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Betoptic Pilo (Betaxolol Hydrochloride / Pilocarpine Hydrochloride) - Drug Interactions, Contraindications, Overdosage, etc



Carcinogenesis, Mutagenesis, Impairment of Fertility

Lifetime studies with betaxolol hydrochloride have been completed in mice at oral doses of 6, 20, or 60 mg/kg/day and in rats at 3, 12, or 48 mg/kg/day; betaxolol hydrochloride demonstrated no carcinogenic effect. Higher dose levels were not tested. In a variety of in vitro bacterial and mammalian cell assays, betaxolol hydrochloride was nonmutagenic.

There have been no long-term studies done using pilocarpine in animals to evaluate carcinogenic potential.


Teratogenic Effects

Pregnancy Category C

Reproduction, teratology, and peri- and postnatal studies have been conducted with orally administered betaxolol HCl in rats and rabbits. There was evidence of drug related post-implantation loss in rabbits and rats at dose levels above 12 mg/kg and 128 mg/kg, respectively. Betaxolol HCl was shown not to be teratogenic, however, and there were no other adverse effects on reproduction at subtoxic dose levels. There are no adequate and well-controlled studies of betaxolol HCl or pilocarpine in pregnant women. Betoptic®Pilo Ophthalmic Suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.


No information is available on overdosage of Betoptic®Pilo Ophthalmic Suspension in humans. The symptoms which might be expected with an overdose of a systemically administered beta-1-adrenergic blocking agent are bradycardia, hypotension and acute cardiac failure. Symptoms associated with pilocarpine toxicity include sweating, salivation, gastrointestinal over activity (nausea, vomiting, diarrhea), tremors, bradycardia, hypotension, atrioventricular block, mental status changes, and bronchial constriction (in asthmatic patients).


Betoptic®Pilo Ophthalmic Suspension is contraindicated in patients with sinus bradycardia, greater than a first degree atrioventricular heart block, cardiogenic shock or patients with overt cardiac failure.

Betoptic®Pilo Ophthalmic Suspension is also contraindicated in conditions where miosis is undesirable (e.g., peripheral anterior synechia, trauma, acute inflammatory disease of the anterior chamber, glaucoma occurring or persisting after extracapsular cataract extraction when posterior synechia may occur, and papillary block glaucoma).

Hypersensitivity to any component of this product.

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