Each mL contains Metoclopramide Hydrochloride eq. to Anhydrous Metoclopramide Hydrochloride 5 mg.
Pharmacology: Pharmacodynamics: Gastrokinetic Effects: Metoclopramide restores the normal motility of upper GI tract without affecting gastric, biliary or pancreatic secretions. Actions of metoclopramide on the motility of stomach are unaffected by vagotomy or pyloroplasty.
Metoclopramide increase the amplitude of lower esophageal contractions and lower esophageal sphincter pressure (LESP) and thus prevents gastro-esophageal reflux (GER).
Metoclopramide increase frequency and depth of antral contractions, restores pyloric sphincter competence, regularises gastric pyloric, duodenal and jejunal motility, thereby resulting in accelerated gastric emptying and intestinal transit, thus preventing duodenogastric reflux. It has little, if any, effect on the motility of colon or gall bladder.
Antiemetic effects: Antiemetic effects of metoclopramide result from its central and peripheral actions. Apart from this, metoclopramide decreases the sensitivity of visceral nerves which transmit afferent impulses from GI tract to the emetic centre in the lateral reticular formation.
Pharmacokinetics: Metoclopramide is weakly bound to serum proteins (30%) and is rapidly and widely distributed in most tissues (Vd is 3.5 L/kg). Metoclopramide is eliminated by both hepatic metabolism (principally N-4 sulphate conjugation) and renal excretion. About 80% of an oral dose is recovered in the urine within 24 hours either as the unchanged drug (20%) or its sulphate and glucuronide conjugates.
The half-life is 3 to 5 hours in patients with normal renal functions, but it is prolonged to about 14 hours in patients with severe renal failure, necessitating a reduction in dosage.
Onset of pharmacological action of metoclopramide is as follows: 10 to 15 minutes following an intramuscular administration; 1 to 3 minutes following an intravenous administration.
Plazilin (Metoclopramide injection) has a wide range of clinical applications in fields as diverse as gastroenterology, surgery, gynaecology, radiology, cardiology, paediatrics and anaesthesiology.
DOSAGE: Total daily dose of metoclopramide, especially for children and young adults, should not normally exceed 0.5mg/kg body weight.
Nausea and Vomiting: Metoclopramide injection is effective in relieving nausea and vomiting induced by: Gastroduodenal disorders like flatulent dyspepsia, gastritis, gastroenteritis, duodenal ulser and hiatus hernia;
Hepato-biliary disorders, uremia, cardiac disease, radiation therapy and migraine;
Drug like digitalis, metronidazole, pethidine morphine, include cancer chemotherapy etc.
Adults: IM: 2ml (10mg) of PLAZILIN injection 1 to 3 times daily.
IV: 1 ampoule i.e. 2ml (10mg) of PLAZILIN injection as and when required.
Children: 0.5 mg/kg body weight per day, in 3 to 4 divided doses.
Gastro-Intestinal Disorders: Delayed gastric emptying, gastric stasis and gastro-esophageal reflux (GER) Metoclopramide injection is useful for the relief of symptoms associated with delayed gastric emptying or with acute and recurrent gastric statis. Symptom of delayed gastric emptying such as anorexia, nausea, vomiting, flatulence, pain in abdomen after meals, early satiety and heartburn respond well to metoclopramide injection.
Anaesthesia in surgery / gynaecology-obstetrics: For control of pre/post-operative nausea, vomiting, injection Metoclopramide 1 ampoule (10mg) I.M.
For control of analgesic-induced vomiting, Injection Metoclopramide 1 ampoule (10mg I.M. at a different site, simultaneously with parenteral analgesic (eg, Pethedine, morphine, etc).
Prior to induction of anaesthesia in case of emergency surgery or obstetric manoeuvers in patients with full stomach to prevent vomiting and aspiration of vomitus (mendelsons syndrome). Metoclopramide Injection 1 ampoule (10mg) I.M. or I.V. preferably 1 to 1 1/2 hour before induction of anaesthesia.
Radiology: Metoclopramide Injection by hastening gastric emptying shortens the duration of barium meal examination of upper gastrointestinal tract in radiology. Metoclopramide improves the clarity of sharpness of the X-ray film by eliminating gas shadow.
Parenteral: 1 to 2 ampoules (10 to 20 mg) of metoclopramide injection I.M. 10 to 15 minutes or I.V. 5 to 10 minutes before the barium meal.
Diagnostic procedure in gastroenterology: Metoclopramide Injection is useful in: Facilitating the passage of a tube in the duodenum and Rapid and convenient endoscopy. Metoclopramide Injection, 1 to 2 ampoules (10 to 20mg) I.M. is given 10-15 minutes before the procedure.
Mode of administration: Slow Intravenous or Intramuscular route.
Metoclopramide in therapeutic doses is well tolerated. Overdoses and antipsychotic doses upto 100 times the recommended dose of metoclopramide have been tolerated without serious side effects.
Metoclopramide does not affect blood pressure, pulse rate or ECG - the three parameters of cardiac function.
PLAZILIN is contraindicated in patients with known hypersensitivity or intolerance to metoclopramide. Metoclopramide should not be used in the presence of gastrointestinal haemorrhage, mechanical obstruction or perforation and immediately after gastrointestinal surgery. Where stimulation of G.I. tract motility might be dangerous. Metoclopramide should not be used in patients with epilepsy or extra-pyramidal syndrome. Metoclopramide is contraindicated in patients of pheochromocytoma because of possibility of precipitating hypertensive crisis due to release of catecholamine from the tumor. Metoclopramide is contraindicated in patients with breast carcinoma as it stimulates prolactin release. However, neither clinical studies nor epidemiologic studies have shown an association between chronic administration of metoclopramide and mammary tumorigenesis.
On no account should PLAZILIN injectable be diluted for injection as this will upset the isotonicity and stability of the drug IV injection of metoclopramide should be given slowly over 1 to 2 minutes because rapid administration may cause intense feeling of anxiety and restlessness followed by drowsiness. The recommended dosage of metoclopramide need not be exceeded, as increasing the dose does not produce a corresponding increase in clinical response.
WARNING: Avoid doses exceeding 0.5mg/kg/day.
Extrapyramidal effects, especially dystonic reaction of metoclopramide are more likely to occur in children shortly after initiation of therapy, and usually with doses higher than 0.5mg per kg of body weight per day.
Animal tests have shown no teratogenic effect with metoclopramide. Although there had been no reported teratogenic effect following the use of metoclopramide during pregnancy, there are no adequate and well-controlled studies in pregnant women. Hence, metoclopramide should be avoided in the first trimester of pregnancy and could be used during second and third trimester of pregnancy only if clearly indicated. Metoclopramide is excreted in breast milk and hence caution should be taken when it is administered to a nursing mother.
Metoclopramide is generally well tolerated and may rarely produce few adverse drug reactions when given in therapeutic doses. ADRs are usually mild, transient and reversible on withdrawal of the drug ADRs like restlessness, drowsiness, fatigue, lassitude, extrapyramidal effects (1 in 500, readily reversible), tardive dyskinesia, Parkinsonian like symptoms, motor restlessness (akathisia), galactorrhoea and gynaecomastia may rarely occur. Anti Parkinsonian drugs of the anticholinergic type may be used to counteract these infrequently seen reactions.
The effects of Metoclopramide on gastrointestinal motility are antagonized by anticholinergic drugs and narcotic analgesics. Additive sedative effects can occur when Metoclopramide is given with Alcohol, Sedatives, Hypnotics, Narcotics or Tranquilizers. The finding that Metoclopramide releases cathecolamines in patients with essential hypertension suggests that it should be used cautiously, if at all, in patients receiving monoamine oxidase inhibitors.
Absorption of drugs from the stomach may be diminished (e.g., Digoxin) by Metoclopramide, whereas the rate and/or extent of absorption of drugs from the small bowel may be increased (e.g., Acetaminophen, Tetracycline, Levodopa, Ethanol, Cyclosporine).
Gastroparesis (gastric stasis) may be responsible for poor diabetic control in some patients.
Exogenously administered insulin may begin to act before food has left the stomach and lead to hypoglycemia. Because the action of Metoclopramide will influence the delivery of food to the intestines and thus the rate of absorption, insulin dose or timing of dosage may require adjustment.
Incompatibilities: If this product is used for the treatment of nausea and vomiting associated with cytotoxic drugs the cytotoxics should be administered as a separate infusion.
Store below 30°C. Protect from light.
Shelf-Life: 3 years.
A03FA01 - metoclopramide ; Belongs to the class of propulsives. Used in the treatment of functional gastrointestinal disorders.
Plazilin inj 5mg/mL
2 mL x 10 × 1's
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