Napasoft

Napasoft Uses, Dosage, Side Effects, Food Interaction and all others data.

Paracetamol (Acetaminophen) is thought to act primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin (PG) synthesis. Unlike NSAIDs, acetaminophen does not inhibit cyclooxygenase in peripheral tissues and, thus, has no peripheral anti-inflammatory affects. While aspirin acts as an irreversible inhibitor of COX and directly blocks the enzyme's active site, studies have found that acetaminophen indirectly blocks COX, and that this blockade is ineffective in the presence of peroxides. This might explain why acetaminophen is effective in the central nervous system and in endothelial cells but not in platelets and immune cells which have high levels of peroxides. Studies also report data suggesting that acetaminophen selectively blocks a variant of the COX enzyme that is different from the known variants COX-1 and COX-2. This enzyme is now referred to as COX-3. Its exact mechanism of action is still poorly understood, but future research may provide further insight into how it works. The antipyretic properties of acetaminophen are likely due to direct effects on the heat-regulating centres of the hypothalamus resulting in peripheral vasodilation, sweating and hence heat dissipation.

The mechanism of the possible anti-hepatotoxic activity of L-methionine is not entirely clear. It is thought that metabolism of high doses of acetaminophen in the liver lead to decreased levels of hepatic glutathione and increased oxidative stress. L-methionine is a precursor to L-cysteine. L-cysteine itself may have antioxidant activity. L-cysteine is also a precursor to the antioxidant glutathione. Antioxidant activity of L-methionine and metabolites of L-methionine appear to account for its possible anti-hepatotoxic activity. Recent research suggests that methionine itself has free-radical scavenging activity by virtue of its sulfur, as well as its chelating ability.

Trade Name Napasoft
Generic Paracetamol + Methionine
Weight 500mg+100mg
Type Tablet
Therapeutic Class Non opioid analgesics
Manufacturer Beximco Pharmaceuticals Ltd
Available Country Bangladesh
Last Updated: September 19, 2023 at 7:00 am
Napasoft
Napasoft

How Napasoft works

The mechanism of the possible anti-hepatotoxic activity of L-methionine is not entirely clear. It is thought that metabolism of high doses of acetaminophen in the liver lead to decreased levels of hepatic glutathione and increased oxidative stress. L-methionine is a precursor to L-cysteine. L-cysteine itself may have antioxidant activity. L-cysteine is also a precursor to the antioxidant glutathione. Antioxidant activity of L-methionine and metabolites of L-methionine appear to account for its possible anti-hepatotoxic activity. Recent research suggests that methionine itself has free-radical scavenging activity by virtue of its sulfur, as well as its chelating ability.

Dosage

Napasoft dosage

Adult dosage: 2 tablets every 4 hours; max. 8 tablets daily.

Child Dosage: Not recommended for children under 12 years of age.

Side Effects

Side effects of recommended doses (up to 8 tablets/capsules a day in adults) are rare, but blood disorders, skin rashes are known to be associated with Napa soft.

Toxicity

Doses of L-methionine of up to 250 mg daily are generally well tolerated. Higher doses may cause nausea, vomiting and headache. Healthy adults taking 8 grams of L-methionine daily for four days were found to have reduced serum folate levels and leucocytosis. Healthy adults taking 13.9 grams of L-methionine daily for five days were found to have changes in serum pH and potassium and increased urinary calcium excretion. Schizophrenic patients given 10 to 20 grams of L-methionine daily for two weeks developed functional psychoses. Single doses of 8 grams precipitated encephalopathy in patients with cirrhosis.

Precaution

This should be used with caution in alcoholism and decreased kidney function. In cases of overdose, immediate advice should be sought from a physician. Alcohol increases the risk of liver damage that can occur if an overdose of paracetamol is taken. The hazards of paracetamol overdose are greater in persistent heavy drinkers and in people with alcoholic liver disease.

Interaction

This should not be used with monoamine-oxidase inhibitor (MAOI), antidepressants (e.g. phenelzine). Prolonged use of paracetamol may enhance the effects of anti-clotting/ blood thinning medicines such as warfarin, leading to an increased risk of bleeding. Methionine may reduce the effect of levodopa. Metoclopramide and domperidone increase the rate of absorption of paracetamol from the gut. The absorption of paracetamol is decreased if cholestyramine is taken at the same time.

Volume of Distribution

Volume of distribution is about 0.9L/kg. 10 to 20% of the drug is bound to red blood cells. Acetaminophen appears to be widely distributed throughout most body tissues except in fat.

Elimination Route

Absorbed from the lumen of the small intestine into the enterocytes by an active transport process.

Half Life

The half-life for adults is 2.5 h after an intravenous dose of 15 mg/kg. After an overdose, the half-life can range from 4 to 8 hours depending on the severity of injury to the liver, as it heavily metabolizes acetaminophen.

Clearance

Adults: 0.27 L/h/kg following a 15 mg/kg intravenous (IV) dose. Children: 0.34 L/h/kg following a 15 mg/kg intravenous (IV dose).

Pregnancy & Breastfeeding use

Since this is a fixed dose combination of methionine and paracetamol, it is advised to consult with physician before use during the period of pregnancy and lactation.This should be used with caution during pregnancy, and only if the expected benefit to the mother is greater than any possible risk to the foetus. This should be used with caution by breast feeding mothers, and only if the expected benefit to the mother is greater than any possible risk to the baby.

Contraindication

Children under 12 years of age, Known sensitivity or allergy to any ingredient, Liver disease.

Special Warning

Pediatric Use: The safety and effectiveness of Paracetamol IV for the treatment of acute pain and fever in pediatric patients ages 2 years and older is supported by evidence from adequate and well-controlled studies of Paracetamol IV in adults.

Geriatric use: No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients.

Patients with Hepatic Impairment: Paracetamol is contraindicated in patients with severe hepatic impairment or severe active liver disease and should be used with caution in patients with hepatic impairment or active liver disease. A reduced total daily dose of Paracetamol may be warranted.

Patients with Renal Impairment: In cases of severe renal impairment (creatinine clearance < 30 ml/min), longer dosing intervals and a reduced total daily dose of Paracetamol may be warranted.

Storage Condition

Store at a cool, dry place, away from light. Keep out of reach of children.

Innovators Monograph

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*** Taking medicines without doctor's advice can cause long-term problems.
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