Celecoxib Capsule
FDA Label NDC 80425-0039

MEDICATION GUIDE

Medication Guide for Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

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

NSAID can cause serious side effects, including:

Increased risk of a heart attack or stroke that can lead to death . This risk may happen early in treatment and may increase:

with increasing doses of NSAIDs
with longer use of NSAIDs

Do not take NSAIDs right before or after a heart surgery called a "coronary artery bypass graft (CABG)."

Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.

Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines :

anytime during use
without warming symptoms
that may cause death

The risk of getting an ulcer or bleeding increases with:
past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs taking medicines called "corticosteroids", "antiplatelet drugs", "anticoagulants", "SSRIs" or "SNRIs"
increasing doses of NSAIDs
longer use of NSAIDs
smoking
drinking alcohol
older age
poor health
advanced liver disease
bleeding problems

NSAIDs should only be used :
exactly as prescribed
at the lowest dose possible for your treatment
for the shortest time needed

What are NSAIDs?

NSAID 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 NSAIDs?

Do not take NSAIDs:

if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs.
right before or after heart bypass surgery.

Before taking NSAIDs, tell your healthcare provider about all of your medical conditions, including if you:

have liver or kidney problems
have high blood pressure
have asthma
are pregnant or plan to become pregnant Talk to your healthcare provider if you are considering taking NSAIDs during pregnancy. You should not take NSAIDs after 29 weeks of pregnancy
are breastfeeding or plan to breast feed

Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.

What are the possible side effects of NSAIDs?

NSAIDs can cause serious side effects, including:

See "What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?

new or worse high blood pressure
heart failure
liver problems including liver failure
kidney problems including kidney failure
low red blood cells (anemia)
life-threatening skin reactions
life-threatening allergic reactions
Other side effects of NSAIDs include : stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

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

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

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

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

If you take too much of your NSAID, call your healthcare provider or get medical help right away.

These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs.

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

Other information about NSAIDs

Aspirin is an NSAID 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 NSAIDs 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.

General information about the safe and effective use of NSAIDs

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NSAIDs for a condition for which it was not prescribed. Do not give NSAIDs to other people, even if they have the same symptoms that you have. It may harm them.

If you would like more information about NSAIDs, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for health professionals.

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

Medication Guides available at www. northstarrxllc.com/products or call 1-800-206-7821.

Manufactured for:

Northstar Rx LLC, Memphis, TN 38141.

Manufactured by:

Cipla Ltd., Kurkumbh, India

Revised: 6/2019

2 DOSAGE AND ADMINISTRATION

2.1 General Dosing Instructions

Carefully consider the potential benefits and risks of celecoxib capsules and other treatment options before deciding to use celecoxib capsules. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].

These doses can be given without regard to timing of meals.

2.2 Osteoarthritis

For OA, the dosage is 200 mg per day administered as a single dose or as 100 mg twice daily.

2.3 Rheumatoid Arthritis

For RA, the dosage is 100 mg to 200 mg twice daily.

2.4 Juvenile Rheumatoid Arthritis

For JRA, the dosage for pediatric patients (age 2 years and older) is based on weight. For patients ≥10 kg to 25 kg the recommended dose is 50 mg twice daily. For patients >25 kg the recommended dose is 100 mg twice daily.

For patients who have difficulty swallowing capsules, the contents of a celecoxib capsule can be added to applesauce. The entire capsule contents are carefully emptied onto a level teaspoon of cool or room temperature applesauce and ingested immediately with water. The sprinkled capsule contents on applesauce are stable for up to 6 hours under refrigerated conditions (2°C to 8°C/35°F to 45°F).

2.5 Ankylosing Spondylitis

For AS, the dosage of celecoxib capsules is 200 mg daily in single (once per day) or divided (twice per day) doses. If no effect is observed after 6 weeks, a trial of 400 mg daily may be worthwhile. If no effect is observed after 6 weeks on 400 mg daily, a response is not likely and consideration should be given to alternate treatment options.

2.6 Management of Acute Pain and Treatment of Primary Dysmenorrhea

For management of Acute Pain and Treatment of Primary Dysmenorrhea, the dosage is 400 mg initially, followed by an additional 200 mg dose if needed on the first day. On subsequent days, the recommended dose is 200 mg twice daily as needed.

2.7 Special Populations

Hepatic Impairment

In patients with moderate hepatic impairment (Child-Pugh Class B), reduce the dose by 50%. The use of celecoxib capsules in patients with severe hepatic impairment is not recommended [see Warnings and Precautions (5.3), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].

Poor Metabolizers of CYP2C9 Substrates

In adult patients who are known or suspected to be poor CYP2C9 metabolizers based on genotype or previous history/experience with other CYP2C9 substrates (such as warfarin, phenytoin), initiate treatment with half of the lowest recommended dose.

In patients with JRA who are known or suspected to be poor CYP2C9 metabolizers, consider using alternative treatments [see Use in Specific populations (8.8) and Clinical Pharmacology (12.5)].

1 INDICATIONS AND USAGE

Celecoxib capsules are indicated

1.1 Osteoarthritis

For the management of the signs and symptoms of OA [see Clinical Studies (14.1)]

1.2 Rheumatoid Arthritis

For the management of the signs and symptoms of RA [see Clinical Studies (14.2)]

1.3 Juvenile Rheumatoid Arthritis

For the management of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3)]

1.4 Ankylosing Spondylitis

For the management of the signs and symptoms of AS [see Clinical Studies (14.4)]

1.5 Acute Pain (AP)

For the management of acute pain in adults [see Clinical Studies (14.5)]

1.6 Primary Dysmenorrhea

For the management of primary dysmenorrhea [see Clinical Studies (14.5)]