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GI Norm

GI Norm

domperidone

Manufacturer:

Amherst Lab

Distributor:

UNILAB, Inc

Marketer:

Westmont
Concise Prescribing Info
Contents
Domperidone
Indications/Uses
Short-term treatment of nausea & vomiting.
Dosage/Direction for Use
Adult & adolescent ≥12 yr weighing ≥35 kg 1 tab tid. Max dose in 24 hr: 30 mg. Max duration of treatment: Should not exceed 1 wk.
Administration
Should be taken on an empty stomach: Take 15-30 mins before meals. Swallow whole, do not crush/chew.
Contraindications
Hypersensitivity. Prolactin-releasing pituitary tumor (prolactinoma); GI hemorrhage, mechanical obstruction or perforation, or when stimulation of gastric motility could be harmful; significant electrolyte disturbances or bradycardia. Conditions where the cardiac conduction intervals are impaired or could be affected & underlying cardiac diseases eg, CHF, when co-administered w/ QT-prolonging drugs or potent CYP3A4 inhibitors. Moderate or severe hepatic impairment.
Special Precautions
QT prolongation & Torsades de pointes. Older patients or those w/ current or history of cardiac disease. Discontinue if signs or symptoms associated w/ cardiac arrhythmia occur. Concomitant use w/ antacids or secretory agents. Increase in plasma prolactin. Avoid in patients w/ Lapp lactase deficiency or glucose-galactose malabsorption. Pregnancy & lactation. Not suitable for childn <35 kg.
Adverse Reactions
Asthenia; ventricular arrhythmias, sudden cardiac death, QTc prolongation, Torsades de pointes; somnolence, headache, convulsion, extrapyramidal disorder, depression, dizziness; loss of libido, anxiety, agitation, nervousness, akathisia; dry mouth, diarrhea; anaphylactic reaction including anaphylactic shock, hypersensitivity; urinary retention; rash, pruritus, urticaria, angioedema; galactorrhea, breast pain, breast tenderness, gynecomastia, amenorrhea, irregular menstruation, breast swelling, lactation disorder; oculogyric crisis, abnormal LFT, increased blood prolactin.
Drug Interactions
Concomitant use w/ QTc prolonging medicinal products (eg, disopyramide, hydroquinidine, quinidine, amiodarone, dofetilide, dronedarone, ibutilide, sotalol, haloperidol, pimozide, sertindole, citalopram, escitalopram, erythromycin, levofloxacin, moxifloxacin, spiramycin, pentamidine, halofantrine, lumefantrine, cisapride, dolasetron, prucalopride, mequitazine, mizolastine, toremifene, vandetanib, vincamine, bepridil, diphemanil, methadone) & potent CYP3A4 inhibitors (eg, amprenavir, atazanavir, fosamprenavir, indinavir, ritonavir, saquinavir, ketoconazole, fluconazole, voriconazole, erythromycin, clarithromycin, telithromycin) is contraindicated. Concomitant use w/ Ca antagonists (eg, diltiazem, verapamil) is not recommended. Caution in concomitant use w/ bradycardia- & hypokalemia-inducing drugs. macrolides involved in QT-interval prolongation (ie, azithromycin & roxithromycin). Lower the oral bioavailability of antacids or antisecretory agents. May antagonize the antidyspeptic effect w/ anticholinergic drugs. Reduces the relaxant effect of atropine on the lower esophageal sphincter. May influence the absorption of concomitantly administered oral medicines eg, SR or EC formulations. Ketoconazole or oral erythromycin.
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
GI Norm FC tab 10 mg
Packing/Price
10's
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