Esafosfina 10 gr. vial

Description

Esafosfina 10 gr. vial is a medical solution mainly used as an adjunctive therapy in the treatment of certain medical conditions. This document is intended to provide comprehensive information about this medication, including its composition, indications, contraindications, side effects, and dosing instructions, among other details.

Esafosfina 10 gr. vial Solution

Composition

Each vial of Esafosfina contains 10 grams of the active ingredient, Sodium fosfomycin. This white crystalline powder, soluble in water, is the main component of the solution. Other inactive ingredients in the solution include water for injection and sodium hydroxide or hydrochloric acid for pH adjustment.

Pharmaceutical Form

Esafosfina 10 gr. vial is a white to off-white sterile powder for solution for injection or infusion. It is available in a vial of 10 grams, which when dissolved in water, constitutes a clear, colorless to pale yellow solution.

Clinical Particulars

Therapeutic Indications

Esafosfina is used as an adjunctive therapy in the treatment of certain types of bacterial infections. These include complicated urinary tract infections (UTIs), including pyelonephritis and acute cystitis, skin and soft tissue infections, lower respiratory tract infections, and intra-abdominal infections. Esafosfina is also used for the prophylaxis of post-operative infections.

Contraindications

Esafosfina is contraindicated in patients with known hypersensitivity to fosfomycin or any other components of the formulation. It is also contraindicated in patients with severe renal impairment.

Special Warnings and Precautions for Use

Esafosfina should be used with caution in patients with a history of seizures, as it may increase the risk of seizure occurrence. It should also be used with care in patients with renal impairment, as the drug is eliminated by the kidneys and dosage adjustment may be required. Regular monitoring of renal function is necessary in these patients.

Interactions with Other Medicaments and Other Forms of Interaction

Esafosfina may interact with certain other drugs, affecting their effectiveness or causing adverse effects. These include metoclopramide, which may decrease the absorption of Esafosfina, and certain antiviral drugs, which may increase the risk of Esafosfina-induced toxicity.

Pregnancy and Lactation

Esafosfina should only be used during pregnancy if the potential benefit outweighs the potential risk to the fetus. It should be used with caution in breastfeeding women, as it is not known whether Esafosfina is excreted into breast milk.

Effects on Ability to Drive and Use Machines

Esafosfina may cause dizziness and confusion, affecting the ability to drive or operate machinery. Patients experiencing these effects should avoid such activities until they feel well enough to perform them safely.

Undesirable Effects

Common side effects of Esafosfina include nausea, vomiting, diarrhea, rash, and fever. Less common side effects may include dizziness, confusion, headache, and increased liver enzymes. Severe side effects, though rare, may include seizures, severe allergic reactions, and severe diarrhea caused by Clostridium difficile.

Pharmacological Properties

Pharmacodynamic Properties

Esafosfina, a broad-spectrum antibiotic, works by inhibiting the synthesis of the bacterial cell wall, leading to bacterial cell death. It is bactericidal against a wide range of gram-positive and gram-negative bacteria.

Pharmacokinetic Properties

After intravenous administration, Esafosfina is rapidly distributed throughout the body. It is primarily excreted unchanged in the urine, with a half-life of approximately 2 to 3 hours.

Pharmaceutical Particulars

Instructions for Use/Handling

Esafosfina should be reconstituted with sterile water for injection. The solution should be used immediately after preparation. Any unused solution should be discarded.

Storage Conditions

Esafosfina should be stored at room temperature, away from light and moisture. The reconstituted solution should be used immediately and should not be stored for later use.