Tygacil

DRUG DESCRIPTION

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]-4,7-bis(dimethylamino)-l,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-l,ll-dioxo-2-naphthacenecarboxamide. The empirical formula is C29H39N5O8 and the molecular weight is 585.65.

The following represents the chemical structure of tigecycline:

TYGACIL (tigecycline)  Structural Formula Illustration"

TYGACIL (tigecycline) 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 any of these serious side effects:

  • diarrhea that is watery or bloody;
  • severe headache, pain behind your eyes, ringing or throbbing in your ears, problems with vision, and nausea or vomiting;
  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart...

Read All Potential Side Effects and See Pictures of Tygacil

What are the precautions when taking tigecycline (Tygacil)?

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 booths or sunlamps. Use a sunscreen and...

Read All Potential Precautions of Tygacil


Tygacil Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, headache, dizziness, or pain/swelling at the injection site may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: sunburn (sun sensitivity), change in the amount of urine, unusual fatigue.

Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal pain, hearing changes (e.g., ringing in the ears, decreased hearing), persistent or severe headache, vision changes (e.g., blurred vision, double vision), irregular heartbeat, easy bleeding/bruising, yellowing of the eyes or skin, dark urine.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a resistant bacteria. This condition may occur weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, or blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection (oral or vaginal fungal infection). Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge or other new symptoms.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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 booths or sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Before having surgery, tell your doctor or dentist that you are using this medication.

This medication should not be used in children younger than 8 years of age because it may cause permanent tooth discoloration and other problems. Tooth discoloration may also occur in older children and young adults. Consult your doctor for more information.

This medication is not recommended for use during pregnancy because of possible harm to an unborn baby. Women of child-bearing age should use effective birth control while using this medication. Consult your doctor for more details.

It is not known whether this drug passes into breast milk. Because of possible harm to a nursing infant, consult your doctor before breast-feeding.


Tygacil Patient Information Including Side Effects

Brand Names: Tygacil

Generic Name: tigecycline (Pronunciation: tye ge SYE kleen)

  • What is tigecycline (Tygacil)?
  • What are the possible side effects of tigecycline (Tygacil)?
  • What is the most important information I should know about tigecycline (Tygacil)?
  • What should I discuss with my healthcare provider before using tigecycline (Tygacil)?
  • How should I use tigecycline (Tygacil)?
  • What happens if I miss a dose (Tygacil)?
  • What happens if I overdose (Tygacil)?
  • What should I avoid while using tigecycline (Tygacil)?
  • What other drugs will affect tigecycline (Tygacil)?
  • Where can I get more information?

What is tigecycline (Tygacil)?

Tigecycline is a tetracycline-like antibiotic. It fights bacteria in the body.

Tigecycline is used to treat many different bacterial infections of the skin or the digestive system.

Tigecycline may also be used for other purposes not listed in this medication guide.

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 any of these serious side effects:

  • diarrhea that is watery or bloody;
  • severe headache, pain behind your eyes, ringing or throbbing in your ears, problems with vision, and nausea or vomiting;
  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • feeling like you might pass out; or
  • easy bruising or bleeding, unusual weakness.

Less serious side effects may include:

  • mild stomach pain, nausea, vomiting, or diarrhea;
  • dizziness, sleep problems (insomnia);
  • increased sweating; or
  • vaginal yeast infection.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about tigecycline (Tygacil)?

Do not use this medication if you are pregnant. Babies born to mothers who use tigecycline during late pregnancy can have permanent tooth discoloration. Do not use tigecycline without your doctor's consent if you are pregnant. Tell your doctor if you become pregnant during treatment.

Tigecycline can make birth control pills less effective. Use a second method of birth control while you are using tigecycline to keep from getting pregnant.

It is not known whether tigecycline passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Children younger than 8 years old should not use tigecycline. Tigecycline can cause permanent tooth discoloration.

Before using tigecycline, tell your doctor if you have liver disease, or if you are allergic to antibiotics such as demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

Tigecycline is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Use this medication for the entire length of time prescribed by your doctor. You may need to use the medication for as long as 2 weeks. Your symptoms may get better before the infection is completely treated. Tigecycline will not treat a viral infection such as the common cold or flu.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Tigecycline can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

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