Farmoten®12,5
Each tablet contains :
Captopril 12, 5 mg
Farmoten® 25
Each tablet contains :
Captopril 12, 5 mg
Farmoten® 50
Each tablet contains :
Captopril 12, 5 mg
Pharmacology
Farmoten® acts on renin angiotensin by inhibiting the conversion of relatively non-active angiotensin I to active angiotensin II (angiotensin-converting enzyme inhibitor). Farmoten®
Is an antihypertensive agent which is also, effective for the treatment of heart failure. The combination with thiazide gives an additive lowering of blood pressure, whereas the combination with β-blocker has less additive effect.
Indications
- Treatment of moderate to severe to severe hypertension which does not respond to other combination therapy. Farmoten® can be used alone and in combination with other antihypertensive agent, eg thiazide.
- For treatment of heart failure in patients who have not responded adequately to treatment with diuretic and digitalis, in this therapy combination of Farmoten® with diretic and digitalis is commonly prescribe.
Dosage And Administration
Farmoten® should be given 1 hr before meals.
Adults
- Hypertension initial dose 12,5-25 mg 2-3 times a day. If lowering of blood pressure is not ssatifactory in 2 weeks after treatment, dose can be increased up to 50 mg 2-3 times a day.
- Mild to moderate hypertension : dosage should not be more than 150 mg/day.
- Severe hypertension : maximum permissible dose is up to 450 mg/day.
- Heart failure : initial dose is usually 25 mg 3 times a day, but it is advisable to commence with 12,5 mg 3 times a day.
Warning And Precautions
- Patients with signs of prior renal disorder may develop proteinuria and hyperkalaemia.
- Combination with potassium-sparing diuretics must be used with caution.
- Caution should be exercised when prescribing Captopril to patients with coronary heart deasese.
- Caution should be taken when administered to patients with aortic stenosis or outflow tract obstruction.
- Rotine blood test is required at the beginning of therapy as neutropenia may develop.
- Use in pregnancy & lactation : Captopril can cause fetal and neonatal morbidity and mortality when administered to pregnant women. If patients become pregnant during therapy with captopril, treatment must be discontined immediately. Administration during the 2nd or 3rd trimesters of pregnancy has been associated with fetal and nonatal injury including hypotension, neonatal skull apoplexy, anuria, reversible and irreversible renal failure and death.
- Oligohydramnios, craniofacial deformity, hypoplastic lung development, premature birth, intrauterine growth retardation and patent ductus arterious have been reported.
- Babies born from mothers who received ACE inhibitor therapy during pregnancy must be under intensive obserbation because of the possibility of hypotension, oligouria and hyperkalaemia. Caution should be observed in nursing mothers.
- Use in children caution should be exercised when administered to children since the safe use and efficacy of captopril for these patient has not been established yet.
Side Effect
- Maculopapular rash often with pruritus and fever has been reported in about 10 % of patients receiving captopril.
- These side effects are usually mild and diapear in a few days after reduction of capropril dosage.
- Transient taste alteration is found in 70% of patients receiving captopril and will disappear without discontinuing captopril therapy.
- Proteinuria developed in 0,5% of patients receiving > 1 g of captopril daily and in 1,2% of patients who had evidence of prior renal disease. Proteinuria subsided eventhough therapy was not interrupted. Proteinuria usually occurred by the 8th month of therapy, therefore it is advisable to have urinay protein checked prior to treatment and periodically thereafter for the first 8 months of therapy.
- Mild potassium retention may develop particulary in patients with renal disorder: therefore, if combination therapy with potassium-retaining diuretics is required, it must be administered cautiously.
- Neutropenia and agranulocytosis; gastrointestinal disturbances, eg nausea and vomiting.
- Elevation of BUN (blood urea nitrogen) and serum creatine; paresthesias, serum disorder, bronchospasm, lymphadenopathy, cough.
Contraindications
Patients hypersensitive to captopril
Drug Interactions
- Combination therapy with diuretics can produce hypotension within the first 1-3 hrs after initial dose. This hypotensive effect can be minimised by either discontining the diuretic or increasing the salt intake approximately 1 week prior to initation of treatment with captopril.
- This transient hypotensive response may not occur in the subsequent doses and diuretics can be administered if necessary.
- Concomitant use of captopril with “potassium-increaseing agents” (salt/potassium-substitutes, potassium-sparing agent), eg spionolactone, triaterene and amiloride may cause the development of hyperkalaemia.
- Concomitant administration with renin-releasing agent or other antihypertensivedrugs may produce additive hypotensive effect.
- Concomitant use with vasodilating agents may produce additive hypotensive effect.
- Caution should be taken when administered together with sympathomimetic agents since blood pressure may be increased. Hypotensive effects is diminished by indomethacin, salicylates and NSAIDS.
Storage
Store below 300C
Presentation
Farmoten®12.5 : Box of 10 strips @ 10 tablets. Reg. No. DKL9131501810B1
Farmoten®25 : Box of 10 strips @ 10 tablets. Reg. No. DKL9131501810A1
ON MEDICAL PRESCRIPTION ONLY
Manufactured by
PT. PRATAPA NIRMALA
Tanggerang – Indonesia
FAHRENHEIT
0 Comments
