COMPOSITIONS :
Acepress® Tablet 12.5 mg, each tablet contains : Captopril 12.5 mg.
DESCRIPTIONS :
Acepress® contains Captopril as an active ingredient is available in tablet 12.5 mg and 25 mg.
INDICATION :
- Treatment of mild to moderate hypertension. In severe hypertension is used if standard therapy is not effective or cannot be used.
- Treatment of congestive heart failure, concomitant use with diuretics and if possible with Digitalis.
DOSAGE AND ADMINISTRATIONS :
- Mild to moderate hypertension
Initial dose is 12.5 mg, twice daily. Maintenance dose is 25 mg, twice daily, which can increase after 2 – 4 weeks until reaching the desired response. Maximum dose is 50 mg, twice daily. Thiazide diuretics can be added if the desired response is not reached. Diuretics dose can be increase after 1 – 2 weeks until reach optimum response or maximum dose reached.
- Severe hypertension
Initial dose is 12.5 mg, twice daily. The dose can gradually increase to maximum 50 mg, three times daily. Captopril must be used with other anti-hypertension drugs with adjustment dose. Captopril dose do not exceed 150 mg daily.
- Heart failure
Captopril is used if therapy using diuretics is not adequate to controlling the symptoms. Initial dose is 6.25 mg or 12.5 mg can minimize the temporary hypotensive effect.
Maintenance dose is 25 mg, 2 – 3 times daily, can gradually increase not less than 2 weeks. Maximum dose is 150 mg daily.
- Elderly
It is recommended the use of a low initial dose, considering the possibility of decreasing renal function or other organs in elderly patients.
- Children
The initial dose of 0.3 mg/kg body weight up to a maximum 6 mg/kg body weight daily in 2 – 3 doses, depend on response.
CONTRAINDICATIONS :
- Patients with hypersensitive to Captopril or other ACE inhibitor (e.g., patient with angioedema during treatment with other ACE inhibitor).
- Pregnant or potentially pregnant woman.
- Lactating woman.
- Renal failure.
- Aortic stenosis.
WARNINGS AND PRECAUTIONS :
- Neutropenia/agranulocytosis, thrombocytopenia and anemia can occur on the user of Captopril. Including in patients with normal renal function, although it is rarely. Neutropenia appeared in 1 – 3 months of treatment, treatment must be discontinued before the patient is exposed to infectious diseases. Patient with high risk should do leukocyte count before treatment, every 2 weeks for the first 3 months of the treatment and periodically.
In patient who experience signs of acute infection (fever, pharyngitis), administration of Captopril should be stopped because it is a hint of neutropenia.
- Caution in patients with collagen vascular disease who received the immunosuppressant therapy, treatment with Allopurinol or Procainamide, because it may lead the occurrence of serious infections. The patient needs to be done to count of white blood cells before therapy, every 2 weeks during the first 3 months of therapy and periodically.
- The safety and effectiveness usage in children is still unknown, so this medicine is only given when there is no another effective drugs to control blood pressure.
- Consumption must bewared because the sensitivity of hypotensive effect.
- Caution if administered in patient with renal disease.
- Treatment should be stopped if there are symptoms of angioedema, such as swelling of the mouth, eyes, lips, tongue, larynx, also difficult to swallow, hard breathing and husky. Consult it to a doctor when you use potassium supplements, potassium sparing diuretic and potassium salts.
- If the woman who used this drug was pregnant, the drug should be discontinued immediately. On II and III trimester pregnancy can cause interference such as hypotension, hypoplasia-neonatal cranial, anuria, reversible and irreversible renal failure and death.
- Can also occur oligohydramnion, craniofacial deformation, hypoplacy lung development, premature, developmental retardation-intrauteri, patent ductus arteriosus.
- Infants with a history of over in the womb of his mother that got the treatment of ACE inhibitor, should be observed intensively about the possibility of hypotension, oligouria and hyperkalemia.
- Nephrotic syndrome can occur as well as membranous glomerulopathy in patients with severe hypertension. Due to proteinuria generally occurs at the time of 8 months of treatment, the patient should check urine protein before and every month during the first 8 months of treatment.
PRESENTATIONS :
Acepress® Tablet 12.5 mg Box, 10 strips @ 10 tablets Reg. No. DKL9502310410B1
STORAGE :
STORE BELOW 30ºC, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
PT. BERNOFARM
Sidoarjo – Indonesia