SUTAB (Page 3 of 5)

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of SUTAB. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal: gastric ulceration, gastritis

Hypersensitivity: anaphylaxis, angioedema, dyspnea, rash, pruritus, urticaria [see Warnings and Precautions ( 5.7)]

7 DRUG INTERACTIONS

7.1 Drugs That May Increase Risks of Fluid and Electrolyte Abnormalities

Use caution when prescribing SUTAB to patients taking medications that increase the risk of fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities [see Warnings and Precautions ( 5.1, 5.2, 5.3, 5.4)] .

7.2 Potential for Reduced Drug Absorption

SUTAB can reduce the absorption of other co-administered drugs [see Dosage and Administration ( 2.1)] :

  • Administer oral medications at least one hour before starting each dose of SUTAB.
  • Administer tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, and penicillamine at least 2 hours before and not less than 6 hours after administration of each dose of SUTAB to avoid chelation with magnesium.

7.3 Stimulant Laxatives

Concurrent use of stimulant laxatives and SUTAB may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking SUTAB [see Warnings and Precautions ( 5.5)] .

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There are no available data on SUTAB use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. No reproduction or developmental studies in animals have been conducted with sodium sulfate, magnesium sulfate, and potassium chloride (SUTAB).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

8.2 Lactation

Risk Summary

There are no available data on the presence of SUTAB in human or animal milk, the effects of on the breastfed child, or the effects on milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SUTAB and any potential adverse effects on the breastfed child from SUTAB or from the underlying maternal condition.

8.4 Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

8.5 Geriatric Use

Of the 471 patients who received SUTAB in pivotal clinical trials, 150 (32%) were 65 years of age or older, and 25 (5%) were 75 years of age or older. No differences in safety or effectiveness of SUTAB were observed between geriatric patients and younger patients. Elderly patients are more likely to have decreased hepatic, renal or cardiac function and may be more susceptible to adverse reactions resulting from fluid and electrolyte abnormalities [see Warnings and Precautions ( 5.1)] .

8.6 Renal Impairment

Use SUTAB with caution in patients with renal impairment or patients taking concomitant medications that may affect renal function. These patients may be at risk for renal injury. Advise these patients of the importance of adequate hydration before, during and after use of SUTAB and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see Warning and Precautions ( 5.4)] .

10 OVERDOSAGE

Overdosage of more than the recommended dose of SUTAB may lead to severe electrolyte disturbances, as well as dehydration and hypovolemia, with signs and symptoms of these disturbances [see Warnings and Precautions ( 5.1, 5.2, 5.3)] . Monitor for fluid and electrolyte disturbances and treat symptomatically.

11 DESCRIPTION

SUTAB (sodium sulfate, magnesium sulfate, and potassium chloride) tablets is an orally administered osmotic laxative and is provided as two bottles, each containing 12 tablets. Each tablet contains: 1.479 g sodium sulfate, 0.225 g magnesium sulfate, and 0.188 g potassium chloride. Inactive ingredients include: polyethylene glycol 8000, sodium caprylate, and ethylene glycol and vinyl alcohol graft copolymer.

Sodium Sulfate, USP

The molecular formula is Na 2 SO 4 . The average molecular weight is 142.04. The structural formula is:

Sodium Sulfate

Magnesium Sulfate, USP

The molecular formula is MgSO 4 . The average molecular weight is 120.37. The structural formula is:

Magnesium Sulfate

Potassium Chloride, USP

The molecular formula is KCl. The average molecular weight is 74.55. The structural formula is:

Potassium ChlorideSodium SulfateMagnesium SulfatePotassium Chloride

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The primary mode of action is osmotic action of sodium sulfate and magnesium sulfate, which induce a laxative effect. The physiological consequence is increased water retention in the lumen of the colon, resulting in loose stools.

12.3 Pharmacokinetics

Absorption
After the oral administration of SUTAB to patients in clinical studies, the median serum sulfate concentration increased by about 2.5-fold at 5 to 8 hours post Dose 2 (0.61 mmol/L) compared to baseline (0.25 mmol/L) and returned to baseline by 24 to 48 hours after colonoscopy.

Elimination
Fecal excretion is the primary route of sulfate elimination.

Use in Specific Populations
Patients with Renal Impairment
The disposition of sulfate after ingestion of a sulfate-based product containing sodium sulfate, potassium sulfate, and magnesium sulfate similar to SUTAB was studied in patients (N=6) with moderate renal impairment (creatinine clearance of 30 to 49 mL/min). In patients with moderate renal impairment, mean AUC was 54% higher and mean Cmax was 44% higher than healthy subjects. The mean sulfate concentrations in healthy subjects and in patients with moderate renal impairment returned to their respective baselines by Day 6 after dose initiation. Urinary excretion of sulfate over 30 hours after the first dose was approximately 16% lower in patients with moderate renal impairment than in healthy subjects. These differences are not considered clinically meaningful.

Patients with Hepatic Impairment The disposition of sulfate after ingestion of a sulfate-based product containing sodium sulfate, potassium sulfate, and magnesium sulfate similar to SUTAB was also studied in patients (N=6) with mild-moderate hepatic impairment (Child-Pugh grades A and B). Systemic exposure of serum sulfate (AUC and Cmax) was similar between healthy subjects and patients with hepatic impairment. The mean sulfate concentrations in healthy subjects and in patients with mild to moderate hepatic impairment returned to their respective baselines by Day 6 after dose initiation. Urinary excretion of sulfate over 30 hours after the first dose was similar between patients with hepatic impairment and healthy subjects.

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