Dosing & Uses
Dosage Forms & Strengths
capsule
- 750mg (Colazal)
tablet
- 1.1g (Giazo)
Ulcerative Colitis
Colazal: 3 capsules (2.25 g total) PO TID (total dose 6.75 g/day x 8-12 weeks
Giazo (males): 3 tablets (3.3 g total) PO BID (total dose 6.6 g/day) x 8 weeks
Dosing Considerations
Giazo: Locally acting aminosalicylate indicated for the treatment of mildly to moderately active ulcerative colitis in male patients 18 years of age and older; effectiveness in female patients was not demonstrated in clinical trials
Administration
May take with or without food
Colazal: Swallow capsule whole, or open capsule, sprinkle contents on applesauce and chew or swallow immediately
Dosage Forms & Strengths
capsule
- 750mg (Colazal)
Ulcerative Colitis
Giazo: Safety and efficacy not established in children <18 years
5-17 years (Colazal)
- <5 years: Safety and efficacy not established
- May initiate at either 6.75 g/day or 2.25 g/day
- 3 capsules (2.25 g total) PO TID (total dose 6.75 g/day) x8 weeks, OR
- 1 capsule (750 mg) PO TID (total dose 2.25 g/day) for up to 8 weeks
Administration
May take with or without food
Colazal: Swallow whole, or open capsule, sprinkle contents on applesauce and chew or swallow immediately
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
>10%
Headache (15% peds)
Abdominal pain (13% peds )
Vomiting (10% peds)
1-10% (Adults)
Headache (8%)
Abdominal pain (6%)
Nausea (5%)
Diarrhea (5%)
Respiratory infection (4%)
Arthralgia (4%)
Vomiting (4%)
Fatigue (2%)
Insomnia (2%)
Cough (2%)
Pharyngitis (2%)
Rhinitis (2%)
Dyspepsia (2%)
Anorexia (2%)
Flatulence (2%)
Fever (2%)
Constipation (1%)
Cramps (1%)
Ulcerative colitis exacerbation (1%)
Flu like syndrome (1%)
Myalgia (1%)
UTI (1%)
Xerostomia (1%)
1-10% (Pediatrics)
Diarrhea (9%)
Fever (6%)
Ulcerative colitis exacerbation (6%)
Pharyngitis (6%)
Fatigue (4%)
Flu like syndrome (4%)
Nausea (4%)
Hematochezia (4%)
Cough (3%)
Dysmenorrhea (3%)
Stomatitis (3%)
Warnings
Contraindications
Hypersensitivity to salicylates, balsalazide, mesalamine
Cautions
Sulfasalazine hypersensitivity, coagulation abnormalities, pyloric stenosis, renal/hepatic impairment, allergy, asthma
Risk of exacerbation of ulcerative colitis
Pregnancy & Lactation
Pregnancy Category: B
Lactation: not known whether drug or metabolites are distributed into breast milk, use caution
Pregnancy Categories
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Pharmacology
Mechanism of Action
Metabolized to mesalamine by intestinal flora
Mesalamine (5-aminosalicylic acid) has anti-inflammatory effect; active component of sulfasalazine, specific MOA unknown; probably inhibits prostaglandin & leukotrienes synthesis & release in colon
Absorption
Bioavailability: Low absorption
Onset: 10 days to 2 wk
Peak Plasma Time: 1-2 hr
Distribution
Protein Bound: 99%
Vd: mesalamine: 0.2 L/kg
Metabolism
Following oral administration, balsalazide passes intact into colon where it is cleaved by intestinal flora to form mesalamine and 4-aminobenzoyl-b-alanine
Mesalamine is rapidly acetylated in colon wall and liver, independent of pt. acetylator status, into N-acetyl-5-aminosalycylic acid
Metabolites: mesalamine (active), N-acetyl-5-aminosalycylic acid (inactive), 4-aminobenzoyl-b-alanine (inactive)
Elimination
Half-Life: Undetermined due to large intersubject variability
Excretion: Feces (as metabolites) >65%; urine (as metabolites) >25%
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Patient Handout
Formulary
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