Clarimicina Dosage

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Dosage of Clarimicina in details

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Clarimicina/Clarimicina 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 Clarimicina Paediatric Suspension. The use of Clarimicina IR has not been studied in children <12 years.

Eradication of H. pylori: Adults and Elderly Triple Therapy Regimen: Clarimicina 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: Clarimicina 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.

Clarimicina may be given without regard to meals as food does not affect the extent of bioavailability.

Clarimicina 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 Clarimicina Paediatric Suspension. The use of Clarimicina MR has not been studied in children <12 years.

Renal Impairment: Clarimicina MR should not be used in patients with renal impairment (creatinine clearance <30 mL/min). Clarimicina immediate-release tablets may be used in this patient population.

Do not crush or chew Clarimicina MR tablets.

Clarimicina Paediatric Suspension: Children 6 months to 12 years: Clinical trials have been conducted using Clarimicina Pediatric Suspension in children 6 months-12 years. Therefore, children 6 months-12 years of age should use Clarimicina 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 Clarimicina 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 Clarimicina should continue as long as clinical benefit is demonstrated. The addition of other antimycobacterial agents may be of benefit.

What other drugs will affect Clarimicina?

Many drugs can interact with Clarimicina. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Clarimicina, especially:

This list is not complete and many other drugs can interact with Clarimicina. 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.

Clarimicina interactions

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Clarimicina: Data available to date indicate that Clarimicina 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 Clarimicina 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 Clarimicina 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 Clarimicina and quinidine or disopyramide. Serum levels of these medications should be monitored during Clarimicina therapy.

Rhabdomyolysis coincident with the co-administration of Clarimicina and the HMG-CoA reductase inhibitors eg, lovastatin and simvastatin has rarely been reported.

Antiretroviral Drug Interactions: Simultaneous oral administration of Clarimicina tablets and zidovudine to HIV-infected adult patients may result in decreased steady-state zidovudine concentrations. Because Clarimicina appears to interfere with the absorption of simultaneously administered oral zidovudine, this interaction can be largely avoided by staggering the doses of Clarimicina and zidovudine. This interaction does not appear to occur in pediatric HIV-infected patients taking Clarimicina suspension with zidovudine or dideoxyinosine.

A pharmacokinetic study demonstrated that the concomitant administration of ritonavir 200 mg every 8 hrs and Clarimicina 500 mg every 12 hrs resulted in a marked inhibition of the metabolism of Clarimicina.

For patients with renal impairment, the following dosage adjustments should be considered: For patients with CrCl 30-60 mL/min, the dose of Clarimicina should be reduced by 50%. For patients with CrCl <30 mL, the dose of Clarimicina should be decreased by 75%. Doses of Clarimicina >1 g/day should not be co-administered with ritonavir.

Clarimicina OD: As with other macrolide antibiotics, the use of Clarimicina 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 Clarimicina 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 Clarimicina and quinidine or disopyramide. Electrocardiogram and serum levels of these medications should be monitored during Clarimicina therapy.

HMG-CoA Reductase Inhibitors: As with other macrolides, Clarimicina 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 Clarimicina to patients receiving theophylline or carbamazepine has been associated with an increase in serum theophylline or carbamazepine levels.

Oral Anticoagulants:

Concomitant administration of Clarimicina and oral anticoagulants may potentiate the effects of oral anticoagulants. Prothrombin time should be carefully monitored while patients are receiving Clarimicina and oral anticoagulants simultaneously.

Ritonavir: Ritonavir increases AUC, Cmax and Cmin of Clarimicina when administered concurrently. Because of the large therapeutic window for Clarimicina, 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 Clarimicina should be reduced by 50%. For patients with CrCl <30 mL/min, the dose of Clarimicina should be decreased by 75%. Doses of Clarimicina >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 Clarimicina and thus, lower the plasma levels of Clarimicina. Since the microbiological activities of Clarimicina and 14-OH-Clarimicina are different for different bacteria, the intended therapeutic effect could be impaired during concomitant administration of Clarimicina 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 Clarimicina. Reduction in sildenafil, tadalafil and vardenafil dosages should be considered when these drugs are co-administered with Clarimicina.

Triazolam: Drug interactions and CNS effects (eg, somnolence and confusion) with the concomitant use of Clarimicina and triazolam have been reported. Monitoring the patient for increased CNS pharmacological effects is suggested.

Colchicine: When Clarimicina and colchicine are administered together, inhibition of Pgp and/or CYP3A by Clarimicina may lead to increased exposure to colchicine. Patients should be monitored for clinical symptoms of colchicine toxicity.

Itraconazole: Both Clarimicina and itraconazole are substrates and inhibitors of CYP3A. Clarimicina may increase the plasma levels of itraconazole, while itraconazole may increase the plasma levels of Clarimicina. Patients taking itraconazole and Clarimicina concomitantly should be monitored closely for signs and symptoms of increased or prolonged pharmacological effect.

Zidovudine: Simultaneous oral administration of Clarimicina 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 Clarimicina suspension with zidovudine or dideoxyinosine.


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References

  1. DailyMed. "CLARITHROMYCIN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. FDA/SPL Indexing Data. "H1250JIK0A: 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).
  3. MeSH. "Cytochrome P-450 CYP3A Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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