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K-TAB (Potassium Chloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS, OR FOR PATIENTS WITH WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS.

  1. For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia.
  2. For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.

The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern, and when low doses of the diuretic are used. 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 and if dose adjustment of the diuretic is ineffective or unwarranted supplementation with potassium salts may be indicated.

DOSAGE AND ADMINISTRATION

The usual dietary potassium intake 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 patient. The dose for the prevention of hypokalemia is typically in the range of 20 mEq per day. Doses of 40-100 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.

K-TAB tablets provide 10 mEq and 20 mEq of potassium chloride.

K-TAB tablets should be taken with meals and with a glass of water or other liquid. This product should not be taken on an empty stomach because of its potential for gastric irritation (see WARNINGS).

NOTE:K-TAB tablets are to be swallowed whole without crushing, chewing or sucking the tablets.

HOW SUPPLIED

Repackaged by Aphena Pharma Solutions - TN.
See Repackaging Information for available configurations.

K-TAB (potassium chloride extended-release tablets, USP) contain 750 mg and 1500 mg of potassium chloride (equivalent to 10 mEq and 20 mEq, respectively). K-TAB tablets are provided as ovaloid, extended-release Filmtab® tablets. K-TAB 750 mg are yellow in color and are debossed with the “a” logo on one side and the trademark K-TAB on the other side. K-TAB 1500 mg are white in color and are debossed with the trademark K-TAB on one side.

K-TAB Tablets are supplied as follows:

10 mEq

Bottles of 30 NDC 0074-7804-30
Bottles of 90 NDC 0074-7804-90
Bottles of 100 NDC 0074-7804-13
Bottles of 1000 NDC 0074-7804-19
Bottles of 5000 NDC 0074-7804-59
Unit dose packages of 100 NDC 0074-7804-11

20 mEq

Bottles of 30 NDC 0074-3023-30
Bottles of 90 NDC 0074-3023-90
Bottles of 100 NDC 0074-3023-13
Bottles of 500 NDC 0074-3023-53

Recommended Storage

Do not store above 77°F (25°C).

Filmtab® - Film-sealed tablets, AbbVie Inc.

©2013 AbbVie Inc.

Manufactured by:
AbbVie LTD
Barceloneta, PR 00617
For:
AbbVie Inc.
North Chicago, IL 60064
03-A823 November, 2013

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets or capsules. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count 10 mEq
30 43353-790-30
60 43353-790-53
90 43353-790-60
120 43353-790-70
180 43353-790-80
200 43353-790-85
270 43353-790-92
360 43353-790-94

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:


Cookeville, TN 38506

20140411SC

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