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balsalazide disodium

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Overview

What is GIAZO?

Each GIAZO tablet contains 1.1 g of balsalazide disodium, an orally available prodrug that is enzymatically cleaved to produce mesalamine (5‑aminosalicylic acid, 5‑ASA), an anti-inflammatory drug.  Balsalazide disodium has the chemical name (E)-5-[[-4-[[(2-carboxyethyl) amino]carbonyl] phenyl]azo]-2-hydroxybenzoic acid, disodium salt, dihydrate.  Its structural formula is:

Molecular Weight: 437.32

Molecular Formula: CHNONa•2HO

Balsalazide disodium is a stable, odorless, orange to yellow, microcrystalline powder.  It is insoluble in acid, but soluble at a pH of at least 4.5. It is freely soluble in water and isotonic saline, sparingly soluble in methanol and ethanol, and practically insoluble in all other organic solvents. 

Inactive Ingredients: Each tablet contains hypromellose, magnesium stearate, and Opadry II Yellow.  The sodium content of each tablet is approximately 126 mg.



What does GIAZO look like?



What are the available doses of GIAZO?

Tablets: 1.1 g ()

What should I talk to my health care provider before I take GIAZO?

How should I use GIAZO?

GIAZO is indicated for the treatment of mildly to moderately active ulcerative colitis in male patients 18 years of age and older.

Limitations of Use:

The dose is three 1.1 g GIAZO tablets to be taken 2 times a day with or without food (6.6 g per day) for up to 8 weeks.


What interacts with GIAZO?

Sorry No Records found


What are the warnings of GIAZO?

Sorry No Records found


What are the precautions of GIAZO?

Sorry No Records found


What are the side effects of GIAZO?

Sorry No records found


What should I look out for while using GIAZO?

GIAZO is contraindicated in patients with hypersensitivity to salicylates, aminosalicylates or their metabolites, or to any of the components of GIAZO tablets


What might happen if I take too much GIAZO?

No case of overdose has been reported with GIAZO.  GIAZO is an aminosalicylate, and symptoms of salicylate toxicity include: hematemesis, tachypnea, hyperpnea, tinnitus, deafness, lethargy, seizures, confusion, or dyspnea.  Severe intoxication may lead to electrolyte and blood pH imbalance and potentially to other organ (e.g., renal and liver) involvement.  There is no specific antidote for balsalazide overdose.  Proper medical care should be sought immediately with appropriate supportive care, including the possible use of emesis, cathartics, and activated charcoal to prevent further absorption. 


How should I store and handle GIAZO?

Store at How SuppliedGIAZO is available as oval, yellow, film-coated tablets containing 1.1 g balsalazide disodium, with BZT debossed on one side of the tablet.NDC 65649-102-02 Bottles of 180 TabletsStorageStore at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].How SuppliedGIAZO is available as oval, yellow, film-coated tablets containing 1.1 g balsalazide disodium, with BZT debossed on one side of the tablet.NDC 65649-102-02 Bottles of 180 TabletsStorageStore at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].How SuppliedGIAZO is available as oval, yellow, film-coated tablets containing 1.1 g balsalazide disodium, with BZT debossed on one side of the tablet.NDC 65649-102-02 Bottles of 180 TabletsStorageStore at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].How SuppliedGIAZO is available as oval, yellow, film-coated tablets containing 1.1 g balsalazide disodium, with BZT debossed on one side of the tablet.NDC 65649-102-02 Bottles of 180 TabletsStorageStore at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].How SuppliedGIAZO is available as oval, yellow, film-coated tablets containing 1.1 g balsalazide disodium, with BZT debossed on one side of the tablet.NDC 65649-102-02 Bottles of 180 TabletsStorageStore at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Balsalazide is a prodrug of mesalamine (5-aminosalicylic acid, 5-ASA).  The mechanism of action of 5-ASA is unknown, but appears to be local to the colonic mucosa rather than systemic.  Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase pathways, i.e., prostanoids, and through the lipoxygenase pathways, i.e., leukotrienes and hydroxyeicosatetraenoic acids, is increased in patients with ulcerative colitis, and it is possible that 5-ASA diminishes inflammation by blocking production of arachidonic acid metabolites in the colon.

Non-Clinical Toxicology
GIAZO is contraindicated in patients with hypersensitivity to salicylates, aminosalicylates or their metabolites, or to any of the components of GIAZO tablets

Psychotropic Agents:





The use of monoamine oxidase inhibitors (MAOIs) intended to treat depression with buspirone or within 14 days of stopping treatment with buspirone is contraindicated because of an increased risk of serotonin syndrome and/or elevated blood pressure. The use of buspirone within 14 days of stopping an MAOI intended to treat depression is also contraindicated.

Starting buspirone in a patient who is being treated with reversible MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome. (see , and )





After addition of buspirone to the amitriptyline dose regimen, no statistically significant differences in the steady-state pharmacokinetic parameters (C , AUC, and C ) of amitriptyline or its metabolite nortriptyline were observed.





After addition of buspirone to the diazepam dose regimen, no statistically significant differences in the steady-state pharmacokinetic parameters (C , AUC, and C ) were observed for diazepam, but increases of about 15% were seen for nordiazepam, and minor adverse clinical effects (dizziness, headache, and nausea) were observed.





In a study in normal volunteers, concomitant administration of buspirone and haloperidol resulted in increased serum haloperidol concentrations. The clinical significance of this finding is not clear.





[see ].





There is one report suggesting that the concomitant use of Desyrel (trazodone hydrochloride) and buspirone may have caused 3- to 6-fold elevations on SGPT (ALT) in a few patients. In a similar study attempting to replicate this finding, no interactive effect on hepatic transaminases was identified.





Coadministration of buspirone with either triazolam or flurazepam did not appear to prolong or intensify the sedative effects of either benzodiazepine.

Other Psychotropics:

Because the effects of concomitant administration of buspirone with most other psychotropic drugs have not been studied, the concomitant use of buspirone with other CNS-active drugs should be approached with caution.





Buspirone has been shown to be metabolized by CYP3A4.  This finding is consistent with the interactions observed between buspirone and the following:





In a study of nine healthy volunteers, coadministration of buspirone (10 mg as a single dose) with verapamil (80 mg t.i.d.) or diltiazem (60 mg t.i.d.) increased plasma buspirone concentrations (verapamil increased AUC and C of buspirone 3.4-fold while diltiazem increased AUC and C 5.5-fold and 4-fold, respectively.)  Adverse events attributable to buspirone may be more likely during concomitant administration with either diltiazem or verapamil.  Subsequent dose adjustment may be necessary and should be based on clinical assessment.





In a study in healthy volunteers, coadministration of buspirone (10 mg as a single dose) with erythromycin (1.5 g/day for 4 days) increased plasma buspirone concentrations     (5-fold increase in C and 6-fold increase in AUC). These pharmacokinetic interactions were accompanied by an increased incidence of side effects attributable to buspirone.  If the two drugs are to be used in combination, a low dose of buspirone (e.g., 2.5 mg b.i.d.) is recommended. Subsequent dose adjustment of either drug should be based on clinical assessment.





In a study in healthy volunteers, coadministration of buspirone (10 mg as a single dose) with grapefruit juice (200 mL double-strength t.i.d. for 2 days) increased plasma buspirone concentrations (4.3-fold increase in C ; 9.2-fold increase in AUC). Patients receiving buspirone should be advised to avoid drinking such large amounts of grapefruit juice.





In a study in healthy volunteers, coadministration of buspirone (10 mg as a single dose) with itraconazole (200 mg/day for 4 days) increased plasma buspirone concentrations (13-fold increase in C and 19-fold increase in AUC). These pharmacokinetic interactions were accompanied by an increased incidence of side effects attributable to buspirone. If the two drugs are to be used in combination, a low dose of buspirone (e.g., 2.5 mg q.d.) is recommended. Subsequent dose adjustment of either drug should be based on clinical assessment.





In a study of steady-state pharmacokinetics in healthy volunteers, coadministration of buspirone (2.5 or 5 mg b.i.d.) with nefazodone (250 mg b.i.d.) resulted in marked increases in plasma buspirone concentrations (increases up to 20-fold in C and up to 50-fold in AUC) and statistically significant decreases (about 50%) in plasma concentrations of the buspirone metabolite 1-PP. With 5 mg b.i.d. doses of buspirone, slight increases in AUC were observed for nefazodone (23%) and its metabolites hydroxynefazodone (HO-NEF) (17%) and meta-chlorophenylpiperazine (9%). Slight increases in C were observed for nefazodone (8%) and its metabolite HO-NEF (11%).

Subjects receiving buspirone 5 mg b.i.d. and nefazodone 250 mg b.i.d experienced lightheadedness, asthenia, dizziness, and somnolence, adverse events also observed with either drug alone. If the two drugs are to be used in combination, a low dose of buspirone (e.g., 2.5 mg q.d.) is recommended. Subsequent dose adjustment of either drug should be based on clinical assessment.





In a study in healthy volunteers, coadministration of buspirone (30 mg as a single dose) with rifampin (600 mg/day for 5 days) decreased the plasma concentrations (83.7% decrease in C ; 89.6% decrease in AUC) and pharmacodynamic effects of buspirone.  If the two drugs are to be used in combination, the dosage of buspirone may need adjusting to maintain anxiolytic effect.

Other Inhibitors and Inducers of CYP3A4:

Substances that inhibit CYP3A4, such as ketoconazole or ritonavir, may inhibit buspirone metabolism and increase plasma concentrations of buspirone while substances that induce CYP3A4, such as dexamethasone, or certain anticonvulsants (phenytoin, phenobarbital, carbamazepine), may increase the rate of buspirone metabolism.  If a patient has been titrated to a stable dosage on buspirone, a dose adjustment of buspirone may be necessary to avoid adverse events attributable to buspirone or diminished anxiolytic activity. Consequently, when administered with a potent inhibitor of CYP3A4, a low dose of buspirone used cautiously is recommended.  When used in combination with a potent inducer of CYP3A4 the dosage of buspirone may need adjusting to maintain anxiolytic effect.

Other Drugs:





Coadministration of buspirone with cimetidine was found to increase C (40%) and T (2–fold), but had minimal effects on the AUC of buspirone.

Protein Binding:





Therapeutic levels of aspirin, desipramine, diazepam, flurazepam, ibuprofen, propranolol, thioridazine, and tolbutamide had only a limited effect on the extent of binding of buspirone to plasma proteins (see ).

Balsalazide is converted to mesalamine, which has been associated with an acute intolerance syndrome that may be difficult to distinguish from an exacerbation of ulcerative colitis.  In controlled clinical trials with GIAZO in adults with ulcerative colitis, 7% of male patients reported exacerbation of the symptoms of ulcerative colitis.  Symptoms include cramping, acute abdominal pain and bloody diarrhea, sometimes fever, headache, and rash.  Observe patients closely for worsening of these symptoms while on treatment. If acute intolerance syndrome is suspected, promptly discontinue treatment with GIAZO.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

Tips

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Interactions

Interactions

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