Ramipril

(ra mi' pril)

PCI / LCI - Contraindicated in pregnancy and lactation

Molecule Info

 
WARNING(s)

WARNING: FETAL TOXICITY
- When pregnancy is detected, discontinue Ramipril as soon as possible.
- Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

 MAJOR DEVELOPMENTS

RECENT MAJOR CHANGES of Ramipril brand with U.S. FDA:

  • Indications and Usage, Hypertension (1.1):  11/2013

  • Contraindications: 10/2013

  • Warnings and Precautions, Anaphylactoid and Possibly Related Reactions (5.1): 9/2013

  • Warnings and Precautions, Anaphylactoid and Possibly Related Reactions (5.7):9/2013

See Brand Manufacturer's Prescribing Information for relevant sections.

Indication(s) & Dosage

Ramipril is an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics.

In patients 55 years or older at high risk of developing a major cardiovascular event, Ramipril is indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes.
Ramipril is indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction.

HYPERTENSION
Adult:Initially, 1.25 mg orally once daily given at bedtime. Maintenance: 2.5-5 mg daily as a single dose, up to 10 mg daily as needed.

CrCl (ml/min) Dosage Recommendation
10-30 Initiate with 1.25 mg once daily. Max dose: 5 mg daily.
<10 Initiate with 1.25 mg once daily. Max dose: 2.5 mg daily.
Hepatic impairment:Initiate with 1.25 mg once daily.
Heart failure
Adult:Initially, 1.25 mg orally once daily. Max dose: 10 mg daily. Doses ≥2.5 mg may be given in 2 divided doses.
Max Dosage:10 mg daily in 1-2 divided doses.
CrCl (ml/min) Dosage Recommendation
10-30 Initiate with 1.25 mg once daily. Max dose: 5 mg daily.
<10 Initiate with 1.25 mg once daily. Max dose: 2.5 mg daily.
Hepatic impairment:Initiate with 1.25 mg once daily.
Post myocardial infarction
Adult:Initially, 2.5 mg orally bid increased after 2 days to 5 mg bid. Start treatment 3-10 days after infarction. Usual dose: 2.5-5 mg bid.
CrCl (ml/min) Dosage Recommendation
10-30 Initiate with 1.25 mg once daily. Max dose: 5 mg daily.
<10 Initiate with 1.25 mg once daily. Max dose: 2.5 mg daily.
Hepatic impairment:Initiate with 1.25 mg once daily.
Prophylaxis of cardiovascular events in high-risk patients
Adult:Initially, 2.5 mg orally once daily increased to 5 mg once daily after 1 wk if tolerated. Maintenance: 10 mg once daily after a further 3 wk.
CrCl (ml/min) Dosage Recommendation
10-30 Initiate with 1.25 mg once daily. Max dose: 5 mg daily.
<10 Initate with 1.25 mg once daily. Max dose: 2.5 mg daily.
Hepatic impairment:Initiate with 1.25 mg once daily.
Special Populations:Reduce dose in patients withrenal impairment.
Administration May be taken with or without food.
Overdosage May lead to severe hypotension. Normal saline infusion may be used for treatment.
Contraindications

Angioedema related to previous treatment with an ACE inhibitor or a history of hereditary or idiopathic angioedema. Do not co-administer aliskiren with ALTACE in patients with diabetes.

Hypersensitivity, bilateral renal artery stenosis, or a single kidney with unilateral renal artery stenosis. Aortic stenosis or outflow tract obstruction. Pregnancy and lactation.
Warning & Precautions

ACE inhibitor use has been associated with the following:
Angioedema, with increased risk in patients with a prior history or when combined with mTOR* inhibitors (e.g. temsirolimus)

  • Hypotension and hyperkalemia
  • Renal impairment: monitor renal function during therapy
  • Increased risk of renal impairment when combined with another blocker of the renin-angiotensin-aldosterone system
  • Avoid concomitant use with aliskiren in patients with moderate to severe renal impairment
  • Rare cholestatic jaundice and hepatic failure
  • Rare neutropenia and agranulocytosis

*mTOR: mammalian Target of Rapamycin is a serine/threonine kinase, which belongs to phosphatidylinositol-3 kinase (PI3K) related kinases (PIKKs) family. It regulates cellular metabolism, growth and proliferation and therefore is a target for the development of a number of mTOR inhibitors.

Adverse Drug Reaction(s)

The most common adverse reactions in patients with hypertension included headache, dizziness, fatigue and cough. Among others there may be nausea, vomiting, diarrhoea & abdominal pain. Rarely symptomatic hypotension. Angioneurotic oedema of face, lips, tongue, glottis and larynx, syncope, renal impairment, hypersensitivity reactions.

Potentially Fatal: Severe hypotension and renal failure, angioedema.
Drug Interactions NSAIDs may increase risk of deterioration of renal function.
Potentially Fatal:Concomitant admin of diuretics may lead to serious hypotension. Severe hyperkalaemia may result when used with potassium-sparing diuretics, potasisum supplements and drugs that cause hyperkalaemia. May increase serum lithium concentration.
Pregnancy Category (FDA) Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
Pharmacology Ramipril is an ACE inhibitor which is metabolised into the active metabolite ramiprilat. It competitively inhibits angiotensin-converting enzyme (ACE) from converting angiotensin I to angiotensin II resulting in increased plasma renin activity and reduced aldosterone secretion. It also increases bradykinin levels. By these mechanisms, ramipril produces a hypotensive effect and a beneficial effect in CHF.
Absorption:50-60% is absorbed from the GI tract (oral); peak plasma concentrations after 2-4 hr (ramiprilat).
Distribution:Protein-binding: 56%.
Metabolism:Hepatic: Converted to ramiprilat.
Excretion:Via urine (60% of the dose), via faeces (remaining dose); 13-17 hr (elimination half-life), may be prolonged in renal impairment.
ATC Classification C09AA05 - ramipril; Belongs to the class of ACE inhibitors. Used in the treatment of cardiovascular disease.

 

Brand/Product Info


Total Products : 28                            
Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price
ACECARD 1.25 Healthcare Pharmacuticals Ltd. Ramipril BP 1.25 mg Tablet 30's MRP 90 Tk
ACECARD 2.5 Healthcare Pharmacuticals Ltd. Ramipril BP 2.5mg Tablet 30's MRP 150 Tk
ACECARD 5 Healthcare Pharmacuticals Ltd. Ramipril BP 5mg Tablet 30's MRP 240 Tk
MYPRIL Eskayef Bangladesh Ltd Ramipril BP 2.5mg & 5mg Tablet 40's MRP: 200.00 & 320.00
PIRAMIL Sandoz/Novartis Ramipril BP 2.5mg & 5mg Tablet 2.5mg x 28's: MRP 168.00 IP 5mg x 28's: MRP 252.00 IP
PRICARD The White Horse Pharma Ramipril BP 2.5mg, 5mg Tablet 2.5mg x 50's, 5mg x 30's: 200.00 & 240.00 MRP
PRIMACE 1.25 Beximco Pharmaceuticals Ltd Ramipril BP 1.25mg Capsule 30's: 75.00 MRP
PRIMACE 10 Beximco Pharmaceuticals Ltd Ramipril BP 10mg Capsule 1's: 12.00 MRP
PRIMACE 2.5 Beximco Pharmaceuticals Ltd Ramipril BP 2.5mg Capsule 30's: 150.00 MRP
PRIMACE 2.5 TABLET Beximco Pharmaceuticals Ltd Ramipril BP 2.5mg Tablet 30's: 150.00 MRP
PRIMACE 5 Beximco Pharmaceuticals Ltd Ramipril BP 5mg Capsule 30's: 240.00 MRP
PRIMACE 5 TABLET Beximco Pharmaceuticals Ltd Ramipril 5mg Tablet 30's: 240.00 MRP
PROTACE Unimed & Unihealth Manufacturers Ltd. Ramipril BP 2.5mg & 5mg Tablet 30's each: 150.00 & 240.00 MRP
R-PIL Biopharma Laboratories Ltd Ramipril BP 1.25, 2.5 & 5mg Tablet 30's each: 90.30, 150.60 & 240.90 MRP
RACARD Pacific Pharmaceuticals Ltd. Ramipril BP 1.25, 2.5 & 5mg Tablet 30's each: 75.00, 138.00 & 240.00 MRP
RAMACE Opsonin Pharma Limited Ramipril BP 1.25, 2.5 & 5mg Tablet 1.25mg x 50's, 2.5mgx 30's, 5mg x 30's: 125.00, 150.00 & 240.00 MRP
RAMICARD Drug International Ltd Ramipril BP 2.5mg, 5mg Tablet 2.5mg x 50's, 5mg x 50's: 150.00 & 350.00 MRP
RAMIL Popular Pharmaceuticals Ltd. Ramipril BP 1.25, 2.5, 5 & 10mg Tablet 1.25 & 5mg x50's: 125 & 401.50, 2.5 & 10mg x30's: 251 & 360.00 MRP
RAMILOK Aristopharma Ltd. Ramipril BP 2.5mg, 5mg Tablet 2.5mg x 50's, 5mg x 30's: 250.00 & 240.00 MRP
RAMIPRESS Silva Pharmaceuticals Limited Ramipril BP 1.25, 2.5 & 5mg Tablet 30's each: 75.28 & 150.57 & 240.90 MRP
RAMIPRO General Pharmaceuticals Ltd Ramipril BP 2.5mg, 5mg Tablet 2.5mg x 50's, 5mg x 30's: 151.00 & 240.90 MRP
RAMORIL Incepta Pharmaceuticals Limited Ramipril BP 1.25, 2.5, 5.0 & 10mg Tablet 1.25, 2.5 & 5mg x50's: 125, 250 & 400.00 MRP; 10mg x30's: 360.00 MRP
RAMPRIL Rangs Pharmaceuticals Ltd. Ramipril BP 2.5mg, 5mg Tablet 30's each:120.00 & 180.00 MRP
RIPRIL 1.25 Square Pharmaceuticals Ltd. Ramipril 1.25mg Tablet 3x10's: 75.60 MRP
RIPRIL 2.5 Square Pharmaceuticals Ltd. Ramipril 2.5mg Tablet 3x10's: 150.90 MRP
RIPRIL 5 Square Pharmaceuticals Ltd. Ramipril 5mg Tablet 3x10's: 241.80 MRP
TRITACE Sanofi Ramipril BP 2.5mg, 5mg & 10mg Tablet 28's each: 241.92, 354.20 & 505.96 MRP
UNIPRIL The Acme Laboratories Ltd. Ramipril BP 2.5mg, 5mg Tablet 30's each: 150.30 & 241.20 MRP

Gen. MedInfo

 IMPORTANT WARNING:

Do not take ramipril if you are pregnant. If you become pregnant while taking ramipril, call your doctor immediately. Ramipril may harm the fetus.

 

Why is this medication prescribed?

Ramipril is used alone or in combination with other medications to treat high blood pressure. It is also used to reduce the risk of heart attack and stroke in patients at risk for these problems and to improve survival in patients with heart failure after a heart attack. Ramipril is in a class of medications called angiotensin-converting enzyme (ACE) inhibitors. It works by decreasing certain chemicals that tighten the blood vessels, so blood flows more smoothly and the heart can pump blood more efficiently.

How should this medicine be used?

Ramipril may come as a tablet or capsule to take by mouth. It is usually taken once or twice a day with or without food. To help you remember to take ramipril, take it around the same time every day. Follow the directions on your prescription carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ramipril exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsule whole, or open the capsule and sprinkle the contents on a small amount of applesauce (about 4 oz.) or in 4 oz. (about 120 mL) of water or apple juice. Eat or drink the entire mixture. This mixture can be prepared in advance and stored for 24 hours at room temperature or 48 hours in the refrigerator.

Your doctor will probably start you on a low dose of ramipril and gradually increase your dose.

Ramipril controls high blood pressure and heart failure but does not cure them. Continue to take ramipril even if you feel well. Do not stop taking ramipril without talking to your doctor.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking ramipril,

  • tell your doctor and pharmacist if you are allergic to ramipril, benazepril, captopril, enalapril, fosinopril (Monopril), lisinopril, moexipril, perindopril (Coversyl), quinapril, trandolapril or any other medications.
  • tell your doctor if you have diabetes (high blood sugar) and you are taking aliskiren (Tekturna). Your doctor will probably tell you not to take ramipril if you have diabetes and you are also taking aliskiren.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as indomethacin; diuretics ('water pills'); lithium; and potassium supplements. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have or have ever had heart, liver, or kidney disease; lupus; scleroderma; diabetes; or angioedema, a condition that causes difficulty swallowing or breathing and painful swelling of the the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs.
  • tell your doctor if you plan to become pregnant or are breast-feeding.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking ramipril.
  • you should know that diarrhea, vomiting, not drinking enough fluids, and sweating a lot can cause a drop in blood pressure, which may cause light-headedness and fainting.

What special dietary instructions should I follow?

Talk to your doctor before using salt substitutes containing potassium. If your doctor prescribes a low-salt or low-sodium diet, follow these directions carefully.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Ramipril may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • headache

  • dizziness

  • cough

  • upset stomach

  • vomiting

  • excessive tiredness

  • weakness

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

  • swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs

  • hoarseness

  • difficulty breathing or swallowing

  • yellowing of the skin or eyes

  • fever, sore throat, chills, and other signs of infection

  • lightheadedness

  • fainting

Ramipril may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, consult your Doctor. If the victim has collapsed or is not breathing, consult local medical emergency services.

Symptoms of overdose may include:

  • lightheadedness

  • fainting

This medication may cause other side effects.  Consult your doctor if you have any unusual problems while taking this.

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to this medicine.

Do not let anyone else use your medication. If you still have symptoms and need further treatment, consult your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.


This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.

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