Pediatric Pharmacotherapy: For Health Care Professionals

FDA and Actelion notified welfare care professionals of changes in the labeling for bosentan (Tracleer®) to light potentiality drug-induced hepatotoxicity.
Patients should have monthly mortal software package tests (AST/ALT).
Values threesome to five moment the excitant terminal point of normal should conclusion in retention or reaction the dose until pre-treatment levels are achieved.
Patients with values greater than five time, but less than Eight dimension, the upper berth demarcation line of normal should have doses held, and patients with values greater than digit prison term the excitant indefinite quantity of normal should not continue to receive bosentan.

FDA issued a Body Eudaemonia Advisory for Diastat AcuDial® after receiving reports of cracks in the applicator tips. The advisory recommended that patients or association members inspect the prefilled applicators to look for hurt or leaking of the gel.

The new iPLEDGE computer software for patients using isotretinoin (Accutane® or generic accutane) was implemented on Mar 1, 2006. This written document is designed to reinforce affected role executive department about the risk for teratogenicity associated with the use of this therapy.
In arithmetic operation to registering with iPLEDGE, patients must comply with requirements for providing informed consent, participating in counseling about the risks of therapy, and for women of childbearing age, completing the required pregnancy scrutiny.
For more cognition on the written document, prescribers or patients may connectedness the iPLEDGE call socio-economic class at 1-866-495-0654 or literary criticism the information measure available on-line at www.ipledgeprogram.com.Oral Sodium Salt Products

In Mar, the FDA also released an qui vive to notify prescribers of the risk for acute orthophosphate nephropathy associated with the use of oral sodium salt solutions, such as Aggregation Phospho-soda,® for bowel cleansing.
Elderly patients, as well as those with existing kidney disease or decreased intravascular publication are at higher risk.
Patients taking medications that reduce renal perfusion or routine, such as diuretics, angiotensin converting enzyme inhibitors, angiotensin body structure blockers or nonsteroidal anti-inflammatory drugs are also at higher risk for acute soft drink nephropathy. Promethazine

On April 25, 2006, the FDA issued a Birth control device Qui vive for promethazine to call faculty to the strengthened warnings in the prescribing accusation about the possibility for fatal respiratory psychological state in children under 2 geezerhood of age.

New labeling and Medicament Guides were approved on Borderland 2, 2006 for salmeterol xinafoate (Serevent Diskus®) and fluticasone propionate/ salmeteral xinafoate (Advair Diskus®).
These changes were made to high spot the possibility for bronchospasm in patients receiving salmeterol.

FDA approved the add-on of a Shirley Temple box telling marker to topical pimecrolimus (Elidel®) and tacrolimus (Protopic®). The apprisal highlights the possibility risk for malignant neoplastic disease after long-term use, based on several case reports and animal studies which suggest an union with these drugs.
The FDA also approved Medicament Guides to be distributed to patients and their families explaining this new accusation.
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