BETIMOL- timolol solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

timolol (UNII: 817W3C6175) (timolol - UNII:817W3C6175)

Disponibil de la:

Vistakon Pharmaceuticals LLC

INN (nume internaţional):

timolol

Compoziție:

timolol 2.5 mg in 1 mL

Calea de administrare:

OPHTHALMIC

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Betimol® is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Betimol® is contraindicated in patients with overt heart failure, cardiogenic shock, sinus bradycardia, second- or third-degree atrioventricular block, bronchial asthma or history of bronchial asthma, or severe chronic obstructive pulmonary disease, or hypersensitivity to any component of this product.

Rezumat produs:

Betimol® (timolol ophthalmic solution) is a clear, colorless solution. Betimol® 0.25% is supplied in a white, opaque, plastic, ophthalmic dispenser bottle with a controlled drop tip as follows: Betimol® 0.5% is supplied in a white, opaque, plastic, ophthalmic dispenser bottle with a controlled drop tip as follows: Rx Only Store between 15-25°C (59-77°F). Do not freeze. Protect from light.

Statutul autorizaţiei:

New Drug Application

Caracteristicilor produsului

BETIMOL- TIMOLOL SOLUTION
VISTAKON PHARMACEUTICALS LLC
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BETIMOL (TIMOLOL OPHTHALMIC SOLUTION)
0.25%, 0.5%
DESCRIPTION
Betimol
(timolol ophthalmic solution), 0.25% and 0.5%, is a non-selective
beta-adrenergic antagonist
for ophthalmic use. The chemical name of the active ingredient is
(S)-1-[(1,1-dimethylethyl)amino]-3-
[(4-(4-morpholinyl)-1,2,5-thiadiazol-3-yl]oxy]-2-propanol. Timolol
hemihydrate is the levo isomer.
Specific rotation is [α]
=-16° (C=10% as the hemihydrate form in 1N HCl).
The molecular formula of timolol is Formula C
H N O S and its structural formula is:
Timolol (as the hemihydrate) is a white, odorless, crystalline powder
which is slightly soluble in water
and freely soluble in ethanol. Timolol hemihydrate is stable at room
temperature.
Betimol
is a clear, colorless, isotonic, sterile, microbiologically preserved
phosphate buffered
aqueous solution.
It is supplied in two dosage strengths, 0.25% and 0.5%.
Each mL of Betimol
0.25% contains 2.56 mg of timolol hemihydrate equivalent to 2.5 mg
Timolol.
Each mL of Betimol
0.5% contains 5.12 mg of timolol hemihydrate equivalent to 5.0 mg
timolol.
Inactive ingredients: monosodium and disodium phosphate dihydrate to
adjust pH (6.5 - 7.5) and water
for injection, benzalkonium chloride 0.01% added as preservative.
The osmolality of Betimol
is 260 to 320 mOsmol/kg.
CLINICAL PHARMACOLOGY
Timolol is a non-selective beta-adrenergic antagonist.
It blocks both beta -and beta -adrenergic receptors. Timolol does not
have significant intrinsic
sympathomimetic activity, local anesthetic (membrane-stabilizing) or
direct myocardial depressant
activity.
Timolol, when applied topically in the eye, reduces normal and
elevated intraocular pressure (IOP)
®
®
25
405nm
13
24
4
3
®
®
®
®
1
2
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 IOP, the greater the likelihood
of glaucomatous visual field loss and optic nerve damage. The
pred