Rolinoz 10 mg / ml 20 ml oral drops

The instruction for medical use of ROLINOZ medicine the Trade name Rolinoz Mezhdunarodnoye the unlicensed name Tsetirizin Lekarstvennaya the Drop form for intake of 10 mg/ml Structure of 1 ml of drug contains active agent – a tsetirizin dihydrochloride of 10 mg, excipients: glitserol 85%, propylene glycol, sodium saccharin, methylparahydroxybenzoate, propilparagidroksibenzoat, acetate sodium trihydrate, the ice acetic acid, water purified. Description Transparent, colourless liquid Pharmacotherapeutic group Respiratory system. Antihistaminic drugs of systemic action. Antihistaminic drugs for system use. Piperazin derivatives. Tsetirizin. The code of automatic telephone exchange R06AE07 the Pharmacological Pharmacokinetics Equilibrium Maximum Concentration properties in plasma makes about 300 ng/ml and is reached through 1.0 ± 0.5 h. Cumulation of a tsetirizin at the subsequent reception of a daily dose of 10 mg within 10 days is not observed. Pharmacokinetic parameters (Cmax and AUC) and distribution have unimodal character. Extent of absorption of a tsetirizin does not decrease with meal though the speed of absorption decreases. Degree of bioavailability is similar when using a tsetirizin in the form of drops for intake, capsules or tablets. The confirmed volume of distribution is 0.50 l/kg. Linking of a tsetirizin with proteins of plasma makes 93 ± 0.3%. Tsetirizin does not influence linking of warfarin with proteins. Tsetirizin is not exposed to the significant presistemny metabolism. About two thirds of a dose are removed in not changed view with urine. Final elimination half-life makes about 10 hours. Tsetirizin shows linear kinetics in the range from 5 to 60 mg. Patients of advanced age After intake of a single dose of 10 mg, elimination half-life at elderly patients in comparison with normal subjects increases approximately by 50%, and the clearance decreased by 40%. Decrease in absorption of a tsetirizin at elderly is connected with reduced function of kidneys. Children of 6-12 years Elimination half-life of a tsetirizin makes about 6 hours. Patients with renal failures At patients to a slight renal failure (the clearance of creatinine
& gt, 40 ml/min.) the pharmacokinetics of drug is similar to pharmacokinetics of healthy. In a moderate renal failure the elimination half-life increases by 3 times and the clearance decreases by 70% in comparison with healthy. Patients on a hemodialysis (KK & lt, 7 ml/min.), at single dose of 10 mg of a tsetirizin observed 3-fold increase in elimination half-life and 70% decrease in clearance in comparison with healthy. Tsetirizin badly leaves by means of a hemodialysis. In a moderate or heavy renal failure the dose adjustment is necessary. Patients with abnormal liver functions At patients with chronic diseases of a liver (hepatocellular, cholestatic and biliary cirrhosis) which applied 10 or 20 mg of a tsetirizin as a single dose the 50% increase in elimination half-life and also 40% decrease in clearance was observed. Correction of a dose is necessary only for patients with a simultaneous abnormal liver function and kidneys. The pharmacodynamics Rolinoz - a selection blocker of peripheral histamine H1 of receptors, Hydroxyzinum metabolite, has antihistaminic, antiallergic effect. Prevents development and facilitates a course of allergic reactions, possesses antipruritic and antiekssudativnym action. Influences an early stage of allergic reactions and also reduces migration of cells of inflammation, discharge of the mediators participating in late allergic reaction oppresses. Reduces permeability of capillaries, prevents edematization of fabrics, removes a spasm of smooth muscles. Indications For adults and for children aged from 2 years - simplification of nasal and eye symptoms of seasonal and year-round allergic rhinitis - relief of symptoms of a small tortoiseshell the Route of administration and doses For intake. Before use of a drop it is necessary to dilute with a small amount of water Children aged from 2 up to 6 years 2.5 mg 2 times a day (5 drops) Children aged from 6 up to 12 years of 5 mg 2 times a day (10 drops) Teenagers of 12 years and is more senior, adult 10 mg once a day (20 drops). The initial dose of 10 drops can be offered if it leads to satisfactory control of symptoms. Elderly people Are not present the data demonstrating that the dose has to be reduced for elderly patients provided that function of kidneys is normal. A moderate and heavy renal failure Dosing has to be individual depending on function of kidneys. Address the following table for correction of a dose as it is specified. When using this table of a dosage, assessment of removal of creatinine (CLcr) in ml/min. is not required. CLcr (ml/min.) can be estimated on the serum of creatinine (mg/dl) determined by the following formula:
x the weight (kg) of CLcr =--------------------------------------------×0.85 (for women) 72 x creatinine of serum (mg/dl) Correction of a dosage for adult patients with impaired renal function. A stage Removal of creatinine (ml/min.) the Dosage and frequency of use Norma ≥80 10 mg once, daily Weak 50-79 10 mg once, daily Moderate 30-49 5 mg once, daily Heavy ˂30 5 mg, each two days Patients, with a final stage of a renal failure, being on dialysis ˂10 are contraindicated For the pediatric patients having a renal failure, the dose has to be picked up on an individual basis taking into account renal clearance of the patient and his body weight. The liver failure Dose adjustment is not required for patients with a liver failure. Patients with a liver and renal failure the Dose decreases depending on clearance of creatinine (see the table of correction of a dosage higher). Side effects Tsetirizin in the recommended dosage has the insignificant side effect on central nervous system which is shown in the form of drowsiness, fatigue, dizziness and a headache. In certain cases, it was reported about paradoxical excitement of central nervous system. In spite of the fact that tsetirizin N1-of receptors is the selection antagonist peripheral and has no anticholinergic activity, was reported about isolated cases of difficulties in urination, disturbance of accommodation and dryness in a mouth. It was reported about cases of disturbance of the hepatic function with the increased level of liver enzymes accompanied with the increased bilirubin level. In most cases these manifestations vanish after the termination of a course of treatment tsetiriziny. Side reactions In the recommended doses (10 mg of a tsetirizin a day), the following undesirable phenomena were registered with a frequency more than 1.0%: Adverse side reactions are distributed in the following order, taking into account emergence frequency: very often (≥1/10), it is frequent (≥1/100 to & lt, 1/10), infrequently (≥1/1000 to & lt, 1/100), is rare (≥1/10000 to & lt, 1/1000), is very rare (& lt, 1/10000) it is frequent - dryness in a mouth, nausea - a headache, increased fatigue, dizziness, drowsiness - rhinitis, pharyngitis Infrequently - diarrhea, an abdominal pain - paresthesia (disturbance of sensitivity) - excitement - rash, an itching - an asthenia, the indisposition Is rare - reaction of hypersensitivity - a spasm - aggression, confusion of consciousness, a depression, hallucinations, a sleep disorder - increase in body weight - tachycardia - urticaria - peripheral swell - increase in activity (increase in transaminase, alkaline phosphatase, gamma GT and bilirubin) is Very rare - an acute anaphylaxis - a dysgeusia, dyskinesia, dystonia, a faint, a tremor, a tic - accommodation disturbance, illegibility of sight, a nystagmus - a Quincke's disease, a resistant erythema - a dysuria, enuresis - thrombocytopenia It is unknown - memory disturbance, including amnesia - the suicide ideas - vertigo - an ischuria - increase in appetite of the Contraindication - hypersensitivity to Hydroxyzinum, other derivatives of piperazin or any component of drug - children under 2 years (because of limited data in safety and efficiency of drug) - patients with a heavy renal failure and clearance of creatinine less than 10 ml/min. - pregnancy and the period of a lactation - it is contraindicated to persons with hereditary intolerance of fructose, deficiency of Lapp-lactoses enzyme, malabsorption of a glyukozo-galactose Medicinal interactions Pharmacokinetic interactions of a tsetirizin and pseudoephedrine, antipyrine, Cimetidinum, a ketokonazol, erythromycin, azithromycin of a glipizid, diazepam, theophylline (400 mg once a day) did not reveal proofs of clinically significant pharmakodinamichesky interactions. Co-administration of a tsetirizin with macroleads (for example, azithromycin, erythromycin) or ketokonazoly did not lead to clinically significant changes of the ECG. At reception of several doses of a ritonavir (600 mg twice a day) and a tsetirizina (10 mg a day) it was revealed that extent of influence of a tsetirizin was increased approximately by 40%, and the arrangement of a ritonavir was slightly changed (-11%) in addition to the accompanying reception of a tsetirizin. Tsetirizin weakens anticoagulating effect of heparin. Azilastin, to alprazola, buprenorphine, a haloperidol, Hydroxyzinum, diazepam, Droperidolum, zolpidy, flurazepam, kvetiapin, Fluphenazin, clozapine, trifluoperazin, thioridazine, phenobarbital, fentanyl, temazepam, risperidon, propofol, remifentanit, promethazine, Perfenazinum, codeine, lorazepam, olanzapine, oxazepam, midazolam, Chlorpromazinum, chlordiazepoxide, to estazola – strengthens (mutually) a deprimation and reduction in the rate of psychomotor reactions. Metohexital, ketamine, izofluran, enfluran, in the post-narcotic period – strengthens (mutually) a deprimation and reduction in the rate of psychomotor reactions. Ethanol strengthens (mutually) a deprimation and reduction in the rate of psychomotor reactions, for the period of treatment it is recommended to refuse alcoholic drinks. Extent of absorption of a tsetirizin does not decrease with meal though the speed of absorption decreases for 1 hour. Tests for a skin allergy are suppressed with antihistaminic drugs, their washing away happens in 3 days, it is recommended to pay attention to it before carrying out them. Special instructions In therapeutic doses clinically significant interaction with alcohol is not revealed (on the blood alcohol level of 0.5 g/l). Nevertheless, it is recommended to observe precautionary measures if alcohol is accepted along with drug. At patients with hypersensitivity, simultaneous use of drug with alcohol or other depressants of central nervous system can arise additional decrease in vigilance and deterioration in performance. Special attention is recommended to be paid to patients with the contributing ischuria factors (for example, problems with a spinal cord, a benign hyperplasia of a prostate) as tsetirizin can increase risk of an ischuria. Special attention to patients with epilepsy and patients with risk of developing spasms is recommended. Tests for a skin allergy are suppressed with antihistaminic drugs, their washing away happens within 3 days, it is recommended to pay attention to it before carrying out them. Excipients which are a part: methylparahydroxybenzoate and propilparagidroksibenzoat – allergic reactions (perhaps late manifestation) can cause. The lactation period Tsetirizin is allocated in breast milk in number of 25%-90% of concentration in blood plasma, depending on sampling time after introduction. Therefore it is necessary to stop breastfeeding for treatment. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Patients who need to be engaged in potentially dangerous types of activity or to work with the equipment, should not exceed the recommended doses and take reaction to medicine into account. Overdose Symptoms: strengthening of side reactions. Treatment: gastric lavage with the subsequent intake of activated carbon, if necessary – symptomatic therapy. The hemodialysis is inefficient. The efficiency of peritoneal dialysis is not established. A form of release and packing On 20 ml of drug in a bottle from glass with a stopper – a dropper and the screwing-up protective cap supplied with a safety ring. On 1 bottle together with the instruction for medical use in the state and Russian languages put in a box of cardboard. To Store storage conditions in the dry place at a temperature not over 250C to Store in the inaccessible place for children! 3 years not to apply a period of storage after an expiration date. Prescription status According to the prescription the Producer Uorld Meditsin Ilach Sang. ve Tidzh. A.Sh. (Bagdzhylar Ilchesi, Gyuneshli, Evren Makhallesi, Dzhami Yolu Dzhad. No. 50 K. 1B Zemin 4-5-6, Istanbul) Turkey the Holder of the registration certificate of ROTAFARM LIMITED, London, Great Britain the Name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan, the accepting claim (offer) on quality of medicines from consumers of TROKA-S PHARMA LLP, RK, Almaty, Turksibsky district, Suyunbaya Ave., 222 Ph. / fax: 8 (7272) 529090 www.worldmedicine.kz the Name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety of medicine of TROKA-S PHARMA LLP, RK, Almaty, Turksibsky district, Suyunbaya Ave., 222 Cellular ph. of +77017863398e-mail:
To Develop pvpharma@worldmedicine.kz