Michael Stewart, Reviewed by Sid Dajani | Last edited 31 May 2017 | Certified by The Information Standard
Klarit is a macrolide antibiotic. It can be taken by people who are allergic to penicillin.
It is important to complete the prescribed course (unless you are told to stop). Otherwise your infection could come back.
Any side-effects are usually mild. The most common are diarrhoea, feeling sick (nausea), tummy (abdominal) discomfort, and unusual tastes.
Median survival time from trial entry (trial 1) was 249 days at the 500 mg twice daily dose compared to 215 days with the 1000 mg twice daily dose. However, during the first 12 weeks of therapy, there were 2 deaths in 53 patients in the 500 mg twice daily group versus 13 deaths in 51 patients in the 1000 mg twice daily group. The reason for this apparent mortality difference is not known. Survival in the two groups was similar beyond 12 weeks. The median survival times for these dosages were similar to recent historical controls with MAC when treated with combination therapies. 2
Median survival time from entry in trial 2 was 199 days for the 500 mg twice a day dose and 179 days for the 1000 mg twice a day dose. During the first four weeks of therapy, while patients were maintained on their originally assigned dose, there were 11 deaths in 255 patients taking 500 mg twice daily and 18 deaths in 214 patients taking 1000 mg twice daily.
Dosage-Ranging Monotherapy Trials In Pediatric AIDS Patients With MAC
Trial 4 was a pediatric trial of 3.75 mg/kg, 7.5 mg/kg, and 15 mg/kg of BIAXIN twice daily in patients with CDC-defined AIDS and CD4 counts less than 100 cells/mcL. The trial enrolled 25 patients between the ages of 1 to 20. The trial evaluated the same endpoints as in the adult trials 1 and 2. Results with the 7.5 mg/kg twice daily dose in the pediatric trial were comparable to those for the 500 mg twice daily regimen in the adult trials.
Combination Therapy In AIDS Patients With Disseminated MAC
Trial 5 compared the safety and efficacy of BIAXIN in combination with ethambutol versus BIAXIN in combination with ethambutol and clofazimine for the treatment of disseminated MAC (dMAC) infection. This 24-week trial enrolled 106 patients with AIDS and dMAC, with 55 patients randomized to receive BIAXIN and ethambutol, and 51 patients randomized to receive Klarit, ethambutol, and clofazime. Baseline characteristics between treatment arms were similar with the exception of median CFU counts being at least 1 log higher in the BIAXIN, ethambutol, and clofazime arm.
Compared to prior experience with Klarit monotherapy, the two-drug regimen of Klarit and ethambutol extended the time to microbiologic relapse, largely through suppressing the emergence of Klarit resistant strains. However, the addition of clofazimine to the regimen added no additional microbiologic or clinical benefit. Tolerability of both multidrug regimens was comparable with the most common adverse events being gastrointestinal in nature. Patients receiving the clofazimine-containing regimen had reduced survival rates; however, their baseline mycobacterial colony counts were higher. The results of this trial support the addition of ethambutol to Klarit for the treatment of initial dMAC infections but do not support adding clofazimine as a third agent.
Following administration of Klarit (500 mg bid) and saquinavir (soft gelatin capsules, 1200 mg tid) to 12 healthy volunteers, the steady-state saquinavir AUC and Cmax increased 177% and 187% respectively compared to administration of saquinavir alone. Klarit AUC and Cmax increased 45% and 39% respectively, whereas the 14–OH Klarit AUC and Cmax decreased 24% and 34% respectively, compared to administration with Klarit alone.
Storage And Handling
BIAXIN Filmtab (Klarit tablets, USP) is supplied as yellow oval film-coated tablets in the following packaging sizes: 250 mg tablets: (imprinted in blue with the “a” logo and KT)
Bottles of 60 (NDC 0074-3368-60) and unit dose strip packages of 100 (NDC 0074-3368-11).
Store BIAXIN Filmtab 250 mg at controlled room temperature 15° to 30°C (59° to 86°F) in a well-closed container. Protect from light.
500 mg tablets: (debossed with the “a” logo on one side and KL on the opposite side)
Bottles of 60 (NDC 0074-2586-60) and unit dose strip packages of 100 (NDC 0074-2586-11).
Store BIAXIN Filmtab 500 mg at controlled room temperature 20° to 25°C (68° to 77°F) in a well-closed container.
BIAXIN XL Filmtab (Klarit extended-release tablets) is supplied as yellow oval film-coated tablets in the following packaging sizes:
500 mg tablets: (debossed with the “a” logo and KJ)
Bottles of 60 (NDC 0074-3165-60), unit dose strip packages of 100 (NDC 0074-3165-11), and BIAXIN XL PAC carton of 4 blister packages 14 tablets each (NDC 0074-3165-41).
Store BIAXIN XL Filmtab at 20° to 25°C (68° to 77°F). Excursions permitted to 15° to 30°C (59° to 86°F).
BIAXIN Granules (Klarit for oral suspension, USP) is supplied as white to off-white granules in the following strengths and sizes:
Store BIAXIN Granules below 25°C (77°F) in a well-closed container. Do not refrigerate the reconstituted BIAXIN granules.
BIAXIN Filmtab 250 mg and 500 mg and BIAXIN XL Filmtab 500 mg Mfd. by AbbVie LTD, Barceloneta, PR 00617. BIAXIN Granules, 125 mg/5 mL and 250 mg/5 mL Mfd. by AbbVie Inc., North Chicago, IL 60064 For AbbVie Inc., North Chicago, IL 60064, U.S.A. Revised: Nov 2018.
Mechanism Of Action
Klarit is a macrolide antimicrobial drug .
How it works
Klarit belongs to a class of drugs called antibiotics (macrolides). A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.
Klarit works by stopping the bacteria that are causing an infection from multiplying.
This drug should only be used to treat or prevent bacterial infections. It shouldn’t be used to treat viruses such as the common cold.
Klarit oral tablet can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.
To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.
What should I tell my health care provider before taking Klarit?
Before taking Klarit, tell your health care provider:
- If you are allergic to Klarit or any other medicines.
- About any medical conditions you have or have had.
- About anything that could affect your ability to take medicines, such as difficulty swallowing or remembering to take pills. A liquid form of Klarit is available for people who have difficulty swallowing pills.
- If you are pregnant or plan to become pregnant. Klarit should not be used during pregnancy except when there are no other treatment options. Talk to your health care provider about the risks of taking Klarit during pregnancy.
- If you are breastfeeding or plan to breastfeed. Do not breastfeed if you have HIV.
- About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Klarit may affect the way other medicines or products work, and other medicines or products may affect how Klarit works. Ask your health care provider if there are interactions between Klarit and the other medicines you take.
Ask your health care provider about possible side effects from Klarit. Your health care provider will tell you what to do if you have side effects.
BIAXIN Granules For Oral Suspension In Pediatric Patients
Klarit penetrates into the middle ear fluid of pediatric patients with secretory otitis media.
Table 10: Middle Ear Fluid and Serum Concentrations of Klarit and 14-OH-Klarit in Pediatric Patients
When pediatric patients (n = 10) were administered a single oral dose of 7.5 mg/kg BIAXIN as an oral suspension, food increased mean peak plasma Klarit concentrations from 3.6 (± 1.5) mcg/mL to 4.6 (± 2.8) mcg/mL and the extent of absorption from 10.0 (± 5.5) hr•mcg/mL to 14.2 (± 9.4) hr•mcg/mL.
In pediatric patients requiring antibacterial therapy, administration of 7.5 mg/kg every 12 hours of BIAXIN as an oral suspension generally resulted in steady-state peak plasma concentrations of 3 mcg/mL to 7 mcg/mL for Klarit and 1 mcg/mL to 2 mcg/mL for 14-OH Klarit.
In HIV-infected pediatric patients taking 15 mg/kg of BIAXIN as an oral suspension every 12 hours, steady-state Klarit peak concentrations generally ranged from 6 mcg/mL to 15 mcg/mL.
Steady-state concentrations of Klarit and 14-OH Klarit observed following administration of 500 mg doses of Klarit every 12 hours to adult patients with HIV infection were similar to those observed in healthy volunteers. In adult HIV-infected patients taking 500-mg or 1000-mg doses of Klarit every 12 hours, steady-state Klarit Cmax values ranged from 2 mcg/mL to 4 mcg/mL and 5 mcg/mL to 10 mcg/mL, respectively.
The steady-state concentrations of Klarit in subjects with impaired hepatic function did not differ from those in normal subjects; however, the 14-OH Klarit concentrations were lower in the hepatically impaired subjects. The decreased formation of 14-OH Klarit was at least partially offset by an increase in renal clearance of Klarit in the subjects with impaired hepatic function when compared to healthy subjects.
The pharmacokinetics of Klarit was also altered in subjects with impaired renal function .