Artoflex 300 mg (Tablet)

Title

• Artoflex

Categories

• Pain Relief
• Anti-inflammatory
• Non-steroidal anti-inflammatory drugs (NSAIDs)
• Osteoarthritis Medication
• Rheumatoid Arthritis Medication

Description

• Effective in relieving signs and symptoms of osteoarthritis
• Indicated for rheumatoidal disorders such as osseous rheumatism, ankylosing spondilitis, juvenile arthritis, muscular rheumatism, degenerative joint diseases
• Acute symptomatic treatment for painful menstruation (primary dysmenorrhea)
• Common headache and fever relief
• Symptomatic treatment of mild to moderate pain, muscle pain, headache, and dental pain
• Adjuvant for common cold and influenza associated with headache

Color Options

• Not applicable

Dimensions

• Not applicable

Materials

• Dexibuprofen (S (+)-ibuprofen)

Technical Specifications

• Dosage: 600-900 mg Dexibuprofen per day, at 2-3 divided doses
• Maximum daily dose: 1200 mg
• Absorption: Primarily from the small intestine
• Metabolic transformation: In the liver (hydroxylation, carboxylation)
• Excretion: Mainly by the kidneys (90%), also in the bile
• Plasma protein binding: Approximately 99%
• Elimination half-life: 1.8-3.5 hours
• Maximum plasma levels reached: About 2 hours after oral administration
• Effect of administration with a meal: Delays time to reach maximum concentrations, decreases maximum plasma concentrations

Functions

• Relief of signs and symptoms of osteoarthritis and rheumatoidal disorders
• Analgesic action
• Inhibiting prostaglandin synthesis
• Acute symptomatic treatment for various conditions including painful menstruation, headache, fever, and common cold

Design Elements

• Not applicable

Usability Features

• Adaptive dosage based on severity of syndrome and patient's complaints
• Adjuvant for common cold and influenza associated with headache
• Ease of administration with 2-3 divided doses

Dosage & Administration

• 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
• Recommended dosage: 600-900 mg Dexibuprofen per day, at 2-3 divided doses
• Temporary dosage raise up to 1200 mg Dexibuprofen per day for acute disorders or exacerbations
• Maximum daily dose: 1200 mg
• Dosage for dysmenorrhea: 600-900 mg Dexibuprofen per day, at a divided dose

Interaction

• Simultaneous use interactions noticed with anticoagulant, hydantoine, sulfonamide, ticlopidine, lithium, other NSAID's, ACE inhibitors, beta blockers, cyclosporine, tacrolimus, corticosteroids, digoxin, methotrexate, pentoxyfiline, phenytoin, probenecid, sulfinpyrazon, sulfonylurea, thiazide and thiazide type diuretics, zidovudine

Contraindications

• Previous history of hypersensitivity to Dexibuprofen, NSAID, or any other component of the product
• Patients who experience attack of asthma, bronchospasm, acute rhinitis, urticaria, or edema after use of similar drugs (e.g. aspirin or other NSAIDs)
• Patients with active or suspected hemorrhage, Crohn's disease, ulcerative colitis, serious heart diseases, kidney function impairment (GFR <30ml/min), and liver function impairment

Side Effects

• Dyspepsia
• Diarrhea
• Fatigue
• Headache
• Nausea
• Vomiting
• Abdominal pain
• Hypersensitivity reactions
• Bleeding
• Ulcer

Pregnancy & Lactation

• Pregnancy: Avoid use due to potential effects on the fetal cardiovascular system
• Lactation: Caution advised as racimic ibuprofen has been shown to proceed in small to negligible degree in mother milk

Precautions & Warnings

• Particular caution in patients with bronchial asthma, chronic diseases of the pulmonary tract, or prone to allergy
• Use with caution in patients with hepatic, renal, or cardiac insufficiency, and with hypertension not responding to treatment
• Extreme caution in active and suspected hemorrhagic conditions such as gastro-duodenal ulcers, ulcerative colitis, Crohn's disease, alcoholism

Use in Special Populations

• Hepatic impairment: Start with low amounts in patients with mild to moderate liver function impairments, avoid use in serious impairments
• Renal impairment: Reduce start amount for patients with mild to moderate kidney function impairments, avoid use in serious impairments
• Children Dose: Some countries permit use in children (e.g., Switzerland allows use in children aged 6 years and over at a specific dose)
• Elderly: Lowest effective dose recommended, can be raised to adult dosage if well tolerated

Overdose Effects

• Low acute toxicities
• Toxicity symptoms occur at doses between 80 and 100 mg/kg body weight
• Mild symptoms: Abdominal pain, nausea, vomiting, lethargy, headache, tinnitus, ataxia
• Moderate to serious symptoms: Flatulence, hypotension, hypothermia, metabolic acidosis, reduced kidney function, coma, apnoea
• Treatment: Symptomatic; no specific antidote available, consider activated charcoal, induce vomiting if life-threatening quantities ingested within 60 minutes, little value in dialysis and hemodialysis

Therapeutic Class

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

Storage Conditions

• Do not store above 30°C
• Keep away from light
• Keep out of the reach of children

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