Description
Release form
Duoprost. Eye drops.
Packing
2.5 ml – polymer dropper bottle with a capacity of 5 ml (1) – packs of cardboard.
Pharmacological action
Anti-glaucoma combination drug.
Latanoprost is an analogue of prostaglandin F2 and a selective FP receptor agonist. It reduces intraocular pressure by increasing the outflow of aqueous humor and has an anti-glaucoma effect. The main mechanism of action of latanoprost is associated with an increase in uveoscleral outflow. It does not significantly affect the production of aqueous humor and does not affect the blood-brain barrier.
Timolol is a non-selective -adrenoreceptor blocker with little internal sympathomimetic and membrane-stabilizing activity. When applied topically, it reduces intraocular pressure by reducing the formation of aqueous humor and a slight increase in its outflow.
Pharmacokinetics
Latanoprost
Absorption and distribution of
Cmax in aqueous humor (approximately 15-30 ng / ml) is achieved 2 hours after instillation in the eye. After applying eye drops, latanoprost is distributed primarily 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 influence of esterases with the formation of 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. T1 / 2 from plasma is 17 min. The main metabolites, 1,2-dinor and 1,2,3,4-tetranor metabolites, do not have or have weak biological activity and are mainly excreted in the urine.
timolol
When applied topically, timolol penetrates quickly through the cornea. After instillation of eye drops, Cmax timolol in aqueous humor of the eye is reached after 1 hour.
T1 / 2 from plasma – 6 hours. It enters a systemic circulation by absorbing through the vessels of the conjunctiva, nasal mucosa and lacrimal tract. Excretion of timolol metabolites is carried out mainly by the kidneys.
Indications
open-angle glaucoma
increased intraocular pressure.
Contraindications
bronchial asthma or a history of bronchial asthma, chronic obstructive pulmonary disease
sinus bradycardia
AV block II-III degree
decompensated chronic heart failure II-III cardiac s splk period srdk period srdk period
hypersensitivity to the components of the drug.
Precautions
Inflammatory, neovascular, angle-closure or congenital glaucoma, open-angle glaucoma combined with pseudophakia, pigmented glaucoma (due to lack of sufficient experience with the drug) aphakia, pseudo-aphakia with rupture of the posterior lens capsule, patients with risk factors for macular edema (cases of macular edema, including cystoid edema, have been described in the treatment of latanoprost).
Use during pregnancy and lactation
Adequate and strictly controlled clinical studies on the safety of the drug during pregnancy and lactation (breastfeeding) have not been conducted.
The use of the drug during pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus or child.
The drug should not be prescribed to lactating women, or breast-feeding should be abandoned (timolol, latanoprost and its metabolites can pass into breast milk).
Composition
Eye drops transparent, colorless.
1 ml
latanoprost 50 mcg
timolol (in the form of maleate) 5 mg
Excipients: disodium hydrogen phosphate dodecahydrate – 11.85 mg, sodium dihydrogen phosphate dihydrate – 5.2 mg, sodium chloride – 4.1 mg, benzalkonium chloride – 0.2 sodium hydroxide solution 1M / hydrochloric acid 1M solution – up to pH 6.0 ± 0.1, purified water – up to 1 ml.
Dosage and Administration
Locally.
Instill 1 drop in the eye (a) 1 time / day. If one dose was missed, then treatment should be continued in the future, introducing the next dose as usual.
If the patient is prescribed more than one drug for topical administration for an ophthalmic disease, then these drugs should be administered with an interval of at least 5 minutes.
Side effects of
From the side of the organ of vision: visual impairment, blepharitis, cataracts, conjunctivitis, allergic lesions of the conjunctiva (including follicles, papillary conjunctival reactions, pinpoint hemorrhages), corneal lesions (erosion, pigmentation, pigmentation refraction, hyperemia of the eye, eye irritation, eye pain, increased pigmentation of the iris, keratitis, photophobia, loss of areas of the visual field.
Infections: sinusitis, upper respiratory tract infections and other infections.
Disorders 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 adverse events that may occur during treatment with individual components of the drug Duoprost (in addition to the above).
Latanoprost
On the part of the organ of vision: eye irritation (burning sensation, feeling of sand in the eyes, itching, tingling and foreign body sensation) transient point erosion of the epithelium, eyelid edema, swelling and erosion of the cornea lengthening, thickening, increasing the number and intensification of eyelash pigmentation and fluffy hair iritis / uveitis macular edema, including cystoid change in the direction of eyelash growth, sometimes blurry vision causing eye irritation.
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.
From the respiratory system: bronchospasm (including acute attacks or exacerbation of the disease in patients with a history of bronchial asthma), shortness of breath.
From the musculoskeletal system: muscle / joint pain.
General and local reactions: nonspecific chest pain.
Timolol (in the form of eye drops):
On the part of the immune system: systemic allergic reactions, including anaphylaxis, angioedema, urticaria, localized and generalized rash.
Disorders of metabolism and nutrition: anorexia, latent symptoms of hypoglycemia in patients with diabetes mellitus.
Mental disorders: behavioral changes and mental disorders, including confusion, hallucinations, anxiety, disorientation, nervousness, memory loss, decreased libido, insomnia and nightmares.
From the nervous system: cerebral ischemia, acute cerebrovascular accident, dizziness, increased symptoms of myasthenia gravis, paresthesia, drowsiness, fainting.
From the side of the organ of vision: cystoid macular edema, decreased sensitivity of the cornea, detachment of the choroid after filtration surgery, ptosis, visual impairment, including change in refraction and diplopia.
On the part of the organ of hearing and the vestibular apparatus: tinnitus.
From the cardiovascular system: arrhythmia, bradycardia, cardiac arrest, heart failure, intracardiac conduction block, palpitations, progression of angina pectoris, intermittent claudication, cooling of arms and legs, lowering blood pressure, Raynaud’s syndrome.
From 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.
From the reproductive system and mammary glands: impotence, Peyronie’s disease.
General and local: asthenia / fatigue, chest pain, swelling.
Drug Interactions
When used with slow calcium channel blockers, drugs that reduce the activity of catecholamines, beta-blockers, antiarrhythmic drugs (including amiodarone and quinidine), cardiac glycosides, cholinomimetics, opioid analgesics and MAO inhibitors, it is possible to increase the hypotensive effect and / or the development of severe bradycardia.
With the simultaneous use of timolol with epinephrine, mydriasis sometimes developed.
overdose
Symptoms: caused by 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.
Storage Conditions
The product should be stored in a dark place at 2 ° C to 8 ° C. After opening the vial, the drug should be stored at a temperature not exceeding 25 ° C.
Shelf life
3 years. After opening the bottle, the drug should be used within 4 weeks.
Terms and conditions
prescription
Drug form
eye drops
Possible product names
DUOPROST 2.5ML FLAC / CAP GL DROPS
Duoprost eye drops 2.5 ml
Duoprost eye drops. bottle cap 2.5ml Romania
Duoprost eye drops 2.5 ml vial cap
Duoprost eye drops 2.5ml vial cap X1
K.O. Rompharm Company S.R.L., Romania
