Mesalamine Rectal 1000 mg/1
Mesalamine · SUPPOSITORY · Amring Pharmaceuticals Inc.
Mesalamine Rectal is a suppository containing mesalamine at 1000 mg/1, taken rectal. Manufactured by Amring Pharmaceuticals Inc..
Key Facts
- Brand Name
- Mesalamine Rectal
- Generic Name
- Mesalamine
- NDC Code (Product)
69918-560- Manufacturer
- Amring Pharmaceuticals Inc.
- Strength
- 1000 mg/1
- Dosage Form
- SUPPOSITORY
- Route
- RECTAL
- Marketing Status
- Application #
- ANDA208362
- Drug Class
- Aminosalicylate [EPC]
- Marketing Start
- 06/24/2019
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1. INDICATIONS AND USAGE Mesalamine Rectal Suppositories are indicated in adults for the treatment of mildly to moderately active ulcerative proctitis. Mesalamine Rectal Suppositories are an aminosalicylate indicated in adults for the treatment of mildly to moderately active ulcerative proctitis. ( 1 )
Dosage & Administration
2. DOSAGE AND ADMINISTRATION Dosage The recommended dosage of Mesalamine Rectal Suppositories in adults is 1000 mg administered rectally once daily at bedtime for 3 to 6 weeks depending on symptoms and sigmoidoscopic findings. Safety and effectiveness of Mesalamine Rectal Suppositories beyond 6 weeks have not been established. Administration Instructions: Evaluate renal function prior to initiation of Mesalamine Rectal Suppository therapy [see Warnings and Precautions (5.1) ] . Do not cut or break the suppository. Retain the suppository for one to three hours or longer, if possible. Drink an adequate amount of fluids [see Warnings and Precautions (5.7) ] If a dose of Mesalamine Rectal Suppositories is missed, administer as soon as possible, unless it is almost time for next dose. Do not use two Mesalamine Rectal Suppositories at the same time to make up for a missed dose. Mesalamine Rectal Suppositories will cause staining of direct contact surfaces, including but not limited to fabrics, flooring, painted surfaces, marble, granite, vinyl, and enamel. Keep Mesalamine Rectal Suppositories away from these surfaces to prevent staining. Dosage The recommended adult dosage is 1000 mg adm…
Contraindications
4. CONTRAINDICATIONS Mesalamine Rectal Suppositories are contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any ingredients in the suppository vehicle [see Warnings and Precautions (5.3) , Adverse Reactions (6.2) , and Description (11) ] . Known or suspected hypersensitivity to salicylates or aminosalicylates or to any ingredients in the formulation. ( 4 , 5.3 )
Drug Interactions
7. DRUG INTERACTIONS Nephrotoxic Agents including NSAIDs: Increased risk of nephrotoxicity; monitor for changes in renal function and mesalamine-related adverse reactions. ( 7.1 ) Azathioprine or 6-Mercaptopurine: Increased risk of blood disorders; monitor complete blood cell counts and platelet counts. ( 7.2 ) 7.1 Nephrotoxic Agents, Including Non-Steroidal Anti-Inflammatory Drugs The concurrent use of mesalamine with known nephrotoxic agents, including nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of nephrotoxicity. Monitor patients taking nephrotoxic drugs for changes in renal function and mesalamine-related adverse reactions [see Warnings and Precautions (5.1) ] . 7.2 Azathioprine or 6-Mercaptopurine The concurrent use of mesalamine with azathioprine or 6-mercaptopurine and/or other drugs known to cause myelotoxicity may increase the risk for blood disorders, bone marrow failure, and associated complications. If concomitant use of Mesalamine Rectal Suppositories and azathioprine or 6-mercaptopurine cannot be avoided, monitor blood tests, including complete blood cell counts and platelet counts. 7.3 Interference With Urinary Normetanephrine Measurements Use…
Adverse Reactions
6. ADVERSE REACTIONS The following serious or clinically significant adverse reactions are described elsewhere in labeling: Renal Impairment [see Warnings and Precautions (5.1) ] Mesalamine-Induced Acute Intolerance Syndrome [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Hepatic Failure [see Warnings and Precautions (5.4) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.5) ] Photosensitivity [see Warnings and Precautions (5.6) ] Nephrolithiasis [see Warnings and Precautions (5.7) ] The most common adverse reactions (≥ 1%) are: dizziness, rectal pain, fever, rash, acne and colitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amring Pharmaceuticals Inc. at 1-844-Amring1 (1-844-267-4641) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reactions in adult patients with mildly to moder…
Frequently Asked Questions
What is Mesalamine Rectal used for?
Mesalamine Rectal contains Mesalamine. It is a suppository taken rectal. Consult your doctor for specific uses.
Is Mesalamine Rectal a controlled substance?
Mesalamine Rectal is not classified as a controlled substance by the DEA.
What is the generic name for Mesalamine Rectal?
The generic name for Mesalamine Rectal is Mesalamine. There are 12 other brand versions of Mesalamine.
What is the NDC code for Mesalamine Rectal 1000 mg/1?
The NDC (National Drug Code) for Mesalamine Rectal 1000 mg/1 is 69918-560, listed by Amring Pharmaceuticals Inc..