Tygacil

Tygacil,

a trademark for tigecycline.

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tigecycline

Tygacil

Pharmacologic class: Glycylcycline antibiotic

Therapeutic class: Anti-infective

Pregnancy risk category D

Action

Inhibits protein translation in bacteria by binding to 30S ribosomal subunit and blocking entry of amino-acyl tRNA molecules into ribosomal A site, which in turn prevents incorporation of amino acid residues into elongating peptide chains

Availability

Powder for injection (lyophilized): 50 mg/5 ml in single-dose vial

⊘Indications and dosages

➣ Skin and skin-structure infections caused by susceptible strains of Escherichia coli, Enterococcus faecalis (vancomycin-susceptible isolates only), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus agalactiae, Streptococcus anginosus group, Streptococcus pyogenes, and Bacteroides fragilis; complicated intra-abdominal infections caused by Citrobacter freundii, E. coli, Enterobacter cloacae, E. faecalis (vancomycin-susceptible isolates only), Klebsiella oxytoca, Klebsiella pneumoniae, S. aureus (methicillin-susceptible isolates only), S. anginosus group, S. pyogenes, B. fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Clostridium perfringens, and Peptostreptococcus micros

Adults age 18 and older: 100 mg I.V. initially, followed by 50 mg I.V. every 12 hours for 5 to 14 days, depending on infection site and severity and patient's clinical and bacteriologic process

Dosage adjustment

• Severe hepatic impairment

Contraindications

• Hypersensitivity to drug or its components

Precautions

Use cautiously in:
• mild to moderate hepatic impairment, complicated intra-abdominal infections secondary to perforation
• pregnant and breastfeeding patients
• children younger than age 18.

Administration

• Reconstitute with 5.3 ml of normal saline solution injection or 5% dextrose injection to yield a concentration of 10 mg/ml (50 mg).
• Swirl vial gently until drug dissolves. Immediately withdraw 5 ml of reconstituted solution from vial and add to 100-ml I.V. bag for infusion. Maximum concentration in I.V. bag should be 1 mg/ml.
• Discard reconstituted solution that isn't yellow or orange.
• Administer through dedicated I.V. line or Y-site. If same I.V. line is used for sequential infusion of several drugs, flush before and after infusion, using either normal saline solution injection or 5% dextrose injection. Use infusion solution compatible with tigecycline and other drugs given through same line.
• Administer over 30 to 60 minutes.
• Don't give amphotericin B, chlorpromazine, methylprednisolone, or voriconazole simultaneously through same Y-site.

Route	Onset	Peak	Duration
I.V.	Unknown	Unknown	Unknown

Adverse reactions

CNS: headache, dizziness, insomnia, asthenia

CV: hypertension, hypotension, phlebitis

GI: nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, increased GI enzymes, pseudomembranous colitis

Hematologic: anemia, leukocytosis, thrombocytopenia

Musculoskeletal: back pain

Respiratory: increased cough, dyspnea

Skin: pruritus, rash, sweating, photosensitivity

Other: abscess, fever, infection, pain, peripheral edema, abnormal healing, superinfection, allergic reaction

Interactions

Drug-drug. Hormonal contraceptives: reduced contraceptive efficacy

Drug-diagnostic tests. Alanine aminotransferase, alkaline phosphatase, amylase, aspartate aminotransferase, bilirubin, blood glucose, blood urea nitrogen: increased

Blood protein, potassium, WBCs: decreased

Patient monitoring

• Monitor prothrombin time or other suitable anticoagulation tests if patient is receiving warfarin concomitantly.
• Closely monitor patients with severe hepatic impairment.

Patient teaching

• Instruct patient to report rash and other signs or symptoms of allergic reaction.
• Tell patient to complete full course of therapy, even if he feels better.
• Advise patient taking oral hormonal contraceptives to use alternative birth control method during therapy.
• Caution female with childbearing potential to avoid pregnancy because drug may harm fetus.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.