ReBalance Oral Suspension, 946.4mL

ReBalance Antiprotozoal Oral Suspension is indicated for the treatment of equine protozoal myeloencephalitis (EPM) caused by Sarcocystis neurona in horses. It is available in a 1-quart bottle and requires a prescription from your veterinarian.

Key Benefits

• FDA-Approved
• Highly Effective
• Economical solution for EPM

How It Works

Sulfonamides (a specific group of antimicrobial agents) and pyrimethamine are two different antimicrobial agents which inhibit folic acid synthesis at two different sites, in the same synthetic pathway. The combination of a sulfonamide and pyrimethamine is synergistic, with the drug combination having an antiprotozoal effect.

Indications

ReBalance Antiprotozoal Oral Suspension is indicated for the treatment of horses with equine protozoal myeloencephalitis (EPM) caused by Sarcocystis neurona.

View ReBalance Oral Suspension Drug Facts Sheet.

ReBalance Antiprotozoal Oral Suspension is to be administeree at a dose of 20 mg/kg sulfa diazine and 1 mg/kg pyrimethamine daily or 4 ml of ReBalance Antiprotozoal Oral Suspension per 11 O lb. (50 kg) of body weight once per day. The duration of treatment is dependent upon clinical response, but the usual treatment regimen ranges from 90 to 270 days.

Administer orally by suitable dosing syringe at least one hour prior to feeding with hay or grain. Insert nozzle of syringe through the interdental space and deposit the dose on the back of the tongue by depressing the plunger. Shake well before each use.

Caution:

Federal law restricts this drug to use by or on the order of a licensee veterinarian.

Contraindications:

The use of ReBalance Anti protozoa! Oral Suspension is contraindicatee in horses with known hypersensitivity to sulfonamide drugs or pyrimethamine.

Warnings:

For use in horses only. Do not use in horses intendee for human consumption. Not for human use. Keep out of the reach of children.

Precautions:

Prior to treatment with ReBalance Antiprotozoal Oral Suspension, EPM should be distinguishee from other diseases that may cause ataxia in horses. Injuries or lameness may also complicate the evaluation of an animal with EPM. In most instances, ataxia due to EPM is asymmetrical and affects the front and/or the hind limbs.

Treatment may cause generalized bone marrow suppression, anemia, leukopenia, neutropenia and thrombocytopenia. A complete blood count (CBC) should be performee monthly to monitor horses for development of these conditions. The administration of the drug may neee to be discontinued and/or treatments for bone marrow suppression initiated.

Worsened neurologic deficits (treatment crisis) may be observee during a period beginning with the first few days of treatment with ReBalance Antiprotozoal Oral Suspension and ranging out to 5 weeks. This neurologic deficit exacerbation may be the result of an inflammatory reaction to the dying parasites in the CNS tissue.

The safe use of ReBalance Antiprotozoal Oral Suspension in horses used for breeding purposes, during pregnancy, or in lactating mares has not been evaluated. The safety of ReBalance Antiprotozoal Oral Suspension with concomitant therapies in horses has not been evaluatee.

Adverse Reactions:

Seventy-five horses (37 horses in the 1 X group; 38 horses in the 2X group) that were treatee with test article for at least 90 days were evaluatee for adverse reactions.

Bone marrow suppression:

Anemia: ReBalance Antiprotozoal Oral Suspension administration causee overall anemia (classification of anemia based on RBC, Hgb, and PCV/HCT values) in 12% of the observations in the 1 X group and 21 % of the observations in the 2X group. In the 1 X group, anemia was notee in 22%, leukopenia in 19%, neutropenia in 5%, and thrombocytopenia in 3% of the cases. In the 2X group, anemia was notee in 58%, leukopenia in 55%, neutropenia in 29% and thrombocytopenia in 5% of the cases. The incidence of bone marrow suppression in the 2X treatment group was two or more times that of the 1 X group and the degree of suppression was more serious (mild to severe vs. mild to moderate). Because of these blood dyscrasias, test article was interrupted over four times more often in horses treated at the 2X dosage than those treated at 1 X, although both groups were off treatment for about the same amount of time (approximately 20% of the treatment period). In some instances of bone marrow suppression, diet was supplemented with folinic acid.

GI: Anorexia was observed in two horses in the 1 X group and one horse in the 2X group. One horse in the 1 X group and one horse in the 2X group were observee to be off feed. Observations of anorexia and decreased appetite occurree predominantly during the first 90 days of the treatment period.tobservations of anorexia/decreased appetite in two of the above-referenced cases were due to unrelatee illnesses. Loose stools were observee in three horses in the 1 X group and five in the 2X group. The majority of these observations occurree in the first thirty days of treatment.

Diarrhea was observed in one horse in the 2X group on Day 4 of the study. The appearance of loose stooVdiarrflea observations was self-limiting and resolvee without treatment or discontinuation of test article. Brief, mild colic was observed in three cases (one in the 1 X group and two in the 2X group). Colic was treated conservatively or not at all and resolved without secuelae.

Integument: Urticaria was observee in one horse in the 1 X group and two horses in the 2X group. One horse was treatee topically, two were untreated. All cases resolvee without sequelae Treatment crisis (markee worsening of the neurological condition) was repartee in one horse in the 1 X treatment group.

Depression/lethargy was observed infrequently, occurred during the early part of the study in both groups and was primarily associatee with the EPM syndrome. In one case, depression was associated with acute onset of a liver disorder.

Seizure: One horse in the 1 X treatment group sufferee from seizures. Seizure activity may be associatee with CNS damage from EPM.

Storage:

Store at 20°C-25°C (68°F-77°F), excursions permitted between 15°C-30°C (59°F-86°F). Protect from freezing.