COMPOSITIONS :
Metolon® Injection 10 mg/2 ml, each 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 :
- Prevention of nausea and vomiting associated with emetogenic cancer chemotherapy.
- Prophylaxis of postoperative nausea and vomiting.
- Stimulates gastric emptying and intestinal transit of barium in cases where delayed emptying interferes with radiological examination of the stomach or small intestine.
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.
- Recommended IV single dose :
Children (< 6 years of age) : 0.1 mg/kgBW Metolon® Injection.
Children (6 – 14 years of age) : 2.5 – 5 mg (0.5 – 1 ml Metolon® Injection).
Adults : 10 mg (2 ml Metolon® Injection).
- Prevention of postoperative nausea and vomiting : Inject IM 2 ml of Metolon® Injection near the end of surgery.
- Radiological examination : A single dose may be administered slowly IV over 1 – 2 minutes.
- Prevention of chemotherapy-induced emesis : 1 – 2 mg/kgBW of Metolon® Injection is administered slowly IV infusion over not less than 15 minutes, 30 minutes before beginning cancer chemotherapy, repeat every 2 hours for 2 doses, then every 3 hours for 3 doses.
- IV admixture :
When diluted in a parenteral solution, administer IV slowly over a period of not less than 15 minutes.
For doses in excess 10 mg, Metolon® Injection should be diluted in 50 ml of a parenteral solution. The preferred parenteral solution is Sodium chloride Injection (Normal saline), because the mixture can be stored frozen for up to 4 weeks. Metoclopramide diluted in Sodium chloride injection or Lactated Ringer’s injection may be stored up to 48 hours (without freezing) after preparation if protected from light.
- Direct IV injection :
Inject undiluted 10 mg (2 ml) of Metolon® Injection slowly IV allowing 1 – 2 minutes, because a transient but intense feeling of anxiety and restlessness followed by drowsiness may occur with rapid administration.
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® Injection 10 mg/2 ml | Box, 10 ampoules @ 2 ml | Reg. No. DKL0302332643A1 |
STORAGE :
STORE BELOW 30°C, PROTECT FROM LIGHT. STORE THE PRODUCT ON THE BOX BEFORE USED.
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
PT. BERNOFARM
Sidoarjo – Indonesia
