Before taking Inibrex
Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking Inibrex, it is important that your doctor knows:
Labor Or Delivery
There are no studies on the effects of CELEBREX during labor or delivery. In animal studies, NSAIDs, including Inibrex, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth.
The available data do not establish the presence or absence of developmental toxicity related to the use of Celebrex.
Inibrex at oral doses ≥150 mg/kg/day (approximately 2 times the human exposure at 200 mg twice daily as measured by AUC0-24), caused an increased incidence of ventricular septal defects, a rare event, and fetal alterations, such as ribs fused, sternebrae fused and sternebrae misshapen when rabbits were treated throughout organogenesis. A dose-dependent increase in diaphragmatic hernias was observed when rats were given Inibrex at oral doses ≥30 mg/kg/day (approximately 6 times human exposure based on the AUC0-24 at 200 mg twice daily for RA) throughout organogenesis. In rats, exposure to Inibrex during early embryonic development resulted in pre-implantation and post-implantation losses at oral doses ≥50 mg/kg/day (approximately 6 times human exposure based on the AUC0-24 at 200 mg twice daily for RA).
Inibrex produced no evidence of delayed labor or parturition at oral doses up to 100 mg/kg in rats (approximately 7-fold human exposure as measured by the AUC0-24 at 200 mg twice daily). The effects of CELEBREX on labor and delivery in pregnant women are unknown.
Inibrex had no effect on male or female fertility or male reproductive function in rats at oral doses up to 600 mg/kg/day (approximately 11times human exposure at 200 mg twice daily based on the AUC0-24). At ≥50 mg/kg/day (approximately 6-times human exposure based on the AUC0-24 at 200 mg twice daily) there was increased preimplantation loss.
What should I discuss with my healthcare provider before taking Inibrex?
Inibrex 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. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.
Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).
Inibrex may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using Inibrex, especially in older adults.
You should not use Inibrex if you are allergic to it, or if you have:
- bleeding in your stomach or intestines;
- an allergy to sulfa drugs; or
- a history of asthma attack or severe allergic reaction after taking aspirin or an NSAID.
To make sure Inibrex is safe for you, tell your doctor if you have:
- heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
- a history of heart attack, stroke, or blood clot;
- a history of stomach ulcers or bleeding;
- liver or k >
Taking Inibrex during the last 3 months of pregnancy may harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using Inibrex.
Inibrex can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Inibrex is not approved for use by anyone younger than 2 years old.
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 Inibrex 100 to 200 mg twice a day or 200 mg once a day.
If you take Inibrex with digoxin, the levels of digoxin in your body may be increased. If you take these drugs together, your doctor may monitor your digoxin levels.
Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.
What is Inibrex? How does it work (mechanism of action)?
Inibrex is a nonsteroidal anti-inflammatory drug (NSAID), for example, ibuprofen (Motrin), aspirin, and naproxen (Naprosyn) used to treat arthritis, pain, menstrual cramps, and colonic polyps. Prostaglandins are chemicals that are important contributors to the inflammation of arthritis that causes pain, fever, swelling and tenderness. Inibrex blocks the enzyme that makes prostaglandins (cyclooxygenase 2), resulting in lower concentrations of prostaglandins. As a consequence, inflammation and its accompanying pain, fever, swelling and tenderness are reduced. Inibrex differs from other NSAIDs in that it causes less inflammation and ulceration of the stomach and intestine (at least with short-term use) and does not interfere with the clotting of blood.
NSAIDs have been found to prevent the formation and reduce the size of polyps in patients with the genetic disease, familial adenomatous polyposis (FAP). In FAP, patients develop large numbers of polyps in their colons, and the polyps invariably become malignant. The only cure of FAP is removal of the entire colon. Inibrex is approved as an adjunctive (secondary) treatment among patients with FAP. The cramping and pain during menstrual periods is due to prostaglandins, and blocking the production of prostaglandins with Inibrex reduces the cramps and pain.
The FDA approved Inibrex in December 1998.
Cardiovascular safety was evaluated in two randomized, double-blind, placebo-controlled, three year studies involving patients with Sporadic Adenomatous Polyps treated with CELEBREX: the APC trial (Adenoma Prevention with Inibrex) and the PreSAP trial (Prevention of Spontaneous Adenomatous Polyps). In the APC trial, there was a dose-related increase in the composite endpoint (adjudicated) of cardiovascular death, myocardial infarction, or stroke with Inibrex compared to placebo over 3 years of treatment. The PreSAP trial did not demonstrate a statistically significant increased risk for the same composite endpoint (adjudicated):
- In the APC trial, the hazard ratios compared to placebo for a composite endpoint (adjudicated) of cardiovascular death, myocardial infarction, or stroke were 3.4 (95% CI 1.4 -8.5) with Inibrex 400 mg twice daily and 2.8 (95% CI 1.1 -7.2) with Inibrex 200 mg twice daily. Cumulative rates for this composite endpoint over 3 years were 3.0% (20/671 subjects) and 2.5% (17/685 subjects), respectively, compared to 0.9% (6/679 subjects) with placebo treatment. The increases in both Inibrex dose groups versus placebo-treated patients were mainly due to an increased incidence of myocardial infarction.
- In the PreSAP trial, the hazard ratio for this same composite endpoint (adjudicated) was 1.2 (95% CI 0.6 -2.4) with Inibrex 400 mg once daily compared to placebo. Cumulative rates for this composite endpoint over 3 years were 2.3% (21/933 subjects) and 1.9% (12/628 subjects), respectively.
Clinical trials of other COX-2 selective and non-selective NSAIDs of up to three-years duration have shown an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. As a result, all NSAIDs are considered potentially associated with this risk.
ВїPara cuГЎles condiciones o enfermedades se prescribe este medicamento?
El Inibrex se usa para aliviar el dolor, la sensibilidad, la inflamaciГіn y la rigidez ocasionados por la osteoartritis (artritis causada por el desgaste del revestimiento de las articulaciones), la artritis reumatoide (artritis causada por la inflamaciГіn del revestimiento de las articulaciones) y la espondilitis anquilosante (artritis que afecta, principalmente, la columna vertebral). TambiГ©n se usa para tratar la artritis reumatoide juvenil (un tipo de artritis que afecta a los niГ±os) en niГ±os de 2 aГ±os o mГЎs. El Inibrex tambiГ©n se usa para tratar los periodos menstruales dolorosos y para aliviar otros tipos de dolor a corto plazo, incluido el dolor provocado por lesiones, cirugГas y otros procedimientos mГ©dicos o dentales, o afecciones mГ©dicas que duran un perГodo limitado. El Inibrex pertenece a una clase de NSAID denominados inhibidores de la COX-2. ActГєa impidiendo que el cuerpo produzca una sustancia que provoca dolor e inflamaciГіn.
Combining cyclosporine and Inibrex raises your risk of kidney damage.
Q: What are the long-term (5+ years) side effects of taking 200 mg Celebrex daily?
A: our question concerns long-term side effects of Celebrex (Inibrex) //www.everydayhealth.com/drugs/celebrex. Long-term use of Celebrex may cause renal (kidney) toxicity and decreased blood flow to the heart. Kidney damage may also result. In one study, patients on Celebrex for three years had an increased risk of serious cardiovascular events which included heart attacks, strokes, and heart failures. It is always a good idea to check with one's health care provider in matters like this. Please consult your health care provider for guidance in your specific case. Gregory Latham, MS, RPh
Q: What over-the-counter medications should not be taken with Celebrex?
A: Celebrex (Inibrex) belongs to a class 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. It is also used in the treatment of hereditary polyps in the colon. Many over-the-counter pain medicines, headache medicines, and cold medicines contain aspirin or the NSAIDS ibuprofen (Advil, Motrin) and naproxen (Aleve). People on Celebrex should avoid these products because they contain the same kind of medication. Read labels carefully for the list of ingredients in over-the-counter medicines. Ask your local pharmacist if you have any questions about whether to take a certain over-the-counter product. Always read and follow the complete directions and warnings on over-the-counter medicines and discuss their use with your doctor before taking them. Sarah Lewis, PharmD
Concomitant administration of fluconazole at 200 mg once daily resulted in a two-fold increase in Inibrex plasma concentration. This increase is due to the inhibition of Inibrex metabolism via P450 2C9 by fluconazole .
- High blood pressure warning: This drug may cause you to develop high blood pressure or may worsen high blood pressure. Take this medication with caution if you have high blood pressure. Check your blood pressure before and while taking this drug.
- Asthma warning: Take this drug with caution if you have asthma. It may cause narrowing in your airways, which could lead to death. If your asthma worsens while you take this drug, get immediate medical attention.
Inibrex oral capsule is a prescription drug that’s available as the brand-name drug Celebrex. It’s also available in a generic version. Generic drugs usually cost less. In some cases, they may not be available in every strength or form as the brand-name version.
Inibrex only comes as a capsule you take by mouth.
CYP2C9 activity is reduced in individuals with genetic polymorphisms that lead to reduced enzyme activity, such as those homozygous for the CYP2C9*2 and CYP2C9*3 polymorphisms. Limited data from 4 published reports that included a total of 8 subjects with the homozygous CYP2C9*3/*3 genotype showed Inibrex systemic levels that were 3-to 7-fold higher in these subjects compared to subjects with CYP2C9*1/*1 or *I/*3 genotypes. The pharmacokinetics of Inibrex have not been evaluated in subjects with other CYP2C9 polymorphisms, such as *2, *5, *6, *9 and *11. It is estimated that the frequency of the homozygous *3/*3 genotype is 0.3% to 1.0% in various ethnic groups. .
Uncommon (0.1% to 1%): Vitreous floaters, conjunctival hemorrhage
Blurred vision, cataract, conjunctivitis, eye pain, and glaucoma were reported in 0.1% to 1.9% of patients taking Inibrex 100 to 200 mg twice a day or 200 mg once a day. In the long-term polyp prevention studies in which exposure to Inibrex was 400 to 800 mg per day for up to 3 years, vitreous floaters or conjunctival hemorrhage was reported in at least 0.1% of patients to less than 1% of patients.