Dexibuprofen is indicated for:

• Relief of signs and symptoms of osteoarthritis
• Management of rheumatic disorders such as bone rheumatism, ankylosing spondylitis, juvenile arthritis, muscular rheumatism, and degenerative joint diseases
• Acute symptomatic treatment of painful menstruation (primary dysmenorrhea)
• Treatment of common headache and fever
• Symptomatic relief of mild to moderate pain, including muscle pain, headache, and dental pain
• Used as an adjuvant in common cold and influenza associated with headache

Dexibuprofen (S(+)-ibuprofen) is the pharmacologically active enantiomer of racemic ibuprofen. Like racemic ibuprofen, it is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and anti-inflammatory properties. It works by inhibiting the synthesis of prostaglandins.

Pharmacokinetics: Dexibuprofen is mainly absorbed from the small intestine. After metabolic conversion in the liver (hydroxylation and carboxylation), the inactive metabolites are eliminated primarily through the kidneys (about 90%) and to a lesser extent via bile. The elimination half-life is approximately 1.8–3.5 hours, and plasma protein binding is about 99%. Peak plasma concentrations are reached about 2 hours after oral administration. Taking dexibuprofen with food delays the time to reach peak levels (from 2.1 hours in fasting state to 2.8 hours in non-fasting state) and slightly reduces the peak concentration (from 20.6 to 18.1 mcg/ml, which is not clinically significant), but it does not affect the overall absorption.

The dosage must be adjusted to the seriousness of the syndrome and the complaints of the patient. During chronic pain, the dosage must be adapted to the lowest effective dose.

The recommended dosage: 600-900 mg Dexibuprofen per day, at 2-3 divided doses. The dosage can be raised temporarily up to 1200 mg Dexibuprofen per day in patients with acute disorders or exacerbations. The maximum daily dose is 1200 mg.

At dysmenorrhea: A dosage of 600 up to 900 mg Dexibuprofen per day, at a divided dose.

The reported drug interactions of dexibuprofen are similar to those of racemic ibuprofen. Interactions may occur when it is used concurrently with anticoagulants, hydantoin and sulfonamide derivatives, ticlopidine, lithium, other NSAIDs, ACE inhibitors, beta-blockers, cyclosporine, tacrolimus, corticosteroids, digoxin, methotrexate, pentoxifylline, phenytoin, probenecid, sulfinpyrazone, sulfonylureas, thiazide and thiazide-like diuretics, and zidovudine.

Dexibuprofen is contraindicated in patients with a known history of hypersensitivity to dexibuprofen, other NSAIDs, or any component of the formulation. It should not be used in patients who develop asthma attacks, bronchospasm, acute rhinitis, urticaria, or edema after taking similar drugs such as aspirin or other NSAIDs. It is also contraindicated in patients with active or suspected bleeding, Crohn’s disease, or ulcerative colitis, as well as in those with severe cardiac disease, renal impairment (GFR < 30 mL/min), or hepatic impairment.

Clinical experience indicates that the adverse effects of dexibuprofen are similar to those of racemic ibuprofen. Common side effects include dyspepsia, diarrhea, fatigue, headache, nausea, vomiting, abdominal pain, as well as hypersensitivity reactions such as bleeding and ulcer formation.

Pregnancy: Although no teratogenic effects have been observed in animal studies with dexibuprofen or ibuprofen, its use should be avoided during pregnancy. However, animal reproduction studies do not always predict human response. Due to the known effects of nonsteroidal anti-inflammatory drugs on the fetal cardiovascular system (such as premature closure of the ductus arteriosus), use in late pregnancy should be avoided.

Lactation: Human studies have shown that racemic ibuprofen is excreted into breast milk in very small or negligible amounts. Therefore, dexibuprofen should be used with caution in breastfeeding mothers.

Dexibuprofen should be used with special caution in patients with bronchial asthma, other chronic respiratory diseases, or in individuals with a tendency toward allergies. It should also be used carefully in patients with hepatic, renal, or cardiac insufficiency, as well as in those with uncontrolled hypertension. Patients with systemic lupus erythematosus or other autoimmune diseases should consult a physician before starting treatment with this medicine. Dexibuprofen must be used with extreme caution in active or suspected bleeding conditions such as gastroduodenal ulcers, ulcerative colitis, Crohn’s disease, and in patients with alcoholism. Allergic reactions may occur even in first-time users; in such cases, the drug should be discontinued immediately.

Hepatic impairment: Patients with mild to moderate liver impairment should start treatment with low doses and be closely monitored. Dexibuprofen should not be used in patients with severe liver dysfunction.

Renal impairment: In patients with mild to moderate kidney impairment, treatment should begin with a reduced dose. Dexibuprofen is contraindicated in patients with severe renal impairment.

Children’s dose: Although Dexibuprofen is not approved for use in children under 18 years in the UK, some countries allow its use. For example, in Switzerland it has been administered to children aged 6 years and above at a dose of 10–15 mg/kg per day, divided into 2–4 doses.

Elderly patients: The lowest effective dose is recommended. If well tolerated, the dose may be increased up to the standard adult dose.

Dexibuprofen has low acute toxicity. Signs of toxicity may appear at doses of 80–100 mg/kg body weight. Mild symptoms include abdominal pain, nausea, vomiting, lethargy, headache, tinnitus, and ataxia. Moderate to severe symptoms may include flatulence, low blood pressure, hypothermia, metabolic acidosis, reduced kidney function, coma, and apnea. Treatment is symptomatic, as there is no specific antidote. In cases of large ingestion, activated charcoal should be administered. Induced vomiting is considered only if life-threatening amounts have been taken and if it can be performed within 60 minutes of ingestion. Dialysis and hemodialysis are of limited value because dexibuprofen is highly protein-bound in plasma.

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Store below 30°C. Protect from light and keep out of reach of children.