Item Name:Amlodipine besylate tablets
Molecular formula:C20H25N2O5Cl⋅C6H6O3S
Item Description
Item nanme:Amlodipine besylate tablets
Item character:This product is white
Indication:
1. Hypertension
This product is suitable for the treatment of hypertension. It can be used alone or in combination with other antihypertensive drugs.
2. Coronary heart disease (CAD)
chronic stable angina
This product is suitable for symptomatic treatment of chronic stable angina pectoris. It can be used alone or in combination with other anti angina drugs.
Vasospasm angina pectoris (Prinzmetal's or variant angina pectoris)
This product is suitable for the treatment of confirmed or suspected vasospasm angina pectoris. It can be used alone or in combination with other anti angina drugs.
Coronary heart disease confirmed by angiography
This product can reduce the risk of hospitalization due to angina pectoris and the risk of coronary artery reconstruction in patients with coronary heart disease confirmed by angiography but with ejection fraction ≥ 40% and no heart failure.
Item specifications: 5mg*28tab/box
Usage and dosage:Adult: usually, the initial dose of this product for the treatment of hypertension is 5mg, once a day, and the maximum dose is 10mg, once a day. For patients with small stature, weakness, old age, or liver dysfunction, the initial dose is 2.5mg, once a day; this dose can also be used in combination with other antihypertensive drugs.
The dose adjustment should be based on the individual response of patients. The general dose adjustment should start after 7-14 days. If clinical needs, in the case of close monitoring of patients, the dose can be adjusted more quickly.
The recommended dose for the treatment of chronic stable or vasospasm angina pectoris is 5-10mg once a day. For the elderly and patients with liver dysfunction, a lower dose is recommended. The effective dose for most patients is 10mg once a day.
The recommended dose for the treatment of coronary heart disease is 5-10mg once a day. In clinical studies, most patients need a dose of 10 mg / day (see [clinical trials]).
Adverse reactions
Adverse events in clinical trials
Because the conditions of clinical trials are very different, the incidence of adverse reactions observed in clinical trials of one drug can not be directly compared with that of another drug, and may not reflect the incidence observed in clinical practice.
The safety of this product has been confirmed in clinical studies in the United States and other countries, involving more than 11000 patients. In general, the patients were well tolerated within the daily dose of 10mg. Most of the adverse reactions reported during the treatment were mild or moderate. In the clinical study of 10mg of amlodipine (n = 1730), which was directly controlled with placebo (n = 1250), only 1.5% of the patients in amlodipine group stopped taking the drug due to adverse reactions, and there was no significant difference compared with the placebo group (about 1%). The most common side effects were headache and edema.
Cardiovascular system: arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, hypotension, peripheral ischemia, syncope, tachycardia, postural dizziness, postural hypotension, vasculitis.
Central and peripheral nervous system: hypoesthesia, peripheral neuropathy, paresthesia, tremor, vertigo.
Gastrointestinal system: loss of appetite, constipation, dyspepsia * *, dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia.
General: allergic reaction, fatigue * *, back pain, hot flashes, general discomfort, pain, stiffness, weight gain, weight loss.
Musculoskeletal system: arthralgia, arthropathy, muscle spasm * *, myalgia.
Psychiatry: sexual dysfunction (male * * and female), insomnia, neuroticism, depression, dream disorders, anxiety, personality disorders.
Respiratory system: dyspnea * *, epistaxis.
Skin and appendages; vascular edema, erythema multiforme, pruritus * *, rash * *, erythema, maculopapular.
**In placebo-controlled studies, the incidence of these events was less than 1%, but in all multi dose studies, the incidence of these side effects was between 1% and 2%.
Paresthesia: visual abnormalities, conjunctivitis, diplopia, eye pain, tinnitus.
Urinary system: frequent urination, dysuria, nocturia.
Autonomic nervous system: dry mouth, sweating.
Nutrition metabolism: hyperglycemia, thirst.
Hematopoietic system: leukopenia, purpura, thrombocytopenia.
The incidence of the following events was less than 0.1%: heart failure, arrhythmia, premature beat, skin discoloration, urticaria, dry skin, alopecia, dermatitis, myasthenia, twitching, ataxia, myotonia, migraine, cold skin, apathy, excitement, forgetfulness, gastritis, increased appetite, loose stool, cough, rhinitis, dysuria, polyuria, dysosmia, taste, vision Mediate abnormalities and dry eyes.
Other incidental adverse reactions are difficult to distinguish from the effects of combined drugs or associated diseases, such as myocardial infarction or angina pectoris.
There was no significant change in routine laboratory test data in amlodipine treatment. Serum potassium, blood glucose, triglyceride, total cholesterol, high density lipoprotein cholesterol, uric acid, urea nitrogen or creatinine had no clinical changes.
In the Camelot and present studies (see [clinical trial]), the adverse reactions were similar to those reported previously (see above). Peripheral edema is the most common adverse event.
Post IPO Report
Because these reactions are voluntarily reported by a population with an unknown sample size, it is not possible to reliably evaluate the frequency or determine the causal relationship with drug exposure.
The following events in post marketing use are rarely reported, and the correlation with the drug has not been determined: male breast enlargement. In the post marketing application, it has been reported that patients with jaundice and transaminase significantly increased due to the use of amlodipine (mostly consistent with biliary obstruction or hepatitis) and need hospitalization.
No other safety issues were found in amlodipine besylate: chronic obstructive pulmonary disease, well compensated congestive heart failure, coronary heart disease, peripheral vascular disease, diabetes and dyslipidemia.
Taboo:
It is forbidden for patients allergic to amlodipine.
Matters needing attention:
1. Hypotension
Symptomatic hypotension may occur, especially in patients with severe aortic stenosis. Because the vasodilating effect of this product is gradually produced, the occurrence of acute hypotension after taking this product is rarely reported.
2. Aggravation of angina pectoris or myocardial infarction
A small number of patients, especially those with severe coronary artery occlusion disease, may have angina pectoris deterioration or acute myocardial infarction when they begin to use amlodipine besylate or increase the dosage.
3. Withdrawal of beta blockers
Because amlodipine is not a beta blocker, it can not provide effective protection for the risk of beta blocker withdrawal; any beta blocker should be withdrawn gradually.
4. Use for patients with impaired liver function
Because this product is metabolized by the liver, and the plasma clearance half-life (T1 / 2) of patients with liver dysfunction is 56 hours, it should be slowly increased in patients with severe liver dysfunction.
Medication for pregnant and lactating women:
Pregnancy classification C (FDA classification)
There was no sufficient and well controlled study in pregnant women. Amlodipine can only be used during pregnancy if the potential benefits exceed the potential risk to the fetus.
No teratogenic or other embryo / fetal toxicity was found when pregnant rats and rabbits received amlodipine 10 mg / kg / day (based on mg/m[sup]2[/sup] conversion, respectively, 8 times of the maximum recommended dose of 10 mg and 23 times of the maximum recommended dose of human beings [calculated according to the weight of the patient] respectively). However, in rats treated with amlodipine maleate (10 mg amlodipine / kg/ day) for 14 days before mating, during the entire mating and pregnancy, a significant decrease in the number of nests (about 50 per cent) and a significant increase in the number of deaths in the uterus (about 5 times) were observed. It has been proved that amlodipine maleate can prolong the pregnancy and delivery period of rats at this dose.
It is not known whether the product can be secreted through milk, and the lactation women taking medicine should stop breastfeeding.
FAQ
1.who are we?
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.
2. how can we guarantee quality?
Always a pre-production sample before mass production;
Always final Inspection before shipment;
3.what can you buy from us?
Pharmaceutical production lines,Intermediates,APIs,Finished Drug Preparations & Vaccines.
4. why should you buy from us not from other suppliers?
We have our own manufacture factories and one professional sales team working for the clients all over the world.
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1. Skilled experience: Our company is a leading manufacturer of professional production in China pharmaceutical field for many years.
2. The highest quality: to ensure high quality, once any problems are found, the package will be re-shipped for you.
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Our Manufacture Factory
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 such as SINOPHARM, 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 SINOPHARM 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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