COMPOSITIONS :
| Domperidone maleate Suspension 5 mg/5 ml, each 5 ml (a measuring spoon) contains : Domperidonee maleate equivalent to Domperidone 5 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 Suspension 5 mg/5 ml Bottle @ 60 ml
Reg. No. GKL1102344933A1
STORAGE :
Domperidone maleate Suspension 5 mg/5 ml :
STORE BELOW 30ºC, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
