PRODUCTS AVAILABLE IN THE UNITED STATES

Please visit our product websites to view complete prescribing information, including a BOXED warning for Lotronex® (alosetron HCl) 0.5 & 1 MG TABLETS. The product information provided is intended only for residents of the United States.

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Important Safety Information

SUPREP® Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 12 years of age and older. DOSAGE AND ADMINISTRATION: Each bottle must be diluted with water to a final volume of 16 ounces (Adults) and 12 ounces (Pediatric patients 12 years of age and older). Must consume additional water after each dose. Stop consumption of all fluids at least 2 hours prior to the colonoscopy. CONTRAINDICATIONS: Use is contraindicated in the following conditions: gastrointestinal (GI) obstruction or ileus, bowel perforation, toxic colitis or toxic megacolon, gastric retention, hypersensitivity to any ingredients in SUPREP Bowel Prep Kit. WARNINGS AND PRECAUTIONS: Risk of fluid and electrolyte abnormalities: Encourage adequate hydration, assess concurrent medications, and consider laboratory assessments prior to and after each use; Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk; Seizures: Use caution in patients with a history of seizures and patients at increased risk of seizures, including medications that lower the seizure threshold; Patients with renal impairment or taking medications that affect renal functions: Use caution, ensure adequate hydration and consider laboratory testing; Suspected GI obstruction or perforation: Rule out the diagnosis before administration; Patients at risk for aspiration: Observe during administration. ADVERSE REACTIONS: Most common adverse reactions: Adults: (> 2%) are overall discomfort, abdominal distention, abdominal pain, nausea, and vomiting; Pediatric Patients (>10%) are nausea, abdominal pain, abdominal bloating and vomiting. DRUG INTERACTIONS: Drugs that may increase the risk of fluid and electrolyte abnormalities.

Click here for Full Prescribing Information and Medication Guide

Click here for Full Prescribing Information and Medication Guide
Motofen (difenoxin and atropine sulfate tablets). Schedule 4.

Motofen is now available in pharmacies nationwide.

Full Prescribing Information
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Important Safety Information

INDICATIONS AND USAGE
Motofen® (difenoxin and atropine sulfate tablets) is indicated as adjunctive therapy in the management of acute nonspecific diarrhea and acute exacerbations of chronic functional diarrhea.

CONTRAINDICATIONS
Motofen® is contraindicated in patients with diarrhea associated with organisms that penetrate the intestinal mucosa (toxigenic E. coli, Salmonella species, Shigella) and pseudomembranous colitis associated with broad spectrum antibiotics.

Motofen® is also contraindicated in children under 2 years of age, in patients with known hypersensitivity to difenoxin, atropine, or any of the inactive ingredients, and in patients who are jaundiced.

WARNINGS
Motofen® is not an innocuous drug and dosage recommendations should be strictly adhered to. Accidental overdose may result in severe respiratory depression and coma, possibly leading to permanent brain damage or death.

The use of Motofen® does not preclude the administration of appropriate fluid and electrolyte therapy. Dehydration, particularly in children, may further influence the variability of response to Motofen® and may predispose to delayed difenoxin intoxication. Drug-induced inhibition of peristalsis may result in fluid retention in the colon, and this may further aggravate dehydration and electrolyte imbalance.

Use with caution in patients with ulcerative colitis or liver or kidney disease.

Motofen® may produce drowsiness or dizziness. Use caution when engaging in activities requiring mental alertness, such as driving or operating dangerous machinery.

Keep out of reach of children.

Please click here for full Prescribing Information

Please click here for full Prescribing Information

IMPORTANT SAFETY INFORMATION

Topical corticosteroids are indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. Use may produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression. May cause local adverse reactions including burning, itching, irritation, and dryness.

Pregnancy: Teratogenic Effects: Pregnancy Category C

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CLICK HERE FOR FULL PRESCRIBING INFORMATION ABOUT ANALPRAM HC® CREAM 2.5%.

NuLYTELY® and GoLYTELY® are indicated for bowel cleansing prior to colonoscopy. Use is contraindicated in patients with gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon or ileus and patients known to be hypersensitive to any of the components. Use with caution in patients with severe ulcerative colitis. Nausea, abdominal fullness and bloating are the most common adverse reactions. Abdominal cramps, vomiting and anal irritation occur less frequently. Isolated cases of urticaria, rhinorrhea, dermatitis, and (rarely) anaphylactic reaction have been reported which may represent allergic reactions.

Refer to full Prescribing Information for additional information.

Click here for NuLYTELY full Prescribing Information.

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Refer to full Prescribing Information for additional information.
Click here for NuLYTELY full Prescribing Information.
Click here for GoLYTELY full Prescribing Information.

NuLYTELY® and GoLYTELY® are indicated for bowel cleansing prior to colonoscopy. Use is contraindicated in patients with gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon or ileus and patients known to be hypersensitive to any of the components. Use with caution in patients with severe ulcerative colitis. Nausea, abdominal fullness and bloating are the most common adverse reactions. Abdominal cramps, vomiting and anal irritation occur less frequently. Isolated cases of urticaria, rhinorrhea, dermatitis, and (rarely) anaphylactic reaction have been reported which may represent allergic reactions.

Refer to full Prescribing Information for additional information.

Click here for NuLYTELY full Prescribing Information.

Click here for GoLYTELY full Prescribing Information.

Refer to full Prescribing Information for additional information.
Click here for NuLYTELY full Prescribing Information.
Click here for GoLYTELY full Prescribing Information.

INDICATIONS AND USAGE

LOTRONEX is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: chronic IBS symptoms (generally lasting 6 months or longer), had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and not responded adequately to conventional therapy. Diarrhea-predominant IBS is severe if it includes diarrhea and one or more of the following: frequent and severe abdominal pain/discomfort, frequent bowel urgency or fecal incontinence, disability or restriction of daily activities due to IBS. Because of infrequent but serious gastrointestinal adverse reactions associated with LOTRONEX, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable. Clinical studies have not been performed to adequately confirm the benefits of LOTRONEX in men.

IMPORTANT SAFETY INFORMATION
WARNING: SERIOUS GASTROINTESTINAL ADVERSE REACTIONS

Infrequent but serious gastrointestinal adverse reactions have been reported with the use of LOTRONEX. These events, including ischemic colitis and serious complications of constipation, have resulted in hospitalization, and rarely, blood transfusion, surgery, and death.

  • LOTRONEX is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have not responded adequately to conventional therapy.
  • LOTRONEX should be discontinued immediately in patients who develop constipation or symptoms of ischemic colitis. Patients should immediately report constipation or symptoms of ischemic colitis to their prescriber. LOTRONEX should not be resumed in patients who develop ischemic colitis. Patients who have constipation should immediately contact their prescriber if the constipation does not resolve after LOTRONEX is discontinued. Patients with resolved constipation should resume LOTRONEX only on the advice of their treating prescriber.

CONTRAINDICATIONS
  • Do not initiate in patients with constipation
  • History of chronic or severe constipation or sequelae from constipation; intestinal obstruction, stricture, toxic megacolon, gastrointestinal perforation, and/or adhesions; ischemic colitis; impaired intestinal circulation, thrombophlebitis, or hypercoagulable state; Crohn’s disease or ulcerative colitis; diverticulitis; severe hepatic impairment
  • Concomitant use of fluvoxamine

WARNINGS AND PRECAUTIONS
  • Serious Complications of Constipation: May occur in some patients without warning. Include obstruction, ileus, impaction, toxic megacolon, and secondary bowel ischemia and in rare cases perforation and death have been reported. Risk is increased in patients who are elderly, debilitated, or taking medications that decrease bowel motility. The incidence of serious complications of constipation was approximately 0.1% (1 per 1,000 patients) in women receiving either LOTRONEX or placebo.
  • Discontinue LOTRONEX immediately if constipation occurs.
  • Ischemic colitis: May occur in some patients without warning. Promptly evaluate patients with signs of ischemic colitis (e.g., rectal bleeding, bloody diarrhea, new or worsening abdominal pain). In IBS clinical trials, the cumulative incidence of ischemic colitis in women receiving LOTRONEX was 0.2% (2 per 1,000 patients, 95% confidence interval 1 to 3) through 3 months and was 0.3% (3 per 1,000 patients, 95% confidence interval 1 to 4) through 6 months.
  • Discontinue LOTRONEX immediately if signs of ischemic colitis occur, such as rectal bleeding, bloody diarrhea, or new or worsening abdominal pain.

ADVERSE REACTIONS
Most common adverse reactions (incidence >2% and >placebo) in clinical studies were constipation, abdominal discomfort and pain, nausea, and gastrointestinal discomfort and pain.

Please see the complete prescribing information for LOTRONEX, including Boxed Warning and Medication Guide.
Please see the complete prescribing information for LOTRONEX, including Boxed Warning and Medication Guide.