Drug Info

Trospium Chloride (marketed as Sanctura)

Sanctura®
Brand Name:	Sanctura ®
Active Ingredient:	Trospium Chloride
Strength(s):	20 mg
Dosage Form(s):	Tablet
Company Name:	Indevus Pharmaceuticals
Availability:	Prescription only
*Date Approved by FDA:	May 28, 2004
*Approval by FDA does not mean that the drug is available for consumers at this time.

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What is Sanctura used for?

Sanctura is used for the treatment of overactive bladder that causes the following symptoms:

• sudden need to urinate right away (urgency)

• unwanted urine leakage after urgency (urge urinary incontinence)

• having to urinate often (urinary frequency)

Who should not take Sanctura?

Do not take Sanctura if you:

• have urinary retention (problems urinating often due to a bladder blockage)

• have gastric retention (problems emptying stomach contents)

• have an eye problem called uncontrolled narrow-angle glaucoma

• are allergic to Sanctura or to any of the ingredients in Sanctura.

Sanctura has not been studied in children.

General Precautions with Sanctura:

Sanctura may cause serious side effects because it belongs to a class of medicines called "anticholinergics". Sanctura may cause:

• dizziness, blurred vision, and fast heart beat

• fever and heat stroke due to decreased sweating (heat prostration) when used in a hot environment

• drowsiness that is made worse when taken with alcohol.

What should I tell my health care provider?

Tell your health care provider if you:

• have or had kidney problems

• have or had liver problems

• are pregnant, are trying to become pregnant, or are breast-feeding.

Tell your health care provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Sanctura and other medicines may affect each other, causing serious side effects. Especially tell your health care provider if you take:

• other anticholinergic medicines

• digoxin (Lanoxin®), procainamide (Pronestyl®), pancuronium (Pavulon®), morphine (MS Contin®), vancomycin (Vancocin®), metformin (Glucophage®) and tenofovir (Viread®).

What are some possible side effects of Sanctura? (This list is NOT a complete list of side effects reported with Sanctura. Your health care provider can discuss with you a more complete list of side effects.)

The most common side effects with Sanctura are dry mouth and constipation.

For more detailed information about Sanctura, ask your health care provider or pharmacist.

Sanctura's Approved Label

 

 

 

This is a summary of the most important information about Baraclude. For details, talk to your healthcare professional.

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What is the most important information about Baraclude?

• Lactic acidosis (buildup of an acid in the blood). Lactic acidosis is a medical emergency and must be treated in the hospital. Call your healthcare professional right away if you get any of the following signs of lactic acidosis:

  • You feel very weak or tired.

  • You have unusual (not normal) muscle pain.

  • You have trouble breathing.

  • You have stomach pain with nausea and vomiting.

  • You feel cold, especially in your arms and legs.

  • You feel dizzy or light-headed.

  • You have a fast or irregular heartbeat.

• Serious liver problems called hepatotoxicity, with liver enlargement (hepatomegaly) and fat in the liver (steatosis). Call your healthcare professional right away if you get any of the following signs of liver problems:

  • Your skin or the white part of your eyes turns yellow (jaundice).

  • Your urine turns dark.

  • Your bowel movements (stools) turn light in color.

  • You don’t feel like eating food for several days or longer.

  • You feel sick to your stomach (nausea).

  • You have lower stomach pain.

• Stopping Baraclude may worsen your hepatitis B infection. Therefore:

  • Take Baraclude exactly as prescribed.

  • Do not run out of Baraclude.

  • Do not stop Baraclude without talking to your healthcare professional.

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What is Baraclude?

Baraclude is a prescription medicine used for chronic infection with hepatitis B virus (HBV) in adults who also have active liver damage.

• Baraclude will not cure HBV.

• Baraclude does not stop you from spreading HBV to others by having sex, sharing needles, or being exposed to your blood.

• Baraclude may lower the amount of HBV in the body.

• Baraclude may lower the ability of HBV to multiply and infect new liver cells.

• Baraclude may improve the condition of your liver.

It is important to stay under your healthcare professional’s care while taking Baraclude. Your healthcare professional will test the level of the hepatitis B virus in your blood regularly.

Who Should Not Use Baraclude?

• Do not take Baraclude if you are allergic to entecavir or any of its ingredients.

• Baraclude has not been studied in children and is not recommended for anyone less than 16 years old.

What are The Risks?

See “What is the most important information about Baraclude?”

• Other common side effects include headache, tiredness, dizziness, and nausea.

What Should I Tell My Health Care Professional?

Before you start taking Baraclude, tell your health care professional if you:

• have kidney problems

• are pregnant or planning to become pregnant

• are breastfeeding

Are There Any Interactions With Drugs or Foods?

Baraclude may interact with certain other medicines that leave the body through the kidneys. Know the medicines that you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Keep a list of them to show your healthcare professional and pharmacist.

How should I take Baraclude?

• Take Baraclude exactly as prescribed. Your dose will depend on whether you have been treated for HBV infection before and what medicine you took. Your dose may be lower if you have kidney problems.

• Take Baraclude once a day on an empty stomach to help it work better. Empty stomach means at least 2 hours after a meal and at least 2 hours before the next meal.

• Do not change your dose or stop taking Baraclude without talking to your healthcare professional. After you stop taking Baraclude, it is important to stay under your healthcare professional’s care.

Your healthcare provider will need to do regular blood tests to check your liver.

 

Brand Name: Aromasin
Other brand Name(s):
Generic Name(s): Exemestane
Generic Ingredient(s):

Patient Information Sheet from the US Food and Drug Administration

Exemestane (marketed as Aromasin)

This is a summary of the most important information about Aromasin. For details, talk to your healthcare professional.

What is Aromasin used for?

Aromasin is used to treat advanced breast cancer in postmenopausal women whose disease has gotten worse after treatment with tamoxifen. Postmenopausal women are women who have gone through the “change of life” and are no longer having menstrual cycles.

Aromasin is used to reduce the risk of breast cancer recurrence (coming back) in postmenopausal women with estrogen receptor positive early stage breast cancer who have received two to three years of tamoxifen and are switched to Aromasin to complete a total of five consecutive years of therapy.

The safety and effectiveness of Aromasin in women who can still have children (premenopausal) has not been determined.

General Precautions with Aromasin:

Do not take Aromasin if you are pregnant. Aromasin may cause birth defects or even death to an unborn baby. Aromasin has only been studied in postmenopausal women.

Tell your doctor if you have a history of liver or kidney problems.

What should I tell my doctor or healthcare provider?

Because certain other medications can interact with Aromasin, review all medications that you are taking with your healthcare provider, including those that you take without a prescription. It is important to avoid taking any medications containing estrogen along with Aromasin, because they may interfere with the action of Aromasin.

If you are breastfeeding and are accidentally exposed to Aromasin tell your doctor right away.

What are some possible side effects of Aromasin? (This is NOT a complete list of side effects reported with Aromasin. Your healthcare provider can discuss with you a more complete list of side effects.)

Side effects of Aromasin are generally mild to moderate. Side effects can include:

• Feeling tired
• Nausea
• Hot flashes
• Pain
• Depression
• Inability to sleep
• Anxiety
• Shortness of breath
• Dizziness
• Headache
• Swelling of arms and legs
• Vomiting
• Stomach pain
• Loss of appetite
• Coughing
• Flu-like symptoms
• High blood pressure
• Constipation

For more detailed information about Aromasin, ask your healthcare provider.

Link to Aromasin's Approved Labeling

 

Brand Name: Sprycel
Other brand Name(s):
Generic Name(s): Dasatinib
Generic Ingredient(s):

 

 

Dasatinib (marketed as Sprycel)

PDF Print Version

This is a summary of the most important information about Sprycel. For details, talk to your healthcare professional.

What Is Sprycel?

Sprycel is a prescription medicine used to treat adults who:

• have chronic myeloid leukemia (CML)
• have acute lymphoblastic leukemia (ALL) called Philadelphia chromosome positive or Ph+ALL
• are no longer benefiting from treatment with the current available therapies for these diseases including a medicine called Gleevec (imatinib mesylate)
• experience severe side effects from Gleevec and are no longer able to take it

The long term benefits and toxicities are currently still being studied.

Sprycel has not been studied in children.

Who Should Not Take Sprycel?

You should not take Sprycel if you:

• have not previously had a trial of Gleevec (imatinib mesylate)
• are pregnant or planning to become pregnant

What Are The Side Effects?

The following are the major side effects of Sprycel therapy. However, this list is not complete.

• Low Blood Counts. Sprycel may cause low red blood cell counts (anemia), low white blood cell counts (neutropenia), and low platelet counts (thrombocytopenia). Your healthcare professional will monitor your blood counts frequently after your start Sprycel, and may adjust your dose of Sprycel or withhold the drug temporarily in the event your blood counts drop too low. In some cases, you may need to receive transfusions of red blood cells or platelets. Notify your healthcare professional immediately if you develop a fever while taking Sprycel.
• Bleeding: Sprycel may cause bleeding. The most serious bleeding events observed in clinical studies included bleeding into the brain leading to death in 1% of patients, and bleeding from the gastrointestinal tract. Less severe events included bleeding from the nose, the gums, bruising of the skin, and excessive menstrual bleeding. Notify your healthcare professional immediately if you experience bleeding or easy bruising while taking Sprycel.
• Fluid Retention: Sprycel may cause fluid to accumulate in your legs and around your eyes. In more severe cases, fluid may accumulate in the lining of your lungs, the sac around your heart, or your abdominal cavity. Notify your healthcare professional immediately if you experience swelling, weight gain, or increasing shortness of breath while taking Sprycel.
• Some common side effects that may occur with Sprycel include:
  • diarrhea
  • skin rash
  • headache
  • fatigue
  • nausea

What Should I Tell My Healthcare Professional?

Before you start taking Sprycel, tell your healthcare professional if you:

• are pregnant or planning to become pregnant. Sprycel may harm the fetus when given to a pregnant woman. Women should avoid becoming pregnant while undergoing treatment with Sprycel. Tell your healthcare professional immediately if you become pregnant or plant to become pregnant while taking Sprycel.
• are breast-feeding. It is not known if Sprycel can pass into your breast milk or if it can harm your baby. Do not breast-feed if you are taking Sprycel.
• are a sexually active male. Men who take Sprycel are advised to use a condom to avoid pregnancy in their partner.
• have a liver or heart problem.
• are lactose intolerant.

Can Other Medicines Or Food Affect Sprycel?

Sprycel and certain other medicines can interact with each other. Tell your healthcare professional about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them with you to show your healthcare professional.

Sprycel is eliminated from your body through the liver. The use of certain other medicines may alter the levels of Sprycel in your bloodstream. Likewise, levels of other medicines in your bloodstream can be affected by Sprycel. Such changes can increase the side effects, or reduce the activity of the medicines you are taking, including Sprycel.

Especially tell your healthcare professional if you take:

• medicines that increase the amount of Sprycel in your bloodstream, such as Nizoral (ketoconazole), Sporanox (itraconazole), Norvir (ritonavir), Reyataz (atazanavir sulfate), Crixivan (indinavir), Viracept (nelfinavir), Invirase (saquinavir), Ketek (telithromycin), E-Mycin (erythromycin), and Biaxin (clarithromycin).
• medicines that decrease the amount of Sprycel in your bloodstream, such as Decadron (dexamethasone), Dilantin (phenytoin), Tegretol (carbamazepine), Rimactane (rifampicin), and Luminal (Phenobarbital).
• medicines whose blood levels might be altered by Sprycel, such as Sandimmune (cyclosporine), Alfenta (alfentanil), fentanyl, Orap (pimozide), Rapamune (sirolimus), Prograf (tacrolimus), and Ergomar (ergotamine).
• medicines that reduce stomach acid, such as Tagamet (cimetidine), Pepcid (famotidine), Zantac (ranitidine), Prilosec (omeprazole), Protonix (pantoprazole), Nexium (esomeprazole), Aciphex (rabeprazole), and Prevacid (lansoprazole).
• medicines that neutralize stomach acid, such as Maalox (aluminum hydroxide/magnesium hydroxide), Tums (calcium carbonate), Rolaids (calcium carbonate and magnesia.
• medicines that thin the blood, such as Coumadin (warfarin sodium) and aspirin.

How Should I Take Sprycel?

• The usual dose is 70 mg (one 70-mg tablet) twice daily, once in the morning and once in the evening, with or without a meal. Try to take Sprycel at the same time each day.
• Take Sprycel whole. Do not break, cut, or crush the tablets.
• Depending on your response to treatment and any side effects that you may experience, your healthcare professional may adjust your dose of Sprycel upward or downward, or may temporarily discontinue Sprycel.
• You should not change your dose or stop taking Sprycel without first talking with your healthcare professional.
• If you miss a dose of Sprycel, take your next scheduled dose at its regular time. Do not take two doses at the same time. Call your healthcare professional or pharmacist if you are not sure what to do.
• If you accidentally take more than the prescribed dose of Sprycel, call your healthcare professional right away.

Regulatory history and labeling available through Drugs@FDA

FDA Update: August 15, 2006

 

This is a summary of the most important information about Amitiza. For details, talk to your healthcare professional.

What Is Amitiza?

Amitiza is used to treat chronic constipation due to unknown medical reasons in adults.

Amitiza has not been studied in patients with liver or kidney problems.

Amitiza has not been studied in children.

Who Should Not Take Amitiza?

You should not take Amitiza if you:

• have or had a blockage in the stomach or intestinal area. Your healthcare professional should examine you if you have symptoms of a stomach or intestinal blockage.
• are allergic to Amitiza or to any of the ingredients in Amitiza

What Are The Risks?

The following are the major side effects of Amitiza therapy. However, this list is not complete.

• Nausea. Nausea may be decreased by taking Amitiza with food.
• Diarrhea. Diarrhea may occur when taking Amitiza. Tell your healthcare professional if you have severe diarrhea when taking Amitiza.
• Some common side effects that may occur with Amitiza include:
  • stomach feels full and tight (bloated)
  • stomach area (abdominal) pain
  • headache
  • gas

What Should I Tell My Healthcare Professional?

Before you start taking Amitiza, tell your healthcare professional if you:

• are pregnant or trying to become pregnant. Amitiza has not been studied in pregnant women. Amitiza has been studied in pregnant animals. Some pregnant animals lost their babies after given Amitiza. Women who can become pregnant should have a negative pregnancy test before starting Amitiza and use effective birth control when taking Amitiza.
• are breastfeeding

Can Other Medicines Or Food Affect Amitiza?

Tell your healthcare professional about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them with you to show your healthcare professional.

How Should I Take Amitiza?

• Amitiza is taken by mouth.
• Amitiza should be taken with food.

Link to Amitiza's Approved Labeling [PDF]

FDA Update: August 11, 2006

Brand Name: Avastin
Other brand Name(s):
Generic Name(s): Bevacizumab
Generic Ingredient(s):

Additional Information Sources

Information	Source
Consumer Health Info	National Library of Medicine

Brand Name: Equetro
Other brand Name(s):
Generic Name(s): Carbamazepine extended release
Generic Ingredient(s):

Additional Information Sources

Information	Source
Consumer Health Info	National Library of Medicine

Brand Name: Tarceva
Other brand Name(s):
Generic Name(s): Erlotinib
Generic Ingredient(s):

Additional Information Sources

Information	Source
Consumer Health Info	National Library of Medicine

Brand Name: Enablex
Other brand Name(s):
Generic Name(s): Darifenacin
Generic Ingredient(s):

Additional Information Sources

Information	Source
Consumer Health Info	National Library of Medicine

This is a summary of the most important information about Enablex. For details, talk to your health care professional.

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What is Enablex?

Enablex is a prescription medicine used in adults to treat the following symptoms due to a condition called overactive bladder:

• having a strong need to go to the bathroom right away, also called “urgency”

• leaking or wetting accidents, also called “urinary incontinence”

• having to go to the bathroom too often, also called “urinary frequency”

Enablex has not been studied in children.

Who Should Not Use Enablex?

Do not take Enablex if you:

• are not able to empty your bladder (also called “urinary retention”)

• have delayed or slow emptying of your stomach (also called “gastric retention”)

• have an eye problem called “uncontrolled narrow-angle glaucoma”

• are allergic to Enablex or any of its ingredients.

What are The Risks?

The most common side effects of Enablex are dry mouth and constipation.

Other less common side effects include:

• Blurred vision. Use caution while driving or doing dangerous activities until you know how Enablex affects you.

• Heat prostration due to decreased sweating can occur when drugs such as Enablex are used in a hot environment.

What Should I Tell My Health Care Professional?

Before you start using Enablex, tell your health care professional if you:

• have any stomach or intestinal problems, or problems with constipation

• have trouble emptying your bladder or you have a weak urine stream

• have an eye problem called narrow angle glaucoma,

• have liver problems

• are pregnant or trying to become pregnant, or are breastfeeding

Are There Any Interactions With Drugs or Foods?

Enablex can interact with certain other medicines. Know the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Keep a list of them to show your healthcare professional.

Your healthcare professional may have to adjust your dose or watch you more closely if you take the following medicines:

• ketoconazole (Nizoral) or itraconazole (Sporonox), antifungal medicines

• clarithromycin (Biaxin), an antibiotic medicine

• ritonivir or nelfinavir (Viracept), antiviral medicines

• nefazadone (Serzone), a depression medicine

• flecainide (Tambocor), an abnormal heartbeat (antiarrhythmia) medicine

• thioridazine (Mellaril), a mental disorder (antipsychotic) medicine

• a medicine called a tricyclic antidepressant

How Do I Take Enablex?

• Take Enablex exactly as prescribed. Your doctor may prescribe the lowest dose if you have certain medical conditions such as liver problems.

• You should take Enablex once a day with liquid.

• Enablex should be swallowed whole and not chewed, divided or crushed.

• Enablex may be taken with or without food.