CHIFENAC Soft Caps.
Aceclofenac 100 mg
Each capsule contains
Each red, oval soft capsule is filled with mucous liquid.
– Toothache, inflammation caused by external wound, lumbago, sciatic pain, post-episiotomy, post-parturition, pains due to nonarticular rheumatism
– Rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, scapulohumeral periarthritis
DOSAGE & ADMINISTRATIONS
Adults: The recommended dose is one capsule twice daily (every 12 hours). Or as prescribed by the physician.
1) If the patients who consume 3 cups or more alcoholic drinks every day take aceclofenac or other pain relievers/fever reducers, they should consult with the physicians. This drug may cause gastric-bleeding to these patients.
2) Gastro-intestinal: Close medical surveillance is imperative on patients with, symptoms indicative of gastro-intestinal disorders, with a history suggestive of gastro-intestinal ulceration, with ulcerative colitis or with Crohns’s disease, bleeding diathesis or haematological abnormalities.
3) Gastro-intestinal bleeding or ulcerative perforation, haemetemesis and melaene have in general more serious consequences in the elderly. They can occur at any time during treatment, with or without warning symptoms or a previous history. In the rare instances where gastro-intestinal bleeding or ulceration occurs in patients receiving aceclofenac the drug should be withdrawn.
4) Hepatic: Close medical surveillance is also imperative in patients suffering from severe impairment of hepatic function.
5) Hypersensitivity reactions: As with other NSAIDs, allergic reactions, including anaphylactoid reactions, can also occur without earlier exposure to the drug.
1) Patients with active peptic ulcer
2) Patients with hypersensitivity to these drugs or other analogues (diclofenac)
3) Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs (containing COX-2 inhibitor). (Rarely as with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, can also occur in these patients.)
4) Patients with asthma; like NSAIDs, acetylsalicylic acid and other drugs (like aspirin) which inhibit prostagladin-synthesis may precipitate attacks of asthma, acute rhinitis or urticaria.
5) For treatment of pain which is ceased before end after Coronary Artery Bypass Graft (CABG)
1) Patients with symptoms indicative of gastro-intestinal disorders, or with a history of gastro-ulceration
2) Patients with severe hepatic impairment
3) Patients with cardiac or renal impairment
4) Patients under the medication of diuretics
5) Patients in recovery after surgical treatment
6) The elderly
The majority of adverse reactions reported have been reversible and of a minor nature. The most frequent are gastro-intestinal disorders particularly dyspepsia, abdominal pain, nausea and diarrhea, rash, ruber, urticaria, symptoms of enuresis, headache, and drowsiness and occasional occurrence of dizziness.
1) Undesirable effects may be minimized by using the minimum effective dose for the shortest possible duration.
2) Renal Patients with mild renal or cardiac impairment and the elderly should be kept under surveillance, since the use of NSAIDs may result in deterioration of renal function. The lowest effective dose should be used and renal function monitored regularly.
3) The importance of prostaglandins in maintaining renal blood flow should be taken into account in patients with impaired cardiac or renal function, those being treated with diuretics or recovering from major surgery. Effects on renal function are usually reversible on withdrawal of aceclofenac.
4) Hepatic: If abnormal liver function test persist or worsen, clinical signs or symptoms consistent with liver disease develop or if other manifestations occur (eosinophilia, rash(, aceclofenac should be discontinued. Hepatitis may occur without prodromel symptoms.
5) Use of aceclofenec in patients with hepatic porphyria may trigger an snack.
6) Haematological Aceclofenec may reversibly inhibit platelet aggregation.
7) Cardiovascular NSAIDs should be given with care to patients with a history of heart failure or hypertension since edema has been reported in association with NSAIDs administration.
8) Long-term treatment: All patients who are receiving NSAIDs should be monitored as a precautionary measure e.g. renal failure hepetic function (elevation of liver enzymes may occur) and blood counts.
9) Fertility: NSAIDs may impair fertility and is not recommended in women trying to conceive. The temporary discontinuation of aceclofenac should be considered on woman having difficulties to conceive or undergoing investigations for infertility.
10) Use with caution in patients suffering from or with a history of bronchial asthma since NSAIDs have been known to cause bronchospasm in such patients.
Lithium: Aceclofenac like many NSAIDs, may increase plasma concentrations of lithium.
Cardiac Glycosides: Through their renal effects, NSAIDs may increase plasma glycoside (including digoxin) levels, exacerbate cardiac failure and reduce the glomerular filtration rate in patients receiving glycosides.
Diuretics: Aceclofenac, like other NSAIDs, may inhibit the activity of diuretics. Although it was not shown to affect blood pressure control when co-administered with bendrofluazide, interactions with other diuretics cannot be ruled out. When concomitant administration with potassium sparing diuretics is employed, serum potassium should be monitored. Diuretics can increase the risk of nephrotoxicity of NSAIDs.
Anticoagulants: Like other NSAIDs, aceclofenac may enhance the activity of anticoagulants. Close monitoring of patients on combined anticoagulant and acaclofenec therapy should be undertaken.
Antidiabetic agents: Clinical studies have shown that diclofenac can be given together with oral antidiabetic agents without influencing their clinical effect. However, there have been isolated reports of hypoglycaemic and hyperglycaemic effects. Thus with aceclofenec, consideration should be given to adjustment of the dosage of hypoglycemic agents.
Methotrexate: Caution should be exercised if NSAIDs and methotrexate are administered within 24 hours of each other, since NSAIDs may increase plasma levels, resulting in increased toxicity.
Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.
Other NSAIDs and steroids: Concomitant therapy with aspirin, other NSAIDs and steroids may increase the frequency of adverse reactions, including the risk of GI bleeding.
Cyclosporin: Cyclosporin nephrotoxity maybe increased by the effect of NSAIDs on renal prostagladins.
Quinolone antimicrobials: Convulsions may occur due to an interaction between quinolones and NSAIDs. This may occur in patients with or without a previous history of epilepsy or convulsions. Therefore, caution should be exercised when considering the use at a quinolone in patients who are already receiving NSAIDs.
USE IN PREGNANCY AND LACTATION
Pregnancy: Congenital abnormalities have been reported in association with NSAID administration in man; however, these are low infrequency and do not appear to follow any discernible pattern. In view of the known effects of NSAIDs on the foetal cardiovascular system (risk of closure of the ductus arteriosus), use in the last trimester of pregnancy is contraindicated. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child. NSAIDs should not be used during the first two trimesters of pregnancy or labour unless the potential benefit to the patient outweighs the potential risk to the foetus.
Animal studies indicate that there was no evidence of teratogenesis in rats although the systemic exposure was low and in rabbits, treatment with aceclofenac (10 mg/kg/day) resulted in a series of morphological changes in some foetuses.
Lactation: There is no information on the secretion of aceclofenac to breast milk; there was however no notable transfer of radio-labelled (14C) aceclofenac to the milk of lactating rats. In limited studies so far available, NSAIDs can appear in breast milk in very low concentrations. NSAIDs should, if possible, be avoided when breastfeeding.
USE IN CHILDREN AND THE ELDERLY
1) The dosage and indication is not established yet for children below the age of 6 years.
2) As with other NSAIDs, cautions should be exercised in the treatment of elderly patients, who are at increased risk of the serious consequences of adverse reactions, and who are generally more likely to be suffering from impaired renal, cardiovascular or hepatic function and receiving concomitant medication. The elderly should be monitored for regularly for GI bleeding during NSAID therapy.
There are no human data available on the consequences of aceclofanec overdosage. If overdosage is observed, therapeutic measures should be taken according to symptoms; supportive and symptomatic treatment should be given far complications such as hypotension, gastro-intestinal irritation, respiratory depression, and convulsions.
SPECIAL PRECAUTIONS FOR STORAGE
1) Keep out of reach of children.
2) Do not preserve in other containers in order to avoid accident or quality control problem.
Preserve in tight containers.
Store at room temperature not exceeding 30oC.
CHI Pharmaceuticals Limited
KOREA UNITED PHARM. INC.
404-10, Nojang-Ri, Jeondong-Myeon, Yeongi-Kun,