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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You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:

• Concurrent use with monoamine oxidase inhibitors (MAOIs)
  - or use within 14 days of MAOI use
  - or starting BRISDELLE in a patient who is being treated with linezolid
  - or intravenous methylene blue
  Because of an increased risk of serotonin syndrome.
• Concomitant use with thioridazine or pimozide due to their increased plasma concentrations and because of the potential of QTc prolongation.
• Hypersensitivity to any ingredient in BRISDELLE.
• Pregnancy because BRISDELLE may cause fetal harm.

WARNINGS AND PRECAUTIONS:

• Suicidality: All patients being treated with BRISDELLE should be observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of treatment.
• Serotonin Syndrome: Serotonin syndrome, which is potentially life-threatening, has been reported with concomitant use of serotonergic drugs, and with drugs that impair metabolism of serotonin (in particular, MAOIs). Monitor patients for the emergence of serotonin syndrome. Discontinue BRISDELLE and any concomitant serotonergic agents and initiate supportive treatment.
• Tamoxifen: Efficacy of tamoxifen may be reduced when administered concomitantly with BRISDELLE.
• Abnormal Bleeding: SSRIs, including BRISDELLE, may increase the risk of bleeding events. Caution patients about the risk of bleeding associated with the concomitant use of BRISDELLE and non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, or other drugs that affect coagulation.
• Angle Closure Glaucoma: Angle-closure glaucoma has occurred in patients treated with antidepressants with untreated anatomically narrow angles
• Hyponatremia: may occur as a result of treatment with SSRIs, including BRISDELLE. Elderly patients may be at greater risk and in many cases it can occur in association with syndrome of inappropriate antidiuretic hormone secretion (SIADH). Consider discontinuation of BRISDELLE in patients with symptomatic hyponatremia and institute appropriate medical intervention.
• Bone fracture: Epidemiological studies have reported an association between SSRI treatment and fractures.
• Activation of Mania/Hypomania: Screen for bipolar disorder and monitor for mania/ hypomania.
• Seizures: Use cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold.
• Akathisia: Can occur, most likely in the first few weeks of treatment. Discontinue treatment with BRISDELLE if akathisia occurs.
• Cognitive and Motor Impairment: May cause impairment; patients should not operate machinery or motor vehicles until certain that BRISDELLE does not affect them adversely.

ADVERSE REACTIONS:

The most common adverse reactions (≥ 2%) reported in clinical trials were: headache, fatigue, and nausea and vomiting. Of these, nausea occurred primarily within the first 4 weeks of treatment and fatigue occurred primarily within the first week of treatment, and decreased in frequency with continued therapy.

To report SUSPECTED ADVERSE REACTIONS, contact Sebela Pharmaceuticals Inc. at 888-271-4621 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DRUG INTERACTIONS:

Paroxetine is a strong CYP2D6 inhibitor. Co-administration of BRISDELLE can alter concentrations of other drugs that are metabolized by CYP2D6. Use caution if coadministering BRISDELLE with other drugs that are metabolized by CYP2D6.

INDICATION

BRISDELLE^® (paroxetine) is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.

BRISDELLE is not indicated for the treatment of any psychiatric condition. BRISDELLE contains a lower dose of paroxetine than that used for psychiatric conditions. The safety and efficacy of this lower dose of paroxetine in BRISDELLE have not been established for any psychiatric condition. Patients who require paroxetine for treatment of a psychiatric condition should discontinue BRISDELLE and initiate a paroxetine-containing medication that is indicated for such use.

These are not all the possible side effects of BRISDELLE. Please read the full Prescribing Information including Boxed WARNING and patient Medication Guide.

BRISDELLE^® is a registered trademark of Sebela Pharmaceuticals Inc.

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.

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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.

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IMPORTANT SAFETY INFORMATION Pramosone^® Lotion 2.5% (Hydrocortisone Acetate 2.5% and Pramoxine HCl 1%) is 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.

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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.

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