ROWASA Rectal suspension (2021)

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Συγγραφείς

Meda Pharmaceuticals

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1. Description

The active ingredient in ROWASA (mesalamine) Rectal Suspension Enema, a disposable (60 mL) unit, is mesalamine, also known as 5-aminosalicylic acid (5-ASA). Chemically, mesalamine is 5-amino-2-hydroxybenzoic ...

2. Clinical Pharmacology

Each ROWASA (mesalamine) Rectal Suspension Enema delivers up to 4 g of mesalamine to the left side of the colon. The mechanism of action of mesalamine (and sulfasalazine) is not fully understood, but appears ...

3. Indications and Usage

ROWASA (mesalamine) Rectal Suspension Enema is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults.

4. Contraindications

ROWASA (mesalamine) Rectal Suspension Enema is contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, sulfites or any other component of this medication. ...

5. Warnings

Hypersensitivity Reactions Sulfite-Related Reactions ROWASA (mesalamine) Rectal Suspension Enema contains potassium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic ...

6. Precautions

Hepatic Failure There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered other products containing mesalamine. Evaluate the risks and benefits of ...

6.4. Drug Interactions

Nephrotoxic Agents, Including Non-Steroidal Anti-Inflammatory Drugs The concurrent use of mesalamine with known nephrotoxic agents, including non‑steroidal anti‑inflammatory drugs (NSAIDs), may increase ...

6.5. Drug/Laboratory Test Interactions

Use of mesalamine may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection because of the similarity in the chromatograms ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Mesalamine caused no increase in the incidence of neoplastic lesions over controls in a 2-year study of Wistar rats fed up to 320 mg/kg/day of mesalamine admixed with diet. Mesalamine is not mutagenic ...

6.7. Pregnancy

Teratologic studies have been performed in rats and rabbits at oral doses up to five and eight times respectively, the maximum recommended human dose, and have revealed no evidence of harm to the embryo ...

6.9. Nursing Mothers

It is not known whether mesalamine or its metabolite(s) are excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human ...

6.10. Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

6.11. Geriatric Use

Clinical trials of ROWASA did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. Reports from uncontrolled clinical studies ...

7. Adverse Reactions

Clinical Adverse Experience ROWASA (mesalamine) Rectal Suspension Enema is usually well tolerated. Most adverse effects have been mild and transient. <b>ADVERSE REACTIONS OCCURRING IN MORE THAN 0.1% OF ...

9. Overdosage

Mesalamine absorption from the colon is limited; however, ROWASA is an aminosalicylate, and symptoms of salicylate toxicity include nausea, vomiting and abdominal pain, tachypnea, hyperpnea, tinnitus, ...

10. Dosage and Administration

The recommended adult dosage of ROWASA (mesalamine) Rectal Suspension Enema in 60 mL units is one rectal instillation (4 grams) once a day, preferably at bedtime, and retained for approximately eight hours. ...

11. How Supplied

ROWASA (mesalamine) Rectal Suspension Enema for rectal administration is an off-white to tan colored suspension. Each disposable enema bottle contains 4.0 grams of mesalamine in 60 mL aqueous suspension. ...

12. Storage and Handling

Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted, please refer to current USP. Once the foil wrapped unit of seven bottles is opened, all enemas should be used promptly ...