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Drug Catalog - Product Detail

Potassium Chloride Extended Release 750mg 10mEq K Capsule 100

NDC Mfr Size Str Form
53746-0542-01 AMNEAL PHARMACEUTICALS 100 10MEQ CAPSULE
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PACKAGE FILES

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Generic Name
POTASSIUM CHLORIDE
Substance Name
POTASSIUM CHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA202128
Description
11 DESCRIPTION Potassium chloride extended-release capsules USP, 10 mEq are an oral dosage form of microencapsulated potassium chloride containing 750 mg of potassium chloride, USP equivalent to 10 mEq of potassium. The chemical name of the active ingredient is potassium chloride and the structural formula is KCl. It has a molecular mass of 74.55. 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 inactive ingredients are, ethylcellulose, FD&C Blue #1, FD&C Red # 40, gelatin, sodium lauryl sulfate, titanium oxide and triethyl citrate.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Potassium chloride extended-release capsules USP, 10 mEq are blue opaque elongated hard gelatin capsules filled with white to off-white coated pellets and imprinting ‘amneal’ on the cap and ‘542’ on the body with white ink, each containing 750 mg microencapsulated potassium chloride (equivalent to 10 mEq K). They are available as follows: Bottles of 100: NDC 53746-542-01 Bottles of 500: NDC 53746-542-05 Bottles of 1,000: NDC 53746-542-10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.
Indications & Usage
1 INDICATIONS AND USAGE Potassium chloride extended-release capsules are indicated for the treatment and prophylaxis of hypokalemia in adults and children 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 capsules contain potassium chloride, 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 dosage accordingly. ( 2.1 ) If serum potassium concentration is < 2.5 mEq/L, use intravenous potassium instead of oral supplementation. ( 2.1 ) Treatment of hypokalemia: Adults: Typical doses range from 40 to 100 mEq/day in 2 to 5 divided doses; limit doses to 40 mEq per dose. ( 2.2 ) Pediatric patients: 2 to 4 mEq/kg/day in divided doses not to exceed 1 mEq/kg as a single-dose or 20 mEq, whichever is lower; if deficits are severe or ongoing losses are great, consider intravenous therapy. ( 2.3 ) Maintenance or Prophylaxis of hypokalemia: Adults: Typical dose is 20 mEq per day. ( 2.2 ) Pediatric patients: Typical dose is 1 mEq/kg/day. ( 2.3 ) 2.1 Administration and Monitoring If serum potassium concentration is < 2.5 mEq/L, use intravenous potassium instead of oral supplementation. Monitoring Monitor serum potassium and adjust dosages accordingly. 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 with meals and with a full glass of water or other liquid. Do not take on an empty stomach because of the potential for gastric irritation [see Warnings and Precautions (5.1) ] . Patients who have difficulty swallowing capsules may sprinkle the contents of the capsule onto a spoonful of soft food. The soft food, such as applesauce or pudding, should be swallowed immediately without chewing and followed with a glass of water or juice to ensure complete swallowing of the microcapsules. Do not added to hot foods. Any microcapsule/food mixture should be used immediately and not stored for future use. 2.2 Adult Dosing Dosage must be adjusted to the individual needs of each patient. Dosages greater than 40 mEq per day should be divided such that no more than 40 mEq is given in a single-dose. Treatment of hypokalemia: Typical dose range is 40 to 100 mEq per day. Maintenance or Prophylaxis: Typical dose is 20 mEq per day. 2.3 Pediatric Dosing Pediatric patients aged birth to 16 years old: Dosage must be adjusted to the individual needs of each patient. Do not exceed as a single-dose 1 mEq/kg or 20 mEq, whichever is lower. Treatment of hypokalemia: The recommended initial dose is 2 to 4 mEq/kg/day in divided doses. If deficits are severe or ongoing losses are great, consider intravenous therapy. Maintenance or Prophylaxis: Typical dose is 1 mEq/kg/day.