(bal SAL a zide)
- Balsalazide Disodium
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral, as disodium:
Colazal: 750 mg
Generic: 750 mg
Tablet, Oral, as disodium:
Giazo: 1.1 g
Brand Names: U.S.
- 5-Aminosalicylic Acid Derivative
- Anti-inflammatory Agent
Balsalazide is a prodrug, converted by bacterial azoreduction to 5-aminosalicylic acid (mesalamine, active), 4-aminobenzoyl-β-alanine (inert), and their metabolites. 5-aminosalicylic acid may decrease inflammation by blocking the production of arachidonic acid metabolites topically in the colon mucosa.
Very low and variable; in children, reported systemic absorption of 5-ASA (active) lower than adults (Cmax: 67% lower, AUC: 64% lower)
Azoreduced in the colon to 5-aminosalicylic acid (active), 4-aminobenzoyl-β-alanine (inert), and N-acetylated metabolites
Feces (65% as 5-aminosalicylic acid, 4-aminobenzoyl-β-alanine, and N-acetylated metabolites); urine (<16% as N-acetylated metabolites); Parent drug: Urine or feces (<1%)
Onset of Action
Delayed; may require several days to weeks (2 weeks); similar in adults and children
Time to Peak
Balsalazide: Capsule: 1 to 2 hours; Tablet: 0.5 hours
Primary effect is topical (colonic mucosa); therapeutic effect appears not to be influenced by the systemic half-life of balsalazide (1.9 hours) or its metabolites (5-ASA [9.5 hours], N-Ac-5-ASA [10.4 hours])
Special Populations Note
Ulcerative colitis: May have increased AUC.
Use: Labeled Indications
Ulcerative colitis: Treatment of mildly- to moderately-active ulcerative colitis
Limitations of use: Efficacy of Giazo has not been demonstrated in females.
Off Label Uses
Ulcerative colitis, remission maintenance
Data from a meta-analysis of randomized, double-blind, placebo controlled trials support the use of balsalazide at standard doses for 6 to 12 months for remission maintenance in ulcerative colitis. Additional trials may be necessary to further define the role of balsalazide for remission maintenance in ulcerative colitis [Ford 2011].
Hypersensitivity to balsalazide or its metabolites, salicylates, or any component of the formulation
Ulcerative colitis: Oral:
Capsule: 2.25 g 3 times daily for 8 to 12 weeks
Tablet: Males: 3.3 g twice daily for up to 8 weeks
Ulcerative colitis, remission maintenance (off-label): 1.5 or 3 g twice daily for 6 to 12 months (Ford 2011)
Refer to adult dosing.
Ulcerative colitis: Children and Adolescents 5 to 17 years: Oral: Capsule: 750 mg 3 times daily for up to 8 weeks or 2.25 g 3 times daily for up to 8 weeks
Dosing: Renal Impairment
There are no dosage adjustments provided in the manufacturer's labeling. Renal toxicity has been observed with other 5-aminosalicylic acid products; use with caution.
Dosing: Hepatic Impairment
There are no dosage adjustments provided in the manufacturer's labeling.
May administer with or without food.
Capsule: May be swallowed whole or may be opened and sprinkled on applesauce. Applesauce mixture may be chewed; swallow immediately, do not store mixture for later use. When sprinkled on food, may cause staining of teeth or tongue.
Some products may contain sodium. Take tablets with or without food.
Store at controlled room temperature of 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
Cardiac Glycosides: 5-Aminosalicylic Acid Derivatives may decrease the serum concentration of Cardiac Glycosides. Monitor therapy
Heparin: 5-Aminosalicylic Acid Derivatives may enhance the adverse/toxic effect of Heparin. Specifically, the risk for bleeding/bruising may be increased. Monitor therapy
Heparins (Low Molecular Weight): 5-Aminosalicylic Acid Derivatives may enhance the adverse/toxic effect of Heparins (Low Molecular Weight). Specifically, the risk for bleeding/bruising may be increased. Monitor therapy
Nonsteroidal Anti-Inflammatory Agents: May enhance the nephrotoxic effect of 5-Aminosalicylic Acid Derivatives. Monitor therapy
Thiopurine Analogs: 5-Aminosalicylic Acid Derivatives may decrease the metabolism of Thiopurine Analogs. Monitor therapy
Varicella Virus-Containing Vaccines: 5-Aminosalicylic Acid Derivatives may enhance the adverse/toxic effect of Varicella Virus-Containing Vaccines. The primary concern is the potential development of Reye's Syndrome, a condition that has been associated with the use of salicylates in children with varicella infections. Consider therapy modification
Central nervous system: Headache (children: 15%; adults: 8%)
Gastrointestinal: Abdominal pain (children: 12% to 13%; adults: ≤6%)
1% to 10%:
Central nervous system: Fatigue (children: 4%; adults: ≤2%), insomnia (adults: 2%)
Gastrointestinal: Vomiting (children: 10%; adults: ≤4%), diarrhea (children: 9%; adults: ≤5%), exacerbation of ulcerative colitis (children: 6%; adults: 1%), nausea (adults: 5%; children: 4%), hematochezia (children: 4%), stomatitis (children: 3%), anorexia (adults: 2%), dyspepsia (adults: 2%), flatulence (adults: ≤2%), abdominal cramps (adults: 1%), constipation (adults: ≤1%), xerostomia (adults: ≤1%)
Genitourinary: Urinary tract infection (adults: 1% to 4%), dysmenorrhea (children: 3%)
Hematologic & oncologic: Anemia (4%)
Neuromuscular & skeletal: Arthralgia (adults: ≤4%), musculoskeletal pain (adults: 2%), myalgia (adults: ≤1%)
Respiratory: Pharyngitis (children: 6%; adults: 2%), flu-like symptoms (children: 4%; adults: 1%), respiratory infection (adults: ≤4%), cough (children: 3%; adults: 2%), pharyngolaryngeal pain (adults: 4%, children: 3%), rhinitis (adults: 2%)
Miscellaneous: Fever (children: 6%; adults: 2%)
<1%, postmarketing, and/or case reports: Alopecia, back pain, bowel urgency, bronchopneumonia, cholestatic jaundice, dizziness, dyspnea, edema, erythema nodosum, facial edema, fecal impaction, gastroenteritis, gastroesophageal reflux disease, hepatic cirrhosis, hepatic failure, hepatic injury, hepatic necrosis, hepatotoxicity, hyperbilirubinemia, hypersensitivity reaction, increased blood pressure, increased heart rate, increased liver enzymes, increased serum AST, interstitial nephritis, jaundice, Kawasaki-like syndrome, lethargy, malaise, myocarditis, pain, pancreatitis, pericarditis, pleural effusion, pneumonia (with and without eosinophilia), pruritus, renal failure, skin rash, vasculitis
Concerns related to adverse effects:
• Colitis: Symptomatic worsening of ulcerative colitis may occur following initiation of treatment.
• Intolerance syndrome: May cause an acute intolerance syndrome (cramping, acute abdominal pain, bloody diarrhea; sometimes fever, headache, rash); discontinue if this occurs.
• Staining: May cause staining of teeth or tongue if capsule is opened and sprinkled on food.
• Hepatic impairment: Use caution in patients with hepatic dysfunction; hepatic failure has been observed with other mesalamine (5-aminosalicylic acid) products.
• Pyloric stenosis: Use with caution in patients with pyloric stenosis; prolonged gastric retention may occur and delay release of drug in the colon.
• Renal impairment: Use with caution in patients with renal impairment; renal toxicity has been observed with other mesalamine (5-aminosalicylic acid) products.
Improvement or worsening of symptoms; renal function (baseline, within first 6 months of initiation, then annually thereafter) (Hanauer 2008); liver function tests (in patients with liver disease)
Pregnancy Risk Factor
Adverse events have not been observed in animal reproduction studies. Mesalamine (5-aminosalicylic acid) is the active metabolite of balsalazide; mesalamine is known to cross the placenta. Refer to the mesalamine monograph for additional information.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience headache, abdominal pain, diarrhea, rhinitis, pharyngitis, common cold symptoms, joint pain, vomiting, or nausea. Have patient report immediately to prescriber signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), severe loss of strength and energy, pain with urination, or signs of ulcerative colitis (severe abdominal pain or cramps; bloody stools; fever; headache; or rash) (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
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- Drug class: 5-aminosalicylates