16 HOW SUPPLIED/STORAGE AND HANDLING
Mesalamine 1000 mg suppositories for rectal administration are available as bullet shaped, light tan to grey suppositories containing 1000 mg mesalamine supplied in boxes of 30 individually plastic wrapped suppositories (NDC 59762-0118-3).
Store below 25ºC (77ºF), may be refrigerated. Keep away from direct heat, light or humidity.
Advise patients to read the FDA-approved patient labeling (Patient Information)
Administration [see Dosage and Administration (2)]
- 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.
- If a dose of mesalamine is missed, administer as soon as possible, unless it is almost time for next dose. Do not use two mesalamine suppositories at the same time to make up for a missed dose.
- Mesalamine suppositories will cause staining of direct contact surfaces, including but not limited to fabrics, flooring, painted surfaces, marble, granite, vinyl, and enamel. Keep mesalamine away from these surfaces to prevent staining.
- Inform patients that mesalamine may decrease their renal function, especially if they have known renal impairment or are taking nephrotoxic drugs, including NSAIDs, and periodic monitoring of renal function will be performed while they are on therapy. Advise patients to complete all blood tests ordered by their healthcare provider [see Warnings and Precautions ( 5.1), Drug Interactions ( 7.1)].
Mesalamine-Induced Acute Intolerance Syndrome and Other Hypersensitivity Reactions
- Inform patients of the signs and symptoms of hypersensitivity reactions. Instruct patients to stop taking mesalamine and report to their healthcare provider if they experience new or worsening symptoms Acute Intolerance Syndrome (cramping, abdominal pain, bloody diarrhea, fever, headache, malaise, conjunctivitis and rash) or other symptoms suggestive of mesalamine-induced hypersensitivity [see Warnings and Precautions ( 5.2, 5.3)].
- Inform patients with known liver disease of the signs and symptoms of worsening liver function and advise them to report to their healthcare provider if they experience such signs or symptoms [see Warnings and Precautions ( 5.4)].
- Advise patients with pre-existing skin conditions to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors [see Warnings and Precautions ( 5.5)].
- Instruct patients to drink an adequate amount of fluids during treatment in order to minimize the risk of kidney stone formation and to contact their healthcare provider if they experience signs or symptoms of a kidney stone (e.g., severe side or back pain, blood in the urine) [ see Warnings and Precautions ( 5.6) ].
- Inform elderly patients and those taking azathioprine or 6-mercaptopurine of the risk for blood disorders and the need for periodic monitoring of complete blood cell counts and platelet counts while on therapy. Advise patients to complete all blood tests ordered by their healthcare provider [see Drug Interactions ( 7.2), Use in Specific Populations ( 8.5)].
© 2020 Allergan. All rights reserved.
Patented. See www.allergan.com/patents
For more information, go to www.greenstonellc.com or call 1-800-438-1985
|PATIENT INFORMATION M esalamine suppositories, for rectal use|
|What is mesalamine ? Mesalamine is a prescription medicine used to treat adults with active ulcerative proctitis (ulcerative rectal colitis).It is not known if mesalamine is safe and effective in children.|
|Do not use mesalamine if you are: |
|Before using mesalamine , tell your doctor if you have any medical conditions, including if you : |
| How should I take mesalamine ? |
| What are the possible side effects of mesalamine ? M esalamine may cause serious side effects, including: |
|o cramps||o fever|
|o stomach (abdominal) pain||o headache|
|o bloody diarrhea||o rash|
|o chest pain||o shortness of breath|
|o decrease in the amount of urineo eye inflammation||o fatigue|
|o yellowing of your eyes||o flu-like symptoms|
|o itchy skin||o nausea or vomiting|
|o feeling very tired|
|o dizziness||o rectal pain|
|o acne||o fever|
|o inflammation of the large intestine (colitis)||o rash|
|These are not all of the possible side effects of mesalamine. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.|
| How should I store mesalamine ? |
|General information about the safe and effective use of mesalamine . Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use mesalamine for a condition for which it was not prescribed. Do not give mesalamine to other people, even if they have the same symptoms that you have. It may harm them.You can ask your pharmacist or healthcare provider for information about mesalamine that is written for health professionals.|
|What are the ingredients in mesalamine ? Active ingredients: mesalamineInactive ingredients: hard fat baseDistributed by: Greenstone LLC, Peapack, NJ 07977© 2020 Allergan. All rights reserved. Patented. See www.allergan.com/patents.For more information, go to www.greenstonellc.com or call 1-800-438-1985.|
This Patient Information has been approved by the U.S. Food and Drug Administration Revised: October 2020
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.