Tigecycline 50mg Inj, 1 Vial

Tigecycline is a glycylcycline antibiotic that inhibits protein translation in bacteria by binding to the 30S ribosomal subunit. This binding prevents the entry of aminoacyl-tRNA molecules into the A site of the ribosome, thereby interfering with peptide chain elongation and inhibiting bacterial protein synthesis. It is generally considered bacteriostatic.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of too much acid in the blood (acidosis), such as:
+ Confusion
+ Fast breathing
+ Fast heartbeat
+ Irregular heartbeat
+ Severe stomach pain, upset stomach, or vomiting
+ Feeling extremely sleepy
+ Shortness of breath
+ Feeling very tired or weak
Other severe symptoms, including:
+ Inability to urinate or changes in urine output
+ Severe diarrhea, stomach cramps, or bloody stools (may be a sign of C. diff-associated diarrhea, a potentially life-threatening condition)
+ Severe stomach pain, back pain, or vomiting (may be a sign of pancreatitis)
+ Headache or vision problems, such as blurred vision, double vision, or loss of vision (may be a sign of raised pressure in the brain)

Common Side Effects

Most people experience mild or no side effects while taking this medication. However, some common side effects may occur, including:

Diarrhea
Stomach pain
Upset stomach
Vomiting
* Headache

If any of these side effects or other symptoms bother you or do not go away, contact your doctor for advice.

Reporting Side Effects

If you experience any side effects, you can report them to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. You can also contact your doctor for guidance on managing side effects.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you have a gastrointestinal (GI) tract perforation (a hole in the GI tract).

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.

Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor.

Important Information for Patients Taking This Medication

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood work and laboratory tests should be performed as directed by your doctor to monitor your condition.

Duration of Use and Risk of Infection

Do not take this medication for longer than prescribed by your doctor. Prolonged use may increase the risk of developing a second infection.

Sun Sensitivity

This medication may increase your susceptibility to sunburn. Exercise caution when exposed to sunlight, and notify your doctor if you experience excessive sunburn or sensitivity.

Dental and Skeletal Effects

In children under 8 years old, or in unborn babies exposed to this medication during certain stages of pregnancy, tooth discoloration (yellow-gray brown) may occur. This change is permanent. Additionally, other tooth problems and effects on bone growth have been reported in these individuals. If you have concerns, consult your doctor.

Contraception and Pregnancy

The effectiveness of birth control pills and other hormone-based contraceptives may be reduced when taking this medication. To prevent pregnancy, use an alternative method, such as condoms, in conjunction with your regular birth control.

If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks to you and your baby.

Use in Children

This medication is not approved for use in children. However, your doctor may determine that the benefits of taking this medication outweigh the risks. If your child has been prescribed this medication, ask your doctor about the potential benefits and risks, and discuss any concerns you may have.

• Warfarin (increased INR/bleeding risk)

• Oral contraceptives (potential for decreased efficacy)
• Other bacteriostatic agents (e.g., chloramphenicol, macrolides, sulfonamides - theoretical antagonism with bactericidal agents, though clinical significance is often debated)

• Nausea
• Vomiting
• Diarrhea
• Abdominal pain
• Headache
• Dizziness
• Injection site reactions (pain, swelling, phlebitis)
• Rash
• Photosensitivity
• Signs of pancreatitis (severe abdominal pain, radiating to back, nausea, vomiting)
• Signs of pseudomembranous colitis (severe, persistent diarrhea, abdominal cramps, fever)
• Signs of hypersensitivity reaction (rash, itching, swelling, severe dizziness, trouble breathing)

Tigecycline is classified as Pregnancy Category D. It should not be used in pregnant women unless the potential benefits outweigh the potential risks to the fetus. Tetracycline-class drugs can cause permanent discoloration of teeth (yellow-gray-brown) and reversible inhibition of bone growth in the fetus.

Tigecycline is excreted in human milk. Due to the potential for serious adverse reactions in the breastfed infant (e.g., permanent tooth discoloration, inhibition of bone growth), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Tigecycline is contraindicated in children under 8 years of age due to the potential for permanent tooth discoloration and reversible inhibition of bone growth. Its use in children and adolescents (under 18 years) is generally not recommended unless other agents are not suitable, due to the lack of established safety and efficacy and the potential for these adverse effects.

No dose adjustment is required based on age. However, elderly patients may be more susceptible to adverse effects, particularly gastrointestinal side effects. Monitor closely for adverse reactions.

• Tigecycline has a broad spectrum of activity, including against MRSA, VRE, and ESBL-producing Gram-negative bacteria, but it lacks activity against *Pseudomonas aeruginosa* and *Proteus* species.
• High incidence of gastrointestinal side effects (nausea, vomiting) is common, often requiring antiemetic prophylaxis.
• The Black Box Warning regarding increased all-cause mortality means tigecycline should be reserved for situations where alternative treatments are not suitable.
• Risk of pancreatitis, sometimes severe, has been reported. Monitor for new or worsening abdominal pain.
• Not indicated for bloodstream infections due to lower serum concentrations compared to tissue concentrations, and concerns about efficacy in bacteremia.
• Administer via IV infusion over 30-60 minutes to minimize infusion-related reactions.

• Carbapenems (e.g., Meropenem, Imipenem/Cilastatin, Ertapenem) for broad-spectrum coverage.
• Linezolid or Daptomycin for MRSA and VRE infections.
• Ceftaroline for MRSA and some Gram-negative coverage.
• Colistin or Polymyxin B for multi-drug resistant Gram-negative infections (often as salvage therapy).
• Other tetracyclines (e.g., Doxycycline, Minocycline) for less severe infections or specific pathogens, but with different spectrums and resistance profiles.

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.