Timolol/ Bimatoprost

Registered South African indications:

• Open angle glaucoma 
• Ocular hypertension

Contraindications

• Hypersensitivity to the active ingredients or any of the excipients in this combination product
• Bronchial asthma or history thereof
• Severe chronic obstructive pulmonary disease
• Sinus bradycardia
• Sick sinus syndrome
• Sino-atrial block
• Second or third degree atrioventricular block, not controlled with pacemaker
• Overt cardiac failure
• Cardiogenic shock

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Cardiovascular diseases
• First degree heart block
• Severe peripheral circulatory disorders
• Mild to moderate chronic obstructive pulmonary disease
• Patients at risk of spontaneous hypoglycemia
• Labile diabetes
• Hyperthyroidism
• Corneal diseases
• Filtration procedures
• History of atopy
• History of severe anaphylactic reaction
• Aphakic patients
• Pseudophakic patients with a torn posterior lens capsule
• Risk factors for macular oedema 
• Active intraocular inflammation
• Contact with skin
• Dry eye conditions
• Compromised cornea 
• Inflammatory ocular conditions
• Neovascular, inflammatory, closed angle glaucoma or congenital glaucoma 
• Concomitant use of soft contact lenses
• May impair ability to drive and operate machinery

Forms avail. in SA and covered in this monograph: opd

Reduction of intraocular pressure in open ­angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta ­blockers or prostaglandin analogues

Timolol/ Bimatoprost
 5/0.3 (mg/ml)

• Ophthalmic (opd): 1 drop into affected eye(s), dly at the same time; Max: 1 drop/eye/24hrs

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If more than one topical ophthalmic medicinal product is to be used, each one should be instilled at least 5 minutes apart

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May cause increased brown iris pigmentation

Not established for use in children below 18 years

Recommendations for this combination product as per highest risk category when comparing individual active ingredients

Pregnancy

• FDA Pregnancy Category C (Timolol, Bimatoprost)

Breastfeeding

• Caution; not recommended (Bimatoprost)

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution; no information available

Elderly

• Caution; no dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Prohibited - In certain sports

Central Nervous System Disorders

• Insomnia
• Nightmares
• Headache
• Dizziness
• Fatigue
• Dysgeusia
• Depression
• Memory loss
• Syncope
• Cerebrovascular accident
• Exacerbation of myasthenia gravis
• Paraesthesia
• Cerebral ischaemia

Cardiovascular Disorders

• Bradycardia
• Atrioventricular block
• Cardiac arrest
• Arrhythmia
• Cardiac failure
• Chest pain
• Palpitations
• Oedema
• Hypotension
• Hypertension
• Raynaud's phenomenon
• Cold hands and feet

Respiratory Disorders

• Rhinitis
• Dyspnoea
• Bronchospasm 
• Asthma or exacerbation thereof
• Exacerbation of chronic obstructive pulmonary disease 
• Cough

Gastrointestinal Disorders

• Nausea and vomiting
• Diarrhoea
• Dyspepsia
• Dry mouth
• Abdominal pain

Hepatobiliary Disorders

• Abnormal liver function tests 

Genitourinary Disorders

• Sexual dysfunction
• Decreased libido

Endocrine and Metabolic Disorders

• Hypoglycaemia

Musculoskeletal Disorders

• Myalgia

Skin and Subcutaneous Tissue Disorders

• Blepharal pigmentation
• Hirsutism
• Skin hyperpigmentation 
• Alopecia
• Psoriasiform rash
• Exacerbation of psoriasis
• Skin rash

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions
• Angioedema
• Eye allergy
• Anaphylaxis

Sensory Disorders

• Conjunctival hyperaemia
• Punctuate keratitis
• Corneal erosion
• Burning sensation
• Conjunctival irritation
• Eye pruritus
• Stinging sensation in the eye
• Foreign body sensation
• Dry eye
• Erythema of eyelid
• Eye pain
• Photophobia
• Eye discharge
• Visual disturbance
• Eyelid pruritus
• Visual acuity worsened
• Blepharitis
• Eyelid oedema
• Eye irritation
• Increased lacrimation 
• Growth of eyelashes
• Iritis
• Conjunctival oedema
• Eyelid pain
• Abnormal sensation in the eye
• Asthenopia
• Trichiasis
• Iris hyperpigmentation
• Deepening of eyelid sulcus
• Eyelid retraction
• Eyelash discolouration
• Cystoid macular oedema
• Eye swelling
• Decreased corneal sensitivity
• Diplopia
• Ptosis
• Choroidal detachment following filtration surgery
• Keratitis
• Blepharospasm
• Retinal haemorrhage
• Uveitis

• Beta blockers
• Calcium channel blockers
• Guanethidine
• Parasympathomimetics
• Anti-arrhythmics
• Digitalis glycosides
• CYP2D6 inhibitors 
• Adrenaline 

None routine

Timolol
Timolol maleate is a non-selective beta-adrenergic receptor blocking agent that does not have significant intrinsic sympathomimetic, direct myocardial depressant, or local anaesthetic activity. It combines reversibly with the beta-adrenergic receptor, and this inhibits the usual biologic response that would occur with stimulation of that receptor. Timolol maleate reduces elevated and normal intraocular pressure whether or not associated with glaucoma and has little or no effect on accommodation or pupil size. 

Bimatoprost
Bimatoprost is a synthetic prostamide, structurally related to prostaglandin F2-alpha. It reduces intraocular pressure by increasing aqueous humour outflow through the trabecular meshwork and enhancing uveoscleral outflow.

COMBINATION PREPARATIONS

Timolol/ Bimatoprost

Eye drops (per ml) 5mg/0.3mg

• Ganfort (Allergan) originator