Sodium SR SERVier tablets treat primary hypertension (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Indapamide

Ingredient

Composition informationContent
Indapamide1.5mg

Uses

indications

Sodium nodium SR is indicated in the following case:

  • Patients with primary hypertension in adults.

    indapamide is a sulphonamide derivative that has an Indole ring and it is this indole that leads to the pharmacological effect of thiazide diuretics. This diuretic inhibits sodium reabsorption in the dilution stage of the renal tubules.

    It increases the secretion of sodium and chloride into the urine and partly increases the excretion of potassium and magnesium, thus increasing the amount of urine and has the effect of lowering blood pressure.

    Pharmaceutical effect

    Studies on phase II and Phase III used single therapy have proven the effectiveness of 24 -hour hypotension. This is present at the dosage with mild diuretic effects.

    The anti -hypertension effect of indapamide is associated with improving artery dilatation and reducing artery urinary resistance and reducing peripheral resistance.

    indapamide reduces left ventricular hypertrophy.

    Thiazide and diuretics related to Thiazide have the effect of lowering the plateau blood pressure when outside the certain doses, while side effects continue to increase. Do not continue to increase the dose if the treatment is ineffective.

    In patients with short -term, medium and long -term hypertension, indepamide:

  • Do not affect lipid metabolism: triglycerides, LDL - cholesterol and HDL - cholesterol
  • There is no effect on the metabolism of carbon, even in hypertension patients with diabetes.
  • pharmacokinetics

    Sodium Srilix SR provides prolonged release based on the system of substrate, in which the active ingredient is dispersed in a support frame that allows the release to prolong indapamide.

    absorption

    The release of indepamide is quickly and completely absorbed through the gastric gastrointestinal tract.

    Eating increases the absorption rate but does not affect the amount of drugs absorbed.

    The peak in the serum after the single dose reaches about 12 hours after taking the drug, repeated use reduces the variation of serum concentration between two doses.

    There is a variable between the forms.

    Distribution

    The cohesion of indapamide with plasma proteins is 79%. Selling duration of plasma is 14 to 24 hours (an average of 18 hours). Stable state achieved after 7 days. Use repeated dose does not cause accumulation of drugs.

    Metabolism

    Elimination mainly through urine (70%) and feces (22%) in the form of inactive metabolites.

    People with high risk

    The pharmacokinetic parameters do not change in patients with renal failure.

    Before taking Sodium SR SERVier tablets treat primary hypertension (3 blisters x 10 tablets)

    How to use

    Sodium nodium SR Used orally.

    Dosage

    A tablet for 24 hours, it is best to take in the morning, should swallow the pill with water and do not chew.

    Higher dose does not improve anti -hypertension effect but will increase the diuretic effect.

    kidney failure

    In the case of kidney failure severe (creatinine clearance below 30ml/minute), contraindicated use of this drug.

    Thiazide and diuretics related to Thiazide are only effective when normal kidney function or slight decline.

    Hepatic failure

    Contraindicated treatment for patients with severe liver failure.

    Elderly

    In older patients, the dose must be adjusted according to creatinine clearance, parameters related to age, weight and gender. Older patients may be treated with sodium sr if normal kidney function or only slight decline.

    Division

    Safety and effectiveness of sodium SR in children and adolescents have not been established. There is currently 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?

    Symptoms

    indapamide does not show toxicity at a dose of up to 40mg, meaning 27 times of treatment.

    Signs of acute poisoning are water and electrolyte disorders (hypoglyc sodium and hypokalemia). Clinical signs may be nausea, vomiting, hypotension, cramps, dizziness, drowsiness, confusion, urination or urinary discharge that can lead to anuria (due to reduced blood volume)

    How to handle

    The first measure is to quickly eliminate the drug from the stomach or use activated carbon, followed by recovery and water/electrolyte balance to normal value in a specialized center.

    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 sodium SR , you may experience unwanted effects (ADR).

    Common (1/100 to

  • Skin and subcutaneous tissue disorders: Hypersensitivity reactions, lumpy rashes.
  • Not common (1/1000 to

  • Gastrointestinal disorders: vomiting.
  • Skin and subcutaneous tissue disorders: BLACK.
  • Rare (1/10000 to

  • Neurological disorders: dizziness, fatigue, headache , paresthesia.
  • Disorders of the digestive system: Nausea, constipation , dry mouth.

    Very rare (1/100000 to

  • Bloody and lymphatic disorders: granulocytes, property anemia, hemolytic anemia, leukopenia, thrombocytopenia, hypercalcemia.
  • heart disorders: arrhythmia.

  • Bloody disorders: Hypotension .
  • Gastrointestinal disorders: pancreatitis , abnormal liver function.

  • Renal and urinary disorders: renal failure.
  • Not determined frequency

  • Metabolic and nutritional disorders: loss of potassium with hypokalemia, especially serious in people with high risk, hypoglyc sodium.
  • neurological disorders: fainting.
  • eye disorders: nearsighted , blurred vision, vision loss.
  • Heart disorders: Twisted (likely death).
  • Liver dysfunctions: The ability to onset of hepatic brain disease in the case of liver failure.

  • Skin disorders and soft tissue under the skin: can worsen the previous acute lupus lupus.
  • Sensitive reactions to light.
  • Testing: extending the qt distance on the electrocyte, increased blood glucose, increased uric acid, increased the concentration of liver enzymes.
  • 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 Srlix SR contraindicated in the following cases:

  • Hypersensitivity to Idapamide, with other sulfonamide or any ingredients of the drug.
  • Severe kidney failure.

    Hepatitis or severe liver failure.

    Hypotension.

    Precautions when using

    Special prudence

    When the liver function is impaired, the thiazide diuretics can cause special liver's brain disease in the context of electrolyte disorders. Must stop taking diuretics immediately if this phenomenon occurs.

    Light sensitivity

    Cases of light -sensitive reactions have been reported when using Thiazide or thiazide diuretic. If the reactions are sensitive to light during treatment, stop treatment. If diuretic use is really necessary, recommending the protection of areas in contact with the sun or artificial UVA rays.

    excipients

    Patients with rare genetic diseases in tolerance Galactose, Lactase deficiency or malposure - Galactase must not use this drug.

    Special prudence when using

    Water and electrolyte balance.

    Plasma sodium

    This parameter must be measured before starting treatment, and checked regularly afterwards. Hypoglycemia may start asymptomatic and therefore, regular testing is necessary, and should be tested more often in older patients and cirrhosis patients. Any diuretics can cause hypoglycemia, sometimes causing serious consequences.

    Hypoglycamy blood hypoglycemia is accompanied by a decrease in blood volume that can lead to dehydration and hypotension. The loss of chloride ions can lead to alkaline infections that metabolize secondary compensation: the incidence and the degree of this effect are light.

    Plasma potassium

    Loss of potassium and hypotension is the main risk of Thiazide and diuretics related to Thiazide. The risk of hypotension (

    Patients with long QT, whether congenital or derived from pathology, are at risk. Hypotension, slow heartbeat is a serious arrhythmia factor, sometimes leading to a death that can be fatal.

    Check more often than serum potassium is required in all of the above cases. The first serum potassium test should be conducted in the first week after the beginning of treatment. When detecting hypokalemia, requires adjustment.

    Plasma calcium

    Thiazide and diuretics related to Thiazide can reduce calcium secretion in the urinary tract and thus increase and temporarily have plasma calcium. The hypercalcemia may also be due to the previous diagnosis of the hyperpigonomic gland. The treatment should be withdrawn before exploring the adjacent gland function.

    Blood glucose

    Checking blood glucose is important in diabetes patients, especially when there is hypokalemia.

    Uric acid

    The trend of gout can increase in patients with hyper uric acid.

    Kidney function and diuretics

    Thiazide and diuretics related to Thiazide are only completely effective when normal kidney function or slight decline (plasma creatinine below 25mg/l, meaning 22μmol/l in adults), in older patients, this plasma creatinine level must be adjusted according to age, weight and gender.

    Loss of circulatory and secondary amounts after dehydration and sodium at the beginning of treatment, causing a reduction in glomerular filtration. This can lead to hyper urea and plasma creatinine. This fleeting renal function is not a problem for people with normal kidney function but can worsen the impairment of the previous kidney function.

    Athletes

    Athletes should pay attention because this drug contains active ingredients that can cause positive reactions in doping tests.

    The ability to drive and operate machinery

    Sodium SR does not affect alertness but some other reactions are related to reducing blood pressure may appear in some patients, especially when starting to start or when in combination with other hypertension medications.

    The result is the ability to drive and operate machinery may be impaired.

    Pregnancy

    without or data restriction (less than 300 pregnant women with research results) on the use of indapamide on pregnant women. Using Thiazide lasts for the last 3 months of pregnancy may reduce the volume of the mother's plasma as well as the blood flow to the uterus - the placenta, which can lead to ischemic anemia and the fetal retardation.

    Animal studies do not show direct or indirect effects related to reproductive toxicity.

    To be wary, it is best to avoid using indapamide during pregnancy.

    Breastfeeding period

    There is no information about the excretion of indapamide/metabolites into human milk. Hypersensitivity to sulphonamide derivatives and hypokalemia may occur. The risk for infants/young children has not been excluded.

    Indapamide is closely related to thiazide diuretics, so during breastfeeding, medication reduces or even inhibit milk.

    Idapamide should not be used for breastfeeding women.

    Medicine interaction

    unnecessary coordinates

    lithium

    Increasing plasma lithium with signs of overdose, such as salt -free diet (reduces lithium excretion through urine). However, if the use of diuretics is necessary, it is necessary to strictly control the amount of plasma lithium and dose adjustment.

    Careful coordination while using

    Medications can cause torsion:

  • LA group arrhythmia (quinidine, hydroquinidine, disopyramide).
  • Anti -arrhythmia group III (amiodarone, sotalol, dofetilide, ibutilide).

  • Phenothiazines (Chlorpromazine, Cyamemazine, Levomepromazine, Thioridazine, Trifluoperazine), Benzamides (AmisulPride, Sulpiride, Superopride, Tiapride), Butyrophenones). Haloperidol)).
  • Other drugs: Bepridil. Cisapride, Diphemanil, Erythromycin used intravenously, halofantrine, mizolastine, pentamidine, sparfloxacin, moxifloxacin, vincamine used intravenously.

    Increased risk of ventricular arrhythmia, especially peak twisting (hypotension is a risk factor).

    Need to monitor hypokalemia and adjust, if necessary, before starting this combination. Clinically monitoring, electrolyte and electrocardiogram.

    Use drugs that do not have weaknesses that cause torsion in the event of hypokalemia.

    Steroid anti -inflammatory analgesics (N.S.A.I.D) (Systemic route), including selective inhibitors COX - 2, high -dose salicylic acid (> 3g/day)

    can reduce the low voltage effect of indapamide.

    The risk of acute renal failure patients dehydration (reducing glomerular filtration level).

    Patient rehydration, kidney function control right from the beginning of treatment.

    Enzyme inhibitors (A.C.E.)

    The risk of sudden hypotension or acute renal failure when starting to treat with an enzyme inhibitor if the patient has previously lost sodium (especially in patients with kidney stenosis).

    In case of hypertension, when the previous diuretics can cause sodium reduction, it is necessary to:

  • Stop diuretics 3 days before cigarettes with an enzyme inhibitor and continue to use potassium diuretics if necessary.

    In case of congestive heart failure, starting with very low doses of enzyme inhibitors, maybe after a decrease in the diuretic dose of potassium diuretics used in combination.

    In all cases, monitoring kidney function (plasma creatinine concentrations) during the first weeks of treatment with enzyme inhibitors.

    Other combinations that cause hypokalemia: amphotericin B (intravenous), glucocorticoids and mineralcorticoids (body use), tetracosactide, irritable laxatives.

    Increased risk of hypokalemia (added effect)

    Strictly control the concentration of potassium and adjust if necessary. Especially, attention must always be paid to the case of Digitalis combination treatment. Use non -stimulating laxatives.

    baclofen

    Increase anti -hypertension effect.

    Patient rehydration, kidney function control at the beginning of treatment.

    Digitalis preparations

    Hypotension increases the toxicity of digitalis.

    Control of plasma potassium, electrocardiograms and, if needed, adjust the treatment.

    Special Caution Caution Collection

    Allopurinol:

    Simultaneous use with indapamid may increase sensitive reaction to allopurinol.

    Collaboration should be considered

    Potassium diuretics (amiloride, spironolactone, triamterene)

    When reasonable coordination is considered useful for some patients, hypokalemia or hyperkalemia (especially in patients with renal impairment or diabetes) may still occur. Should monitor plasma potassium and electrocardiograms, if necessary, review the sketch of treatment.

    metformin

    Increased risk of lactic acidic acidosis due to the function of renal failure due to diuretics and especially diuretics.

    Do not use metformin when plasma creatinine concentration exceeds 15mg/l (135μmol/l) in men and 12mg/l (110μmol/l) in women.

    contrast drugs have iodine

    In case of dehydration due to diuretics, the risk of acute renal failure, especially when bringing a large amount of contrast drugs with iodine into the body. Water compensation before taking contrast drugs has iodine.

    antidepressants like imipramine, nervous drugs

    Effective anti -hypertension and the risk of hypotension increases (combined effect).

    Calcium (salt form)

    The risk of hypercalcemia due to decreased calcium secretion through urine.

    ciclosporin, tacrolimus

    The risk of increased plasma creatinine does not accompany the cyclosporine concentration change during the circulation, even in the absence of dehydration/ electrolyte.

    corticosteroid, tetracosactide (body use)

    Anti -hypertension effect is reduced (retaining water/salt due to corticosteroids).

  • Storage

    Store at temperatures below 30 ° C.

    Other drugs

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