Drug Interaction:
ACE inhibitors include- Benazepril, Captopril, Enalapril, Enalaprilat, Fosinopril, Lisonopril, Moexipril, Perindopril, Quinapril, Ramipril, Trandolapril
Refer Captopril
Drug Interactions - summary
+ ACE inhibitors
Potassium salts- concurrent use result in elevated serum potsssium concentrations in certain patients
Concomittant administration of diuretics may lead to serious hypotension. With potassium-sparing diuretics dangerous hypokalaemia may result.
May increase serum lithium concentration.
NSAIDs may reduce the effect of the drug and cause deterioation of renal function.
Reduction in BP may affect, ability to drive and operate machinery. This is exacerbated by alcohol. Inhibits tachycardia mediated by vasodilators (hydrlazine,minoxdil).
Indication:
U.S FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
77.Ramipril 5mg 20-02-08
+ HCTZ 12.5mg tablets
(Addl.Stgth)
same as approved
Approved by FDA in 1991
U.S FDA APPROVED DRUGS DURING 2007
21. Ramipril 10mg + 20-02-07
HCTZ 12.5mg tablet
(addl.stgth)
As approved
ACE inhibitors include- Benazepril, Captopril, Enalapril, Enalaprilat, Fosinopril, Lisonopril, Moexipril, Perindopril, Quinapril, Ramipril, Trandolapril Refer Captopril
Indications:
Hypertension alone or in combination with diuretics. Heart Failure
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Ramipril ACE Inhibitor August 1991
2.Ramipril 1.25/2.5/5/10mg 24-05-2010
Addl.Indn.
For the treatment of non-diabetic overt glomerular or incipient
Nephropathy
3.Ramipril 10mg 20-02-2007
+ HCTZ 12.5mg tablet
As approved
4.Ramipril 5mg 20-02-2008
+ HCTZ 12.5mg tablets
Addl.Stgth
Asapproved
5.Ramipril MR 10mg Capsules 30-07-2009
For the treatment of hypertension /cardiac Failure and myocardial
Infarction
6.Ramipril MR 2.5/5mg Capsules 03-07-2010
Addl.stgth
Same as approved
7.Each combipack contains Part 28-11-2011
(A) One strip of FDC Ramipril
+ Amlodipine Tablets-
Each uncoated tablet contains
Ramipril IP 5mg, Amlodipine Besylate
IP eq to Amlodipine 5mg
(B) Each Tablet contains -
Atorvastatin Calcium IP eq to
Atorvastatin 10mg/20mg
For the treatment of hypertension and as an adjunct to diet in patients
to reduce elevated total cholesterol and Triglyceride levels Hypertension
and Dyslipidemia. The polypack should be used in patients to whom treatment
with all the three i.e. Ramipril, Amlodipine, and Atorvastatin is appropriate
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1.Ramipril 5mg + 5-11-2005
Telmistran 40mg tablet
For hypertension
2. Ramipril 2.5mg + 12-09-2003
Losartan Potassium 50mg/50mg tablet
Mild to moderate hypertension
3.Ramipril 2.5mg/5mg + 26-08-1996
Hydrochlorthiazide 12.5mg/25mg tablet
Mild to moderate hypertension in patients( in when
combination therapy is appropiate) who have been
established on the individual components given in the
same proportion
4. Ramipril 2.5mg + 11-02-2003
S(-) Besylate eq. to S(-) Amlodipine 2.5mg tablet
and capsule
For treatment of essential hypertension
5.Ramipril BP 2.5mg/5mg + 11-12-2007
Telmistran 40mg uncoated tablet
For the treatment of mild to moderate hypertension in
adults
6. Ramipril BP 2.5mg/5mg + 01-08-2003
Candesartan cliexatil eq.to Candesartan 8mg/8mg
bilayer tablet
For mild to moderate essential hypertension and
congestive Heart Failure (CHF)
Adverse Reaction:
RAMIPRIL
Adverse Reactions -
Cardiovascular -
Chest pain, hypotension, palpitations, angina pectoris, cardiovascular accident, myocardial infarction, rhytum disturbances, tachycardia, < 1%
CNS-
Insomnia, disturbed sleep, somnolence, depression, drowsiness, malaise, nervouseness, vertigo, anxiety < 1 % headache 5%, dizziness 2%, fatigue 2%
GI/GU
Abdominal pain < 1 %, vomiting, nausea, 1%diarrhea, dysgesia, constipation, oliguria, dry mouth,dyspepsia, < 1%,
Respiratory-
Dyspnea, < 1%, cough 12%,
Dermatologic-
Diaphoresis /increased sweating, photosentivity, < 1%
Miscellaneous-
Angioedema, impotence ,muscle cramps , syncope, myalgia < 1%, Asthenia 2%
Renal-
Decrease in hemoglobin or hemotocrit were rare occuring in 0.4% of patients on Ramipril alone and 1.5% of those on Ramipril plus a diuretic.
Occasional leukopenia eosinophilla and proteinuria reported
Contra-Indications:
Hypersens,history of angioedema with ACE inhibitors,bilateral artery stenosis, or a single kidney with uniateral renal artery stenosis.
Pregnancy,lactation. Special precautions: Stop medicaction when pregnacy is detected.
Dosages/ Overdosage Etc:
Approved by FDA in 1991
Indications:
Hypertension alone or in combination with diuretics.
Dosage: Initial 2.5mg once daily Adjust dose according to response.
Maintenance- 2.5 to 20mg/day as single or divided doses.
Missed dose-
1. If you miss a dose of this medicine, and remember within 6 hours of take it as soon as possible unless the dose is less than 4 hours.
2. However, if you do not remember until later, skip the missed dose and go back to your regular dosing schedule.
3. Do not double doses.
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:
Pharmacology:
The angiotensin converting enzyme inhibitors (ACEIs) appear to act primarily through suppression of the renin-angiotensin-aldosterone system, however no consistent correlation has been described between the renin levels and the drug response. Inhibiting ACE results in decreased plasma angiotensin II and increased plasma renin activity, the latter resulting from loss of negative feedback on renin release caused by reduction in angiotensin II. The ACEIs produce a reduction of peripheral arterial resistence in hypertensive patients, and either as no change or an increase in cardiac output.
Interaction with Food:
ACE inhibitors-
Captopril, enalapril, lisonopril, quinopril, moexipril, ramipril, fosinopril, benzapril Food significantly reduces the bioavailability of captopril by 30 to 40%. Administer captopril 1 hour after meals. Food intake reduces absorption of moexipril.
Take moexipril in the fasting state The rate and extent of quinapril are diminished moderately when administered during a high fat meal.
The rate but not extent of ramipril and fosinopril absorption is reduced by food. Food does not reduce the GI absorption of benzapril, enalapril and lisonopril
Pregnancy and lactation:
ACE inhibitors-
Captopril, enalapril, lisonopril, quinapril, moexipril,ramipril, fosinopril, benzapril
Pregnancy: ACEIs can cause fetal and neonatal morbidity and death when administered to pregnant women when pregnancy is detected, discontinue ACEIs as soon as possible.
Lactation: Excercise caution when these drugs are administered to nursing women.
Children: Safety and efficacy have not been established.
Manufacturer Details