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Betoptic Eye Drop

NAFDAC Reg. No. 04-1568 · Drug

Registered with NAFDAC — registration activeAs of 5 November 2026 · synced automatically from official sources.
Product
Betoptic Eye Drop
NAFDAC number
04-1568
Active ingredient
Betaxolol (Betaxolol Hydrochloride)
Strength
0.5%
Form
Solution/Drops
Pack size
1 x 5 mL (in LDPE bottle)
Manufacturer
Not listed
Applicant (holder)
Novartis Nigeria Limited
Approved
28 Mar 2023
Status
Active View on NAFDAC ↗
Registration valid to
27 Mar 2028
WHO alerts
None found
Community reports
None
Times checked
0

RxVerify commentary

  • Betoptic Eye Drop is on the NAFDAC register with an active registration (04-1568). 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. Not medical advice — always follow your doctor or pharmacist.

What Betoptic Eye Drop is used for

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

What it is used for

Betaxolol is indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly thiazide-type diuretics.

Possible side effects

Most adverse reactions have been mild and transient and are typical of beta-adrenergic blocking agents, eg, bradycardia, fatigue, dyspnea, and lethargy. Withdrawal of therapy in U.S. and European controlled clinical trials has been necessary in about 3.5% of patients, principally because of bradycardia, fatigue, dizziness, headache, and impotence. Frequency estimates of adverse events were derived from controlled studies in which adverse reactions were volunteered and elicited in U.S. studies and volunteered and/or elicited in European studies. …

Do not use if

Betaxolol is contraindicated in patients with known hypersensitivity to the drug. Betaxolol is contraindicated in patients with sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure. (see Warnings ).

Warnings

Cardiac Failure Sympathetic stimulation may be a vital component supporting circulatory function in congestive heart failure, and beta-adrenergic receptor blockade carries the potential hazard of further depressing myocardial contractility and precipitating more severe heart failure. In hypertensive patients who have congestive heart failure controlled by digitalis and diuretics, beta-blockers should be administered cautiously. Both digitalis and beta-adrenergic receptor blocking agents slow AV conduction. In Patients Without a History of Cardiac Failure Continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure. …

Pregnancy & breastfeeding

Pregnancy Pregnancy Category C In a study in which pregnant rats received betaxolol at doses of 4, 40, or 400 mg/kg/day, the highest dose (600 × MRHD) was associated with increased postimplantation loss, reduced litter size and weight, and an increased incidence of skeletal and visceral abnormalities, which may have been a consequence of drug-related maternal toxicity. …

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

Check your pack of Betoptic Eye Drop

Add the expiry date printed on your pack for a full Trust Score — or look up uses, side effects and cheaper generics.

3 free checks left today · no signup Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About Betoptic Eye Drop

What is in Betoptic Eye Drop?

Betoptic Eye Drop contains Betaxolol (Betaxolol Hydrochloride) (0.5%), as solution/drops, according to its NAFDAC registration record.

Is Betoptic Eye Drop registered with NAFDAC?

Yes. Betoptic Eye Drop is listed on the NAFDAC register under registration number 04-1568, and its registration is active as of 5 November 2026.

Has Betoptic Eye Drop been flagged as fake or recalled?

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

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

Run a free authenticity scan with the NAFDAC number 04-1568, 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 Betoptic Eye Drop used for?

Betaxolol is indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly thiazide-type diuretics. (Summarised from the official U.S. FDA label for betaxolol (betaxolol hydrochloride). Always follow your doctor or pharmacist.)

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