Aldecox

Valdecoxib

Presentation

Aldecox  10 tablet : Each  tablet contains Valdecoxib INN 10 mg.

Aldecox  20 tablet : Each  tablet contains Valdecoxib INN 20 mg.

Description

Valdecoxib is chemically designated as 4-(5-methyl-3-phenyl-4-isoxazolyl) benzenesulfonamide and is a diaryl substituted isoxazole. Valdecoxib is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic and antipyretic properties in animal models. The mechanism of action is believed to be due to inhibition of  prostaglandin synthesis primarily through inhibition of cyclooxygenase-2 (COX-2). At therapeutic plasma concentrations in humans Valdecoxib does not inhibit cyclooxygenase-1 (COX-1).

Indications and Uses

Aldecox Tablets are indicated for:

* Chronic pain including both osteoarthritis and adult rheumatoid arthritis.

* Acute pain including RTA, dental pain and pre and postoperative pain.

* The treatment of primary dysmenorrhea. 

Dosage and Administration

Osteoarthritis and Adult Rheumatoid Arthritis: The recommended dose of Aldecox Tablets for the relief of the signs and symptoms of arthritis is 10 mg once daily.

Acute pain: 20-40 mg Valdecoxib per day.

Primary Dysmenorrhea: The recommended dose of Aldecox tablets for treatment of primary dysmenorrhea is 20 mg twice daily, as needed.

Combined therapy with opioid analgesic: 20-40 mg Valdecoxib per day.

Side-effects

Adverse events with incidence 2% in Valdecoxib treatment groups include abdominal fullness, abdominal pain, diarrhoea, dyspepsia, flatulence, nausea, dizziness, headache and rash.

Precautions

Cautions should be taken in patients with liver and renal insufficiency, anemia and pre-existing asthma precipited by aspirin-like drugs.

Use in Pregnancy & Lactation 

Pregnancy : Valdecoxib should not be used in third trimester of pregnancy.

Nursing Mothers : It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for adverse reactions in nursing infants from Valdecoxib, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother and the importance of nursing to the infant.

Use in Children

Safety and effectiveness of Valdecoxib in pediatric patients below the age of 18 years have not been evaluated.

Use in Elderly Patients

No overall differences in effectiveness were observed between patients over 75 years and adult patients.

Contraindications

Valdecoxib is contraindicated in patients with pre-existing asthma precipited by aspirin-like drugs, hepatic and renal insufficiency, anemia, urticaria & hypersensitivity to Valdecoxib and sulfonamide drugs.

Drug Interactions

The drug interaction of Valdecoxib has been noticed with Aspirin, Methotrexate, ACEinhibitors, Furosemide, Anticonvulsants, Dextromethorphan, Lithium, Warfarin, Fluconazole, Ketoconazole and Glyburide.

Overdosage

Symptoms following acute NSAID overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care.  Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose. Patients should be managed by symptomatic and supportive care following an NSAID overdose. There are no specific antidotes.

Commercial Pack

Aldecox  10 tablet : Each box contains 5 blister strips of 10 tablets.

Aldecox  20 tablet : Each box contains 3 blister strips of 10 tablets.