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Atropine Eye Drops

NAFDAC Reg. No. 04-3886 · Drug

Registered with NAFDAC. Registration activeAs of 28 October 2026 · synced automatically from official sources.
Product
Atropine Eye Drops
NAFDAC number
04-3886
Active ingredient
Atropine Sulfate
Strength
1%
Form
Solution/Drops
Pack size
1 x 10 mL (in LDPE bottle)
Manufacturer
Not listed
Applicant (holder)
Lin-Kabs Pharmaceutical Limited
Approved
28 Sep 2021
Status
Inactive View on NAFDAC ↗
Registration valid to
27 Sep 2026
WHO alerts
None found
Community reports
None
Times checked
0

What we found

  • Atropine Eye Drops is on the NAFDAC register with an active registration (04-3886). 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 Atropine Eye Drops

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

Who it is for

Atropine Sulfate Injection, USP, is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest.

How to take it and how often
  • General Administration Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit
  • Do not administer unless solution is clear and seal is intact
  • Each vial is intended for single dose only
  • Discard unused portion
  • For Intravenous administration
  • Titrate based on heart rate, PR interval, blood pressure and symptoms
  • Adult Dosage Pediatric Dosage Dosing
  • In pediatric populations has not been well studied
  • Usual initial dose is 0.01 to 0.03 mg/kg
  • Dosing in Patients with Coronary Artery Disease Limit the total dose of atropine sulfate to 0.03 to 0.04 mg/kg [see WARNINGS AND PRECAUTIONS ]
  • DOSAGE
Strengths it comes in

3 DOSAGE FORM & STRENGTH Injection: supplied as a clear, colorless solution in a 1 mL glass vial in the following concentrations: 0.4 mg/mL: containing 0.4 mg of atropine sulfate monohydrate equivalent to 0.332 mg of atropine. 1 mg/mL: containing 1 mg atropine sulfate monohydrate equivalent to 0.83 mg of atropine.

Talk to a doctor first if

None.

Medicines it may not mix with

7.1 Mexiletine Atropine Sulfate Injection decreased the rate of mexiletine absorption without altering the relative oral bioavailability; this delay in mexiletine absorption was reversed by the combination of atropine and intravenous metoclopramide during pretreatment for anesthesia.

Warnings

5.1 Tachycardia When the recurrent use of atropine is essential in patients with coronary artery disease, the total dose should be restricted to 2 to 3 mg (maximum 0.03 to 0.04 mg/kg) to avoid the detrimental effects of atropine-induced tachycardia on myocardial oxygen demand. 5.2 Acute Glaucoma Atropine may precipitate acute glaucoma. 5.3 Pyloric Obstruction Atropine may convert partial organic pyloric stenosis into complete obstruction. 5.4 Complete Urinary Retention Atropine may lead to complete urinary retention in patients with prostatic hypertrophy. …

Possible side effects

The following adverse reactions have been identified during post-approval use of atropine sulfate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Most of the side effects of atropine are directly related to its antimuscarinic action. Dryness of the mouth, blurred vision, photophobia and tachycardia commonly occur. Anhidrosis can produce heat intolerance. Constipation and difficulty in micturition may occur in elderly patients. …

Pregnancy and breastfeeding

IN SPECIFIC POPULATION 8.1 Pregnancy Pregnancy Risk Summary There are risks to the mother and fetus associated with untreated severe or life-threatening muscarinic events (see Clinical Considerations). Available data from published observational studies on atropine use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). …

If you take too much

Excessive dosing may cause palpitation, dilated pupils, difficulty in swallowing, hot dry skin, thirst, dizziness, restlessness, tremor, fatigue and ataxia. Toxic doses lead to restlessness and excitement, hallucinations, delirium and coma. Depression and circulatory collapse occur only with severe intoxication. In such cases, blood pressure declines and death due to respiratory failure may ensue following paralysis and coma. The fatal adult dose of atropine is not known. In pediatric populations, 10 mg or less may be fatal. …

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 2024-01-28.

Label for atropine sulfate, the active ingredient registered with NAFDAC.

Check your pack of Atropine Eye Drops

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

3 free checks left today Official sources: NAFDAC · WHO · U.S. FDA · Health Canada · NLM

About Atropine Eye Drops

What is in Atropine Eye Drops?

Atropine Eye Drops contains Atropine Sulfate (1%), as solution/drops, according to its NAFDAC registration record.

Is Atropine Eye Drops registered with NAFDAC?

Yes. Atropine Eye Drops is listed on the NAFDAC register under registration number 04-3886, and its registration is active as of 28 October 2026.

Has Atropine Eye Drops been flagged as fake or recalled?

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

How can I check that my pack of Atropine Eye Drops is genuine?

Run a free authenticity scan with the NAFDAC number 04-3886, 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 Atropine Eye Drops?

Follow your prescription or the leaflet in your pack. The official label says: 2.1 General Administration Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer unless solution is clear and seal is intact. Each vial is intended for single dose only. Discard unused portion. For Intravenous administration. Titrate based on heart rate, P…

What is Atropine Eye Drops used for?

Atropine Sulfate Injection, USP, is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest. (Summarised from the official U.S. FDA label for atropine sulfate. Always follow your doctor or pharmacist.)

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Reviews are personal experiences from PillVera users, not medical advice. Report side effects to your doctor and to NAFDAC.