Pymme-AM5 pymepharco medicine for hypertension (10 blisters x 14 tablets)
Dosage form Box of 10 blisters x 14 tablets
Specifications Amlodipine
Ingredient
| Composition information | Content |
| Amlodipine | 5mg |
Uses
indications
Pymme AM5 drugs are indicated in the following cases:
Amlodipine's hypotension 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.
Dynamic pharmacokinetics
absorption
After taking the doses of treatment, Amlodipin is well absorbed with peak concentration in plasma reaching about 6 - 12 hours after drinking.
Absolute bioavailability is estimated at about 64 - 80%.
Distribution
The distribution volume is about 21 l/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 and elimination
Amlodipin's plasma semi -discharged time is about 35 - 50 hours and suitable for the dosage 1 time/day.
The concentration in the state of plasma is achieved after 7-8 days of continuous drug use.
Amlodipin is metabolized mostly in the liver into non -active metabolites, with 10% of the initial substance and 60% of metabolic substances are excreted in the urine.
Before taking Pymme-AM5 pymepharco medicine for hypertension (10 blisters x 14 tablets)
How to use
pyme AM5 uses oral.
Dosage
Adults
For hypertension and angina, the normal starting dose is 5 mg/time/day, which can increase to a maximum dose of 10 mg/time/day depending on the response of each patient.
In patients with hypertension, amlodipine 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 simultaneously with other anti -angina drugs on patients with angina resistant to nitrate derivatives and/or appropriate beta blockers.
No need 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 the elderly and young patients is the same when using the same amlodipine dose. Recommendation of the usual dosage and should be cautious when increasing the dose.
Patients with hepatic failure: 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. Amlodipine should be started from the lowest doses and increases 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 is recommended. Amlodipin cannot be separated.
Children and teenagers
Children and teenagers from 6 to 17 years old with hypertension dose on anti -hypertension oral hypertension is recommended in children from 6 to 17 years old is 2.5 mg/time/day, then can be increased to 5 mg/time/day if the desired blood pressure has not been achieved after four weeks. Doses higher than 5 mg/time/day have not been studied in children.
Children
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 do
do when overdose? There is a report on blood pressure drop, may be prolonged and including death shock ..
Amlodipine absorption decreases significantly when indicating activated carbon right after or within 2 hours after taking Amlodipin 10 mg 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 should be taken, including regular monitoring of cardiovascular and respiratory functions, high limbs and pay attention to the volume of circulation and urine.
Can use a vasoconstrictor to recover blood vessels and blood pressure, as long as the patient does not have contraindicated use of the drug.
can be intravenous with calcium gluconate 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 Pyme AM5 you can experience unwanted effects (ADR).
Common, ADR> 1/100
Uncommon, 1/1000 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, back pain, muscle contraction, muscle pain. Rare, ADR Instructions on how to handle ADR When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Pymme AM5 is contraindicated in the following cases:
Unstable hemodynamic heart failure after acute myocardial infarction.
Caution when using
used 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 related to the increase in pulmonary edema ratio. However, there is no significant difference in the proportion of patients with heart failure worse in the amlodipine group than the placebo group.
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.
The ability to drive and operate machinery
amlodipine may have a slight or medium impact to the ability to drive and operate machinery.
If patients use amlodipine dizziness, headache, fatigue or nausea, their reaction possibility may be impaired. Patients need to be carefully warned, especially at the beginning of treatment.
Pregnancy
should only use amlodipine during pregnancy when there is no safer replacement and when the disease itself contains greater risks for mothers and embryos.
Breastfeeding period
Experience used on humans shows that amlodipine has passed through breast milk.
Drug interaction
Amlodipin has been shown to be safe for thiazid diuretics, alpha-adrenergic receptor inhibitors, beta-adrenergic receptor inhibitors, ACE inhibitors, long-lasting nitrate, nitroglycerin under the tongue, steroid anti-inflammatory drugs, antibodies and antibiotics Blood.
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 10 mg amlodipine simultaneously with 80 mg of simvastatin increases 77% of exposure rate with simvastatin compared to only simvastatin. For patients with amlodipine, the dose limit of simvastatin is 20 mg/day.
Grapefruit juice: simultaneously use 240 ml of grapefruit juice with a single dose of 10 mg in 20 healthy volunteers does not significantly affect Amlodipin's dynamics. 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 inhibitor: simultaneously use 180 mg of daily dose of diltiazem with 5 mg of amlodipine in the elderly (69 - 87 years old) with hypertension increases 57% of the system exposure rate with amlodipine. Concentrated with Erythromycin on a healthy volunteer (18 - 43 years old) does not significantly change the system exposure rate with amlodipine (an increase of 22% under the curve of the curve of blood concentration of blood drugs over time [AUC]). Although clinically related to these studies is not sure, the pharmacokinetic change may be more pronounced in the elderly patients.
Strong CYP3A4 inhibitors (such as ketoconazole, iTraconazole, ritonavir) may increase the level of amlodipine in the blood than diltiazem. Should be cautious when using amlodipine along with CYP3A4 inhibitors.
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 Amlodipin. 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.
The effect of other drugs on amlodipine
Simultaneous use amlodipine and cimetidine does not change the kinetics of amlodipine.
Concentrated use of antacids is aluminum salt and magnesium salt with a single dose of amlodipine does not significantly affect the dynamics of Amlodipin.
Use a single dose of 100 mg 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
Simultaneously use 10 mg of amlodipine with 80 mg Atorvastatin does not significantly change the pharmacokinetic parameters of Atorvastatin in a stable concentration state in plasma.
Simultaneous use of amlodipine with digoxin does not change the concentration of digoxin in plasma or the renal clearance of digoxin in healthy volunteers.
Use single -dose or multi -dose 10 mg of amlodipine does not significantly affect ethanol kinetics.
Simultaneous use amlodipine with warfarin does not change the time of prothrombin inhibitors of warfarin.
There are no studies on drug interaction between cyclosporin and amlodipine in healthy volunteers or other groups of subjects except for kidney transplant patients.
There are no studies on 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%.
It is necessary to consider to monitor cyclosporin levels in kidney transplant patients using amlodipine.
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, the blood tacrolimus concentration must be monitored and adjust the dose of Tacrolimus if appropriate.
Mechanical goals of Rapamycin inhibitors (MTOR) MTOR inhibitors such as syrolimus, temsirolimus and everolimus are CYP3A substrates. Amlodipine is a weak CYP3A inhibitor. When used simultaneously with MTor inhibitors, Amlodipine may increase the exposure of MTor inhibitors.
Interactions between drugs and biochemical tests: unknown.
Storage
less than 30 ° C, avoid moisture and light.
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