Prokinin tablet & susp patient information leaflet

Prokinin tablet & susp patient information leaflet

• 1.
  Prokinin@ Domperidone Tablets andSuspension Composition: Prokinln Tablets: Each tablet contains to mg Domperidone. Proklnln suspension: Each 5m1contains 5 mg Domperidone. Properties: Domperidone is a dopamine-receptor blocking agent. Its action on the dopamine-receptors in the chemo-emetic trigger zone produces an anti-emetic effect. It does not cross the blood-brain barrier to any appreciable degree. Domperidone increases the duration 01 antral and duodenal CQl)tractiQ!!Uo increase gastric emptying,. but it does not alter gastric secretions and has no effect on intracranial pressure or in the cardiovascular system. Domperidone is rapidly absorbed, with peak plasma concentration at approximately 1 hour after oral administration, the bioavailability is low (approximately 15%) due to first pass hepatic and intestinal metabolism, it is 91-93 % bound to plasma proteins, the plasma half life after a single oral dose is 7-9 hours in healthy patients but it is prolonged in patients with sever renal insufficiency. Indications: A) The dyspeptJc symptom complex that is often assooateo With delayed gastric emptying, gastro-oesophageal reflux and oesophagitis: epigastric sense of fullness, early satiety, feeling of abdominal distension, upper abdominal pain; bloating, eructation, flatulence; nausea and vomiting; heartburn with or without regurgitations of gastric contents in the mouth. b) Nausea and vomiting of functional, organIC_ Infectious or dietetic origin or .induced b radiotherapy 0( therapy_ A SPOCllIIC'lnOica . is nausea . dopa.- agonists, as used in Parkinson's tflSea5e (such as L- dopa and brornocriptine). Contraindications: Proklnin is contraindicated for patients with known hypersensitivity to any of tts components. Dompendone should not be used whenever stimulation of gastric motilijy is to be avoided or could be harmful, ego In case of gastro-intestinal haemorrhage, obstruction or perforation. Domperidone is contraindicated.Ja.patients wilb a prolactin- releasing pituitary tumor (prolactinoma). --- Precautions: Domperidone given to animals at doses up ID 160 mgI1<g/day did not produce teratoge . e eels. However, as most mecflClneS, Prokinin shou during the first trimester of pregnancy if anticipated therapeutIC bene Up to now, there has been no evidence of any III the risk of malformations in humans. The drug is excreted in breast rnilk of ~ rats metabolites: peak concentration of 40 and 800 ngJml after o<aI and i.v. administration of 2.5 mglkg respectively). In women domperidone concentrations in breast milk are 4 times lower than corresponding plasma concentrations. It is not known whether this is harmful to the new born. Therefore nursing is not recommended for mothers who are taking Proklnin, unless the expected benefits outweigh any potential risk. Interactions with other drugs: Concomitant administration with Amantadine leads to extrapyramidal side effects. Anti-muscarinic agents and opioid analgesics may antagonize the effect of prokinin. Concomitant administration with Bromocriptine or Cabergoline leads to Possible antagonism of hypoprolacbnaemic effect. Concomitant administration with Paracetamol or Benorllate increases the absorption of them. Warnings: Generally patients on prologed therapy should be reviewd regularly. Domperidone is highly metabolised in liver, so prokinin should be used with caution in patients ~ hepatic impairment (and in the elderly). Used with caution in patients with renal impairment or in those at risk of fluid retention. Dosageand Administration: 1. Chronic dyspepsia Adults: 10 mg (1 tablet or 10 ml) 3 times daily, 15-30 minutes before meals and if necessary, once more before retiring. Children: Oral suspension: 2.5 ml per 10 kg body weigh~ 3 times daily before meals and, if necessary, once more •• the evening. When results are not satisfactory, the above dosage may be doubled in aduijs and children over 1 year of age. 2. Acute and subacute conditions (pat1JCUIar1ynausea and vomiting) Aduijs: 20 mg (2 tablets or 20 mI) 3-4 tmes dally be ore meals and before bedtime. ChoIdren: 2 x 2.5 ml per 10 body weight, 3-4 times daily belore meals and before bedtime. Overdosage: Symptoms of overdosage may include drowsiness, disorientation. In case of 0V€<00Sage gastric lavage and administration 01 activated charcoal may be Symptomatic and st:lIXl<1IVe treatment are recommended. Side Effects: R3Jsed proiactm concentratIOn (possible galactorrhoea and gynaecomastia), reduced libido, rasihes and other allergic reactions, acute dystonic reactions. Coosutt your Pharmacist or Physician if any side effect is observed. PharmaceuticalPrecautions: Keep at room temperature (15-30 ·C). Do not use beyond the expiry date Of if the product shows any sign of deterioration. Presentation: Proklnln Suspension: Bottle of 18Oml. Proklnln Tablets: Pad< of 30 Tablets. Hospital packs are available. ® is a trademarl<. IS A MEDICAMENT a :.oduct which affects your health and lis O:~~~~~~~~ k¥S _ 5 prescnpoon, the method of use and '" instructions of the pharmacist who sold the medicament. • The doctor and the pharmacist are experts in medicine, its benefits and risks. • Do not by yourself interrupt the period of treatment prescribed for you. • Do not repeat the same prescription without consulting your doctor. Keep medicament out of reach of children. Council ers & Unoon at Arab Pharmacists. ManuloC_br. TABUl( CEUTICAL MANUFACTURING COMPANY, P.O. Box 3633. ABUK, SAUDI ARABIA. pharmacia pharmacia pharmacia pharmacia