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MONOPRIL
generic name: fosinopril

Pharmacological category: Hypotensive agent

Reviews

Fosinopril

Stroke. 2005 Mar;36(3):649-53. Epub 2005 Feb 03.
Effects of fosinopril and pravastatin on carotid intima-media thickness in subjects with increased albuminuria.
Asselbergs FW, van Roon AM, Hillege HL, de Jong PE, Gans RO, Smit AJ, van Gilst WH; PREVEND IT Investigators.
Department of Clinical Pharmacology, University of Groningen, Antonius Deusinglaan 1, 9713 AV, Groningen, The Netherlands.

BACKGROUND AND PURPOSE: Elevated urinary albumin excretion (UAE) is associated with an increased carotid intima-media thickness (IMT). Because angiotensin-converting enzyme inhibitors as well as statins have been shown to lower UAE and the progression of IMT, we assessed the effects of fosinopril and pravastatin on carotid IMT in subjects with an increased UAE (15 to 300 mg/24 h). METHODS: IMT was measured at the posterior wall of the left common carotid artery using radio-frequency signal analysis obtained by M-mode ultrasonography. 642 subjects were double-blind randomized to fosinopril 20 mg or matching placebo and to pravastatin 40 mg or matching placebo and were available for intention-to-treat analysis. RESULTS: Mean age was 51+/-11 years, 65% were male, the median UAE was 22.5 (15.5 to 40.8) mg/24 h, and the mean IMT at baseline was 0.77+/-0.18 mm. The overall progression rate of IMT in 4 years was 0.037+/-0.006 mm. No significant difference in IMT progression was found between fosinopril, pravastatin, or matching placebo. IMT after 4 years was predicted by IMT at baseline, age, gender, pulse pressure, and low-density lipoprotein cholesterol levels. Furthermore, a higher incidence of clinical events was observed in subjects with an IMT >1 mm after a mean follow-up of 46+/-7 months (hazard ratio, 3.13; 95% confidence interval, 1.59 to 6.16; P=0.001). CONCLUSIONS: In subjects with an increased UAE, treatment with fosinopril and pravastatin showed no significant effect on carotid IMT. Furthermore, an IMT <1 mm at baseline is an important indicator for event-free survival
Am Fam Physician. 2002 Aug 1;66(3):461-8.
Using ACE inhibitors appropriately.
Bicket DP.
Family Practice Residency Program, University of Pittsburgh Medical Center-McKeesport, Pennsylvania 15132, USA.

When first introduced in 1981, angiotensin-converting enzyme (ACE) inhibitors were indicated only for treatment of refractory hypertension. Since then, they have been shown to reduce morbidity or mortality in congestive heart failure, myocardial infarction, diabetes mellitus, chronic renal insufficiency, and atherosclerotic cardiovascular disease. Pathologies underlying these conditions are, in part, attributable to the renin-angiotensin-aldosterone system. Angiotensin II contributes to endothelial dysfunction. altered renal hemodynamics, and vascular and cardiac hypertrophy. ACE inhibitors attenuate these effects. Clinical outcomes of ACE inhibition include decreases in myocardial infarction (fatal and nonfatal), reinfarction, angina, stroke, end-stage renal disease, and morbidity and mortality associated with heart failure. ACE inhibitors are generally well tolerated and have few contraindications. (Am Fam Physician 2002;66:473.)
Fundam Clin Pharmacol. 2002 Oct;16(5):353-60
FOSIDIAL: a randomised placebo controlled trial of the effects of fosinopril on cardiovascular morbidity and mortality in haemodialysis patients. Study design and patients' baseline characteristics
Zannad F, Kessler M, Grunfeld JP, Thuilliez C; FOSInopril in DIALysis Investigators
Hypertension and Preventive Cardiology Division, Department of Cardiovascular disease, and Centre d'Investigations Cliniques INSERM-CHU, Toul, France.

The prevalence of end stage renal disease (ESRD) is growing in western countries. Patients with ESRD are more frequently elderly and diabetic and are exposed to very high cardiovascular morbidity and mortality. The main aim of the FOSIDIAL study is to assess the efficacy and safety of fosinopril, an angiotensin converting enzyme (ACE) inhibitor, in reducing the mortality and cardiovascular events in haemodialysis patients presenting with left ventricular hypertrophy. A total number of 397 patients are included in the study. They are aged 50-80 years (average 66.7 years) and have been undergoing haemodialysis for 4.8 years. All have left ventricular hypertrophy with cardiac mass index > 100 g/m2 in women and > 130 g/m2 in men, measured within 3 months prior to inclusion. Baseline cardiac mass index is 174 g/m2. After a 2 week placebo period, the patients are randomised into two groups receiving either fosinopril 5-20 mg/day, or a placebo for a duration of 24 months. The target dose is reached at the sixth, seventh or eighth week of treatment. Depending on tolerance, 300 patients reached the maximum recommended dose. Patients are subsequently assessed clinically every 3 months until the end of the study. The primary outcome is a composite endpoint of fatal and nonfatal major cardiovascular events. Secondary endpoints are individual cardiovascular events, event-free survival, overall mortality and all-cause hospitalisations. The trial began in October 1998. All patients were included by December 2000 and follow-up is ongoing. The last visit for the last patient is scheduled for 30 December 2002. We report here on the study design and the baseline characteristics of the study population.
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Drug information

GENERIC NAME: fosinopril sodium
BRAND NAME: Monopril


DRUG CLASS AND MECHANISM: Angiotensin converting enzyme (ACE) is the enzyme in blood which controls the formation of angiotensin II, a chemical in blood that causes constriction of arteries and veins. Constriction of arteries and veins elevates blood pressure. Fosinopril is in a class of drugs called ACE inhibitors which inhibit ACE and block the formation of angiotensin II. By blocking the formation of angiotensin II, fosinopril relaxes the arteries and veins and lowers blood pressure. By reducing blood pressure, fosinopril also reduces the work that the heart must do to pump blood through the arteries and veins. This improves the output of blood from the heart.

PREPARATIONS: Tablets (white-to-off-white): 10mg (biconvex-diamond-shaped); 20mg (oval)

STORAGE: Tablets should be stored between 15 and 30°C (86°F).

PRESCRIBED FOR: Fosinopril is used in treating high blood pressure. Its blood pressure lowering effect can be further enhanced by adding a diuretic medication ("water pill") such as hydrochlorothiazide. Fosinopril also is used in the treatment of congestive heart failure, a condition in which the heart is not able to pump enough blood. In patients with congestive heart failure, the ACE inhibitor class of medications has been shown to reduce symptoms and hospitalization and to improve survival. After a heart attack, ACE inhibitors improve the function of the damaged heart and reduce symptoms and hospitalizations due to congestive heart failure.

DOSING: Fosinopril is generally prescribed once daily, although some patients may need two doses per day. Patients with reduced kidney function need lower doses since their kidneys do not eliminate fosinopril from the body as well as normal kidneys Fosinopril may be taken with or without food.

DRUG INTERACTIONS: Although the combination of ACE inhibitors and diuretics is generally a favorable one (see above), fosinopril (and other ACE inhibitors) can work "too well" with diuretics and cause an excessive drop in blood pressure. This can cause symptoms of weakness, dizziness, and light-headedness. This is most likely to occur when patients already taking a diuretic start taking an ACE inhibitor. Combining fosinopril with potassium supplements, potassium containing salt substitutes, or potassium-conserving diuretics such as amiloride (Moduretic), spironolactone (Aldactone), and triamterene (Dyazide, Maxzide), can lead to dangerously high blood levels of potassium.

It is recommended that fosinopril not be taken at the same time as aluminum or magnesium-based antacids, such as Mylanta or Maalox, since these antacids decrease the amount of fosinopril that is absorbed from the intestine. Patients should take antacids and fosinopril at least two hours apart. Fosinopril can cause an increase in the amount of lithium in the body in patients taking lithium, sometimes causing lithium- associated side effects.

PREGNANCY: ACE inhibitors, including fosinopril, can be harmful to the fetus and should not be taken by pregnant women.

NURSING MOTHERS: Fosinopril is secreted in breast milk and is not recommended for nursing mothers.

SIDE EFFECTS: Fosinopril is generally well tolerated. The most common side effects are headache, cough, dizziness, diarrhea, fatigue, nausea, vomiting, complaints of sexual dysfunction, and abnormal liver tests. Impairment of kidney function has been reported with ACE inhibitors, especially in patients with severe heart failure or kidney disease. In rare instances, low white blood cell counts have been reported with the use of captopril, another ACE inhibitor. (Low white blood cells increase a patient's risk of infections.)

 

Caution! Before starting to take this medicine, it is vital that you should consult your doctor! Do not use it on your own initiative, without medical advice.

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MONOPRIL
Generic name: Fosinopril

Dosage
Packing
Price
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10 mg
28 tab
USD 29.00
20 mg
28 tab
USD 32.00
 

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