Olfen 75 mg/2 ml 6 ampoules
Composition:
Each 2 ml ampoule contains:
Diclofenac sodium — 75 mg.
Lidocaine hydrochloride — 20 mg.
Excipients:
disodium edetate, propylene glycol, polyethylene glycol, sodium hydroxide, water for injection.
Product Description:
Olfen is a nonsteroidal anti‑inflammatory drug (NSAID) with pronounced antirheumatic, analgesic, anti‑inflammatory, and antipyretic properties.
Diclofenac provides systemic pain relief and inflammation reduction, while lidocaine minimizes injection site discomfort.
Indications for Use:
- Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, spondyloarthritis, extra‑articular rheumatism.
- Vertebral pain syndromes.
- Renal and hepatic colic.
- Acute gout attacks.
- Pain, swelling, and inflammation after trauma or surgery.
- Migraine attacks.
Method of Administration and Dosage:
- For intramuscular use only, injected deeply into the gluteal muscle.
- Adults: 1 ampoule (75 mg) once daily.
- For colic or severe pain: up to 2 injections per day with 2–3 hour interval.
- Maximum: 2 injections per day.
- Duration of therapy: up to 2 days, then switch to oral or rectal forms.
- Total daily diclofenac dose must not exceed 150 mg.
Contraindications:
- Pediatric use.
- Hypersensitivity to diclofenac, lidocaine, aspirin, or excipients.
- Severe cardiac, hepatic, or renal insufficiency.
- Bradycardia, marked hypotension.
- Gastrointestinal bleeding.
- Pregnancy and breastfeeding.
Precautions:
- Discontinue if liver dysfunction occurs.
- Patients with cardiovascular disorders require medical supervision.
- Elderly, frail, or low‑weight patients should receive minimal effective doses.
- Caution in patients with peptic ulcers, GI bleeding, hepatic or renal disease, hypertension.
- In asthma, nasal polyps, hay fever, or respiratory disorders, NSAIDs may trigger bronchospasm.
Adverse Reactions / Side Effects:
- Rare: injection site abscesses.
- Nervous system: headache, dizziness, vertigo.
- Cardiovascular: tachycardia, bradycardia, hypertension, arrhythmia, heart failure.
- Gastrointestinal: abdominal pain, nausea, vomiting, diarrhea, dyspepsia, flatulence, cramps.
- Fluid retention, edema.
- Allergic: rash, angioedema.
- Local: pain or reaction at injection site.
Pregnancy and Lactation:
Contraindicated.
Storage Conditions:
Store at temperatures not exceeding 30 °C.
Keep out of reach of children.
Packaging:
Carton box containing 6 ampoules of 2 ml each and leaflet.