PLASIL          Tablets, Syrup
 
Metoclopramide HCL

Plasil Tablets

Composition:-

- Active Ingredients: Metoclopramide HCL.
- Inactive Ingredients:
- Syrup: Hydroxy ethyl cellulose, Sorbic acid, natural, Caramel custard essence, Sodium
hydroxide pellets.
- Tablet: Guar gum, Methyl cellulose, Ethyl cellulose, Silica hydrate, Starch, Pentaerythritol, Magnesium
stearate.

Pharmaceutical Forms:-

Tablets and Syrup.

Pharmacological Actions:-

  1. Plasil (metoclopramide) is an original synthetic compound that selectively regulates gastrointestinal behaviour.
  2. It facilitates gastric empting, as also demonstrated radiologically without altering the volume of acidity of the gastric secretion.
  3. Plasil also possesses marked anti – emetic properties.
  4. Plasil exerts a prompt therapeutic action on a whole series of gastroenteric disorders commonly observed in medical practice: nausea, vomiting, feeling of epigastric fullness, aerophag, anorexia.
  5. Plasil is very well tolerated both by adults and children, it does not cause dryness of the mouth, insomnia, constipation or diarrhea.
  6. It does not affect renal function or cause urinary retention.
  7. Metoclopramide is a dopamine antagonist which stimulates gastric emptying and small intestine transit and enhances the strength of eosophagal sphincter contraction.

Pharmacokinetics:-

The preparation is well absorbed after oral administration and it is widely distributed through out the body with the highest concentration appearing in the liver, intestinal mucosa, antibiotics, biliary tract and lesser concentration appearing in the heart and central nervous system.

Indications:-

General medicine: Gastric intolerance to antimitotics, chemotherapeutic agents ( PAS and ethionamide in particular ), digitalis preparations,  morphine, codeine, etc, gastrointestinal disorders associated with acidosis and uraemia, headache and gastrointestinal disorders during the menstrual period digestive disorders in psychoneurotic subjects.
Gastroenterology: Gastritis, gastric and duodenal ulcers, enterocolic and dyspeptic syndromes – pyloric spasm, disorders due to gastric ptosis-biliary cyskinesia and lithiasis, digestive disturbances in cirrhosis – sequelae of gastrectomy and cholecystectomy.
Surgery and Anaesthesia: Nausea, vomiting, or hiccup of digestive, peritoneal or neurosurgical origin - vomiting due to anaesthesia or of post-operative nature.
Radiology: Radiological exploration of the gastrointestinal tract, intestinal disorders due to x-ray and cobalt therapy.
Pediatrics: Nausea and vomiting of any origin-gastric intolerance to drugs.

Dosage and Administration:-

- Adults:
- Tablets
: 1 tablet three times daily before meals.
- Syrup: 10 ml three times daily before meals, the measuring plastic included in the packing is graduated at 2 .5,5 and 7.5 ml. The measure should be washed thoroughly with water after use.
- Children: The dosage is adjusted according to body weight and age, However, it should never exceed the daily dose of 0.5 mg/kg body weight since the higher doses may lead to extrapyramidal effects.
- Syrup : 2.5 ml daily/5 kg body weight, subdivided during the day in single doses preferably before meals.
- Plasil may be associated with all the classic drugs used in gastroenterology, it has no effect on the blood pressure or the heart even when associated with digitalis preparations.

Contraindications:-
Plasil Syrup
Metoclopramide should not be given with phenothiazine derivatives.

Side Effects:-

1- Extrapyramidal symptoms may appear on overdosage of metoclopramide, but regress on continuation of treatment.
2- The phenomenon may exceptionally occur, even at therapeutic doses, in patients who are particularly sensitive or simultaneously treated with neuroleptics.

Drug Interactions:-

Metoclopramide should be used with caution in patient taking other drugs that can also cause extrapyramidal effects such as phenothiazines.

Pregnancy and Lactation:-

- Pregnancy: Plasil is not recommended during the first three months of pregnancy.
- Lactation: Use with caution in breast feeding women.

Precaution and Warning:-

- When concurrent use of anticholinergics is considered, they should be administered several hours after plasil.
- Use of similar precautions should be taken in the treatment of subjects with sever renal or hepatic insufficiency, in whom blood levels of metoclopramide may be higher or more sustained.

Package and Storage:-

- Tablets: Boxes of 20 tablets.
- Syrup: Bottle of 120 ml.
- Storage: Store at temperature below 30°C.

Instructions to Patients:-

1- Do not use the drug for more than 12 weeks.
2- Take the drug 30 minute before meal.
3- Plasil may be taken with other formal drugs used for treatment of gastrointestinal tract.
4- Plasil has no effect on blood pressure or heart.
5- Keep the medicament out of reach of children.

 

 

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