Vancomycin Hydrochloride 5 g/1
Vancomycin Hydrochloride · INJECTION, POWDER, FOR SOLUTION · Hikma Pharmaceuticals USA Inc.
Vancomycin Hydrochloride is a injection, powder, for solution containing vancomycin hydrochloride at 5 g/1, taken intravenous. Manufactured by Hikma Pharmaceuticals USA Inc..
Key Facts
- Brand Name
- Vancomycin Hydrochloride
- Generic Name
- Vancomycin Hydrochloride
- NDC Code (Product)
0143-9358- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Strength
- 5 g/1
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA204360
- Marketing Start
- 10/15/2018
Recall History
Actavis Inc
Subpotent Drug.
AuroMedics Pharma LLC
Discoloration: Product complaints of discoloration after reconstitution of vials.
Pfizer Inc.
Presence of Particulate Matter: glass particulate found in vial
Actavis Inc
Subpotent Drug
Azurity Pharmaceuticals, Inc.
Product Mix-up: Incorrect diluent component included in the kit.
Actavis Inc
Subpotent Drug
Pfizer Inc.
Presence of Particulate Matter: Glass particulate matter detected in injectable.
Hospira Inc.
Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another product.
Actavis Inc
Subpotent Drug
Hospira Inc.
Presence of Particulate Matter: Cardboard
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin Hydrochloride for Injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin Hydrochloride for Injection, USP has been re…
Dosage & Administration
DOSAGE AND ADMINISTRATION Infusion-related events are related to both the concentration and the rate of administration of vancomycin. Concentrations of no more than 5 mg/mL and rates of no more than 10 mg/min, are recommended in adults (see also age-specific recommendations). In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be used; use of such higher concentrations may increase the risk of infusion-related events. An infusion rate of 10 mg/min or less is associated with fewer infusion-related events (see ADVERSE REACTIONS ). Infusion-related events may occur, however, at any rate or concentration. Patients with Normal Renal Function Adults The usual daily intravenous dose is 2 g divided either as 500 mg every 6 hours or 1 g every 12 hours. Each dose should be administered at no more than 10 mg/min or over a period of at least 60 minutes, whichever is longer. Other patient factors, such as age or obesity, may call for modification of the usual intravenous daily dose. Pediatric patients The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every 6 hours. Each dose should be administered over a period of at least 60 minutes. Close …
Warnings
WARNINGS Infusion Reactions Rapid bolus administration (e.g., over several minutes) may be associated with exaggerated hypotension, including shock and rarely cardiac arrest. Vancomycin hydrochloride for injection should be administered in a diluted solution over a period of not less than 60 minutes to avoid rapid-infusion-related reactions. Stopping the infusion usually results in prompt cessation of these reactions. Nephrotoxicity Systemic vancomycin exposure may result in acute kidney injury (AKI). The risk of AKI increases as systemic exposure/serum levels increase. Monitor renal function in all patients, especially patients with underlying renal impairment, patients with co-morbidities that predispose to renal impairment, and patients receiving concomitant therapy with a drug known to be nephrotoxic. Ototoxicity Ototoxicity has occurred in patients receiving vancomycin hydrochloride for injection. It may be transient or permanent. It has been reported mostly in patients who have been given excessive doses, who have an underlying hearing loss, or who are receiving concomitant therapy with another ototoxic agent, such as an aminoglycoside. Vancomycin should be used with caution …
Contraindications
CONTRAINDICATIONS Vancomycin hydrochloride for injection is contraindicated in patients with known hypersensitivity to this antibiotic.
Drug Interactions
Drug Interactions Concomitant administration of vancomycin and anesthetic agents has been associated with erythema and histamine-like flushing (see Pediatric Use, PRECAUTIONS ) and anaphylactoid reactions (see ADVERSE REACTIONS ). Monitor renal function in patients receiving vancomycin and concurrent and/or sequential systemic or topical use of other potentially, neurotoxic and/or nephrotoxic drugs, such as amphotericin B, aminoglycosides, bacitracin, polymyxin B, colistin, viomycin, or cisplatin.
Adverse Reactions
ADVERSE REACTIONS Infusion-Related Events During or soon after rapid infusion of vancomycin hydrochloride for injection, patients may develop anaphylactoid reactions, including hypotension (see ANIMAL PHARMACOLOGY ), wheezing, dyspnea, urticaria, or pruritus. Rapid infusion may also cause flushing of the upper body (“red neck”) or pain and muscle spasm of the chest and back. These reactions usually resolve within 20 minutes but may persist for several hours. Such events are infrequent if vancomycin hydrochloride for injection is given by a slow infusion over 60 minutes. In studies of normal volunteers, infusion-related events did not occur when vancomycin hydrochloride for injection was administered at a rate of 10 mg/min or less. Nephrotoxicity Systemic vancomycin exposure may result in acute kidney injury (AKI). The risk of AKI increases as systemic exposure/serum levels increase. Additional risk factors for AKI in patients receiving vancomycin include receipt of concomitant drugs known to be nephrotoxic, in patients with pre-existing renal impairment, or with co-morbidities that predispose to renal impairment. Interstitial nephritis has also been reported in patients receiving v…
Frequently Asked Questions
What is Vancomycin Hydrochloride used for?
Vancomycin Hydrochloride contains Vancomycin Hydrochloride. It is a injection, powder, for solution taken intravenous. Consult your doctor for specific uses.
Is Vancomycin Hydrochloride a controlled substance?
Vancomycin Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Vancomycin Hydrochloride?
The generic name for Vancomycin Hydrochloride is Vancomycin Hydrochloride. There are 3 other brand versions of Vancomycin Hydrochloride.
What is the NDC code for Vancomycin Hydrochloride 5 g/1?
The NDC (National Drug Code) for Vancomycin Hydrochloride 5 g/1 is 0143-9358, listed by Hikma Pharmaceuticals USA Inc..
Other Vancomycin Hydrochloride Dosages
- Vancomycin Hydrochloride1 g/172572-029
- Vancomycin Hydrochloride1.5 g/30mL82449-007
- Vancomycin Hydrochloride1.5 g/139822-0470
- Vancomycin Hydrochloride100 g/166288-7100
- Vancomycin Hydrochloride10 g/100mL67457-342
- Vancomycin Hydrochloride10 g/168001-407
- Vancomycin Hydrochloride1.5 g/168083-597
- Vancomycin Hydrochloride1 g/170594-123
Other Vancomycin Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)