Amiodarone Hydrochloride Tablets for Atrial Arrhythmia

• Transport Package: Box
• Specification: 0.2g*10s/box
• Trademark: FUL
• Origin: China
• Model NO.: YP166
• Production Capacity: 10000PCS/ Month

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 in patients with organic heart disease (coronary insufficiency and heart failure).

Item specifications:0.2g*10s/box

Usage and dosage:Load: usually 600mg (3 tablets) a day, which can be used continuously for 8-10 days.
-Maintenance dose: the minimum effective dose should be used. According to the individual reaction, 100-400mg can be given every day. Due to the prolonged therapeutic effect of amiodarone, 200mg can be given every other day or 100mg can be given every other day. It has been recommended to discontinue the drug for two days a week.

Adverse reactions
Adverse reactions were classified according to system organs and incidence, and the classification of occurrence frequency was as follows:
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 limited to the area below the pupil and does not suggest a contraindication for treatment. In exceptional cases, they may be accompanied by colored dazzling halos or blurred vision. This corneal microprecipitation consists of complex lipid deposition and is usually completely reversible after cessation of amiodarone treatment.
·Very rare: optic neuropathy (optic neuritis) with blurred vision, decreased vision and fundus optic papilledema. Visual sensitivity 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.
Signs of skin:
Very common: photoallergic reaction. During amiodarone treatment, patients are advised to avoid exposure to sunlight (and ultraviolet light).
Common: lavender or bluish gray pigmentation on the patient's skin during daily high-dose long-term treatment; After treatment is stopped, this pigmentation will slowly disappear (10-24 months).
Very rare:
·Erythema during radiotherapy.
·Rash generally has no very strong specificity.
·Exfoliative dermatitis, although the relationship between exfoliative dermatitis and amiodarone has not been established.
·Hair loss.
Rubella

Taboo:
Sinus bradycardia and sinoatrial block without pacing;
·Sinus node disease without pacing treatment (with risk of sinus arrest);
·High atrioventricular block without pacing;
·Hyperthyroidism, because amiodarone may lead to the deterioration of hyperthyroidism;
·Known allergy to iodine, amiodarone or excipients therein:
·Middle and last trimester of pregnancy:
·Lactating women:
·The combination of the following drugs may induce the tendency of torsade de pointe ventricular tachycardia:
-La class antiarrhythmic drugs f quinidine, hydroquinidine and propitiamine).
-Sichuan antiarrhythmic drugs (sotalol, dofelide, ibutilide).
-Other drugs, such as benpridil, cisapride, diphenylmeron, erythromycin f (intravenous administration), mizolastine, moxifloxacin, spiramycin (intravenous administration), vinblastine (intravenous administration), etc. (see drugs)
Substance interaction).
-Sutobili
-Psychodepressant, pentamidine (for injection).

Matters needing attention:
Special warning
[u] Cardiac effect [/ u]
·ECG examination and serum potassium examination must be carried out before treatment. It is recommended to monitor transaminase and ECG during treatment.
·In elderly patients, the heart rate slowing effect may be more prominent.
·Amiodarone can modify ECG. This "reachable dragon" modification includes the extension of QT interval, which reflects the extension of repolarization and can be accompanied by U Wave: This is a sign of reaching therapeutic concentration, not toxic effect.
·If there is grade II or III atrioventricular block, sinoatrial block or double branch block, the treatment should be suspended. If grade I atrioventricular block occurs, intensive monitoring is needed.
·It has been reported that in the application of amiodarone, new arrhythmias can occur, and the previously existing and treated arrhythmias may deteriorate (see adverse reactions).
·The antiarrhythmic effect of amiodarone is weak, even smaller than that of various antiarrhythmic drugs. The antiarrhythmic effect is generally seen in the combination with some drugs (see drug interaction), or in electrolyte balance disorder.
·Especially in the long-term use of antiarrhythmic drugs, there are reports of elevated ventricular defibrillation threshold and / or pacemaker pacing threshold or implantable cardioverter defibrillator defibrillation threshold. Potentially affecting the above treatment. Therefore, it is recommended to reconfirm the role of implant devices before and during amiodarone treatment.
[u] Thyroid signs [/ u]
·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 the treatment process and within a few months after the cessation of treatment. TSH analysis is also required in case of clinically suspected thyroid dysfunction (see adverse reactions).
[u] Lung signs: [/ u] if there is dyspnea or dry cough, whether alone or in combination with the deterioration of the general state, it indicates that there may be pulmonary toxicity (such as interstitial lung disease), which requires radiological control examination (see adverse reactions).
[u] Liver signs: [/ u] regular monitoring of liver function is recommended at the beginning of amiodarone treatment, and then liver function should be monitored regularly 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 eyes: [/ u] in case of blurred vision or decreased visual acuity, a complete ophthalmic assessment must be carried out immediately, including fundus observation. If amiodarone induced neuropathy or optic neuritis occurs, it is necessary to stop amiodarone treatment due to the risk of progression to blindness (see adverse reactions).
Combined use with the following drugs (see drug interactions):
·Can be associated with β Combination of receptor blockers, but not with sotalol (contraindication), combination with esmolol requires preventive measures.
·Combination with verapamil and diltiazem should only be considered 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 precautions for application
·Electrolyte disorder, 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 their severity can be 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: before the patient receives surgical treatment, the anesthesiologist should be informed that the patient is receiving amiodarone treatment. In terms of adverse reactions, chronic amiodarone makes people under general or local anesthesia prone to hemodynamic instability, including bradycardia, hypotension, decreased cardiac output and conduction disorder. 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 have not shown any teratogenic effects of the drug. Since the drug lacks teratogenic effect in animals, it is expected that the drug has no teratogenic effect in humans. So far, studies in humans and animals have shown that substances causing malformations in humans also show teratogenic effect in animals.
In clinical cases, there are not enough data to evaluate the possible teratogenic effects of amiodarone during the first three months of pregnancy.
Since the fetal thyroid begins to combine with iodine from the 14th week of amenorrhea, there is no expected effect on the fetal thyroid in previous applications. Therefore, after this period, the iodine overload caused by the application of this drug can cause fetal biological or clinical (thyroid gland swelling) hypothyroidism.
Therefore, this drug should not be used during the third and last three months of pregnancy.
Lactation: Amiodarone, its metabolites and iodine can be secreted in milk, and its concentration is higher than that in maternal plasma. Due to the risk of neonatal hypothyroidism, breastfeeding is contraindicated when using this drug.

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We are based in Fujian, China, start from 2000,sell to North America(40.00%),Southeast Asia(25.00%),Western Europe(25.00%),Africa(10.00%).There are total about 50 people in our office.

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Fuzhou FUL Fluid Equipment & Pharmaceutical Co., Ltd is a comprehensive enterprise which integrates R & D, production and construction of pharmaceutical production equipments, development and transfer of biotechnology, and cooperative production and sales of drugs and vaccines. The self-developed pharmaceutical production equipment branded FUL has been put into operation in many well-known pharmaceutical enterprises, CSPC and also cooperates with many well-known pharmaceutical enterprises in production and sales, including pharmaceutical intermediates, APIs and finished drug preparations.

Fuzhou FUL Fluid Equipment & Pharmaceutical Co., Ltd business radiates to all levels, including direct supply cooperation with government departments and industry representatives, as well as establishing supply cooperation relationship with retail industry. We supply high quality, safe and effective medicines and medical equipment to governments, hospitals, clinics and licensed pharmacies in different countries with timely and effective services at reasonable prices.

At present Fuzhou FUL Fluid Equipment & Pharmaceutical Co., Ltd has the  authorization to sell its intermediates and APIs,and has the authorizations of CSPC & HUABEI PHARM sell its finished drug preparations;then FUL is the only manufacture in China which can supply the complete service from pharmaceutical produciton lines,intermediates and APIs to finished drug preparations and vaccines.Then we are seeking the professional pharmaceutical enterprices to work together for further cooperations.




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