OSPHOS- clodronate disodium injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CLODRONATE DISODIUM (UNII: N030400H8J) (CLODRONIC ACID - UNII:0813BZ6866)

Available from:

Dechra Veterinary Products

INN (International Name):

CLODRONATE DISODIUM

Composition:

CLODRONATE DISODIUM 60 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION

Therapeutic indications:

INDICATION: For the control of clinical signs associated with navicular syndrome in horses. CONTRAINDICATIONS: Horses with hypersensitivity to clodronate disodium should not receive OSPHOS. Do not use in horses with impaired renal function or with a history of renal disease.

Product summary:

HOW SUPPLIED: OSPHOS is supplied in cartons with each carton containing one clear glass 20 mL vial with 15 mL (900 mg) clodronate disodium (60 mg/mL) per vial. NDC 17033-460-15

Authorization status:

New Animal Drug Application

Summary of Product characteristics

OSPHOS- CLODRONATE DISODIUM INJECTION, SOLUTION
DECHRA VETERINARY PRODUCTS
----------
OSPHOS
(CLODRONATE INJECTION)
Bisphosphonate
CAUTION: Federal law (USA) restricts this drug to use by or on the
order of a licensed veterinarian.
For intramuscular use in horses only.
DESCRIPTION: Clodronate disodium is a non-amino, chloro-containing
bisphosphonate. Chemically,
clodronate disodium is (dichloromethylene) diphosphonic acid disodium
salt and is manufactured from
the tetrahydrate form.
The structural formula of clodronate disodium is:
Molecular Formula: CH Cl
Na O P Molecular Weight: 288.85
Active substance clodronate disodium tetrahydrate 74.98 mg/mL
corresponds to clodronate disodium
60.0 mg/mL. Each mL contains 60 mg clodronate disodium, sodium
hydroxide (to adjust pH) and water
for injection.
INDICATION: For the control of clinical signs associated with
navicular syndrome in horses.
DOSAGE AND ADMINISTRATION: Administer 1.8 mg/kg by intramuscular
injection up to a
maximum dose of 900 mg per horse. Divide the total volume evenly into
three separate injection sites.
Discard unused vial contents. OSPHOS is provided in a single use vial
and does not contain a
preservative.
Clinical improvement is most evident at 2 months post-treatment (see
EFFECTIVENESS). Of the
horses that responded to treatment with OSPHOS in the field study, 65%
maintained their level of
improvement through the 6 month evaluation.
If there is no response to initial therapy, the horse should be
re-evaluated. For horses that initially
respond to OSPHOS but do not maintain their clinical improvement for 6
months, OSPHOS may be re-
administered at 3 to 6 month intervals based on recurrence of clinical
signs. For horses that respond to
OSPHOS and maintain clinical improvement for 6 months, OSPHOS should
be re-administered after
clinical signs recur.
CONTRAINDICATIONS: Horses with hypersensitivity to clodronate disodium
should not receive
OSPHOS.
Do not use in horses with impaired renal function or with a history of
renal disease.
WARNINGS: Do not use