DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DORZOLAMIDE HYDROCHLORIDE (UNII: QZO5366EW7) (DORZOLAMIDE - UNII:9JDX055TW1), TIMOLOL MALEATE (UNII: P8Y54F701R) (TIMOLOL - UNII:817W3C6175)

Available from:

Physicians Total Care, Inc.

INN (International Name):

DORZOLAMIDE HYDROCHLORIDE

Composition:

DORZOLAMIDE 20 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution b.i.d. was slightly less than seen with the concomitant administration of 0.5% timolol b.i.d. and 2.0% dorzolamide t.i.d. (see CLINICAL PHARMACOLOGY, Clinical Studies ). Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution is contraindicated in patients with (1) bronchial asthma; (2) a history of bronchial asthma; (3) severe chronic obstructive pulmonary disease (see WARNINGS); (4) sinus bradycardia; (5) second or third degree atrioventricular block; (6) overt cardiac failure (see WARNINGS); (7) cardiogenic shock; or (8) hypersensitivity to any component of this product.

Product summary:

Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution is a clear, colorless to nearly colorless, slightly viscous solution. Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution is supplied sterile in 10 mL white LDPE plastic dropper bottles with white LDPE dropper tips and blue P/P caps of the following size: NDC 54868-5982-0, 10 mL Storage Store Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution between 20 and 25°C (68-77°F). Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE - DORZOLAMIDE
HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS
PHYSICIANS TOTAL CARE, INC.
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DORZOLAMIDE HYDROCHLORIDE - TIMOLOL MALEATE OPHTHALMIC SOLUTION
STERILE OPHTHALMIC SOLUTION
DESCRIPTION
Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution is the
combination of a topical
carbonic anhydrase inhibitor and a topical beta-adrenergic receptor
blocking agent.
Dorzolamide hydrochloride is described chemically as:
(4_S_-_trans_)-4-(ethylamino)-5,6-dihydro-6-
methyl-4_H_-thieno[2,3-_b_]thiopyran-2-sulfonamide 7,7-dioxide
monohydrochloride. Dorzolamide
hydrochloride is optically active. The specific rotation is:
[α ] 25°C (C=1, water) = ~-17°.
405 nm
Its empirical formula is C
H N O S •HCl and its structural formula is:
Dorzolamide hydrochloride has a molecular weight of 360.91. It is a
white to off-white, crystalline
powder, which is soluble in water and slightly soluble in methanol and
ethanol.
Timolol maleate is described chemically as: (-) -1-(_tert_-butylamino)
-3-[(4-morpholino-1,2,5-thiadiazol-
3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses
an asymmetric carbon atom in its
structure and is provided as the levo-isomer. The optical rotation of
timolol maleate is
[α ] 25°C in 1N HCI (C = 5) = -12.2° (-11.7° to -12.5°).
405 nm
Its molecular formula is C
H N O S•C H O and its structural formula is:
Timolol maleate has a molecular weight of 432.50. It is a white,
odorless, crystalline powder which is
soluble in water, methanol, and alcohol. Timolol maleate is stable at
room temperature.
Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution is
supplied as a sterile, isotonic,
buffered, slightly viscous, aqueous solution. The pH of the solution
is approximately 5.65, and the
osmolarity is 242-323 mOsM. Each mL of Dorzolamide
Hydrochloride-Timolol Maleate Ophthalmic
Solution contains 20 mg dorzolamide (22.26 mg of dorzolamide
hydrochloride) and 5 mg timolol (6.83
mg timolol maleate). Inactive ingredients are s