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Ammonium Molybdate

FULL PRESCRIBING INFORMATION

STERILE, NONPYROGENIC

TRACE ELEMENT ADDITIVE

FOR IV USE AFTER DILUTION

Rx Only

Ammonium Molybdate Injection, USP is a sterile, nonpyrogenic solution for use as an additive to solutions for Total Parenteral Nutrition (TPN). Each mL contains Ammonium Molybdate Tetrahydrate (NH₄)₆MO₇O₂₄•4H₂O, 46 mcg and Water for Injection q.s. Each mL provides 25 mcg of Molybdenum. Ammonium Hydroxide and/or Hydrochloric Acid may have been added to adjust pH.

Molybdenum is a constituent of the enzymes xanthine oxidase, sulfite oxidase, and aldehyde oxidase. Among other reactions, xanthine oxidase catalyzes conversion of xanthine and hypoxanthine to uric acid; sulfite oxidase converts sulfite to sulfate; and aldehyde oxidase detoxifies a variety of harmful organic molecules (such as aldehydes into acids).

In humans, molybdenum deficiency resulting from prolonged TPN support has been reported in literature. The deficiency syndrome included tachycardia, tachypnea, headache, night blindness, nausea, vomiting, central scotomas, culminating in generalized edema, lethargy, disorientation, and coma. The biochemical changes associated with the syndrome were: hypermethioninemia, hypouricemia, hypouricosuria, low urinary excretion of inorganic sulfate and elevated urinary excretion of Thiosulfate. Supplementation of TPN solutions with Molybdenum has been reported to alleviate the symptoms and normalize the biochemical abnormalities.

In animals, diet induced molybdenum deficiency has been produced experimentally with tungstate. The deficiency symptoms are characterized by decreased weight gain, food consumption, and life expectancy and deranged microbiological processes in the rumen. Renal xanthine calculi have been reported in sheep grazing on low-molybdenum pasture.

Tissue storage of molybdenum varies with the intake levels and are affected by the amount of copper and sulfate in the diet. Consistent levels are observed in liver, kidney, and adrenal cortex.

Molybdenum is primarily excreted via kidneys. Some excretion through bile also occurs.

Ammonium Molybdate Injection, USP is indicated for use as a supplement to TPN solutions. Administration of Molybdenum in TPN solutions helps to prevent depletion of endogenous stores and subsequent deficiency symptoms.

Ammonium Molybdate Injection, USP should not be given undiluted by direct injection into a peripheral vein because of the potential of infusion phlebitis.
Ammonium Molybdate Injection, USP without copper supplementation should not be given to copper-deficient patients.

Molybdenum has been reported to promote the mobilization of tissue copper, and increase urinary excretion of copper both in humans and animals. Excessive amounts of Molybdenum can therefore produce copper deficiency. The metabolism of copper in patients receiving Molybdenum supplements in TPN solution should be frequently checked.
Purine and sulfur metabolic profiles should be frequently carried out in patients receiving molybdenum supplements in TPN solutions.
Ammonium Molybdate Injection, USP is a hypotonic solution and should be administered in admixtures only.

This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

As molybdenum is excreted in urine and bile, Molybdenum supplements may need to be adjusted, reduced, or omitted in renal dysfunction and bile duct obstruction.

Molybdenum metabolism has been reported to be inversely related to copper, sulfate ions, tungsten, methionine, and cysteine.

Pregnancy Category C

Animal reproduction studies have not been conducted with Ammonium Molybdate Injection, USP. It is also not known whether Ammonium Molybdate Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Ammonium Molybdate Injection, USP should be given to a pregnant woman only if clearly needed. Molybdenum has been reported to cross placenta. Molybdenum has also been detected in cow and sheep milk.

The amount of molybdenum in Ammonium Molybdate Injection, USP is small and toxicity symptoms are unlikely to occur at the recommended dosage level.

In humans, consumption of food grown in molybdeniferous soils, estimated to provide 10 to 15 mg molybdenum/day, has been associated with goutlike syndrome with increased blood levels of molybdenum, uric acid, and xanthine oxidase.

In animals, cattle grazing on molybdeniferous pasture have been reported to develop molybdenosis known as “teart” or “peat scours”. The condition is characterized by diarrhea, bone deformities, growth failure, alopecia and anemia. Similar conditions except diarrhea, have been experimentally induced in rat, chicken, and sheep maintained on high dietary Molybdenum intakes.

No information on the treatment of molybdenosis in humans is available. Among animals, treatment with copper, sulfate ions, and tungsten has been reported to enhance excretion of molybdenum thus imparting protection against molybdenosis. The sulfur-containing amino acids, methionine and cysteine, have also been reported to afford limited protection in molybdenosis in sheep.

Ammonium Molybdate Injection, USP provides 25 mcg molybdenum/mL. For metabolically stable adults receiving TPN, the suggested additive dosage level is 20 to 120 mcg molybdenum/day. For pediatric patients, the additive dosage level should be calculated by extrapolation.

In an adult, molybdenum deficiency state resulting from prolonged TPN support, intravenous administration of molybdenum as ammonium molybdate at 163 mcg/day for 21 days has been reported to reverse deficiency symptoms without toxicity.

Aseptic addition of Ammonium Molybdate Injection, USP to TPN solutions under a laminar flow hood is recommended. Molybdenum is physically compatible with the electrolytes and other trace elements usually present in amino acid/dextrose solutions used for TPN. Monitoring of sulfur and purine metabolism is suggested as a guideline. Since copper and molybdenum are antagonistic to each other, frequent monitoring of blood copper levels should be carried out during molybdenum TPN supplementation.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Ammonium Molybdate Injection, USP (molybdenum 25 mcg/mL)

NDC 0517-6610-25 10 mL Single Dose Vial packed in boxes of 25

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).

AMERICAN REGENT, INC.
SHIRLEY, NY 11967

IN6610

Rev. 1/09

PRINCIPAL DISPLAY PANEL – 10 mL Carton

AMMONIUM MOLYBDATE
INJECTION, USP

Molybdenum 250 mcg/10 mL

(25 mcg/mL)

Trace Element Additive

NDC 0517-6610-25

25 x 10 mL SINGLE DOSE VIALS

FOR INTRAVENOUS USE AFTER DILUTION

PRESERVATIVE FREE

Rx Only

Each mL contains: Ammonium Molybdate (Tetrahydrate) 46 mcg, Water for Injection q.s.
pH adjusted with Ammonium Hydroxide and/or Hydrochloric Acid. Sterile, nonpyrogenic.

WARNING: DISCARD UNUSED PORTION. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature).

Directions for Use: See Package Insert.

AMERICAN
REGENT, INC.

SHIRLEY, NY 11967

Rev. 11/05