Fludex sr инструкция по применению на русском языке

Содержание

Действующее вещество

ATX

Фармакологическая группа

Лекарственная форма

Состав

Описание лекарственной формы

Фармакологические свойства

Показания

Противопоказания

Способ применения и дозы

Побочные действия

Взаимодействие

Передозировка

Особые указания

Форма выпуска

Условия отпуска из аптек

Условия хранения

Срок годности

Производитель

Описание проверено

• Комкова Людмила Александровна
  (Провизор)
  
  Опыт работы: более 12 лет

Fludex SR is a diuretic antihypertensive. It appears to cause vasodilation, probably by inhibiting the passage of calcium and other ions (sodium, potassium) across membranes. It has an extra-renal antihypertensive action resulting in a decrease in vascular hyperreactivity and a reduction in total peripheral and arteriolar resistance.

Classified as a sulfonamide diuretic, indapamide is an effective antihypertensive agent and by extension, has shown efficacy in the prevention of target organ damage.Administration of indapamide produces water and electrolyte loss, with higher doses associated with increased diuresis. Severe and clinically significant electrolyte disturbances may occur with indapamide use — for example, hypokalemia resulting from renal potassium loss may lead to QTc prolongation. Further electrolyte imbalances may occur due to renal excretion of sodium, chloride, and magnesium.

Other indapamide induced changes include increases in plasma renin and aldosterone, and reduced calcium excretion in the urine. In many studies investigating the effects of indapamide in both non-diabetic and diabetic hypertensive patients, glucose tolerance was not significantly altered. However, additional studies are necessary to assess the long term metabolic impacts of indapamide, since thiazide related impaired glucose tolerance can take several years to develop in non-diabetic patients.

Uses

Fludex SR is used for the treatment of essential hypertension . It is effective in treating hypertension in patients with renal function impairment, although its diuretic effect is reduced. Fludex SR is also used for the treatment of salt and fluid retention associated with congestive heart failure.

Fludex SR is also used to associated treatment for these conditions:
High Blood Pressure (Hypertension), Recurrent Nephrolithiasis, Sodium and fluid retention

How Fludex SR works

Fludex SR acts on the nephron, specifically at the proximal segment of the distal convoluted tubule where it inhibits the Na+/Cl- cotransporter, leading to reduced sodium reabsorption. As a result, sodium and water are retained in the lumen of the nephron for urinary excretion. The effects that follow include reduced plasma volume, reduced venous return, lower cardiac output, and ultimately decreased blood pressure.

Interestingly, it is likely that thiazide-like diuretics such as indapamide have additional blood pressure lowering mechanisms that are unrelated to diuresis. This is exemplified by the observation that the antihypertensive effects of thiazides are sustained 4-6 weeks after initiation of therapy, despite recovering plasma and extracellular fluid volumes.

Some studies have suggested that indapamide may decrease responsiveness to pressor agents while others have suggested it can decrease peripheral resistance. Although it is clear that diuresis contributes to the antihypertensive effects of indapamide, further studies are needed to investigate the medication’s ability to decrease peripheral vascular resistance and relax vascular smooth muscle.

Dosage

One tablet daily preferably in the morning. In more sever case Fludex SR can be combine with other categories of anti-hypertensive agent. The safety and effectiveness in pediatric patients have not been established

Side Effects

Side effects of Fludex SR include headache, anorexia, gastric irritation,nausea, vomiting, constipation, diarrhoea etc.

Toxicity

Fludex SR overdose symptoms may include but are not limited to nausea, vomiting, gastrointestinal disorders, electrolyte disturbances and weakness. Other signs of overdose include respiratory depression and severe hypotension. In cases of overdose, supportive care interventions may be necessary to manage symptoms. Emesis and gastric lavage may be recommended to empty the stomach; however, patients should be monitored closely for any electrolyte or fluid imbalances.

Precaution

Monitoring of potassium and uric acid serum levels is recommended, especially in subjects with a predisposition or sensitivity to hypokalemia and in patients with gout. Although no allergic manifestations have been reported during clinical trials, patients with a history of allergy to sulfonamide derivatives should be closely monitored.

Interaction

Other antihypertensive: Fludex SR may add to or potentiate the action of other antihypertensive drugs.

Norepinephrine: Fludex SR like thiazides, may decrease arterial responsiveness to norepinephrine.

Lithium: In general, diuretics should not be given concomitantly with lithium because they reduce its renal clearance and add a high risk of lithium toxicity.

Food Interaction

• Avoid alcohol. Alcohol may potentiate orthostatic hypotension.
• Increase consumption of potassium-rich foods. Fludex SR my cause potassium depletion leading to hypokalemia.
• Take with or without food.

Fludex SR Alcohol interaction

[Moderate]

Many psychotherapeutic and CNS-active agents (e.g., anxiolytics, sedatives, hypnotics, antidepressants, antipsychotics, opioids, alcohol, muscle relaxants) exhibit hypotensive effects, especially during initiation of therapy and dose escalation.

Caution and close monitoring for development of hypotension is advised during coadministration of these agents.

Some authorities recommend avoiding alcohol in patients receiving vasodilating antihypertensive drugs.

Patients should be advised to avoid rising abruptly from a sitting or recumbent position and to notify their physician if they experience dizziness, lightheadedness, syncope, orthostasis, or tachycardia.

Fludex SR Cholesterol interaction

[Moderate] Thiazide diuretics may increase serum triglyceride and cholesterol levels, primarily LDL and VLDL.

Whether these effects are dose-related and sustained during chronic therapy are unknown.

Patients with preexisting hyperlipidemia may require closer monitoring during thiazide therapy, and adjustments made accordingly in their lipid-lowering regimen

Drug Interaction

Moderate: metoprolol, metoprolol, cholecalciferol, cholecalciferolUnknown: aspirin, aspirin, rosuvastatin, rosuvastatin, omega-3 polyunsaturated fatty acids, omega-3 polyunsaturated fatty acids, atorvastatin, atorvastatin, acetaminophen, acetaminophen, levothyroxine, levothyroxine, cyanocobalamin, cyanocobalamin, ascorbic acid, ascorbic acid

Disease Interaction

Major: anuria, electrolyte losses, liver disease, lupus erythematosus, renal function disordersModerate: asthma, diabetes, hyperlipidemia, hyperparathyroidism, hyperuricemia, thyroid function tests

Volume of Distribution

Some sources report an apparent volume of distribution of 25 L for indapamide, while others report a value of approximately 60 L.

Elimination Route

The bioavailability of indapamide is virtually complete after an oral dose and is unaffected by food or antacids. Fludex SR is highly lipid-soluble due to its indoline moiety — a characteristic that likely explains why indapamide’s renal clearance makes up less than 10% of its total systemic clearance. The Tmax occurs approximately 2.3 hours after oral administration. The Cmax and AUC_0-24 values are 263 ng/mL and 2.95 ug/hr/mL, respectively.

Half Life

Fludex SR is characterized by biphasic elimination. In healthy subjects, indapamide’s elimination half-life can range from 13.9 to 18 hours. The long half-life is conducive to once-daily dosing.

Clearance

Fludex SR’s renal and hepatic clearance values are reported to be 1.71 mL/min and 20-23.4 mL/min, respectively.

Elimination Route

An estimated 60-70% of indapamide is eliminated in the urine, while 16-23% is eliminated in the feces.

Pregnancy & Breastfeeding use

There are no adequate and well-controlled studies in pregnant women and so Fludex SR is not recommended. Mothers taking Fludex SR should not breast feed.

Contraindication

This drug must not be taken in the following conditions:

• Hypersensitivity to sulfonamides
• Severe renal failure
• Hepatic encephalopathy or severe hepatic failure
• Hypokalaemia

Acute Overdose

Symptoms: These could include: allergies, skin rashes, epigastric pain, nausea, photosensitivity, dizziness, weakness and paraesthesia.Treatment: Treatment is supportive and symptomatic, directed at correcting the electrolyte abnormalities.

Storage Condition

Store in a cool and dry place. Protect from light and moisture.

Innovators Monograph

тонкая брошюра

                                _ _
_ _
_ _
1/8
KULLANMA TALİMATI
FLUDEX SR 1.5 MG SÜREKLI SALIM SAĞLAYAN TABLET
AĞIZ YOLUYLA ALINIR.
_ _
•
_ETKIN MADDE_:
1.5 mg indapamid.
•
_YARDIMCI MADDELER: _
Titanyum dioksit, gliserol, hipromelloz, polietilen glikol 6000
(makrogol
6000), povidon, anhidr kolloidal silis, magnezyum stearat ve laktoz
monohidrat (buzağı kaynaklı)
içermektedir.
_ _
BU ILACI KULLANMAYA BAŞLAMADAN ÖNCE BU KULLANMA TALİMATINI
DIKKATLICE
OKUYUNUZ ÇÜNKÜ SIZIN IÇIN ÖNEMLI BILGILER IÇERMEKTEDIR.
•
_Bu kul
                                
                                	Прочитать полный документ
                                
                            

Характеристики продукта

                                1
KISA ÜRÜN BİLGİSİ
1.
BEŞERİ TIBBİ ÜRÜNÜN ADI
FLUDEX SR 1.5 mg sürekli salım sağlayan tablet.
2.
KALİTATİF VE KANTİTATİF BİLEŞİM
ETKIN MADDE:
1,5 mg indapamid
YARDIMCI MADDELER:
124,5 mg laktoz monohidrat (buzağı kaynaklı)
Yardımcı maddeler için (bkz. Bölüm 6.1.)
3.
FARMASÖTİK FORM
Yuvarlak, beyaz, sürekli salım sağlayan film kaplı tablet.
4.
KLİNİK ÖZELLİKLER
4.1
TERAPÖTIK ENDIKASYONLAR
Fludex SR yetişkinlerde esansiyel hipertansiyon tedavisinde
endikedir.
4.2
POZO
                                
                                	Прочитать полный документ