Flurbiprofen-Pharmstandard (Tablets) Instructions for Use

Marketing Authorization Holder

Pharmstandard-Lexredstva OJSC (Russia)

ATC Code

R02AX01 (Flurbiprofen)

Active Substance

Flurbiprofen (Rec.INN registered by WHO)

Dosage Form

Flurbiprofen-Pharmstandard

Lozenges 8.75 mg: 10, 20, 30, or 40 pcs.

Dosage Form, Packaging, and Composition

Lozenges round, white or almost white, biconvex, with a characteristic odor.

Excipients: sorbitol – 756.85 mg, lactose monohydrate – 153.8 mg, povidone – 20.8 mg, betadex (beta-cyclodextrin) – 15 mg, mint flavor – 12 mg, magnesium stearate – 10 mg, citric acid monohydrate – 8.3 mg, colloidal silicon dioxide – 5 mg, sucralose – 5 mg, levomenthol – 2 mg, peppermint oil – 2 mg, eucalyptus oil – 0.5 mg.

10 pcs. – blister packs – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (4) – cardboard packs.

Clinical-Pharmacological Group

NSAID

Pharmacotherapeutic Group

Drugs for the treatment of throat diseases; other drugs for the treatment of throat diseases

Pharmacological Action

NSAID. It has pronounced analgesic, anti-inflammatory, and antipyretic activity. The mechanism of action is associated with inhibition of COX and suppression of prostaglandin synthesis. It inhibits platelet aggregation.

Pharmacokinetics

After oral administration, it is well and completely absorbed from the gastrointestinal tract. C_max is reached after 1.5 hours. Plasma protein binding is more than 90%. It is metabolized in the liver. T_1/2 is about 6 hours. It is excreted by the kidneys: 20% unchanged, the rest as metabolites.

Indications

For oral administration: rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute bursitis and tenosynovitis, soft tissue injuries; pain syndrome (mild to moderate intensity): arthralgia, myalgia, neuralgia, migraine, toothache and headache, dysmenorrhea, pain from injuries, burns; febrile syndrome in colds and infectious diseases.

For topical use: as a symptomatic agent to relieve sore throat in infectious and inflammatory diseases of the oral cavity and pharynx.

ICD codes

Dosage Regimen

Use orally or allow to dissolve slowly in the mouth for local effect.

For sore throat relief in adults and adolescents 15 years and older, dissolve one 8.75 mg lozenge in the mouth.

Repeat dosing every 3 to 6 hours as needed for pain.

Do not exceed 5 lozenges in any 24-hour period.

Limit the total duration of self-medication for sore throat to 3 days.

Discontinue use and consult a physician if symptoms persist or worsen.

For other indications requiring systemic administration, use the appropriate tablet formulation and follow the specific prescribed dosage.

The systemic dose must be individually tailored based on the condition being treated, its severity, and patient response.

Adhere strictly to the maximum daily dose for the specific formulation to avoid increased risk of adverse effects.

Adverse Reactions

From the digestive system: dyspepsia (nausea, vomiting, heartburn, diarrhea), NSAID-gastropathy, abdominal pain, impaired liver function; with long-term use in high doses – ulceration of the gastrointestinal mucosa, bleeding (gastrointestinal, hemorrhoidal, from the gums).

From the cardiovascular system: increased blood pressure, tachycardia, heart failure.

From the hematopoietic system: rarely – anemia (iron deficiency, hemolytic, aplastic), agranulocytosis, leukopenia, thrombocytopenia.

From the central and peripheral nervous system: headache, dizziness, drowsiness or insomnia, asthenia, depression, amnesia, tremor, agitation, rarely – ataxia, paresthesia, impaired consciousness.

From the urinary system: tubulointerstitial nephritis, edematous syndrome, impaired renal function.

Allergic reactions: skin rash, itching, urticaria, bronchospasm, photosensitivity, angioedema, anaphylactic shock.

Other: hearing loss, tinnitus, increased sweating.

Contraindications

Hypersensitivity to flurbiprofen and other NSAIDs; erosive and ulcerative lesions of the gastrointestinal tract in the acute phase, “aspirin triad” (bronchial asthma, vasomotor rhinitis, intolerance to acetylsalicylic acid), gastrointestinal bleeding, cerebrovascular hemorrhage, heart failure, edema, arterial hypertension, hemostasis disorders (including hemophilia, hypocoagulation), severe hepatic failure, severe renal failure, confirmed hyperkalemia, treatment of postoperative pain after coronary artery bypass grafting, pregnancy, breastfeeding period; for oral administration – children under 15 years of age.

With caution

Anemia, bronchial asthma, hematopoietic disorders, chronic heart failure, arterial hypertension, coronary artery disease, edematous syndrome, hepatic and/or renal failure, chronic alcoholism, inflammatory bowel diseases, diverticulitis, erosive and ulcerative lesions of the gastrointestinal tract in remission, diabetes mellitus, conditions after extensive surgical interventions, inducible porphyria, elderly age.

Use in Pregnancy and Lactation

Flurbiprofen is contraindicated for use during pregnancy and breastfeeding.

Use in Hepatic Impairment

Contraindicated in severe hepatic impairment.

Use in Renal Impairment

Contraindicated in severe renal impairment.

Pediatric Use

Oral administration is contraindicated in children under 15 years of age.

Geriatric Use

Use with caution in elderly patients.

Special Precautions

During flurbiprofen administration, periodic monitoring of the peripheral blood picture and bleeding time is necessary.

Effect on ability to drive vehicles and operate machinery

During treatment, one should refrain from engaging in potentially hazardous activities that require increased attention and speed of mental and motor reactions.

Drug Interactions

Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites.

When used concomitantly, Flurbiprofen reduces the effectiveness of uricosuric drugs, enhances the effect of anticoagulants (increases the risk of bleeding), antiplatelet agents, fibrinolytics, side effects of mineralocorticoids, glucocorticosteroids, estrogens; reduces the effectiveness of antihypertensive and diuretic agents; enhances the hypoglycemic effect of sulfonylurea derivatives.

Acetylsalicylic acid increases the plasma concentration of the drug, ranitidine decreases it.

Antacids and cholestyramine reduce the absorption of flurbiprofen.

When used concomitantly, Flurbiprofen increases the blood concentration of lithium and methotrexate drugs.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.