Tablets 1mg DESCRIPTION stimulating gastric motility could be harmful. Cinita (Cinitapride) is a substituted bezamide used for its - Proven tardive dyskinesia to neuroleptic drugs. prokinetic (gastrointestinal motility stimulants) properties. Chemically, Cinitapride is 4-Amino-N-[1-(3-cyclohexen-1- ADVERSE REACTIONS ylmethyl)-4-piperidyl]-2-ethoxy-5-nitrobenzamide. Its Some patients may notice a slight sedation although molecular formula is C21H30N4O4.C4H6O6 and its structural cinitapride has not shown sedation while taking the formula is: recommended dose. On rare occasion, there may be extrapyramidal effects with spasm in the muscles of the face, neck and tongue which disappear when the treatment is stopped. H O N HO The following may appear on very rare occasions: O OH N - Skin reactions: rash, pruritus. - Gynecomastia. HO OH O - Very occasionally angioedema. N+ O O NH PRECAUTIONS 2 Prolonged treatment with cinitapride can cause tardive Cinitapride hydrogen tartrate dyskinesia in elderly patients. Cinitapride can prolong cardiac repolarization in invitro studies with much higher QUANTITATIVE & QUALITATIVE COMPOSITION concentrations than the plasma concentrations found in Cinita (Cinitapride) Tablets are available for oral clinical practice. administration as: Effects on ability to drive and use machines: Cinita Tablets 1mg During treatment with cinitapride, care should be taken Each tablet contains: when; Cinitapride hydrogen tartrate - driving vehicles. equivalent to cinitapride…1mg - using dangerous/ heavy machines
CLINICAL PHARMACOLOGY Pregnancy Mechanism of Action Cinitapride should not be administered in the first three Cinitapride is an orthopramide with gastrointestinal months of pregnancy Therefore, cinitapride should be prokinetic activity, with considerable muscarinic properties. used during pregnancy only if the potential benefit justifies It blocks the presynaptic serotonin receptors and increases the potential risk to the fetus. its release, resulting in greater serotonergic activity. Though it has discrete antidopaminergic activity, this adds to DRUG INTERACTIONS cinitapride’s therapeutic effect. Cinitapride efficacy could The prokinetic activity of cinitapride can alter the effects be due not only to an increase in the pressure of the of drugs listed below. inferior oesophageal sphincter but also due to its prokinetic - Cinitapride can potentiate the effects of phenothiazine effect. and other antidopaminergic drugs on the CNS. - Cinitapride can reduce the effect of digoxin by reducing Pharmacokinetics its absorption. The maximum plasma levels are reached two hours after - Anticholinergic drugs and opioid analgesics can reduce the oral administration of cinitapride. Its elimination half- the effects of Cinitapride on the digestive tract. life is 3 to 5 hours for the first 8 hours, with a residual half- life of over 15 hours with extremely low plasma levels HOW SUPPLIED after that time. No accumulation has been observed after Cinita (Cinitapride) Tablets 1mg are available in blister the repeated administra tions of Cinitapride. packs of 10’s
THERAPEUTIC INDICATIONS STORAGE Cinita (Cinitapride) is indicated in the treatment of; Store below 30°C. - Gastroesophageal Reflux. Protect from sunlight and moisture. - Functional Gastrointestinal Motility Disorders (slow The expiration date refers to the product correctly stored gastricemptying). in the required conditions. Keep out of reach of children. DOSAGE AND ADMINISTRATION Adults To be sold on prescription of a registered medical The recommended oral dose for the treatment of practitioner only. gastroesophageal reflux and functional gastrointestinal motility disorders (slow gastricemptying) is one tablet three Please read the contents carefully before use. times daily, 15 minutes before each meal. This package insert is continually updated from time to time.
Children Not recommended.
CONTRAINDICATIONS Cinitapride should not be administered to patients with, - Hemorrhages, obstructions or perforations with EX00-200007539 Manufactured by: Getz Pharma (Pvt.) Limited, 29-30/27, K.I.A., Karachi - 74900, Pakistan.