Mesalamine
Generic: MESALAMINE
Basic Information
Manufacturer
Rising Pharma Holdings, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
RECTAL
FDA Set ID
de981df1-747a-480d-a866-e72332a1544d
Indications & Usage
1 INDICATIONS AND USAGE Mesalamine suppositories are indicated in adults for the treatment of mildly to moderately active ulcerative proctitis.
Mesalamine suppositories are an aminosalicylate indicated in adults for the treatment of mildly to moderately active ulcerative proctitis.
Mesalamine suppositories are an aminosalicylate indicated in adults for the treatment of mildly to moderately active ulcerative proctitis.
Adverse Reactions
6 ADVERSE REACTIONS The most serious adverse reactions seen in mesalamine suppositories clinical trials or with other products that contain or are metabolized to mesalamine are: • 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) ] The most common adverse reactions (≥ 1%) are: dizziness, rectal pain, fever, rash, acne and colitis.
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharmaceuticals, Inc.
at 1-866-562-4597 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 moderately active ulcerative proctitis in double-blind, placebo-controlled trials are summarized in the Table 1 below.
Table 1: Adverse Reactions Occurring In More Than 1% of Mesalamine Suppository Treated Patients (Comparison to Placebo) Symptom Mesalamine (n = 177) Placebo (n = 84) N % N % Dizziness 5 3 2 2.4 Rectal Pain 3 1.8 0 0 Fever 2 1.2 0 0 Rash 2 1.2 0 0 Acne 2 1.2 0 0 Colitis 2 1.2 0 0 In a multicenter, open-label, randomized, parallel group study in 99 patients comparing the mesalamine 1000 mg suppository administered nightly to that of the mesalamine 500 mg suppository twice daily.
The most common adverse reactions in both groups were headache (14%), flatulence (5%), abdominal pain (5%), diarrhea (3%), and nausea (3%).
Three (3) patients discontinued medication because of an adverse reaction; one of these adverse reactions (headache) was deemed possibly related to study medication.
The recommended dosage of mesalamine suppositories is 1000 mg administered rectally once daily at bedtime [ see Dosage and Administration (2) ] .
6.2 Postmarketing Experience In addition to the adverse reactions reported above in clinical trials involving mesalamine suppositories, the adverse reactions listed below have been identified during post-approval use of mesalamine suppositories and other mesalamine-containing products.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• Body as a Whole: drug fever, fatigue, lupus-like syndrome, medication residue • Cardiac Disorders : myocarditis, pericarditis, pericardial effusion [ see Warnings and Precautions (5.3) ] • Endocrine: Nephrogenic diabetes insipidus • Eye disorders: eye swelling • Gastrointestinal Disorders: abdominal cramps, abdominal distension, anal pruritus, anorectal discomfort, constipation, feces discolored, flatulence, frequent bowel movements, gastrointestinal bleeding, mucus stools, nausea, painful defecation, pancreatitis, proctalgia, rectal discharge, rectal tenesmus, stomach discomfort, vomiting • Hepatic Disorders : cholestatic jaundice, hepatitis, jaundice, Kawasaki-like syndrome including changes in liver enzymes, liver necrosis, liver failure • Hematologic Disorders: agranulocytosis, aplastic anemia, thrombocytopenia • Neurological/Psychiatric Disorders : Guillain-Barre syndrome, peripheral neuropathy, transverse myelitis, intracranial hypertension • Renal Disorders: interstitial nephritis, renal failure, minimal change nephropathy [ see Warnings and Precautions (5.1) ] • Respiratory, Thoracic and Mediastinal Disorders : hypersensitivity pneumonitis (including allergic alveolitis, eosinophilic pneumonitis, interstitial pneumonitis) • Skin and Subcutaneous Tissue Disorder : alopecia, erythema, erythema nodosum, pruritus, psoriasis, pyoderma gangrenosum, urticaria • Urogenital: reversible oligospermia
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharmaceuticals, Inc.
at 1-866-562-4597 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 moderately active ulcerative proctitis in double-blind, placebo-controlled trials are summarized in the Table 1 below.
Table 1: Adverse Reactions Occurring In More Than 1% of Mesalamine Suppository Treated Patients (Comparison to Placebo) Symptom Mesalamine (n = 177) Placebo (n = 84) N % N % Dizziness 5 3 2 2.4 Rectal Pain 3 1.8 0 0 Fever 2 1.2 0 0 Rash 2 1.2 0 0 Acne 2 1.2 0 0 Colitis 2 1.2 0 0 In a multicenter, open-label, randomized, parallel group study in 99 patients comparing the mesalamine 1000 mg suppository administered nightly to that of the mesalamine 500 mg suppository twice daily.
The most common adverse reactions in both groups were headache (14%), flatulence (5%), abdominal pain (5%), diarrhea (3%), and nausea (3%).
Three (3) patients discontinued medication because of an adverse reaction; one of these adverse reactions (headache) was deemed possibly related to study medication.
The recommended dosage of mesalamine suppositories is 1000 mg administered rectally once daily at bedtime [ see Dosage and Administration (2) ] .
6.2 Postmarketing Experience In addition to the adverse reactions reported above in clinical trials involving mesalamine suppositories, the adverse reactions listed below have been identified during post-approval use of mesalamine suppositories and other mesalamine-containing products.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• Body as a Whole: drug fever, fatigue, lupus-like syndrome, medication residue • Cardiac Disorders : myocarditis, pericarditis, pericardial effusion [ see Warnings and Precautions (5.3) ] • Endocrine: Nephrogenic diabetes insipidus • Eye disorders: eye swelling • Gastrointestinal Disorders: abdominal cramps, abdominal distension, anal pruritus, anorectal discomfort, constipation, feces discolored, flatulence, frequent bowel movements, gastrointestinal bleeding, mucus stools, nausea, painful defecation, pancreatitis, proctalgia, rectal discharge, rectal tenesmus, stomach discomfort, vomiting • Hepatic Disorders : cholestatic jaundice, hepatitis, jaundice, Kawasaki-like syndrome including changes in liver enzymes, liver necrosis, liver failure • Hematologic Disorders: agranulocytosis, aplastic anemia, thrombocytopenia • Neurological/Psychiatric Disorders : Guillain-Barre syndrome, peripheral neuropathy, transverse myelitis, intracranial hypertension • Renal Disorders: interstitial nephritis, renal failure, minimal change nephropathy [ see Warnings and Precautions (5.1) ] • Respiratory, Thoracic and Mediastinal Disorders : hypersensitivity pneumonitis (including allergic alveolitis, eosinophilic pneumonitis, interstitial pneumonitis) • Skin and Subcutaneous Tissue Disorder : alopecia, erythema, erythema nodosum, pruritus, psoriasis, pyoderma gangrenosum, urticaria • Urogenital: reversible oligospermia