Amiodarone Hydrochloride Tablets for Atrial Arrhythmia

• Transport Package: Box
• Specification: 0.2g*10tab/box
• Trademark: FUL
• Origin: China
• Model NO.: FC50
• Production Capacity: 10000PCS/

Product Description

Item Name:Amiodarone HYdrochloride Tablets 
Molecular formula:C₂₅H₂₉I₂NO₃·HCl

Item Description

Item nanme:Amiodarone HYdrochloride Tablets 
Item character:This product is white

Indication:
1. Atrial arrhythmia (atrial flutter, atrial fibrillation conversion and maintenance of sinus rhythm after conversion).
2. Nodal arrhythmia.
3. Ventricular arrhythmia (treatment of life-threatening ventricular premature contraction and ventricular tachycardia and prevention of ventricular tachycardia or ventricular fibrillation).
4. Arrhythmia with W-P-W syndrome.
According to its pharmacological characteristics, amiodarone is suitable for the above arrhythmias, especially for patients with organic heart disease (coronary insufficiency and heart failure).

Item specifications: 0.2g*10tab/box

Usage and dosage:-Load: usually 600mg (3 tablets) a day, and can be used for 8-10 days continuously.
-Maintenance quantity: the minimum effective dose should be applied. According to individual reaction, 100-400mg can be given one day. Due to the extended therapeutic effect of amiodarone, 200mg or 100mg can be given every day. It is recommended that the treatment should be stopped for two days a week.

Adverse reactions
According to the system organ and incidence, the adverse reactions were classified
Very common (≥ 10%); common (≥ 1%, < 10%); uncommon (≥ 0.1%, < 1%); rare (≥ 0.01%, < 0.1%), very rare (< 0.01%).
Signs of eyes:
·Very common: corneal microprecipitation, which is almost common in adults, is usually confined to the area below the pupil and does not indicate contraindication for treatment. In exceptional cases, they may be accompanied by colored, dazzling halos or blurred vision. This corneal microprecipitation is composed of complex lipid deposits and is usually completely reversible after the cessation of amiodarone treatment.
·Very rare: optic neuropathy (optic neuritis) with blurred vision, decreased vision, and fundus papilledema. Visual acuity may be reduced more or less. At present, the relationship between this optic neuropathy and amiodarone has not been established. However, if there are any other obvious reasons, it is recommended to suspend amiodarone administration.
The signs of skin were as follows
Very common: photoallergic reaction. During amiodarone treatment, patients are advised to avoid exposure to sunlight (as well as ultraviolet light).
Common: during the daily high-dose long-term treatment, the patient's skin appears lavender or blue gray pigmentation; after the treatment stops, this pigmentation will slowly disappear (10-24 months).
Very rare:
·Erythema during radiotherapy.
·Rash, generally not very strong specificity.
·Exfoliative dermatitis, although the relationship between exfoliative dermatitis and amiodarone has not been established.
·Hair loss.
Rubella
Thyroid signs: 1
Very common:
·In the absence of any clinical signs of thyroid dysfunction, there can be "detached" thyroid hormone levels (increased T4, normal or slightly decreased T3), which do not require discontinuation of treatment.
Common:
·Hypothyroidism with typical manifestations: weight gain, chills, apathy, drowsiness; if there is a clear increase in TSH, it indicates the above diagnosis. Within 1-3 months after stopping amiodarone treatment, thyroid function can gradually return to normal: stopping treatment is not necessary. If there are justifiable indications for treatment, amiodarone therapy can be continued, and L-thyroxine replacement therapy can be combined with amiodarone therapy, and TSH level can be used as the guidance of dosage.
·Hyperthyroidism is more misleading: patients rarely have symptoms (mild unexplained weight loss, decreased effectiveness of anti angina and / or antiarrhythmic treatment): in elderly patients, it appears to be a form of psychosis, or even thyrotoxicosis.
·The decrease of hypersensitive TSH level can confirm this diagnosis. It is necessary to suspend amiodarone treatment: within 3-4 weeks, it is usually enough to achieve clinical recovery. Severe cases can lead to the death of patients, and need urgent and appropriate treatment.
·If thyrotoxicosis is considered, whether it is caused by thyroid itself or cardiac imbalance caused by thyroid, when the effect of synthetic antithyroid drugs is not constant, it suggests that corticosteroid (1mg / kg) should be used directly, and the treatment time should be long enough (3 months). Within a few months after the cessation of amiodarone treatment, hyperthyroidism was still reported.
The lung signs were as follows
Common: diffuse interstitial or alveolar lung disease and bronchiolitis obliterans with organizing pneumonia (BOOP) have been reported, and sometimes these diseases are fatal. If there is dyspnea or dry cough, whether single or combined with deterioration of general condition (fatigue, weight loss, fever), a radiologic control examination is required. If necessary, the treatment should be suspended. These forms of lung disease can actually develop into pulmonary fibrosis.
Early withdrawal of amiodarone can lead to the recovery of this disorder, regardless of whether it is related to corticosteroid treatment. Clinical signs usually disappear within 3 or 4 weeks. Radiology and functional improvement are usually slower (several months).
Some cases of pleurisy have been reported, which are generally associated with interstitial lung disease.
Very rare:
·Bronchospasm, especially in patients with asthma.
·Acute respiratory distress syndrome, sometimes fatal, sometimes immediately after surgery (it has been thought that there may be an interaction with high-dose oxygen) (see caution).
·Pulmonary hemorrhage
The neurological signs were as follows
Common:
·Tremor or other extrapyramidal symptoms.
·Sleep disorders at night.
·Sensory, motor or mixed peripheral neuropathy.
Unusual:
·Myopathy. Sensory, motor or mixed peripheral neuropathy and myopathy may occur several months after treatment, but sometimes several years after treatment. After stopping treatment, these diseases can generally recover. However, the recovery was incomplete and very slow, starting only a few months after the cessation of treatment.
Very rare:
·Cerebellar ataxia.
·Benign intracranial hypertension.
·Headache. If isolated headache occurs, the underlying cause needs to be systematically examined.
The liver signs were as follows
Cases of liver dysfunction have been reported: these cases can be diagnosed by elevated serum transaminases. The following diseases have been reported:
·Very common: the transaminase generally appears moderate and isolated increase (1.5-3 times of the normal value), which can be recovered after reducing the dosage, or even recover by itself.
·Common: acute liver damage, elevated blood transaminase and / or jaundice, occasionally fatal outcome, need to stop amiodarone treatment.
·Very rare: chronic liver damage during long-term treatment. Histological examination was consistent with pseudoalcoholic hepatitis. The clinical and biological characteristics of this disease show the characteristics of separation (irregular hepatomegaly, elevated blood transaminase, value between 1.5-5 times of normal value), which requires regular detection of liver function. If the level of serum transaminase is moderately increased after more than 6 months of treatment, the diagnosis of chronic liver damage should be considered. After cessation of treatment, clinical and biological disorders can usually be restored. There are also some cases of irreversible liver damage reported.
Cardiac effects:
·Common: generally moderate, dose-dependent bradycardia.
·Uncommon: conduction disorder (sinoatrial block, varying degrees of atrioventricular block). Arrhythmia attacks or worsens, sometimes with cardiac arrest.
·Very rare: significant bradycardia, very few reports of sinus arrest (sinoatrial node dysfunction, elderly patients).
Gastrointestinal effects:
·Very common: benign gastrointestinal disorders (nausea, vomiting, taste disorders) usually occur during initial treatment and disappear when the dosage is reduced.
Effects on reproductive system:
·Very rare: epididymitis, impotence. The relationship between the disease and amiodarone has not been established.
Vascular effect:
·Very rare: vasculitis.
Abnormal laboratory results:
·Very rare: renal impairment, moderate elevation of creatinine.
Effects on blood and lymphatic system:
·Very rare: thrombocytopenia, hemolytic anemia, aplastic anemia.
Endocrine effect:
·Very rare: syndrome of inappropriate antidiuretic hormone secretion (SIADH)

Taboo:
·Sinus bradycardia without pacing therapy and sinus atrial block;
·Sinus node disease without pacing treatment (with the risk of sinus arrest);
·High atrioventricular block without pacing therapy;
·Hyperthyroidism, due to amiodarone may lead to the deterioration of hyperthyroidism;
·Known allergy to iodine, amiodarone or excipients thereof:
·In the second and third trimester of pregnancy:
·Lactating women:
·The tendency of torsade de pointe may be induced by the combination of the following drugs
-La antiarrhythmic drugs (fquinidine, hydroquinidine, propidium).
-Sichuan antiarrhythmic drugs (sotalol, dofetilide, ibutilide).
-Other drugs, such as benprodil, cisapride, diphenylmeron, erythromycin F, mizolastine, moxifloxacin, spiramycin (intravenous), vinorelbine (intravenous), etc. (see Pharmacopoeia)
The interaction of two substances.
-Shutobili
-Psychodepressant, pentamidine (for injection).

Matters needing attention:
Special warning
[u] Heart effect
·ECG examination and serum potassium examination must be carried out before treatment. Transaminase and ECG monitoring are recommended during treatment.
·In elderly patients, the effect of bradycardia may be more prominent.
·Amiodarone can modify ECG. This "darrone" modification includes the prolongation of QT interval, which reflects the prolongation of repolarization and may be accompanied by U Wave: it is a sign of reaching therapeutic concentration, not a toxic effect.
·If there is degree II or III atrioventricular block, sinoatrial block or double branch block, the treatment should be suspended. If there is first degree atrioventricular block, intensive care is needed.
·It has been reported that in the application of amiodarone, new arrhythmias can occur, and the original arrhythmias that have been treated may worsen (see adverse reactions).
·The arrhythmogenic effect of amiodarone is weak, even smaller than that of various antiarrhythmic drugs. The arrhythmogenic effect is generally seen in combination with some drugs (see drug interaction), or in electrolyte imbalance.
·Especially in the long-term use of antiarrhythmic drugs, there are reports of ventricular defibrillation threshold and / or pacemaker pacing threshold or implantable cardioverter defibrillator defibrillation threshold increase. These treatments are potentially affected. Therefore, it is recommended to reconfirm the role of implanted devices before and during amiodarone treatment.
[u] Thyroid signs
·The presence of iodine in drugs interferes with some thyroid tests (binding with radioactive iodine, PBI); however, thyroid function assessment is still possible (T3, T4, tshus).
·Amiodarone can cause thyroid abnormalities, especially in patients with a history of thyroid disease. Before treatment, it is recommended to conduct TSH analysis for all patients, and then conduct TSH analysis regularly during treatment and within a few months after treatment. TSH analysis is also required when thyroid dysfunction is suspected clinically (see adverse reactions).
[u] Lung signs: [/ u] if dyspnea or dry cough occurs, either alone or in combination with deterioration of general condition, it indicates that pulmonary toxicity (such as interstitial lung disease) may occur, and a radiologic control examination is required (see adverse reactions).
[u] Liver signs: [/ u] regular monitoring of liver function is recommended at the beginning of amiodarone treatment, and then, regular monitoring of liver function should be carried out throughout amiodarone treatment (see adverse reactions).
[u] Neuromuscular signs: [/ u] amiodarone can cause sensory, motor or mixed peripheral neuropathy and myopathy (see adverse reactions).
[u] Signs of the eye: [/ u] in case of blurred vision or decreased visual acuity, complete ophthalmic assessment, including fundus observation, must be performed immediately. In the case of amiodarone induced neuropathy or optic neuritis, it is necessary to stop amiodarone treatment because of the risk of progression to blindness (see adverse reactions).
In combination with the following drugs (see drug interactions)
·It can be combined with β - blockers, but not with sotalol (contraindication). It needs preventive measures to combine with esmolol.
·The combination of verapamil and diltiazem should be considered only in the prevention of life-threatening ventricular arrhythmias.
·Due to the presence of lactic acid, the drug is contraindicated in patients with congenital galactosemia, glucose and galactose malabsorption syndrome or lactase deficiency.
Special considerations for application
·Electrolyte disturbance, especially hypokalemia: pay attention to the situation prone to hypokalemia, because hypokalemia may promote the occurrence of proarrhythmic effect.
Hypokalemia should be corrected before amiodarone administration.
·The adverse effects mentioned below are usually associated with excessive drug levels, which can be avoided or minimized by strictly selecting the minimum maintenance dose.
·During treatment, patients should be advised to avoid exposure to sunlight, or take solar protection measures.
The safety and efficacy of amiodarone in children have not been evaluated in controlled clinical trials.
Anesthesia: the anesthesiologist should be informed that the patient is receiving amiodarone treatment before surgery. As far as adverse reactions are concerned, chronic amiodarone makes general anesthesia or local anesthesia prone to hemodynamic instability, including bradycardia, hypotension, decreased cardiac output and conduction disorders. In addition, some cases of acute respiratory distress syndrome have been observed in patients treated with amiodarone immediately after surgery. Therefore, these patients should be closely observed during artificial respiration (see adverse reactions).

Medication for pregnant and lactating women:
Pregnancy: animal studies did not show any teratogenic effects of the drug. Because the drug lacks teratogenic effect in animals, it is expected that the drug has no teratogenic effect in human body. So far, research in human and animal has shown that the abnormal substances in human body also show teratogenic effect in animals.
In clinical cases, there is not enough data to assess the potential teratogenic effects of amiodarone for the first three months of pregnancy.
Since the 14th week of amenorrhea, the thyroid gland of fetus begins to combine with iodine, and no effect on fetal thyroid is expected in previous application. Therefore, after this period, the iodine overload caused by the application of this drug can cause the biological or clinical hypothyroidism of fetus.
Therefore, this drug is forbidden to be used in three months and three months after pregnancy.
Lactation: Amiodarone and its metabolites and iodine can be secreted in milk, and its concentration is higher than that in maternal plasma. Because of the risk of hypothyroidism in newborn, breastfeeding is forbidden in the case of the


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