BTig (50mg) 1 Vial Injection

Tigecycline is a glycylcycline antibiotic that primarily acts by inhibiting protein synthesis in bacteria. Its mechanism of action involves binding to the 30S ribosomal subunit, specifically near the A site of the ribosome, thereby preventing the binding of aminoacyl-tRNA molecules to the ribosome. This binding interferes with the proper positioning of tRNA molecules, leading to incorrect decoding of mRNA and subsequent inhibition of bacterial protein synthesis. Tigecycline is unique in that it can also bind to the 50S ribosomal subunit, further contributing to its potent antibacterial activity. This dual binding capability allows tigecycline to maintain its effectiveness against a wide range of bacteria, including those with resistance to other antibiotics, as it can disrupt multiple steps in the protein synthesis process.

Glycylcycline antibiotic.

Injection

The following are the uses of Tigecycline 50mg injection:

• Used for treating complicated skin and skin structure infections caused by susceptible bacteria.
• Used for managing serious intra-abdominal infections when other treatment options are not suitable.
• Used as a last-resort option for complicated intra-abdominal infections in critically ill patients.
• Used for the treatment of community-acquired bacterial pneumonia in specific cases.
• Used to control bacterial infections in patients with a history of severe allergies or resistance to other antibiotics.
• Used to stabilize patients with severe bacterial infections before surgery.
• Used in certain cases to prevent infections during high-risk surgical procedures.

In the case of an overdose of Tigecycline 50mg injection, prompt medical attention is necessary. Symptoms may include an increased risk of adverse effects, such as nausea, vomiting, and diarrhea. The severity of symptoms can vary based on the amount ingested. It is crucial to contact a healthcare professional or poison control center immediately for guidance and potential treatment options. They will provide specific instructions and may recommend monitoring or additional interventions to address the overdose.

In the case of a missed dose of Tigecycline 50mg injection, it is important to administer the medication as soon as possible. If it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. However, do not double the dose to make up for a missed one, as this may increase the risk of side effects. If you miss multiple doses, contact your healthcare provider for guidance on how to safely resume your treatment. It is crucial to maintain a consistent medication routine for optimal therapeutic benefits.

To administer Tigecycline 50mg injection, prepare the medication by drawing the prescribed dose into a syringe, ensuring it is reconstituted properly, and inject it slowly into a vein or as directed by your healthcare professional, following the recommended administration guidelines provided.

Following are the conditions when Tigecycline 50mg injection should not be used:

• Should not be used in patients with a known allergy to Tigecycline or other tetracycline antibiotics.
• Contraindicated in patients with severe liver impairment.
• Not recommended for individuals with a history of severe renal impairment.
• Avoid using in pregnant or breastfeeding women.
• Should not be used in children below 8 years of age.
• Not suitable for patients with a history of hypersensitivity reactions to similar medications.
• Tigecycline should not be used if you have had a recent intracranial surgery or have a condition like intracranial hypertension.
• Contraindicated in patients with a history of Clostridioides difficile-associated diarrhea or colitis.

The side effects of Tigecycline 50mg injection may include:

• Nausea and vomiting
• Diarrhea
• Dizziness
• Headache
• Tooth discoloration (more common in children)
• Increased sensitivity to sunlight
• Changes in liver function
• Allergic reactions (such as rash, itching, or difficulty breathing)

Following are the precautions and warnings for Tigecycline 50mg Injection:

• Tigecycline should be used with caution in patients with a history of hypersensitivity to tetracyclines, as it may cause allergic reactions such as rash, pruritus, or anaphylaxis.
• This drug is not recommended for use in patients with known or suspected bacterial infections caused by Pseudomonas aeruginosa, Proteus spp., or Morganella spp., as it may not be effective against these pathogens.
• Caution is required in patients with liver impairment, as tigecycline is primarily metabolized in the liver and hepatic function should be monitored regularly during treatment.
• The use of tigecycline may lead to the development of Clostridium difficile-associated diarrhea (CDAD). If severe diarrhea occurs, the treatment should be discontinued and appropriate management should be initiated.
• Tigecycline can cause or worsen pancreatitis, so caution is required in patients with a history of pancreatitis.
• It should not be used during pregnancy unless the potential benefits outweigh the risks, as it falls under pregnancy category D, indicating potential harm to the fetus.
• The safety and effectiveness of tigecycline have not been established in pediatric patients under the age of 18.
• Tigecycline may cause or worsen renal function impairment, especially in patients with pre-existing renal conditions. Regular renal monitoring is recommended.
• Patients receiving tigecycline should be monitored for signs of thrombocytopenia or other hematological changes, as it can cause decreased platelet count.
• Caution is required in elderly patients, as they may be more vulnerable to side effects such as renal and hepatic complications.
• Tigecycline can cause photosensitivity, so patients should avoid excessive sunlight or tanning while on treatment.
• Prolonged use of antibiotics like tigecycline may lead to the overgrowth of non-susceptible organisms, including fungi.
• Tigecycline is not recommended for use as a sole agent in the treatment of complicated urinary tract infections (cUTIs) or bloodstream infections due to its limited activity against some pathogens.
• The injection should not be given to patients who are hypersensitive to tigecycline or any of its components.

Following are the drug interactions for Tigecycline 50mg Injection:

• Concomitant use with medications that prolong the QT interval (e.g., Class IA or III antiarrhythmic agents) may increase the risk of cardiac arrhythmias.
• Tigecycline may reduce the effectiveness of oral contraceptives, requiring the use of additional contraceptive methods.
• It can decrease the plasma levels of oral typhoid vaccine, potentially reducing its efficacy.
• The efficacy of live bacterial vaccines may be diminished when administered during Tigecycline treatment.
• Antacids containing aluminum, magnesium, or calcium can reduce the absorption of Tigecycline, so they should be avoided.
• Avoid concurrent use with carbapenems, as Tigecycline may antagonize their activity.
• Warfarin's anticoagulant effect can be altered, requiring close monitoring of INR.

Following are the food interactions for Tigecycline 50mg injection:

• Tigecycline should be administered on an empty stomach, at least 1 hour before or 2 hours after a meal, as food can significantly reduce its absorption.
• Avoid consuming dairy products or calcium-fortified juices within 1 hour of taking Tigecycline, as calcium can bind to the medication and reduce its effectiveness.
• Grapefruit and grapefruit juice are known to interact with many medications, and Tigecycline is no exception. Avoid consuming grapefruit products while on this medication.
• Alcohol may increase the risk of adverse effects and should be avoided or consumed in moderation during Tigecycline therapy.
• Vitamin and mineral supplements, especially those containing iron, calcium, or multivitamins, can interfere with Tigecycline absorption. Take these supplements at least 2 hours apart from the medication.
• High-fat meals can delay the absorption of Tigecycline, leading to reduced effectiveness. It is best to avoid high-fat foods before and after taking the injection.
• No significant interactions have been reported with specific foods, but maintaining a balanced diet is essential for overall health during antibiotic treatment.
• Always follow the instructions provided by your healthcare professional regarding dietary restrictions and interactions.

Tigecycline 50mg injection should be stored in a controlled room temperature environment, typically between 20°C and 25°C (68°F to 77°F), in its original packaging to protect it from light and moisture. It is crucial to keep the injection away from children and pets, ensuring it is stored in a secure location. Do not freeze the medication as it may affect its potency. Dispose of any unused or expired Tigecycline injection through appropriate medical waste disposal channels, such as returning it to a pharmacy or healthcare facility, to ensure it is handled in an environmentally friendly manner, and to prevent accidental exposure or misuse. Do not attempt to dispose of it by flushing or pouring it down the drain.

Following are the quick tips for Tigecycline 50mg Injection:

• Administer the injection under medical supervision for optimal therapeutic effects.
• Ensure the injection is prepared and administered by trained medical professionals.
• Tigecycline is typically given once every 12 hours; follow the prescribed dosing schedule.
• Inform your doctor if you have liver or kidney problems for appropriate dosage adjustment.
• Avoid rapid infusion; administer the injection over 30-60 minutes as directed.
• Monitor for potential side effects like nausea, vomiting, or diarrhea, and report severe reactions.
• Store the injection as directed, away from light and moisture, and do not freeze.
• Dispose of any unused or expired medication properly; do not reuse needles or syringes.