Aminosalicylate

Mesalamine

Approved 21 Jun 2019RectalSuppository

The FDA lists this product in 36 strengths and forms.

Indications

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 )

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 )

Warnings and precautions

5. WARNINGS AND PRECAUTIONS

Renal Impairment : Evaluate the risks and benefits in patients with known renal impairment or taking nephrotoxic drugs; monitor renal function. Discontinue Mesalamine Rectal Suppositories if renal function deteriorates. ( 5.1 , 7.1 , 8.6 )
Mesalamine-Induced Acute Intolerance Syndrome : Symptoms may be difficult to distinguish from an exacerbation of ulcerative colitis; monitor for worsening symptoms; discontinue treatment if acute intolerance syndrome is suspected. ( 5.2 )
Hypersensitivity Reactions, including Myocarditis and Pericarditis: Evaluate patients immediately and discontinue if a hypersensitivity reaction is suspected. ( 5.3 )
Hepatic Failure: Evaluate the risks and benefits in patients with known liver impairment. ( 5.4 )
Severe Cutaneous Adverse Reactions: Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. ( 5.5 )
Photosensitivity: Advise patients with pre-existing skin conditions to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors. ( 5.6 )
Nephrolithiasis : Mesalamine-containing stones are undetectable by standard radiography or computed tomography (CT). Ensure adequate hydration during treatment. ( 5.7 )
Interaction with Laboratory Test for Urinary Normetanephrine : Spuriously elevated test results may occur with liquid chromatography with electrochemical detection in patients receiving Mesalamine Rectal Suppositories; use alternative, selective assay for normetanephrine. ( 5.8 )

At a glance

Brand name: Mesalamine
Pharmacologic class: Aminosalicylate
Route: Rectal
Dosage form: Suppository
Applicant: Amring Pharms
Status: Prescription
FDA approval: 21 Jun 2019
Application: ANDA208362-001

Indications

Contraindications

Warnings and precautions

5. WARNINGS AND PRECAUTIONS

Renal Impairment : Evaluate the risks and benefits in patients with known renal impairment or taking nephrotoxic drugs; monitor renal function. Discontinue Mesalamine Rectal Suppositories if renal function deteriorates. ( 5.1 , 7.1 , 8.6 )
Mesalamine-Induced Acute Intolerance Syndrome : Symptoms may be difficult to distinguish from an exacerbation of ulcerative colitis; monitor for worsening symptoms; discontinue treatment if acute intolerance syndrome is suspected. ( 5.2 )
Hypersensitivity Reactions, including Myocarditis and Pericarditis: Evaluate patients immediately and discontinue if a hypersensitivity reaction is suspected. ( 5.3 )
Hepatic Failure: Evaluate the risks and benefits in patients with known liver impairment. ( 5.4 )
Severe Cutaneous Adverse Reactions: Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. ( 5.5 )
Photosensitivity: Advise patients with pre-existing skin conditions to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors. ( 5.6 )
Nephrolithiasis : Mesalamine-containing stones are undetectable by standard radiography or computed tomography (CT). Ensure adequate hydration during treatment. ( 5.7 )
Interaction with Laboratory Test for Urinary Normetanephrine : Spuriously elevated test results may occur with liquid chromatography with electrochemical detection in patients receiving Mesalamine Rectal Suppositories; use alternative, selective assay for normetanephrine. ( 5.8 )

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 .

6.1Clinical 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 Rectal Suppository 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 Rectal Suppositories is 1000 mg administered rectally once daily at bedtime [see Dosage and Administration (2) ] .

6.2Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Mesalamine Rectal Suppositories or 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 disease, nephrolithiasis [see Warnings and Precautions (5.1 , 5.7) ] Urine discoloration occurring ex-vivo caused by contact of mesalamine, including inactive metabolite, with surfaces or water treated with hypochlorite containing bleach Respiratory, Thoracic and Mediastinal Disorders: hypersensitivity pneumonitis (including allergic alveolitis, eosinophilic pneumonitis, interstitial pneumonitis), pleuritis/pleurisy Skin and Subcutaneous Tissue Disorder: alopecia, erythema, erythema nodosum, pruritus, psoriasis, pyoderma gangrenosum, urticaria, SJS/TEN, DRESS and AGEP [see Warnings and Precautions (5.5) ] Urogenital: reversible oligospermia

Mesalamine

Indications

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

Mesalamine

Indications

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

5.1Renal Impairment

5.2Mesalamine-Induced Acute Intolerance Syndrome

5.3Hypersensitivity Reactions

5.4Hepatic Failure

5.5Severe Cutaneous Adverse Reactions

5.6Photosensitivity

5.7Nephrolithiasis Cases

5.8Interaction with Laboratory Test for Urinary Normetanephrine Use

Interactions

7.1Nephrotoxic Agents, Including Non-Steroidal Anti-Inflammatory Drugs

7.2Azathioprine or 6-Mercaptopurine

7.3Interference With Urinary Normetanephrine Measurements Use

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Strengths and forms

Official product information