Finished product reference · In the Hanpars portfolio

Vancomycin

Capsule, Liquid Filled · Oral · 250 mg

List code
1702
Salt form
Hydrochloride

What it is and how it works

Mechanism of Action Vancomycin is an antibacterial drug .

Indications

Vancomycin Hydrochloride for Injection is a glycopeptide antibacterial indicated in adult and pediatric patients (neonates and older) for the treatment of: • Septicemia • Infective Endocarditis • Skin and Skin Structure Infections • Bone Infections • Lower Respiratory Tract Infections To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection and other antibacterial drugs, Vancomycin Hydrochloride for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Septicemia Vancomycin Hydrochloride for Injection is indicated in adults and pediatric patients (neonates and older) for the treatment of septicemia due to: • Susceptible isolates of methicillin-resistant Staphylococcus aureus (MRSA) and coagulase negative staphylococci. • Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins.

Dosage and administration (summary)

• Administer Vancomycin Hydrochloride for Injection in a diluted solution over 60 minutes or greater to reduce the risk of infusion reactions. • See full prescribing information for further important administration and preparation instructions ( 2.1 , 2.5 ) • Adult Patients: 2 g divided either as 0.5 grams (g) every 6 hours or 1 g every 12 hours • Pediatric Patients (1 month and older): 10 mg/kg per dose given every 6 hours • Neonates: See full prescribing information for recommended doses in neonates • Patients with renal impairment: See full prescribing information for recommended doses in patients with renal impairment Important Administration Instructions To reduce the risk of infusion r…

Contraindications

Vancomycin Hydrochloride for Injection is contraindicated in patients with known hypersensitivity to vancomycin. Hypersensitivity to vancomycin

Warnings and precautions

• Infusion Reactions: Hypotension, including shock and cardiac arrest, wheezing, dyspnea, urticaria, muscular, chest pain and “vancomycin infusion reaction” which manifests as pruritus and erythema that involves the face, neck and upper torso may occur with rapid intravenous administration. To reduce the risk of infusion reactions, administer Vancomycin Hydrochloride for Injection in a diluted solution over a period of 60 minutes or greater and also prior to intravenous anesthetic agents.

Pregnancy

Pregnancy Risk Summary There are no available data on vancomycin use in pregnant women to inform a drug associated risk of major birth defects or miscarriage. Available published data on vancomycin use in pregnancy during the second and third trimesters have not shown an association with adverse pregnancy related outcomes (see Data ).

Storage and supply

Vancomycin Hydrochloride for Injection, USP is a sterile lyophilized powder for injection supplied as an off-white to light tan colored powder or plug in single-dose flip top vials that contain vancomycin hydrochloride, USP equivalent to 750 mg, 1.25 g, or 1.5 g of vancomycin base.

Source: Vancomycin Hydrochloride (Vancomycin Hydrochloride) — US FDA prescribing information, 2025-12-23, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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