CORDARONE® 200 mg — Amiodarone Hydrochloride
1. Disclaimer
This information is provided for educational and reference purposes only and is not a substitute for the official package leaflet, the prescribing information, or individualized advice from a qualified physician or pharmacist. Amiodarone is a potent antiarrhythmic drug with potentially serious and sometimes delayed cardiac, pulmonary, hepatic, thyroid, ocular, neurologic, and skin toxicity, and treatment should be used under appropriate medical supervision.
We do not guarantee the accuracy, currency or completeness of information regarding medications or medical products, and official sources should be verified before making any decisions. Readers are responsible for independently verifying the information before relying on it.
2. Summary
Cordarone® 200 mg contains amiodarone hydrochloride, a Class III antiarrhythmic agent. It is used for the treatment and prevention of selected clinically significant cardiac rhythm disorders, particularly when other antiarrhythmic treatments are ineffective, unsuitable, or contraindicated. Because amiodarone has a very long elimination half-life and extensive tissue accumulation, its effects and drug interactions may persist for weeks or months after treatment is stopped.
3. Brand Name
Cordarone® 200 mg
The current Egyptian market presentation identified online is Cordarone 200 mg, 30 scored tablets, manufactured by Global Napi Pharmaceuticals. Current Egyptian pharmacy listings continue to show this presentation.
4. Category
Antiarrhythmic — Class III (Vaughan-Williams classification)
ATC code: C01BD01 — Amiodarone.
5. Active Ingredient
Amiodarone hydrochloride — 200 mg per tablet.
The active moiety is amiodarone.
6. Pharmaceutical Form & Strength
Pharmaceutical form: Oral scored tablet
Strength: 200 mg amiodarone hydrochloride per tablet.
For the current Egyptian presentation identified, the pack contains 30 scored tablets, commonly arranged as 3 × 10 tablets. The Egyptian market barcode identified for this presentation is 6223003992057.
The tablet is designed to be split when a half-tablet dose is prescribed.
7. Manufacturer & Marketing Authorization Holder
Egyptian manufacturer: Global Napi Pharmaceuticals (GNP), Egypt, whose current official company information lists its production site in the 2nd Industrial Zone, Plot 40, Street 18, 6th of October City, Egypt.
The Egyptian market pack is identified as being manufactured by Global Napi Pharmaceuticals under licence from Sanofi-Aventis, France. Independent current literature also identifies the Egyptian Cordarone 200 mg product as manufactured by Global Napi under licence from Sanofi-Aventis.
Marketing authorisation holder: For the currently authorised French Cordarone product, the public French medicines database identifies SANOFI WINTHROP INDUSTRIE as the marketing-authorisation holder. A separate current Egyptian EDA public record identifying a distinct Egyptian MAH for the specific Cordarone 200 mg presentation was not accessible, so no separate Egyptian MAH is asserted here.
8. Mechanism of Action
Amiodarone has predominantly Class III electrophysiological effects, mainly by reducing potassium current and prolonging phase 3 repolarization, thereby increasing cardiac action-potential duration and refractory periods.
It also has additional effects, including:
- slowing sinus-node automaticity and heart rate;
- slowing sinoatrial, atrial, and nodal conduction;
- increasing refractory periods and reducing myocardial excitability;
- prolonging refractoriness in accessory atrioventricular pathways;
- possessing non-competitive alpha- and beta-adrenergic antagonistic properties.
Its overall effect is to suppress or prevent abnormal cardiac electrical activity and reduce the recurrence of various tachyarrhythmias.
9. Spectrum of Activity
The term “spectrum of activity” is not applicable in the antimicrobial sense, because amiodarone is not an antimicrobial drug.
Its electrophysiological activity extends across atrial, nodal, ventricular, and accessory-pathway tissues, and it is used clinically against selected supraventricular and ventricular tachyarrhythmias and ventricular fibrillation.
10. Pharmacokinetics
Amiodarone is slowly and variably absorbed after oral administration and has extensive tissue distribution and strong tissue affinity.
Key pharmacokinetic characteristics include:
- Oral bioavailability: approximately 30–80%, with an average around 50% according to current Cordarone product information.
- Peak plasma concentration: generally 3–7 hours after a single oral dose.
- Therapeutic effect: may begin after several days but commonly requires approximately 1 week, with full clinical effects potentially taking longer.
- Elimination half-life: very long and highly variable, approximately 20–100 days in the current Cordarone information; an average plasma half-life of about 50 days is also reported in Sanofi product information.
- Significant accumulation occurs in tissues, particularly adipose tissue.
- Elimination continues for months after discontinuation, so adverse effects and drug interactions may persist after treatment is stopped.
- Amiodarone is metabolized mainly by CYP3A4 and also by CYP2C8.
- Its elimination is predominantly non-renal; urinary elimination is negligible, and the drug is not dialyzable.
11. Indications
According to current Cordarone product information, amiodarone is indicated for selected severe or clinically significant rhythm disorders, including:
- prevention of recurrence of life-threatening ventricular tachycardia, with initiation under hospital monitoring;
- prevention of recurrent documented, symptomatic, disabling ventricular tachycardia;
- prevention of recurrent documented supraventricular tachycardia when treatment is necessary and other therapies have failed or cannot be used;
- ventricular fibrillation;
- treatment of selected supraventricular tachycardias, including slowing or reducing atrial fibrillation or atrial flutter.
Amiodarone may be used in patients with coronary artery disease and/or impaired left-ventricular function when clinically appropriate.
12. Administration
Route: Oral.
For the current Cordarone 200 mg product information, the usual adult regimen is:
Loading treatment:
3 tablets daily (600 mg/day) for 8–10 days.
In some circumstances, higher short-term loading doses such as 4–5 tablets daily may be used under appropriate medical and ECG supervision.
Maintenance treatment:
The minimum effective dose should be used and is individualized, generally ranging from ½ tablet daily (100 mg/day) to 2 tablets daily (400 mg/day).
The precise regimen depends on the arrhythmia, clinical response, tolerance, previous treatment, and specialist judgment. The dose should not be increased, decreased, or stopped without medical advice.
13. Method of Preparation
No reconstitution or special preparation is required because Cordarone 200 mg is supplied as a ready-to-use oral tablet.
The tablet may be swallowed with water and may be taken before, during, or outside meals. Current Cordarone patient information states that crushing the tablet does not alter its efficacy. The scored tablet can be divided into two halves when a half-tablet dose has been prescribed.
14. Contraindications
Cordarone is contraindicated in patients with:
- sinus bradycardia or unpaced sinoatrial block;
- unpaced sick-sinus syndrome;
- high-grade atrioventricular conduction disorders when not protected by an appropriate pacemaker;
- hyperthyroidism;
- known hypersensitivity to amiodarone, iodine, or any component of the product;
- pregnancy from the second trimester onward under the current French Cordarone product information, except where specifically determined otherwise in exceptional clinical circumstances;
- breastfeeding;
- concomitant treatment with specified medicines capable of producing QT prolongation and torsades de pointes, including certain Class Ia and Class III antiarrhythmics and specified other QT-prolonging medicines;
- concomitant telaprevir or cobicistat under the current French product information.
Severe conduction disease or sinus-node disease may permit use only with appropriate pacing support where specifically indicated.
15. Warnings & Precautions
Amiodarone requires careful and usually long-term monitoring because serious adverse effects can be delayed and may involve several organ systems.
Important precautions include:
Cardiac monitoring: An ECG should be obtained before treatment, and ECG monitoring should continue during therapy. Amiodarone can cause bradycardia, conduction abnormalities, QT prolongation, and, less commonly, new or worsening arrhythmias.
Thyroid: Thyroid-function testing, particularly TSH, should be performed before treatment and periodically thereafter. Hypothyroidism and hyperthyroidism may occur, including severe hyperthyroidism. Monitoring should continue for several months after discontinuation.
Liver: Liver function, particularly transaminases, should be assessed before treatment and periodically during therapy. Acute or chronic hepatic injury can occur and may rarely be severe or fatal.
Lungs: New unexplained dyspnea, persistent non-productive cough, fever, fatigue, or deterioration in general health should prompt urgent evaluation for pulmonary toxicity, including interstitial pneumonitis or pulmonary fibrosis. Chest imaging and pulmonary-function assessment may be required.
Eyes: Corneal microdeposits are very common and usually benign, but blurred or reduced vision requires prompt ophthalmologic assessment. Optic neuropathy or optic neuritis may threaten vision and requires discontinuation when attributed to amiodarone.
Skin: Patients should limit ultraviolet exposure and use protective measures because photosensitivity can occur and may persist for months after treatment. Severe reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis require immediate discontinuation and urgent medical care.
Electrolytes: Hypokalaemia and other electrolyte abnormalities should be corrected because they can increase the risk of proarrhythmia and torsades de pointes.
Implanted cardiac devices: Amiodarone can increase defibrillation or pacing thresholds, so device function should be checked after treatment initiation and dosage changes.
Surgery and anaesthesia: The anaesthetist should be informed before surgery because amiodarone can contribute to bradycardia, hypotension, conduction disturbances, reduced cardiac output, and postoperative respiratory complications.
Lactose: The product contains lactose and should be avoided in patients with rare hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
16. Drug Interactions
Amiodarone has numerous clinically important interactions.
Interactions that may be contraindicated or particularly hazardous include drugs that prolong the QT interval and increase the risk of torsades de pointes, especially:
- Class Ia antiarrhythmics such as quinidine, hydroquinidine, and disopyramide;
- Class III antiarrhythmics such as sotalol, dofetilide, and ibutilide;
- selected QT-prolonging drugs including moxifloxacin, intravenous erythromycin, intravenous spiramycin, certain antipsychotics, and several other medicines specified in the official product information.
Other clinically important interactions include:
- Digoxin: increased digoxin exposure and increased risk of bradycardia and AV-conduction abnormalities; clinical/ECG monitoring and dose adjustment are required.
- Warfarin and other vitamin-K antagonists: increased anticoagulant effect; closer INR monitoring and dose adjustment are necessary.
- Phenytoin: increased plasma concentrations and possible toxicity.
- Flecainide: increased concentrations; dose reduction and close monitoring may be required.
- Beta-blockers, diltiazem and verapamil: increased risk of bradycardia and conduction disturbance.
- Ciclosporin, tacrolimus and sirolimus: increased exposure and potential toxicity.
- Dabigatran: increased exposure and bleeding risk.
- CYP3A4 substrates and inhibitors: clinically relevant interactions may occur.
- Grapefruit juice: may increase amiodarone exposure and should be avoided during oral therapy.
- Sofosbuvir-containing hepatitis-C treatment: potentially severe symptomatic bradycardia can occur; concomitant use requires exceptional caution and appropriate cardiac monitoring.
- Stimulant laxatives and medicines causing hypokalaemia: can increase the risk of torsades de pointes.
- Simvastatin: concomitant use increases the risk of myopathy/rhabdomyolysis. The U.S. labeling for simvastatin specifies a maximum simvastatin dose of 20 mg/day when used with amiodarone; use of a statin not substantially dependent on CYP3A4 may be preferred.
Because amiodarone has a very long half-life, clinically relevant interactions may persist for months after discontinuation.
17. Side Effects
Frequency terminology in the current Cordarone information is:
Very common (≥10%)
- corneal microdeposits, sometimes producing halos or blurred vision;
- photosensitivity;
- biochemical thyroid-hormone abnormalities without overt thyroid disease;
- elevated liver transaminases;
- nausea, vomiting, and taste disturbance.
Common (≥1% to <10%)
- hypothyroidism or hyperthyroidism;
- pulmonary toxicity, including pneumonitis/fibrosis;
- tremor and other neurologic symptoms;
- sleep disturbances, including nightmares;
- peripheral neuropathy;
- acute hepatitis/liver injury;
- bradycardia;
- grey or slate-coloured skin pigmentation.
Uncommon (≥0.1% to <1%)
- conduction abnormalities such as sinoatrial or AV block;
- new or worsening arrhythmias;
- peripheral myopathy.
Rare
- hyponatraemia/SIADH.
Very rare
- optic neuropathy/optic neuritis with possible severe visual loss;
- marked bradycardia or sinus arrest;
- chronic hepatitis;
- thrombocytopenia;
- haemolytic or aplastic anaemia;
- increased creatinine/renal impairment;
- ataxia;
- alopecia;
- severe postoperative respiratory failure;
- vascularitis and other uncommon reactions.
Frequency not known
- torsades de pointes;
- pancreatitis;
- severe cutaneous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis;
- DRESS;
- neutropenia/agranulocytosis;
- anaphylactic/anaphylactoid reactions and angioedema;
- hallucinations, delirium and parkinsonian symptoms;
- other reported reactions.
Urgent medical assessment is warranted for severe breathlessness, persistent dry cough, fainting, marked slow heart rate, new severe palpitations, chest pain, sudden visual deterioration, jaundice, or a rapidly spreading blistering rash.
18. Use in Special Populations
Pregnancy: Amiodarone should generally be avoided during pregnancy unless the clinical situation makes it necessary. Current French Cordarone information specifically contraindicates use from the second trimester onward because of fetal thyroid effects. Thus, the statement that it is contraindicated “starting from the first trimester” is not accurate for the current French Cordarone product information.
Breastfeeding: Contraindicated because amiodarone and its metabolite, together with iodine, pass into breast milk and may expose the infant to clinically important thyroid effects.
Children: Safety and efficacy have not been established in controlled clinical trials. Limited published pediatric experience exists, but pediatric treatment requires specialist dosing and monitoring.
Older adults: Elderly patients may be more susceptible to bradycardia and conduction abnormalities and generally require particularly careful dose selection and thyroid monitoring.
Renal impairment: Because renal elimination is negligible, usual doses can generally be used without routine renal dose adjustment; however, clinical judgment remains necessary.
Hepatic impairment: Liver disease requires particular caution because amiodarone itself may cause clinically significant hepatic injury; treatment and laboratory monitoring should be individualized.
19. Storage Conditions
Storage conditions are product- and market-specific and the temperature printed on the Egyptian pack should be followed.
The current French Cordarone product information states: store at a temperature not exceeding 30°C. Other amiodarone products may have different labelled storage conditions. The medicine should be kept in its original packaging, protected as directed on the specific pack, and out of the reach of children.
20. Additional Sections
Overdose: Acute overdose is uncommon but can cause severe bradycardia, ventricular arrhythmias including torsades de pointes, hypotension, and hepatic injury. Treatment is supportive and requires cardiac and haemodynamic monitoring; amiodarone and its metabolite are not removed by dialysis.
Missed dose: An occasional missed dose generally does not create an immediate special risk because of the drug's long half-life. The patient should not take a double dose to compensate.
Stopping treatment: Do not discontinue amiodarone without medical advice. Residual drug stores can remain in the body for months and antiarrhythmic effects may persist after discontinuation.
Driving and machinery: Amiodarone itself does not automatically prohibit driving, but clinically significant visual impairment or other symptoms that affect alertness or performance may impair safe driving.
Excipients: The current Cordarone formulation listed in the French product information contains lactose, maize/corn starch, povidone, colloidal anhydrous silica, and magnesium stearate.
Current Egyptian market information: The identified Egyptian presentation is Cordarone 200 mg, 30 scored tablets, with Global Napi Pharmaceuticals as the local manufacturer. Current Egyptian pharmacy listings continue to show the product, and the Egyptian Drug Authority's 2025 Essential Medicines List includes amiodarone 200 mg tablets.
21. Frequently Asked Questions (FAQ)
Is Cordarone 200 mg an antibiotic?
No. It is a Class III antiarrhythmic medicine used to manage selected abnormal heart rhythms.
Can Cordarone 200 mg be taken without a prescription or monitoring?
It should be used under medical supervision because of its potentially serious and delayed toxicities and its numerous drug interactions.
Can Cordarone be stopped suddenly?
It should not be stopped without medical advice. Although its effects persist because of its long half-life, stopping therapy may allow the underlying arrhythmia to recur.
Can Cordarone be taken with simvastatin?
It may be used only with appropriate medical assessment because amiodarone increases the risk of statin-associated muscle toxicity. U.S. simvastatin labeling limits simvastatin to 20 mg/day with amiodarone.
Can I take Cordarone during pregnancy or breastfeeding?
It should not be used during pregnancy unless specifically justified by a specialist; current French Cordarone information contraindicates it from the second trimester onward. Breastfeeding is contraindicated during treatment.
What symptoms require urgent medical attention?
Severe or unexplained shortness of breath, persistent dry cough, fainting, marked slow or irregular heartbeat, chest pain, sudden visual deterioration, jaundice, or severe blistering skin reactions require prompt medical assessment.
22. References
French Ministry of Health — Base de Données Publique des Médicaments: CORDARONE 200 mg, comprimé sécable — current database page updated 31 August 2026; current product information updated 5 June 2025.
Sanofi: CORDARONE 200 mg — Product Information (Sanofi product information for amiodarone tablets).
Egyptian Drug Authority: Egyptian Drug Formulary — Cardiovascular System and National Egyptian Essential Medicine List 2025, confirming amiodarone 200 mg tablets.
DailyMed / U.S. prescribing information: current amiodarone hydrochloride tablet warnings, pharmacokinetics, adverse effects, interactions, pregnancy and overdose information.
Sanofi France: current list of marketed medicines including CORDARONE 200 mg, comprimé sécable.
Current Egyptian pharmacy/product listings: Cordarone 200 mg, 30 scored tablets, Global Napi Pharmaceuticals.
Final accuracy check: the scientifically important corrections have been incorporated. In particular, the previous claims that thyroid disease, pulmonary problems, tremor, neuropathy, acute liver injury, and bradycardia were all “very frequent” were corrected to the frequency categories supported by the current product information; “dysphagia” was corrected to taste disturbance/dysgeusia; pregnancy was corrected from “starting from the 1st trimester” to the current Cordarone wording concerning the second trimester onward; and the interaction section was expanded and reclassified to distinguish contraindicated, discouraged, and clinically monitored combinations.