Dexium-sp label

Dexium-sp

Dexium-sp Recall

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Side Effects & Adverse Reactions

WARNINGS:

Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta and metritis.  Additionally, corticosteroids administered to dogs, rabbits, and rodents during pregnancy have produced cleft palate.  Other congenital anomalies including deformed forelegs, phocomelia, and anasarca have been reported in offspring of dogs which received corticosteroids during pregnancy.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

INDICATIONS AND USAGE:

Dexamethasone Sodium Phosphate Injection is indicated as a rapid adrenal glucocorticoid and/or anti-inflammatory agent in horses.

History

There is currently no drug history available for this drug.

Other Information

Dexium-SP™

(dexamethasone sodium phosphate)

INJECTION USP FOR HORSES

4 mg/mL

Equivalent to dexamethasone 3 mg/mL

Multiple Dose Vial

CAUTION: Federal (U.S.A) law restricts this drug to use by or on the order of a licensed veterinarian.

ANADA #200-317, Approved by FDA

Net Contents: 100mL

FOR INTRAVENOUS USE IN HORSES ONLY

NOT FOR USE IN HUMANS

KEEP OUT OF REACH OF CHILDREN

WARNING: DO NOT USE IN HORSES INTENDED FOR FOOD

DESCRIPTION:

Dexamethasone sodium phosphate (a synthetic adrenocortical steroid), is a white or slightly yellow crystalline powder.  It is freely soluble in water and is exceedingly hygroscopic.  Each mL of sterile aqueous solution contains Dexamethasone Sodium Phosphate 4 mg (equivalent to dexamethasone 3 mg).  Sodium Citrate 10 mg, Sodium Bisulfite 2 mg, Benzyl Alcohol 1.5% as preservative, in Water for Injection q.s. Sodium Hydroxide and/or Hydrochloric Acid to adjust pH to between 7.0 and 8.5.

Dexium-sp Manufacturers

  • Bimeda, Inc. Division Of Cross Vetpharm Group
    Dexium-sp | Bimeda, Inc. Division Of Cross Vetpharm Group
    No Recall

    Dexium-sp | Bimeda, Inc. Division Of Cross Vetpharm Group

    Dexium-sp | Bimeda, Inc. Division Of Cross Vetpharm Group

    DOSAGE AND ADMINISTRATION:

    For Intravenous Use Only.

    Horses:  The usual intravenous dosage is 2.5 mg to 5 mg (based on 3 mg per mL of dexamethasone content).  If permanent corticosteroid effect is required, oral therapy with dexamethasone may be substituted.  When therapy is to be withdrawn after prolonged corticosteroid administration, the daily dose should be reduced gradually over a number of days, in stepwise fashion.