COMPOSITIONS :
Metolon® Syrup 5 mg/5 ml, each 5 ml contains : Metoclopramide HCl monohydrate equivalent to Metoclopramide 5 mg.
DESCRIPTIONS :
Metolon® containing Metoclopramide HCl monohydrate (equivalent to Metoclopramide), which is available in tablet 10 mg, drops 2 mg/ml, syrup 5 mg/5 ml and injection 10 mg/2 ml.
INDICATIONS :
- Relief of metabolic nausea and vomiting caused by drug or post operative conditions.
- Relief of symptoms associated with acute and recurrent gastroparesis.
DOSAGE AND ADMINISTRATIONS :
Dosage recommendations given should be strictly followed to avoid dystonia side effects. Total daily dosage especially for children and adult should not exceed 0.5 mg/kgBW under normal circumstances. Dosage should be at reduced levels in patients with significant renal or hepatic impairment.
- Adults of 20 years and older :
1 tablet of Metolon® Tablet or 2 measurement spoonfuls of Metolon® Syrup, 3 times daily, it may be used for patients with body weight > 60 kg. To avoid adverse reactions, patients should be strictly followed the dosage recommendations and patients should examine to the doctor if on prolonged therapy.
- 15 – 19 years old :
Only use Metolon® carefully after examination to avoid masking an underlying disorder, such as cerebral irritation.
Weight 60 kg and over : 1 tablet of Metolon® Tablet or 2 measuring spoonfuls of Metolon® Syrup, 3 times daily.
Weight 30 – 59 kg : ½ tablet of Metolon® Tablet or 1 measuring spoonful of Metolon® Syrup, 3 times daily.
- Children :
Tablet properties should not be given to children under 15 years, oral solution properties may be given to younger.
- 9 – 14 years old (weight 30 kg and over) : 1 measuring spoonful of Metolon®
- 5 – 9 years old (weight 20 – 29 kg) : ½ measuring spoonful of Metolon® Syrup (2½ mg), 3 times daily.
- 3 – 5 years old (weight 15 – 19 kg) : 2 mg (1 ml of Metolon® Drops), 2 – 3 times daily.
- Under 1 year old (weight 1 – 10 kg) : 1 mg (0.5 ml of Metolon® Drops), 2 times daily.
CONTRAINDICATIONS :
Metolon® is contraindicated for :
- The stimulation of intestinal motility can be dangerous, such as : Gastrointestinal hemorrhage, mechanical obstruction, or perforation.
- Patients with pheochromocytoma, because the drug may cause hypersensitive crisis.
- Hypersensitivity or intolerance to Metoclopramide.
- Epileptics or patients receiving other drugs which are likely cause extrapyramidal symptoms.
WARNINGS AND PRECAUTIONS :
- Metoclopramide can cause psycho interference.
- Patients should be use with caution while operate machinery or driving or performing other tasks requiring alertness, coordination and physical dexterity.
- Mental depression has occured in patients with and without a history depression. Give Metoclopramide to patients with a prior history of depression only if the expected benefits outweigh the potential risks.
- Extrapyramidal symptoms can be occured. If this symptoms should occur, inject 50 mg Diphenhydramine HCl intramuscularly.
- Parkinson-like symptoms have occured, more commonly within the first 6 months after beginning treatment with Metoclopramide but occasionally after longer periods. These symptoms generally subside within 2 – 3 months following discontinuance of Metoclopramide.
- Use caution in hypertensive patients.
- Metoclopramide is distributed into breast milk, however, exercise caution when administering to a nursing mother.
- Use only when clearly needed and the potential benefits outweigh the potential hazards to the fetus.
PRESENTATIONS :
| Metolon® Syrup 5 mg/5 ml | Box, bottle @ 60 ml | Reg. No. DKL8502308737A1 |
STORAGE :
STORE BELOW 30°C, PROTECT FROM LIGHT
After packaging is opened, the product is stable for 8 days at storage below 30ºC.
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
PT. BERNOFARM
Sidoarjo – Indonesia
