Tigecycline
Generic Name: tigecycline
Brand Names:
Tigecycline
11 DESCRIPTION Tigecycline for Injection, USP is a tetracycline class antibacterial for intravenous infusion. The chemical name of tigecycline is (4 S ,4a S ,5a R ,12a S )- 9-[2-( tert -butylamino)acetamido]-4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2 naphthacenecarboxamide. The molecular formula is C 29 H 39 N 5 O 8 and the molecular weight is 585.65.
Overview
11 DESCRIPTION Tigecycline for Injection, USP is a tetracycline class antibacterial for intravenous infusion. The chemical name of tigecycline is (4 S ,4a S ,5a R ,12a S )- 9-[2-( tert -butylamino)acetamido]-4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2 naphthacenecarboxamide. The molecular formula is C 29 H 39 N 5 O 8 and the molecular weight is 585.65.
Uses
1 INDICATIONS AND USAGE Tigecycline for injection is a tetracycline class antibacterial indicated in patients 18 years of age and older for: Complicated skin and skin structure infections ( 1.1 ) Complicated intra-abdominal infections ( 1.2 ) Community-acquired bacterial pneumonia ( 1.3 ) Limitations of Use: Tigecycline for injection is not indicated for treatment of diabetic foot infection or hospital-acquired pneumonia, including ventilator-associated pneumonia ( 1.4 ). To reduce the development of drug-resistant bacteria and maintain the effectiveness of tigecycline for injection and other antibacterial drugs, tigecycline for injection should be used only to treat infections that are proven or strongly suspected to be caused by bacteria ( 1.5 ).
Dosage
2 DOSAGE AND ADMINISTRATION Initial dose of 100 mg, followed by 50 mg every 12 hours administered intravenously over approximately 30 to 60 minutes. (2.1) Severe hepatic impairment (Child Pugh C): Initial dose of 100 mg followed by 25 mg every 12 hours. ( 2.2 ) Obtain baseline blood coagulation parameters, including fibrinogen, and continue to monitor regularly during treatment with tigecyclineetracycline. ( 2.4 , 5.6 ) 2.1 Recommended Adult Dosage The recommended dosage regimen for tigecycline for injection is an initial dose of 100 mg, followed by 50 mg every 12 hours. Intravenous infusions of tigecycline for injection should be administered over approximately 30 to 60 minutes every 12 hours.
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: All-Cause Mortality [see Boxed Warning and Warnings and Precautions ( 5.1 )] Mortality Imbalance and Lower Cure Rates in Hospital-Acquired Pneumonia [see Warnings and Precautions ( 5.2 )] Anaphylaxis [Warning and Precautions ( 5.3 )] Hepatic Adverse Effects [Warnings and Precautions ( 5.4 )] Pancreatitis [Warnings and Precautions ( 5.5 )] The most common adverse reactions (incidence >5%) are nausea, vomiting, diarrhea, abdominal pain, headache, and increased SGPT.
Interactions
7 DRUG INTERACTIONS Warfarin: Suitable anticoagulation test should be monitored if tigecycline for injection is administered to patients receiving warfarin. ( 7.1 ) Calcineurin Inhibitors: Serum concentrations of calcineurin inhibitors (e.g., tacrolimus, cyclosporine) should be monitored during treatment with tigecycline for injection due to risk of toxicity. ( 7.2 ) 7.1 Warfarin Prothrombin time or other suitable anticoagulation test should be monitored if tigecycline is administered with warfarin [see Clinical Pharmacology ( 12.3 )] . 7.2 Calcineurin Inhibitors Concomitant use of tigecycline for injection and calcineurin inhibitors such as tacrolimus or cyclosporine may lead to an increase in serum trough concentrations of the calcineurin inhibitors.
Warnings
WARNING: ALL-CAUSE MORTALITY An increase in all-cause mortality has been observed in a meta-analysis of Phase 3 and 4 clinical trials in tigecycline-treated patients versus comparator. The cause of this mortality risk difference of 0.6% (95% CI 0.1, 1.2) has not been established. Tigecycline for injection should be reserved for use in situations when alternative treatments are not suitable [see Indications and Usage ( 1.4 ), Warnings and Precautions (5.1, 5.2) and Adverse Reactions (6.1)]. 5 WARNINGS AND PRECAUTIONS All-Cause Mortality: A meta-analysis of Phase 3 and 4 clinical trials demonstrated an increase in all-cause mortality in tigecycline-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, 1.2)]. The greatest difference in mortality was seen in tigecycline-treated patients with ventilator-associated pneumonia. ( 5.1 , 5.2 ) Anaphylactic Reactions: have been reported with tigecycline for injection, and may be life-threatening. Avoid use in patients with known hypersensitivity to tetracyclines. ( 5.3 ) Hepatic Adverse Effects: have been reported with tigecycline for injection. 4 CONTRAINDICATIONS Tigecycline for injection is contraindicated for use in patients who have known hypersensitivity to tigecycline or to any of the excipients. Reactions have included anaphylactic reactions [ see Warnings and Precautions ( 5.3 ) and Adverse Reactions ( 6.2 ) ] . Known hypersensitivity to tigecycline. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Tigecycline for injection, 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 [see Warnings and Precautions ( 5.7 , 5.8), Data, and Use in Specific Populations ( 8.4 )] . There are no available data on the risk of major birth defects or miscarriage following the use of tigecycline for injection during pregnancy.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Tigecycline for injection, USP is supplied in a single-dose 5 mL glass vial, each containing 50 mg tigecycline, USP lyophilized powder for reconstitution. Supplied: 10 single-dose vials in one box.
Frequently Asked Questions
What is Tigecycline used for?▼
1 INDICATIONS AND USAGE Tigecycline for injection is a tetracycline class antibacterial indicated in patients 18 years of age and older for: Complicated skin and skin structure infections ( 1.1 ) Complicated intra-abdominal infections ( 1.2 ) Community-acquired bacterial pneumonia ( 1.3 ) Limitations of Use: Tigecycline for injection is not indicated for treatment of diabetic foot infection or hospital-acquired pneumonia, including ventilator-associated pneumonia ( 1.4 ). To reduce the development of drug-resistant bacteria and maintain the effectiveness of tigecycline for injection and other antibacterial drugs, tigecycline for injection should be used only to treat infections that are proven or strongly suspected to be caused by bacteria ( 1.5 ).
What are the side effects of Tigecycline?▼
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: All-Cause Mortality [see Boxed Warning and Warnings and Precautions ( 5.1 )] Mortality Imbalance and Lower Cure Rates in Hospital-Acquired Pneumonia [see Warnings and Precautions ( 5.2 )] Anaphylaxis [Warning and Precautions ( 5.3 )] Hepatic Adverse Effects [Warnings and Precautions ( 5.4 )] Pancreatitis [Warnings and Precautions ( 5.5 )] The most common adverse reactions (incidence >5%) are nausea, vomiting, diarrhea, abdominal pain, headache, and increased SGPT.
Can I take Tigecycline during pregnancy?▼
8.1 Pregnancy Risk Summary Tigecycline for injection, 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 [see Warnings and Precautions ( 5.7 , 5.8), Data, and Use in Specific Populations ( 8.4 )] . There are no available data on the risk of major birth defects or miscarriage following the use of tigecycline for injection during pregnancy.
What are the important warnings for Tigecycline?▼
WARNING: ALL-CAUSE MORTALITY An increase in all-cause mortality has been observed in a meta-analysis of Phase 3 and 4 clinical trials in tigecycline-treated patients versus comparator. The cause of this mortality risk difference of 0.6% (95% CI 0.1, 1.2) has not been established. Tigecycline for injection should be reserved for use in situations when alternative treatments are not suitable [see Indications and Usage ( 1.4 ), Warnings and Precautions (5.1, 5.2) and Adverse Reactions (6.1)]. 5 WARNINGS AND PRECAUTIONS All-Cause Mortality: A meta-analysis of Phase 3 and 4 clinical trials demonstrated an increase in all-cause mortality in tigecycline-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, 1.2)]. The greatest difference in mortality was seen in tigecycline-treated patients with ventilator-associated pneumonia. ( 5.1 , 5.2 ) Anaphylactic Reactions: have been reported with tigecycline for injection, and may be life-threatening. Avoid use in patients with known hypersensitivity to tetracyclines. ( 5.3 ) Hepatic Adverse Effects: have been reported with tigecycline for injection. 4 CONTRAINDICATIONS Tigecycline for injection is contraindicated for use in patients who have known hypersensitivity to tigecycline or to any of the excipients. Reactions have included anaphylactic reactions [ see Warnings and Precautions ( 5.3 ) and Adverse Reactions ( 6.2 ) ] . Known hypersensitivity to tigecycline. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.