Sodium sodium tablets 1.5mg/10mg Servier treat hypertension (6 blisters x 5 tablets)

Dosage form Box of 6 blisters x 5 tablets
Specifications Indapamide, amlodipine

Ingredient

Composition information	Content
Indapamide	1.5mg
Amlodipine	10mg

Uses

Indications

Sodium -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 blockage or calcium ion antagonist) and inhibit the flow of calcium ionic membranes into the heart muscle and blood vessel muscles.

ANGLODIPINE's anti -hypertension effect 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 1.5 mg is provided in the form of prolonged release dose based on the core (Matrix), in which the active ingredient is dispersed in the carrier that allows the release of slowly indepamide.

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 for plasma is 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 well absorbed with peak concentration in the blood for 6 - 12 hours. Absolute bioavailability is estimated in about 64–80%. Amlodipine's bioavailability is not affected by food.

Distribution

The distribution volume is about 21 l/kg. In vitro studies show that about 97.5% amlodipine circulating in the circulation associated with plasma proteins.

Metabolism - except for

The end of the phase of the drug in plasma is about 35–50 hours and is consistent with the one -time dosage of the 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 Sodium sodium tablets 1.5mg/10mg Servier treat hypertension (6 blisters x 5 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?

indapamide

Initial measures include quickly eliminating substances into the digestive system by gastrointestinal and/or drinking activated carbon, then restoring the water/electrolyte balance back to normal at a specialized medical center.

amlodipine

Clinical hypotension clinically due to amlodipine overdose requires supportive support activities for cardiovascular and respiratory function regularly, the edema of the limbs and paying attention to the volume of circulation and 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 10 mg 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:

Hypersensitivity to any ingredients of the drug, other sulfonamide drugs, dihydropyridine derivatives or any excipients. Sucking.

Severe hypotension.

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:

Sodium 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 diuretics and related to the Thiazide group can reduce calcium secretion 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 only promote effectively when normal kidney function or only mild kidney failure (plasma creatinine levels lower than 25 mg/l, meaning 220 μmol/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 can be used for patients with renal failure at normal 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 exhaust half -life time and the area under the higher curve 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 the form of sodiumam combination 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 sodiums 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:

Unreasonable 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

Peaks that cause torsion: IIA anti -arrhythmic drugs (Quinidine, hydroquinidine, disopyramide), Ili anti -arrhythmic drugs (amiodarone, sotalol, dofetilide, ibutilide), some anti -psychotic drugs (phenothiazine drugs (chlorpromazine, cyamemazine, levomemazine, levomemazine, levomemazine, levomemazine, levomemazine, levomemazine Thioridazine, trifluoperazine), Benzamide groups (Amisulpride, Sulpiride, Sultopride, Tiapride), Butyrophenone groups (Droperidol, Haloperidol)), Bupridil, Cisaprid, Diphemanil, Erythromycin intravenous sugar, Halofantrin, Mizolastin, Mizolastin, Mizolastin, Mizolastin, Mizolastin, Mizolastin, Mizolastin Pentamidin, parfloxacin, moxifloxacin, venous vannine.

Increased risk of ventricular arrhythmia, especially torsion (decreased potassium is a danger factor). It is necessary to control hypokalemia and adjust if necessary before using this combination form. Clinical control, electrolytes in plasma and electrocardiograms. Use substances that are not at risk of torsion when you are in a state of hypokalemia.

Non-steroid anti-inflammatory drugs (NSAIDs) (systemic routes) include COX-2 inhibitors, high-dose salicylic acid (≥ 3 g/day): Ability to reduce the anti-hypertension effect of indapamide. The risk of acute renal failure in patients with dehydration (reduced glomerular filtration). Conduct water rehydration for patients; Control kidney function at the beginning of treatment.

Angiotensin transferring enzyme inhibitors: The risk of sudden hypotension and/or acute renal failure when treated with an enzyme inhibitor appears when the patient is having sodium loss (especially in patients with kidney stenosis).

In patients with hypertension, when the previous diuretic treatment can cause sodium loss, it is necessary to stop diuretics 3 days before starting treatment with enzyme inhibitors and start using potassium -lowering diuretics if necessary; Or use the low starting dose to inhibit the enzyme inhibitors and increase the dose gradually.

In patients with congestive heart failure, starting treatment with very low doses of enzyme inhibitors, maybe after reducing the dose of potassium diuretics simultaneously.

In general, it is necessary to control kidney function (creatinine plasma) in the first weeks that start treatment with transferred enzyme inhibitors.

Other drugs that cause potassium lower: amphotericin B (intravenous line), Gluco- and mineral-corticoid (use of systemic sugar), tetracosactid, irritable laxatives: increased risk of hypotension (copper effect). Monitor plasma potassium and adjust if necessary. Special attention should be paid in case of simultaneous treatment with the digitalis group. Use non -irritating 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; Control kidney function at the beginning of treatment.

allopurinol: Concomitant treatment with indapamide may increase the risk of sensitive reactions to allopurinol.

Coordination should be considered

Potassium diuretics (amiloride, spironolactone, triamterene): while reasonable coordination is in some patients, the reduction or hyperkalemia (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 failure in diuretic and especially with diuretics. Do not use metformin when plasma creatinine exceeds 15 mg/l (135 μmol/l) in men and 12 mg/l (110 μmol/l) in women.

Iodine -containing contrast drugs: When diuretics cause dehydration, the risk of acute renal impairment 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 -hypertension effect and the risk of hypotension increases (the effect of copper).

Calcium (salt form): The risk of hypercalcemia due to a decrease in calcium secretion through urine.

cyclosporin, tacrolimus: The risk of increased plasma creatinine is not accompanied by any changes in cyclosporin levels during circulation, even the case of patients not dehydrated or sodium loss.

Corticosteroid, tetracosactid drugs (using systemic sugar): Reducing anti -hypertension effect (water/sodium retention due to corticosteroid drugs).

amlodipine:

Dantrolen (transmission form): on animals, ventricular and cardiovascular collapse leads to deaths that have 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:

No drug interaction studies have been conducted with cyclosporin and amlodipine in healthy volunteers or other populations, except for kidney transplant patients, but the base concentration of cyclosporin increases (average 0–40%) observed. Cyclosporine concentration should be monitored in kidney transplant patients using amlodipine, and should reduce the dosage of cyclosporin if necessary.

Simvastatin:

Simultaneous use of Amlodipine 10 mg repeated doses and 80 mg of simvastatin increases 77% of simvastatin concentration in the circulation compared to when using Simvastatin alone. In patients with amlodipine, the maximum dose of simvastatin is 20 mg/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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