Prokinin- Domperidone Tablets and Suspension

Composition

Prokinin Tablets: Each tablet contains 10 mg Domperidone.

Prokinin suspension : Each 5ml contains 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 of antral and duodenal gastric emptying but it does not alter gastric secretions and has no effect on intracranial pressure or on 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 severe renal insufficiency.

PROKININ TABLETS
PROKININ TABLETS

Indications

The dyspeptic symptom comptex that is often associated 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 regurgitation of gastric contents in the mouth.

Nausea and vomiting of functional, organic, infectious or dietetic origin or induced by radiotherapy or drug therapy.  A specific indication is nausea and vomiting induced by dopamine agonists, as used in Parkinson’s disease (such as L- dopa and bromocriptine).

Contraindications

  • Prokinin is contraindicated for patients with known hypersensitivity to any of its components.
  • Domperidone should not be used whenever stimulation of gastric motility is to be avoided or could be harmful, eg. In case of gastro-intestinal haemorrhage, obstruction or perforation.
  • Domperidone is contraindicated on-patients with a prolactin-releasing pituitary tumor prolactinoma).

Precautions

Domperidone given to animals at doses up to 160 mg/kg/day did not produce teratogenic effects. However, as most medicines, Prokinin only be used during the first trimester of pregnancy if this is justified by the anticipated therapeutic benefit up to now, there has been no evidence of any increase in the risk of malformations in humans.

The drug is excreted in breast milk of lactating rats( mostly as metabolites: peak concentration of 40 and 800 ng/ml after oral and i.v. administration of 2.5 mg/kg 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 newborn.

Therefore nursing is not recommended for mothers who are taking Prokinin, unless the expected benefits outweigh any potential risk.

Interactions with other drugs

Concomitant administration with Amantadine leads to extrapyramidal side effects.

Antimuscarinic agents and opioid analgesics may antagonize the effect of prokinin.

Concomitant administration with Bromocriptine or Cabergoline leads to Possible antagonism of hyperprolactinemic effect.

Concomitant administration with Paracetamol or Benorilate increases the absorption of them.

Prokinin syrup
Prokinin syrup

Warnings

  • Generally patients on prolonged therapy should be reviewed regularly.
  • Domperidone is highly metabolised in liver so prokinin should be used with caution in patients with hepatic impairment (and in the elderly).
  • Used with caution in patients with renal impairment or in those at risk of fluid retention.

Dosage and Administration

    • Chronic dyspepsia- Adults dosage: 10 mg( 1 tablet or 10 ml) 3 times  daily, 15 to 30 minutes before meals and it necessary, once more before retiring.
    • Chronic dyspepsia- Children dosage: Oral suspension: 2.5 ml per 10 kg body weight, 3 times daily  before meals and, if necessary, once more in the evening.
    • When results are not satisfactory. the above dosage may be doubled in adults and children over 1 year of age.
    • Acute and subacute conditions (particularly nausea and vomiting)- Adults dosage: 20 mg  (2 tablets or 20 ml) 3 to 4 times daily before meals and before bedtime.
  • Acute and subacute conditions (particularly nausea and vomiting)- children dosage: 2 x 2.5 ml per 10 kg body weight, 3 to 4 times daily before meals and before bedtime.

Overdosage

Symptoms of overdosage may include drowsiness, disorientation. In case of overdosage gastric lavage and administration of activated charcoal may be useful. Symptomatic  treatment are recommended.

Side effects

Side effects are rare.Raised prolactin concentration (possible galactorrhoea and gynaecomastia), reduced libido. rashes and other allergic reactions, acute dystonic reactions. Consult your Pharmacist or Physician if any side effect is observed.

Pharmaceutical Precautions

  • Keep at room temperature.
  • Do not use beyond the expiry date or it the product shows any sign of deterioration.
  • Presentation: Prokinin Suspension: Bottle of 180 ml. Prokinin Tablets: Pack of 30 Tablets.

Patient information leaflet

Patient_Information_Leaflet
بروكينين- نشرة معلومات المريض
ENG - Patient Information Leaflet
PROKININ – Patient Information Leaflet

Category: ALIMENTARY TRACT AND METABOLISM.

Tags: DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS, PROPULSIVES, domperidone, ATC code: A03FA03.

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