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(tigecycline) for Injection for Intravenous Use
An increase in all-cause mortality has been observed in a meta-analysis of Phase 3 and 4 clinical trials in TYGACIL-treated patients versus comparator. The cause of this mortality risk difference of 0.6% (95% CI 0.1, 1.2) has not been established. TYGACIL should be reserved for use in situations when alternative treatments are not suitable [see INDICATIONS AND USAGE, WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].
TYGACIL (tigecycline) is a tetracycline derivative (a glycylcycline) for intravenous infusion. The chemical name of tigecycline is (4S,4aS,5aR,12aS)-9-[2-(tert-butylamino)acetamido]-4,7bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2naphthacenecarboxamide. The empirical formula is C29H39N5O8 and the molecular weight is 585.65.
The following represents the chemical structure of tigecycline:
TYGACIL is an orange lyophilized powder or cake. Each TYGACIL vial contains 50 mg tigecycline lyophilized powder for reconstitution for intravenous infusion and 100 mg of lactose monohydrate. The pH is adjusted with hydrochloric acid, and if necessary sodium hydroxide. The product does not contain preservatives.
What are the possible side effects of tigecycline (Tygacil)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using tigecycline and call your doctor at once if you have a serious side effect such as:
- diarrhea that is watery or bloody;
- severe headache, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes;
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
- severe pain in your upper...
What are the precautions when taking tigecycline (Tygacil)?
See also Side Effects section.
Before using tigecycline, tell your doctor or pharmacist if you are allergic to it; or to tetracyclines (such as doxycycline, minocycline, tetracycline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe liver disease.
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning...
Last reviewed on RxList: 10/10/2013
This monograph has been modified to include the generic and brand name in many instances.
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