FURIDAP [Indapamide] 2.5 mg Tablets
FURIDAP
instructions for medical use of the medicinal product
Tradename
Furidap,
International non-proprietary name
Indapamide,
Compound
Each coated tablet contains:
active ingredient: indapamide 2.5 mg
excipients: starch, dextrin, microcrystalline cellulose, hypromellose, talc, magnesium stearate
Dosage form
Tablets.
Pharmacotherapeutic group
Diuretic .
Pharmacological properties
Pharmacodynamics
Antihypertensive agent (diuretic, vasodilator). By pharmacological properties, it is close to thiazide diuretics (violation of Na reabsorption in the cortical segment of the loop of Henle). Increases urinary excretion of sodium, chloride and, to a lesser extent, potassium and magnesium ions. Possessing the ability to selectively block "slow" calcium channels, it increases the elasticity of arterial walls and reduces overall peripheral vascular resistance. Helps to reduce hypertrophy of the left ventricle of the heart. Does not affect the content of lipids in blood plasma (TG, low density lipoprotein, high density lipoprotein); does not affect carbohydrate metabolism (including in patients with concomitant diabetes mellitus). Reduces the sensitivity of the vascular wall to norepinephrine 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 on the background of a single dose.
Pharmacokinetics
After oral administration, it is rapidly and completely absorbed from the gastrointestinal tract; bioavailability - high (93%). Eating somewhat slows down the rate of absorption, but does not affect the amount of absorbed substance. The maximum concentration in blood plasma is 12 hours after ingestion. With repeated doses, fluctuations in the concentration of the drug in the blood plasma in the interval between taking two doses are reduced. The equilibrium concentration is established after 7 days of regular intake. T1 / 2 - 18 hours, communication with plasma proteins - 79%. It also binds to the elastin of the smooth muscles of the vascular wall. Has a high volume of distribution, passes through histohematic barriers (including placental), penetrates into breast milk.
Metabolized in the liver. The kidneys excrete 60-80% as metabolites (about 5% is excreted unchanged), through the intestines - 20%. In patients with renal insufficiency, the pharmacokinetics do not change. Does not accumulate.
Indications for use
• arterial hypertension.
Contraindications
• anuria;
• hypokalemia;
• severe hepatic (including with encephalopathy) and / or renal failure;
• pregnancy;
• lactation period (breastfeeding);
• age up to 18 years (efficacy and safety have not been established);
• concomitant use of drugs that prolong the QT interval;
• Hypersensitivity to the drug and other sulfonamide derivatives.
Dosage and administration
Tablets are taken orally, without chewing, with a sufficient amount of liquid.
The daily dose of the drug is 1 tab. (2.5 mg) per day (morning). If after 4-8 weeks of treatment the desired therapeutic effect is not achieved, it is not recommended to increase the dose of the drug (increased risk of side effects without enhancing the antihypertensive effect). Instead, it is recommended to include another antihypertensive drug that is not a diuretic in the drug regimen.
In cases where treatment must be started with two drugs, the dose of Furidap remains equal to 2.5 mg in the morning once a day.
Special instructions and precautions
While taking Furidap, the concentration of potassium, sodium, magnesium ions in the blood plasma should be systematically monitored (electrolyte disturbances may develop), pH, concentration of glucose, uric acid and residual nitrogen.
The most careful monitoring is indicated in patients with cirrhosis of the liver (especially with edema or ascites - the risk of developing metabolic alkalosis, which increases the manifestations of hepatic encephalopathy), coronary heart disease, chronic heart failure, and also in the elderly. The high-risk group also includes patients with an increased QT interval on the electrocardiogram (congenital or developed against the background of any pathological process).
The first measurement of potassium concentration in the blood should be carried out during the first week of treatment.
Hypercalcemia while taking the drug may be the result of previously undiagnosed hyperparathyroidism.
Prescribed with caution in diabetes mellitus in the stage of decompensation, hyperuricemia (especially accompanied by gout and urate nephrolithiasis).
Significant dehydration can lead to the development of acute renal failure (reduced glomerular filtration rate). Patients need to compensate for the loss of water and carefully monitor kidney function at the beginning of treatment.
Patients with arterial hypertension and sponatremia (due to taking diuretics) should stop taking diuretics 3 days before the start of taking ACE inhibitors (if necessary, taking diuretics can be resumed a little later), or they are prescribed initial low doses of ACE inhibitors.
Sulfonamide derivatives can exacerbate the course of systemic lupus erythematosus (must be borne in mind when prescribing the drug).
Influence on the ability to drive vehicles and mechanisms
During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions.
Use during pregnancy and during breastfeeding
Contraindicated during pregnancy and lactation (breastfeeding).
Interaction with other drugs
Saluretics, cardiac glycosides, gluco- and mineralocorticoids, tetracosactide, amphotericin B (iv), laxatives increase the risk of hypokalemia.
When taken simultaneously with cardiac glycosides, the likelihood of developing digitalis intoxication increases; with drugs Ca2 - hypercalcemia; with metformin - aggravation of lactic acidosis is possible.
Increases the concentration of lithium ions in the blood plasma (decreased excretion in the urine), lithium has a nephrotoxic effect.
Astemizole, IV erythromycin, pentamidine, sultopride, terfenadine, vincamine, class 1a antiarrhythmic drugs (quinidine, disopyramide) and class III (amiodarone, bretilium, sotalol) can lead to the development of "torsades de pointes" arrhythmia.
Non-steroidal anti-inflammatory drugs, glucocorticosteroids, tetracosactide, sympathomimetics reduce the hypotensive effect, baclofen enhances.
The combination with potassium-sparing diuretics may be effective in some categories of patients, however, the possibility of developing hypo- or hyperkalemia is not completely excluded, especially in patients with diabetes mellitus and renal insufficiency.
ACE inhibitors increase the risk of arterial hypotension and / or acute renal failure (especially with existing renal artery stenosis).
Increases the risk of developing renal dysfunction when using iodine-containing contrast agents in high doses (dehydration). Before using iodine-containing contrast agents, patients need to restore fluid loss.
Tricyclic antidepressants and antipsychotic drugs enhance the hypotensive effect and increase the risk of orthostatic hypotension.
Cyclosporine increases the risk of developing hypercreatininemia.
Reduces the effect of indirect anticoagulants (coumarin or indandione derivatives) due to an increase in the concentration of coagulation factors as a result of a decrease in circulating blood volume and an increase in their production by the liver (dose adjustment may be required).
It enhances the blockade of neuromuscular transmission, which develops under the influence of non-depolarizing muscle relaxants.
Side effect
From the digestive system: nausea, anorexia, dry mouth, gastralgia, vomiting, diarrhea, constipation are possible.
From the nervous system: asthenia, nervousness, headache, dizziness, drowsiness, vertigo, insomnia, depression; rarely - increased fatigue, general weakness, malaise, muscle spasm, tension, irritability, anxiety.
From the senses: conjunctivitis, blurred vision.
From the respiratory system: cough, pharyngitis, sinusitis; rarely - rhinitis.
From the side of the cardiovascular system: orthostatic hypotension, changes in the electrocardiogram characteristic of hypokalemia, arrhythmia, palpitations.
From the urinary system: frequent infections, nocturia, polyuria.
Allergic reactions: rash, urticaria, itching, hemorrhagic vasculitis.
Laboratory indicators: hyperuricemia, hyperglycemia, hypokalemia, hypochloremia, hyponatremia, hypercalcemia, increased plasma urea nitrogen, hypercreatininemia, glucosuria.
Others: flu-like syndrome, chest pain, back pain, infections, decreased potency, decreased libido, rhinorrhea, sweating, weight loss, tingling in the extremities, pancreatitis, exacerbation of systemic lupus erythematosus.
If any of the side effects listed in the instructions get worse, or if you notice any other side effects not listed in the instructions, tell your doctor.
Overdose
Symptoms: nausea, vomiting, weakness, dysfunction of the gastrointestinal tract, water and electrolyte disturbances, in some cases - an excessive decrease in blood pressure, respiratory depression. Patients with cirrhosis of the liver may develop hepatic coma.
Treatment: gastric lavage, correction of water and electrolyte balance, symptomatic therapy. There is no specific antidote.
Storage conditions
Store in a cool and dry place, at a temperature not exceeding 30°C.
Keep out of the reach of children.
Best before date
3 years. Do not use after the expiry date stated on the packaging.
Holiday conditions
Released by prescription.
Release form
10 tablets in an aluminum foil blister. 3 blisters with instructions for use in a cardboard box.