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Levamlodipine Besylate Tablets

China Levamlodipine Besylate Tablets, Find details about China West Medicine, Medicine from Levamlodipine Besylate Tablets

Model NO.
2.5mg
Pharmaceutical Technology
Chemical Synthesis
Drug Reg./Approval No.
H20093088
Trademark
Xin Ta
Transport Package
Box Carton
Specification
2.5mg
Origin
China
HS Code
3004909000
Model NO.
2.5mg
Pharmaceutical Technology
Chemical Synthesis
Drug Reg./Approval No.
H20093088
Trademark
Xin Ta
Transport Package
Box Carton
Specification
2.5mg
Origin
China
HS Code
3004909000
Levamlodipine Besylate Tablet

Generic name: Levamlodipine Besylate Tablets
Brand name:XinTa
Chemical Name: (S) - (-) - 3-Ethyl-5- methyl-2- (2-aminoethoxymethyl) -4- Methyl- 3,5- pyridinedicarboxylate besylate
Chemical Structure:
Levamlodipine Besylate Tablets
 
Molecular formula: C20H25 Cl N2O5·C6H6O3S
Molecular weight: 567.05
Description: White round Tablet.
Strength: 2.5mg
Indications: (1) hypertension; (2)Angina.
Dosage and Administration:
 (1) The initial dose for the treatment of hypertension and angina pectoris is 2.5 mg once a day. Depending on the patient's clinical response, the dose may be increased up to 5 mg once daily. 
(2) This product and thiazide diuretics, β-blockers and angiotensin converting enzyme inhibitors do not need to adjust the dose when combined.Adverse ReactionsAdverse reactions to patients with this product can be well tolerated.
(1) The less common side effects : headache, edema, fatigue, insomnia, nausea, abdominal pain, redness, heart palpitations and dizziness;
(2) rare side effects: itching, rash, difficulty breathing, weakness, muscle spasms and indigestion;
(3) similar to other calcium antagonists, with minimal adverse reactions to myocardial infarction and chest pain, and these adverse reactions can not be clearly distinguished from the patient's underlying disease;
(4) Have not found the laboratory-related parameters of this product abnormalities.
ContraindicationsDisable dihydropyridine calcium antagonist patients.
Precautions:
 (1) the use of impaired liver function, and all other calcium antagonists the same, the use of this product should be very careful when impaired liver function.
 (2) the use of renal failure patients, patients with impaired renal function can use the normal dose.
 (3) This product is not dialysis.
Pharmacology and toxicology:
(1) This product is calcium influx blockers (calcium channel blockers or calcium antagonists), block myocardial and vascular smooth muscle extracellular calcium ion through the cell membrane calcium channel(slow Channel) into the cell. 
(2) This product directly vasodilator smooth muscle, with anti-hypertensive effect. 
(3) The mechanism of relieving angina pectoris has not yet been fully determined, but it can reduce myocardial ischemia by a) expanding the peripheral arterioles and reducing the peripheral resistance(afterload), thereby reducing the myocardial energy expenditure and oxygen demand; b) Dilatation of
coronary arteries and coronary arteries in both normal and ischemic areas increases myocardial oxygen supply to patients with coronary artery spasm (variant angina).
(4) This product is metabolized for a long time in liver, and is the same with all other calcium antagonists.
It is very careful to use this product when liver function is damaged.
Pharmacokinetics:
 (1) According to the literature, oral administration of amlodipine besylate tablets, 6-12 hours plasma concentration reached its peak, the absolute bioavailability of about 64-80%, the apparent volume of distribution of about 21L / kg, terminal elimination half-life of about 35-50 hours.  Once a day, continuous administration of blood plasma concentration 7-8 days steady state, amlodipine besylate widely metabolized by the liver as inactive metabolites to 10% of the prototype drug and 60% of the metabolites by the urine Excretion, plasma protein binding rate of 97.5%. 
(2) According to the literature, 18 healthy volunteers once oral administration of 20mg racemic amlodipine, pharmacologically active levamlodipine and inactive dexamtrodipine average peak plasma concentration ratio of 47: 53, the average AUC ratio of 41:49.  The average terminal elimination half-life of levamlodipine
was 49.6 hours, and dexamlodipine was 34.9 hours. The half-life of elimination of amlodipine was significantly correlated with the half-life of levamlodipine.
Storage: Shading, sealed, cool place (no more than 20 ºC preservation.
Packing :Double aluminum blister packaging.  7Tablets/ Blister,14Tablet/box, 21Tablet/box.
Shelf-life: 24 months   
                                         
 

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