Ponstel

Generic Name: mefenamic acid (Oral route)

mef-e-NAM-ik AS-id

Oral route(Capsule)

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Mefenamic acid is contraindicated for the treatment of perioperative pain in the setting of CABG surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .

Commonly used brand name(s)

In the U.S.

• Ponstel

Available Dosage Forms:

• Capsule

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Fenamate

Uses For Ponstel

Mefenamic acid is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain. This medicine may also be used to treat menstrual cramps and other conditions as determined by your doctor.

This medicine is available only with your doctor's prescription.

Before Using Ponstel

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of mefenamic acid in children below 14 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mefenamic acid in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving mefenamic acid.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Ketorolac


• Pentoxifylline

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab


• Ardeparin


• Argatroban


• Beta Glucan


• Bivalirudin


• Certoparin


• Cilostazol


• Citalopram


• Clopidogrel


• Clovoxamine


• Dabigatran Etexilate


• Dalteparin


• Danaparoid


• Desirudin


• Dipyridamole


• Enoxaparin


• Escitalopram


• Femoxetine


• Flesinoxan


• Fluoxetine


• Fluvoxamine


• Fondaparinux


• Ginkgo


• Heparin


• Lepirudin


• Methotrexate


• Nadroparin


• Nefazodone


• Parnaparin


• Paroxetine


• Pemetrexed


• Protein C


• Reviparin


• Rivaroxaban


• Sertraline


• Sibutramine


• Tacrolimus


• Ticlopidine


• Tinzaparin


• Tirofiban


• Vilazodone


• Zimeldine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol


• Acetohexamide


• Alacepril


• Alprenolol


• Amiloride


• Arotinolol


• Atenolol


• Azilsartan Medoxomil


• Azosemide


• Befunolol


• Bemetizide


• Benazepril


• Bendroflumethiazide


• Benzthiazide


• Betaxolol


• Bevantolol


• Bisoprolol


• Bopindolol


• Bucindolol


• Bumetanide


• Bupranolol


• Buthiazide


• Candesartan Cilexetil


• Canrenoate


• Captopril


• Carteolol


• Carvedilol


• Celiprolol


• Chlorothiazide


• Chlorpropamide


• Chlorthalidone


• Cilazapril


• Clopamide


• Cyclopenthiazide


• Cyclosporine


• Delapril


• Desvenlafaxine


• Dilevalol


• Duloxetine


• Enalaprilat


• Enalapril Maleate


• Eprosartan


• Esmolol


• Ethacrynic Acid


• Fosinopril


• Furosemide


• Gliclazide


• Glimepiride


• Glipizide


• Gliquidone


• Glyburide


• Hydrochlorothiazide


• Hydroflumethiazide


• Imidapril


• Indapamide


• Irbesartan


• Labetalol


• Landiolol


• Levobetaxolol


• Levobunolol


• Lisinopril


• Lithium


• Losartan


• Mepindolol


• Methyclothiazide


• Metipranolol


• Metolazone


• Metoprolol


• Milnacipran


• Moexipril


• Nadolol


• Nebivolol


• Nipradilol


• Olmesartan Medoxomil


• Oxprenolol


• Penbutolol


• Pentopril


• Perindopril


• Pindolol


• Piretanide


• Polythiazide


• Propranolol


• Quinapril


• Ramipril


• Sotalol


• Spirapril


• Spironolactone


• Talinolol


• Tasosartan


• Telmisartan


• Temocapril


• Tertatolol


• Timolol


• Tolazamide


• Tolbutamide


• Torsemide


• Trandolapril


• Triamterene


• Trichlormethiazide


• Valsartan


• Venlafaxine


• Xipamide


• Zofenopril

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia or


• Asthma or


• Bleeding problems or


• Blood clots or


• Edema (fluid retention or body swelling) or


• Heart attack, history of or


• Heart disease (e.g., congestive heart failure) or


• Hypertension (high blood pressure) or


• Kidney disease or


• Liver disease (e.g., hepatitis) or


• Stomach or intestinal ulcers or bleeding, history of or


• Stroke, history of—Use with caution. This medicine may make these conditions worse.

• Aspirin-sensitive asthma or


• Kidney disease, advanced or


• Stomach ulcers, active—This medicine should not be used in patients with these conditions.

• Heart surgery (e.g., coronary artery bypass graft [CABG] surgery)—This medicine should not be used to relieve pain right before or after the surgery.

Proper Use of Ponstel

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients.

This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

To lessen stomach upset, you may take this medicine with food unless your doctor tells you otherwise.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  
  • For menstrual cramps:
    
    • Adults and children over 14 years of age—At first, 500 milligrams (mg), then 250 mg every six hours as needed, usually for up to two to three days.
    
    
    • Children up to 14 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For mild to moderate pain:
    
    • Adults and children over 14 years of age—At first, 500 milligrams (mg), then 250 mg every six hours as needed, usually for not more than one week.
    
    
    • Children up to 14 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Ponstel

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk.

This medicine may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely to occur if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years of age, are in poor health, or if you are using certain other medicines (such as a steroid medicine or a blood thinner).

Liver problems may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you are having more than one of these symptoms: abdominal pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; itching; loss of appetite; nausea and vomiting; skin rash; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin.

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, or loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat; sores, ulcers, white spots in the mouth or on the lips; or unusual tiredness or weakness.

Possible warning signs of some serious side effects that can occur during treatment with this medicine may include swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; yellow skin or eyes; decreased urination; bleeding or bruising; and/or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, unusual flushing or warmth of skin, weakness, or slurring of speech. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs.

This medicine may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur often in patients who are allergic to aspirin or other nonsteroidal anti-inflammatory drugs. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in skin color of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swelling of the eyelids or around the eyes. If these effects occur, get emergency help at once.

Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away.

Tell your doctor if you have unexplained weight gain or edema (fluid retention or body swelling) with this medicine.

Before having any kind of surgery or medical tests, tell your doctor that you are taking this medicine. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Ponstel Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Bloody urine


• bloody, black, or tarry stools


• decreased frequency or amount of urine


• heartburn


• increased bleeding time


• increased blood pressure


• increased thirst


• indigestion


• itching skin


• loss of appetite


• lower back or side pain


• nausea


• pale skin


• rashes


• severe abdominal pain, cramping, or burning


• stomach bloating


• swelling


• swelling of the face, fingers, feet, or lower legs


• trouble breathing with or without exertion


• unusual bleeding or bruising


• unusual tiredness or weakness


• vomiting


• vomiting of material that looks like coffee grounds, severe and continuing


• weight gain


• weight loss

Less common

• Bleeding gums


• blood in vomit


• blurred vision


• burning feeling in the chest or stomach


• chest pain


• clay-colored stools


• cloudy urine


• confusion


• constipation


• cough or hoarseness


• dark urine


• difficult or labored breathing


• difficult, burning, or painful urination


• difficulty in swallowing


• dilated neck veins


• dizziness


• extreme fatigue


• fainting


• fast, pounding, or irregular heartbeat or pulse


• fever or chills


• frequent urge to urinate


• headache


• increased volume of pale, dilute urine


• irregular breathing


• irregular heartbeat


• large, flat, blue, or purplish patches in the skin


• light-colored stools


• lightheadedness


• nervousness


• noisy breathing


• pain or burning throat


• pinpoint red or purple spots on the skin


• pounding in the ears


• rapid, slow breathing


• redness, swelling, or soreness of tongue


• severe or continuing stomach pain


• shortness of breath


• slow heartbeat


• sore throat


• sores, ulcers, or white spots on the lips or tongue or inside the mouth


• stomach upset


• swelling or inflammation of the mouth


• swollen glands


• tenderness in the stomach area


• tightness in the chest


• tremors


• unpleasant breath odor


• upper right abdominal pain


• weight changes


• wheezing


• yellow eyes and skin

Rare

• Blistering, peeling, or loosening of the skin


• change in consciousness


• chest discomfort


• continuing vomiting


• cracks in the skin


• diarrhea


• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly


• drowsiness


• fever with or without chills


• flushed, dry skin


• fruit-like breath odor


• general body swelling


• general feeling of illness


• high fever


• hives


• increased hunger


• irregular, fast or slow, or shallow breathing


• joint or muscle pain


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• leg pain


• loss of consciousness


• loss of heat from the body


• no blood pressure


• no breathing


• no pulse


• nosebleeds


• painful glands


• pain or discomfort in the arms, jaw, back, or neck


• pains in the stomach, side, or abdomen, possibly radiating to the back


• pale or blue lips, fingernails, or skin


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• racing heartbeat or pulse


• red skin lesions, often with a purple center


• red, irritated eyes


• red, swollen skin


• redness or soreness of the skin


• scaly skin


• seeing, hearing, or feeling things that are not there


• seizures


• severe headache


• sneezing


• sores, welting, or blisters


• stiff neck and/or back


• sweating


• swollen, painful, or tender lymph glands in the neck, armpit, or groin


• unexplained weight loss

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Acid or sour stomach


• belching


• continuing ringing or buzzing or other unexplained noise in the ears


• excess air or gas in the stomach or intestines


• full feeling


• hearing loss


• passing gas


• stomach discomfort

Less common

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• discouragement


• dry mouth


• fear


• feeling of constant movement of self or surroundings


• feeling sad or empty


• hair loss, thinning of the hair


• increased sensitivity of skin to sunlight


• irritability


• lack of appetite


• lack of interest or pleasure


• lack or loss of strength


• redness or other discoloration of the skin


• sensation of spinning


• severe sunburn


• sleepiness


• sleeplessness


• trouble concentrating


• trouble sleeping


• unable to sleep

Rare

• Appetite changes


• burning, dry, or itching eyes


• change in hearing


• discharge, excessive tearing


• redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Ponstel side effects (in more detail)

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More Ponstel resources

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

• Ponstel Prescribing Information (FDA)


• Ponstel MedFacts Consumer Leaflet (Wolters Kluwer)


• Ponstel Concise Consumer Information (Cerner Multum)


• Ponstel Monograph (AHFS DI)


• Mefenamic Acid Prescribing Information (FDA)


• Mefenamic Acid Professional Patient Advice (Wolters Kluwer)

Compare Ponstel with other medications

• Pain
• Period Pain

Emo-Cort Topical application

Generic Name: hydrocortisone butyrate (Topical application route)

hye-droe-KOR-ti-sone BUE-ti-rate

Commonly used brand name(s)

In the U.S.

• Locoid


• Locoid Lipocream

In Canada

• Barriere-Hc


• Cortate


• Cort-Eze


• Cortoderm Mild Ointment


• Cortoderm Regular Ointment


• Emo-Cort


• Emo-Cort Scalp Solution


• Hydrocortisone Cream


• Novo-Hydrocort


• Novo-Hydrocort Cream


• Prevex Hc


• Sarna Hc

Available Dosage Forms:

• Ointment


• Lotion


• Cream


• Solution

Therapeutic Class: Corticosteroid, Intermediate

Pharmacologic Class: Hydrocortisone

Uses For Emo-Cort

Hydrocortisone butyrate topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions (e.g., atopic dermatitis, seborrheic dermatitis). This medicine is a corticosteroid (cortisone-like medicine or steroid).

This medicine is available only with your doctor's prescription.

Before Using Emo-Cort

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of hydrocortisone butyrate topical in children 3 months of age or older. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hydrocortisone butyrate topical in the elderly.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cushing's syndrome (adrenal gland disorder) or


• Diabetes or


• Hyperglycemia (high blood sugar) or


• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Infection of the skin at or near the place of application or


• Large sores, broken skin, or severe skin injury at the place of application—The chance of side effects may be increased.

Proper Use of hydrocortisone butyrate

This section provides information on the proper use of a number of products that contain hydrocortisone butyrate. It may not be specific to Emo-Cort. Please read with care.

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

Do not use the topical cream or lotion on the face, groin, or underarms unless directed to do so by your doctor, and do not use these forms for more than 4 weeks.

To use:

• Wash your hands with soap and water before and after using this medicine.


• Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.


• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.


• If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.


• If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with your doctor.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For atopic dermatitis:
  
  • For topical dosage forms (cream and lotion):
    
    • Children 3 months to 18 years of age—Apply to the affected area of the skin two times per day.
    
    
    • Children younger than 3 months of age—Use and dose must be determined by your doctor.
    
    
  
  

• For redness, itching, and swelling of the skin:
  
  • For topical dosage forms (cream and ointment):
    
    • Adults—Apply to the affected area of the skin two or three times per day.
    
    
    • Children—Apply to the affected area of the skin two or three times per day.
    
    
  
  

• For seborrheic dermatitis:
  
  • For topical dosage form (solution):
    
    • Adults—Apply to the affected area of the skin two or three times per day.
    
    
    • Children—Apply to the affected area of the skin two or three times per day.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Emo-Cort

It is very important that your doctor check the progress of you or your child at regular visits for any unwanted effects that may be caused by this medicine.

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Do not use cosmetics or other skin care products on the treated areas.

Emo-Cort Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Burning sensation of skin


• flushing or redness of skin


• itching skin


• red, scaling, or crusted skin


• scaly rash


• skin irritation


• unusually warm skin

Incidence not known

• Blistering, burning, crusting, dryness, or flaking of the skin


• irritation


• itching, scaling, severe redness, soreness, or swelling of the skin


• redness and scaling around the mouth


• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)


• thinning, weakness, or wasting away of the skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Acne or pimples


• lightening of normal skin color

Incidence not known

• Burning and itching of the skin with pinhead-sized red blisters


• burning, itching, and pain in hairy areas, or pus at the root of the hair


• increased hair growth on the forehead, back, arms, and legs


• reddish purple lines on the arms, face, legs, trunk, or groin


• softening of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Emo-Cort Topical application resources

• Emo-Cort Topical application Use in Pregnancy & Breastfeeding
• Emo-Cort Topical application Drug Interactions
• Emo-Cort Topical application Support Group
• 15 Reviews for Emo-Cort Topical application - Add your own review/rating

Compare Emo-Cort Topical application with other medications

• Anal Itching
• Aphthous Stomatitis, Recurrent
• Atopic Dermatitis
• Dermatitis
• Eczema
• Gingivitis
• Hemorrhoids
• Proctitis
• Pruritus
• Psoriasis
• Seborrheic Dermatitis
• Skin Rash
• Ulcerative Colitis, Active

emtricitabine

Generic Name: emtricitabine (em trye SYE ta been)

Brand Names: Emtriva

What is emtricitabine?

Emtricitabine is an antiviral medication. It is in a category of HIV medicines called reverse transcriptase inhibitors. Emtricitabine works by preventing HIV cells from multiplying in the body.

Emtricitabine is used to treat the human immunodeficiency virus (HIV), which causes the acquired immunodeficiency syndrome (AIDS). Emtricitabine is not a cure for HIV or AIDS.

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

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

Some people have developed a life-threatening condition called lactic acidosis while taking entricitabine. Early signs of lactic acidosis generally get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired. Emtricitabine may also cause severe liver damage, which can be fatal. Call your doctor at once if you have any of these symptoms of liver problems: nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Treatment of HIV/AIDS almost always requires using many medicines together. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

Avoid having unprotected sex or sharing needles, razors, or toothbrushes. Taking this medication will not prevent you from passing HIV to other people. Talk with your doctor about safe methods of preventing HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

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

Do not use this medication if you are allergic to emtricitabine, or if you are also using:

• emtricitabine and tenofovir (Truvada);


• 
  

  efavirenz, emtricitabine, and tenofovir (Atripla); or

  
  


• 
  

  any medication containing lamivudine (Combivir, Epivir, Epivir-HBV, Epzicom, or Trizivir).

  
  

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use emtricitabine:

• kidney disease;


• 
  

  hepatitis B (HBV) infection;

  
  


• tuberculosis;


• 
  

  pneumonia; or

  
  


• 
  

  cytomegalovirus.

  
  

Some people have developed a life-threatening condition called lactic acidosis while taking emtricitabine. You may be more likely to develop lactic acidosis if you are overweight or have liver disease, or if you have taken certain HIV or AIDS medications for a long time. Talk with your doctor about your individual risk. FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Your name may need to be listed on an antiviral pregnancy registry when you start using this medication.

You should not breast-feed while you are using emtricitabine. Women with HIV or AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk.

How should I take emtricitabine?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take emtricitabine with a full glass of water.

Emtricitabine can be taken with or without food. Take the medicine at the same time each day to get the most benefit.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function at regular visits for several months after you stop using emtricitabine. Do not miss any scheduled appointments.

Treatment of HIV/AIDS almost always requires using many medicines together. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled visits to your doctor.

Store emtricitabine capsules at room temperature away from moisture, heat, and direct light. Store emtricitabine liquid in the refrigerator. Do not freeze.

See also: Emtricitabine dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of an emtricitabine overdose are not known.

What should I avoid while taking emtricitabine?

Avoid having unprotected sex or sharing needles, razors, or toothbrushes. Taking this medication will not prevent you from passing HIV to other people. Talk with your doctor about safe methods of preventing HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Emtricitabine side effects

Stop using emtricitabine and 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. Emtricitabine may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as:

• 
  

  muscle pain or weakness;

  
  


• 
  

  numb or cold feeling in your arms and legs;

  
  


• 
  

  trouble breathing;

  
  


• 
  

  feeling dizzy, light-headed, tired, or very weak;

  
  


• 
  

  stomach pain, nausea with vomiting; or

  
  


• 
  

  slow or uneven heart rate.

  
  

Emtricitabine may also cause severe liver damage, which can be fatal. Call your doctor at once if you have any of these symptoms of liver problems:

• 
  

  nausea, stomach pain;

  
  


• 
  

  loss of appetite;

  
  


• 
  

  low fever;

  
  


• 
  

  dark urine;

  
  


• 
  

  clay-colored stools; or

  
  


• 
  

  jaundice (yellowing of the skin or eyes).

  
  

Early in your treatment with emtricitabine, you may have a flare-up of other infections such as tuberculosis, pneumonia, or cytomegalovirus. Contact your doctor if you develop any possible symptoms of other infections, such as fever, chills, sore throat, cough, flu symptoms, or problems with breathing or vision.

Less serious side effects may include:

• 
  

  headache;

  
  


• 
  

  diarrhea, mild nausea or stomach pain;

  
  


• 
  

  darkened patches of skin on your palms and/or soles;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  cough, runny nose;

  
  


• 
  

  skin rash; or

  
  


• 
  

  change in the shape or location of body fat (especially in the arms, legs, face, neck, breasts, and trunk).

  
  

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.

Emtricitabine Dosing Information

Usual Adult Dose for HIV Infection:

Capsules: 200 mg orally once a day
Oral solution: 240 mg (24 mL) orally once a day

Usual Adult Dose for Nonoccupational Exposure:

(Not approved by FDA)

Centers for Disease Control and Prevention recommendations:
Capsules: 200 mg orally once a day plus efavirenz plus (tenofovir or zidovudine), or plus lopinavir-ritonavir plus zidovudine
Duration: 28 days

Prophylaxis should be initiated as soon as possible, within 72 hours of exposure.

Usual Pediatric Dose for HIV Infection:

0 to 3 months:
Oral solution: 3 mg/kg orally once a day

3 months through 17 years:
Oral solution: 6 mg/kg orally once a day
Maximum dose: 240 mg (24 mL)

34 kg or more and able to swallow intact capsules: 200 mg (1 capsule) orally once a day

What other drugs will affect emtricitabine?

There may be other drugs that can affect emtricitabine, making it less effective or making side effects more likely to occur. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More emtricitabine resources

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

• emtricitabine Advanced Consumer (Micromedex) - Includes Dosage Information


• Emtricitabine Professional Patient Advice (Wolters Kluwer)


• Emtricitabine MedFacts Consumer Leaflet (Wolters Kluwer)


• Emtricitabine Monograph (AHFS DI)


• Emtriva Prescribing Information (FDA)


• Emtriva Consumer Overview

Compare emtricitabine with other medications

• HIV Infection
• Nonoccupational Exposure

Where can I get more information?

• Your pharmacist can provide more information about emtricitabine.

See also: emtricitabine side effects (in more detail)

Galpseud Linctus

1. Name Of The Medicinal Product

Galpseud Linctus

2. Qualitative And Quantitative Composition

Active Ingredients:

Pseudoephedrine hydrochloride 30.0mg (Per 5ml dose)

For full list of excipients, see section 6.1

3. Pharmaceutical Form

Oral liquid.

A deep orange coloured liquid.

4. Clinical Particulars

4.1 Therapeutic Indications

Indicated for the relief of nasal, sinus and upper respiratory congestion.

4.2 Posology And Method Of Administration

For oral administration.

Adult:

Two 5ml spoonfuls three times daily.

Children:

Under 2: Not recommended

2-6 years: 2.5ml three or four times daily.

6-12 years: 5ml three or four times daily.

Elderly:

Adult dose is appropriate.

4.3 Contraindications

Galpseud Linctus should not be used in patients hypersensitive to pseudoephedrine, or any of the other ingredients. It is contra-indicated in patients receiving monoamine oxidase inhibitors or who have received these agents in the last two weeks. Galpseud Linctus is contra-indicated in patients with severe renal impairment.

4.4 Special Warnings And Precautions For Use

Caution should be used in prescribing Galpseud Linctus for patients with cardiovascular disease including hypertension, those with diabetes, hyperthyroidism, raised intra-occular pressure, prostatic enlargement, bladder dysfunction or renal impairment.

Amaranth (E123) and Sunset Yellow (E110) may cause allergic reactions.

Sodium hydroxybenzoates (E215, E217 & E219) may cause allergic reactions (possibly delayed).

Galpseud Linctus contains 1.9 vol% ethanol (alcohol), ie. up to 154 mg per dose (10 ml), equivalent to 4 ml of beer or 2 ml of wine. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast feeding women, children and high risk groups such as patients with liver disease, or epilepsy.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Caution should be exercised with patients receiving other sympathomimetic agents, appetite suppressants or amphetamine type agents. Pseudoephedrine may antagonise the pressor effects of antihypertensive agents, severe hypertension may occur in patients receiving beta blockers. Hypertensive crisis may occur if pseudoephedrine is co-administered with MAOIs.

There may be an increased risk of arrhythmias if pseudoephedrine is given to patients receiving cardiac glycosides or tricyclic antidepressants.

The antibacterial agent furazolidone is known to cause progressive inhibition of monoamine oxidase. Although there have been no reports of hypertensive crisis, it may not be administered concurrently with Galpseud Linctus.

4.6 Pregnancy And Lactation

No data are available on the use of Galpseud Linctus in pregnancy. Pseudoephedrine has been used for many years without reports of serious problems.

However, caution is required and pseudoephedrine should be avoided during the first trimester of pregnancy. Pseudoephedrine has been detected in human milk with a small percentage of the total maternal dose potentially administered to the suckling infant. Although the effects on the infant have not been monitored the risk is judged to be low.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Pseudoephedrine may cause insomnia, anxiety, restlessness, tremor, tachycardia, cardiac arrhythmias, palpitations, hypertension, nausea, vomiting and headache in some patients. Skin rashes and urinary retention in men have occasionally been reported. Sleep disturbances and hallucinations have been reported rarely. A fixed drug eruption, in the form of erythematous nodular patches, has been rarely associated with pseudoephedrine. Rare cases of psychosis have occurred following misuse of pseudoephedrine.

4.9 Overdose

The symptoms of overdose include irritability, nervousness, tremor, palpitations, convulsions, urinary retention and hypertension, restlessness, difficulty in micturition, nausea, vomiting, tachycardia and cardiac arrhythmias.

Overdose should be treated by general supportive measures. In the event of gross overdose, the stomach should be emptied using airway protective gastric lavage. Respiratory and circulatory function should be maintained by supportive measures. Convulsions should be controlled using anti-convulsant therapy. Catherterisation of the bladder may be required.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic Group: Nasal Decongestants for Systemic Use, Sympathomimetics. ATC code : R01B A02

Pseudoephedrine has direct and indirect sympathomimetic activity and is an orally effective upper respiratory tract decongestant.

Pseudoephedrine is substantially less potent than ephedrine in producing both tachycardia and elevation in systolic blood pressure and considerably less potent in causing stimulation of the central nervous system.

5.2 Pharmacokinetic Properties

Pseudoephedrine hydrochloride is readily and completely absorbed from the gasto-intestinal tract. It is resistant to metabolism by monoamine oxidase and is largely excreted unchanged in the urine.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber, which are additional to those already included in other sections of the SmPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Citric acid monohydrate

Sodium hydroxybenzoates (E215, E217 & E219)

Alcohol 96%

Amaranth (E123)

Sunset yellow FCF (E110)

Carmellose sodium

Saccharin sodium

Menthol

Condensed milk flavour (F12516)

Orange flavour (17.40.7040)

Glycerol

Purified water

6.2 Incompatibilities

None stated.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Store below 25°C. Protect from light.

6.5 Nature And Contents Of Container

Amber HDPE 2 litre Winchester with a polypropylene cap.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Thornton & Ross Ltd

Linthwaite

Huddersfield

HD7 5QH

United Kingdom

8. Marketing Authorisation Number(S)

PL 00240/0350

9. Date Of First Authorisation/Renewal Of The Authorisation

23^rd July 2008

10. Date Of Revision Of The Text

23^rd July 2008

11 DOSIMETRY (IF APPLICABLE)

Not Applicable

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

Not Applicable

Pradaxa

Generic Name: dabigatran (da BIG a tran)

Brand Names: Pradaxa

What is dabigatran?

Dabigatran keeps the platelets in your blood from coagulating (clotting).

Dabigatran is used to prevent blood clots and to reduce the risk of stroke in people with a certain type of heart rhythm disorder.

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

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

Because dabigatran keeps your blood from coagulating (clotting) to prevent unwanted blood clots, this medicine can also make it easier for you to bleed, even from a minor injury. Avoid activities that may increase your risk of bleeding or injury. Contact your doctor or seek emergency medical attention if you have bleeding that will not stop.

Call your doctor at once if you have any signs of bleeding such as weakness, feeling like you might pass out, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin, pink or brown urine, bloody or tarry stools, coughing up blood, joint pain or swelling, or heavy menstrual bleeding.

If you need surgery, dental work, or any type of medical test or treatment, tell the doctor or dentist ahead of time if you have taken dabigatran within the past 12 hours. You may need to stop taking dabigatran for a short time before you have surgery or other medical procedures.

Do not stop taking the medicine without first talking to your doctor. You should not take dabigatran if you are allergic to it, or if you have any active bleeding from a surgery, injury, or other cause. Tell your doctor if you have recently used or received any other medications to treat or prevent blood clots.

Before taking dabigatran, tell your doctor if you have kidney disease, a history of stomach ulcer or bleeding, if you are older than 75, or if you are using a blood thinner such as heparin or warfarin (Coumadin, Jantoven).

Do not crush, chew, break, or open a dabigatran capsule. Swallow the pill whole.

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

You should not take dabigatran if you are allergic to it, or if you have any active bleeding from a surgery, injury, or other cause.

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

• 
  

  kidney disease;

  
  


• 
  

  a history of stomach ulcer or bleeding; or

  
  


• 
  

  if you are older than 75.

  
  

FDA pregnancy category C. It is not known whether dabigatran 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 dabigatran 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.

How should I take dabigatran?

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.

Because dabigatran keeps your blood from coagulating (clotting) to prevent unwanted blood clots, this medicine can also make it easier for you to bleed, even from a minor injury. Contact your doctor or seek emergency medical attention if you have any bleeding that will not stop.

If you need surgery, dental work, or any type of medical test or treatment, tell the doctor or dentist ahead of time if you have taken dabigatran within the past 12 hours. You may need to stop taking dabigatran for a short time before you have surgery or other medical procedures.

Do not stop taking the medicine without first talking to your doctor. Do not crush, chew, break, or open a dabigatran capsule. Swallow the pill whole.

Your kidney function may need to be checked with blood tests before and during treatment with dabigatran. Visit your doctor regularly.

Keep the capsules in their original container or blister pack. Do not put dabigatran capsules into a daily pill box or pill organizer.

If you have received more than a 30-day supply of this medication, do not open more than one bottle at a time. Open a new bottle only after all the capsules in the old bottle are gone.

Store at room temperature, away from moisture and heat. Keep each capsule in the bottle or blister pack until you are ready to take the medicine. Keep the bottle tightly closed when not in use. Throw away any unused capsules if it has been longer than 4 months since you first opened the bottle. Capsules stored in a blister pack should be thrown away after the expiration date on the label has passed.

What happens if I miss a dose?

If you are less than 6 hours late in taking your medicine, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Try not to miss any doses of dabigatran to best prevent a stroke.

What happens if I overdose?

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

Overdose symptoms may include excessive bleeding or any bleeding that will not stop.

What should I avoid while taking dabigatran?

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth. Avoid drinking alcohol. It may increase your risk of bleeding in your stomach or intestines.

Dabigatran 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. Call your doctor at once if you have a serious side effect such as:

• 
  

  any bleeding that will not stop;

  
  


• 
  

  weakness, feeling like you might pass out;

  
  


• 
  

  easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  
  


• 
  

  blood in your urine or stools, black or tarry stools;

  
  


• 
  

  coughing up blood or vomit that looks like coffee grounds;

  
  


• 
  

  pink or brown urine;

  
  


• 
  

  joint pain or swelling; or

  
  


• 
  

  heavy menstrual bleeding.

  
  

Less serious side effects may include:

• 
  

  stomach pain or upset, indigestion, heartburn;

  
  


• 
  

  nausea, diarrhea; or

  
  


• 
  

  mild skin rash or itching.

  
  

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 dabigatran?

Before you take dabigatran, tell your doctor if you have recently received any other medications to treat or prevent blood clots, such as:

• 
  

  abciximab (ReoPro), anagrelide (Agrylin), cilostazol (Pletal), clopidogrel (Plavix), dipyridamole (Persantine, Aggrenox), eptifibatide (Integrelin), prasugrel (Effient), ticlopidine (Ticlid), tirofiban (Aggrastat);

  
  


• 
  

  heparin or warfarin (Coumadin, Jantoven);

  
  


• 
  

  argatroban (Acova), bivalirudin (Angiomax), lepirudin (Refludan);

  
  


• 
  

  dalteparin (Fragmin), enoxaparin (Lovenox), fondaparinux (Arixtra), tinzaparin (Innohep); or

  
  


• 
  

  alteplase (Activase), tenecteplase (TNKase), urokinase (Abbokinase).

  
  

Tell your doctor about all other medications you use, especially:

• 
  

  rifampin (Rifater, Rifadin, Rifamate);

  
  


• 
  

  quinidine (Guin-G);

  
  


• 
  

  St. John's wort;

  
  


• 
  

  antifungal medicine such as itraconazole (Sporanox) or ketoconazole (Nizoral);

  
  


• 
  

  aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Motrin, Advil), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), ketoprofen (Actron, Orudis), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others; or

  
  


• 
  

  heart or blood pressure medication such as amiodarone (Cordarone, Pacerone), dronedarone (Multaq), or verapamil (Calan, Covera, Isoptin, Verelan).

  
  

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

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

• Pradaxa Prescribing Information (FDA)


• Pradaxa Advanced Consumer (Micromedex) - Includes Dosage Information


• Pradaxa MedFacts Consumer Leaflet (Wolters Kluwer)


• Pradaxa Consumer Overview

Compare Pradaxa with other medications

• Prevention of Thromboembolism in Atrial Fibrillation

Where can I get more information?

• Your pharmacist can provide more information about dabigatran.

See also: Pradaxa side effects (in more detail)

Pentoxil

Generic Name: pentoxifylline (Oral route)

pen-tox-IF-i-lin

Commonly used brand name(s)

In the U.S.

• Pentopak


• Pentoxil


• Trental

Available Dosage Forms:

• Tablet, Extended Release

Therapeutic Class: Hemorheologic

Chemical Class: Methylxanthine

Uses For Pentoxil

Pentoxifylline improves the flow of blood through blood vessels. It is used to reduce leg pain caused by poor blood circulation. Pentoxifylline makes it possible to walk farther before having to rest because of leg cramps.

Pentoxifylline is available only with your doctor's prescription.

Before Using Pentoxil

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of pentoxifylline in children with use in other age groups.

Geriatric

Side effects may be more likely to occur in the elderly, who are usually more sensitive than younger adults to the effects of pentoxifylline.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Aceclofenac


• Acemetacin


• Alclofenac


• Benoxaprofen


• Bromfenac


• Bufexamac


• Carprofen


• Clometacin


• Clonixin


• Dexketoprofen


• Diclofenac


• Diflunisal


• Dipyrone


• Droxicam


• Etodolac


• Etofenamate


• Felbinac


• Fenbufen


• Fenoprofen


• Fentiazac


• Floctafenine


• Flufenamic Acid


• Flurbiprofen


• Ibuprofen


• Indomethacin


• Indoprofen


• Isoxicam


• Ketoprofen


• Ketorolac


• Lornoxicam


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Nabumetone


• Naproxen


• Niflumic Acid


• Nimesulide


• Oxaprozin


• Oxyphenbutazone


• Phenylbutazone


• Pirazolac


• Piroxicam


• Pirprofen


• Propyphenazone


• Proquazone


• Sulindac


• Suprofen


• Tenidap


• Tenoxicam


• Tiaprofenic Acid


• Tolmetin


• Zomepirac

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cimetidine


• Dicumarol


• Theophylline

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Any condition in which there is a risk of bleeding (e.g., recent stroke)—Pentoxifylline may make the condition worse

• Kidney disease or


• Liver disease—The chance of side effects may be increased

Proper Use of pentoxifylline

This section provides information on the proper use of a number of products that contain pentoxifylline. It may not be specific to Pentoxil. Please read with care.

Swallow the tablet whole. Do not crush, break, or chew it before swallowing.

Pentoxifylline should be taken with meals to lessen the chance of stomach upset. Taking an antacid with the medicine may also help.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (extended-release tablets):
  
  • For peripheral vascular disease (circulation problems):
    
    • Adults—400 milligrams (mg) two to three times a day, taken with meals.
    
    
    • Children—Use must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Pentoxil

It may take several weeks for this medicine to work. If you feel that pentoxifylline is not working, do not stop taking it on your own. Instead, check with your doctor.

Smoking tobacco may worsen your condition since nicotine may further narrow your blood vessels. Therefore, it is best to avoid smoking.

Pentoxil Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

• Chest pain


• irregular heartbeat

Signs and symptoms of overdose (in the order in which they may occur)

• Drowsiness


• flushing


• faintness


• unusual excitement


• convulsions (seizures)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Dizziness


• headache


• nausea or vomiting


• stomach discomfort

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Pentoxil side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Pentoxil resources

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

• Pentoxil MedFacts Consumer Leaflet (Wolters Kluwer)


• Pentoxil Concise Consumer Information (Cerner Multum)


• Pentoxil Prescribing Information (FDA)


• Pentoxifylline Prescribing Information (FDA)


• Pentoxifylline Professional Patient Advice (Wolters Kluwer)


• Pentoxifylline Monograph (AHFS DI)


• Trental Prescribing Information (FDA)

Compare Pentoxil with other medications

• Intermittent Claudication

Pulmicort Turbohaler 200

1. Name Of The Medicinal Product

Pulmicort^® Turbohaler^® 200.

2. Qualitative And Quantitative Composition

Budesonide 200 micrograms/actuation.

There are no inactive ingredients.

3. Pharmaceutical Form

Breath-actuated metered dose powder inhaler.

4. Clinical Particulars

4.1 Therapeutic Indications

Pulmicort is recommended in patients with bronchial asthma.

4.2 Posology And Method Of Administration

Pulmicort Turbohaler is for oral inhalation.

When transferring patients to Turbohaler from other devices, treatment should be individualised, whether once or twice daily dosing is being used. The drug and method of delivery should be considered.

Divided doses (twice daily):

The dosage should be individualised.

The dose should always be reduced to the minimum needed to maintain good asthma control.

Adults (including elderly) and children over 12 years of age: When starting treatment, during periods of severe asthma and while reducing or discontinuing oral glucocorticosteroids, the dosage in adults should be 200 - 1600 micrograms daily, in divided doses.

In less severe cases and children over 12 years of age, 200 - 800 micrograms daily, in divided doses, may be used. During periods of severe asthma, the daily dosage can be increased to up to 1600 micrograms, in divided doses.

Children 5 - 12 years of age: 200 - 800 micrograms daily, in divided doses. During periods of severe asthma, the daily dose can be increased up to 800 micrograms.

Once daily dosage:

The dosage should be individualised.

The dose should always be reduced to the minimum needed to maintain good asthma control.

Adults (including elderly) and children over 12 years of age: 200 micrograms to 400 micrograms may be used in patients with mild to moderate asthma who have not previously received inhaled glucocorticosteroids.

Up to 800 micrograms may be used by patients with mild to moderate asthma already controlled on inhaled steroids (e.g. budesonide or beclomethasone dipropionate), administered twice daily.

Children 5 - 12 years of age: 200 micrograms to 400 micrograms may be used in children with mild to moderate asthma who have not previously received inhaled glucocorticosteroids, or who are already controlled on inhaled steroids (e.g. budesonide or beclomethasone dipropionate), administered twice daily.

The patient should be transferred to once daily dosing at the same equivalent total daily dose; the drug and method of delivery should be considered. The dose should subsequently be reduced to the minimum needed to maintain good asthma control.

Patients should be instructed to take the once daily dose in the evening. It is important that the dose is taken consistently and at a similar time each evening.

There are insufficient data to make recommendations for the transfer of patients from newer inhaled steroids to once daily Pulmicort Turbohaler.

Patients, in particular those receiving once daily treatment, should be advised that if their asthma deteriorates (e.g. increased frequency of bronchodilator use or persistent respiratory symptoms) they should double their steroid dose, by administering it twice daily, and should contact their doctor as soon as possible.

In patients where an increased therapeutic effect is desired, an increased dose of Pulmicort is recommended because of the lower risk of systemic effects as compared with a combined treatment with oral glucocorticosteroids.

Patients maintained on oral glucocorticosteroids

Pulmicort Turbohaler may permit replacement or significant reduction in dosage of oral glucocorticosteroids while maintaining asthma control. For further information on the withdrawal of oral corticosteroids, see section 4.4.

Patients should be reminded of the importance of taking prophylactic therapy regularly, even when they are asymptomatic. A short-acting inhaled bronchodilator should be made available for the relief of acute asthma symptoms.

Instructions for the correct use of Pulmicort Turbohaler

Turbohaler is inspiratory flow-driven which means that, when the patient inhales through the mouthpiece, the substance will follow the inspired air into the airways.

Note: It is important to instruct the patient:

• To carefully read the instructions for use in the patient information leaflet, which is packed with each Turbohaler

• To breathe in forcefully and deeply through the mouthpiece to ensure that an optimal dose is delivered to the lungs

• Never to breathe out through the mouthpiece

• To rinse the mouth out with water and spit it out, or to brush the teeth after inhaling the prescribed dose, to minimise the risk of oropharyngeal thrush

The patient may not taste or feel any medication when using Turbohaler due to the small amount of drug dispensed.

4.3 Contraindications

Hypersensitivity to budesonide.

4.4 Special Warnings And Precautions For Use

Special caution is necessary in patients with active or quiescent pulmonary tuberculosis, and in patients with fungal or viral infections in the airways.

Non steroid: A therapeutic effect is usually reached within 10 days. In patients with excessive mucus secretion in the bronchi, a short (about 2 weeks) additional oral corticosteroid regimen can be given initially.

Steroid-dependent patients: When transferral from oral steroids to Pulmicort Turbohaler is started, the patient should be in a relatively stable phase. A high dose of Pulmicort Turbohaler is then given in combination with the previously used oral steroid dose for about 10 days.

After that, the oral steroid dose should be gradually reduced (by for example 2.5 milligrams prednisolone or the equivalent each month) to the lowest possible level. In many cases, it is possible to completely substitute Pulmicort for the oral steroid.

During transfer from oral therapy to Pulmicort, a generally lower systemic steroid action will be experienced which may result in the appearance of allergic or arthritic symptoms such as rhinitis, eczema and muscle and joint pain. Specific treatment should be initiated for these conditions. During the withdrawal of oral steroids, patients may feel unwell in a non-specific way, even though respiratory function is maintained or improved. Patients should be encouraged to continue with Pulmicort therapy whilst withdrawing the oral steroid, unless there are clinical signs to indicate the contrary. . A general insufficient glucocorticosteroid effect should be suspected if, in rare cases, symptoms such as tiredness, headache, nausea and vomiting should occur. In these cases a temporary increase in the dose of oral glucocorticosteroids is sometimes necessary.

As with other inhalation therapy, paradoxical bronchospasm may occur, with an immediate increase in wheezing after dosing. If a severe reaction occurs, treatment should be reassessed and an alternative therapy instituted if necessary.

Patients who have previously been dependent on oral steroids may, as a result of prolonged systemic steroid therapy, experience the effects of impaired adrenal function. Recovery may take a considerable amount of time after cessation of oral steroid therapy, hence oral steroid-dependent patients transferred to budesonide may remain at risk from impaired adrenal function for some considerable time. In such circumstances, HPA axis functions should be monitored regularly.

Acute exacerbations of asthma may need an increase in the dose of Pulmicort or additional treatment with a short course of oral corticosteroid and/or an antibiotic, if there is an infection. The patient should be advised to use a short-acting inhaled bronchodilator as rescue medication to relieve acute asthma symptoms.

If patients find short-acting bronchodilator treatment ineffective or they need more inhalations than usual, medical attention must be sought. In this situation consideration should be given to the need for or an increase in their regular therapy, e.g., higher doses of inhaled budesonide or the addition of a long-acting beta agonist, or for a course of oral glucocorticosteroid.

Prolonged treatment with high doses of inhaled corticosteroids, particularly higher than the recommended doses, may result in clinically significant adrenal suppression. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery. These patients should be instructed to carry a steroid warning card indicating their needs. Treatment with supplementary systemic steroids or Pulmicort should not be stopped abruptly.

Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids. Possible systemic effects include adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma.

It is important, therefore, that the dose of inhaled corticosteroid is titrated to the lowest dose at which effective control of asthma is maintained.

It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of inhaled corticosteroid, if possible, to the lowest dose at which effective control of asthma is maintained. In addition, consideration should be given to referring the patient to a paediatric respiratory specialist.

Reduced liver function may affect the elimination of glucocorticosteroids. The plasma clearance following an intravenous dose of budesonide however was similar in cirrhotic patients and in healthy subjects. After oral ingestion systemic availability of budesonide was increased by compromised liver function due to decreased first pass metabolism. The clinical relevance of this to treatment with Pulmicort is unknown as no data exist for inhaled budesonide, but increases in plasma levels and hence an increased risk of systemic adverse effects could be expected.

In vivo studies have shown that oral administration of ketoconazole and itraconazole (known inhibitors of CYP3A4 activity in the liver and in the intestinal mucosa causes an increase in the systemic exposure to budesonide. Concomitant treatment with ketoconazole and itraconazole or other potent CYP3A4 inhibitors should be avoided (see section 4.5 Interactions). If this is not possible, the time interval between administration of the interacting drugs should be as long as possible. A reduction in the dose of budesonide should also be considered.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The metabolism of budesonide is primarily mediated by CYP3A4, one of the cytochrome p450 enzymes. Inhibitors of this enzyme, e.g. ketoconazole and itraconazole, can therefore increase systemic exposure to budesonide, (see Section 4.4 Special Warnings and Special Precautions for Use and Section 5.2 Pharmacokinetic Properties). Other potent inhibitors of CYP3A4 are also likely to markedly increase plasma levels of budesonide.

4.6 Pregnancy And Lactation

Data on approximately 2000 exposed pregnancies indicate no increased teratogenic risk associated with the use of inhaled budesonide. In animal studies, glucocorticosteroids have been shown to induce malformations (see Section 5.3). This is not likely to be relevant for humans given recommended doses, but therapy with inhaled budesonide should be regularly reviewed and maintained at the lowest effective dose.

The administration of budesonide during pregnancy requires that the benefits for the mother be weighed against the risk for the foetus. Inhaled glucocorticosteroids should be considered in preference to oral glucocorticosteroids because of the lower systemic effects at the doses required to achieve similar pulmonary responses.

Budesonide is excreted in breast milk. However, at therapeutic doses of Pulmicort Turbohaler no effects on the suckling child are anticipated. Pulmicort Turbohaler can be used during breast feeding.

4.7 Effects On Ability To Drive And Use Machines

Pulmicort Turbohaler does not affect the ability to drive or to use machines.

4.8 Undesirable Effects

Clinical trials, literature reports and post-marketing experience suggest that the following adverse drug reactions may occur:

Common (>1/100, <1/10)	• Mild irritation in the throat • Candida infection in the oropharynx • Hoarseness • Coughing
Rare (>1/10 000, <1/1 000)	• Nervousness, restlessness, depression, behavioural disturbances • Immediate and delayed hypersensitivity reactions including rash, contact dermatitis, urticaria, angioedema, bronchospasm and anaphylactic reaction. • Skin bruising

The candida infection in the oropharynx is due to drug deposition. Advising the patient to rinse the mouth out with water after each dosing will minimise the risk.

As with other inhalation therapy, paradoxical bronchospasm may occur in very rare cases (see Section 4.4).

Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids. Possible systemic effects include adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma. The effect is probably dependent on dose, exposure time, concomitant and previous steroid exposure, and individual sensitivity.

4.9 Overdose

The only harmful effect that follows inhalation of large amounts of the drug over a short period is suppression of hypothalamic-pituitary-adrenal (HPA) function. No special emergency action needs to be taken. Treatment with Pulmicort Turbohaler should be continued at the recommended dose to control the asthma.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Budesonide is a glucocorticosteroid which possesses a high local anti-inflammatory action, with a lower incidence and severity of adverse effects than those seen with oral corticosteroids.

Pharmacotherapeutic group: Other drugs for obstructive airway diseases, inhalants, glucocorticoids. ATC Code: RO3B A02.

Topical anti-inflammatory effect

The exact mechanism of action of glucocorticosteroids in the treatment of asthma is not fully understood. Anti-inflammatory actions, such as inhibition of inflammatory mediator release and inhibition of cytokine-mediated immune response are probably important.

A clinical study in asthmatics comparing inhaled and oral budesonide at doses calculated to achieve similar systemic bioavailability demonstrated statistically significant evidence of efficacy with inhaled but not oral budesonide compared with placebo. Thus, the therapeutic effect of conventional doses of inhaled budesonide may be largely explained by its direct action on the respiratory tract.

In a provocation study pre-treatment with budesonide for four weeks has shown decreased bronchial constriction in immediate as well as late asthmatic reactions.

Onset of effect

After a single dose of orally inhaled budesonide, delivered via dry powder inhaler, improvement of the lung function is achieved within a few hours. After therapeutic use of orally inhaled budesonide delivered via dry powder inhaler, improvement in lung function has been shown to occur within 2 days of initiation of treatment, although maximum benefit may not be achieved for up to 4 weeks.

Airway reactivity

Budesonide has also been shown to decrease airway reactivity to histamine and methacholine in hyper-reactive patients.

Exercise-induced asthma

Therapy with inhaled budesonide has effectively been used for prevention of exercise-induced asthma.

Growth

Limited data from long term studies suggest that most children and adolescents treated with inhaled budesonide ultimately achieve their adult target height. However, an initial small but transient reduction in growth (approximately 1 cm) has been observed. This generally occurs within the first year of treatment (see section 4.4).

HPA axis function

Studies in healthy volunteers with Pulmicort Turbohaler have shown dose-related effects on plasma and urinary cortisol. At recommended doses, Pulmicort Turbohaler, causes less effect on the adrenal function than prednisolone 10mg, as shown by ACTH tests.

5.2 Pharmacokinetic Properties

After inhalation via Turbohaler, about 25 - 30% of the metered dose is deposited in the lungs.

Of the fraction which is swallowed, approximately 90% is inactivated by first pass metabolism in the liver.

The maximal plasma concentration after inhalation of 1 milligram budesonide is about 3.5 nmol/L and is reached after about 20 minutes.

Budesonide undergoes an extensive degree (approximately 90%) of biotransformation in the liver, to metabolites of low glucocorticosteroid activity. The glucocorticosteroid activity of the major metabolites, 6β-hydroxybudesonide and 16α-hydroxyprednisolone, is less than 1% of that of budesonide. The metabolism of budesonide is primarily mediated by CYP3A4, one of the cytochrome p450 enzymes.

In a study, 100 mg ketoconazole taken twice daily, increased plasma levels of concomitantly administered oral budesonide (single dose of 10 mg) on average, by 7.8-fold. Information about this interaction is lacking for inhaled budesonide, but marked increases in plasma levels could be expected.

5.3 Preclinical Safety Data

The acute toxicity of budesonide is low and of the same order of magnitude and type as that of the reference glucocorticosteroids studied (beclomethasone dipropionate, fluocinolone acetonide).

Results from subacute and chronic toxicity studies show that the systemic effects of budesonide are less severe than, or similar to, those observed after administration of the other glucocorticosteroids, e.g. decreased body-weight gain and atrophy of lymphoid tissues and adrenal cortex.

An increased incidence of brain gliomas in male rats, in a carcinogenicity study, could not be verified in a repeat study in which the incidence of gliomas did not differ between any of the groups on active treatment (budesonide, prednisolone, triamcinolone acetonide) and the control groups.

Liver changes (primary hepatocellular neoplasms) found in male rats in the original carcinogenicity study were noted again in the repeat study with budesonide, as well as with the reference glucocorticosteroids. These effects are most probably related to a receptor effect and thus represent a class effect.

Available clinical experience shows no indication that budesonide, or other glucocorticosteroids, induce brain gliomas or primary hepatocellular neoplasms in man.

In animal reproduction studies, corticosteroids such as budesonide have been shown to induce malformations (cleft palate, skeletal malformations). However, these animal experimental results do not appear to be relevant in humans at the recommended doses.

Animal studies have also identified an involvement of excess prenatal glucocorticosteroids, in increased risk for intrauterine growth retardation, adult cardiovascular disease and permanent changes in glucocorticoid receptor density, neurotransmitter turnover and behaviour at exposures below the teratogenic dose range.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Pulmicort Turbohaler contains only active drug, budesonide. There are no propellants, lubricants, preservatives, carrier substances or other additives.

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Do not store above 30°C.

6.5 Nature And Contents Of Container

Polyethylene container consisting of a cover screwed onto a bottom plate. Inside this is the inhaler with its main parts: a mouthpiece, a dosing mechanism and a substance store.

The device also contains a desiccant.

200 micrograms/actuation, 100 actuations.

6.6 Special Precautions For Disposal And Other Handling

See section 4.2

7. Marketing Authorisation Holder

AstraZeneca UK Ltd.

600 Capability Green,

Luton, LU1 3LU, UK.

8. Marketing Authorisation Number(S)

PL 17901/0163

9. Date Of First Authorisation/Renewal Of The Authorisation

18^th June 2002

10. Date Of Revision Of The Text

13^th August 2009