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Risk Management Plan Dorzolamide/Timolol Is Used To

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Risk Management Plan Dorzolamide/Timolol Is Used To Risk Management Plan VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology Dorzolamide/Timolol is used to reduce pressure in the eye in relatively common conditions known as open angle glaucoma or pseudoexfoliative glaucoma which result from a build-up of fluid. Around 2% of people older than 40 years of age have long-term open angle glaucoma, a figure which rises to almost 10% in people older than 75 years.1 Untreated open angle glaucoma leads to gradual vision loss. Hence, prevention or at least minimisation of ongoing damage is paramount to maintenance of vision. Pseudoexfoliative glaucoma is less common. 1 Risk Management Plan Risk factors for open-angle glaucoma include increased age, African ethnicity, family history and other eye disorders1 , for pseudoexfoliative glaucoma include sex (female gender), age (rarely seen before age 50) and Scandinavian origin2. VI.2.2 Summary of treatment benefits In clinical studies, the effect of the dorzolamide and timolol eye drops prescribed in combination to reduce eye pressure has been shown to be greater than when either substance is administered alone. The eye pressure lowering effect has been demonstrated when measured at various time points throughout the day and has been maintained during long-term administration. The effect was also similar in patients given dorzolamide-timolol in a fixed combination compared to a group that received treatment with separate drops of dorzolamide and timolol. The benefit of dorzolamide timolol fixed combination lies in the simplification of the dosing regimen by reducing the prescribed number of doses per day. It has been documented that less frequent dosing regimens results in better adherence to the drug dosage regimen by patients 3 Use of the fixed combination also decreases the load of preservatives (chemicals that discourage the growth of bacteria that may irritate eyes once the bottle has been opened) to which the patient’s eyes are exposed. In addition, it eliminates the effects of the need for the first instilled drug to be diluted or “washed out” by the second instilled drug, when two drugs are administered separately.4 VI.2.3 Unknowns relating to treatment benefits Currently, there is a lack of data regarding the the use of dorzolamide/timolol in paediatric populations, in pregnant women/lactating mothers and patients with hepatic or severe renal impairment. VI.2.4 Summary of safety concerns Table 42 Important identified risks Important Identified Risk What is known Preventability Generalized effects in the body Like other medicines applied into Pressing the finger against the associated with a group of eyes, Dorzolamide/Timolol is corner of the closed eye (the side medicines known as “beta- absorbed into the blood. This may where the eye meets the nose) and blockers” in which timolol belongs cause similar side effects as seen holding for 2 minutes. This helps (systemic beta-blockade with systemic intra-venous and/or to stop timolol getting into the rest associated side effects) oral beta-blocking agents. Side of the body. effects after topical application into the eyes are lower than when medicines are, for example, taken by mouth or injected. Risk Management Plan Heart (cardiac) disorders This medicinal product can cause Patients with poor heart conditions disturbances of heart rate such as (cardiac disorders) should be slow heart beat (bradycardia), monitored closely by the attending worsening of angina and awareness physician. The doctor and/or of heart rhythm (palpitations). pharmacist should be aware of this condition. Circulatory (vascular) disorders This medicinal product can cause Patients with poor blood low blood pressure (hypotension), circulation disease (such as poor blood circulation disease Raynaud’s disease or Raynaud’s (such as Raynaud’s disease or syndrome) should be monitored Raynaud’s syndrome) and cold closely by the attending physician. hands and feet. The doctor and/or pharmacist should be aware of this condition. Breathing (respiratory) disorders This medicinal product can cause The medicinal product should not asthma, worsening of asthma, be used in patients that have or shortness of breath and worsening have a history of respiratory of pre-existing reactive respiratory problems such as asthma, severe diseases that can lead to a fatal chronic obstructive bronchitis outcome. (severe lung disease which may cause wheeziness, difficulty in breathing and/or long-standing cough). Low blood sugar Timolol may mask signs and Patients with low blood sugar (hypoglycaemia/diabetes) symptoms of low blood sugar, (hypoglycaemia)/diabetes should which is a frequent sign of be monitored closely by the individuals with diabetes. attending physician. The doctor and/or pharmacist should be aware of this condition. Interaction with surgical Dorzolamide/Timolol may change The anaesthesiologist should be anaesthesia the effect of some medicines used informed when the patient is during anaesthesia. receiving timolol. Drug interaction with other The medicinal product interacts The doctor or pharmacist should be medicinal products that belong to with drugs used to treat high blood aware if the patient is taking any the same group of medicines as pressure such as oral calcium type of these medicinal products. timolol and dorzolamide (“beta- channel blockers, guanethidine, This situation should be closely blocking agents”), and with other beta-blockers; antiarrhythmics monitored by a healthcare medicinal products (e.g. CYP2D6 (medications that normalise the professional. inhibitors, adrenaline) heart rhythm); digitalis glycosides (used to treat heart failure); parasympathomimetic agents (e.g. for the treatment of high blood pressure); quinidine (used to treat heart conditions and some types of malaria); antidepressants known as monoamine oxidase inhibitors, fluoxetine and paroxetine. The interaction could lead to the hypotension (low blood pressure) and bradycardia (slow heart beat). The effect on the eye pressure or the known effects of generalised Risk Management Plan effects may be potentiated when timolol is given to the patients already receiving a “beta-blocking agent”. The use of two local “beta- blockers” is not recommended. Severe sudden life-threatening Allergic reactions include swelling The medicinal product should not allergic reaction (anaphylactic beneath the skin that can occur in be used in the patients that are reaction) areas such as the face and limbs allergic to dorzolamide or timolol and can obstruct the airway which or “beta-blockers” (group of may cause difficulty swallowing or medicines which timolol belongs), breathing, (angioedema) hives or or any of the other ingredients of itchy rash, localized and Dorzolamide/Timolol. generalized rash, itchiness, severe The doctor or pharmacist should be sudden life-threatening allergic aware if the patient has now or has reaction (anaphylactic reaction). had in the past suffering from These allergic reactions can be severe allergic reactions that would associated with the use of usually require hospital treatment. Dorzolamide/Timolol. Eye (ophthalmic) disorders Signs and symptoms of eye The doctor or pharmacist should be (including corneal disorders and irritation (e.g. burning, stinging, aware if the patient has any kind of choroidal detachment) itching, tearing, redness), eye surgery (including cataract inflammation of the eyelid, surgery) or has had any kind of eye inflammation in the cornea, blurred surgery in the past), if the patient vision, choroidal detachment suffer from eye problems (such as (detachment of the layer below the eye pain, eye irritation, eye retina that contains blood vessels inflammation or blurred vision) or following filtration surgery which if the patient suffers from dry eyes. may cause visual disturbances), These situations should be closely decreased corneal sensitivity, dry monitored by the healthcare eyes, corneal erosion (damage to professionals. the front layer of the eyeball), drooping of the upper eyelid (making the eye stay half closed) and double vision are effects that can be associated with use of Dorzolamide/Timolol. Table 43 Important potential risks Important Potential Risk What is known (including reason why it is considered a potential risk) Severe hypersensitivity reactions (undesirable reaction Dorzolamide molecule contains a sulfonamide group, produced by the immune system) associated with which also occurs in sulphonamides (several groups of sulfonamide group (part of the dorzolamide molecule) drugs used e.g. as antibacterial drugs, anti-diabetic drugs and drugs against high blood pressure). The same types of adverse reactions found with systemic administration (into the circulatory system, the entire body is affected) of sulphonamides may occur with local administration (e.g. eye drops), including severe reactions such as Stevens-Johnson syndrome and toxic Risk Management Plan epidermal necrolysis (rare, potentially deadly skin diseases in which the skin and mucous membranes react severely with the loosing of outer layer). Causal relationship with medicinal product is identified as an area requiring confirmation or further investigation. Urinary tract stones (urolithiasis) Oral therapy with the similar drugs as dorzolamide (oral carbonic anhydrase inhibitors) is associated with urinary tract stones (urolithiasis), especially in patients with a prior history of kidney stone. Causal relationship between dorzolamide administration into eyes and urinary tract stones (urolithiasis) required further
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