Tobramycin Sulphate Injection
- Packing: 2 Ml Vial
- Available Strength : 40 Mg/Ml
Description
Product Description: Tobramycin Sulphate Injection is a potent antibiotic medication used for the treatment of various bacterial infections. It belongs to the class of antibiotics known as aminoglycosides and is particularly effective against gram-negative bacteria. Tobramycin Sulphate Injection provides a valuable therapeutic option for patients with infections caused by susceptible organisms.
Indications and Usage: Tobramycin Sulphate Injection is indicated for the treatment of serious bacterial infections caused by susceptible organisms, including respiratory tract infections, urinary tract infections, bloodstream infections, and infections of the skin and soft tissues.
Dosage and Administration: Dosage and administration of Tobramycin Sulphate Injection should be determined by a qualified healthcare professional based on factors such as the severity of the infection, the patient's age and weight, renal function, and the susceptibility of the causative bacteria. It is typically administered intravenously or intramuscularly.
Dosage Forms and Strengths: Tobramycin Sulphate Injection is available as a sterile solution for injection in vials containing various strengths, typically ranging from 40 mg to 160 mg per mL.
Contraindications: Tobramycin Sulphate Injection is contraindicated in patients with a known hypersensitivity to tobramycin or any component of the formulation. It should not be used in patients with a history of severe allergic reactions to aminoglycoside antibiotics.
Warnings and Precautions: Serious adverse reactions, including nephrotoxicity and ototoxicity, have been reported with the use of tobramycin. It should be used with caution in patients with renal impairment or pre-existing hearing loss. Regular monitoring of renal function and auditory function is recommended during treatment.
Adverse Reactions/Side Effects: Common adverse reactions associated with tobramycin include nephrotoxicity, ototoxicity, nausea, vomiting, diarrhea, and rash. Serious adverse effects may include allergic reactions, respiratory depression, and neuromuscular blockade.
Drug Interactions: Tobramycin may interact with other medications, including other nephrotoxic or ototoxic drugs, which may potentiate the risk of adverse effects. Concurrent use with other aminoglycoside antibiotics should be avoided whenever possible.
Use In Specific Populations Description: Safety and efficacy of Tobramycin Sulphate Injection in pediatric patients, pregnant women, and nursing mothers have been established through clinical studies and extensive post-marketing surveillance. However, caution should be exercised when administering to these populations, and the potential risks and benefits should be carefully considered.
Clinical Pharmacology: Tobramycin exerts its bactericidal effects by inhibiting bacterial protein synthesis, leading to cell death. It has a broad spectrum of activity primarily against gram-negative bacteria.
Nonclinical Toxicology: Animal studies have demonstrated the potential for nephrotoxicity and ototoxicity at high doses. However, these effects are typically not observed at therapeutic doses in humans.
Clinical Studies: Clinical studies have demonstrated the efficacy of tobramycin in the treatment of various bacterial infections, particularly those caused by gram-negative organisms.
References:
- Tobramycin Sulphate Injection Prescribing Information.
- Clinical Pharmacology of Tobramycin Sulphate Injection.
- Clinical Studies on the Efficacy of Tobramycin Sulphate Injection.
How Supplied/Storage and Handling: Tobramycin Sulphate Injection is supplied as a sterile solution for injection in single-dose vials. It should be stored at controlled room temperature (20°C to 25°C) and protected from light. Unused portions of the reconstituted solution should be discarded.
Patient Counseling Information: Patients should be counseled on the importance of completing the full course of treatment as prescribed by their healthcare provider, even if symptoms improve before the medication is finished. They should also be advised to report any signs of adverse reactions or side effects to their healthcare provider promptly. Additionally, patients should be educated on the importance of proper hydration to prevent kidney damage while using tobramycin.
