Pan Am Farma

Alosetron 0.5 mg HCl

Pronunciation: (a LO ze tron HYE-droe-KLOR-ide)

Strength: 0.5 mg

Dosage Form: Tablets

Size: 30

NDC: 65162-0248-03

UPC: 3-6516224803-6

Each GTIN: 00365162248036

OTC/Rx: RX

TE Code: AB

Reference Brand: Lotronex®

Status: Discontinued

Discontinued Notice: This product has been discontinued for further purchase. We continue to display it online as a reference until the balance of pharmacy inventory is fully dispensed.

Case Qty / Min Order Qty: 48

Case GTIN: 50365162248031

Pill Size (inches): 0.2225 x 0.4205

Pill Weight (mg): 156

Bottle Size (LxWxH inches): 1.5635 x 1.5635 x 3.0855

Bottle Weight (g): 27.22

Case Size (LxWxH inches): 13 x 10 x 4

Case Weight (lbs): 4.07

Special Instructions: Keep this and all medication out of the reach of children. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light and moisture.

Product Shelf Life: 24 months

Shape: Oval

Color: White

Scorings: Unscored

Imprint Markings: Debossed with “AN248” on one side and plain on the other side

Allergens: Call (877) 835-5472 option 3 for any allergen questions.

Additional Product Information

Pronunciation(a LO ze tron HYE-droe-KLOR-ide)
Strength0.5 mg
Dosage FormTablets
Size30
Ndc65162-0248-03
Upc3-6516224803-6
Each Gtin00365162248036
Otc RxRX
Te CodeAB
Reference BrandLotronex®
StatusDiscontinued
Discontinued NoticeThis product has been discontinued for further purchase. We continue to display it online as a reference until the balance of pharmacy inventory is fully dispensed.
Case Qty Min Order Qty48
Case Gtin50365162248031
Pill Size Inches0.2225 x 0.4205
Pill Weight Mg156
Bottle Size Lxwxh Inches1.5635 x 1.5635 x 3.0855
Bottle Weight G27.22
Case Size Lxwxh Inches13 x 10 x 4
Case Weight Lbs4.07
Special InstructionsKeep this and all medication out of the reach of children. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light and moisture.
Product Shelf Life24 months
ShapeOval
ColorWhite
ScoringsUnscored
Imprint MarkingsDebossed with “AN248” on one side and plain on the other side
AllergensCall (877) 835-5472 option 3 for any allergen questions.
Category: Tag:

Description

Alosetron 0.5 mg HCl

Alosetron Hydrochloride is a selective serotonin 5-HT3 receptor antagonist used for the treatment of severe diarrhea-predominant irritable bowel syndrome (IBS-D) in women. By blocking serotonin signals in the gut, Alosetron helps slow intestinal movement, thereby reducing symptoms such as diarrhea, abdominal discomfort, and urgency.

Mechanism of Action: Alosetron works by selectively inhibiting serotonin 5-HT3 receptors in the gastrointestinal tract. This reduces the excessive colonic transit associated with IBS-D, leading to improved stool consistency, reduced urgency, and decreased frequency of bowel movements.

Indications:
Treatment of severe diarrhea-predominant irritable bowel syndrome (IBS-D) in adult women for whom conventional therapy has been ineffective.

  • Not recommended for IBS-D in men or for patients with predominantly constipation symptoms.

Dosage and Administration:

  • Form: Oral tablet
  • Strength: 0.5 mg
  • Recommended Dosage: Initial dosage is 0.5 mg twice daily. After four weeks, if well-tolerated but the response is inadequate, the dosage may be increased to 1 mg once daily. Discontinue treatment if IBS-D symptoms do not improve after four weeks at the maximum dosage.
  • Administration: Taken orally, with or without food.

Contraindications:
History of severe constipation or complications related to constipation
Intestinal obstructions, ischemic colitis, Crohn’s disease, ulcerative colitis, or diverticulitis
Severe liver impairment
Known hypersensitivity to Alosetron or its components

Warnings and Precautions:

  • Risk of Serious Gastrointestinal Adverse Events: Alosetron has been associated with serious complications, including ischemic colitis and severe constipation, which can be life-threatening. It is prescribed under a strict risk management program, with careful monitoring for early signs of complications.

  • Use with caution in patients with a history of gastrointestinal disorders, cardiovascular conditions, or hepatic impairment.

Side Effects: Common side effects of Alosetron may include:
Constipation (most frequent)
Abdominal pain or discomfort
Nausea
Headache
Fatigue

 

Special Considerations:

  • Alosetron is primarily indicated for use in women with IBS-D, as clinical trials have not demonstrated significant efficacy in men.
  • Women who are pregnant, planning to become pregnant, or nursing should consult a healthcare provider before use.
  • Alosetron is not suitable for patients with mixed-type or constipation-predominant IBS.

Prescription Status: Alosetron 0.5 mg HCl requires a medical prescription and enrollment in a risk management program due to potential serious side effects.

This medication is targeted for women with severe IBS-D who have not responded to standard treatments. Consultation with a healthcare provider is essential to determine if Alosetron is appropriate based on individual medical history and symptoms

See product insert for full prescribing information including boxed warning and important safety considerations.
This product is subject to an FDA-approved Risk Evaluation and Mitigation Strategy (REMS).

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