Indications

Ace 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.

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Pharmacology

Paracetamol exhibits analgesic action by peripheral blockage of pain impulse generation. It produces antipyresis by inhibiting the hypothalamic heat-regulating centre. Its weak anti-inflammatory activity is related to inhibition of prostaglandin synthesis in the CNS.

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

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.

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.

IV Infusion:

• Adults and adolescents weighing 50 kg and over: the recommended dosage of Paracetamol IV is 1000 mg every 6 hours or 650 mg every 4 hours, with a maximum single dose of Paracetamol IV of 1000 mg, a minimum dosing interval of 4 hours, and a maximum daily dose of Paracetamol of 4000 mg per day.
• Adults and adolescents weighing under 50 kg: the recommended dosage of Paracetamol IV is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of Paracetamol IV of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of Paracetamol of 75 mg/kg per day.
• Children >2 to 12 years of age: the recommended dosage of Paracetamol IV is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of Paracetamol IV of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of Paracetamol of 75 mg/kg per day.

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Interaction

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

Contraindications

It is contraindicated in known hypersensitivity to Paracetamol.

Side Effects

Side effects of Ace 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 Ace 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 Ace XR-containing products concurrently. Ace XR should only be used by the patient for whom it is prescribed when clearly necessary.

Administration of Ace XR in doses higher than recommended may result in hepatic injury, including the risk of severe hepatotoxicity and death. Do not exceed the maximum recommended daily dose of Ace XR. Use caution when administering Ace XR in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia (e.g., due to dehydration or blood loss), or severe renal impairment (creatinine clearance < 30 ml/min). There were infrequent reports of life-threatening anaphylaxis requiring emergent medical attention. Discontinue Ace XR IV immediately if symptoms associated with allergy or hypersensitivity occurs. Do not use Ace XR IV in patients with Ace XR allergy.

Use in Special Populations

Pediatric Use: The safety and effectiveness of Ace XR 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 Ace XR 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: Ace XR 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 Ace XR 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 Ace XR may be warranted.

Overdose Effects

Liver damage is possible in adults who have taken 10 g or more of Ace XR. Ingestion of 5 g or more of Ace 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 Ace 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 Ace XR overdose. Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma Ace 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 Ace 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

Common Questions about Ace XR 665 mg Tablet

What is Ace XR 665 mg XR Tablet?

Ace 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 Ace XR 665 mg XR Tablet?

Ace 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 Ace XR 665 mg XR Tablet Ace 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 Ace XR 665 mg XR Tablet?

Ace 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 Ace XR 665 mg XR Tablet empty stomach, before food or after food?

If you take Ace 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 Ace XR 665 mg XR Tablet before I see improvement in my conditions?

Ace 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 Ace XR 665 mg XR Tablet?

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

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

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

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

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

Can I take Ace 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 Ace XR 665 mg XR Tablet at the same time that you take the antibiotic.

Is Ace XR 665 mg XR Tablet an NSAID drug?

No, Ace 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

• Ace XR 665 mg XR Tablet should be taken with food or milk to prevent upset stomach.
• Take Ace 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 Ace XR 665 mg XR Tablet.
• Avoid consuming alcohol while taking Ace 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 Ace XR 665 mg XR Tablet for long-term treatment.

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