Nurofen 200mg liquid capsules

1. Name Of The Medicinal Product

Ibuprofen 200mg Liquicaps

Nurofen Express 200mg Liquid Capsules

Nurofen 200mg Liquid Capsules

2. Qualitative And Quantitative Composition

Each capsule, soft contains Ibuprofen 200 mg.

Excipients:

Potassium hydroxide

Sorbitol

For a full list of excipients see 6.1.

3. Pharmaceutical Form

Capsule, soft.

A clear red oval soft gelatin capsule printed with an identifying logo in white.

4. Clinical Particulars

4.1 Therapeutic Indications

Adults and children over 12 years:

Ibuprofen 200mg Liquicaps are indicated for the symptomatic relief of rheumatic or muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness colds and influenza symptoms

4.2 Posology And Method Of Administration

For oral administration and short-term use only.

Adults, the elderly and children over 12 years:

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms.

The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days.

Take one or two capsules, up to three times a day as required.

Leave at least 4 hours between doses.

Do not take more than 6 capsules in any 24 hour period.

4.3 Contraindications

Patients with a known hypersensitivity to ibuprofen or any other constituent of the medicinal product.

Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).

Patients with a history of, or existing gastrointestinal ulceration/perforation or bleeding, including that associated with NSAIDs. (See Section 4.4)

Patients with severe hepatic failure, severe renal failure or severe heart failure. See also Section 4.4

Use with concomitant NSAIDs, including cyclo-oxygenase-2 specific inhibitors – increased risk of adverse reactions (see section 4.5)”

During the last trimester of pregnancy as there is a risk of premature closure of the fetal ductus arteriosus with possible persistent pulmonary hypertension. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child (see Section 4.6).

4.4 Special Warnings And Precautions For Use

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see GI and cardiovascular risks below).

The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal.

Respiratory:

Bronchospasm may be precipitated in patients suffering from, or with a history of, bronchial asthma or allergic disease.

Other NSAIDs:

The use of ibuprofen with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided (see section 4.5)

SLE and mixed connective tissue disease:

Systemic lupus erythematosus and mixed connective tissue disease – increased risk of aseptic meningitis (see section 4.8).

Renal:

Renal impairment as renal function may further deteriorate (see sections 4.3 and 4.8)

Hepatic:

Hepatic dysfunction (see Sections 4.3 and 4.8)

Cardiovascular and cerebrovascular effects:

Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAID therapy.

Clinical trial and epidemiological data suggest that the use of ibuprofen, particularly at high doses (2400 mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g.

Impaired female fertility:

There is some evidence that drugs which inhibit cyclo-oxygenase/ prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment.

Gastrointestinal:

NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8).

GI bleeding, ulceration or perforation, which can be fatal has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of GI events.

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complaicated with haemorrhage or perforation (see section 4.3), and in the elderly. These patients should commence treatment on the lowest dose available.

Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.

Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin (see section 4.5).

When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn.

Dermatological:

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Ibuprofen should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

The label will include:

Read the enclosed leaflet before taking this product

Do not take if you:

• have (or have had two or more episodes of ) a stomach ulcer, perforation or bleeding

• are allergic to ibuprofen, to any of the ingredients, or to aspirin or other painkillers

• are taking other NSAID pain killers or aspirin with a daily dose above 75mg

Speak to a pharmacist or your doctor before taking if you:

• have or have had asthma, diabetes, high cholesterol, high blood pressure, a stroke, heart, liver, kidney or bowel problems

• Are a smoker

• Are pregnant

This medicine contains 14 mg of potassium per dose. To be taken into consideration by patients on a controlled potassium diet.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Contains 50.5 mg of sorbitol per dose, a source of 12.6 mg of fructose per dose.

If symptoms persist or worsen, or if new symptoms occur, consult your doctor or pharmacist.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Ibuprofen (like other NSAIDs) should be avoided in combination with:

• Aspirin: unless low-dose aspirin (not above 75mg daily) has been advised by a doctor as this may increase the risk of adverse reactions (see Section 4.4).

Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1).

• Other NSAIDs including cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs as this may increase the risk of adverse effects (see section 4.4)

Ibuprofen should be used with caution in combination with:

• Corticosteroids: as these may increase the risk of gastrointestinal ulceration or bleeding (see Section 4.4)

• Antihypertensives and diuretics: since NSAIDs may diminish the effects of these drugs. Diuretics can increase the risk of nephrotoxicity of NSAIDs.

• Anticoagulants. NSAIDs may enhance the effects of anti-coagulants, such as warfarin (See section 4.4).

• Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4).

• Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.

• Lithium. There is evidence for potential increase in plasma levels of lithium.

• Methotrexate: There is evidence for the potential increase in plasma levels of methotrexate.

•Ciclosporin: Increased risk of nephrotoxicity.

• Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.

• Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.

• Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk haemarthroses and haematoma in HIV (+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.

• Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.

4.6 Pregnancy And Lactation

Whilst no teratogenic effects have been demonstrated in animal experiments, the use of Ibuprofen 200mg Liquicaps should, if possible, be avoided during the first 6 months of pregnancy.

During the 3^rd trimester, ibuprofen is contraindicated as there is a risk of premature closure of the foetal ductus arteriosus with possible persistent pulmonary hypertension. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child. (See section 4.3 Contraindications).

In limited studies, ibuprofen appears in the breast milk in very low concentration and is unlikely to affect the breast-fed infant adversely.

See section 4.4 regarding female fertility.

4.7 Effects On Ability To Drive And Use Machines

None expected at recommended dose and duration of therapy.

4.8 Undesirable Effects

Hypersensitivity reactions have been reported and these may consist of

a. non-specific allergic reactions and anaphylaxis

b. respiratory tract reactivity e.g. asthma, aggravated asthma, bronchospasm, dyspnoea

c. various skin reactions e.g. pruritus, urticaria, angioedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme)

The list of the following adverse effects relates to those experienced with ibuprofen at OTC doses, for short-term use. In the treatment of chronic conditions, under long-term treatment, additional adverse effects may occur.

Gastrointestinal Disorders	Uncommon:	abdominal pain, dyspepsia and nausea.
	Rare:	diarrhoea, flatulence, constipation and vomiting
	Very rare:	Peptic ulcer, perforation or gastrointestinal haemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly. Ulcerative stomatitis gastritis. Exacerbation of ulcerative colitis and Crohn's disease (See section 4.4) (see section 4.4)
Nervous System	Uncommon: Very rare	Headache Aseptic meningitis – single cases have been reported very rarely
Kidney	Very rare:	Decrease of urea excretion and oedema can occur. Also, acute renal failure. Papillary necrosis, especially in long-term use, and increased serum urea concentrations have been reported.
Liver	Very rare:	Liver disorders, especially in long-term treatment.
Blood	Very rare:	Haematopoietic disorders (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis). First signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising.
Skin	Uncommon Very rare:	Various skin rashes Severe forms of skin reactions such as bullous reactions, including Stevens-Johnson Syndrome, erythema multiforme and toxic epidermal necrolysis can occur.
Immune System	Very rare:	In patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease) during treatment with ibuprofen, single cases of symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever or disorientation have been observed (see section 4.4)
Hypersensitivity Reactions	Uncommon:	Hypersensitivity reactions with urticaria and pruritus.
	Very rare	severe hypersensitivity reactions. Symptoms could be: facial, tongue and larynx swelling, dyspnoea, tachycardia, hypotension, (anaphylaxis, angioedema or severe shock). Exacerbation of asthma and bronchospasm.

Cardiovascular and Cerebrovascular:

Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment.

Clinical trial and epidemiological data suggest that use of ibuprofen (particularly at high doses 2400mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).

4.9 Overdose

In children ingestion of more than 400 mg/kg may cause symptoms. In adults the dose response effect is less clear cut. The half-life in overdose is 1.5-3 hours.

Symptoms – Most patients who have ingested clinically important amounts of NSAIDs will develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop convulsions. In serious poisoning metabolic acidosis may occur and the prothrombin time/ INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics.

Management –

Management should be symptomatic and supportive and include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of activated charcoal if the patient presents within 1 hour of ingestion of a potentially toxic amount. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodilators for asthma.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC Code: M01A E01 Propionic acid derivative.

Ibuprofen is a propionic acid derivative NSAID that has demonstrated its efficacy by inhibition of prostaglandin synthesis. In humans, ibuprofen reduces inflammatory pain, swellings and fever. Furthermore, ibuprofen reversibly inhibits platelet aggregation.

Clinical evidence demonstrates that when 400mg of ibuprofen is taken the pain relieving effects can last for up to 8 hours.

Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. In one study, when a single dose of ibuprofen 400mg was taken within 8 h before or within 30 min after immediate release aspirin dosing (81mg), a decreased effect of ASA on the formation of thromboxane or platelet aggregation occurred. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no relevant effect is considered to be likely for occasional ibuprofen use.

5.2 Pharmacokinetic Properties

Ibuprofen is well absorbed from the gastrointestinal tract. Ibuprofen is extensively bound to plasma proteins.

Ibuprofen 200mg Liquicaps consist of ibuprofen 200 mg dissolved in a hydrophilic solvent inside a gelatin shell. On ingestion, the gelatin shell disintegrates in the gastric juice releasing the solubilised ibuprofen immediately for absorption. The median peak plasma concentration is achieved approximately 30 minutes after administration.

The median peak plasma concentration for Nurofen tablets is achieved approximately 1-2 hours after administration.

Ibuprofen is metabolised in the liver to two major metabolites with primary excretion via the kidneys, either as such or as major conjugates, together with a negligible amount of unchanged ibuprofen. Excretion by the kidney is both rapid and complete.

Elimination half-life is approximately 2 hours.

No significant differences in pharmacokinetic profile are observed in the elderly.

5.3 Preclinical Safety Data

No relevant information, additional to that contained elsewhere in the SPC

6. Pharmaceutical Particulars

6.1 List Of Excipients

Macrogol 600

Potassium hydroxide 50% solution (E525)

Gelatin

Sorbitol Liquid, Partially Dehydrated (E420)

Purified Water

Ponceau 4R (E124)

Lecithin (E322)

Triglycerides , medium chain

Ethanol

White ink*

The ink contains the following residual materials after application: Titanium Dioxide (E171), Polyvinyl Acetate Phthalate, Macrogol 400, Ammonium hydroxide (E527), Propylene Glycol.

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Store below 25°C

6.5 Nature And Contents Of Container

Blisters formed from Opaque Duplex PVC/PVdC 250µm/60gsm heat sealed to 20µm aluminium foil

or

opaque Tristar (Triplex) PVC/PE/PVdC 250µm/25µm/90gsm heat sealed to 20µm aluminium foil packed into cartons

Each carton may contain 10, 12, 16 in blister strips

Not all packs will be marketed.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Ltd

Slough

SL1 4AQ

8. Marketing Authorisation Number(S)

PL 00063/0648

9. Date Of First Authorisation/Renewal Of The Authorisation

25/01/2008

10. Date Of Revision Of The Text

04/06/2011

Alphanate

Generic Name: antihemophilic factor-von Willebrand factor complex (an tee hee moe FIL ik FAK tor - von WIL e brand FAK tor)

Brand Names: Alphanate, Humate-P

What is Alphanate (antihemophilic factor-von Willebrand factor complex)?

Antihemophilic factor is a naturally occurring protein in the blood that helps blood to clot.

A lack of antihemophilic factor VIII is the cause of hemophilia A. A lack of an antihemophilic factor called von Willebrand factor is the cause of von Willebrand disease.

This medication works by temporarily raising levels of factor VIII or von Willebrand factor in the blood to aid in clotting.

Antihemophilic factor-von Willebrand factor complex is used to treat or prevent bleeding episodes in adults with hemophilia A. It is also used to treat injury-related bleeding episodes in adults and children with von Willebrand disease.

Antihemophilic factor-von Willebrand factor complex may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Alphanate (antihemophilic factor-von Willebrand factor complex)?

Do not use this medication if you have ever had a severe allergic reaction to antihemophilic factor in the past.

Before using antihemophilic factor-von Willebrand factor complex, tell your doctor if you have ever had a stroke or a blood clot.

Your body may develop antibodies to this medication, making it less effective. Call your doctor if this medicine seems to be less effective in controlling your bleeding.

To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Visit your doctor regularly.

Wear a medical alert tag or carry an ID card stating that you have hemophilia or von Willebrand disease in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding or blood-clotting disorder.

Antihemophilic factor-von Willebrand factor complex is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

What should I discuss with my health care provider before using Alphanate (antihemophilic factor-von Willebrand factor complex)?

Do not use this medication if you have ever had a severe allergic reaction to antihemophilic factor in the past.

To make sure you can safely use this medication, tell your doctor if you have ever had a stroke or a blood clot.

FDA pregnancy category C. It is not known whether antihemophilic factor-von Willebrand factor complex will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether antihemophilic factor-von Willebrand factor complex passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Antihemophilic factor-von Willebrand factor complex is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Your doctor may want you to receive a hepatitis vaccination before you start using antihemophilic factor-von Willebrand factor complex.

How should I use Alphanate (antihemophilic factor-von Willebrand factor complex)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Antihemophilic factor-von Willebrand factor complex is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Antihemophilic factor-von Willebrand factor complex is usually given every 8 to 12 hours for up to 7 days, depending on the reason you are using the medication.

Always wash your hands before preparing and giving your injection.

Antihemophilic factor-von Willebrand factor complex must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication.

You may gently swirl the medicine and diluent to mix them, but do not shake the vial (bottle). Vigorous shaking can ruin the medicine. After mixing the medicine with a diluent, store at room temperature and use it within 3 hours. Do not refrigerate.

Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

Each single use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Your body may develop antibodies to antihemophilic factor, making it less effective. Call your doctor if this medicine seems to be less effective in controlling your bleeding.

To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Visit your doctor regularly.

Wear a medical alert tag or carry an ID card stating that you have hemophilia or von Willebrand disease in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding or blood-clotting disorder. Store the medication and diluent at room temperature, away from moisture and heat. Throw away any unused medicine after the expiration date on the label has passed.

What happens if I miss a dose?

Antihemophilic factor-von Willebrand factor complex is sometimes used only as needed, so you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Alphanate (antihemophilic factor-von Willebrand factor complex)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Alphanate (antihemophilic factor-von Willebrand factor complex) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  easy bruising, increased bleeding episodes;

  
  


• 
  

  bleeding from a wound or where the medicine was injected;

  
  


• 
  

  low fever with skin rash, and joint pain, swelling, or stiffness;

  
  


• 
  

  sudden numbness or weakness, especially on one side of the body;

  
  


• 
  

  sudden severe headache, confusion, problems with vision, speech, or balance;

  
  


• 
  

  black, bloody, or tarry stools;

  
  


• 
  

  coughing up blood or vomit that looks like coffee grounds; or

  
  


• 
  

  nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

  
  

Less serious side effects may include:

• 
  

  constipation;

  
  


• 
  

  swelling, stinging, or irritation where the injection was given;

  
  


• 
  

  skin rash or itching;

  
  


• 
  

  swelling in your hands or feet;

  
  


• 
  

  pain in your arms or legs;

  
  


• 
  

  chills; or

  
  


• 
  

  dizziness.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Alphanate (antihemophilic factor-von Willebrand factor complex)?

There may be other drugs that can interact with antihemophilic factor-von Willebrand factor complex. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Alphanate resources

• Alphanate Side Effects (in more detail)
• Alphanate Use in Pregnancy & Breastfeeding
• Alphanate Support Group
• 0 Reviews for Alphanate - Add your own review/rating

• Alphanate Prescribing Information (FDA)


• Alphanate MedFacts Consumer Leaflet (Wolters Kluwer)


• Alphanate Advanced Consumer (Micromedex) - Includes Dosage Information


• Humate-P MedFacts Consumer Leaflet (Wolters Kluwer)


• Humate-P Prescribing Information (FDA)


• Wilate MedFacts Consumer Leaflet (Wolters Kluwer)


• Wilate Consumer Overview

Compare Alphanate with other medications

• Hemophilia A
• von Willebrand's Disease

Where can I get more information?

• Your pharmacist can provide more information about antihemophilic factor-von Willebrand factor complex.

See also: Alphanate side effects (in more detail)

Ticagrelor

Pronunciation: tye-KA-grel-or
Generic Name: Ticagrelor
Brand Name: Brilinta

Ticagrelor can cause serious and sometimes fatal bleeding problems. Do not use Ticagrelor if you have an active bleeding problem or a history of bleeding in the brain.

Tell your doctor if you have recently had surgery or if you are scheduled to have surgery. You may need to stop taking Ticagrelor before you have surgery. Discuss any questions or concerns with your doctor.

Ticagrelor should be taken along with aspirin. Do not exceed the dose of aspirin recommended by your doctor while you are taking Ticagrelor. Taking doses of aspirin that are higher than the dose recommended while you are taking Ticagrelor may decrease Ticagrelor's effectiveness.

Ticagrelor is used for:

Reducing the risk of stroke, heart attack, or death in certain patients who have had a heart attack or who have angina (chest pain). It should be used along with aspirin as directed by your doctor. It also may be used for other conditions as determined by your doctor.

Ticagrelor is a platelet aggregation inhibitor. It works by slowing or stopping platelets from sticking to blood vessel walls or injured tissues.

Do NOT use Ticagrelor if:

• you are allergic to any ingredient in Ticagrelor


• you have an active bleeding problem (eg, bleeding stomach ulcer, bleeding in the brain) or a history of bleeding in the brain


• you have severe liver problems


• you are taking certain azole antifungals (eg, itraconazole, ketoconazole, voriconazole), carbamazepine, dexamethasone, certain macrolide antibiotics (eg, clarithromycin), nefazodone, phenobarbital, phenytoin, certain protease inhibitors (eg, atazanavir, ritonavir), rifampin, or telithromycin

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ticagrelor:

Some medical conditions may interact with Ticagrelor. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have liver or kidney problems, lung or breathing problems (eg, asthma, chronic obstructive pulmonary disease [COPD]), recent stomach or bowel bleeding, or a history of ulcers or bowel polyps


• if you have had a recent injury or surgery, including dental surgery; if you will be having surgery or a dental procedure; or if you are on dialysis


• if you have certain irregular heartbeat problems (eg, sick sinus syndrome, second- or third-degree heart block), or you have fainting caused by slow heartbeat and you do not have a permanent pacemaker


• if you have a history of bleeding or clotting problems, stroke, gouty arthritis, or high blood uric acid levels


• if you have received medicine to dissolve a blood clot (eg, alteplase) within 24 hours of taking Ticagrelor


• if you take another medicine to prevent or treat blood clots

Some MEDICINES MAY INTERACT with Ticagrelor. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticoagulants (eg, heparin, warfarin), direct thrombin inhibitors (eg, dabigatran, desirudin), nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, celecoxib, ibuprofen), rivaroxaban, or salicylates (eg, aspirin) because the risk of bleeding may be increased


• Azole antifungals (eg, fluconazole, ketoconazole, voriconazole), macrolide antibiotics (eg, clarithromycin, erythromycin), nefazodone, protease inhibitors (eg, amprenavir, atazanavir, ritonavir), or telithromycin because they may increase the risk of Ticagrelor's side effects


• Carbamazepine, dexamethasone, efavirenz, hydantoins (eg, phenytoin), phenobarbital, primidone, rifamycins (eg, rifampin), or St. John's wort because they may decrease Ticagrelor's effectiveness


• Digoxin, lovastatin, or simvastatin because the risk of their side effects may be increased by Ticagrelor

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ticagrelor may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ticagrelor:

Use Ticagrelor as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Ticagrelor comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Ticagrelor refilled.


• Take Ticagrelor by mouth with or without food.


• Take Ticagrelor on a regular schedule to get the most benefit from it.


• If you miss a dose of Ticagrelor, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ticagrelor.

Important safety information:

• Ticagrelor may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Ticagrelor with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not stop taking Ticagrelor without checking with your doctor. This may increase the risk of certain heart problems. If you need to stop taking Ticagrelor, follow your doctor's directions carefully.


• Do not exceed the dose of aspirin recommended by your doctor while you are taking Ticagrelor. Before you start any new medicine, check the label to see if it has aspirin in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Ticagrelor reduces the action of the clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.


• Tell your doctor or dentist that you take Ticagrelor before you receive any medical or dental care, emergency care, or surgery. You may need to stop Ticagrelor before you have certain types of surgery.


• Use Ticagrelor with caution in the ELDERLY; they may be more sensitive to its effects, especially bleeding problems.


• Ticagrelor should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Avoid becoming pregnant while you are taking Ticagrelor. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Ticagrelor while you are pregnant. It is not known if Ticagrelor is found in breast milk. Do not breast-feed while taking Ticagrelor.

Possible side effects of Ticagrelor:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; cough; diarrhea; dizziness; headache; nausea; minor bleeding; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bleeding in the eye; bloody or black, tarry stools; chest pain; coughing up blood; dark or bloody urine; fainting; fast, slow, or irregular heartbeat; light-headedness; purple skin patches; severe or persistent headache or dizziness; shortness of breath; symptoms of stroke (eg, sudden numbness or weakness of an arm, leg, or the face; one-sided weakness; sudden confusion, trouble speaking, or trouble understanding others; loss of balance, coordination, or trouble walking; sudden severe headache or dizziness with no known cause); unusual bruising; unusual, prolonged, or severe bleeding (eg, excessive bleeding from cuts, increased menstrual bleeding, nosebleeds, unexplained vaginal bleeding, unusual bleeding from the gums when brushing); vomiting blood or vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Ticagrelor side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include irregular heartbeat; severe diarrhea, nausea, or vomiting; unusual bruising or bleeding.

Proper storage of Ticagrelor:

Store Ticagrelor at room temperature, between 59 and 86 degrees F (15 and 30 degrees C) in its original container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ticagrelor out of the reach of children and away from pets.

General information:

• If you have any questions about Ticagrelor, please talk with your doctor, pharmacist, or other health care provider.


• Ticagrelor is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Ticagrelor. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Ticagrelor resources

• Ticagrelor Side Effects (in more detail)
• Ticagrelor Use in Pregnancy & Breastfeeding
• Ticagrelor Drug Interactions
• Ticagrelor Support Group
• 0 Reviews for Ticagrelor - Add your own review/rating

• Ticagrelor Professional Patient Advice (Wolters Kluwer)


• ticagrelor Advanced Consumer (Micromedex) - Includes Dosage Information


• Brilinta Consumer Overview

Compare Ticagrelor with other medications

• Acute Coronary Syndrome

Triaminic Sore Throat Formula Liquid

Pronunciation: a-seet-a-MIN-oh-fen/dex-troe-meth-OR-fan/sue-doe-eh-FED-rin
Generic Name: Acetaminophen/Dextromethorphan/Pseudoephedrine
Brand Name: Examples include DayQuil and Triaminic Sore Throat Formula

Triaminic Sore Throat Formula Liquid is used for:

Relieving pain, congestion, and cough due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Triaminic Sore Throat Formula Liquid is an analgesic, decongestant, and cough suppressant combination. It works by constricting blood vessels and reducing swelling in the nasal passages, which helps you breathe more easily. The analgesic and cough suppressant work in the brain to decrease pain and reduce the cough reflex.

Do NOT use Triaminic Sore Throat Formula Liquid if:

• you are allergic to any ingredient in Triaminic Sore Throat Formula Liquid


• you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)


• you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Triaminic Sore Throat Formula Liquid:

Some medical conditions may interact with Triaminic Sore Throat Formula Liquid. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, plan to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of glaucoma, an enlarged prostate gland or other prostate problems, heart problems, diabetes, high blood pressure, blood vessel problems, adrenal gland problems, an overactive thyroid, seizures, stroke, or liver problems, or if you consume more than 3 alcohol-containing drinks per day


• if you have a history of asthma, chronic cough, chronic obstructive pulmonary disease (COPD), or other lung problems (eg, chronic bronchitis, emphysema), or if your cough produces large amounts of mucus

Some MEDICINES MAY INTERACT with Triaminic Sore Throat Formula Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, isoniazid, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects from Triaminic Sore Throat Formula Liquid may be increased


• Anticoagulants (eg, warfarin), digoxin, or droxidopa because the risk of side effects such as bleeding, irregular heartbeat, or heart attack may be increased


• Bromocriptine because the risk of side effects may be increased by Triaminic Sore Throat Formula Liquid


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Triaminic Sore Throat Formula Liquid

This may not be a complete list of all interactions that may occur. Ask your health care provider if Triaminic Sore Throat Formula Liquid may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Triaminic Sore Throat Formula Liquid:

Use Triaminic Sore Throat Formula Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Triaminic Sore Throat Formula Liquid may be taken with or without food.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Triaminic Sore Throat Formula Liquid, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Triaminic Sore Throat Formula Liquid.

Important safety information:

• Triaminic Sore Throat Formula Liquid may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Triaminic Sore Throat Formula Liquid. Using Triaminic Sore Throat Formula Liquid alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


• Do not take appetite suppressants while you are taking Triaminic Sore Throat Formula Liquid without checking with your doctor.


• Triaminic Sore Throat Formula Liquid contains acetaminophen and pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains acetaminophen or pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.


• Do NOT exceed the recommended dose or take Triaminic Sore Throat Formula Liquid for longer than prescribed without checking with your doctor.


• If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.


• Triaminic Sore Throat Formula Liquid may cause liver damage. If you consume 3 or more alcohol-containing drinks every day, ask your doctor if you should take Triaminic Sore Throat Formula Liquid or other pain relievers/fever reducers. Alcohol use combined with Triaminic Sore Throat Formula Liquid may increase your risk for liver damage.


• Triaminic Sore Throat Formula Liquid may interfere with certain lab test results. Make sure that all of your doctors and lab personnel know that you are taking Triaminic Sore Throat Formula Liquid.


• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Triaminic Sore Throat Formula Liquid.


• Use Triaminic Sore Throat Formula Liquid with caution in the ELDERLY because they may be more sensitive to its effects.


• Caution is advised when using Triaminic Sore Throat Formula Liquid in CHILDREN because they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Triaminic Sore Throat Formula Liquid, discuss with your doctor the benefits and risks of using Triaminic Sore Throat Formula Liquid during pregnancy. It is unknown if Triaminic Sore Throat Formula Liquid is excreted in breast milk. Do not breast-feed while taking Triaminic Sore Throat Formula Liquid.

Possible side effects of Triaminic Sore Throat Formula Liquid:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; stomach pain; tremor; yellowing of skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Triaminic Sore Throat Formula side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; stomach pain; unusually fast, slow, or irregular heartbeat; vomiting; yellowing of skin or eyes.

Proper storage of Triaminic Sore Throat Formula Liquid:

Store Triaminic Sore Throat Formula Liquid at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Triaminic Sore Throat Formula Liquid out of the reach of children and away from pets.

General information:

• If you have any questions about Triaminic Sore Throat Formula Liquid, please talk with your doctor, pharmacist, or other health care provider.


• Triaminic Sore Throat Formula Liquid is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Triaminic Sore Throat Formula Liquid. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Triaminic Sore Throat Formula resources

• Triaminic Sore Throat Formula Side Effects (in more detail)
• Triaminic Sore Throat Formula Use in Pregnancy & Breastfeeding
• Triaminic Sore Throat Formula Drug Interactions
• Triaminic Sore Throat Formula Support Group
• 1 Review for Triaminic Sore Throat Formula - Add your own review/rating

Compare Triaminic Sore Throat Formula with other medications

• Cold Symptoms

Oral and Dental Conditions Medications

Definition of Oral and Dental Conditions: Oral and Dental Conditions include disorders relating to the mouth.

Drugs associated with Oral and Dental Conditions

The following drugs and medications are in some way related to, or used in the treatment of Oral and Dental Conditions. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

See sub-topics

Topics under Oral and Dental Conditions

• Aphthous Ulcer (85 drugs in 3 topics)

• Burning Mouth Syndrome (17 drugs)

• Dental Abscess (22 drugs)

• Excessive Salivation (1 drug)

• Periodontitis (24 drugs)

• Prevention of Dental Caries (58 drugs)

• Stomatitis (107 drugs in 3 topics)

• Xerostomia (4 drugs)

Drug List:

Anbesol-Liquid

Anbesol-Baby

Beegentle-Gel

Benz-O-Sthetic-Gel

Benzo-Jel

Cepacol-Dual-Relief-Spray

Cepacol-Fizzlers

Dent-O-Kain

Denti-Care-Denti-Freeze-Topical-Anesthetic

Hurricaine

Maintain

Num-Zit

Numzident

Ora-Film-Strips

Orabase

Orabase-Baby-Teething-Gel

Orajel

Orajel-Baby

Orajel-D

Oramagic-Plus-Suspension

Super-Dent-Topical-Anesthetic-Gel

Topex

Topical-Anesthetic-Dental-Gel

Altace

Generic Name: Ramipril
Class: Angiotensin-Converting Enzyme Inhibitors
VA Class: CV800
Chemical Name: [2S - [1[R*(R*)],2α,3aβ,6aβ]] - 1 - [2 - [[1 - (Ethoxycarbonyl) - 3 - phenylpropyl]amino] - 1 - oxopropy l]octahydrocylopenta[b]pyrrole-2-carboxylic acid
Molecular Formula: C₂₁H₂₈N₂O₅
CAS Number: 87333-19-5

• 
  

  May cause fetal and neonatal morbidity and mortality if used during pregnancy.^{1 38 39 40 41 42 43 44 45 46 88 89} (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

  
  


• 
  

  If pregnancy is detected, discontinue ramipril as soon as possible.^{1 89}

  
  

Introduction

Nonsulfhydryl ACE inhibitor.^{1 2 3}

Uses for Altace

Hypertension

Management of hypertension (alone or in combination with other classes of antihypertensive agents).^{1 2 4 11 38}

One of several preferred initial therapies in hypertensive patients with heart failure, postmyocardial infarction, high coronary disease risk, diabetes mellitus, chronic renal failure, and/or cerebrovascular disease.⁶⁹

Can be used as monotherapy for initial management of uncomplicated hypertension; however, thiazide diuretics are preferred by JNC 7.⁶⁹

CHF after AMI

Reduction of the risk of mortality in hemodynamically stable patients who have demonstrated clinical signs of CHF within a few days following AMI.^{1 2 12 18 21 24 27 28 62} Also may reduce rate of heart failure-associated hospitalization and progression to severe and/or resistant heart failure.^{1 2 12 18 21 24 27 28 62}

Prevention of Cardiovascular Events

Reduction of the risk of cardiovascular death, MI, and stroke in patients ≥55 years of age who are at high risk for cardiovascular events (e.g., those with a history of CAD, stroke, peripheral vascular disease, or diabetes mellitus in addition to ≥1 other cardiovascular risk factor [e.g., hypertension, elevated total cholesterol and/or decreased HDL-cholesterol concentrations, smoking, documented microalbuminuria]) but who are not known to have low ventricular ejection fraction or heart failure.^{1 47 48}

Reduction in the incidence of diabetic complications and in new diagnosis of diabetes also reported.^{47 48}

CHF

Management of symptomatic CHF†, usually in conjunction with cardiac glycosides, diuretics, and β-blockers.^{62 70 71 72 73 74}

Diabetic Nephropathy

A first-line agent in the treatment of diabetic nephropathy† in hypertensive patients with type 2 diabetes mellitus.^{78 79}

Altace Dosage and Administration

Administration

Oral Administration

Administer orally once or twice daily.¹

Swallow capsules whole.¹ Alternatively, open capsules and sprinkle contents on small amount (about 4 oz) of applesauce or mix in 120 mL of water or apple juice.¹ Consume entire mixture to ensure that no drug is lost.¹ (See Storage under Stability.)

Dosage

Adults

Hypertension

Oral

Initially, 1.25–2.5 mg once daily in patients not receiving diuretic therapy.^{1 2 3 11 38} Adjust dosage at approximately monthly intervals (more aggressively in high-risk patients) to achieve BP control.¹

In patients currently receiving diuretic therapy, discontinue diuretic, if possible, 2–3 days before initiating ramipril.¹ May cautiously resume diuretic therapy if BP not controlled adequately with ramipril alone.¹ If diuretic cannot be discontinued, increase sodium intake or initiate ramipril at 1.25 mg daily under close medical supervision.¹

Usual dosage: 2.5–20 mg daily,⁶⁹ given in 1 dose or 2 divided doses.^{1 11 38}

If effectiveness diminishes toward end of dosing interval in patients treated once daily, consider increasing dosage or administering drug in 2 divided doses.^{1 38}

CHF after MI

Oral

Initially, 2.5 mg twice daily, beginning as early as 2 days after MI.^{1 12} If hypotension occurs, reduce dosage to 1.25 mg twice daily.¹ After 1 week at initial dosage, adjust dosage as tolerated at 3-week intervals to target dosage of 5 mg twice daily.^{1 1}

Following initial dose, monitor closely for ≥2 hours and until BP has stabilized for at least an additional hour.¹ To minimize risk of hypotension, reduce diuretic dosage, if possible.¹

Prevention of Cardiovascular Events

Oral

Initially, 2.5 mg once daily for 1 week, followed by 5 mg once daily for 3 weeks; subsequently increase dosage as tolerated to maintenance dosage of 10 mg once daily.¹ In patients with hypertension or those with recent MI, may administer total daily dosage in divided doses.¹

Special Populations

Renal Impairment

Initial dosage of 1.25 mg once daily recommended in patients with renal artery stenosis.¹

In patients with Cl_cr <40 mL/minute per 1.73 m², 25% of the usual doses are expected to induce full therapeutic concentrations of ramiprilat.¹

Hypertension

Oral

Initially, 1.25 mg once daily in patients with Cl_cr <40 mL/minute per 1.73 m².¹ Titrate until BP is controlled or to maximum dosage of 5 mg daily.¹

CHF after MI

Oral

Initially, 1.25 mg once daily in patients with Cl_cr <40 mL/minute per 1.73 m².¹ May increase dosage to 1.25 mg twice daily; subsequently titrate according to clinical response and tolerance up to maximum dosage of 2.5 mg twice daily.¹

Volume-and/or Salt-Depleted Patients

Correct volume and/or salt depletion prior to initiation of therapy or initiate therapy at dosage of 1.25 mg once daily.¹

Cautions for Altace

Contraindications

• 
  

  Known hypersensitivity (e.g., history of angioedema) to ramipril or another ACE inhibitor.¹

  
  

Warnings/Precautions

Warnings

Hepatic Effects

Clinical syndrome that usually is manifested initially by cholestatic jaundice and may progress to fulminant hepatic necrosis (occasionally fatal) reported rarely with ACE inhibitors.¹

If jaundice or marked elevation of liver enzymes occurs, discontinue drug and monitor patient.¹

Hypotension

Possible symptomatic hypotension, particularly in volume- and/or salt depleted patients (e.g., those receiving prolonged diuretic therapy or undergoing dialysis, those with dietary salt restriction, patients with diarrhea or vomiting).¹ Risk of excessive hypotension, sometimes associated with oliguria, azotemia, and, rarely, acute renal failure and death in patients with CHF with or without associated renal insufficiency.¹

Hypotension may occur in patients undergoing surgery or during anesthesia with agents that produce hypotension; recommended treatment is fluid volume expansion.¹

To minimize potential for hypotension, consider recent antihypertensive therapy, extent of BP elevation, sodium intake, fluid status, and other clinical circumstances.¹ Correct volume and/or salt depletion (e.g., by withholding diuretic therapy, increasing sodium intake) prior to initiation of ramipril or reduce initial dosage.¹ (See Dosage and also Special Populations, under Dosage and Administration.)

In patients at risk of excessive hypotension, initiate therapy under close medical supervision; monitor closely for first 2 weeks following initiation of ramipril or any increase in ramipril or diuretic dosage.¹

If hypotension occurs, place patient in supine position, and if necessary, administer IV infusion of physiological saline.¹ Ramipril therapy usually can be continued following restoration of volume and BP.¹

Hematologic Effects

Neutropenia and agranulocytosis reported with captopril; risk appears to depend principally on presence of renal impairment and/or presence of collagen vascular disease (e.g., systemic lupus erythematosus, scleroderma);¹ also reported in patients receiving immunosuppressive therapy.^{5 6} Hematologic effects (e.g., agranulocytosis; pancytopenia; bone marrow depression; reductions in hemoglobin content or leukocyte, erythrocyte, or platelet counts) reported rarely with ramipril.¹

Consider monitoring leukocytes in patients with collagen vascular disease, especially if renal impairment exists.¹

Fetal/Neonatal Morbidity and Mortality

Possible fetal and neonatal morbidity and mortality when used during pregnancy.^{1 88 89} (See Boxed Warning.) Such potential risks occur throughout pregnancy, especially during the second and third trimesters.⁸⁹

Also may increase the risk of major congenital malformations when administered during the first trimester of pregnancy.^{88 89}

Discontinue as soon as possible when pregnancy is detected, unless continued use is considered lifesaving.⁸⁹ Nearly all women can be transferred successfully to alternative therapy for the remainder of their pregnancy.^{44 46}

Sensitivity Reactions

Anaphylactoid reactions and/or head and neck angioedema possible; if associated with laryngeal edema, may be fatal.¹ Immediate medical intervention (e.g., epinephrine) for involvement of tongue, glottis, or larynx.¹

Intestinal angioedema possible; consider in differential diagnosis of patients who developabdominal pain.¹

Anaphylactoid reactions reported in patients receiving ACE inhibitors while undergoing LDL apheresis with dextran sulfate absorption or following initiation of hemodialysis that utilized high-flux membrane.¹

Life-threatening anaphylactoid reactions reported in at least 2 patients receiving ACE inhibitors while undergoing desensitization treatment with hymenoptera venom.¹

Contraindicated in patients with a history of angioedema associated with ACE inhibitors.^{1 47} Patients with history of angioedema unrelated to ACE inhibitors may be at increased risk of angioedema associated with ACE inhibitor therapy.¹

General Precautions

Renal Effects

Transient increases in BUN and S_cr possible, especially in patients with preexisting renal impairment or those receiving concomitant diuretic therapy.¹ Possible increases in BUN and S_cr in patients with unilateral or bilateral renal artery stenosis; generally reversible following discontinuance of ramipril and/or diuretic therapy.¹

Possible oliguria, progressive azotemia, and, rarely, acute renal failure and/or death in patients with severe CHF.¹

Closely monitor renal function for the first few weeks of therapy in hypertensive patients with unilateral or bilateral renal-artery stenosis.¹ Some patients may require dosage reduction or discontinuance of ACE inhibitor or diuretic therapy.¹

Hyperkalemia

Possible hyperkalemia, especially in patients with renal impairment or diabetes mellitus and those receiving drugs that can increase serum potassium concentration (e.g., potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes).¹ (See Interactions.)

Cough

Persistent and nonproductive cough; resolves after drug discontinuance.¹

Specific Populations

Pregnancy

Category C (1st trimester); Category D (2nd and 3rd trimesters).¹ (See Fetal/Neonatal Morbidity and Mortality under Cautions and see Boxed Warning.)

Lactation

Undetectable in human milk following single oral dose; not known whether distributed into milk following multiple doses.¹ Use not recommended.¹

Pediatric Use

Safety and efficacy not established in children <18 years of age.¹

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.¹

Hepatic Impairment

Use with caution in patients with cirrhosis and/or ascites, due to possible increased activity of renin-angiotensin-aldosterone system.¹

Possible marked increase in plasma ramipril concentrations; peak plasma ramiprilat concentrations not appreciably altered. (See Absorption: Special Populations, under Pharmacokinetics.)¹

Renal Impairment

Systemic exposure to ramiprilat may be increased.¹ (See Pharmacokinetics.) Initial dosage adjustment may be necessary depending on degree of renal impairment.¹ (See Renal Impairment under Dosage and Administration.)

Deterioration of renal function may occur.¹ (See Renal Effects under Cautions.)

Blacks

BP reduction may be smaller in black patients compared with nonblack patients;^{1 14 15 67 68} however, no apparent population difference during combined therapy with ACE inhibitor and thiazide diuretic.^{11 14 16 17 38} Use in combination with a diuretic.^{11 14 16 17 38}

Higher incidence of angioedema reported with ACE inhibitors in blacks compared with other races.^{1 68 69}

Common Adverse Effects

Patients with hypertension: Headache, dizziness, fatigue.¹

Patients with CHF: Dizziness, cough, nausea, vomiting, angina pectoris, syncope, postural hypotension, vertigo, hypotension.¹

Interactions for Altace

Specific Drugs

Drug	Interaction	Comments
Antacid	Pharmacokinetic interaction unlikely1
Antidiabetic agents (insulin, oral agents)	Possible hypoglycemia in diabetic patients1	Monitor closely for symptoms of hypoglycemia following initiation or dosage adjustment of ramipril; adjust dosage of antidiabetic agent as necessary1
Cimetidine	Pharmacokinetic interaction unlikely1
Digoxin	Pharmacokinetic interaction unlikely1
Diuretics	Increased hypotensive effect1	If possible, discontinue diuretic before initiating ramipril1 (see Dosage and also Special Populations, under Dosage and Administration)
Diuretics, potassium-sparing (amiloride, spironolactone, triamterene)	Enhanced hyperkalemic effect1	Use with caution; monitor serum potassium concentrations frequently1
Lithium	Increased serum lithium concentrations; possible toxicity1	Use with caution; monitor serum lithium concentrations frequently1
NSAIAs	Potential for reduction of renal function and increase in serum potassium1 No interaction observed with indomethacin1
Potassium supplements or potassium-containing salt substitutes	Enhanced hyperkalemic effect1	Use with caution; monitor serum potassium concentrations frequently1
Simvastatin	Pharmacokinetic interaction unlikely1
Warfarin	Pharmacologic interaction unlikely1

Altace Pharmacokinetics

Absorption

Bioavailability

Following oral administration, peak plasma concentrations of ramipril usually attained within 1 hour.¹ Peak plasma concentrations of ramiprilat attained within 2–4 hours after oral dose.¹ About ≥50–60% of an oral dose is absorbed.¹

Onset

Following multiple oral doses (≥2 mg), >90% inhibition of plasma ACE activity achieved 4 hours after dosing.¹

Duration

Following multiple oral doses (≥2 mg), inhibition of >80% of plasma ACE activity persists for about 24 hours.¹

Food

Food decreases rate but not extent of absorption.¹ Opening the capsules and sprinkling the contents on applesauce or mixing the contents in apple juice does not alter serum concentrations of ramiprilat.¹ (See Oral Administration under Dosage and Administration.)

Special Populations

In patients with hepatic impairment, plasma concentrations of ramipril are increased; peak plasma ramiprilat concentrations are similar to those in individuals with normal hepatic function.¹

In patients with renal impairment (Cl_cr <40 mL/minute per 1.73m²), plasma concentrations and AUC of ramiprilat are increased, and time to peak plasma ramiprilat concentrations is slightly prolonged.¹

Distribution

Extent

Distributes into a large peripheral compartment.¹ Crosses the placenta.¹ Undetectable in human milk following single oral dose; not known whether distributed into milk following multiple doses.¹

Plasma Protein Binding

Ramipril: About 73%.¹

Ramiprilat: About 56%.¹

Elimination

Metabolism

Metabolized mainly in the liver, principally to an active metabolite, ramiprilat.¹

Elimination Route

Excreted in urine (60%) as unchanged drug and ramiprilat and in feces (approximately 40%).¹

Half-life

Triphasic; apparent elimination half-life of ramiprilat: Approximately 13–17 hours.¹

Special Populations

In patients with Cl_cr <40 mL/minute per 1.73m², urinary excretion of ramipril, ramiprilat, and their metabolites is decreased.¹

Stability

Storage

Oral

Capsules

15–30 ºC.¹

Mixtures of ramipril with applesauce, water, or apple juice (see Oral Administration under Dosage and Administration) are stable for 24 hours at room temperature and 48 hours when refrigerated.¹

ActionsActions

• 
  

  Prodrug; has little pharmacologic activity until metabolized to ramiprilat.¹

  
  


• 
  

  Suppresses the renin-angiotensin-aldosterone system.¹

  
  

Advice to Patients

• 
  

  Risk of angioedema, anaphylactoid reactions, or other sensitivity reactions.^{1 47} Importance of reporting sensitivity reactions (e.g., edema of face, eyes, lips, tongue, larynx, or extremities; hoarseness; swallowing or breathing with difficulty) immediately to clinician and of discontinuing the drug.¹

  
  


• 
  

  Importance of reporting signs of infection (e.g., sore throat, fever).¹

  
  


• 
  

  Risk of hypotension.¹ Importance of informing clinicians promptly if lightheadedness or fainting occurs.¹

  
  


• 
  

  Importance of adequate fluid intake; risk of volume depletion with excessive perspiration, dehydration, vomiting, or diarrhea.¹

  
  


• 
  

  Risks of use during pregnancy.^{1 88 89} (See Boxed Warning.)

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs (including salt substitutes containing potassium).¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of advising patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Ramipril

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	1.25 mg*	Altace	Monarch
			Ramipril Capsules	Cobalt
		2.5 mg*	Altace	Monarch
			Ramipril Capsules	Cobalt
		5 mg*	Altace	Monarch
			Ramipril Capsules	Cobalt
		10 mg*	Altace	Monarch
			Ramipril Capsules	Cobalt

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Altace 1.25MG Capsules (MONARCH PHARMACEUTICALS): 30/$67.99 or 90/$185.97

Altace 10MG Capsules (MONARCH PHARMACEUTICALS): 30/$85.99 or 90/$239.95

Altace 2.5MG Capsules (MONARCH PHARMACEUTICALS): 30/$76.99 or 90/$211.97

Altace 5MG Capsules (MONARCH PHARMACEUTICALS): 30/$75.99 or 90/$209.97

Ramipril 10MG Capsules (WATSON LABS): 30/$65.99 or 90/$179.97

Ramipril 2.5MG Capsules (WATSON LABS): 30/$49.99 or 90/$139.97

Ramipril 5MG Capsules (WATSON LABS): 30/$55.99 or 90/$149.99

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions April 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Monarch. Altace (ramipril) capsules prescribing information. Kansas City, MO; 2005 Sep.

2. Frampton JE, Peters DH. Ramipril: an updated review of its therapeutic use in essential hypertension and heart failure. Drugs. 1995;49:440-466.

3. Anon. Three new ACE inhibitors for hypertension. Med Lett Drugs Ther. 1991; 33:83-4. [PubMed 1831531]

4. McAreavey D, Robertson JI. Angiotensin converting enzyme inhibitors and moderate hypertension. Drugs. 1990; 40:326-45. [PubMed 2226219]

5. Squibb. Capoten (captopril) tablets prescribing information. In: Physician’s desk reference. 47th ed. Montvale, NJ: Medical Economics Company Inc; 1993:2356-62.

6. Reviewers’ comments on Enalaprilat/Enalapril 24:32.04 (personal observations).

7. Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. The 1984 report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. Ann Intern Med. 1984; 144:1045-57.

8. Anon. Drugs for hypertension. Med Lett Drugs Ther. 1984; 26:107-12. [PubMed 6150424]

9. Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. The 1988 report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. Arch Intern Med. 1988; 148:1023-38. [IDIS 242588] [PubMed 3365073]

10. US Food and Drug Administration. Dangers of ACE inhibitors during second and third trimesters of pregnancy. FDA Med Bull. 1992; 22:2.

11. Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. The fifth report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (JNC V). Arch Intern Med. 1993; 153:154-83. [IDIS 309043] [PubMed 8422206]

12. The Acute Infarction Ramipril Efficacy (AIRE) Study Investigators. Effect of ramipril on mortality and morbidity of survivors of acute myocardial infarction with clinical evidence of heart failure. Lancet. 1993; 342:821-8. [IDIS 320478] [PubMed 8104270]

13. 1988 Joint National Committee. The 1988 report of the Joint National Committee on detection, Evaluation, and Treatment of High Blood Pressure. Arch Intern Med. 1988; 148:1023-38. [IDIS 242588] [PubMed 3365073]

14. Saunders E. Tailoring treatment to minority patients. Am J Med. 1990; 88(Suppl 3B):21-23S. [PubMed 2294761]

15. Chrysant SG, Danisa K, Kem DC et al. Racial differances in pressure, volume and renin interrelationships in essential hypertension. Hypertension. 1979; 1:136-41. [PubMed 399939]

16. Holland OB, Kuhnert L, Campbell WB et al. Synergistic effect of captopril with hydrochlorothiazide for the treatment of low-renin hypertensive black patients. Hypertension. 1983; 5:235-9. [PubMed 6337951]

17. Ferguson RK, Vlasses PH, Rotmesch HH. Clinical applications of angiotensin-enzyme inhibitors. Am J Med. 1984; 77:690-8. [IDIS 191617] [PubMed 6091446]

18. LeJemtel TH, Hochman JS, Sonnenblick EH. Indications for immedicate angiotensin-converting enzyme inhibition in patients with acute myocardial infarction. J Am Coll Cardiol. 1995; 25(Suppl):47-51S. [PubMed 7798525]

19. Gruppo Italiano per lo Studio della Sopravvivenza nell’Infarto Miocardico. GISSI-3: effects of lisinopril and transdermal glyceryl trinitrate single and together on 6-week mortality and ventricular function after acute myocardial infarction. Lancet. 1994; 343:1115-22. [IDIS 329049] [PubMed 7910229]

20. Ambrosioni E, Borghi C, Magnani B for the Survival of Myocardial Infarction Long-Term Evaluation (SMILE) Study Investigators. The effect of the angiotensin-converting-enzyme inhibitor zofenopril on mortality and morbidity after anterior myocardial infarction. N Engl J Med. 1995; 332:80-5. [IDIS 340649] [PubMed 7990904]

21. Ball SG, Hall AS, Murray GD. Angiotensin-converting enzyme inhibitors after myocardial infarction: indications and timing. J Am Coll Cardiol. 1995; 25(Suppl):42-6S.

22. ISIS-4 Collaborative Group. Fourth international study of infarct survival: protocol for a large simple study of the effects of oral mononitrate, of oral captopril, and of intravenous magnesium. Am J Cardiol. 1991; 68:87-100D.

23. Simoons ML. Myocardial infarction: ACE inhibitors for all? for ever? Lancet. 1994; 344:279-81. Editorial.

24. Anon. An ACE inhibitor after a myocardial infarction. Med Lett Drugs Ther. 1994; 36:69-70. [PubMed 8035753]

25. Ertl G, Jugdutt B. ACE inhibition after myocardial infarction: can megatrials provide answers? Lancet. 1994; 344:1068-9.

26. Ertl G. Angiotensin converting enzyme inhibitors in angina and myocardial infarction: what role will they play in the 1990s? Drugs. 1993; 46:209-18.

27. Purcell H, Coats A, Fox K et al. Improving outcome after acute myocardial infarction: what is the role of ACE inhibitors? Br J Clin Pract. 1995; 49:195-9. (IDIS 349780)

28. Ball SG, Hass AS. What to expect from ACE inhibitors after myocardial infarction. Br Heart J. 1994; 72(Suppl):S70-4.

29. ISIS-4 (Fourth International Study of Infarct Survival) Collaborative Group. ISIS-4: a randomised factorial trial assesssing early oral captopril, oral mononitrate, and intravenous magnesium sulphate in 58 050 patients with suspected acute myocardial infarction. Lancet. 1995; 345:669-85. [PubMed 7661937]

30. Chinese Cardiac Study Collaborative Group. Oral captopril versus placebo among 13 634 patients with suspected acute myocardial infarction: interim report from the Chinese Cardiac Study (CCS-1). Lancet. 1995; 345:686-7. [IDIS 344925] [PubMed 7885123]

31. Cohn JN. The prevention of heart failure—a new agenda. N Engl J Med. 1992; 327:725-7. [IDIS 301135] [PubMed 1495526]

32. Pfeffer MA, Braunwald E, Moyé LA et al. Effect of captopril on mortality and morbidity in patients with left ventricular dysfunction after myocardial infarction. N Engl J Med. 1992; 327:669-77. [IDIS 301129] [PubMed 1386652]

33. Swedberg K, Held P, Kjekshus J et al. Effects of the early administration of enalapril on mortality in patients with acute myocardial infarction: results of the Cooperative New Scandinavian enalapril survival study II (Consensus II). N Engl J Med. 1992; 327:678-84. [IDIS 301130] [PubMed 1495520]

34. Sharpe N, Smith H, Murphy J et al. Early prevention of left ventricular dysfunction after myocardial infarction with angiotensin-converting-enzyme inhibition. Lancet. 1991; 337:872-6. [IDIS 279768] [PubMed 1672967]

35. Oldroyd KG, Pye MP, Ray SG et al. Effects of early captopril administration on infarct expansion, left ventricular remodeling and exercise capacity after acute myocardial infarction. Am J Cardiol. 1991; 68:713-8. [IDIS 288996] [PubMed 1892076]

36. Sharpe N, Murphy J, Smith H et al. Treatment of patients with symptomless left ventricular dysfunction after myocardial infarction. Lancet. 1988; 1:255-9. [IDIS 238337] [PubMed 2893080]

37. Pfeffer MA, Lamas GA, Vaughan DE et al. Effect of captopril on progressive ventricular dilatation after anterior myocardial infarction. N Engl J Med. 1988; 319:80-6. [IDIS 243316] [PubMed 2967917]

38. National Heart, Lung, and Blood Institute National High Blood Pressure Education Program. The sixth report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VI). Bethesda, MD: National Institutes of Health; 1997 Nov. (NIH publication No. 98-4080.)

39. Rey E, LeLorier J, Burgess E et al. Report of the Canadian Hypertension Society consensus conference: 3. pharmacologic treatment of hypertensive disorders in pregnancy. CMAJ. 1997; 157:1245-54. [IDIS 396283] [PubMed 9361646]

40. American College of Obstetricians and Gynecologists. ACOG technical bulletin No. 219: hypertension in pregnancy. 1996 Jan.

41. Hanssens M, Keirse MJ, Van Assche FA. Fetal and neonatal effects of treatment with angiotensin-converting enzyme inhibitors in pregnancy. Obstet Gynecol. 1991; 78:128-35. [IDIS 284531] [PubMed 2047053]

42. Brent RL, Beckman D. Angiotensin-converting enzyme inhibitors, an embryopathic class of drugs with unique properties: information for clinical teratology counselors. Teratology. 1991; 43:543-6. [PubMed 1882342]

43. Piper JM, Ray WA, Rosa FW. Pregnancy outcome following exposure to angiotensin-converting enzyme inhibitors. Obstet Gynecol. 1992; 80:429-32. [IDIS 300973] [PubMed 1495700]

44. Sibai BM. Treatment of hypertension in pregnant women. N Engl J Med. 1996; 335:257-65. [IDIS 369138] [PubMed 8657243]

45. Barr M, Cohen MM. ACE inhibitor fetopathy and hypocalvaria: the kidney-skull connection. Teratology. 1991; 44:485-95. [PubMed 1771591]

46. US Food and Drug Administration. Dangers of ACE inhibitors during pregnancy. FDA Med Bull. 1992; 22:2.

47. Yusuf S, Sleight P, Pogue J et al for the Heart Outcomes Prevention Evaluation Study Investigators. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on death from cardiovascular causes, myocardial infarction, and stroke in high-risk patients. N Engl J Med. (in press)

48. Kleinert S. HOPE cardiovascular disease prevention with ACE inhibitor ramipril. Lancet. 1999; 354:841. [PubMed 10485736]

49. Hansson L, Lindholm LH, Niskanen L et al. Effects of angiotensin-converting enzyme inhibition compared with conventional therapy on cardiovascular morbidity and mortality in hypertension: the Captopril Prevention Project (CAPPP) randomised trial. Lancet. 1999; 353:611-616. [IDIS 421531] [PubMed 10030325]

50. Lonn EM, Yusuf S, Jha P et al. Emerging role of angiotensin-converting enzyme inhibitors in cardiac and vascular protection. Circulation. 1994; 90:2056-69. [IDIS 336978] [PubMed 7923694]

51. American Diabetes Association. Clinical Practice Recommendations 1999. Position Statement. Diabetic nephropathy. Diabetes Care. 1999; 22(Suppl 1):S66-9.

52. Genuth S. United Kingdom prospective diabetes study results are in. J Farm Pract. 1998; 47(Suppl 5):S27.

53. Watkins PJ. UKPDS: a message of hope and a need for change. Diabetic Med. 1998; 15:895-6. [PubMed 9827842]

54. UK Prospective Diatetes Study Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ. 1998; 317:703-13. [IDIS 412064] [PubMed 9732337]

55. Bretzel RG, Voit K, Schatz H et al. The United Kingdom Prospective Diabetes Study (UKPDS): implications for the pharmacotherapy of type 2 diabetes mellitus. Exp Clin Endocrinol Diabetes. 1998; 106:369-72. [PubMed 9831300]

56. American Diabetes Association. Clinical Practice Recommendations 1999. Position statement. Implications of the United Kingdom Prospective Diabetes Study. Diabetes Care. 1999; 22(Supl 1):

57. Tatti P, Pahor M, Byington RP et al. Outcome results of the fosinopril versus amlodipine cardiovascular events randomized trial (FACET) in patients with hypertension and NIDDM. Diabetes Care. 1998; 21:597-603. [IDIS 403787] [PubMed 9571349]

58. American Diabetes Association. The United Kingdom Prospective Diabetes Study (UKPDS) for type 2 diabetes: what you need to know about the results of a long-term study. Washington, DC; 1998 Sep 15 from American Diabetes Association web site.

59. UK Prospective Diabetes Study Group. Efficacy of atenolol and captopril in reducing risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 39. BMJ. 1998; 317:713-20. [IDIS 412065] [PubMed 9732338]

60. Davis TM. United Kingdom Prospective Diabetes Study: the end of the beginning? Med J Aust. 1998; 169:511-2.

61. American Diabetes Association. Clinical Practice Recommendations 1999. Position Statement. Standard of medical care for patients with diabetes mellitus. Diabetes Care. 1999; (Suppl 1):S32-41.

62. Anon. Consensus recommendations for the management of chronic heart failure. On behalf of the membership of the advisory council to improve outcomes nationwide in heart failure. Part II. Management of heart failure: approaches to the prevention of heart failure. Am J Cardiol. 1999; 83:9-38A.

63. Izzo JL, Levy D, Black HR. Importance of systolic blood pressure in older Americans. Hypertension. 2000; 35:1021-4. [PubMed 10818056]

64. Frohlich ED. Recognition of systolic hypertension for hypertension. Hypertension. 2000; 35:1019-20. [PubMed 10818055]

65. Bakris GL, Williams M, Dworkin L et al. Preserving renal function in adults with hypertension and diabetes: a consensus approach. Am J Kidney Dis. 2000; 36:646-61. [IDIS 452007] [PubMed 10977801]

66. Associated Press (American Diabetes Association). Diabetics urged: drop blood pressure. Chicago, IL; 2000 Aug 29. Press Release from web site.

67. Appel LJ. The verdict from ALLHAT—thiazide diuretics are the preferred initial therapy for hypertension. JAMA. 2002; 288:3039-60. [IDIS 490723] [PubMed 12479770]

68. The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA. 2002; 288:2981-97. [IDIS 490721] [PubMed 12479763]

69. National Heart, Lung, and Blood Institute National High Blood Pressure Education Program. The seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VII) Express. Bethesda, MD: May 14 2003. From NIH website. (Also published in JAMA. 2003; 289.

70. Merck & Co. Vasotec tablets (enalapril maleate) prescribing information. Whitehouse Station, NJ; 2002 Jan.

71. Bristol-Myers Squibb. Monopril (fosinopril sodium) tablets prescribing information. Princeton, NJ; 2002 Feb.

72. Merck. Prinivil (lisinopril) tablets prescribing information. Whitehouse Station, NJ; 2002 Jan.

73. AstraZeneca. Zestril (lisinopril) tablets prescribing information. Wilmington, DE: 2002 Jan.

74. Parke Davis. Accupril (quinapril hydrochloride) tablets prescribing information. Morris Plains, NJ; 2001 Mar.

75. American Diabetes Association. Treatment of hypertension in adults with diabetes. Diabetes Care. 2003; 26(Suppl 1):S80-2.

76. Guidelines Committee. 2003 European Society of Hypertension–European Society of Cardiology guidelines for the management of arterial hypertension. J Hypertension. 2003; 21:1011-53.

77. Novartis. Diovan (valsartan) tablets prescribing information. East Hanover, NJ; 2002 Aug.

78. American Diabetes Association. Treatment of hypertension in adults with diabetes. Diabetes Care. 2002; 25:134-47. [IDIS 479088] [PubMed 11772914]

79. American Diabetes Association. Standards of medical care for patients with diabetes mellitus. Diabetes Care. 2002; 25(Suppl 1):S33-43.

80. American Diabetes Association. Clinical Practice Recommendations 2002. Position Statement. Diabetic nephropathy. Diabetes Care. 2002; 25(Suppl 1):S85-9.

81. Lewis EJ, Hunsicker LG, Bain RP et al. The effect of angiotensin-converting-enzyme inhibition on diabetic nephropathy. N Engl J Med. 1993; 329:1456-62. [IDIS 321612] [PubMed 8413456]

82. Remuzzi G. Slowing the progression of diabetic nephropathy. N Engl J Med. 1993; 329:1496-7. [PubMed 8413463]

83. Kaplan NM. Choice of initial therapy for hypertension. JAMA. 1996; 275:1577-80. [IDIS 365188] [PubMed 8622249]

84. Viberti G, Mogensen CE, Groop LC et al. Effect of captopril on progression to clinical proteinuria in patients with insulin-d