Captopril-H 50/25 mg Tablets
Captopril 50 mg/tab. + Hydrochlorothiazide 25 mg/tab.
Company Name
Alexandria
Therapeutic Group
ACE INH COMB+A-HYP/DIURET
Pharmaceutical form
Tablets
Package
2 strips x 10 tab.
Indications
Arterial hypertension (except for hyperaldosteronism).
Captopril – H is also indicated for cardiac insufficiency.
Warning & Precautions
"Do not use during pregnancy as it may cause injury or death of fetus Hypotension: Although the antihypertensive action of Captopril is generally well-tolerated, sensation of vertigo and dizziness can occur. In rare cases, the primary dose of Captopril provokes symptomatic arterial hypotension. In hypertensive patients, the risk of hypotension is much serious in case of hypovolemia e.g. upon treatment with diuretics, hyposodium regimen, or after diarrhea and vomiting. In the beginning of treatment, Captopril-H is to be administered with small doses. Symptoms generally disappear when the patient is lying down with his legs elevated. In case of severe hypotension, the patient can administer physiological saline solution by perfusion. Renal insufficiency: In case of serious nephropathies, caution is paid when taking thiazides due to the risk of azotemia (increase in BUN levels) and accumulation of the drug due to renal insufficiency. In patients with renal insufficiency, the dose and/or frequency of doses should be decreased as a consequence of seriousness of insufficiency. At the time of serious or late rapid fall in blood pressure, glomerular filtration rate can be decreased transiently which involves temporary increase in serum creatinine and uric azote (BUN). Filtration rate remains unchanged in most cases. Surgery / Anesthesia: Upon essential surgical intervention or during anesthesia by preparations of hypotensive action, Captopril blocks the formation of Angiotensin II secondary to the compensatory secretion of renin. Supposed arterial hypotension resulted from this mechanism can be corrected by volume expansion. Hepatic diseases: Thiazide diuretics are utilized with caution in hepatic insufficiency or in progressive hepatic disease because minimal changes in the hydro-electrolyte equilibrium can induce hepatic coma. So, the use of this medication in these patients is done with caution. Paediatric use: Efficacy and tolerance of Captopril-H on infants is not verified yet.
Product Type
Human
Dosage
"As directed by the physician or as followed:
Dosage must be individualized according to the state of illness.
Captopril-H is generally taken once a day in the morning 1/2 hour before breakfast/meals.
In elderly patients, renal insufficiency and/or hypovolemic agents e.g. after administration of diuretics, the initial dose is decreased.
The maximum daily dose is 150 mg of captopril and 50 mg hydrochlorothiazide.
Arterial hypertension:
To avoid hypotension in the primary dose, treatment is begun with 25 mg (1/2 tablet) once daily. The dose can be increased to 50 mg (1 tablet) once daily in the morning for maintenance.If blood pressure is still elevated after 4 – 6 weeks of therapy, administration of 50 mg (1 tablet) twice daily should be done.If necessary, supplementary antihypertensive agents can be administered.
Cardiac Insufficiency:
In cardiac insufficiency, captopril is utilized in association with diuretics and / or digitalis.
The combination should not be used to initiate therapy; however, once the optimal dose of Captopril and diuretic has been established, Captopril-H may be substituted for continued therapy.
Special posology:
In patients suffering from cardiac and renal insufficiency, the doses must be spaced greatly or they may be reduced.
In progressive renal insufficiency which is manifested by increase in BUN serum levels, treatment should be re-evaluated and reduction of thiazide dose or stopping the diuretic administration must be considered.
Adverse Reactions
"In majority of cases , the side effects observed are mild and temporary and treatment should not be suspended.
Secondary effects following administration of Captopril-H are most frequently cutaneous eruptions. These symptoms are generally reversible upon long-term treatment or when the initial and maintenance doses are decreased.
Cutaneous eruptions can be treated with antihistaminics.
Occasionally, vertigo, sensation of tiredness due to hypotension, gastro-intestinal troubles, non-productive dry cough can occur. In rare cases, orthostatic hypotension occurs.
In some cases: angioneurotic oedema of the face, lips, tongue, glottis, larynx and extremities is rarely observed in patients treated with ACE inhibitors of which is captopril. In these cases treatment should be stopped.
Elevation of levels of hepatic enzymes can occur and in some cases secondary cholestasis may occur.
Proteinuria, pre-existing nephropathy, development of nephrotic syndrome, pemphigus, Stevens-Johnson Syndrome, orthostatic effects, tachycardia, myalgia, arthralgia, nephritis, eosinophilia, headache, dyspnea, alopecia, pancreatitis and dry mouth may occur.
Results of laboratory clinical tests: Administration of Captopril-H is rarely accompanied by significant clinical modifications of standard laboratory values (hypokalemia, increase in the level of serum creatinine).
Contra Indications
Captopril-H is contraindicated in hypersensitivity to Captopril , thiazides , or any sulfonamide derived drug.
Drug Interactions
"There can be synergistic effect between Captopril and other antihypertensives particularly diuretics.
In association with Captopril-H , potassium supplements or potassium sparing diuretics such as spironolactone, triamterene or amiloride and other hyperkalemic agents (e.g. heparin) can provoke significant increase in serum potassium especially in patients with renal insufficiency.
The hypotensive action of Captopril-H can be decreased when associated with anti-inflammatory drugs such as acetylsalicylic acid or indomethacin.
Decrease in efficacy of antidiabetic agents is possible.
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