Xpa 125 Suppository

Generic

Paracetamol

Indications

Fever, common cold, and influenza, headache, toothache, earache, bodyache, myalgia, neuralgia, dysmenorrhoea, sprains, colic pain, back pain, post-operative pain, postpartum discomfort, inflammatory pain, and post vaccination pain in children are among the conditions for which paracetamol is prescribed. It's also used to treat rheumatic and osteoarthritic pain, as well as joint stiffness.

Pharmacology

Paracetamol is an analgesic and antipyretic with just a minor anti-inflammatory effect. Paracetamol (Acetaminophen) is hypothesized to work largely in the central nervous system (CNS), improving pain threshold by blocking both isoforms of the cyclooxygenase enzymes COX-1, COX-2, and COX-3, which are involved in prostaglandin (PG) formation. Paracetamol is a para aminophenol derivative that has analgesic, antipyretic, and anti-inflammatory effects. One of the most extensively used, safest, and fastest acting analgesics is paracetamol. It is well tolerated and free of aspirin's different adverse 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.

Interaction

Barbiturates, tricyclic antidepressants, and alcohol may impair the ability of patients to metabolize large doses of paracetamol. Overdosing on paracetamol can cause hepatotoxicity if consumed with alcohol. Anticonvulsants and oral steroid contraceptives cause liver enzymes to increase, which may prevent therapeutic Paracetamol levels from being reached by increasing first-pass metabolism or clearance.

Contraindications

It is contraindicated in known hypersensitivity to Paracetamol.

Side Effects

Side effects of paracetamol are usually mild, though haematological reactions including thrombocytopenia, leucopenia, pancytopenia, neutropenia, and agranulocytosis have been reported. Pancreatitis, skin rashes, and other allergic reactions occur occasionally.

Pregnancy & Lactation

Pregnancy category B according to USFDA. This drug should be used during pregnancy only if clearly needed

Precautions & Warnings

Paracetamol should be given with caution to patients with impaired kidney or liver function. Paracetamol should be given with care to patients taking other drugs that affect the liver.

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

Aristopharma Ltd.