Chitogast 60

POSOLOGY AND METHOD OF ADMINISTRATION

Administration

CHITOGAST is administered orally and may be taken with or without food.

Dosage

Dosage in adults:

Osteoarthritis: The recommended dose is 30 mg once daily. In some patients with insufficient relief from symptoms, the dose may be increased but should not exceed 60 mg daily.

Rheumatoid arthritis and ankylosing spondylitis: 90 mg once daily.

Acute gouty arthritis: The recommended dose is 120 mg once daily, limited to a maximum of 8 days treatment.

Chronic pain relief: 60 mg once daily

Relief of acute pain or primary dysmenorrhe: 120 mg once daily

- Children and adolescents: not recommended if under 16 years old.

- Patients with hepatic impairment:

• Patients with mild hepatic impairment: 60 mg once daily

• Patients with moderate hepatic impairment: 30 mg once daily

CONTRAINDICATIONS

- Hypersensitivity to the etoricoxib or to any of the excipients.

- Active peptic ulceration or active gastro-intestinal (GI) bleeding.

- Severe hepatic dysfunction or estimated renal creatinine clearance <30 ml/min.

- Inflammatory bowel disease and congestive heart failure (NYHA II-IV)

- Established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease.

- Children and adolescents under 16 years of age

- Pregnancy and lactation.

WARNINGS AND PRECAUTION

- Risk of cardiovascular thrombosis:

+Clinical trials suggest that the selective COX-2 inhibitor class of drugs may be associated with a risk of thrombotic events (especially myocardial infarction (MI) and stroke), relative to placebo and some NSAIDs. As the cardiovascular risks of etoricoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The risk of cardiovascular thrombosis was observed mainly at high doses.

+ Physicians should periodically evaluate the occurrence of cardiovascular events, even if the patient hasn't prior cardiovascular symptoms. Patients should be alerted to the symptoms of a serious cardiovascular event and should seek medical attention as soon as these symptoms appear.

+ To reduce the risk of adverse events, etoricoxib should be used at the shortest duration possible and the lowest effective daily dose.

- Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking) should only be treated with etoricoxib after careful consideration.

- Etoricoxib may be associated with more frequent and severe hypertension than some other NSAIDs and selective COX-2 inhibitors, particularly at high doses. Therefore, hypertension should be controlled before treatment with etoricoxib and special attention should be paid to blood pressure monitoring during treatment with etoricoxib.

- Caution should be used when initiating treatment with etoricoxib in patients with dehydration. It is advisable to rehydrate patients prior to starting therapy with etoricoxib.

- Medically appropriate supervision should be maintained when using etoricoxib in the elderly and in patients with renal, hepatic, or cardiac dysfunction. If during treatment, patients deteriorate in any of the organ system functions described above, appropriate measures should be taken and discontinuation of etoricoxib therapy should be considered.

- Etoricoxib should be used with caution in patients with a prior history of perforated and bleeding peptic ulcer and the elderly

SHELF LIFE

36 months from the manufacturing date. Do not use after the expiry date.

 Box of 03 blisters x 10 film-coated tablets