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Archive for the ‘functional bowel disorder agents’ Category

Lotronex

Posted by admin on November 3rd, 2009

Lotronex

Generic Name: alosetron (oral) (a LO ze tron)

What is Lotronex?

Lotronex (alosetron) blocks the action of a chemical called serotonin in the intestines. This slows the movement of stools (bowel movements) through the intestines.

Lotronex is used to treat severe, chronic irritable bowel syndrome (IBS) in women who have had diarrhea as the main symptom for at least 6 months. It should be used only in women who have tried other IBS treatments without success. Lotronex has not been shown to be effective in men with IBS.

Lotronex should be prescribed only by a qualified doctor who is enrolled in a prescribing program specific for this drug. You will be required to read and sign a Patient-Physician Agreement form before you get a prescription for Lotronex.

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

Important information about Lotronex

Do not start taking Lotronex if you are constipated. If you have constipation while taking this medication, stop taking the medication and call your doctor right away.

Lotronex should be prescribed only by a qualified doctor who is enrolled in a prescribing program specific for this drug. You will be required to read and sign a Patient-Physician Agreement form before you get a prescription for this medicine.

Serious or fatal side effects on the stomach and intestines have occurred in some people taking Lotronex. In rare cases, this medicine has caused severe constipation, or ischemic colitis (caused by reduced blood flow to the intestines).

Stop taking Lotronex and call your doctor right away if you develop new or worsening constipation, stomach pain, bloody diarrhea, or blood in your stools (bowel movements). If constipation does not improve or if it gets worse, do not start taking this medicine again until you talk to your doctor.

Lotronex does not improve the symptoms of IBS for everyone. When Lotronex does work well, it helps reduce stomach pain and discomfort, bowel urgency, and diarrhea. Some or all symptoms may improve within one to two weeks of treatment.

Before taking Lotronex

Do not use Lotronex if you have:

constipation (especially if it is your main IBS symptom);

a history of severe or ongoing constipation;

obstruction or perforation of your intestines;

Crohn’s disease, ulcerative colitis, or diverticulitis;

blood clots or circulation problems affecting your intestines;

severe liver disease; or

if you are also taking fluvoxamine (Luvox) to treat obsessive-compulsive disorder.

Tell your doctor if you have ever had any of the conditions listed above.

Serious or fatal side effects on the stomach and intestines have occurred in some people taking Lotronex. In rare cases, alosetron has caused severe constipation, or ischemic colitis (caused by reduced blood flow to the intestines).

Stop taking Lotronex and call your doctor right away if you develop new or worsening constipation, stomach pain, bloody diarrhea, or blood in your stools (bowel movements). If constipation does not improve or if it gets worse, do not start taking Lotronex again until you talk to your doctor.

FDA pregnancy category B. Lotronex is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether alosetron passes into breast milk or if it could harm a nursing baby. Do not take Lotronex without telling your doctor if you are breast-feeding a baby. Older adults and those who are ill or debilitated may be more likely to have serious complications from constipation. This medicine should not be given to a child younger than 18 years old.

How should I take Lotronex?

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

Take each dose with a full glass of water.

Alosetron can be taken with or without food.

Stop taking Lotronex and call your doctor if you become constipated while taking this medicine.

Lotronex does not improve the symptoms of IBS for everyone. When this medication does work well, it helps reduce stomach pain and discomfort, bowel urgency, and diarrhea. Some or all symptoms may improve within one to two weeks of treatment.

Lotronex is not a cure for irritable bowel syndrome. If you stop taking this medicine, symptoms may return within one week.

Stop taking Lotronex if your IBS symptoms do not improve after 4 weeks of treatment. If you stop taking this medication, do not start taking it again without your doctor’s advice.

Store alosetron at room temperature away from moisture and heat.

What happens if I miss a dose?

Skip the missed dose and take the medicine at the next regularly scheduled time. Do not take two doses at once, or take extra medicine to make up the missed dose.

What happens if I overdose?

Symptoms of an Lotronex overdose are not known.

What should I avoid while taking Lotronex?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are using this medicine.

Lotronex side effects

Get emergency medical help if you have any of these signs

f an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking Lotronex and call your doctor right away if you have any of these serious side effects:

new or worsening stomach pain;

bleeding from your rectum or blood in your stools; or

fast or uneven heartbeats.

Less serious Lotronex side effects may include:

mild stomach discomfort, bloating, or nausea;

burping with heartburn;

rectal hemorrhoids;

bloating or gas;

headache; or

skin rash.

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 Lotronex?

Do not take Lotronex if you are also taking fluvoxamine (Luvox) to treat obsessive-compulsive disorder.

Before taking Lotronex, tell your doctor if you are using any of the following drugs:

cimetidine (Tagamet);

ketoconazole (Nizoral), itraconazole (Sporanox), voriconazole, (VFEND);

isoniazid (Nydrazid);

hydralazine (BiDil);

procainamide (Procanbid, Procan SR, Pronestyl);

clarithromycin (Biaxin) or telithromycin (Ketek);

HIV medicines such as tipranavir (Aptivus), indinavir (Crixivan), saquinavir (Invirase), lopinavir/ritonavir (Kaletra), fosamprenavir (Lexiva), ritonavir (Norvir), atazanavir (Reyataz), or nelfinavir (Viracept); or

an antibiotic such as ciprofloxacin (Cipro), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), or ofloxacin (Floxin).

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

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Zelnorm

Posted by admin on November 3rd, 2009

Zelnorm

Generic Name: tegaserod (te GAS e rod)

What is Zelnorm?

Zelnorm increases the action of a chemical called serotonin in the intestines. This speeds the movement of stools through the bowels.

Zelnorm is used to treat severe, chronic, irritable bowel syndrome (IBS) in women who have constipation (and not diarrhea) as their main bowel problem. It is also used to treat chronic constipation in patients younger than 55 years old.

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

Important information about Zelnorm

Zelnorm was withdrawn from the U.S. market on March 30, 2007. This medication may still be used in limited emergency situations.

Zelnorm is not for use in people with diarrhea as the main symptom of their irritable bowel condition.

You should not use this medication if you are allergic to tegaserod, or if you have a history of stroke or heart attack, high blood pressure, uncontrolled angina, high cholesterol or triglycerides, diabetes, depression, or anxiety.

You also should not use Zelnorm if you smoke, if you are older than 55 years, if you are overweight, or if you have a history of suicidal thoughts or actions.

Before taking Zelnorm, tell your doctor if you have gallbladder problems, a blockage in your intestines, other stomach or intestinal disorders, kidney disease, or liver disease.

Zelnorm has not been shown to be helpful for men with irritable bowel syndrome. Stop taking Zelnorm and call your doctor at once if you have new or worsening stomach pain, blood in your stools, ongoing diarrhea, severe stomach pain or cramps, or feel like you might pass out.

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

You should not use Zelnorm if you are allergic to tegaserod, or if you have:

a history of stroke or heart attack;

untreated or uncontrolled angina (chest pain);

high blood pressure;

high cholesterol or triglycerides;

diabetes;

depression or anxiety;

if you smoke;

if you are older than 55 years;

if you are overweight; or

if you have a history of suicidal thoughts or actions.

Before taking Zelnorm, tell your doctor if you are allergic to any drugs, or if you have:

diarrhea or if diarrhea is your main symptom of IBS;

gallbladder problems;

a blockage in your intestines;

any other stomach or intestinal disorders;

kidney disease; or

If you have any of these conditions, you may need a dose adjustment or special tests to safely use Zelnorm.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether Zelnorm passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Zelnorm has not been shown to be helpful for men with irritable bowel syndrome.

How should I take Zelnorm?

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

Take this medication with a full glass of water. Take Zelnorm on an empty stomach.

Zelnorm is usually taken twice daily. Follow your doctor’s instructions.

It may take up to 2 weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 4 to 6 weeks of treatment.

Zelnorm is not a cure for irritable bowel syndrome. If you stop taking Zelnorm, your symptoms may return within 1 or 2 weeks.

Store Zelnorm 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, wait until it is time for your next dose and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include diarrhea, stomach pain, nausea, and vomiting.

What should I avoid while taking Zelnorm?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are using Zelnorm.

Zelnorm side effects

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

new or worsening stomach pain;

blood in your stools;

ongoing diarrhea;

severe stomach pain or cramps; or

feeling like you might pass out.

Less serious side effects may include:

headache, dizziness or migraine;

back pain or joint pain; or

mild stomach pain, nausea or gas.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect Zelnorm?

Other drugs may interact with Zelnorm. Talk your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

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Entereg

Posted by admin on November 3rd, 2009

Entereg

Generic Name: alvimopan (AL vi MOE pan)

What is Entereg?

Entereg reduces certain side effects of narcotic medications that are often used to prevent pain caused by surgery.

Narcotic medications can cause stomach pain, bloating, nausea, vomiting, and constipation. These side effects can delay recovery in patients undergoing gastrointestinal surgery.

Entereg works by preventing these side effects without reducing the pain-relieving effects of the narcotic.

Entereg is used to speed recovery of stomach and intestinal functions after a gastrointestinal surgery and to prevent side effects caused by narcotic medications.

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

Important information about Entereg

You should not use Entereg if you are allergic to alvimopan, or if you have used a narcotic medication within the past 7 days. You may be more likely to have unpleasant effects on your stomach if you have recently taken a narcotic medication.

Before you receive Entereg, tell your doctor if you have liver or kidney disease.

Entereg is given only in a hospital for a short period of time.

Tell your caregivers right away if you have pale skin, easy bruising or bleeding, painful or difficult urination, or confusion with uneven heart rate, leg discomfort, muscle weakness or limp feeling, and increased urination.

What should I discuss with my health care provider before I receive Entereg?

You should not use Entereg if you are allergic to alvimopan, or if you have used a narcotic medication within the past 7 days, such as:

fentanyl (Actiq, Duragesic);

hydrocodone (Lortab, Vicodin);

hydromorphone (Dilaudid, Palladone);

levorphanol (Levo-Dromoran);

meperidine (Demerol);

methadone (Methadose, Diskets, Dolophine);

morphine (Kadian, MS Contin, Oramorph, and others);

nalbuphine (Nubain);

oxycodone (OxyContin);

oxymorphone (Numorphan, Opana); or

pentazocine (Talwin).

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using Entereg, tell your doctor if you have:

liver disease; or

kidney disease.

How is Entereg given?

Entereg is given only in a hospital for a short period of time.

You will receive your first dose of Entereg up to 5 hours before your surgery. You will then be given additional doses two times per day for up to 7 days.

What happens if I miss a dose?

Since Entereg is given as needed by a healthcare professional, it is not likely that you will miss a dose.

What happens if I overdose?

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

Since Entereg is given by a healthcare professional, an overdose of this medication is not likely to occur.

What should I avoid while receiving Entereg?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are receiving Entereg.

Entereg 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. Tell your caregivers at once if you have a serious side effect such as:

pale skin, easy bruising or bleeding, weakness;

painful or difficult urination;

urinating less than usual or not at all; or

confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling.

Less serious side effects may include:

stomach pain or upset;

nausea, vomiting; diarrhea;

constipation, gas; or

back pain.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Entereg?

Tell your doctor about all other medications you are using. It is especially important to tell your doctor if you have taken a narcotic medication within the past 7 days. You may be more likely to have unpleasant effects on your stomach if you have recently taken a narcotic medication.

There may be other drugs that can interact with Entereg. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

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Relistor

Posted by admin on November 3rd, 2009

Relistor

Generic Name: methylnaltrexone (METh IL nal TREX own)

What is Relistor?

Relistor is a special narcotic drug that blocks certain effects of other narcotic medicines.

Relistor reduces constipation caused by narcotic medications that are often used to treat pain in people with terminal illness.

Relistor works by preventing this side effect without reducing the pain-relieving effects of the narcotic. It is usually given after laxatives have been tried without successful treatment of constipation.

Relistor may also be used for purposes other than those listed in this medication guide.

Important information about Relistor

You should not use Relistor if you are allergic to methylnaltrexone, or if you have a blockage in your stomach or intestines.

Before you use Relistor, tell your doctor if you have severe or ongoing diarrhea.

Do not draw your Relistor dose into a syringe until you are ready to give yourself an injection. After loading a syringe, if you cannot give the injection right away keep it at room temperature and use it within 24 hours.

Relistor can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Before receiving Relistor, tell your doctor if you use any narcotic medication.

Before receiving Relistor

You should not use Relistor if you are allergic to methylnaltrexone, or if you have a blockage in your stomach or intestines.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you use Relistor, tell your doctor if you have severe or ongoing diarrhea.

FDA pregnancy category B. Relistor is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether Relistor passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is Relistor used?

Relistor is given as a shot under the skin of your upper arm, stomach, or thigh. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

This medication is usually given once every other day, but not more often than once every 24 hours.

Relistor can produce a bowel movement within 30 minutes after injection.

Do not draw your Relistor dose into a syringe until you are ready to give yourself an injection. After loading a syringe, if you cannot give the injection right away keep it at room temperature and use it within 24 hours.

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

A single-use vial (bottle) of Relistor is for one injection only. Throw the used vial away after one use, even if there is still medicine left in it.

Relistor should look clear or slightly yellow in color. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.

Store Relistor at room temperature away from moisture, heat, and light. Do not freeze.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

Do not use this medication more than once in a 24-hour period.

What happens if I overdose?

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

Overdose symptoms may include extreme dizziness, or feeling like you might pass out.

What should I avoid while using Relistor?

Relistor can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Do not use any other laxatives that your doctor has not prescribed.

Relistor 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 severe or ongoing diarrhea, stomach pain that will not go away, or nausea or vomiting that are new or worsening symptoms.

Less serious Relistor side effects may include:

sweating;

stomach pain, gas;

mild nausea; or

mild diarrhea.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Relistor?

The pain-relieving effects of any narcotic pain medications you use will be blocked if you use them during your treatment with Relistor. Harmful side effects could also occur.

Before receiving Relistor, tell your doctor if you use any narcotic medication, such as:

buprenorphine (Buprenex, Subutex);

butorphanol (Stadol);

codeine (Tylenol with codeine);

hydrocodone (Lortab, Vicodin);

dezocine (Dalgan);

hydromorphone (Dilaudid);

levorphanol (Levo-Dromoran);

meperidine (Demerol);

methadone (Dolophine, Methadose);

morphine (Kadian, MS Contin, Roxanol);

nalbuphine (Nubain);

nalmefene (Revex);

naloxone (Narcan);

oxycodone (OxyContin, Roxicodone, Percocet);

oxymorphone (Numorphan); or

propoxyphene (Darvon, Darvocet).

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

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Amitiza

Posted by admin on November 3rd, 2009

Amitiza

Generic Name: lubiprostone (loo bee PROS tone)

What is Amitiza?

Amitiza is a chloride channel activator. It increases fluid secretion in your intestines which increases intestinal muscle movement and helps make it easier to pass stools (bowel movements).

Amitiza is used to treat chronic constipation in adults. It is also used to treat irritable bowel syndrome in women with constipation as the main symptom.

Amitiza may also be used for other purposes not listed here.

Important information about Amitiza

Use Amitiza exactly as it was prescribed for you. Do not use it in larger doses or for longer than recommended by your doctor.

Do not take Amitiza if you have severe diarrhea. Call your doctor for instructions.

Before using this medication, tell your doctor if you have a history of hernia, gallstones, Crohn’s disease, Hirschsprung’s disease, impacted bowel movement, diverticulitis, polyps, or any other cause for obstruction in your gastrointestinal (digestive) system.

You may have tightness in your chest or feel short of breath within 1 hour after taking Amitiza. This side effect should go away within 3 hours, but it may occur again when you take your next dose. Talk with your doctor if this side effect becomes bothersome.

Stop using this medication and get emergency medical help if you think you have used too much medicine, or if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious Amitiza side effects are more likely, and you may have none at all. Talk to your doctor about any side effect that seems unusual or is especially bothersome.

Before taking Amitiza

You should not use Amitiza if you have blockage in your digestive tract, or if you have severe diarrhea.

Before using this medication, tell your doctor if you have a history of hernia, gallstones, Crohn’s disease, Hirschsprung’s disease, impacted bowel movement, diverticulitis, polyps, or any other cause for obstruction in your gastrointestinal (digestive) system.

If you have any of these conditions, you may not be able to use Amitiza or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category C: This medication may be harmful to an unborn baby. Do not use Amitiza without telling your doctor if you are pregnant. You may be asked to have a pregnancy test before you start taking Amitiza. Tell your doctor if you become pregnant during treatment. It is not known if Amitiza passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Amitiza should not be given to a child.

How should I take Amitiza?

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

Take Amitiza with food. Drink a full glass of water when you take this medication.

You may have tightness in your chest or feel short of breath within 1 hour after taking Amitiza. This side effect should go away within 3 hours, but it may occur again when you take your next dose. Talk with your doctor if this side effect becomes bothersome.

Do not take Amitiza if you have severe diarrhea. Call your doctor for instructions. Store Amitiza at room temperature away from moisture and heat.

What happens if I miss a dose?

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

What happens if I overdose?

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

Overdose symptoms may include vomiting, diarrhea, stomach pain, dizziness, hot flashes, trouble breathing, pale skin, headache, or fainting.

What should I avoid while taking Amitiza?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are using Amitiza.

Amitiza side effects

Stop using Amitiza and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have severe vomiting or diarrhea.

Less serious Amitiza side effects are more likely to occur. Continue using Amitiza and talk with your doctor if you have any of these less serious side effects:

nausea, vomiting, mild diarrhea, loss of appetite;

stomach pain, bloating, gas;

sore throat, cough;

headache, dizziness;

swelling in your hands, ankles, or feet;

joint or muscle pain; or

anxiety, cold sweats.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Amitiza?

There may be other drugs that can affect Amitiza. 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.

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