País: Cingapura
Língua: inglês
Origem: HSA (Health Sciences Authority)
DOMPERIDONE
JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
A03FA03
1 mg/ml
SUSPENSION
DOMPERIDONE 1 mg/ml
ORAL
Prescription Only
JANSSEN PHARMACEUTICA NV
ACTIVE
1989-05-22
PRODUCT NAME MOTILIUM (domperidone base) DOSAGE FORMS AND STRENGTHS One film-coated tablet contains 10 mg domperidone. The oral suspension contains 1 mg domperidone per ml. For excipients, see _List of Excipients_. CLINICAL INFORMATION INDICATIONS 1. The dyspeptic symptom complex that is often associated with delayed gastric emptying, gastro-oesophageal reflux and oesophagitis: • epigastric sense of fullness, early satiety, feeling of abdominal distension, upper abdominal pain; • bloating, eructation, flatulence; • nausea and vomiting; • heartburn with or without regurgitations of gastric contents in the mouth. 2. Nausea and vomiting of functional, organic, infectious or dietary origin. 3. Nausea and vomiting induced by: • radiotherapy or drug therapy • dopamine agonists (such as L-dopa and bromocriptine) used in the treatment of Parkinson's disease.. DOSAGE AND ADMINISTRATION It is recommended to take oral MOTILIUM before meals. If taken after meals, absorption of the drug is somewhat delayed. ADULTS AND ADOLESCENTS (OVER 12 YEARS AND WEIGHING 35 KG OR MORE) The dose of MOTILIUM ® should be the lowest effective dose for the individual situation (typically 30mg/day) and can be increased if necessary to a maximum daily oral dose of 40mg. The initial duration of treatment is up to four weeks. If treatment exceeds four weeks, patients should be reevaluated and the need for continued treatment reassessed. FORMULATION (DOMPERIDONE PER UNIT) DOSAGE MAXIMUM DOSE PER DAY Film-coated tablets (10 mg/tablet) 1 tablet three to four times per day 40 mg (4x10mg tablet) Oral suspension (1 mg/ml) 10 mL three to four times per day 40 ml (40 ml of 1mg/ml oral suspension) Doses above 30mg/day should be used wit Leia o documento completo
1 PRODUCT NAME MOTILIUM (domperidone base) DOSAGE FORMS AND STRENGTHS One film-coated tablet contains 10 mg domperidone. The oral suspension contains 1 mg domperidone per mL. For excipients, see _List of Excipients_ . CLINICAL INFORMATION INDICATIONS 1. The dyspeptic symptom complex that is often associated with delayed gastric emptying, gastro-esophageal reflux and esophagitis: • epigastric sense of fullness, early satiety, feeling of abdominal distension, upper abdominal pain; • bloating, eructation, flatulence; • nausea and vomiting; • heartburn with or without regurgitations of gastric contents in the mouth. 2. Nausea and vomiting of functional, organic, infectious or dietary origin. 3. Nausea and vomiting induced by: • radiotherapy or drug therapy • dopamine agonists (such as L-dopa and bromocriptine) used in the treatment of Parkinson's disease. DOSAGE AND ADMINISTRATION It is recommended to take oral MOTILIUM 15-30 minutes before meals. If taken after meals, absorption of the drug is somewhat delayed. ADULTS AND ADOLESCENTS ≥ 12 YEARS OF AGE AND WEIGHING ≥ 35 KG The dose of MOTILIUM ® should be the lowest effective dose for the individual situation (typically 30mg/day) and can be increased if necessary to a maximum daily oral dose of 40mg. Usually, the maximum treatment duration should not exceed one week for the treatment of acute nausea and vomiting. If nausea and vomiting persists for longer than one week, patients should consult their physician. For other indications, the initial duration of treatment is up to four weeks. If treatment exceeds four weeks, patients should be re-evaluated and the need for continued treatment reassessed. FORMULATION (DOMPERIDONE PER UNIT) DOSAGE MAXIMUM DOSE PER DAY Film-coated tablets (10 mg/tablet) 1 tablet three to four times per day 40 mg (4x10mg tablet) Oral suspension (1 mg/ml) 10 mL three to four times per day 40 mg (40 mL of 1mg/mL oral suspension) 2 Doses above 30mg/day should be used with caution due to potential risk of arrhythmias assoc Leia o documento completo