Indocin Rectal

Name: Indocin Rectal

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Uses For Indocin

Indomethacin is a nonsteroidal anti-inflammatory drug (NSAID) used to help relieve symptoms of moderate to severe arthritis (eg, osteoarthritis and rheumatoid arthritis) or gout, such as inflammation, swelling, stiffness, and joint pain. However, this medicine does not cure arthritis and will help you only as long as you continue to use it.

Indomethacin is also used to treat moderate to severe ankylosing spondylitis, which is a type of arthritis that affects the joints in the spine. This medicine may also be used to treat painful shoulder caused by bursitis or tendinitis.

This medicine is available only with your doctor's prescription.

Before Using Indocin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of indomethacin rectal suppositories in children up to 14 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of indomethacin rectal suppositories in the elderly. However, elderly patients may be more sensitive to the effects of indomethacin than younger adults, and are more likely to have unwanted effects (eg, stomach ulcers, confusion, psychosis) and age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving indomethacin rectal suppositories.

Pregnancy

	Pregnancy Category	Explanation
1st Trimester	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
2nd Trimester	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
3rd Trimester	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Ketorolac

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abciximab
Aceclofenac
Acemetacin
Acenocoumarol
Amiloride
Amineptine
Amitriptyline
Amitriptylinoxide
Amoxapine
Amtolmetin Guacil
Anagrelide
Apixaban
Ardeparin
Argatroban
Aspirin
Balsalazide
Bemiparin
Bendroflumethiazide
Benzthiazide
Betamethasone
Betrixaban
Bismuth Subsalicylate
Bivalirudin
Bromfenac
Budesonide
Bufexamac
Bumetanide
Cangrelor
Celecoxib
Certoparin
Chlorothiazide
Chlorthalidone
Choline Magnesium Trisalicylate
Choline Salicylate
Cilostazol
Citalopram
Clomipramine
Clonixin
Clopamide
Clopidogrel
Cortisone
Cyclopenthiazide
Cyclosporine
Dabigatran Etexilate
Dalteparin
Danaparoid
Deflazacort
Desipramine
Desirudin
Desmopressin
Desvenlafaxine
Dexamethasone
Dexibuprofen
Dexketoprofen
Diazoxide
Dibenzepin
Diflunisal
Digoxin
Dipyridamole
Dipyrone
Dothiepin
Doxepin
Droxicam
Duloxetine
Edoxaban
Enoxaparin
Eplerenone
Epoprostenol
Eptifibatide
Escitalopram
Ethacrynic Acid
Etodolac
Etofenamate
Etoricoxib
Felbinac
Fenoprofen
Fepradinol
Feprazone
Feverfew
Floctafenine
Flufenamic Acid
Fluocortolone
Fluoxetine
Flurbiprofen
Fluvoxamine
Fondaparinux
Furosemide
Ginkgo
Gossypol
Heparin
Hydrochlorothiazide
Hydrocortisone
Hydroflumethiazide
Ibuprofen
Iloprost
Imipramine
Indapamide
Ketoprofen
Lepirudin
Levomilnacipran
Lithium
Lofepramine
Lornoxicam
Loxoprofen
Lumiracoxib
Magnesium Salicylate
Meadowsweet
Meclofenamate
Mefenamic Acid
Melitracen
Meloxicam
Mesalamine
Methotrexate
Methyclothiazide
Methylprednisolone
Metolazone
Milnacipran
Morniflumate
Nabumetone
Nadroparin
Naproxen
Nefazodone
Nepafenac
Niflumic Acid
Nimesulide
Nimesulide Beta Cyclodextrin
Nortriptyline
Olsalazine
Opipramol
Oxaprozin
Oxyphenbutazone
Paramethasone
Parecoxib
Parnaparin
Paroxetine
Pemetrexed
Pentosan Polysulfate Sodium
Pentoxifylline
Phenindione
Phenprocoumon
Phenylbutazone
Phenyl Salicylate
Piketoprofen
Piroxicam
Polythiazide
Potassium
Pralatrexate
Prasugrel
Prednisolone
Prednisone
Probenecid
Proglumetacin
Propyphenazone
Proquazone
Protein C
Protriptyline
Reboxetine
Reviparin
Rivaroxaban
Rofecoxib
Salicylamide
Salicylic Acid
Salsalate
Sertraline
Sibutramine
Sodium Salicylate
Spironolactone
Sulfasalazine
Sulindac
Tacrolimus
Tenoxicam
Tianeptine
Tiaprofenic Acid
Ticagrelor
Ticlopidine
Tinzaparin
Tirofiban
Tolfenamic Acid
Tolmetin
Torsemide
Treprostinil
Triamterene
Trichlormethiazide
Trimipramine
Trolamine Salicylate
Valdecoxib
Vasopressin
Venlafaxine
Vilazodone
Vorapaxar
Vortioxetine
Warfarin
Xipamide

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol
Alacepril
Atenolol
Azilsartan
Azilsartan Medoxomil
Benazepril
Betaxolol
Bisoprolol
Candesartan
Captopril
Carteolol
Carvedilol
Celiprolol
Cilazapril
Delapril
Enalapril
Enalaprilat
Eprosartan
Esmolol
Fosinopril
Gentamicin
Imidapril
Irbesartan
Labetalol
Levobunolol
Lisinopril
Losartan
Metipranolol
Metoprolol
Moexipril
Nadolol
Nebivolol
Olmesartan
Oxprenolol
Penbutolol
Pentopril
Perindopril
Pindolol
Practolol
Propranolol
Quinapril
Ramipril
Sotalol
Spirapril
Telmisartan
Temocapril
Timolol
Trandolapril
Valsartan
Zofenopril

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Indocin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Acid or sour stomach
belching
diarrhea
heartburn
indigestion
nausea
stomach discomfort, upset, or pain
vomiting

Rare

Abdominal or stomach cramping, burning, or tenderness
back or leg pains
bleeding gums
blistering, peeling, or loosening of the skin
bloody or black, tarry stools
blue lips and fingernails
blurred vision
breast enlargement and tenderness
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
burning upper abdominal or stomach pain
canker sores
change in consciousness
change in hearing
chest pain, discomfort, or burning
clay colored stools
cloudy or bloody urine
confusion
continuing diarrhea
cough or hoarseness
coughing that sometimes produces a pink frothy sputum
cracks in the skin
dark urine
decreased appetite
decreased vision or any change in vision
depression
difficult or labored breathing
difficulty with swallowing
dilated neck veins
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
double vision
dry mouth
extreme fatigue
false sense of well-being
feeling of unreality
feeling of warmth
fever with or without chills
flushed, dry skin
fruit-like breath odor
general body swelling
greatly decreased frequency of urination or amount of urine
hair loss
headache
heavier menstrual periods
hives or welts, itching skin, or rash
increased hunger
increased sweating
increased thirst
increased urination
irregular breathing
irritation and swelling of the eye
jerky movements of the head, face, mouth, and neck
joint pain
large, flat, blue or purplish patches in the skin
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
loss of balance control
loss of bladder control
loss of consciousness
loss of hearing
loss of heat from the body
lower back or side pain
mask-like face
mental confusion
mood swings
muscle aches, pains, or weakness
muscle spasm or jerking of all extremities
nervousness
noisy, rattling breathing
nosebleeds
numbness or tingling in the hands, feet, or lips
pain in the ankles or knees
pain or discomfort in the upper stomach or throat
pain with swallowing
painful or difficult urination
painful, red lumps under the skin, mostly on the legs
pale skin
persistent bleeding or oozing from puncture sites, mouth, or nose
personality changes
pinpoint red or purple spots on the skin
pounding in the ears
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
red skin lesions, often with a purple center
red, irritated eyes
red, swollen skin
redness of the face, neck, arms and occasionally, upper chest
scaly skin
seeing double
seeing, hearing, or feeling things that are not there
seizures
sense of detachment from self or body
severe constipation
severe mental changes
severe or continuing stomach pain
shuffling walk
slow, fast, irregular, pounding, or racing heartbeat or pulse
slowed movements
slurred speech
small red or purple spots on the skin
sore throat
sores, ulcers, or white spots on the lips or tongue or inside the mouth
stiffness of the arms and legs
sudden loss of consciousness
swelling in the legs and ankles
swelling of the face, fingers, feet, or lower legs
swelling of the breasts or breast soreness in both females and males
swollen or painful glands
tightness in the chest
trembling and shaking of the fingers and hands
troubled breathing at rest
troubled breathing with exertion
unexplained weight loss
unpleasant breath odor
unsteadiness or awkwardness
unusual bleeding or bruising
unusual tiredness or weakness
vaginal bleeding
vomiting of blood or material that looks like coffee grounds
weakness in the arms, hands, legs, or feet
weight gain
yellow eyes or skin

Incidence not known

Frequent urge to defecate
rectal bleeding, burning, dryness, itching, or pain
straining while passing stool

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Confusion about identity, place, and time
severe headache
unusual drowsiness, dullness, or feeling of sluggishness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Mild headache

Less common

Continuing ringing or buzzing or other unexplained noise in the ears
difficulty having a bowel movement (stool)
discouragement
feeling sad or empty
general feeling of discomfort or illness
hearing loss
irritability
loss of interest or pleasure
sleepiness
trouble with concentrating

Rare

Anxiety
bloated full feeling
changes in patterns and rhythms of speech
excess air or gas in the stomach or intestines
feeling of constant movement of self or surroundings
involuntary muscle movements
lightheadedness
passing gas
sensation of spinning
tiredness
trouble with speaking
trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Uses

Indomethacin is used to relieve pain, swelling, and joint stiffness caused by arthritis, gout, bursitis, and tendonitis. Reducing these symptoms helps you do more of your normal daily activities. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID).

If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.

How to use Indocin Suppository, Rectal

Read the Medication Guide provided by your pharmacist before you start using indomethacin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

If the suppository is too soft to insert, put it in cold water or refrigerate it for 30 minutes before removing the foil wrapper. Unwrap the foil and moisten the suppository with a little water. Lie down on your left side with right knee bent. Push the suppository into the rectum with your finger. Remain lying down for a few minutes, and avoid having a bowel movement for at least an hour to allow the drug to be completely absorbed.

The dosage is based on your medical condition and response to treatment. Adults should not use more than 200 milligrams per day. For children, dosage is also based on weight. The maximum dose for children is 4 milligrams per kilogram a day or 150 to 200 milligrams a day, whichever is less. To reduce your risk of side effects (such as stomach bleeding), use this medication at the lowest effective dose for the shortest possible time. Do not increase your dose or use it more often than prescribed. For ongoing conditions such as arthritis, continue using it as directed. Discuss the risks and benefits with your doctor or pharmacist.

For certain conditions (such as arthritis), it may take up to 4 weeks of using this drug regularly before you get the full benefit.

If you are using this drug "as needed" (not on a regular schedule), remember that pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.

Tell your doctor if your condition worsens.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: aliskiren, ACE inhibitors (such as captopril, lisinopril), angiotensin II receptor blockers (such as valsartan, losartan), cidofovir, corticosteroids (such as prednisone), lithium, methotrexate (high-dose treatment), "water pills" (diuretics such as furosemide).

This medication may increase the risk of bleeding when used with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others.

Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as celecoxib, diflunisal, ibuprofen, or ketorolac). These drugs are similar to indomethacin and may increase your risk of side effects if taken together. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

This medication may interfere with certain laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.