KLOR-CON Extended-release tablet (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Upsher-Smith Laboratories, LLC

Λέξεις κλειδιά

0245-5315 0245-5316

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1. Indications and Usage

Klor-Con 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 ...

2. Dosage and Administration

2.1 Administration and Monitoring If serum potassium concentration is less than 2.5 mEq/L, use intravenous potassium instead of oral supplementation. Monitoring Monitor serum potassium and adjust dosages ...

3. Dosage Forms and Strengths

Klor-Con extended-release tablets are supplied as: 600 mg (8 mEq) are film-coated, round light blue tablets debossed with KC 8. 750 mg (10 mEq) are film-coated, round yellow tablets debossed with KC 10 ...

4. Contraindications

Potassium chloride is contraindicated in patients on triamterene and 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 if the drug maintains contact ...

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 ...

7. Drug Interactions

7.1 Triamterene or amiloride Use with triamterene or amiloride can produce severe hyperkalemia. Concomitant use is contraindicated <em>[see Contraindications (4)]</em>. 7.2 Renin-angiotensin-aldosterone ...

8. Use in Specific Populations

8.6 Cirrhotics 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 ...

8.1. Pregnancy

Risk Summary There are no human data related to use of Klor-Con during pregnancy, and animal reproduction studies have not been conducted. Potassium supplementation that does not lead to hyperkalemia is ...

8.2. Lactation

h3.Risk Summary The normal potassium ion content of human milk is about 13 mEq per liter. Since oral potassium becomes part of the body potassium pool, so long as body potassium is not excessive, the contribution ...

8.4. Pediatric Use

Safety and effectiveness in the pediatric population have not been established.

8.5. Geriatric Use

Clinical studies of Klor-Con extended-release did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical ...

8.7. Renal Impairment

Patients with renal impairment have reduced urinary excretion of potassium and are at substantially increased risk of hyperkalemia. Patients with impaired renal function, particularly if the patient is ...

10. Overdosage

10.1 Symptoms The administration of oral potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired, potentially ...

11. Description

Klor-Con extended-release tablets are a solid oral dosage form of potassium chloride. Each contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq of potassium in a wax matrix tablet. ...

12.1. Mechanism of Action

The potassium ion is the principal intracellular cation of most body tissues. Potassium ions participate in a number of essential physiological processes including the maintenance of intracellular tonicity, ...

12.3. Pharmacokinetics

The potassium chloride in Klor-Con extended-release is completely absorbed before it leaves the small intestine. The wax matrix is not absorbed and is excreted in the feces; in some instances the empty ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity and fertility studies in animals have not been performed. Potassium is a normal dietary constituent.

16.1. How Supplied

Klor-Con (potassium chloride, USP) contains 600 mg or 750 mg of potassium chloride (equivalent to 8 mEq or 10 mEq of potassium respectively). Klor-Con is provided as extended-release tablets. <b>Table ...

16.2. Storage and Handling

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight container with a child-resistant closure.

17. Patient Counseling Information

Inform patients to take each dose with meals and with a full glass of water or other liquid, and to not crush, chew, or suck the tablets. Inform patients that the wax matrix is not absorbed and is excreted ...