Amlodipine Stada 5mg tab Treatment of hypertension, angina (10 blisters x 14 tablets)
Dosage form Box of 10 blisters x 14 tablets
Specifications Amlodipine
Ingredient High blood pressure, angina
Ingredient
| Composition information | Content |
| Amlodipine | 5mg |
Uses
Indications
Amlodipin Stada 5mg is indicated in the following cases:
Amlodipine's blood pressure lowering mechanism is due to the effect of direct relaxation of blood vessel muscles. Amlodipine's exact mechanism reduces angina has not been fully determined, but Amlodipine reduces the overall anemia burden due to the following two effects:
The mechanism of action of amlodipine may also include the relaxation of the main coronary arteries and coronary arteries, both in anemia and normal areas. This vasodilation increases the supply of oxygen to the heart muscle in patients with coronary artery spasms (Prinzmetal angina or angina variables) and reduces smoking coronary spasms.
In patients with hypertension, one -time dose/day shows a significant hypotension in both lying and standing in the 24 -hour dose. Due to the slow -on -effect trigger, fasting blood pressure is not one of the effects of amlodipine.
In patients with angina, the use of amlodipin once a day increases the overall exertion time, the starting time of angina and time until the 1mm ST segment inhibitors and reduces both the frequency of angina and reduces the use of nitroglycerin tablets.
Not found that amlodipine is related to any adverse effects on metabolism or changes in plasma lipids and amlodipine suitable for use in patients with asthma, diabetes and gout.
Used in patients with coronary artery disease
The effectiveness of amlodipine in preventing clinical events in patients with coronary artery disease has been assessed in an independent, multi -central, random, double -blindly, control, amlodipin and enalapril in limiting the appearance of thrust (Camelot). The results show that amlodipine treatment is associated with reducing cases of hospitalization due to angina and performing tricks in patients with coronary artery disease.
Used in patients with heart failure
Hemodynamic studies and clinical trials are based on exertion tests in patients with heart failure II - IV according to NYHA showing that amlodipine does not lead to clinical decline, based on the ability to withstand exertion activities, blood emulsion of left ventricular ventricular and clinical symptoms. A place for a place to use a fatal control (praise) designed to evaluate patients with heart failure III - IV according to NYHA using digoxin, diuretics and ACE inhibitors show that Amlodipine does not lead to an increase in mortality or a combination of mortality rates and illnesses in patients with heart failure.
In the next study, there is a place to use a place where long-term monitoring (praise-2) about amlodipine in patients with heart failure III and IV according to NYHA without clinical symptoms or without objective results suggesting hidden ischemic disease, with stable dose of ACE inhibitors, heart failure and diuretic, non-mortality or death rates. On the top of this research complex, Amlodipine is related to the increase in the recognition of cases of lungs, although there is no significant difference in the proportion of cases of more severe heart failure between the group using amlodipine compared to the placebo group.
Use on children (6 to 17 years old)
The effect of amlodipine on children with hypertension from 6 to 17 years old is shown in a random drug test, placebo, double blindness, for 8 weeks on 268 patients with hypertension. All patients are randomly divided into the treatment branch of 2.5mg or 5mg and are monitored for 4 weeks, then they are randomly selected to continue using 2.5mg or 5mg of Amlodipine or placebo for another 4 weeks. Compared to the initial time, treated once a day with amlodipin 5mg reduces the systolic and diastolic blood pressure. The average reduction of systolic blood pressure in a placebuilded sitting position is estimated at 5.0 mmHg for amlodipine 5mg and 3.3 mmHg dose for 2.5mg amlodipine dose. Group analysis shows the effectiveness of younger children from 6 to 13 years old is equivalent to the older children from 14 to 17 years old.
pharmacokinetics
absorption/distribution
After taking treatment doses, Amlodipin is well absorbed with peak concentration in plasma reaching about 6 to 12 hours after drinking. Absolute bioavailability is estimated at 64 % - 80 %. The distribution volume is about 21L/kg. Amlodipine absorption is not affected by food. In vitro studies show that about 97.5 % amlodipine in the circulation is attached to plasma proteins.
Metabolism/excretion
Amlodipin's plasma semi -discharged time ranges from 35 to 50 hours and is suitable for daily dosage daily. The concentration of the constant state in plasma is achieved after 7 to 8 days of continuous medication. Amlodipine is metabolized in liver into liver into non -active metabolites, with 10 % of the original substance and 60 % of the metabolic substance eliminated through the urine.
Used in the elderly
Time to reach the peak concentration of amlodipine plasma is the same between the elderly and young people. However, Amlodipine's clearance tends to decrease with an increase in the area under the curve (AUC) and the sale time in elderly patients. The area under the curve and the sale time in patients with congestive heart failure (CHF) also increased as expected in the age group.
Use in children
In a long -term clinical study, 73 patients with hypertension from 12 months of age to less or 17 years old are used amlodipine at an average daily dose of 0.17mg/kg. The clearance of the objects weighing the average weight of 45kg is 23.7L/hour and 17.6L/hour respectively in men and women. This index is similar to the announced estimates of 24.8L/hour in adults 70kg. The average estimated distribution volume for a 45kg patient is 1130L (25.11L/kg). Observing the effect on blood pressure is maintained throughout the 24 -hour dose, with a small difference of the effect of variation at the top and the bottom. When compared to the existing information about pharmacokinetics in adults, these research parameters show that the one -time daily dose is appropriate.
Before taking Amlodipine Stada 5mg tab Treatment of hypertension, angina (10 blisters x 14 tablets)
How to use
Take oral use.
Dosage
Adults
For hypertension and angina, the normal starting dose is 5mg of amlodipine once a day, which can increase to the maximum dose of 10mg once a day depending on the response of each patient.
In patients with hypertension, Amlodipin has been used simultaneously with thiazid diuretics, alpha blockers, beta blockers or angiotensin -shaped enzyme inhibitors. For angina, amlodipine can be used in monomers or at the same time with other anti -angina drugs on patients with angina resistant to nitrate derivatives or appropriate beta blockers. It is not necessary to adjust the amlodipine dose in case of simultaneous use with thiazid diuretics, alpha blockers, beta blockers or enzyme inhibitors in the form of angiotensin.
Special subjects
Elderly
The ability to tolerate elderly and young patients is the same when using the same amlodipine dose. The usual dose is recommended for the elderly, and should be cautious when increasing the dose.
Patients with liver function impairment
The recommended dose has not been set in patients with mild to medium liver failure; Therefore, the dose should be careful and the treatment begins with the lowest doses effectively. Amlodipine pharmacokinetic properties have not been studied in cases of severe liver failure. Should start using amlodipine from the lowest dose and increasing slowly in patients with severe liver failure.Patients with renal failure
The change of amlodipine concentration in plasma is not related to the level of renal failure; Therefore, the usual dosage recommendations. Amlodipin cannot be appraised.
children and teenagers
Children and teenagers from 6 to 17 years old with hypertension
The oral hypertension starting dose is recommended in children from 6 to 17 years old, 2.5mg once a day, then can be increased to 5mg once a day if the desired blood pressure has not been achieved after four weeks. The doses higher than 5mg once daily have not been studied in children. Amlodipine dose cannot be divided by 2.5mg for this form of preparation, the proposal to use other cell format has the appropriate content.
Children under 6 years old
No data.
Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.
What to do when overdose?
In case of overdose in large quantities can cause peripheral vessels and may be accompanied by tachycardia. There is a report on strong hypotension, prolonged and including death shock.
How to handle overdose drugs
Amlodipine absorption decreases significantly when indicating activated carbon right after or within 2 hours after taking Amlodipin 10mg in healthy volunteers. In some cases, the stomach may need. In cases of severe hypotension due to the use of amlodipine overdose, positive cardiovascular support measures are needed, including regular monitoring of cardiovascular and respiratory functions, high limbs and attention to circulating volume and urine amount.
Can use a vasoconstrictor to recover blood vessel tone and blood pressure, as long as the patient does not have the contraindication to use the drug. Calcium gluconate intravenous injection can be reversed to reverse the effect of calcium channel blockers. Because amlodipine is heavily connected to plasma proteins, the appraisal does not bring results in this case.
What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.
Side Effects
When using Amlodipin Stada 5mg, you may experience unwanted effects (ADR).
Common (1/100 ≤ ADR
Uncommon (1/1,000 ≤ ADR
Nervous system disorders: increase muscle tone, reduce tactile/paresthesia, peripheral neuropathy, unconsciousness, taste disorders, tremor, pagan system disorders.
Respiratory, chest and mediastinum disorders: cough, shortness of breath, rhinitis.
Gastrointestinal disorders: Change the habit of going out, dry mouth, indigestion (including gastritis), hyperplasia, pancreatitis, vomiting.
Disorders of musculoskeletal and connective tissue: joint pain, muscle pain, cramps, back pain.
Rare (1/10,000 ≤ ADR
Very rare (ADR
Myocardial infarction, arrhythmia (including slow rhythm, tachycardia, atrial fibrillation), chest pain.
Pediatric 6 - 17 years old
Vascular disorders: vasodilation. Respiratory, chest and mediastinum disorders: nosebleeds. Digestive disorders: abdominal pain. Most of the desired effects in children are usually mild or medium. Instructions on how to handle ADR Notice immediately to the doctor or pharmacist the harmful reactions encountered when using the drug.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Contraindicated use amlodipine in the following patients:
Precautions for use
Use in patients with heart failure
In a long-term study of placebo-verified (Praise-2 research) using amlodipine in patients with heart failure due to anemia, III and IV according to the New York Heart Association (NYHA), amlodipine is reported to be related to the increase in pulmonary edema ratio. However, there is no significant difference in the proportion of patients with heart failure more serious in the amlodipine group than the placebo group (see the pharmacological characteristics).
Used in patients with impaired liver function
Like all other calcium channel blockers, Amlodipine's waste time is prolonged in patients with liver function impairment and recommended doses for these patients have not been set up. Therefore, Amlodipin needs to be used cautiously in these patients.
Pills containing starch, patients allergic to flour (except for coeliac) should not use this drug.
The ability to drive and operate machinery
Amlodipine may have a slight or medium impact to the ability to drive, operate machinery. If the patient uses amlodipine dizziness, headache, fatigue or nausea, their reaction ability may be impaired. Patients need to be carefully warned, especially from the beginning of treatment.
Pregnancy
Amlodipin's safety in pregnant women has not been established. Amlodipine is not toxic in animal reproductive studies, except for slowing labor and prolonging the rat time at a dose of 50 times higher than the recommended dose for maximum use in humans. Therefore, it is recommended to use amlodipine during pregnancy when there is no safer replacement measure and when the disease itself contains greater risks for mothers and embryos. There is no effect on the ability to conceive on mice using amlodipine.
Breastfeeding period
Amlodipin safety in breastfeeding women has not been set. Experience used on humans shows that Amlodipin has passed through breast milk. The median concentration ratio of amlodipine in milk/plasma in 31 women who are breastfeeding has hypertension due to pregnancy is 0.85 after using amlodipine at the starting dose of 5mg once daily, this dose is adjusted if needed (average daily dose and daily dose in the form of weight are 6mg and 98.7 mcg/kg. 4.17mcg/kg.
Drug interaction
Amlodipin has been shown to be safe to use with diuretics of thiazid group, alpha blockers, beta blockers, angiotensin enamel inhibitors, long -lasting nitrate, glyceryl trinitrate under the tongue, non -steroid anti -inflammatory drugs, antibiotics
In vitro data from plasma studies have shown that amlodipine does not affect the cohesion of plasma proteins of research drugs (digoxin, phenytoin, warfarin or indomethacin).
Simvastatin
Use multiple doses of 10mg of Amlodipine simultaneously with 80mg of simvastatin increases 77 % of exposure rate with simvastatin compared to only simvastatin. For patients with amlodipine, the dose limit of simvastatin is 20mg/day.
Grapefruit juice
Simultaneous use 240ml of grapefruit juice with a single dose of 10mg of amlodipine in 20 healthy volunteers does not significantly affect Amlodipin's pharmacokinetics. This research does not allow the test of the effects of genetic diversity of CYP3A4, the main enzyme is responsible for transforming amlodipine; Therefore, it is not advisable to use amlodipine along with grapefruit or grapefruit juice because bioavailability can increase in some patients leading to increased hypotension effect.
CYP3A4 inhibitors
Simultaneously use 180mg of diltiazem daily doses with 5mg of amlodipine in the elderly (69 - 87 years old) with hypertension increases 57% of the system exposure rate with amlodipine. Simultaneously used with erythromycin on healthy volunteers (18 - 43 years old) does not significantly change the exposure rate of system infection with amlodipine (up 22 % under the curve under the curve of blood concentration of blood drugs over time [AUC]). Although clinically related to these studies are not sure, pharmacokinetic changes may be more pronounced in elderly patients. Strong inhibitors CYP3A4 (such as ketoconazole, otraconazole, ritonavir) may increase the concentration of amlodipine in the blood larger than the diltiazem. Should be cautious when using amlodipine along with CYP3A4 inhibitors.
Clarithromycin
Clarithromycin is a CYP3A4 inhibitor. The risk of increased hypotension in patients using clarithromycin along with amlodipine. Should monitor patients closely when using simultaneously amlodipine with clarithromycin.
CYP3A4 induction substances
There is currently no data on the effects of CYP3A4 induction substances on amlodipine. Simultaneous use with CYP3A4 induction substances (such as rifampicin, hypericum perforatum) can reduce amlodipine levels in plasma. Should be cautious when using amlodipine along with CYP3A4 induction substances. In the following studies, there is no significant change in pharmacokinetics of amlodipine or other drugs in the study when used in combination.
Special studies
The effect of other drugs on amlodipin
cimetidine
Simultaneous use amlodipine and cimetidine does not change the pharmacokinetics of amlodipine.
Aluminum/Magnesi salt (stomach acid neutralization)
Concentrated use of antacids is aluminum salt and magnesium salt with a single dose of amlodipine does not significantly affect the pharmacokinetics of Amlodipin.
Sildenafil
Use a single dose of 100mg of Sildenafil in objects with idiopathic hypertension does not affect the pharmacokinetic parameters of Amlodipin. When used in combination with amlodipine and sildenafil, each drug has its own lowering effect.
The effect of amlodipine on other drugs
Atorvastatin
Simultaneously use 10mg of amlodipine with 80mg of Atorvastatin does not significantly change the pharmacokinetic parameters of Atorvastatin in a stable concentration state in plasma.
digoxin
Simultaneous use of amlodipine with digoxin does not change the concentration of digoxin in plasma or the renal clearance of digoxin in healthy volunteers.
Ethanol (alcohol)
Use single -dose or multi -dose 10mg of amlodipine does not significantly affect the pharmacokinetics of ethanol.
warfarin
Simultaneous use amlodipine with warfarin does not change the time of prothrombin inhibitors of warfarin.
cyclosporin
There is no study of drug interaction between cyclosporin and amlodipine in healthy volunteers or other groups of subjects except for kidney transplant patients. Different studies in kidney transplant patients show that simultaneous use of amlodipine with cyclosporin affects the bottom concentration of cyclosporin from unchanged to an average increase of 40%. Consider to monitor cyclosporin levels in kidney transplant patients using amlodipine.
tacrolimus
There is a risk of increased blood tacrolimus concentration when used simultaneously with amlodipine. To avoid the toxicity of tacrolimus, when using amlodipine in patients treated with tacrolimus, it is necessary to monitor the concentration of Tacrolimus in the blood and adjust the tacrolimus dose if appropriate.
Mechanical goals of Rapamycin inhibitors (MTOR)
Mtor inhibitors such as syrolimus, temsirolimus, and Everolimus are CYP3A substrate. Amlodipine is a weak CYP3A inhibitor. When used simultaneously with MTor inhibitors, Amlodipine can increase the exposure of MTOR inhibitors.
Interactions between drugs and biochemical tests
Not known.
Storage
Store in a dry place, avoid light, temperatures below 30 ° C.
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