METIPRANOLOL solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

METIPRANOLOL (UNII: X39AL81KEB) (METIPRANOLOL - UNII:X39AL81KEB)

Available from:

Falcon Pharmaceuticals, Ltd.

INN (International Name):

METIPRANOLOL

Composition:

METIPRANOLOL 3 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METIPRANOLOL- METIPRANOLOL SOLUTION/ DROPS
FALCON PHARMACEUTICALS, LTD.
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METIPRANOLOL
OPHTHALMIC SOLUTION 0.3%
STERILE OPHTHALMIC SOLUTION
RX ONLY
DESCRIPTION
Metipranolol ophthalmic solution 0.3% is a sterile solution that
contains metipranolol, a non-selective
beta-adrenergic receptor blocking agent. Metipranolol is a white,
odorless, crystalline powder. The
chemical name of metipranolol is (±)-1-(4-Hydroxy-2,
3,5-trimethylphenoxy)-3-(isopropylamino)-2-
propanol-4-acetate.
The chemical structural of metipranolol is:
Each mL of metipranolol ophthalmic solution, for ophthalmic
administration, contains 3 mg
metipranolol. INACTIVES: povidone, glycerol, hydrochloric acid, sodium
chloride, edetate disodium,
and purified water. Sodium Hydroxide may be added to adjust pH.
PRESERVATIVE ADDED:
Benzalkonium chloride 0.004%. DM-00
CLINICAL PHARMACOLOGY
Metipranolol blocks beta and beta (non-selective) adrenergic
receptors. It does not have significant
intrinsic sympathomimetic activity, and has only weak local anesthetic
(membrane-stabilizing) and
myocardial depressant activity.
Orally administered beta-adrenergic blocking agents reduce cardiac
output in both healthy subjects and
patients with heart disease. In patients with severe impairment of
myocardial function, beta-adrenergic
receptor antagonists may inhibit the sympathetic stimulatory effect
necessary to maintain adequate
cardiac output.
Beta-adrenergic receptor blockade in the bronchi and bronchioles may
result in significantly increased
airway resistance from unopposed para-sympathetic activity. Such an
effect is potentially dangerous in
patients with asthma or other bronchospastic conditions (see
CONTRAINDICATIONS and
WARNINGS).
Metipranolol when applied topically in the eye, has the action of
reducing elevated as well as normal
intraocular pressure (IOP), whether or not accompanied by glaucoma.
Elevated intraocular pressure is a
major risk factor in the pathogenesis of glaucomatous visual field
loss. The higher the level of
intraocular pressure, the g