Each ml contains
Paracetamol 150 mg
Benzyl Alcohol 1.5% v/v
Propylene Glycol 60% v/v
Water for Injection q.s.
Pharmacotherapeutic group: Other Analgesics and Antipyretics
ATC Code: N02BE01
Paracetamol is a clinically proven analgesic and antipyretic. It produces analgesia by elevation of the pain threshold and antipyresis through action on the hypothalamic heat regulating centers. Paracetamol may act predominantly by inhibiting prostaglandin synthesis in the central nervous
system and to a lesser extent through a peripheral action by blocking pain impulse generation. The peripheral action may also be due to inhibition of prostaglandin synthesis or inhibition of the synthesis or actions of other substances that sensitize pain receptors to mechanical or chemical stimulation.
Paracetamol produces antipyresis by acting centrally on the hypothalamic heat-regulating center to produce peripheral vasodilation resulting in increased blood flow through the skin, sweating and heat loss. The central action probably involves inhibition of prostaglandin synthesis in the
Paracetamol is distributed throughout most body tissues. About 25% of Paracetamol in blood is bound to plasma proteins. The plasma half-life is 1.25 to 3 hours but may be increased by liver damage and following overdose. Paracetamol is metabolized in the liver. About 85% of a dose of Paracetamol is excreted in urine as free and conjugated Paracetamol within 24 hours.
INDICATION AND USAGE
Pyrexia of unknown origin, fever and pain, associated with common childhood disorders, tonsilitis, upper respiratory tract infection, postimmunization reactions, post operative fever, after tonsillectomy and other conditions, where patient is unable to take oral medications but where Paracetamol can be administered with advantage for prevention of febrile convulsion, headache, cold, sinusitis, muscle pain, arthritis and toothache. NOTE: Specific therapy with antibiotics or chemotherapeutic drugs of choice should be carried out whenever indicated.
Hypersensitivity to Paracetamol. Repeated administration is contraindicated in patients with anemia, cardiac, pulmonary, renal, and hepatic disease.
Paracetamol may enhance the activity of coumarin anticoagulants, but its effect is not generally of clinical significance.
WARNINGS AND PRECAUTIONS
Contains sodium sulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life threatening or less severe asthamatic episodes in certain susceptible persons. Also contains Benzyl Alcohol. This should not be administered to new born or premature infants. Paracetamol should be given with care to patients with impaired kidney or liver function.
Paracetamol has rarely been found to produce any side effects in therapeutic doses and is usually well tolerated by aspirin sensitive patients. Toxicity may result from a single toxic dose of the drug or from chronic ingestion. The following adverse reactions have been reported: skin eruption, haematological toxicity.
Symptoms of overdosage may include nausea, vomiting, abdominal pain, diaphoresis, generalized weakness & lethargy. If an overdose of Paracetamol is suspected, blood should be withdrawn immediately for Paracetamol plasma assay, without regard to the presence or absence of symptomatology. The acute hepatotoxicity, nephrotoxicity of paracetamol can be overcome by the administration of sulfinydryl donors, e.g, N-acetyl cysteine which should be given as soon as possible after ingestion. Treatment after 12 hours is not effective. Paracetamol overdose should be treated with gastric lavage if the patient is seen within 24 hours of ingestion of the drug.
DOSAGE & MODE OF ADMINISTRATION
Adults: 2 – 3 ml every 4 to 6 hours.
Children (2 -12 years / > 33 kg): Up to 2 ml every 4 to 6 hours.
Below 2 years of age: Half to 1 ml every 4 to 6 hours.
In cases of severe renal impairment, the elimination of paracetamol is slightly delayed, the elimination half-life ranging from 2 to 5.3 hours. For the glucuronide and sulphate conjugates, the elimination rate is 3 times slower in subjects with severe renal impairment than in healthy subjects.Therefore when giving paracetamol to patients with severe renal impairment, the minimum interval between each administration should be increased to at least 6 hours.
Method of administration
The administration is I.M./I.V.
PREGNANCY AND LACTATION
Clinical experience of the intravenous administration of paracetamol is limited. However, epidemiological data from the use of oral therapeutic doses of paracetamol indicate no undesirable effects in pregnancy or on the health of the foetus / newborn infant.
Prospective data on pregnancies exposed to overdoses did not show an increase in malformation risk.
Reproductive studies with the intravenous form of paracetamol have not been performed in animals. However, studies with the oral route did not show any malformation of foetotoxic effects.
Nevertheless, paracetamol should only be used during pregnancy after a careful benefit/risk assessment. In this case, the recommended dose and duration of treatment must be strictly observed.
After oral administration, paracetamol is excreted into breast milk in small quantities. No undesirable effects on nursing infants have been reported.
Consequently, Paracetamol may be used in breast-feeding women.
Store below 30°C, Protected from light, Do not freeze.
KEEP OUT OF REACH OF CHILDREN
2ml ampoules packed in cardboard carton along with pack insert.
Pack of 10 ampoules.
Paracetamol Injection 150mgml