Drug Interaction:
Should not be given with lactulose or other drugs which lower pH thereby preventing release of mesalazine.
NSAIDs . Coumarin anti-coagulants
Sulphonyl ureas, methotrexate probenicid
Azathioprine, Sulphinpyrazone, Sulphanolactone
Frusemide, rifampicin, glucocorticoids
Lab test abnormalities:
Elevated AST,ALT, alkaline phophatase, serum creatinine, BUN, amylase,lipase,GGTP, and LDH.
Indication:
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Mesalamine 30-03-2009
PR tablets 1.2gm
For the induction of remission in patients with active, mild to moderate
ulcerative colitis
2.Mesalamine SR 04-04-2002
Bowel Disease Inflammatory
Ulcerative colitis Crohns colitis or ileocolitis
Adverse Reaction:
Sinusitis, interstital pneumonitis, asthma exacerabations, pulmonary infiltrates.
Pericarditis, myocarditis, vasodilations.
Anxiety, depression, somnolence, emotional lability,
Vertigo, nervousness, confusion, parathesia, tremor.
Anorexia, pancreatitis, gastritis
Contra-Indications:
Hypersensitivity to mesalamine, salicylates
Salicylate hpersensitivity or renal sensitivity to sulphasalazine
Severe renal or hepatic impairment
Active peptic ulcer
Bleeding tendencies
Blood clotting anbormalities
Special precautions:
Lactation,pregnancy,children,renal/hepatic dysfunction.
Hepatic impairment
Monitor renal function before and periodically during treatment
Maintain adequate hydration
Raised blood urea or proteinuria
Advice patients to report unusal bleeding
Dosages/ Overdosage Etc:
Approved on 2002
Indications:
Chronic inflammatory bowel disease
Dosage:
Oral- tablets- 800mg 3 times daily for a total dose of 2.4g/day for 6 weeks
Capsules- 1g 4 times daily for a total dose of 4g for upto 8 weeks
Overdosage-
Symptoms
Symptoms of salicylate toxicity may be possible. Such as tinnitus, vertigo, headache, confusion, drowsiness, sweating, hyperventilation, vomiting and diarrhea.
Severe intoxification with salicylates can lead to disruption of electrolyte balance and blood pH, hyperthermia and dehyratation.
Treatment
1. Conventinal therapy of salicylate toxicity may be beneficial in the event of acute overdosage.
2. This includes prevention of further GI tract absorption by emesis and if necessary by gastric lavage
3. Correct fluid and electrolyte imbalance by the administration of appropriate IV therapy
4. Maintain adequate renal function.
Missed dose-
1. If you miss a dose of this medicine, take it as soon as possible.
2. However, if it is almost time for next dose, skip the missed dose and go back to your regular dosing
schedule.
3. Do not double doses.
Other Information:
REFER 5amino salicylic acid- ASA or Mesalamine
Patient Information:
REFER- 5 amio salicylic 0r ASA or Mesalamine
1. Tablets- swallow tablets whole, do not break the outer coating, which is designed to remain intact to protect the active ingredient. In 2 to 3% of patients, intact or partially intact tablets are found in the stool. If this occurs, inform the physician
Pharmacology/ Pharmacokinetics:
Pharmacology:
Sulfasalazine is split by bacterial action in the colon into sulfapyridine (SP) and messalamine
(5-ASA). It is thought that the mesalamine component is therapeutically active in ulcerative colitis.
The mechanism of action is unknown, but appears to be topical than systemic.
Pharmacokinetics:
Mesalamine administered rectally as a suspension enema is poorly absorbed from the colon
and is excreted principally in the feces during subsequent bowel movements.
Pregnancy and lactation:
Pregnancy:
Use during only if needed.
Lactation:
Excercise caution while administering to a nursing woman.
Manufacturer Details