Colcibra capsules

Colcibra

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

The active ingredient of Colcibra 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

Colcibra 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 Colcibra include: clay-colored stools; itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at site; vomiting; wheezing; voice changes; stuffy or runny nose; sweating.

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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 Colcibra 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 Colcibra was equivalent when Colcibra 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 .

Colcibra metabolism is primarily mediated via CYP2C9. Three metabolites, a primary alcohol, the corresponding carboxylic acid and its glucuronide conjugate, have been identified in human plasma. These metabolites are inactive as COX-1 or COX-2 inhibitors.

Colcibra is eliminated predominantly by hepatic metabolism with little ( 25 kg should achieve plasma concentrations similar to those observed in a clinical trial that demonstrated the non-inferiority of Colcibra to naproxen 7.5 mg/kg twice daily (see DOSAGE AND ADMINISTRATION). Colcibra has not been studied in JRA patients under the age of 2 years, in patients with body weight less than 10 kg (22 lbs), or beyond 24 weeks.

Meta-analysis of pharmacokinetic studies has suggested an approximately 40% higher AUC of Colcibra in Blacks compared to Caucasians. The cause and clinical significance of this finding is unknown.

Mechanism Of Action

CELECOXIB has analgesic, anti-inflammatory, and antipyretic properties.

The mechanism of action of CELEBREX is believed to be due to inhibition of prostaglandin synthesis, primarily via inhibition of cyclooxygenase-2 (COX-2).

Colcibra is a potent inhibitor of prostaglandin synthesis in vitro. Colcibra concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Since Colcibra is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.

What Is Celebrex (Colcibra)?

Celebrex is the brand name for the prescription pain reliever Colcibra, the drug's active ingredient. Doctors prescribe Celebrex to treat pain, swelling, and stiffness of arthritis and some other conditions.

Celebrex is a non-steroidal anti-inflammatory drug, often referred to simply as an NSAID. NSAIDs block swelling, pain, and fever. Celebrex works by stopping the production of COX-2, a natural substance in the body that causes pain and inflammation. Celebrex is an NSAID and a COX-2 inhibitor.

The Food and Drug Administration (FDA) approved Colcibra in 1998 for the drug company G.D. Searle under the brand name Celebrex. In May 2014, the FDA approved the generic version of Colcibra.

The FDA has approved Celebrex to treat:

  • Osteoarthritis (the type of arthritis that results from wear and tear)
  • Rheumatoid arthritis (the inflammatory type of arthritis)
  • Rheumatoid arthritis in children older than 2
  • Ankylosing spondylitis (inflammatory arthritis of the spine)
  • Short-term pain caused by injury
  • Pain associated with menstrual periods
  • Polyps that grow in the colon and rectum in people with a condition called familial adenomatous polyposis.

Also, a study in the May 2014 issue of the journal Human Psychopharmacology suggested that Colcibra holds promise as an add-on treatment for people with depression. The researchers noted, though, that more study needs to be done to determine its safety and effectiveness long-term.

Intervention:Monitor patients with concomitant use of CELEBREX with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding .AspirinClinical Impact:Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone . In two studies in healthy volunteers, and in patients with osteoarthritis and established heart disease respectively, Colcibra (200-400 mg daily) has demonstrated a lack of interference with the cardioprotective antiplatelet effect of aspirin (100-325 mg).Intervention:Concomitant use of CELEBREX and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding . CELEBREX is not a substitute for low dose aspirin for cardiovascular protection.ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-BlockersClinical Impact:
  • NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol).
  • In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible.

Genitourinary

Common (1% to 10%): Urinary tract infection

Uncommon (0.1% to 1%): Ovarian cyst

Frequency not reported: Albuminuria, cystitis, dysuria, hematuria, micturition frequency, renal calculus, dysmenorrhea, urinary incontinence, menstrual disorder, vaginal hemorrhage, vaginitis, prostatic disorder

Albuminuria, cystitis, dysuria, hematuria, micturition frequency, renal calculus, dysmenorrhea, urinary incontinence, menstrual disorder, vaginal hemorrhage, vaginitis, and prostatic disorder were reported in 0.1% to 1.9% of patients taking Colcibra 100 to 200 mg twice a day or 200 mg once a day. In the long-term polyp prevention studies in which exposure to Colcibra was 400 to 800 mg per day for up to 3 years, ovarian cyst was reported in at least 0.1% of patients to less than 1% of patients.

Metabolic

Frequency not reported: Increased blood urea nitrogen, increased creatinine phosphokinase, diabetes mellitus, hypercholesterolemia, hyperglycemia, hypokalemia, non-protein nitrogen increased, creatinine increased, alkaline phosphatase increased, weight increased, anorexia

Increased blood urea nitrogen, increased creatinine phosphokinase, diabetes mellitus, hypercholesterolemia, hyperglycemia, hypokalemia, non-protein nitrogen increased, creatinine increased, alkaline phosphatase increased, anorexia, and increased weight increase were reported in 0.1% to 1.9% of patients taking Colcibra 100 to 200 mg twice a day or 200 mg once a day.

Q: Is there another medication that I can take that is equally as good as Celebrex. It's very good but so expensive!

A: Celebrex (there is no generic but the active ingredient is Colcibra) is an expensive NSAID (non-steroidal-anti-inflammatory-drug), and there are no alternatives exactly like it, but you may be able to try something similar. Most NSAIDS follow two pathways in the body, COX-1 inhibition and COX-2 inhibition. The second one is desirable, as it decreases the inflammation. The first pathway can slowly destroy the stomach lining and over time, cause ulcers or GI bleeding. Celebrex is the only medication that does not go down the COX-1 pathway very much. Others were developed (Vioxx and Bextra), but then recalled due to issues with people having heart problems. So, if you do not have GI bleeding or an ulcer, you may want to ask your doctor about other NSAIDS. Mobic (the generic name is meloxicam) is a great alternative, because it is generic and has less GI/ulcer problems than most of the NSAIDS. Ultimately, you should see what your doctor thinks is best for you. If your doctor insists on Celebrex, you may want to contact the company and see if they have any discount coupons that your pharmacy can process. Many companies do this. The company to contact is Pfizer. For more information on pain management, please visit our link at: //www.everydayhealth.com/pain-management/pain-treatment.aspx Patti Brown, PharmD Brown, PharmD

Animal Toxicology

An increase in the incidence of background findings of spermatocele with or without secondary changes such as epididymal hypospermia as well as minimal to slight dilation of the seminiferous tubules was seen in the juvenile rat. These reproductive findings while apparently treatment-related did not increase in incidence or severity with dose and may indicate an exacerbation of a spontaneous condition. Similar reproductive findings were not observed in studies of juvenile or adult dogs or in adult rats treated with Colcibra. The clinical significance of this observation is unknown.

In the PRECISION-ABPM substudy, among the total of 444 analyzable patients at Month 4, Colcibra dosed at 100 mg twice daily decreased mean 24-hour systolic blood pressure (SBP) by 0.3 mmHg, whereas ibuprofen and naproxen at the doses taken increased mean 24-hour SBP by 3.7 and 1.6 mmHg, respectively. These changes resulted in a statistically significant and clinically meaningful difference of 3.9 mmHg (p=0.0009) between Colcibra and ibuprofen and a non-statistically significant difference of 1.8 (p=0.119) mmHg between Colcibra and naproxen.

Q: I had prostate surgery in November 2009. I also have rheumatoid arthritis. I go to the bathroom very often at night, every 1 1/2 to 2 hrs. Whenever I take Celebrex for pain, it reduces urination frequency. Can you educate me, please. Is it good or bad?

A: Celebrex (Colcibra) is frequently used to reduce pain caused by a variety of conditions. Usually, after prostate surgery the frequency of urination will increase. It is normally not a problem to reduce the frequency of urination with medication. However, with Celebrex, you should notify your health care provider about the decrease in urinary frequency as this is listed as a more serious side effect of Celebrex. Anytime you notice changes in your daily routine, you should let your health care provider know. Sometimes, the changes will not matter and other times they may need to adjust your medication regimen. It is also good to keep a current list of any prescription medication and over-the-counter products you take and review it with your health care providers and your pharmacist. If possible, use one pharmacy for all your prescription medications and over-the-counter products. This allows your pharmacist to keep a complete record of all your prescription drugs and to advise you about drug interactions and side effects. For more specific information, consult with your doctor or pharmacist for guidance based on your health status and current medications, particularly before taking any action. Megan Uehara, PharmD


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