Sodiumamam 1.5mg/5mg les drugs for hypertension (30 tablets)
Dosage form Box of 30 tablets
Specifications Amlodipine, indapamide
Ingredient
| Composition information | Content |
| Amlodipine | 5mg |
| Indapamide | 1.5mg |
Uses
Indications
Sodium -nodium drugs are indicated for replacement in the treatment of hypertension for patients who have used indepamide and amlodipine separately with the same content.
Pharmacokic of
indapamide is a sulfonamide derivative with indol nucleus, pharmacological effect is similar to thiazide diuretics, which inhibit the reabsorption of sodium in the dilution stage of the kidney shell. The drug increases sodium, chlored and increased sodium ions at a lesser level for potassium and magnesi, thus increasing the urology and has the effect of lowering blood pressure.
Amlodipine is a calcium channel blocker of the dihydropyridine group (slow channel blockers or calcium ion antagonists) and inhibit the flow of calcium ionic membranes entering the heart muscle and blood vessel muscles. The anti -hypertension effect of Amlodipine is due to the effect of direct relaxation of blood vessel muscles.
pharmacokinetics
simultaneous use of indapamide and amlodipine does not change the pharmacokinetic properties when compared to individual drugs.
indapamide
Indapamide 1.5mg is provided in the form of prolonged release dose based on the core (Matrix), in which the active ingredient is dispersed in the carrier allowed to slowly release from indapamide.
absorption
The release of IndiaMide is absorbed quickly and completely through the digestive tract. Food slightly increases the absorption rate but does not affect the active ingredient is absorbed. The peak concentration in the serum after the single dose appears about 12 hours after oral, the dose reduces the oscillation of the serum concentration between the two doses. There is oscillation between individuals.
Distribution
The ratio of cohesion to the plasma protein of indapamide is 79%. Stable state achieved after 7 days. Repeated dose does not cause cumulative drugs.
Elimination
Mainly excreted drugs (70% dose) and feces (22%) in the form of non -active metabolites. Selling time in plasma 14 - 24 hours (average 18 hours).
Pharmacokinetic parameters do not change in patients with renal failure.
amlodipine
Amlodipine is provided in the form of instantaneous release.
absorption
After taking the dose of treatment, Amlodipine is absorbed well with peak concentration in the blood for 6 - 12 hours. Absolute bioavailability is estimated in the range of 64 - 80%. Amlodipine's bioavailability is not affected by food.
Distribution
The distribution volume is about 21L/kg. In vitro studies show that about 97.5% amlodipine circulating in the circulation associated with plasma proteins.
Metabolism - Elimination
The last phase selling time of plasma is about 35-50 hours and is suitable for a one -time dosage a day. Amlodipine is metabolized mainly in the liver into non -active metabolites with 10% of the mother medicine and 60% of the metabolites are eliminated through the urine.
Before taking Sodiumamam 1.5mg/5mg les drugs for hypertension (30 tablets)
How to use
oral drugs. The drug should be taken in the morning. Take intact tablets with water, do not chew the medicine.
Dosage
Take 1 capsule/time x 1 time/day.
Fixed dose combination form is not suitable for the initial treatment. Only used for patients who used indepamide and amlodipine separately have the same content.
If it is necessary to adjust the dose, dose adjustment on each component by using the component single tablets.
Children:
Safety and effectiveness of sodiums in children and minors have not been established. There is no data.
Elderly:
Can be treated with sodium sodium depending on the kidney function.
Patients with renal failure:
In patients with severe renal impairment (creatinine clearance below 30 ml/min), contraindicated treatment with sodium. In patients with mild to moderate renal failure, no dose adjustment.
Patients with liver failure:
In patients with severe liver failure, contraindicated use of sodiumamam. The recommended dose of Amlodipine has not been set in patients with mild to moderate liver failure, so it is necessary to be cautious when choosing the dose and need to start at a low dose below the allowed dose range.
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?
Amlodipine: Clinical hypotension clinically due to amlodipine overdose requires supportive activities for cardiovascular support including regular monitoring of the heart and respiratory function, the edema of the limbs and paying attention to the volume of circulation and the amount of urine. Using a vasoconstriction may be useful in restoring blood vessel and blood pressure in the absence of contraindications.
Intravenous calcium infoica can be effective against the effects of calcium channel blockers. Gastrointestinal lavage may be valid in some cases. On healthy volunteers, the use of activated carbon up to 2 hours after using Amlodipine 10mg reduces Amlodipine's absorption rate. Dialysis is not effective due to amlodipine attached to plasma proteins.
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 sodiums, you may experience unwanted effects (ADR).
The unwanted effects are the most common reports of indapamide and amlodipine include hypokalemia, drowsiness, dizziness, headache, vision impairment, double vision, chest drum, blushing, shortness of breath, abdominal pain, nausea, indigestion, changing the habits of the intestines, diarrhea, constipation, lumpy bodies, swollen legs, and fatigue.
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
Sodium -to -contraindicated drugs in the following cases:
Severe liver failure or liver enhancement.
Heart failure with unstable hemodynamics after acute myocardial infarction.
Precautions for use
When the liver is impaired, thiazide diuretics can cause liver's brain disease, especially in the case of electrolyte imbalance. Due to the presence of indapamide, it is necessary to stop drinking sodiums immediately if this situation occurs.
Light sensitivity:
There have been reports on light sensitivity reactions caused by thiazide and diuretics related to Thiazide. If the light sensitive reaction occurs during treatment, the patient is recommended to stop treatment. If the use of diuretics is supposed to be necessary, the patient is recommended to protect the skin -exposed skin areas or artificial UVA rays.
Hypertension:
Safety and effectiveness of amlodipine on unpaid hypertension.
Water and electrolyte balance:
Plasma sodium: must check this parameter before starting treatment, then conduct regular tests. Reducing sodium levels may start with no special symptoms, so regular checking is necessary. It is necessary to conduct more frequent tests in the elderly and cirrhosis patients. Treatment with diuretics can also cause sodium hypoglycemia, sometimes causing very serious consequences. Sodium hypoglycemia and hypotension may cause dehydration and hypotension. The loss of chloride ions can lead to secondary metabolic alkaline infections. The frequency and degree of this effect are light.
Plasma potassium: Hypotension is the main risk when taking thiazide diuretics and diuretics related to the Thiazide group. It is necessary to prevent the risk of reducing the concentration of potassium potassium (
Patients with long QT are also at risk, although the cause is congenital or due to treatment. Hypotension as well as slow heart rate will be a factor that promotes the risk of serious arrhythmia, especially the risk of torsion, which can lead to death.
In all above, it is necessary to regularly check the concentration of potassium. The first measurement of blood potassium should be conducted in the first week of treatment. If the concentration of low blood potassium is detected, it is necessary to adjust.
plasma calcium:
Thiazide diuretic and related to the thiazide group can reduce calcium excretion through the urinary tract, causing slight increase and airy blood calcium concentration. A significant increase in calcium concentration may be associated with the previous diagnosis of the parathyroid gland. In that case, it is necessary to stop taking the drug before checking the parathyroid function.
Blood glucose:
Due to the presence of indapamide, control of blood glucose levels is important in patients with diabetes, especially when low blood potassium concentration.
heart failure:
Patients with heart failure should be treated carefully. In a long -term study with a place of placebo in patients with severe heart failure (NYHA level III and IV level), pulmonary edema occurs at a higher frequency in the amlodipine treatment group compared to the control group. Calcium channel blockers including amlodipine should be used carefully in patients with congestive heart failure, because these drugs may increase the risk of cardiovascular events and death afterwards.
Kidney function:
Thiazide diuretics and related to the Thiazide group are only fully effective when normal kidney function or only mild renal failure (plasma creatinine concentrations lower than 25mg/l, meaning 220μmol/l in adults). In the elderly, plasma creatinine values should be adjusted according to the age, weight and gender of the patient.
Reduce the volume of secondary circulation after dehydration and sodium due to diuretics when starting treatment leads to reduced glomerular filtration. This causes increased blood urea and increased plasma creatinine. This temporary influence on renal function does not cause complications in patients with normal renal function, but can cause severe causes in patients who have previously suffered from renal failure.
Amlodipine may be used for patients with renal impairment at conventional doses. The change in plasma amlodipine concentration is not correlated with the degree of renal failure. Amlodipine is not excluded through dialysis.
The impact of the form of sodiumam combination has not been tested in patients with impaired renal function. In patients with renal failure, sodium dose needs to follow the dose of each ingredient when used alone.
Uric acid:
Due to the presence of indapamide, the risk of gout can increase in patients with hyperuricemia.
Liver function:
Amlodipine's waste time is prolonged and the area below the curve is higher in patients with liver failure. The recommended dose for this subject has not been set up. Therefore, Amlodipine needs to be started at the lowest dose of the dose and should be cautious when starting treatment as well as when increasing the dose.
The impact of a combination of sodium sodium has not been tested in patients with impaired liver function. According to the impact of each ingredient indapamide and amlodipine, contraindicated use of sodiums for patients with severe liver failure and need to be cautious in patients with mild to medium liver failure.
Elderly:
Need to be treated with sodiumams depending on the kidney function.
Do not use sodium sodium for patients with rare genetic problems galactose intolerance, lactase deficiency or glucose - galactose.
The ability to drive and operate machinery
Sodium sodium has a slight impact on the average to drive and operate machinery.Despite the low risk of indapamide, the various reactions related to hypotension in some patients, especially in the early stages of treatment or when the patient uses another lower blood pressure. Therefore, the ability to drive and operate machinery can be affected.
Amlodipine may have light to medium influences on the ability to drive and operate machinery. If the patient uses amlodipine with symptoms of dizziness, headache, fatigue or nausea, the ability to react may be affected. Precautions especially in the first stage of treatment.
Pregnancy
do not recommend using sodiums for pregnant women.
Breastfeeding period
Contraindications to use sodiums when breastfeeding.
Drug interaction
indapamide
Uncountable coordination:
Lithi: Lithi increases plasma lithiums with symptoms of overdose, similar to salt -free diet (excretion of lithiums through the urinary tract decreases). However, if you need diuretics, it is necessary to strictly control the plasma lithium levels and need to adjust the dose.
Caution should be careful:
The drug causes the torsion phenomenon:
Non -steroid anti -inflammatory drugs (NSAID) (Systemic routes) include selective inhibitors of COX - 2, high -dose salicylic acid (≥ 3g/day): capable of reducing anti -hypertension effect of indapamide. The risk of acute renal failure in patients with dehydration (reduced glomerular filtration). Conduct water rehydration, kidney function control at the beginning of treatment.
Angiotensin transferred enzyme inhibitors:
Other drugs that cause potassium: amphotericin B (intravenous line), gluco - and mineral - corticoid (using systemic sugar), tetracosactid, irritant laxatives:
Digitalis group: Hypotension leads to toxic effects of the digitalis group. Need to control plasma potassium and electrocardiograms and if necessary, adjust the treatment.
baclofen: Increased anti -hypertension effect. Water compensation for patients, kidney control at the beginning of treatment.
Allopurinol: Concomitant treatment with indapamide may increase the risk of hypersensitivity reactions to allopurinol.
Coordination needs to consider:
Potassium diuretics (amiloride, spironolactone, triamterene): while reasonable coordination is beneficial in some patients, reduced or hyperpassing (especially in patients with renal impairment or diabetes) may still occur. It is necessary to control the concentration of potassium and electrocardiograms, if necessary, it is necessary to review the treatment.
Metformin: The increased risk of lactic acid contamination of metformin due to the ability to cause renal impairment is related to diuretic and especially with strap diuretics. Do not use Metformin when plasma creatinine exceeds 15mg/l (135μmol/l) in men and 12mg/l (110μmol/l) in women.
contrast drug contains iodine: When diuretics cause dehydration, the risk of acute renal failure increases, especially when patients use high doses of contrast drugs containing iodine. Need to rehydrate before using drugs containing iodine.
Antidepressants similar to imipramine, sedative: Anti -blood pressure and the risk of lowering blood pressure are increased (the effect of synergies).
Calcium (salt form): The risk of hypercalcemia due to a decrease in calcium secretion through urine.
cyclosporin, tacrolimus: The risk of increased plasma creatinine does not accompany any changes in cyclosporin levels during the circulation, even if the patient is not dehydrated or lost sodium.
Corticosteroid, tetracosactid drugs (using systemic sugar): reducing anti -hypertension effect (water/sodium retention due to corticosteroid groups).
amlodipine
dantrolen (transmission form):
In animals, ventricular vibration and cardiovascular collapse lead to death has been recorded related to hyperkalemia when combining Verapamil and intravenous dantrolen. Due to the risk of hyperkalemia, it is recommended to avoid simultaneous use of calcium channel blockers such as amlodipine with dantrolen in patients with the ability to increase malignant body temperature and in the treatment of malignant body temperature.
It is not recommended to simultaneously use amlodipine along with grapefruit or grapefruit juice due to the use of the drug can increase in some patients, leading to an increase in the effect of reducing blood pressure.
CYP3A4 inhibitors:
Simultaneous use of amlodipine with strong or medium inhibitors CYP3A4 (Protease inhibitors, Azole antifungal drugs, macrolids such as erythromycin and Clarithromycin, Verapamil or Diltiazem) can significantly increase amlodipine levels in circulation. Clinical manifestations corresponding to this pharmacokinetic change of the drug can be more clear in elderly patients. Therefore, clinical monitoring and dose adjustment.
Increased risk of hypotension in patients taking clarithromycin along with amlodipine. It is recommended to closely monitor patients with simultaneous use of amlodipine with clarithromycin.
CYP3A4 induction drugs:
There is no data on the effects of CYP3A4 induction drugs with amlodipine. Used with CYP3A4 induction drugs (Rifampicin, Hypericum Perforatum) can reduce amlodipine levels in plasma. Should be cautious when taking amlodipine and drugs causing CYP3A4.
The impact of amlodipine on other drugs:
AMLODIPINE's blood pressure reduction effect resonates with the impact of reducing blood pressure of other anti -hypertension drugs.
In clinical drug interactive studies, Amlodipine does not affect the pharmacokinetics of Atorvastatin, Digoxin, Warfarin.
tacrolimus: The risk of increased blood tacrolimus concentration when used with amlodipine. To avoid the toxicity of Tacrolimus, the use of Amlodipine in patients who used Tacrolimus should monitor the concentration of Tacrolimus in the blood and adjust the dose of Tacrolimus if necessary.
Cyclosporin: There has been no medical interactive studies conducted with cyclosporin and amlodipine in healthy volunteers or other populations except for kidney transplant patients, whose base concentration of cyclosporin increases (average 0 - 40%) has been observed. Cyclosporine concentration should be monitored in kidney transplant patients using amlodipine, and should reduce the dosage of cyclosporin if necessary.
Simvastatin: simultaneously use Amlodipine 10mg repeated doses and 80mg of simvastatin increases 77% of simvastatin concentration in the circulatory compared to when using Simvastatin alone. In patients with amlodipine, the maximum dose of simvastatin is 20mg/day.
Storage
Store under 30ºC.
Do not use the drug after the expiry date recorded on the box and blister.
Do not pour medicine through wastewater or domestic waste. Ask your pharmacist how to handle if you don't use the drug anymore. This will help protect the environment.
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