Clarinix-DT is used to treat bacterial infections in many different parts of the body. It is also used in combination with other medicines to treat duodenal ulcers caused by H. pylori. Clarinix-DT is also used to prevent and treat Mycobacterium avium complex (MAC) infection.
Clarinix-DT belongs to the class of medicines known as macrolide antibiotics. It works by killing bacteria or preventing their growth. However, Clarinix-DT will not work for colds, flu, or other virus infections.
Clarinix-DT is available only with your doctor's prescription.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, Clarinix-DT is used in certain patients with the following medical condition:
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
Acute Bacterial Exacerbation of Chronic Bronchitis
Clarinix-DT tablets, Clarinix-DT for oral suspension and Clarinix-DT extended-release tablets are indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.
Acute Maxillary Sinusitis
Clarinix-DT tablets, Clarinix-DT for oral suspension and Clarinix-DT extended-release tablets (in adults) are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.
Clarinix-DT tablets, Clarinix-DT for oral suspension and Clarinix-DT extended-release tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to:
Haemophilus influenzae (in adults)
Haemophilus parainfluenzae (Clarinix-DT extended-release tablets in adults)
Moraxella catarrhalis (Clarinix-DT extended-release tablets in adults)
Mycoplasma pneumoniae, Streptococcus pneumoniae, Chlamydophila pneumoniae (Clarinix-DT extended-release tablets [in adults]; Clarinix-DT tablets and Clarinix-DT for oral suspension [in adults and pediatric patients])
Clarinix-DT tablets and Clarinix-DT for oral suspension are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Streptococcus pyogenes as an alternative in individuals who cannot use first line therapy.
Uncomplicated Skin and Skin Structure Infections
Clarinix-DT tablets and Clarinix-DT for oral suspension are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Staphylococcus aureus, or Streptococcus pyogenes.
Acute Otitis Media
Clarinix-DT tablets and Clarinix-DT for oral suspension are indicated in pediatric patients for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.
Treatment and Prophylaxis of Disseminated Mycobacterial Infections
Clarinix-DT tablets and Clarinix-DT for oral suspension are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Mycobacterium avium or Mycobacterium intracellulare in patients with advanced HIV infection.
Helicobacter pylori Infection and Duodenal Ulcer Disease
Clarinix-DT tablets are given in combination with other drugs in adults as described below to eradicate H. pylori. The eradication of H. pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence.
Clarinix-DT tablets in combination with amoxicillin and PREVACID (lansoprazole) or PRILOSEC (omeprazole) delayed-release capsules, as triple therapy, are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or five-year history of duodenal ulcer) to eradicate H. pylori.
Clarinix-DT tablets in combination with PRILOSEC (omeprazole) capsules are indicated for the treatment of patients with an active duodenal ulcer associated with H. pylori infection. Regimens which contain Clarinix-DT tablets as the single antibacterial agent are more likely to be associated with the development of Clarinix-DT resistance among patients who fail therapy. Clarinix-DT-containing regimens should not be used in patients with known or suspected Clarinix-DT resistant isolates because the efficacy of treatment is reduced in this setting.
Limitations of Use
Clarinix-DT extended-release tablets are indicated only for acute maxillary sinusitis, acute bacterial exacerbation of chronic bronchitis, and community-acquired pneumonia in adults. The efficacy and safety of Clarinix-DT extended-release tablets in treating other infections for which Clarinix-DT tablets and Clarinix-DT for oral suspension are approved have not been established.
There is resistance to macrolides in certain bacterial infections caused by Streptococcus pneumoniae and Staphylococcus aureus. Susceptibility testing should be performed when clinically indicated.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Clarinix-DT and other antibacterial drugs, Clarinix-DT should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
How should I use Clarinix-DT?
Use Clarinix-DT extended-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Take Clarinix-DT extended-release tablets by mouth with food.
Swallow Clarinix-DT extended-release tablets whole. Do not break, crush, or chew before swallowing.
If you are also taking zidovudine, do not take it within 2 hours before or after Clarinix-DT extended-release tablets.
Clarinix-DT extended-release tablets works best if it is taken at the same time each day.
To clear up your infection completely, take Clarinix-DT extended-release tablets for the full course of treatment. Keep taking it even if you feel better in a few days.
Do not miss any doses. If you miss a dose of Clarinix-DT extended-release tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Clarinix-DT extended-release tablets.
Uses of Clarinix-DT in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
Use: Labeled Indications
Chronic obstructive pulmonary disease, acute exacerbation: Treatment of acute bacterial exacerbation of chronic bronchitis in adults due to susceptible Haemophilus influenzae, Haemophilus parainfluenzae, Moraxellacatarrhalis, or Streptococcus pneumoniae.
Helicobacter pylori eradication: Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence as a component of combination therapy (triple therapy) in adults with H. pylori infection and duodenal ulcer disease (active or 5-year history of duodenal ulcer).
Limitations of use: Regimens that contain Clarinix-DT as the single antibacterial agent are more likely to be associated with the development of Clarinix-DT resistance. Clarinix-DT-containing regimens should not be used in patients with known or suspected Clarinix-DT-resistant isolates (efficacy is reduced).
Mycobacterial (nontuberculous) infection: Prophylaxis and treatment of disseminated mycobacterial infections due to Mycobacterium avium complex (MAC) in patients with advanced HIV infection.
Otitis media: Treatment of acute otitis media in pediatric patients due to susceptible H. influenzae, M. catarrhalis, or S. pneumoniae.
Pneumonia, community-acquired: Treatment of community-acquired pneumonia due to susceptible Mycoplasma pneumoniae, S. pneumoniae, or Chlamydophila pneumoniae (adult and pediatric patients) and H. influenzae, H. parainfluenzae, or M. catarrhalis (adults).
Skin/skin structure infection: Treatment of uncomplicated skin/skin structure infection due to susceptible Staphylococcus aureus or Streptococcus pyogenes.
Streptococcal pharyngitis: Treatment of pharyngitis/tonsillitis due to susceptible S. pyogenes (alternative agent for patients with severe penicillin allergy).
Off Label Uses
Bartonella spp. infection
Based on the US Department of Health and Human Services guidelines for prevention and treatment of opportunistic infections in adults and adolescents with HIV, Clarinix-DT is an effective and recommended alternative agent for treatment or long-term suppression of bartonellosis infection.
Clinical experience also suggests the utility of Clarinix-DT for the treatment of cat scratch disease.
Oral Suspension (Pediatric Suspension): Each 5 ml of the granules for suspension contains 250 mg of Clarinix-DT.
Clarinix-DT is a semisynthetic macrolide antibiotic obtained by substitution of a CH3O group for the hydroxyl (OH) group in position 6 of the erythromycin lactonic ring. Specifically, Clarinix-DT is 6-O-methyl erythromycin A. The white to off-white antibiotic powder is practically odorless, essentially insoluble in water and slightly soluble in ethanol, methanol and acetonitrile. Its molecular weight is 747.96.
Clarinix-DT Paediatric Suspension is an oral dosage form of Clarinix-DT for use primarily in children.
Clarinix-DT Paediatric Suspension: Granule Component and Coating:Carbopol carbomers, povidone, hypromellose phthalate, castor oil. Other Ingredients: Sucrose, xanthan gum, silicon dioxide, potassium sorbate, citric acid, maltodextrin, titanium dioxide, fruit punch flavor.
Clarinix-DT/Clarinix-DT 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 Clarinix-DT Paediatric Suspension. The use of Clarinix-DT IR has not been studied in children <12 years.
Eradication of H. pylori:Adults and Elderly Triple Therapy Regimen: Clarinix-DT 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: Clarinix-DT 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.
Clarinix-DT may be given without regard to meals as food does not affect the extent of bioavailability.
Clarinix-DT 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 Clarinix-DT Paediatric Suspension. The use of Clarinix-DT MR has not been studied in children <12 years.
Renal Impairment: Clarinix-DT MR should not be used in patients with renal impairment (creatinine clearance <30 mL/min). Clarinix-DT immediate-release tablets may be used in this patient population.
Do not crush or chew Clarinix-DT MR tablets.
Clarinix-DT Paediatric Suspension: Children 6 months to 12 years: Clinical trials have been conducted using Clarinix-DT Pediatric Suspension in children 6 months-12 years. Therefore, children 6 months-12 years of age should use Clarinix-DT Pediatric Suspension (granules for oral suspension).
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 Clarinix-DT 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 Clarinix-DT should continue as long as clinical benefit is demonstrated. The addition of other antimycobacterial agents may be of benefit.
Clarinix-DT: Data available to date indicate that Clarinix-DT 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 Clarinix-DT 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 Clarinix-DT 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 Clarinix-DT and quinidine or disopyramide. Serum levels of these medications should be monitored during Clarinix-DT therapy.
Rhabdomyolysis coincident with the co-administration of Clarinix-DT and the HMG-CoA reductase inhibitors eg, lovastatin and simvastatin has rarely been reported.
Antiretroviral Drug Interactions: Simultaneous oral administration of Clarinix-DT tablets and zidovudine to HIV-infected adult patients may result in decreased steady-state zidovudine concentrations. Because Clarinix-DT appears to interfere with the absorption of simultaneously administered oral zidovudine, this interaction can be largely avoided by staggering the doses of Clarinix-DT and zidovudine. This interaction does not appear to occur in pediatric HIV-infected patients taking Clarinix-DT suspension with zidovudine or dideoxyinosine.
A pharmacokinetic study demonstrated that the concomitant administration of ritonavir 200 mg every 8 hrs and Clarinix-DT 500 mg every 12 hrs resulted in a marked inhibition of the metabolism of Clarinix-DT.
For patients with renal impairment, the following dosage adjustments should be considered: For patients with CrCl 30-60 mL/min, the dose of Clarinix-DT should be reduced by 50%. For patients with CrCl <30 mL, the dose of Clarinix-DT should be decreased by 75%. Doses of Clarinix-DT >1 g/day should not be co-administered with ritonavir.
Clarinix-DT OD: As with other macrolide antibiotics, the use of Clarinix-DT 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 Clarinix-DT 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 Clarinix-DT and quinidine or disopyramide. Electrocardiogram and serum levels of these medications should be monitored during Clarinix-DT therapy.
HMG-CoA Reductase Inhibitors: As with other macrolides, Clarinix-DT 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 Clarinix-DT to patients receiving theophylline or carbamazepine has been associated with an increase in serum theophylline or carbamazepine levels.
Concomitant administration of Clarinix-DT and oral anticoagulants may potentiate the effects of oral anticoagulants. Prothrombin time should be carefully monitored while patients are receiving Clarinix-DT and oral anticoagulants simultaneously.
Ritonavir: Ritonavir increases AUC, Cmax and Cmin of Clarinix-DT when administered concurrently. Because of the large therapeutic window for Clarinix-DT, 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 Clarinix-DT should be reduced by 50%. For patients with CrCl <30 mL/min, the dose of Clarinix-DT should be decreased by 75%. Doses of Clarinix-DT >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 Clarinix-DT and thus, lower the plasma levels of Clarinix-DT. Since the microbiological activities of Clarinix-DT and 14-OH-Clarinix-DT are different for different bacteria, the intended therapeutic effect could be impaired during concomitant administration of Clarinix-DT 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 Clarinix-DT. Reduction in sildenafil, tadalafil and vardenafil dosages should be considered when these drugs are co-administered with Clarinix-DT.
Triazolam: Drug interactions and CNS effects (eg, somnolence and confusion) with the concomitant use of Clarinix-DT and triazolam have been reported. Monitoring the patient for increased CNS pharmacological effects is suggested.
Colchicine: When Clarinix-DT and colchicine are administered together, inhibition of Pgp and/or CYP3A by Clarinix-DT may lead to increased exposure to colchicine. Patients should be monitored for clinical symptoms of colchicine toxicity.
Itraconazole: Both Clarinix-DT and itraconazole are substrates and inhibitors of CYP3A. Clarinix-DT may increase the plasma levels of itraconazole, while itraconazole may increase the plasma levels of Clarinix-DT. Patients taking itraconazole and Clarinix-DT concomitantly should be monitored closely for signs and symptoms of increased or prolonged pharmacological effect.
Zidovudine: Simultaneous oral administration of Clarinix-DT 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 Clarinix-DT suspension with zidovudine or dideoxyinosine.
The most frequent and common adverse reactions related to Clarinix-DT therapy for both adult and pediatric populations are abdominal pain, diarrhea, nausea, vomiting and taste perversion. These adverse reactions are usually mild in intensity and are consistent with the known safety profile of macrolide antibiotics.
There was no significant difference in the incidence of these gastrointestinal adverse reactions during clinical trials between the patient population with or without preexisting mycobacterial infections.
The following table displays adverse reactions reported in clinical trials and from post-marketing experience with Clarinix-DT immediate release, granules for oral suspension, IV and MR.
The reactions considered at least possibly related to Clarinix-DT are displayed by system organ class and frequency using the following convention: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100) and not known (adverse reactions from post-marketing experience; cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness when the seriousness could be assessed.
There have been post-marketing reports of colchicine toxicity with concomitant use of Clarinix-DT and colchicine, especially in the elderly, some of which occurred in patients with renal insufficiency. Deaths have been reported in some such patients.
Immunocompromised Patients: In AIDS and other immunocompromised patients treated with the higher doses of Clarinix-DT over long periods of time for mycobacterial infections, it was often difficult to distinguish adverse events possibly associated with Clarinix-DT administration from underlying signs of HIV disease or intercurrent illness.
Clarinix-DT/Clarinix-DT Forte: In adult patients, the most frequently reported adverse events by patients treated with total daily doses of Clarinix-DT 1000 mg were: Nausea, vomiting, taste perversion, abdominal pain, diarrhea, rash, flatulence, headache, constipation, hearing disturbance, SGOT and SGPT elevations. Additional low-frequency events included dyspnea, insomnia and dry mouth.
In these immunocompromised patients evaluations of laboratory values were made by analyzing those values outside the seriously abnormal level (ie, the extreme high or low limit) for the specified test. On the basis of this criteria, about 2-3% of these patients who received Clarinix-DT 1000 mg daily had seriously abnormal elevated levels of SGOT and SGPT, and abnormally low white blood cell and platelet counts. A lower percentage of patients also had elevated BUN levels.
Clarinix-DT Paediatric Suspension: A limited number of pediatric AIDS patients have been treated with Clarinix-DT Pediatric Suspension for mycobacterial infections. The most frequently reported adverse events, excluding those due to the patient's concurrent condition, were tinnitus, deafness, vomiting, nausea, abdominal pain, purpuric rash, pancreatitis and increased amylase. Evaluations of laboratory values for these patients were made by analyzing those values outside the seriously abnormal level (ie, the extreme high or low limit) for the specified test. Based on these criteria, 1 pediatric AIDS patient receiving <15 mg/kg/day of Clarinix-DT had a seriously abnormal (elevated) total bilirubin; of the patients receiving 15 to <25 mg/kg/day of Clarinix-DT, there was 1 each reported as seriously abnormal SGPT, BUN, and seriously decreased platelet count. None of these seriously abnormal values for these laboratory parameters were reported for patients receiving the highest dosage (≤25 mg/kg/day) of Clarinix-DT.
Clarinix-DT is contraindicated in patients with a known hypersensitivity to Clarinix-DT, erythromycin, or any of the macrolide antibacterial drugs.
Concomitant administration of Clarinix-DT with cisapride and pimozide is contraindicated [seeDRUG INTERACTIONS (7)].
There have been postmarketing reports of drug interactions when Clarinix-DT is coadministered with cisapride or pimozide, resulting in cardiac arrhythmias (QT prolongation, ventricular tachycardia, ventricular fibrillation, and torsades de pointes) most likely due to inhibition of metabolism of these drugs by Clarinix-DT. Fatalities have been reported.
Cholestatic Jaundice/Hepatic Dysfunction
Clarinix-DT is contraindicated in patients with a history of cholestatic jaundice or hepatic dysfunction associated with prior use of Clarinix-DT.
Concomitant administration of Clarinix-DT and colchicine is contraindicated in patients with renal or hepatic impairment.
HMG-CoA Reductase Inhibitors
Do not use Clarinix-DT concomitantly with HMG-CoA reductase inhibitors (statins) that are extensively metabolized by CYP3A4 (lovastatin or simvastatin), due to the increased risk of myopathy, including rhabdomyolysis.
Concomitant administration of Clarinix-DT and ergotamine or dihydroergotamine is contraindicated.
Contraindications for Coadministered Drugs
For information about contraindications of other drugs indicated in combination with Clarinix-DT, refer to their full prescribing information (contraindications section).
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).
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