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Tobrex Eye Drop

NAFDAC Reg. No. 04-1488 · Drug

Registered with NAFDAC. Registration activeAs of 31 October 2026 · synced automatically from official sources.
Product
Tobrex Eye Drop
NAFDAC number
04-1488
Active ingredient
Tobramycin
Strength
0.3%
Form
Eye drops
Pack size
1 x 5 mL
Manufacturer
Not listed
Applicant (holder)
Novartis Nigeria Limited
Approved
26 Aug 2021
Status
Inactive View on NAFDAC ↗
Registration valid to
25 Aug 2026
WHO alerts
None found
Community reports
None
Times checked
0

About the medicine: Tobramycin: uses, dosage and brands worldwide

What we found

  • Tobrex Eye Drop is on the NAFDAC register with an active registration (04-1488). 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.

How to use Tobrex Eye Drop

What the official label says. If a doctor prescribed it, follow the prescription. Your pack's leaflet comes first if it is different.

Serious warning: Patients treated with Tobramycin Injection and other aminoglycosides should be under close clinical observation, because these drugs have an inherent potential for causing ototoxicity and nephrotoxicity. Neurotoxicity, manifested as both auditory and vestibular ototoxicity, can occur. The auditory changes are irreversible, are usually bilateral, and may be partial or total. …
Who it is for

Tobramycin injection is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below: Septicemia in the neonate, child, and adult caused by P. aeruginosa , E. coli , and Klebsiella sp Lower respiratory tract infections caused by P. aeruginosa , Klebsiella sp, Enterobacter sp, Serratia sp, E. coli , and S. aureus (penicillinase- and non-penicillinase-producing strains) Serious central-nervous-system infections (meningitis) caused by susceptible organisms Intra-abdominal infections, including peritonitis, caused by E. coli , Klebsiella sp, and Enterobacter sp. …

How to take it and how often
  • Tobramycin may be given intramuscularly or intravenously
  • Recommended dosages are the same for both routes
  • This insert is for a Pharmacy Bulk Package and is intended for preparing I.V. admixtures only
  • Dosage recommendations for intramuscular use are for informational purposes only
  • The patient’s pretreatment body weight should be obtained for calculation of correct dosage
  • It is desirable to measure both peak and trough serum concentrations (see WARNINGS box and PRECAUTIONS )
  • Administration for Patients with Normal Renal Function— Adults with Serious Infections : 3 mg/kg/day in 3 equal doses every 8 hours (see Table 3)
  • Adults with Life-Threatening Infections : Up to 5 mg/kg/day may be administered in 3 or 4 equal doses (see Table 3)
  • The dosage should be reduced to 3 mg/kg/day as soon as clinically indicated
  • To prevent increased toxicity due to excessive blood levels, dosage should not exceed 5 mg/kg/day unless serum levels are monitored (see WARNINGS box and PRECAUTIONS ). …
Talk to a doctor first if
  • A hypersensitivity to any aminoglycoside is a contraindication to the use of tobramycin
  • A history of hypersensitivity or serious toxic reactions to aminoglycosides may also contraindicate the use of any other aminoglycoside because of the known cross-sensitivity of patients to drugs in this class
Warnings

See WARNINGS box above. This product 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. Serious allergic reactions including anaphylaxis and dermatologic reactions including exfoliative dermatitis, toxic epidermal necrolysis, erythema multiforme, and Stevens-Johnson Syndrome have been reported rarely in patients on tobramycin therapy. …

Possible side effects

Neurotoxicity — Adverse effects on both the vestibular and auditory branches of the eighth nerve have been noted, especially in patients receiving high doses or prolonged therapy, in those given previous courses of therapy with an ototoxin, and in cases of dehydration. Symptoms include dizziness, vertigo, tinnitus, roaring in the ears, and hearing loss. Hearing loss is usually irreversible and is manifested initially by diminution of high-tone acuity. Tobramycin and gentamicin sulfates closely parallel each other in regard to ototoxic potential. …

If you take too much

Signs and Symptoms— The severity of the signs and symptoms following a tobramycin overdose are dependent on the dose administered, the patient’s renal function, state of hydration, and age and whether or not other medications with similar toxicities are being administered concurrently. Toxicity may occur in patients treated more than 10 days, in adults given more than 5 mg/kg/day, children given more than 7.5 mg/kg/day, or patients with reduced renal function whose dose has not been appropriately adjusted. …

If you miss a dose

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.

From the official U.S. FDA label for this active ingredient. Your pack may have a different strength, so always read its leaflet. If a doctor prescribed it, follow the prescription. Ask a pharmacist if you are unsure. Label dated 2023-02-27.

Label for tobramycin, the active ingredient registered with NAFDAC.

Check your pack of Tobrex Eye Drop

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

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3 free checks left today Official sources: U.S. FDA · EMA (EU) · NAFDAC · WHO alerts

About Tobrex Eye Drop

What is in Tobrex Eye Drop?

Tobrex Eye Drop contains Tobramycin (0.3%), as eye drops, according to its NAFDAC registration record.

Is Tobrex Eye Drop registered with NAFDAC?

Yes. Tobrex Eye Drop is listed on the NAFDAC register under registration number 04-1488, and its registration is active as of 31 October 2026.

Has Tobrex Eye Drop been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Tobrex Eye Drop in our automatically synced alert list.

How can I check that my pack of Tobrex Eye Drop is genuine?

Run a free authenticity scan with the NAFDAC number 04-1488, 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.

How do I take Tobrex Eye Drop?

Follow your prescription or the leaflet in your pack. The official label says: Tobramycin may be given intramuscularly or intravenously. Recommended dosages are the same for both routes. This insert is for a Pharmacy Bulk Package and is intended for preparing I.V. admixtures only. Dosage recommendations for intramuscular use are for informational purposes only. The patient’s pretreatment body weight should be obtained for calculation of correct dosage. It…

What is Tobrex Eye Drop used for?

Tobramycin injection is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below: Septicemia in the neonate, child, and adult caused by P. aeruginosa , E. coli , and Klebsiella sp Lower respiratory tract infections caused by P. aeruginosa , Klebsiella sp, Enterobacter sp, Serratia sp, E. coli , and S. au (Summarised from the official U.S. FDA label for tobramycin. Always follow your doctor or pharmacist.)

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