MESALAMINE

Generic Name : MESALAMINE

TradeName : 5A tab ASACOL tab COSACOL tab ELMES sachet ETIASA 500 sachet MESACOL LIQ-enema MESACOL SUPPOS. supp MESACOL tab PENTASA-500 SR-tab SALOFALK GR tab TIDOCOL tab WALASA tab

Why it is prescribed (Indications) : Treating and causing remission of various forms of mild to moderate ulcerative colitis (inflammation of the colon). It may also be used for other conditions as determined by your doctor.Controlled-Release Capsules are a 5-aminosalicylic acid (5-ASA). It works by preventing the production of substances that cause inflammation of the colon.

When it is not to be taken (Contraindications) : Hypersensitivity to mesalazine, salicylates and sulfasalazine. Severe impaired kidney or liver function, children less than 2 yr.

When it is to be taken : Oral: Ulcerative colitis Dose is dependant on preparation and brand used. Pentasa® tab: Acute attack: Initially, up to 4 g/day in 2-3 divided doses; maintenance of remission: Initially, 1.5 g/day in 2-3 divided doses, adjust subsequently based on response. Pentasa® granules: Acute attack: Initially, up to 4 g/day in 2-4 doses; maintenance of remission: 2 g/day in 2 divided doses.

How it should be taken : It comes as a delayed-release tablet and a controlled-release capsule to take by mouth and as a suppository and an enema to use in the rectum. The delayed-release tablet is usually taken three times a day, and the controlled-release capsule is usually taken four times a day. The suppository is usually used one to three times a day, and the enema is usually used once a day at bedtime. Should be taken with food. (Take after meals.)

Special Instruction :
 Mild to moderate impaired kidney or liver function (test serum creatinine before treatment, every 3 month for 1st yr, every 6 month for next 4 yr, then annually).  Caution need for patients with history of elderly; active peptic ulcer; pregnancy, lactation; patients predisposed to inflammation of pericardium or heart muscle  Counsel patients to report any unexplained bleeding, bruising, discoloration of the skin, sore throat, fever or malaise during treatment; perform blood count and stop treatment if blood plasma cancer suspected.  Counsel patients taking delayed release tablets to report repeatedly unbroken or partially broken tablets in their faeces. Narrowing of part of the stomach may delay release into colon.

Side Effects :
HEART
Dilatation of blood vessel; inflammation of heart muscle or pericardium(the covering of the heart), abnormal accumulation of fluid in the pericardial cavity.
CENTRAL NERVOUS SYSTEM
Headache; dizziness; weakness, Increased tightness of muscle; fatigue, general discomfort, tiredness, anxiety, migraine, nervousness, tingling, sleeplessness, confusion, depression, emotionallability, peripheral nerve disease, drowsiness, tremor.
SKIN
Rash, itching, sweating, hair loss, acne, dry skin, skin inflammation that results in reddish, painful, tender lumps, psoriasis, deep ulceration, hives.
EENT
Inflammation pharynx, stuffy nose, perception of sound within the human ear in the absence of corresponding external sound, type of dizziness, ear disorder, ear pain, sinusitis, visual abnormalities, inflammation of conjunctiva, sore throat, blurred vision, eye pain, taste perversion.
GI
Abdominal pain, eructation, nausea, abdominal cramps/discomfort, diarrhea, upset stomach, flatulence, constipation, vomiting, ulcerative colitis, gastroenteritis, GI bleeding, rectal disorder, stool abnormalities, bloating, rectal pain, loss of appetite, hemorrhoids, blood in stool, gallstones, dry mouth, increased appetite, oral ulcers, perforated peptic ulcer.
GENITOURINARY
Painful menstruation, urinary tract infection, decreased CrCl, blood in urine, urinary frequency, absence of urine, inflammation of the epididymis, irregular periods, minimal change kidney disease, kidney failure, reversible low sperm, urinary urgency.
BLOOD-LYMPHATIC
Decrease in red blood cells, white blood cells, platelets. Increase in eosinophils, disease of the lymph nodes.
LIVER
Obstruction of bile flow or secretion, increased transaminases, liver damage (including liver necrosis and liver failure), hepatotoxicity (including cholestatic jaundice, hepatitis, and jaundice).
LAB TESTS
Decreased blood volume and hemoglobin, increased triglycerides, elevated alkaline phosphatase, Alanine transaminase, aspartate aminotransferase, bilirubin, blood urea nitrogen, gamma-glutamyltransferase, Lactate dehydrogenase, and serum creatinine.
LOCAL
Pain on insertion of enema tip, rectal pain with suppositories.
METABOLIC-NUTRITIONAL
Peripheral edema, facial edema.
MUSCULOSKELETAL
Back pain, joint pain, muscle pain, joint disorder, inflammation of joints, gout, neck pain.
RESPIRATORY
Difficulty in breathing, inflammation of bronchus, cold, increased cough, sore throat, eosinophil accumulates in the lung, exacerbated asthma, scaring of lungs, inflammation of pleura.
MISCELLANEOUS
Pain; fever; flu syndrome; chest pain, chills; infection; itching; rapid swelling of dermis, drug fever, Kawasaki-like syndrome lupus-like syndrome, autoimmune disease.

Other Precautions :
Consult with your doctor for dosage changes.

Storage Conditions :
Oral: Tablets: store at below 25°C. Capsule: protect from light and store at 15-30°C. Rectal: Store <25°C; may be refrigerated; do not freeze. Protect from direct heat, light and humidity.