PRODUCTS AVAILABLE IN THE UNITED STATES

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IMPORTANT SAFETY INFORMATION

SUTAB® (sodium sulfate, magnesium sulfate, potassium chloride) tablets for oral use is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults.

DOSAGE AND ADMINISTRATION:
A low residue breakfast may be consumed. After breakfast, only clear liquids may be consumed until after the colonoscopy. Administration of two doses of SUTAB (24 tablets) are required for a complete preparation for colonoscopy. Twelve (12) tablets are equivalent to one dose. Water must be consumed with each dose of SUTAB and additional water must be consumed after each dose. Complete all SUTAB tablets and required water at least 2 hours before colonoscopy.

CONTRAINDICATIONS:
Use is contraindicated in the following conditions: gastrointestinal obstruction or ileus, bowel perforation, toxic colitis or toxic megacolon, gastric retention, hypersensitivity to any ingredients in SUTAB.

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 concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider laboratory testing; Mucosal ulcerations: Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients with IBD. Consider potential for mucosal ulcerations in patients undergoing esophageal gastroduodenoscopy. Suspected GI obstruction or perforation: Rule out the diagnosis before administration.

ADVERSE REACTIONS:
Most common gastrointestinal adverse reactions are: nausea, abdominal distension, vomiting and upper abdominal pain.

DRUG INTERACTIONS:
Drugs that increase risk of fluid and electrolyte imbalance.

See Full Prescribing Information and Medication Guide
See Full Prescribing Information and Medication Guide

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%.

Important Safety Information

GoLYTELY® (polyethylene glycol 3350 and electrolytes for oral solution) is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults. DOSAGE AND ADMINISTRATION: On day prior to colonoscopy, a light breakfast may be consumed at least 2 hours before starting GoLYTELY. Fill the supplied container to the 4-liter fill line and cap. Shake vigorously several times to ensure that the ingredients are dissolved. Drink 8 oz. every 10 minutes until 4 liters are consumed, or rectal effluent is clear. Complete all GoLYTELY at least 2 hours before colonoscopy. CONTRAINDICATIONS: Use is contraindicated in the following conditions: gastrointestinal obstruction or ileus, bowel perforation, toxic colitis or toxic megacolon, gastric retention, hypersensitivity to components of GoLYTELY. 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 of serious cardiac arrhythmias; 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 concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider laboratory testing; Mucosal ulcerations: Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease; Patients at risk for aspiration: Observe during administration; Hypersensitivity reactions including anaphylaxis: Patients should seek medical attention if symptoms occur. ADVERSE REACTIONS: Most common adverse reactions are: nausea, abdominal fullness, bloating, abdominal cramps, vomiting and anal irritation. DRUG INTERACTIONS: Drugs that increase risk of fluid and electrolyte imbalance.

See Full Prescribing Information and Medication Guide.

See Full Prescribing Information and Medication Guide.

Important Safety Information

NuLYTELY® (polyethylene glycol 3350, sodium chloride, sodium bicarbonate, and potassium chloride for oral solution) is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy in adults and pediatric patients aged 6 months or greater. DOSAGE AND ADMINISTRATION: On day prior to colonoscopy, a light breakfast may be consumed at least 2 hours before starting NuLYTELY. Fill the supplied container to the 4-liter fill line and cap. Shake vigorously several times to ensure that the ingredients are dissolved. Adults: Drink 8 oz. every 10 minutes until 4 liters are consumed, or rectal effluent is clear. Pediatric patients (aged 6 months or greater): Drink 25 mL/kg/hour orally or administer by NGT. Continue drinking until watery stool is clear and free of solid matter. Complete all NuLYTELY at least 2 hours before colonoscopy. CONTRAINDICATIONS: Use is contraindicated in the following conditions: gastrointestinal obstruction, ileus or gastric retention, bowel perforation, toxic colitis or toxic megacolon, known allergy or hypersensitivity to components of NuLYTELY. WARNINGS AND PRECAUTIONS: Risk of fluid and electrolyte abnormalities, arrhythmias, seizures and renal impairment: Assess concurrent medications and consider testing in some patients; Patients with renal insufficiency: Use caution, ensure adequate hydration and consider testing; Suspected GI obstruction or perforation: Rule out the diagnosis before administration; Patients at risk for aspiration: Observe during administration; Not for direct ingestion: Dilute and take with additional water. ADVERSE REACTIONS: Most common adverse reactions are: nausea, abdominal fullness, bloating, abdominal cramps, vomiting and anal irritation. DRUG INTERACTIONS: Drugs that increase risk of fluid and electrolyte imbalance.

See Full Prescribing Information and Medication Guide.

See Full Prescribing Information and Medication Guide.

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.