GI Norm

GI Norm

domperidone

Manufacturer:

Amherst Lab

Distributor:

UNILAB, Inc
Concise Prescribing Info
Contents
Domperidone
Indications/Uses
Dyspeptic symptom complex associated w/ delayed gastric emptying, GERD, esophagitis eg, epigastric sense of fullness, feeling of abdominal distention, upper abdominal pain; eructation, flatulence, heartburn. Short-term treatment of nausea & vomiting of various origins including functional, organic, infectious, dietetic origin or induced by radiotherapy or medicine therapy. Nausea & vomiting induced by dopamine agonists. Nausea & vomiting associated w/ migraine together w/ paracetamol.
Dosage/Direction for Use
Adult & childn >12 yr weighing ≥35 kg Short-term treatment of nausea & vomiting 10-20 mg tid-qid. Max: 80 mg/day. Dyspeptic symptom complex associated w/ delayed gastric emptying, GERD or esophagitis 10 mg qid (last dose to be taken at night), may be increased to 20 mg if necessary. Initial course of treatment should not exceed 2-4 wk. Symptomatic treatment of nausea & vomiting associated w/ migraine 20 mg 4 hrly w/ paracetamol, as needed, up to a max of 4 doses in 24 hr. Treatment should not exceed 2 wk.
Administration
Should be taken on an empty stomach: Take 15-30 min before meals & if necessary, at bedtime.
Special Precautions
Hypersensitivity. Patients w/ long QT syndrome; GI hemorrhage, GI obstruction, perforation or conditions where GI stimulation or movements may be dangerous; prolactin-releasing pituitary tumor (prolactinoma).
Adverse Reactions
Diarrhea; abnormal liver function test; QTc prolongation, ventricular arrhythmia, sudden death. Life-threatening tachyarrhythmias, atrial fibrillation, ventricular tachycardia, bradycardia, palpitation, torsades de pointes, cardiac arrest; central effects eg, extrapyramidal reactions (Parkinson-like movements), including acute dystonic reactions, convulsions; drowsiness, dry mouth, headache/migraine, insomnia, somnolence, nervousness, agitation, dizziness, thirst, lethargy, irritability; increased prolactin levels leading to galactorrhea, mastalgia, amenorrhea, gynecomastia, decreased libido; gynecomastia w/o galactorrhea; increase thyroid stimulating hormone (TSH); skin rashes, itch.
Drug Interactions
Increased plasma conc & prolonged QTc interval w/ oral ketoconazole, fluconazole, voriconazole, erythromycin, clarithromycin, telithromycin, amiodarone, SSRIs, HIV PIs, Ca antagonists.
ATC Classification
A03FA03 - domperidone ; Belongs to the class of propulsives. Used in the treatment of functional gastrointestinal disorders.
Presentation/Packing
Form
GI Norm FC tab 10 mg
Packing/Price
10's
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