Lotronex

DRUG DESCRIPTION

The active ingredient in LOTRONEX Tablets is alosetron hydrochloride (HCl), a potent and selective antagonist of the serotonin 5-HT3receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula: C17H18N4O•HCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer, and < 0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is:

LOTRONEX® (alosetron hydrochloride) Structural Formula Illustration

LOTRONEX (alosetron hydrochloride) Tablets are supplied for oral administration as 0.5-mg (white) and 1-mg (blue) tablets. The 0.5-mg tablet contains 0.562 mg alosetron HCl equivalent to 0.5 mg alosetron and the 1-mg tablet contains 1.124 mg alosetron HCl equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients: lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film-coat for the 0.5-mg tablet contains hypromellose, titanium dioxide, and triacetin. The blue film-coat for the 1-mg tablet contains hypromellose, titanium dioxide, triacetin, and indigo carmine.

What are the possible side effects of alosetron (Lotronex)?

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 alosetron 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 side effects may include:

  • mild stomach discomfort, bloating, or nausea;
  • ...

Read All Potential Side Effects and See Pictures of Lotronex »

What are the precautions when taking alosetron hydrochloride (Lotronex)?

Before taking alosetron, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain intestinal disorders (e.g., ileus, ischemic colitis, impaired intestinal circulation, constipation or its complications, obstruction, megacolon, stricture/adhesions, or perforation), Crohn's disease, ulcerative colitis, diverticulitis, severe liver disease, blood disorders (e.g., history of blood clots).

Before using this medication, tell your doctor your...

Read All Potential Precautions of Lotronex »


Lotronex Consumer (continued)

SIDE EFFECTS: Headache, stomach upset, or hemorrhoids may occur. If these effects persist or worsen, notify your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if you have any of these unlikely but serious side effects: bloating, depression.

Stop taking this medication and seek immediate medical attention if any of these unlikely but serious side effects occur: constipation, bloody stools, unexplained fever, unusually fast pulse, new or sudden worsening of stomach/abdominal/bowel pain.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking alosetron, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain intestinal disorders (e.g., ileus, ischemic colitis, impaired intestinal circulation, constipation or its complications, obstruction, megacolon, stricture/adhesions, or perforation), Crohn's disease, ulcerative colitis, diverticulitis, severe liver disease, blood disorders (e.g., history of blood clots).

Before using this medication, tell your doctor your medical history, including: liver disease.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of constipation if it occurs.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Lotronex Patient Information Including Side Effects

Brand Names: Lotronex

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

  • What is alosetron (Lotronex)?
  • What are the possible side effects of alosetron (Lotronex)?
  • What is the most important information I should know about alosetron (Lotronex)?
  • What should I discuss with my healthcare provider before taking alosetron (Lotronex)?
  • How should I take alosetron (Lotronex)?
  • What happens if I miss a dose (Lotronex)?
  • What happens if I overdose (Lotronex)?
  • What should I avoid while taking alosetron (Lotronex)?
  • What other drugs will affect alosetron (Lotronex)?
  • Where can I get more information?

What is alosetron (Lotronex)?

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

Alosetron 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. Alosetron should be used only in women who have tried other IBS treatments without success. Alosetron has not been shown to be effective in men with IBS.

Alosetron 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 alosetron.

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

What are the possible side effects of alosetron (Lotronex)?

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 alosetron 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 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 is the most important information I should know about alosetron (Lotronex)?

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

Alosetron 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 alosetron.

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

Stop taking alosetron 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 alosetron again until you talk to your doctor.

Alosetron does not improve the symptoms of IBS for everyone. When alosetron 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.

Related Drug Centers
  • Lotronex


Related Drugs Index: