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Gentamicin 80 mg/2 mL Injection

NAFDAC Reg. No. C4-1263 · Drug

Registered with NAFDAC. Registration activeAs of 28 October 2026 · synced automatically from official sources.
Product
Gentamicin 80 mg/2 mL Injection
NAFDAC number
C4-1263
Active ingredient
Gentamicin (Gentamicin Sulfate)
Strength
80 mg/2 mL
Form
Solution for injection
Pack size
1 x 2 mL ampoule
Manufacturer
Not listed
Applicant (holder)
IDA Foundation
Approved
30 Nov 2020
Status
Inactive View on NAFDAC ↗
Registration valid to
29 Nov 2025
WHO alerts
None found
Community reports
None
Times checked
0

What we found

  • Gentamicin 80 mg/2 mL Injection is on the NAFDAC register with an active registration (C4-1263). A valid number alone does not prove a pack is genuine — counterfeiters copy real numbers, so also check the expiry date, seal and print quality.

Generated automatically from the NAFDAC register, WHO alerts and community data as of today. This is not medical advice. Always follow your doctor or pharmacist.

What Gentamicin 80 mg/2 mL Injection is used for

From the official U.S. FDA label for gentamicin (gentamicin sulfate), the active ingredient registered with NAFDAC.

Boxed warning: S Patients treated with aminoglycosides should be under close clinical observation because of the potential toxicity associated with their use. As with other aminoglycosides, gentamicin injection is potentially nephrotoxic. The risk of nephrotoxicity is greater in patients with impaired renal function and in those who receive high dosage of prolonged therapy. …
What it is used for

To reduce the development of drug-resistant bacteria and maintain the effectiveness of gentamicin injection and other antibacterial drugs, gentamicin injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. …

Possible side effects

To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Nephrotoxicity Adverse renal effects, as demonstrated by the presence of casts, cells or protein in the urine or by rising BUN, NPN, serum creatinine or oliguria, have been reported. They occur more frequently in patients with a history of renal impairment (especially if dialysis is required) and in patients treated for longer periods or with larger doses than recommended. …

Do not use if

Hypersensitivity to gentamicin is a contraindication to its use. A history of hypersensitivity or serious toxic reactions to other aminoglycosides may contraindicate use of gentamicin because of the known cross-sensitivity of patients to drugs in this class.

Warnings

(See BOXED WARNINGS .) Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people. Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycoside antibiotics cross the placenta, and there have been several reports of total irreversible bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. …

Pregnancy & breastfeeding

Pregnancy See WARNINGS section.

General information only, not dosing advice. Always follow the leaflet in your pack and your doctor or pharmacist.

Check your pack of Gentamicin 80 mg/2 mL Injection

Add the expiry date on your pack for a full Trust Score.

3 free checks left today Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About Gentamicin 80 mg/2 mL Injection

What is in Gentamicin 80 mg/2 mL Injection?

Gentamicin 80 mg/2 mL Injection contains Gentamicin (Gentamicin Sulfate) (80 mg/2 mL), as solution for injection, according to its NAFDAC registration record.

Is Gentamicin 80 mg/2 mL Injection registered with NAFDAC?

Yes. Gentamicin 80 mg/2 mL Injection is listed on the NAFDAC register under registration number C4-1263, and its registration is active as of 28 October 2026.

Has Gentamicin 80 mg/2 mL Injection been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Gentamicin 80 mg/2 mL Injection in our automatically synced alert list.

How can I check that my pack of Gentamicin 80 mg/2 mL Injection is genuine?

Run a free authenticity scan with the NAFDAC number C4-1263, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.

What is Gentamicin 80 mg/2 mL Injection used for?

To reduce the development of drug-resistant bacteria and maintain the effectiveness of gentamicin injection and other antibacterial drugs, gentamicin injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying an (Summarised from the official U.S. FDA label for gentamicin (gentamicin sulfate). Always follow your doctor or pharmacist.)

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