Indomethacin (Page 8 of 8)

MEDICATION GUIDE


Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs)

What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?
NSAIDs 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:
o with increasing doses of NSAIDs
o 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:
o anytime during use
o without warning symptoms
o that may cause death
The risk of getting an ulcer or bleeding increases with:
o past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs
o taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs”
o increasing doses of NSAIDs
o longer use of NSAIDs
o older age
o longer use of NSAIDs
o poor health
o smoking
o advanced liver disease
o drinking alcohol
o bleeding problems
NSAIDs should only be used:
o exactly as prescribed
o at the lowest dose possible for your treatment
o for the shortest time needed
What are NSAIDs?
NSAIDs 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. Taking NSAIDs at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take NSAIDs for more than 2 days when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby. You should not take NSAIDs after about 30 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

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

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.

Medication Guide available at https://www.xlcarepharma.com/medication-guides

Manufactured for:
XLCare Pharmaceuticals, Inc.
242 South Culver Street, Suite 202,
Lawrenceville, GA 30046.

Manufactured by:
Evaric Pharmaceuticals Inc.
155 Commerce Drive, Hauppauge, New York 11788, United States (USA).

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

Revised: 06/2021

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Indomethacin Capsules USP, 25 mg-100s Count Container Label

25mg100s
(click image for full-size original)

Indomethacin Capsules USP, 50 mg-100s Count Container Label

50mg100s
(click image for full-size original)
INDOMETHACIN indomethacin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72865-148
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INDOMETHACIN (INDOMETHACIN) INDOMETHACIN 25 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
MAGNESIUM STEARATE
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 1
D&C YELLOW NO. 10
FERROSOFERRIC OXIDE
Product Characteristics
Color green (Light green) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code H;103
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72865-148-30 30 CAPSULE in 1 BOTTLE None
2 NDC:72865-148-01 100 CAPSULE in 1 BOTTLE None
3 NDC:72865-148-05 500 CAPSULE in 1 BOTTLE None
4 NDC:72865-148-10 1000 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091240 07/27/2021
INDOMETHACIN indomethacin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72865-149
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INDOMETHACIN (INDOMETHACIN) INDOMETHACIN 50 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
MAGNESIUM STEARATE
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 1
D&C YELLOW NO. 10
FERROSOFERRIC OXIDE
Product Characteristics
Color green (Light green) Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code H;104
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72865-149-30 30 CAPSULE in 1 BOTTLE None
2 NDC:72865-149-01 100 CAPSULE in 1 BOTTLE None
3 NDC:72865-149-05 500 CAPSULE in 1 BOTTLE None
4 NDC:72865-149-10 1000 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091240 07/27/2021
Labeler — XLCare Pharmaceuticals Inc. (080991142)
Establishment
Name Address ID/FEI Operations
Evaric Pharmaceuticals Inc 080470330 analysis (72865-148), analysis (72865-149), manufacture (72865-148), manufacture (72865-149)

Revised: 01/2023 XLCare Pharmaceuticals Inc.

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