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Tobradex Eye Drop

NAFDAC Reg. No. B4-3477 · Drug

Registered with NAFDAC. Registration activeAs of 30 October 2026 · synced automatically from official sources.
Product
Tobradex Eye Drop
رقم NAFDAC
B4-3477
المادة الفعالة
Dexamethasone (Dexamethasone Sodium Phosphate); Tobramycin
التركيز
0.1%; 0.3%
الشكل
Suspension/Drops
حجم العبوة
1 x 5 mL
Manufacturer
Not listed
Applicant (holder)
Novartis Nigeria Limited
Approved
2 Dec 2021
الحالة
Active View on NAFDAC ↗
التسجيل ساري حتى
1 Dec 2026
تنبيهات منظمة الصحة العالمية
None found
Community reports
None
Times checked
0

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

What we found

  • Tobradex Eye Drop is on the NAFDAC register with an active registration (B4-3477). 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 Tobradex Eye Drop

ما تقوله النشرة الرسمية. إذا وصفه لك طبيب، فاتبع الوصفة. وإذا اختلفت نشرة عبوتك، فالأولوية لها.

لمن هو

A l l ergic States: Control of severe or incapacitating a llergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Dermatologic Diseases: Bul l ous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). …

كيف يُتناول وكم مرة
  • For Oral Administration The initial dosage varies from 0.75 to 9 mg a day depending on the disease being treated
  • It Should Be Emphasized That Dosage Requirements Are Variable And Must Be Individualized On The Basis Of The Disease Under Treatment And The Response Of The Patient
  • After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage that maintains an adequate clinical response is reached
  • Situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment
  • In this latter situation it may be necessary to increase the dosage of the corticosteroid for a period of time consistent with the patient's condition
  • If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly
  • In the treatment of acute exacerbations of multiple sclerosis, daily doses of 30 mg of dexamethasone for a week followed by 4 to 12 mg every other day for one month have been shown to be effective (see PRECAUTIONS : Neuro-Psychiatric )
  • In pediatric patients, the initial dose of dexamethasone may vary depending on the specific disease entity being treated
  • The range of initial doses is 0.02 to 0.3 mg/kg/day in three or four divided doses (0.6 to 9 mg/m2bsa/day). …
Children
  • The efficacy and safety of corticosteroids in the pediatric population are based on the we l -established course of effect of corticosteroids, which is similar
  • In pediatric and adult populations
  • Published studies provide evidence of efficacy and safety
  • In pediatric patients
  • For the treatment of nephrotic syndrome (patients >2 years of age), and aggressive lymphomas and leukemias (patients >1 month of age). …
Older adults

Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. …

While you are taking it
  • Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision
  • As prolonged use may cause adrenal insufficiency and make patients dependent on corticosteroids, they should advise any medical attendants that they are taking corticosteroids and they should seek medical advice at once should they develop an acute illness including fever or other signs of infection
  • Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including, myalgia, arthralgia, and malaise
  • Persons who are on corticosteroids should be warned to avoid exposure to chickenpox or measles. …
Talk to a doctor first if

Contraindicated in systemic fungal infections (see WARNINGS : Infections: Fungal Infections ) and patients with known hypersensitivity to the product and its consituents.

Medicines it may not mix with

Drug Interactio ns Aminoglutethimide: Aminoglutethimide may diminish adrenal suppression by corticosteroids. Amphotericin B injection and potassium-depleting agents: When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure. …

Warnings

General Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS ). Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy subjected to any unusual stress before, during, and after the stressful situation. Cardio-Renal Average and large doses of corticosteroids can cause elevation of blood pressure, sodium and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. …

الآثار الجانبية المحتملة

(listed alphabetica ll y, under each subsection) The following adverse reactions have been reported with dexamethasone or other corticosteroids: A ll ergic Reactions: Anaphylactoid reaction, anaphylaxis, angioedema. Cardiovascular: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory co l apse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction (see WARNINGS: Cardio-Renal ), edema, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis. …

Pregnancy and breastfeeding

Pregnancy Teratogenic Effects: Pregnancy Category C. Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. …

إذا نسيت جرعة

تناولها عندما تتذكر، إلا إذا اقترب موعد الجرعة التالية. عندها تخطَّ الجرعة المنسية. لا تتناول جرعتين معًا أبدًا للتعويض. راجع النشرة، فبعض الأدوية مختلفة.

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 2025-10-29.

Label for dexamethasone (dexamethasone sodium phosphate) and tobramycin, the active ingredient registered with NAFDAC.

Check your pack of Tobradex Eye Drop

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

أو التقط صورًا للعبوة
تبقّت 3 عمليات تحقق مجانية اليوم المصادر الرسمية: FDA الأمريكية · EMA (الاتحاد الأوروبي) · NAFDAC · تنبيهات منظمة الصحة العالمية

About Tobradex Eye Drop

What is in Tobradex Eye Drop?

Tobradex Eye Drop contains Dexamethasone (Dexamethasone Sodium Phosphate); Tobramycin (0.1%; 0.3%), as suspension/drops, according to its NAFDAC registration record.

Is Tobradex Eye Drop registered with NAFDAC?

Yes. Tobradex Eye Drop is listed on the NAFDAC register under registration number B4-3477, and its registration is active as of 30 October 2026.

Has Tobradex Eye Drop been flagged as fake or recalled?

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

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

Run a free authenticity scan with the NAFDAC number B4-3477, 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 Tobradex Eye Drop?

Follow your prescription or the leaflet in your pack. The official label says: For Oral Administration The initial dosage varies from 0.75 to 9 mg a day depending on the disease being treated. It Should Be Emphasized That Dosage Requirements Are Variable And Must Be Individualized On The Basis Of The Disease Under Treatment And The Response Of The Patient. After a favorable response is noted, the proper maintenance dosage should be determined by decreasin…

What is Tobradex Eye Drop used for?

A l l ergic States: Control of severe or incapacitating a llergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Dermatologic Diseases: Bul l ous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and sev (Summarised from the official U.S. FDA label for dexamethasone (dexamethasone sodium phosphate) and tobramycin. Always follow your doctor or pharmacist.)

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