New Articles Directory Sint Eustatius: 2010

Monday, December 27, 2010

Ursobilane

Ursobilane may be available in the countries listed below.

Ingredient matches for Ursobilane

Ursodeoxycholic Acid

Ursodeoxycholic Acid is reported as an ingredient of Ursobilane in the following countries:

Spain

International Drug Name Search

Axilur

Axilur may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Axilur

Fenbendazole

Fenbendazole is reported as an ingredient of Axilur in the following countries:

Finland

Sweden

International Drug Name Search

Sunday, December 26, 2010

Béta Septigen

Béta Septigen may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Béta Septigen

Betamethasone

Betamethasone 17α-valerate (a derivative of Betamethasone) is reported as an ingredient of Béta Septigen in the following countries:

France

Betamethasone 21-(disodium phosphate) (a derivative of Betamethasone) is reported as an ingredient of Béta Septigen in the following countries:

France

Gentamicin

Gentamicin sulfate (a derivative of Gentamicin) is reported as an ingredient of Béta Septigen in the following countries:

France

International Drug Name Search

Cardosin Retard

Cardosin Retard may be available in the countries listed below.

Ingredient matches for Cardosin Retard

Doxazosin

Doxazosin mesilate (a derivative of Doxazosin) is reported as an ingredient of Cardosin Retard in the following countries:

Denmark

International Drug Name Search

Friday, December 24, 2010

Corubin

Corubin may be available in the countries listed below.

Ingredient matches for Corubin

Carvedilol

Carvedilol is reported as an ingredient of Corubin in the following countries:

Argentina

Levocarnitine

Levocarnitine is reported as an ingredient of Corubin in the following countries:

Greece

International Drug Name Search

Colobolina

Colobolina may be available in the countries listed below.

Ingredient matches for Colobolina

Scopolamine

Scopolamine butylbromide (a derivative of Scopolamine) is reported as an ingredient of Colobolina in the following countries:

Argentina

International Drug Name Search

Tuesday, December 21, 2010

Metformin Heumann

Metformin Heumann may be available in the countries listed below.

Ingredient matches for Metformin Heumann

Metformin

Metformin hydrochloride (a derivative of Metformin) is reported as an ingredient of Metformin Heumann in the following countries:

Germany

International Drug Name Search

Monday, December 13, 2010

Cavit D3

Cavit D3 may be available in the countries listed below.

Ingredient matches for Cavit D3

Calcium Phosphate

Calcium Phosphate is reported as an ingredient of Cavit D3 in the following countries:

Indonesia

Colecalciferol

Colecalciferol is reported as an ingredient of Cavit D3 in the following countries:

Indonesia

International Drug Name Search

Sunday, December 12, 2010

Cyclopan

Cyclopan may be available in the countries listed below.

Ingredient matches for Cyclopan

Dicycloverine

Dicycloverine hydrochloride (a derivative of Dicycloverine) is reported as an ingredient of Cyclopan in the following countries:

Bangladesh

International Drug Name Search

Saturday, December 11, 2010

Ingredient matches for Anexate

Flumazenil

Flumazenil is reported as an ingredient of Anexate in the following countries:

Australia

Austria

Bahrain

Belgium

Bosnia & Herzegowina

Brazil

Canada

Croatia (Hrvatska)

Cuba

Cyprus

Czech Republic

Egypt

Estonia

France

Germany

Greece

Hong Kong

Hungary

Iceland

Iran

Iraq

Ireland

Israel

Italy

Jamaica

Japan

Jordan

Kenya

Kuwait

Lebanon

Luxembourg

Malaysia

Malta

Mauritius

Mexico

Morocco

Namibia

Netherlands

New Zealand

Norway

Oman

Pakistan

Peru

Philippines

Poland

Portugal

Qatar

Romania

Russian Federation

Saudi Arabia

Serbia

Singapore

Slovakia

Slovenia

South Africa

South Korea

Spain

Sri Lanka

Switzerland

Syria

Taiwan

Thailand

Turkey

United Arab Emirates

United Kingdom

United States

Uruguay

Yemen

Zimbabwe

International Drug Name Search

Friday, December 10, 2010

Midane

Midane may be available in the countries listed below.

Ingredient matches for Midane

Cyproterone

Cyproterone 17α-acetate (a derivative of Cyproterone) is reported as an ingredient of Midane in the following countries:

Austria

Ethinylestradiol

Ethinylestradiol is reported as an ingredient of Midane in the following countries:

Austria

International Drug Name Search

Tuesday, December 7, 2010

Cromoglin

Cromoglin may be available in the countries listed below.

Ingredient matches for Cromoglin

Cromoglicic Acid

Cromoglicic Acid disodium salt (a derivative of Cromoglicic Acid) is reported as an ingredient of Cromoglin in the following countries:

Austria

Russian Federation

International Drug Name Search

Oxaliplatin Hexal

Oxaliplatin Hexal may be available in the countries listed below.

Ingredient matches for Oxaliplatin Hexal

Oxaliplatin

Oxaliplatin is reported as an ingredient of Oxaliplatin Hexal in the following countries:

Germany

International Drug Name Search

Saturday, December 4, 2010

Oral Vit A

Oral Vit A may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Oral Vit A

Retinol

Retinol is reported as an ingredient of Oral Vit A in the following countries:

South Africa

Tocopherol, α-

Tocopherol, α- is reported as an ingredient of Oral Vit A in the following countries:

South Africa

International Drug Name Search

Friday, December 3, 2010

Duexis

Pronunciation: EYE-bue-PROE-fen/fam-OH-ti-deen
Generic Name: Ibuprofen/Famotidine
Brand Name: Duexis

Duexis contains a nonsteroidal anti-inflammatory drug (NSAID). It may cause an increased risk of serious and sometimes fatal heart and blood vessel problems (eg, heart attack, stroke). The risk may be greater if you already have heart problems or if you take Duexis for a long time. Do not use Duexis right before or after bypass heart surgery.

Duexis may cause an increased risk of serious and sometimes fatal stomach or bowel ulcers and bleeding. Elderly patients may be at greater risk. This may occur without warning signs.

Duexis is used for:

Treating rheumatoid arthritis and osteoarthritis. It is also used to decrease the risk of developing stomach or bowel ulcers in patients using ibuprofen to treat these conditions. It may also be used for other conditions as determined by your doctor.

Duexis is an NSAID and H₂ (histamine) blocker combination. Exactly how the NSAID works is not known. It may block certain substances in the body that are linked to inflammation. NSAIDs treat the symptoms of pain and inflammation. They do not treat the disease that causes those symptoms. The H₂ blocker works to reduce stomach acid by blocking one of the chemicals (histamine) that stimulates the release of acid into the stomach.

Do NOT use Duexis if:

you are allergic to any ingredient in Duexis or to another H₂ blocker (eg, ranitidine)

you have had an asthma attack or a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) after taking aspirin or an NSAID (eg, naproxen, celecoxib)

you have recently had or will be having bypass heart surgery

you have moderate to severe kidney problems

you are 30 weeks pregnant or more

you are taking dasatinib

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

Before using Duexis:

Some medical conditions may interact with Duexis. 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 product, or dietary supplement

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

if you have a history of kidney or liver problems, diabetes, or stomach or bowel problems (eg, bleeding, perforation, ulcers, inflammation)

if you have a history of swelling or fluid buildup, a connective tissue disease (eg, lupus), asthma, growths in the nose (nasal polyps), or mouth inflammation

if you have high blood pressure, blood disorders, bleeding or clotting problems, heart problems (eg, heart failure), or blood vessel disease, or if you are at risk for any of these diseases

if you have poor health, dehydration or low fluid volume, swelling or fluid retention, or low blood sodium levels; you drink alcohol or smoke; or you have a history of alcohol abuse

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

Anticoagulants (eg, warfarin), antiplatelet medicines (eg, clopidogrel), bisphosphonates (eg, alendronate), aspirin, corticosteroids (eg, prednisone), dabigatran, desirudin, heparin, low molecular weight heparins (LMWHs) (eg, enoxaparin), other NSAIDs (eg, naproxen), salicylates (eg, aspirin), rivaroxaban, or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because the risk of stomach or bowel bleeding or irritation may be increased

Probenecid because it may increase the risk of Duexis's side effects

Cyclosporine, lithium, methotrexate, or quinolones (eg, ciprofloxacin) because the risk of their side effects may be increased by Duexis

Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), dasatinib, diuretics (eg, furosemide, hydrochlorothiazide), itraconazole, or ketoconazole because their effectiveness may be decreased by Duexis

This may not be a complete list of all interactions that may occur. Ask your health care provider if Duexis 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 Duexis:

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

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

Take Duexis by mouth with or without food. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.

Swallow Duexis whole. Do not break, crush, or chew before swallowing.

If you take cholestyramine, erlotinib, itraconazole, or ketoconazole, ask your doctor or pharmacist how to take it with Duexis.

Take Duexis with a full glass of water (8 oz/240 mL) as directed by your doctor.

If you miss a dose of Duexis, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. 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 the proper use of Duexis.

Important safety information:

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

Serious stomach ulcers or bleeding can occur with the use of Duexis. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Duexis with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.

Do NOT take more than the recommended dose, use for longer than prescribed, or stop taking Duexis without checking with your doctor.

Duexis has ibuprofen in it. Before you start any new medicine, check the label to see if it has ibuprofen or any other NSAID (eg, naproxen) in it too. If it does or if you are not sure, check with your doctor or pharmacist.

Do not take aspirin while you are taking Duexis unless your doctor tells you to.

Lab tests, including kidney or liver function, complete blood cell counts, and blood pressure, may be performed while you use Duexis. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Duexis with caution in the ELDERLY; they may be more sensitive to its effects, including stomach or bowel bleeding and kidney problems.

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

PREGNANCY and BREAST-FEEDING: Duexis may cause harm to the fetus. Do not take it if you are 30 weeks pregnant or more. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Duexis while you are pregnant. Duexis is found in breast milk. Do not breast-feed while taking Duexis.

Possible side effects of Duexis:

All medicines can 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:

Constipation; diarrhea; dizziness; gas; headache; heartburn; mild stomach pain or upset; nausea.

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

Severe allergic reactions (rash; hives; itching; trouble breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); blisters or sores in the mouth; bloody or black, tarry stools; change in the amount of urine produced; chest, jaw, or left arm pain; confusion; fainting; fever, chills, or persistent sore throat; irregular heartbeat; loss of balance or coordination; mental or mood changes (eg, depression); numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; seizures; severe headache, dizziness, or drowsiness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; slurred speech; stiff neck; sudden cold sweat; sudden or unexplained weight gain; swelling of hands, legs, or feet; symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; flu-like symptoms; itching; right upper stomach pain; unusual tiredness, loss of appetite, or nausea); trouble walking; unusual bruising or bleeding; unusual joint or muscle pain; unusual sensitivity to light; unusual tiredness or weakness; vision changes (eg, blurred vision, color vision changes, blind spots); 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: Duexis 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 decreased urination; loss of consciousness; seizures; severe dizziness or drowsiness; severe nausea or stomach pain; slow or troubled breathing; unusual bleeding or bruising; unusual eye movements; vomit that looks like coffee grounds.

Proper storage of Duexis:

Store Duexis 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 Duexis out of the reach of children and away from pets.

General information:

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

Duexis 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 Duexis. 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

More Duexis resources

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

Duexis Prescribing Information (FDA)

Duexis Advanced Consumer (Micromedex) - Includes Dosage Information

Duexis Consumer Overview

Compare Duexis with other medications

NSAID-Induced Ulcer Prophylaxis
Osteoarthritis
Rheumatoid Arthritis

Wednesday, December 1, 2010

Artane

In the US, Artane (trihexyphenidyl systemic) is a member of the drug class anticholinergic antiparkinson agents and is used to treat Cerebral Spasticity, Extrapyramidal Reaction and Parkinson's Disease.

US matches:

Artane

Ingredient matches for Artane

Trihexyphenidyl

Trihexyphenidyl is reported as an ingredient of Artane in the following countries:

Israel

Portugal

Tunisia

Trihexyphenidyl hydrochloride (a derivative of Trihexyphenidyl) is reported as an ingredient of Artane in the following countries:

Argentina

Australia

Belgium

Brazil

Chile

Ethiopia

France

Germany

Italy

Japan

Luxembourg

Netherlands

Peru

Serbia

Spain

Taiwan

International Drug Name Search

Tuesday, November 30, 2010

Ceti TAD

Ceti TAD may be available in the countries listed below.

Ingredient matches for Ceti TAD

Cetirizine

Cetirizine dihydrochloride (a derivative of Cetirizine) is reported as an ingredient of Ceti TAD in the following countries:

Germany

International Drug Name Search

Polyvidone

Polyvidone may be available in the countries listed below.

Ingredient matches for Polyvidone

Povidone

Polyvidone (DCF) is known as Povidone in the US.

International Drug Name Search

Glossary

DCF

Dénomination Commune Française

Click for further information on drug naming conventions and International Nonproprietary Names.

Sunday, November 28, 2010

Stibatin

Stibatin may be available in the countries listed below.

Ingredient matches for Stibatin

Sodium Stibogluconate

Sodium Stibogluconate is reported as an ingredient of Stibatin in the following countries:

Bangladesh

International Drug Name Search

Friday, November 26, 2010

Nonflamin

Nonflamin may be available in the countries listed below.

Ingredient matches for Nonflamin

Tinoridine

Tinoridine hydrochloride (a derivative of Tinoridine) is reported as an ingredient of Nonflamin in the following countries:

Indonesia

International Drug Name Search

Carduran CR

Carduran CR may be available in the countries listed below.

Ingredient matches for Carduran CR

Doxazosin

Doxazosin mesilate (a derivative of Doxazosin) is reported as an ingredient of Carduran CR in the following countries:

Norway

International Drug Name Search

Thursday, November 25, 2010

Felden-Quick-Solve

Felden-Quick-Solve may be available in the countries listed below.

Ingredient matches for Felden-Quick-Solve

Piroxicam

Piroxicam is reported as an ingredient of Felden-Quick-Solve in the following countries:

Austria

International Drug Name Search

Wednesday, November 24, 2010

risedronate

Generic Name: risedronate (rih SED ro nayt)

Brand Names: Actonel, Atelvia

What is risedronate?

Risedronate is in a group of medicines called bisphosphonates (bis FOS fo nayts). It alters the cycle of bone formation and breakdown in the body. Risedronate slows bone loss while increasing bone mass, which may prevent bone fractures.

Risedronate is used to treat or prevent osteoporosis in men and women. Risedronate is also used to treat Paget's disease of bone.

Risedronate may also be used for purposes not listed in this medication guide.

What is the most important information I should know about risedronate?

Take the Actonel tablet first thing in the morning with a full glass (6 to 8 ounces) of water, at least 30 minutes before you eat or drink anything or take any other medicine.

Take the Atelvia tablet just after breakfast, with at least 4 ounces of water.

Use only plain water (not mineral water) when taking a risedronate tablet.

For at least the first 30 minutes after taking a risedronate tablet, do not lie down or recline; do not eat or drink anything other than plain water; and do not take any other medicines including vitamins, calcium, or antacids.

Some people using medicines similar to risedronate have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and pre-existing dental problems.

If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using risedronate. You may need to stop using the medicine for a short time.

Talk with your doctor about the risks and benefits of using this medication.

What should I discuss with my healthcare provider before taking risedronate?

Do not take a risedronate tablet if you cannot sit upright or stand for at least 30 minutes. Risedronate can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 30 minutes after taking this medication. You should not take this medication if you are allergic to risedronate, or if you have low levels of calcium in your blood (hypocalcemia), or a problem with the movement of muscles in your esophagus.

To make sure you can safely take risedronate, tell your doctor if you have any of these other conditions:

low blood calcium (hypocalcemia);

a vitamin D deficiency;

kidney disease; or

an ulcer in your stomach or esophagus.

You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and dental surgery or pre-existing dental problems.

Talk with your doctor about the risks and benefits of using this medication.

FDA pregnancy category C. It is not known whether risedronate 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 risedronate passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking risedronate.

How should I take risedronate?

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

Risedronate tablets come in different strengths (number of milligrams per pill). Some tablets are taken once each day. Some tablets are taken once each week, or only 1 or 2 times each month.

Your dosing schedule will depend on the tablet strength your doctor has prescribed. If you change tablet strengths, you may also need to change your schedule. Follow the directions on your prescription label.

Take the Actonel tablet first thing in the morning with a full glass (6 to 8 ounces) of water, at least 30 minutes before you eat or drink anything or take any other medicine.

Take the Atelvia tablet just after breakfast, with at least 4 ounces of water.

Use only plain water (not mineral water) when taking a risedronate tablet.

After taking a risedronate tablet, carefully follow these instructions:

Do not lie down or recline for at least 30 minutes after taking risedronate.

Do not eat or drink anything other than plain water.

Do not take any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking risedronate. It may be best to take your other medicines at a different time of the day. Talk with your doctor about the best dosing schedule for your other medicines.

Do not take two different strengths of risedronate tablet at the same time.

If you take risedronate only once a week, take it on the same day and time each week.

Do not crush, chew, or suck the risedronate tablet. Swallow the pill whole. The enteric coated pill has a special coating to protect your stomach. Breaking the pill will damage this coating. If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using risedronate. You may need to stop using the medicine for a short time.

To be sure this medication is helping your condition, your bone mineral density will need to be tested on a regular basis. Visit your doctor regularly.

Risedronate is only part of a complete program of treatment that may also include diet changes, exercise, and taking calcium and vitamin supplements. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture and heat.

See also: Risedronate dosage (in more detail)

What happens if I miss a dose?

If you take risedronate tablets once daily: If you forget to take this medicine first thing in the morning, do not take it later in the day. Wait until the following morning to take the medicine and skip the missed dose. Do not take two (2) tablets in one day.

If you take risedronate tablets once a week, or once or twice per month: If you forget to take risedronate on your scheduled day, take it first thing in the morning on the day after you remember the missed dose. Then return to your regular weekly schedule on your chosen dose day. Do not take two (2) tablets in one day.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Drink a full glass of milk and call your local poison control center or emergency room right away. Do not make yourself vomit and do not lie down.

Overdose symptoms may include nausea, heartburn, stomach pain, diarrhea, muscle cramps, numbness or tingling, tight muscles in your face, seizure (convulsions), irritability, and unusual thoughts or behavior.

What should I avoid while taking risedronate?

Avoid taking any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking a risedronate tablet. Some medicines can make it harder for your body to absorb risedronate.

Risedronate side effects

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

chest pain;

difficulty or pain when swallowing;

pain or burning under the ribs or in the back;

new or worsening heartburn;

severe or ongoing indigestion;

severe joint, bone, or muscle pain;

new or unusual pain in your thigh or hip; or

jaw pain, numbness, or swelling.

Less serious side effects may include:

flu symptoms, muscle pain;

mild stomach pain or upset stomach;

diarrhea, constipation;

mild joint or back pain; or

headache.

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.

Risedronate Dosing Information

Usual Adult Dose for Paget's Disease:

30 mg orally once a day. Therapy should be continued for 2 months. A drug free interval of at least 2 months should be allowed to assess response. Retreatment may be considered after a 2 month period for patients who have relapsed or did not respond based on a failure to normalize serum alkaline phosphatase levels. Data are not available regarding more than one course of treatment.

Usual Adult Dose for Osteoporosis:

For prevention or treatment of postmenopausal osteoporosis: 5 mg orally once daily or 35 mg orally once a week. Also, risedronate 75 mg may be given orally once a day on two consecutive days, for a total of two tablets monthly. Additionally, risedronate 150 mg may be given orally once a month.

For treatment of osteoporosis in men: 35 mg orally once a week.

For prevention or treatment of glucocorticoid induced osteoporosis: 5 mg orally once daily.

Patients should receive adequate supplements of calcium and vitamin D.

Patients should be instructed that if they miss a dose of risedronate 35 mg once a week, they should take 1 tablet on the morning after they remember and return to taking 1 tablet once a week, as originally scheduled on their chosen day. Patients should not take 2 tablets on the same day.

If one or both tablets of risedronate 75 mg on two consecutive days/month are missed, and the next month's scheduled doses are more than 7 days away, the patient should be instructed as follows: If both tablets are missed, take one risedronate 75 mg tablet in the morning after the day it is remembered and then the other tablet on the next consecutive morning; if only one risedronate 75 mg tablet is missed, take the missed tablet in the morning after the day it is remembered. Patients should then return to taking their risedronate 75 mg on two consecutive days/month as originally scheduled. Patients should not take more than two 75 mg tablets within 7 days. If one or both tablets of risedronate 75 mg on two consecutive days/month are missed, and the next month's scheduled doses are within 7 days, patients should wait until their next month's scheduled doses and then continue taking risedronate 75 mg on two consecutive days/month as originally scheduled.

If the dose of risedronate 150 mg once a month is missed, and the next month's scheduled dose is more than 7 days away, the patient should be instructed to take the missed tablet in the morning after the day it is remembered. Patients should then return to taking their risedronate 150 mg once a month as originally scheduled. Patients should not take more than one 150 mg tablet within 7 days. If the dose of risedronate 150 mg once a month is missed, and the next month's scheduled dose is within 7 days, patients should wait until their next month's scheduled dose and then continue taking risedronate 150 mg once a month as originally scheduled.

Usual Adult Dose for Prevention of Osteoporosis:

What other drugs will affect risedronate?

Before using risedronate, tell your doctor if you also use aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as celecoxib (Celebrex), diclofenac (Voltaren), diflunisal (Dolobid), ibuprofen (Motrin, Advil), indomethacin, ketoprofen (Orudis), ketorolac (Toradol), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.

This list is not complete and other drugs may interact with risedronate. 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 risedronate resources

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

risedronate Advanced Consumer (Micromedex) - Includes Dosage Information

Risedronate Prescribing Information (FDA)

Risedronate MedFacts Consumer Leaflet (Wolters Kluwer)

Actonel Prescribing Information (FDA)

Actonel MedFacts Consumer Leaflet (Wolters Kluwer)

Actonel Monograph (AHFS DI)

Actonel Consumer Overview

Atelvia Consumer Overview

Atelvia Prescribing Information (FDA)

Atelvia Delayed-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare risedronate with other medications

Osteoporosis
Paget's Disease
Prevention of Osteoporosis

Where can I get more information?

Your pharmacist can provide more information about risedronate.

See also: risedronate side effects (in more detail)

Saturday, November 20, 2010

Cipasid

Cipasid may be available in the countries listed below.

Ingredient matches for Cipasid

Cisapride

Cisapride is reported as an ingredient of Cipasid in the following countries:

Thailand

International Drug Name Search

Thursday, November 18, 2010

Endo-Paractol

Endo-Paractol may be available in the countries listed below.

Ingredient matches for Endo-Paractol

Simeticone

Simeticone is reported as an ingredient of Endo-Paractol in the following countries:

Germany

International Drug Name Search

Tuesday, November 16, 2010

Oxymorphone Suppositories

Pronunciation: ox-ee-MOR-fone
Generic Name: Oxymorphone
Brand Name: Numorphan

Oxymorphone Suppositories are used for:

Treating moderate to severe pain. It may be used before surgery to cause sedation and reduce anxiety. It may also be used for other conditions as determined by your doctor.

Oxymorphone Suppositories are a narcotic pain reliever. It works by dulling the pain perception center in the brain. It may also affect other body systems (eg, respiratory and circulatory systems) at higher doses.

Do NOT use Oxymorphone Suppositories if:

you are allergic to any ingredient in Oxymorphone Suppositories or any other oxymorphone- or morphine-related medicine (eg, codeine)

you are taking sodium oxybate (GHB)

you have severe bowel motility problems (eg, paralytic ileus) or severe diarrhea associated with antibiotic use (pseudomembranous colitis)

you have severely slow or difficult breathing, fluid in the lungs due to chemical irritation, or severe asthma, or you are having an asthma attack

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

Before using Oxymorphone Suppositories:

Some medical conditions may interact with Oxymorphone Suppositories. 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 or other substances

if you have a history of asthma, chronic obstructive pulmonary disease (COPD), trouble breathing while asleep (eg, sleep apnea), or other lung or breathing problems

if you have a history of recent head injury, increased pressure in the brain, growths in the brain (eg, tumors), or seizures

if you have a history of heart problems, low blood pressure, liver or kidney problems, underactive thyroid, adrenal gland problems (eg, Addison disease), increased pressure in the eye, glaucoma, stomach or bowel problems, gallbladder problems, inflammation of the pancreas, a blockage of the bladder or bowel, an enlarged prostate, or the blood disease porphyria

if you have a history of drug or alcohol abuse, mood or mental problems, or suicidal thoughts or behavior

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

Cimetidine, furazolidone, monoamine oxidase (MAO) inhibitors (eg, phenelzine), phenothiazines (eg, chlorpromazine), sodium oxybate (GHB ), or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects such as severe drowsiness, slow or difficult breathing, confusion, and seizures may be increased

Buprenorphine, butorphanol, nalbuphine, naltrexone, or pentazocine because the effectiveness of Oxymorphone Suppositories may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Oxymorphone Suppositories 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 Oxymorphone Suppositories:

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

Oxymorphone Suppositories are a rectal suppository. If the suppository is too soft to use, put it in the refrigerator for about 15 minutes or run cold water over it. Then remove the wrapper and moisten the suppository with cool water. Lie down on your side. Insert the pointed end of the suppository into the rectum, then use your finger to push it in completely. Wash your hands thoroughly after using Oxymorphone Suppositories.

If you miss a dose of Oxymorphone Suppositories and you are using it regularly, use 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 use 2 doses at once.

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

Important safety information:

Oxymorphone Suppositories 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 Oxymorphone Suppositories. Using Oxymorphone Suppositories alone, with other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.

Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Oxymorphone Suppositories. Oxymorphone Suppositories will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.

Oxymorphone Suppositories may cause dizziness, lightheadedness, or fainting. Alcohol, hot weather, exercise, and fever can increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness, lightheadedness, or weakness.

Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Oxymorphone Suppositories.

Use Oxymorphone Suppositories with caution in the ELDERLY because they may be more sensitive to its effects.

Use Oxymorphone Suppositories with extreme caution in CHILDREN younger than 18 years of age. Safety and effectiveness in this age group have not been confirmed.

PREGNANCY AND BREAST-FEEDING: If you become pregnant while taking Oxymorphone Suppositories, discuss with your doctor the benefits and risks of using Oxymorphone Suppositories during pregnancy. It is unknown if Oxymorphone Suppositories are excreted in breast milk. If you are or will be breast-feeding while you are using Oxymorphone Suppositories, check with your doctor or pharmacist to discuss the risks to your baby.

When used for long periods of time or at high doses, Oxymorphone Suppositories may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Oxymorphone Suppositories stops working well. Do not take more than prescribed.

When used for long periods of time or at high doses, some people develop a need to continue taking Oxymorphone Suppositories. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Oxymorphone Suppositories, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; hallucinations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Oxymorphone Suppositories:

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:

Constipation; dizziness; drowsiness; headache; nausea; sleeplessness; vomiting; weakness.

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); confusion; difficulty urinating; fast or slow heartbeat; seizures; severe dizziness, lightheadedness, or fainting; slowed or difficult breathing; stomach pain; tremor; vision changes.

See also: Oxymorphone 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 cold and clammy skin; confusion; loss of consciousness; seizures; severe drowsiness, dizziness, or lightheadedness; slow breathing; slow heartbeat.

Proper storage of Oxymorphone Suppositories:

Store Oxymorphone Suppositories in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Do not store in the bathroom. Keep Oxymorphone Suppositories out of the reach of children and away from pets.

General information:

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

Oxymorphone Suppositories are 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 Oxymorphone Suppositories. 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

More Oxymorphone resources

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

Compare Oxymorphone with other medications

Labor Pain
Pain

Di-Fedril

Di-Fedril may be available in the countries listed below.

Ingredient matches for Di-Fedril

Diphenhydramine

Diphenhydramine hydrochloride (a derivative of Diphenhydramine) is reported as an ingredient of Di-Fedril in the following countries:

Venezuela

International Drug Name Search

Monday, November 15, 2010

Zaso

Zaso may be available in the countries listed below.

Ingredient matches for Zaso

Zaleplon

Zaleplon is reported as an ingredient of Zaso in the following countries:

India

International Drug Name Search

Thursday, November 11, 2010

Mentax

In the US, Mentax (butenafine topical) is a member of the drug class topical antifungals and is used to treat Tinea Corporis, Tinea Cruris and Tinea Pedis.

US matches:

Mentax Cream

Mentax

Mentax Topical

Ingredient matches for Mentax

Butenafine

Butenafine hydrochloride (a derivative of Butenafine) is reported as an ingredient of Mentax in the following countries:

Estonia

Israel

Japan

Latvia

Lithuania

Taiwan

United States

International Drug Name Search

Tuesday, November 9, 2010

Carnon

Carnon may be available in the countries listed below.

Ingredient matches for Carnon

Levocarnitine

Levocarnitine is reported as an ingredient of Carnon in the following countries:

Indonesia

Ubidecarenone

Ubidecarenone is reported as an ingredient of Carnon in the following countries:

Indonesia

International Drug Name Search

Monday, November 1, 2010

Amebismo

Amebismo may be available in the countries listed below.

Ingredient matches for Amebismo

Bismuth Subsalicylate

Bismuth Subsalicylate is reported as an ingredient of Amebismo in the following countries:

Vietnam

International Drug Name Search

Wednesday, October 27, 2010

Clob

Clob may be available in the countries listed below.

Ingredient matches for Clob

Clobazam

Clobazam is reported as an ingredient of Clob in the following countries:

Bangladesh

International Drug Name Search

Sunday, October 24, 2010

Mintezol

In some countries, this medicine may only be approved for veterinary use.

In the US, Mintezol (thiabendazole systemic) is a member of the drug class anthelmintics and is used to treat Angiostrongylosis, Ascariasis, Capillariasis, Cutaneous Larva Migrans, Dracunculiasis, Hookworm Infection - Necator or Ancylostoma, Strongyloidiasis, Trichinosis, Trichostrongylosis, Visceral Larva Migrans - Toxicariasis and Whipworm Infection.

US matches:

Mintezol

Mintezol Suspension

Ingredient matches for Mintezol

Tiabendazole

Tiabendazole is reported as an ingredient of Mintezol in the following countries:

Egypt

Ethiopia

Greece

Ireland

United Kingdom

United States

International Drug Name Search

Saturday, October 23, 2010

Fosfestrolo

Fosfestrolo may be available in the countries listed below.

Ingredient matches for Fosfestrolo

Fosfestrol

Fosfestrolo (DCIT) is also known as Fosfestrol (Rec.INN)

International Drug Name Search

Glossary

DCIT	Denominazione Comune Italiana
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Friday, October 22, 2010

Proxalyoc

Proxalyoc may be available in the countries listed below.

Ingredient matches for Proxalyoc

Piroxicam

Piroxicam is reported as an ingredient of Proxalyoc in the following countries:

France

Tunisia

International Drug Name Search

Tuesday, October 19, 2010

Ropenem

Ropenem may be available in the countries listed below.

Ingredient matches for Ropenem

Meropenem

Meropenem trihydrate (a derivative of Meropenem) is reported as an ingredient of Ropenem in the following countries:

Bangladesh

International Drug Name Search

Monday, October 18, 2010

Aptivus

Aptivus is a brand name of tipranavir, approved by the FDA in the following formulation(s):

APTIVUS (tipranavir - capsule; oral)

Manufacturer: BOEHRINGER INGELHEIM

Approval date: June 22, 2005

Strength(s): 250MG ^[RLD]

APTIVUS (tipranavir - solution; oral)

Manufacturer: BOEHRINGER INGELHEIM

Approval date: June 23, 2008

Strength(s): 100MG/ML ^[RLD]

Has a generic version of Aptivus been approved?

No. There is currently no therapeutically equivalent version of Aptivus available.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Aptivus. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

Pyranone compounds useful to treat retroviral infections
Patent 5,852,195
Issued: December 22, 1998
Inventor(s): Romines; Karen Rene & Bundy; Gordon L. & Schwartz; Theresa M. & Tommasi; Ruben A. & Strohbach; Joseph W. & Turner; Steven Ronald & Thaisrivongs; Suvit & Aristoff; Paul Adrian & Johnson; Paul D. & Skulnick; Harvey Irving & Skaletzky; Louis L. & Anderson; David John & Morris; Joel
Assignee(s): Pharmacia & Upjohn Company
The present invention relates to compounds of formulae (I) and (II) which are pyran-2-ones, 5,6-dihydro-pyran-2-ones, 4-hydroxy-benzopyran-2-ones, 4-hydroxy-cycloalkyl›b!pyran-2-ones, and derivatives thereof, useful for inhibiting a retrovirus in a mammalian cell infected with said retrovirus, wherein R.sub.10 and R.sub.20 taken together are formulae (III) and (IV). ##STR1##
Patent expiration dates:
- June 22, 2019
  ✓
  Drug substance
- December 22, 2019
  ✓
  Pediatric exclusivity

Method for improving the pharmacokinetics of tipranavir
Patent 6,147,095
Issued: November 14, 2000
Inventor(s): Ferry; James J. & Baldwin; John R. & Borin; Marie T.
Assignee(s): Pharmacia & Upjohn Company
The present invention relates to a novel method for improving the pharmacokinetics of tipranavir, comprising administering to a human in need of such treatment a combination of a therapeutically effective amount of tipranavir or a pharmaceutically acceptable salt thereof, and a therapeutically effective amount of ritonavir or a pharmaceutically acceptable salt thereof.
Patent expiration dates:
- October 29, 2019
  ✓
  Patent use: TREATMENT OF HIV-1 INFECTION BY THE CO-ADMINISTRATION OF TIPRANAVIR AND RITONAVIR.
- April 29, 2020
  ✓
  Pediatric exclusivity

Compounds useful to treat retroviral infections
Patent 6,169,181
Issued: January 2, 2001
Inventor(s): Romines; Karen Rene & Bundy; Gordon L. & Schwartz; Theresa M. & Tommasi; Ruben A. & Strohbach; Joseph W. & Turner; Steven Ronald & Thaisrivongs; Suvit & Aristoff; Paul Adrian & Johnson; Paul D. & Skulnick; Harvey Irving & Skaletzky; Louis L. & Anderson; David John & Morris; Joel
Assignee(s): Pharmacia & Upjohn Company
The present invention relates to compounds of formula I and II which are pyran-2-ones, 5,6-dihydro-pyran-2-ones, 4-hydroxy-benzopyran-2-ones, 4-hydroxy-cycloalkyl[b]pyran-2-ones, and derivatives thereof, useful for inhibiting a retrovirus in a mammalian cell infected with said retrovirus. ##STR1## wherein R.sub.10 and R.sub.20 taken together are: ##STR2##
Patent expiration dates:
- May 6, 2014
  ✓
  Drug substance
- November 6, 2014
  ✓
  Pediatric exclusivity

Pharmaceutical composition for acidic lipophilic compounds in a form of a self-emulsifying formulation
Patent 6,231,887
Issued: May 15, 2001
Inventor(s): Gao; Ping & Morozowich; Walter
Assignee(s): Pharmacia & Upjohn Company
The present invention provides a novel pharmaceutical composition based on the use of a particular amount of basic amine which comprises a pyranone compound as a pharmaceutically active agent, a basic amine in an amount of from about 0.1% to about 10% by weight of the total composition, one or more pharmaceutically acceptable solvents, and one or more pharmaceutically acceptable surfactants. In addition, the composition may further comprises one or more pharmaceutically acceptable oils. The composition is in a form of self-emulsifying formulation which provides high concentration and high oral bioavailability for lipophilic pyranone compounds.
Patent expiration dates:
- July 27, 2018
  ✓
  Drug product
- January 27, 2019
  ✓
  Pediatric exclusivity

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

Exclusivity expiration dates:
- December 22, 2010 - PEDIATRIC EXCLUSIVITY
- June 23, 2011 - USE OF APTIVUS, CO-ADMINISTERED W/RITONAVIR, FOR COMBINATION ANTIRETROVIRAL TREATMENT OF HIV-1 INFECTED PED (AGE 2-18 YRS) PATIENTS WHO ARE TREATMENT-EXPERIENCED AND INFECTED W/HIV-1 STRAINS RESISTANT TO MORE THAN ONE PROTEASE INHIBITOR
- December 23, 2011 - PEDIATRIC EXCLUSIVITY

Saturday, October 16, 2010

Misol

Misol may be available in the countries listed below.

Ingredient matches for Misol

Sertraline

Sertraline hydrochloride (a derivative of Sertraline) is reported as an ingredient of Misol in the following countries:

Turkey

International Drug Name Search

Tuesday, October 12, 2010

Budesonide

Class: Adrenals
VA Class: NT200
Chemical Name: [11β,16α(R)]-16,17-Butylidene-bis(oxy)-11,21-dihydroxy-pregna-1,4-diene-3,20-dione and 16α,17-[(S)-butylidinebis(oxy)]-11β,21-dihydroxypregna-1,4-diene-3,20-dione
Molecular Formula: C₂₅H₃₄O₆
CAS Number: 51333-22-3
Brands: Entocort EC, Pulmicort, Symbicort

Special Alerts:

[Posted 02/18/2010] FDA notified healthcare professionals and consumers that, due to safety concerns, FDA is requiring a risk management strategy (REMS) and class-labeling changes for all Long-Acting Beta-Agonists (LABAs). The REMS will require a revised Medication Guide written specifically for patients, and a plan to educate healthcare professionals about the appropriate use of LABAs. These changes are based on FDA's analyses of studies showing an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations in pediatric and adult patients as well as death in some patients using LABAs for the treatment of asthma.

Healthcare professionals are reminded that to ensure the safe use of these products:

Single-ingredient LABAs should only be used in combination with an asthma controller medication; they should not be used alone.

LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications.

LABAs should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved. Patients should then be maintained on an asthma controller medication.

Pediatric and adolescent patients who require the addition of a LABA to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA, to ensure compliance with both medications.

FDA has determined that the benefits of LABAs in improving asthma symptoms outweigh the potential risks when used appropriately with an asthma controller medication in patients who need the addition of LABAs. FDA believes the safety measures recommended will improve the safe use of these drugs. For more information visit the FDA website at: and .

REMS:

FDA approved a REMS for budesonide to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of budesonide and consists of the following: communication plan. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Synthetic, nonhalogenated corticosteroid; potent glucocorticoid and weak mineralocorticoid activity.¹ ² ³ ⁶ ³¹ ^j

Uses for Budesonide

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Crohn’s Disease

Used orally for the management of an active episode of mild-to-moderate Crohn’s disease involving the ileum and/or ascending colon¹ ⁴ ⁵ ⁶ ⁷ ⁸ ⁹ ¹⁰ ¹¹ ¹² ¹³ ¹⁵ ¹⁶ ¹⁷ ¹⁸ ³¹ and for maintenance of clinical remission for up to 3 months in this condition.¹ ⁴⁰

Has been used for the management of mild to moderately active Crohn’s disease† in a limited number of children 9.5–18 years of age.¹⁰

Asthma

Long-term prevention of bronchospasm in patients with asthma.³ ²⁸ ^j

In corticosteroid-dependent patients, may permit a substantial reduction in daily maintenance dosage of systemic corticosteroid and gradual discontinuance of corticosteroid maintenance dosages.² ³ ²⁸ ^j

Used in fixed combination with formoterol in asthmatic patients whose disease is inadequately controlled with other anti-asthma therapy (e.g., low-to-medium dosages of inhaled corticosteroids) or whose disease severity warrants treatment with 2 maintenance therapies.^g

Fixed combination with formoterol should not be used in patients whose asthma can be successfully managed with inhaled corticosteroids and occasional use of inhaled short-acting β₂-adrenergic agonists.^g

Not indicated for management of acute bronchospasm.² ³ ^g ^j

Not indicated for treatment or prevention of exercise-induced bronchospasm.^g

Budesonide Dosage and Administration

General

Asthma

Individualize dosage carefully according to disease severity.^j

Base initial and maximum dosages of oral inhalation on previous asthma therapy.² ³

After a satisfactory response is obtained, decrease dosage gradually to the lowest dosage that maintains an adequate clinical response.² ³ ^j Achieve the lowest effective dosage, particularly in children, since inhaled corticosteroids have the potential to affect growth.^g ^j (See Pediatric Use under Cautions.)

Conversion to Orally Inhaled Therapy in Patients Receiving Systemic Corticosteroids

When switching from systemic corticosteroids to orally inhaled budesonide, asthma should be reasonably stable before initiating withdrawal from systemic corticosteroids.^j

Initially, administer the oral inhalation therapy concurrently with the maintenance dosage of the systemic corticosteroid.² ^a ^j After about 1 week, gradually withdraw systemic corticosteroid, followed by further reductions after an interval of 1 or 2 weeks.² ³ ^j

Usual decrements of ≤2.5 mg or ≤25% of prednisone dosage (or its equivalent) every 1–2 weeks used in patients receiving budesonide powder for inhalation or inhalation suspension, respectively.² ³ ^j Once oral corticosteroids are discontinued and symptoms of asthma have been controlled, titrate the dosage to the lowest effective level.² ³ ^g

Death has occurred in some individuals due to adrenal insufficiency in whom systemic corticosteroids were withdrawn too rapidly.^j If evidence of adrenal insufficiency occurs, increase systemic corticosteroid dosage temporarily and then continue withdrawal from systemic corticosteroids more slowly.^j (See Withdrawal of Systemic Corticosteroid Therapy under Cautions.)

Administration

Administer orally as delayed-release capsules.¹ ⁶ ⁷ ⁹ ¹¹ ¹² ¹⁵ ³¹

Administer by oral inhalation via nebulization (Pulmicort Respules),² ^d an oral aerosol inhaler (Symbicort), or an oral powder inhaler (Pulmicort Flexhaler, Pulmicort Turbuhaler).³ ²⁸ ^g ^j

Oral Administration

Administer orally once daily as delayed-release capsules containing enteric-coated granules.¹ ⁶ ²⁸ ³¹

Swallow the capsules intact; do not chew or break.¹ ⁶ However, limited data indicate that the release characteristics of capsules were not affected when unencapsulated granules were added to applesauce for 30 minutes.²⁸

Avoid concomitant use of the capsules and grapefruit juice.¹ ⁶ (See Specific Drugs or Food under Interactions.)

Manufacturer makes no specific recommendations regarding administration with meals;¹ a high-fat meal may decrease the rate of absorption.¹ ⁶ (See Absorption under Pharmacokinetics.)

Oral Inhalation

Following each dose, rinse the mouth with water to remove residual drug and to minimize the development of fungal overgrowth and/or infection.² ³ ²⁴ ²⁵ ²⁸ ^g ^h

Inhalation Powder

Prime the oral inhaler prior to initial use.³ ²⁵ ^j ^k

Do not shake Pulmicort Flexhaler.^j

Actuate inhaler and inhale deeply and forcefully.³ ²⁵ ^j ^k

Pulmicort Turbuhaler and Pulmicort Flexhaler cannot be refilled; discard when empty.³ ²⁵ ^j ^k

Inhalation Suspension

Do not administer the oral inhalation suspension parenterally or use with ultrasonic nebulizers.² ²⁴ ²⁸

Using in vitro testing at a flow rate of 5.5 L per minute for an average of 5 minutes, the Pari-LC-Jet Plus nebulizer delivered at the mouthpiece approximately 17% of the original dose.^f

Administer using a jet nebulizer (with face mask or mouthpiece) connected to a compressor that has an adequate air flow.² ²⁸ To optimize delivery and to avoid exposure of the eyes to nebulized drug, adjust the face mask properly.² ²⁴

When a face mask is used for nebulization, wash the face after each use to avoid dermatologic corticosteroid effects (e.g., rash, contact dermatitis).² ²⁸

Safety and efficacy of budesonide inhalation suspension administered by a nebulizer other than the Pari-LC-Jet Plus Nebulizer or a compressor other than the Pari Master compressor not established.² ²⁸

Inhalation Aerosol

Administer budesonide in fixed combination with formoterol using an aerosol inhaler device.^g Administer twice daily (morning and evening).^g ^h

Test spray 2 times before first use, if not used for >7 days, or if dropped.^g ^h

Shake well for 5 seconds immediately prior to use.^g ^h

Clean inhaler every 7 days by wiping mouthpiece with a dry cloth.^g ^h

Use the actuator supplied with the product to administer budesonide in fixed combination with formoterol.^g ^h

Symbicort cannot be refilled; discard when empty.^h

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Dosage of budesonide inhalation powder is expressed in mcg delivered from the mouthpiece.^a ^j The amount of drug powder delivered to the lungs depends on factors such as the patient’s inspiratory flow.³ ²⁸ ^j

Each actuation of the Pulmicort Turbuhaler inhaler contains 200 mcg of budesonide inhalation powder and delivers approximately 160 mcg of budesonide per activation from the mouthpiece.³

Each actuation of the Pulmicort Flexhaler inhaler contains 90 or 180 mcg of budesonide inhalation powder and delivers approximately 80 or 160 mcg of budesonide, respectively, per activation from the mouthpiece.^j

When switching between Pulmicort Turbuhaler and Pulmicort Flexhaler, dose may vary and is not predictable by dose of other inhaler.^j Follow dosage recommendations; titrate based on clinical response.^j

Delivery of oral inhalation suspension (Pulmicort Respules) to the lungs depends on the type of jet nebulizers used, performance of the compressor, and on factors such as the patient’s inspiratory flow.² ²⁸

Dosage of budesonide in fixed combination with formoterol fumarate dihydrate (Symbicort) inhalation aerosol is expressed in mcg delivered from the mouthpiece.^g Each actuation of the Symbicort inhalation aerosol delivers 91 or 181 mcg of budesonide and 5.1 mcg of formoterol fumarate dihydrate from the valve, and 80 or 160 mcg of budesonide and 4.5 mcg of formoterol fumarate dihydrate from the actuator per metered spray.^g The amount of drug delivered to the lungs depends on factors such as the patient’s inspiratory flow.^g The aerosol inhaler delivers 60 metered sprays per 6- or 6.9-g canister, and 120 metered sprays per 10.2-g canister.^g

Pediatric Patients

Asthma

Maintenance Monotherapy

Oral Inhalation Powder (Pulmicort Turbuhaler)

Children ≥6 years of age previously receiving bronchodilators alone: Initially, 160 mcg (labeled 200 mcg) twice daily.³ ²⁸ ^a If required, may increase dosage to a maximum of 320 mcg (labeled 400 mcg) twice daily.³ ²⁸ ^a

Children ≥6 years of age previously receiving inhaled corticosteroids: Initially, 160 mcg (labeled 200 mcg) twice daily.³ ²⁸ ^a If required, may increase dosage to a maximum of 320 mcg (labeled 400 mcg) twice daily.³ ²⁸ ^a

In children with mild-to-moderate asthma whose asthma is adequately controlled with inhaled corticosteroids, consider 160 or 320 mcg (labeled 200 or 400 mcg, respectively) once daily.³ ^a

Oral Inhalation Powder (Pulmicort Flexhaler)

Children and adolescents 6–17 years of age: Initially, 160 mcg (labeled 180 mcg) twice daily.^j If required, may increase dosage to a maximum of 320 mcg (labeled 360 mcg) twice daily.^j In some patients, an initial dosage of 320 mcg (labeled 360 mcg) twice daily may be appropriate.^j

Oral Inhalation Suspension

Children 1–8 years of age inadequately controlled with nonsteroidal (e.g., bronchodilator, mast-cell stabilizer) therapy: Initially, 0.25 mg once daily.² ²⁸ If the response is inadequate, increase the total daily dosage and/or administer in divided doses.²

Children 1–8 years of age previously receiving bronchodilators alone: 0.5 mg daily, given in 1 or 2 divided doses.² ²⁸

Children 1–8 years of age previously receiving inhaled corticosteroids: Initially, 0.5 mg daily, given in 1 or 2 divided doses.² If response is inadequate, dosage may be increased to a maximum of 1 mg daily and/or administered in divided doses.²

Children 1–8 years of age previously receiving oral corticosteroids: 1 mg daily, given in 1 or 2 divided doses.²

Budesonide/Formoterol Fixed-combination Therapy

Oral Inhalation Aerosol

Adolescents ≥12 years of age not currently receiving an orally inhaled corticosteroid: Initially, 160 or 320 mcg of budesonide and 9 mcg of formoterol fumarate dihydrate twice daily, depending on asthma severity.^g

Adolescents ≥12 years of age inadequately controlled with low-to-medium dosages of an inhaled corticosteroid: Initially, 160 mcg of budesonide and 9 mcg of formoterol fumarate dihydrate twice daily.^g

Adolescents ≥12 years of age inadequately controlled with medium-to-high dosages of an inhaled corticosteroid: Initially, 320 mcg of budesonide and 9 mcg of formoterol fumarate dihydrate twice daily.^g

If control of asthma is inadequate after 1–2 weeks of therapy at the lower dosage, a higher strength (higher strengths contain higher dosages of budesonide only) may provide additional asthma control.^g

Adults

Crohn’s Disease

Management of Mild to Moderately Active Crohn’s Disease

Oral

Initially, 9 mg daily in the morning for 8 weeks.¹ ⁶

In patients who have not experienced remission during the initial 8-week course,²⁸ ²⁹ a second 8-week course (16 weeks of continuous therapy) may be used.¹ ⁶ ²⁸ ²⁹

Maintenance of Remission

Oral

6 mg once daily for up to 3 months.¹ ⁴⁰ If symptom control is maintained at 3 months, attempt to taper dosage to complete cessation.¹ The manufacturer states that continued therapy beyond 3 months has not been shown to provide substantial clinical benefit.¹

Asthma

Maintenance Monotherapy

Oral Inhalation Powder (Pulmicort Turbuhaler)

Previously receiving bronchodilators alone: Initially, 160–320 mcg (labeled 200–400 mcg) twice daily.³ ^a If required, dosage may be increased to a maximum of 320 mcg (labeled 400 mcg) twice daily.³ ^a

Previously receiving inhaled corticosteroids: Initially, 160–320 mcg (labeled 200–400 mcg) twice daily.³ ^a If required, may increase dosage to a maximum 640 mcg (labeled 800 mcg) twice daily.³ ^a

In patients with mild-to-moderate asthma whose asthma is adequately controlled with inhaled corticosteroids, consider 160 or 320 mcg (labeled 200 or 400 mcg, respectively) once daily.³ ^a

Pulmicort Turbuhaler in adults previously receiving oral corticosteroids: Initially, 320–640 mcg (labeled 400–800 mcg) twice daily.³ ^a If required, may increase dosage to a maximum of 640 mcg (labeled 800 mcg) twice daily.³ ^a

Oral Inhalation Powder (Pulmicort Flexhaler)

Usual initial dosage is 320 mcg (labeled 360 mcg) twice daily.^j In some patients and in well-controlled patients, an initial dosage of 160 mcg (labeled 180 mcg) twice daily may be adequate.^j If required, may increase dosage to a maximum of 640 mcg (labeled 720 mcg) twice daily.^j

Budesonide/Formoterol Fixed-combination Therapy

Oral Inhalation Aerosol

Patients not currently receiving an orally inhaled corticosteroid: Initially, 160 or 320 mcg of budesonide and 9 mcg of formoterol fumarate dihydrate twice daily, depending on asthma severity.^g

Patients inadequately controlled with low-to-medium dosages of an inhaled corticosteroid: Initially, 160 mcg of budesonide and 9 mcg of formoterol fumarate dihydrate twice daily.^g

Patients inadequately controlled with medium-to-high dosages of an inhaled corticosteroid: Initially, 320 mcg of budesonide and 9 mcg of formoterol fumarate dihydrate twice daily.^g

Prescribing Limits

Pediatric Patients

Asthma

Maintenance Monotherapy

Oral Inhalation Powder

Pulmicort Turbuhaler in children ≥6 years of age: Maximum 320 mcg (labeled 400 mcg) twice daily.³ ^a

Pulmicort Flexhaler in children and adolescents 6–17 years of age: Maximum 320 mcg (labeled 360 mcg) twice daily.^j

Oral Inhalation Suspension

Children 1–8 years of age, previously receiving bronchodilators alone: Maximum 0.5 mg daily.² ²⁸

Children 1–8 years of age, previously receiving inhaled corticosteroids: Maximum 1 mg daily.²

Children 1–8 years of age, previously receiving oral corticosteroids: Maximum 1 mg daily.²

Budesonide/Formoterol Fixed-combination Therapy

Oral Inhalation Aerosol

Adolescents ≥12 years of age: Maximum 320 mcg of budesonide and 9 mcg of formoterol fumarate dihydrate twice daily.^g

Adults

Asthma

Maintenance Monotherapy

Oral Inhalation Powder

Pulmicort Turbuhaler in patients previously receiving bronchodilators alone: Maximum 320 mcg (labeled 400 mcg) twice daily.³ ^a

Pulmicort Turbuhaler in patients previously receiving inhaled corticosteroids: Maximum 640 mcg (labeled 800 mcg) twice daily.³ ^a

Pulmicort Turbuhaler in patients previously receiving oral corticosteroids: Maximum 640 mcg (labeled 800 mcg) twice daily.³ ^a

Pulmicort Flexhaler in patients ≥18 years of age: Maximum 640 mcg (labeled 720 mcg) twice daily.^j

Budesonide/Formoterol Fixed-combination Therapy

Oral Inhalation Aerosol

Maximum 320 mcg of budesonide and 9 mcg of formoterol fumarate dihydrate twice daily.^g

Special Populations

Hepatic Impairment

Crohn’s Disease

Consider dosage reduction in moderate to severe hepatic impairment.¹ ⁶ (See Special Populations under Absorption in Pharmacokinetics.)

Asthma

No specific dosage recommendations at this time.^g

Renal Impairment

Asthma

No specific dosage recommendations at this time.^g

Geriatric Patients

Oral monotherapy: Careful dosage selection recommended due to possible age-related decrease in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.¹

Oral inhalation powder (Pulmicort Flexhaler): Careful dosage selection recommended due to possible age-related decrease in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.^j

Fixed combination of budesonide and formoterol fumarate dihydrate: No dosage adjustment required.^g (See Geriatric Use under Cautions.)

Cautions for Budesonide

Contraindications

Known hypersensitivity to budesonide or any ingredient in the formulation.¹ ² ³ ^g ^j

Orally inhaled budesonide for primary treatment of acute asthmatic attacks or status asthmaticus when intensive measures (e.g., an orally inhaled β₂-adrenergic agonist, an orally inhaled anticholinergic agent, subcutaneous epinephrine, IV aminophylline, and/or an oral/IV glucocorticoid) are required.² ³ ¹⁹ ²⁷ ^g ^j

Warnings/Precautions

Warnings

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Withdrawal of Systemic Corticosteroid Therapy

Possible life-threatening adrenal insufficiency in patients being switched from systemic corticosteroids to orally inhaled budesonide.² ³ ²⁸ ^j

Withdraw systemic corticosteroid therapy gradually.¹ ² ³ ⁶ ^j In general, the greater the dosage and duration of systemic corticosteroid therapy, the greater the time required for withdrawal of systemic corticosteroids and replacement by orally inhaled corticosteroids.¹⁴

Monitor carefully for objective signs of adrenal insufficiency (e.g., fatigue, lassitude, weakness, nausea, vomiting, hypotension) and asthma instability (e.g., airway function) during withdrawal of systemic therapy.¹ ^j Carefully monitor lung function (forced expiratory volume in 1 second [FEV₁], morning peak expiratory flow [PEF]), adjunctive β₂-adrenergic agonist use, and asthma symptoms.^j Patients who have been maintained on ≥20 mg of prednisone (or its equivalent) daily may be most susceptible to such adverse events, particularly during latter part of the transfer.² ³ ^j (See Conversion to Orally Inhaled Therapy in Patients Receiving Systemic Corticosteroids under Dosage and Administration.)

Corticosteroid withdrawal symptoms (e.g., joint pain, muscular pain, lassitude, depression) may occur.¹ ² ³ ^g ^j

Adrenal insufficiency may occur during exposure to trauma, surgery, infection (particularly gastroenteritis), or other conditions associated with acute electrolyte loss.¹ ² ³ ^j

Possible unmasking of allergic conditions previously controlled by systemic corticosteroid therapy (e.g., rhinitis, conjunctivitis, eczema, arthritis, eosinophilic conditions).¹ ² ³ ⁶ ^j

Do not use the fixed combination of budesonide and formoterol fumarate dihydrate for transferring therapy from systemic to inhaled corticosteroids.^g

Immunosuppressed Patients

Increased susceptibility to infections in patients taking immunosuppressant drugs compared with healthy individuals.¹ ² ³ ^g ^j Certain infections (e.g., varicella [chickenpox], measles) can have a more serious or even fatal outcome in such patients, particularly in children.¹ ² ³ ^g

Take particular care to avoid exposure in susceptible patients.¹ ² ³ ^e ^g ^j If exposure to varicella or measles occurs in susceptible patients, consider administering varicella zoster immune globulin (VZIG) or pooled immune globulin (IG), respectively.¹ ² ³ ²⁸ ^e ^g ^j Consider treatment with an antiviral agent if varicella develops.¹ ² ³ ^e ^g ^j

Paradoxical Bronchospasm

Possible life-threatening, acute, paradoxical bronchospasm and/or wheezing.² ³ ^g ^j If bronchospasm occurs, treat immediately with a short-acting bronchodilator, discontinue treatment with budesonide, and institute alternative therapy.² ³ ²⁸ ^g ^j

General Precautions

Ocular Effects

Glaucoma, increased IOP, and cataracts reported rarely in patients receiving orally inhaled corticosteroids.² ³ ^g ^h ^j

Use delayed-release capsules with caution in patients with glaucoma, cataracts, or a family history of glaucoma.¹ ⁶

Consider regular eye examinations.^h ^j

Systemic Corticosteroid Effects

Administration of higher than recommended dosages of orally inhaled budesonide or prolonged oral administration of budesonide capsules may result in manifestations of hypercorticism and suppression of HPA function.¹ ² ³ ^g ^j To minimize potential for such changes, do not exceed recommended dosages of orally inhaled budesonide-containing therapy.^a ^g ^j

Monitor patients receiving orally inhaled budesonide-containing therapy for any evidence of systemic corticosteroid effects.^a ^g If systemic corticosteroid effects occur, reduce the dosage of budesonide-containing therapy slowly, consistent with accepted procedures for reducing corticosteroid dosage and management of asthma symptoms.^a ^g ^j

Take particular care in monitoring patients postoperatively or during periods of stress for evidence of inadequate adrenal response.^a ^g ^j Supplemental therapy with a systemic corticosteroid required during stress or severe asthma attacks.¹ ^a ^g

Musculoskeletal Effects

Long-term use may affect normal bone metabolism, resulting in a loss of bone mineral density (BMD).^g

Use of orally inhaled corticosteroids can pose additional risks in patients with major risk factors for decreased BMD, such as tobacco use, advanced age, sedentary lifestyle, poor nutrition, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants, additional corticosteroids).^g ^h

Use delayed-release capsules with caution in patients with osteoporosis.¹ ⁶

Possible growth suppression in pediatric patients.² ³ ^g ^j (See Pediatric Use under Cautions.)

Concomitant Disease States

Use delayed-release capsules with caution in patients with hypertension, diabetes mellitus, peptic ulcer, a family history of diabetes, or any other condition in which glucocorticoids may be associated with adverse effects.¹ ⁶

Infection

Localized candidal infections of the mouth and/or pharynx reported with oral inhalation therapy.² ³ ^g ^j

If infection occurs, initiate appropriate local or systemic antifungal treatment while still continuing with inhaled budesonide therapy.² ³ ^g ^j May require discontinuance of budesonide therapy (under close medical supervision) in some patients.² ³ ^g ^j

Lower respiratory tract infections, including pneumonia, reported with orally inhaled corticosteroid therapy.^g Use oral inhalation therapy with extreme caution, if at all, in patients with clinical tuberculosis or latent M. tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.² ³ ^g ^j

Use delayed-release capsules with caution in patients with tuberculosis.¹ ⁶

Other Effects

Unknown long-term local and systemic effects of the drug in humans, particularly local effects on developmental or immunologic processes in the mouth, pharynx, trachea, and lung.² ^g ^j

Use of Fixed Combinations

When used in fixed combination with formoterol fumarate dihydrate, consider the cautions, precautions, and contraindications associated with formoterol.^g

Specific Populations

Pregnancy

Category B (orally inhaled powder and inhalation suspension); category C (oral capsules, inhalation aerosol).¹ ² ³ ²⁸ ^g ^j

Hypoadrenalism may occur in infants of women receiving corticosteroid therapy during pregnancy; monitor these infants carefully.¹ ² ³ ^g ^j

Lactation

Distributed into milk.^g ^j

Use of oral capsules, oral inhalation aerosol, or oral inhalation powder (Pulmicort Turbuhaler) not recommended; discontinue nursing or the drug.¹ ³ ^g Caution advised if inhalation suspension is used.^f

Use oral inhalation powder (Pulmicort Flexhaler) only if clinically appropriate; titrate to lowest effective dosage and use inhaler immediately after nursing to minimize infant exposure.^j

Pediatric Use

Safety and efficacy of oral budesonide delayed-release capsules not established in pediatric patients <18 years of age with Crohn’s disease.¹ ²⁸

Safety and efficacy of budesonide inhalation powder not established in children <6 years of age.³ ^j

Efficacy of budesonide inhalation suspension not established in children <1 year of age,² while safety of the suspension not evaluated in children <6 months of age.²

Efficacy of inhalation aerosol containing budesonide in fixed combination with formoterol fumarate dihydrate not established in children <12 years of age.^g Safety of combination therapy in children 6 to <12 years of age similar to that in adolescents and adults.^g

With long-term use, slows growth rate in children and adolescents.² ³ ^g ^j Monitor routinely (e.g., via stadiometry) growth and development of pediatric patients receiving orally inhaled corticosteroid therapy.² ³ ^g ^j Weigh benefits of orally inhaled corticosteroid therapy versus possibility of growth suppression and the risks associated with alternative therapies.^a ^g Use the lowest possible dosage that effectively controls asthma.³⁵ ^a ^g

Geriatric Use

Insufficient experience with oral drug in patients ≥65 years of age to determine whether geriatric patients respond differently than younger patients.¹ ⁶ (See Geriatric Patients under Dosage and Administration.)

Safety and efficacy of inhalation powder, inhalation suspension, or inhalation aerosol in patients ≥65 years of age similar to that in younger adults.² ³ ⁶ ²⁸ ^g

Hepatic Impairment

Monitor patients with Crohn’s disease and moderate to severe hepatic impairment for increased signs and symptoms of hypercorticism.¹ ⁶ (See Hepatic Impairment under Dosage and Administration.)

Common Adverse Effects

With oral capsules, headache,¹ ⁶ ⁷ ⁴⁰ dizziness,¹ nausea,¹ ⁶ ⁷ ¹¹ ⁴⁰ vomiting,¹ ⁶ ⁷ ¹¹ ⁴⁰ dyspepsia,¹ ⁶ ¹¹ ⁴⁰ diarrhea,¹ ⁴⁰ sinusitis,¹ ⁴⁰ symptoms of hypercorticism,¹ respiratory infection,¹ ⁶ ⁴⁰ viral infection,¹ ⁴⁰ pain (including back pain),¹ ⁴⁰ arthralgia,¹ ⁴⁰ fatigue.¹ ⁶ ⁴⁰ Adverse effect profile in long-term treatment similar to short-term treatment.¹

With oral inhalation, respiratory infection,² ³ pharyngitis,³ rhinitis,² ³ sinusitis, ³ cough,² ³ otitis (media or externa),² flu-like syndrome,² headache,³ pain (e.g., back pain).³

Interactions for Budesonide

Metabolized by the CYP3A4 isoenzyme.¹ ² ³ ⁶ ³¹ ^g ^j

Drugs or Foods Affecting Hepatic Microsomal Enzymes

Inhibitors of CYP3A4: Potential pharmacokinetic interaction (increased plasma budesonide concentrations).¹ ² ³ ⁶ ³¹ ^g ^j

Inducers of CYP3A4: Potential pharmacokinetic interaction (decreased plasma budesonide concentrations).¹

Drugs Affecting GI pH

Potential pharmacokinetic interaction (may affect release properties and systemic absorption of enteric coated budesonide capsules).¹ ⁶

Specific Drugs or Food

Drug	Interaction	Comments
Antibiotics, macrolide (e.g., clarithromycin, erythromycin)	Increased systemic exposure of budesonide¹ ² ³ ⁶ ³¹ ^j	Monitor carefully if used concomitantly with oral budesonide capsules;² ³ ³¹ consider reduction of budesonide dosage¹ ⁶ ⁸
Antifungals, azole (e.g., itraconazole, ketoconazole)	Increased systemic exposure of budesonide¹ ² ³ ⁶ ³¹ ^g ^j	Monitor carefully if used concomitantly with oral budesonide capsules;³ ³¹ consider reduction of budesonide dosage¹