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CELEBREX
Overview
What is CELEBREX?
CELEBREX (celecoxib) is chemically designated as 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The empirical formula is CHFNOS, and the molecular weight is 381.38; the chemical structure is as follows:
CELEBREX oral capsules contain either 50 mg, 100 mg, 200 mg or 400 mg of celecoxib, together with inactive ingredients including: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate.
What does CELEBREX look like?



What are the available doses of CELEBREX?
Capsules: 50 mg, 100 mg, 200 mg and 400 mg ()
What should I talk to my health care provider before I take CELEBREX?
How should I use CELEBREX?
Carefully consider the potential benefits and risks of CELEBREX and other treatment options before deciding to use CELEBREX. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals []
Use lowest effective dose for the shortest duration consistent with treatment goals for the individual patient.
These doses can be given without regard to timing of meals.
What interacts with CELEBREX?
Sorry No Records found
What are the warnings of CELEBREX?
Sorry No Records found
What are the precautions of CELEBREX?
Sorry No Records found
What are the side effects of CELEBREX?
Sorry No records found
What should I look out for while using CELEBREX?
CELEBREX is contraindicated:
What might happen if I take too much CELEBREX?
No overdoses of CELEBREX were reported during clinical trials. Doses up to 2400 mg/day for up to 10 days in 12 patients did not result in serious toxicity. Symptoms following acute NSAID overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which 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, and may occur following an overdose.
Patients should be managed by symptomatic and supportive care following an NSAID overdose. There are no specific antidotes. No information is available regarding the removal of celecoxib by hemodialysis, but based on its high degree of plasma protein binding (>97%) dialysis is unlikely to be useful in overdose. Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose. Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.
How should I store and handle CELEBREX?
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP] .CELEBREX 100 mg capsules are white, with reverse printed white on blue band of body and cap with markings of 7767 on the cap and 100 on the body, supplied as:NDC NumberSize21695-022-15 bottle of 1521695-022-30 bottle of 3021695-022-60 bottle of 6021695-022-00 bottle of 10021695-022-72 bottle of 120CELEBREX 200 mg capsules are white, with reverse printed white on gold band with markings of 7767 on the cap and 200 on the body, supplied as:NDC NumberSize21695-023-14 bottle of 1421695-023-15 bottle of 1521695-022-30 bottle of 3021695-022-60 bottle of 60CELEBREX 100 mg capsules are white, with reverse printed white on blue band of body and cap with markings of 7767 on the cap and 100 on the body, supplied as:NDC NumberSize21695-022-15 bottle of 1521695-022-30 bottle of 3021695-022-60 bottle of 6021695-022-00 bottle of 10021695-022-72 bottle of 120CELEBREX 200 mg capsules are white, with reverse printed white on gold band with markings of 7767 on the cap and 200 on the body, supplied as:NDC NumberSize21695-023-14 bottle of 1421695-023-15 bottle of 1521695-022-30 bottle of 3021695-022-60 bottle of 60CELEBREX 100 mg capsules are white, with reverse printed white on blue band of body and cap with markings of 7767 on the cap and 100 on the body, supplied as:NDC NumberSize21695-022-15 bottle of 1521695-022-30 bottle of 3021695-022-60 bottle of 6021695-022-00 bottle of 10021695-022-72 bottle of 120CELEBREX 200 mg capsules are white, with reverse printed white on gold band with markings of 7767 on the cap and 200 on the body, supplied as:NDC NumberSize21695-023-14 bottle of 1421695-023-15 bottle of 1521695-022-30 bottle of 3021695-022-60 bottle of 60CELEBREX 100 mg capsules are white, with reverse printed white on blue band of body and cap with markings of 7767 on the cap and 100 on the body, supplied as:NDC NumberSize21695-022-15 bottle of 1521695-022-30 bottle of 3021695-022-60 bottle of 6021695-022-00 bottle of 10021695-022-72 bottle of 120CELEBREX 200 mg capsules are white, with reverse printed white on gold band with markings of 7767 on the cap and 200 on the body, supplied as:NDC NumberSize21695-023-14 bottle of 1421695-023-15 bottle of 1521695-022-30 bottle of 3021695-022-60 bottle of 60CELEBREX 100 mg capsules are white, with reverse printed white on blue band of body and cap with markings of 7767 on the cap and 100 on the body, supplied as:NDC NumberSize21695-022-15 bottle of 1521695-022-30 bottle of 3021695-022-60 bottle of 6021695-022-00 bottle of 10021695-022-72 bottle of 120CELEBREX 200 mg capsules are white, with reverse printed white on gold band with markings of 7767 on the cap and 200 on the body, supplied as:NDC NumberSize21695-023-14 bottle of 1421695-023-15 bottle of 1521695-022-30 bottle of 3021695-022-60 bottle of 60CELEBREX 100 mg capsules are white, with reverse printed white on blue band of body and cap with markings of 7767 on the cap and 100 on the body, supplied as:NDC NumberSize21695-022-15 bottle of 1521695-022-30 bottle of 3021695-022-60 bottle of 6021695-022-00 bottle of 10021695-022-72 bottle of 120CELEBREX 200 mg capsules are white, with reverse printed white on gold band with markings of 7767 on the cap and 200 on the body, supplied as:NDC NumberSize21695-023-14 bottle of 1421695-023-15 bottle of 1521695-022-30 bottle of 3021695-022-60 bottle of 60CELEBREX 100 mg capsules are white, with reverse printed white on blue band of body and cap with markings of 7767 on the cap and 100 on the body, supplied as:NDC NumberSize21695-022-15 bottle of 1521695-022-30 bottle of 3021695-022-60 bottle of 6021695-022-00 bottle of 10021695-022-72 bottle of 120CELEBREX 200 mg capsules are white, with reverse printed white on gold band with markings of 7767 on the cap and 200 on the body, supplied as:NDC NumberSize21695-023-14 bottle of 1421695-023-15 bottle of 1521695-022-30 bottle of 3021695-022-60 bottle of 60CELEBREX 100 mg capsules are white, with reverse printed white on blue band of body and cap with markings of 7767 on the cap and 100 on the body, supplied as:NDC NumberSize21695-022-15 bottle of 1521695-022-30 bottle of 3021695-022-60 bottle of 6021695-022-00 bottle of 10021695-022-72 bottle of 120CELEBREX 200 mg capsules are white, with reverse printed white on gold band with markings of 7767 on the cap and 200 on the body, supplied as:NDC NumberSize21695-023-14 bottle of 1421695-023-15 bottle of 1521695-022-30 bottle of 3021695-022-60 bottle of 60CELEBREX 100 mg capsules are white, with reverse printed white on blue band of body and cap with markings of 7767 on the cap and 100 on the body, supplied as:NDC NumberSize21695-022-15 bottle of 1521695-022-30 bottle of 3021695-022-60 bottle of 6021695-022-00 bottle of 10021695-022-72 bottle of 120CELEBREX 200 mg capsules are white, with reverse printed white on gold band with markings of 7767 on the cap and 200 on the body, supplied as:NDC NumberSize21695-023-14 bottle of 1421695-023-15 bottle of 1521695-022-30 bottle of 3021695-022-60 bottle of 60CELEBREX 100 mg capsules are white, with reverse printed white on blue band of body and cap with markings of 7767 on the cap and 100 on the body, supplied as:NDC NumberSize21695-022-15 bottle of 1521695-022-30 bottle of 3021695-022-60 bottle of 6021695-022-00 bottle of 10021695-022-72 bottle of 120CELEBREX 200 mg capsules are white, with reverse printed white on gold band with markings of 7767 on the cap and 200 on the body, supplied as:NDC NumberSize21695-023-14 bottle of 1421695-023-15 bottle of 1521695-022-30 bottle of 3021695-022-60 bottle of 60CELEBREX 100 mg capsules are white, with reverse printed white on blue band of body and cap with markings of 7767 on the cap and 100 on the body, supplied as:NDC NumberSize21695-022-15 bottle of 1521695-022-30 bottle of 3021695-022-60 bottle of 6021695-022-00 bottle of 10021695-022-72 bottle of 120CELEBREX 200 mg capsules are white, with reverse printed white on gold band with markings of 7767 on the cap and 200 on the body, supplied as:NDC NumberSize21695-023-14 bottle of 1421695-023-15 bottle of 1521695-022-30 bottle of 3021695-022-60 bottle of 60CELEBREX 100 mg capsules are white, with reverse printed white on blue band of body and cap with markings of 7767 on the cap and 100 on the body, supplied as:NDC NumberSize21695-022-15 bottle of 1521695-022-30 bottle of 3021695-022-60 bottle of 6021695-022-00 bottle of 10021695-022-72 bottle of 120CELEBREX 200 mg capsules are white, with reverse printed white on gold band with markings of 7767 on the cap and 200 on the body, supplied as:NDC NumberSize21695-023-14 bottle of 1421695-023-15 bottle of 1521695-022-30 bottle of 3021695-022-60 bottle of 60CELEBREX 100 mg capsules are white, with reverse printed white on blue band of body and cap with markings of 7767 on the cap and 100 on the body, supplied as:NDC NumberSize21695-022-15 bottle of 1521695-022-30 bottle of 3021695-022-60 bottle of 6021695-022-00 bottle of 10021695-022-72 bottle of 120CELEBREX 200 mg capsules are white, with reverse printed white on gold band with markings of 7767 on the cap and 200 on the body, supplied as:NDC NumberSize21695-023-14 bottle of 1421695-023-15 bottle of 1521695-022-30 bottle of 3021695-022-60 bottle of 60CELEBREX 100 mg capsules are white, with reverse printed white on blue band of body and cap with markings of 7767 on the cap and 100 on the body, supplied as:NDC NumberSize21695-022-15 bottle of 1521695-022-30 bottle of 3021695-022-60 bottle of 6021695-022-00 bottle of 10021695-022-72 bottle of 120CELEBREX 200 mg capsules are white, with reverse printed white on gold band with markings of 7767 on the cap and 200 on the body, supplied as:NDC NumberSize21695-023-14 bottle of 1421695-023-15 bottle of 1521695-022-30 bottle of 3021695-022-60 bottle of 60CELEBREX 100 mg capsules are white, with reverse printed white on blue band of body and cap with markings of 7767 on the cap and 100 on the body, supplied as:NDC NumberSize21695-022-15 bottle of 1521695-022-30 bottle of 3021695-022-60 bottle of 6021695-022-00 bottle of 10021695-022-72 bottle of 120CELEBREX 200 mg capsules are white, with reverse printed white on gold band with markings of 7767 on the cap and 200 on the body, supplied as:NDC NumberSize21695-023-14 bottle of 1421695-023-15 bottle of 1521695-022-30 bottle of 3021695-022-60 bottle of 60
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
CELEBREX is a nonsteroidal anti-inflammatory drug that exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models. The mechanism of action of CELEBREX is believed to be due to inhibition of prostaglandin synthesis, primarily via inhibition of cyclooxygenase-2 (COX-2), and at therapeutic concentrations in humans, CELEBREX does not inhibit the cyclooxygenase-1 (COX-1) isoenzyme. In animal colon tumor models, CELEBREX reduced the incidence and multiplicity of tumors.
Non-Clinical Toxicology
CELEBREX is contraindicated:Drug Interactions
CNS-Active Drugs
Imipramine: Coadministration of single doses of zaleplon 20 mg and imipramine 75 mg produced additive effects on decreased alertness and impaired psychomotor performance for 2 to 4 hours after administration. The interaction was pharmacodynamic with no alteration of the pharmacokinetics of either drug.
Paroxetine: Coadministration of a single dose of zaleplon 20 mg and paroxetine 20 mg daily for 7 days did not produce any interaction on psychomotor performance. Additionally, paroxetine did not alter the pharmacokinetics of zaleplon, reflecting the absence of a role of CYP2D6 in zaleplon's metabolism.
Thioridazine: Coadministration of single doses of zaleplon 20 mg and thioridazine 50 mg produced additive effects on decreased alertness and impaired psychomotor performance for 2 to 4 hours after administration. The interaction was pharmacodynamic with no alteration of the pharmacokinetics of either drug.
Venlafaxine: Coadministration of a single dose of zaleplon 10 mg and multiple doses of venlafaxine ER (extended release) 150 mg did not result in any significant changes in the pharmacokinetics of either zaleplon of venlafaxine. In addition, there was no pharmacodynamic interaction as a result of coadministration of zaleplon and venlafaxine ER.
Promethazine: Coadministration of a single dose of zaleplon and promethazine (10 and 25 mg, respectively) resulted in a 15% decrease in maximal plasma concentrations of zaleplon, but no change in the area under the plasma concentration-time curve. however, the pharmacodynamics of coadministration of zaleplon and promethazine have not been evaluated. Caution should be exercised when these 2 agents are coadministered.
Drugs That Induce CYP3A4Rifampin: CYP3A4 is ordinarily a minor metabolizing enzyme of zaleplon. Multiple-dose administration of the potent CYP3A4 inducer rifampin (600 mg every 24 hours, q24h, for 14 days), however, reduced zaleplon C and AUC by approximately 80%. The coadministration of a potent CYP3A4 enzyme inducer, although not posing a safety concern, thus could lead to ineffectiveness of zaleplon. An alternative non-CYP3A4 substrate hypnotic agent may be considered in patients taking CYP3A4 inducers such as rifampin, phenytoin, carbamazepine, and phenobarbital.
Drugs That Inhibit CYP3A4CYP3A4 is a minor metabolic pathway for the elimination of zaleplon because the sum of desethylzaleplon (formed via CYP3A4 in vitro) and its metabolites, 5-oxo-desethylzaleplon and 5-oxo-desethylzaleplon glucuronide, account for only 9% of the urinary recovery of a zaleplon dose. Coadministration of single, oral doses of zaleplon with erythromycin (10 mg and 800 mg respectively), a strong, selective CYP3A4 inhibitor, produced a 34% increase in zaleplon's maximal plasma concentrations and a 20% increase in the area under the plasma concentration-time curve. The magnitude of interaction with multiple doses of erythromycin is unknown. Other strong selective CYP3A4 inhibitors such as ketoconazole can also be expected to increase the exposure of zaleplon. A routine dosage adjustment of zaleplon is not considered necessary.
Drugs That Inhibit Aldehyde Oxidase
The aldehyde oxidase enzyme system is less well studied than the cytochrome P450 enzyme system. Diphenhydramine: Diphenhydramine is reported to be a weak inhibitor of aldehyde oxidase in rat liver, but its inhibitory effects in human liver are not known. There is no pharmacokinetic interaction between zaleplon and diphenhydramine following the administration of a single dose (10 mg and 50 mg, respectively) of each drug. However, because both of these compounds have CNS effects, an additive pharmacodynamic effect is possible.
Drugs That Inhibit Both Aldehyde Oxidase and CYP3A4
Cimetidine: Cimetidine inhibits both aldehyde oxidase (in vitro) and CYP3A4 (in vitro and in vivo), the primary and secondary enzymes, respectively, responsible for zaleplon metabolism. Concomitant administration of zaleplon (10 mg) and cimetidine (800 mg) produced an 85% increase in the mean Cmax and AUC of zaleplon. An initial dose of 5 mg should be given to patients who are concomitantly being treated with cimetidine (see ).
Drugs Highly Bound to Plasma Protein
Zaleplon is not highly bound to plasma proteins (fraction bound 60%±15%); therefore, the disposition of zaleplon is not expected to be sensitive to alterations in protein binding. In addition, administration of zaleplon to a patient taking another drug that is highly protein bound should not cause transient increase in free concentrations of the other drug.
Drugs with a Narrow Therapeutic Index Digoxin: zaleplon (10 mg) did not affect the pharmacokinetic or pharmacodynamic profile of digoxin (0.375 mg q24h for 8 days).Warfarin: Multiple oral doses of zaleplon (20 mg q24h for 13 days) did not affect the pharmacokinetics of warfarin (R+)- or (S-)-enantiomers or the pharmacodynamics (prothrombin time) following a single 25-mg oral dose of warfarin.
Drugs That Alter Renal ExcretionIbuprofen: Ibuprofen is known to affect renal function and, consequently, alter the renal excretion of other drugs. There was no apparent pharmacokinetic interaction between zaleplon and ibuprofen following single dose administration (10 mg and 600 mg, respectively) of each drug. This was expected because zaleplon is primarily metabolized and renal excretion of unchanged zaleplon accounts for less than 1% of the administered dose.
Chronic use of CELEBREX may cause an increased risk of serious adverse cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. In the APC (Adenoma Prevention with Celecoxib) trial, the hazard ratio for the composite endpoint of cardiovascular death, MI, or stroke was 3.4 (95% CI 1.4 – 8.5) for CELEBREX 400 mg twice daily and 2.8 (95% CI 1.1 – 7.2) with CELEBREX 200 mg twice daily compared to placebo. 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 celecoxib dose groups versus placebo-treated patients were mainly due to an increased incidence of myocardial infarction [].
All NSAIDs, both COX-2 selective and non-selective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with CELEBREX, the lowest effective dose should be used for the shortest duration consistent with individual patient treatment goals. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or symptoms of serious CV toxicity and the steps to take if they occur.
There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and CELEBREX does increase the risk of serious GI events [].
Two large, controlled, clinical trials of a different COX-2 selective NSAID for the treatment of pain in the first 10–14 days following CABG surgery found an increased incidence of myocardial infarction and stroke [].
Of the CELEBREX-treated patients in the pre-marketing controlled clinical trials, approximately 4,250 were patients with OA, approximately 2,100 were patients with RA, and approximately 1,050 were patients with post-surgical pain. More than 8,500 patients received a total daily dose of CELEBREX of 200 mg (100 mg twice daily or 200 mg once daily) or more, including more than 400 treated at 800 mg (400 mg twice daily). Approximately 3,900 patients received CELEBREX at these doses for 6 months or more; approximately 2,300 of these have received it for 1 year or more and 124 of these have received it for 2 years or more.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
Review
Professional
Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
Tips
Interactions
Interactions
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