Pharmaceutical-Approval Update: Tigecycline (Tygacil™)

Manufacturer: Wyeth Pharmaceuticals, Madison, NJ

Indications: Treatment of complicated skin and skin structure infections (cSSSIs) in adults. This agent is also approved for adults with complicated intra-abdominal infections (clAIs) caused by Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Enterococcus faecalis (vancomycin-susceptible isolates only), Streptococcus anginosus grp. (includes S. anginosus, S. inter-medius, and S. constellatus), Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Clostridium perfringens, and Peptostreptococcus micros.

Drug Class: This is the first approved antibiotic in a new class called glycylcyclines. kamagra soft tablets

Uniqueness of Drug: This intravenous (IV) antibiotic has a broad spectrum of antimicrobial activity, including activity against the drug-resistant bacteria methicillin-resistant Staphylococcus aureus (MRSA). Tigecycline can be used as an empirical monotherapy to treat a variety of hospital-acquired and community-acquired infections (e.g., complicated appen­dicitis, infected burns, intra-abdominal abscesses, deep soft-tissue infections, and infected ulcers).

Precautions and Contraindications: Tigecycline is contraindicated in patients with known hypersensitivity to this agent. It should be administered with caution in patients with known hypersensitivity to the tetracycline class of antibiotics, and it may have adverse effects similar to those of the tetra-cyclines. In clinical trials, the most common treatment-emergent ADEs were nausea (29.5%) and vomiting (19.7%).

Tigecycline may cause fetal harm when administered during pregnancy. The safety and effectiveness of tigecycline in patients younger than 18 years of age and in lactating women have not been established.
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The use of tigecycline during tooth development may cause permanent discoloration of the teeth.

Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range from mild to life-threatening.

Monotherapy should be used with caution in patients with clinically apparent intestinal perforation.

Dosage: The recommended dosage of tigecycline is 100 mg infused over 30-60 minutes followed by 50 mg infused every 12 hours for 5-14 days. The length of treatment should be guided by the severity of the infection, the patient’s bacteriological response, and the patient’s clinical progress.

Patients with severe liver impairment should receive a starting dose of 100 mg, followed by 25 mg every 12 hours. No dosage adjustment is needed for patients with mild or moderate liver impairment.

The dosage does not need to be adjusted in renally impaired patients, and the drug is conveniently administered every 12 hours.

Commentary: Tigecycline is an agent that restores some faith in the tetracyclines, given its enhanced activity against resistant organisms and its broad spectrum of activity. It is a novel glycylcycline antibiotic with activity against a broad range of gram-positive, gram-negative, atypical, anaerobic and antibiotic-resistant bacteria. Its activities are typical of earlier tetracyclines, and it is more potent against tetracycline-resistant organisms.

The glycylcyclines, which were designed to overcome the development of acquired resistance normally associated with tetracycline antibiotics, are the result of adding dimethyl-glyclamido or tertiary butylglyclamido groups to tetracycline structures.

Although tetracycline is bacteriostatic in vitro, its effectiveness in clinical trials suggests that traditional laboratory thinking about using bacteriostatic drugs in serious infections needs to be revised. Unlike existing tetracyclines, tigecycline is available only as an IV preparation. It is administered twice daily, although its long half-life and post-antibiotic effect may make once-daily dosing a possibility.
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Tigecycline appears to have good tissue penetration (e.g., under the skin). No dose adjustment is needed in patients with renal or hepatic disease.

In three clinical trials, the drug was well tolerated despite an increased frequency of nausea and vomiting.

Category: Drug

Tags: Byetta, Lyrica, Tygacil

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