NTP-Indomethacin: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Your health care provider has prescribed NTP-INDOMETHACIN, for you for one or more of the following medical conditions:

• treat the symptoms of certain types of arthritis,

  including gout.

• helps to relieve joint pain, swelling, stiffness and

  fever by reducing the production of certain substances (prostaglandins)

• help to control inflammation and other body

  reactions.

What it does:

NTP-INDOMETHACIN (indomethacin), as a nonsteroidal anti-inflammatory drug (NSAID), can reduce the chemicals produced by your body which cause pain and swelling.

NTP-INDOMETHACIN, as a nonsteroidal anti-inflammatory drug (NSAID), does NOT cure your illness or prevent it from getting worse. NTP-INDOMETHACIN can only relieve pain and reduce swelling as long as you continue to take it.

When it should not be used:

DO NOT TAKE NTP-INDOMETHACIN if you have any of the following medical conditions:

• Heart bypass surgery (planning to have or recently had)
• Severe, uncontrolled heart failure
• Bleeding in the brain or other bleeding disorders

• Current pregnancy (after 28 weeks of pregnancy)

• Currently breastfeeding (or planning to breastfeed)

• Allergy to ASA (Acetylsalicylic Acid) or other

  NSAIDs (Nonsteroidal Anti- Inflammatory Drugs)

  • Ulcer (active)
  • Bleeding from the stomach or gut (active)
  • Inflammatory bowel disease (Crohn’s Disease or Ulcerative Colitis)
  • Liver disease (active or severe)
  • Kidney disease (severe or worsening)
  • High potassium in the blood

Patients who took a drug in the same class as NTP-INDOMETHACIN after a type of heart surgery (coronary artery bypass grafting (CABG)) were more likely to have heart attacks, strokes, blood clots in the leg(s) or lung(s), and infections or other complications than those who did NOT take that drug.

NTP-INDOMETHACIN should NOT be used in children since the safety and effectiveness have NOT been established.

What the medicinal ingredient is:

Indomethacin.

What the nonmedicinal ingredients are:

Non-medicinal ingredients: Lactose monohydrate, magnesium stearate, sodium lauryl, sulfate, talc and empty gelatin capsules containing: D&C Red #28, FD&C Blue #1, gelatin and titanium dioxide.

What dosage forms it comes in:

NTP-INDOMETHACIN (indomethacin) is available as follows:

Capsules: 25 mg or 50 mg.

WARNINGS AND PRECAUTIONS

If you have, or previously had, any of the following medical conditions, see your health care provider to discuss treatment options other than NTP-INDOMETHACIN:

• Heart Attack or Angina
• Stroke or Mini-stroke
• Loss of Vision
• Current Pregnancy (less than 28 weeks)
• Congestive Heart Failure

Before taking this medication, tell your health care provider if you have any of the following:

• High blood pressure
• High cholesterol
• Diabetes mellitus or on a low sugar diet
• Atherosclerosis
• Poor circulation to your extremities
• Smoker or ex-smoker
• Kidney disease or urine problems
• Previous ulcer or bleeding from the stomach or gut
• Previous bleeding in the brain
• Bleeding problems

• Family history of allergy to NSAIDs, such as

  acetylsalicylic acid (ASA), celecoxib, diclofenac, diflunisal, etodolac, fenoprofen, flurbiprofen, ibuprofen, indomethacin, ketoprofen, ketorolac, mefenamic acid, meloxicam, nabumetone, naproxen, oxaprozin, piroxicam, rofecoxib, sulindac, tenoxicam, tiaprofenic acid, tolmetin, or valdecoxib (NOT a complete list)

• Family history of asthma, nasal polyps, long-term

  swelling of the sinus (chronic sinusitis) or hives

• Family history of allergy to sulfonamide drugs

• A previous allergic reaction could increase the risk of

  an allergic reaction to NTP-INDOMETHACIN.

• if you ever had an ulcer with or without bleeding, of the stomach, duodenum, or any part of the digestive tract, liver or kidney diseases or any other medical problems.

Also, before taking this medication, tell your health care provider if you are planning to get pregnant.

Note also that NTP-INDOMETHACIN is not recommended for use during pregnancy and that one should not breast-feed while on NTP-INDOMETHACIN.

While taking this medication:

• tell any other doctor, dentist, pharmacist or other

  health care professional that you see, that you are taking this medication, especially if you are planning to have heart surgery;

• do NOT drink alcoholic beverages while taking this

  medication because you would be more likely to develop stomach problems;

• fertility may be decreased. The use of NTP-

  INDOMETHACIN is not recommended in women trying to get pregnant. In women who have difficulty conceiving, stopping NTP-INDOMETHACIN should be considered.

• be cautious about driving or participating in activities

  that require alertness if you are drowsy, dizzy or lightheaded after taking this medication;

• check with your physician if you are not getting any

  relief or if any problems develop;

• report any untoward reactions to your physician. This

  is very important as it will aid in the early detection and prevention of potential complications.

  • your regular medical checkups are essential;
  • if you require more information on this drug, consult your physician or pharmacist.
  • keep this medication, and all others, out of the reach of children

INTERACTIONS WITH THIS MEDICATION

Talk to your health care provider and pharmacist if you are taking any other medication (prescription or non-prescription) such as any of the following (NOT a complete list):

• Acetylsalicylic Acid (ASA) or other NSAIDs e.g. ASA, celecoxib, diclofenac, ibuprofen, indomethacin, ketorolac, meloxicam, naproxen
• Antacids

• Antidepressants

  • Selective Serotonin Reuptake Inhibitors (SSRIs)

    e.g. citalopram, fluoxetine, paroxetine, sertraline

• Blood pressure medications

  • ACE (angiotensin converting enzyme) inhibitors e.g. enalapril, lisinopril, perindopril, ramipril

  • ARBs (angiotensin II receptor blockers)

    e.g. candesartan, irbesartan, losartan, valsartan

• Blood thinners e.g. warfarin, ASA, clopidogrel

• Corticosteroids (including glucocorticoids)

  e.g. prednisone

• Cyclosporin
• Digoxin
• Diuretics e.g. furosemide, hydrochlorothiazide
• Lithium
• Methotrexate
• Oral contraceptives
• Oral hypoglycemics (diabetes medications)
• Tacrolimus

Do not take ASA (acetylsalicylic acid), ASA compounds or other drugs used to relieve symptoms of arthritis while taking NTP-INDOMETHACIN unless directed to do so by your physician.

If you are prescribed this medication for use over a long period of time, your physician will check your health during regular visits to assess your progress and to ensure that this medication is not causing unwanted effects.

Along with its beneficial effects, NTP-INDOMETHACIN like other NSA1D drugs, may cause some undesirable reactions. Elderly, frail or debilitated patients often seem to experience more frequent or more severe side effects. Although not all of these side effects are common, when they do occur they may require medical attention. Check with physician immediately if any of the following are noted:

• bloody or black tarry stools.

• shortness of breath, wheezing, any trouble in breathing or

  tightness in the chest;

• skin rash, swelling, hives or itching;
• indigestion, nausea, vomiting, stomach pain or diarrhea;

• yellow discolouration of the skin or eyes, with or without

  fatigue;

• any changes in the amount or colour of your urine (such

  as dark, red or brown);

• swelling of the feet or lower legs;
• blurred vision or any visual disturbance;

• mental confusion, depression, dizziness, lightheadedness,

  hearing problems.

Your health care provider may prescribe low dose ASA (acetylsalicylic acid) as a blood thinner to reduce your risk of having a heart attack or stroke while you are taking NTP-INDOMETHACIN. Take only the amount of ASA prescribed by your health care provider. You are more likely to upset or damage your stomach if you take both NTP-

INDOMETHACIN and ASA than if you took NTP-INDOMETHACIN alone.

PROPER USE OF THIS MEDICATION

Usual Dose:

In chronic disorders, treatment should be started with a dosage of 25 mg two or three times a day. By starting therapy with low dosage, increased gradually when necessary, maximum benefit will be produced with fewer adverse reactions. Always give NTP-INDOMETHACIN with food immediately after meals or with antacids to reduce gastric irritation.

As with all drugs, the lowest possible effective dose should be utilized for each individual patient.

HOW TO USE THIS MEDICINE

To lessen stomach upset, take this medicine immediately after a meal or with food or milk. If stomach upset (indigestion, nausea, vomiting, stomach pain or diarrhea) occurs and continues, contact your physician.

PLEASE ADHERE TO THE DOSAGE AND ADMINISTRATION INSTRUCTIONS WHICH YOUR PHYSTCIAN HAS GIVEN YOU

• Do not take more of it, do not take it more often, and

  do not take it for a longer period of time than your physician prescribed

If you are taking NTP-INDOMETHACIN to relieve arthritis, you must take it regularly as prescribed by your physician. In some types of arthritis, up to 2 weeks may

pass before you begin to feel better and up to 1 month may pass before you feel the full effects of this medicine.

Take NTP-INDOMETHACIN only as directed by your health care provider. Do NOT take more of it, do NOT take it more often and do NOT take it for a longer period of time than your health care provider recommended. If possible, you should take the lowest dose of this medication for the shortest time period.

Taking too much NTP-INDOMETHACIN may increase your chances of unwanted and sometimes dangerous side effects, especially if you are elderly, have other diseases or take other medications.

If you will be using NTP-INDOMETHACIN for more than 7 days, see your health care provider regularly to discuss whether this medicine is working for you and if it is causing you any unwanted effects.

This medication has been prescribed specifically for you. Do NOT give it to anyone else. It may harm them, even if their symptoms seem to be similar to yours. ^{Ref. 50, page 28}

NTP-INDOMETHACIN is NOT recommended for use in children since safety and effectiveness have NOT been established.

NTP-INDOMETHACIN must be taken with food.

Missed Dose:

If you miss a dose of NTP-INDOMETHACIN and remember within an hour or so, take it right away. Then go back to your regular dosing schedule.

But if you do not remember until later, do not take the missed dose at all and do not double the next one. Instead, go back to your regular dosing schedule.

Overdose:

If you take more than the prescribed dose, contact your health care provider immediately.

In case of accidental overdose, consult a physician immediately or contact your regional Poison Control Centre.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

NTP-INDOMETHACIN may cause some side effects, especially when used for a long time or in large doses. When these side effects occur, you may require medical attention. Report all symptoms or side effects to your health care provider.

NTP-INDOMETHACIN may cause you to become drowsy or tired. Be careful about driving or participating in activities that require you to be alert. If you become drowsy, dizzy or light-headed after taking NTP-INDOMETHACIN , do NOT drive or operate machinery.

NTP-INDOMETHACIN may cause you to become more sensitive to sunlight. Any exposure to sunlight or sunlamps may cause sunburn, skin blisters, skin rash, redness, itching or discolouration, or vision changes. If you have a reaction from the sun, check with your health care provider.

Check with your health care provider IMMEDIATELY if you develop chills, fever, muscle aches or pains, or other flu-like symptoms, especially if they occur before or together with a skin rash. These symptoms may be the first signs of a SERIOUS ALLERGIC REACTION to this medication.

This is NOT a complete list of side effects. If you develop any other symptoms while taking NTP-INDOMETHACIN, see your health care provider.

HOW TO STORE IT

No specific storage condition is recommended.

Do NOT keep outdated medicine or medicine no longer needed. Any outdated or unused medicine should be returned to your pharmacist.

Keep out of reach of children.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

------------------------------------------------------------ $ Report online at www.healthcanada.gc.ca/medeffect $ Call toll-free at 1-866-234-2345

$ Complete a Canada Vigilance Reporting Form and:

• Fax toll-free to 1-866-678-6789, or

• Mail to: Canada Vigilance Program Health Canada

  Postal Locator 0701C

  Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at

www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting Teva Canada Limited.

at: 1-800-268-4127 ext. 5005

or druginfo@tevecanada.com

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

Last revised: October 7, 2013