H. P. Acthar

Generic Name: corticotropin (Injection route)

kor-ti-koe-TROE-pin ree-POZ-i-tor-ee

Commonly used brand name(s)

In the U.S.

• H.P. Acthar

In Canada

• Acthar

Available Dosage Forms:

• Gel/Jelly

Therapeutic Class: Diagnostic Agent, Adrenocortical Function

Pharmacologic Class: Corticotropin

Uses For H.P. Acthar

Repository corticotropin injection is used to treat infantile spasms (seizures) in babies and children younger than 2 years of age. It is also used to treat multiple sclerosis in adults.

This medicine is also used to treat joint disorders (e.g., psoriatic arthritis, rheumatoid arthritis, ankylosing spondylitis); autoimmune diseases (e.g., systemic lupus erythematosus or SLE, polymyositis); and certain conditions of the skin (e.g., erythema multiforme, Stevens-Johnson syndrome), eyes (e.g., keratitis, optic neuritis), and lungs (e.g., sarcoidosis). It is also used to treat certain allergies (e.g., serum sickness) and swelling (edema) of the body.

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

Before Using H.P. Acthar

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 repository corticotropin injection to treat infantile spasms in babies and children younger than 2 years of age.

Geriatric

No information is available on the relationship of age to the effects of repository corticotropin injection in geriatric patients.

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.

• Rotavirus Vaccine, Live

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.

• Bupropion

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.

• Alatrofloxacin


• Balofloxacin


• Cinoxacin


• Ciprofloxacin


• Clinafloxacin


• Enoxacin


• Fleroxacin


• Flumequine


• Gemifloxacin


• Grepafloxacin


• Itraconazole


• Levofloxacin


• Licorice


• Lomefloxacin


• Moxifloxacin


• Norfloxacin


• Ofloxacin


• Pefloxacin


• Prulifloxacin


• Rosoxacin


• Rufloxacin


• Saiboku-To


• Sparfloxacin


• Temafloxacin


• Tosufloxacin


• Trovafloxacin Mesylate

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:

• Adrenal problems or


• Allergy to pork proteins, history of or


• Congenital (inborn) infections or


• Congestive heart failure or


• Fungus infections, systemic or


• Herpes simplex of the eye or


• Hypertension (high blood pressure), uncontrolled or


• Osteoporosis (thinning of the bones) or


• Peptic ulcer, or history of or


• Scleroderma (autoimmune disease) or


• Surgery, recent—Should not be used in patients with these conditions.

• Cataracts or


• Cirrhosis (liver problem) or


• Cushing's syndrome (adrenal gland disorder) or


• Depression, history of or


• Diabetes or


• Edema (fluid retention or swelling) or


• Emotional problems or


• Eye infections (fungus, virus) or


• Glaucoma or


• Hypertension (high blood pressure), controlled or


• Hypokalemia (low potassium in the blood) or


• Hypothyroidism (underactive thyroid) or


• Kidney disease, severe or


• Mental illness (e.g., psychosis) or


• Myasthenia gravis (severe muscle weakness) or


• Stomach problems (ulcer, bleeding, or perforation) or


• Tuberculosis, latent—Use with caution. May make these conditions worse.

• Infection (bacteria, virus, parasite, or protozoa)—May decrease your body's ability to fight infection.

• Lennox-Gastaut syndrome—May cause this condition to occur while using this medicine to treat infantile spasms.

Proper Use of corticotropin

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

A nurse or other trained health professional will give you or your child this medicine. This medicine is given as a shot under your skin or into one of your muscles.

Repository corticotropin injection may sometimes be given at home to patients who do not need to be in the hospital. If you are using this medicine at home, your or your child's doctor will teach you how to prepare and inject the medicine. Be sure that you understand exactly how the medicine is prepared and injected.

If your child is receiving repository corticotropin injection to treat infantile spasms, this medicine usually comes with a Medication Guide. It is very important that you read and follow the instructions carefully. Be sure to ask your child's doctor about anything you do not understand.

You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections.

To use:

• Take the vial from the refrigerator and let it warm to room temperature before using it. Do not over-pressurize the vial before withdrawing the medicine.


• Wash your hands before and after using this medicine.


• Wipe the injection site with a new sterile alcohol wipe and let it dry before giving an injection.


• Clean the top of the rubber stopper vial with a new sterile alcohol wipe.


• Use a new needle or syringe to get the prescribed amount of medicine to be injected.


• Give the medicine the way your doctor has instructed you.


• Return the vial to the refrigerator after using it.

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 injection dosage form (gel):
  
  • For infantile spasms:
    
    • Children 2 years of age and older—Use and dose must be determined by your doctor.
    
    
    • Infants and children younger than 2 years of age—Dose is based on body size and must be determined by your child's doctor. The dose is 150 units per square meter (U/m2) of body size divided into two equal doses injected into a muscle per day for 2 weeks. Your child's doctor will adjust the dose as needed.
    
    
  
  
  • For multiple sclerosis:
    
    • Adults—The dose is usually 80 to 120 units injected under your skin or into a muscle per day for 2 to 3 weeks. Your doctor will adjust your dose as needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For other indications (joint disorders, autoimmune diseases, allergies, swelling, and certain conditions of the skin, eyes, and lungs):
    
    • Adults—The dose is usually 40 to 80 units injected under your skin or into a muscle every 24 to 72 hours. Your doctor will adjust your dose as needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage

Store in the refrigerator. Do not freeze.

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.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using H.P. Acthar

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for any unwanted effects.

Do not receive live vaccines while you or your child are using this medicine.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may increase your risk of developing infections. Avoid being near people who are sick or have infections while you are using this medicine. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems (e.g., Cushing's syndrome). 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; fractures; increased thirst or urination; irritability; round or "moon" face, neck, or trunk; stomach pain; thin skin or easy bruising; weight gain or loss; or unusual tiredness or weakness.

This medicine may cause fluid retention (edema) in some patients. Carefully follow your doctor's instructions about any special diet (especially on salt intake).

This medicine may mask or hide symptoms of other diseases while you are using it. Check with your doctor if you or your child have symptoms of infection; black, tarry stools; changes in body weight; difficulty with breathing; fast heart rate; increased thirst; stomach pain; unusual tiredness; or vomiting.

Check with your doctor right away if you start having severe abdominal or stomach burning, cramps, or pains; bloody or black, tarry stools; constipation or diarrhea; heartburn; indigestion; nausea; or vomiting of material that looks like coffee grounds. These could be symptoms of a serious stomach or bowel problem.

This medicine may cause changes in mood and behavior. Check with your doctor if you or your child have trouble sleeping, feeling depressed or irritable, mood swings, or other changes in behavior.

Check with your doctor right away if you or your child have any changes to your eyes, such as redness, itching, swelling, or vision changes while you are using this medicine. Your doctor may want you to have your eyes checked by an eye doctor.

This medicine may decrease bone mineral density when used for a long time. A low bone mineral density can cause slow growth and may lead to osteoporosis at any age. If you have any questions about this ask your doctor.

Do not stop using this medicine suddenly without checking first with your doctor. Your doctor may want you or your child to gradually reduce the amount you are using before stopping it completely.

H.P. Acthar 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

• Backache


• blurred vision


• body aches or pain


• chest pain


• cough


• difficulty with breathing


• dizziness


• ear congestion


• earache


• facial hair growth in females


• fever or chills


• fractures


• full or round face, neck, or trunk


• headache


• increased thirst or urination


• irritability


• loss of sexual desire or ability


• loss of voice


• menstrual irregularities


• muscle wasting


• nasal congestion


• nervousness


• pounding in the ears


• redness or swelling in the ear


• runny nose


• shortness of breath


• slow or fast heartbeat


• sneezing


• sore throat


• tightness in the chest


• troubled breathing


• unusual tiredness or weakness


• wheezing


• white patches in the mouth or throat or on the tongue


• white patches with diaper rash

Less common

• Convulsions (seizures)

Incidence not known

• Accumulation of pus


• bruising


• bulging soft spot on the head of an infant


• change in the ability to see colors, especially blue or yellow


• cold, clammy skin


• confusion


• decreased range of motion


• decreased urine output


• dilated neck veins


• extreme fatigue


• eyeballs bulge out of eye sockets


• fast, weak pulse


• full or bloated feeling


• heartburn


• insomnia


• irregular breathing


• irregular heartbeat


• joint pain


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


• lightheadedness


• limp


• loss of appetite


• nausea and vomiting


• pressure in the stomach


• severe headache


• small red or purple spots on the skin


• sweating


• swelling of abdominal or stomach area


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


• swollen, red, or tender area of infection


• trouble healing


• weight gain


• wheezing

Incidence not known-For adults only

• Bloating


• chills


• confusion


• constipation


• coughing up blood


• darkened urine


• fast heartbeat


• fever


• headache


• headache, sudden and severe


• increased sweating


• indigestion


• loss of appetite


• pain in the muscles


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


• redness of the face


• skin rash


• unusual weight loss


• weakness


• yellow eyes or skin

Incidence not known-For infants only

• Decreased carbohydrate tolerance


• hypokalemic alkalosis


• reversible brain shrinkage

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

• Blemishes on the skin


• diarrhea


• pimples

Less common

• Increased or decreased appetite

Incidence not known

• Increased hair growth, especially on the face


• menstrual changes


• muscle weakness

Incidence not known-For adults only

• Feeling of constant movement of self or surroundings


• sensation of spinning


• thinning 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.

See also: H.P. Acthar 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.

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More H.P. Acthar resources

• H.P. Acthar Side Effects (in more detail)
• H.P. Acthar Use in Pregnancy & Breastfeeding
• H.P. Acthar Drug Interactions
• H.P. Acthar Support Group
• 2 Reviews for H.P. Acthar - Add your own review/rating

Compare H.P. Acthar with other medications

• Allergies
• Eye Conditions
• Inflammatory Bowel Disease
• Multiple Sclerosis
• Psoriasis
• Rheumatoid Arthritis
• Systemic Lupus Erythematosus
• Ulcerative Colitis

Cascara Sagrada

Pronunciation: kass-KA-rah sah-GRAH-dah
Generic Name: Cascara Sagrada
Brand Name: Generic only. No brands available.

Cascara Sagrada is used for:

Relieving occasional constipation (irregularity).

Cascara Sagrada is a stimulant laxative. Exactly how Cascara Sagrada works is unknown, but it may work by irritating the bowel tissue and drawing fluid into the intestines, resulting in a bowel movement.

Do NOT use Cascara Sagrada if:

• you are allergic to any ingredient in Cascara Sagrada


• you have appendicitis, rectal bleeding, or a history of stomach or intestinal problems (eg, blockage, inflammation, ulcers, Crohn disease, bleeding, severe constipation)


• you have had recent abdominal surgery

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

Before using Cascara Sagrada:

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

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


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


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


• if you have stomach pain, nausea, vomiting, or heart problems (eg, congestive heart failure)


• if you have frequent diarrhea

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

• Digoxin because actions and side effects may be increased by Cascara Sagrada

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

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

• Take Cascara Sagrada with a full glass (8 ounces/240 mL) of water.


• Take Cascara Sagrada with a meal, if possible.


• Cascara Sagrada may be swallowed whole, opened and prepared as tea, or dissolved in liquid.


• Drinking extra fluids (eight 6 oz/180 mL glasses of water daily) while you are taking Cascara Sagrada is recommended. Check with your doctor for instructions.


• Do not take additional laxatives or stool softeners with Cascara Sagrada unless directed by your doctor.


• If you miss a dose of Cascara Sagrada and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

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

Important safety information:

• A bowel movement usually occurs within 6 to 12 hours after using Cascara Sagrada.


• Contact your doctor if you do not have a bowel movement or if rectal bleeding occurs after using Cascara Sagrada. This could be a sign of a serious condition requiring medical attention.


• Do not use Cascara Sagrada for longer than 1 week unless advised to do so by your doctor.


• Do not exceed the recommended dose or use Cascara Sagrada for longer than prescribed without checking with your doctor. Overuse of laxatives may result in a loss of normal bowel function and dependence on laxatives to have a bowel movement. Severe overuse may damage the intestines or bowel.


• If you have noticed a sudden change in bowel habits that lasts for more than 2 weeks, consult your health care provider before using Cascara Sagrada.


• Do not use Cascara Sagrada if stomach pain, nausea, vomiting, or rectal bleeding are present unless directed to do so by your doctor.


• Cascara Sagrada may color your urine pink, red, violet, yellow, brown, or black.


• Cascara Sagrada is not recommended for use 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 Cascara Sagrada, discuss with your doctor the benefits and risks of using Cascara Sagrada during pregnancy. Cascara Sagrada is excreted in breast milk. Do not breast-feed while taking Cascara Sagrada.

Possible side effects of Cascara Sagrada:

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:

Stomach upset.

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); diarrhea; failure to have a bowel movement; loose stools; rectal bleeding; stomach pain or cramps.

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: Cascara Sagrada 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 diarrhea; stomach cramps.

Proper storage of Cascara Sagrada:

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

General information:

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


• Cascara Sagrada 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 Cascara Sagrada. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Cascara Sagrada resources

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

Compare Cascara Sagrada with other medications

• Constipation

Hydeltrasol

Generic Name: prednisolone (pred NIS oh lone)

Brand Names: Bubbli-Pred, Flo-Pred, Hydeltrasol, Key-Pred SP, Millipred, Orapred, Orapred ODT, Pediapred, Pred-Ject-50, Predacort 50, Predalone 50, Predate-50, Veripred 20

What is Hydeltrasol (prednisolone)?

Prednisolone is in a class of drugs called steroids. Prednisolone prevents the release of substances in the body that cause inflammation.

Prednisolone is used to treat many different conditions such as allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, psoriasis, or breathing disorders.

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

What is the most important information I should know about Hydeltrasol (prednisolone)?

You should not use this medication if you are allergic to prednisolone, or if you have a fungal infection anywhere in your body.

Before taking prednisolone, tell your doctor about all of your medical conditions, and about all other medicines you are using. There are many other diseases that can be affected by steroid use, and many other medicines that can interact with steroids.

Your steroid medication needs may change if you have any unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you during treatment.

Steroid medication can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

Do not receive a "live" vaccine while you are taking prednisolone. Vaccines may not work as well while you are taking a steroid.

Do not stop using prednisolone suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication. Carry an ID card or wear a medical alert bracelet stating that you are taking a steroid, in case of emergency.

What should I discuss with my healthcare provider before taking Hydeltrasol (prednisolone)?

You should not use this medication if you are allergic to prednisolone, or if you have a fungal infection anywhere in your body.

Steroid medication can weaken your immune system, making it easier for you to get an infection. Steroids can also worsen an infection you already have, or reactivate an infection you recently had. Before taking this medication, tell your doctor about any illness or infection you have had within the past several weeks.

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

• 
  

  liver disease (such as cirrhosis);

  
  


• 
  

  kidney disease;

  
  


• 
  

  a thyroid disorder;

  
  


• 
  

  diabetes;

  
  


• 
  

  a history of malaria;

  
  


• 
  

  tuberculosis;

  
  


• 
  

  osteoporosis;

  
  


• 
  

  a muscle disorder such as myasthenia gravis;

  
  


• 
  

  glaucoma or cataracts;

  
  


• 
  

  herpes infection of the eyes;

  
  


• 
  

  stomach ulcers, ulcerative colitis, or diverticulitis;

  
  


• 
  

  depression or mental illness;

  
  


• 
  

  congestive heart failure; or

  
  


• 
  

  high blood pressure

  
  

FDA pregnancy category C. It is not known whether prednisolone is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Prednisolone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Steroids can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

How should I take Hydeltrasol (prednisolone)?

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.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Your steroid medication needs may change if you have unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you.

Measure the liquid form of prednisolone 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.

Keep the disintegrating tablet (Orapred ODT) in its blister pack until you are ready to take the medicine. Open the package using dry hands, and peel back the foil from the tablet blister (do not push the tablet through the foil). Remove the tablet and place it in your mouth.

Allow the disintegrating tablet to dissolve in your mouth without chewing. Swallow several times as the tablet dissolves. If desired, you may drink liquid to help swallow the dissolved tablet.

Steroids can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using prednisolone.

Do not stop using prednisolone suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication. Carry an ID card or wear a medical alert bracelet stating that you are taking a steroid, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking steroid medication. Store prednisolone at room temperature away from moisture and heat.

What happens if I miss a dose?

If you miss a dose or forget to take your medicine, contact your doctor or pharmacist for instructions.

What happens if I overdose?

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

A single large dose of prednisolone is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while taking Hydeltrasol (prednisolone)?

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

Do not receive a "live" vaccine while you are being treated with prednisolone. Vaccines may not work as well while you are taking a steroid.

Avoid drinking alcohol while you are taking prednisolone.

Hydeltrasol (prednisolone) 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 any of these serious side effects:

• 
  

  problems with your vision;

  
  


• 
  

  swelling, rapid weight gain, feeling short of breath;

  
  


• 
  

  severe depression, unusual thoughts or behavior, seizure (convulsions);

  
  


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  bloody or tarry stools, coughing up blood;

  
  


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  pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate);

  
  


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  low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or

  
  


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  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

  
  

Less serious side effects may include:

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  sleep problems (insomnia), mood changes;

  
  


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  acne, dry skin, thinning skin, bruising or discoloration;

  
  


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  slow wound healing;

  
  


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  increased sweating;

  
  


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  headache, dizziness, spinning sensation;

  
  


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  nausea, stomach pain, bloating; or

  
  


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  changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

  
  

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 Hydeltrasol (prednisolone)?

There are many other medicines that can interact with steroids. Below is only a partial list of these medicines:

• 
  

  aspirin (taken on a daily basis or at high doses);

  
  


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  a diuretic (water pill);

  
  


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  a blood thinner such as warfarin (Coumadin);

  
  


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  cyclosporine (Gengraf, Neoral, Sandimmune);

  
  


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  insulin or diabetes medications you take by mouth;

  
  


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  ketoconazole (Nizoral);

  
  


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  rifampin (Rifadin, Rifater, Rifamate, Rimactane); or

  
  


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  seizure medications such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton).

  
  

This list is not complete and there may be other drugs that can interact with prednisolone. 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 Hydeltrasol resources

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

• Bubbli-Pred Advanced Consumer (Micromedex) - Includes Dosage Information


• Flo-Pred Prescribing Information (FDA)


• Flo-Pred Consumer Overview


• Flo-Pred Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Millipred Prescribing Information (FDA)


• Millipred DP MedFacts Consumer Leaflet (Wolters Kluwer)


• Orapred Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Orapred Prescribing Information (FDA)


• Orapred Consumer Overview


• Orapred ODT Prescribing Information (FDA)


• Orapred ODT MedFacts Consumer Leaflet (Wolters Kluwer)


• PediaPred Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Prednisolone tablets Prescribing Information (FDA)


• Prednisolone Monograph (AHFS DI)


• Prednisolone MedFacts Consumer Leaflet (Wolters Kluwer)


• Prednisolone Professional Patient Advice (Wolters Kluwer)


• Prednisolone Acetate eent Monograph (AHFS DI)


• Prelone Syrup MedFacts Consumer Leaflet (Wolters Kluwer)


• Veripred 20 Prescribing Information (FDA)

Compare Hydeltrasol with other medications

• Asthma, acute
• Bronchopulmonary Dysplasia
• Bullous Pemphigoid
• Dermatitis
• Immunosuppression
• Inflammatory Conditions
• Multiple Sclerosis
• Nephrotic Syndrome
• Pemphigoid
• Pemphigus

Where can I get more information?

• Your pharmacist can provide more information about prednisolone.

See also: Hydeltrasol side effects (in more detail)

Rosiglitazone

Dosage Form: tablet, film coated
FULL PRESCRIBING INFORMATION

 WARNING: CONGESTIVE HEART FAILURE AND MYOCARDIAL ISCHEMIA

● Thiazolidinediones, including Rosiglitazone, cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions (5.1)]. After initiation of Rosiglitazone maleate, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of Rosiglitazone maleate must be considered.

● Rosiglitazone Maleate is not recommended in patients with symptomatic heart failure. Initiation of Rosiglitazone maleate in patients with established NYHA Class III or IV heart failure is contraindicated. [See Contraindications (4)  and Warnings and Precautions (5.1 ).]

● A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared Rosiglitazone maleate to placebo, showed Rosiglitazone maleate to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. Three other studies (mean duration 41 months; 14,067 total patients), comparing Rosiglitazone maleate to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive. [See Warnings and Precautions (5.2) .]

Indications and Usage for Rosiglitazone

Monotherapy and Combination Therapy

Rogislitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Important Limitations of Use

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  Due to its mechanism of action, Rosiglitazone maleate is active only in the presence of endogenous insulin. Therefore, Rosiglitazone maleate should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

  
  


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  The coadministration of Rosiglitazone maleate and insulin is not recommended.

  
  


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  The use of Rosiglitazone maleate with nitrates is not recommended.

  
  

Rosiglitazone Dosage and Administration

The management of antidiabetic therapy should be individualized. All patients should start Rosiglitazone maleate tablets at the lowest recommended dose. Further increases in the dose of Rosiglitazone maleate tablets should be accompanied by careful monitoring for adverse events related to fluid retention [see Boxed Warning and Warnings and Precautions (5.1) ].

Rosiglitazone maleate tablets may be administered at a starting dose of 4 mg either as a single daily dose or in 2 divided doses. For patients who respond inadequately following 8 to 12 weeks of treatment, as determined by reduction in fasting plasma glucose (FPG), the dose may be increased to 8 mg daily as monotherapy or in combination with metformin, sulfonylurea, or sulfonylurea plus metformin. Reductions in glycemic parameters by dose and regimen are described under Clinical Studies (14.1) . Rosiglitazone maleate tablets may be taken with or without food.

The total daily dose of Rosiglitazone maleate tablets should not exceed 8 mg.

Monotherapy

The usual starting dose of Rosiglitazone maleate tablets is 4 mg administered either as a single dose once daily or in divided doses twice daily. In clinical trials, the 4-mg twice-daily regimen resulted in the greatest reduction in FPG and hemoglobin A1c (HbA1c).

Combination With Sulfonylurea or Metformin

When Rosiglitazone maleate tablets is added to existing therapy, the current dose(s) of the agent(s) can be continued upon initiation of therapy with Rosiglitazone maleate tablets.

Sulfonylurea

When used in combination with sulfonylurea, the usual starting dose of Rosiglitazone maleate  is 4 mg administered as either a single dose once daily or in divided doses twice daily. If patients report hypoglycemia, the dose of the sulfonylurea should be decreased.

Metformin

The usual starting dose of Rosiglitazone Maleate in combination with metformin is 4 mg administered as either a single dose once daily or in divided doses twice daily. It is unlikely that the dose of metformin will require adjustment due to hypoglycemia during combination therapy with Rosiglitazone Maleate.

Combination With Sulfonylurea Plus Metformin

The usual starting dose of Rosiglitazone maleate tablets in combination with a sulfonylurea plus metformin is 4 mg administered as either a single dose once daily or divided doses twice daily. If patients report hypoglycemia, the dose of the sulfonylurea should be decreased.

Specific Patient Populations

Renal Impairment

No dosage adjustment is necessary when Rosiglitazone maleate is used as monotherapy in patients with renal impairment. Since metformin is contraindicated in such patients, concomitant administration of metformin and Rosiglitazone maleate is also contraindicated in patients with renal impairment.

Hepatic Impairment

Liver enzymes should be measured prior to initiating treatment with Rosiglitazone maleate. Therapy with Rosiglitazone maleateshould not be initiated if the patient exhibits clinical evidence of active liver disease or increased serum transaminase levels (ALT >2.5X upper limit of normal at start of therapy). After initiation of Rosiglitazone maleate, liver enzymes should be monitored periodically per the clinical judgment of the healthcare professional. [See Warnings and Precautions (5.6)  and Clinical Pharmacology (12.3) .]

Pediatric

Data are insufficient to recommend pediatric use of Rosiglitazone maleate [see Use in Specific Populations (8.4 )].

Dosage Forms and Strengths

Oval film-coated tablet contains Rosiglitazone as the maleate as follows::

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  2 mg - Pink oval film coated tablets, engraved with W41.

  
  


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  4 mg - Orange oval film coated tablets, engraved with W42.

  
  


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  8 mg - Brick red oval film coated tablets, engraved with W43.

  
  

Contraindications

Initiation of Rosiglitazone maleate in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated [see Boxed Warning ].

Warnings and Precautions

Cardiac Failure

Rosiglitazone maleate, like other thiazolidinediones, alone or in combination with other antidiabetic agents, can cause fluid retention, which may exacerbate or lead to heart failure. Patients should be observed for signs and symptoms of heart failure. If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of Rosiglitazone must be considered [see Boxed Warning ].

Patients with congestive heart failure (CHF) NYHA Class I and II treated with Rosiglitazone maleate have an increased risk of cardiovascular events. A 52-week, double-blind, placebo-controlled echocardiographic study was conducted in 224 patients with type 2 diabetes mellitus and NYHA Class I or II CHF (ejection fraction ≤45%) on background antidiabetic and CHF therapy. An independent committee conducted a blinded evaluation of fluid-related events (including congestive heart failure) and cardiovascular hospitalizations according to predefined criteria (adjudication). Separate from the adjudication, other cardiovascular adverse events were reported by investigators. Although no treatment difference in change from baseline of ejection fractions was observed, more cardiovascular adverse events were observed following treatment with Rosiglitazone maleate compared to placebo during the 52-week study. (See Table 1.)

Table 1. Emergent Cardiovascular Adverse Events in Patients With Congestive Heart Failure (NYHA Class I and II) Treated With Rosiglitazone Maleate Tablets or Placebo (in Addition to Background Antidiabetic and CHF Therapy)

Events	Rosiglitazone maleate tablets	Placebo
	N = 110 n (%)	N = 114 n (%)
Adjudicated
Cardiovascular deaths	5 (5%)	4 (4%)
CHF worsening	7 (6%)	4 (4%)
– with overnight hospitalization	5 (5%)	4 (4%)
– without overnight hospitalization	2 (2%)	0 (0%)
New or worsening edema	28 (25%)	10 (9%)
New or worsening dyspnea	29 (26%)	19 (17%)
Increases in CHF medication	36 (33%)	20 (18%)
Cardiovascular hospitalization*	21 (19%)	15 (13%)
Investigator-reported, non-adjudicated
Ischemic adverse events	10 (9%)	5 (4%)
– Myocardial infarction	5 (5%)	2 (2%)
– Angina	6 (5%)	3 (3%)
* Includes hospitalization for any cardiovascular reason.

Initiation of Rosiglitazone maleate in patients with established NYHA Class III or IV heart failure is contraindicated. Rosiglitazone maleate is not recommended in patients with symptomatic heart failure. [See Boxed Warning .]

Patients experiencing acute coronary syndromes have not been studied in controlled clinical trials. In view of the potential for development of heart failure in patients having an acute coronary event, initiation of Rosiglitazone maleate is not recommended for patients experiencing an acute coronary event, and discontinuation of Rosiglitazone maleate during this acute phase should be considered.

Patients with NYHA Class III and IV cardiac status (with or without CHF) have not been studied in controlled clinical trials. Rosiglitazone maleate is not recommended in patients with NYHA Class III and IV cardiac status.

Myocardial Ischemia

Meta-Analysis of Myocardial Ischemia in a Group of 42 Clinical Trials

A meta-analysis was conducted retrospectively to assess cardiovascular adverse events reported across 42 double-blind, randomized, controlled clinical trials (mean duration 6 months).1 These studies had been conducted to assess glucose-lowering efficacy in type 2 diabetes, and prospectively planned adjudication of cardiovascular events had not occurred in the trials. Some trials were placebo-controlled and some used active oral antidiabetic drugs as controls. Placebo-controlled studies included monotherapy trials (Monotherapy with Rosiglitazone maleate  versus placebo monotherapy) and add-on trials (Rosiglitazone maleate or placebo, added to sulfonylurea, metformin, or insulin). Active control studies included monotherapy trials (monotherapy with Rosiglitazone maleate versus sulfonylurea or metformin monotherapy) and add-on trials (Rosiglitazone maleate plus sulfonylurea or Rosiglitazone maleate plus metformin, versus sulfonylurea plus metformin). A total of 14,237 patients were included (8,604 in treatment groups containing Rosiglitazone maleate, 5,633 in comparator groups), with 4,143 patient-years of exposure to Rosiglitazone maleate and 2,675 patient-years of exposure to comparator. Myocardial ischemic events included angina pectoris, angina pectoris aggravated, unstable angina, cardiac arrest, chest pain, coronary artery occlusion, dyspnea, myocardial infarction, coronary thrombosis, myocardial ischemia, coronary artery disease, and coronary artery disorder. In this analysis, an increased risk of myocardial ischemia with Rosiglitazone maleate versus pooled comparators was observed (2% Rosiglitazone maleate versus 1.5% comparators, odds ratio 1.4, 95% confidence interval [CI] 1.1, 1.8). An increased risk of myocardial ischemic events with Rosiglitazone maleate was observed in the placebo-controlled studies, but not in the active-controlled studies. (See Figure 1.)

A greater increased risk of myocardial ischemic events was observed in studies where Rosiglitazone maleate was added to insulin (2.8% for Rosiglitazone maleate plus insulin versus 1.4% for placebo plus insulin, [OR 2.1, 95% CI 0.9, 5.1]). This increased risk reflects a difference of 3 events per 100 patient-years (95% CI -0.1, 6.3) between treatment groups. [See Warnings and Precautions (5.3) .]

Figure 1 - Forest Plot of Odds Rations (95% Confidence Intervals) for Myocardial Ischemic Events in the Meta-Analysis of 42 Clinical Trials

A greater increased risk of myocardial ischemia was also observed in patients who received Rosiglitazone maleate and background nitrate therapy. For Rosiglitazone maleate (N = 361) versus control (N = 244) in nitrate users, the odds ratio was 2.9 (95% CI 1.4, 5.9), while for non-nitrate users (about 14,000 patients total), the odds ratio was 1.3 (95% CI 0.9, 1.7). This increased risk represents a difference of 12 myocardial ischemic events per 100 patient-years (95% CI 3.3, 21.4). Most of the nitrate users had established coronary heart disease. Among patients with known coronary heart disease who were not on nitrate therapy, an increased risk of myocardial ischemic events for Rosiglitazone maleate versus comparator was not demonstrated.

Myocardial Ischemic Events in Large Long-Term Prospectice Randomized Controlled Trials of Rosiglitazone maleate

Data from 3 other large, long-term, prospective, randomized, controlled clinical trials of Rosiglitazone maleate were assessed separately from the meta-analysis. These 3 trials include a total of 14,067 patients (treatment groups containing Rosiglitazone maleate N = 6,311, comparator groups N = 7,756), with patient-year exposure of 21,803 patient-years for Rosiglitazone maleate and 25,998 patient-years for comparator. Duration of follow-up exceeded 3 years in each study. ADOPT (A Diabetes Outcomes Progression Trial) was a 4- to 6-year randomized, active-controlled study in recently diagnosed patients with type 2 diabetes naïve to drug therapy. It was an efficacy and general safety trial that was designed to examine the durability of Rosiglitazone maleate as monotherapy (N = 1,456) for glycemic control in type 2 diabetes, with comparator arms of sulfonylurea monotherapy (N = 1,441) and metformin monotherapy (N = 1,454). DREAM (Diabetes Reduction Assessment with Rosiglitazone and Ramipril Medication, published report2) was a 3- to 5-year randomized, placebo-controlled study in patients with impaired glucose tolerance and/or impaired fasting glucose. It had a 2x2 factorial design, intended to evaluate the effect of Rosiglitazone maleate, and separately of ramipril (an angiotensin converting enzyme inhibitor [ACEI]), on progression to overt diabetes. In DREAM, 2,635 patients were in treatment groups containing rosligtazone maleate, and 2,634 were in treatment groups not containing Rosiglitazone maleate. Interim results have been published 3 for RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes), an ongoing open-label, 6-year cardiovascular outcomes study in patients with type 2 diabetes with an average treatment duration of 3.75 years. RECORD includes patients who have failed metformin or sulfonylurea monotherapy; those who have failed metformin are randomized to receive either add-on Rosiglitazone maleate or add-on sulfonylurea, and those who have failed sulfonylurea are randomized to receive either add-on Rosiglitazone maleate or add-on metformin. In RECORD, a total of 2,220 patients are receiving add-on Rosiglitazone maleate, and 2,227 patients are on one of the add-on regimens not containing Rosiglitazone maleate.

For these 3 trials, analyses were performed using a composite of major adverse cardiovascular events (myocardial infarction, cardiovascular death, or stroke), referred to hereafter as MACE. This endpoint differed from the meta-analysis’ broad endpoint of myocardial ischemic events, more than half of which were angina. Myocardial infarction included adjudicated fatal and nonfatal myocardial infarction plus sudden death. As shown in Figure 2, the results for the 3 endpoints (MACE, MI, and Total Mortality) were not statistically significantly different between Rosiglitazone maleate and comparators.

Figure 2. Hazard Ratios for the Risk of MACE (Myocardial Infarction, Cardiovascular Death, or Stroke), Myocardial Infarction, and Total Mortality With Rosiglitazone Maleate Compared With a Control Group

In preliminary analyses of the DREAM trial, the incidence of cardiovascular events was higher among subjects who received Rosiglitazone maleate in combination with ramipril than among subjects who received ramipril alone, as illustrated in Figure 2. This finding was not confirmed in ADOPT and RECORD (active-controlled trials in patients with diabetes) in which 30% and 40% of patients respectively, reported ACE-inhibitor use at baseline.

In their entirety, the available data on the risk of myocardial ischemia are inconclusive. Definitive conclusions regarding this risk await completion of an adequately-designed cardiovascular outcome study.

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with AVANDIA or any other oral antidiabetic drug.

Congestive Heart Failure and Myocardial Ischemia During Coadministration of AVANDIA With Insulin

In studies in which Rosiglitazone maleate was added to insulin, Rosiglitazone maleate increased the risk of congestive heart failure and myocardial ischemia. (See Table 2.) Coadministration of Rosiglitazone maleate and insulin is not recommended. [See Indications and Usage (1.2)  and Warnings and Precautions (5.1, 5.2) .]

In five, 26-week, controlled, randomized, double-blind trials which were included in the meta-analysis [see Warnings and Precautions (5.2)  ], patients with type 2 diabetes mellitus were randomized to coadministration of AVANDIA and insulin (N = 867) or insulin (N = 663). In these 5 trials, Rosiglitazone maleate was added to insulin. These trials included patients with long-standing diabetes (median duration of 12 years) and a high prevalence of pre-existing medical conditions, including peripheral neuropathy, retinopathy, ischemic heart disease, vascular disease, and congestive heart failure. The total number of patients with emergent congestive heart failure was 21 (2.4%) and 7 (1.1%) in the Rosiglitazone maleate plus insulin and insulin groups, respectively. The total number of patients with emergent myocardial ischemia was 24 (2.8%) and 9 (1.4%) in the Rosiglitazone maleate plus insulin and insulin groups, respectively (OR 2.1 [95% CI 0.9, 5.1]). Although the event rate for congestive heart failure and myocardial ischemia was low in the studied population, consistently the event rate was 2-fold or higher with coadministration of Rosiglitazone maleate and insulin. These cardiovascular events were noted at both the 4 mg and 8 mg daily doses of Rosiglitazone maleate. (See Table 2.)

Table 2. Occurrence of Cardiovascular Events in 5 Controlled Trials of Addition of Rosiglitazone Maleate to Established Insulin Treatment

Event*	Rosiglitazone Maleate + Insulin (n = 867) n (%)	Insulin (n = 663) n (%)
Congestive heart failure	21 (2.4%)	7 (1.1%)
Myocardial ischemia	24 (2.8%)	9 (1.4%)
Composite of cardiovascular death, myocardial infarction, or stroke	10 (1.2%)	5 (0.8%)
Stroke	5 (0.6%)	4 (0.6%)
Myocardial infarction	4 (0.5%)	1 (0.2%)
Cardiovascular death	4 (0.5%)	1 (0.2%)
All deaths	6 (0.7%)	1 (0.2%)
*Events are not exclusive; i.e., a patient with a cardiovascular death due to a myocardial infarction would be counted in 4 event categories (myocardial ischemia; cardiovascular death, myocardial infarction or stroke; myocardial infarction; cardiovascular death).

In a sixth, 24-week, controlled, randomized, double-blind trial of rosiglitaszone maleate and insulin coadministration, insulin was added to AVANDAMET® (Rosiglitazone maleate and metformin HCl) (n = 161) and compared to insulin plus placebo (n = 158), after a single-blind 8-week run-in with AVANDAMET. Patients with edema requiring pharmacologic therapy and those with congestive heart failure were excluded at baseline and during the run-in period. In the group receiving AVANDAMET plus insulin, there was one myocardial ischemic event and one sudden death. No myocardial ischemia was observed in the insulin group, and no congestive heart failure was reported in either treatment group.

Edema

Rosiglitazone maleate should be used with caution in patients with edema. In a clinical study in healthy volunteers who received 8 mg of Rosiglitazone maleate once daily for 8 weeks, there was a statistically significant increase in median plasma volume compared to placebo.

Since thiazolidinediones, including Rosiglitazone, can cause fluid retention, which can exacerbate or lead to congestive heart failure, Rosiglitazone maleate should be used with caution in patients at risk for heart failure. Patients should be monitored for signs and symptoms of heart failure [see Boxed Warning , Warnings and Precautions (5.1 ), and Patient Counseling Information (17.1) ].

In controlled clinical trials of patients with type 2 diabetes, mild to moderate edema was reported in patients treated with Rosiglitazone maleate, and may be dose related. Patients with ongoing edema were more likely to have adverse events associated with edema if started on combination therapy with insulin and Rosiglitazone maleate [see Adverse Reactions (6.1)] .

Weight Gain

Dose-related weight gain was seen with Rosiglitazone maleate alone and in combination with other hypoglycemic agents (Table 3). The mechanism of weight gain is unclear but probably involves a combination of fluid retention and fat accumulation.

In postmarketing experience, there have been reports of unusually rapid increases in weight and increases in excess of that generally observed in clinical trials. Patients who experience such increases should be assessed for fluid accumulation and volume-related events such as excessive edema and congestive heart failure [see Boxed Warning ].

Table 3. Weight Changes (kg) From Baseline at Endpoint During Clinical Trials

		Control Group		Rosiglitazone maleate 4 mg	Rosiglitazone maleate 8 mg
Monotherapy	Duration		Median (25th, 75th percentile)	Median (25th, 75th percentile)	Median (25th, 75th percentile)
	26 weeks	placebo	-0.9 (-2.8, 0.9) n = 210	1.0 (-0.9, 3.6) n = 436	3.1 (1.1, 5.8) n = 439
	52 weeks	sulfonylurea	2.0 (0, 4.0) n = 173	2.0 (-0.6, 4.0) n = 150	2.6 (0, 5.3) n = 157
Combination therapy
Sulfonylurea	24-26 weeks	sulfonylurea	0 (-1.0, 1.3) n = 1,155	2.2 (0.5, 4.0) n = 613	3.5 (1.4, 5.9) n = 841
Metformin	26 weeks	metformin	-1.4 (-3.2, 0.2) n = 175	0.8 (-1.0, 2.6) n = 100	2.1 (0, 4.3) n = 184
Insulin	26 weeks	insulin	0.9 (-0.5, 2.7) n = 162	4.1 (1.4, 6.3) n = 164	5.4 (3.4, 7.3) n = 150
Sulfonylurea + metformin	26 weeks	sulfonylurea + metformin	0.2 (-1.2, 1.6) n = 272	2.5 (0.8, 4.6) n = 275	4.5 (2.4, 7.3) n = 276

In a 4- to 6-year, monotherapy, comparative trial (ADOPT) in patients recently diagnosed with type 2 diabetes not previously treated with antidiabetic medication [see Clinical Studies (14.1) ], the median weight change (25th, 75th percentiles) from baseline at 4 years was 3.5 kg (0.0, 8.1) for Rosiglitazone maleate, 2.0 kg (-1.0, 4.8) for glyburide, and -2.4 kg (-5.4, 0.5) for metformin.

In a 24-week study in pediatric patients aged 10 to 17 years treated with Rosiglitazone maleate 4 to 8 mg daily, a median weight gain of 2.8 kg (25th, 75th percentiles: 0.0, 5.8) was reported.

Hepatic Effects

Liver enzymes should be measured prior to the initiation of therapy with Rosiglitazone maleate in all patients and periodically thereafter per the clinical judgment of the healthcare professional. Therapy with Rosiglitazone maleate should not be initiated in patients with increased baseline liver enzyme levels (ALT >2.5X upper limit of normal). Patients with mildly elevated liver enzymes (ALT levels ≤−2.5X upper limit of normal) at baseline or during therapy with Rosiglitazone maleate should be evaluated to determine the cause of the liver enzyme elevation. Initiation of, or continuation of, therapy with Rosiglitazone maleate in patients with mild liver enzyme elevations should proceed with caution and include close clinical follow-up, including liver enzyme monitoring, to determine if the liver enzyme elevations resolve or worsen. If at any time ALT levels increase to >3X the upper limit of normal in patients on therapy with Rosiglitazone maleate, liver enzyme levels should be rechecked as soon as possible. If ALT levels remain >3X the upper limit of normal, therapy with Rosiglitazone maleate should be discontinued.

If any patient develops symptoms suggesting hepatic dysfunction, which may include unexplained nausea, vomiting, abdominal pain, fatigue, anorexia and/or dark urine, liver enzymes should be checked. The decision whether to continue the patient on therapy with Rosiglitazone maleate should be guided by clinical judgment pending laboratory evaluations. If jaundice is observed, drug therapy should be discontinued. [See Adverse Reactions (6.2, 6.3).] 

Macular Edema

Macular edema has been reported in postmarketing experience in some diabetic patients who were taking Rosiglitazone maleate or another thiazolidinedione. Some patients presented with blurred vision or decreased visual acuity, but some patients appear to have been diagnosed on routine ophthalmologic examination. Most patients had peripheral edema at the time macular edema was diagnosed. Some patients had improvement in their macular edema after discontinuation of their thiazolidinedione. Patients with diabetes should have regular eye exams by an ophthalmologist, per the Standards of Care of the American Diabetes Association. Additionally, any diabetic who reports any kind of visual symptom should be promptly referred to an ophthalmologist, regardless of the patient’s underlying medications or other physical findings. [See Adverse Reactions (6.1) .]

Fractures

In a 4- to 6-year comparative study (ADOPT) of glycemic control with monotherapy in drug-naïve patients recently diagnosed with type 2 diabetes mellitus, an increased incidence of bone fracture was noted in female patients taking Rosiglitazone maleate. Over the 4- to 6-year period, the incidence of bone fracture in females was 9.3% (60/645) for Rosiglitazone maleate versus 3.5% (21/605) for glyburide and 5.1% (30/590) for metformin. This increased incidence was noted after the first year of treatment and persisted during the course of the study. The majority of the fractures in the women who received Rosiglitazone maleate occurred in the upper arm, hand, and foot. These sites of fracture are different from those usually associated with postmenopausal osteoporosis (e.g., hip or spine). No increase in fracture rates was observed in men treated with Rosiglitazone maleate. The risk of fracture should be considered in the care of patients, especially female patients, treated with Rosiglitazone maleate, and attention given to assessing and maintaining bone health according to current standards of care.

Hematologic Effects

Decreases in mean hemoglobin and hematocrit occurred in a dose-related fashion in adult patients treated with Rosiglitazone maleate[see Adverse Reactions (6.2)].  The observed changes may be related to the increased plasma volume observed with treatment with Rosiglitazonemaleate.

Diabetes and Blood Glucose Control

Patients receiving Rosiglitazone maleate in combination with other hypoglycemic agents may be at risk for hypoglycemia, and a reduction in the dose of the concomitant agent may be necessary.

Periodic fasting blood glucose and HbA1c measurements should be performed to monitor therapeutic response.

Ovulation

Therapy with Rosiglitazone maleate, like other thiazolidinediones, may result in ovulation in some premenopausal anovulatory women. As a result, these patients may be at an increased risk for pregnancy while taking Rosiglitazone maleate [see Use in Specific Populations (8.1 )]. Thus, adequate contraception in premenopausal women should be recommended. This possible effect has not been specifically investigated in clinical studies; therefore, the frequency of this occurrence is not known.

Although hormonal imbalance has been seen in preclinical studies [see Nonclinical Toxicology (13.1 )], the clinical significance of this finding is not known. If unexpected menstrual dysfunction occurs, the benefits of continued therapy with Rosiglitazone maleate should be reviewed.

Adverse Reactions

Clinical Trial Experience

Adult

In clinical trials, approximately 9,900 patients with type 2 diabetes have been treated with Rosiglitazone maleate.

Short-Term Trials of Rosiglitazone Maleate as Monotherapy and in Combination With Other Hypoglycemic Agents

The incidence and types of adverse events reported in short-term clinical trials of Rosiglitazone maleate as monotherapy are shown in Table 4.

Table 4. Adverse Events (≥5% in Any Treatment Group) Reported by Patients in Short-Term* Double-Blind Clinical Trials With Rosiglitazone Maleate as Monotherapy

Preferred Term	Rosiglitazone maleate  Monotherapy	Placebo	Metformin	Sulfonylureas†
	N = 2,526	N = 601	N = 225	N = 626
	%	%	%	%
Upper respiratory tract infection	9.9	8.7	8.9	7.3
Injury	7.6	4.3	7.6	6.1
Headache	5.9	5.0	8.9	5.4
Back pain	4.0	3.8	4.0	5.0
Hyperglycemia	3.9	5.7	4.4	8.1
Fatigue	3.6	5.0	4.0	1.9
Sinusitis	3.2	4.5	5.3	3.0
Diarrhea	2.3	3.3	15.6	3.0
Hypoglycemia	0.6	0.2	1.3	5.9
* Short-term trials ranged from 8 weeks to 1 year.
† Includes patients receiving glyburide (N = 514), gliclazide (N = 91), or glipizide (N = 21).

Overall, the types of adverse reactions without regard to causality reported when Rosiglitazone maleate was used in combination with a sulfonylurea or metformin were similar to those during monotherapy with Rosiglitazone maleate.

Events of anemia and edema tended to be reported more frequently at higher doses, and were generally mild to moderate in severity and usually did not require discontinuation of treatment with Rosiglitazone maleate.

In double-blind studies, anemia was reported in 1.9% of patients receiving Rosiglitazone maleate as monotherapy compared to 0.7% on placebo, 0.6% on sulfonylureas, and 2.2% on metformin. Reports of anemia were greater in patients treated with a combination of AVANDIA and metformin (7.1%) and with a combination of AVANDIA and a sulfonylurea plus metformin (6.7%) compared to monotherapy with ARosiglitazone maleate or in combination with a sulfonylurea (2.3%). Lower pre-treatment hemoglobin/hematocrit levels in patients enrolled in the metformin combination clinical trials may have contributed to the higher reporting rate of anemia in these studies [see Adverse Reactions (6.2)]. 

In clinical trials, edema was reported in 4.8% of patients receiving Rosiglitazone maleate as monotherapy compared to 1.3% on placebo, 1.0% on sulfonylureas, and 2.2% on metformin. The reporting rate of edema was higher for Rosiglitazone maleate 8 mg in sulfonylurea combinations (12.4%) compared to other combinations, with the exception of insulin. Edema was reported in 14.7% of patients receiving Rosiglitazone maleate in the insulin combination trials compared to 5.4% on insulin alone. Reports of new onset or exacerbation of congestive heart failure occurred at rates of 1% for insulin alone, and 2% (4 mg) and 3% (8 mg) for insulin in combination with Rosiglitazone maleate [see Boxed Warning  and Warnings and Precautions (5.3 )].

In controlled combination therapy studies with sulfonylureas, mild to moderate hypoglycemic symptoms, which appear to be dose related, were reported. Few patients were withdrawn for hypoglycemia (<1%) and few episodes of hypoglycemia were considered to be severe (<1%). Hypoglycemia was the most frequently reported adverse event in the fixed-dose insulin combination trials, although few patients withdrew for hypoglycemia (4 of 408 for Rosiglitazone maleate plus insulin and 1 of 203 for insulin alone). Rates of hypoglycemia, confirmed by capillary blood glucose concentration ≤50 mg/dL, were 6% for insulin alone and 12% (4 mg) and 14% (8 mg) for insulin in combination with Rosiglitazone maleate. [See Warnings and Precautions (5.10) .]

Long-Term Trial of Rosiglitazone Maleate as Monotherapy

A 4- to 6-year study (ADOPT) compared the use of Rosiglitazone maleate (n = 1,456), glyburide (n = 1,441), and metformin (n = 1,454) as monotherapy in patients recently diagnosed with type 2 diabetes who were not previously treated with antidiabetic medication. Table 5 presents adverse reactions without regard to causality; rates are expressed per 100 patient-years (PY) exposure to account for the differences in exposure to study medication across the 3 treatment groups.

In ADOPT, fractures were reported in a greater number of women treated with Rosiglitazone maleate (9.3%, 2.7/100 patient-years) compared to glyburide (3.5%, 1.3/100 patient-years) or metformin (5.1%, 1.5/100 patient-years). The majority of the fractures in the women who received Rosiglitazone were reported in the upper arm, hand, and foot. [See Warnings and Precautions (5.7 ).] The observed incidence of fractures for male patients was similar among the 3 treatment groups.

Table 5. On-Therapy Adverse Events (≥5 Events/100 Patient-Years [PY]) in Any Treatment Group Reported in a 4- to 6-Year Clinical Trial of Rosiglitazone Maleate as Monotherapy (ADOPT)

	Rosiglitazone Maleate	Glyburide	Metformin
	N = 1,456	N = 1,441	N = 1,454
	PY = 4,954	PY = 4,244	PY = 4,906
Nasopharyngitis	6.3	6.9	6.6
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Ranitidine 75 Drug Facts

Dosage Form: tablet
Major Pharmaceuticals Ranitidine 75 Tablets Drug Facts

Active ingredient (in each tablet)

Ranitidine 75 mg (as ranitidine hydrochloride 84 mg)

Purpose

Acid reducer

Uses

• relieves heartburn associated with acid indigestion and sour stomach


• prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages

Warnings

Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers

Do not use

• if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.


• with other acid reducers

Ask a doctor before use if you have

• frequent chest pain


• frequent wheezing, particularly with heartburn


• unexplained weight loss


• nausea or vomiting


• stomach pain


• had heartburn over 3 months. This may be a sign of a more serious condition


• heartburn with lightheadedness, sweating or dizziness


• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness

Stop use and ask a doctor if

• your heartburn continues or worsens


• you need to take this product for more than 14 days

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 12 years and over:


• to relieve symptoms, swallow 1 tablet with a glass of water


• to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn


• can be used up to twice daily (do not take more than 2 tablets in 24 hours)


• children under 12 years: ask a doctor

Other information

• do not use if printed foil under cap is broken or missing


• store at 20° - 25°C (68° - 77°F)


• avoid excessive heat or humidity


• this product is sugar free

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, diethyl phthalate, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, titanium dioxide.

Questions or comments?

1-800-719-9260

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Ranitidine 75

Ranitidine Tablets, 75 mg

Acid Reducer

One Tablet Relieves and Prevents:

Heartburn Associated with Acid Indigestion and Sour Stomach

Compare to the active ingredient of Zantac 75®

# Doses {Replace "#" with number tablets in package}

Ranitidine 75 Tablets Carton

RANITIDINE 75  ranitidine  tablet

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0904-5818 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE 75 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color PINK Score no score Shape HEXAGON (6 sided) Size 8mm Flavor Imprint Code W75 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0904-5818-46 1 BOTTLE In 1 CARTON contains a BOTTLE 1 30 TABLET In 1 BOTTLE This package is contained within the CARTON (0904-5818-46) 2 0904-5818-52 1 BOTTLE In 1 CARTON contains a BOTTLE 2 60 TABLET In 1 BOTTLE This package is contained within the CARTON (0904-5818-52)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076760	05/26/2009

Labeler - Major Pharmaceuticals (191427277)

Revised: 07/2009Major Pharmaceuticals

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