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Sebela Pharmaceuticals Announces U.S. Launch of SUTAB® Tablets, An Alternative to Liquid Colonoscopy Preparation

Sebela Pharmaceuticals is uniquely positioned for significant growth organically and through acquisitions, in-licensing and partnerships. We offer market-leading treatments in gastroenterology, dermatology and women’s health, including:

SUTAB® (sodium sulfate, magnesium sulfate, and potassium chloride) Tablets, a sulfate-based tablet preparation for colonoscopy

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 ADMINSTRATION: 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. 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; 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

SUPREP® Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution, the #1 prescribed branded bowel prep kit1

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. Most common adverse reactions (>2%) are overall discomfort, abdominal distention, abdominal pain, nausea, vomiting and headache. Use is contraindicated in the following conditions: gastrointestinal (GI) obstruction, bowel perforation, toxic colitis and toxic megacolon, gastric retention, ileus, known allergies to components of the kit. Use caution when prescribing for patients with a history of seizures, arrhythmias, impaired gag reflex, regurgitation or aspiration, severe active ulcerative colitis, impaired renal function or patients taking medications that may affect renal function or electrolytes. Use can cause temporary elevations in uric acid. Uric acid fluctuations in patients with gout may precipitate an acute flare. Administration of osmotic laxative products may produce mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Patients with impaired water handling who experience severe vomiting should be closely monitored including measurement of electrolytes. Advise all patients to hydrate adequately before, during, and after use. Each bottle must be diluted with water to a final volume of 16 ounces and ingestion of additional water as recommended is important to patient tolerance.

Click here for Full Prescribing Information and Medication Guide

NAFTIN® GEL 2% (Naftifine HCl), the #1 prescribed brand for interdigital tinea pedis1

INDICATIONS AND USAGE: NAFTIN (Naftifine HCl) GEL 2% is an allylamine antifungal indicated for the treatment of interdigital tinea pedis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum in patients 12 years of age and older.

IMPORTANT SAFETY INFORMATION

ADVERSE REACTIONS: In clinical trials with NAFTIN GEL 2%, the most common adverse reactions (2%) were application site reactions.

WARNINGS AND PRECAUTIONS: If redness or irritation develops with the use of NAFTIN GEL 2%, treatment should be discontinued.

Please click here for full Prescribing Information about NAFTIN GEL 2%.

Our Products

Sebela Pharmaceuticals is dedicated to providing innovative prescription products to meet patients’ medical needs in gastroenterology, dermatology and women’s health

Professional Resources

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Sebela Pharmaceuticals’ Commitment

Sebela Pharmaceuticals is committed to improving patients’ lives by developing, marketing, and selling differentiated brands of prescription pharmaceuticals for patients whose needs are not adequately satisfied. Sebela Pharmaceuticals’ commercial activities are focused on niche therapeutic markets in the United States, including gastroenterology, dermatology and women’s health.

REFERENCE: 1. IQVIA. National Prescription Audit Report. December 2019.