Oraxin syrup

Cyproheptadine is a serotonin and histamine antagonist with sedative property. It finds clinical application in stimulating the appetite and growth. The appetite stimulating effect of cyproheptadine is probably a consequence of serotonin antagonism.

It antagonizes the satiety stimulating effects of serotonin on the satiety center.

Weight gain and increased growth in children that have been observed with cyproheptadine can be attributed to an interference with regulation of the secretion of growth hormone.

Peptone is a rich source of not only essential but also of other amino acids. Lysine is an essential amino acid, which is required for the growth. A diet consisting mainly of rice or wheat is largely deficient in lysine and has to be supplemented.

Oraxin Syrup is indicated for loss of appetite, weight loss, anorexia nervosa and as an adjunct to antitubercular and antiretroviral regimens for weight gain.

• Use of Oraxin Syrup is contraindicated in newborn or premature infants.

• Because of the higher risk of antihistamines, newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers.

• Other contraindications to Oraxin Syrup include hypersensitivity to any ingredient of formulation, angle-closure glaucoma, stenosing peptic ulcer, symptomatic prostatic hypertrophy, bladder neck obstruction and pyloroduodenal obstruction.

PRECAUTIONS:

Cyproheptadine has an atropine-like action and therefore, should be used with caution in patients with history of bronchial asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease and hypertension.

Antihistamines may diminish mental alertness; conversely, particularly, in a young child, they may occasionally produce excitation. Patients should be warned about engaging in activities requiring mental alertness and motor co-ordination.

WARNING:

Overdose of antihistamines, particularly in infants and children, may produce hallucinations, central nervous system (CNS) depression, convulsions and death. Antihistamines are more likely to cause dizziness, sedation and hypotension in elderly patients.

Monoamine oxidase (MAO) inhibitors prolong and intensify the anticholinergic effects of antihistamines.

Oraxin Syrup may have additive effects with alcohol and other CNS depressants, e.g., hypnotics, sedatives, tranquilizers, antianxiety agents.

Adverse reactions associated with Oraxin Syrup can be attributed to cyproheptadine.

These may Include sedation (often transient), dizziness, disturbed co-ordination, confusion, restlessness; rash, urticaria; blurred vision, diplopia, vertigo, tinnitus; hypotension, palpitations, tachycardia; dryness of mouth, anorexia, diarrhoea, constipation, urinary retention; dryness of nose and throat and thickening of bronchial secretions.

Children:

Below 3 years – 2.5 mL twice daily,

4-7 years – 2.5 mL thrice daily,

7-14 years – 5 mL thrice daily.

Adults:

10 mL thrice daily.

OVERDOSAGE:

With Oraxin Syrup overdosage reactions may vary from CNS depression to simulation especially in children. Also, atropine-like signs and symptoms as well as gastrointestinal symptoms may occur.

If vomiting has not occurred spontaneously, the patient should be induced to vomit with syrup of ipecac.

If patient is unable to vomit, perform gastric lavage followed by activated charcoal. Isotonic saline is the lavage of choice.

Precautions against aspiration must be taken especially in infants and children. When life threatening CNS signs and symptoms are present, intravenous physostigmine salicylate may be considered.

Dosage and frequency of administration are dependent on age, clinical response and recurrence after response. Saline cathartics, as milk of magnesia, by osmosis draw into the bowel and therefore, are valuable for their action in rapid dilution of bowel content. Stimulants should not be used.

Vasopressors may be used to treat hypotension. The oral LD50 of cyproheptadine is 123 mg/kg, and 295 mg/kg in the mouse and rat, respectively.

Store at temperature between 15 – 30°C in a dark place.

Keep medicines out of the reach of children.