POSATEX

SECTION 2: Hazards identification

OSHA EMERGENCY OVERVIEW Oily Suspension White to off-white Odorless May cause allergic reactions in susceptible individuals. May be an aspiration hazard if ingested (mineral oil). May cause developmental effects. May cause effects to: fetus gastrointestinal tract central nervous system liver blood

Potential health effects

The following summary is based upon available information about the individual ingredients of the mixture, or of the expected properties of the mixture. Orbifloxacin is a broad-spectrum antibacterial agent from the class of fluoroquinolone carboxylic acid derivatives. The effects of orbifloxacin in animals are characteristic of fluoroquinolone antimicrobial agents where the target organs are the cartilage and gastrointestinal tract. In immature animals, quinolones and fluoroquinolones are known to cause lesions in the cartilage of weight bearing joints and other signs of diseases affecting the joints. In humans, this class of compounds may cause central nervous system disturbances such as dizziness, insomnia and convulsions, gastrointestinal disturbances, rashes, including photosensitive eruptions, elevated liver enzymes, hepatitis, blood in urine, and anaphylactic reactions. Mometasone furoate (MF) is a very potent intranasal steroid. MF, when given as a nasal suspension or when applied as an ointment (0.1% MF) to intact skin for eight hours, without occlusion, is <1% bioavailable. Several factors including degree of occlusion, inflammation, and/or integrity of skin will increase the percutaneous absorption of topical corticosteroids. Due to its lack of bioavailability, the systemic toxicity of MF is significantly lower than that of traditional steroids and is not observed at therapeutic doses. MF appears to have little or no effect on HPA axis function. Studies using higher than therapeutic inhaled doses up to 4 mg MF/day and oral doses up to 8 mg MF/day have not demonstrated suppression of the HPA axis. Long-term treatment with lower, recommended therapeutic doses has also been reported not to affect HPA axis function as measured by cortisol levels in plasma and urine. This observation is believed to be related to the low systemic bioavailability of MF. Reported occupational effects from mometasone furoate include allergic skin reactions such as inflammation and rash. Corticosteroids are teratogenic in laboratory animals and may be considered teratogenic in non-human primates as well. Widespread clinical use of corticosteroids has resulted in very few reports of teratogenic activity in humans. There is no evidence of impaired fertility in humans treated with corticosteroids although hypo-adrenalism may occur in infants born to mothers receiving corticosteroids during pregnancy. Posaconazole is a broad-spectrum triazole antifungal compound developed for the treatment and/or prophylaxis of a wide variety of superficial and invasive fungal infections. The most common serious adverse effects with posaconazole in human clinical trials were a low incidence of cardiac arrhythmias, decreased neutrophils (white blood cells), nausea or vomiting, abnormal liver function tests, anemia, headache, dizziness, fatigue, fever, abdominal pain, back pain, flatulence, insomnia, dry mouth, rashes, anorexia, and diarrhea. At therapeutic doses, posaconazole has been shown to bioaccumulate with repeated daily dosing which may increase the incidence and severity of adverse effects. Antifungal triazoles may cause adverse effects in the adrenal glands and reproductive organs. Repeated administration of posaconazole to laboratory animals for months or years produces clear evidence of phospholipidosis (disorder of phospholipid metabolism) in a wide variety of organ systems. This effect is species-specific and is shared by other antifungal triazoles already extensively used in clinical settings without adverse effects in humans. POSATEX Otic Suspension has been shown to alter HPA axis function in dogs with exaggerated/prolonged dosing. Ingestion of mineral oil may cause laxative effect, nausea, dehydration or lipid pneumonia. Long-term dermal exposure to mineral oil may cause dermatitis and oil acne. LISTED CARCINOGENS INGREDIENT CAS NUMBER