Composition, form of production and packaging
Eye drops transparent, colorless.
latanoprost 50 Ојg
timolol (in the form of maleate) 5 mg
Additives: disodium hydrogen phosphate dodecahydrate - 11.85 mg, sodium dihydrogen phosphate dihydrate - 5.2 mg, sodium chloride - 4.1 mg, benzalkonium chloride - 0.2 mg, sodium hydroxide solution 1M / hydrochloric acid solution 1M - up to pH 6.0 В± 0.1, purified water - up to 1 ml.
2.5 ml - a bottle of dropper polymer with a capacity of 5 ml (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
Antiglaucoma combined preparation.
Latanoprost is an analogue of prostaglandin F 2? and a selective agonist of FP receptors. Reduces intraocular pressure by increasing the outflow of aqueous humor and has anti-glaucoma effect. The main mechanism of action of latanoprost is associated with an increase in uveoscleral outflow. Does not have a significant effect on the production of aqueous humor and does not affect the hemato-ophthalmic barrier.
Timolol is a non-selective blocker of ОІ-adrenoreceptors with a slight internal sympathomimetic and membrane-stabilizing activity. With topical application lowers the intraocular pressure by reducing the formation of watery moisture and a small increase in its outflow.
Suction and distribution
Cmax in aqueous humor (approximately 15-30 ng / ml) is achieved 2 hours after instillation into the eye. After the application of eye drops, latanoprost is distributed, first of all, in the anterior segment of the eye, in the conjunctiva and in the eyelids. Only a small amount of the drug reaches the posterior segment. Latanoprost undergoes hydrolysis in the cornea under the action of esterases to form a biologically active acid.
Metabolism and excretion
Metabolism of latanoprost acid in the tissues of the eye practically does not occur. The main metabolism occurs in the liver. T 1/2 of the plasma is 17 minutes. The main metabolites, 1,2-dinor- and 1,2,3,4-tetranor metabolites, do not or have weak biological activity and are mainly excreted in the urine.
With topical application timolol quickly penetrates through the cornea. After instillation of eye drops C max timolol in the aqueous humor of the eye is achieved after 1 h.
T 1/2 from the plasma - 6 hours. In an insignificant amount, it enters the systemic bloodstream by absorption through the vessels of the conjunctiva, the nasal mucosa and the lacrimal tract. The excretion of timolol metabolites is mainly carried out by the kidneys.
- open-angle glaucoma;
increased intraocular pressure.
The drug is used topically.
Bury 1 drop in the eye (a) 1 time / day. If one dose was missed, then in the future it is necessary to continue treatment, introducing the next dose as usual.
If a patient is assigned more than one preparation for topical administration for an ophthalmic disease, then these drugs should be administered at intervals of not less than 5 minutes.
From the side of the organ of vision: blurred vision, blepharitis, cataract, conjunctivitis, allergic lesions of the conjunctiva (including follicles, conjunctival papillary reactions, pinpoint hemorrhages), cornea lesions (erosion, pigmentation, spot keratitis), refractive disorders, irritation of the eye, pain in the eyes, increased pigmentation of the iris, keratitis, photophobia, loss of fields of vision.
Infections: sinusitis, upper respiratory infections and other infections.
From the side of metabolism and nutrition: diabetes, hypercholesterolemia.
Mental disorders: depression.
From the nervous system: headache.
From the cardiovascular system: increased blood pressure.
From the skin and subcutaneous tissues: hypertrichosis, rash and skin changes (irritation, chalazion).
From the musculoskeletal system: arthritis.
The following are other undesirable effects that may occur with therapy with certain Duoprost components (apart from the above).
From the side of the organ of vision: irritation of the eyes (burning sensation, sensation of sand in the eyes, itching, tingling and sensation of foreign body); transient point erosions of the epithelium, edema of the eyelids, edema and erosion of the cornea; lengthening, thickening, increasing the number and increasing pigmentation of eyelashes and gun hair; iritis / uveitis; macular edema, incl. cystoid; changing the direction of growth of eyelashes, sometimes causing eye irritation; blurred vision.
From the skin and subcutaneous tissues: skin rash, darkening of the skin of the eyelids and local skin reactions on the eyelids.
From the nervous system: dizziness.
On the part of the respiratory system: bronchospasm (including acute attacks or exacerbation of the disease in patients with bronchial asthma in the anamnesis), dyspnea.
From the musculoskeletal system: pain in the muscles / joints.
General and local reactions: nonspecific pain in the chest.
Timolol (in the form of eye drops):
From the side of the immune system: systemic allergic reactions, incl. anaphylaxis, angioedema, urticaria, localized and generalized rash.
From the side of metabolism and nutrition: anorexia, hidden symptoms of hypoglycemia in patients with diabetes mellitus.
Mental disorders: behavioral changes and mental disorders, incl. confusion, hallucinations, anxiety, disorientation, nervousness, memory loss, decreased libido, insomnia and nightmares.
From the nervous system: cerebral ischemia, acute disorders of cerebral circulation, dizziness, increased symptoms of myasthenia gravis, paresthesia, drowsiness, fainting.
From the side of the organ of vision: cystoid macular edema, a decrease in the sensitivity of the cornea; abruption of the choroid after filtration surgical interventions;ptosis, visual impairment, incl. change refraction and diplopia.
From the side of the organ of hearing and the vestibular apparatus: noise in the ears.
From the cardiovascular system: arrhythmia, bradycardia, cardiac arrest, heart failure, blockade of intracardiac conduction, palpitations, progression of angina pectoris, intermittent claudication, coldness of hands and feet, lowering of blood pressure, Raynaud's syndrome.
On the part of the respiratory system: bronchospasm (mainly in patients with previous bronchospastic diseases), cough, shortness of breath, nasal congestion, pulmonary edema and respiratory failure.
From the digestive system: diarrhea, dry mouth, dyspepsia, nausea, retroperitoneal fibrosis.
From the skin and subcutaneous tissues: alopecia, pseudopemphigoid, psoriasis-like rash or exacerbation of psoriasis.
From the musculoskeletal system: systemic lupus erythematosus.
On the part of the reproductive system and mammary glands: impotence, Peyronie's disease.
General and local: asthenia / fatigue, chest pain, swelling.
- bronchial asthma or a history of bronchial asthma;
- sinus bradycardia;
- AV-blockade of II-III degree;
Decompensated chronic heart failure of II-III degree;
- cardiogenic shock;
- age up to 18 years;
- the period of breastfeeding;
- Hypersensitivity to the components of the drug.
Caution should be given to the preparation with inflammatory, neovascular, occlusive or congenital glaucoma, open-angle glaucoma in combination with pseudophakia, pigmentary glaucoma (due to lack of sufficient experience in the use of the drug), aphakia, pseudoafakia with a rupture of the posterior capsule of the lens, patients with risk factors for macular edema (in the treatment with latanoprost there are described cases of development of macular edema, including cystoid).
PREGNANCY AND LACTATION
Adequate and strictly controlled clinical studies on the safety of the drug during pregnancy and lactation (breastfeeding) was not conducted.
The use of the drug in pregnancy is possible only if the intended benefit to the mother exceeds the potential risk to the fetus or child.
The drug should not be given to breastfeeding women, or breastfeeding should be abandoned (timolol, latanoprost and its metabolites can enter breast milk).
APPLICATION FOR CHILDREN
Contraindicated in the use of drugs under the age of 18 years.
The drug can cause a gradual change in eye color by increasing the amount of brown pigment in the iris, periodic monitoring of the treating physician is recommended.
The drug contains a preservative of benzalkonium chloride, which can be absorbed by contact lenses and have a damaging effect on the eye tissue. Therefore, it is necessary to remove contact lenses and re-install them 15 minutes after instillation.
Impact on the ability to drive vehicles and manage mechanisms
Burying eye drops can cause a transient feeling of "shroud before your eyes" for several minutes, which should be taken into account when driving a car and working with moving mechanisms. While this effect does not disappear, patients should not drive a car or use sophisticated technology.
Symptoms: due to latanoprost - eye irritation, conjunctival or episcleral hyperemia, dizziness; caused by timolol - headache, arrhythmia, bradycardia, bronchospasm, nausea, vomiting.
Treatment: immediately flush eyes with water or 0.9% sodium chloride solution, symptomatic therapy.
With simultaneous application with slow calcium channel blockers, drugs that reduce the activity of catecholamines, beta-blockers, antiarrhythmics (including amiodarone and quinidine), cardiac glycosides, cholinomimetics, opioid analgesics and MAO inhibitors, hypotensive effect and / or development of severe bradycardia may be enhanced.
With the simultaneous use of timolol with epinephrine, mydriasis sometimes developed.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a place protected from light, inaccessible to children at a temperature of 2 В° to 8 В° C. Shelf life - 3 years.
After opening the vial, the drug should be stored at a temperature of no higher than 25 В° C and used for 4 weeks.