DOMPERIDONE 10mg Film Coated Tablet

COMPOSITIONS :

Domperidone maleate Film coated tablet 10 mg, each film coated tablet contains : Domperidone maleate equivalent to Domperidone 10 mg.

 

DESCRIPTIONS : 

Domperidone maleate contains Domperidone maleate (equivalent to Domperidone) is available in film coated tablet 10 mg and suspension 5 mg/5 ml.

Domperidone contains Domperidone is available in drops 5 mg/ml.

 

INDICATIONS :

Adults :

  • For acute nausea and vomiting. Not recommended for prevention routinely in vomiting after operation.
  • For nausea and vomiting induced by Levodopa and Bromocriptine, Domperidone should not be use for more than 12 weeks.
  • Treatment of functional dyspepsia symptoms. Not recommended for prolonged therapy.

Children :

  • Not recommended, except for nausea and vomiting in patients on chemotherapy and radiotherapy.

 

DOSAGE AND ADMINISTRATIONS : 

Film coated tablet

Functional dyspepsia :

  • Adults and elderly : 1 – 2 tablets, 3 times daily and 1 – 2 tablets once more before retiring depending on clinical response. Do not use exceeding 12 weeks.
  • Children : Not recommended.

Nausea and vomiting (include induced by Levodopa and Bromocriptine) :

  • Adults (and in the elderly) : 1 – 2 tablets, with interval 4 – 8 hours.
  • Children (on chemotherapy and radiotherapy) : 0.2 – 0.4 mg/kgBW daily, with interval 4 – 8 hours.

Suspension

Functional dyspepsia :

  • Adults and elderly : 2 – 4 measuring spoons (10 – 20 ml), 3 times daily and 2 – 4 measuring spoons (10 – 20 ml) once more before retiring depending on clinical response. Do not use exceeding 12 weeks.
  • Children : Not recommended.

Nausea and vomiting (include induced by Levodopa and Bromocriptine) :

  • Adults (and elderly) : 2 – 4 measuring spoons (10 – 20 ml), with interval 4 – 8 hours.
  • Children (on chemotherapy and radiotherapy) : 0.2 – 0.4 mg/kgBW daily, with interval 4 – 8 hours.

Drops

  • Children (on chemotherapy and radiotherapy) : 0.2 – 0.4 mg/kgBW daily, with interval 4 – 8 hours.

Domperidone Film coated tablet, suspension and drops should be taken 15 – 30 minutes before meals and before retiring.

 

OVERDOSAGE : 

  • There has been no experience with overdosage of oral Domperidone.
  • There is no specific antidote to Domperidone, but in the event of overdosage, gastric lavage may be useful.

 

CONTRAINDICATIONS : 

    • Patient with known hypersensitivity to Domperidone.
    • Children (except for preventing nausea and vomiting on chemotherapy and radiotherapy).
  • Patient with prolactinoma and pituitary tumor which produce prolactin.

 

WARNINGS AND PRECAUTIONS : 

  • Used with caution in pregnant women or nursing mothers. 
  • Not recommended for long term treatment.
  • Used with caution in patients with hepatic and renal impairments.

 

DRUG INTERACTIONS : 

  • Domperidone reduce hypoprolactinaemic effects of Bromocriptine.
  • Concomitant administration of anticholinergic drugs and opioid analgesic may antagonize the effects of Domperidone.
  • Concomitant administration of Domperidone with antacids may decrease the bioavailability of Domperidone. 
  • The bioavailability effects may increase from 13% become 23% if the drug is taken 1½ hours after meals.

 

ADVERSE REACTIONS : 

  • Rare cases have been reported : Sedation, dystonic extrapyramidal reactions, Parkinson, tardive dyskinesia (in adults and elderly) and may give antiparkinson drugs.
  • Increased plasma prolactin levels and it may cause galactorrhea and gynaecomastia.
  • Dry mouth, headache, diarrhea, rash, thirst, anxiety, pruritus.

 

PRESENTATIONS :

Domperidone maleate Film coated tablet 10 mg Box, 10 blisters @ 10 film coated tablets         Reg. No. GKL1102343417A1

 

STORAGE : 

Domperidone maleate Film coated tablet 10 mg :

STORE BELOW 30ºC, PROTECT FROM LIGHT

 

ON MEDICAL PRESCRIPTION ONLY

 

Manufactured by :

BERNOFARM

Sidoarjo – Indonesia