EFFER-K 10 MEQ UNFLAVORED- potassium bicarbonate tablet, effervescent EFFER-K 10 MEQ CHERRY VANILLA- potassium bicarbonate tabl

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

POTASSIUM BICARBONATE (UNII: HM5Z15LEBN) (POTASSIUM CATION - UNII:295O53K152)

Available from:

Nomax Inc.

INN (International Name):

POTASSIUM BICARBONATE

Composition:

POTASSIUM CATION 391 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

- For therapeutic use in patients with hypokalemia with or without metabolic alkalosis; in chronic digitalis intoxication; and in patients with hypokalemic familial periodic paralysis. - For prevention of potassium depletion when the dietary intake of potassium ion is inadequate in the following conditions; patients receiving digitalis and diuretics for congestive heart failure; hepatic cirrhosis with ascites; states of aldosterone excess with normal renal function; potassium-losing nephropathy, and certain diarrheal states; long-term corticosteroid therapy. - The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension or receiving certain antibiotics is often unnecessary when such patients have a normal dietary pattern. Serum potassium should be checked periodically, however, and, if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. In more severe cases supplementation with potassium salts may be indica

Product summary:

Each tablet of Effer-K® 10 mEq Tablets (Effervescent Potassium Bicarbonate/ Citric Acid Tablets for Oral Solution, USP) in solution provides 10 mEq (391 mg) of elemental potassium as potassium citrate. Each tablet of Effer-K® 20 mEq Tablets (Effervescent Potassium Bicarbonate/ Citric Acid Tablets for Oral Solution, USP) in solution provides 20 mEq (782 mg) of elemental potassium as potassium citrate. Store below 40°C (104°F), preferably between 15° and 30°C (59° and 86°F), in original hermetic package. The 10 mEq tablets are 11/16 inch diameter round, flat face on both sides with large bevels. EK 10 is imprinted on one side of the tablet. Each tablet is pouched with the product description on one side of the pouch and the lot number, expiration date and barcode on the other. The 20 mEq tablets are 7/8 inch diameter round, flat face on both sides with large bevels. EK 20 is imprinted on one side of the tablet. Each tablet is pouched with the product description on one side of the pouch and the lot number, expiration date and barcode on the other. NDC 51801-01330 Unflavored, 10 mEq, package of 30 tablets NDC 51801-01430 Cherry Vanilla, 10 mEq, package of 30 tablets NDC 51801-01130 Unflavored, 20 mEq, package of 30 tablets NDC 51801-01230 Orange Cream, 20 mEq, package of 30 tablets Nomax, Inc. St. Louis, MO 63123 - Made in USA MSN 015-183 Rev. 05/12

Authorization status:

unapproved drug other

Summary of Product characteristics

EFFER-K 10 MEQ UNFLAVORED- POTASSIUM BICARBONATE TABLET, EFFERVESCENT
EFFER-K 10 MEQ CHERRY VANILLA- POTASSIUM BICARBONATE TABLET,
EFFERVESCENT
EFFER-K 20 MEQ UNFLAVORED- POTASSIUM BICARBONATE TABLET, EFFERVESCENT
EFFER-K 20 MEQ ORANGE CREAM- POTASSIUM BICARBONATE TABLET,
EFFERVESCENT
NOMAX INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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EFFER-K
DES CRIPTION
_EFFER-K_ 10mEq and 20 mEq Tablets (Effervescent Potassium
Bicarbonate/ Citric Acid Tablets for Oral
Solution, USP) are intended for the preparation of an oral solution of
potassium.
Each 10 mEq tablet contains 1.0g potassium bicarbonate and 0.84g
citric acid which, after effervescing,
provides a solution containing 10 mEq (391 mg) of elemental potassium
as potassium citrate.
Each 20 mEq tablet contains 2.0g potassium bicarbonate and 1.68g
citric acid which, after effervescing,
provides a solution containing 20 mEq (782 mg) of elemental potassium
as potassium citrate.
Tablets also contain maltodextrin, anhydrous dextrose and l-leucine.
In addition, the flavored tablets
contain SD flavors, and sucralose.
The 10 mEq Cherry Vanilla tablets contain FD&C Red #40 and the 20 mEq
Orange Cream tablets
contain FD&C Yellow #6 and FD&C Red #40. The Unflavored 10 and 20 mEq
tablets do not contain
any natural or synthetic dyes, flavors or sweeteners.
The 10 mEq tablets are 11/16 inch diameter round, flat face on both
sides with large bevels. EK 10 is
imprinted on one side. The 20 mEq tablets are 7/8 inch diameter round,
flat face on both sides with large
bevels. EK 20 is imprinted on one side. Each tablet is pouched with
the product description on one side
of the pouch and the lot number, expiration date and bar code on the
other
CLINICAL PHARMACOLOGY
Potassium ion is the principal intracellular cation of most body
tissues, whereas sodium ion is relatively
low in concentration. In extracellular fluid the opposite exists,