K PHOS ORIGINAL (POTASSIUM PHOSPHATE, MONOBASIC) TABLET, SOLUBLE [CARILION MATERIALS MANAGEMENT]

K PHOS ORIGINAL (POTASSIUM PHOSPHATE, MONOBASIC) TABLET, SOLUBLE [CARILION MATERIALS MANAGEMENT]
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NDC 68151-2193-0
Set ID 0d128959-ddfe-4255-a5fe-6e6c09764d82
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Carilion Materials Management
Generic Name
Product Class
Product Number
Application Number
  • DESCRIPTION

    Each tablet contains potassium acid phosphate 500 mg. Each tablet yields approximately 114 mg of phosphorus and 144 mg of potassium or 3.7 mEq.

    Inactive ingredients: Magnesium stearate, microcrystalline cellulose, silicon dioxide, starch, stearic acid.

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  • ACTIONS

    K-PHOS® ORIGINAL is a highly effective sodium-free urinary acidifier.

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  • INDICATONS AND USAGE

    For use in patients with elevated urinary pH. K-PHOS® ORIGINAL helps keep calcium soluble and reduces odor and rash caused by ammoniacal urine. Also, by acidifying the urine, it increases the antibacterial activity of methenamine mandelate and methenamine hippurate.

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  • CONTRAINDICATIONS

    This product is contraindicated in patients with infected phosphate stones; in patients with severely impaired renal function (less than 30% of normal) and in the presence of hyperphosphatemia and hyperkalemia.

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  • PRECAUTIONS

    General

    This product contains potassium and should be used with caution if regulation of this element is desired. Occasionally, some individuals may experience a mild laxative effect during the first few days of phosphate therapy. If laxation persists to an unpleasant degree, reduce the daily dosage until this effect subsides or, if necessary, discontinue the use of this product.

    Caution should be exercised when prescribing this product in the following conditions: Cardiac disease (particularly in digitalized patients); severe adrenal insufficiency (Addison's disease); acute dehydration; severe renal insufficiency or chronic renal disease; extensive tissue breakdown (such as severe burns); myotonia congenita; hypoparathyroidism; and acute pancreatitis. Rickets may benefit from phosphate therapy, but caution should be exercised. High serum phosphate levels may increase the incidence of extra-skeletal calcification.

    Information for Patients

    Patients with kidney stones may pass old stones when phosphate therapy is started and should be warned of this possibility. Patients should be advised to avoid the use of antacids containing aluminum, calcium, or magnesium, which may prevent the absorption of phosphate. To assure against gastrointestinal injury associated with oral ingestion of concentrated potassium salt preparations, patients should be instructed to dissolve tablets completely in an appropriate amount of water before taking.

    Laboratory Tests

    Careful monitoring of renal function and serum calcium, phosphorus and potassium may be required at periodic intervals during potassium phosphate therapy. Other tests may be warranted in some patients, depending on conditions.

    Drug Interactions

    The use of antacids containing magnesium, calcium, or aluminum in conjunction with phosphate preparations may bind the phosphate and prevent its absorption. Potassium-containing medications or potassium-sparing diuretics may cause hyperkalemia when used concurrently with potassium salts. Patients should have serum potassium level determinations at periodic intervals. Concurrent use of salicylates may lead to increased serum salicylate levels since excretion of salicylates is reduced in acidified urine. Serum salicylate levels should be closely monitored to avoid toxicity.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    No long-term or reproduction studies in animals or humans have been performed with K-PHOS® ORIGINAL to evaluate its carcinogenic, mutagenic, or impairment of fertility potential.

    Pregnancy

    Teratogenic Effects

    Pregnancy Category C

    Animal reproduction studies have not been conducted with K-PHOS® ORIGINAL. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. This product should be given to a pregnant woman only if clearly needed.

    Nursing Mothers

    It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.

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  • ADVERSE REACTIONS

    Gastrointestinal upset (diarrhea, nausea, stomach pain, and vomiting) may occur with the use of potassium phosphate. Also, bone and joint pain (possible phosphate-induced osteomalacia) could occur. The following adverse effects may be observed with potassium administration: irregular heartbeat; dizziness; mental confusion; weakness or heaviness of legs; unusual tiredness; muscle cramps; numbness, tingling, pain, or weakness in hands or feet; numbness or tingling around lips; shortness of breath or troubled breathing.

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  • DOSAGE AND ADMINISTRATION

    Two tablets dissolved in 6-8 oz. of water 4 times daily with meals and at bedtime. For best results, let the tablets soak in water for 2 to 5 minutes, or more if necessary, and stir. If any tablet particles remain undissolved, they may be crushed and stirred vigorously to speed dissolution.

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  • HOW SUPPLIED

    NDC:68151-2193-0 in a PACKAGE of 1 TABLET, SOLUBLES

    STORAGE

    Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F).

    Dispense in tight, light-resistant containers with child-resistant closures.

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  • SPL UNCLASSIFIED SECTION

    BEACH PHARMACEUTICALS, Div. of Beach Products, Inc., Tampa, FL 33611

    Rev: 07/09B

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  • Potassium Acid Phosphate 500 mg tabs
  • INGREDIENTS AND APPEARANCE
    K PHOS   ORIGINAL
    potassium phosphate, monobasic tablet, soluble
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68151-2193(NDC:0486-1111)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Potassium Phosphate, Monobasic (UNII: 4J9FJ0HL51) (Phosphate Ion - UNII:NK08V8K8HR, Potassium Cation - UNII:295O53K152) Potassium Phosphate, Monobasic 500 mg
    Inactive Ingredients
    Ingredient Name Strength
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Starch, Corn (UNII: O8232NY3SJ)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code BEACH;1111
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68151-2193-0 1 in 1 PACKAGE; Type 0: Not a Combination Product 03/29/1977
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 03/29/1977
    Labeler - Carilion Materials Management (079239644)
    Registrant - Carilion Materials Management (079239644)
    Establishment
    Name Address ID/FEI Business Operations
    Carilion Materials Management 079239644 REPACK(68151-2193)
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