ProkininⓇ Patient Information Leaflet

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 that acts on the chemo-emetic trigger zone, producing an anti-emetic effect. It does not cross the blood-brain barrier significantly.

  • Increases duration of antral and duodenal contractions for enhanced gastric emptying.
  • No effect on gastric secretions, intracranial pressure, or the cardiovascular system.
  • Rapid absorption with peak plasma concentration at approximately 1 hour after oral administration.

Indications

Prokinin is indicated for:

  • Dyspeptic symptoms associated with delayed gastric emptying, gastro-oesophageal reflux, and oesophagitis.
  • Nausea and vomiting of various origins, including functional, organic, infectious, or induced by radiotherapy or drug therapy.

Contraindications

Do not use Prokinin if:

  • Hypersensitivity to any of its components.
  • Stimulation of gastric motility is to be avoided (e.g., gastrointestinal hemorrhage, obstruction, or perforation).
  • Patients have a prolactin-releasing pituitary tumor (prolactinoma).

Precautions

Exercise caution in:

  • Patients with hepatic or renal impairment.
  • Use during the first trimester of pregnancy is justified by therapeutic benefit.
  • Nursing mothers; benefits should outweigh potential risks.

Dosage and Administration

Chronic Dyspepsia:

  • Adults: 10 mg (1 tablet or 10 ml) 3 times daily before meals, and if necessary, once more before retiring.
  • Children: Oral suspension: 2.5 ml per 10 kg body weight, 3 times daily before meals, and if necessary, once more in the evening.

Acute and Subacute Conditions:

  • Adults: 20 mg (2 tablets or 20 ml) 3-4 times daily before meals and bedtime.
  • Children: 2 x 25 ml per 10 kg body weight, 3-4 times daily before meals and bedtime.

Overdosage

Symptoms may include drowsiness and disorientation. In case of overdosage, gastric lavage and activated charcoal may be useful. Seek symptomatic and supportive treatment.

Side Effects

Side effects are rare and may include raised prolactin concentration, reduced libido, rashes, and acute dystonic reactions. Consult your healthcare professional if any side effects are observed.

Pharmaceutical Precautions

  • Keep at room temperature (15-30 °C).
  • Do not use beyond the expiry date or if the product shows any sign of deterioration.

Warnings

Patients on prolonged therapy should be regularly reviewed. Use with caution in patients with hepatic impairment or renal impairment. Do not interrupt the prescribed treatment without consulting your doctor.

Manufactured by

Rosheta.com, Tabuk Pharmaceutical Manufacturing Company, P.O. Box 3633, Tabuk, Saudi Arabia.

Important Note

This information is intended for educational purposes and is not a substitute for professional medical advice. Always follow your doctor’s prescription and consult your healthcare professional if you have any concerns or questions.