Amiodarone Sandoz

Amiodarone Sandoz

amiodarone

Manufacturer:

Sandoz

Distributor:

Zuellig
/
Firma Vai Hong
Full Prescribing Info
Contents
Amiodarone hydrochloride.
Description
Each tablet contains 200 mg amiodarone hydrochloride.
Excipients/Inactive Ingredients: lactose monohydrate, magnesium stearate (Ph.Eur.), maize starch, povidone (K 25), colloidal silicon dioxide.
Indications/Uses
Amiodarone Sandoz Tab 200 mg is a medicine for the treatment of arrhythmias (antiarrhythmic Class III).
Amiodarone Sandoz Tab 200 mg is used in symptomatic and tachycardiac supraventricular arrhythmias necessitating treatment such as AV node tachycardia, supraventricular tachycardia in Wolff-Parkinson-White syndrome or paroxysmal atrial fibrillation.
Severe symptomatic tachycardiac ventricular arrhythmias.
These indications apply to patients who do not respond to treatment with other antiarrhythmics or for whom other antiarrhythmics are not indicated.
Dosage/Direction for Use
Always take Amiodarone Sandoz Tab 200 mg exactly as the doctor has told. Check with the doctor or pharmacist if not sure.
The dosage should be determined on an individual basis - particularly depending on the success of treatment.
The following dosage guidelines apply: As a loading dose, 600 mg amiodarone hydrochloride (equivalent to 3 tablets of Amiodarone Sandoz Tab 200 mg) per day for 8-10 days; in some cases, dosages up to 1200 mg amiodarone hydrochloride (equivalent to 6 tablets of Amiodarone Sandoz Tab 200 mg) per day may become necessary.
Afterwards, reduction to a maintenance dose which is generally 200 mg amiodarone hydrochloride (equivalent to l tablet of Amiodarone Sandoz Tab 200 mg) during 5 days per week.
In some cases during long-term therapy, higher dosages of 200 mg up to 600 mg amiodarone hydrochloride (equivalent to 1-3 tablets of Amiodarone Sandoz Tab 200 mg) are necessary per day.
In the treatment of children, the dose should be adjusted according to the body surface area or body weight.
Special note: As most side effects are dose-dependent, the lowest effective maintenance dose should be administered.
Method of use: The tablets should be swallowed without chewing and with sufficient liquid during or after a meal.
The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Duration of use: The duration of use is determined by the doctor.
Please talk to the doctor or pharmacist if the patient has the impression that the effect of Amiodarone Sandoz Tab 200 mg is too strong or too weak.
Missed dose: Do not take a double or multiple dose after one or several forgotten single doses, but continue treatment with the dose prescribed.
Discontinuation of dose: Do not interrupt or stop treatment with Amiodarone Sandoz Tab 200 mg without consulting the doctor. If the patient has any further questions on the use of this product, ask the doctor or pharmacist.
Overdosage
In cases of suspected overdose with Amiodarone Sandoz Tab 200 mg, inform the doctor without delay; he/she will decide on possible, if at all necessary measures according to the symptoms. In case of intoxication and/or in case of severe symptoms, immediate medical treatment is necessary.
Little is known to date about acute overdoses with Amiodarone Sandoz Tab 200 mg. Overdose is generally only possible in the course of long-term therapy, because of the specific pharmacokinetics.
In general, symptoms are limited to sinus bradycardia, sinoatrial and nodal conduction impairment and spontaneously regressing tachycardia.
Bradycardia caused by Amiodarone Sandoz Tab 200 mg is atropine-resistant. Temporary pacemaker control may thus be necessary.
If an overdose is suspected, the patient should be monitored for a sufficiently long period, due to the pharmacokinetics of amiodarone hydrochloride, with special regard to the cordiological situation.
Neither amiodarone nor its metabolites are dialyzable.
Contraindications
Do not take Amiodarone Sandoz Tab 200 mg in iodine allergy and hypersensitivity to amiodarone hydrochloride or to any of the other ingredients of Amiodarone Sandoz Tab 200 mg; in sinus bradycardia (less than 55 pulse beats per minute); in all forms of delayed conduction (sinoatrial and nodal conduction delay), including sick sinus syndrome, second and third degree AV block and bi- and tri-fascicular blocks if a pacemaker is not in use; in thyroid disorders; in pre-existing QT prolongation; in hypokalaemia; in concomitant treatment with MAO inhibitors; in concomitant treatment with medicines that might induce torsades de pointes (see Interactions); concomitant use of simvastatin (medicine to lower elevated blood fats) at a daily dose higher than 20 mg.
Special Precautions
The following describes when the patient may use Amiodarone Sandoz Tab 200 mg only under certain conditions and only with special caution. Ask the doctor regarding this. It also applies if the data was relevant for the patient once before.
Heart: The adjustment to the antiarrhythmic used for ventricular arrhythmias requires careful cardiological monitoring and may be performed only in the presence of cardiological emergency equipment and when monitoring is possible.
During treatment, check-ups should be undertaken at regular intervals (e.g. standard ECG at intervals of one month or long-term ECG at intervals of three months and possibly exercise ECG). Therapy should be reviewed if individual parameters deteriorate, e.g. prolongation of QRS time or QT time by more than 25% or PQ time by more than 50% or QT prolongation to more than 500 ms or increase in the number or severity of arrhythmias.
ECG changes which impress as QT prolongation (depending on prolonged repolarisation), possibly in connection with the development of a U wave as well as prolongation and deformation of the T wave, are the manifestation of the pharmacological activity of Amiodarone Sandoz Tab 200 mg.
Excessive QT prolongation involves an increased risk for the occurrence of "torsades de pointes".
Eyes: Regular ophthalmological examinations, including funduscopy and examinations by means of slit lamp, are indicated during treatment with Amiodarone Sandoz Tab 200 mg (see Adverse Reactions).
If optic neuropathy and/or optic neuritis occur, Amiodarone Sandoz Tab 200 mg should be discontinued as there is the risk of progression, possibly proceeding to blindness.
Skin: Exposure to sunlight should be avoided during therapy with Amiodarone Sandoz Tab 200 mg; this also applies to exposure to UV light and solaria. If this is not possible, uncovered skin parts, particularly the face, should be protected by applying a sun protection ointment with high sun protection factor. Sun protection is still necessary for some time after withdrawal of Amiodarone Sandoz Tab 200 mg.
Thyroid gland: Due to risk of developing a thyroid dysfunction (hyperthyroidism or hypothyroidism) during treatment with Amiodarone Sandoz Tab 200 mg, thyroid function check-ups should be carried out prior to the onset of treatment.
During therapy and up to one year after withdrawing therapy, these examinations should be repeated at regular intervals and the patients be examined for clinical symptoms of hyperthyroidism or hypothyroidism.
Amiodarone Sandoz Tab 200 mg inhibits the conversion of thyroxine (T4) to triiodothyronine (T3) and may lead to elevated T4 values as well as to reduced T3 values in patients without clinical symptoms (euthyroid patients). This finding constellation alone should not result in discontinuation of Amiodarone Sandoz Tab 200 mg.
The clinical diagnosis of hypothyroidism is confirmed by determination of an evidently increased content of the ultrasensitive hormone TSH as well as reduced T4. In case of proven hypothyroidism, the dose of amiodarone hydrochloride should be reduced, if possible, and/or substitution with L-thyroxine be started. In isolated cases discontinuation of Amiodarone Sandoz Tab 200 mg may become necessary.
The clinical diagnosis of hyperthyroidism is confirmed by determination of an evidently reduced ultrasensitive TSH as well as increased T3 and T4. If thyroid hyperfunction is confirmed, the dose should be reduced, if possible, or Amiodarone Sandoz Tab 200 mg should be discontinued and, in severe cases treatment should be started with thyroid depressants, beta-blockers and/or corticosteroids.
Due to its content of iodine, Amiodarone Sandoz Tab 200 mg falsifies standard thyroid tests (iodine binding tests).
Lung: During therapy with Amiodarone Sandoz Tab 200 mg there is the risk of developing severe inflammatory lung diseases (hypersensitivity pneumonitis, alveolar or interstitial pneumonitis). A thoracic X-ray and a lung function test should therefore be carried out before treatment is initiated.
In the course of further treatment, these examinations should be repeated at intervals of approx. 3-6 months.
These examinations should also be carried out if dyspnoea occurs (a symptom of possible pulmonary-toxic effect).
As required, lung function tests should be performed more frequently in patients with severe lung diseases, as these patients have a poorer prognosis if pulmonary-toxic effects occur.
If hypersensitivity pneumonitis is confirmed, Amiodarone Sandoz Tab 200 mg must be discontinued immediately and treatment with corticosteroids commenced.
By proof of alveolar/interstitial pneumonia, treatment with corticosteroids should be performed and the dosage be reduced or, if possible, Amiodarone Sandoz Tab 200 mg be discontinued.
Liver: Liver parameters should be monitored at regular intervals, particularly at higher dosage.
In case of persistent clinically relevantly elevated liver enzymes, cholestatic jaundice or hepatomegaly, withdrawal of Amiodarone Sandoz Tab 200 mg should be considered.
Other notes: Exposure to sunlight should be avoided (the same applies to UV light and solaria). If this is not possible, uncovered skin parts, particularly the face, should be protected by applying a sun protection ointment with high sun protection factor. Sun protection is still necessary for some time after withdrawal of Amiodarone Sandoz Tab 200 mg.
In patients who develop weakness during the treatment with amiodarone, the possibility of a syndrome of inappropriate (increased) antidiuretic hormone secretion (SIADH) should be considered: Sodium levels and osmolality in serum as well as osmolality and sodium concentration in the urine should be measured.
In case of concomitant use of amiodarone and simvastatin (medicine to lower elevated blood fats), the risk of symptoms affecting the musculature (myopathy) or break-up of muscle cells (rhabdomyolysis) is increased, depending on the daily dose of simvastatin.
Concomitant therapy of amiodarone with a statin (medicine to lower elevated blood fats) should therefore be performed with special care. As it may be assumed only during concomitant use of amiodarone and simvastatin at daily doses of up to 20 mg that there is no risk of the above-named side effects, this daily dose of simvastatin should not be exceeded. Statins other than simvastatin should be used at low dose during concomitant therapy with amiodarone.
Important information about some of the ingredients of Amiodarone Sandoz Tab 200 mg: This medicine contains lactose. If the patient has been told by the doctor that he/she has intolerance to some sugars, contact the doctor before taking Amiodarone Sandoz Tab 200 mg.
Driving and using machines: Treatment with this medicine requires regular monitoring by a doctor.
Even when used as recommended, this medicine can influence reactions to such an extent that the ability to drive, operate machines or work in potentially hazardous situations is impaired.
This applies particularly at the beginning of treatment, after a dose increase or change of preparation, and also in conjunction with alcohol.
Elderly patients: Amiodarone Sandoz Tab 200 mg causes decelerated heart rate which can be more pronounced in elderly patients. If the heart rate is considerably lowered, treatment must be discontinued.
Use In Pregnancy & Lactation
Pregnancy: Insufficient experience is available regarding safe use during pregnancy. The most common complications are growth disturbances, premature births and thyroid dysfunctions in the newborn. Women who want to become pregnant should plan the onset of pregnancy 6 months after the end of therapy at the earliest, due to the long half-life of amiodarone hydrochloride, in order to avoid the child's exposure in early pregnancy.
Breast-feeding: If treatment is necessary during breast-feeding or if amiodarone hydrochloride has been taken during pregnancy, the mother should not breast-feed her infant, since the active substance passes into breast milk and can reach effective concentrations in the infant.
Ask the doctor or pharmacist for advice before taking/using any medicine.
Side Effects
Like all medicines, Amiodarone Sandoz Tab 200 mg can cause side effects, although not everybody gets them.
The evaluation of side effects is based on the following information on frequencies: very common: more than 1 in 10 treated patients; common: less than 1 in 10, but more than 1 in 100 treated patients; uncommon: less than 1 in 100, but more than 1 in 1,000 treated patients; rare: less than 1 in 1,000, but more than 1 in 10,000 treated patients; very rare: less than 1 in 10,000 treated patients, or unknown.
Eyes: Microdeposits at the front face of the cornea of the eye are found in almost all patients, are usually limited to the area below the pupil and may commonly lead to visual disturbances (clouded vision, coloured haloes around light sources).
They generally regress within 6-12 months of discontinuation of Amiodarone Sandoz Tab 200 mg.
Cases of optic neuropathy and/or optic neuritis have been reported which very rarely led to permanent blindness.
During therapy with Amiodarone Sandoz Tab 200 mg, regular ophthalmic examinations, including funduscopy and examinations by means of a split lamp, are therefore indicated (see Precautions).
Skin: Photosensitization with increased tendency to sunburn may uncommonly occur and may lead to erythema and skin rash.
During longer-term treatment, hyperpigmentation with black-violet to slate-grey skin discoloration (pseudocyanosis) may occur, particularly affecting skin parts exposed to sunlight.
The discoloration slowly subsides within 1-4 years after discontinuation of the product.
Cases of erythema developing during radiotherapy have been reported. Cases of erythema nodosum and poorly specific exanthema including occasional cases of exfoliative dermatitis have been reported.
For preventive measures, see Precautions.
Thyroid gland: Amiodarone Sandoz Tab 200 mg inhibits the conversion of thyroxine (T4) to triiodothyronine (T3) and may lead to elevated T4 values as well as to reduced T3 values in patients without clinical symptoms (euthyroid patients).
Thyroid dysfunctions (hyperthyroidism or hypothyroidism) uncommonly occur.
The following symptoms may be evidence of thyroid dysfunctions: Hypothyroidism: Weight gain, exhaustion, extreme bradycardia beyond the effect to be expected with Amiodarone Sandoz Tab 200 mg.
Hyperthyroidism: Weight loss, tachycardia, tremor, nervousness, increased sweating and intolerance of warmth, recurrence of arrhythmias or angina pectoris, heart failure.
Severe hyperthyroidism, in isolated cases with fatal course, has been described.
For follow-ups, diagnostic and therapeutic measures, see Precautions.
Lung: As a result of the pulmonary toxicity of Amiodarone Sandoz Tab 200 mg, atypical pneumonia as a sign of a hypersensitivity reaction (hypersensitivity pneumonitis), alveolar or interstitial pneumonias or fibrosis, pleuritis, bronchiolitis obliterans with pneumonia/BOOP can uncommonly occur.
Non-productive cough and dyspnoea are commonly first signs of the above-mentioned lung changes. In addition, weight loss, fever and a sensation of weakness can occur.
If Amiodarone Sandoz Tab 200 mg is discontinued in good time, the above-mentioned lung changes usually subside. Isolated cases of a fatal course have been reported.
Usually after surgical procedures, some cases of shock lung (ARDS) occurred which were fatal in isolated cases.
For follow-ups, diagnostic and therapeutic measures, see Precautions.
Gastrointestinal tract/liver: Nausea and vomiting commonly occur. Uncommonly, abdominal pain, feeling of fullness, constipation and anorexia occur.
Uncommonly, isolated increases in serum transaminases occur which are usually not very pronounced.
Rarely, the occurrence of acute hepatitis (in isolated cases with lethal course), cholestatic jaundice or liver cirrhosis has been described.
In case of persistent clinically relevantly increased liver enzymes, cholestatic jaundice or hepatomegaly, withdrawal of Amiodarone Sandoz Tab 200 mg should be considered.
Heart: As a result of the pharmacological effect of Amiodarone Sandoz Tab 200 mg, sinus bradycardia - which may be more pronounced in elderly patients or impaired sinus node function, or in exceptional cases, sinus node arrest may occur.
The following changes were seen in the ECG: QT prolongation, occurrence of a U wave, prolongation or deformation of the T wave.
If pronounced bradycardia or sinus node arrest occur, therapy must be discontinued.
In isolated cases, conduction disturbances (sinoatrial block, atrioventricular block) occurred; in isolated cases, the occurrence of asystole has been observed.
Pro-arrhythmic effects in the form of changes or enhancement of arrhythmias, which may lead to considerably impaired heart activity with the possible consequence of cardiac arrest.
Isolated cases of torsades de pointes and ventricular fibrillation/flutter have been described.
Other side effects: Uncommonly, tiredness, headache, sleep disturbances, nightmares, dizziness, reduced libido, muscle weakness, tremor, impaired coordination, paraesthesia, peripheral neuropathy or ataxia occur.
Rarely, taste changes as well as reversible hair loss occur.
Rarely, hypersensitivity reactions may occur, as well as vasculitis, thrombocytopenia, transiently impaired kidney function, epididymitis.
Isolated cases of haemolytic or plastic anaemia as well as an increase in intracranial pressure (pseudotumor cerebri) have been reported.
Isolated cases of a syndrome of inappropriate (increased) antidiuretic hormone secretion (SIADH) with lowered sodium serum levels have been described in association with amiodarone.
Countermeasures: If the patient notices any of the previously mentioned side effects, please tell the doctor so that he/she can decide on the severity and possible, if at all necessary further measures.
If any of the side effects gets serious, or if the patient notices any side effects not listed in this leaflet, please tell the doctor or pharmacist.
Drug Interactions
Please tell the doctor or pharmacist if the patient is taking/using or have recently taken/used any other medicines, including medicines obtained without a prescription.
Co-administration of Amiodarone Sandoz Tab 200 mg and cardiac glycosides may lead to disorders of automatism (excessive bradycardia) and atrioventricular conduction, due to the synergistic effect of both products.
Co-administration of Amiodarone Sandoz Tab 200 mg and digoxin may lead to increased digoxin serum level (due to lowered digoxin clearance). For this reason, be aware of symptoms of digitalis overdose in these patients, and the digoxin plasma levels should be determined as a precaution. If necessary, the dose should be adjusted.
Amiodarone Sandoz Tab 200 mg may lead to an enhanced anticoagulant effect of vitamin K antagonists (dicoumarol, warfarin, phenprocoumon) and thus to an increased bleeding risk.
The Quick's value should therefore be checked more frequently during and after treatment with Amiodarone Sandoz Tab 200 mg and the dose of the vitamin K antagonists adjusted if necessary.
Amiodarone Sandoz Tab 200 mg may increase the serum level of phenytoin when administered concomitantly with phenytoin and induce symptoms of phenytoin overdose (e.g. visual disturbances, tremor, dizziness). As soon as such symptoms occur, the phenytoin dose should therefore be reduced. If necessary, the phenytoin plasma levels should be determined.
Amiodarone Sandoz Tab 200 mg may increase the ciclosporin serum levels and reduce the clearance of ciclosporin by more than 50%. The dose of ciclosporin should therefore be adjusted during concomitant administration.
Amiodarone Sandoz Tab 200 mg may increase the plasma levels of other antiarrhythmics (e.g. quinidine, procainamide, flecainide).
With concomitant use of class I antiarrhythmics (particularly quinidine-like substances), other class III antiarrhythmics (e.g. sotalol) and other medicines that prolong the QT interval (e.g. vincamine, sulpiride, intravenous pentamidine and intravenous erythromycin) there is the risk of excessive QT prolongation, associated with an increased risk of ventricular arrhythmias, including torsades de pointes. Concomitant use of these medicines is therefore contraindicated.
In case of concomitant use of amiodarone and simvastatin (medicine to lower elevated blood fats), the risk of symptoms affecting the musculature (myopathy) or break-up of muscle cells (rhabdomyolysis) is increased (see Precautions).
With concomitant administration of potassium-depleting diuretics (e.g. hydrochlorothiazide, furosemide), laxatives, systemic corticosteroids, tetracosactide or intravenous amphotericin B and Amiodarone Sandoz Tab 200 mg there is an increased risk of arrhythmias due to hypokalaemia (including torsades de pointes).
Concomitant use of Amiodarone Sandoz Tab 200 mg and calcium antagonists of the verapamil and diltiazem type or beta-blockers can lead to excessive bradycardia, higher-grade atrioventricular conduction disturbances and to an additive cardiodepressive effect. Calcium antagonists of the verapamil and diltiazem type or beta-blockers should therefore not be combined with Amiodarone Sandoz Tab 200 mg.
In patients treated with Amiodarone Sandoz Tab 200 mg who must undergo general anaesthesia, cases of atropine-resistant bradycardia, fall in blood pressure, conduction disturbances and reduced cardiac output have been observed.
In isolated cases, severe respiratory complications (shock lung, ARDS) occurred, usually directly after surgery. A possible increase in the toxic effect of oxygen has been assumed.
For this reason, the anaesthetist should be informed before surgery about therapy with Amiodarone Sandoz Tab 200 mg.
Storage
Store below 25°C. Protect from light.
MIMS Class
ATC Classification
C01BD01 - amiodarone ; Belongs to class III antiarrhythmics.
Presentation/Packing
Tab 200 mg (white, round, biconvex with one-sided scoreline) x 30's.
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