Param

Paracetamol.

Each mL contains: Paracetamol BP 10 mg.

Analgesic & Antipyretic.

Paracetamol is indicated for the management of mild to moderate pain, management of moderate to severe pain with adjunctive opioid analgesics, and for reduction of fever.

The Paracetamol solution is administered as a 15-minute intravenous infusion.
Adolescents and adults weighing more than 50 kg: Paracetamol 1 g per administration, up to four times a day or 650 mg every 4 hours to a maximum of 4 g per day period minimum dosing interval of 4 hours.
Children, adolescents and adults weighing less than 50 kg: Paracetamol 15 mg/kg per administration, i.e. 1.5 mL solution per kg up to four times a day or 12.5 mg/kg every 4 hours to a maximum of 75 mg/kg per day. The minimum interval between each administration must be 4 hours.
Severe renal insufficiency: It is recommended, when giving Paracetamol to patients with severe renal impairment (creatinine clearance 30 mL/min), to increase the minimum interval between each administration to 6 hours.
In adults with hepatocellular insufficiency, chronic alcoholism, chronic malnutrition (low reserves of hepatic glutathione) and dehydration, the maximum daily dose must not exceed 3 g.

Paracetamol is contraindicated: in patients with hypersensitivity to Paracetamol or to proparacetamol hydrochloride (prodrug of paracetamol) or to any of the excipients.
In cases of severe hepatic impairment or severe active liver disease.

Doses higher than those recommended entail the risk of very serious liver damage hepatic injury, including the rise of liver failure and death. Clinical signs and symptoms of liver damage (including fulminant hepatitis, hepatic failure, cholestatic hepatitis, cytolytic hepatitis) are usually first seen after two days of drug administration with a peak seen, usually after 4-6 days. Treatment with antidote should be given as soon as possible.
Use in Pregnancy & Lactation: See Use in Pregnancy & Lactation for further information.

Paracetamol should only be used during pregnancy after a careful benefit-risk assessment. In this case, the recommended posology and duration 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.

Serious adverse effects: Hepatic injury.
Serious skin reactions: Acute generalised exanthematous pustulosis (AGEP); Stevens-Johnson Syndrome (SJS); Toxic epidermal necrolysis (TEN).
Allergy and hypersensitivity: Swelling of the face, mouth and throat, respiratory distress, urticaria, rash, and pruritis.
Most common adverse effects: Gastrointestinal disorder: Nausea, vomiting.
General disorders and administration site conditions: Pyrexia.
Nervous system disorders: Headache.
Psychiatric: Insomnia.
Other adverse effects in Adults: Blood and lymphatics system disorders: Anemia.
General disorders and administration site conditions: Fatigue, infusion site pain, peripheral edema.
Investigations: Aspartate aminotransferase increases breath sounds abnormal.
Metabolism and Nutrition disorders: Hypokalemia.
Musculoskeletal and connective tissue disorders: Muscle spasms, tissues.
Psychiatric disorders: Anxiety.
Respiratory, thoracic and mediastinal disorders: Dyspnea.
Vascular disorders: Hypertension, hypotension.
Other adverse effects in pediatrics: Blood and lymphatics system disorders: Anemia.
Cardiac disorders: Tachycardia.
Gastrointestinal disorder: Abdominal pain, diarrhea.
General disorders and administration site conditions: Injection site pain, peripheral edema, pyrexia.
Investigations: Hepatic enzyme increase.
Metabolism and Nutrition disorders: Hypoalbuminemia, hypokalemia, hypomagnesemia, hypophosphatemia, hypervolemia.
Musculoskeletal and connective tissue disorders: Muscle spasm, pain in extremity.
Nervous system disorders: Headache.
Psychiatric distress: Insomnia.
Renal and urinary disorders: Oliguria.
Respiratory, thoracic and mediastinal disorders: Pulmonary edema, hypoxia, pleural effusion, stridor, wheezing.
Skin and subcutaneous tissue disorders: Periorbital edema, rash.
Vascular disorders: Hypertension, hypotension.

Probenecid causes an almost 2-fold reduction in clearance of paracetamol by inhibiting its conjugation with glucuronic acid. A reduction in the paracetamol dose should be considered if it is to be used concomitantly with probenecid.
Salicylamide may prolong the elimination t½ of paracetamol.
Caution should be taken with the concomitant intake of enzyme-inducing substances.

Store at temperatures not exceeding 30°C. Protect from light.

Analgesics (Non-Opioid) & Antipyretics

N02BE01 - paracetamol ; Belongs to the class of anilide preparations. Used to relieve pain and fever.

Rx