DRUGS & SUPPLEMENTS

Intazide

Name: Intazide drug & pharmaceuticals. Intazide available forms, doses, prices
Creator: sdrugs.com
Published: 2021-11-11T10:10:10+00:00

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Intazide uses

Indications and usage
Dosage and administration
Dosage forms and strengths
Contraindications
Warnings and precautions
Adverse reactions
Drug interactions
Use in specific populations
Overdosage
Description
Clinical pharmacology
Nonclinical toxicology
Clinical studies
How supplied/storage and handling
Patient counseling information
Intazide reviews

1 INDICATIONS AND USAGE

Intazide is indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. Safety and effectiveness of Intazide beyond 8 weeks in children (ages 5-17 years) and 12 weeks in adults have not been established.

Intazide is a locally acting aminosalicylate indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. (1)
Safety and effectiveness of Intazide beyond 8 weeks in children (ages 5-17 years) and 12 weeks in adults have not been established. (1)

2 DOSAGE AND ADMINISTRATION

Adult dose is three 750 mg Intazide capsules 3 times a day with or without food for 8 weeks. Some adult patients required treatment for up to 12 weeks. (2.1)
Pediatric dose is EITHER: (2.2, 8.4)
1. Three 750 mg Intazide capsules 3 times a day (6.75 g/day) with or without food for 8 weeks.

OR:

One 750 mg Intazide capsule 3 times a day (2.25 g/day) with or without food for up to 8 weeks.
Capsules may be swallowed whole or may be opened and sprinkled on applesauce, then chewed or swallowed immediately. (2.3, 12.3)

2.1 Adult Dose

For treatment of active ulcerative colitis in adult patients, the usual dose is three 750 mg Intazide capsules to be taken 3 times a day (6.75 g per day) for up to 8 weeks. Some patients in the adult clinical trials required treatment for up to 12 weeks.

2.2 Pediatric Dose

For treatment of active ulcerative colitis in pediatric patients, aged 5 to 17 years, the usual dose is EITHER:

three 750 mg Intazide capsules 3 times a day for up to 8 weeks;
OR:
one 750 mg Intazide capsule 3 times a day (2.25 g per day) for up to 8 weeks.

Use of Intazide in the pediatric population for more than 8 weeks has not been evaluated in clinical trials. .

2.3 Administration Alternatives

Intazide capsules may also be administered by carefully opening the capsule and sprinkling the capsule contents on applesauce. The entire drug/applesauce mixture should be swallowed immediately; the contents may be chewed, if necessary, since contents of Intazide are NOT coated beads/granules. Patients should be instructed not to store any drug/applesauce mixture for future use.

If the capsules are opened for sprinkling, color variation of the powder inside the capsules ranges from orange to yellow and is expected due to color variation of the active pharmaceutical ingredient.

Teeth and/or tongue staining may occur in some patients who use Intazide in sprinkle form with food.

3 DOSAGE FORMS AND STRENGTHS

Intazide is available as beige capsules containing 750 mg Intazide disodium and CZ imprinted in black.

Capsules: 750 mg (3)

4 CONTRAINDICATIONS

Patients with hypersensitivity to salicylates or to any of the components of Intazide capsules or Intazide metabolites. Hypersensitivity reactions may include, but are not limited to the following: anaphylaxis, bronchospasm, and skin reaction.

5 WARNINGS AND PRECAUTIONS

Exacerbation of the symptoms of ulcerative colitis was reported in both adult and pediatric patients. Observe patients closely for worsening of these symptoms while on treatment.
Prolonged gastric retention of Intazide may occur in patients with pyloric stenosis. (5.2)

5.1 Exacerbations of Ulcerative Colitis

In the adult clinical trials, 3 out of 259 patients reported exacerbation of the symptoms of ulcerative colitis. In the pediatric clinical trials, 4 out of 68 patients reported exacerbation of the symptoms of ulcerative colitis.

Observe patients closely for worsening of these symptoms while on treatment.

5.2 Pyloric Stenosis

Patients with pyloric stenosis may have prolonged gastric retention of Intazide capsules.

5.3 Renal

Renal toxicity has been observed in animals and patients given other mesalamine products. Therefore, caution should be exercised when administering Intazide to patients with known renal dysfunction or a history of renal disease. .

6 ADVERSE REACTIONS

Most common adverse reactions are headache, abdominal pain, diarrhea, nausea, vomiting, respiratory infection, and arthralgia. Adverse reactions in children were similar. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Adult Ulcerative Colitis

During clinical development, 259 adult patients with active ulcerative colitis were exposed to 6.75 g/day Intazide in 4 controlled trials.

In the 4 controlled clinical trials patients receiving a Intazide dose of 6.75 g/day most frequently reported the following adverse reactions: headache (8%), abdominal pain (6%), diarrhea (5%), nausea (5%), vomiting (4%), respiratory infection (4%), and arthralgia (4%). Withdrawal from therapy due to adverse reactions was comparable among patients on Intazide and placebo.

Adverse reactions reported by 1% or more of patients who participated in the 4 well-controlled, Phase 3 trials are presented by treatment group (Table 1).

The number of placebo patients (35), however, is too small for valid comparisons. Some adverse reactions, such as abdominal pain, fatigue, and nausea were reported more frequently in women than in men. Abdominal pain, rectal bleeding, and anemia can be part of the clinical presentation of ulcerative colitis.

Adverse Reaction

Intazide 6.75 g/day

[N=259]

Placebo

[N=35]

*Adverse reactions occurring in at least 1% of Intazide patients which were less frequent than placebo for the same event were not included in the table.

Abdominal pain

16 (6%)

1 (3%)

Diarrhea

14 (5%)

1 (3%)

Arthralgia

9 (4%)

Rhinitis

6 (2%)

Insomnia

6 (2%)

Fatigue

6 (2%)

Flatulence

5 (2%)

Fever

5 (2%)

Dyspepsia

5 (2%)

Pharyngitis

4 (2%)

Coughing

4 (2%)

Anorexia

4 (2%)

Urinary tract infection

3 (1%)

Myalgia

3 (1%)

Flu-like disorder

3 (1%)

Dry mouth

3 (1%)

Cramps

3 (1%)

Constipation

3 (1%)

Pediatric Ulcerative Colitis

In a clinical trial in 68 pediatric patients aged 5 to 17 years with mildly to moderately active ulcerative colitis who received 6.75 g/day or 2.25 g/day Intazide for 8 weeks, the most frequently reported adverse reactions were headache (15%), abdominal pain upper (13%), abdominal pain (12%), vomiting (10%), diarrhea (9%), colitis ulcerative (6%), nasopharyngitis (6%), and pyrexia (6%). .

One patient who received Intazide 6.75 g/day and 3 patients who received Intazide 2.25 g/day discontinued treatment because of adverse reactions. In addition, 2 patients in each dose group discontinued because of a lack of efficacy.

Adverse reactions reported by 3% or more of pediatric patients within either treatment group in the Phase 3 trial are presented in Table 2.

Intazide

Adverse Reaction

6.75 g/day

[N=33]

2.25 g/day

[N=35]

Total

[N=68]

Headache

5 (15%)

5 (14%)

10 (15%)

Abdominal pain upper

3 (9%)

6 (17%)

9 (13%)

Abdominal pain

4 (12%)

4 (11%)

8 (12%)

Vomiting

1 (3%)

6 (17%)

7 (10%)

Diarrhea

2 (6%)

4 (11%)

6 (9%)

Colitis ulcerative

2 (6%)

4 (6%)

Nasopharyngitis

3 (9%)

1 (3%)

4 (6%)

Pyrexia

0 (0%)

4 (11%)

4 (6%)

Hematochezia

0 (0%)

3 (9%)

3 (4%)

Nausea

0 (0%)

3 (9%)

3 (4%)

Influenza

1 (3%)

2 (6%)

3 (4%)

Fatigue

2 (6%)

1 (3%)

3 (4%)

Stomatitis

0 (0%)

2 (6%)

2 (3%)

Cough

0 (0%)

2 (6%)

2 (3%)

Pharyngolaryngeal pain

2 (6%)

0 (0%)

2 (3%)

Dysmenorrhea

2 (6%)

0 (0%)

2 (3%)

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Intazide in clinical practice:

myocarditis, pericarditis, vasculitis, pruritus, pleural effusion, pneumonia (with and without eosinophilia), alveolitis, renal failure, interstitial nephritis, pancreatitis, and alopecia.

Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These adverse reactions have been chosen for inclusion due to a combination of seriousness, frequency of reporting, or potential causal connection to Intazide.

Hepatic

Postmarketing adverse reactions of hepatotoxicity have been reported for products which contain (or are metabolized to) mesalamine, including elevated liver function tests (SGOT/AST, SGPT/ALT, GGT, LDH, alkaline phosphatase, bilirubin), jaundice, cholestatic jaundice, cirrhosis, hepatocellular damage including liver necrosis and liver failure. Some of these cases were fatal; however, no fatalities associated with these adverse reactions were reported in Intazide clinical trials. One case of Kawasaki-like syndrome which included hepatic function changes was also reported, however, this adverse reaction was not reported in Intazide clinical trials.

7 DRUG INTERACTIONS

In an in vitro study using human liver microsomes, Intazide and its metabolites [5-aminosalicylic acid (5-ASA), N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA), 4-aminobenzoyl-ß-alanine (4-ABA) and N-acetyl-4-aminobenzoyl- ß-alanine (N-Ac-4-ABA)] were not shown to inhibit the major CYP enzymes evaluated (CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A4/5). Therefore, Intazide and its metabolites are not expected to inhibit the metabolism of other drugs which are substrates of CYP1A2, CYP2C9, CYP2C19, CYP2D6, or CYP3A4/5.

In an in vitro study using human liver microsomes, Intazide and its metabolites were not shown to inhibit the major CYP enzymes evaluated (CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A4/5). (7)

8 USE IN SPECIFIC POPULATIONS

Renal impairment: Use Intazide with caution in patients with a history of renal disease.

8.1 Pregnancy

Reproduction studies were performed in rats and rabbits at oral doses up to 2 g/kg/day, 2.4 and 4.7 times the recommended human dose based on body surface area for the rat and rabbit, respectively, and revealed no evidence of impaired fertility or harm to the fetus due to Intazide disodium. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

8.3 Nursing Mothers

It is not known whether Intazide disodium is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Intazide is administered to a nursing woman.

8.4 Pediatric Use

Use of Intazide in pediatric and adolescent patients 5 to 17 years of age for the treatment of mildly to moderately active ulcerative colitis is supported by:

extrapolation of results from clinical studies that supported the approval of Intazide for adults.
a clinical trial of 68 patients ages 5-17 years comparing two doses of Intazide (6.75 g/day and 2.25 g/day), and
a pharmacokinetic study performed on a subset of the pediatric study population. .

Based on the limited data available, dosing can be initiated at either 6.75 or 2.25 g/day.

Safety and efficacy of Intazide in pediatric patients below the age of 5 years have not been established.

10 OVERDOSAGE

No case of overdose has occurred with Intazide. A 3-year-old boy is reported to have ingested 2 g of another mesalamine product. He was treated with ipecac and activated charcoal with no adverse reactions.

If an overdose occurs with Intazide, treatment should be supportive, with particular attention to correction of electrolyte abnormalities.

11 DESCRIPTION

Each Intazide capsule contains 750 mg of Intazide disodium, a prodrug that is enzymatically cleaved in the colon to produce mesalamine (5-aminosalicylic acid or 5-ASA), an anti-inflammatory drug. Each capsule of Intazide (750 mg) is equivalent to 267 mg of mesalamine. Intazide 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: C₁₇H₁₃N₃O₆Na₂●2H₂O

Intazide disodium is a stable, odorless orange to yellow microcrystalline 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.

colazal-1

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Intazide disodium is delivered intact to the colon where it is cleaved by bacterial azoreduction to release equimolar quantities of mesalamine, which is the therapeutically active portion of the molecule, and the 4-aminobenzoyl-ß-alanine carrier moiety. The carrier moiety released when Intazide 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.e., prostanoids, and through the lipoxygenase pathways, i.e., leukotrienes and hydroxyeicosatetraenoic acids, is increased in patients with chronic inflammatory bowel disease, and it is possible that 5-ASA diminishes inflammation by blocking production of arachidonic acid metabolites in the colon.

12.3 Pharmacokinetics

Intazide capsules contain a powder of Intazide disodium that is insoluble in acid and designed to be delivered to the colon as the intact prodrug. Upon reaching the colon, bacterial azoreductases cleave the compound to release 5-ASA, the therapeutically active portion of the molecule, and 4-aminobenzoyl-ß-alanine. The 5-ASA is further metabolized to yield N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA), a second key metabolite.

Absorption

The plasma pharmacokinetics of Intazide and its key metabolites from a crossover study in healthy volunteers are summarized in Table 3. In this study, a single oral dose of Intazide 2.25 g was administered to healthy volunteers as intact capsules (3 x 750 mg) under fasting conditions, as intact capsules (3 x 750 mg) after a high-fat meal, and unencapsulated (3 x 750 mg) as sprinkles on applesauce.

Fasting

N=17

High-fat Meal

N=17

Sprinkled

N=17

C_max (µg/mL)

Balsalazide

0.51 ± 0.32

0.45 ± 0.39

0.21 ± 0.12

5-ASA

0.22 ± 0.12

0.11 ± 0.136

0.29 ± 0.17

N-Ac-5-ASA

0.88 ± 0.39

0.64 ± 0.534

1.04 ± 0.57

AUC_last(µg·hr/mL)

Balsalazide

1.35 ± 0.73

1.52 ± 1.01

0.87 ± 0.48

5-ASA

2.59 ± 1.46

2.10 ± 2.58

2.99 ± 1.70

N-Ac-5-ASA

17.8 ± 8.14

17.7 ± 13.7

20.0 ± 11.4

T_max (h)

Balsalazide

0.8 ± 0.85

1.2 ± 1.11

1.6 ± 0.44

5-ASA

8.2 ± 1.98

22.0 ± 8.23

8.7 ± 1.99

N-Ac-5-ASA

9.9 ± 2.49

20.2 ± 8.94

10.8 ± 5.39

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 Intazide disodium and its metabolites. The data indicate that both C_max and AUC_lastwere lower, while T_max was markedly prolonged, under fed (high-fat meal) compared to fasted conditions. Moreover, the data suggest that dosing Intazide 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 Intazide and its metabolites in this study might predict the clinical efficacy under different dosing conditions (i.e., fasted, fed with high-fat meal, or sprinkled on applesauce) since clinical efficacy after Intazide disodium administration is presumed to be primarily due to the local effects of 5-ASA on the colonic mucosa.

In a separate study of adult patients with ulcerative colitis, who received Intazide, 1.5 g twice daily, for over 1 year, systemic drug exposure, based on mean AUC values, was up to 60 times greater (0.008 µg●hr/mL to 0.480 µg●hr/mL) when compared to that obtained in healthy subjects who received the same dose.

Distribution

The binding of Intazide to human plasma proteins was ≥99%.

Metabolism

The products of the azoreduction of this compound, 5-ASA and 4-aminobenzoyl-ß-alanine, and their N-acetylated metabolites have been identified in plasma, urine and feces.

Elimination

Following single-dose administration of 2.25 g Intazide (three 750 mg capsules) under fasting conditions in healthy subjects, mean urinary recovery of Intazide, 5-ASA, and N-Ac-5-ASA was 0.20%, 0.22% and 10.2%, respectively.

In a multiple-dose study in healthy subjects receiving a Intazide dose of two 750 mg capsules twice daily (3 g/day) for 10 days, mean urinary recovery of Intazide, 5-ASA, and N-Ac-5-ASA was 0.1%, 0%, and 11.3%, respectively. During this study, subjects received their morning dose 0.5 hours after being fed a standard meal, and subjects received their evening dose 2 hours after being fed a standard meal.

In a study with 10 healthy volunteers, 65% of a single 2.25-gram dose of Intazide was recovered as 5-ASA, 4-aminobenzoyl-ß-alanine, and the N-acetylated metabolites in feces, while <1% of the dose was recovered as parent compound.

In a study that examined the disposition of Intazide in patients who were taking 3-6 g of Intazide daily for more than 1 year and who were in remission from ulcerative colitis, less than 1% of an oral dose was recovered as intact Intazide in the urine. Less than 4% of the dose was recovered as 5-ASA, while virtually no 4-aminobenzoyl-ß-alanine was detected in urine. The mean urinary recovery of N-Ac-5-ASA and N-acetyl-4-aminobenzoyl-ß-alanine comprised <16% and <12% of the Intazide dose, respectively. No fecal recovery studies were performed in this population.

Pediatric Population

In studies of pediatric patients with mild-to-moderate active ulcerative colitis receiving three 750 mg Intazide capsules 3 times daily (6.75 g/day) for 8 weeks, steady state was reached within 2 weeks, as observed in adult patients. Likewise, the pharmacokinetics of Intazide, 5-ASA, and N-Ac-5-ASA were characterized by very large inter-patient variability, which is also similar to that seen in adult patients.

The pro-drug moiety, Intazide, appeared to exhibit dose-independent (i.e., dose-linear) kinetics in children, and the systemic exposure parameters (C_max and AUC_0-8) increased in an almost dose-proportional fashion after the 6.75 g/day versus the 2.25 g/day doses. However, the absolute magnitude of these exposure parameters was greater relative to adults. The C_max and AUC_0-8observed in pediatric patients were 26% and 102% greater than those observed in adult patients at the 6.75 g/day dosage level. In contrast, the systemic exposure parameters for the active metabolites, 5-ASA and N-Ac-5-ASA, in pediatric patients increased in a less than dose-proportional manner after the 6.75 g/day dose versus the 2.25 g/day dose. Additionally, the magnitude of these exposure parameters was decreased for both metabolites relative to adults. For the metabolite of key safety concern from a systemic exposure perspective, 5-ASA, the C_max and AUC_0-8observed in pediatric patients were 67% and 64% lower than those observed in adult patients at the 6.75 g/day dosage level. Likewise, for N-Ac-5-ASA, the C_max and AUC_0-8observed in pediatric patients were 68% and 55% lower than those observed in adult patients at the 6.75 g/day dosage level.

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

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 24-month rat carcinogenicity study, oral (dietary) Intazide disodium at doses up to 2 g/kg/day was not tumorigenic. For a 50-kg person of average height this dose represents 2.4 times the recommended human dose on a body surface area basis. Intazide disodium was not genotoxic in the following in vitro or in vivo tests: Ames test, human lymphocyte chromosomal aberration test, and mouse lymphoma cell (L5178Y/TK+/-) forward mutation test, or mouse micronucleus test. However, it was genotoxic in the in vitro Chinese hamster lung cell (CH V79/HGPRT) forward mutation test.

4-aminobenzoyl-ß-alanine, a metabolite of Intazide disodium, was not genotoxic in the Ames test and the mouse lymphoma cell (L5178Y/TK+/-) forward mutation test but was positive in the human lymphocyte chromosomal aberration test. N-acetyl-4-aminobenzoyl-ß-alanine, a conjugated metabolite of Intazide disodium, was not genotoxic in Ames test, the mouse lymphoma cell (L5178Y/TK+/-) forward mutation test, or the human lymphocyte chromosomal aberration test. Intazide disodium at oral doses up to 2 g/kg/day, 2.4 times the recommended human dose based on body surface area, was found to have no effect on fertility and reproductive performance in rats.

13.2 Animal Toxicology

Renal Toxicity

In animal studies conducted at doses up to 2000 mg/kg (approximately 21 times the recommended 6.75 g/day dose on a mg/kg basis for a 70 kg person), Intazide demonstrated no nephrotoxic effects in rats or dogs.

Overdosage

A single oral dose of Intazide disodium at 5 g/kg or 4-aminobenzoyl-ß-alanine, a metabolite of Intazide disodium, at 1 g/kg was non-lethal in mice and rats. No symptoms of acute toxicity were seen at these doses.

14 CLINICAL STUDIES

14.1 Adult Studies

Two randomized, double-blind studies were conducted in adults. In the first trial, 103 patients with active mild-to-moderate ulcerative colitis with sigmoidoscopy findings of friable or spontaneously bleeding mucosa were randomized and treated with Intazide 6.75 g/day or Intazide 2.25 g/day. The primary efficacy endpoint was reduction of rectal bleeding and improvement of at least one of the other assessed symptoms. 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 Intazide (Figure 1).

A second study, conducted in Europe, confirmed findings of symptomatic improvement.

colazal-2

14.2 Pediatric Studies

A clinical trial was conducted comparing two doses (6.75 g/day and 2.25 g/day) of Intazide in 68 pediatric patients (age 5 to 17, 23 males and 45 females) with mildly to moderately active ulcerative colitis. 28/33 (85%) patients randomized to 6.75 g/day and 25/35 (71%) patients randomized to 2.25 g/day completed the study. 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). Fifteen (45%) patients in the Intazide 6.75 g/day group and 13 (37%) patients in the Intazide 2.25 g/day group showed this clinical improvement. In both groups, patients with higher MUCAI total scores at baseline were likely to experience greater improvement.

Rectal bleeding improved in 64% of patients treated with Intazide 6.75 g/day and 54% of patients treated with Intazide 2.25 g/day. Colonic mucosal appearance upon endoscopy improved in 61% of patients treated with Intazide 6.75 g/day and 46% of patients treated with Intazide 2.25 g/day.

16 HOW SUPPLIED/STORAGE AND HANDLING

Intazide is available as beige capsules containing 750 mg Intazide disodium and CZ imprinted in black.

NDC 65649-101-02 Bottles of 280 capsules.

Storage

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F)

17 PATIENT COUNSELING INFORMATION

17.1 Important Precautions Regarding Intazide

Instruct patients not to take Intazide if they have a hypersensitivity to salicylates.
Patients should be instructed to contact their health care provider under the following circumstances:
- If they experience a worsening of their ulcerative colitis symptoms.
- If they are diagnosed with pyloric stenosis, because Intazide capsules may be slow to pass through their digestive tract.
- If they are diagnosed with renal dysfunction. Damage to the kidney has been observed in people given medications similar to Intazide.

17.2 What Patients Should Know About Adverse Reactions

In adult clinical trials the most common adverse reactions were headache, abdominal pain, diarrhea, nausea, vomiting, respiratory infection, and arthralgia.
In the pediatric clinical trial the most common adverse reactions were headache, abdominal pain, vomiting, diarrhea, ulcerative colitis, nasopharyngitis, and pyrexia.
Inform patients that this listing of adverse reactions is not complete and not all adverse reactions can be anticipated. If appropriate, a more comprehensive list of adverse reactions can be discussed with patients.

17.3 What Patients Should Know About Taking Intazide with Other Medication

Based upon limited studies conducted in a test tube, Intazide is not believed to interfere with other drugs by preventing how the liver functions. However, as the studies were limited in scope, you should always consult your doctor and discuss potential interactions prior to initiating any new drug.

Manufactured for:

Salix Pharmaceuticals, Inc., a division of

Valeant Pharmaceuticals North America LLC,

Bridgewater, NJ 08807 USA

By:

Nexgen Pharma

Irvine, CA 92614

Intazide is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.

Product protected by U.S. Patent No. 7,452,872 and U.S. Patent No. 7,625,884

Please see www.salix.com for patent information.

9462601

Rev. 06/2016

NDC 65649-101-02

Intazide^®

(balsalazide disodium)

Capsules

750 mg

280 Capsules

Rx only

Salix

PHARMACEUTICALS

ColazalCarton.jpg

Intazide pharmaceutical active ingredients containing related brand and generic drugs:

Balsalazide

Intazide available forms, composition, doses:

Capsules; Oral; Balsalazide 750 mg

Intazide destination | category:

Human:
GIT regulators, antiflatulents and anti-inflammatories

Intazide Anatomical Therapeutic Chemical codes:

A07EC04 - Balsalazide

Intazide pharmaceutical companies:

Intas Pharmaceuticals

References

Dailymed."BALSALAZIDE DISODIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
"BALSALAZIDE". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
"BALSALAZIDE". http://www.drugbank.ca/drugs/DB0101... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Intazide?

Depending on the reaction of the Intazide after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Intazide not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Intazide addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

Review

sdrugs.com conducted a study on Intazide, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Intazide consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.