COSOPT (PF) (dorzolamide hcl/timolol maleate/pf)

There are 6 contraindications. Absolute contraindication.

Contraindication List
Acute decompensated heart failure
Asthma
Cardiogenic shock
Complete atrioventricular block
Incomplete AV heart block
Sinus bradycardia

There are 2 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Chronic obstructive pulmonary disease
Hyperthyroidism

There are 4 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Diabetes mellitus
Hypoglycemic disorder
Myasthenia gravis
No disease contraindications

There are 36 severe adverse reactions.

More Frequent	Less Frequent
Ocular itching	Conjunctivitis

Rare/Very Rare

Acute myocardial infarction Acute respiratory failure Agranulocytosis Anaphylaxis Angioedema Aplastic anemia Bradycardia Bronchospastic pulmonary disease Cardiac arrhythmia Cerebrovascular accident Choroidal detachment Contact dermatitis Cystoid macular edema Decreased corneal sensitivity Dyspnea Epistaxis Heart block Heart failure Hepatic necrosis Hypertension Hypotension Iridocyclitis Keratitis Muscle weakness Myopia Ocular pain Paresthesia Peyronie's disease Skin rash Sore throat Stevens-johnson syndrome Systemic lupus erythematosus Toxic epidermal necrolysis Urolithiasis

There are 68 less severe adverse reactions.

More Frequent	Less Frequent
Dysgeusia Eyelid erythema Ocular irritation Ocular itching Punctate keratitis	Blurred vision Conjunctivitis Dizziness Dry eye Eye tearing Ocular discharge Ocular pain Ocular redness Photophobia Upper respiratory infection

Rare/Very Rare

Acute cognitive impairment Alopecia Angina Anorexia Behavioral disorders Blepharitis Blepharoptosis Blurred vision Chest pain Cough Delirium Depression Diarrhea Diplopia Dizziness Drowsy Dry eye Dyspepsia Dyspnea Dysuria Erectile dysfunction Erythema Eye tearing Eyelid crusting Fatigue Foreign body sensation of eye General weakness Hallucinations Headache disorder Insomnia Libido changes Memory impairment Nasal congestion Nausea Nervousness Nightmares Ocular irritation Ocular redness Palpitations Paresthesia Pruritus of skin Psoriasiform eruption Raynaud's phenomenon Sensation of cold Skin pigmentation enhancement Skin rash Symptoms of anxiety Tinnitus Urticaria Vertigo Visual changes Vomiting Xerostomia

Reproduction studies in rabbits using oral dorzolamide at dosages that resulted in estimated peak plasma concentrations that were 37 times higher than the lower limit of detection in human plasma following ocular administration revealed malformations of the vertebral bodies. These malformations occurred at dosages that caused metabolic acidosis and decreased body weight gain in dams and decreased fetal weight. Reproductive studies in rabbits using oral dorzolamide at dosages that resulted in estimated peak plasma concentrations that were 15 times higher than the lower limit of detection in human plasma following ocular administration did not reveal evidence of teratogenic effects or embryotoxicity.

There are no adequate and controlled studies to date using dorzolamide in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the possible risks to the fetus. Reproduction studies in mice, rats, and rabbits using oral timolol dosages up to 50 mg/kg daily (7000 times the systemic exposure following the maximum recommended human ophthalmic dosage) have not revealed evidence of harm to the fetus. Although delayed fetal ossification was observed at this dosage in rats, no adverse effects on postnatal development occurred in this species.

Oral timolol dosages of 1 g/kg daily (142,000 times the systemic exposure following the maximum recommended human ophthalmic dosage) were maternotoxic and resulted in an increased number of fetal resorptions in mice. Increased fetal resorptions were also observed in rabbits receiving oral timolol dosages 14,000 times the systemic exposure following the maximum recommended human ophthalmic dosage. There are no adequate and controlled studies to date using timolol ophthalmic solution in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the possible risks to the fetus.

In lactating rats given oral dorzolamide at dosages that resulted in estimated peak plasma concentrations that were 52 times higher than the lower limit of detection in human plasma following ocular administration, decreases of 5-7% in body weight gain in offspring and developmental delay (i.e., incisor eruption, vaginal canalization, eye opening) secondary to lower fetal body weight have been reported. It is not known whether dorzolamide is distributed into human milk. Because of the potential for serious adverse reactions to dorzolamide in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

Timolol is distributed into milk following oral or topical ophthalmic administration. Because of the potential for serious adverse reactions from timolol in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

No enhanced Geriatric Use information available for this drug.