Amoxycillin + Cloxacillin Injection

Description

Product Description: Amoxicillin + Cloxacillin Injection is a combination antibiotic formulation containing two active ingredients, amoxicillin and cloxacillin. It is indicated for the treatment of bacterial infections caused by susceptible organisms.

Indications and Usage: Amoxicillin + Cloxacillin Injection is indicated for the treatment of infections caused by susceptible strains of bacteria. These infections may include respiratory tract infections, skin and soft tissue infections, urinary tract infections, and others caused by susceptible organisms.

Dosage and Administration: The dosage and administration of Amoxicillin + Cloxacillin Injection depend on the severity of the infection, the patient's weight, and renal function. It is typically administered intravenously or intramuscularly at a dose determined by the prescribing healthcare provider based on the specific infection being treated.

Dosage Forms and Strengths: Amoxicillin + Cloxacillin Injection is available as a sterile solution in vials containing a fixed ratio of amoxicillin to cloxacillin, typically in strengths such as 500 mg/500 mg per vial or 1 gram/1 gram per vial.

Contraindications: Amoxicillin + Cloxacillin Injection is contraindicated in patients with a known hypersensitivity to penicillins or any component of the formulation. It should not be used in patients with a history of severe allergic reactions to penicillins or cephalosporins.

Warnings and Precautions:

• Patients with a history of allergic reactions to penicillins or cephalosporins may be at increased risk of hypersensitivity reactions to Amoxicillin + Cloxacillin Injection. Use caution and monitor patients closely for signs of allergic reactions.
• Prolonged use of antibiotics may result in the overgrowth of nonsusceptible organisms, including fungi. Monitor patients for signs of superinfection during therapy.
• Use caution in patients with renal impairment, as dosage adjustment may be necessary.

Adverse Reactions/Side Effects: Common adverse reactions associated with Amoxicillin + Cloxacillin Injection include gastrointestinal disturbances such as nausea, vomiting, and diarrhea. Hypersensitivity reactions, including rash, pruritus, and urticaria, may also occur.

Drug Interactions: Amoxicillin + Cloxacillin Injection may interact with other medications, including oral contraceptives and anticoagulants. Use caution when administering concomitant medications and monitor for potential drug interactions.

Use In Specific Populations Description: Safety and efficacy of Amoxicillin + Cloxacillin Injection in pediatric patients, pregnant women, and nursing mothers have not been established. Use in these populations should be carefully considered, and the potential risks and benefits should be weighed.

Clinical Pharmacology: Amoxicillin and cloxacillin are both beta-lactam antibiotics that inhibit bacterial cell wall synthesis. They exhibit a broad spectrum of activity against gram-positive and gram-negative bacteria.

Nonclinical Toxicology: Animal studies have shown evidence of dose-related toxicity with both amoxicillin and cloxacillin. However, these effects are typically not observed at therapeutic doses in humans.

Clinical Studies: Clinical studies have demonstrated the efficacy of Amoxicillin + Cloxacillin Injection in the treatment of various bacterial infections, including respiratory tract infections, skin and soft tissue infections, and urinary tract infections.

References:

1. Amoxicillin + Cloxacillin Injection Prescribing Information.
2. Clinical Pharmacology of Amoxicillin + Cloxacillin Injection.
3. Clinical Studies on the Efficacy of Amoxicillin + Cloxacillin Injection.

How Supplied/Storage and Handling: Amoxicillin + Cloxacillin Injection is supplied as a sterile solution in single-dose vials. It should be stored at controlled room temperature (20°C to 25°C) and protected from light. Reconstituted solutions should be used within the recommended time frame and stored according to instructions.

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 during treatment.