Hepatic dysfunction, including increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, with or without jaundice, has been reported with Claritromix. This hepatic dysfunction may be severe and is usually reversible. In some instances, hepatic failure with fatal outcome has been reported and generally has been associated with serious underlying diseases and/or concomitant medications. Symptoms of hepatitis can include anorexia, jaundice, dark urine, pruritus, or tender abdomen. Discontinue BIAXIN immediately if signs and symptoms of hepatitis occur.
BIAXIN Filmtab Immediate-Release Tablets
Steady-state peak plasma Claritromix concentrations were attained within 3 days and were approximately 1 mcg/mL to 2 mcg/mL with a 250 mg dose administered every 12 hours and 3 mcg/mL to 4 mcg/mL with a 500 mg dose administered every 8 hours to 12 hours. The elimination half-life of Claritromix was about 3 hours to 4 hours with 250 mg administered every 12 hours but increased to 5 hours to 7 hours with 500 mg administered every 8 hours to 12 hours. The nonlinearity of Claritromix pharmacokinetics is slight at the recommended doses of 250 mg and 500 mg administered every 8 hours to 12 hours. With a 250 mg every 12 hours dosing, the principal metabolite, 14-OH Claritromix, attains a peak steady-state concentration of about 0.6 mcg/mL and has an elimination half-life of 5 hours to 6 hours. With a 500 mg every 8 hours to 12 hours dosing, the peak steady-state concentration of 14-OH Claritromix is slightly higher (up to 1 mcg/mL), and its elimination half-life is about 7 hours to 9 hours. With any of these dosing regimens, the steady-state concentration of this metabolite is generally attained within 3 days to 4 days.
After a 250 mg tablet every 12 hours, approximately 20% of the dose is excreted in the urine as Claritromix, while after a 500 mg tablet every 12 hours, the urinary excretion of Claritromix is somewhat greater, approximately 30%. In comparison, after an oral dose of 250 mg (125 mg/5 mL) suspension every 12 hours, approximately 40% is excreted in urine as Claritromix. The renal clearance of Claritromix is, however, relatively independent of the dose size and approximates the normal glomerular filtration rate. The major metabolite found in urine is 14-OH Claritromix, which accounts for an additional 10% to 15% of the dose with either a 250 mg or a 500 mg tablet administered every 12 hours.
BIAXIN XL Filmtab Extended-Release Tablets
In healthy human subjects, steady-state peak plasma Claritromix concentrations of approximately 2 mcg/mL to 3 mcg/mL were achieved about 5 hours to 8 hours after oral administration of 1000 mg BIAXIN XL Filmtab once daily; for 14-OH Claritromix, steady-state peak plasma concentrations of approximately 0.8 mcg/mL were attained about 6 hours to 9 hours after dosing. Steady-state peak plasma Claritromix concentrations of approximately 1 mcg/mL to 2 mcg/mL were achieved about 5 hours to 6 hours after oral administration of a single 500 mg BIAXIN XL Filmtab once daily; for 14-OH Claritromix, steady-state peak plasma concentrations of approximately 0.6 mcg/mL were attained about 6 hours after dosing.
Steady-state peak plasma concentrations were attained in 2 days to 3 days and were approximately 2 mcg/mL for Claritromix and 0.7 mcg/mL for 14-OH Claritromix when 250-mg doses of the Claritromix suspension were administered every 12 hours. Elimination half-life of Claritromix (3 hours to 4 hours) and that of 14-OH Claritromix (5 hours to 7 hours) were similar to those observed at steady state following administration of equivalent doses of BIAXIN Filmtab.
Before taking Claritromix, tell your doctor or pharmacist if you are allergic to it; or to other macrolide antibiotics (such as erythromycin, azithromycin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease (including liver problems with past Claritromix use), kidney disease, heart disease (coronary artery disease, heart attack), a certain type of muscle disease (myasthenia gravis).
Claritromix may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.
The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using Claritromix, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).
Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using Claritromix safely.
Claritromix may cause live bacterial vaccines (such as typhoid vaccine) to not work as well. Do not have any immunizations/vaccinations while using this medication unless your doctor tells you to.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults may be more sensitive to the side effects of this drug, especially hearing loss and QT prolongation (see above).
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
This medication passes into breast milk. Consult your doctor before breast-feeding.
Rated Claritromix for Pneumonia Report
I honestly am so grateful for this drug. I got double pneumonia and amoxicillin did absolutely nothing for it. The gp prescribed Claritromix and although i was ill for a while it was the only thing that worked. Yes it tastes absolutely disgusting and you wake up with the taste throughout the night. but id take that any day over double pneumonia.
Which drugs or supplements interact with Claritromix?
Claritromix interacts with several drugs because it reduces the activity of liver enzymes that breakdown many drugs. This leads to increased blood levels and side effects from the affected drugs. Examples of such interactions include
Claritromix increases blood levels of sildenafil (Viagra, Revatio), tadalafil (Cialis, Adcirca), vardenafil (Levitra), theophylline and carbamazepine (Tegretol), thereby increasing side effects of these drugs.
Ritonavir (Norvir) and atazanavir (Reyataz) increase blood levels of Claritromix while efavirenz (Sustiva), nevirapine (Viramune), rifampin, decrease blood levels of Claritromix.
Itraconazole (Sporanox) and saquinavir (Invirase) may increase blood levels of Claritromix while Claritromix increases blood levels or both drugs.
The occurrence of abnormal heart beats may increase when Claritromix is combined with drugs that affect heart beat (for example, amiodarone , quinidine , and disopyramide).
Before taking this medicine
You should not use this medicine if you are allergic to Claritromix or similar medicines such as azithromycin (Zithromax, Z-Pak, Zmax), erythromycin, or telithromycin, or if:
you have had jaundice or liver problems caused by taking Claritromix; or
you have liver or kidney disease and you also take a medicine called colchicine.
Some medicines can cause unwanted or dangerous effects when used with Claritromix. Your doctor may need to change your treatment plan if you use any of the following drugs:
To make sure this medicine is safe for you, tell your doctor if you have ever had:
long QT syndrome (in you or a family member);
an electrolyte imbalance (such as low levels of potassium or magnesium in your blood).
Claritromix may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine. Tell your doctor if you become pregnant.
In animal studies, Claritromix caused birth defects. However, it is not known whether these effects would occur in humans. Ask your doctor about your risk.
Claritromix can pass into breast milk and may cause side effects in the nursing baby. Tell your doctor if you are breast-feeding.
This medicine is not approved for use by anyone younger than 6 months old.
1. About Claritromix
Claritromix is an antibiotic.
It's used to treat chest infections, such as pneumonia, skin problems such as cellulitis, and ear infections.
It's also used to get rid of Helicobacter pylori, a bacteria that can cause stomach ulcers.
Claritromix is sometimes used by people who have an allergy to penicillin and antibiotics similar to penicillin, like amoxicillin.
Claritromix is only available on prescription.
It comes as tablets, granules, or a liquid that you drink.
It can also be given by injection, but this is usually only done in hospital.