U.S. Brand Names

Indocin®; Indocin® I.V.

Canadian Brand Names

Apo-Indomethacin®; Indocid® P.D.A.; Novo-Methacin; Nu-Indo; Pro-Indo; ratio-Indomethacin; Sandoz-Indomethacin

Mexican Brand Names

Antalgin; Indaflex; Indanet; Indocid; Malival; Stratasin

Dosage Forms

• This medicine is available as a capsule, an injection, a liquid, and a rectal suppository.

Pharmacologic Category

Nonsteroidal Anti-inflammatory Drug (NSAID), Oral; Nonsteroidal Anti-inflammatory Drug (NSAID), Parenteral

What key warnings should I know about before giving this medicine to my child?

• This medicine may increase the risk of ulcer or bleeding from the stomach or intestines. Talk with your child's healthcare provider.

• This medicine does not mix well with some medicines. Serious reactions may occur. Check all medicines with child's healthcare provider.

• Please read the medication guide.

Is it safe for my child to take this medicine?

• Not if your child has an allergy to indomethacin or any other part of this medicine.

• Be sure to let healthcare provider know if your child has any allergies or reactions to medicine, food preservatives, or dyes. Make sure to tell about the allergy and how it affected your child. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other symptoms involved.

• Injection: Not if your child has any of the following conditions: Bleeding problems, infection, intestinal problems, low platelet count, severe kidney disease.

Why does my child need this medicine?

• This medicine is used to relieve pain, inflammation, and fever.

• This medicine is used to treat arthritis.

• This medicine is used to treat patent ductus arteriosus (PDA).

How does this medicine work?

• Indomethacin blocks production and release of chemicals that cause pain and inflammation.

• It reduces fever by adjusting the body's thermostat in the brain.

• It tightens the muscle to close the PDA.

How is this medicine given?

• Give this medicine with food to prevent upset stomach.

• A liquid (suspension) is available if your child cannot swallow pills. Shake well before use.

• Children who have feeding tubes can also use the liquid. Flush the feeding tube before and after medicine is given.

• Measure liquid doses carefully. Use measuring device that comes with the medicine. If none is available, get an oral syringe, a medicine dropper, a medicine spoon, or a medicine cup (only for older children) from your pharmacist.

• Use suppository rectally.

Arthritis:

• To gain the most benefit, do not miss giving your child doses.

• Give prescription as directed, even if your child is feeling better.

Injection:

• This medicine is given as a shot into a vein over a period of time.

How long does this medicine take to work?

• Your child may start feeling better soon after starting this medicine.

• Your child may start feeling better several weeks after starting this medicine for arthritis.

What do I do if my child misses a dose? (does not apply to patients in the hospital)

• Give a missed dose as soon as possible.

• If it is almost time for the next dose, skip the missed dose and return to your child's regular schedule.

• Do not give a double dose or extra doses.

• Many times this medicine is given on an as needed basis.

What safety measures should I take while my child is using this medicine?

All forms:

• If your child has kidney disease, talk with healthcare provider.

• Check your child's medicines with healthcare provider. This medicine may not mix well with other medicines.

Oral:

• If your child has asthma, talk with healthcare provider.

• If your child has high blood pressure, talk with healthcare provider.

• If your child has had an ulcer or bleeding from the stomach or intestines, talk with healthcare provider.

• If your child has a weakened heart, talk with healthcare provider.

• Your child may bleed more easily. Encourage him/her to be more careful and avoid injury. Wear a bike helmet, for example, while riding a bike.

• Tell dentists, surgeons, and other healthcare providers that your child is using this medicine.

What are some possible side effects of this medicine?

• Headache.

• Belly pain.

• Nausea or vomiting. Small frequent meals and frequent mouth care may help. Older children may suck hard, sugar-free candy.

• Diarrhea.

• Constipation. More liquids, regular exercise, or a fiber-containing diet may help. Talk with healthcare provider about a stool softener or laxative.

Injection:

• Skin irritation.

• Long pauses between breaths.

• Low blood sugar. Signs include anger, shaking, fast heartbeat, confusion, or sweating. Keep hard candies, glucose tablets, liquid glucose, or juice on hand for low blood sugar.

What should I monitor?

• Change in condition being treated. Is it better, worse, or about the same?

• For the occurrence of side effects.

• Follow up with healthcare provider.

When should I call my child's healthcare provider?

• If any of this information causes you to be concerned, any of the common side effects occur, or if your child's symptoms do not improve after taking this medicine.

• If you suspect an overdose, call your local poison control center or emergency department immediately.

• If your child shows signs of a life-threatening reaction, call healthcare provider or emergency department immediately. These include wheezing; chest tightness; fever; itching; bad cough; blue skin color; fits; swelling of face, lips, tongue, or throat; or if your child exhibits any other unusual behavior.

• If your child has difficulty breathing.

• If your child has severe nausea or vomiting.

• If your child has severe belly pain.

• If your child has swelling of feet or hands.

• If your child has significant weight gain.

• If your child has black, tarry, or bloody stools.

• If your child has low blood sugar.

• If your child has blood in the urine.

• If your child has severe diarrhea.

• If your child has unusual bruising or bleeding.

• If your child develops a rash.

• No improvement in condition or if you believe your child's condition is worse.

How should I store and/or dispose of this medicine?

• Store at room temperature.

• Protect from light.

• Protect capsules from moisture. Do not store in a bathroom or kitchen.

• The injection will be given to your child in a healthcare setting. You will not store it at home.

General statements

• If your child has a life-threatening allergy, he/she should wear allergy identification at all times.

• This medicine is available by prescription only. If there are refills, contact your pharmacy. If no refills remain, you may need to contact your child's healthcare provider.

• This medicine should be thrown out when your child no longer needs it or if the medicine becomes outdated.

• Most medicines can be thrown away in household trash after mixing with coffee grounds or kitty litter and sealing in a plastic bag.

• Do not share your child's medicine with others and do not give anyone else's medicine to your child.

• Keep all medicine out of the reach of children and pets.

• Many medications interact with other medications. Keep a list of all your child's medicines (prescription, natural products, supplements, vitamins, over-the-counter) with you. Give this list to your child's healthcare provider (doctor, nurse, nurse practitioner, pharmacist, physician assistant).

• Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or in Canada to Health Canada's Canada Vigilance Program at 1-866-234-2345.

• Talk with your child's healthcare provider before giving him/her any new medicine, including over-the-counter, natural products, or vitamins.

• Medicine can be dangerous if used incorrectly. Follow directions given by healthcare provider.

Created: 2006-10-16 11:29:41.0

Modified: 2010-09-22 06:39:58.0

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