PHOSPHO-TRIN 250 NEUTRAL- sodium phosphate, dibasic, anhydrous, potassium phosphate, monobasic, and sodium phosphate, monobasic, monohydrate tablet

Phospho-Trin 250 Neutral by

Drug Labeling and Warnings

Phospho-Trin 250 Neutral by is a Other medication manufactured, distributed, or labeled by Patrin Pharma, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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).

OTHER INGREDIENTS

Cellulose, Pregelatinized Starch, Magnesium Stearate, Silicon Dioxide and Natural Flavor

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. ln 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 the 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 in absorbed from the bowel, most of which is rapidly excreted into the urine.

INDICATIONS AND USAGE

Phospho-Trin™ 250 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.

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.

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 dose until this effect subsides or, if necessary, discontinue the use of the 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 extraskeletal 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

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 medication 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 Phospho-Trin™ 250 Neutral to evaluate its carcinogenic, mutagenic, or impairment of fertility potential.

Pregnancy

Teratogenic Effects

Pregnancy Class C

Animal reproduction studies have not been conducted with Phospho-Trin™ 250 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.

ADVERSE REACTIONS

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.

DOSAGE AND ADMINISTRATION

Phospho-Trin™ 250 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.

Pediatric Patients under 4 years of age

Use only as directed by physician.

HOW SUPPLIED

White, oval-shaped tablet, debossed with P107 on each tablet.

NDC #39328-107-10
Bottles of 100 tablets

STORAGE

Keep tightly closed. Store upright at 20 to 25°C (68 to 77°F). Excursions permitted 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children. Dispense in tight, light-resistant containers with child resistant closures.

IDENTITY

Phospho-Trin™ 250 Neutral is an orally administered medical food for use only under medical supervision for the dietary management of hypophosphatemia.

SPL UNCLASSIFIED SECTION

Manufactured for:
Patrin Pharma, Inc.
P.O. Box 1481
Skokie, IL 60076

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

Rx
39328-107-10

Phospho-Trin™
250 Neutral

250 mg per tablet

Phosphorus Supplement

100 Tablets

PATRIN
PHARMA

INGREDIENTS AND APPEARANCE

PHOSPHO-TRIN 250 NEUTRAL 
sodium phosphate, dibasic, anhydrous, potassium phosphate, monobasic, and sodium phosphate, monobasic, monohydrate tablet

Product Information
Product Type	MEDICAL FOOD	Item Code (Source)	NHRIC:39328-107
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) (PHOSPHATE ION - UNII:NK08V8K8HR)	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	852 mg
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51) (PHOSPHATE ION - UNII:NK08V8K8HR)	POTASSIUM PHOSPHATE, MONOBASIC	155 mg
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) (PHOSPHATE ION - UNII:NK08V8K8HR)	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	130 mg

Inactive Ingredients
Ingredient Name	Strength
Microcrystalline Cellulose (UNII: OP1R32D61U)
Starch, Corn (UNII: O8232NY3SJ)
Magnesium Stearate (UNII: 70097M6I30)
Silicon Dioxide (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	P107
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:39328-107-10	100 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Medical Food		03/01/2017

Labeler - Patrin Pharma, Inc. (806841677)