Description

Alosetron Hydrochloride 1 mg Tablets (Pack of 30)

Alosetron Hydrochloride is a prescription medication that functions as a selective serotonin 5-HT3 receptor antagonist, specifically designed for women with severe diarrhea-predominant irritable bowel syndrome (IBS-D) who have not responded adequately to conventional treatments. By slowing colonic transit, Alosetron helps alleviate symptoms like diarrhea, abdominal discomfort, and frequent bowel urgency, enhancing patient quality of life.

Mechanism of Action: Alosetron acts by blocking serotonin 5-HT3 receptors in the gastrointestinal tract, reducing the overactivity of the gut and improving stool consistency, decreasing urgency, and reducing the frequency of bowel movements.

Indications:

• Indicated for women with severe, chronic IBS-D who have not benefited from standard therapy.
• Not recommended for use in men or patients with mixed or constipation-predominant IBS.

Dosage and Administration:

• Form: Oral tablet
• Strength: 1 mg
• Recommended Dosage: Start with 0.5 mg twice daily; if tolerated but response is insufficient, increase to 1 mg once or twice daily after four weeks. Discontinue if symptoms do not improve within this period.
• Administration: Taken orally, with or without food. The maximum daily dosage is 2 mg. Adjust based on individual patient response and tolerance.

Contraindications:

• History of severe or chronic constipation
• Conditions like ischemic colitis, intestinal obstruction, Crohn’s disease, ulcerative colitis, or diverticulitis
• Severe hepatic impairment
• Hypersensitivity to Alosetron or its ingredients

Warnings and Precautions:

• Serious Gastrointestinal Adverse Events: Alosetron carries a risk of severe complications, including constipation and ischemic colitis, which may be life-threatening. Careful monitoring and patient education are necessary.
• Patients should report any early symptoms of constipation or ischemic colitis, such as rectal bleeding or worsening abdominal pain.

Side Effects:

• The most common side effect is constipation, which can be severe in some cases.
• Other potential side effects include abdominal pain, nausea, fatigue, and headache.

Special Considerations:

• Alosetron is intended for female patients only, as clinical studies have not shown effectiveness in men.
• Pregnant or nursing women should consult a healthcare provider before using this medication.
• Requires a risk management program due to potential severe adverse events.

Packaging: Available in a pack of 30 tablets, with each tablet containing 1 mg of Alosetron Hydrochloride.

Prescription Status: Alosetron 1 mg requires a medical prescription and enrollment in a risk management program, emphasizing its use only when strictly indicated.

This medication is for women with IBS-D who have exhausted other treatment options. Consult a healthcare provider to ensure that Alosetron is suitable and safe for individual needs.

See product insert for additional details including ingredients, dosage and administration. /n  This product is subject to an FDA-approved Risk Evaluation and Mitigation Strategy (REMS). Click the REMS like under Product Resources for more information.
This product is subject to an FDA-approved Risk Evaluation and Mitigation Strategy (REMS).