® (clo­dronate in­jec­tion)

EQUUS - - Equus -

Bis­pho­s­pho­nate For use in horses only. Brief Sum­mary (For Full Pre­scrib­ing In­for­ma­tion, see pack­age insert) CAU­TION: Fed­eral (USA) law re­stricts this drug to use by or on the or­der of a li­censed vet­eri­nar­ian. DE­SCRIP­TION: Clo­dronate dis­odium is a non-amino, chloro­con­tain­ing bis­pho­s­pho­nate. Chem­i­cally, clo­dronate dis­odium is (di ch lo rom eth­yl­ene) dip hos phonic acid di sodium salt and is man­u­fac­tured from the tetrahy­drate form. IN­DI­CA­TION: For the con­trol of clin­i­cal signs as­so­ci­ated with nav­ic­u­lar syn­drome in horses. CON­TRA IN­DI­CA­TIONS: Horses with hy­per­sen­si­tiv­ity to clod rona tedi sodium should not re­ceive OSPHOS. WARN­INGS: Do not use in horses in­tended for hu­man con­sump­tion. HU­MAN WARN­INGS: Not for hu­man use. Keep this and all drugs out of the reach of chil­dren. Con­sult a physi­cian in case of ac­ci­den­tal hu­man ex­po­sure. PRE­CAU­TIONS: As a class, bis­pho­s­pho­nates may be as­so­ci­ated with gas­troin­testi­nal and re­nal tox­i­c­ity. Sen­si­tiv­ity to drug as­so­ci­ated ad­verse re­ac­tions varies with the in­di­vid­ual pa­tient. Re­nal and gas­troin­testi­nal ad­verse re­ac­tions may be as­so­ci­ated with plasma con­cen­tra­tions of the drug. Bis­pho­s­pho­nates are ex­creted by the kid­ney; there­fore, con­di­tions caus­ing re­nal im­pair­ment may in­crease plasma bis­pho­s­pho­nate con­cen­tra­tions re­sult­ing in an in­creased risk for ad­verse re­ac­tions. Con­cur­rent ad­min­is­tra­tion of other po­ten­tially nephro­toxic drugs should be ap­proached with cau­tion and re­nal func­tion should be mon­i­tored. Use of bis­pho­s­pho­nates in pa­tients with con­di­tions or dis­eases af­fect­ing re­nal func­tion is not rec­om­mended. Ad­min­is­tra­tion of bis­pho­s­pho­nates has been as­so­ci­ated with ab­dom­i­nal pain (colic), dis­com­fort, and ag­i­ta­tion in horses. Clin­i­cal signs usu­ally oc­cur shortly af­ter drug ad­min­is­tra­tion and may be as­so­ci­ated with al­ter­ations in in­testi­nal motil­ity. In horses treated with OSPHOS these clin­i­cal signs usu­ally be­gan within 2 hours of treat­ment. Horses should be mon­i­tored for at least 2 hours fol­low­ing ad­min­is­tra­tion of OSPHOS. Bis­pho­s­pho­nates af­fect plasma con­cen­tra­tions of some min­er­als and elec­trolytes such as cal­cium, mag­ne­sium and potas­sium, im­me­di­ately post-treat­ment, with ef­fects last­ing up to sev­eral hours. Cau­tion should be used when ad­min­is­ter­ing bis­pho­s­pho­nates to horses with con­di­tions af­fect­ing min­eral or elec­trolyte home­osta­sis (e.g. hy­per­kalemic pe­ri­odic paral­y­sis, hypocal­cemia, etc.). The safe use of OSPHOS has not been eval­u­ated in horses less than 4 years of age. The ef­fect of bis­pho­s­pho­nates on the skele­ton of grow­ing horses has not been stud­ied; how­ever, bis­pho­s­pho­nates in­hibit os­teo­clast ac­tiv­ity which im­pacts bone turnover and may af­fect bone growth. Bis­pho­s­pho­nates should not be used in preg­nant or lac­tat­ing mares, or mares in­tended for breed­ing. The safe use of OSPHOS has not been eval­u­ated in breed­ing horses or preg­nant or lac­tat­ing mares. Bis­pho­s­pho­nates are in­cor­po­rated into the bone ma­trix, from where they are grad­u­ally re­leased over pe­ri­ods of months to years. The ex­tent of bis­pho­s­pho­nate in­cor­po­ra­tion into adult bone, and hence, the amount avail­able for re­lease back into the sys­temic cir­cu­la­tion, is di­rectly re­lated to the to­tal dose and du­ra­tion of bis­pho­s­pho­nate use. Bis­pho­s­pho­nates have been shown to cause fe­tal devel­op­men­tal ab­nor­mal­i­ties in lab­o­ra­tory an­i­mals. The up­take of bis­pho­s­pho­nates into fe­tal bone may be greater than into ma­ter­nal bone cre­at­ing a pos­si­ble risk for skele­tal or other ab­nor­mal­i­ties in the fe­tus. Many drugs, in­clud­ing bis­pho­s­pho­nates, may be ex­creted in milk and may be ab­sorbed by nurs­ing an­i­mals. In­creased bone fragility has been ob­served in an­i­mals treated with bis­pho­s­pho­nates at high doses or for long pe­ri­ods of time. Bis­pho­s­pho­nates in­hibit bone re­sorp­tion and de­crease bone turnover which may lead to an in­abil­ity to re­pair mi­cro dam­age within the bone. In hu­mans, atyp­i­cal fe­mur frac­tures have been re­ported in pa­tients on long term bis­pho­s­pho­nate ther­apy; how­ever, a causal re­la­tion­ship has not been es­tab­lished. AD­VERSE RE­AC­TIONS: The most com­mon ad­verse re­ac­tions re­ported in the field study were clin­i­cal signs of dis­com­fort or ner­vous­ness, colic and/or paw­ing. Other signs re­ported were lip lick­ing, yawn­ing, head shak­ing, in­jec­tion site swelling, and hives/pru­ri­tus.

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