Ammonium Molybdate Injection

Name: Ammonium Molybdate Injection

Indications and Usage for Ammonium Molybdate Injection

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.

Contraindications

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

Overdosage

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 Dosage and Administration

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.

How is Ammonium Molybdate Injection Supplied

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

Package label.principal display panel

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

AMMONIUM MOLYBDATE 
Ammonium Molybdate Injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0517-6610
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMMONIUM MOLYBDATE (MOLYBDENUM) AMMONIUM MOLYBDATE 46 ug  in 1 mL
Inactive Ingredients
Ingredient Name Strength
AMMONIA  
HYDROCHLORIC ACID  
WATER  
Packaging
# Item Code Package Description
1 NDC:0517-6610-25 25 VIAL, SINGLE-DOSE (VIAL) in 1 TRAY
1 10 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 09/30/1990
Labeler - American Regent, Inc. (622781813)
Revised: 10/2011   American Regent, Inc.
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