Biogesic

Paracetamol.

Biogesic 120 mg/5 mL suspension comes in: A pink-colored, thick suspension with fruity strawberry odor, and sweet strawberry taste using the TasteRite Technology.
Biogesic 250 mg/5 mL suspension comes in: A pink-colored, thick suspension with fruity strawberry odor, and sweet strawberry taste using the TasteRite Technology.
Each 5 mL suspension contains: Active Ingredient: Paracetamol 120 mg or 250 mg.
Excipients/Inactive Ingredients: This preparation contains sodium benzoate (10 mg every 5 mL) as preservative.

Pharmacology: Pharmacodynamics: Paracetamol is a centrally acting analgesic and antipyretic with minimal anti-inflammatory properties.
The mechanism of analgesic action has not been fully determined. Paracetamol may act predominantly by inhibiting prostaglandin synthesis in the central nervous system [specifically cyclooxygenase (COX-2)] 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 to inhibition of the synthesis or actions of other substances that sensitize pain receptors to mechanical or chemical stimulation.
Antipyretic: Paracetamol acts centrally on the hypothalamic heat-regulating center to produce peripheral vasodilatation resulting in increased blood flow through the skin, sweating and heat loss. Paracetamol reduces fever by inhibiting the formulation and release of prostaglandins in the CNS and by inhibiting endogenous pyrogens at the hypothalamic thermoregulator center.
Pharmacokinetics: Following oral administration paracetamol is rapidly absorbed. Paracetamol absorption takes place mainly in the small intestine and therefore the rate of absorption is depending on the rate of gastric emptying.
It has been shown that drugs which delay gastric emptying also delay the absorption of paracetamol whereas metoclopramide (a drug which increases the rate of gastric emptying) accelerates absorption of the analgesic though the total amount absorbed does not increase. The presence of food in the stomach has also been reported to reduce the rate of absorption of paracetamol. Alterations in gastric pH have no appreciable effect on paracetamol absorption.
During absorption, the amount of paracetamol which is inactivated is negligible and it has been shown that paracetamol does not affect gastric mucosal permeability and does not produce mucosal bleeding. Peak plasma concentrations are reached 1 hour after absorption. The plasma half life is 1 to 3 hours. Paracetamol penetrates the brain and is present in breast milk of human.
Paracetamol is metabolized by the microsomal enzyme system of the liver. This metabolism is mainly to the glucuronide and sulphate conjugates, accounting for approximately 49% and 26% of the ingested dose respectively. About 4% is excreted as free paracetamol. Other minor pathways include the production of catechol derivatives and cysteine conjugates (via glutathione). Paracetamol excretion is rapid and occurs via the urine.

For the relief of fever.
For the relief of mild to moderate pain.

Dosing in Children: 15 mg/kg body weight per dose given every 4-6 hours as needed, with maximum of 4 doses in 24 hours. (See Tables 1 and 2.)

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Route of Administration: Oral.

Symptoms: Toxic symptoms include vomiting, abdominal pain, hypotension and sweating. The most serious adverse effect of acute overdose of paracetamol is a dose-dependent, potentially fatal hepatic necrosis. Clinical and laboratory evidence of hepatotoxicity may be delayed for up to one week. Major manifestations of liver failure such as jaundice, hypoglycemia and metabolic acidosis may take at least 3 days to develop.
Treatment: If a paracetamol overdose is suspected, obtain a serum paracetamol assay as soon as possible, but no sooner than 4 hours following oral ingestion. Obtain liver function studies initially and repeat at 24-hour intervals. Administer the antidote N-acetylcysteine (NAC) as early as possible. As a guide to treatment of acute ingestion, the paracetamol level can be plotted against time since oral ingestion on a nomogram (Rumack-Matthew). The lower toxic line on the nomogram is equivalent to 150 mcg/mL at 4 hours and 37.5 mcg/mL at 12 hours. If serum level is above the lower line, administer the entire course of NAC treatment. Withhold NAC therapy if the paracetamol level is below the lower line.

Hypersensitivity to paracetamol or any other ingredients/components of the product.
Severe and active hepatic impairment.

This preparation contains PARACETAMOL.
Do not take any other paracetamol containing medicines at the same time.
Allergy Alert: Paracetamol may cause severe skin reactions. Symptoms may include skin reddening, blister or rash. These could be signs of a serious condition. If these reactions occur, stop use and seek medical assistance right away.

Adverse effects of paracetamol are rare and usually mild, although haematological reactions have been reported. Skin rashes and other hypersensitivity reactions occur occasionally. Cutaneous hypersensitivity reactions including skin rashes, angioedema, Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis have been reported.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

Store at temperatures not exceeding 30°C.

Analgesics (Non-Opioid) & Antipyretics

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

NP