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- Angina or severe coronary failure (antianginal and antiischemic properties of Amiodarone).
- Or in cases of heart failure (weak effect of Amiodarone on myocardial contractility).
Dosage and Administration
Atlansil
Initial saturation dose: 1 tablet, three times a day administered during the course of the day or after principal meals, during 8 to 10 days.
Maintenance therapy: Based upon each patient’s needs minimum effective dose has to be established. It may vary between ½ tablet once daily (1 tablet every 2 days) and 2 tablets every day, according to the physician’s criteria. Once tissue saturation and desired therapeutic effect were achieved, treatment should be continued with the minimum effective dose.
Clinical experience showed that the recover y achieved can be maintained applying intermittent administration during 3 weeks per months or 5 days per week.
Contraindications
Atlansil should not be administered in cases of sinus bradycardia, atrio-ventricular block
without the association of other arrhythmias, cardiovascular collapse, thyroid gland diseases,
pregnancy, lactation. It is contraindicated in iodine allergy.
E a c h t a b l e t c o n t a i n s A m i o d a r o n e h y d r o c h l o r i d e 2 0 0 m g . E x c i p i e n t s : L a c t o s e ; Microcr ystalline cellulose; Sodium starch glycolate; Magnesium stearate.
Precautions and Warnings
Atlansil, due to its mechanism of action, usually produces a moderate delay in heart rate,
Therapeutic Action
which is more pronounced in cases of increased values at the beginning of therapy. In cases Broad-spectrum antiarrhythmic. Antianginal.
of overdosage (specially in elderly patients) bradycardia may appear which improves with maintenance dose reduction. In patients with history of thyroid gland diseases Amiodarone Pharmacological Action
should be administered with caution and under clinical supervision. The presence of iodine in the Amiodarone molecule may alter some thyroid function tests (e.g. PB, scintigram) but not - Prolongation of phase 3 of the cardiac fiber action potential due to a decrease in potassium others (e.g. determination of T3, T4 and TSH). flow (class III of Vaughan-Williams).
Presence of a special morphology or U-waves in the electrocardiogram is due to the - Bradycardic effect due to reduction of sinus node automaticity.
therapeutic action of Amiodarone and should not be attributed to adverse events. - Non-competitive α and ß-adrenergic receptor antagonism.
Avoid or minimize exposure to direct sunlight during regular Amiodarone treatment.
- Prolongation of refractoriness and reduction of myocardial excitation at atrial, nodal and In cases of concomitant administration with Simvastatine, the maximum daily dose of this - Reduction of sinoatrial, atrial and nodal conduction, being more pronounced in cases of Adverse Reactions
- Slow down of conduction and increase in refractory periods of the accessory atrioventricular Adverse drug reactions are related to dosage and duration of treatment and can be avoided or minimized using the most appropriate maintenance dose.
- Increase in coronary debit due to direct effect on the coronary artery smooth muscle.
After prolonged administration to sensitive patients corneal microdeposits may appear, - Decrease in oxygen consumption due to a moderate reduction in peripheral vascular resistance which do not need treatment discontinuation and revert within a variable time period and reduction of heart rate, without significant reduction of coronary debit nor systolic volume.
after discontinuation of therapy. These deposits can be avoided or their incidence - Decrease in oxygen-supply demand in myocardial ischemia and of the infarcted zone of the reduced by administering the product intermittently, i.e. during 3 weeks per month or 5 days per week. Corneal microdeposits do not alter retina integrity and are without risk.
Non competitive α and ß-adrenergic receptor antagonist properties.
Rarely, after weeks or months of treatment photosensitivity or pigmentation reactions were described which can be avoided reducing exposure to direct sunlight.
Indications
E x c e p t i o n a l l y, a f t e r v e r y l a r g e t r e a t m e n t p e r i o d s , s i g n s o f d i f f u s e i n t e r s t i t i a l pneumopathies have been informed, with ver y small impact and which improve after Supraventricular rhythm disorders: Paroxysmal supraventricular tachycardia, atrial fibrillation treatment discontinuation or simultaneous corticosteroid administration.
and flutter; functional tachycardia, rhythm disorders in Wolff-Parkinson-White syndrome.
At the beginning of treatment a slight increase in transaminase serum values may be Ventricular rhythm disorders: Ventricular extrasystoles, ventricular tachycardia.
obser ved, which reverts with treatment discontinuation.
Prophylaxis of ventricular tachycardia crisis or ventricular fibrillation episodes.
Ver y rarely, reversible chronic hepatitis has been informed af ter some months of Based upon Atlansil’s pharmacological properties, it is specially indicated in rhythm disorders as
treatment. It is advised to monitor liver function tests.
Ing.8657 a complication of underlying heart diseases:
In very rare cases of peripheral neuropathies, their evolution was reversible in most cases.
Under treatment with Atlansil electrocardiographic alterations may occur which consist
Medicinal Product
in prolonged QT inter val, with a consequent increase in repolarization time. Eventually Keep out of the reach of children
a U-wave may appear, as a sign of therapeutic saturation but not toxicity.
Keep in a dry place at temperature below 30° C
Hypo- or hyperthyroidism is due to the presence of iodine in the Amiodarone molecule and may therefore alter some thyroid function tests. In case of doubt, titrate T Information to Health Care Professionals and Patients:
0-800-333-5658
T4 and perform a TRH-TSH test. Increase in T4 values with concomitant normal or Roemmers S.A.I.C.F.
3 values, is not to be considered pathological. In case of severe hyperthyroidism, treatment should be discontinued. Amiodarone is contraindicated in During initial saturation treatment slight digestive disorders may appear (nausea, vomiting, dysgeusia), which disappear when reducing the administered dose. Amiodarone should not be administered concomitantly with MAO inhibitors or betablockers. When administered concomitantly with digoxin, the possible potentiation of bradycardic effect and the influence on atrio-ventricular conduction should be evaluated as well as the possible increase in digoxin serum levels.
Drug Interactions
Substances with bradycardic or negative dromothrope effect (betablockers, verapamil,
diltiazem) due to the risk of alterations in automatism and conduction.
Substances that may lead to hypokalemia: Diuretics, laxatives.
Antiarrhythmics (specially class I).
S u b s t a n c e s a c t i n g o n r e p o l a r i z a t i o n : B e p r i d i l ( c o n c o m i t a n t a d m i n i s t r a t i o n
contraindicated).
Oral anticoagulants: The risk of potentiation through Amiodarone requires prothrombin
monitoring and adjustement of the doses of oral anticoagulants during and af ter
treatment with Amiodarone.
Phenytoin: Increase of phenytoin plasma levels with signs of overdosage.
S i m v a s t a t i n e : H i g h d o s e s o f t h i s h y p o l i p i d e m i c d r u g m a y i n c r e a s e t h e r i s k o f
myopathy.
Overdosage
In the event of overdosage go to the nearest hospital or contact the Toxicology Centers:
Children’s Hospital Ricardo Gutiérrez: (011) 4962-6666 / 2247, Hospital A. Posadas:
(011) 4654-6648 / 4658-7777.
How Supplied
Atlansil Tablets: Packages containing 20 and 50 tablets.
Yellowish white, round tablets, scored and coded AT 200 on one side of the tablet and marked with Roemmers’ identification isologue on the other side.
Other Dosage Forms / How Supplied
Atlansil Injectable: Packages containing 6 ampoules of 3 ml each.
Sold under prescriptionMade in ArgentinaProduct authorized by the Ministry of HealthCertificate Nº 36,581 Technical Director: Mirta Beatriz Fariña, PharmacistManufactured at José E. Rodó 6424, C1440AKJ Autonomous City of Buenos AiresLast revised: November 2002 1105402846
B Ing.8657

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