Producer: CJSC FP OBOLENSKOYE Russia
Code of automatic telephone exchange: M01AE02
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active ingredient: 275 mg or 550 mg of Naproxenum of sodium in 1 tablet.
Excipients: calcium stearate, коповидон, silicon dioxide colloid (aerosil), sugar milk (lactose), cellulose microcrystallic, talc, a gipromelloz (gidroksipropilmetiltsellyuloz), a macrogoal 6 000, titanium dioxide, dye diamond blue - enough before receiving a tablet with a cover weighing 360 mg and 720 mg.
Drug reduces a pain syndrome, morning constraint and a swelling of joints, promotes increase in volume of movements. Has antiinflammatory, analgeziruyushchy and febrifugal effect.
Pharmacodynamics. Algezir Ultra, represents Naproxenum drug, possesses anesthetic, febrifugal and antiinflammatory action. The mechanism of action is connected with non-selective suppression of activity of cyclooxygenase 1 (TsOG1) and cyclooxygenase 2 (TsOG2).
Tablets, film coated, are well dissolved, quickly soaked up from the digestive tract (DT) and provide bystry approach of analgesic effect.
Pharmacokinetics. Absorption from a GIT - bystry and full, bioavailability - 95% (meal practically does not influence neither completeness, nor absorption speed). Time of achievement of the maximum concentration (TCmax) - in 1-2 hours, communication with proteins of plasma> 99%.
The elimination half-life (T1/2) makes 12-15 h. Metabolism - in a liver to dimethylnaproxenum with participation of an isoenzyme of CYP2C9. Clearance - 0.13 ml/min. It is brought to 98% by kidneys, 10% from them are removed in not changed look; with bile - 0.5-2.5%. Equilibrium concentration is defined to reception of 4-5 doses of drug (2-3 days). At the chronic renal failure (CRF) cumulation of metabolites is possible.
Indications to use:
Algezir Ultra is used for symptomatic therapy (for reduction of pain, an inflammation and decrease in the increased body temperature) and does not influence progressing of a basic disease.
· Musculoskeletal system diseases (a pseudorheumatism, the psoriasis, juvenile chronic arthritis ankylosing a spondylarthritis (Bekhterev's disease); gouty arthritis, rheumatic defeat of soft tissues, an osteoarthrosis of peripheral joints and a backbone, including with a radicular syndrome, a tendovaginitis, a bursitis).
· Pain syndrome of weak or moderate degree of manifestation: neuralgia, an ossalgiya, a mialgiya, a lumbar ishialgia, the posttraumatic pain syndrome (stretchings and bruises) which is followed by an inflammation, postoperative pain (in traumatology, orthopedics, gynecology, maxillofacial surgery), a headache, migraine, альгодисменорея, an adnexitis, a dentagra.
· A feverish syndrome at "catarrhal" and infectious diseases.
Route of administration and doses:
Inside. A pill should be taken without chewing, with enough water or other liquid, perhaps, to apply during food.
The usual daily dose used for pain relief makes 550-1100 mg.
At very severe pains and absence in the anamnesis of gastrointestinal diseases, the doctor can increase a daily dose to 1650 mg, but no more than for 2 weeks.
When using drug as an antipyretic the initial dose makes 550 mg, further is accepted on 275 mg each 6-8 hours.
For removal of a pain syndrome at migraine about 550 mg twice a day are recommended. However treatment has to be stopped if frequency, intensity and duration of attacks of migraine do not decrease within 4 - 6 weeks. At the first signs of a migrenozny attack it is necessary to accept 825 mg, and in need of 275-550 more mg 30 minutes later.
For simplification of menstrual pains, pains after introduction of Naval Forces (intrauterine spirals) and other gynecologic pains (adnexitis) purpose of drug in the initial dose making 550 mg, further on 275 mg each 6-8 hours is recommended.
At a bad attack of gout the initial dose makes 825 mg, further 550 mg 8 hours later, and then to 275 mg there are each 8 hours before the termination of an attack.
At rhematoid diseases (a pseudorheumatism, an osteoarthritis and an ankylosing spondylarthritis) the usual initial dose of drug makes from 550 mg to 1100 mg, twice a day in the morning and in the evening.
The initial daily dose making from 825 mg to 1650 mg is recommended to patients with the expressed night pain and/or the expressed morning constraint, to the patients transferred to treatment by Naproxenum from high doses of other NPVP and patients at whom pain is the leading symptom. Usually daily dose makes 550-1100 mg appointed in two steps.
Features of use:
Pregnancy and period of a lactation: алгезир Ultra it is not recommended to apply during pregnancy and feeding by a breast.
Do not exceed the doses specified in the instruction, for decrease in risk of development of the undesirable phenomena from a GIT it is necessary to use a minimal effective dose minimum possible short course.
If pain and fever remain or become more severe, it is necessary to see a doctor.
At treatment by anticoagulants it must be kept in mind that Naproxenum can increase a bleeding time.
Patients with bronchial asthma, with disturbance of coagulability of blood, and also to patients with hypersensitivity to other analgetics before Algezir Ultr's reception should consult with the doctor.
With care patients should appoint with diseases of a liver and a renal failure. At patients with a renal failure it is necessary to control the level of clearance of creatine. At the level of clearance of creatinine it is lower than 20 ml/min., it is not recommended to appoint drug.
At chronic alcoholic and other forms of cirrhosis concentration of untied Naproxenum increases therefore lower doses are recommended to such patients.
Algezir Ultra it is not necessary to accept together with other antiinflammatory and soothing drugs, except for appointments of the doctor.
Lower doses are recommended to patients of advanced age.
It is necessary to avoid administration of drug within 48 hours to surgical intervention.
In need of definition of 17 ketosteroids in urine drug should be cancelled in 48 hours prior to a research. Naproxenum is also capable to influence result of definition of concentration of 5-hydroxyindole acetic acid in urine.
Each tablet of Algezir Ultr contains about 25 mg of sodium. At salt consumption restriction, it needs to be considered.
- From the alimentary system: the gastropathies connected with reception of non-steroidal anti-inflammatory drugs (defeat of antral department of a stomach in the form of an erythema of a mucous membrane, hemorrhages, erosion and ulcers), nausea, vomiting, discomfort in epigastriums, an abdominal pain, diarrhea, a lock, stomacaces, bleeding and perforation of a GIT, increase in activity of "hepatic" enzymes, an abnormal liver function, jaundice, hepatitis, vomiting with blood, a melena.
- From the central nervous system: dizziness, headache, drowsiness, depression, sleep disorder, sleeplessness, indisposition, mialgiya and muscular weakness, difficulty of concentration of attention and delay of speed of response, cognitive dysfunction, aseptic meningitis.
- From integuments: an itch, ecchymomas, the increased perspiration, a Werlhof's disease, an alopecia, photodermatoses.
- From respiratory system: eosinophilic pneumonia.
Interaction with other medicines:
It is not necessary to use drug along with other non-steroidal anti-inflammatory drugs (the risk development of side effects increases).
At the concomitant use of Phenytoinum, dipheninum, anticoagulants or other medicines contacting substantially proteins of plasma strengthening of action or overdose of these drugs is possible.
Drug Algezir Ultra can reduce anti-hypertensive effect of propranolol or other beta adrenoblockers, and also can increase risk of the renal failure connected using APF inhibitors. Under the influence of Naproxenum the natriuretic effect of furosemide is inhibited.
The inhibition of renal clearance of lithium leads to increase in concentration of lithium in plasma. Reception of a probenetsid increases concentration of Naproxenum in plasma. Cyclosporine increases risk of development of a renal failure.
Naproxenum slows down excretion of a methotrexate, Phenytoinum, streptocides, increasing risk of development of their toxic action.
The antiacid drugs containing magnesium and aluminum reduce absorption of Naproxenum.
Myelotoxic medicines strengthen manifestations of a gematotoksichnost of drug.
· Hypersensitivity to Naproxenum; with anamnestic data on an attack of a bronkhoobstruktion, rhinitis, a small tortoiseshell after reception of acetylsalicylic acid or other non-steroidal anti-inflammatory drug (NPVP) (the full or incomplete syndrome of intolerance of acetylsalicylic acid - rinosinusit, a small tortoiseshell, polyps of a mucous membrane of a nose, bronchial asthma).
· The period after performing aortocoronary shunting.
· Erosive and ulcer changes of a mucous membrane of a stomach or 12-perstny gut, active gastrointestinal bleeding.
· Inflammatory diseases of intestines, in an aggravation phase (the nonspecific ulcer colitis (NUC), a disease Krone).
· Cerebrovascular bleeding or other bleedings and disturbance of a hemostasis.
· The expressed renal failure (clearance of creatinine less than 20 ml/min.).
· Oppression of a marrowy hemopoiesis.
· Pregnancy, breastfeeding period.
· Children and teenagers are younger than 15 years.
With care: chronic heart failure, coronary heart disease, cerebrovascular diseases, дислипидемия / a lipidemia, a diabetes mellitus, diseases of peripheral arteries, smoking, clearance of creatinine from 20 to 60 ml/min., GIT cankers in the anamnesis, existence of an infection of Helicobacter pylori, long use of NPVP, frequent alcohol intake, heavy somatopathies, advanced age, a concomitant use of peroral glucocorticosteroids (including Prednisolonum), anticoagulants (including warfarin), antiagregant (including acetylsalicylic acid, klopidogret), selective serotonin reuptake inhibitors (including a tsitaloprama, fluoxetine, a paroksetin, sertraline). For decrease in risk of development of the undesirable phenomena from a GIT it is necessary to use a minimal effective dose minimum possible course.
The considerable overdose of drug can be characterized by drowsiness, dispeptic frustration (heartburn, nausea, vomiting, an abdominal pain), weakness, a sonitus, in hard cases – vomiting with blood, a melena, spasms and a renal failure.
List B. To store in the dry, protected from light place at a temperature not above 25 °C. To store in the place, not available to children. A period of validity - 2 years. Not to use after expiry date.
Tablets, film coated 275 and 550 mg. On 5, 10, 12 and 15 tablets in a blister strip packaging from a film of the polyvinyl chloride and printing aluminum foil varnished. On 1, 2, 3, 5, 6 or 10 blister strip packagings together with the application instruction place in a pack from a cardboard.