Properties
What is it?
Composition: 1ml contains: Aceclofenac I.P.-150mg; anhydrous base-sufficient quantity. Indications: Aceclofenac is used for acute and chronic pain and inflammatory processes, e.g., rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, cervicalgia, lumbago, tendinitis, ligament sprains and periarthritis of the shoulder. Aceclofenac is also used for painful conditions, e.g., odontalgia, back pain, myalgia, pain after episiotomy, postpartum pain, primary dysmenorrhea and extra-articular rheumatism. Contraindications: Contraindicated in patients with peptic ulcer disease, gastrointestinal bleeding, hypersensitivity to the drug. Patients in whom substances with similar action (e.g., aspirin or other non-steroidal anti-inflammatory drugs) cause asthma attacks, bronchospasm, acute rhinitis or urticaria, or patients with hypersensitivity to the drugs. Severe heart failure, liver or kidney dysfunction, last trimester of pregnancy. Dosage and administration: AceflexTM Injection is administered intramuscularly. Adults: The recommended dose is 150mg once or twice daily for 5 days or as recommended by a doctor. Elderly: Dose reduction is not necessary; however, use with caution. Children: Safety and efficacy in children and adolescents have not been established. Hepatic impairment: The dose of aceclofenac should be reduced in patients with mild to moderate hepatic impairment. The recommended starting dose is 100mg per day. Renal impairment: Dose adjustment is not required in mild renal impairment; however, use with caution. Pregnancy and lactation: Pregnancy: Regular use of aceclofenac during pregnancy can cause premature closure of the ductus arteriosus in the fetus and prolonged pulmonary hypertension in the newborn, inhibit the onset of labor and prolong labor and blood loss. Avoidance of aceclofenac use in the first and third trimesters of pregnancy is necessary. Lactation: It is not known whether aceclofenac is excreted in breast milk. The decision to discontinue lactation or aceclofenac use will be made after assessing the expected benefit to the mother and the potential risk to the infant. Effects on the ability to drive and operate machinery: In the event of dizziness or other central nervous system disorders while taking non-steroidal anti-inflammatory drugs, avoid driving and operating hazardous machinery. Storage: Store in a dark, dry place, protected from direct sunlight and out of reach of children, at a temperature not exceeding 25C. Dispensing category: Pharmaceutical product group III, available without prescription. Manufacturer: ZEE LABORATORIES LIMITED, India.