Celoxx capsules

Celoxx

  • Active Ingredient: Celecoxib
  • 200 mg, 100 mg
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What is Celoxx?

The active ingredient of Celoxx brand is celecoxib. Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID). Celecoxib works by reducing hormones that cause inflammation and pain in the body.

Used for

Celoxx is used to treat diseases such as: Ankylosing Spondylitis, Familial Adenomatous Polyposis, Fibromatosis, Juvenile Rheumatoid Arthritis, Osteoarthritis, Pain, Period Pain, Rheumatoid Arthritis, Spondyloarthritis.

Side Effect

Possible side effects of Celoxx include: wheezing; troubled breathing; Back pain; difficult, burning, or painful urination; change in sense of taste; inability to sleep.

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Q: My husband just started taking Celebrex for pain in his shoulder, back, and arm. Is there a generic version, or another medication that is similar but less expensive?

A: Celebrex (Celoxx) belongs to a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by reducing hormones that cause inflammation and pain. Currently, there is no generic available in the United States for Celebrex. For cheaper alternatives, consult with your health care provider. For more information on this medication, go to //www.everydayhealth.com/drugs/celebrex. Kimberly Hotz, PharmD

Mental health drug

Celoxx may increase the levels of lithium in your body. Signs of lithium toxicity include slurred speech and tremors.

Celoxx dosing information

Usual Adult Dose for Pain:

Acute pain: 400 mg initially, followed by 200 mg if needed on the first day. Then, 200 mg twice daily as needed.

Usual Adult Dose for Dysmenorrhea:

400 mg initially, followed by 200 mg if needed on the first day. Then, 200 mg twice daily as needed.

Usual Adult Dose for Osteoarthritis:

200 mg orally once daily or 100 mg orally twice daily.

Usual Adult Dose for Rheumatoid Arthritis:

100 to 200 mg orally twice daily.

Usual Adult Dose for Familial Adenomatous Polyposis:

400 mg orally twice daily with food.

Usual Adult Dose for Ankylosing Spondylitis:

200 mg orally once daily or 100 mg orally twice daily. If after 6 weeks of therapy no results are observed, a trial dose of 400 mg orally daily may be worthwhile. If no response is seen after 6 weeks, consideration should be given to alternate treatment options.

Usual Pediatric Dose for Juvenile Rheumatoid Arthritis:

2 years or older:

10 to less than or equal to 25 kg: 50 mg orally twice daily

Greater than 25 kg: 100 mg orally twice daily

Other

Otitis media, deafness, ear abnormality, earache, and tinnitus were reported in 0.1% to 1.9% of patients taking Celoxx 100 to 200 mg twice a day or 200 mg once a day. In the long-term polyp prevention studies in which exposure to Celoxx was 400 to 800 mg per day for up to 3 years, labyrinthitis was reported in at least 0.1% of patients to less than 1% of patients.

Uncommon (0.1% to 1%): Labyrinthitis

Very rare (less than 0.01%): Hearing decreased

Frequency not reported: Otitis media, deafness, ear abnormality, earache, tinnitus

Q: Does prolonged use of Celebrex hinder your kidneys or liver?

A: Celebrex (Celoxx) is a nonsteroidal anti-inflammatory drug (NSAID) similar to ibuprofen, naproxen, diclofenac, and many others. According to the manufacturer, Celebrex has the advantage of causing fewer stomach and intestinal side effects compared to other NSAIDs. Like other NSAIDs, Celebrex may cause kidney and liver complications after extended use at high dosage. Clinical studies show Celebrex may cause acute renal failure in less than 0.1 percent of patients treated with Celebrex 800 mg per day. The FDA Adverse Event Reporting System reported 122 cases of renal failure associated with the use of Celebrex at the recommended dose. The prescribing information by the manufacturer also states that Celebrex should be used with caution in patients with pre-existing renal impairment. For low-risk patients, it is customary for clinician to order labs for renal function within three months after initiating therapy and repeated every six to 12 months. For those at high risk for renal failure (older than 60 years, pre-existing renal insufficiency), monitoring of renal function should be more frequent. Celebrex has been associated with increasing liver enzymes. According to research data by the manufacturer, elevated liver enzymes were reported in 0.1 percent to 1.9 percent of patients taking Celebrex up to 800 mg per day. Although liver enzymes were elevated, liver failure is rare. For patients at low risk, liver enzymes should be monitored within three months of starting treatment and repeated every six to 12 months. In high risk patients, more frequent monitoring is required. //www.everydayhealth.com/drugs/celebrex, //www.everydayhealth.com/symptom-checker/, and //www.everydayhealth.com/conditions/. Lori Mendoza, PharmD

Q: How often should you take Celebrex?

A: How often you should take Celebrex (Celoxx) depends upon the reason for treatment. Celebrex is approved for the relief of symptoms caused by pain or inflammation associated with several medical conditions, including osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis in children ages two and older, ankylosing spondylitis, primary dysmenorrhea, acute pain or familial adenomatous polyposis as an adjunct treatment to usual care. When prescribed for the symptomatic relief in patients with osteoarthritis, Celebrex is usually taken once or twice daily. As a treatment option for relief of signs and symptoms of rheumatoid arthritis in the adult population, Celebrex is typically taken twice daily. For the treatment of symptoms of juvenile rheumatoid arthritis in the pediatric population, the usual administration schedule for Celebrex is twice daily. For the relief of signs and symptoms associated with ankylosing spondylitis, Celebrex is typically administered once or twice daily. In adult patients being treated with Celebrex for the management of acute pain or the treatment of primary dysmenorrhea, the usual dose is initially a higher dose, followed by a lower dose if needed on the first day and typically administered twice daily as needed on subsequent days of treatment when required. Lastly, when Celebrex is used as an adjunct to usual care in patients with familial adenomatous polyposis, the dose is usually taken twice daily with food. When deciding upon Celebrex as a treatment option, health care providers are urged to carefully consider the risk versus benefit of treatment with Celebrex and use the lowest effective dose for the shortest duration of treatment possible to achieve positive therapeutic outcomes.

Cancer drugs

Taking Celoxx with certain drugs used to treat cancer raises the risk of side effects from those drugs. These side effects include kidney damage and a decrease in cells that help you fight infection. Examples of these drugs include:

What is the dosage for Celoxx?

The lowest effective dose should be used for each patient.

  • For the management of osteoarthritis, the dose usually is 100 mg twice daily or 200 mg as a single dose.
  • For rheumatoid arthritis, the dose usually is 200 mg twice daily.
  • For acute pain or menstrual cramps, the dose is 400 mg as a single dose on the first day followed by an additional 200 mg if needed, then 200 mg twice daily as needed.
  • For FAP, the recommended dose is 400 mg twice daily.

Q: My doctor prescribed Celebrex and I have GERD and Barrett's. Is it safe for me to take the Celebrex? What else can I take for the bursitis in my hip?

A: Celebrex (Celoxx) is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDS work by reducing hormones that cause inflammation and pain in the body. Celebrex is used to treat pain or inflammation caused by many conditions such as arthritis, ankylosing spondylitis, and menstrual pain. Celoxx is also used in the treatment of hereditary polyps in the colon. Common side effects of Celebrex include upset stomach, mild heartburn, diarrhea, constipation, bloating, gas, dizziness, nervousness, headache, skin rash, itching, blurred vision, and ringing in your ears. More serious side effects can occur and this is not a complete list of possible side effects associated with Celebrex. Using Celebrex increases the risk of serious conditions involving the stomach and intestines, including bleeding, ulceration, and perforation (forming a hole in the wall of the stomach or intestines). These conditions can be life-threatening and can occur without warning at any time during treatment with Celebrex. Because of this risk, people with a history of stomach ulcers or bleeding should not use Celebrex. The risk is also increased in elderly patients (over the age of 65) and with longer duration of therapy. There is no specific warning against using Celebrex in patients with GERD and/or Barrett's contained in the prescribing information for Celebrex. If you are concerned about the safety of Celebrex use, talk to your doctor for information based on your specific circumstances. Contact your doctor right away if you have symptoms of bleeding from your digestive tract. These include black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee. For more specific information, consult with your doctor or local pharmacist for guidance based on your health status and current medications. Sarah Lewis, RPh

Dermatologic

Common (1% to 10%): Rash

Frequency not reported: Alopecia, dermatitis, nail disorder, photosensitivity reaction, pruritus, rash erythematous, maculopapular rash, skin disorder, dry skin, sweating increased, urticaria

Postmarketing reports: Erythema multiforme, dermatitis exfoliative, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), dermatitis bullous

Alopecia, dermatitis, nail disorder, photosensitivity reaction, pruritus, rash erythematous, maculopapular rash, skin disorder, dry skin, sweating increased, and urticaria were reported in 0.1% to 1.9% of patients taking Celoxx 100 to 200 mg twice a day or 200 mg once a day.

Celoxx was not carcinogenic in Sprague-Dawley rats given oral doses up to 200 mg/kg for males and 10 mg/kg for females (approximately 2-to 4-times the human exposure as measured by the AUC0-24 at 200 mg twice daily) or in mice given oral doses up to 25 mg/kg for males and 50 mg/kg for females (approximately equal to human exposure as measured by the AUC0-24 at 200 mg twice daily) for two years.

Celoxx

Pharmacologic class: Nonsteroidal cyclooxygenase-2 (COX-2) inhibitor, nonsteroidal anti-inflammatory drug (NSAID)

Therapeutic class: Antirheumatic

Pregnancy risk category C

Oncologic

Breast fibroadenosis and breast neoplasm were reported in 0.1% to 1.9% of patients taking Celoxx 100 to 200 mg twice a day or 200 mg once a day.

Frequency not reported: Breast fibroadenosis, breast neoplasm

What is the most important information I should know about Celoxx?

Celoxx can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Celoxx may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using Celoxx, especially in older adults. You should not take this medicine if you already have bleeding in your stomach or intestines.

When CELEBREX capsules were taken with a high fat meal, peak plasma levels were delayed for about 1 to 2 hours with an increase in total absorption (AUC) of 10% to 20%. Under fasting conditions, at doses above 200 mg, there is less than a proportional increase in Cmax and AUC, which is thought to be due to the low solubility of the drug in aqueous media.

Coadministration of CELEBREX with an aluminum-and magnesium-containing antacids resulted in a reduction in plasma Celoxx concentrations with a decrease of 37% in Cmax and 10% in AUC. CELEBREX, at doses up to 200 mg twice daily, can be administered without regard to timing of meals. Higher doses (400 mg twice daily) should be administered with food to improve absorption.

In healthy adult volunteers, the overall systemic exposure (AUC) of Celoxx was equivalent when Celoxx was administered as intact capsule or capsule contents sprinkled on applesauce. There were no significant alterations in Cmax, Tmax or t½ after administration of capsule contents on applesauce .


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