Prescription Drug Information: POTASSIUM CHLORIDE EXTENDED RELEASE (Page 2 of 2)

ADVERSE REACTIONS:

One of the most severe adverse effects is hyperkalemia (see CONTRAINDICATIONS, WARNINGS, AND OVERDOSAGE). Gastrointestinal bleeding and ulceration have been reported in patients treated …

One of the most severe adverse effects is hyperkalemia (see CONTRAINDICATIONS, WARNINGS, AND OVERDOSAGE). Gastrointestinal bleeding and ulceration have been reported in patients treated with Potassium Chloride Extended- release Capsules, USP, 8 mEq and 10 mEq (see CONTRAINDICATIONS and WARNINGS). In addition to gastrointestinal bleeding and ulceration, perforation and obstruction have been reported in patients treated with other solid KCl dosage forms, and may occur with Potassium Chloride Extended-release Capsules, USP, 8 mEq and 10 mEq. The most common adverse reactions to the oral potassium salts are nausea, vomiting, flatulence, abdominal discomfort, and diarrhea. These symptoms are due to irritation of the gastrointestinal tract and are best managed by taking the dose with meals, or reducing the amount taken at one time. Skin rash has been reported rarely with potassium preparations.

To report SUSPECTED ADVERSE EVENTS, contact Adare at 1-877-731-5116 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.

OVERDOSAGE:

The administration of oral potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired or if potassium is administered too rapidly intravenously, potentially fatal hyperkalemia can result (see CONTRAINDICATIONS and WARNINGS). It is important to recognize that hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration (6.5-8.0 mEq/L) and characteristic electrocardiographic changes (peaking of T-waves, loss of P-waves, depression of ST segment, and prolongation of the QT interval). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest (9-12 mEq/L).

Treatment measures for hyperkalemia include the following: (1) elimination of foods and medications containing potassium and of any agents with potassium-sparing properties; (2) intravenous administration of 300 to 500 mL/hr of 10% dextrose solution containing 10 to 20 units of crystalline insulin per 1,000 mL; (3) correction of acidosis, if present, with intravenous sodium bicarbonate; (4) use of exchange resins, hemodialysis, or peritoneal dialysis. In treating hyperkalemia, it should be recalled that in patients who have been stabilized on digitalis, too rapid a lowering of the serum potassium concentration can produce digitalis toxicity. The extended release feature means that absorption and toxic effects may be delayed for hours. Consider standard measures to remove any unabsorbed drug.

DOSAGE AND ADMINISTRATION:

The usual dietary intake of potassium by the average adult is 50 to 100 mEq per day. Potassium depletion sufficient to cause hypokalemia usually requires the loss of 200 or more mEq of potassium from the total body store.

Dosage must be adjusted to the individual needs of each patients. The dose for the prevention of hypokalemia is typically in the range of 20 mEq per day. Doses of 40 to 100 mEq per day or more are used for the treatment of potassium depletion. Dosage should be divided if more than 20 mEq per day is given such that no more than 20 mEq is given in a single dose. Because of the potential for gastric irritation (see WARNINGS), Potassium Chloride Extended-release Capsules, USP, 8 mEq and 10 mEq should be taken with meals and with a full glass of water or other liquid.

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 cool water or juice to ensure complete swallowing of the microcapsules. The food used should not be hot and should be soft enough to be swallowed without chewing. Any microcapsule/food mixture should be used immediately and not stored for future use.

HOW SUPPLIED:

Potassium Chloride Extended-release Capsules, USP, 8 mEq are white to ivory opaque capsules printed with “102” and containing 600 mg microencapsulated potassium chloride (equivalent to 8 mEq K) in bottles of 100 (NDC 59917-102-01), bottles of 500 (NDC 59917-102-05) and bottles of 1000 (NDC 59917-102-10).

Potassium Chloride Extended-release Capsules, USP, 10 mEq are light blue opaque capsules printed with “103” and containing 750 mg microencapsulated potassium chloride (equivalent to 10 mEq K) in bottles of 100 (59917-103-01) , bottles of 500 (NDC 59917-103-05) and bottles of 1000 (NDC 59917-103-10).

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Dispense in tight container.

Manufactured by:
Adare Pharmaceuticals, Inc.
Vandalia, OH 45377 USA
Rev. date: 6/2016

Potassium Chloride Extended-Release Capsules 8 mEq

8 mEq Label
(click image for full-size original)

Potassium Choride Extended-Release Capsules 10 mEq

10 mEq Label
(click image for full-size original)

POTASSIUM CHLORIDE EXTENDED RELEASE
potassium chloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59917-102
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POTASSIUM CHLORIDE (POTASSIUM CATION) POTASSIUM CHLORIDE 600 mg
Inactive Ingredients
Ingredient Name Strength
ETHYLCELLULOSES
GELATIN
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
MAGNESIUM STEARATE
Product Characteristics
Color white (Opaque) Score no score
Shape CAPSULE (CAPSULE) Size 23mm
Flavor Imprint Code 102
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59917-102-01 100 CAPSULE in 1 BOTTLE, PLASTIC contains a CAPSULE
1 1 CAPSULE in 1 CAPSULE This package is contained within the BOTTLE, PLASTIC (59917-102-01)
2 NDC:59917-102-05 500 CAPSULE in 1 BOTTLE, PLASTIC contains a CAPSULE
2 1 CAPSULE in 1 CAPSULE This package is contained within the BOTTLE, PLASTIC (59917-102-05)
3 NDC:59917-102-10 1000 CAPSULE in 1 BOTTLE, PLASTIC contains a CAPSULE
3 1 CAPSULE in 1 CAPSULE This package is contained within the BOTTLE, PLASTIC (59917-102-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208864 04/01/2018
POTASSIUM CHLORIDE EXTENDED RELEASE
potassium chloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59917-103
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POTASSIUM CHLORIDE (POTASSIUM CATION) POTASSIUM CHLORIDE 750 mg
Inactive Ingredients
Ingredient Name Strength
ETHYLCELLULOSES
GELATIN
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FD&C BLUE NO. 1
FD&C RED NO. 3
FERROSOFERRIC OXIDE
MAGNESIUM STEARATE
Product Characteristics
Color blue (Light Blue, Opaque) Score no score
Shape CAPSULE (CAPSULE) Size 23mm
Flavor Imprint Code 103
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59917-103-01 100 CAPSULE in 1 BOTTLE, PLASTIC contains a CAPSULE
1 1 CAPSULE in 1 CAPSULE This package is contained within the BOTTLE, PLASTIC (59917-103-01)
2 NDC:59917-103-05 500 CAPSULE in 1 BOTTLE, PLASTIC contains a CAPSULE
2 1 CAPSULE in 1 CAPSULE This package is contained within the BOTTLE, PLASTIC (59917-103-05)
3 NDC:59917-103-10 1000 CAPSULE in 1 BOTTLE, PLASTIC contains a CAPSULE
3 1 CAPSULE in 1 CAPSULE This package is contained within the BOTTLE, PLASTIC (59917-103-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208864 04/01/2018
Labeler — Adare Pharmaceuticals Inc (079819927)
Establishment
Name Address ID/FEI Operations
Adare Pharmaceuticals Inc 079819927 manufacture (59917-102), manufacture (59917-103)

Revised: 09/2019 Adare Pharmaceuticals Inc

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