Cosopt Pf
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
COSOPT® PF is indicated for the reduction of elevated intraocular pressure (IOP) 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 COSOPT® administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [see Clinical Studies (14.1)].
History
There is currently no drug history available for this drug.
Other Information
COSOPT PF (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: (4S-trans)-4-(ethylamino)-5,6-dihydro-6-methyl-4H-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 C10H16N2O4S3•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 HCl (C = 5) = -12.2° (-11.7° to -12.5°). |
| 405 nm |
Its molecular formula is C13H24N4O3S•C4H4O4 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.
COSOPT PF is supplied as a sterile, clear, colorless to nearly colorless, 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 COSOPT PF contains 20 mg dorzolamide (22.26 mg of dorzolamide hydrochloride) and 5 mg timolol (6.83 mg timolol maleate). Inactive ingredients are sodium citrate, hydroxyethyl cellulose, sodium hydroxide, mannitol, and water for injection.
COSOPT PF does not contain a preservative.
Sources
Cosopt Pf Manufacturers
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Merck Sharp & Dohme Corp.
![Cosopt Pf (Dorzolamide Hydrochloride And Timolol Maleate) Solution [Merck Sharp & Dohme Corp.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Cosopt Pf | Merck Sharp & Dohme Corp.
The dose is one drop of COSOPT PF in the affected eye(s) two times daily.
If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart [see Drug Interactions (7.3)].
The solution from one individual unit is to be used immediately after opening for administration to one or both eyes. Since sterility cannot be maintained after the individual unit is opened, the remaining contents should be discarded immediately after administration.
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Akorn, Inc.
Cosopt Pf | Akorn, Inc.
The dose is one drop of COSOPT PF in the affected eye(s) two times daily.
If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart [see Drug Interactions (7.3)].
The solution from one individual unit is to be used immediately after opening for administration to one or both eyes. Since sterility cannot be maintained after the individual unit is opened, the remaining contents should be discarded immediately after administration.
![Cosopt Pf (Dorzolamide Hydrochloride And Timolol Maleate) Solution/ Drops [Akorn, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a8d4e2b5-c7bb-48fc-9314-7095cd77617e&name=cos03-0000-07.jpg)
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