Lauras SR - instructions for use, dose, side effects, contraindications

Excipients: lactose monohydrate 144.22 mg, pregelatinized starch 6.88 mg, hypromellose (Methocel K100 MCR) 50 mg, silicon dioxide colloid 0.4 mg, magnesium stearate 1.0 mg;

film sheath: hypromellose 6 cps (pharmacoate 606) 0.43 mg, macrogol (polyglycol 6000 PF) 0.43 mg, titanium dioxide 0.85 mg.

Description:

White or almost white round biconvex tablets, covered with a film membrane.

Pharmacotherapeutic group:Diuretics

ATX: & nbsp

C.03.B.A.11 Indapamide

Pharmacodynamics:

Hypotensive agent (diuretic, vasodilator).By pharmacological properties is close to thiazide diuretics (violation of reabsorption of sodium ions in the cortical segment of the Henle loop). Increases the release of kidney ions of sodium, chlorine and, to a lesser extent, potassium and magnesium ions. Possessing the ability to selectively block "slow" calcium channels, increases the elasticity of the walls of the arteries and reduces the overall peripheral vascular resistance. Helps reduce hypertrophy of the left ventricle of the heart. Does not affect the content of lipids in the blood plasma (triglycerides, low-density lipoproteins, high-density lipoproteins); does not affect carbohydrate metabolism (including in patients with diabetes mellitus). Reduces the sensitivity of the vascular wall to noradrenaline and angiotensin II, stimulates the synthesis of prostaglandin E2, reduces the production of free and stable oxygen radicals.

The hypotensive effect develops by the end of the first week, persists for 24 hours against a background of a single dose.

Pharmacokinetics:

After oral administration, it is quickly and completely absorbed from the gastrointestinal tract; bioavailability is high (93%). Eating somewhat slows the rate of absorption,but does not affect the amount of absorbed substance.

Time to reach the maximum concentration in the blood plasma after ingestion - 12 hours. With repeated administration of fluctuations in the concentration of the drug in the blood plasma in the interval between doses of two doses are reduced. The equilibrium concentration is established after 7 days of regular intake. The half-life is 18 hours, the connection with blood plasma proteins is 79%. It also binds to the elastin of the smooth muscles of the vascular wall. Has a high volume of distribution, passes through the histohematological barriers (including placental), penetrates into breast milk.

Metabolised in the liver. The kidneys excrete 60-80% in the form of metabolites (in unchanged form, about 5% is excreted), through the intestine - 20%.

In patients with renal insufficiency, pharmacokinetics does not change. Do not cumulate.

Indications:

Arterial hypertension.

Contraindications:

Hypersensitivity to the drug and other sulfonamide derivatives, severe renal failure (anuria stage), hypokalemia, marked hepatic (including encephalopathy) insufficiency, pregnancy, lactation, age under 18 years (efficacy and safety not established).

In connection with the fact that the composition of the drug includes lactose, the drug is contraindicated in patients with lactose intolerance, galactosemia, a syndrome of impaired glucose / galactose absorption.

Carefully:

In case of violations of the liver and / or kidney function, violation of water-electrolyte balance, hyperparathyroidism, patients with an increased interval QT on the ECG or receiving a combination therapy, as a result of which the lengthening of the interval is possible QT (see section "Interaction with other drugs"), diabetes mellitus in the stage of decompensation, hyperuricemia (especially accompanied by gout and urate nephrolithiasis).

Dosing and Administration:

Tablets are taken whole by mouth, without chewing, squeezed with enough liquid. The daily dose of Lorvas ® SR is 1 tablet once a day (in the morning).

Side effects:

From the digestive system: nausea, anorexia, dry mouth, stomachalgia, vomiting, diarrhea, constipation, abdominal pain, possible development of hepatic encephalopathy; rarely - pancreatitis.

From the central nervous system: asthenia, nervousness, headache, dizziness, drowsiness, vertigo, insomnia,depression; rarely - increased fatigue, general weakness, malaise, muscle spasm, tension irritability, anxiety.

From the respiratory system: cough, pharyngitis, sinusitis; rarely rhinitis.

From the side of the cardiovascular system: orthostatic hypotension, changes on the electrocardiogram (hypokalemia), arrhythmia, palpitations.

From the urinary system: frequent infections, nocturia, polyuria.

Allergic reactions: skin rash, hives, itching, hemorrhagic vasculitis.

Laboratory indicators: hyperuricemia, hyperglycemia, hypokalemia, hypochloraemia, hyponatremia, hypercalcemia, elevated plasma urea nitrogen urea, hypercreatininemia, glucosuria. Very rarely: thrombocytopenia, leukopenia, agranulocytosis, bone marrow aplasia and hemolytic anemia.

Other: exacerbation of the systemic lupus erythematosus.

Overdose:

Symptoms: nausea, vomiting, weakness, dysfunction of the gastrointestinal tract, water-electrolyte disorders, in some cases - excessive lowering of blood pressure, respiratory depression. Patients with cirrhosis may develop hepatic coma.

Treatment: gastric lavage, correction of water-electrolyte balance, symptomatic therapy. There is no specific antidote.

Interaction:

Saluretics, cardiac glycosides, gluco- and mineralocorticoids, tetracosactide, amphotericin B (IV), laxatives increase the risk of hypokalemia.

With simultaneous admission with cardiac glycosides, the likelihood of developing digitalis intoxication increases; with calcium preparations - hypercalcemia; with metformin - may aggravate lactic acidosis.

Increases the concentration of lithium ions in the blood plasma (decreased excretion in the urine), lithium has a nephrotoxic effect,

Astemizole, erythromycin in / in, pentamidine, sultopride, terfenadine, wincamine, antiarrhythmics IA class (quinidine, disopyramide) and III class (amiodarone, brethility, sotalol) can lead to the development of arrhythmias of the type "pirouette" ("torsades de pointes").

Non-steroidal anti-inflammatory drugs, glucocorticosteroid agents, tetracosactide, adrenostimulants reduce the hypotensive effect, baclofen - Strengthens.

Combination with potassium-sparing diuretics can be effective in some patients, however, the possibility of developing hypo- or hyperkalemia is not completely excluded,especially in patients with diabetes mellitus and renal insufficiency.

Angiotensin converting enzyme (ACE) inhibitors increase the risk of developing arterial hypotension and / or acute renal failure (especially with existing renal artery stenosis).

Increases the risk of violations functionand kidneys when using iodine-containing contrast agents in high doses (dehydration of the body).

Before using iodine-containing contrast agents, patients need to restore fluid loss.

Imipramine (tricyclic) antidepressants and neuroleptics increase the hypotensive effect and increase the risk of orthostatic hypotension.

Cyclosporine increases the risk of hypercreatininaemia.

Reduces the effect of indirect anticoagulants (coumarin or indanedione derivatives) due to an increase in the concentration of clotting factors as a result of a decrease in the volume of circulating blood and increase in their production by the liver (dosage adjustment may be required).

Strengthens the blockade of the neuromuscular transmission, which develops under the action of nondepolarizing muscle relaxants.

Special instructions:

In patients taking cardiac glycosides, laxatives, against the background of hyperaldosteronism, as well as in elderly patients, regular monitoring of the content of potassium and creatinine ions is shown.

Against the background of taking Lovas ® CP, the concentration of potassium, sodium, magnesium ions in the blood plasma (electrolyte disturbances may develop), pH, glucose concentration, uric acid and residual nitrogen should be systematically monitored.

The most thorough control is indicated in patients with cirrhosis of the liver (especially with edema or ascites - the risk of metabolic alkalosis, which increases the manifestation of hepatic encephalopathy), coronary heart disease, heart failure, and also in elderly patients.

To the group of the raised risk also patients with the increased interval QT on ECG (congenital or developed against a background of some pathological process).

The first measurement of the potassium concentration in the blood should be performed during the first week of treatment.

Hypercalcemia on the background of taking indapamide may be a consequence of previously undiagnosed hyperparathyroidism.

In patients with diabetes, it is extremely important to monitor blood glucose levels, especially when hypokalemia is present.

Significant dehydration can lead to the development of acute renal failure (decreased glomerular filtration rate).

Patients need to compensate for fluid loss and at the beginning of treatment carefully monitor kidney function.

Indapamide can give a positive result in the conduct of doping control.

Patients with hypertension and hyponatremia (due to taking diuretics) need to stop taking diuretics 3 days before the start of taking ACE inhibitors (if necessary, diuretics can be taken a little later) or they are given initial low doses of ACE inhibitors.

Derivatives of sulfonamides can exacerbate the course of systemic lupus erythematosus (should be borne in mind when administering indapamide).

Efficiency and safety in children is not established.

Effect on the ability to drive transp. cf. and fur:

In some cases, individual reactions associated with changes in blood pressure are possible, especially at the beginning of treatment and with the addition of another antihypertensive agent.As a result, the ability to drive and work with mechanisms that require increased attention.

Form release / dosage:

Controlled-release tablets coated with a film coat, 1.5 mg.

Packaging:

10 tablets in PVC / Al. blister.

3 or 10 blisters with instructions for use are placed in a cardboard box.

Storage conditions:

Store in a dry place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

5 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-004128/09

Date of registration:26.05.2009 / 07.08.2015

Expiration Date:Unlimited

The owner of the registration certificate:Torrent Pharmaceuticals Co., Ltd.Torrent Pharmaceuticals Co., Ltd. India

Manufacturer: & nbsp

TORRENT PHARMACEUTICALS, Ltd. India

Representation: & nbspTORRENT PHARMACEUTICALS LTD. TORRENT PHARMACEUTICALS LTD. India

Information update date: & nbsp19.03.2018

Illustrated instructions

Instructions

Lorvas® SR (Lorvas® SR)