| Customization: | Available |
|---|---|
| Application: | Internal Medicine |
| Usage Mode: | For oral administration |
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Indications:
Hypertension
Congestive heart failure
In patients on doses of over 100 mg daily plus or minus a diuretic, in those with severe renal impairment or those with severe congestive heart failure use of captopril should be under specialist supervision.
Myocardial Infarction
Before starting therapy, cardiac function should be determined by radionuclide ventriculography or echocardiography.
Type I Diabetic nephropathy
Captopril can be used alone or in combination with other antihypertensive agents.
Dosage and Administration:
For Oral Administration
Dose should be individualised according to patient's profile and blood pressure response. The recommended maximum daily dose is 150 mg.
Captopril may be taken before, during and after meals.
Precautions & Warning:
Pregnancy:
The use of ACE inhibitors is not recommended during the first trimester of pregnancy. The use of ACE inhibitors is contra-indicated during the 2nd and 3rd trimester of pregnancy.
Lactation:
Limited pharrnacokinetic data demonstrate very low concentrations in breast milk , Although these concentrations seem to be clinically irrelevant, the use of this product in breast feeding is not recommended for pre-term infants and for the first few weeks after delivery, because of the hypothetical risk of cardiovascular and renal effects and because there is not enough clinical experience, In the case of an older infant, the use of Captopril tablets in a breast-feeding mother may be considered if this treatment is necessary for the mother and the child is observed for any adverse effect.
Storage instructions:
Do not store above 25°C. Store in the original package.
| Testing terms | Standards | Results |
| Characeters | white tablets | Complies |
| ldentification | Positive reaction | Complies |
| Content uniformity | Meet the specification | Complies |
| Dissolution rate | ≥80% | 86% |
| Microbial limit | Meet the specification | Complies |
| Assay | 90.0%-110.0% | 98.2% |
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