Version May 2024
Ulcerative colitis, mildly to moderately active (alternative agent): Note: Alternative monotherapy for induction of remission for distal disease, or in combination with topical agents for induction of remission for left-sided/extensive disease or refractory distal disease (Ref).
Induction of remission: Note: Alternative monotherapy for induction of remission for distal disease, or in combination with topical agents for induction of remission for left-sided/extensive disease or refractory distal disease (Ref).
Oral: 2.25 g 3 times daily for 8 to 12 weeks, followed by maintenance dosing.
Maintenance of remission (off-label use): Oral: 1.5 or 3 g twice daily (Ref). Some experts use 2.25 to 6.75 g/day in three divided doses (Ref).
Kidney impairment prior to treatment initiation: 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.
Kidney impairment during treatment: Discontinue use if kidney function deteriorates during treatment.
There are no dosage adjustments provided in the manufacturer's labeling; evaluate risk versus benefit in patients with preexisting impairment.
Refer to adult dosing.
(For additional information see "Balsalazide: Pediatric drug information")
Ulcerative colitis:
Children ≥5 years and Adolescents: Capsules: Oral:
2.25 g (three 750 mg capsules) 3 times daily (total daily dose: 6.75 g/day) for up to 8 weeks.
or
750 mg (one capsule) 3 times daily (total daily dose: 2.25 g/day) for up to 8 weeks.
Note: A multicenter, double-blind clinical trial in pediatric patients (n=68, ages 5 to 17 years) showed clinical improvement in both treatment groups (2.25 g/day and 6.75 g/day); there was not a statistical difference in clinical response between the two treatment groups (Ref).
Adolescents ≥18 years: Capsules: Oral: 2.25 g (three 750 mg capsules) 3 times daily (total daily dose: 6.75 g/day) for up to 12 weeks.
Kidney impairment prior to treatment initiation: 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.
Kidney impairment during treatment: Discontinue use if kidney function deteriorates during treatment.
There are no dosage adjustments provided in manufacturer's labeling; evaluate risk versus benefit in patients with preexisting impairment.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in children, adolescents, and adults unless otherwise indicated.
>10%:
Gastrointestinal: Abdominal pain (6% to 12%), diarrhea (5% to 11%), upper abdominal pain (children and adolescents: 9% to 17%), vomiting (children and adolescents: 3% to 17%; adults: 4%)
Nervous system: Headache (8% to 15%)
Miscellaneous: Fever (children and adolescents: 11%; adults: 2%)
1% to 10%:
Gastrointestinal: Abdominal cramps (adults: 1%), anorexia (adults: 2%), constipation (adults: 1%), dyspepsia (adults: 2%), flatulence (adults: 2%), hematochezia (children and adolescents: 9%), nausea (5% to 9%), stomatitis (children and adolescents: 6%), xerostomia (adults: 1%)
Genitourinary: Dysmenorrhea (children and adolescents: 6%), urinary tract infection (adults: 1%)
Infection: Influenza (children and adolescents: 3% to 6%)
Nervous system: Fatigue (children and adolescents: 3% to 6%; adults: 2%), insomnia (adults: 2%)
Neuromuscular & skeletal: Arthralgia (adults: 4%), myalgia (adults: 1%)
Respiratory: Cough (children and adolescents: 6%; adults: 2%), flu-like symptoms (adults: 1%), nasopharyngitis (children and adolescents: 3% to 9%), pharyngitis (adults: 2%), pharyngolaryngeal pain (children and adolescents: 6%), respiratory tract infection (adults: 4%), rhinitis (adults: 2%)
Postmarketing:
Cardiovascular: Kawasaki-like syndrome, myocarditis, pericarditis, vasculitis
Dermatologic: Acute generalized exanthematous pustulosis, alopecia, pruritus, skin photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis
Gastrointestinal: Pancreatitis
Hepatic: Cholestatic jaundice, hepatic cirrhosis, hepatic failure, hepatic injury (hepatocellular), hepatic necrosis, hepatotoxicity, increased liver enzymes, jaundice
Hypersensitivity: Drug reaction with eosinophilia and systemic symptoms
Renal: Interstitial nephritis, kidney failure, nephrolithiasis
Respiratory: Pleural effusion, pleurisy, pneumonia (with and without eosinophilia), pulmonary alveolitis
Hypersensitivity to balsalazide or its metabolites, aminosalicylates, salicylates, or any component of the formulation.
Concerns related to adverse effects:
• Dermatologic reactions: Severe cutaneous adverse reactions, including acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported. If a reaction occurs, discontinue immediately and consider further evaluation.
• Hypersensitivity reactions: Mesalamine-induced hypersensitivity reactions have been reported and may include internal organ involvement, such as hepatitis, myocarditis, pericarditis, nephritis, hematologic abnormalities, and/or pneumonitis. Monitor for signs and symptoms of hypersensitivity; discontinue treatment if hypersensitivity occurs.
• Intolerance syndrome: May cause an acute intolerance syndrome (cramping, acute abdominal pain, bloody diarrhea; sometimes fever, headache, rash); may be hard to discern from an exacerbation; monitor for worsening of symptoms, and discontinue immediately if syndrome occurs or is suspected.
• Photosensitivity: Use with caution in patients with preexisting skin conditions (including atopic dermatitis and atopic eczema); severe photosensitivity reactions have been reported. Use skin protection (protective clothing and broad-spectrum sunscreen) and avoid prolonged exposure to sunlight and ultraviolet light.
• Renal effects: Renal impairment (including minimal change disease, acute and chronic interstitial nephritis, and renal failure) has been reported. A renal function evaluation is recommended prior to initiation of therapy and periodically during treatment. Evaluate risk versus benefit in patients with renal impairment, history of renal disease, or concurrently taking nephrotoxic medications. Cases of nephrolithiasis (including stones with 100% mesalamine content) have occurred with mesalamine use. Stones may be radiotransparent and undetectable by standard imaging. Ensure patients are adequately hydrated during therapy.
• Staining: May cause staining of teeth or tongue if capsule is opened and sprinkled on food.
• Sulfasalazine hypersensitivity: Patients with hypersensitivity to sulfasalazine may react to mesalamine.
Disease-related concerns:
• GI tract obstruction: Avoid use in patients at risk for upper GI tract obstruction (eg, pyloric stenosis); may cause prolonged gastric retention and delay release of drug in the colon.
• Hepatic impairment: Evaluate risk versus benefit of therapy in patients with hepatic impairment; hepatic failure has been observed with other mesalamine (5-aminosalicylic acid) products.
• Renal impairment: Use with caution in patients with renal impairment, with a history of renal disease, or on nephrotoxic medications.
Special populations:
• Older adult: Use with caution in older adults; uncontrolled studies and postmarketing reports suggest an increased incidence of blood dyscrasias (ie, agranulocytosis, neutropenia, pancytopenia) in patients >65 years of age taking mesalamine-containing products.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral, as disodium:
Colazal: 750 mg
Generic: 750 mg
Yes
Capsules (Balsalazide Disodium Oral)
750 mg (per each): $1.60
Capsules (Colazal Oral)
750 mg (per each): $7.84
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Oral: May administer with or without food. Swallow capsule whole; do not cut, break, crush, or chew. May also be opened and sprinkled on ~10 mL of applesauce if patient cannot swallow whole; mix contents within the 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. Maintain adequate hydration during therapy (to minimize nephrolithiasis risk).
Oral: May administer with or without food; administer with an adequate amount of fluid. Maintain adequate hydration during therapy (to minimize nephrolithiasis risk).
Capsules: Should be swallowed whole or may be opened and sprinkled on applesauce. Applesauce mixture may be chewed if necessary. The entire amount of applesauce mixture should be consumed immediately; do not store mixture for later use. When sprinkled on food, may cause staining of teeth or tongue. Color variation of powder inside capsule (ranging from orange to yellow) is expected.
Ulcerative colitis, mildly to moderately active: Treatment of mildly to moderately active ulcerative colitis in patients ≥5 years of age.
Ulcerative colitis, mildly to moderately active, remission maintenance
Colazal may be confused with Clozaril
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Cardiac Glycosides: 5-Aminosalicylic Acid Derivatives may decrease the serum concentration of Cardiac Glycosides. Risk C: Monitor therapy
Myelosuppressive Agents: 5-Aminosalicylic Acid Derivatives may enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Nonsteroidal Anti-Inflammatory Agents: May enhance the nephrotoxic effect of 5-Aminosalicylic Acid Derivatives. Risk C: Monitor therapy
Thiopurine Analogs: 5-Aminosalicylic Acid Derivatives may enhance the myelosuppressive effect of Thiopurine Analogs. 5-Aminosalicylic Acid Derivatives may increase serum concentrations of the active metabolite(s) of Thiopurine Analogs. Specifically, exposure to the active 6-thioguanine nucleotides (6-TGN) may be increased. Risk C: 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. Management: Avoid administration of salicylates for at least 6 weeks after adminstration of a varicella virus-containing vaccine. Risk D: Consider therapy modification
Vitamin K Antagonists (eg, warfarin): 5-Aminosalicylic Acid Derivatives may enhance the anticoagulant effect of Vitamin K Antagonists. 5-Aminosalicylic Acid Derivatives may diminish the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy
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.
It is not known if balsalazide is present in breast milk.
Mesalamine, 5-aminosalicylic acid, is the active metabolite of balsalazide. Mesalamine is present in breast milk; refer to the mesalamine monograph for additional information. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Breastfed infants should be monitored for diarrhea.
Some products may contain sodium.
Renal function (prior to and periodically during therapy); CBC (particularly in elderly patients); hepatic function; signs/symptoms of worsening acute intolerance syndrome or hypersensitivity reactions.
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.
Absorption: Very low and variable; in children, reported systemic absorption of balsalazide is increased compared to adults, but exposure to 5-ASA (active) is lower than adults (Cmax: 67% lower, AUC: 64% lower); time to steady state: ~2 weeks in pediatric and adult patients.
Protein binding: Balsalazide: ≥99%.
Metabolism: Azoreduced in the colon to 5-aminosalicylic acid (active), 4-aminobenzoyl-β-alanine (inert), and N-acetylated metabolites.
Half-life elimination: 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]).
Time to peak: Balsalazide: 1 to 2 hours.
Excretion: 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%).
Ulcerative colitis: May have increased AUC.
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