PCaution when used during lactation - Caution when used during pregnancy

LCaution when used during lactation - Caution when used during lactation

Molecule Info

Indication(s) & Dosage Oral route
Ulcerative colitis
Adult: Dose is dependant on preparation and brand used. Pentasa® tablets: Acute attack: Initially, up to 4 g daily in 2-3 divided doses; maintenance of remission: Initially, 1.5 g daily in 2-3 divided doses, adjust subsequently based on response. Pentasa® granules: Acute attack: Initially, up to 4 g daily in 2-4 doses; maintenance of remission: 2 g daily in 2 divided doses. Asacol® tablets: Acute attack: Initially, 2.4 g daily in divided doses; maintenance of remission: 1.2-2.4 g daily in divided doses. Salofalk® tablets: Acute attack: Initially, 1.5 g daily in 3 divided doses; maintenance of remission: 0.75-1.5 g daily in divided doses. Salofalk® granules: Acute attack: Initially, 1.5-3 g daily in 1-3 divided doses; maintenance of remission: 1.5 g daily in 3 divided doses. 
Child: Dose is dependant on preparation and brand used. Pentasa® tablets: 5-15 yr: Acute attack: 15-20 mg/kg (max: 1 g) tid; maintenance of remission: 10 mg/kg (max: 500 mg) 2-3 times daily. Pentasa® granules: 5-12 yr: Acute attack: 15-20 mg/kg (max: 1 g) tid; maintenance of remission: 10 mg/kg (max: 500 mg) 2-3 times daily. Asacol® tablets: 12-18 yr: Acute attack: Initially, 2.4 g daily in divided doses; maintenance of remission: 1.2-2.4 g daily in divided doses. Salofalk® tablets: 12-18 yr: Acute attack: Initially, 1.5 g daily in 3 divided doses; maintenance of remission: 250-500 mg 2-3 times daily. Salofalk® granules: 6-12 yr: Acute attack: 10-15 mg/kg (max: 1 g) tid; maintenance of remission: 7.5-15 mg/kg (max: 500 mg) bid or 250 mg tid for patients weighing <40 kg.

 

Rectal route

Ulcerative proctitis
Adult: Pentasa® suppository or suspension enema: 1 g daily. Asacol® suppository: 0.75-1.5 g daily in divided doses; Asacol ® foam enema: 1 g daily if disease affects the rectosigmoid regions or 2 g daily if disease affects the descending colon. Salofalk® suppository: 0.5-1 g bid-tid; Salofalk® foam or suspension enema: 2 g daily.
Child: As suppository: Pentasa®: 12-18 yr: 1 g daily for 2-4 wk. Salofalk®: 12-18 yr: 0.5-1 g bid-tid according to response.

Special Condition:

Hepatic impairment: Avoid in severe impairment.

Contraindications Hypersensitivity to mesalazine, salicylates and sulfasalazine. Severe impaired renal (CrCl < 20 ml/min) or hepatic function. Children <2 yr.
Special Precautions Mild to moderate impaired renal or hepatic function (test serum creatinine before treatment, every 3 mth for 1st yr, every 6 mth for next 4 yr, then annually). Elderly; active peptic ulcer; pregnancy, lactation; patients predisposed to pericarditis or myocariditis. Counsel patients to report any unexplained bleeding, bruising, purpura, sore throat, fever or malaise during treatment; perform blood count and stop treatment if blood dyscrasias suspected. Counsel patients taking delayed release tablets to report repeatedly unbroken or partially broken tablets in their faeces. Pyloric stenosis may delay release into colon.
Adverse Drug Reaction(s) Abdominal pain (if new abdominal pain - consider pancreatitis); headache, nausea; flu; fatigue; fever, rash; sore throat; diarrhoea; joint pain; dizziness; bloating; back pain; haemorrhoids; itching; rectal pain, constipation; hair loss; intolerance syndrome; peripheral oedema; UTI; myocarditis, pre-existing pericarditis; pancreatitis; nephritis; hepatitis; lupus-like syndrome; alopecia; myalgia, arthralgia; increased liver enzyme values.
Potentially Fatal: Blood dyscrasias, aplastic anaemia, agranulocytosis; renal toxicity.
Drug Interactions Do not give with lactulose or other drugs which lower pH for they prevent release of mesalazine. May decrease digoxin absorption.
Lab Interference Interferes with tests for glucosuria using copper reagents and for urobilinogen using Erhlick's reagent.
Pregnancy Category (FDA) Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1sttrimester (and there is no evidence of a risk in later trimesters).
Storage 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.
Pharmacology Mesalazine is considered to be the active moiety of sulfasalazine. The mechanism of action is uncertain, but may be due to its ability to inhibit local chemical mediators of the inflammatory response especially leukotriene synthesis in the GI mucosa. Action may be topical in terminal ileum and colon rather than systemic.
Absorption: Absorption variable, depending on formulation and route of admin.
Distribution: Enters breast milk and crosses placenta (small amounts) after oral dosing; protein-binding: 40-80%. Distribution into other tissues: variable depending on route of admin.
Metabolism: Exact metabolism pathways not established. Main site of metabolism is probably liver with some N-acetylation occurring in the intestinal wall and/or lumen (where intestinal flora are involved in the acetylation).
Excretion: Dependant upon route of admin. Eliminated via urine <8% as unchanged metabolites) and faeces (<2%).
ATC Classification A07EC02 - mesalazine; Belongs to the class of aminosalicylic acid and similar antiinflammatory. Used in the treatment of intestinal inflammation.

Search Google: Mesalazine

Brand/Product Info


Total Products : 2  
Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price
MESACOL Sun Pharmaceutical (Bangladesh) Ltd. Mesalazine or 5-aminosalicylic acid 400mg Tablet 50's: 377.50 MRP
MESAMIN 250 Pharmasia Limited Mesalazine or 5-aminosalicylic acid USP 250mg Capsule (extended release) 250mg x 28's: 280.00 MRP

Gen. MedInfo

Why do I need Mesalazine?

Mesalazine is used to treat ulcerative colitis and Crohn's disease. These diseases cause inflammation in the digestive tract (bowel) and are also known as "inflammatory bowel diseases".

Mesalazine helps to relieve the diarrhoea, stomach cramps and pain commonly experienced by people with ulcerative colitis and Crohn's Disease.

How do I take Mesalazine?

Take Mesalazine exactly as directed by your doctor. Do not take more or less than instructed by your doctor. 

You may need to take Mesalazine for some time before the full benefits can be felt. Continue to take it even when you feel better. Do not skip any doses. Do not stop taking Mesalazine unless advised by your doctor to do so. 

Take Mesalazine together with food or immediately after a meal. Swallow Mesalazine whole, do not chew or crush it.

Inform your doctor if you find whole or partially whole tablets in your stool on more than one occasion.

What to do if I have forgotten to take Mesalazine?

Take the missed dose as soon as you remember. 

If it is almost time for your next dose, skip the missed dose and return to your normal dosing schedule. 

DO NOT double a dose under any circumstances. If you often forget to take your medicine, let your doctor know.

When to not use Mesalazine?

Inform your doctor immediately if you are allergic to medicines similar to Mesalazine, such as salicylates (e.g. aspirin) or sulfur-containing drugs (e.g. certain types of antibiotics or diabetes medicine).

Inform your doctor if you have blood disorders, any kidney or liver problems, urinary or intestinal (bowel) blockage or asthma.

Inform your doctor if you are pregnant or if you become pregnant while being treated with Mesalazine.

What to take note of while taking Mesalazine?

Inform your doctor if you are breastfeeding.

You may need to have regular blood tests to make sure that your blood counts and kidney function are normal while you are being treated with Mesalazine. Your doctor will advise you about how often you need to have these blood tests.

What side effects could I experience?

Mesalazine may cause nausea, vomiting, constipation, stomach pain, bloating and wind in the stomach, headache, back pain, muscle ache, rash, itch, problems sleeping (insomnia), cough or runny nose. 

Mesalazine may also cause dizziness and tiredness. If you feel dizzy, do not drive or take part in any activity in which you need to be Inform. 

If you feel that your bowel problems became worse after taking Mesalazine, let your doctor know.

Other side effects are not common, but may be serious. Inform your doctor immediately if you experience any of these symptoms: 
- chest pain or difficulty breathing
- rash, headache, fever, bloody diarrhoea, stomach cramps
- fever, sore throat, mouth ulcers, unusual bruising or bleeding

Can I take this with other medicines?

Inform your doctor if you are taking any other medicines, especially those listed here:

- heart medicines such as digoxin and talinolol 
- blood-thinning medicine such as warfarin
- TB medicines such as rifampicin and ethambutol
- other medicines such as ciclosporin, azathioprine, mercaptopurine, thioguanine and methotrexate

Always inform your doctor if you are taking any other medicines, including herbal tonics, supplements and medicines that you buy without a prescription.

What special dietary instructions to follow?

Avoid alcohol.

How to store Mesalazine?

Store in a cool, dry place away from the reach of children.
Medicines must be used within the expiry date.