Sunnypyramid Injection
Qualitative and quantitative composition
Each 2ml ampoule contains Metoclopramide Hydrochloride equivalent to 10mg of the anhydrous substance.
Pharmaceutical form
Clear colorless solution for intramuscular or intravenous administration.
Clinical particulars
Therapeutic indications
– In adults, metoclopramide remains indicated for prevention of post-operative nausea and vomiting (PONV), radiotherapy-induced nausea and vomiting and delayed (but not acute) chemotherapy-induced nausea and vomiting, and for symptomatic treatment of nausea and vomiting including that associated with acute migraine (where it may also be used to improve absorption of oral analgesics).
– In children, metoclopramide is only licensed as a second-line option for prevention of delayed chemotherapy-induced nausea and vomiting and treatment of established PONV.
Posology and method of administration
Route of administration:
‘Sunnypyramid’ injection may be administered either intramuscularly or by slow intravenous injection (1-2 minutes).
The dosage recommendations given below should be strictly adhered to if side effects of the dystonic type are to be avoided. It should be noted that total daily dosage of ‘Sunnypyramid’, especially for children and young adults, should not normally exceed 0.5mg/kg body weight.
In patients with clinically significant degrees of renal or hepatic impairment, therapy should be at reduced dosage. Metoclopramide is metabolised in the liver and the predominant route of elimination of metoclopramide and its metabolites is via the kidney.
Contraindications:
‘Sunnypyramid’ should not be used in patients with phaeochromocytoma as it may induce an acute hypertensive response.
‘Sunnypyramid’ should not be used in patients suffering from epilepsy, since the frequency and severity of seizures may be increased.
‘Sunnypyramid’ should not be used during the first three to four days following operations such as pyloroplasty or gut anastomosis as vigorous muscular contractions may not help healing.
‘Sunnypyramid’ should not be administered to patients with gastrointestinal obstruction, perforation or haemorrhage.
‘Sunnypyramid’ is contraindicated in patients who have previously shown hypersensitivity to metoclopramide or any of its components.
‘Sunnypyramid’ is contraindicated in children under 1 year of age.
Pregnancy and lactation
Animal tests in several mammalian species and clinical experience have not indicated a teratogenic effect. Nevertheless ‘Sunnypyramid’ should only be used when there are compelling reasons and is not advised during the first trimester
During lactation metoclopramide is found in breast milk,therefore it should not be used during lactation
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Overdose
In cases of overdosage, acute dystonic reactions have occurred. Very rarely AV block has been observed. Should treatment of a dystonic reaction be required, an anticholinergic anti-Parkinsonian drug or a benzodiazepine may be used.
Pharmacodynamic properties
The action of metoclopramide is closely associated with parasympathetic nervous control of the upper gastro-intestinal tract, where it has the effect of encouraging normal peristaltic action. This provides for a fundamental approach to the control of those conditions where
disturbed gastro-intestinal motility is a common underlying factor .
Pharmacokinetic properties
Metoclopramide is metabolised in the liver and the predominant route of elimination of metoclopramide and its metabolites is via the kidney.
Preclinical safety data
No additional data available.
Special precautions for storage
Do not store above 30°C. If ampoules are removed from their carton, they should be stored away from light. If inadvertent exposure occurs, ampoules showing discolouration must be discarded.
Marketing authorisation holder
Sunny pharmaceutical
Badr City , Cairo. Egyp
SUMMARY OF PRODUCT CHARACTERISTICS for FERCAYL
Sunnypyramid Injection Qualitative and quantitative composition
SUNNYFUNGAL NAME OF THE MEDICINAL PRODUCT
Peptrelif Injection 50 mg/2ml NAME OF
FERMED 20 mg .Name of the
Etasylsunny 250/2ml solution for IV injection
