GI Norm

GI Norm

domperidone

Manufacturer:

Amherst Lab

Distributor:

UNILAB, Inc
Full Prescribing Info
Contents
Domperidone.
Action
Pharmacologic Classification: Gastrokinetic/Antiemetic.
Pharmacology: This product contains domperidone, a prokinetic agent which increases the movements or contractions of the stomach and intestines. This results in increased motility and coordination facilitating stomach emptying and decreased small bowel transit time.
Domperidone also acts as an antiemetic by suppressing the vomiting center in the brain.
Pharmacokinetics: Bioavailability: Domperidone is completely and rapidly absorbed after oral administration. It has a rapid onset of action with peak serum concentrations occurring within 30-60 minutes. It undergoes extensive first pass metabolism in the gut wall and the liver and thus has a low oral bioavailability of approximately 15%. Concomitant administration of food increases domperidone's bioavailabilty in healthy subjects. The area under the curve (AUC) of domperidone is increased and time of peak absorption is slightly delayed when taken after meals. It is recommended that patients take domperidone 15-30 minutes before meals.
Approximately 91-93% of domperidone is bound to plasma proteins. The plasma half-life after a single oral dose is about 7-9 hours in healthy subjects but is prolonged in patients with severe kidney failure. Studies in animals have shown wide tissue distribution but low brain concentration. Small amounts of domperidone are distributed into breastmilk. Domperidone has been shown to cross the placenta in rats.
Domperidone is primarily metabolized in the liver by aromatic hydroxylation and oxidative N-dealkylation. In vitro metabolism experiments with diagnostic inhibitors showed that CYP3A4 is the major form of cytochrome P-450 involved in N-dealkylation whereas CYP3A4, CYP1A2 and CYP2E1 are involved in aromatic hydroxylation of domperidone.
Thirty-one percent and 66% of an oral dose is excreted in the urine and feces, respectively, within 24 hours. A small amount of unchanged domperidone is excreted in the urine (about 1%) and feces (10%).
Indications/Uses
This medicine is used for the following conditions: Dyspeptic symptom complex often associated with delayed gastric emptying, gastroesophageal reflux disease (GERD) or esophagitis: epigastric sense of fullness, feeling of abdominal distention, upper abdominal pain, flatulence (gassiness), eructation (belching), heartburn.
Short-term treatment of nausea and vomiting of various origins including functional, organic, infectious, dietetic origin, or induced by radiotherapy or medicine therapy.
(It is NOT considered suitable for chronic nausea and vomiting, nor for the routine prophylaxis of postoperative vomiting).
Treatment of nausea and vomiting induced by dopamine agonists, i.e., L-dopa, and bromocriptine used in Parkinson's disease.
Domperidone may also be given as needed, together with paracetamol, for the symptomatic treatment of nausea and vomiting associated with migraine.
Dosage/Direction for Use
See table.

Click on icon to see table/diagram/image
Overdosage
Symptoms of domperidone overdosage may include gastrointestinal disturbances, disorientation, drowsiness, and extrapyramidal reactions (difficulty in movement), convulsions, and coma especially in infants and children.
Special Precautions
If patient is allergic to domperidone or any ingredient in the product.
If patient is taking oral ketoconazole, fluconazole, voriconazole, erythromycin, clarithromycin, telithromycin, amiodarone, selective serotonin reuptake inhibitors, HIV protease inhibitors, calcium antagonists) which can increase plasma concentrations of domperidone leading to a prolonged QTc interval. These medicines can increase plasma concentrations of domperidone leading to a prolonged QTc interval. Patients with long QT syndrome develop a very fast heart rhythm disturbance leading to a sudden loss of consciousness.
If patient has gastrointestinal hemorrhage (bleeding), gastrointestinal obstruction, perforation or conditions where gastrointestinal stimulation or movements may be dangerous.
If patient has prolactin-releasing pituitary tumor (prolactinoma).
Adverse Reactions
Gastrointestinal Effects: Diarrhea; transient intestinal cramps have occurred very rarely. Domperidone may cause abnormal liver function test.
Cardiovascular Effects: QTc prolongation, ventricular arrhythmia, and sudden death have been reported. Other adverse events include life-threatening tachyarrhythmias, atrial fibrillation, ventricular tachycardia, bradycardia, palpitation, torsades de pointes, and cardiac arrest.
CNS Effects: Central effects such as extrapyramidal reactions (Parkinson-like movements), including acute dystonic reactions (sustained muscle contractions which cause twisting and repetitive movements), convulsions; drowsiness, dry mouth, headache/migraine, insomnia, somnolence, nervousness, agitation, dizziness, thirst, lethargy, irritability.
Endocrine Effects: Increased prolactin levels leading to galactorrhea (excessive milk production), mastalgia (breast pain), amenorrhea (missed menstrual periods), gynecomastia (breast enlargement), or decreased libido may occur. Gynecomastia without galactorrhea has also been reported.
Domperidone has been shown to increase levels of thyroid stimulating hormone (TSH) in hypothyroid women.
Sensitivity Reactions: Urticaria, allergic/anaphylactic reactions and angioneurotic edema have occurred very rarely.
Dermatologic Effects: Skin rashes and itch.
ATC Classification
A03FA03 - domperidone ; Belongs to the class of propulsives. Used in the treatment of functional gastrointestinal disorders.
Presentation/Packing
FC tab 10 mg x 10's.
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