COMPOSITION
Phenylbutazone ……………………………………….....……………20,00 g
Excipient ……s.q.f.…………………………………….................... 100 mL
PHARMACEUTICAL PROPERTIES
Phenylbutazone (PBZ) is a widely used nonsteroidal anti-inflammatory drug in veterinary medicine, especially in horses. The PBZ is endowed with powerful anti-inflammatory, antipyretic and analgesic activities. PBZ is well absorbed via digestive system in monogastrics. However, its bioavailability is greatly reduced by taking eating. At the blood level, PBZ binds highly to plasma proteins, which limits consequently its tissue diffusion. Its half-life is about 6 hours in horse. PBZ undergoes intense metabolism in the liver generating a very active metabolite (oxyphenbutazone) especially in horses. PBZ and its metabolites are partly eliminated in the urine.
TARGET SPECIES
Equidae not intended for slaughter.
DIRECTIONS
Treatment of inflammatory and painful phenomena in the target species. The product is particularly indicated in the following cases:
Arthritis, osteoarthritis, tendonitis, tendinosynovitis, bursitis, joint and muscle rheumatism, congestive processes, hyperthermia, heatstroke, inflammatory complications of ailments various traumatic or microbial.
ADMINISTRATION AND DOSAGE
Slow and strict intravenous route.
The dosage is 2.2 to 4.4 mg of phenylbutazone/Kg of body weight, corresponding to 1.1 to 2.2 ml of ATLABUTAZONE Injection per 100 kg of body weight, per day for a maximum of 5 days.
The treatment can be continued by using the oral form.
The maximum dose is 4 g per day per adult animal.
CONTRAINDICATIONS AND INTERACTIONS
- Hepatic, renal or cardiac disorders.
- Haematological history (dyscrasia).
- Do not administer to animals whose meat is intended for human consumption
- Do not administer to animals with ulcers of the digestive tract
- Hypersensitivity to phenylbutazone or any of the excipients
- For safety reasons, it is not recommended to use PBZ in females during the first third and finally of gestation.
Interactions are possible with the following substances :
- Coumarin derivatives such as warfarin,
- Penicillin G,
- Furosemide and other diuretics,
Disadvised combinations :
- Other NSAIDs (including salicylates at high doses): increased risk of ulceration and digestive hemorrhagic (additive synergy),
- Heparin (parenteral route): increased risk of bleeding,
- Hypoglycemic sulfonamides: increase in the hypoglycemic effect of sulfonamides (displacement of their binding to plasma proteins and/or reduction of their elimination).
Combinations requiring precautions for use :
-Pentoxifylline: increased risk of bleeding.
SIDE EFFECTS
The side effects that may be observed are the following:
- Local reactions; risk of thrombophlebitis
- Gastrointestinal disorders,
- Decreased plasma levels of thyroid hormones,
- Kidney damage up to papillary necrosis.
- Bleeding, but the incidence of these symptoms is very low.
PRECAUTIONS FOR USE
- Intravenous injections should be performed slowly.
- Avoid splashing blood in the syringe:
- Respect the dose, especially in weak or dehydrated subjects.
- As a precaution, use gloves when handling
- Do not smoke or eat while using the product.
- The product should always be handled with great care to reduce the risk of self injection
- In case of accidental contact with the skin wash immediately with water.
- In case of accidental self-injection seek medical advice immediately and show the package leaflet or the label.
- Keep the product out of the reach of children.
WITHDRAWAL PERIOD
Do not use in animals whose meat is intended for human consumption
STORAGE CONDITIONS
Stable product for 2 years in the original packaging, protected from light and at a temperature y 25°C.
Stability after opening: 4 weeks
PHARMACEUTICAL FORM AND PRESENTATION:
Bottle of 50 and 100 ml