cyproheptadine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Paediatric use:

Safety and effectiveness in paediatric patients below the age of two have not been established.

Cautions:

Drug Interactions:

MAO inhibitors prolong and intensify the anticholinergic effects of cyproheptadine.

Antihistamines may have additive effects with alcohol and other CNS depressants, e.g. hypnotics, sedatives, tranquillizers and anti-anxiety agents.

Storage:

Store below 40 C, protected from light. Keep out of the reach of children.

Packing:

Arictin Tablet: Box containing 10×10's tablets in blister pack.