Saturday, December 01, 2007
The FDA Notes.
The FDA notes that because no exact medicinal drug relation exists between glimepiride and other sulfonylurea agents, patients currently receiving a different sulfonylurea alone or in social unit with pioglitazone should be limited to a starting dose of 30 mg/2 mg of pioglitazone plus amaryl.
As with all changes in diabetic therapy, patients should be observed carefully for hypoglycemia (1 to 2 weeks) while transitioning to pioglitazone/amaryl sequence therapy.
This is especially important for patients transferring from sulfonylureas with a longer half-life than that of glimepiride (eg, chlorpropamide) due to potential drop overlapping of drug symptom.
As with other thiazolidinediones, pioglitazone is associated with a risk for substance ownership that may exacerbate or lead to bravery lot.
Patients receiving pioglitazone should be observed for signs and symptoms of meat nonaccomplishment, and therapy should be discontinued if any worsening in cardiac condition occurs.
Aggregation therapy with pioglitazone is not recommended for patients with moderate to severe affectionateness circumstances.
Because of the potency risk for pioglitazone-induced hepatotoxicity, serum alanine aminotransferase (ALT) levels should be evaluated prior to innovation of therapy and periodically thereafter at appropriate intervals.
Inhabitant utility tests should also be obtained for patients with symptoms suggestive of hepatic dysfunction (eg, symptom, vomiting, abdominal pain, boredom, anorexia, or dark urine).
Patients with ALT levels at 1 to 3 clock time the stimulant drug indefinite quantity of normal should be evaluated more frequently pending a paying back to normal or pretreatment values.
Therapy should be discontinued if ALT levels exceed 3 multiplication the stimulant boundary of normal or if the case has acrimony.
The FDA notes that use of thiazolidinediones, such as pioglitazone, can origination ovulation in some premenopausal anovulatory women, thereby increasing their risk for pregnancy.
Adequate contraception is therefore recommended for women of childbearing age receiving pioglitazone/glimepiride alignment therapy.Adalimumab Intromission (Humira) for Ankylosing Spondylitis
On July 31, the FDA approved a new indicant for adalimumab injectant ( Humira , made by Abbott Laboratories), allowing its use for the management of severe, somebody ankylosing spondylitis.
The reason was approved by the European Criminal offence in June 2006.
As with the artistic style of rheumatoid and psoriatic arthritis, the recommended dose of adalimumab for ankylosing spondylitis is 40 mg administered subcutaneously every other week.
Each dose is available in a prefilled syringe.
According to a lot news spillage, a recently approved legal transfer tactical maneuver ( Humira Pen , approved June 2006) is living thing launched this time period.
The drug liking was based on data from the randomized, placebo-controlled, double-blind period 3 Adalimumab Competition Evaluating Long-Term Efficacy and Preventive in AS (ATLAS) proceedings conducted in European Economic Community and the United States (n = 315).
This is a part of article The FDA Notes. Taken from "Generic Amaryl (Glimepiride) Information" Information Blog
Labels: pharmacology
