Ampol XR Tablet (Extended Release)

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Paracetamol

Indications

Ampol XR is indicated for fever, common cold and influenza, headache, toothache, earache, bodyache, myalgia, neuralgia, dysmenorrhoea, sprains, colic pain, back pain, post-operative pain, postpartum pain, inflammatory pain and post vaccination pain in children. It is also indicated for rheumatic & osteoarthritic pain and stiffness of joints.

Pharmacology

Paracetamol has analgesic and antipyretic properties with weak anti-inflammatory activity. 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. Paracetamol is a para aminophenol derivative, has analgesic and antipyretic properties with weak anti-inflammatory activity. Paracetamol is one of the most widely used, safest and fast acting analgesic. It is well tolerated and free from various side effects of aspirin.

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

Patients who have taken barbiturates, tricyclic antidepressants and alcohol may show diminished ability to metabolise large doses of Ampol XR. Alcohol can increase the hepatotoxicity of Ampol XR overdosage. Chronic ingestion of anticonvulsants or oral steroid contraceptives induce liver enzymes and may prevent attainment of therapeutic Ampol XR levels by increasing first-pass metabolism or clearance.

Contraindications

It is contraindicated in known hypersensitivity to Paracetamol.

Side Effects

Side effects of Ampol XR 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

Epidemiological studies in human pregnancy have shown no ill effects due to Paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use. Paracetamol is excreted in breast milk, but not in a clinically significant amount. Available published data do not contraindicate breast feeding.

Precautions & Warnings

Care is advised in the administration of Ampol XR to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. Do not exceed the stated dose. Patients should be advised not to take other Ampol XR-containing products concurrently. Ampol XR should only be used by the patient for whom it is prescribed when clearly necessary.

Overdose Effects

Liver damage is possible in adults who have taken 10 g or more of Ampol XR. Ingestion of 5 g or more of Ampol XR may lead to liver damage if the patient has following risk factors: If the patient is on long term treatment with Carbamazepine, Phenobarbitone, Phenytoin, Primidone, Rifampicin, St John’s Wort or other drugs that induce liver enzymes, or regularly consumes Ethanol in excess of recommended amounts, or is likely to be Glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms: Symptoms of Ampol XR overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Immediate treatment is essential in the management of Ampol XR overdose. Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma Ampol XR concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of Ampol XR. However, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral Methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24 hours from ingestion should be discussed with the NPIS or a liver unit.

Therapeutic Class

Non opioid analgesics

Storage Conditions

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

Chemical Structure

Molecular Formula :C8H9NO2
Chemical Structure :Chemical Structure of Paracetamol

Common Questions about Ampol XR 665 mg Tablet

What is Ampol XR 665 mg XR Tablet?

Ampol XR 665 mg XR Tablet is a medication that performs its action by obstructing the release of pain and fever chemical messengers.

What are the uses of Ampol XR 665 mg XR Tablet?

Ampol XR 665 mg XR Tablet is used for the treatment and prevention of conditions and symptoms of diseases like Post immunization pyrexia, menstrual cramps and fever.

What are the Side Effects of Ampol XR 665 mg XR Tablet Ampol XR 665 mg XR Tablet?

Allergic reaction, gastric ulcers, fatigue, anemia, nausea and vomiting are possible side effects.

What are the instructions for storage and disposal Ampol XR 665 mg XR Tablet?

Ampol XR 665 mg XR Tablet should be stored at room temperature, away from heat and direct light. Keep it away from the reach of children and pets.

Should I use Ampol XR 665 mg XR Tablet empty stomach, before food or after food?

If you take Ampol XR 665 mg XR Tablet with the food, the reactions that took place in the body carry-outs in a much effective manner.

How long do I need to use Ampol XR 665 mg XR Tablet before I see improvement in my conditions?

Ampol XR 665 mg XR Tablet should be consumed, until the complete eradication of the disease. It is advised to use, till the time directed by your doctor.

Is there any food or drink I need to avoid while taking Ampol XR 665 mg XR Tablet?

You can follow your normal diet under the usage of Ampol XR 665 mg XR Tablet.

Will Ampol XR 665 mg XR Tablet be more effective if taken in more than the recommended dose?

There is no need to take Ampol XR 665 mg XR Tablet more than its recommended doses.

Can I take other medications along with Ampol XR 665 mg XR Tablet?

Do not use any OTC for cough, cold, allergy, or pain medication without consulting your doctor or pharmacist. Ampol XR 665 mg XR Tablet contains many combination of medicines. If you use certain products together you may accidentally use too much of Ampol XR 665 mg XR Tablet.

Can I take Ampol XR 665 mg XR Tablet with antibiotics?

There are hundreds of antibiotics used to treat infections, so once you receive your prescription, ask your doctor or pharmacist if you can also take Ampol XR 665 mg XR Tablet at the same time that you take the antibiotic.

Is Ampol XR 665 mg XR Tablet an NSAID drug?

No, Ampol XR 665 mg XR Tablet is not classified as an NSAID (nonsteroidal anti-inflammatory drug). It is classified as a miscellaneous analgesic for mild to moderate pain and fever.

Quick Tips

  • Ampol XR 665 mg XR Tablet should be taken with food or milk to prevent upset stomach.
  • Take Ampol XR 665 mg XR Tablet as per the dose and duration prescribed by your doctor. Long term use may lead to serious complications such as stomach bleeding and kidney problems.
  • Do not take indigestion remedies (antacids) within two hours of taking Ampol XR 665 mg XR Tablet.
  • Avoid consuming alcohol while taking Ampol XR 665 mg XR Tablet as it can increase your risk of stomach problems.
  • Inform your doctor if you have liver disease as your dose may need to be adjusted.
  • Your doctor may regularly monitor your kidney function, liver function and levels of blood components if you are taking Ampol XR 665 mg XR Tablet for long-term treatment.