Monell

Monell

domperidone

Manufacturer:

Novell Pharma
Full Prescribing Info
Contents
Domperidone.
Action
Domperidone is a dopamine antagonist which has antiemetic properties.
The antiemetic effect is caused by a combination of peripheral (gastrokinetics) and antagonist effect to the dopamine receptor at the chemoreceptor trigger zone (CTZ) in the area postrema at the outer part of the blood brain barrier.
Domperidone given by oral administration prolongs antral and duodenal contraction, enhance gastric emptying of liquid and semisolid form in healthy people and solid form in delayed gastric emptying patient, and increases lower esophageal sphincter pressure.
Indications/Uses
Acute nausea and vomiting. Not recommended for routine prophylaxis of postoperative vomiting.
Nausea and vomiting caused by levodopa and bromocriptine administration for more than 12 weeks.
Symptomatic treatment of functional dyspepsia. Not recommended for long term administration.
Dosage/Direction for Use
Dyspepsia Functional: Adult and geriatric: 10-20 mg equivalent to 2-4 mL, 3 times daily and 10-20 mg equivalent to 2-4 mL once before bed time, depending on clinical responses. Medication should not exceed 12 weeks.
Children: The recommended dose is 0.2-0.4 mg/kg body weight.
Nausea and vomiting (including those caused by levodopa and bromocriptine): Adult and geriatric: 10-20 mg equivalent to 2-4 mL, interval time 4-8 hours.
Children (in cancer chemotherapy and radiotherapy case): 1-2 mg/kg body weight, equivalent to 0.2-0.4 mL/kg body weight per day. Take the medicine 15-30 minutes before meal and bed time.
Overdosage
Overdosage data of domperidone by oral administration has not been reported.
The specific antidote for domperidone overdose has not been determined yet. It may be performed by immediate gastric emptying.
Contraindications
Patients hypersensitive to Domperidone.
Children (except to prevent nausea and vomiting caused by cancer chemotherapy and irradiation).
Special Precautions
Caution should be taken in pregnant and lactating women.
Not recommended for long-term treatment.
Caution should be taken in patients with liver function disturbances and renal insufficiency.
Use In Pregnancy & Lactation
Caution should be taken in pregnant and lactating women.
Side Effects
Rare case: sedation, extrapyramidal reactions, dystonic parkinsonism, tardive dyskinesia (in adult and geriatric patient).
Raised serum-prolactin concentration that may lead to gallactorrhea and gynecomastia.
Dry mouth, headache, diarrhea, skin rash, thirst, anxiety urticaria.
Drug Interactions
Domperidone reduces hypoprolactinemia effect of bromocriptine.
Administration of muscarinic anticholinergic and opioid analgesic concomitantly can reduce the bioavailability of domperidone.
Antacids can reduce the bioavailability of domperidone if administered concomitantly.
Drug bioavailability may increase from 13% to 23% if administered 1.5 hours after meals.
Storage
Store below 30°C.
MIMS Class
GIT Regulators, Antiflatulents & Anti-Inflammatories
ATC Classification
A03FA03 - domperidone ; Belongs to the class of propulsives. Used in the treatment of functional gastrointestinal disorders.
Presentation/Packing
Form
Monell tab 10 mg
Packing/Price
5 × 10's (Rp190,100/boks)
Form
Monell oral susp 5 mg/5 mL
Packing/Price
60 mL x 1's (Rp42,500/botol)
Form
Monell oral drops 5 mg/mL
Packing/Price
10 mL x 1's (Rp42,500/botol)
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