Timolol maleate B.P 0.25%/ 0.5% W/V eye drops
Occumol eye drops is a non-selective beta-adrenergic receptor blocking agent with no significant intrinsic sympathomimetic activity. Being water soluble and free from local anaesthetic properties, it is suitable for topical administration.
Timolol is reported to suppress the formation of aqueous humor and thereby reduce the intraocular pressure. Topical application of timolol dose has no endothelial permeability
In a study of plasma drug concentration in six subjects, the systemic exposure to timolol was determined following twice daily administration of OCCUMOL 0.5%w/v. the mean peak plasma concentration following dosing was 0.46 mg/ml and following afternoon dosing was 0.35 mg/ml
OCCUMOL is indicated in chronic open angle glaucoma, ocular hypertension, aphakic glaucoma and secondary glaucoma.
Dosage and administration
One drop twice daily or as advised by the ophthalmologist.
When a patient is transferred from a single anti-glaucoma agent, continue the drug in use and add a drop of 0.25% or 0.5% of OCCUMOL in each affected eye twice a day. On the following day, discontinue the formerly used drug completely and continue with Occumol.
Occumol is contraindicated in patients with
- Bronchial asthma
- History of bronchial asthma
- Severe chronic obstructive pulmonary disease
- Sinus bradycardia
- Second or third degree atrioventricular block
- Overt cardiac failure
- Cardiogenic shock
- Hypersensitivity to any component of this product
Warning and precautions
Caution should be exercised in the use of benzalkonium chloride preserved topical medication over an extended period in patients with extensive ocular surface disease
As the possibility of an adverse effect on corneal permeability and the danger of disruption of the corneal epithelium with prolonged usage of benzalkonium chloride preserved ophthalmological preparations cannot be excluded, regular ophthalmic examination is required
Owing to systemic absorption, the side effects associated with beta blockers are likely to occur. Caution should be exercised in patients with bronchial asthma, COPD or CHF.
The preserved in Occumol eye drops, may be deposited in soft contact lenses. Occumol eye drops should not be used while wearing these lenses. Lenses should be removed before application of the eye drops and should not be reinserted earlier than 15 minutes after use.
Safety in pregnancy has not been established. Administration to pregnant mothers shortly before birth or during labour may result in the newborn infants being born hypotonic, collapsed and hypoglycemic or hypovolaemia or blood loss may be obscured during or after surgery. Particular caution should be taken in this regard.
Timolol maleate is detectable in human milk. Because of the potential for serious adverse reactions to timolol maleate in infants, a decision should be made whether to discontinue nursing or to discontinue the medication, taking into consideration the importance of the medication to the mother.
The usual starting dose is one drop of Occumol 0.25% in the affected eye (s) every 12 hours, in addition to other antiglaucoma medication. The dosage may be increased to one drop of 0.50% solution in the affected eye (s) every 12 hours, if necessary.
The use of Occumol eye drops is not recommended in premature infants or neonates
Eyes: signs and symptoms of ocular irritation, including conjunctivitis, blepharitis and keratitis and decrease in corneal sensitivity, have been reported. Visual disturbances including refractive changes (due to withdrawal of miotic therapy in some cases), diplopia and ptosis have been reported.
Cardiovascular: bradycardia, arrhythmia, hypotension, syncope, heartblock, cerebrovascular accident, cerebral ischaemia, congestive heart failure, palpitation, cardiac arrest.
Respiratory: bronchospasm (predominantly in patients with pre-existing bronchospastic disease), respiratory failure, dysponea.
Body as whole: headache, asthenia, fatigue, chest pain
Integumentary: hypersensitivity reactions, including localized and generalized rash, urticarial and alopecia
Nervous system: dizziness, depression, increases in signs and symptoms of myasthenia gravis