- MIOTICS AND ANTIGLAUCOMA DRUGS
- OPHTHALMOLOGICAL DRUGS
- Pharmaceutical Form : Eye Drops
- Composition : Dorzolamid HCl 22.26 mg Eq.Dorzolamid 20 mg + Timolol Maleate 6.83 mgEq.Timolol 5 mg / 1 ml
- Active Substance : Dorzolamid HCl+ Timolol Maleate
COSOPTOOL is comprised of two components : dorzolamide hydrochloride and timolol maleate .
Each of these two components decreases elevated intraocular pressure , whether or not associated with
glaucoma, by reducing aqueous humor secretion . Elevated intraocular pressur is a major risk factor in
the pathogenesis of optic nerve damage and glaucomatous visual field loss.
Dorzolamide hydrochloride is an inhibitor of human carbonic anhydrase II. Inhibition of carbonic
anhydrase decreases aqueous humor secretion ,Timolol maleats is a beta 1 and beta 2 ( non-selective )
adrenergic receptor blocking agent that does not have significant intrinsic sympathomimetic , Direct
myocardial depressant .
COSOPTOOL is indicated for the reduction of elevated intraocular pressure in patients with open angle
glaucoma or ocular hypertension who are insufficiently responsive to Beta-blokers .
COSOPTOOL is contraindicated in patients with bronchial asthma, a 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.
– Sympathetic stimulation may be essential for support of the circulation in
individuals with diminished myocardial contractility , and its inhibition by beta-adrenergic receptor
blockade may precipitate more severe failure .
-In patients without a history of cardiac failure continued depression of the myocardium with
beta-blocking agents over a period of time can, in some cases, lead to cardiac failure.at the first sign or
symptom of cardiac failure , COSOPTOOL should be discontinued
-Patients with chronic obstructive pulmonary disease of mild or moderate severity , bronchospastic
disease,or a history of bronchospastic disease ( other than bronchial asthma or a history of bronchial
asthma in which COSOPTOOL is contraindicated ) should , in general, not receive beta-blocking
agents, including COSOPTOOL.
– Beta-adrenergic blocking agents should be administered with caution in patients subject to spontaneous hypoglycemia or to diabetic patients who are receiving insulin or oral hypoglycemic agents.
Beta-adrenergic receptor blocking agents may mask the signs and symptoms of acute hypoglycemia.
-Beta-adrenergic blocking agents may mask certain clinical signs(e.g.,tachycardia) of hyperthyroidism.
Patients suspected of developing thyrotoxicosis should be manage carefully to avoid abrupt withdrawal
of beta-adrenergic blocking agents that might precipitate a thyroid storm .
-COSOPTOOL is not recommended in patients with severe renal impairment because dorzolamide and
its metabolite are excreted predominantly by the kidney,
-Dorzolamide has not been studied in patients with hepatic impairment and should therefore be used
with caution in such patients.
-Local ocular adverse effects,primarily conjunctivitis and lid reactions , were reported with chronic
administration of COSOPTOOL
-Patients with bronchial asthma, a history of bronchial asthma, severe chronic obstructive pulmonary
disease, sinus bradycardia, second or third degree atrioventricular block, or cardiac failure should be
advised not to take this product.
-Patients should be advised that if serious or unusual reactions or signs of hypersensitivity occur, they
should discontinue the use of the product.
-Patients should be advised that if they develop any ocular reactions, particularly Conjunctivitis and lid
reactions, they should discontinue use and seek their physician advice.
– COSOPTOOL has not been studied in patients with acute angle-closure glaucoma .
– Contact lenses should be removed prior to administration of the solution. Lenses may be reinserted 15
minutes following administration of COSOPTOOL .
Pregnancy and lactations :
* COSOPTOOL should be used during pregnancy only if the potential benefit justifies the potential
risk to the fetus . Because of the potential for serious adverse reactions from COSOPTOOL in nursing
Infants , a decision should be made whether to discontinue nursing or to discontinue the drug .
DRUG INTERACTIONS :-The concomitant administration of COSOPTOOL and oral carbonic
anhydrase inhibitors is not recommended.
-The concomitant use of two topical beta-adrenergic blocking agents is not recommended.
-Caution should be used in the coadministration of beta-adrenergic blocking agents, such as
COSOPTOOL,and oral or intravenous calcium antagonists .
-Close observation of the patient is recommended when a beta-blocker is administered to patients
receiving catecholamine- depleting drugs such as reserpine,
ADVERSE REACTIONS :
The most frequently reported adverse events were taste perversion(bitter, sour,or unusual taste) or ocular burning and/or stinging , conjunctival hyperemia, blurred vision, superficial punctate keratitis or eye itching .the less following adverse events are : blepharitis, cloudy vision,dizziness,dryness of eyes ,
eye pain,eyelid edema, eyelid pain or discomfort, foreign body sensation, headache, hypertension,
DOSAGE AND ADMINISTRATION :
The dose is one drop of COSOPTOOL in the affected eye(s) two times daily .
If more than one topical ophthalmic drug is being used , the drugs should be administered at least ten
minutes apart .
Storage conditions : Store up to 25°c
Packaging : Bottle of 5 ml.