Clanza/Clanza CR/Clanza S

Clanza/Clanza CR/Clanza S

aceclofenac

Manufacturer:

Korea United Pharma

Distributor:

One Pharma
Full Prescribing Info
Contents
Aceclofenac.
Description
Clanza: Each tablet contains Aceclofenac 100 mg.
Clanza CR: Each controlled-release tablet contains Acelofenac 200 mg.
Clanza S: Each softgel capsule contains Aceclofenac 100 mg.
Action
Pharmacology: Pharmacokinetics: Aceclofenac is well-absorbed from the gastro-intestinal tract; peak plasma concentrations are reached 1 to 3 hours after an oral dose. Aceclofenac is more than 99% bound to plasma proteins. The plasma-elimination half-life is approximately 4 hours. About two-thirds of a dose is excreted in the urine, mainly as hydroxymetabolites.
Indications/Uses
Aceclofenac is indicated for the relief of pain and inflammation in toothache, trauma, lumbago, osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
Dosage/Direction for Use
Clanza: Adults: The recommended dose is 200 mg daily, taken as two separate doses (every 12 hours). Or, as prescribed by the physician.
Clanza CR: Adults: The recommended dose is 200 mg daily, taken as one dose (every 24 hours). Or, as prescribed by the physician.
Clanza S: Adults: The recommended dose is one capsule twice daily (every 12 hours). Or, as prescribed by the physician.
Overdosage
There are no human data available on the consequences of aceclofenac overdosage. If overdosage is observed, therapeutic measures should be taken according to symptoms; supportive and symptomatic treatment should be given for complications such as hypotension, gastro-intestinal irritation, respiratory depression and convulsions.
Contraindications
Absolute contraindications: Not to be given to those patients who have history of: Stroke: cerebrovascular accident, CVA.
Heart attack: Myocardial infarction, MI.
Coronary artery bypass graft, CABG.
Uncontrolled hypertension.
Congestive heart failure (CHF) NYHA II-IV.
Patients with allergy to these drugs or other analogues (diclofenac).
Patients with asthma. Non-steroidal anti-inflammatory drugs, acetylsalicylic acid and other drugs which inhibit prostaglandin-synthesis may precipitate attacks of asthma, acute rhinitis or urticaria.
Patients with active peptic ulcer.
Warnings
Close medical surveillance is imperative when a patient who drinks alcohol regularly should take this drug or other antipyretics and analgesics. It may cause gastric bleeding to this person.
Special Precautions
Patients with symptoms of gastro-intestinal disorders and with a history of gastric ulcer.
Patients with moderate to severe hepatic impairment or cardiac or renal impairment. Dose adjustment and monitoring of liver and renal functions should be instituted.
Patients under the medication of diuretics.
Patients in recovery after surgical treatment.
The elderly.
Effects on the Ability to Drive or Operate Machineries: Patients suffering from dizziness, vertigo, or other central nervous system disorders while taking NSAIDs (Non-steroidal anti-inflammatory drugs) should refrain from driving or handling dangerous machinery.
Use in Children: The dosage and indication is not yet established for children less than 6 years old.
Use In Pregnancy & Lactation
Since there is no information on the safe use of aceclofenac during pregnancy and lactation, the use of aceclofenac should be avoided in pregnancy and lactation.
Adverse Reactions
The majority of adverse-effects observed have been reversible and of a minor nature and include gastro-intestinal disorders (dyspepsia, abdominal pain, nausea), rash, urticaria, symptoms of enuresis, headache, dizziness and drowsiness.
Drug Interactions
There has been no drug interactions reported, but close monitoring of patients on combination with lithium and digoxin, oral antidiabetic agents, anticoagulants, diuretics, and other analgesics should be observed.
Storage
Store at temperatures not exceeding 30°C.
ATC Classification
M01AB16 - aceclofenac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
Presentation/Packing
Clanza: Tab 100 mg (film-coated, white, round, biconvex, engraved with "A" on one side, "UT" on the other side) x 100's.
Clanza CR: CR Tab 200 mg (white, oblong, biconvex, controlled-release, film-coated, engraved with "UT" on one side and "CL CR" on the other side) x 100's.
Clanza S: Softgel cap 100 mg (red, oval, printed with "CLS", filled with mucous fluid) x 100's.
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