Asacol HD

Name: Asacol HD

What other drugs will affect Asacol HD (mesalamine)oral?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • azathioprine;

  • mercaptopurine; or

  • NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may interact with mesalamine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Precautions While Using Asacol HD

It is important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood or urine tests may be needed to check for unwanted effects.

Check with your doctor right away if you have abdominal or stomach pain, bloody diarrhea, cramps, fever, headache, or a rash while you are using this medicine. These may be symptoms of a condition called mesalamine-induced acute intolerance syndrome.

Call your doctor right away if you have difficult breathing or swallowing, a fast heartbeat, itching, rash, or skin redness, or swelling of the face, throat, or tongue. These may be symptoms of an allergic reaction to this medicine.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Do not take antacids (eg, Amphojel®, Maalox®, Mylanta®, Tums®) while you are taking the Apriso™ capsules. Using these medicines together may change the amount of medicine that is released in the body.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Uses of Asacol HD

  • It is used to treat ulcerative colitis.
  • It is used to help keep ulcerative colitis flares from coming back.
  • It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Asacol HD?

  • If you have an allergy to mesalamine, salicylates, sulfasalazine, or any other part of Asacol HD (mesalamine tablets).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Kidney disease or liver disease.
  • If you have had the varicella vaccine in the past 6 weeks.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Asacol HD with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Drug interactions

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

The concurrent use of mesalamine with known nephrotoxic agents, including nonsteroidal anti- inflammatory drugs (NSAIDs) may increase the risk of nephrotoxicity. Monitor patients taking nephrotoxic drugs for changes in renal function and mesalamine-related adverse reactions [see Warnings and Precautions (5.1)].

7.2       Azathioprine or 6-Mercaptopurine

The concurrent use of mesalamine with azathioprine or 6-mercaptopurine may increase the risk for blood disorders. If concomitant use of Asacol HD and azathioprine or 6-mercaptopurine cannot be avoided, monitor blood tests, including complete blood cell counts and platelet counts.

Description

Each Asacol HD delayed-release tablet for oral administration contains 800 mg of mesalamine, an aminosalicylate. Asacol HD delayed-release tablets have an outer protective coat consisting of a combination of acrylic based resins, Eudragit S (methacrylic acid and methyl methacrylate copolymer (1:2), NF) and Eudragit L (methacrylic acid and methyl methacrylate copolymer (1:1), NF). The inner coat consists of an acrylic based resin, Eudragit S, which dissolves at pH 7 or greater, releasing mesalamine in the terminal ileum and beyond for topical anti- inflammatory action in the colon. Mesalamine (also referred to as 5-aminosalicylic acid or 5-ASA) has the chemical name 5-amino-2-hydroxybenzoic acid; its structural formula is:

Inactive Ingredients: Each tablet contains colloidal silicon dioxide, dibutyl sebacate, edible black ink, ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, methacrylic acid and methyl methacrylate copolymer (1:2) (Eudragit S), methacrylic acid and methyl methacrylate copolymer (1:1) (Eudragit L), polyethylene glycol, povidone, sodium starch glycolate, and talc.

For Healthcare Professionals

Applies to mesalamine: compounding powder, oral capsule extended release, oral delayed release capsule, oral delayed release tablet, rectal enema, rectal kit, rectal suppository

General

The most common adverse events were headache, eructation, and aggravation of ulcerative colitis.[Ref]

Gastrointestinal

Very common (10% or more): Eructation (up to 16%), ulcerative colitis aggravated (up to 15%)
Common (1% to 10%): Abdominal pain/cramps/discomfort, diarrhea, flatulence, nausea, gastroenteritis, gastrointestinal hemorrhage, rectal disorder, stool abnormalities (color or texture change), urinary frequency, dyspepsia, vomiting, bloating, rectal distension, pain on insertion of tip (enema formulation), hemorrhoids, rectal pain, colitis, constipation, abdominal distension
Uncommon (0.1% to 1%): Acute pancreatitis, melena (bloody diarrhea), rectal pain/soreness/burning, pancolitis, neonate diarrhea, anal discomfort, defecation urgency, colitis ulcer (proctitis ulcer), glossitis, rectal polyp, pancreatitis, application site irritation (rectal foam formulation), painful rectal tenesmus, rectal urgency
Rare (less than 0.1%): Increased amylase
Frequency not reported: Duodenal ulcer, dysphagia, esophageal ulcer, fecal incontinence, GI bleeding, mouth ulcer, oral candidiasis, rectal bleeding, rectal polyp, mild indigestion and cramping, bloody diarrhea, stomatitis, abdominal enlargement, lipase increase
Postmarketing reports: Frequent bowel movements, mucus stools, painful defecation, proctalgia, rectal discharge, stomach discomfort, gastritis, dry mouth, oral ulcers, perforated peptic ulcer, amylase increased[Ref]

Nervous system

Very common (10% or more): Headache (up to 24%)
Common (1% to 10%): Dizziness
Uncommon (0.1% to 1%): Paresthesia, peripheral neuropathy, somnolence, tremor,
Very rare (less than 0.01%): Vertigo
Frequency not reported: Neuropathy, mild disorientation
Postmarketing reports: Guillain-Barre syndrome, hypertonia, transverse myelitis, hyperesthesia, taste perversion, tinnitus[Ref]

Other

Very common (10% or more): Pain (up to 14%)
Common (1% to 10%): Asthenia, fatigue, pyrexia, infection
Uncommon (0.1% to 1%): Ear pain, peripheral edema
Rare (less than 0.1%): Drug fever
Frequency not reported: Malaise, mesalamine-induced acute intolerance syndrome, plugged ears, adenovirus infection, aching, decreased body mass index,
Postmarketing reports: Medication residue, elevated alkaline phosphatase, elevated GGT, elevated LDH, ear congestion[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis (up to 15%)
Common (1% to 10%): Upper respiratory tract infection, influenza like symptoms, rhinitis, cold/sore throat
Uncommon (0.1% to 1%): Allergic and fibrotic lung reactions, dyspnea, cough, bronchospasm, pleural effusion, alveolitis, pulmonary eosinophilia, lung infiltration, pneumonitis, pharyngolaryngeal pain
Very rare (less than 0.01%): Eosinophilic pneumonia
Frequency not reported: Hypersensitivity pneumonitis (including interstitial pneumonitis, allergic alveolitis, eosinophilic pneumonitis, stuffy head, interstitial pulmonary fibrosis, bronchiolitis obliterans, sinusitis
Postmarketing reports: Fibrosing alveolitis, asthma exacerbation, pleuritis, bronchitis[Ref]

Cardiovascular

Common (1% to 10%): Hypertension, vasodilation,
Uncommon (0.1% to 1%): Pericarditis, myocarditis, pericardial effusion, tachycardia, hypotension
Frequency not reported: Chest pain, T-wave abnormalities, Kawasaki-like syndrome[Ref]

Dermatologic

Common (1% to 10%): Rash, alopecia, urticaria, pruritus, acne
Uncommon (0.1% to 1%): Lupus erythematosus syndrome, allergic exanthema, increased sweating, angioedema, Stevens-Johnson syndrome, face edema
Very rare (less than 0.01%): Reversible alopecia, bullous skin reactions including erythema multiforme
Frequency not reported: Dry skin, eczema, erythema nodosum, nail disorder, photosensitivity, lichen planus, ecchymosis
Postmarketing reports: Prurigo, erythema, psoriasis, pyoderma gangrenosum[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, arthralgia, leg/joint pain
Uncommon (0.1% to 1%): Myalgia, chills, myositis, arthritis
Frequency not reported: Leg cramps, lower back discomfort, muscle cramps, neck pain
Postmarketing reports: Joint disorder, rheumatoid arthritis[Ref]

Hepatic

Common (1% to 10%): Hepatic function abnormal, increased alanine aminotransferase
Uncommon (0.1% to 1%): Hepatitis, increased liver enzymes (transaminase activity), intrahepatic cholestasis, increased bilirubin
Very rare (less than 0.01%): Hepatotoxicity (including cirrhosis, hepatic failure), changes in liver function parameters
Frequency not reported: GGTP increase, SGOT increase, SGPT increase, sclerosing cholangitis, increased alkaline phosphatase
Postmarketing reports: Jaundice, cholestatic jaundice, liver necrosis, cholecystitis[Ref]

Metabolic

Common (1% to 10%): Anorexia
Frequency not reported: Thirst, edema
Postmarketing reports: Increased appetite, gout[Ref]

Ocular

Common (1% to 10%): Vision abnormalities
Uncommon (0.1% to 1%): Conjunctivitis
Postmarketing reports: Blurred vision, eye pain[Ref]

Renal

Uncommon (0.1% to 1%): Acute or chronic interstitial nephritis, renal insufficiency, renal failure, nephrotoxicity
Very rare (less than 0.01%): Nephrotic syndrome, urine discoloration
Frequency not reported: Creatinine clearance decreased
Postmarketing reports: Minimal change nephropathy, elevated serum creatinine and BUN[Ref]

Hematologic

Uncommon (0.1% to 1%): Thrombocytopenia, aplastic anemia, hemolytic anemia, agranulocytosis, leukopenia, neutropenia, pancytopenia, platelet count decreased
Very rare (less than 0.01%): Eosinophilia (as part of an allergic reaction), anemia, bone marrow depression
Frequency not reported: Thrombocythemia
Postmarketing reports: Granulocytopenia, lymphadenopathy[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Allergic reaction, anaphylactic reaction, drug reaction with eosinophilia and systemic symptoms (DRESS)
Frequency not reported: Anaphylactic shock, angioedema[Ref]

Genitourinary

Uncommon (0.1% to 1%): Oligospermia (reversible), UTI/urinary burning
Frequency not reported: Albuminuria, amenorrhea, breast pain, hematuria, hypomenorrhea, menorrhagia, metrorrhagia, urinary frequency
Postmarketing reports: Dysuria, urinary urgency, epididymitis[Ref]

Psychiatric

Uncommon (0.1% to 1%): Insomnia
Frequency not reported: Depression, anxiety, decreased libido
Postmarketing reports: Nervousness, confusion, emotional lability, confusion[Ref]

Some side effects of Asacol HD may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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