Enalapril information.

Enalapril: uses

Enalapril is used to treat high blood pressure ( hypertension ) . Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems.

Enalapril contains two medications, enalapril and hydrochlorothiazide. Enalapril is called an ACE inhibitor and works by relaxing blood vessels so blood can flow more easily. Hydrochlorothiazide is called a water pill ( diuretic ) and causes your body to get rid of extra salt and water. This increases the amount of urine we make. Getting rid of extra water and salt probably also helps to relax blood vessels so that blood can flow more easily. These medications are used together when one drug isn't controlling your blood pressure.

Enalapril: how to use

Take Enalapril by mouth with or without food, usually once or twice daily or as directed by your doctor. If we take this drug too close to bedtime, we may need to wake up to urinate. Therefore, it's best to take Enalapril at least 4 hours before your bedtime. Consult your doctor or pharmacist if we have questions about your dosing schedule.

The dosage is based on your age, medical condition and response to therapy. If we have severe liver or kidney problems, your dosage may need to be adjusted.

Use Enalapril regularly in order to get the most benefit from it. To help we remember, take it at the same time each day. It is important to continue taking Enalapril even if we feel well. Most people with high blood pressure do not feel sick. It may take up to several weeks before the full benefit of Enalapril takes effect.

Don't stop taking Enalapril without first consulting your doctor. Some conditions may become worse when drug is abruptly stopped. Your dose may need to be gradually decreased.

Inform your doctor if your condition worsens ( e. g. , your routine blood pressure readings increase ) .

Enalapril: other used

This section contains uses of Enalapril that aren't listed in approved professional labeling for drug but that may be prescribed by your health care professional. Use Enalapril for a condition that is listed in this section only if it has been so prescribed by your health care professional.

Enalapril may also be used to treat certain heart conditions ( e. g. , congestive heart failure ) .

Enalapril: side effects

Dizziness or lightheadedness may occur while use Enalapril as your body adjusts to medication. Nausea, tiredness, headache or dry cough may also occur. We may also experience decreased sexual ability or increased sensitivity to the sun. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed Enalapril because he or she has judged that the benefit to we is greater than risk of side effects. Many people using Enalapril don't have serious side effects.

The hydrochlorothiazide in Enalapril may cause too much body water and salts to be lost ( dehydration ) . Tell your doctor immediately if we have any of these unlikely but serious symptoms of dehydration:

Tell your doctor immediately if any of these unlikely but serious side effects occur:

Enalapril may rarely cause serious ( possibly fatal ) liver problems. Tell your doctor immediately if you notice any of following rare but very serious side effects:

Tell your doctor immediately if any of these rare but very serious side effects occur:

A very serious allergic reaction to Enalapril is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include:

This is not a complete list of possible side effects. If we notice other effects not listed above, contact your doctor or pharmacist.

Enalapril: precautions

Before taking Enalapril, tell your doctor or pharmacist if you are allergic to either enalapril or hydrochlorothiazide; or to other ACE inhibitors ( e. g. , captopril, lisinopril ) ; or to other thiazides ( e. g. , polythiazide ) ; or to sulfa medications; or if we have any other allergies.

Enalapril shouldn't be used if we have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if we have:

Before using Enalapril, tell your doctor or pharmacist your medical history, especially of:

Enalapril may make we dizzy; use caution while engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages.

To reduce risk of dizziness and lightheadedness, get up slowly when rising from a seated or lying position.

Drink plenty of fluids while taking Enalapril to help prevent dizziness. Too much sweating, diarrhea or vomiting may cause we to feel lightheaded. Avoid heavy exercise. Report prolonged diarrhea or vomiting to your doctor.

Before having surgery, tell your doctor or dentist that you are taking Enalapril.

Enalapril may make we more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Enalapril may increase or decrease your potassium levels. Before using potassium supplements or salt substitutes containing potassium, consult your doctor or pharmacist. If you have diabetes, this product may increase your blood sugar levels. Check your blood glucose levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high blood sugar, such as increased thirst and urination. Your anti-diabetic medication or diet may need to be adjusted.

Caution is advised when using Enalapril in the elderly because they may be more sensitive to its effects, especially dizziness.

Enalapril is not recommended for use during pregnancy due to risk for harm to an unborn baby. Consult your doctor for more details. ( See also Warning section. )

The enalapril and hydrochlorothiazide in Enalapril pass into breast milk and may have undesirable effects on a nursing infant. Breast-feeding while using Enalapril isn't recommended. Consult your doctor before breast-feeding.

Enalapril: interactions

Also see Precautions. Your healthcare professionals ( e. g. , doctor or pharmacist ) may already be aware of any possible drug interactions and may be monitoring you for it. Don't start, stop or change dosage of any medicine before checking with them first.

Enalapril should not be used with following medication because very serious interactions may occur while use Enalapril:

Before using Enalapril, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of:

A very serious reaction may occur while use Enalapril if we are getting injections for bee/wasp sting allergy ( desensitization ) and are also taking enalapril with hydrochlorothiazide. Make sure all your doctors know which medicines you're using.

If taken together with Enalapril, cholestyramine and colestipol can decrease amount of Enalapril that's absorbed by your body. If you're taking either of these drugs, separate them from this medication by at least 4 hours.

Check labels on all your medicines ( e. g. , cough-and-cold products, diet aids, nonsteroidal anti-inflammatory drugs-NSAIDs for pain/fever reduction ) because they may contain ingredients that could increase your blood pressure or cause a fast heartbeat ( e. g. , pseudoephedrine, phenylephrine, chlorpheniramine, diphenhydramine, clemastine, ibuprofen, naproxen ) . Ask your pharmacist about safe use of those products.

Some nonprescription medicines may also contain aspirin, which may decrease effect of enalapril in Enalapril. Low-dose aspirin, as prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention ( usually at dosages of 81-325 milligrams per day ) should be continued. Consult your doctor or pharmacist for more details.

Enalapril can affect the results of certain lab tests ( e. g. , parathyroid, certain tests that measure digoxin drug levels ) . Make sure laboratory personnel and your doctors know you use Enalapril.

This document doesn't contain all possible interactions. Therefore, before using Enalapril, tell your doctor or pharmacist of all products we use. Keep a list of all your medications with you, and share list with your doctor and pharmacist.

Enalapril: overdose

If overdose of Enalapril is suspected, contact your local poison control center or emergency room immediately. US residents can call US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: severe dizziness.

Enalapril: notes

Do not share Enalapril with others. Lifestyle changes such as stress reduction programs, exercise, and dietary changes may increase the effectiveness of this medicine. Talk to your doctor or pharmacist about lifestyle changes that might benefit you.

Laboratory and/or medical tests ( e. g. , white blood cell count, blood sodium and potassium levels, kidney function, liver function ) should be performed from time to time to monitor your progress or check for side effects. Consult your doctor for more details.

Check your blood pressure regularly while taking this medication, especially when we first start Enalapril or when your dose is changed. Learn how to monitor your own blood pressure at home, and share results with your doctor.

Enalapril: missed dose

If you miss a dose Enalapril, take it as soon as we remember. If it is near time of next dose, skip missed dose and resume your usual dosing schedule. Don't double the dose of Enalapril to catch up.

Enalapril: storage

Store US products at a temperature below 86 degrees F ( 30 degrees C ) away from light and moisture. Brief storage up to 122 degrees F ( 50 degrees C ) is permitted.

Store Canadian product 59 to 86 degrees F ( 15 to 30 degrees C ) away from light and moisture.

Don't store Enalapril in the bathroom. Keep all medicines away from children and pets.

Properly discard Enalapril when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Enalapril: warning

Enalapril can cause serious ( possibly fatal ) harm to an unborn baby if used during pregnancy. Therefore, it's important to prevent pregnancy while taking Enalapril. Consult your doctor for more details and to discuss use of reliable forms of birth control while taking this medication. If we are planning pregnancy, become pregnant or think we may be pregnant, contact your doctor immediately.

Shipping options for Enalapril

Chronic Constipation - Three Presentations And Four Additional Posters Reinforce Efficacy And Safety Profile Of RESOLOR

Movetis NV, a European-based GI specialist pharmaceutical company, announces that it has presented substantial new data from different studies this week at the prestigious Digestive Disease Week ( DDW ) 2008 Congress. The data, that are part of a comprehensive development program with over 82 trials, reinforce efficacy and safety profile of RESOLOR ( R ) ( prucalopride ) , most advanced in the class of novel and highly selective, high-affinity 5-HT4 receptor agonists that has the potential to normalize impaired lower GI motility. RESOLOR has been studied in treatment of patients suffering from chronic constipation for whom laxatives don't provide adequate relief ( 1-7 ) .

A combined analysis of three identical and pivotal phase III studies, including 1, 924 patients, demonstrated that over 12 weeks treatment period both 2 mg and 4 mg RESOLOR significantly improved bowel function ( as measured by a number of rigorous primary and secondary endpoints ) as well as a variety of predominant symptoms in patients with chronic constipation compared with placebo. These results are also reflected in other efficacy parameters including quality of life ( 1 ) , adding support to RESOLOR data presented for first time at UEGW ( United European Gastroenterology Week ) in October 2007.

Additional data over 24 months ( 2 ) presented at DDW shows that RESOLOR has a favourable safety profile and is well tolerated, and that patients' satisfaction with bowel function was maintained during this long treatment period ( 2 ) . Furthermore, in a specifically designed safety trial, RESOLOR showed favourable CV safety and tolerability data ( including comprehensive set of QTc measurements ) at repeated doses of up to 20 mg daily - 10 times anticipated therapeutic dose for chronic constipation ( 4 ) .

Jan Tack, Professor and Head of Clinic, Division of Gastroenterology, University Hospital Gasthuisberg, University of Leuven, Belgium, and author of one of abstracts, commented, " The debilitating effects of chronic constipation on work, mental health and relationships are often underestimated, and there's a recognised and significant unmet need for an effective treatment with a novel mechanism of action for this condition. RESOLOR's unique selectivity means it is likely to be safer than older motility agents and more effective than existing treatments, and may also potentially provide a faster return to normalized bowel health. The variety and strength of new RESOLOR data presented at DDW demonstrates how RESOLOR may potentially help fill unmet need and offer hope towards normal bowel habits, symptom relief and improved quality of life to the many patients who suffer from the condition. "

Further data were also presented on treatment with RESOLOR of various sub-populations of patients, where there remains a significant challenge of treating chronic constipation. In these studies, RESOLOR improved bowel function and was shown to be safe and well tolerated in the elderly ( 5 ) , in whom chronic constipation is a common problem due to a combination of factors including reduced colonic motility. It was also safe and well tolerated in a phase II trial in Post Operative Ileus and in a phase II trial in those who receive high dose opioid medication for chronic pain, and for whom constipation is most common and debilitating symptom. ( 6 )

Staf Van Reet, Chairman of Movetis, added, " We're delighted that all three presentations and four abstracts submitted to DDW were accepted. The data, that are part of our overall and comprehensive development program with RESOLOR, further supports depth of data package, and illustrates our continued commitment to bring this product to market and to patients with chronic constipation. Millions of people worldwide with constipation visit physicians seeking help after unsatisfactory results with over-the-counter medicines. RESOLOR is different from existing therapies in that it is expected to not only improve bowel habits in a satisfactory way but also to alleviate broad range of symptoms in these patients with minimal side effects. We believe RESOLOR helps address this debilitating condition and may therefore improve lives of these patients, especially those who are more challenging to treat. "

About the studies presented at Digestive Disease Week

Seven abstracts ( three oral presentations and four posters ) were presented at DDW focusing on evaluating efficacy and safety of RESOLOR in a wide variety of patient populations with chronic constipation ( 1-3, 5-7 ) , including patients that do not respond adequately to laxatives, the elderly ( 5 ) and those with opioid-induced constipation ( 6 ) , and patients undergoing elective partial colectomies ( 7 ) . These studies assessed a wide range of primary and secondary endpoints covering bowel movements, symptoms and disease-related quality of life, including overall satisfaction with treatment. RESOLOR was also investigated for impact on cardiovascular variables ( ECG, blood pressure, heart rate, QTc ) in healthy subjects at very high doses ( 4 ) . In all populations, RESOLOR had a favourable efficacy and safety profile.

About RESOLOR

RESOLOR is a novel enterokinetic treatment for chronic constipation in a patient population not adequately relieved by laxative treatments. It is a highly selective, high-affinity 5-HT4 receptor agonist, which increases colon motility and restores slow movement of bowels in a dose-dependent manner. It's intended to become available in film-coated tablets of 1 mg and 2 mg for oral administration at a recommended dose level of 2 mg once daily ( o. d. ) in adults. RESOLOR has completed three Phase III studies and has been tested in more than 3, 000 patients.

About chronic constipation

Chronic constipation is a disorder of gastrointestinal tract. It's a prevalent and debilitating condition that's not always well recognized and understood and is in many cases inadequately treated. The recent ROME III guidelines define chronic constipation as two or more of following symptoms at least a quarter of the time for at least six months: straining, lumpy or hard stools, a sensation of incomplete evacuation, a sensation of anorectal obstruction or blockage, and/or less than 3 defecations per week ( 8 ) . In Europe, an estimated 10 million patients frequently visit their Doctors with complaints of constipation after dissatisfactory results with over-the-counter medication ( 9 ) . Constipation is more common in women than men ( estimated prevalence ratio of 2. 2: 1 ) ( 10 ) .

About Movetis

Through a clear focus on gastroenterology, Movetis seeks to improve lives of millions of patients - both adults and children - by discovering, developing and ultimately commercializing innovative treatments targeting GI conditions with a high unmet medical need. Movetis NV - founded in Belgium in December 2006 - aims to become a leading European specialty pharmaceutical organization focused on GI diseases. Movetis has a broad GI portfolio with four products in clinical and four in preclinical development, all addressing important GI areas with fewer innovative products, including chronic constipation, ascites, reflux in infants, diabetic gastroparesis, non-erosive and refractory reflux disease and post-infectious IBS. In addition, Movetis owns a large library of qualified lead compounds for further development addressing GI disorders such as secretory diarrhoea. The current portfolio has been licensed from Janssen Pharmaceutica NV, Belgium and Ortho-McNeil Pharmaceutical Inc. , two Johnson & Johnson ( J&J ) companies.

The current clinical portfolio includes:

- RESOLOR ( prucalopride ) , a compound for treatment of chronic constipation currently in final preparation for filing.

- M0002, a selective V2 receptor antagonist compound for treatment of ascites that has concluded a Phase IIa trial. Results are expected before the end of Q2 2008.

- M0003, a gastrokinetic compound for treatment of reflux in infants and symptoms of gastroparesis, which has entered a Phase IIa clinical trial in Q1 2008. - M0004, another gastrokinetic compound for motility complaints related to non-erosive or refractory gastro-oesophageal reflux disease ( GORD ) .

References

1. Camilleri M et al. Efficacy of 12-week treatment with prucalopride ( Resolor ( R ) ) in patients with chronic constipation: combined results of three identical randomized, double-blind, placebo-controlled phase III trials. Poster 435293, DDW 2008

2. Van Outryve MJ et al. Long-term follow-up study of oral prucalopride ( Resolor ( R ) ) administered to patients with chronic constipation. Poster 438541, DDW 2008

3. Tack JF et al. Safety and tolerability of prucalopride ( Resolor ( R ) ) in patients with chronic constipation: pooled data from three pivotal phase III studies. Poster 437976, DDW 2008

4. Boyce MJ et al. Cardiovascular safety of prucalopride ( Resolor ( R ) ) in healthy subjects: results from a randomized, double-blind, placebo-controlled, cross-over trial. Poster 430410, DDW 2008

5. Mueller-Lissner SA et al. Randomized double-blind placebo-controlled trial to evaluate efficacy and safety of prucalopride ( Resolor ( R ) ) in elderly patients with chronic constipation. Research Forum 438210, DDW 2008

6. Moulin DE et al. Randomized, double-blind, placebo-controlled trial to evaluate efficacy and safety of prucalopride ( Resolor ( R ) ) in patients with opioid-induced constipation. Topic Forum 438068, DDW 2008

7. Galandiuk S. Evaluation of the efficacy, safety and tolerability of prucalopride ( Resolor ( R ) ) given subcutaneously in patients undergoing elective partial colectomies. Research forum 438293, DDW 2008

8. Drossman A. Rome III: The new criteria. Chinese Journal of Digestive Diseases 2006 ; 7 ( 4 ) : 181-185.

9. IMS Health

10. Higgins PD, Johanson JF. Epidemiology of constipation in North America: a systematic review. Am J Gastroenterol 2004; 99: 750-9

Movetis NV

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