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mesalamine suppository patient assistance program

by Adolf Kling MD Published 1 year ago Updated 1 year ago
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Patient Assistance & Copay Programs for Mesalamine Patient assistance programs (PAPs) are usually sponsored by pharmaceutical companies and provide free or discounted medicines and copay programs to low income or uninsured and under-insured people who meet specific guidelines. Eligibility requirements vary for each program.

Full Answer

What are patient assistance programs for mesalamine?

Patient Assistance Programs for Mesalamine Patient assistance programs (PAPs) are usually sponsored by pharmaceutical companies and provide free or discounted medicines to low income or uninsured and under-insured people who meet specific guidelines. Eligibility requirements vary for each program.

What are mesalamine suppositories used for?

Mesalamine suppositories are a prescription medicine used to treat adults with active ulcerative proctitis (ulcerative rectal colitis). It is not known if mesalamine suppositories are safe and effective in children. allergic to medicines that contain salicylates, including aspirin.

What is the recommended dosage of mesalamine rectal suppository?

2. DOSAGE AND ADMINISTRATION. The recommended dosage of Mesalamine Rectal Suppository 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 Suppository beyond 6 weeks have not been established.

Can mesalamine suppositories cause renal failure?

WARNINGS AND PRECAUTIONS Renal impairment, including minimal change disease, acute and chronic interstitial nephritis, and renal failure, has been reported in patients given products such as mesalamine suppositories that contain mesalamine or are converted to mesalamine.

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What is mesalamine used for?

Mesalamine is a member of the 5-aminosalicylates drug class and is commonly used for Crohn's Disease, Crohn's Disease - Maintenance, Inflammatory Bowel Disease, and others.

How much does mesalamine cost?

The cost for mesalamine oral delayed release tablet 1.2 g is around $131 for a supply of 30, depending on the pharmacy you visit. Prices are for cash paying customers only and are not valid with insurance plans.

Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

Uses

This medication is used to treat swelling and inflammation of the colon or rectum. It is often used to treat ulcerative colitis.

How To Use

Unwrap the suppository and insert it gently but completely into the rectum, pointed end first. Do not handle the suppository excessively. It may melt. For maximum benefit, keep the suppository in the rectum for 1 to 3 hours or longer. This medication is usually used twice a day. Use this exactly as prescribed.

Side Effects

Dizziness, indigestion, bloating, gas, belching or minor stomach ache may occur the first several days as your body adjusts to the medication. Constipation, diarrhea, weakness, hemorrhoids, cough, dry mouth, hair loss, acne, general body aches, swelling of the feet or ankles (edema) or sweating may also occur.

Precautions

Tell your doctor your medical history, especially of: kidney disease, asthma, allergies (especially to aspirin-like medications or sulfasalazine). This medicine may cause stomach bleeding. Daily use of alcohol, especially when combined with this medicine, may increase your risk for stomach bleeding.

Drug Interactions

Tell your doctor of all over-the-counter and prescription medication you may use, especially of: methotrexate, oral diabetes drugs, certain gout medicines (e.g., probenecid), sulfasalazine, olsalazine, acetazolamide-type drugs (CAI). Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately. This medicine may be harmful if swallowed.

What is a mesalamine suppository?

Mesalamine suppositories are indicated in adults for the treatment of mildly to moderately active ulcerative proctitis.

How long can you use mesalamine suppository?

Do not cut or break the suppository. Use mesalamine suppositories 1 time each day at bedtime, for 3 to 6 weeks. It is not known if mesalamine suppositories are safe and effective for use for longer than 6 weeks.

How much mesalamine is in milk?

The concentration of mesalamine in milk ranged from non-detectable to 0.11 mg/L. The concentration of the N-acetyl-5aminosalicylic acid metabolite ranged from 5 to 18.1 mg/L. Based on these concentrations, estimated infant daily dosages for an exclusively breastfed infant are 0 to 0.017 mg/kg/day of mesalamine and 0.75 to 2.72 mg/kg/day of N-acetyl-5-aminosalicylic acid.

What organs are affected by mesalamine?

Toxicology studies of mesalamine were conducted in rats, mice, rabbits and dogs, and the kidney was the main target organ of toxicity. In rats, adverse renal effects were observed at a single oral dose of 600 mg/kg (about 3.2 times the recommended human intra-rectal dose of mesalamine suppositories, based on body surface area) and at intravenous doses of >214 mg/kg (about 1.2 times the recommended human intra-rectal dose of mesalamine suppositories, based on body surface area). In a 13-week oral gavage toxicity study in rats, papillary necrosis and/or multifocal tubular injury were observed in males receiving 160 mg/kg (about 0.86 times the recommended human intra-rectal dose of mesalamine suppositories, based on body surface area) and in both males and females at 640 mg/kg (about 3.5 times the recommended human intra-rectal dose of mesalamine suppositories, based on body surface area). In a combined 52-week toxicity and 127-week carcinogenicity study in rats, degeneration of the kidneys and hyalinization of basement membranes and Bowman's capsule were observed at oral doses of 100 mg/kg/day (about 0.54 times the recommended human intra-rectal dose of mesalamine suppositories, based on body surface area) and above. 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 suppositories, based on body surface area) was not associated with any adverse effects. In a six-month oral toxicity study in dogs, doses of 80 mg/kg (about 1.4 times the recommended human intra-rectal dose of mesalamine suppositories, based on body surface area) and higher caused renal pathology similar to that described for the rat. 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 suppositories, based on body surface area) produced chronic nephritis and pyelitis. 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 suppositories, based on body surface area) and above.

How long does mesalamine last?

The recommended dosage of mesalamine 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 suppositories beyond 6 weeks have not been established.

What is the active ingredient in mesalamine?

Mesalamine Suppository Description. The active ingredient in mesalamine 1000 mg suppositories for rectal use is mesalamine USP , also known as mesalazine or 5-aminosalicylic acid (5-ASA). Chemically, mesalamine, USP is 5-amino-2-hydroxybenzoic acid, and is classified as an aminosalicylate.

How often is mesalamine given?

The regimen in Study 1 was a 500 mg Mesalamine Suppository administered rectally three times daily and in Study 2 was a 500 mg Mesalamine Suppository administered rectally twice daily. 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. A total of 173 patients were evaluated (Study 1, N=79; Study 2, N=94), of which 89 patients received mesalamine, and 84 patients received placebo. The mean age of patients was 39 years (range 17 to 73 years), 60% were female, and 97% were white.

Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

Uses

This medication is used to treat swelling and inflammation of the colon or rectum. It is often used to treat ulcerative colitis.

How To Use

Swallow tablets whole. Do not crush or chew them. It is important for the outer coating of the tablet to remain intact for the medication to reach the lower intestines. Take this medication exactly as prescribed. Do not increase your dose or take this more often than directed.

Side Effects

Dizziness, indigestion, bloating, gas, belching or minor stomach ache may occur the first several days as your body adjusts to the medication. Constipation, diarrhea, weakness, hemorrhoids, cough, dry mouth, hair loss, acne, general body aches, swelling of the feet or ankles (edema) or sweating may also occur.

Precautions

Tell your doctor your medical history, especially of: kidney disease, asthma, any allergies (especially to aspirin- like medications or to sulfasalazine). This medicine may cause stomach bleeding. Daily use of alcohol, especially when combined with this medicine, may increase your risk for stomach bleeding.

Drug Interactions

Tell your doctor of all over-the-counter and prescription medication you may use, especially of: methotrexate, oral diabetes drugs, certain gout medicines (e.g., probenecid), sulfasalazine, olsalazine, acetazolamide-type drugs (CAI). Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include ringing in ears, headache, confusion, drowsiness, sweating, fast breathing, vomiting, and diarrhea.

Can Medicare patients get extra help?

Medicare patients may qualify for Extra Help from Medicare.

Can you get Delzicol free with no insurance?

You may be eligible to receive free Delzicol capsules if you: Have been prescribed Delzicol capsules. Have limited or no health insurance coverage. Live in the United States. Are being treated by a licensed U.S. health care provider on an outpatient basis.

Is copay assistance available for Medicare?

Available to patients with commercial prescription insurance coverage who meet eligibility criteria. Copay assistance program is not available to patients receiving prescription reimbursement under any federal, state, or government-funded insurance programs (for example, Medicare [including Part D], Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs) or where prohibited by law. Offer subject to change or discontinuance without notice. Restrictions, including monthly maximums, may apply. This is not health insurance.

How much aspartame is in Apriso?

Inform patients with phenylketonuria (PKU) or their caregivers that each APRISO capsule contains aspartame equivalent to 0.56 mg of phenylalanine, so that the recommended adult dosing provides an equivalent of 2.24 mg of phenylalanine per day.

How to report a drug reaction to Salix?

To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-508-0024 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What is APRISO capsule?

APRISO ® (mesalamine) extended-release capsules are indicated for the maintenance of remission of ulcerative colitis (UC) in adults

Is mesalamine a nephrolithiasis?

Cases of nephrolithiasis have been reported with the use of mesalamine, Mesalamine-containing stones are radiotransparent and undetectable by standard radiography or computed tomography ( CT). Ensure adequate fluid intake during treatment with APRISO.

Does mesalamine cause diarrhea?

Symptoms include cramping, acute abdominal pain and bloody diarrhea, sometimes fever, headache, and rash.

Can mesalamine cause liver failure?

There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered mesalamine. Caution should be exercised when administering APRISO to patients with liver disease.

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Important Note

  • The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug. MESALAMINE - RECTAL SUPPOSITORY (mess-A…
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Uses

  • This medication is used to treat swelling and inflammation of the colon or rectum. It is often used to treat ulcerative colitis.
See more on patientassistance.com

How to Use

  • Unwrap the suppository and insert it gently but completely into the rectum, pointed end first. Do not handle the suppository excessively. It may melt. For maximum benefit, keep the suppository in the rectum for 1 to 3 hours or longer. This medication is usually used twice a day. Use this exactly as prescribed. Do not increase your dose or use this ...
See more on patientassistance.com

Side Effects

  • Dizziness, indigestion, bloating, gas, belching or minor stomach ache may occur the first several days as your body adjusts to the medication. Constipation, diarrhea, weakness, hemorrhoids, cough, dry mouth, hair loss, acne, general body aches, swelling of the feet or ankles (edema) or sweating may also occur. If any of these effects persist or worsen, inform your doctor promptly. …
See more on patientassistance.com

Precautions

  • Tell your doctor your medical history, especially of: kidney disease, asthma, allergies (especially to aspirin-like medications or sulfasalazine). This medicine may cause stomach bleeding. Daily use of alcohol, especially when combined with this medicine, may increase your risk for stomach bleeding. Check with your doctor or pharmacist for more information. Tell your doctor if you are …
See more on patientassistance.com

Drug Interactions

  • Tell your doctor of all over-the-counter and prescription medication you may use, especially of: methotrexate, oral diabetes drugs, certain gout medicines (e.g., probenecid), sulfasalazine, olsalazine, acetazolamide-type drugs (CAI). Do not start or stop any medicine without doctor or pharmacist approval.
See more on patientassistance.com

Overdose

  • If overdose is suspected, contact your local poison control center or emergency room immediately. This medicine may be harmful if swallowed.
See more on patientassistance.com

Missed Dose

  • If you miss a dose, use it as soon as remembered; do not use it if it is near the time for the next dose, instead, skip the missed dose and resume your usual dosing schedule. Do not "double-up" the dose to catch up.
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Storage

  • Store suppositories at room temperature between 59 and 79 degrees F (15 to 30 degrees C) away from heat and light. Do not store in the bathroom.
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Indications and Usage

Dosage and Administration

Contraindications

Warnings and Precautions

  • Renal Impairment
    Renal impairment, including minimal change disease, acute and chronic interstitial nephritis, and renal failure, has been reported in patients given products such as mesalamine suppositories that contain mesalamine or are converted to mesalamine. In animal studies, the kidney was the princ…
  • Mesalamine-Induced Acute Intolerance Syndrome
    Mesalamine has been associated with an acute intolerance syndrome that may be difficult to distinguish from an exacerbation of ulcerative colitis. Although the exact frequency of occurrence has not been determined, it has occurred in 3% of patients in controlled clinical trials of mesala…
See more on drugs.com

Adverse Reactions

Drug Interactions

Use in Specific Populations

Overdosage

Description

Clinical Pharmacology

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