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Use the medicine exactly as directed. If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of applesauce.

Swallow the mixture right away. Do not save the mixture for later use. Colazal is usually taken only for a short time 8 to 12 weeks.

Follow your doctor's dosing instructions very carefully. Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose.

Do not take two doses at one time. Get emergency medical help if you have signs of an allergic reaction : hives ; difficult breathing; swelling of your face, lips, tongue, or throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Colazal side effects in more detail. Other drugs may affect Colazal, including prescription and over-the-counter medicines, vitamins , and herbal products.

Tell your doctor about all your current medicines and any medicine you start or stop using. Colazal drug interactions in more detail.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Other brands: Giazo.

The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records.

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Skip to Content. See also: Colazal side effects in more detail. See also: Colazal drug interactions in more detail. Drug Status Availability Prescription only Rx.

Salix Pharmaceuticals, Inc. Bausch Health Companies Inc. Drug Class. Balsalazide disodium has the chemical name E [[[[ 2-carboxyethyl amino]carbonyl] phenyl]azo]hydroxybenzoic acid, disodium salt, dihydrate.

Its structural formula is:. Balsalazide disodium is a stable, orange to yellow crystalline powder. 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 hard gelatin capsule contains colloidal silicon dioxide and magnesium stearate. The sodium content of each capsule is approximately 86 mg.

The carrier moiety released when balsalazide disodium is cleaved is only minimally absorbed and is largely inert. 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. Colazal capsules contain a powder of balsalazide disodium that is insoluble in acid and designed to be delivered to the colon as the intact prodrug.

In a study of adult patients with ulcerative colitis, who received balsalazide, 1. The plasma pharmacokinetics of balsalazide and its key metabolites from a crossover study in healthy volunteers are summarized in Table 3.

In this study, a single oral dose of Colazal 2. A relatively low systemic exposure was observed under all three administered conditions fasting, fed with high-fat meal, sprinkled on applesauce , which reflects the variable, but minimal absorption of balsalazide disodium and its metabolites.

The data indicate that both C max and AUC last were lower, while T max was markedly prolonged, under fed high-fat meal compared to fasted conditions.

Moreover, the data suggest that dosing balsalazide disodium as a sprinkle or as a capsule provides highly variable, but relatively similar mean pharmacokinetic parameter values.

No inference can be made as to how the systemic exposure differences of balsalazide and its metabolites in this study might predict the clinical efficacy under different dosing conditions i.

Following single-dose administration of 2. During this study, subjects received their morning dose 0. No fecal recovery studies were performed in this population.

Use in Specific Populations Pediatric Patients. In studies of pediatric patients with mild-to-moderate active ulcerative colitis receiving three mg Colazal capsules 3 times daily 6.

Likewise, the pharmacokinetics of balsalazide, 5-ASA, and N-AcASA were characterized by very large inter-patient variability, which is also similar to that seen in adult patients.

The pro-drug moiety, balsalazide, appeared to exhibit dose-independent i. However, the absolute magnitude of these exposure parameters was greater relative to adults.

In contrast, the systemic exposure parameters for the active metabolites, 5-ASA and N-AcASA, in pediatric patients increased in a less than dose-proportional manner after the 6.

Additionally, the magnitude of these exposure parameters was decreased for both metabolites relative to adults.

All pharmacokinetic studies with Colazal are characterized by large variability in the plasma concentration versus time profiles for balsalazide and its metabolites, thus half-life estimates of these analytes are indeterminate.

For a kg person of average height this dose represents 2. No symptoms of acute toxicity were seen at these doses. Two randomized, double-blind studies were conducted in adults.

In the first trial, patients with active mild-to-moderate ulcerative colitis with sigmoidoscopy findings of friable or spontaneously bleeding mucosa were randomized and treated with balsalazide 6.

Outcome assessment for rectal bleeding at each interim period week 2, 4, and 8 encompassed a 4-day period 96 hours. Results demonstrated a statistically significant difference between high and low doses of Colazal Figure 1.

A clinical trial was conducted comparing two doses 6. The primary endpoint for this study was the proportion of subjects with clinical improvement defined as a reduction of at least 3 points in the Modified Sutherland Ulcerative Colitis Activity Index [MUCAI] from baseline to 8 weeks.

In both groups, patients with higher MUCAI total scores at baseline were likely to experience greater improvement.

Other brands: Giazo. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records.

Available for Android and iOS devices. Subscribe to Drugs. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment.

Skip to Content. Drug Status Availability Prescription only Rx. Salix Pharmaceuticals, Inc. Bausch Health Companies Inc.

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Pharyngolaryngeal pain. T max h.

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