AMDEPIN DUO CADILA CADILA TRECE TREATMENT OF LIPIDIA DISEASE, Hypertension (10 blisters x 10 tablets)
Dosage form Box of 10 blisters x 10 tablets
Specifications Atorvastatin, amlodipine
Ingredient Cadila
Ingredient
| Composition information | Content |
| Atorvastatin | 10mg |
| Amlodipine | 5mg |
Uses
Indications
AMDEPIN DUO can use a combination dose of 1 -tablet to start treatment for patients with lipid disorders accompanied by hypertension or angina. The recommended dose when using a combined tablet is based on a combination dose when using a single tablet. Dark dose multi -calculated according to amlodipine in combination tablets is 10mg/1 time/day. The maximum dose according to Atorvastatin in the combination tablet is 80mg/time/day.
amlodipin
Hypertension: Amlodipine is indicated for treating hypertension. Drugs are indicated individually or in combination with other hypertension medications.
Stable angina: Amlodipine is indicated for stable chronic angina treatment, in the case of treatment of angina due to vastractive spasms that have been identified or suspected, and treat hypertension. Can use amlodipine individually or in combination with anti -angina or other hypertension drugs.
Angina due to coronary vasodilation (Prinzmetal angina or angina): Amlodipin is prescribed to treat angina due to coronary spasms that have been identified or suspected. Can use amlodipine separately or in combination with other anti -angina drugs.
atorvastatin
Increased heterozygic cholesterol of family or no: Atorvastatin is indicated to support diets to reduce total cholesterol, LDL-C, VLDL-C, APO B, TG and to increase HDL-C in hypercholesterol patients with primary blood cholesterol (hypercastological hyperlymer hypertension with family or not) and mixed blood lipid lipid disorders ( llb).
Serum hyperplasia: Atorvastatin is indicated to support diets to treat patients with high TG levels (tube IV).
dysbetalipoproteinemia: Atorvastatin is indicated to treat patients with Dysbetalipoproteinemia first (tube III) that they do not respond well to diet therapy.
Increased clinical cholesterol of family properties: Atorvastatin is indicated for treatment support for total cholesterol reduction therapy and LDL-C in patients with hyperplastomic hyperplasia patients with family nature (such as cholesterol therapy in diet), or when there is no appropriate therapy
Pediatric patients: Atorvastatin is indicated for treatment to support diet to reduce total cholesterol, LDL-C and APO B in boys and girls when they begin to have menstruation, 10-17 years old, suffer from cholesterol hyperplasia due to family zygote, after trying all diet measures without responding to the desired.
Pharmacokic
PEOPLE contains 1 calcium channel blocker Dihydropyridin (amlodipin) and a 3-hydroxy-3-methylutaryl coenzymic inhibitor (HMG-COA Reductase inhitior) (Atorvastatin).
amlodipin
Amlodipin is a derivative of dihydropyridine that has a calcium blocker through cell membranes. Amlodipine blocks calcium type L -type calcium depends on the voltage, acting on the blood vessels in the heart and muscle.
Amlodipine has anti -hypertension effects by directly relaxing smooth muscles around the peripheral artery and has less effect on the heart muscle calcium channel. Therefore, the drug does not conduct the atrial transmission in the heart worse and does not adversely affect muscle contraction force. Amlodipine also works well as reducing kidney blood vessels, thus increasing blood flow in the kidneys and improving kidney function. So the drug can also be used to treat people with heart failure.
Amlodipin has no adverse effects on plasma lipid concentrations or glucose metabolism, so it can be used amlodipine to treat hypertension in people with diabetes. However, there are no long -term clinical trials to prove that Amlodipine has the effect of reducing death, in many countries, the standard treatment to protect patients with hypertension from stroke and death is still beta and diuretics, these drugs are first selected for treatment. However, Amlodipin can be used in combination with beta blockers along with thiazid or diuretics and with angiotensin conversion enzyme inhibitors. Amlodipine works well when standing, lying as well as sitting and while working. Because amlodipine is slowly acting, there is less risk of acute or reflective hypotension.
Anti -angina effect: Amlodipin relaxes peripheral arteries, thus reducing the entire obstacle in the peripheral circuit (after the burden of the burden). Because the heart frequency is not affected, the post -burden of the heart reduces the heart, along with reducing the need for oxygen and energy to the heart muscle. This reduces the risk of angina. In addition, Amlodipine also causes coronary artery dilatation both in ischemic area and the area is provided with normal blood. This vasodilation increases the supply of oxygen for patients with cramped angina (Prinzmetal angina). This reduces the demand for nitroglycerin and by in this way, the risk of nitroglycerin resistance may decrease. The time for anti -angina effect is 24 hours. People with angina can use amlodipine in combination with beta blockers and always use with nitrate (basic treatment of angina).
atorvastatin
Atorvastatin inhibits HMG-COA Reductase and the synthesis of liver cholesterol, while increasing the low density lipoprotein receptor (LDL) on the cell surface, thus reducing plasma concentrations of cholesterol and lipoprotein.
Atorvastatin reduces total cholesterol. LDL-C, APOB in patients with genetically increased cholesteol (homozygous or heterozygous family properties), cholesterol hypercondition is not family nature and mixed blood lipid metabolism disorders. Atorvastatin also reduces VLDL-C TG and creates an uneven increase of HLDL-C and Apolipoprotein A1. Atorvastatin reduces total cholesterol. LDL-C, VLDL-C, APO B, TG, and Non-HLDL-C and increased HLDL-C in patients with high triglycerides. Atorvastatin reduces cholesterol of lipoprotein average (IDL-C) in people with dysbetalipoproteinemia.
Clinical trials show that the dosage of amlodipine once a day, the systolic blood pressure decreased by 12-13 mmHg and diastolic blood pressure decreased by 7-6mmHg with statistical significance.
Atorvastatin clinical experiments at 10-80 mg dose caused a decrease of 29% -45% of total cholesterol, 39% -60% LDL-C, 19% -37% TG and 5% -9% HDL-C after 6 weeks of treatment for patients with hyperplasia.
The combination of both drugs effectively reduces blood pressure and reduces LDL-C depends on the dose and does not change the effect of any ingredient compared to when using each individual substance.
pharmacokinetic
After drinking, amlodipine reaches the top concentration of plasma within 6 to 12 hours. Atorvastatin reaches a peak plasma concentration within 1 to 2 hours.
Absolutely bioavailability of Amlodipin is estimated at about 64%to 90%, of Atorvastatin about 14%
About 93% amlodipine and> 98% Atorvastatin attached to plasma proteins.
Amlodipine is strongly metabolized (about 90%) in the liver into the non -active substance. Atorvastatin is strongly metabolized in the liver by the enamel system of Cytochrom P450 3A4 into Ortho and Parahydroxy derivatives.
Amlodipin is excreted through 10% in the original form of compound, 60% is a substance with the sale time of about 30 to 50 hours, Atorvastatin has a selling time of about 14 hours with 98% of the dosage excreted through bile.
Both Amlodipine and Atorvastatin show the increase in plasma concentrations in the elderly (30% to 64%) and need to have a lower starting dose than normal.
Before taking AMDEPIN DUO CADILA CADILA TRECE TREATMENT OF LIPIDIA DISEASE, Hypertension (10 blisters x 10 tablets)
How to use
Oral drugs.
Dosage
Use 1 capsule/day at any time not dependent on meals.
The drug has two forms of 5mg of amlodipine combination with 10mg or 20mg atorvastatin.
Dosage of 1 -tablet combination type needs to be suitable for each individual based on the effectiveness of treatment and tolerance for each substance when used individually while treating hypertension/ angina and lipid disorders, or as directed by the doctor.
Simultaneous use of statin lipid medications with HIV and hepatitis C (HCV) can increase the risk of muscle damage, the most serious muscle, kidney damage leads to renal failure and can be fatal. The recommended dosage is as follows:
• Telaprevir
• Lopinavir + ritonavir
• Fosamprenavir,
• Fosamprenavir + ritonavir,
• Saquinavir + ritonavir.
• NELFINAVIR What to do when overdose? The lag of prolonged blood pressure may be prolonged and including death shock.
Absorbing amlodipine significantly decreases when using activated carbon immediately or until 2 hours after taking Amlodipin 10mg in healthy volunteers. In some cases, the stomach may need. In cases of severe amlodipine hypotension, the positive cardiovascular support measures are required, including regular monitoring of cardiovascular and respiratory functions, high limbs and pay attention to the volume of circulation and urine.
can use vasoconstrictor drugs to restore vascular tone and blood pressure, as long as the patient does not have the contraindication to use the drug. Calcium gluconate can be injured to reduce the effect of calcium channel blockers. Because amlodipine is heavily connected to plasma proteins, the appraisal does not bring results in this case.
Atorvastatin: There is no specific treatment when overdose Atorvastatin, so when suspected overdose, patients need symptoms and apply necessary supportive measures.
Due to the strong drug associated with plasma proteins, hemorrhage is not significantly reduced atorvastatin levels.
In an emergency, call the 115 emergency center immediately or go to the nearest local health station.
What to do when forgetting 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.
Side Effects
When using AMDEPIN DUO often has unwanted effects (ADR) such as:
amlodipin
Atorvastatin
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
AMDEPIN DUO drugs are contraindicated in the following cases:
Precautions when using
The type of combination of 1 tablet contraindicated for patients who are allergic to any component of the drug.
amlodipin
Use in patients with heart failure.
In a long-term study of placebo-verification (praise-2) using amlodipine in patients with heart failure due to anemia, level III and micro-classification of NYHA (New York Heart Association), Amlodipin is reported to be related to an increase in pulmonary edema.
Used in patients with liver function impairment.
Like all other calcium channel blockers, Amlodipine's exhaust time is prolonged in patients with impaired liver function, so it is necessary to be used cautiously in this patient.
Used for patients with renal failure:
Amlodipine is broadly transformed into non -active substances with 10% eliminated in a constant form in the urine. Amlodipine plasma changes are not related to the level of renal failure. Amlodipin can be used for these patients in normal doses. Amlodipin cannot be appraised.
Used for the elderly:
Time reaches the maximum concentration in amlodipin's plasma in the elderly is the same as young people. Amlodipine clearance tends to decrease, thus resulting in an increase in AUC and the semi -disposal time in the elderly. The increase in AUC and the sale time in patients with congestive heart failure is also suitable for forecasts in patients in the research age group. Amlodipin used in the same dose for the elderly and young people are also well tolerated. Therefore, the usual dosage can also be used for the elderly.
Use for children:
Not known the effectiveness of amlodipine on blood pressure in patients under 6 years old.
Atorvastatin
Effects on the liver: monitor the liver function before starting treatment and in case of clinical indications for testing later.
Mechanical effects: Treatment with muscle pain, muscle disease and rarely occur acute muscle pepper. Creatine kinase (CK) should be monitored when patients have any manifestations of muscle disease such as muscle pain, muscle weakness, cramps.
Before treatment, CK tests should be conducted in the following cases: impaired renal function, hypothyroidism, self -history or family history of genetic muscle disease, a history of muscle disease due to the use of statin or fibrat before, a history of liver disease and/or drinking lots of alcohol, elderly patients (> 70 years old) with risk factors for muscle patterns, drugs that occur with special patients.
In these cases, it is necessary to consider benefits/risks and monitor patients clinically when treated with statin. If the results of CK test> 5 times the upper limit of normal levels, do not start treatment with statin.
During statin treatment, patients need to notify when there are muscle manifestations such as muscle pain, muscle stiffness, muscle weakness, ... When these manifestations, patients need to do CK test to take appropriate interventions.
Due to the increased risk of muscle disease when treating HMG-CAA Reductase inhibitors with cyclosporin, Fabric acid derivatives, erythromycin, niacin or antifungal group Azol, should be cautious when indicated to combine these drugs and monitor the symptoms and signs of muscle disease in the early stage of treatment or the time of changing the dose of each drug. In these cases, CPK can be tested but it does not prevent the occurrence of serious muscle disease.
Due to the risk of acute muscle pattern (such as acute infections, hypotension, surgery, injury, excessive metabolism, hormonal and electrolyte disorders and uncontrolled convulsions) lead to secondary renal failure, temporarily stop or stop the use of drugs when the patient has any significant signs of muscle disease. The simultaneous use of statin lipid medications with HIV and hepatitis C (HCV) can increase the risk of injury, the most serious is the muscle pattern, kidney damage leads to kidney failure and can cause from death.
The effect of the drug on driving and operating machinery
amlodipine may affect the ability to operate machinery, due to some symptoms such as aches, dizziness, fatigue ..., need to be cautious when starting treatment with amlodipine.
Using drugs for women during pregnancy and lactation
Amlodipine safety in pregnant and breastfeeding people has not been established. Amlodipine is not toxic in animal reproductive studies, except for slowing labor and prolonging mouse delivery time with a dose of 50 times higher than the recommended dose for humans. Therefore, it is advisable to use amlodipine during pregnancy when there is no safer replacement and when the disease itself contains greater risks for mothers and embryos. Do not use for breastfeeding women.
Contraindicated amlodipine and Atorvastatin during pregnancy and during breastfeeding.
Drug interaction
amlodipin
Anesthesia increases the anti -hypertension effect of amlodipine and can make blood pressure more sharply.
Lithi when used with amlodipine, can cause nerves, nausea, vomiting, diarrhea. Non -steroid anti -inflammatory drugs, especially indomethacin, can reduce the anti -hypertension effect of amlodipine due to prostaglandin synthesis and/or keep sodium and fluid.
High -linked drugs with protein (such as Coumarin, Hytantoin ...) must be used to be careful with amlodipin, because amlodipine is also highly linked to protein, the concentration of the above drugs is free (non -linked), can change in serum.
atorvastatin
Increased risk of muscle disease during treatment when combining HMG-CoA Reductase inhibitors with cyclosporin, Fabric acid derivatives, erythromycin, niacin or antifungal group Azol.
Antacid: Antacid causes the plasma concentration of Atorvastatin to decrease by about 35% when used in combination, but does not reduce LDL-C.
Antyrin: Atorvastatin does not affect the pharmacokinetics of antipipin nor interact with the metabolic drugs through cytochrom iszym.
Colestipol: Atorvastatin concentration decreases 25% when combining Atorvastatin with Colestipol, but LDL-C decreases more than when only one of the two drugs.
cimetidine: No change in cubic concentration in plasma and LDL-C when combined with cimetidin with Atorvastatin.
Digoxin: When taken at the same time, Atorvastatin and prolonged digoxin can cause the concentration in plasma digoxin to increase by about 20%, so because it is necessary to apply the appropriate monitoring measure.
erythromycin, clarithromycin: when combined can increase the concentration of Atorvastatin in plasma.
Oral contraceptive: When combining oral contraceptive pills with Atorvastatin can lead to an increase in AUC of Norethididid and Ethinyl Estradiol are about 30% and 20% respectively, so it is necessary to choose the appropriate contraceptive for women who are using Atorvastatin.
Warfarin: Atorvastatin hardly affects prothrombin with chronic patients treated with warfarin.
Increased risk of muscle damage when used simultaneously with drugs: gemfibrozil and other fibrat blood cholesterol, high -dose niacin (> 1 g/day) and Colchicin.
Simultaneous use of statin lipid medications with HIV and hepatitis C (HCV) can increase the risk of muscle damage, the most serious muscle, kidney damage leading to kidney failure and may be fatal.
The recommended dosage is as follows:
Interactive protease inhibitors
Statistics recommendations
• Telaprevir
Avoid using Atorvastatin
Use carefully and if necessary, the lowest dose of Atorvastatin
• Fosamprenavir,
• Fosamprenavir + ritonavir,
• Saquinavir + ritonavir.
Not more than 20 mg atorvastatin/day
• Nelfinavir
Not more than 40 mg atorvastatin/day
Storage
Leave a cool place, avoid light, temperature below 30⁰C.
To be out of reach of children.
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