Adult Dosing

Increased intraocular pressure

• 1 drop in affected eye(s) q12 hrs

Pediatric Dosing

• Safety and efficacy in pediatric patients <2 yrs of age have not been established

Increased intraocular pressure

• 1 drop in affected eye(s) q12 hrs

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of increased IOP in patients with open angle glaucoma or ocular hypertension having insufficient response to beta-blockers

• Hypersensitivity to any of the ingredients of the product
• Bronchial asthma
• History of bronchial asthma
• Severe COPD
• Sinus bradycardia
• Second or third degree atrioventricular block
• Overt cardiac failure
• Cardiogenic shock
• Severe renal impairment

• N/A

Renal Dose Adjustment (Based on CrCl)

• < 30 mL/min: Avoid Use

Hepatic Dose Adjustment

• Hepatic impairment: Use cautiously; dose adjustments not defined

See Supplemental Patient Information

• Severe respiratory and cardiac reactions, including death due to bronchospasm in patients with asthma, and rare occasions of death in association with cardiac failure have occurred
• Rare occasion of fatalities with sulfonamides have occurred
• Sensitization may recur. Discontinue therapy on occurrence of signs of serious reactions or hypersensitivity
• More severe failure is precipitated due to beta-adrenergic receptor blockade in individuals with diminished myocardial contractility
• May cause cardiac failure even in patients without history; discontinue therapy on occurrence
• Gradually withdraw the drug in patients undergoing elective surgery due to risk of severe hypotension
• Provide sufficient dose of adrenergic agonists to counteract the effect of beta-adrenergic blocking agents
• Beta-adrenergic blockers may mask signs and symptoms of acute hypoglycemia and hyperthyroidism
• Patient developing thyrotoxicosis should slowly taper the dose as abrupt withdrawal might precipitate a thyroid storm
• Severe anaphylactic reactions have occurred in patients with a history of atopy or history of severe anaphylactic reactions
• Local ocular adverse effects, primarily conjunctivitis and lid reactions have occurred which resolved upon discontinuation of therapy; evaluate patients before restarting the therapy
• Increased muscle weakness in patients with myasthenia gravis or myasthenic symptoms have been reported
• Bacterial keratitis has occurred on use of multiple dose containers, which may be contaminated by patients having concurrent corneal disease or a disruption of the ocular epithelial surface
• Not recommended in patients with severe renal impairment
• Efficacy is not established in patients with acute angle-closure glaucoma

Cautions: Use cautiously in

• Hepatic impairment
• Corneal edema
• Sulfonamides hypersensitivity
• History of severe anaphylactic reaction
• Diabetes mellitus
• Myasthenia gravis
• Acute angle-closure glaucoma
• Low endothelial cell counts
• Major surgery
• Hyperthyroidism

Supplemental Patient Information

• If more than one ophthalmic drug is used, administer the drug at least 10 minutes apart
• Contact lens should be removed prior to administration of drug
• Advise patients that if they have ocular surgery or develop any other ocular condition (e.g., trauma or infection) to immediately seek their physician's advice regarding continued use of the drug

Pregnancy Category:C

Breastfeeding: Safety unknown; Dorzolamide, is unlikely to adversely affect the breastfed infant. Timolol is excreted variably in breast milk; prefer other drugs especially while nursing a newborn or preterm infant. To substantially diminish the amount of drug reaching the breastmilk after using eye drops, place pressure over the tear duct by the corner of the eye for 1 minute or more and remove the excess solution with an absorbent tissue. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 3 January 2010). Manufacturer recommends discontinuation of nursing or discontinuation of therapy, by analyzing risk and benefit ratio in nursing mothers.

• EENT: Conjunctival hyperemia, ocular burning and/or stinging, blurred vision, eye itching, conjunctival discharge, blepharitis, conjunctival edema, conjunctival follicles, conjunctival injection, conjunctivitis, corneal erosion, corneal staining, cortical lens opacity, dryness of eyes, eye debris, eye discharge, eye pain, eye tearing, eyelid edema, eyelid erythema, eyelid exudate/scales, eyelid pain, glaucomatous cupping, lens nucleus coloration, lens opacity, post-subcapsular cataract, foreign body sensation, sinusitis, vitreous detachment, nasal congestion, choroidal detachment, ocular allergy, photophobia
• DERM: Stevens-Johnson syndrome, toxic epidermal necrolysis, keratitis
• HEMA: Agranulocytosis, aplastic anemia, blood dyscrasias
• GI: Unusual taste, abdominal pain, dyspepsia, nausea
• RESP: Bronchitis, cough, influenza, pharyngitis, bronchospasm, respiratory failure, URTI
• ENDO: Masking of hypoglycemia and hyperthyroidism, myasthenia gravis exacerbation
• HEPA: Hepatic necrosis
• CNS: Dizziness, headache
• CV: Hypertension, cardiac failure, bradycardia, heart block
• GU: UTI
• MISC: Back pain

Dorzolamide

• Carbonic anhydrase II inhibitor, it decreases aqueous humor secretion, delaying the formation of bicarbonate ions with reduction in sodium and fluid secretion
• Metabolized by liver in to active metabolite N-desethyl; CYP450: Unknown
• Excretion: Urine (unchanged form); Active metabolite: Urine
• Half-life: 4 months

Timolol

• Beta-adrenergic blocker; antagonizes Beta 1,2 adrenergic receptors thereby decreasing elevated aqueous humor secretion
• Systemic absorption possible
• Metabolized by the liver; CYP450: 2D6 substrate
• Excreted in urine
• Half-belife: 2.5-5 hrs

US Trade Name(s)

• Cosopt

US Availability

dorzolamide/timolol (generic)

• OPTH SOLN: 2%/0.5%

Cosopt (dorzolamide/timolol)

• OPTH SOLN: 2%/0.5%

Canadian Trade Name(s)

• Cosopt
• Cosopt (preservative free)

Canadian Availability

dorzolamide/timolol (generic)

• OPTH SOLN: 2%/0.5%

Cosopt (dorzolamide/timolol)

• OPTH SOLN: 2%/0.5%

Cosopt (dorzolamide/timolol) (preservative free)

• OPTH SOLN: 2%/0.5%

UK Trade Name(s)

• Cosopt
• Cosopt (preservative free)

UK Availability

dorzolamide/timolol (generic)

• OPTH SOLN: 2%/0.5%

Cosopt (dorzolamide/timolol)

• OPTH SOLN: 2%/0.5 %

Cosopt (dorzolamide/timolol) (preservative free)

• OPTH SOLN: 2%/0.5 %

Australian Trade Name(s)

• Cosopt

Australian Availability

Cosopt (dorzolamide/timolol)

• OPTH SOLN: 2%/0.5%

[Outline]

Ophthalmic

Ophthalmic Glaucoma Agents

Pricing data from www.DrugStore.com in U.S.A.

• Cosopt 2-0.5 % SOLN [Bottle] (MERCK SHARP & DOHME)
  10 % = $135.99
  30 % = $392.95

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.