Metipranolol use in specific populations
Metipranolol |
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METIPRANOLOL® FDA Package Insert |
Indications and Usage |
Dosage and Administration |
Contraindications |
Warnings and Precautions |
Adverse Reactions |
Drug Interactions |
Use in Specific Populations |
Overdosage |
Description |
Clinical Pharmacology |
How Supplied/Storage and Handling |
Patient Counseling Information |
Labels and Packages |
Clinical Trials on Metipranolol |
ClinicalTrials.gov |
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Use in Specific Populations
Pregnancy
Teratogenic Effects
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. Metipranolol 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. Metipranolol ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers
It is not known whether metipranolol ophthalmic solution is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when metipranolol ophthalmic solution is administered in nursing women.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients.[1]
References
Adapted from the FDA Package Insert.