Nalgezin

Nalgezin – non-steroidal anti-inflammatory drug (NPVS).

Form of release and structure

Is issued in tablets, film coated: blue, biconvex, oval (on 10 pieces in blisters, about 1 or 2 blisters are packed into a cardboard pack).

Active ingredient: sodium Naproxenum, in 1 tablet – 275 mg.

Excipients: the water purified talc, cellulose microcrystallic, magnesium stearate, povidone.

Structure of a cover: опадрай YS-1-4215 consisting of a gipromelloza, titanium of dioxide (E171), a macrogoal and dye of indigo carmine (E132).

Indications to use

• Weak and moderate pain syndrome: a lumbar ishialgia, an ossalgiya, neuralgia, a mialgiya, a posttraumatic pain syndrome (bruises or stretching) with inflammatory process, an adnexitis, альгодисменорея, migraine, head and a dentagra, and also postoperative pain (in gynecology, orthopedics, traumatology, maxillofacial surgery);
• Musculoskeletal system diseases: Bekhterev's disease (an ankylosing spondylarthritis), arthritis (juvenile chronic, psoriasis, rhematoid, gouty), a bursitis, a tendovaginitis, rheumatic defeat of soft tissues, an osteoarthrosis of a backbone and peripheral joints (including with a radicular syndrome);
• The infectious and inflammatory LOR-diseases which are followed by the expressed pain syndrome (as a part of complex therapy): tonsillitis, pharyngitis, otitis;
• The feverish syndrome caused by infectious or catarrhal diseases.

Nalgezin is applied to symptomatic therapy (i.e. to reduction of inflammatory process and pain, decrease in the increased body temperature). Does not exert impact on progressing of the disease.

Contraindications

Absolute:

• Period of an exacerbation of inflammatory diseases of intestines (disease Krone, nonspecific ulcer colitis);
• Erosive cankers mucous stomach and 12-perstny gut;
• Existence of gastrointestinal bleeding;
• The period after aortocoronary shunting;
• Cerebrovascular and other bleedings, disturbances of a hemostasis;
• Oppression of a marrowy hemopoiesis;
• Active disease of a liver or the expressed liver failure;
• The progressing diseases of kidneys, the expressed renal failure (clearance of creatinine less than 20 ml/min.), including the confirmed hyperpotassemia;
• Pregnancy and lactation;
• The children's age up to 9 years and/or body weight is up to 27 kg;
• Existence in the anamnesis of the patient of data on development of an attack of a bronkhoobstruktion, small tortoiseshell, rhinitis after reception of acetylsalicylic acid (ASK) or other NPVS;
• Hypersensitivity to components of drug or other NPVS, including ASK.

Relative (it is necessary to observe extra care during treatment because of risk of development of complications):

• Coronary heart disease;
• Cerebrovascular diseases;
• Congestive heart failure;
• Дислипидемия / lipidemia;
• Diabetes mellitus;
• Diseases of peripheral arteries;
• The clearance of creatinine is less than 60 ml/minute;
• Anamnestic data on development of a canker of digestive tract and/or existence of an infection of Helicobacter pylori;
• Smoking;
• Heavy somatopathies;
• Disturbances of coagulability of blood;
• Bronchial asthma;
• Advanced age;
• Frequent alcohol intake;
• Prolonged use of NPVS;
• The accompanying treatment by the following drugs: selective serotonin reuptake inhibitors (for example, пароксетин, fluoxetine, sertraline, to tsitalopra), peroral glucocorticosteroids (for example, Prednisolonum), antiagregant (for example, klopidogret, ASK), anticoagulants (for example, warfarin);
• Children's age of 9-12 years.

Route of administration and dosage

Nalgezin accept inside.

At use of drug as anesthetic the average daily dose for adults makes 550-1100 mg (2-4 tablets). At very severe pains, but on condition of absence in the past of diseases of gastrointestinal system, the doctor can increase a dose to 1650 mg (6 tablets). However in such dose it is possible to accept drug no more than 2 weeks.

At use of drug as an antipyretic at first reception of 2 tablets is allowed at once, further it is possible to accept on 1 tablet each 6-8 hours.

The recommended doses for adults at other indications:

• Prevention of attacks of migraine: on 2 tablets 2 times a day. If within 4-6 weeks intensity, frequency and duration of attacks do not decrease, drug should be cancelled;
• First signs of a migrenozny attack: 3 tablets once, in need of 1-2 more tablets, but not earlier than in 30 minutes;
• Menstrual pains, spasms and pains after introduction of intrauterine spirals, other gynecologic pains: an initial dose – 2 tablets, further – on 1 tablet each 6-8 hours;
• Bad attack of gout: an initial dose – 3 tablets, 8 hours later – 2 tablets, further – on 1 tablet each 8 hours until the termination of an attack;
• Rhematoid diseases: an average initial dose – 2-4 tablets a day (accept in the morning and in the evening, at the same time a morning and evening dose shall not be identical). At the expressed night pain and/or morning constraint, at diseases which leading symptom is pain and also in cases when the patient is transferred to Nalgezin from other NPVS accepted in high doses, the initial daily dose of Naproxenum can be increased to 3-6 tablets. Depending on dominance of symptoms further the daily dose can be changed by the doctor.

To children Nalgezin is more senior than 9 years (weighing not less than 27 kg) appoint 10 mg/kg/days in a dose, having divided it into 2 receptions.

Purpose of lower doses is recommended to patients of advanced age.

Side effects

• Alimentary system: a stomacace, nausea, diarrhea, dyspepsia, an abdominal pain, a lock, erosive cankers and bleedings in digestive tract, a hematemesis, jaundice, a melena, an abnormal liver function, increase in activity of liver enzymes;
• Central nervous system: drowsiness, a headache, a depression, a mialgiya and muscular weakness, an indisposition, delay of speed of response, sleeplessness, aseptic meningitis, sleep disorders, decrease in hearing, cognitive dysfunction, impossibility to concentrate, dizziness;
• Integuments: a purpura, the increased perspiration, an alopecia, ecchymomas, photodermatoses, an itch;
• Cardiovascular system: heartbeat, vasculitis, asthma, puffiness, congestive heart failure;
• Urinogenital system: renal failure, nephrotic syndrome, renal papillary necrosis, hamaturia, glomerulonephritis, intersticial nephrite, disturbances of a menstrual cycle;
• Respiratory system: eosinophilic pneumonites;
• Bodies of a hemopoiesis: thrombocytopenia, leukopenia, aplastic anemia, granulocytopenia, eosinophilia;
• Sense bodys: sonitus, hearing disorder and sight;
• Allergic reactions: epidermal necrosis, Quincke's disease, small tortoiseshell, mnogoformny erythema, skin rash, Stephens-Johnson's syndrome;
• Others: hypoglycemia, hyperglycemia, hemolitic anemia, hyperthermia, thirst.

Most often side effects arise in case of Nalgezin's reception in high doses.

Special instructions

For decrease in risk of emergence of side effects from the alimentary system it is recommended to use minimum effective doses the most possible short courses.

If fever and/or pain remain or amplify, it is necessary to cancel drug and to address the doctor.

Without appointment of the doctor Nalgezin it is forbidden to accept along with other analgetics or antiinflammatory drugs.

In case of planned carrying out surgical intervention drug should be cancelled in 48 hours. The same concerns carrying out a research on definition of 17 corticosteroids, and also 5-hydroxyindolacetic acid in urine.

The patients adhering to a diet with limited consumption of salt have to consider that each tablet contains 25 mg of sodium.

Naproxenum exerts a negative impact on the speed of reactions that the drivers of vehicles and people occupied on the productions requiring special attention have to consider.

Medicinal interaction

• Anticoagulants: increase in a bleeding time;
• Other NPVS: risk of development of side effects;
• Propranolol and other beta adrenoblockers: decrease in their anti-hypertensive action, risk of development of a renal failure;
• Furosemide: suppression of its natriuretic effect;
• Lithium drugs: increase in concentration of lithium in a blood plasma;
• Probenetsid: increase in level of Naproxenum in plasma;
• Cyclosporine: risk of development of a renal failure;
• Phenytoinum, methotrexate, streptocides: delay of their excretion, risk of development of their toxic action;
• Magnesium - and aluminum-bearing antacids: reduction of absorption of Naproxenum.

Terms and storage conditions

To store in the place, unavailable to children, at a temperature up to 25 °C.

Period of validity – 5 years.