Paracap

Paracetamol.

Tab: Each tablet contains: Paracetamol 500 mg.
Oral susp: Name and Strength of Active Substance(s): Paracetamol 250 mg/5 mL in the form of a suspension.
Excipients/Inactive Ingredients: Tab: Corn starch 6.44 mg, Tapioca starch 3.92 mg, Povidone K90 5.52 mg, Sodium metabisulfite 0.36 mg, Methylparaben 0.52 mg, Sodium starch glycolate 8.70 mg, Magnesium stearate 4.56 mg, Purified water 0.088 mL.
Oral susp: Methylparaben 9.00 mg and Propylparaben 1.50 mg/5 mL.

Pharmacology: Pharmacodynamics: Paracetamol is a centrally acting analgesic and antipyretic with minimal anti-inflammatory properties.
Analgesic: 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 act centrally on the hypothalamic heat-regulating center to produce peripheral vasodilation resulting in increase 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 through the total amount absorbed doses 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.

Tab: For the relief from mild to moderate including: headache, migraine, backache, musculoskeletal pain, myalgia and neuralgia, dysmenorrhea, pain of osteoarthritis, toothache, pain after dental procedures/tooth extraction, pain after vaccination and the discomfort from colds, influenza and sore throats.
Oral susp: For the relief of fever and pain.

Recommended Dosage: Tab: Adults and children aged 12 years and over: 500 mg to 1 g (1-2 tablets) paracetamol, taken every 4-6 hours as required up to a maximum of 4 g daily.
Oral susp: For children aged 6 to 12 years. Give in 6 hourly intervals; not more than 4 times a day.
Children 6 - 9 years of age: 6.0 mL - 10.0 mL.
Children 9 - 12 years of age: 10.0 mL - 15.0 mL.
The previously mentioned is based on the average weight-age grid of children. If the parents know the body weight of their child, it's always more accurate to use the weight to arrive at the correct dose. Refer as follows.
Using the body weight of a child, calculate the dose of Paracetamol Suspension 250 mg/5 mL a child needs. Calculation is based on recommended dose of 15 mg per body weight in kg (BW).
Table as follows provides the dose of Paracetamol Suspension 250 mg/5 mL to be given, based on body weight: (See table).

Click on icon to see table/diagram/image

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: In cases of overdose, methods of reducing the absorption of ingested drug are important. Gastric lavage is essential even if several hours have elapsed. Prompt administration of 50 g activated charcoal and 500 ml iced mannitol 20% by mouth, may reduce absorption. If the history suggests that 15 g Paracetamol or more has been ingested, administer one of the following antidotes: Acetylcysteine 20% i.v: Administer intravenously, 20% acetylcysteine (Parvolex, Glaxo) immediately without waiting for positive urine test or plasma level results: initial dose of 150 mg/kg over 15 minutes, followed by continuous infusion of 50 mg/kg in 500 mL 5% glucose/dextrose over 4 hours and 100 mg/kg in 1L 5% glucose/dextrose over 16 hours.
Oral Methionine: 2.5 g immediately followed by three further doses of 2.5 g at four hourly intervals. For a 3-year old child, 1 g methionine every four hours for four doses has been used.
Oral Acetylcysteine 5%: 140 mg/kg as a loading dose, then 70 mg/kg every 4 hours for a total of 17 maintenance doses. If more than ten hours have elapsed since the overdosage was taken, the antidote may be in ineffective.

Hypersensitivity to paracetamol or any of the 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.

Do not take if allergic to paracetamol.
Patients should contact their healthcare provider if symptoms persist (if the pain lasts for more than 10 days, if there is redness or fever lasts more than 3 days).
Paracetamol should be given with care to patients with impaired kidney or liver function.
Large doses should be avoided in patients with hepatic impairment. Paracetamol overdose may harm the liver.
Do not exceed recommended dose.
Paracetamol provides symptomatic relief only, additional therapy to treat the cause of the pain or fever should be instituted when necessary.
Paracetamol may cause severe skin reactions. Symptoms may include skin reddening, blisters or rash. These could be signs of serious condition. If these reactions occur, stop use and seek medical assistance right away.
Tab: It should be given with care to patients with alcohol dependence.
This preparation contains Sodium Metabisulphite that may cause serious allergy reactions in certain susceptible patients. Do not use if serious allergic type reactions in certain susceptible patients. Do not use if known to be hypertensive to bisulphites.
Effects on Ability to Drive and Use Machines: It is unlikely to impair a patient's ability to drive or use machinery.

Tab: Use in pregnancy: Considered to be analgesic of choice in pregnant patients.
Although it crosses placenta, paracetamol is considered to be safe in normal therapeutic doses for short-term use as a minor analgesic/antipyretic in pregnancy.
Use in lactation: Excreted in breast milk.
Maternal ingestion of paracetamol in normal therapeutic doses does not appear to present a risk to the nursing infant.

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

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 below 30°C.
Shelf-life: Tab: 3 years from the date of manufacture.
Oral susp: 2 years from manufacturing date.

Analgesics (Non-Opioid) & Antipyretics

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

NP