COMPOSITIONS :
Metoclopramide HCl Monohydrate Drops 2 mg/ml, each ml contains : Metoclopramide HCl monohydrate equivalent to Metoclopramide 2 mg.
DESCRIPTIONS :
Metoclopramide HCl Monohydrate containing Metoclopramide HCl monohydrate (equivalent to Metoclopramide) is available in 2 mg/ml drops and 10 mg/2 ml injection.
INDICATIONS :
Metoclopramide HCl Monohydrate Drops is indicated for :
Relief of metabolic nausea and vomiting caused by drug or post operative conditions.
Relief of symptoms associated with acute and recurrent gastroparesis.
Metoclopramide HCl Monohydrate Injection is indicated for :
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.
Metoclopramide HCl Monohydrate Drops :
Children :
3 – 5 years old (Weight 15 – 19 kg) : 2 mg (1 ml of Metoclopramide HCl Monohydrate Drops), 2 – 3 times daily.
Under 1 year old (Weight 1 – 10 kg) : 1 mg (0.5 ml of Metoclopramide HCl Monohydrate Drops), 2 times daily.
Metoclopramide HCl Monohydrate Injection :
Recommended IV single dose :
Children (< 6 years) : 0.1 mg/kgBW Metoclopramide HCl Monohydrate Injection.
Children (6 – 14 years) : 2.5 – 5 mg (0.5 – 1 ml Metoclopramide HCl Monohydrate Injection).
Adults : 10 mg (2 ml Metoclopramide HCl Monohydrate Injection).
Prevention of postoperative nausea and vomiting : Inject IM 2 ml of Metoclopramide HCl Monohydrate 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 Metoclopramide HCl Monohydrate 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, Metoclopramide HCl Monohydrate 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 Metoclopramide HCl Monohydrate Injection slowly IV allowing 1 to 2 minutes, because a transient but intense feeling of anxiety and restlessness, followed by drowsiness may occur with rapid administration.
CONTRAINDICATIONS :
Metoclopramide HCl Monohydrate 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 to 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.
DRUG INTERACTIONS :
The effects of Metoclopramide are antagonized by anticholinergic drugs and narcotic analgesics.
Additive sedatif effects can occur when Metoclopramideis given with sedatives, hypnotics, narcotics, transquilizers and alcohol.
Concurrent administration of Metoclopramide and Cimetidine may reduce the absorption of Cimetidine.
Using concomitantly Metoclopramide with Digoxin may diminish absorption of Digoxin.
Metoclopramide may enhance absorption of drug that are mainly absorbed in the small intestine, such as Acetaminophen, Tetracycline, Levodopa and Cyclosporine.
Metoclopramide should not be given to patients receiving MAOIs.
Metoclopramide may increase the neuromuscular blocking effects of Succynilcholine.
ADVERSE REACTIONS :
Anxiety, dry mouth, lassitude and restlessness.
Galactorrhea, amenorrhea, gynecomastia.
Hypotension, hypertension, supraventricular tachycardia, bradycardia.
Bowel disturbances, diarrhea.
Urticaria, bronchospasm especially in patients with a history of asthma.
Leucopenia, neutropenia, agranulocytosis.
Visual disturbance, porphyria.
PRESENTATIONS :
Metoclopramide HCl Monohydrate Drops 2 mg/ml Box, 10 bottles @ 10 ml
Reg. No. GKL1702355736A1
STORAGE :
Metoclopramide HCl Monohydrate Drops :
STORE BELOW 30°C, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
