The instruction for medical use of medicine of Glaumaks Plus Torgovoye nazvaniye Glaumaks Plus the International unlicensed name Is not present the Dosage form of the Drop eye 20 mg/ml + 5 mg/ml, 5 ml Structure of 1 ml of drug contain active agents: dorzolamid – 20.00 mg (in the form of a dorzolamid of a hydrochloride of 22.25 mg), Timololum – 5.00 mg (in the form of Timololum of a maleate of 6.83 mg), excipients: a benzalkoniya chloride, Mannitolum, sodium citrate, sodium hydroxide, the hydroxyethylcellulose, water purified. The description Transparent, colourless or almost colourless solution, without visible particles. Pharmacotherapeutic group Drugs for treatment of diseases of eyes. Protivoglaukomny drug and miotik. Beta blockers. Timololum in a combination with other drugs. The ATX S01ED51 code the Pharmacological Pharmacokinetics Gets properties in an eye mainly through a cornea (to a lesser extent through a sclera or a limb). System absorption – low. After hit in blood quickly gets into erythrocytes where contacts karboangidrazy the II type, maintaining extremely low concentration of free drug in blood plasma. Dorzolamid is metabolized with formation of the only thing of N-dezetilirovannogo of a metabolite which is less active concerning a karboangidraza of the II type, but is capable to inhibit a karboangidraza of the I type. At prolonged use kumulirut in erythrocytes. Communication of a dorzolamid with proteins of blood plasma makes about 33%. It is removed by kidneys in not changed look, and also in the form of metabolites. After drug withdrawal dorzolamid it is not linearly washed away from erythrocytes that at first leads to fast decrease in its concentration, further removal slows down. Elimination half-life (T ½) makes about 4 months. The pharmacodynamics of Glaumaks Plus – the combined drug, has protivoglaukomny effect. Each of components lowers intraocular pressure by means of reduction of secretion of watery moisture. Dorzolamid – karboangidraza inhibitor. Reduces secretion of intraocular liquid, slowing down formation of a hydrocarbonate with the subsequent weakening of transfer of sodium and water. Does not cause an accommodation spasm, a miosis, a hemeralopia. Timololum – a non-selective blocker of beta adrenoceptors. Prevents the stimulating influence of catecholamines on beta adrenoceptors. At topical administration in the form of eye drops lowers intraocular pressure due to reduction of formation of watery moisture and small increase in its outflow. Indications – an open angle glaucoma – pseudo-exfoliative glaucoma the Route of administration and doses On 1 drop in a conjunctival sac of each affected eye twice a day. Duration of a course of treatment is defined by the doctor. At simultaneous use of other local ophthalmologic means the interval between instillations has to be not less than 10 minutes. Before use of medicine it is necessary to wash up carefully hands, it is necessary to avoid contact of the pipette with eyes and surrounding objects. At misuse the bottle can be infected and to become the reason of infectious damages of an eye and the subsequent loss of sight. Side effects Very often (≥ 1/10) – burning, pricking – disturbance of taste Is frequent (≥ 1/100, & lt, 1/10) – a headache – conjunctivitis, the obscured sight, an erosion of a cornea, an itching of eyes, lachrymation, inflammation a century, irritation a century, signs and symptoms of irritation of an eye, including blepharitis, a keratitis, hyposensitivity of a cornea, xerophthalmus – sinusitis – nausea Infrequently (≥ 1/1,000, & lt, 1/100) – dizziness, a depression – an iridocyclitis, a disorder of vision, including changes of a refraction (because of the termination of miotic therapy) – bradycardia, faints – short wind – nausea, dyspepsia – an urolithiasis – asthenia/fatigue Seldom (≥ 1/10,000, & lt, 1/1,000) – a system lupus erythematosus – dizziness, paresthesia – insomnia, nightmares, a loss of consciousness, paresthesia, increase of signs and symptoms of a myasthenia gravis, lowering of a libido, disturbance of cerebral circulation – irritation, reddening of eyes, eye pain, crusting during a century, temporary short-sightedness (disappears after the treatment termination), cornea hypostasis, eye hypotonia, amotio of a choroid of an eye (after the filtering operation), a ptosis, a diplopia – a ring in ears – hypotension, a stethalgia, heartbeat, hypostasis, arrhythmia, stagnant heart failure, heart block, cardiac arrest, brain ischemia, lameness, Reynaud’s syndrome, cold hands and legs – an asthma, respiratory insufficiency, rhinitis – nasal bleeding – a bronchospasm (mainly at patients with bronchial asthma), cough – irritation of a throat, dryness in a mouth – diarrhea – contact dermatitis – an alopecia, psoriazopodobny rash or exacerbation of psoriasis – Bolezen Peyroni – signs and symptoms of system allergic reactions, including a Quincke’s edema, urticaria, an itching, the Contraindication anaphylaxis – hypersensitivity to a dorzolamid, Timololum or any component of drug – hypersensitivity to other beta-blockers – allergic rhinitis of heavy degree – bronchial asthma or a chronic obstructive pulmonary disease – sinus bradycardia, AV blockade of II and III, heart failure, – cardiogenic shock – a heavy renal failure (КК<, 30 ml/min.) or giperkhloremichesky acidosis – pregnancy and the period of a lactation – children’s and teenage age up to 18 years Medicinal interactions of Researches of interaction of Glaumaks Plus with other specific medicines was not carried out. There is a possibility of strengthening of hypotensive effect and/or development of the profound bradycardia at combined use of ophthalmologic solution of Timololum of a maleate and blockers of calcium channels, the drugs reducing the maintenance of catecholamines, beta blockers, antiarrhytmic means (including Amiodaronum), glycosides of a foxglove, parasympathomimetics, opioid analgetics and MAO inhibitors. At combined use of Timololum and CYP2D6 inhibitors (for example, quinidine or selective serotonin reuptake inhibitors) it was reported about the potentiated effect of system blockade of beta adrenoceptors (for example, decrease in the heart rate (HR), a depression). In spite of the fact that Glaumaks Plus is used locally, it can get into a system blood stream and strengthen toxic reactions at use of salicylates in high doses. Combined use of Glaumaks Plus and system inhibitors of a karboangidraza is not recommended since there is a probability of strengthening of the known system effects of inhibition of a karboangidraza. Special instructions Timololum which is beta blocker is a part of Glaumaks Plus. At topical administration of Glaumaks Plus there can be side effects characteristic of system use of beta blockers. Therefore patients with heavy pathology of heart in the anamnesis and symptoms of heart failure have to be under careful observation. During treatment the control of maintenance of K+, electrolytes in blood serum and its pH is necessary. At patients with a coronary artery disease the gradual cancellation of beta blockers is recommended. Timololum can hide hypoglycemia symptoms at patients with diabetes or symptoms of hyperfunction of a thyroid gland. Sharp cancellation of beta blocker can lead to aggravation or emergence of new symptoms of a disease. Treatment by beta blockers can lead to aggravation of a myasthenia gravis. Dorzolamida the hydrochloride which is a part of drug is streptocide and, despite topical administration, is exposed to system absorption. In this regard, at use of a dorzolamid in the form of eye drops there can be side reactions characteristic of streptocides. At emergence of serious side reactions or at manifestation of hypersensitivity the use should be stopped. Dorzolamida a hydrochloride is karboangidraza inhibitor for topical administration which can be exposed to system absorption therefore patients with an urolithiasis in the anamnesis can have an increased risk of emergence of an urolithiasis. Use of 2% of ophthalmologic solution of a dorzolamid of a hydrochloride for patients with a bad attack of closed-angle glaucoma was not studied. With care apply at patients with abnormal liver functions. It is necessary to use with care 2% ophthalmologic solution of a dorzolamid of a hydrochloride at the patients having the low density of endothelial cells of a cornea of an eye and/or transferred surgical intervention to eyes as at this category of patients the likelihood of developing hypostasis of a cornea and an irreversible decompensation of a cornea is raised. Glaumaks Plus contains preservative a benzalkoniya chloride which can be absorbed by soft contact lenses and have the damaging effect on eye tissues. Therefore the patients carrying soft contact lenses should remove them before use of drops and to establish back not earlier than in 15 min. after burying. Can change color of soft contact lenses. Use in pediatrics Medicine is not recommended to children and teenagers up to 18 years in view of lack of data on safety and efficiency. Pregnancy and the period of a lactation Eye drops of Glaumaks Plus should not be used during pregnancy. Timololum is excreted in breast milk. In need of use in the period of a lactation it is necessary to stop breastfeeding. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms As drug can cause dizzinesses and visual disturbances during treatment it is necessary to avoid potentially dangerous types of activity connected with need of concentration of attention and the increased speed of psychomotor reactions. Overdose Symptoms: dizziness, headache, short wind, bradycardia, bronchospasm, cardiac arrest. The most expected symptoms of overdose of a dorzolamid are disturbance of electrolytic balance, development of acidosis, possible side effects from the central nervous system. Treatment: symptomatic. It is necessary to control the level of electrolytes (first of all potassium) and rn blood plasma. In researches it is also shown that Timololum is not removed at dialysis. The form of release and packing On 5 ml of drug place in a plastic bottle with a stopper dropper and the screwing-up protective cap supplied with a safety ring. On 1 bottle together with the instruction for use in the state and Russian languages put in a pack from cardboard. To Store storage conditions at a temperature not over 30 ºС, in the place protected from light. To store out of children’s reach! Period of storage 2 years. The use period after opening of a bottle – within 4 weeks. Not to apply after an expiration date. Prescription status According to the prescription JSC YaDRAN Producer of Galenski of Laboratories, Svilno 20, 51000 Rijeka, Croatia the Name and the country of the owner of the registration certificate of JSC Yadran Galenski of Laboratories, Croatia the Name and the country of the JSC Yadran organization packer Galenski of Laboratories, Croatia in Republic of Kazakhstan, Almaty, Zhamakayev St., 126
to Develop the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) Representative office of JSC Yadran Galenski of Laboratories
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