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

Active substance: naproxen

Type: NSAIDs

Manufacturer: KRKA (Slovenia) packing and packing KRKA (Slovenia)
Composition, form of production and packaging
The tablets covered with a film covering of
blue color, oval, biconcave, with risk on one side.

1 tab.

naproxen sodium 550 mg

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

Composition of the shell: dye litter YS-1-4216 (titanium dioxide (E171), macrogol, indigo carmine dye (E132), hypromellose).

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

PHARMACOKINETICS

Suction

Absorption from the gastrointestinal tract is fast and complete.
Bioavailability is 95%. The intake of food practically does not affect either the completeness or the rate of absorption. T max is 1-2 h.
Distribution

Binding to plasma proteins is more than 99%.
C ss is achieved by taking 4-5 doses of the drug (2-3 days).
Metabolism

Metabolized in the liver to dimethylnaproxen with the participation of the isoenzyme CYP2C9.

Excretion

Т 1/2 - 12-15 hours. Clearance - 0.13 ml / min / kg.
It is excreted by the kidneys (98%), 10% of which - unchanged; with bile excreted 0.5-2.5% of the dose.
Pharmacokinetics in special clinical cases

With renal failure, metabolites can be accumulated.

INDICATIONS

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

- pain syndrome of mild or moderate severity: neuralgia, ossalgia, myalgia, lumboschialgia, posttraumatic pain syndrome (sprains 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 forte is used for symptomatic therapy (to reduce pain, inflammation and reduce elevated body temperature) and does not affect the progression of the underlying disease.

DOSING MODE

The drug is prescribed inside.
Do not stop treatment or change the dosage without first consulting a doctor.
For relief of pain appoint 1-2 tab.
(550-1100 mg).
With very severe pain and absence of an anamnesis of gastrointestinal diseases, the daily dose can be increased to 3 tab.
(1650 mg), but not more than 2 weeks.
As an antipyretic agent, the initial dose is 1 tab.
(550 mg), then - 1/2 tab. (275 mg) every 6-8 hours.
To prevent migraine attacks - 1 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 1.5 tab. (825 mg), and, if necessary, another 1 / 2-1 tab. (275-550 mg) after 30 minutes.
To facilitate menstrual pains and spasms, pain after injection of IUD (intrauterine spirals) and other gynecological pains (adnexitis, labor - as an analgesic and tocolytic agent), it is recommended that the drug be administered at an initial dose of 1 tab.
(550 mg), then - 1/2 tab. (275 mg) every 6-8 hours.
With an acute attack of gout, the initial dose is 1.5 tab.
(825 mg), then - 1 tab. (550 mg) after 8 hours, and then - 1/2 tab. (275 mg) every 8 hours until the seizure stopped.
In rheumatoid diseases (rheumatoid arthritis, osteoarthritis and ankylosing spondylitis), the initial dose is 1-2 tablets.
(550-1100 mg) 2 times a day in the morning and evening. The initial daily dose of 1.5-3 tablets. (825-1650 mg) is recommended for patients with severe night pain and / or severe morning stiffness, patients being treated for treatment with naproxen sodium with high doses of other NSAIDs, and patients who have pain as the leading symptom. Usually the daily dose is 1-2 tablets. (550-1100 mg), administered in two doses. Morning and evening doses may not be the same. You can change them depending on the prevalence of symptoms, i.e. night pain and / or morning stiffness.
SIDE EFFECT

Side effects are most often noted when using high doses of Nalgezin forte.

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

From the side of the central nervous system: hearing loss, dizziness, headache, drowsiness, depression, sleep disorders, impaired concentration, insomnia, malaise, slow reaction, aseptic meningitis, cognitive dysfunction.

Dermatological reactions: 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 hemopoietic system: eosinophilia, granulocytopenia, leukopenia, thrombocytopenia, aplastic anemia, hemolytic anemia.

From the respiratory system: eosinophilic pneumonitis.

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

Other: thirst, hyperthermia, hyperglycemia, hypoglycemia, lengthening bleeding time.

CONTRAINDICATIONS

- period after aortocoronary shunting;

- erosive and ulcerative lesions 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;

- anamnestic data on the onset of bronchospasm, rhinitis, urticaria after taking acetylsalicylic acid or other NSAIDs (complete or incomplete acetylsalicylic acid intolerance syndrome - rhinosinusitis, urticaria, polyps of the nasal mucosa, asthma);

- Hypersensitivity to naproxen or naproxen sodium.

The drug is not recommended for children and adolescents under 15 years of age.

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, anamnestic data on the development of gastric ulcerative lesions, the presence of Helicobacter pylori infection, prolonged use NSAIDs, frequent alcohol use, severe somatic diseases, elderly patients, concomitant therapy with the following drugs: anticoagulants (eg, warfarin), antiagra
eugant (eg, acetylsalicylic acid, clopidogrel), oral GCS (eg, prednisolone), selective serotonin reuptake inhibitors (eg, citalopram, fluoxetine, paroxetine, sertraline).
PREGNANCY AND LACTATION

Nalgezin forte is not recommended for use during pregnancy and during breastfeeding.

APPLICATION FOR FUNCTIONS OF THE LIVER

The drug is 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

The drug is contraindicated in severe hepatic insufficiency or active liver disease.

APPLICATION FOR CHILDREN

The drug is not recommended for children and adolescents under 15 years of age.

APPLICATION IN ELDERLY PATIENTS

Caution should be given to elderly patients.

SPECIAL INSTRUCTIONS

Do not exceed recommended doses.

To reduce the risk of developing adverse events from the gastrointestinal tract, the minimum effective dose should be given a short course.

If pain and fever persists or worsens, a doctor's consultation is necessary.
Patients with bronchial asthma, blood clotting disorders, and also patients with hypersensitivity to other analgesics before taking Nalgezin forte should consult a doctor.
With caution should prescribe the drug to patients with liver disease and kidney failure.
In patients with renal insufficiency, it is necessary to control QC. With QC less than 20 ml / min, naproxen is not recommended.
In chronic alcoholic and other forms of cirrhosis, the concentration of unbound naproxen increases, therefore, such patients are recommended lower doses.

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

Older patients are also recommended lower doses.

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.
1 tablet of Nalgezin Fort 550 mg contains approximately 50 mg of sodium, which should be considered when limiting salt intake.

Use in Pediatrics

Children younger than 16 years of age, the drug is prescribed only on the advice of 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: a significant overdose can be characterized by drowsiness, dyspeptic symptoms (heartburn, nausea and vomiting, abdominal pain), weakness, tinnitus, irritability, severe vomiting, melena, impaired consciousness, convulsions and kidney failure.

Treatment: a patient who accidentally or intentionally has a large amount of Nalgezin forte should wash his stomach and conduct 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 forte can reduce the antihypertensive effect of propranolol and other beta-blockers, and may increase the risk of developing 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 its concentration in the blood plasma.

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

Cyclosporine increases the risk of developing kidney failure.

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

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

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

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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