Dragpharma

Species

Horses

Dosage form

Injectable suspension.

Therapeutic action

Steroidal anti-inflammatory.

Composition

Each 1 mL of suspension contains:         
Triamcinolone Acetonide............... 6 mg
Excipients q.s.p.............................1 mL

Indications

Anti-inflammatory of long lasting effect for allergic, dermatologic disorders and arthritis.

Route od administration and dosage

Administration route: Intramuscular, subcutaneous, intra-articular and intrasynovial.

Recommended dose:
Horses:

• Intramuscular or subcutaneous route: 2 to 5 mL in a single dose.
• Intra-articular or intrasynovial route: 1 to 5 mL in a single dose. Repeat if necessary under Veterinary Medical recommendation.

It is not recommended to repeat the treatment beyond 3 consecutive times.

Drug interactions

• Amphotericin B or caliuretic diuretics (Furosemide, Thiazides) can cause hypokalemia when administered concomitantly with glucocorticoids. When these drugs are used simultaneously with digitalis glycosides, it may increase the possibility of toxicity if hypokalemia is generated. Diligent monitoring of potassium and digitalis levels is recommended.
• Glucocorticoids can lower blood levels of salicylates.
• Insulin requirements may increase in patients receiving glucocorticoids.
• Phenytoin, Phenobarbital, Rifampicin can increase glucocorticoid metabolism.
• Concomitant administration of glucocorticoids and cyclosporine can increase the blood levels of each, with mutual inhibition of liver metabolism. The clinical importance of this interaction is uncertain. Glucocorticoids can also inhibit hepatic metabolism of Cyclophosphamide. Dosage adjustments may be required.
• Mitotane can alter steroid metabolism; higher doses than usual may be necessary to treat mitotane-induced adrenal insufficiency.
• Patients treated with corticosteroids at immunosuppressive doses should not receive live attenuated live virus vaccines because viral replication may be enhanced. A decreased immune response may occur after administration of a vaccine, toxoid, or bacterin, in patients receiving glucocorticoids.
• Administration of ulcerogenic drugs (eg, nonsteroidal anti-inflammatory drugs) with glucocorticoids may increase the risk of gastrointestinal ulceration.
• The effects of Hydrocortisone, and possibly other glucocorticoids, can be potentiated by concomitant administration with estrogens.
• In patients with myasthenia gravis, concomitant administration of glucocorticoids and anticholinesterases (eg, Pyridostigmine, Neostigmine, etc.) can induce pronounced muscle weakness. If possible, discontinue anticholinesterase medication for at least 24 hours before glucocorticoid administration.

Contraindications

• Do not use in viral infectious processes and generalized fungal infections.
• Do not use in musculoskeletal disorders where immobility is required.
• Do not use in animals with tuberculosis, chronic nephritis or Cushing's syndrome, except for emergency therapy.
• Do not use in case of bone metaplasia and osteoporosis.
• Do not use in treatment of laminitis.
• Do not use in patients with diabetes mellitus, kidney or heart failure.
• Do not use in patients with hypersensitivity to the active substance.
• Do not use in animals with gastrointestinal or corneal ulcers.
• Do not use in pregnant or lactating females.

Special precautions for the operator

• The product is irritating in the case of contact with the eyes. It can be dangerous in the case of accidental ingestion and in the case of contact with the skin.
• Pregnant women should not handle the product.

Warnings

Special warnings and precautions for use:

• In bacterial infections the use must be associated with antibacterials.
• Corticosteroids can precipitate labor during the final stages of pregnancy.
• Shake before using.
• Keep out of the reach of children.

Adverse effects

Unwanted effects and adverse reactions:
Prolonged use of Depodrag® can cause suppressive effects on the hypothalamic-pituitary-adrenal axis leading to adrenal atrophy (adrenal insufficiency). It can also cause bone resorption or inhibition of growth and bone repair, inhibition of collagen synthesis, decreased growth rate, delayed healing, diarrhea, gastrointestinal irritation, gastrointestinal ulceration, hematopoietic changes, retention of sodium and fluid and flares of latent infections.
The most frequent side effects are polyuria, polydipsia, polyphagia, lethargy, weakness and bilateral alopecia. Less frequent are weight loss, anorexia, and diarrhea.

Guard period

Do not use in horses intended for human consumption.

Observations

Use during pregnancy, lactation and in breeding animals:

• Do not use in pregnant and lactating females.
• Glucocorticoids are probably necessary for normal fetal development.
• They may be required for adequate surfactant production and development of myelin, retina, pancreas, and breasts.
• Excessive doses early in pregnancy can lead to teratogenic effects. In horses, the administration of exogenous steroids can induce labor when used in late pregnancy. It is recommended not to use high doses in pregnant animals.
• Glucocorticoids not bound to plasma proteins enter milk. High doses or prolonged administration in mothers can potentially inhibit the growth of newborns.

Conservation

Store at a temperature between 2 ° and 30° C, protected from light. Once opened, use within 3 months. Discard the unused product after that period of time.

Condition of sale

To be supply only with veterinary prescription.

Presentation

Ampule containing 20 mL in a box with 3 ampules containing 5 mL each.

Prepared by

Drag Pharma Laboratory.

Records

• Chile: Reg. SAG Nº 0529
• Bolivia: Reg. SENASAG PUV-F-N° 005515/13
• Uruguay: Reg. MGAP N° A-4493
• Rep. Dominicana: Reg. Nº 5607
• Perú: Reg. SENASA F.06.42.I.0240