Dorzolamide Other names: Dorzolamide hydrochloride

There is a potential for an additive effect on the known systemic effects of carbonic anhydrase inhibition in patients receiving an oral carbonic anhydrase inhibitor and dorzolamide. The concomitant administration of dorzolamide and oral carbonic anhydrase inhibitors is not recommended.

Corneal oedemas and irreversible corneal decompensations have been reported in patients with pre-existing chronic corneal defects and/or a history of intra-ocular surgery while using dorzolamide. Topical dorzolamide should be used with caution in such patients.

Dorzolamide should not be used during pregnancy. There are no or limited amount of data from the use of dorzolamide in pregnant women. In rabbits, dorzolamide produced teratogenic effects at maternotoxic doses.

It is unknown whether dorzolamide/metabolites are excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of dorzolamide/metabolites in milk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from dorzolamide therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. A risk to the newborns/infants cannot be excluded.

Fertility

Animal data do not suggest an effect of treatment with dorzolamide on male and female fertility. Human data are lacking.

No studies on the effects on the ability to drive and use machines have been performed. Possible side effects such as dizziness and visual disturbances may affect the ability to drive and use machines.

Dorzolamide was evaluated in more than 1400 individuals in controlled and uncontrolled clinical studies. In long-term studies of 1108 patients treated with dorzolamide as monotherapy or as adjunctive therapy with an ophthalmic beta-blocker, the most frequent cause of discontinuation (approximately 3%) from treatment with dorzolamide was drug-related ocular adverse reactions, primarily conjunctivitis and lid reactions.

The following adverse reactions have been reported either during clinical trials or during post-marketing experience with dorzolamide:

[Very common: (≥1/10), Common: (≥1/100 to <1/10), Uncommon: (≥1/1,000 to <1/100), Rare: (≥1/10,000 to <1/1,000), Not known: (cannot be estimated from the available data)]

Nervous system disorders

Common: headache

Rare: dizziness, paraesthesia

Eye disorders

Very common: burning and stinging

Common: superficial punctate keratitis, tearing, conjunctivitis, eyelid inflammation, eye itching, eyelid irritation, blurred vision

Uncommon: iridocyclitis

Rare: irritation including redness, pain, eyelid crusting, transient myopia (which resolved upon discontinuation of therapy), corneal oedema, ocular hypotony, choroidal detachment following filtration surgery

Not known: foreign body sensation in eye

Cardiac disorders

Not known: palpitations

Respiratory, thoracic, and mediastinal disorders

Rare: epistaxis

Not known: dyspnoea

Gastrointestinal disorders

Common: nausea, bitter taste

Rare: throat irritation, dry mouth

Skin and subcutaneous tissue disorders

Rare: contact dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis

Renal and urinary disorders

Rare: urolithiasis

General disorders and administration site conditions

Common: asthenia/fatigue

Rare: hypersensitivity: signs and symptoms of local reactions (palpebral reactions) and systemic allergic reactions, including angioedema, urticaria and pruritus, rash, shortness of breath, rarely bronchospasm

Investigations

Dorzolamide was not associated with clinically meaningful electrolyte disturbances.