Pentasa Microgranules
5 Aminosalicylic Acid (Mesalamine/Mesalazine)
2gm
Radiant Pharmaceutical Ltd.
| Pack size | 60 Sachet |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 186.00 AED |
Available as:
Indications
Pentasa Microgranules is used for:
Inflammatory bowel disease, Ulcerative colitis, Ulcerative proctitis, Crohn's Disease
Adult Dose
Oral
Adult: Dose is dependent on preparation
Ulcerative colitis
Delayed Release (DR) Tablet (400mg)
Treatment of mild to moderate ulcerative colitis, acute attack
2.4 g daily in divided doses
Maintenance of remission of ulcerative colitis
1.2–2.4 g daily in divided doses
Delayed Release (DR) Tablet (800mg)
Acute attack: Induction of remission: Initially, up to 2.4 - 4.8 g daily or in 2-4 divided doses for 6 (six) weeks;
Maintenance of remission: 1.2 - 2.4 g daily in 2-3 divided doses.
Mild acute exacerbations: 2.4 g daily in divided doses.
Moderate acute exacerbations: 4.8 g daily in divided doses.
Controlled Release Capsules (250mg/500mg)
Induction of remission and the symptomatic treatment of mild to moderate active Ulcerative colitis
1 g (4, 250-mg capsules or 2, 500-mg capsules) 4 times a day for a total daily dosage of 4 g.
Treatment duration in controlled trials was up to 8 weeks.
Granules (Sachet) (1 gm/2 gm)
Ulcerative colitis
Individual dosage, up to 4 g daily in divided doses.
Acute attack: Initially, up to 4 g daily in 2-4 divided doses.
Maintenance of remission: 2 g once daily or in divided doses.
Crohn's disease
Delayed Release (DR) Tablet (400mg)
Maintenance treatment: 1.2–2.4 g daily in divided doses
Delayed Release (DR) Tablet (800mg)
Maintenance treatment: up to 2.4 g daily in divided doses
Suppository
Ulcerative proctitis
1 suppository P/R 1-2 times daily.
Child Dose
Oral
Dose is dependent on preparation
Ulcerative colitis
Delayed Release (DR) Tablet (400mg)
Treatment of mild to moderate ulcerative colitis, acute attack
800 mg 3 times a day
Maintenance of remission of ulcerative colitis
400–800 mg 2–3 times a day
Crohn's disease
Delayed Release (DR) Tablet (400mg)
Maintenance of remission of Crohn's disease
400–800 mg 2–3 times a day
Granules/Sachet
Ulcerative colitis
Treatment of mild to moderate ulcerative colitis, acute attack
Children >6 yrs: (body-weight up to 40 kg): 10–20 mg/kg 3 times a day
Body-weight 40 kg and above: 1–2 g twice daily, total daily dose may alternatively be given in 3–4 divided doses
Maintenance of remission of ulcerative colitis
Children >6 yrs: (body-weight up to 40 kg): 7.5–15 mg/kg twice daily, total daily dose may alternatively be given in 3 divided doses
Children >6 yrs: (body-weight 40 kg and above): 2 g once daily
Renal Dose
Renal impairment:
CrCl (ml/min)
<20 Avoid.
Renal impairment
Renal function deteriorates while in therapy: Discontinue use
Administration
May be taken with or without food
Contra Indications
Hypersensitivity to salicylates, aminosalicylates, or any component of the product.- Severe renal impairment (GFR less than 30 mL per minute).- Severe liver impairment.- Gastric and duodenal ulcers- Children under the age of 2 years
Precautions
Mild to moderate impaired renal or hepatic function. Elderly; active peptic ulcer; pregnancy, lactation; patients predisposed to pericarditis or myocariditis.
Sulfasalazine hypersensitivity, renal insufficiency, coagulation abnormalities, pyloric stenosis
Use caution in active PUD, severe renal failure
Do not use with lactulose or drugs that lower intestinal pH
Although pericarditis rarely occurs, investigate any chest pain or dyspnea
Oligospermia has been reported in males
Hepatic failure may occur, particularly with preexisting liver impairment
Worsening of colitis/IBD may occur following the initiation of therapy
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. Patients with pulmonary disease, in particular asthma, should be very carefully monitored during a course of treatment.
Treatment must be stopped immediately if acute symptoms of intolerance occur such as abdominal cramps, acute abdominal pain, fever, severe headache and rash. Paediatric population: There is only limited documentation for an effect in children (age 6-18 years).
Monitoring Parameter:
Monitor hepatic and renal function. Evaluate renal function in all patients prior to initiation and periodically while on therapy. (Test serum creatinine before treatment, every 3 mth for 1st yr, every 6 mth for next 4 yr, then annually)
Evaluate the risks and benefits in patients with known liver impairment.
Pregnancy-Lactation
FDA
Pregnancy: Limited published data on mesalamine use in pregnant women are insufficient to inform a drug-associated risk; no evidence of teratogenicity was observed in rats or rabbits when treated during gestation with orally administered mesalamine at doses greater than the recommended human intra-rectal dose.
Lactation: Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on the breastfed child from therapy or from underlying maternal conditions; mesalamine and its N-acetyl metabolite are present in human milk in undetectable to small amounts; there are limited reports of diarrhea in breastfed infants; there is no information on effects of drug on milk production; monitor breastfed infants for diarrhea.
Interactions
Concurrent use of mesalamine with known nephrotoxic agents, including non-steroidal anti-inflammatory drugs (NSAIDs), may increase risk of nephrotoxicity; monitor patients taking nephrotoxic drugs for changes in renal function and mesalamine-related adverse reactions.
The concurrent use of mesalamine with azathioprine or 6-mercaptopurine and/or any other drugs known to cause myelotoxicity may increase risk for blood disorders, bone marrow failure, and associated complications; if concomitant use of drug and azathioprine or 6-mercaptopurine cannot be avoided, monitor blood tests, including complete blood cell counts and platelet counts.
Contraindicated (0)
Serious - Use Alternative (9)
• dexlansoprazole
• esomeprazole
• lansoprazole
• measles, mumps, rubella and varicella vaccine, live
• nizatidine
• omeprazole
• pantoprazole
• rabeprazole
• varicella virus vaccine live
Adverse Effects
Side effects of 5 Aminosalicylic Acid (Mesalamine/Mesalazine) :
1-10%
Abdominal pain (4-8%)
GI discomfort (4-8%)
Headache (7%)
Flatulence (1-6%)
Nausea (1-6%)
Fatigue (3%)
Asthenia (3%)
Malaise (3%)
Weakness (3%)
Fever (3%)
Exacerbation of colitis (3%)
Dizziness (2-3%)
Rash (1-3%)
Pruritus (1-3%)
Acne (1-3%)
Frequency Not Defined
Pericarditis (rare)
Pharyngitis
Sensitivity reaction
Cholestatic hepatitis
Creatinine clearance decreased
Flu-like syndrome
Discolored urine
Renal Impairment
Mesalamine-induced acute intolerance syndrome
Hypersensitivity reactions
Hepatic failure
Mechanism of Action
Anti-inflammatory agent; mesalamine/mesalazine (5-aminosalicylic acid) is the active component of sulfasalazine, but specific MOA is unknown; probably inhibits prostaglandin and leukotriene synthesis and release in colon. Action may be topical in terminal ileum and colon rather than systemic.
Note
Pentasa 2gm Microgranules manufactured by Radiant Pharmaceutical Ltd.. Its generic name is 5 Aminosalicylic Acid (Mesalamine/Mesalazine). Pentasa is availble in Bangladesh.
Farmaco BD drug index information on Pentasa Microgranules is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.