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Betoptic Pilo (Betaxolol Hydrochloride / Pilocarpine Hydrochloride) - Warnings and Precautions

 
 



WARNINGS

NOT FOR INJECTION OR ORAL ADMINISTRATION. FOR TOPICAL OPHTHALMIC USE ONLY. COMBINE PARTS I AND II PRIOR TO DISPENSING AND LABEL WITH A TWO (2) WEEK EXPIRATION DATE

Topically applied beta-adrenergic blocking agents may be absorbed systemically. The same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration. For example, severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma and, rarely, death in association with cardiac failure, have been reported with topical application of beta-adrenergic blocking agents.

Betaxolol has been shown to have a minor effect on heart rate and blood pressure in clinical studies. Caution should be used in treating patients with a history of cardiac failure or heart block. Betoptic®Pilo Ophthalmic Suspension should be discontinued at the first signs of cardiac failure.

PRECAUTIONS

General

Ocular. Pilocarpine-induced miosis may cause difficulty in dark adaptation. Patients should be advised to exercise caution in night driving and hazardous tasks performed in poor illumination.

In patients with angle-closure glaucoma, the immediate treatment objective is to re-open the angle by constriction of the pupil with a miotic agent. Betoptic®Pilo Ophthalmic Suspension contains pilocarpine HCl 1.75%, a miotic, which, while having an effect on the pupil, is unlikely to be sufficient to effectively treat an angle closure event.

Diabetes Mellitus. Beta-adrenergic blocking agents should be administered with caution in patients subject to spontaneous hypoglycemia or to diabetic patients (especially those with labile diabetes) who are receiving insulin or oral hypoglycemic agents. Beta-adrenergic receptor blocking agents may mask the signs of acute hypoglycemia.

Thyrotoxicosis. Beta-adrenergic blocking agents may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-adrenergic blocking agents, which might precipitate a thyroid storm.

Muscle Weakness. Beta-adrenergic blockage has been reported to potentiate muscle weakness consistent with certain myasthenic symptoms (e.g., diplopia, ptosis and generalized weakness).

Major Surgery. Consideration should be given to the gradual withdrawal of beta-adrenergic blocking agents prior to general anesthesia because of reduced ability of the heart to respond to beta-adrenergically mediated sympathetic reflex stimuli.

Pulmonary. Caution should be exercised in the treatment of glaucoma patients with excessive restriction of pulmonary function. There have been reports of asthmatic attacks and pulmonary distress during betaxolol treatment. Although rechallenges of such patients with ophthalmic betaxolol have not adversely affected pulmonary function test results, the possibility of adverse pulmonary effects in patients sensitive to beta blockers cannot be ruled out.

Risk from Anaphylactic Reaction. While taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated accidental, diagnostic, or therapeutic challenge with such allergens. Such patients may be unresponsive to the usual doses of epinephrine used to treat anaphylactic reactions.

Information for Patients

There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or disruption of the ocular epithelial surface.

The preservative in Betoptic®Pilo, benzalkonium chloride, may be absorbed by soft contact lenses. Betoptic®Pilo should not be administered while wearing soft contact lenses.

Drug Interactions

Patients who are receiving a beta-adrenergic blocking agent orally and Betoptic®Pilo Ophthalmic Suspension should be observed for a potential additive effect on the intraocular pressure or on the known systemic effects of beta blockade.

Close observation of the patient is recommended when a beta blocker is administered to patients receiving catecholamine-depleting drugs (e.g., reserpine) or calcium-channel blockers because of possible additive effects and the production of hypotension or marked bradycardia, which may produce vertigo, syncope, or postural hypotension.

Betaxolol is an adrenergic blocking agent; therefore, caution should be exercised in patients using concomitant adrenergic psychotropic drugs.

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.

Pregnancy

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.

Nursing Mothers

It is not known whether topical ocular betaxolol, pilocarpine or Betoptic®Pilo Ophthalmic Suspension is excreted in human milk; however, oral betaxolol is excreted in human milk. Because many drugs are excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue Betoptic®Pilo Ophthalmic Suspension usage, taking into account the benefit of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Page last updated: 2006-06-19

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