K-Tab

K-TAB- potassium chloride tablet, film coated, extended release
REMEDYREPACK INC.

1 INDICATIONS AND USAGE

K-TAB is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.

2 DOSAGE AND ADMINISTRATION

2.1 Monitoring and Administration

If serum potassium concentration is less than 2.5 mEq/L, use intravenous potassium instead of oral supplementation.

Monitoring

Monitor serum potassium and adjust the dose based on serum potassium level. Monitor serum potassium periodically during maintenance therapy to ensure potassium remains in desired range.

The treatment of potassium depletion, particularly in the presence of cardiac disease, renal disease, or acidosis, requires careful attention to acid-base balance, volume status, electrolytes, including magnesium, sodium, chloride, phosphate, and calcium, electrocardiograms, and the clinical status of the patient. Correct volume status, acid-base balance, and electrolyte deficits as appropriate.

Administration

Take K-TAB with meals and with a glass of water or other liquid. Do not take on an empty stomach because of its potential for gastric irritation [see Warnings and Precautions ( 5.1)] .

Swallow tablets whole without crushing, chewing or sucking.

2.2 Dosing

Dosage must be adjusted to the individual needs of each patient. Dosages greater than 20 mEq per day should be divided such that no more than 20 mEq is given in a single dose.

Treatment of hypokalemia: Typical dose range is 40-100 mEq per day.

Prevention of hypokalemia: Typical dose is 20 mEq per day.

3 DOSAGE FORMS AND STRENGTHS

  • 8 mEq (600 mg): Round, yellow, debossed extended-release tablets with “K-TAB” on one side
  • 10 mEq (750 mg): Ovaloid, yellow, debossed extended-release tablets with “10” on one side and “K‑TAB” on the other side
  • 10 mEq (750 mg): Ovaloid, yellow, debossed extended-release tablets with the “a” logo on one side and “K‑TAB” on the other side
  • 20 mEq (1500 mg): Ovaloid, white, debossed extended-release tablets with “K-TAB” on one side

4 CONTRAINDICATIONS

Potassium chloride is contraindicated in patients on triamterene or amiloride.

5 WARNINGS AND PRECAUTIONS

5.1 Gastrointestinal Adverse Reactions

Solid oral dosage forms of potassium chloride can produce ulcerative and/or stenotic lesions of the gastrointestinal tract, particularly when the drug remains in contact with the gastrointestinal mucosa for a prolonged period of time. Consider the use of liquid potassium in patients with dysphagia, swallowing disorders, or severe gastrointestinal motility disorders.

If severe vomiting, abdominal pain, distention, or gastrointestinal bleeding occurs, discontinue K-TAB and consider possibility of ulceration, obstruction or perforation.

K-TAB should not be taken on an empty stomach because of its potential for gastric irritation [see Dosage and Administration ( 2.1)] .

6 ADVERSE REACTIONS

The following adverse reactions have been identified with use of oral potassium salts. 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.

The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea.

There have been reports of hyperkalemia and of upper and lower gastrointestinal conditions including obstruction, bleeding, ulceration, perforation [see Warnings and Precautions ( 5.1) and Overdosage ( 10)] .

Skin rash has been reported rarely.

7 DRUG INTERACTIONS

7.1 Triamterene and Amiloride

Use with triamterene or amiloride can produce severe hyperkalemia. Avoid concomitant use [see Contraindications ( 4)] .

7.2 Renin-Angiotensin-Aldosterone System Inhibitors

Drugs that inhibit the renin-angiotensin-aldosterone system (RAAS) including angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), spironolactone, eplerenone, or aliskiren produce potassium retention by inhibiting aldosterone production. Closely monitor potassium in patients receiving concomitant RAAS therapy.

7.3 Nonsteroidal Anti-Inflammatory Drugs

Nonsteroidal anti-inflammatory drugs (NSAIDs) may produce potassium retention by reducing renal synthesis of prostaglandin E and impairing the renin-angiotensin system. Closely monitor potassium in patients receiving concomitant NSAID therapy.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There are no human data related to use of K-TAB during pregnancy, and animal reproduction studies have not been conducted. Potassium supplementation that does not lead to hyperkalemia is not expected to cause fetal harm.

The background risk for major birth defects and miscarriage in 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 2-4% and 15-20%, respectively.

8.2 Lactation

Risk Summary

The normal potassium ion content of human milk is about 13 mEq per liter. Since potassium from oral supplements such as K-TAB becomes part of the body potassium pool, as long as body potassium is not excessive, the contribution of potassium chloride supplementation should have little or no effect on the level in human milk.

8.4 Pediatric Use

Safety and effectiveness of K-TAB in children have not been established.

8.5 Geriatric Use

Clinical studies of K‑TAB did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

8.6 Cirrhotics

Doses of potassium in patients with cirrhosis produce a larger increase in potassium levels compared to the response in normal patients. Based on published literature, the baseline corrected serum concentrations of potassium measured over 3 hours after administration in cirrhotic subjects who received an oral potassium load rose to approximately twice that of normal subjects who received the same load. Patients with cirrhosis should usually be started at the low end of the dosing range, and the serum potassium level should be monitored frequently.

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