Tigecycline

What is Tigecycline?

• Tigecycline (Tygacil) is a tetracycline class antibacterial used for treatment of serious infections due to susceptible organisms.

Tigecycline

Tigecycline chemical structure

What are the uses of this medicine?

Tigecycline (Tygacil) is used in patients 18 years of age and older for:

• Complicated skin and skin structure infections
• Complicated intra-abdominal infections
• Community-acquired bacterial pneumonia

Limitations of Use: TYGACIL is not indicated for treatment of diabetic foot infection or hospital-acquired pneumonia, including ventilator-associated pneumonia.

How does this medicine work?

• Tigecycline (tye" ge sye' kleen) is new generation of tetracycline, known as a glycycline.
• Like other tetracyclines, tigecycline is a broad spectrum bacteriostatic agent that acts by binding to bacterial ribosomes inhibiting protein synthesis.
• Tigecycline binds to the 30S ribosomal subunit and blocking entry of amino-acyl tRNA molecules into the A site of the ribosome.
• This prevents incorporation of amino acid residues into elongating peptide chains.
• In general, tigecycline is considered bacteriostatic; however, TYGACIL has demonstrated bactericidal activity against isolates of S. pneumoniae and L.pneumophila.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have known hypersensitivity to tigecycline.

What drug interactions can this medicine cause?

• Suitable anticoagulation test should be monitored if TYGACIL is administered to patients receiving warfarin.
• Concurrent use of antibacterial drugs with oral contraceptives may render oral contraceptives less effective.
• Concomitant use of TYGACIL and calcineurin inhibitors such as tacrolimus or cyclosporine may lead to an increase in serum trough concentrations of the calcineurin inhibitors.

Is this medicine FDA approved?

• Tigecycline was approved for use in the United States in 2005.

How should this medicine be used?

Recommended dosage:

• The recommended dosage regimen for TYGACIL is an initial dose of 100 mg, followed by 50 mg every 12 hours.

• Dosage in Patients With Hepatic Impairment:
• No dosage adjustment is warranted in patients with mild to moderate hepatic impairment.
• In patients with severe hepatic impairment, the initial dose of TYGACIL should be 100 mg followed by a reduced maintenance dose of 25 mg every 12 hours.

• Obtain baseline blood coagulation parameters, including fibrinogen, and continue to monitor regularly during treatment with TYGACIL.

Administration:

• Intravenous infusions of TYGACIL should be administered over approximately 30 to 60 minutes every 12 hours.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Injection: 50 mg, lyophilized powder for reconstitution in a single-dose 10 mL vial.

This medicine is available in fallowing brand namesː

• TYGACIL

What side effects can this medication cause?

The most common side effects of this medicine include:

• nausea
• vomiting
• diarrhea
• abdominal pain
• headache
• increased SGPT

What special precautions should I follow?

• A meta-analysis of Phase 3 and 4 clinical trials demonstrated an increase in all-cause mortality in TYGACIL-treated patients compared to controls with a risk difference of 0.6% (95% CI 0.1, 1.2). The cause of this increase has not been established. An increase was also seen in a meta-analysis limited to the approved indications [0.6% (95% CI 0.0, 1.2)]. The greatest difference in mortality was seen in TYGACIL-treated patients with ventilator-associated pneumonia.
• Anaphylactic reactions have been reported with TYGACIL, and may be life-threatening. Avoid use in patients with known hypersensitivity to tetracyclines.
• Hepatic adverse effects have been reported with TYGACIL. Patients who develop abnormal liver function tests during TYGACIL therapy should be monitored for evidence of worsening hepatic function and evaluated for risk/benefit of continuing tigecycline therapy.
• Pancreatitis including fatalities, has been reported with TYGACIL. If pancreatitis is suspected, then consider stopping TYGACIL.
• Hypofibrinogenemia has been reported with TYGACIL. Monitor blood coagulation parameters, including fibrinogen, at baseline and regularly during treatment with TYGACIL.
• The use of TYGACIL during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.
• The use of TYGACIL during the second and third trimester of pregnancy, infancy, and childhood up to the age of 8 years may cause reversible inhibition of bone growth.
• Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including TYGACIL. Evaluate if diarrhea occurs.
• TYGACIL is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse effects. Such effects may include: photosensitivity, pseudotumor cerebri, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, and hyperphosphatemia).
• Prescribing TYGACIL in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• nausea and vomiting

Management of overdosage:

• No specific information is available on the treatment of overdosage with tigecycline.
• In the event of an overdose, appropriate supportive treatment should be initiated.
• Tigecycline is not removed in significant quantities by hemodialysis.

Can this medicine be used in pregnancy?

• TYGACIL, like other tetracycline class antibacterial drugs, may cause permanent discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy.
• There are no available data on the risk of major birth defects or miscarriage following the use of TYGACIL during pregnancy.
• Advise the patient of the potential risk to the fetus if TYGACIL is used during the second or third trimester.

Can this medicine be used in children?

• Use in patients under 18 years of age is not recommended. Safety and effectiveness in pediatric patients below the age of 18 years have not been established.
• Because of effects on tooth development, use in patients under 8 years of age is not recommended.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• TIGECYCLINE

Inactive ingredients:

• HYDROCHLORIC ACID
• SODIUM HYDROXIDE
• LACTOSE MONOHYDRATE

Who manufactures and distributes this medicine?

Packager: Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

What should I know about storage and disposal of this medication?

• Prior to reconstitution, TYGACIL should be stored at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).
• The reconstituted solution of TYGACIL may be stored at room temperature (not to exceed 25°C/77°F) for up to 24 hours (up to 6 hours in the vial and the remaining time in the intravenous bag).

List of tetracyclines

• Demeclocycline
• Doxycycline
• Minocycline
• Tetracycline
• Tigecycline

• Dailymed label info on Tigecycline
• FDA Tigecycline

Tigecycline Resources
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