CELEBREX (Page 8 of 8)

16. HOW SUPPLIED/STORAGE AND HANDLING

CELEBREX 50 mg capsules are white, with reverse printed white on red band of body and cap with markings of 7767 on the cap and 50 on the body, supplied as:

NDC Number Size

0025-1515-01 bottle of 60

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 Number Size

0025-1520-31 bottle of 100

0025-1520-51 bottle of 500

0025-1520-34 carton of 100 unit dose

CELEBREX 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 Number Size

0025-1525-31 bottle of 100

0025-1525-51 bottle of 500

0025-1525-34 carton of 100 unit dose

CELEBREX 400 mg capsules are white, with reverse printed white on green band with markings of 7767 on the cap and 400 on the body, supplied as:

NDC Number Size

0025-1530-02 bottle of 60

0025-1530-01 carton of 100 unit dose

Storage: Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]

17. PATIENT COUNSELING INFORMATION

Patients should be informed of the following information before initiating therapy with CELEBREX and periodically during the course of ongoing therapy.

17.1 Medication Guide

Patients should be informed of the availability of a Medication Guide for NSAIDs that accompanies each prescription dispensed, and should be instructed to read the Medication Guide prior to using CELEBREX.

17.2 Cardiovascular Effects

Patients should be informed that CELEBREX may cause serious CV side effects such as MI or stroke, which may result in hospitalization and even death. Patients should be informed of the the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and to seek immediate medical advice if they observe any of these signs or symptoms. [see Warnings and Precautions (5.1) ].

Patients should be informed that CELEBREX can lead to the onset of new hypertension or worsening of preexisting hypertension, and that CELEBREX may impair the response of some antihypertensive agents. Patients should be instructed on the proper follow up for monitoring of blood pressure. [see Warnings and Precautions (5.2) and Drug Interactions (7.4)].

17.3 Gastrointestinal Effects

Patients should be informed that CELEBREX can cause gastrointestinal discomfort and more serious side effects, such as ulcers and bleeding, which may result in hospitalization and even death. Patients should be informed of the signs and symptoms of ulcerations and bleeding, and to seek immediate medical advice if they observe any signs or symptoms that are indicative of these disorders, including epigastric pain, dyspepsia, melena, and hematemesis. [see Warnings and Precautions (5.4) ].

17.4 Hepatic Effects

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). Patients should be instructed that they should stop therapy and seek immediate medical therapy if these signs and symptoms occur [see Warnings and Precautions (5.5), Use in Specific Populations (8.6)].

17.5 Adverse Skin Reactions

Patients should be informed that CELEBREX is a sulfonamide and can cause serious skin side effects such as exfoliative dermatitis, SJS, and TEN, which may result in hospitalizations and even death. Although serious skin reactions may occur without warning, patients should be informed of the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching, and seek immediate medical advice when observing any indicative signs or symptoms.

Patients should be advised to stop CELEBREX immediately if they develop any type of rash and contact their physician as soon as possible.

Patients with prior history of sulfa allergy should not take CELEBREX [see Warnings and Precautions (5.8) ].

17.6 Weight Gain and Edema

Long-term administration of NSAIDs including CELEBREX has resulted in renal injury. Patients at greatest risk are those taking diuretics, ACE-inhibitors, angiotensin II antagonists, or with renal or liver dysfunction, heart failure, and the elderly [see Warnings and Precautions (5.3, 5.6), Use in Specific Populations (8)].

Patients should be instructed to promptly report to their physicians signs or symptoms of unexplained weight gain or edema following treatment with CELEBREX [see Warnings and Precautions (5.3) ].

17.7 Anaphylactoid Reactions

Patients should be informed of the signs and symptoms of an anaphylactoid reaction (e.g., difficulty breathing, swelling of the face or throat). Patients should be instructed to seek immediate emergency assistance if they develop any of these signs and symptoms [see Warnings and Precautions (5.7) ].

17.8 Effects During Pregnancy

Patients should be informed that in late pregnancy CELEBREX should be avoided because it may cause premature closure of the ductus arteriosus [see Warnings and Precautions (5.9), Use in Specific Populations (8.1)].

17.9 Preexisting Asthma

Patients should be instructed to tell their physicians if they have a history of asthma or aspirin-sensitive asthma because the use of NSAIDs in patients with aspirin-sensitive asthma has been associated with severe bronchospasm, which can be fatal. Patients with this form of aspirin sensitivity should be instructed not to take Celebrex. Patients with preexisting asthma should be instructed to seek immediate medical attention if their asthma worsens after taking Celebrex [see Warnings and Precautions (5.13) ].

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LAB-0036-14.0January 2011

Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

(See the end of this Medication Guide for a list of prescription NSAID medicines.)

What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.

This chance increases:

  • with longer use of NSAID medicines
    • in people who have heart disease

NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”

NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:

  • can happen without warning symptoms
  • may cause death

The chance of a person getting an ulcer or bleeding increases with:

  • taking medicines called “corticosteroids” and “anticoagulants”
  • longer use
  • smoking
  • drinking alcohol
  • older age
  • having poor health

NSAID medicines should only be used:

  • exactly as prescribed
  • at the lowest dose possible for your treatment
  • for the shortest time needed

What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:

  • different types of arthritis
  • menstrual cramps and other types of short-term pain

Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?

Do not take an NSAID medicine:

  • if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
  • for pain right before or after heart bypass surgery

Tell your healthcare provider:

  • about all of your medical conditions.
  • about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist.
  • if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy.
  • if you are breastfeeding. Talk to your doctor.

What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

Serious side effects include: Other side effects include:
  • heart attack
  • stroke
  • high blood pressure
  • heart failure from body swelling (fluid retention)
  • kidney problems including kidney failure
  • bleeding and ulcers in the stomach and intestine
  • low red blood cells (anemia)
  • life-threatening skin reactions
  • life-threatening allergic reactions
  • liver problems including liver failure
  • asthma attacks in people who have asthma
  • stomach pain
  • constipation
  • diarrhea
  • gas
  • heartburn
  • nausea
  • vomiting
  • dizziness

Get emergency help right away if you have any of the following symptoms:

  • shortness of breath or trouble breathing
  • chest pain
  • weakness in one part or side of your body
  • slurred speech
  • swelling of the face or throat

Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:

  • nausea
  • more tired or weaker than usual
  • itching
  • your skin or eyes look yellow
  • stomach pain
  • flu-like symptoms
  • vomit blood
  • there is blood in your bowel movement or it is black and sticky like tar
  • skin rash or blisters with fever
  • unusual weight gain
  • swelling of the arms and legs, hands and feet

These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

  • Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
  • Some of these NSAID medicines are sold in lower doses without a prescription (over –the –counter). Talk to your healthcare provider before using over –the –counter NSAIDs for more than 10 days.
NSAID medicines that need a prescription
Generic NameTradename
*
Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.
CelecoxibCelebrex
DiclofenacCataflam, Voltaren, Arthrotec (combined with misoprostol)
DiflunisalDolobid
EtodolacLodine, Lodine XL
FenoprofenNalfon, Nalfon 200
FlurbiprofenAnsaid
IbuprofenMotrin, Tab-Profen, Vicoprofen * (combined with hydrocodone), Combunox (combined with oxycodone)
IndomethacinIndocin, Indocin SR, Indo-Lemmon, Indomethagan
KetoprofenOruvail
KetorolacToradol
Mefenamic AcidPonstel
MeloxicamMobic
NabumetoneRelafen
NaproxenNaprosyn, Anaprox, Anaprox DS, EC-Naproxyn, Naprelan, Naprapac (copackaged with lansoprazole)
OxaprozinDaypro
PiroxicamFeldene
SulindacClinoril
TolmetinTolectin, Tolectin DS, Tolectin 600

This Medication Guide has been approved by the U.S. Food and Drug Administration.

image of label

celebrex 100mg label
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CELEBREX celecoxib capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49999-383(NDC:0025-1520)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Celecoxib (Celecoxib) Celecoxib 100 mg
Inactive Ingredients
Ingredient Name Strength
croscarmellose sodium
gelatin
lactose monohydrate
magnesium stearate
povidone
sodium lauryl sulfate
Product Characteristics
Color white Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 7767;100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49999-383-60 60 CAPSULE in 1 BOTTLE None
2 NDC:49999-383-30 30 CAPSULE in 1 BOTTLE None
3 NDC:49999-383-10 10 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020998 11/22/2011
Labeler — Lake Erie Medical DBA Quality Care Products LLC (831276758)
Establishment
Name Address ID/FEI Operations
Lake Erie Medical DBA Quality Care Products LLC 831276758 repack (49999-383)

Revised: 03/2017 Lake Erie Medical DBA Quality Care Products LLC

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