AMIOHEXAL. 200 mg. 20 tablets
- Life-threatening ventricular tachycardia (fast heart beat): treatment is performed in a hospital setting under medical supervision .
AMIOHEXAL. 200 mg. 20 tablets
What is the active ingredient?
1 tablet contains 200 mg amiodarone hydrochloride.
What else contain AmioHEXAL 100 mite tablets?
Lactose monohydrate, magnesium stearate, corn starch, povidone (K25), highly dispersed silicon dioxide.
Pharmaceutical form and content:
Original package containing 20, 50 and 100 tablets.
What AmioHEXAL 100 mite tablets?
Medicine for the treatment of cardiac arrhythmias (antiarrhythmic class III).
- Life-threatening ventricular tachycardia (fast heart beat): treatment is performed in a hospital setting under medical supervision;
- Established symptomatic and disabling ventricular tachycardia;
- Established supraventricular tachycardia, if clearly needed treatment or contraindications to other treatments;
- Ventricular fibrillation.
Treatment of supraventricular tachycardia, a slow heart rate in atrial fibrillation or atrial flutter.
When you must not take AmioHEXAL 100 mite tablets?
AmioHEXAL100 mite does not have to be administered to:
- Sinus bradycardia (heart rate below 55 beats per minute)
- All forms of detention holding (sino-atrial block and nodal), including sinus node disease, AV-block N and 111 degree (partial or complete interruption of conduction chambers) and hip (bifastsikularni and trifastsikularni) blocks if you use a pacemaker
- Pre-existing prolonged QT-interval
- Reduced level of potassium in the blood
- Allergies to iodine hypersensitivity to the drug or any of the excipients
- Concomitant treatment with MAOIs
- Concomitant treatment with products inducing "torsades de pointes" as:
* Class la antiarrhythmic drugs (quinidine, hydroquinidine, disopyramide)
* Class III antiarrhythmic drugs (sotalol, dofetilide, ibutilide, etc.).
* Other drugs such as bepridil, cisapride, diphemanil, parenteral erythromycin, mizolastine, sparfloxacin and others.
What special precautions should be taken?
Before starting treatment with this product should make sure you do eleetrokardiofama.
In ventricular arrhythmias adaptation antiarrhythmic product requires careful monitoring of cardiac function and may be held if there is equipment for emergency cardiology and possible cardiac monitoring. During treatment should be conducted checkups at regular intervals (for example, standard ECG intervals of 1 month, continuous ECG intervals of three months and ECG during exercise). It is of therapeutic verification in the deterioration of some parameters, for example during prolonged QRS-or QT-time by more than 25%, PQ-time by more than 50%, the QT-interval prolongation of more than 500 ms or increasing the number or severity of of aritmiite.EKG-changes that are manifested with prolonged QT-time (depending on the prolonged repolarization), probably associated with the occurrence of U-wave, and elongated and deformed T-wave show pharmacological activity of AmioHEXAL 100 mite. When excessive prolongation of the QT-interval have an increased risk of "torsades de pointes". There is an increased risk of partial or complete interruption of conduction chambers (II, Ill-degree AV-block), interruption of conduction to the atria (SA-block) or femoral (bifastsikularen) block and require discontinuation of treatment. AV-block, first-degree warranting closer nablyudenie.Narusheniyata electrolyte balance and in particular Low levels of potassium in the blood is important to imatpredvid, because the latter can cause arrhythmia. Before starting the use of amiodarone decreased potassium levels should be adjusted. Chronic treatment with amiodarone may lead to increased side effects in relation to the risk of bleeding of general and local anesthetics, especially slow heart rate, low blood pressure, decreased cardiac output, conduction abnormalities.
During treatment with 100 AmioHEXAL mite must perform regular eye examinations by an eye specialist, including a view of the fundi and research with slit lamp (see "Undesirable effects").
When treated with 100 AmioHEXAL mite should avoid exposure to sunlight; This applies also to UV-light and solarium. If this is impossible, having skin that is exposed to this influence, especially that of the person to be coated with sunscreen with a high SPF.
Because of the risk of disturbances in the function of the thyroid gland (increased or decreased function of the thyroid gland) in the treatment of mite AmioHEXAL 100 is necessary to conduct tests prior to initiating therapy. During treatment and one year after breaking her patients should be reviewed at regular intervals and examined for clinical signs of hyperthyroidism and hypothyroidism. AmioHEXAL 100 mite inhibits the conversion of thyroxine (T4) in a triiodothyronine (T3), and may lead to increased levels of T4 and decreased levels of T3 in the clinical attention neprivlichashti patients with normal thyroid function. The establishment of such changes do not necessarily lead to discontinuation of treatment. Clinical diagnosis of hypothyroidism should be confirmed by rising silnochuvstvitelniya hormone TSH and decreased levels of T4. In hypothyroidism proven dosage should be reduced if possible and to start replacement therapy with L-thyroxine. In some cases it may be necessary to discontinue treatment with AmioHEXAL100 mite. The clinical diagnosis was confirmed by hyperthyroidism demonstrating decreased levels of silnochuvstvitelniya TSH hormone and increased levels of T3 and T4. In hyperthyroidism proven AmioHEXAL100 mite dose should be reduced if possible to discontinue the product. In severe cases, you should begin treatment with thyreostatics, beta-blockers and / or corticosteroids. Because the iodine content AmioHEXAL100 mite gives erroneous results in the classical iodine-binding assays for thyroid.
When treated with 100 AmioHEXAL mite risk of developing severe inflammatory lung diseases (allergic pneumonitis, interstitial or alveolar pneumonitis). Therefore prior to treatment should be initiated chest X-ray and functional studies of the lung. These studies must be carried out in about 3-6 months. . They must be made and difficulties in breathing (symptoms of possible pulmonary toxicity). In patients with severe lung disease must often be monitored lung function since its in their prognosis of pulmonary toxicity is worse. When proven hypersensitivity pneumonitis treatment AmioHEXAL 100 mite is interrupted immediately and begin therapy with proven kortikosteroidi.Pri alveolar / interstitial pneumonia proceed to treatment with corticosteroids and to reduce the dose of 100 AmioHEXAL mite or, if possible, its application is interrupted.
Liver values are to be monitored at regular intervals of time, especially at higher doses. In cases of chronic clinically significant elevated liver enzymes, congestive jaundice or elevated liver is necessary to consider discontinuation.
Other products that impact the effect of mite AmioHEXAL 100 tablets or can be influenced by the product?
Co-administration of 100 AmioHEXAL mite and cardiac glycosides may lead to disturbances in automaticity (severe bradycardia) and abnormal atrioventricular conduction due to synergistic effects of both produkta.Ednovremennoto application AmioHEXAL 100 mite and digoxin may lead to increased serum digoxin levels (due to reduced clearance of digoxin). These patients should pay attention to the symptoms of digoxin overdose and as a precaution plasma digoxin levels be determined. If necessary, the dose should be 100 korigirana.AmioHEXAL mite may enhance the anticoagulant effect of vitamin K antagonist (eg warfarin, phenprocoumon) and significantly increase the risk of bleeding. Thus, during and after treatment with AmioHEXAL100 mite should be monitored frequently at the time Quick and to adjust the doses of antagonists of vitamin K. In the case of application AmioHEXAL100 mite and phenytoin (a medicine for the treatment of seizures) it is possible to increase in plasma levels of phenytoin and phenytoin symptoms of overdose (eg, visual disturbances, tremor, dizziness). At the onset of such symptoms is necessary to reduce the dose of phenytoin. Phenytoin levels should be determined. AmioHEXAL 100 mite can increase serum levels of cyclosporin and its decrease the clearance of more than 50%. Therefore, the application of the two products both have correct doses of cyclosporine. AmioHEXAL mite 100 may increase the serum levels of other antiarrhythmics (quinidine, procainamide, flecainide). There is a risk of a significant prolongation of QT-time in combination with an increased risk of ventricular arrhythmias including "torsades de pointes", when used in conjunction with class antiarrhythmics \ (such as quinidine and disopyramide) and class 111 (e.g., sotalol), and and other drugs that prolong the QT-time (eg vincamine, sulpiride, pentamidine iv and erythromycin iv). Therefore, concomitant use of these products is 100 protivopokazano.AmioHEXAL mite may increase plasma levels of inhibitors of cholesterol synthesis. When treated with high doses of simvastatin (80 mg / day) increased risk of developing disease musculoskeletal (myopathy). Therefore, combination therapy doses of simvastatin should not exceed 20 mg / day. Concomitant administration of potassium-wasting 'water products (such as hydrochlorothiazide, furosemide), laxatives, systemic corticosteroids, or tetrakozaktit iv amphotericin B and AmioHEXAL 100 mite increases the risk of arrhythmias induced by low potassium levels (including "torsades de pointes").
Concurrent administration of 100 AmioHEXAL mite and calcium channel blockers such as verapamil or diltiazem or the beta-blockers may result in severe bradycardia, high grade abnormalities in atrial-ventricular conduction, and additional effects of suppression of cardiac activity. Calcium channel blockers such as verapamil, diltiazem and should not be combined with AmioHEXAL mite.Pri 100 patients treated with 100 AmioHEXAL mite and subjected to general anesthesia, have been described occasionally atropine-resistant low heart rate, fall in blood pressure, abnormal in conducting and decreased cardiac debit.V some cases, mainly after surgical procedures were observed serious complications of the respiratory system (shock lung, respiratory distress syndrome in adults). It is assumed as enhancing the toxic effect of oxygen. The anesthetist should be informed about the application of AmioHEXAL100 mite before operatsii.Molya aware that this information applies to the recently adopted products.
What foods and spices you should avoid?
No evidence of foods and spices should be avoided.
What special precautions should be taken during pregnancy and lactation?
There is insufficient data on safety in the use of the product during pregnancy. The most common complications include growth failure, premature birth, and the thyroid gland. Because of the long half-life of amiodarone hydrochloride women who want to become pregnant should plan their pregnancy as early as six months after stopping treatment to avoid exposing children to risk in the early stages of bremennostta.Ako is imperative treatment lactation or amiodarone hydrochloride was administered during pregnancy, the mother to refrain from breast feeding as the active ingredient passes into breast milk and reaches effective concentrations in the child.
What to be aware when driving or operating machinery or insecure (eg climbing stairs)?
Treatment with this medicine requires regular monitoring. Even when the drug was administered as recommended, it is possible to change the reactivity and impair the ability to drive, operate machinery or uncertain polozhenie.Tova is especially true for the beginning of therapy, increasing the dose or changing the product and in combination with alcohol.
Dose, route and duration of administration:
Unless otherwise prescribed by AmioHEXAL 100 mite by your doctor recommended the following daily dosage. Please adhere to the instructions for use, as otherwise the product will not work properly!
How much and how often you can take AmioHEXAL 100 mite tablets?
The dosage must be individualized with respect to the therapeutic success. The following dosages: saturation dose: 600 mg amiodarone hydrochloride (corresponding to 6 tablets AmioHEXAL100 mite) daily for 8-10 days. In cases in which the necessary doses of up to 1200 mg amiodarone hydrochloride, saturation is achieved with the tablets of 200 mg, as necessary 6 tablets of 200 mg.Sled switching to the maintenance dose of 200 mg amiodarone hydrochloride (corresponding to 2 tablets AmioHEXAL100 mite) within 5 days of the week. In some cases during long-term therapy requires the administration of higher doses of 200-400 mg per day amiodarone hydrochloride (corresponding to 2-4 tablets AmioHEXAL100 mite). Special Note: Since most of the side effects are dose-dependent, must apply the minimum effective maintenance dose.
When and how you can take AmioHEXAL100 mite tablets?
The tablets should be taken during or after a meal, not chewed and a sufficient amount of liquid.
How long you can apply AmioHEXAL100 mite tablets?
The duration of treatment is determined by the attending physician.
What should I do if AmioHEXAL100 mite tablets was adopted in very large quantities (intentional or unintentional overdose)?
In case of overdose expected AmioHEXAL100 mite inform your doctor. It will determine the appropriate measures depending on the symptoms. Intoxication and / or in case of serious symptoms require emergency medical pomosht.Ogranichena the information of acute overdose with AmioHEXAL100 mite. Total overdose is possible during prolonged therapy, due to the specific ???????????????.?????????? symptoms are limited to sinus slow heartbeat, abnormal transmission of impulses in the atria or chambers and spontaneous tachycardia. Slowing of the pulse resulting from the application of AmioHEXAL100 mite is resistant to treatment with atropine. It may therefore not require a temporary pacemaker. In the event of an expected overdose the patient should be observed for long periods due pharmacokinetics of amiodarone hydrochloride in cardiac monitoring. Amiodarone hydrochloride and its metabolites are not dialysable.
What should you do if you take more than the prescribed dose AmioHEXAL100 mite tablets or you forget to take the product?
Do not take double or multiple dose after one or more omitted single dose and resume treatment with the prescribed dose.
What you should know if you have discontinued or have it terminated prematurely? AmioHEXAL100 mite treatment may be interrupted or terminated after consulting a doctor.
What side effects can cause application AmioHEXAL 100 mite tablets?
Most of the patients are found mikrootlaganiya on the front surface of the cornea. Usually they extend to the edge of the pupil, and sometimes lead to visual disturbances (blurred vision, visual spots). These disturbances disappeared 6-12 months after discontinuation of AmioHEXAL100 mite.Saobshteni few cases of inflammation of the optic nerve, which led to permanent blindness in some cases. During treatment with AmioHEXAL100 mite must be performed regular eye examinations by a specialist (including a view of the fundi and research with slit lamp).
Rarely observed photosensitivity with increased tendency to sunburn, which can lead to redness and obrivi.Pri prolonged therapy skin area exposed to direct sunlight are highly pigmented and acquire black-violet or dark gray (psevdotsianoza). Reversibility of this adverse reaction takes place very slowly (1-4 years) after discontinuation of terapiyata.Dokladvani cases of redness in radiotherapy. Also reported cases of nodular rash, rare specific rash, rare cases of skin exfoliation.
AmioHEXAL100 mite blocking the conversion of thyroxine (T4) to triiodothyronine (T3), and may lead to increased levels of T4 and decreased levels of T3 in the clinical attention neprivlichashti (euthyroid) patients. Rarely disturbances in the function of the thyroid gland (increased and decreased thyroid function).