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.