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Drug Catalog - Product Detail

Potassium Chloride Tab ER 20 mEq 1500 MG 100 EA

NDC Mfr Size Str Form
69680-0134-00 VITRUVIAS THERAPEUTICS 100 20MEQ NA
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Generic Name
POTASSIUM CHLORIDE
Substance Name
POTASSIUM CHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA209688
Description
11 DESCRIPTION Potassium chloride extended-release tablets is a solid oral dosage form of potassium chloride containing 750 mg and 1500 mg of potassium chloride, USP, equivalent to 10 mEq and 20 mEq of potassium, respectively, in a film-coated (not enteric-coated), wax matrix tablet. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP, occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. The 10 mEq tablets also contain colloidal silicon dioxide, D&C Yellow No. 10 aluminum Lake, ethylcellulose, FD&C Yellow No. 6, magnesium stearate, paraffin wax, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and triethyl citrate. The 20 mEq tablets also contain colloidal silicon dioxide, ethylcellulose, magnesium stearate, paraffin wax, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and triethyl citrate. USP Dissolution Test pending.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Potassium chloride extended-release tablets, USP contain 750 mg and 1500 mg of potassium chloride (equivalent to 10 mEq and 20 mEq of potassium, respectively). Potassium chloride extended-release tablets is provided as extended-release film-coated tablets. Strength Description Bottle Count NDC# 10 mEq (750 mg) Yellow film coated capsule shaped tablets; plain on one side and debossed with "P10" on the other side 100 NDC 69680-133-00 500 NDC 69680-133-92 1000 NDC 69680-133-93 20 mEq (1500 mg) White to off-white film coated capsule shaped tablets; plain on one side and debossed with "P20" on the other side 100 NDC 69680-134-00 500 NDC 69680-134-92 Recommended Storage Store at room temperature 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND USAGE Potassium chloride extended-release tablets 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. Potassium chloride extended-release tablets is a potassium salt 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. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Monitor serum potassium and adjust dosages accordingly. ( 2.1 ) If serum potassium concentration is less than 2.5 mEq/L, use intravenous potassium instead of oral supplementation ( 2.1 ) Take with meals and with a glass of water or other liquid. Swallow tablets whole. ( 2.1 ) Treatment of hypokalemia : Typical dose range is 40-100 mEq per day in divided doses. Limit doses to 20 mEq per dose. ( 2.2 ) Prevention of hypokalemia : Typical dose is 20 mEq per day ( 2.2 ) 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 potassium chloride extended-release tablets 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.