B Tig 50 mg Ingredients and Usage

The active ingredient is Tigecycline, a bacteriostatic agent chemically related to the tetracyclines. The 50 mg vial contains a lyophilized powder that must be reconstituted and diluted for slow intravenous (IV) infusion (over 30 to 60 minutes).

B Tig is clinically indicated for the treatment of severe infections where resistance to other antibiotics is suspected or confirmed, including:

• Complicated Skin and Soft-Tissue Infections (cSSTI): Including those caused by MRSA.
• Complicated Intra-Abdominal Infections (cIAI): Including those caused by MDR Gram-negative and Gram-positive organisms.
• Community-Acquired Bacterial Pneumonia (CABP): Specific severe cases.

How Does B Tig Work?

Tigecycline is a protein synthesis inhibitor. Its unique structure gives it broader activity and resistance to common resistance mechanisms compared to older tetracyclines. The mechanism is:

1. Ribosomal Binding: Tigecycline binds to the 30S subunit of the bacterial ribosome.
2. Aminoacyl-tRNA Blockade: It specifically prevents the binding of aminoacyl transfer RNA (tRNA) molecules to the A site on the ribosome.
3. Protein Synthesis Inhibition: By blocking tRNA from delivering amino acids, Tigecycline inhibits the assembly of bacterial proteins, thereby halting bacterial growth and reproduction.
4. MDR Activity: Crucially, it bypasses the two most common mechanisms of tetracycline resistance: ribosomal protection and active efflux (pumping out) of the drug.

B Tig 50 mg Side Effects and Warnings

Tigecycline is associated with specific gastrointestinal side effects and a controversial mortality risk that warrants caution.

Black Box Warnings and Critical Precautions:

1. Increased Mortality Risk: A pooled analysis of clinical trials showed an increased all-cause mortality risk in patients treated with Tigecycline compared to comparator antibiotics. It should be reserved for use in situations where alternative treatments are not suitable.
2. Nausea and Vomiting: Nausea and vomiting are very common, often severe, side effects and may require supportive antiemetic therapy. They are generally dose-related.
3. Superinfection: As with all antibiotics, treatment can lead to the overgrowth of non-susceptible organisms, including fungi and Clostridium difficile, which can cause severe colitis (CDAD).
4. Contraindications: Should not be used in children under 8 years of age due to potential tooth discoloration (like tetracyclines) and bone growth inhibition. Contraindicated in patients with known hypersensitivity to the drug.

B Tig 50 mg Storage Conditions

Tigecycline powder requires careful handling and preparation:

• Store the unopened vials at controlled room temperature, typically between 20°C and 25°C (68°F and 77°F). Protect from light.
• Reconstitution: The 50 mg powder must be reconstituted with 5.3 mL of an appropriate diluent (0.9% NaCl or 5% Dextrose) to achieve a 10 mg/mL concentration. The solution should be yellow to orange.
• Dilution: The reconstituted solution must be immediately diluted further in a 100 mL bag of 0.9% NaCl or 5% Dextrose for infusion.
• Stability: The diluted solution must be used within 6 hours at room temperature or 24 hours if refrigerated.