Danilo 120

Indications of Danilo 120

Osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and the pain and symptoms of inflammation associated with acute gouty arthritis are all treated with etoricoxib.

For the management of mild discomfort caused by dental surgery in the short term.

 

Pharmaceutical Name of Danilo 120

Healthcare Pharmaceuticals Ltd.

 

Pharmacology

Etoricoxib is a potent orally active specific cyclooxygenase 2 (COX2) inhibitor, within the clinical dose range and significantly higher than this range. Two isoforms of cyclooxygenase have been identified: cyclooxygenase 1 (COX1) and cyclooxygenase 2 (COX2). COX1 is responsible for normal prostaglandin-mediated physiological functions, such as gastric cell protection and platelet aggregation. The inhibition of COX1 by non-selective NSAID is related to the inhibition of gastric injury and platelet aggregation. COX2 has been shown to be mainly responsible for the synthesis of prostaglandin mediators for pain, inflammation and fever. The selective inhibition of COX2 by etoricoxib (within the clinical dose range) reduces these clinical signs and symptoms, while reducing the possibility of GI toxicity and the effect on platelet aggregation. Etoricoxib produces a dose-dependent inhibition of COX2, but does not inhibit COX1, at doses up to 150 mg per day. Etoricoxib does not inhibit the synthesis of gastric prostaglandin.

 

Dosage & Administration

Adult and adolescent over 16 years:

• Osteoarthritis: The recommended dose is 30 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 60 mg once daily may increase efficacy.
• Rheumatoid arthritis: The recommended dose is 90 mg once daily.
• Ankylosing spondylitis: The recommended dose is 90 mg once daily.
• Acute gouty arthritis: The recommended dose is 120 mg once daily. In clinical trials for acute gouty arthritis, Etoricoxib was given for 8 days.
• Postoperative dental surgery pain: The recommended dose is 90 mg once daily, limited to a maximum of 3 days.

Some patients may require additional postoperative analgesia. 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 patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis.

 

Interaction of Danilo 120

With medicine:

• Oral anticoagulants: In subjects stabilized on chronic warfarin therapy, the administration of Etoricoxib was associated with an increase in prothrombin time.
• Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
• Acetylsalicylic Acid: Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
• Ciclosporin and tacrolimus: Although this interaction has not been studied with Etoricoxib, coadministration of ciclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.
• Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.

With food & others: Take without regards to meals.

 

Contraindications

Allergy to active substances or any excipients.

Active peptic ulcer or active gastrointestinal (GI) bleeding.

Patients with bronchospasm, acute rhinitis, nasal polyps, angioedema, urticaria, or allergic reactions after taking acetylsalicylic acid or NSAIDs including COX2 (cyclooxygenase 2) inhibitors.

Pregnancy and breastfeeding.

Severe liver dysfunction (serum albumin <25 g/l or ChildPugh score 10).

The estimated renal creatinine clearance is <30 ml/min.

children and adolescents under 16 years of age.

Inflammatory bowel disease.

Congestive heart failure (NYHA llIV).

Patients with hypertension whose blood pressure continued to rise above 140/90 mmHg and were not adequately controlled.

Ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease identified.

 

Side Effect of Danilo 120

Palpitation, fatigue, influenza-like symptoms, and ecchymosis are common side effects; less common side effects include dry mouth, taste disturbance, mouth ulcer, appetite and weight change, atrial fibrillation, transient ischaemic attack, chest pain, flushing, cough, dyspnoea, epistaxis, anxiety, mental acuity impairment, paraesthesia, electrolyte disturbance, myalgia, and arthralgia; very rarely confusion and hall

 

Pregnancy & Lactation

Etoricoxib, like any other medication that inhibits COX-2, is not suggested for women who are trying to conceive. Etoricoxib is not known to be eliminated in human milk. Lactating rats excrete etoricoxib in their milk. Breastfeeding is not recommended for women who take Etoricoxib.

 

Precautions & Warnings

It is recommended to treat patients who are more likely to develop gastrointestinal complications from NSAIDs; elderly, patients taking any other NSAIDs or acetylsalicylic acid at the same time, or patients with a history of gastrointestinal diseases (such as ulcers and gastrointestinal bleeding).

Patients with significant risk factors for cardiovascular events (such as hypertension, hyperlipidaemia, diabetes, smoking) should be treated with etoricoxib after careful consideration.

Etoricoxib intake may cause decreased prostaglandin formation, which in turn leads to decreased renal blood flow, impairing renal function. Monitoring of renal function in these patients should be considered.

Caution should be exercised in patients with a history of heart failure, left ventricular dysfunction, or hypertension, and in patients with pre-existing edema for any other reason.

Any patient with symptoms and/or signs suggesting liver dysfunction, or with abnormal liver function tests, should be monitored. If signs of liver failure appear or persistent abnormal liver function tests are detected (three times the upper limit of normal), etoricoxib should be discontinued.

Etoricoxib should be discontinued at the first appearance of a rash, mucosal lesions, or any other signs of hypersensitivity.

Etocoxib may mask fever and other signs of inflammation. Caution should be used when combining etoricoxib with warfarin or other oral anticoagulants.

 

Therapeutic Class

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

 

Storage Conditions

Store at a temperature of below 30°C, protect from light & moisture. Keep out of reach of children.

 

Generic of Danilo 120

Etoricoxib