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Amiodarone 200 Mg Tablet

NAFDAC Reg. No. C4-1836 · Drug

Registered with NAFDAC — registration activeAs of 5 November 2026 · synced automatically from official sources.
Product
Amiodarone 200 Mg Tablet
NAFDAC number
C4-1836
Active ingredient
Amiodarone
Strength
200 mg
Form
Tablet
Pack size
2 x 14's (in blisters)
Manufacturer
Not listed
Applicant (holder)
SK Medicines 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

RxVerify commentary

  • Amiodarone 200 Mg Tablet is on the NAFDAC register with an active registration (C4-1836). 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 Amiodarone 200 Mg Tablet is used for

From the official U.S. FDA label for amiodarone, the active ingredient registered with NAFDAC.

Boxed warning: PULMONARY, HEPATIC and CARDIAC TOXICITY Pacerone is intended for use only in patients with the indicated life-threatening arrhythmias because its use is accompanied by substantial toxicity [see Indications and Usage (1) ] . Pacerone can cause pulmonary toxicity (hypersensitivity pneumonitis or interstitial/alveolar pneumonitis) that has resulted in clinically manifest disease at rates as high as 17% in some series of patients. Pulmonary toxicity has been fatal about 10% of the time . …
What it is used for

Pacerone is indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated. Pacerone is an antiarrhythmic indicated for: Recurrent ventricular fibrillation. ( 1 ) Recurrent hemodynamically unstable ventricular tachycardia. ( 1 )

Possible side effects

The following serious adverse reactions are described in more detail in other sections of the prescribing information: Pulmonary Toxicity [see Warnings and Precautions (5.2) ] Hepatic Injury [see Warnings and Precautions (5.3) ] Worsened Arrhythmia [see Warnings and Precautions (5.4) ] Visual Impairment and Loss of Vision [see Warnings and Precautions (5.5) ] Thyroid Abnormalities [see Warnings and Precautions (5.6) ] Bradycardia [see Warnings and Precautions (5.7) ] Peripheral Neuropathy [see Warnings and Precautions (5.10) ] Photosensitivity and Skin Discoloration [see Warnings and Precautions (5.11) ] The most common reactions (>1%) leading to discontinuation of amiodarone include pulmona …

Do not use if

Cardiogenic shock. Sick sinus syndrome, second- or third-degree atrioventricular block, bradycardia leading to syncope without a functioning pacemaker. Known hypersensitivity to the drug or to any of its components, including iodine. Pacerone is contraindicated in patients with ( 4 ): Cardiogenic shock. Sick sinus syndrome, second- or third-degree AV block, bradycardia leading to syncope without a functioning pacemaker. Known hypersensitivity to the drug or any of its components.

Warnings

Persistence of Adverse Effects: Adverse reactions and drug interaction can persist for several weeks following discontinuation. ( 5.1 ) Impaired Vision: Corneal microdeposits (common; reversible), optic neuropathy/neuritis (rare; may lead to blindness). ( 5.5 ) Thyroid Abnormalities: Hyperthyroidism or hypothyroidism. ( 5.6 ) 5.1 Persistence of Adverse Effects Because of the long half-life of amiodarone (15 to 142 days) and its active metabolite desethylamiodarone (14 to 75 days), adverse reactions and drug interactions can persist for several weeks following amiodarone discontinuation [see Clinical Pharmacology (12.3) ] . …

Pregnancy & breastfeeding

8.1 Pregnancy Risk Summary Available data from post-marketing reports and published case series indicate that amiodarone use in pregnant women may increase the risk for fetal adverse effects including neonatal hypo- and hyperthyroidism, neonatal bradycardia, neurodevelopmental abnormalities, preterm birth and fetal growth restriction. Amiodarone and its metabolite, desethylamiodarone (DEA), cross the placenta. …

Storage

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container with a child-resistant closure.

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

Check your pack of Amiodarone 200 Mg Tablet

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 Amiodarone 200 Mg Tablet

What is in Amiodarone 200 Mg Tablet?

Amiodarone 200 Mg Tablet contains Amiodarone (200 mg), as tablet, according to its NAFDAC registration record.

Is Amiodarone 200 Mg Tablet registered with NAFDAC?

Yes. Amiodarone 200 Mg Tablet is listed on the NAFDAC register under registration number C4-1836, and its registration is active as of 5 November 2026.

Has Amiodarone 200 Mg Tablet been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Amiodarone 200 Mg Tablet in our automatically synced alert list.

How can I check that my pack of Amiodarone 200 Mg Tablet is genuine?

Run a free authenticity scan with the NAFDAC number C4-1836, 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 Amiodarone 200 Mg Tablet used for?

Pacerone is indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated. Pacerone is an antiarrhythmic indicated for: Recurrent ventricular fibrillation. ( 1 ) Recu (Summarised from the official U.S. FDA label for amiodarone. Always follow your doctor or pharmacist.)

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