Sanmeto

Sanmeto

metoclopramide

Manufacturer:

Caprifarmindo

Marketer:

Caprifarmindo
Full Prescribing Info
Contents
Metoclopramide.
Description
Each tablet contains: Metoclopramide Hydrochloride equivalent to Metoclopramide 10 mg.
Each 5 ml syrup contains: Metoclopramide Hydrochloride equivalent to Metoclopramide 5 mg.
Each mL of oral drops contains: Metoclopramide Hydrochloride equivalent to Metoclopramide 4 mg.
Each mL of inj contains: Metoclopramide Hydrochloride 5 mg.
Action
Pharmacology: Metoclopramide Hydrochloride is used in the treatment of several functional impairments of digestive apparatus.
Metoclopramide Hydrochloride increases the gastric motility, relaxes the pyloric sphincter and duodenal bulb, and increases peristalsis of the duodenum and jejunum resulting in accelerated gastric emptying.
Metoclopramide Hydrochloride is also endowed with an antiemetic effect.
Metoclopramide Hydrochloride stimulates motility of the upper gastrointestinal tract without stimulating gastric, biliary, and pancreatic secretions.
Therefore, Metoclopramide Hydrochloride is useful application in numerous pathologic manifestations of the digestive apparatus functional or following gastroduodenal ulcer, surgical operations, anesthesia, exogenous or endogenous intoxication.
Indications/Uses
SANMETO is indicated for the relief of symptoms associated with acute and recurrent diabetic gastroparesis.
SANMETO is used in the treatment of drug related postoperative nausea and vomiting.
SANMETO is indicated for the symptomatic short-term treatment of heartburn secondary to reflux oesophagitis.
Dosage/Direction for Use
Tablet: Adults: 1 tablet 3 times a day. Take medication 30 minutes before meals or bedtime. All doses above may be increased according to physician's advise.
Syrup: Adults:10 ml oral solution 3 times a day. Take medication 30 minutes before meals or bedtime. All doses above may be increased according to physician's advise.
Children: 1- 6 years of age: 0.1 mg/kg of body weight, 2-3 times a day.
Under 1 year of age: 0.1 mg/kg of body weight, twice daily.
Take medication 30 minutes before meals or bedtime.
Oral drops: Children: 1 - 6 years of age: 0.1 mg/kg of body weight, 2-3 times daily.
Under 1 year of age: 0.1 mg/kg of body weight twice daily.
Take medication 30 minutes before meals or bedtime.
In patients with renal impairment, the dose should be reduced minimum 60% of normal dose.
Injection: Treatment of delayed gastric emptying: Adults: 10 mg i.v. over a 1 to 2 minute period.
Children: 6 -14 years of age: 2.5-5 mg i.v.
Under 6 years of age: 0.1 mg/kg of body weight, i.v.
Prevention of nausea and vomiting associated with chemotherapy: 1- 2 mg/kg of body weight over a period of not less than 15 minutes, given 30 minutes prior to the chemotherapy.
The administration is repeated every 2 hours for two doses, then every 3 hours for three doses and not more than 10 mg/kg of body weight in each 24 hours.
Prevention of post operative nausea and vomiting: 10-20 mg (i.m.), given near the end of surgery over 1 to 2 minutes period.
Contraindications
Patients with known hypersensitivity or intolerance to Metoclopramide Hydrochloride.
Metoclopramide Hydrochloride should not be used in epileptic or patients receiving other drugs which are likely to cause extrapyramidal reactions.
In the presence of gastrointestinal hemorrhage, obstruction or perforation.
Patients with “Pheochromocytoma”.
Special Precautions
Reduced dosages are recommended in patients with renal failure, since the risk of extrapyramidal effects may increase.
Patients undergoing treatment with this drug should not take charge of vehicles or machineries.
It should be given with caution in patients taking other drugs that can also cause extrapyramidal reactions, such as phenothiazines.
Tablet/Syrup/Injection: It should be used with caution in nursing mothers because Metoclopramide Hydrochloride is excreted in breast milk.
Syrup/Injection: Metoclopramide Hydrochloride should not be used during the first trimester of pregnancy. In the subsequent period of pregnancy, the use of the drug should be limited only in those cases of clear symptom where an alternative intervention would not be possible, thus excluding the frequent and simple cases of vomiting of pregnancy and prevention of same.
Tablet: It is not recommended to be used anticholinergic drug concomitantly.
Adverse Reactions
Drowsiness, fatigue, lassitude, restlessness, constipation, diarrhea, urticaria, dryness of the mouth, glossal or periorbital oedema, methaemoglobinemia, extrapyramidal reactions such as parkinsonian symptoms, tardive dyskinesia more likely to occur in children and the elderly.
Drug Interactions
Syrup/Oral drops/Injection: The effects of anticholinergic drugs and narcotic analgesics are antagonized by Metoclopramide Hydrochloride.
Additive sedative effects can occur when Metoclopramide Hydrochloride is given with alcohol, sedatives, hypnotics, narcotics or tranquilizers.
Increase absorption rate of Acetaminophen/paracetamol, Tetracycline, Levodopa, Alcohol/ethanol, Cyclosporine, and decrease absorption rate of Digoxin.
Patients receiving MAO inhibitor therapy.
Storage
Tablet/Syrup/Drops: Store below 30°C, away from light.
Injection: Store below 25°C and in dry place, away from light.
Store the ampoule in the box until used.
MIMS Class
GIT Regulators, Antiflatulents & Anti-Inflammatories / Antiemetics
ATC Classification
A03FA01 - metoclopramide ; Belongs to the class of propulsives. Used in the treatment of functional gastrointestinal disorders.
Presentation/Packing
Form
Sanmeto inj 5 mg/mL
Packing/Price
2 mL x 5 × 1's (Rp47,250/boks)
Form
Sanmeto oral drops 4 mg/mL
Packing/Price
10 mL x 1's (Rp20,500/boks)
Form
Sanmeto syr 5 mg/5 mL
Packing/Price
60 mL x 1's (Rp12,300/boks)
Form
Sanmeto tab 10 mg
Packing/Price
10 × 10's (Rp62,000/boks)
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