Xipogamma 20 mg tablets # 30

Author Ольга Кияница

2017-05-11

Amount in a package 30
Product form Pills
Manufacturer Woerwag Pharma (Germany)
Registration certificate UA/6557/01/02
The main medicament Xipogamma
morion code 98819

Xipogamma instructions for use

Composition

active ingredient: xipamid; 1 tablet contains 10 mg or 10 mg of xypamide; or 20 mg or 40 mg;
auxiliary substances: 10 mg of starch, microcrystalline cellulose, povidone (K 25), cetyl alcohol, lactose, silicon, highly dispersed dioxide, magnesium stearate, iron oxide (iii) yellow (E172)

20 mg of starch, microcrystalline cellulose, povidone (K 25), cetyl alcohol, lactose, silicon dioxide highly dispersed, magnesium stearate

40 mg of starch, microcrystalline cellulose, povidone (K 25), cetyl alcohol, lactose, silicon dioxide, finely dispersed, magnesium stearate, iron oxide (iii) yellow (E 172), indigoid dye.

Dosage form

Pills.

Pharmacological group

Nethiazide diuretics with moderately pronounced activity. Sulfamides, simple preparations. The code of automatic telephone exchange С0ЗВ А10.

Indications

Arterial hypertension.

Cardiac, renal and geopathic edema.

Contraindications

  • Hypersensitivity to xypamide, in other sulfonamide derivatives or thiazides or other components of the drug
  • severe liver dysfunction (precoma and Coma ceraticum)
  • severe renal failure
  • hypokalemia that does not respond to treatment;
  • severe hyponatremia
  • hypercalcemia;
  • hypovolemia;
  • gout
  • hereditary intolerance to galactose, deficiency of lactase, malabsorption, glucose and galactose.

Dosing and Administration

Adults take once a day 10-20 mg of xenopamide in both arterial hypertension and edema.

For the treatment of edema, the dose can be 40 mg. In the case of a high degree of restriction of kidney function, the daily dose of xypamide can be increased to 80 mg.

It is not recommended to increase the dose of more than 80 mg of xypamide per day.

After removal of edema, you can go to a dose of 20 mg or 10 mg of xypamide to prevent relapse.

After long-term treatment, you should gradually stop taking xypamide.

Tablets without chewing by washing down with enough water (about 1 glass), it is best in the morning after breakfast.

Violation of the functions of the liver. If the liver function is disturbed, the dosage of xypamide should correspond to the degree of restriction of function.

Decreased cardiac function. In severe cardiac decompensation, the resorption of xypamide can be significantly limited.

Adverse Reactions

On the part of the nervous system and eyesight organs, headache, dizziness, fatigue, a slight impairment of vision, an increase in existing myopia.

From the side of the cardiovascular system: orthostatic hypotension, palpitation, with a high dosage, in particular for venous diseases, increases the risk of thrombosis and embolism.

From the digestive tract: spastic abdominal pain, diarrhea, dry mouth, constipation hemorrhagic pancreatitis, acute cholecystitis with existing cholelithiasis, jaundice.

From the skin: allergic reactions (including itching, erythema, urticaria, photosensitization), increased sweating, anaphylactic shock.

From the hemopoietic organs: gipokaliemia, which can be expressed in such symptoms as nausea, vomiting, changes in the ECG, increased sensitivity to glycosides, violation of heart rhythm or hypotension of skeletal muscles;thrombocytopenia, leukopenia, agranulocytosis, aplastic anemia.

Others: hypomagnesiuria; disturbances of water-electrolyte balance (dehydration, hyponatremia, hypomagnesia, and hypochloraemic alkalosis) increase in substances containing nitrogen and should be excreted in urine (urea, creatinine), especially at the beginning of treatment; an increase in the level of uric acid in the serum and the development of gout in patients are susceptible to this; increase in blood glucose in patients with diabetes mellitus hypokalemia: polyuria, pathological case. Hypokalemia of severe degree can lead to paralytic ileus, loss of consciousness or coma.

Rarely hyperlipidemia, latent diabetes, anaphylactoid reactions may occur; very rarely: acute interstitial nephritis due to hypovolemia can reach hemoconcentration and occasionally to convulsions, loss of consciousness, vascular collapse, spasms and muscle cramps, lethargy, fear, arousal.

Consumption of potassium decreases or loss of potassium increases in cases: vomiting, with chronic diarrhea, with severe sweating.

A consequence of increased renal potassium loss may be hypokalemia, which can manifest as neuromuscular syptomy (muscle weakness, paresthesia, paresis), gastrointestinal symptoms (vomiting, constipation, flatulence) and cardiac symptoms (eg impairment of pulse generation and conduction of the heart ).

Due to the increased loss of sodium in patients, hyponatremia may occur, accompanied by a restriction of sodium chloride (salt). Often observed symptoms of hyponatremia: apathy, convulsions, loss of appetite, weakness, drowsiness, vomiting, confusion.

With hypocalcemia, tetany is possible.

Overdose

Acute intoxication manifests itself primarily in the violation of water and electrolyte balance (hyponatremia, hypokalemia). Clinical symptoms may be nausea, vomiting, a sharp drop in blood pressure, convulsions, dizziness, drowsiness, confusion, polyuria or oliguria up to anuria (due to hypovolemia).

Urgent measures: reception of activated carbon. Restoration of water and electrolyte balance.

In cases of overdose, stop taking the medication immediately and consult a doctor. Treatment is symptomatic.

Use during pregnancy and lactation

The use of xypamide during pregnancy and lactation is contraindicated.

Children

Children can not use xypamide because the safety and effect of the drug for this category of patients is not defined.

Application features

You should not use xypamide for electrolyte imbalance, which is not amenable to treatment, orthostatic violation of blood pressure regulation, central nervous system disorders, pancreatitis, changes in the blood picture (anemia, leukopenia, thrombocytopenia), acute cholecystitis, vasculitis, increased myopia.

In liver diseases, hepatic encephalopathy can occur. In this case, stop taking the medication immediately.

In chronic excessive use of diuretics, Bartter's pseudosyndrome (extra-adrenal hyperaldosteronism) with edema can occur. These swelling are a manifestation of increased renin with subsequent secondary hyperaldosteronism.

The serum sodium level should be checked before starting treatment, and then regularly, at regular intervals. Since the lowering of the sodium level in the blood can initially take place without symptoms, it should be kept under control, and regular checks should be carried out for elderly patients and patients with cirrhosis.

The level of potassium in the serum. During long-term treatment with xypamide, hypokalemia may occur. Serum electrolytes (in particular potassium, sodium, calcium), bicarbonate, creatinine, urea and uric acid, as well as blood sugar should be checked regularly. Potassium replacement may be needed for elderly patients who do not have sufficient potassium.

The occurrence of hypokalemia (a level of potassium in the blood of less than 3.4 μmol / L) should be avoided, in particular in the case of large fluid loss (for example, due to vomiting, diarrhea, or intense sweating) and at risk, that is, in elderly patients and / or depleted patients and / or patients who received repeated medication, as well as patients with cirrhosis and edema and ascites, patients with coronary heart disease and heart failure. In such patients due to hypokalemia cardiotoxicity of cardiac glycosides and risk of heart rhythm disturbances increase. Hypovolemia or dehydration, as well as significant electrolyte disturbances or acid-base balance disorders should be monitored. In case of need, it is necessary to temporarily stop the treatment with Xipogam.

Patients at risk are patients with an extended QT interval.

In all the cases mentioned above, it is necessary to check the potassium level in the blood more often, and the first analysis should be done in the first week of treatment. Hypokalemia should be adjusted.

The level of calcium in the blood. Treatment with thiazide diuretics and drugs close to them can lead to a decrease in the release of calcium in the urine and a significant temporary increase in the level of calcium in the blood. Explicit hypercalcemia can occur on the basis of an unknown hyperfunction of the parathyroid glands.

Before examining the function of parathyroid glands, treatment should be discontinued.

Blood sugar. Patients with diabetes mellitus should check the blood sugar level, in particular with the simultaneous hypokalemia.

Function of the kidneys and diuretics. Thiazide diuretics and their derivatives are effective to the full in the case of normal kidney function or with a slight violation of them (serum creatinine level <25 mg / L or <220 μmol / L in adults). In elderly patients, the serum creatinine level should be adapted according to age, weight and patient's article.

Hypovolemia caused by loss of fluid or sodium, caused by diuretics at the beginning of treatment, leads to a decrease in glomerular (glomerular) filtration. Therefore, the level of urea and nitrogen in the blood can increase. This temporary functional kidney failure in people with healthy kidneys does not leave consequences, but can worsen the previous (already existing) kidney failure.

In case of unsuccessful correction of the electrolyte balance, treatment should be stopped.

The ability to influence the reaction rate when driving vehicles or other mechanisms

Since the reaction to the drug is individual, the reaction rate can vary so much that the ability to actively participate in road traffic, service and machine control, equilibrium, can be violated. This can be at the beginning of treatment, with increasing doses and changing drugs.

Interaction with other drugs and other interactions

The hypotensive effect of xypamide can be enhanced by other diuretics, antihypertensive drugs, beta-adrenoreceptor blockers, nitrates, vasodilators, barbiturates, phenothiazines, tricyclic antidepressants, and alcohol use.

With simultaneous use of xypamide and diuretics, the risk of disturbance of the water-electrolyte balance increases.

Hypotensive and diuretic effects of xypamide can decrease with the simultaneous use of salicylates or other non-steroidal anti-inflammatory drugs (eg indomethacin).

May diminish the effect of antidiabetics, which reduce the level of uric acid in the blood, norepinephrine and epinephrine.

Lithium. With simultaneous treatment with lithium, cardio- and neurotoxic effects of lithium are enhanced. If treatment can not be avoided, the level of lithium in the blood should be monitored and dosage adjusted.

Special precautions should be taken with the simultaneous administration of xypamide with such drugs

- Class Ia of antiarrhythmic agents (eg, quinidine, hydroquinidine, disopyramide)

- Class IIII of antiarrhythmic agents (eg amiodarone, sotalol, dofetilide, ibutilide)

- Certain antipsychotics: phenothiazines (sulpiride, sultopride, tiaprid), butyrophenones (eg droperidol, haloperidol)

- Other: bepridil, cisapril, difemanyl, erythromycin, halofantrine, misolastine, pentamidine, sparfloxacin, moxifloxacin, vincarinin intravenously.

Since there is an increased risk of ventricular arrhythmia when taking xipamide, in particular bidirectional ventricular tachycardia (promoted by hypokalemia), it is necessary to correct hypokalemia prior to treatment in such a combination.It is necessary to monitor the electrolytes of blood plasma and ECG monitoring.

Non-steroidal anti-inflammatory drugs, including selective COX-2 inhibitors, salicylic acid (> 3 g / day). Possible reduction of hypotensive effect of xypamide. Risk of acute renal failure with dehydration (glomerular filtration). It is necessary to monitor the sufficient intake of fluid and monitor kidney function at the beginning of treatment. Treatment with a high dose of salicylate can enhance its toxic effect on the central nervous system.

ACE inhibitors. The risk of lowering blood pressure and / or acute renal failure with the onset of treatment with ACE inhibitors in patients with pre-existing sodium deficiency (particularly in renal artery stenosis).

If treatment with xipamid in hypertension led to a decrease in sodium, it is necessary:

- Or to refuse reception of a xypamide for 3 days prior to the beginning of treatment by inhibitors ACE and then in addition to accept a xypamide;

- Or start treatment with low-dose ACE inhibitors and then gradually increase them.

When decompensated heart failure should be started with a very low dose of ACE inhibitors.

In any case, kidney function (determination of creatinine in the blood) in the first weeks of treatment with ACE inhibitors should be monitored.

Other drugs that lower the level of potassium: other potassium reducing substances, amphotericin B (c), gluco- and mineralocorticoids (systemic), tetracosactide, stimulant laxatives.

Control and correction of the level of potassium in the blood plasma. It should be observed in particular in the treatment of cardiac glycosides.

Baclofen. Increases the drop in blood pressure. It is necessary to monitor the sufficient intake of fluid and monitor kidney function at the beginning of treatment.

Cardiac glycosides. Hypokalemia and / or hypomagnesemia, which increase the toxic side effects of digitalis glycosides.Need control of potassium in the blood and ECG.

Potassium-sparing diuretics (amiloride, spironolactone, triamterene). Even if this combination is appropriate for some patients, it can lead to hypokalemia or hyperkalemia (especially in patients with renal insufficiency or diabetes mellitus).It is necessary to check the potassium level in plasma and ECG, as well as adjust the therapy if necessary.

Diuretics that promote the excretion of potassium (eg, furosemide), SCS, ACTH (ACTH), carbenoxolone, penicillin G, amphotericin or laxatives. Simultaneous use with xypamide may lead to an increase in potassium losses. Especially with the simultaneous use of xypampamide and loop diuretics (eg, furosemide), the risk of developing abnormalities in electrolyte balance and fluid balance increases. Close monitoring is necessary.

Metformin. Metformin is not used if the creatinine in the blood is 15 mg / L (135 μmol / L) in men and 12 mg / L (110 μmol / L) in women.

Contrasting agents with iodine content. With hydration caused by diuretics, there is an increased risk of acute renal failure if you use contrast agents containing iodine (in particular in high doses). Rehydration before use of contrast agents with iodine content.

Tricyclic antidepressants (imipramine), antipsychotics. Hypotensive effect and increased risk of orthostatic hypotension.

Calcium. The risk of hypercalcemia due to a decrease in the release of calcium in the urine.

Ciclosporin, tacrolimus. Risk of increased serum creatinine levels.

GCS, tetracosactide. Reduction of hypotensive action (fluid and sodium retention due to GCS).

Cytotoxic agents (eg cyclophosphamide, fluorouracil, methotrexate). The risk of toxicity, in particular the reduction of granulocytes.

Antidiabetic drugs, drugs that reduce the level of uric acid in the serum, norepinephrine, adrenaline. The effect of these drugs may be weakened by simultaneous administration with xypamide.

Quinidine. Allocation can be reduced.

Miorelaxants (curare alkaloids). Neuromuscular blockade may increase.

Kolestipol and colstiraamine. The resorption of xypamide can decrease.

Pharmacological properties

Pharmacodynamics. Xipamid is a diuretic that suppresses reabsorption in the distal tubule of the nephron and first leads to the conclusion of chlorine and sodium, then to an increase in polyuria due to osmotically bound water. By increasing the current in the distal tubule, the secretion of potassium is stimulated. Also increases the excretion of bicarbonate, calcium and magnesium. The mechanism of action of xypamide is different from thiazides, despite structural affinity.Xipamid does not affect renal hemodynamics, on the share of glomerular filtration. Diuretic action occurs after 1:00 and reaches its maximum between the third and six hours. The withdrawal of chlorine and sodium is carried out for 12-24 hours, so there is no ricochet effect. The limiting dose of xypamide is 5 mg (orally). At excess of 80 mg further salure and diuresis is not present.

Hypotensive action of xypamide comes at the beginning of treatment. The maximum effect of lowering blood pressure is achieved in 2-3 weeks.

Pharmacokinetics. Approximately after 1:00 the maximum concentration of xypamide in the blood plasma is reached.The protein-binding capacity is 99%. The elimination half-life is 7:00. Oral resorption xipamide is complete.

In renal insufficiency, the half-life is increased to 9:00, liver cirrhosis, despite xipamide elevated levels in the blood plasma remains unchanged.

Renal output unchanged substance is 30-40%. Extrarenal O (about 2/3 natural xipamide) is carried out by half due to glucuronidation. Inactive metabolite that is created in this way is output via the kidney, and the rest - through the intestines.

Basic physical and chemical properties

10 mg tablets: yellow, possibly interspersed with black, round tablets with "SNEP-tab" on one side, practically odorless;
20 mg tablets: White round tablets with "SNEP-tab" on one side, practically odorless;
40 mg tablets: light green, optionally with black patches, round tablets with "SNEP-tab" on one side, almost odorless.

Shelf life

5 years.

Storage conditions

At temperatures above 25 ° C, in the original package of the reach of children.

Packaging

10 tablets in a blister, 3 or 5, 10 blisters per box.

Category of leave

On prescription.


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