Amioxilto 200

Rx

Indications

• Indicated only for the treatment of severe rhythm disorders not responding to other therapies or when other treatments cannot be used.
• Tachyarrhythmias associated with Wolff-Parkinson-White Syndrome.
• Atrial flutter and fibrillation when other drugs cannot be used.
• All types of tachyarrhythmias of paroxysmal nature.

Dosage

Adults

• It is particularly important that the minimum effective dose be used.
• Initial stabilisation:
  Treatment should be started with 200 mg, three times a day and may be continued for 1 week. The dosage should then be reduced to 200 mg, twice daily for a further week.
• Maintenance:
  After the initial period, the dosage should be reduced to 200 mg daily, or less if appropriate. The scored 100 mg tablet should be used to titrate the minimum dosage required to maintain control of the arrhythmia. The maintenance dose should be regularly reviewed, especially where this exceeds 200 mg daily.

Specific populations

• Paediatric population
  The safety and efficacy of Amioxilto 200 in children has not been established.
• Elderly
  As with all patients it is important that the minimum effective dose is used. Particular attention should be paid to monitoring thyroid function.
• Hepatic impairment
  It is advisable to monitor liver function particularly transaminases before treatment and six monthly thereafter. Amioxilto 200 dose should be reduced or the treatment discontinued if the transaminases increase exceeds three times the normal range.
• Renal impairment
  Usual dosages can be used in patients with kidney failure.
  

Usage

Amioxilto 200 is for oral administration. The tablets can be taken before, during or away meals; crushing them does not change their properties.

• Sinus bradycardia and sino-atrial heart block. In patients with severe conduction disturbances (high grade AV block, bifascicular or trifascicular block) or sinus node disease, Amioxilto 200 should be used only in conjunction with a pacemaker.
• Evidence or history of thyroid dysfunction..
• Known hypersensitivity to iodine or to amiodarone, or to any of the excipients.
• Drugs which may induce torsades de pointes.
• Pregnancy – except in exceptional circumstances.
• Lactation.

Very common

• Corneal microdeposits usually limited to the area under the pupil, which are usually only discernable by slit-lamp examinations. They may be associated with colored halos in dazzling light or blurred vision. Corneal micro-deposits consist of complex lipid deposits and are reversible following discontinuation of treatment.
• Benign gastrointestinal disorders (nausea, vomiting, dysgeusia).
• Isolated increase in serum transaminases, which is usually moderate (1.5 to 3 times normal range), occurring at the beginning of therapy.
• Photosensitivity.

Common

• Bradycardia, generally moderate and dose-related.
• Hypothyroidism; hyperthyroidism, sometimes fatal.
• Constipation.
• Acute liver disorders with high serum transaminases and/or jaundice, including hepatic failure, which are sometimes fatal.
• Extrapyramidal tremor, for which regression usually occurs after reduction of dose or withdrawal; nightmares; sleep disorders.
• Pulmonary toxicity [hypersensitivity pneumonitis, alveolar/ interstitial pneumonitis or fibrosis, pleuritis, bronchiolitis obliterans organising pneumonia (BOOP)], sometimes fatal.
• Slate grey or bluish pigmentations of light-exposed skin, particularly the face, in case of prolonged treatment with high daily dosages; such pigmentations slowly disappear following treatment discontinuation; eczema.

• Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• As undesirable effects are usually dose-related, the minimum effective maintenance dose should be given.

Cardiac disorders

• Too high a dosage may lead to severe bradycardia and to conduction disturbances with the appearance of an idioventricular rhythm, particularly in elderly patients or during digitalis therapy.
• Treatment should be discontinued in case of onset of 2nd or 3rd degree A-V block, sino-atrial block, or bifascicular block.
• Before starting Amioxilto 200, it is recommended to perform an ECG and serum potassium measurement.

Severe bradycardia

• Cases of severe, potentially life-threatening bradycardia and heart block have been observed when Amioxilto 200 is used in combination with sofosbuvir in combination with another hepatitis C virus (HCV) direct acting antiviral (DAA).
• Patients receiving these hepatitis C medicines with Amioxilto 200, with or without other medicines that lower heart rate, should be warned of the symptoms of bradycardia and heart block and should be advised to seek urgent medical advice if they experience them.

Endocrine disorders

• Amioxilto 200 may induce hypothyroidism or hyperthyroidism, particularly in patients with a personal history of thyroid disorders.
• Amioxilto 200 contains iodine and thus may interfere with radio-iodine uptake.

Hypothyroidism

• Hypothyroidism should be suspected if the following clinical signs occur: weight gain, cold intolerance, reduced activity, excessive bradycardia.

Hyperthyroidism

• Hyperthyroidism may occur during Amioxilto 200 treatment, or, up to several months after discontinuation. Clinical features, such as weight loss, asthenia, restlessness, increase in heart rate, onset of arrhythmia, angina, congestive heart failure should alert the physician.
• In the case of hyperthyroidism, therapy should be withdrawn.

Eye disorders

• If blurred or decreased vision occurs, complete ophthalmologic examination including fundoscopy should be promptly performed. Appearance of optic neuropathy and/or optic neuritis requires amiodarone withdrawal due to the potential progression to blindness.

Hepato-biliary disorders

• Amioxilto 200 may be associated with a variety of hepatic effects, including cirrhosis, hepatitis, jaundice and hepatic failure.
• Patients should be advised to moderate their alcohol intake while taking Amioxilto 200.

Nervous system disorders

• Amioxilto 200 may induce peripheral sensorimotor neuropathy and/or myopathy. Both these conditions may be severe, although recovery usually occurs within several months after Amioxilto 200 withdrawal, but may sometimes be incomplete.

Respiratory, thoracic and mediastinal disorders

• Onset of dyspnoea or non-productive cough may be related to pulmonary toxicity (hypersensitivity pneumonitis, alveolar/interstitial pneumonitis or fibrosis, pleuritis, bronchiolitis obliterans organising pneumonitis).
• Patients should be carefully evaluated clinically and consideration given to chest X-rays before starting therapy.

Skin and subcutaneous tissue disorders

• Patients should be instructed to avoid exposure to sun and to use protective measures during therapy as patients taking Amioxilto 200 can become unduly sensitive to sunlight, which may persist after several months of discontinuation of Amioxilto 200.

Severe bullous reactions

• Life-threatening or even fatal cutaneous reactions Stevens-Johnson syndrome (SJS), Toxic Epidermal Necrolysis (TEN).

Drug interactions

• Concomitant use of Amioxilto 200 is not recommended with the following drugs: beta-blockers, heart rate lowering calcium channel inhibitors (verapamil, diltiazem), stimulant laxative agents which may cause hypokalaemia.
• Increased plasma levels of flecainide have been reported with co-administration of Amioxilto 200. The flecainide dose should be reduced accordingly and the patient closely monitored.