- Approval Id
- e8f8d8ff6348bc34
- Drug Name
- AIRTAL FILM COATED TABLETS 100MG
- Product Name
- AIRTAL FILM COATED TABLETS 100MG
- Approval Number
- SIN15700P
- Approval Date
- 2019-05-29
- Registrant
- EURODRUG LABORATORIES SINGAPORE PTE. LTD.
- Licence Holder
- EURODRUG LABORATORIES SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- **DOSAGE AND ADMINISTRATION:**
Aceclofenac (Airtal®) tablet should not be taken with an empty stomach. To be taken with or after food.
When Aceclofenac (Airtal®) was administered to fasting and fed healthy volunteers, only the rate and not the extent of aceclofenac absorption was affected.
Aceclofenac (Airtal®) tablet should be taken whole with a sufficient amount of liquid.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
**Adults:**
- The recommended dose is 200 mg daily, taken as two separate 100 mg doses, one tablet in the morning and one in the evening.
**Children:**
- There are no clinical data regarding the use of Aceclofenac (Airtal®) in children and therefore it is not recommended for use in children.
**For Elderly:**
- The pharmacokinetics of Aceclofenac (Airtal®) is not affected in elderly patients, so it is therefore not considered necessary to alter the dose or the frequency of administration. However, as with any other non-steroidal anti-inflammatory drug, precautions must be taken when treating elderly patients which should be monitored regularly for gastrointestinal bleeding. These patients are at increased risk of the serious consequences of adverse reactions, have a greater chance of developing cardiovascular disorders and renal or liver impairment, and are often taking concomitant medication.
**For patients with Renal Impairment:**
- There is no evidence to suggest that the dosage of Aceclofenac (Airtal®) should be altered in patients with minor renal impairment, but as with other NSAIDs caution should be exercised.
**For patients with Liver Impairment:**
- Some evidence suggests that the dose of Aceclofenac (Airtal®) must be reduced in patients with liver impairment, with a recommended dose of 100 mg/day.
- Route Of Administration
- ORAL
- Indication Info
- **INDICATION:**
Aceclofenac (Airtal®) is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
- Contraindications
- **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) and recent revascularization procedures
- Uncontrolled hypertension
- Congestive Heart Failure (CHF) NYHA II–IV, ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease
- Gastrointestinal bleeding or perforation, active or history of recurrent peptic ulcer / haemorrhage or to patients with in whom one is suspected.
Not to be given to patients:
- with known hypersensitivity to any of the excipients of this medicinal product
- with bleeding or a blood clotting disorder
- with severe renal failure or severe liver failure
- during the third trimester of pregnancy and lactation, or to women who are planning to become pregnant.
- in whom acetylsalicylic acid or non-steroidal anti-inflammatory drugs trigger asthma attacks, acute rhinitis or urticaria, or to patients with hypersensitivity to these drugs.
- Atc Code
- M01AB16
- Atc Item Name
- aceclofenac
- Pharma Manufacturer Name
- EURODRUG LABORATORIES SINGAPORE PTE. LTD.
