Universal reference book for medicines
Product name: NALGESIN (NALGESIN)

Active substance: naproxen

Type: NSAIDs

Manufacturer: KRKA (Slovenia)
Composition, form of production and packaging
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The tablets covered with a film membrane of blue color, oval, biconcave.
1 tab.

naproxen sodium 275 mg

Excipients: povidone, microcrystalline cellulose, talc, magnesium stearate, purified water.

Sheath composition: opadrai YS-1-4215 (titanium dioxide (E171), macrogol, indigo carmine dye (E132), hypromellose).

10 pieces.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (2) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2015.

PHARMACHOLOGIC EFFECT

Non-steroidal anti-inflammatory drug (NSAID).
Possesses analgesic, antipyretic and anti-inflammatory action. The mechanism of action is associated with a non-selective inhibition of cyclooxygenase 1 and 2 (COX-1, COX-2) activity.
The tablets, covered with a film membrane, dissolve well, are quickly absorbed from the digestive tract and provide a rapid onset of the analgesic effect.

PHARMACOKINETICS

Suction and distribution

Absorption from the gastrointestinal tract - fast and complete, bioavailability - 95% (the intake of food practically does not affect either the completeness or the rate of absorption).
The time to reach C max is 1-2 h.
The connection with plasma proteins is more than 99%.
C ss is determined after 4-5 doses in a single dose (ie 2-3 days of taking the drug).
Metabolism and excretion

Metabolized in the liver to dimethylnaproxen with the participation of the enzyme system CYP2C9.

T 1/2 - 12-15 hours. Clearance - 0.13 ml / min / kg.
98% of the dose is excreted in the urine, 10% of them are excreted unchanged; with bile is excreted 0.5-2.5%.
With renal failure, metabolites can be accumulated.

INDICATIONS

- Diseases of the musculoskeletal system (rheumatoid arthritis, psoriatic arthritis, juvenile chronic arthritis, ankylosing spondylitis (Bechterew's disease), gouty arthritis, rheumatic soft tissue damage, osteoarthrosis of the peripheral joints and spine, including radicular syndrome, tendovaginitis, bursitis );

- pain syndrome of mild or moderate severity: neuralgia, osalia, myalgia, lumboschialgia, posttraumatic pain syndrome (distension and bruises), accompanied by inflammation, postoperative pain (in traumatology, orthopedics, gynecology, maxillofacial surgery), headache, migraine, algodismenorea , adnexitis, toothache;

- in the complex therapy of infectious and inflammatory diseases of the ear, throat, nose with severe pain syndrome (pharyngitis, tonsillitis, otitis);

- febrile syndrome with "colds" and infectious diseases.

Nalgezin is used for symptomatic therapy (to reduce pain, inflammation and decrease in elevated body temperature) and does not affect the progression of the underlying disease.

DOSING MODE

Tablets should be taken with a sufficient amount of water.

When using the drug as an analgesic, the average daily dose is 2-4 tab.
(550-1100 mg).
With very severe pain and absence of an anamnesis of gastrointestinal diseases, a doctor can increase the daily dose to 6 tablets.
(1650 mg), but not more than 2 weeks.
When using the drug as an antipyretic agent, the initial dose is 2 tab.
Nalgezin, then you should take 1 tab. (275 mg) every 6-8 hours.
To prevent migraine attacks is recommended for 2 tab.
(550 mg) 2 times / day. However, treatment should be discontinued if the frequency, intensity and duration of migraine attacks do not decrease within 4-6 weeks.
At the first signs of a migraine attack should take 3 tab.
(825 mg), and, if necessary, 1-2 tablespoons. (275-550 mg) after 30 minutes.
To alleviate menstrual pains and spasms, pain after the introduction of IUD (intrauterine spirals) and other gynecological pain, the drug is prescribed in an initial dose of 2 tab.
(550 mg), then - 1 tab. (275 mg) every 6-8 hours.
With an acute attack of gout, the initial dose is 3 tab.
(825 mg), then - 2 tab. (550 mg) after 8 hours, and then 1 tab. (275 mg) every 8 hours until the seizure stopped.
In rheumatoid diseases (rheumatoid arthritis, osteoarthritis and ankylosing spondylitis), the average initial dose of the drug is 2-4 tab.
(550-1100 mg) 2 times a day in the morning and evening. The initial daily dose, ranging from 3 (825 mg) to 6 tablets. (1650 mg) is recommended for patients with severe night pain and / or severe morning stiffness, patients transferred to treatment with naproxen sodium from other NSAIDs in high doses, and patients with pain is the leading symptom.
The average daily dose is 2-4 tab.
(550-1100 mg), administered in two doses. Morning and evening doses may not be the same. After consultation with the attending physician, you can change them depending on the prevalence of symptoms, i.e. night pain and / or morning stiffness.
Children older than 9 years and / or with a body weight of more than 27 kg the drug is prescribed in a daily dose of 10 mg / kg in 2 divided doses.

SIDE EFFECT

Side effects are most frequent when Nalgezin is used in high doses:

On the part of the digestive system: constipation, abdominal pain, indigestion, nausea, diarrhea, ulcerative stomatitis, erosive and ulcerative lesions and gastrointestinal bleeding, increased activity of hepatic enzymes, impaired liver function, jaundice, bloody vomiting, melena.

From the side of the central nervous system: hearing loss, dizziness, headache, drowsiness, depression, sleep disorders, inability to concentrate, insomnia, malaise, myalgia and muscle weakness, slow reaction, aseptic meningitis, cognitive dysfunction.

From the skin: itching, ecchymosis, increased sweating, purpura, alopecia, photodermatosis.

From the senses: tinnitus, visual impairment, hearing impairment.

From the cardiovascular system: puffiness, shortness of breath, palpitations, congestive heart failure, vasculitis.

On the part of the genitourinary system: glomerulonephritis, hematuria, interstitial nephritis, nephrotic syndrome, renal failure, renal papillary necrosis, menstrual irregularities.

On the part of the organs of hematopoiesis: eosinophilia, granulocytopenia, leukopenia, thrombocytopenia, aplastic anemia.

From the respiratory system: eosinophilic pneumonitis.

Allergic reactions: skin rash, hives, angioedema, epidermal necrosis, erythema multiforme, Stevens-Johnson syndrome.

Other: thirst, hyperthermia, hyperglycemia, hypoglycemia, hemolytic anemia.

CONTRAINDICATIONS

- period after aortocoronary shunting;

- erosive and ulcerative changes in the mucosa of the stomach or duodenum, active gastrointestinal bleeding;

- Inflammatory bowel disease in the phase of exacerbation (NNC, Crohn's disease);

- cerebrovascular bleeding or other bleeding and hemostasis disorders;

- severe hepatic impairment or active liver disease;

- marked renal failure (CC less than 20 ml / min), incl.
confirmed hyperkalemia, progressive kidney disease;
- oppression of bone marrow hematopoiesis;

- Pregnancy;

- the period of breastfeeding;

- hypersensitivity to naproxen, naproxen sodium, acetylsalicylic acid or other NSAIDs;

- anamnestic data on an attack of bronchial obstruction, rhinitis, urticaria after taking acetylsalicylic acid or other NSAIDs (complete or incomplete acetylsalicylic acid intolerance syndrome - rhinosinusitis, urticaria, polyps of the nasal mucosa, bronchial asthma).

1 tablet of Nalgezin contains 275 mg of naproxen, so the drug is not recommended for children under 9 years of age and / or with a body weight of less than 27 kg.

With caution should prescribe the drug in IHD, cerebrovascular diseases, congestive heart failure, dyslipidemia / hyperlipidemia, diabetes, peripheral arterial disease, smoking, CC less than 60 ml / min, with anamnestic data on the development of gastrointestinal lesions, the presence of Helicobacter pylori, patients of advanced age, with prolonged use of NSAIDs, with frequent use of alcohol, with severe somatic diseases, with concomitant therapy with the following drugs: anticoagulants (
For example, warfarin), antiplatelet agents (e.g., aspirin, clopidogrel), oral corticosteroids (e.g., prednisone), selective serotonin reuptake inhibitor (such as citalopram, fluoxetine, paroxetine, sertraline).
In children aged 9 to 12 years, the drug is used only as directed by a doctor.

PREGNANCY AND LACTATION

It is not recommended to prescribe Nalgezin during pregnancy and lactation (breastfeeding).

APPLICATION FOR FUNCTIONS OF THE LIVER

Contraindicated in severe renal failure (CC less than 20 ml / min), incl.
confirmed hyperkalemia, progressive kidney disease.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Contraindicated use of the drug in hepatitis, severe hepatic insufficiency or active liver disease.

APPLICATION FOR CHILDREN

Contraindication: children under 9 years.

In children aged 9 to 12 years, the drug is used only as directed by a doctor.

APPLICATION IN ELDERLY PATIENTS

Elderly people (over 65 years of age) are prescribed no more than 2 tablets / day.

SPECIAL INSTRUCTIONS

To reduce the risk of developing adverse events on the part of the gastrointestinal tract, a minimum effective dose should be used with the minimum possible short course.

If pain and fever persists or becomes worse, you should consult your doctor.

With caution and only after consulting a doctor should take the drug to patients with bronchial asthma, with violations of blood clotting, as well as patients with increased sensitivity to other analgesics.

Caution should be given to patients with liver disease and kidney failure.
In patients with renal insufficiency, it is necessary to control the clearance of creatinine.When QC is below 20 ml / min, naproxen is not recommended. In chronic alcoholic and other forms of cirrhosis, the concentration of unbound naproxen increases, so such patients are recommended to take the drug at lower doses.
Older patients are also recommended to administer the drug at lower doses.

Nalgezin should not be taken with other anti-inflammatory drugs and analgesics, except for doctor's prescriptions.

You should avoid taking naproxen for 48 hours before surgery.

If it is necessary to determine 17-corticosteroids, the drug should be discontinued 48 hours before the study.
Similarly, naproxen may affect the determination of 5-hydroxyindoleacetic acid in the urine.
Each Nalgezin tablet contains approximately 25 mg of sodium.
This should be taken into account when observing a diet with a restriction of salt intake.
Use in Pediatrics

Children aged 9 to 12 years, the drug is prescribed only by a doctor.

Impact on the ability to drive vehicles and manage mechanisms

Naproxen slows the reaction rate in patients.
This should be taken into account when driving a car and performing tasks that require special attention.
OVERDOSE

Symptoms: drowsiness, dyspeptic disorders (heartburn, nausea and vomiting, abdominal pain), weakness, tinnitus, irritability;
in severe cases - bloody vomiting, melena, impaired consciousness, convulsions and kidney failure.
Treatment: gastric lavage and symptomatic therapy: activated charcoal, antacids, histamine H2 blockers, proton pump inhibitors.
Hemodialysis is ineffective.
DRUG INTERACTION

In the treatment of anticoagulants should be borne in mind that naproxen can increase the time of bleeding.

Do not use the drug simultaneously with other NSAIDs (increased risk of side effects).

Patients who simultaneously receive hydantoins, anticoagulants, or other medications that bind to a large extent with plasma proteins should monitor signs of potentiation of the action or overdose of these drugs.

The drug Nalgezin can reduce the antihypertensive effect of propranolol and other beta-blockers, and may increase the risk of renal failure associated with the use of ACE inhibitors.

Under the action of naproxenum, natriuretic action of furosemide is inhibited.

Inhibition of renal clearance of lithium leads to an increase in the concentration of lithium in plasma.

The use of probenecid increases the level of naproxen in plasma.

Cyclosporine with simultaneous application with naproxen increases the risk of developing kidney failure.

Naproxen slows the excretion of methotrexate, phenytoin, sulfonamides, increasing the risk of developing their toxic effects.

Antacid preparations containing magnesium and aluminum reduce the absorption of naproxen.

TERMS OF RELEASE FROM PHARMACY

The drug is approved for use as a means of OTC.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 25 ° C.
Shelf life - 5 years.
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