Indap®
capsules
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- Manufacturer:
- PRO.MED.CS Praha a.s.
- Marketing authorisation holder:
- PRO.MED.CS Praha a.s.
- Composition:
- Indapamide 2.5 mg i.e.indapamidum 2,44 mg in 1 gelatine capsule.
- Indication group:
- antihypertensive, diuretic
The following information is for health professionals only.
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Characteristics:
Indapamide a derivate of sulphonamides is an effective drug for mild and moderate hypertension.It decrease blood vessel reactivity and peripheral vessel resistence, considerable diuretic effect in higher doses appears.Indapamide does not interfere nor with lipid neither with sacharide metabolism. After oral administration indapamide is rapidly absorbed.Biological availability is high ( 93 %). Its plasma half-life is 14 - 24 hours. Kidneys eliminate 60 - 80 % administered dose.
Indications:
Indap® cps. is convenient for the therapy of hypertension in adults. It can be used separately or in combination with other antihypertensives. Due to its pharmacological properties it is convenient for the therapy of elderly people, patients with renal insufficiency, diabetes and an increased level of blood lipids.
Contraindications:
Hypersensitivity to indapamide and sulphonamides. Severe hepatic insufficiency (risk of encephalopathy), hypokalaemia,hypeuricaemia. Pregnancy and lactation. Children bellow 18 years of age.
Undesirable effects:
Indap® cps. is very well tolerated and the occurrence of undesirable effects is rare. In the course of administration dizziness, fatigue,headaches, nausea, and hypersensitive reaction may occur. Hypokalaemia and increasing in uric plasma level are dose dependent. The preparation can slightly decrease potassium blood level and increase uric acid blood level.
Interactions:
Decrease in potassium level during Indap® cps. Therapy can be clinically significant when cardiotonics and anti-arrythmics are used concomitantly. When co-administration of lithium and diuretics is necessary, monitoring of lithium plasma level should be performed. High doses of salicylates may reduce antihypertensive effect of indapamide,tricyclic antidepressants and neuroleptic agents enhance antihypertensive effect and risk of orthostatic hypotension.
Caution:
During long-term administration of Indap® cps., it is recommended to check potassium and uric acid blood level regularly. Potasium plasma level should be monitored in patiens taking drugs that may cause arrythmia "torsade de pointes" (predisposition factors are hypokalemia, tachycardia and pre- existing long QT interval). Caution is necessary in patiens with several renal insufficiency.
Dosage:
Usual daily dose of Indap® cps. is 1 capsule (2.5 mg indapamide) best the morning. In case that the results of treatment are not being satisfactory, another antihypertensive agent should be added rather than the dose of INDAP® cps. increased. Capsules should be swallowed unchewed with some liquid.
Package:
30 capsules of 2.5 mg.
For greater details about the preparation see the product data summary.
Date of the latest revision of the text: October 14, 2009.
The preparation available on medical prescription only.