Calpol-T Dosage

• Dosage of Calpol-T in details
• Calpol-T interactions
• Calpol-T reviews

Dosage of Calpol-T in details

Unless otherwise prescribed, Calpol-T should be administered as follows:

Adults and Children >16 years: Maximum Single Dose: 1-2 tabs every 4-6 hrs as needed for pain relief up to a maximum of 8 tabs/day.

Children <16 years: The safety and effectiveness of Calpol-T has not been established in the pediatric population.

Elderly: No overall differences with regard to safety or pharmacokinetics were noted between subjects ≥65 years of age and younger subjects.

Calpol-T can be administered without regard to food.

Calpol-T interactions

CYP2D6 and CYP3A4 Inhibitors: Concomitant administration of CYP2D6 and/or CYP3A4 inhibitors eg, quinidine, fluoxetine, paroxetine and amitriptyline (CYP2D6 inhibitors) and ketoconazole and erythromycin (CYP3A4 inhibitors), may reduce metabolic clearance of Tramadol (Calpol-T) increasing the risk for serious adverse events, including seizures and serotonin syndrome.

Serotonergic Drugs: There have been post-marketing reports of serotonin syndrome with use of Tramadol (Calpol-T) and SSRIs/SNRIs or MAOIs and α2-adrenergic blockers. Caution is advised when Calpol-T are co-administered with other drugs that may affect the serotonergic neurotransmitter systems eg, SSRIs, MAOIs, triptans, linezolid (an antibiotic which is a reversible nonselective MAOI), lithium or St. John’s Wort. If concomitant treatment of Calpol-T with a drug affecting the serotonergic neurotransmitter system is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.

Triptans: Based on the mechanism of action of Tramadol (Calpol-T) and the potential for serotonin syndrome, caution is advised when Calpol-T are co-administered with a triptan. If concomitant treatment of Tramadol (Calpol-T) HCl and Paracetamol (Calpol-T) tablets with a triptan is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.

Use With Carbamazepine: Patients taking carbamazepine may have a significantly reduced analgesic effect of Tramadol (Calpol-T). Because carbamazepine increases Tramadol (Calpol-T) metabolism and because of the seizure risk associated with Tramadol (Calpol-T), concomitant administration of Calpol-T and carbamazepine is not recommended.

Use With Quinidine: Tramadol (Calpol-T) is metabolized to M1 by CYP2D6. Quinidine is a selective inhibitor of that isoenzyme, so that concomitant administration of quinidine and Tramadol (Calpol-T) results in increased concentrations of Tramadol (Calpol-T) and reduced concentrations of M1. The clinical consequences of these findings are unknown. In vitro drug interaction studies in human liver microsomes indicate that Tramadol (Calpol-T) has no effect on quinidine metabolism.

Potential for Other Drugs to Affect Tramadol (Calpol-T): In vitro drug interaction studies in human liver microsomes indicate that concomitant administration with inhibitors of CYP2D6 eg, fluoxetine, paroxetine and amitriptyline could result in some inhibition of the metabolism of Tramadol (Calpol-T). Administration of CYP3A4 inhibitors eg, ketoconazole and erythromycin or inducers eg, rifampin and St. John’s Wort, with Calpol-T, may affect the metabolism of Tramadol (Calpol-T) leading to altered Tramadol (Calpol-T) exposure.

Potential for Tramadol (Calpol-T) to Affect Other Drugs: In vitro studies indicate that Tramadol (Calpol-T) is unlikely to inhibit the CYP3A4-mediated metabolism of other drugs when Tramadol (Calpol-T) is administered concomitantly at therapeutic doses. Tramadol (Calpol-T) does not appear to induce its own metabolism in humans, since observed maximal plasma concentrations after multiple oral doses are higher than expected based on single-dose data. Tramadol (Calpol-T) is a mild inducer of selected drug metabolism pathways measured in animals.

Use With Cimetidine: Concomitant administration of Calpol-T and cimetidine has not been studied. Concomitant administration of Tramadol (Calpol-T) and cimetidine does not result in clinically significant changes in Tramadol (Calpol-T) pharmacokinetics. Therefore, no alteration of the Calpol-T dosage regimen is recommended.

Use With Digoxin: Tramadol (Calpol-T) has revealed rare reports of digoxin toxicity.

Use With Warfarin-Like Compounds: Both Tramadol (Calpol-T) and Paracetamol (Calpol-T) individual products have revealed rare alterations of warfarin effect, including elevation of prothrombin times.

While such changes have been generally of limited clinical significance for the individual products, periodic evaluation of prothrombin time should be performed when Calpol-T and warfarin-like compounds are administered concurrently.

References

1. FDA/SPL Indexing Data. "0NG5TTM63P: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
2. MeSH. "Narcotics". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
3. European Chemicals Agency - ECHA. "Tramadol: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Calpol-T are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Calpol-T. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology