Enalapril maleate - @ ACE (angiotensin convert enzyme)inhibitors- (FDC- List ) (Aug 1989)
Drug Interaction:
ACE inhibitors include- Benazepril, Captopril, Enalapril, Enalaprilat, Fosinopril, Lisonopril, Moexipril,Perindopril, Quinapril, Ramipril, Trandolapril
Refer Captopril
Interacting drugs
Spironolactone
Rifampicin
ACE inhibitors with
Spirinolactone
use of ACE inhibitors may elevate serum potassium. Concurent use with spirtonolactone may lead to significant hyperkalemia
Rifampicin
pharmacologic effects of enalapril may be decreased
Risk of bone marrow supression increased with concomittant treatment with immunosupressive drugs(cyclophosphamide,azotripine),
Hypokalemia with Pot sparing diuretics or Potassium supplements especially in the presence of renal failure. Probenicid delays excretion Potentiates analgesia and respiratory depression produced by morphine.
NSAIDs blunt its hypotensive effect.
Diuretics potentiates hypotensive effect but the starting dosage of Enapril must be kept low.
May increase lithium levels.
Indication:
Hypertension
ACE inhibitors include- Benazepril, Captopril, Enalapril, Enalaprilat, Fosinopril, Lisonopril, Moexipril, Perindopril, Quinapril, Ramipril, Trandolapril
Refer Captopril
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Enalapril Maleate All grades of hypertension August 1989
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Enalapril Cardiovascular Meck 30-12-2001
Maleate
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1.Enalapril 2.5mg/5mg + 17-10-2005
HCTZ 12.5mg tablet
Addl.stgth
For Hypertension
2.Enalapril 10mg/20mg + 08-10-1992
HCTZ 12.5mg/25mg
Addl.stgth
Hypertension in patients for whom combination therapy is appropiate
Adverse Reaction:
Adverse reactions summary-
ENALAPRIL
----------------
Adverse Reactions -
CARDIOVASCULAR- Hypotension 6.7%, Orthostatic effects 2.2% Chest pain 2.1% Orthostatic hypotension 1.6 %
Angina pectoris 1.5 % Myocardial infarctn < 1.2 % Palpitations,Cardiac arrest
Cerebrovascular accident, < 1%
CNS Dizziness 7 %, Headache 5% Fatigue 3 % Vertigo 1.6%
Insomnia, drowsiness, Ataxia, Confusion, Depression,Nervousness < 1%
GI/GU Diarrhea 2%, Abdominal pain 1.6% Vomiting, Nausea 1.3%
Dysgeusia, Anorexia, Constipation, Oliguria , Dry mouth < 1%
RESPIRATORY - Cough 2.2%, Bronchitis, Dyspnea, 1.3%,
Bronchospasm , Upper respiratory tract infection < 1%
DERMATOLOGIC - Rash 1.4%, Alopecia, Increased sweating, Erythema multiforme,
Exfoliative dermatitis , flushing , Pruritus ,< 1%
MISCELLANEOUS - Syncope 2.2%, Asthenia 1.6%, Impotence, blurred vision < 1%
Initial hypotension may be severe and prolonged. Dizziness, headache,fatigue, persistent dry
cough, lassitude,rash, angioedema, neutropenia, renal impairment (failure).
Contra-Indications:
Hypersentive to ACE inhibitors.History of angioedema due to previous treatment with ACE
inhibitiors. Pregancy and lactation. Children.
Special Precautions:
Impaired renal function. Hyperkalema,hypotension due to volume depletion,patients on diuretic
therapy. Periodic monitoring of white blood counts to preclude neutropenia/ agranulocytosis.
Dosages/ Overdosage Etc:
Date of approval August 1989
Indications:
Hypertension
Dosage:
Patients taking taking diuretics- Initial dose of 2.5mg/day.
Patients not taking diuretics- Initial dose 5mg once a day.
Adjust dosage depending on blood pressure.
Other Information:
For Availability/supplies
Contact -
1.Indian Drug Manufacturers Association (IDMA)
Phone- 022- 24944624/ 24974308
Fax- 022- 24950723
Email- idma@vsnl.com
Website: www.idma-assn.org
2.Bulk Drug Manufacturers Association (India)(BDMA)
Phone - 040-23703910/ 23706718
Fax- 040-23704804
Email- info@bdmai.org
Website: www.info@bdmai.org
Patient Information:
1. Take captopril 1 hour before meals. Take moexipril in the fasting state
2. Do not interupt or discontinue medication without consulting physician
3. Notify physician if any of the following occur- sore throat, fever, swelling of hands or feet,
irregular heart beat , chest pains, signs of angioedema, excessive prespiration, dehydration, vomiting and diarrhea may lead to a fall in blood pressure.
4. May cause dizziness, fainting or lightheadedness, especially during the first days of therapy; avoid sudden changes in posture. If syncope occurs, discontinue drug until physician has been contacted. Heart failure patients should avoid rapid increases in physical activity.
5. May cause skin rash or impaired taste perception. Notify physician if these persist.
6. Do not use salt substitutes containing potassium without consulting a physician
7. A persistent dry cough may occur and usually does not subside unless the medication is stopped. If this effect become bothersome, consult a physician.
Pharmacology/ Pharmacokinetics:
Refer Ramipril- ACE inhibitors
Interaction with Food:
Refer Ramipril- ACE inhibitors
Pregnancy and lactation:
Refer Ramipril- ACE inhibitors
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