What is K-Phos Neutral and how is it used?
K-Phos Neutral is a prescription medicine used to treat the symptoms of Hypophosphatemia. K-Phos Neutral may be used alone or with other medications.
K-Phos Neutral belongs to a class of drugs called Electrolytes.
It is not known if K-Phos Neutral is safe and effective in children younger than 4 years of age.
What are the possible side effects of K-Phos Neutral?
K-Phos Neutral may cause serious side effects including:
- severe or ongoing diarrhea,
- shortness of breath,
- little or no urinating,
- painful or difficult urination,
- swelling in your feet or ankles,
- tiredness, and
- shortness of breath
Get medical help right away, if you have any of the symptoms listed above.
The most common side effects of K-Phos Neutral include:
- stomach pain,
- bone or joint pain,
- muscle pain or weakness,
- increased thirst, and
- numbness or tingly feeling
Tell the doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of K-Phos Neutral. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Each tablet contains 852 mg dibasic sodium phosphate anhydrous, 155 mg monobasic potassium phosphate, and 130 mg monobasic sodium phosphate monohydrate. Each tablet yields approximately 250 mg of phosphorus, 298 mg of sodium (13.0 mEq) and 45 mg of potassium (1.1 mEq).
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K-PHOS® NEUTRAL (potassium and sodium phosphate) increases urinary phosphate and pyrophosphate. As a phosphorus supplement, each tablet supplies 25% of the U.S. Recommended Daily Allowance (U.S. RDA) of phosphorus for adults and children over 4 years of age.
DOSAGE AND ADMINISTRATION
K-PHOS® NEUTRAL (potassium and sodium phosphate) tablets should be taken with a full glass of water, with meals and at bedtime. Adults: One or two tablets four times daily; Pediatric Patients over 4 years of age: One tablet four times daily. For Pediatric Patients under 4 years of age, use only as directed by a physician.
White, film-coated, capsule-shaped tablet with the name BEACH and number 1125 imprinted on each tablet. Bottles of 100 (NDC 0486-1125-01) and 500 (NDC 0486-1125-05) tablets.
Gastrointestinal upset (diarrhea, nausea, stomach pain, and vomiting) may occur with phosphate therapy. Also, bone and joint pain (possible phosphate-induced osteomalacia) could occur. The following adverse effects may be observed (primarily from sodium or potassium): headaches; dizziness; mental confusion; seizures; weakness or heaviness of legs; unusual tiredness or weakness; muscle cramps; numbness, tingling, pain, or weakness of hands or feet; numbness or tingling around lips; fast or irregular heartbeat; shortness of breath or troubled breathing; swelling of feet or lower legs; unusual weight gain; low urine output; unusual thirst.
The use of antacids containing magnesium, aluminum, or calcium in conjunction with phosphate preparations may bind the phosphate and prevent its absorption. Concurrent use of antihypertensives, especially diazoxide, guanethidine, hydralazine, methyldopa, or rauwolfia alkaloid; or corticosteroids, especially mineralocorticoids or corticotropin, with sodium phosphate may result in hypernatremia. Calcium-containing preparations and/or Vitamin D may antagonize the effects of phosphates in the treatment of hypercalcemia. Potassium-containing medications or potassium-sparing diuretics may cause hyperkalemia. Patients should have serum potassium level determinations at periodic intervals.
No Information Provided.
General: This product contains potassium and sodium and should be used with caution if regulation of these elements 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; renal function impairment or chronic renal disease; extensive tissue breakdown (such as severe burns); myotonia congenita; cardiac failure; cirrhosis of the liver or severe hepatic disease; peripheral> or pulmonary edema; hypernatremia; hypertension; toxemia of pregnancy; 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, magnesium, or calcium which may prevent the absorption of phosphate.
Laboratory Tests: Careful monitoring of renal function and serum calcium, phosphorus, potassium, and sodium may be required at periodic intervals during phosphate therapy. Other tests may be warranted in some patients, depending on conditions.
Drug Interactions: The use of antacids containing magnesium, aluminum, or calcium in conjunction with phosphate preparations may bind the phosphate and prevent its absorption. Concurrent use of antihypertensives, especially diazoxide, guanethidine, hydralazine, methyldopa, or rauwolfia alkaloid; or corticosteroids, especially mineralocorticoids or corticotropin, with sodium phosphate may result in hypernatremia. Calcium-containing preparations and/or Vitamin D may antagonize the effects of phosphates in the treatment of hypercalcemia. Potassium-containing medications or potassium-sparing diuretics may cause hyperkalemia. Patients should have serum potassium level determinations at periodic intervals.
Carcinogenesis, Mutagenesis, Impairment of Fertility: No long term or reproduction studies in animals or humans have been performed with K-PHOS® NEUTRAL (potassium and sodium phosphate) 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® NEUTRAL (potassium and sodium phosphate) . 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.
Pediatric Use: See DOSAGE AND ADMINISTRATION .
Phosphorus has a number of important functions in the biochemistry of the body. The bulk of the body's phosphorus is located in the bones, where it plays a key role in osteoblastic and osteoclastic activities. Enzymatically catalyzed phosphate-transfer reactions are numerous and vital in the metabolism of carbohydrate, lipid and protein, and a proper concentration of the anion is of primary importance in assuring an orderly biochemical sequence. In addition, phosphorus plays an important role in modifying steady-state tissue concentrations of calcium. Phosphate ions are important buffers of the intracellular fluid, and also play a primary role in the renal excretion of hydrogen ion.
In general, in adults, about two thirds of the ingested phosphate is absorbed from the bowel, most of which is rapidly excreted into the urine.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.