Table Of Contents
- Bextra Price Comparison Table
- Bextra Information
- Bextra Ingredients and Composition
- How Does Bextra Work?
- How To Take Bextra and Bextra Dosage and Administration
- If you suspect a Bextra Overdose
- Bextra Side Effects
- Bextra Precautions and Contraindications
- Contraindications to Bextra
- Bextra Warnings
- Bextra Clinical Trials and Studies
- Storing Bextra
- Credits for Bextra Information
Brand names: Bextra
Bextra Price Comparison Table
| Product | Qty | Medical Fees & Shipping | Price/ Qty | Price | Click to Order |
|---|---|---|---|---|---|
| Bextra 20mg | 100 | $10.95 | $1.96ea | $195.59 | Buy from PharmaWebCanada |
Bextra 20mg| Product | Qty | Medical Fees & Shipping | Price/ Qty | Price | Click to Order |
|---|---|---|---|---|---|
| Bextra 10mg | 30 | $18.00 | $6.30ea | $189.00 | Buy from Billing-md |
| Bextra 10mg | 90 | $18.00 | $4.12ea | $371.00 | Buy from Billing-md |
| Bextra 10mg | 100 | $10.95 | $1.79ea | $178.95 | Buy from PharmaWebCanada |
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Bextra Information
Brand Name: Bextra
Generic Name: Valdecoxib
Other Common Names: Valdure
Bextra tablets are indicated for:
- For relief of the signs and symptoms of osteoarthritis and adult rheumatoid arthritis.
- For the treatment of primary dysmenorrhea.
Bextra Ingredients and Composition
Valdecoxib, the active ingredient in Bextra, is chemically designated as 4-(5-methyl-3-phenyl-4-isox-azolyl) benzenesulfonamide and is a diaryl substituted isoxazole.
The empirical formula for valdecoxib, the active ingredient Bextra, in is C16H14N2O3S,and the molecular weight is 314.36.Valdecoxib is a white crystalline powder that is relatively insoluble in water (10 µg/mL) at 25°C and pH 7.0, soluble in methanol and ethanol, and freely soluble in organic solvents and alkaline (pH=12) aqueous solutions.
Bextra Tablets for oral administration contain either 10 mg or 20mg of valdecoxib. Inactive Bextra ingredients include:
- lactose mono-hydrate
- microcrystalline cellulose
- pregelatinized starch
- croscarmel-lose sodium
- magnesium stearate
- hydroxypropyl methylcellulose
- polyethylene glycol
- polysorbate 80
- titanium dioxide
How Does Bextra Work?
Mechanism of Action
Valdecoxib, the active ingredient in Bextra, 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 Bextra (valdecoxib) does not inhibit cyclooxygenase-1 (COX-1).
How To Take Bextra and Bextra Dosage and Administration
Osteoarthritis and Adult Rheumatoid Arthritis
The recommended dose of Bextra Tablets for the relief of the signs and symptoms of arthritis is 10 mg once daily.
Primary Dysmenorrhea
The recommended dose of Bextra Tablets for treatment of primary dysmenorrhea is 20 mg twice daily, as needed.
If you suspect a Bextra Overdose
Symptoms following acute Bextra (and other NSAIDs) overdoses are usually limited to:
- lethargy
- drowsiness
- nausea
- vomiting
- epigastric pain
These are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare.
Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs such as Bextra, and may occur following an overdose.
Patients should be managed by symptomatic and supportive care following an NSAID overdose. There are no specific antidotes. Hemodialysis removed only about 2% of administered valdecoxib (active Bextra ingredient) from the systemic circulation of 8 patients with end-stage renal disease and, based on its degree of plasma protein binding (>98%), dialysis is unlikely to be useful in overdose. Forced diuresis, alkaliniza-tion of urine, or hemoperfusion also may not be useful due to high protein binding.
Bextra Side Effects
Of the patients treated with Bextra Tablets in controlled arthritis trials for Bextra side effects, 2665 were patients with OA, and 2684 were patients with RA. More than 4000 patients have received a chronic total daily dose of Bextra 10 mg or more. More than 2800 patients have received Bextra 10 mg/day,or more, for at least 6 months and 988 of these have received Bextra for at least 1 year.
Osteoarthritis and Rheumatoid Arthritis
All Bextra side effects are listed, regardless of causality, that occurred in ≥ 2.0% of patients receiving Bextra 10 and 20mg/day in studies of three months or longer from 7 controlled studies conducted in patients with OA or RA that included a placebo and/or a positive control group.
In these placebo- and active-controlled clinical trials, the discontinuation rate due to adverse events was 7.5% for arthritis patients receiving Bextra (valdecoxib) 10 mg daily, 7.9% for arthritis patients receiving valdecoxib 20 mg daily and 6.0% for patients receiving placebo.
In the seven controlled OA and RA studies, the following Bextra side effects occurred in 0.1-1.9% of patients treated with 10 -20 mg daily, regardless of causality.
- Application site disorders: Cellulitis, dermatitis contact
- Cardiovascular: Aggravated hypertension, aneurysm, anginapectoris, arrhythmia, cardiomyopathy, congestive heart failure, coronary artery disorder, heart murmur, hypotension
- Central, peripheral nervous system: Cerebrovascular disorder, hypertonia, hypoesthesia, migraine, neuralgia, neuropathy, pares-thesia, tremor, twitching, vertigo
- Endocrine: Goiter
- Female reproductive: Amenorrhea, dysmenorrhea, leukorrhea, mastitis, menstrual disorder, menorrhagia, menstrual bloating, vagi-nal hemorrhage
- Gastrointestinal: Abnormal stools, constipation, diverticulosis, dry mouth, duodenal ulcer, duodenitis, eructation, esophagitis, fecal incontinence, gastric ulcer, gastritis, gastroenteritis, gastroe-sophageal reflux, hematemesis, hematochezia, hemorrhoids, hem-orrhoids bleeding, hiatal hernia, melena, stomatitis, stool frequency increased, tenesmus, tooth disorder, vomiting
- General: Allergy aggravated, allergic reaction, asthenia, chest pain, chills, cyst NOS, edema generalized, face edema, fatigue, fever, hot flushes, halitosis, malaise, pain, periorbital swelling, peripheral pain Hearing and vestibular: Ear abnormality, earache, tinnitus
- Heart rate and rhythm: Bradycardia, palpitation, tachycardia
- Hemic: Anemia
- Liver and biliary system: Hepatic function abnormal, hepatitis, ALT increased, AST increased
- Male reproductive: Impotence, prostatic disorder
- Metabolic and nutritional: Alkaline phosphatase increased, BUN increased, CPK increased, creatinine increased, diabetes mellitus, glycosuria, gout, hypercholesterolemia, hyperglycemia, hyperkalemia, hyperlipemia, hyperuricemia, hypocalcemia, hypokalemia, LDH increased, thirst increased, weight decrease, weight increase, xerophthalmia
- Musculoskeletal: Arthralgia, fracture accidental, neck stiffness, osteoporosis, synovitis, tendonitis
- Neoplasm: Breast neoplasm, lipoma, malignant ovarian cyst
- Platelets (bleeding or clotting): Ecchymosis, epistaxis, hematoma NOS, thrombocytopenia
- Psychiatric: Anorexia, anxiety, appetite increased, confusion, depression, depression aggravated, insomnia, nervousness, morbid dreaming, somnolence
- Resistance mechanism disorders: Herpes simplex, herpes zoster, infection fungal,infection soft tissue, infection viral, moniliasis, moniliasis genital, otitis media
- Respiratory: Abnormal breath sounds, bronchitis, bronchospasm, coughing, dyspnea, emphysema, laryngitis, pneumonia, pharyngitis, pleurisy, rhinitis
- Skin and appendages: Acne, alopecia, dermatitis, dermatitis fun-gal, eczema, photosensitivity allergic reaction, pruritus, rash ery-thematous, rash maculopapular, rash psoriaform, skin dry, skin hypertrophy, skin ulceration, sweating increased, urticaria
- Special senses: Taste perversion
- Urinary system: Albuminuria, cystitis, dysuria, hematuria, micturition frequency increased, pyuria, urinary incontinence, urinary tract infection
- Vascular: Claudication intermittent, hemangioma acquired, varicose vein
- Vision: Blurred vision, cataract, conjunctival hemorrhage, con-junctivitis, eye pain, keratitis, vision abnormal
- White cell and RES disorders: Eosinophilia, leukopenia, leukocytosis, lymphadenopathy, lymphangitis, lymphopenia
There may be additional undocumented Bextra side effects.
Bextra Precautions and Contraindications
Patients taking Bextra should report to their physicians, signs or symptoms of gastrointestinal ulceration or bleeding, skin rash, weight gain, or edema.
Patients should be informed of the warning signs and symptoms of hepatotoxicity (e.g.,nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and flu-like symptoms).If these occur, patients should be instructed to stop Bextra therapy and seek immediate medical attention.
Patients should also be instructed to seek immediate emergency help in the case of an anaphylactoid reaction after taking Bextra.
Contraindications to Bextra
Bextra Tablets are contraindicated in patients with known hypersensitivity to valdecoxib. Bextra should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs are possible in such patients.
Bextra should not be given to patients who have demonstrated allergic-type reactions to sulfonamides.
Bextra Warnings
Gastrointestinal (GI) Bextra Effects - Risk of GI Ulceration, Bleeding, and Perforation
Serious gastrointestinal toxicity such as bleeding, ulceration and perforation of the stomach, small intestine or large intestine can occur at any time with or without warning symptoms in patients treated with nonsteroidal anti-inflammatory drugs (NSAIDs) such as Bextra. Minor gastrointestinal problems such as dyspepsia are common and may also occur at any time during NSAID therapy. Therefore, physicians and patients should remain alert for ulceration and bleeding even in the absence of previous GI tract symptoms. Patients should be informed about the signs and symptoms of serious GI toxicity and the steps to take if they occur. The utility of periodic laboratory monitoring has not been demonstrated, nor has it been adequately assessed. Only one in five patients who develop a serious upper GI adverse event on NSAID (Bextra) therapy is symptomatic. It has been demonstrated that upper GI ulcers, gross bleeding or perforation caused by NSAIDs appear to occur in approximately 1% of patients treated for 3 to 6months and 2-4% of patients treated for one year. These trends continue, thus increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk.
NSAIDs such as Bextra should be prescribed with extreme caution in patients with a prior history of ulcer disease or gastrointestinal bleeding. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore special care should be taken in treating this population. For high risk patients, alternate therapies that do not involve NSAIDs should be considered.
Studies have shown that patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding and who use NSAIDs such as Bextra, have a greater than 10-fold higher risk for developing a GI bleed than patients with neither of these risk factors. In addition to a past history of ulcer disease, pharmacoepidemiological studies have identified several other co-therapies or co-morbid conditions that may increase the risk for GI bleeding such as: treatment with oral corti-costeroids, treatment with anticoagulants, longer duration of NSAID therapy, smoking, alcoholism, older age, and poor general health status.
Serious Skin Reactions
Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported through postmarketing surveillance in patients receiving Bextra.
As these reactions can become life threatening, Bextra should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
Anaphylactoid Reactions
Anaphylactoid reactions were not reported in patients receiving BEXTRA in clinical trials. However, as with NSAIDs in general, ana-phylactoid reactions may occur in patients without known prior exposure to Bextra. Bextra should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs. Emergency help should be sought in cases where an anaphylactoid reaction occurs.
In postmarketing experience, cases of hypersensitivity reactions (anaphylactoid reactions and angioedema) have been reported in patients receiving Bextra. These cases have occurred in patients with and without a history of allergic-type reactions to sulfonamides.
Bextra Clinical Trials and Studies
The efficacy and clinical utility of Bextra Tablets have been demonstrated in osteoarthritis (OA),rheumatoid arthritis (RA) and in the treatment of primary dysmenorrhea.
Osteoarthritis
Bextra was evaluated for treatment of the signs and symptoms of osteoarthritis of the knee or hip,in five double-blind,randomized, controlled trials in which 3918 patients were treated for 3 to 6 months. Bextra was shown to be superior to placebo in improvement in three domains of OA symptoms:(1) the WOMAC (Western Ontario and McMaster Universities) osteoarthritis index,a composite of pain, stiffness and functional measures in OA,(2) the overall patient assessment of pain,and (3) the overall patient global assess-ment.The two 3-month pivotal trials in OA generally showed changes statistically significantly different from placebo,and comparable to the naproxen control,in measures of these domains for the 10 mg/day dose. No additional benefit from Bextra was seen with a valde-coxib 20-mg daily dose.
Rheumatoid Arthritis
Bextra demonstrated significant reduction compared to placebo in the signs and symptoms of RA,as measured by the ACR (American College of Rheumatology) 20 improvement, a composite defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five: patient global,physician global,patient pain,patient function assessment, and C-reactive protein (CRP). Bextra was evaluated for treatment of the signs and symptoms of rheumatoid arthritis in four double-blind, randomized, controlled studies in which 3444 patients were treated for 3 to 6 months. The two 3-month pivotal trials compared valdecoxib to naproxen and placebo. Trials of BEXTRA in rheumatoid arthritis allowed concomitant use of corticosteroids and/or disease-modifying anti-rheumatic drugs (DMARDs), such as methotrexate, gold salts, and hydroxychloroquine. No additional benefit was seen with a Bextra (valdecoxib) 20-mg daily dose.
Primary Dysmenorrhea
Bextra was compared to naproxen sodium 550 mg in two placebo-controlled studies of women with moderate to severe primary dys-menorrhea. The onset of analgesia was within 60 minutes for Bextra 20 mg. The onset, magnitude, and duration of analgesic effect with Bextra 20 mg were comparable to naproxen sodium 550mg.
Storing Bextra
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)
Credits for Bextra Information
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