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Clarineo Dosage |
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Clarineo/Clarineo Forte: Respiratory Tract/Skin and Soft Tissue Infections: Adults and Children ≥12 years: Usual Dose: 250 mg twice daily for 7 days, although this may be increased to 500 mg twice daily for up to 14 days in severe infections.
Children <12 years: Use Clarineo Paediatric Suspension. The use of Clarineo IR has not been studied in children <12 years.
Eradication of H. pylori: Adults and Elderly Triple Therapy Regimen: Clarineo 500 mg twice daily in conjunction with amoxicillin 1000 mg twice daily and a proton-pump inhibitor in standard dose twice daily for 7 days.
Dual Therapy Regimen: Clarineo 500 mg 3 times daily in conjunction with omeprazole 40 mg once daily for 14 days, followed by omeprazole 40 mg once daily for an additional 14 days. Supportive studies have been conducted with omeprazole 40 mg once daily for 14 days.
Renal Impairment: Dosage adjustments are not usually required except in patients with severe renal impairment (creatinine clearance <30 mL/min). If adjustment is necessary, the total daily dosage should be reduced by ½ eg, 250 mg once daily or 250 mg twice daily in more severe infections.
Clarineo may be given without regard to meals as food does not affect the extent of bioavailability.
Clarineo MR: Adults and Children >12 years: Usual Recommended
Dosage: 1 modified-release tab daily to be taken with food. In more severe infections, the dosage can be increased to 2 tabs daily. The usual duration of treatment is 7-14 days.
Children <12 years: Use Clarineo Paediatric Suspension. The use of Clarineo MR has not been studied in children <12 years.
Renal Impairment: Clarineo MR should not be used in patients with renal impairment (creatinine clearance <30 mL/min). Clarineo immediate-release tablets may be used in this patient population.
Do not crush or chew Clarineo MR tablets.
Clarineo Paediatric Suspension: Children 6 months to 12 years: Clinical trials have been conducted using Clarineo Pediatric Suspension in children 6 months-12 years. Therefore, children 6 months-12 years of age should use Clarineo Pediatric Suspension (granules for oral suspension).
Recommended Daily
Dosage: 7.5 mg/kg twice daily up to a maximum dose of 500 mg twice daily for nonmycobacterial infections. The usual duration of treatment is for 5-10 days depending on the pathogen involved and the severity of the condition. The prepared suspension can be taken with or without meals, and can be taken with milk.
Table 3 is a suggested guide for determining
Dosage: See Table 3.
Patients with Renal Impairment: In children with creatinine clearance <30 mL/min, the dosage of Clarineo should be reduced by ½ ie, up to 250 mg once daily or 250 mg twice daily in more severe infections. Dosage should not be continued >14 days in these patients.
Patients with Mycobacterial Infections: In children with disseminated or localized mycobacterial infections (M. avium, M. intracellulare, M. chelonae, M. fortuitum, M. kansasii), the recommended dose is 15-30 mg/kg/day in 2 divided doses.
Treatment with Clarineo should continue as long as clinical benefit is demonstrated. The addition of other antimycobacterial agents may be of benefit.
Many drugs can interact with Clarineo. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Clarineo, especially:
saquinavir;
carbamazepine;
theophylline;
a blood thinner (warfarin, Coumadin, Jantoven);
sildenafil (Viagra) and other erectile dysfunction medicines;
ergot medicine--ergonovine, methylergonovine; or
heart rhythm medication such as amiodarone, disopyramide, dofetilide, procainamide, quinidine, or sotalol.
This list is not complete and many other drugs can interact with Clarineo. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.
Clarineo: Data available to date indicate that Clarineo is metabolized primarily by the hepatic cytochrome P-450 3A (CYP3A) isozyme. This is an important mechanism determining many drug interactions.
The metabolism of other drugs by this system may be inhibited by concomitant administration with Clarineo and may be associated with elevations in serum levels of drug classes known or suspected to be metabolized by the same CYP450 and CYP3A isozyme.
Other Drug Interactions: Elevated digoxin serum concentrations have been reported in patients receiving Clarineo tablets and digoxin concomitantly. Monitoring of serum digoxin levels should be considered.
There have been post-marketing reports of Torsades de pointes occurring with concurrent use of Clarineo and quinidine or disopyramide. Serum levels of these medications should be monitored during Clarineo therapy.
Rhabdomyolysis coincident with the co-administration of Clarineo and the HMG-CoA reductase inhibitors eg, lovastatin and simvastatin has rarely been reported.
Antiretroviral Drug Interactions: Simultaneous oral administration of Clarineo tablets and zidovudine to HIV-infected adult patients may result in decreased steady-state zidovudine concentrations. Because Clarineo appears to interfere with the absorption of simultaneously administered oral zidovudine, this interaction can be largely avoided by staggering the doses of Clarineo and zidovudine. This interaction does not appear to occur in pediatric HIV-infected patients taking Clarineo suspension with zidovudine or dideoxyinosine.
A pharmacokinetic study demonstrated that the concomitant administration of ritonavir 200 mg every 8 hrs and Clarineo 500 mg every 12 hrs resulted in a marked inhibition of the metabolism of Clarineo.
For patients with renal impairment, the following dosage adjustments should be considered: For patients with CrCl 30-60 mL/min, the dose of Clarineo should be reduced by 50%. For patients with CrCl <30 mL, the dose of Clarineo should be decreased by 75%. Doses of Clarineo >1 g/day should not be co-administered with ritonavir.
Clarineo OD: As with other macrolide antibiotics, the use of Clarineo in patients concurrently taking drugs metabolized by the cytochrome P-450 system (eg, cilostazol, methylprednisolone, anticoagulants eg, warfarin, quinidine, sildenafil, ergot alkaloids, alprazolam, triazolam, midazolam, disopyramide, lovastatin, rifabutin, phenytoin, cyclosporin, vinblastine, valproate and tacrolimus) may be associated with elevations in serum levels of these other drugs.
Digoxin: Elevated digoxin serum concentrations have been reported in patients receiving Clarineo tablets and digoxin concomitantly. Monitoring of serum digoxin levels should be considered.
Quinidine/Disopyramide: There have been post-marketed reports of Torsades de pointes occurring with concurrent use of Clarineo and quinidine or disopyramide. Electrocardiogram and serum levels of these medications should be monitored during Clarineo therapy.
HMG-CoA Reductase Inhibitors: As with other macrolides, Clarineo has been reported to increase concentrations of HMG-CoA reductase inhibitors (eg, statins). Rhabdomyolysis has also been reported in patients taking these drugs concomitantly.
Theophylline, Carbamazepine: The administration of Clarineo to patients receiving theophylline or carbamazepine has been associated with an increase in serum theophylline or carbamazepine levels.
Ritonavir: Ritonavir increases AUC, Cmax and Cmin of Clarineo when administered concurrently. Because of the large therapeutic window for Clarineo, no dosage reduction should be necessary in patients with normal renal function. However, for patients with renal impairment, the following dosage adjustments should be considered: For patients with CrCl 30-60 mL/min, the dose of Clarineo should be reduced by 50%. For patients with CrCl <30 mL/min, the dose of Clarineo should be decreased by 75%. Doses of Clarineo >1 g/day should not be co-administered with ritonavir.
Efavirenz, Nevirapine, Rifampicin and Rifabutin: Strong inducers of the cytochrome P-450 metabolism system eg, efavirenz, nevirapine, rifampicin and rifabutin may accelerate the metabolism of Clarineo and thus, lower the plasma levels of Clarineo. Since the microbiological activities of Clarineo and 14-OH-Clarineo are different for different bacteria, the intended therapeutic effect could be impaired during concomitant administration of Clarineo and enzyme inducers.
Sildenafil, Tadalafil and Vardenafil: Each of these phosphodiesterase inhibitors is metabolized, at least in part, by CYP3A, and CYP3A may be inhibited by concomitantly administered Clarineo. Reduction in sildenafil, tadalafil and vardenafil dosages should be considered when these drugs are co-administered with Clarineo.
Triazolam: Drug interactions and CNS effects (eg, somnolence and confusion) with the concomitant use of Clarineo and triazolam have been reported. Monitoring the patient for increased CNS pharmacological effects is suggested.
Colchicine: When Clarineo and colchicine are administered together, inhibition of Pgp and/or CYP3A by Clarineo may lead to increased exposure to colchicine. Patients should be monitored for clinical symptoms of colchicine toxicity.
Itraconazole: Both Clarineo and itraconazole are substrates and inhibitors of CYP3A. Clarineo may increase the plasma levels of itraconazole, while itraconazole may increase the plasma levels of Clarineo. Patients taking itraconazole and Clarineo concomitantly should be monitored closely for signs and symptoms of increased or prolonged pharmacological effect.
Zidovudine: Simultaneous oral administration of Clarineo tablets and zidovudine to HIV-infected adult patients may result in decreased steady-state zidovudine concentrations. This interaction does not appear to occur in pediatric HIV-infected patients taking Clarineo suspension with zidovudine or dideoxyinosine.
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Information checked by Dr. Sachin Kumar, MD Pharmacology
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