A randomized, double-blind clinical trial (trial 3) compared Clarithromycine 500 mg twice a day to placebo in patients with CDC-defined AIDS and CD4 counts less than 100 cells/μL. This trial accrued 682 patients from November 1992 to January 1994, with a median CD4 cell count at entry of 30 cells/mcL. Median duration of BIAXIN was 10.6 months vs. 8.2 months for placebo. More patients in the placebo arm than the BIAXIN arm discontinued prematurely from the trial (75.6% and 67.4%, respectively). However, if premature discontinuations due to Mycobacterium avium complex (MAC) or death are excluded, approximately equal percentages of patients on each arm (54.8%) on BIAXIN and 52.5% on placebo) discontinued study drug early for other reasons. The trial was designed to evaluate the following endpoints:
- MAC bacteremia, defined as at least one positive culture for Mycobacterium avium complex bacteria from blood or another normally sterile site
- Clinically significant disseminated MAC disease, defined as MAC bacteremia accompanied by signs or symptoms of serious MAC infection, including fever, night sweats, weight loss, anemia, or elevations in liver function tests
In patients randomized to BIAXIN, the risk of MAC bacteremia was reduced by 69% compared to placebo. The difference between groups was statistically significant (p
Table 13: Mortality Rates at 18 months in Trial 3
Clinically Significant Disseminated MAC Disease
In association with the decreased incidence of MAC bacteremia, patients in the group randomized to BIAXIN showed reductions in the signs and symptoms of disseminated MAC disease, including fever, night sweats, weight loss, and anemia.
How should Clarithromycine be stored?
- Store Clarithromycine tablets at room temperature, 68°F to 77°F (20°C to 25°C). Protect the tablets from light.
- Store Clarithromycine granules for oral suspension below 77ºF ( 25ºC). After mixing Clarithromycine granules with water as instructed by your health care provider or pharmacist, do not refrigerate the mixture (also called an oral suspension). Store the oral suspension between 59ºF and 86ºF (15ºC to 30ºC) and use within 14 days.
- Keep Clarithromycine in the container that it came in and keep the container tightly closed.
- Do not use Clarithromycine if the original seal over the container opening is broken or missing.
- Throw away Clarithromycine that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
- Keep Clarithromycine and all medicines out of reach of children.
The following adverse reactions have been identified during post-approval use of BIAXIN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and Lymphatic System: Thrombocytopenia, agranulocytosis
Cardiac: Ventricular arrhythmia, ventricular tachycardia, torsades de pointes
Ear and Labyrinth: Deafness was reported chiefly in elderly women and was usually reversible.
Gastrointestinal: Pancreatitis acute, tongue discoloration, tooth discoloration was reported and was usually reversible with professional cleaning upon discontinuation of the drug.
There have been reports of BIAXIN XL Filmtab in the stool, many of which have occurred in patients with anatomic (including ileostomy or colostomy) or functional gastrointestinal disorders with shortened GI transit times. In several reports, tablet residues have occurred in the context of diarrhea. It is recommended that patients who experience tablet residue in the stool and no improvement in their condition should be switched to a different Clarithromycine formulation (e.g. suspension) or another antibacterial drug.
Hepatobiliary: Hepatic failure, jaundice hepatocellular. Adverse reactions related to hepatic dysfunction have been reported with Clarithromycine .
Infections and Infestations: Pseudomembranous colitis
Immune System: Anaphylactic reactions, angioedema
Investigations: Prothrombin time prolonged, white blood cell count decreased, international normalized ratio increased. Abnormal urine color has been reported, associated with hepatic failure.
Metabolism and Nutrition: Hypoglycemia has been reported in patients taking oral hypoglycemic agents or insulin.
Musculoskeletal and Connective Tissue: Myopathy rhabdomyolysis was reported and in some of the reports, Clarithromycine was administered concomitantly with statins, fibrates, colchicine or allopurinol .
Nervous System: Parosmia, anosmia, ageusia, paresthesia and convulsions
Psychiatric: Abnormal behavior, confusional state, depersonalization, disorientation, hallucination, depression, manic behavior, abnormal dream, psychotic disorder. These disorders usually resolve upon discontinuation of the drug.
Renal and Urinary: Nephritis interstitial, renal failure
Skin and Subcutaneous Tissue: Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), Henoch-Schonlein purpura, acne, acute generalized exanthematous pustulosis
Rated Clarithromycine for Helicobacter pylori Infection Report
Absolutely minging taste. Had me up in the night loads and I can’t bare to carry them on. Also, nausea and headaches. I came home early from work as I felt so rubbish. If you can complete a week of these, you deserve a medal ??
Clarithromycine should not be used in pregnant women except in clinical circumstances where no alternative therapy is appropriate. If BIAXIN is used during pregnancy, or if pregnancy occurs while the patient is taking this drug, the patient should be apprised of the potential hazard to the fetus. Clarithromycine has demonstrated adverse effects on pregnancy outcome and/or embryo-fetal development in monkeys, rats, mice, and rabbits at doses that produced plasma levels 2 times to 17 times the serum levels achieved in humans treated at the maximum recommended human doses .