This kind of activity is part of an constant CME/CE initiative to provide information on tag changes reported by the Fda standards. Activities of this nature might be posted on Medscape on a weekly basis.

September 16, 2007 — The US Fda standards (FDA) has approved safety product labels revisions to advise of drug interactions that resulted in myopathy/rhabdomyolysis associated with the lovastatin component of niacin extended-release/lovastatin tablets, the risks associated with concomitant use of calcium or even calcium-containing solutions/products and injection, drug affairs with tinidazole tablets, and the probability for Candida vaginitis in individuals with bacterial vaginosis receiving a treatment with tinidazole.

Lovastatin Component of Advicor Linked to Medicine Interactions That Increase Risk for Myopathy

On April Half-dozen, the FDA approved safety labeling revisions for niacin extended-release/lovastatin tablets ( Advicor; KOS Pharmaceutical products, Inc) to advise regarding certain drug interactions that will increase the risk for myopathy/rhabdomyolysis associated with the lovastatin component.

Like with other 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors, lovastatin may cause myopathy that will presents as muscle soreness, tenderness, or weakness using creatine kinase levels greater than 10 times the upper limit of ordinary. Myopathy may also take the form of rhabdomyolysis together with or without acute renal failure secondary to myoglobinuria, plus rare fatalities have occurred.

Because lovastatin is metabolized through the cytochrome P-450 isoform 3A4 (CYP 3A4) enzyme, concomitant administration of potent CYP 3A4 inhibitors results in elevated 3-hydroxy-3-methylglutaryl coenzyme A plasma televisions activity levels and may increase the risk for myopathy. According to the FDA, serious skeletal muscular disorders (eg, rhabdomyolysis) have been reported during concomitant use of these prescription drugs.

Drugs considered to be potent CYP 3A4 inhibitors contain cyclosporine, itraconazole, ketoconazole, and other antifungal azoles; the macrolide antibiotics erythromycin and clarithromycin; the ketolide antibiotic telithromycin; Aids protease inhibitors; and nefazodone. Large quantities of grape fruit juice (> 1 quart daily) may also exert this effect.

As a result of additive effect on the risk regarding myopathy, the dose of niacin/lovastatin ought to generally not exceed A thousand mg/20 mg in patients obtaining concomitant therapy with cyclosporine, danazol, or fibrates. Being interrupted of treatment should be considered through use of a systemic antifungal azole, macrolide antibiotic, or ketolide antibiotic.

Niacin/lovastatin capsules are indicated for the remedy for hypercholesterolemia when use of both elements is appropriate.

Injection ( Rocephin) Plus Calcium supplement Linked to Neonate Fatalities

On May well 11, the FDA approved alterations to the safety labeling with regard to ceftriaxone sodium injection ( Rocephin; Roche Pharmaceuticals, Corporation) to advise of the prospective risks associated with concomitant use of lime scale or calcium-containing solutions and products.

 

Situations of fatal reactions by using calcium-ceftriaxone precipitates in the lungs and renal system of both term plus premature neonates have been reported, many of which occurred when ceftriaxone and the calcium-containing merchandise were administered by distinct routes at different instances.

In vitro studies have shown that ceftriaxone might displace bilirubin from binding to serum albumin, probably leading to bilirubin encephalopathy, the FDA said. Use of ceftriaxone is therefore contraindicated in neonates by using hyperbilirubinemia, especially those who are premature.

Because of the risk for particulate rain, ceftriaxone should not be mixed with calcium-containing solutions/products or reconstituted together with calcium-containing diluents such as Ringer’s or Hartmann’s solution.

Concomitant operations of ceftriaxone with calcium-containing solutions and also products is also contraindicated, even through different infusion lines; 48 hours ought to elapse between the last dose with ceftriaxone and their use.

Ceftriaxone injection can be indicated for the treatment of cheaper respiratory tract infections, urinary tract infections, microbe septicemia, skin and skin framework infections, bone and joint infections, pelvic -inflammatory disease, uncomplicated gonorrhea, intra-abdominal infections, extreme bacterial otitis media, and meningitis caused by susceptible microorganisms. It also is approved for surgical prophylaxis in affected individuals undergoing certain procedures grouped as contaminated or probably contaminated.

Tinidazole ( Tindamax) Linked to Drug Communications, Risk for Candida Vaginitis

On May 21, the Approved by the fda revisions to the safety trademarks for tinidazole tablets ( Tindamax; Mission Pharmacal Corp) to advise of pill interactions, the risk for Thrush vaginitis in patients with bacterial vaginosis, and certain contraindications.

In accordance with clinical study data, people receiving tinidazole for the treatment of bacterial vaginosis could be at risk for Candida vaginitis. In the study, 11 (4.7%) of 235 girls developed a vaginal fungal infection.

Mainly because tinidazole is biotransformed mainly by the cytochrome P-450 isoform 3A4 (CYP 3A4) molecule, simultaneous administration with CYP 3A4 inducers (like, phenobarbital, rifampin, phenytoin, and fosphenytoin) can accelerate it has the elimination and decrease plasma ranges. Similarly, administration of CYP 3A4 inhibitors (for example, cimetidine and ketoconazole) may prolong tinidazole half-life and reduce plasma clearance, thereby raising plasma levels.

Use of tinidazole will be contraindicated in patients with a past history of having a reaction to tinidazole or any other nitroimidazole derivatives, the FDA aware, noting that reported responses have ranged in severity out of urticaria to Stevens-Johnson syndrome.

Because tinidazole is usually excreted in breast whole milk at serum concentrations and can end up being detected in breast dairy for up to 72 hours following administration, interruption of breast-feeding during therapy and for 3 days after the last dose is advised. ceftriaxone sodium manufacturer

The FDA also warned that carcinogenicity has been welcomed in mice and rats addressed long term with metronidazole, another nitroimidazole antimicrobial. Despite the fact that similar data have not been reported with tinidazole, its use ought to be limited to approved indications due to similar nature of these medications.

As with other antimicrobials, prescribing tinidazole without a proven or strongly thought bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient along with increases the risk for the development of drug-resistant microbes.

Tinidazole is a nitroimidazole antimicrobial indicated for the treating trichomoniasis; giardiasis and amebiasis in patients older 3 years and older; and also bacterial vaginosis in nonpregnant adult women of all ages.