RPhLink.com
January, 2003
From: Abbott Pharmaceuticals
Please find enclosed some important information regarding Biaxin® XL (clarithromycin extended-release tablets) and its patient benefits - greater tolerability than Biaxin (clarithromycin) tablets and convenient QD dosing. Biaxin XL prescriptions are written for the Biaxin XL Pac, a convenient 7-day patient pack.
Biaxin XL is widely prescribed by the physician community, with approximately 59% of all new Biaxin/Biaxin XL tablet prescriptions being written for the extended release formulation - Biaxin XL. Furthermore, nearly 27% of Biaxin XL prescriptions are written for the Biaxin XL Pac, a convenient 7-day patient pack.
Biaxin XL extended release tablets provide patients with greater tolerability vs. Biaxin tablets, the original formulation of Biaxin. In fact, in clinical trials, patients experienced 67% fewer discontinuations due to GI events or abnormal taste within Biaxin XL than Biaxin.
An improvement over Biaxin tablets, Biaxin XL offers patients convenient QD dosing and a short course of therapy. Biaxin XL should be prescribed 2 x 500 mg QD for 7 days for the treatment of community-acquired pneumonia and acute bacterial exacerbations of chronic bronchitis and for 14 days for the treatment of acute maxillary sinusitis.
To order Biaxin XL, please order from your usual source or call Abbott customer service at 1-800-255-5162.
Biaxin XL Indications
BIAXIN XL is indicated for mild to moderate infections in adults for the treatment of; acute bacterial exacerbation of chronic bronchitis (ABECB) due to H influenzae, H parainfluenzae, M catarrhalis, or S pneumoniae; community-acquired pneumonia due to H influenzae, H parainfluenzae, M catarrhalis, S pneumonia, C pneumoniae (TWAR), or M pneumoniae and for acute maxillary sinusitis (AMS) due to H influenzae, M catarrhalis, or S pneumoniae.
The efficacy and safety of BIAXIN XL in treating other infections for which other formulations of BIAXIN are approved have not been established.
Common Adverse Events
The most frequently reported adverse events in adults taking BIAXIN XL were diarrhea (6%), abnormal taste (7%), and nausea (3%). Overall gastrointestinal adverse events were reported by a similar proportion of patients taking either BIAXIN XL or BIAXIN tablets; however patients taking Biaxin XL tablets reported significantly less severe gastrointestinal symptoms compared to patients taking BIAXIN tablets. In addition, patients taking BIAXIN XL had significantly fewer discontinuations for drug-related gastrointestinal adverse events or abnormal taste compared to BIAXIN tablets.
Other Safety Considerations
Clarithromycin is contraindicated in patients taking cisapride, pimozide, astemizole, or terfenadine due to the potential for cardiac arrhythmias when taken in combination; and in patients with a known hypersensitivity to clarithromycin or any macrolide antibiotic.
Clarithromycin may elevate digoxin serum concentrations. Serum digoxin concentrations should be carefully monitored while digoxin and clarithromycin are taken concomitantly.
Clarithromycin should not be used in pregnant women except in circumstances for which no alternative therapy is appropriate.
We hope you find these materials to be educational and useful. If you have any questions regarding Biaxin XL, please call (800) 633-9110.
Please see enclosed full prescribing information.
Sincerely,
Tip Parker, R.Ph. Sr. Manager, Trade Relations and National Accounts
RPhLink.com The Pharmaceutical Care Network!
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From: Wyeth February 15, 2005 Dear Pharmacist: We are writing to make you aware of the latest information on labeling changes to the CONTRAINDICATIONS, WARNINGS/Use in Pediatric Patients, and DOSAGE AND ADMINISTRATION sections of the prescribing information for Phenergan (promethazine hydrochloride) Tablets and Suppositories. Based on a review of adverse events for Phenergan in pediatric patients, the Food and Drug Administration has requested that the following changes, shown here underlined, be made to the product prescribing information. CONTRAINDICATIONS Phenergan Tablets and Suppositories are contraindicated for use in pediatric patients less than two years of age. WARNINGS PHENERGAN SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. POSTMARKED CASES OF RESPIRATORY DEPRESSION INCLUDING FATALITIES HAVE BEEN REPORTED WITH USE OF PHENERGAN IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PHENERGAN HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. CAUTION SHOULD BE EXERCISED WEN ADMINISTERING PHENERGAN TO PEDIATRIC PATENTS 2 YEARS OF AGE AND OLDER. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PHENERGAN BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED. Warnings Use in Pediatric Patients PHENERGAN TABLETS AND SUPPOSITORIES ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PHENERGAN TABLETS AND SUPPOSITORIES TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. RESPIRATORY DEPRESSION AND APNEA, SOMETIMES ASSOCIATED WITH DEATH, ARE STRONGLY ASSOCIATED WITH PROMETHAZINE PRODUCTS AND ARE NOT DIRECTLY RELATED TO INDIVIDUALIZED WEIGHT-BASED DOSING, WHICH MIGHT OTHERWISE PERMIT SAFE ADMINISTRATION. CONCOMITANT ADMINISTRATION OF PROMETHAZINE PRODUCTS WITH OTHER RESPIRATORY DEPRESSANTS HAS AN ASSOCIATION WITH RESPIRATORY DEPRESSION, AND SOMETIMES DEATH, IN PEDIATRIC PATIENTS. ANTIEMETICS ARE NOT RECOMMENDED FOR THE TREATMENT OF UNCOMPLICATED VOMITING IN PEDIATRIC PATIENTS, AND THEIR USE SHOULD BE LIMITED TO PROLONGED VOMITING OF KNOWN ETIOLOGY. THE EXTRAPYRAMIDAL SYMPTOMS WHICH CAN OCCUR SECONDARY TO PHENERGAN TABLETS AND SUPPOSITORIES ADMINISTRATION MAY BE CONFUSED WITH THE CNS SIGNS OF UNDIAGNOSED PRIMARY DISEASE, e.g., ENCEPHALOPATHY OR REYE'S SYNDROME. THE USE OF PHENERGAN TABLETS AND SUPPOSITORIES SHOULD BE AVOIDED IN PEDIATRIC PATIENTS WHOSE SIGNS AND SYMPTOMS MAY SUGGEST REYE'S SYNDROME OR OTHER HEPATIC DISEASES. DOSAGE AND ADMINISTRATION Phenergan Tablets and Phenergan Rectal Suppositories are contraindicated for children under 2 years of age (see WARNINGS-Black Box Warning and Use in Pediatric Patients). Please see enclosed Prescribing Information. If you require further information, please contact Global Medical Communications at 1-800-934-5556. Regards, Joseph Camardo, MD Senior Vice President Global Medical Affairs
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