K-Phos Neutral
K-Phos® Neutral
(potassium and sodium phosphate)
DRUG DESCRIPTION
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).
Last updated on RxList: 7/24/2008
INDICATIONS
K-PHOS® NEUTRAL 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 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.
HOW SUPPLIED
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.
Last updated on RxList: 7/24/2008
SIDE EFFECTS
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.
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.
Last updated on RxList: 7/24/2008
PRECAUTIONS
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 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 . 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 .
Last updated on RxList: 7/24/2008
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.
Last updated on RxList: 7/24/2008
CLINICAL PHARMACOLOGY
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.
Oral administration of inorganic phosphates increases serum phosphate levels. Phosphates lower urinary calcium levels in idiopathic hypercalciuria.
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.
Last updated on RxList: 7/24/2008
PATIENT INFORMATION
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.
Last updated on RxList: 7/24/2008
Consumer
IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.
POTASSIUM/SODIUM PHOSPHATE - ORAL
(poh-TASS-ee-um/SO-dee-um FOSS-fate)
COMMON BRAND NAME(S): K-Phos
USES: This drug may be used in people who cannot get enough phosphorus from their diets. Phosphorus is a natural body mineral that is very important for building and maintaining bone. It helps control the amount of calcium in the body and urine.
HOW TO USE: Take this medication by mouth, usually 4 times a day with meals and at bedtime or as directed by your doctor. Take this medication with a full glass of water (8 ounces or 240 milliliters). Do not lie down for 30 minutes after taking this medication.
Take this medication regularly in order to get the most benefit from it. To help you remember, take it at the same times each day.
Your dosage depends on your condition and response to therapy.
Take this medication 2-3 hours before or after taking any products containing magnesium, aluminum, or calcium. Some examples include quinapril, didanosine, vitamins/minerals, and antacids. Dairy products (e.g., milk, yogurt), calcium-enriched juice, sucralfate, bismuth subsalicylate, iron, and zinc are also included. These products bind with phosphate, preventing its full absorption.
Take this medication as prescribed. Do not increase your dose or take this more often without your doctor's approval.
Consumer (continued)
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
When this medication is first started, there is a chance an old kidney stone will be passed.
Tell your doctor immediately if any of these unlikely but serious side effects occur: bone/joint aches, muscle cramps, stomach pain, swollen hands/legs/feet.
Tell your doctor immediately if any of these rare but very serious side effects occur: confusion, fast/irregular heartbeat, seizures, unusual weakness, tingling/numbness of the hands/feet, change in the amount of urine.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: infection with kidney stones, high phosphate/potassium/sodium levels, severe kidney disease.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: adrenal gland problems (e.g., Addison's disease), breathing problems (pulmonary edema), bone problems (e.g., osteomalacia, rickets), heart disease (e.g., heart failure, irregular heartbeat), high blood pressure, a certain hormone problem (hypoparathyroidism), kidney disease (including kidney stones), liver disease, certain muscle problem (myotonia congenita), pancreatitis, late pregnancy problems (preeclampsia), severe loss of body water (dehydration), severe burns/wounds, special diet (e.g., sodium- or potassium-restricted diet), swelling (edema).
This medication contains sodium. Consult your doctor for more information if you are on a salt-restricted diet or if increased salt intake could worsen your condition (e.g., congestive heart failure).
Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially swelling legs/feet (due to sodium and water retention).
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.
Consumer (continued)
Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: aspirin, corticosteroids (e.g., prednisone), digoxin, eplerenone, high blood pressure drugs (e.g., ACE inhibitors such as lisinopril, ARBs such as valsartan), potassium supplements/salt substitutes, vitamin products (e.g., vitamin D, calcium), certain "water pills" (e.g., potassium-sparing diuretics such as amiloride/spironolactone/triamterene).
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe diarrhea, muscle spasms.
NOTES: Do not share this medication with others.
Laboratory and/or medical tests (e.g., calcium/phosphorus/potassium/sodium levels, kidney tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from heat, light, and moisture. Do not store in the bathroom. Keep all medicines away from children and pets
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.
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.
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