Because of potential effects of beta-adrenergic receptor blocking agents relative
to blood pressure and pulse, these agents should be used with caution in patients
with cerebrovascular insufficiency. If signs or symptoms suggesting reduced
cerebral blood flow develop following initiation of therapy with OptiPranolol (metipranolol ophthalmic solution)
Ophthalmic Solution, alternative therapy should be considered.
Some authorities recommend gradual withdrawal of beta-adrenergic receptor blocking
agents in patients undergoing elective surgery. If necessary during surgery,
the effects of beta-adrenergic receptor blocking agents may be reversed by sufficient
doses of such agonists as isoproterenol, dopamine, dobutamine or levarterenol.
While OptiPranolol (metipranolol ophthalmic solution) Ophthalmic Solution has demonstrated a low potential for
systemic effect, it should be used with caution in patients with diabetes (especially
labile diabetes) because of possible masking of signs and symptoms of acute
Beta-adrenergic receptor blocking agents may mask certain signs and symptoms
of hyperthyroidism, and their abrupt withdrawal might precipitate a thyroid
Beta-adrenergic blockade has been reported to potentiate muscle weakness consistent
with certain myasthenic symptoms (e.g., diplopia, ptosis, and generalized weakness).
Risk of anaphylactic reaction: While taking beta-blockers, patients with a
history of severe anaphylactic reaction to a variety of allergens may be more
reactive to repeated challenge, either accidental, diagnostic, or therapeutic.
Such patients may be unresponsive to the usual doses of epinephrine used to
treat allergic reaction.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Lifetime studies with metipranolol have been conducted in mice at oral doses
of 5, 50, and 100 mg/kg/day and in rats at oral doses of up to 70 mg/kg/day.
Metipranolol demonstrated no carcinogenic effect. In the mouse study, female
animals receiving the low, but not the intermediate or high dose, had an increased
number of pulmonary adenomas. The significance of this observation is unknown.
In a variety of in vitro and in vivo bacterial and mammalian cell assays, metipranolol
Reproduction and fertility studies of metipranolol in rats and mice showed
no adverse effect on male fertility at oral doses of up to 50 mg/kg/day, and
female fertility at oral doses of up to 25 mg/kg/day.
Pregnancy Category C
No drug related effects were reported for the segment II teratology study in
fetal rats after administration, during organogenesis, to dams of up to 50 mg/kg/day.
OptiPranolol (metipranolol ophthalmic solution) Ophthalmic Solution has been shown to increase fetal resorption,
fetal death, and delayed development when administered orally to rabbits at
50 mg/kg/day during organogenesis.
There are no adequate and well-controlled studies in pregnant women. OptiPranolol (metipranolol ophthalmic solution)
Ophthalmic Solution should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus.
It is not known whether OptiPranolol (metipranolol ophthalmic solution) Ophthalmic Solution is excreted in human
milk. Because many drugs are excreted in human milk, caution should be exercised
when OptiPranolol (metipranolol ophthalmic solution) Ophthalmic Solution is administered to nursing women.
Safety and effectiveness in pediatric patients have not been established.
No overall differences in safety or effectiveness have been observed between
elderly and younger patients.