Galoxin Plus

Galoxin Plus

Manufacturer:

Sanbe
Concise Prescribing Info
Contents
Hyoscine butylbromide 10 mg, acetaminophen 500 mg
Indications/Uses
Decrease paroxysmal pain of the stomach or intestine spastic pain & functional disorders in the biliary & urinary tracts & female genital organs (eg, dysmenorrhea).
Dosage/Direction for Use
Adult 1-2 caplets 3 times daily. Max: 6 caplets daily.
Administration
May be taken with or without food: Swallow whole w/ sufficient amount of water, do not chew.
Contraindications
Hypersensitivity to hyoscine butylbromide, acetaminophen. Mechanical-stenosis of GIT, achalasia, paralytic ileus, intestinal atony, prostatic hypertrophy w/ urinary retention, myasthenia gravis, glaucoma, pathological tachyarrhythmia, megacolon. Patients w/ porphyria; hepatic dysfunction. Case of rare hereditary conditions. Severe hepatocellular insufficiency (Child-Pugh C).
Special Precautions
Discontinue use at the first signs of hypersensitivity reaction following administration. Seek medical advice immediately in case of severe, unexplained abdominal pain that persists or worsens, or occurs together w/ symptoms like fever, nausea, vomiting, changes in bowel movements, abdominal tenderness, decreased BP, fainting or blood in the stool; if new symptoms occur, or if redness or swelling is present. Ensure that any other drugs taken concurrently do not contain acetaminophen to prevent overdosing. G6PD deficiency, Gilbert's syndrome. Monitor blood count, renal & liver function after prolonged use. May induce headache w/ extensive use of analgesics, especially at high doses. Abrupt discontinuation of analgesics after a prolonged use at high doses may induce w/drawal symptoms (eg, headache, tiredness, nervousness). Not to be taken for >3 days. Patients prone to narrow angle glaucoma, susceptible to intestinal or urinary outlet obstructions & in those inclined to tachyarrhythmia. Contains Na; patients on a controlled Na diet. Liver damage w/ overdosage of acetaminophen. Do not drive or operate machinery as hyoscine butylbromide may cause drowsiness. Impaired renal function; hepatic dysfunction (eg, due to chronic alcohol abuse, hepatitis); hepatocellular insufficiency (Child-Pugh A/B). Not recommended during pregnancy. Lactation. Not suitable for childn <10 yr.
Adverse Reactions
Pancytopenia, agranulocytosis, thrombocytopenia, leucopenia; anaphylactic shock, anaphylactic reactions, drug eruption, dyspnoea, abnormal sweating, pruritus, skin reactions, hypersensitivity (eg, angioderma, rash, urticaria, exanthema, erythema, nausea, decreased BP including shock); tachycardia; bronchospasm (especially in patients w/ history of bronchial asthma or allergy); dry mouth; increased transaminases; urinary retention.
Drug Interactions
May cause liver damage w/ drugs leading to enzyme induction eg, certain hypnotics & anti-epileptics (eg, glutethimide, phenobarb, phenytoin, carbamazepine), rifampicin; potentially hepatotoxic substances & alcohol abuse. Prolonged t½ of chloramphenicol w/ the risk of increased toxicity. Concomitant use w/ anticoagulants (eg, warfarin, coumarin derivatives). Enhanced tendency towards reducing leucocytes (neutropenia) w/ zidovudine or retovir. Probenecid inhibits the binding of acetaminophen to glucoronic acid. Reduced acetaminophen absorption w/ cholestyramine. May impact the lab determination of uric acid by phosphotungstic acid & of blood glucose by glucose oxidase-peroxidase. Intensified anticholinergic effects of tri- & tetracyclic antidepressants, antihistamines, antipsychotics, quinidine, amantadine, disopyramide & other anticholinergics (eg, tiotropium, ipratropium, atropine like compd). Concomitant treatment w/ dopamine antagonists eg, metoclopramide HCl may result in diminution of the effects of both drugs on the GIT. Enhanced tachycardiac effects of β-adrenergic agents. Reduced rate of absorption & delayed onset of action of acetaminophen w/ propantheline. Increased absorption rate of acetaminophen w/ metoclopramide.
MIMS Class
Antispasmodics
ATC Classification
A03DB04 - butylscopolamine and analgesics ; Belongs to the class of belladonna and derivatives antispasmodics in combination with analgesics. Used in the treatment of functional gastrointestinal disorders.
Presentation/Packing
Form
Galoxin Plus FC caplet
Packing/Price
10 × 10's (Rp400,000/boks)
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