Paragesic Tablet 500 mg

Generic

Paracetamol

Indications

Paracetamol is suitable for fever, common cold and flu, headache, toothache, earache, body pain, myalgia, neuralgia, dysmenorrhea, sprain, colic, back pain, postoperative pain, postpartum pain, inflammatory pain and pain in children after vaccination. It is also suitable for rheumatic pain and osteoarthritis and joint stiffness.

Pharmacology

Paracetamol has analgesic and antipyretic properties, and its anti-inflammatory activity is weak. Paracetamol (acetaminophen) is believed to act mainly on the central nervous system, increasing the pain threshold by inhibiting two isoforms of cyclooxygenase COX1, COX2 and COX3, which are involved in the synthesis of prostaglandin (PG). Paracetamol is a derivative of p-aminophenol, has analgesic and antipyretic effects, and has weak anti-inflammatory activity. Paracetamol is one of the most widely used, safest, and quick-acting analgesics. It is well tolerated and does not have various aspirin side effects.

Dosage & Administration

Tablet:

• Adult: 1-2 tablets every 4 to 6 hours up to a maximum of 4 gm (8 tablets) daily.
• Children (6-12 years): ½ to 1 tablet 3 to 4 times daily. For long term treatment it is wise not to exceed the dose beyond 2.6 gm/day.

Extended Release Tablet:

• Adults & Children over 12 years: Two tablets, swallowed whole, every 6 to 8 hours (maximum of 6 tablets in any 24 hours).The tablet must not be crushed.

Syrup/Suspension:

• Children under 3 months: 10 mg/kg body weight (reduce to 5 mg/kg if jaundiced) 3 to 4 times daily.
• 3 months to below 1 year: ½ to 1 teaspoonful 3 to 4 times daily.
• 1-5 years: 1 -2 teaspoonful 3 to 4 times daily.
• 6-12 years: 2-A teaspoonful 3 to 4 times daily.
• Adults: 4-8 teaspoonful 3 to 4 times daily.

Suppository:

• Children 3-12 months: 60-120 mg,4 times daily.
• Children 1-5 years: 125-250 mg 4 times daily.
• Children 6-12 years: 250-500 mg 4 times daily.
• Adults & children over 12 years: 0.5-1 gm 4 times daily.

Paediatric Drop:

• Children Upto 3 months: 0.5 ml (40 mg)
• 4 to 11 months: 1.0 ml (80 mg)
• 7 to 2 years: 1.5 ml (120 mg). Do not exceed more than 5 dose daily for a maximum of 5 days.

Paracetamol tablet with actizorb technology: It dissolves up to five times faster than standard Paracetamol tablets. It is a fast acting and safe analgesic with marked antipyretic property. It is specially suitable for patients who, for any reason, can not tolerate aspirin or other analgesics.

• Adults and children (aged 12 years and over): Take 1 to 2 Tablets every four to six hours as needed. Do not take more than 8 caplets in 24 hours.
• Children (7 to 11 years): Take ½-1 Tablet every four to six hours as needed. Do not take more than 4 caplets in 24 hours. Not recommended in children under 7 years.

Interactions

Patients taking barbiturates, tricyclic antidepressants, and alcohol may have a reduced ability to metabolize large doses of paracetamol. Alcohol can increase liver toxicity from acetaminophen overdose. Long-term use of anticonvulsants or oral steroid contraceptives may induce liver enzymes and may prevent therapeutic levels of paracetamol from being achieved by increasing metabolism or first-pass clearance.

Contraindications

It is contraindicated in known hypersensitivity to Paracetamol.

Side Effects

The side effects of paracetamol are usually mild, but haematological reactions including thrombocytopenia, leukopenia, pancytopenia, neutropenia, and agranulocytosis have been reported. Occasionally, pancreatitis, skin rash, and other allergic reactions can occur.

Pregnancy & Lactation

U.S. Food and Drug Administration (USFDA) prescribed pregnancy category B. This medicine should be used during pregnancy only if it is clearly needed.

Precautions & Warnings

Paracetamol should be used with caution in patients with renal or liver damage. Patients taking other drugs that affect the liver should use paracetamol with caution.

Therapeutic Class

Non opioid analgesics

Storage Conditions

Keep in a dry place away from light and heat. Keep out of the reach of children.

Pharmaceutical Name

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