Stamlo 5 Dr. Dr. Reddy's treatment of hypertension, chronic stable angina (2 blisters x 10 tablets)

Dosage form Box of 2 blisters x 10 tablets
Specifications Amlodipine

Ingredient

Composition informationContent
Amlodipine5mg

Uses

Indications

Stamlo - 5 mg is indicated in the following cases:

  • Hypertension;
  • Half -chronic stable angina; Calcium ions) and inhibit calcium ions through cell membranes into myocardial cells and blood vessel smooth muscles.

    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:

  • Amlodipin relaxes peripheral arteries and thus reduces the peripheral resistance total of the heart (reducing the burden). Because the heart rate does not change, this burden reduces the heart to reduce energy consumption and oxygen needs of the heart muscle.
  • 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, once a day significantly reduces clinical blood pressure in both lying and standing for 24 hours. Due to the slow starting characteristic, amlodipine avoids the drop in blood pressure when used.

    In patients with angina, once/day, amlodipine increases the overall exertion time, the starting time of angina and the ST segment time to 1 mm, reducing the frequency of angina and reducing the amount of nitroglycerin to be used.

    Amlodipin is not related to any adverse effects on metabolism or changes in lipids and is suitable for use in patients with asthma, diabetes and gout (gout).

    pharmacokinetic pharmacokinetics

    absorption and 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 approximately 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.

    Extraction of excretion

    Amlodipin's plasma semi -discharged time is 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.

    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.

    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 selling time also increases in patients with congestion heart failure (CHF).

    Use in children

    In a regular approaching clinical study, 73 patients from 12 months of age to smaller or 17 years old with hypertension use amlodipine average daily is 0.17 mg/kg. The clearance of these children with an average weight of 45 kg is 23.7 l/hour and 17.6 l/hour respectively for men and women. This clearance is also within the same limit as the assessment announced in the 70 kg adult adults is 24.8 l/hour. The average distribution of distribution is 1130 l (25.11 l/kg) in a patient with a weight of 45 kg. The effect of maintaining blood pressure during a 24 -hour period between observed doses has very little differences in maximum and minimum fluctuations. When compared to the pharmacokinetics in adults, the parameters in this study show that the one -time daily dose is appropriate.

    Clinical safety data

    Cancer ability: There is no sign of cancer in rats and rats used amlodipine in a diet for 2 years, with a calculated concentration so that the daily dose level is 0.5; 1.25 and 2.5 mg/kg/day. The highest dose (in mice and similar to mice is double* Maximum clinical dose is 10 mg on a unit of Mg/m) close to the total tolerance dose in mice, but not in the rat.

    The ability to cause mutations: Studies on mutant possibilities show that the drug does not affect the genome or chromosomes.

    Power decline: There is no effect on the reproductive function of mice using amlodipin (male mice use 64 days and female mice use 14 days before mating) at a dose of up to 10 mg/kg/day (8 times* Maximum dose indicated for humans, 10 mg on a unit of mg/m2).

    *Based on patients with weight 50 kg.

    Before taking Stamlo 5 Dr. Dr. Reddy's treatment of hypertension, chronic stable angina (2 blisters x 10 tablets)

    How to use

    stamlo - 5 mg orally.

    Dosage

    For Hypertension and angina , the normal starting dose is 5 mg x 1 time/day, which can increase to the maximum dose of 10 mg x 1 time/day depending on the response of each patient.

    In patients with hypertension, amlodipine has been simultaneously used with thiazid diuretics, alpha blockers, beta blockers and angiotensin enzyme inhibitors. For angina, amlodipine can be used in the form of monomers or simultaneously with other anti -angina drugs in patients with angina resistance to nitrate derivatives and/or appropriate beta blockers.

    There is no need to adjust the dose when using amlodipine simultaneously with thiazid diuretics, alpha blockers, beta blockers or angiotensin transferring enzymes inhibitors.

    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 (see carefully when used and pharmacokinetics).

    Patients with liver failure:

    The recommended dose has not been set for patients with mild to moderate liver failure: Therefore, be careful when choosing the dose and starting treatment with the lowest dose effectively (see the kidney item during use and pharmacokinetics). Amlodipine pharmacological properties have not been studied in cases of severe liver failure. It is necessary to start using amlodipine at the lowest doses and increasing slowly in patients with severe liver failure.

    Patients with renal failure:

    The change of amlodipine concentration in plasma is not correlated with the degree of renal failure. Therefore, the usual dosage recommendations. Amlodipine cannot be separated.

    Children and teenagers:

    Children and teenagers from 6 to 17 years old with hypertension: The recommended starting dose is used for oral treatment to treat hypertension in children from 6 to 17 years old is 2.5 mg x 1 time/day, and may increase to 5 mg/day without the desired blood pressure after four weeks. The dose greater than 5 mg/day has not been studied in children (see the pharmacokinetic and pharmacokinetic section).

    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? There is a report on the drop of blood pressure, may be prolonged and including death shock.

    Amlodipine absorption decreases significantly when indicating activated carbon at that time 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 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, dialysis bruises do 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 Stamlo-5mg medicine , you may experience unwanted effects (ADR).

    Common, ADR> 1/100

  • Neurological: headache, dizziness, sleeping chicken.
  • circuit: flushed face.
  • Body and on -site: edema, fatigue, weakness.
  • Blood and lymphatic system: leukemia, thrombocytopenia.
  • The immune system: allergic reactions
  • Neurology: Increasing muscle tone, reducing tactile/paresthesia, peripheral neuropathy, unconsciousness, taste disorders, trembling, pagoda disorders.
  • hearing and inner ears: tinnitus.
  • vascular: lower blood pressure, vascular inflammation.
  • digestive: dry mouth, indigestion (including gastritis), hyperllying, pancreatitis By the way, urinate at night.
  • Reproductive and breast system: Big breast in the South, erectile dysfunction .
  • Body and topical: discomfort, pain, chest pain.
  • Immune: allergic reactions include itching, skin rash, angioedema and diverse roses
  • liver: jaundice and increased liver enzymes have also been reported with very small rate (mainly accompanied by bile blockage).
  • Cardiovascular: myocardial infarction , arrhythmia (including slow rhythm, tachycardia in ventricular and atrial fibrillation) and chest pain.
  • Pediatric (6 - 17 years old)

    Amlodipin tolerates well in children. These unwanted effects are similar to the unwanted effects to see in adults.

    Common, ADR> 1/100

  • Neurological: headache, dizziness.
  • vasodilation.
  • Body and on -site: weakness.
  • Instructions on how to handle ADR:

    Notify the doctor for unwanted effects when using the drug.

    Warnings

    Before using the drug you need to read the instructions carefully and refer to the information below.

    Contraindicated

    Stamlo - 5 mg Contraindicated in patients:

  • Sensitive to the derivatives of dihydropyridine, amlodipine or any excipients of the drug.
  • Serious hypotension.
  • SHARE (including cardiac shock).
  • Conclusion of the output of the left ventricle (for example: severe aorta stenosis).
  • Unstable hemodynamic heart failure after acute myocardial infarction.

    Precautions for use

    Use in heart failure patients:

    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), Amlodipin is reported to be related to the increase in pulmonary edema. However, there is no significant difference in the proportion of patients with severe heart failure in the amlodipine group compared to the placebo group (see the pharmacological section).

    Use in patients with impaired liver function:

    Like other calcium channel blockers, Amlodipine's waste time is prolonged in patients with impaired liver function and recommended doses for these patients has not been set up. Therefore, Amlodipin needs to be used cautiously in these patients.

    Used in elderly patients:

    Should be cautious when increasing the dose.

    Used in patients with renal failure:

    Amlodipin can be used in these patients at normal doses. Change in amlodipine concentration in plasma is not correlated with the degree of renal failure. Amlodipin cannot be fertilized.

    The ability to drive and operate machinery

    Amlodipine may have a slight or medium impact on the ability to drive and operate machinery. If the patient uses amlodipine dizziness, headache, fatigue or nausea, it may reduce reflexes. Need to be careful especially when starting 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 time to stay in mice with a dose of 50 times higher than the recommended dose for maximum use in humans.

    Therefore, amlodipine should only be used during pregnancy when there is no safer replacement measure and when the disease itself contains greater risks for mothers and embryos. There is no impact on the fertility of mice treated with amlodipine (see section of preclinical safety data).

    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 5 mg/time/day and is adjusted if needed (average daily dose and daily dose in weight are 6 mg and 98.7 mcg/kg). The estimated daily dose of Amlodipin that babies receives through breast milk is 4.17 mcg/kg.

    Drug interaction

    amlodipin has been shown to be safe to use with thiazide diuretics, alpha receptor inhibitors, beta receptor inhibitors, angiotensin transferring enzymes inhibitors, prolonged nitrate, nitroglycerin under the tongue, anti -inflammatory drugs, antibiotics

    In vitro data from plasma studies has 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 of amlodipine simultaneously with 80 mg of simvastatin increases 77% of exposure rate with simvastatin compared to only simvastatin. For patients with amlodipine, the limit of simvastatin is 20 mg/day.

    Grapefruit juice: Simultaneously use 240 ml of grapefruit juice with a single dose of 10 mg amlodipine in 20 healthy Nguyen lovers does not significantly affect the pharmacokinetics of amlodipine. This research does not allow the test of the genetic polymorphic effect of CYP3A4, the main enzyme is responsible for transforming amlodipine; Therefore, it should not be used amlodipine with grapefruit or grapefruit juice because bioavailability can increase in some patients leading to increased hypotension.

    CYP3A4 inhibitors:

  • Simultaneously use 180 mg of diliazem daily dose with 5 mg of amlodipine for the elderly (69 - 87 years old) with hypertension increases 57% of the system exposure rate with amlodipine. Simultaneous use with Erythromycin on healthy volunteers (18 - 43 years old) does not significantly change the system exposure rate 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 can be notified more in elderly patients. 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 Amlodipin. Simultaneous use with CYP3A4 induction substances (such as rifampicin, hypericum perforatum) can reduce the concentration of amlodipine in the blood. Should be cautious when using amlodipine along with CYP3A4 induction substances. In the following studies, there are no significant changes in pharmacokinetics of amlodipine or other drugs in the study when used in combination.

    Special studies: The effect of other drugs on amlodipin

    cimetidine: simultaneously use amlodipine and cimetidine does not change the pharmacokinetics of amlodipin.

    Aluminum/ Magnesi salt (antacids): simultaneously use antacids is aluminum and magnesium salt with a single dose of amlodipine does not significantly affect the kinetics of amlodipine.

    Sildenafil: Using a single dose of 100 mg of Sildenafil in objects with idiopathic hypertension does not affect amlodipine pharmacokinetic parameters. When using Amlodipine and Sildenafil combination, each drug has its own antihypertensive effect.

    Special studies: The effect of amlodipine on other drugs

    Atorvastatin: simultaneously using 10 mg of amlodipine with 80 mg atorvastatin does not significantly change the kinetic parameters of Atorvastatin in a stable plasma concentration state.

    Digoxin: simultaneously use 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 10 mg of amlodipine does not significantly affect the pharmacokinetics of ethanol.

    warfarin: simultaneously use Amlodipin with warfarin does not change the time of prothrombin inhibitors of warfarin.

    Cyclosporin: There are no studies on interaction between cyclosporin and amlodipine in healthy volunteers or other groups of objects, 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 concentration in the blood when used simultaneously with amlodipine. To avoid the toxicity of tacrolimus, when using amlodipine for patients being treated with tacrolimus, the blood tacrolimus concentration should be monitored and adjust the dose of Tacrinus when appropriate.

    Mechanical goals of Rapanycin inhibitors (MTOR): MTOR inhibitors, such as syrolimus, temsirolimus and Everolimus are the substrate of CYP3A. Amlodipine is a weak CYP3A inhibitor. When used simultaneously with MTor inhibitors, Amlodipine can increase exposure of MTOR inhibitors.

    Interactions between drugs and biochemical tests: unknown.

    Storage

    Storage below 30 ° C. Avoid light and moisture.

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