endobj >> In a 14-day rectal toxicity study of mesalamine suppositories in rabbits, intra-rectal doses up to 800 mg/kg (about 8.6 times the recommended human intra-rectal dose of mesalamine, based on body surface area) was not associated with any adverse effects. Available for Android and iOS devices. /Annots 21 0 R endobj [0 /XYZ 69.5999999 ��9�ā��d�r.|�2�6 ?�l��[�^���vڎO�]�F���/���tP#2_�/�Cj"@a���'���q 0x����*��_K�O4r�����DX���� �?�G�e��P�p��b��: %���ж�u,�z*�0T�t�`Q��).��(������h��Q�EX6�141�{B� �:���u���#Yؘ�����n]�[�a���5�0L�����]�O�ǭ`9t�fAh.��Q���%{Pn���&� \꓀-D/��־��� hXJsr]\� �U�i�"3���.3��(ٌ�o]gw6/�J��R�uA�) 7g�p)�\�`P��"�;�m�ɍ���l����u�-Z�j����U���h!���AW�ɧ�#ժ��Pu���Q'@lk.���-]� endobj If concomitant use of mesalamine suppositories and azathioprine or 6-mercaptopurine cannot be avoided, monitor blood tests, including complete blood cell counts and platelet counts.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 of normetanephrine and mesalamine's main metabolite,  N-acetylaminosalicylic acid. /Length 19 0 R >> Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid, and is classified as an anti-inflammatory drug. /PCSp 4 0 R /CSpg /DeviceGray /F7 7 0 R /Resources 20 0 R In a rectal toxicity study of mesalamine suppositories in dogs, a dose of 166.6 mg/kg (about 3 times the recommended human intra-rectal dose of mesalamine, based on body surface area) produced chronic nephritis and pyelitis. <<

The structural formula is:Each rectal suspension enema unit contains 4 grams of Mesalamine. In both trials, patients had an average extent of proctitis (upper disease boundary) of approximately 10 cm and approximately 80% of patients had multiple prior episodes of proctitis. >> /Type /Page endobj CONTRAINDICATIONS Mesalamine is contraindicated in patients with known or suspected hypersensitivity to salicylates 4. You may report side effects to FDA at 1-800-FDA-1088.Keep mesalamine suppositories and all medicines out of the reach of children.General information about the safe and effective use of mesalamine suppositories.What are the ingredients in mesalamine suppositories?We comply with the HONcode standard for trustworthy health information - Contraindications also include patients with severe renal or hepatic impairment due to the toxic nature of mesalamine in the kidneys and the liver. Keep away from direct heat, light or humidity.Advise patients to read the FDA-approved patient labeling (Patient Information)Mesalamine Suppositories, for rectal use 1000 mg 30s CartonMesalamine Suppositories, for rectal use 1000 mg 42s CartonMesalamine Suppositories, for rectal use 1000 mg Foil front viewMesalamine Suppositories, for rectal use 1000 mg Foil rear viewThe easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. x��]M�ܸ����9��ER�@�����C c�a�C��n����!?TK�ͮ��+�)��n��aKE���UEλ���;�����}U��O����5{�}�}���>_w�=��?��{��7����o����?,~������~������� �y�{_���ٿ&~�3�>j벶l���k�s7p�{���[��������f��������S� �,�G��4W�&�yϊa>W��s���?�\�X��x_� ���e������>5l���I,��`��9��� 0�ț��V`����A�\�i|No W�`�a.m����� In the 12-month eye toxicity study in dogs, keratoconjunctivitis sicca (KCS) occurred at oral doses of 40 mg/kg (about 0.72 times the recommended human intra-rectal dose of mesalamine, based on body surface area) and above.Two double-blind, placebo-controlled, multicenter trials of mesalamine suppositories were conducted in North America in adult patients with mildly to moderately active ulcerative proctitis.

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Adverse reactions seen in pediatric patients in this trial (abdominal pain, headache, pyrexia, pharyngolaryngeal pain, diarrhea and vomiting) were similar to those seen in adult patients.Clinical trials of mesalamine suppositories did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

endobj Evaluate the risks and benefits of using mesalamine suppositories in patients with known liver impairment.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 of normetanephrine and mesalamine's main metabolite,  N-acetylaminosalicylic acid.