DORZOLAMIDE HYDROCHLORIDE-TIMOLOL MALEATE solution

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 ANHYDROUS - UNII:5JKY92S7BR)

Available from:

Lannett Company, 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 that 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. Please follow  these instruction

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 in a white, opaque, LDPE plastic ophthalmic dispenser with a transparent LDPE dropper and a dark blue HDPE cap labeled as follows: NDC 0527-1763-73, 10 mL in a 10 mL capacity bottle. Storage Store dorzolamide hydrochloride-timolol maleate ophthalmic solution at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Manufactured for: Lannett Company, Inc. Philadelphia, PA 19136 Manufactured by: Wintac Limited Bangalore – 562 123 India Mfg. Lic. No: KTK/28/289/97 Rev. 08/11, Revision 1

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DORZOLAMIDE HYDROCHLORIDE-TIMOLOL MALEATE- DORZOLAMIDE HYDROCHLORIDE-
TIMOLOL MALEATE SOLUTION
LANNETT COMPANY, INC.
----------
DORZOLAMIDE HYDROCHLORIDE-TIMOLOL MALEATE OPHTHALMIC SOLUTION
STERILE OPHTHALMIC SOLUTION
RX ONLY
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] 25ºC (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-morpho-lino-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] 25ºC in 1N HCl (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:
10
16
2
4
3
13
24
4
3
4
4
4
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 ingredi