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USP DI Vol. II - ANTI-INFLAMMATORYDRUGS, NONSTEROIDAL (Systemic)

ANTI-INFLAMMATORYDRUGS, NONSTEROIDAL (Systemic)


Some commonly used brand names are:

In the U.S.?

  • Actron 9
  • Advil 7
  • Advil Caplets 7
  • Advil, Children's 7
  • Aleve 14
  • Anaprox 14
  • Anaprox DS 14
  • Ansaid 6
  • Bayer Select Ibuprofen Pain Relief Formula Caplets 7
  • Cataflam 1
  • Clinoril 18
  • Cotylbutazone 16
  • Cramp End 7
  • Daypro 15
  • Dolgesic 7
  • Dolobid 2
  • EC-Naprosyn 14
  • Excedrin IB 7
  • Excedrin IB Caplets 7
  • Feldene 17
  • Genpril 7
  • Genpril Caplets 7
  • Haltran 7
  • Ibifon 600 Caplets 7
  • Ibren 7
  • Ibu 7
  • Ibu-200 7
  • Ibu-4 7
  • Ibu-6 7
  • Ibu-8 7
  • Ibuprin 7
  • Ibuprohm 7
  • Ibuprohm Caplets 7
  • Ibu-Tab 7
  • Indocin 8
  • Indocin SR 8
  • Lodine 3
  • Lodine XL 3
  • Meclomen 10
  • Medipren 7
  • Medipren Caplets 7
  • Midol IB 7
  • Mobic 12
  • Motrin 7
  • Motrin Chewables 7
  • Motrin, Children's 7
  • Motrin, Children's Oral Drops 7
  • Motrin-IB 7
  • Motrin-IB Caplets 7
  • Motrin, Junior Strength Caplets 7
  • Nalfon 4
  • Nalfon 200 4
  • Naprelan 14
  • Naprosyn 14
  • Nuprin 7
  • Nuprin Caplets 7
  • Orudis 9
  • Orudis KT 9
  • Oruvail 9
  • Pamprin-IB 7
  • Ponstel 11
  • Q-Profen 7
  • Relafen 13
  • Rufen 7
  • Tolectin 200 21
  • Tolectin 600 21
  • Tolectin DS 21
  • Trendar 7
  • Voltaren 1

In Canada?

  • Actiprofen Caplets 7
  • Advil 7
  • Advil Caplets 7
  • Albert Tiafen 20
  • Alka Butazolidin 16
  • Anaprox 14
  • Anaprox DS 14
  • Ansaid 6
  • Apo-Diclo 1
  • Apo-Diflunisal 2
  • Apo-Flurbiprofen 6
  • Apo-Ibuprofen 7
  • Apo-Indomethacin 8
  • Apo-Keto 9
  • Apo-Keto-E 9
  • Apo-Napro-Na 14
  • Apo-Napro-Na DS 14
  • Apo-Naproxen 14
  • Apo-Phenylbutazone 16
  • Apo-Piroxicam 17
  • Apo-Sulin 18
  • Apo-Tenoxicam 19
  • Butazolidin 16
  • Clinoril 18
  • Daypro 15
  • Dolobid 2
  • Feldene 17
  • Froben 6
  • Froben SR 6
  • Idarac 5
  • Indocid 8
  • Indocid SR 8
  • Medipren Caplets 7
  • Mobiflex 19
  • Motrin 7
  • Motrin-IB 7
  • Nalfon 4
  • Naprosyn 14
  • Naprosyn-E 14
  • Naprosyn-SR 14
  • Naxen 14
  • Novo-Difenac 1
  • Novo-Difenac SR 1
  • Novo-Diflunisal 2
  • Novo-Flurprofen 6
  • Novo-Keto-EC 9
  • Novo-Methacin 8
  • Novo-Naprox 14
  • Novo-Naprox Sodium 14
  • Novo-Naprox Sodium DS 14
  • Novo-Pirocam 17
  • Novo-Profen 7
  • Novo-Sundac 18
  • Novo-Tenoxicam 19
  • Novo-Tolmetin 21
  • Nu-Diclo 1
  • Nu-Flurbiprofen 6
  • Nu-Ibuprofen 7
  • Nu-Indo 8
  • Nu-Naprox 14
  • Nu-Pirox 17
  • Orudis 9
  • Orudis-E 9
  • Orudis-SR 9
  • Oruvail 9
  • PMS-Piroxicam 17
  • Ponstan 11
  • Relafen 13
  • Rhodis 9
  • Rhodis-EC 9
  • Surgam 20
  • Surgam SR 20
  • Synflex 14
  • Synflex DS 14
  • Tolectin 200 21
  • Tolectin 400 21
  • Tolectin 600 21
  • Voltaren 1
  • Voltaren Rapide 1
  • Voltaren SR 1

Other commonly used names are: Etodolic acid Indometacin Meclofenamic acid

Note:

For quick reference, the following nonsteroidal anti-inflammatorydrugs are numbered to match the corresponding brand names.

This information applies to the following medicines:
1.Diclofenac (dye-KLOE-fen-ak)
2.Diflunisal (dye-FLOO-ni-sal)?
3.Etodolac (ee-TOE-doe-lak)?
4.Fenoprofen (fen-oh-PROE-fen)?
5.Floctafenine (flok-ta-FEN-een)*
6.Flurbiprofen (flure-BI-proe-fen)??
7.Ibuprofen (eye-byoo-PROE-fen)??
8.Indomethacin (in-doe-METH-a-sin)?
9.Ketoprofen (kee-toe-PROE-fen)?
10.Meclofenamate (me-kloe-FEN-am-ate)??
11.Mefenamic Acid (me-fe-NAM-ik)
12.Meloxicam (mel-OX-i-cam)?
13.Nabumetone (na-BYOO-me-tone)
14.Naproxen (na-PROX-en)?
15.Oxaprozin (ox-a-PROE-zin)
16.Phenylbutazone (fen-ill-BYOO-ta-zone)?
17.Piroxicam (peer-OX-i-kam)?
18.Sulindac (sul-IN-dak)?
19.Tenoxicam (ten-OX-i-kam)*
20.Tiaprofenic Acid (tie-a-pro-FEN-ik)*
21.Tolmetin (TOLE-met-in)?
* Not commercially available in the U.S.
? Not commercially available in Canada
? Generic name product may be available in the U.S.
? Generic name product may be available in Canada

This informationdoes not apply to aspirin or other salicylatesor to ketorolac (e.g., Toradol).


Category

  • Analgesic?Diclofenac; Diflunisal; Etodolac; Fenoprofen; Floctafenine; Ibuprofen; Ketoprofen; Meclofenamate; Mefenamic Acid; Naproxen
  • Anti-inflammatory,nonsteroidal?Flurbiprofen; Indomethacin; Naproxen; Sulindac; Tenoxicam
  • Antidysmenorrheal?Diclofenac; Flurbiprofen; Ibuprofen; Indomethacin; Ketoprofen; Meclofenamate; MefenamicAcid; Naproxen; Piroxicam
  • Antigout agent?Diclofenac; Diflunisal; Etodolac; Fenoprofen; Floctafenine; Ibuprofen; Indomethacin; Ketoprofen; Naproxen; Phenylbutazone; Piroxicam; Sulindac
  • Antipyretic?Ibuprofen; Indomethacin; Naproxen
  • Antirheumatic, nonsteroidal anti-inflammatory?Diclofenac; Diflunisal; Etodolac; Fenoprofen; Flurbiprofen; Ibuprofen; Indomethacin; Ketoprofen; Meclofenamate; Nabumetone; Naproxen; Oxaprozin; Phenylbutazone; Piroxicam; Sulindac; Tenoxicam; TiaprofenicAcid; Tolmetin
  • Prostaglandin synthesis inhibitor, renal, Bartter's syndrome?Indomethacin
  • Vascular headacheprophylactic?Fenoprofen; Ibuprofen; Indomethacin; Mefenamic Acid; Naproxen
  • Vascular headache suppressant?Diclofenac; Diflunisal; Etodolac; Fenoprofen; Floctafenine; Ibuprofen; Indomethacin; Ketoprofen; Meclofenamate; Mefenamic Acid; Naproxen

Description

Nonsteroidal anti-inflammatory drugs (also calledNSAIDs) are used to relieve some symptoms caused by arthritis (rheumatism),such as inflammation, swelling, stiffness, and joint pain. However, this medicinedoes not cure arthritis and will help you only as long as you continue totake it.

Some of these medicines are also used to relieve other kinds of pain orto treat other painful conditions, such as:

  • gout attacks;
  • bursitis;
  • tendinitis;
  • sprains, strains, or other injuries; or
  • menstrual cramps.

Ibuprofen and naproxen are also used to reduce fever.

Meclofenamate is also used to reduce the amount of bleeding in some womenwho have very heavy menstrual periods.

Nonsteroidal anti-inflammatory drugs may also be used to treat other conditionsas determined by your doctor.

Any nonsteroidal anti-inflammatory drug can cause side effects, especiallywhen it is used for a long time or in large doses. Some of the side effectsare painful or uncomfortable. Others can be more serious, resulting in theneed for medical care and sometimes even death. If you will be taking thismedicine for more than one or two months or in large amounts, you should discusswith your doctor the good that it can do as well as the risks of taking it.Also, it is a good idea to ask your doctor about other forms of treatmentthat might help to reduce the amount of this medicine that you take and/orthe length of treatment.

One of the nonsteroidal anti-inflammatory drugs, phenylbutazone, is especiallylikely to cause very serious side effects. These serious side effects aremore likely to occur in patients 40 years of age or older than in youngeradults, and the risk becomes greater as the patient's age increases. Beforeyou take phenylbutazone, be sure that you have discussed its use with yourdoctor. Also, do not use phenylbutazone to treat anypainful condition other than the one for which it was prescribed by your doctor.

Although ibuprofen and naproxen may be used instead of aspirin to treatmany of the same medical problems, they must not be used by people who areallergic to aspirin.

The 200-mg strength of ibuprofen and the 220-mg strength of naproxen areavailable without a prescription. However, your health care professional mayhave special instructions on the proper dose of these medicines for your medicalcondition.

Other nonsteroidal anti-inflammatory drugs and other strengths of ibuprofenand naproxen are available only with your medical doctor's or dentist's prescription.These medicines are available in the following dosage forms:

    Oral
  • Diclofenac
    • Tablets (U.S. and Canada)
    • Delayed-release tablets (U.S. and Canada)
    • Extended-release tablets (Canada)
  • Diflunisal
    • Tablets (U.S. and Canada)
  • Etodolac
    • Capsules (U.S.)
    • Tablets (U.S.)
    • Extended-release tablets (U.S.)
  • Fenoprofen
    • Capsules (U.S. and Canada)
    • Tablets (U.S. and Canada)
  • Floctafenine
    • Tablets (Canada)
  • Flurbiprofen
    • Extended-release capsules (Canada)
    • Tablets (U.S. and Canada)
  • Ibuprofen
    • Oral suspension (U.S.)
    • Tablets (U.S. and Canada)
    • Chewable tablets (U.S.)
  • Indomethacin
    • Capsules (U.S. and Canada)
    • Extended-release capsules (U.S. and Canada)
    • Oral suspension (U.S.)
  • Ketoprofen
    • Capsules (U.S. and Canada)
    • Extended-release capsules (U.S. and Canada)
    • Tablets (U.S.)
    • Delayed-release tablets (Canada)
    • Extended-release tablets (Canada)
  • Meclofenamate
    • Capsules (U.S.)
  • Mefenamic Acid
    • Capsules (U.S. and Canada)
  • Meloxicam
    • Tablets (U.S.)
  • Nabumetone
    • Tablets (U.S. and Canada)
  • Naproxen
    • Oral suspension (U.S. and Canada)
    • Tablets (U.S. and Canada)
    • Delayed-release tablets (U.S. and Canada)
    • Extended-release tablets (U.S. and Canada)
  • Oxaprozin
    • Tablets (U.S. and Canada)
  • Phenylbutazone
    • Capsules (U.S.)
    • Tablets (U.S. and Canada)
    • Buffered tablets (Canada)
  • Piroxicam
    • Capsules (U.S. and Canada)
  • Sulindac
    • Tablets (U.S. and Canada)
  • Tenoxicam
    • Tablets (Canada)
  • Tiaprofenic Acid
    • Extended-release capsules (Canada)
    • Tablets (Canada)
  • Tolmetin
    • Capsules (U.S. and Canada)
    • Tablets (U.S. and Canada)
    Rectal
  • Diclofenac
    • Suppositories (Canada)
  • Indomethacin
    • Suppositories (U.S. and Canada)
  • Ketoprofen
    • Suppositories (Canada)
  • Naproxen
    • Suppositories (Canada)
  • Piroxicam
    • Suppositories (Canada)


Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your health care professional will make. Forthe nonsteroidal anti-inflammatory drugs, the following should be considered:

Allergies?Tell your health care professional if you have everhad any unusual or allergic reaction to any of the nonsteroidal anti-inflammatorydrugs, or to any of the following medicines:

  • Aspirin or other salicylates
  • Ketorolac (e.g., Toradol)
  • Oxyphenbutazone (e.g., Oxalid, Tandearil)
  • Suprofen (e.g., Suprol)
  • Zomepirac (e.g., Zomax)

Also tell your health care professional if you are allergic to any othersubstances, such as foods, preservatives, or dyes.

Diet?Make certain your health care professionalknows if you are on any special diet, such as a low-sodium or low-sugar diet.Some of these medicines contain sodium or sugar.

Pregnancy?Studies on birth defects with these medicines havenot been done in humans. However, there is a chance that these medicines maycause unwanted effects on the heart or blood flow of the fetus or newbornbaby if they are taken regularly during the last few months of pregnancy.Also, studies in animals have shown that these medicines, if taken late inpregnancy, may increase the length of pregnancy, prolong labor, or cause otherproblems during delivery. If you are pregnant, do not take any of these medicines,including nonprescription (over-the-counter [OTC]) ibuprofen or naproxen,without first discussing its use with your doctor.

Studies in animals have not shown that fenoprofen, floctafenine, flurbiprofen,ibuprofen, ketoprofen, nabumetone, phenylbutazone, piroxicam, tiaprofenicacid, or tolmetin causes birth defects. Diflunisal caused birth defects ofthe spine and ribs in rabbits, but not in mice or rats. Diclofenac and meclofenamatecaused unwanted effects on the formation of bones in animals. Etodolac andoxaprozin caused birth defects in animals. Indomethacin caused slower developmentof bones and damage to nerves in animals. In some animal studies, sulindaccaused unwanted effects on the development of bones and organs. Studies onbirth defects with mefenamic acid have not been done in animals.

Even though most of these medicines did not cause birth defects in animals,many of them did cause other harmful or toxic effects on the fetus, usuallywhen they were given in such large amounts that the pregnant animals becamesick.

For naproxen: Before taking this medicine, makesure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding?

  • For indomethacin: Indomethacin passesinto the breast milk and has been reported to cause unwanted effects in nursingbabies.
  • For meclofenamate: Use of meclofenamateby nursing mothers is not recommended, because in animal studies it causedunwanted effects on the newborn's development.
  • For nabumetone: Use of nabumetone is notrecommended because it may cause unwanted effects in nursing babies
  • For naproxen: Use of naproxen is not recommendedbecause it may cause unwanted effects in nursing babies
  • For phenylbutazone: Phenylbutazone passesinto the breast milk and may cause unwanted effects, such as blood problems,in nursing babies.
  • For piroxicam: Studies in animals haveshown that piroxicam may decrease the amount of milk.
Although other anti-inflammatory analgesics have not beenreported to cause problems in nursing babies, diclofenac, diflunisal, fenoprofen,flurbiprofen, meclofenamate, mefenamic acid, naproxen, piroxicam, and tolmetinpass into the breast milk. It is not known whether etodolac, floctafenine,ibuprofen, ketoprofen, nabumetone, oxaprozin, sulindac, or tiaprofenic acidpasses into human breast milk.

Children?

  • For ibuprofen: Ibuprofen has been testedin children 6 months of age and older. It has not been shown to cause differentside effects or problems than it does in adults.
  • For indomethacin and for tolmetin: Indomethacinand tolmetin have been tested in children 2 years of age and older and havenot been shown to cause different side effects or problems than they do inadults.
  • For naproxen: Studies with naproxen inchildren 2 years of age and older have shown that skin rash may be more likelyto occur.
  • For oxaprozin: Oxaprozin has been usedin children with arthritis. However, there is no specific information comparinguse of this medicine in children with use in other age groups.
  • For phenylbutazone: Use of phenylbutazonein children up to 15 years of age is not recommended.
  • For other anti-inflammatory analgesics:There is no specific information on the use of other anti-inflammatory analgesicsin children.
Most of these medicines, especially indomethacin and phenylbutazone,can cause serious side effects in any patient. Therefore, it is especiallyimportant that you discuss with the child's doctor the good that this medicinemay do as well as the risks of using it.

Older adults?Certain side effects, such as confusion, swellingof the face, feet, or lower legs, or sudden decrease in the amount of urine,may be especially likely to occur in elderly patients, who are usually moresensitive than younger adults to the effects of nonsteroidal anti-inflammatorydrugs. Also, elderly people are more likely than younger adults to get verysick if these medicines cause stomach problems. With phenylbutazone, bloodproblems may also be more likely to occur in the elderly.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takinga nonsteroidal anti-inflammatory drug, it is especially important that yourhealth care professional know if you are taking any of the following:

  • Alcohol or
  • Corticosteroids taken orally (cortisone-like medicine) or
  • Corticotropin (e.g., HP Acthar) or
  • Potassium supplements (e.g., K-Dur, Slow-K)?May increase therisk of serious stomach problems such as ulcers and bleeding
  • Anticoagulants (blood thinners) or
  • Cefamandole (e.g., Mandol) or
  • Cefoperazone (e.g., Cefobid) or
  • Cefotetan (e.g., Cefotan) or
  • Heparin or
  • Plicamycin (e.g., Mithracin) or
  • Valproic acid?The chance of bleeding may be increased
  • Aspirin?The chance of serious side effects may be increasedif aspirin is used together with a nonsteroidal anti-inflammatory drug ona regular basis
  • Ciprofloxacin (e.g., Cipro) or
  • Enoxacin (e.g., Penetrex) or
  • Itraconazole (e.g., Sporanox) or
  • Ketoconazole (e.g., Nizoral) or
  • Lomefloxacin (e.g., Maxaquin) or
  • Norfloxacin (e.g., Noroxin) or
  • Ofloxacin (e.g., Floxin) or
  • Tetracyclines, oral?The buffered form of phenylbutazone (e.g.,Alka Butazolidin) may keep these medicines from working properly if the 2medicines are taken too close together
  • Cyclosporine (e.g., Sandimmune) or
  • Digitalis glycosides (heart medicine) or
  • Lithium (e.g., Lithane) or
  • Methotrexate (e.g., Mexate) or
  • Phenytoin (e.g., Dilantin)?Higher blood levels of these medicinesand an increased chance of side effects may occur
  • Penicillamine (e.g., Cuprimine)?The chance of serious sideeffects may be increased, especially with phenylbutazone (e.g., Cotylbutazone)
  • Probenecid (e.g., Benemid)?Higher blood levels of the nonsteroidalanti-inflammatory drug and an increased chance of side effects may occur
  • Triamterene (e.g., Dyrenium)?The chance of kidney problemsmay be increased, especially with indomethacin
  • Zidovudine (e.g., AZT, Retrovir)?The chance of serious sideeffects may be increased, especially with indomethacin

Other medical problems?The presence of other medicalproblems may affect the use of nonsteroidal anti-inflammatory drugs. Makesure you tell your doctor if you have any other medical problems, especially:

  • Alcohol abuse or
  • Bleeding problems or
  • Colitis, Crohn's disease, diverticulitis, stomach ulcer, or otherstomach or intestinal problems or
  • Diabetes mellitus (sugar diabetes) or
  • Hemorrhoids or
  • Hepatitis or other liver disease or
  • Kidney disease (or history of) or
  • Rectal irritation or bleeding, recent, or
  • Stomach or colon irritation or bleeding, recent, or
  • Systemic lupus erythematosus (SLE) or
  • Tobacco use (or recent history of)?The chance of side effectsmay be increased
  • Anemia or
  • Asthma or
  • Epilepsy or
  • Fluid retention (swelling of feet or lower legs) or
  • Heart disease or
  • High blood pressure or
  • Kidney stones (or history of) or
  • Low platelet count or
  • Low white blood cell count or
  • Mental illness or
  • Parkinson's disease or
  • Polymyalgia rheumatica or
  • Porphyria or
  • Temporal arteritis?Some nonsteroidal anti-inflammatory drugsmay make these conditions worse
  • Ulcers, sores, or white spots in mouth?Ulcers, sores, or whitespots in the mouth sometimes mean that the medicine is causing serious sideeffects; if these sores or spots are already present before you start takingthe medicine, it will be harder for you and your doctor to recognize thatthese side effects might be occurring

Proper Use of This Medicine

For patientstaking a capsule, tablet (including caplet), or liquidform of this medicine:

  • Take tablet or capsule forms of these medicineswith a full glass (8 ounces) of water. Also, do not lie down for about15 to 30 minutes after taking the medicine. This helps to prevent irritationthat may lead to trouble in swallowing.
  • To lessen stomach upset, these medicines should be taken with foodor an antacid. This is especially important when you are taking indomethacin,mefenamic acid, phenylbutazone, or piroxicam, which should always be takenwith food or an antacid. Taking the extended-release tablet dosage form offlurbiprofen or naproxen and taking nabumetone with food may also help themedicine be absorbed into your body more quickly. However, your doctor maywant you to take the first 1 or 2 doses of other nonsteroidal anti-inflammatorydrugs 30 minutes before meals or 2 hours after meals. This helps the medicinestart working a little faster when you first begin to take it. However, afterthe first few doses, take the medicine with food or an antacid.
  • It is not necessary to take delayed-release (enteric-coated) tabletswith food or an antacid, because the enteric coating helps protect your stomachfrom the irritating effects of the medicine. Also, it is not necessary totake ketoprofen extended-release capsules (e.g., Oruvail) with food or anantacid, because the medicine inside the capsules is enteric coated.
  • If you will be taking your medicine together with an antacid, onethat contains magnesium and aluminum hydroxides (e.g., Maalox) may be thebest kind of antacid to use, unless your doctor has directed you to use anotherantacid. However, do not mix the liquid form of ibuprofen, indomethacin, ornaproxen together with an antacid, or any other liquid, before taking it.To do so may cause the medicine to break down. If stomach upset (indigestion,nausea, vomiting, stomach pain, or diarrhea) continues or if you have anyquestions about how you should be taking this medicine, check with your healthcare professional.
  • Some of these medicines must be swallowed whole. Tablets should notbe crushed, chewed, or broken, and capsules should not be emptied out, beforeyou take the medicine. These include delayed-release (enteric-coated) or extended-releasetablets or capsules, diflunisal tablets (e.g., Dolobid), and phenylbutazonetablets (e.g., Butazolidin). If you are not sure whether you are taking adelayed-release or extended-release form of your medicine, check with yourpharmacist.

For patients using a suppository form of thismedicine:

  • If the suppository is too soft to insert, chill it in the refrigeratorfor 30 minutes or run cold water over it before removing the foil wrapper.
  • To insert the suppository: First remove the foil wrapper and moistenthe suppository with cold water. Lie down on your side and use your fingerto push the suppository well up into the rectum.
  • Indomethacin suppositories should be kept inside the rectum for atleast one hour so that all of the medicine can be absorbed by your body. Thishelps the medicine work better.

For patients taking nonprescription (over-the-counter[OTC]) ibuprofen or naproxen:

  • This medicine comes with a patient information sheet. Read it carefully.If you have any questions about this information, check with your health careprofessional.

For safe and effective use of this medicine, do nottake more of it, do not take it more often, and do not take it for a longertime than ordered by your health care professional or directed on the nonprescription(over-the-counter [OTC]) package label. Taking too much of any of thesemedicines may increase the chance of unwanted effects, especially in elderlypatients.

When used for severe or continuing arthritis, a nonsteroidalanti-inflammatory drug must be taken regularly as ordered by your doctorin order for it to help you. These medicines usually begin to work withinone week, but in severe cases up to two weeks or even longer may pass beforeyou begin to feel better. Also, several weeks may pass before you feel thefull effects of the medicine.

For patients taking mefenamic acid:

  • Always take mefenamic acid with food or antacids.
  • Do not take mefenamic acid for more than 7 daysat a time unless otherwise directed by your doctor. To do so may increasethe chance of side effects, especially in elderly patients.

For patients taking phenylbutazone:

  • Phenylbutazone is intended to treat your current medical problemonly. Do not take it for any other aches or pains.Also, phenylbutazone should be used for the shortest time possible becauseof the chance of serious side effects, especially in patients who are 40 yearsof age or older.

Dosing?The dose of these medicines will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe average doses of these medicines. If your dose isdifferent, do not change it unless your doctor tells you to do so.

The number of capsules or tablets or teaspoonfuls of suspension that youtake, or the number of suppositories that you use, depends on the strengthof the medicine. Also, the number of doses you take eachday, the time allowed between doses, and the length of time you take the medicinedepend on the medical problem for which you are taking the medicine.

People with arthritis usually need to take more of a nonsteroidal anti-inflammatorydrug during a flare-up than they do between flare-ups of arthritis symptoms.Therefore, your dose may need to be increased or decreased as your conditionchanges.

    For diclofenac
  • For tablet dosage form:
    • For relieving pain or menstrual cramps:
      • Adults?50 milligrams (mg) three times a day as needed. Yourdoctor may direct you to take 100 mg for the first dose only.
      • Children?Use and dose must be determined by your doctor.
    • For rheumatoid arthritis:
      • Adults?At first, 50 mg three or four times a day. Your doctormay increase the dose, if necessary, up to a total of 225 mg a day. Afteryour condition improves your doctor may direct you to take a lower dose.
      • Children?Use and dose must be determined by your doctor.
    • For osteoarthritis:
      • Adults?At first, 50 mg two or three times a day. Usually, nomore than a total of 150 mg a day should be taken. After your condition improvesyour doctor may direct you to take a lower dose.
      • Children?Use and dose must be determined by your doctor.
    • For spondylitis (lower back pain):
      • Adults?At first, 25 mg four or five times a day. After yourcondition improves your doctor may direct you to take a lower dose.
      • Children?Use and dose must be determined by your doctor.
  • For delayed-release tablet dosage form:
    • For rheumatoid arthritis:
      • Adults?At first, 50 mg three or four times a day. Your doctormay increase the dose, if necessary, up to a total of 225 mg a day. Afteryour condition improves your doctor may direct you to take a lower dose.
      • Children?Use and dose must be determined by your doctor.
    • For osteoarthritis:
      • Adults?At first, 50 mg two or three times a day. Usually, nomore than a total of 150 mg a day should be taken. After your condition improvesyour doctor may direct you to take a lower dose.
      • Children?Use and dose must be determined by your doctor.
    • For spondylitis (lower back pain):
      • Adults?At first, 25 mg four or five times a day. After yourcondition improves your doctor may direct you to take a lower dose.
      • Children?Use and dose must be determined by your doctor.
  • For extended-release tablet dosage form:
    • For rheumatoid arthritis, osteoarthritis, or spondylitis:
      • Adults?Usually 75 or 100 mg once a day, in the morning or evening.Some people may need 75 mg twice a day, in the morning and evening. Take themedicine at the same time every day.
      • Children?Use and dose must be determined by your doctor.
  • For rectal dosage form (suppositories):
    • For rheumatoid arthritis, osteoarthritis, or spondylitis:
      • Adults?One 50-mg or 100-mg suppository, inserted into the rectum.The suppository is usually used only at night by people who take tablets duringthe day. Usually, no more than a total of 150 mg of diclofenac should be usedin a day from all dosage forms combined.
      • Children?Use and dose must be determined by your doctor.
    For diflunisal
  • For oral dosage form (tablets):
    • For pain:
      • Adults?1000 milligrams (mg) for the first dose, then 500 mgevery eight to twelve hours as needed. Some people may need only 500 mg forthe first dose, then 250 mg every eight to twelve hours as needed. Usually,no more than a total of 1500 mg a day should be taken.
      • Children?Dose must be determined by your doctor.
    • For rheumatoid arthritis or osteoarthritis:
      • Adults?At first, 250 or 500 mg twice a day. Your doctor mayincrease the dose, if necessary, up to a total of 1500 mg a day. After yourcondition improves your doctor may direct you to take a lower dose.
      • Children?Dose must be determined by your doctor.
    For etodolac
  • For oral dosage forms (capsules or tablets):
    • For pain:
      • Adults?400 milligrams (mg) for the first dose, then 200 to400 mg every six to eight hours as needed. Usually, no more than a total of1200 mg a day should be taken.
      • Children?Use and dose must be determined by your doctor.
    • For osteoarthritis:
      • Adults?At first, 400 mg two or three times a day or 300 mgthree or four times a day. Usually, no more than a total of 1200 mg a dayshould be taken. After your condition improves your doctor may direct youto take a lower dose.
      • Children?Use and dose must be determined by your doctor.

    For extended-release tablet dosage form:
    • For rheumatoid arthritis, osteoarthritis, or spondylitis:
      • Adults?Usually 400 to 1000 mg once a day. Take the medicineat the same time every day.
      • Children?Use and dose must be determined by your doctor.
    For fenoprofen
  • For oral dosage forms (capsules or tablets):
    • For pain:
      • Adults?200 milligrams (mg) every four to six hours as needed.
      • Children?Use and dose must be determined by your doctor.
    • For arthritis:
      • Adults?At first, 300 to 600 mg three or four times a day. Yourdoctor may increase the dose, if necessary, up to a total of 3200 mg a day.After your condition improves your doctor may direct you to take a lower dose.
      • Children?Use and dose must be determined by your doctor.
    For floctafenine
  • For oral dosage form (tablets):
    • For pain:
      • Adults?200 to 400 milligrams (mg) every six to eight hours,as needed. Usually, no more than 1200 mg a day should be taken.
      • Children?Use is not recommended.
    For flurbiprofen
  • For oral tablet dosage form:
    • For menstrual cramps:
      • Adults?50 milligrams (mg) four times a day.
      • Children?Use and dose must be determined by your doctor.
    • For bursitis, tendinitis, or athletic injuries:
      • Adults?50 mg every four to six hours as needed.
      • Children?Use and dose must be determined by your doctor.
    • For rheumatoid arthritis or osteoarthritis:
      • Adults?At first, 200 to 300 mg a day, divided into smalleramounts that are taken two to four times a day. Usually, no more than a totalof 300 mg a day should be taken. After your condition improves your doctormay direct you to take a lower dose.
      • Children?Use and dose must be determined by your doctor.
    • For spondylitis (lower back pain):
      • Adults?At first, 50 mg four times a day. Your doctor may increasethe dose, if necessary, up to a total of 300 mg a day. After your conditionimproves your doctor may direct you to take a lower dose.
      • Children?Use and dose must be determined by your doctor.
  • For extended-release capsule dosage form:
    • For arthritis:
      • Adults?200 mg once a day, in the evening. Take the medicineat the same time every day.
      • Children?Use and dose must be determined by your doctor.
    For ibuprofen
  • For oral dosage forms (oral suspension,tablets, chewable tablets):
    • For pain or menstrual cramps:
      • Adults and teenagers?200 to 400 milligrams (mg) every fourto six hours as needed. If you are taking the medicine without a prescriptionfrom your health care professional, do not take more than a total of 1200mg (six 200-mg tablets) a day.
      • Children up to 12 years of age?Use and dose must be determinedby your doctor.
    • For fever:
      • Adults and teenagers?200 to 400 mg every four to six hoursas needed. If you are taking the medicine without a prescription from yourhealth care professional, do not take more than a total of 1200 mg (six 200-mgtablets) a day.
      • Children 6 months to 12 years of age?The medicine should beused only with a prescription from your doctor. The dose is based on bodyweight and on the body temperature. For fevers lower than 102.5 ?F (39.2?C) the dose is 5 mg per kilogram (kg) (about 2.2 mg per pound) of bodyweight. For higher fevers the dose is 10 mg per kg (about 4.5 mg per pound)of body weight.
      • Infants younger than 6 months of age?Use and dose must be determinedby your doctor.
    • For arthritis:
      • Adults and teenagers?At first, a total of 1200 to 3200 mg aday, divided into smaller amounts that are taken three or four times a day.After your condition improves your doctor may direct you to take a lower dose.
      • Children 6 months to 12 years of age?The dose is based on bodyweight. At first, a total of 30 to 40 mg per kg (about 13.6 to 18 mg per pound)of body weight a day, divided into smaller amounts that are taken three orfour times a day. Your doctor may increase the dose, if necessary, up to atotal of 50 mg per kg (about 21 mg per pound) of body weight a day. Afteryour condition improves your doctor may direct you to take a lower dose.
      • Infants younger than 6 months of age?Use and dose must be determinedby your doctor.
    For indomethacin
  • For capsule or oral suspension dosageforms:
    • For arthritis:
      • Adults?At first, 25 or 50 milligrams (mg) two to four timesa day. Your doctor may increase the dose, if necessary, up to a total of 200mg a day. After your condition improves your doctor may direct you to takea lower dose.
      • Children?The dose is based on body weight. At first, 1.5 to2.5 mg per kilogram (kg) (about 0.7 to 1.1 mg per pound) of body weight aday, divided into smaller amounts that are taken three or four times a day.Your doctor may increase the dose, if necessary, up to a total of 4 mg perkg (about 1.8 mg per pound) of body weight or 200 mg a day, whichever is less.After your condition improves your doctor may direct you to take a lower dose.
    • For gout:
      • Adults?100 mg for the first dose, then 50 mg three times aday. After the pain is relieved, your doctor may direct you to take a lowerdose for a while before stopping treatment completely.
      • Children?Use and dose must be determined by your doctor.
    • For bursitis or tendinitis:
      • Adults?25 mg three or four times a day or 50 mg three timesa day.
      • Children?Use and dose must be determined by your doctor.
  • For extended-release capsule dosage form:
    • For arthritis:
      • Adults?75 mg once a day, in the morning or evening. Some peoplemay need to take 75 mg twice a day, in the morning and evening. Take the medicineat the same time each day.
      • Children?Dose must be determined by your doctor.
  • For rectal suppository dosage form:
    • For arthritis, bursitis, tendinitis, or gout:
      • Adults?One 50-mg suppository, inserted into the rectum up tofour times a day.
      • Children?One 50-mg suppository, inserted into the rectum upto four times a day. The suppository dosage form is too strong for small children.However, the suppositories may be used for large or heavy children if theyneed doses as large as 50 mg.
    For ketoprofen
  • For capsule, tablet, or delayed-release tablet dosage forms:
    • For pain or menstrual cramps:
      • Adults?25 to 50 milligrams (mg) every six to eight hours asneeded. Some people may need to take as much as 75 mg every six to eight hours.Doses larger than 75 mg are not likely to give better relief.
      • Over-the-counter medication?12.5 mg every 4 to 6 hours.
      • Children?Use and dose must be determined by your doctor.
    • For arthritis:
      • Adults?At first, 50 mg four times a day or 75 mg three timesa day. Your doctor may increase the dose, if necessary, up to a total of 300mg a day. After your condition improves your doctor may direct you to takea lower dose.
      • Children?Use and dose must be determined by your doctor.
  • For extended-release capsule or extended-releasetablet dosage forms:
    • For arthritis:
      • Adults?150 or 200 mg once a day, in the morning or evening.Take the medicine at the same time every day.
      • Children?Use and dose must be determined by your doctor.
  • For rectal suppository dosage form:
    • For arthritis:
      • Adults?50 or 100 mg twice a day, inserted into the rectum,in the morning and evening. Sometimes, the suppository is used only at nightby people who take an oral dosage form (capsules or delayed-release tablets)during the day. Usually, no more than a total of 300 mg of ketoprofen shouldbe used in a day from all dosage forms combined.
      • Children?Use and dose must be determined by your doctor.
    For meclofenamate
  • For oral dosage form (capsules):
    • For arthritis:
      • Adults and teenagers 14 years of age and older?At first, 50milligrams (mg) four times a day. Your doctor may increase the dose, if necessary,up to a total of 400 mg a day. After your condition improves your doctor maydirect you to take a lower dose.
      • Children up to 14 years of age?Use and dose must be determinedby your doctor.
    • For pain:
      • Adults and teenagers 14 years of age and older?50 mg everyfour to six hours. Some people may need as much as 100 mg every four to sixhours.
      • Children up to 14 years of age?Use and dose must be determinedby your doctor.
    • For menstrual cramps and heavy menstrual bleeding:
      • Adults and teenagers 14 years of age and older?100 mg threetimes a day for up to six days.
      • Children up to 14 years of age?Use and dose must be determinedby your doctor.
    For mefenamic acid
  • For oral dosage form (capsules):
    • For pain and for menstrual cramps:
      • Adults and teenagers 14 years of age and older?500 milligrams(mg) for the first dose, then 250 mg every six hours as needed for up to sevendays.
      • Children up to 14 years of age?Use and dose must be determinedby your doctor.
    For meloxicam
  • For oraldosage form (tablets):
    • For osteoarthritis:
      • Adults?7.5 milligrams (mg) daily in a single dose.
    For nabumetone
  • For oral dosage form (tablets):
    • For arthritis:
      • Adults?At first, 1000 milligrams (mg) once a day, in the morningor evening, or 500 mg twice a day, in the morning and evening. Your doctormay increase the dose, if necessary, up to a total of 2000 mg a day. Afteryour condition improves your doctor may direct you to take a lower dose.
      • Children?Use and dose must be determined by your doctor.
    For naproxen
  • For naproxen (e.g., Naprosyn) tablet and oralsuspension dosage forms:
    • For rheumatoid arthritis, osteoarthritis, and spondylitis (lowerback pain):
      • Adults?At first, 250, 375, or 500 milligrams (mg) two timesa day, in the morning and evening. Your doctor may increase the dose, if necessary,up to a total of 1500 mg a day. After your condition improves your doctormay direct you to take a lower dose.
      • Children?The dose is based on body weight. At first, 5 mg perkilogram (kg) (about 2.25 mg per pound) of body weight twice a day. Afteryour condition improves your doctor may direct you to take a lower dose.
    • For bursitis, tendinitis, menstrual cramps, and other kinds of pain:
      • Adults?500 mg for the first dose, then 250 mg every six toeight hours as needed.
      • Children?Use and dose must be determined by your doctor.
    • For gout:
      • Adults?750 mg for the first dose, then 250 mg every eight hoursuntil the attack is relieved.
      • Children?Use and dose must be determined by your doctor.
  • For naproxen delayed-release tablet (e.g., EC-Naprosyn) dosage form:
    • For rheumatoid arthritis, osteoarthritis, and spondylitis (lowerback pain) :
      • Adults?At first, 375 or 500 milligrams (mg) two times a day,in the morning and evening. Your doctor may increase the dose, if necessary,up to a total of 1500 mg a day. After your condition improves your doctormay direct you to take a lower dose.
      • Children?The delayed-release tablets are too strong for usein children.
  • For naproxen extended-release tablet (e.g.,Naprelan) dosage form:
    • For arthritis and pain:
      • Adults?750 to 1000 mg once a day, in the morning or evening.
      • Children?The extended-release tablets are too strong for usein children.
  • For naproxen (e.g., Naprosyn) rectal suppository dosage form:
    • For arthritis:
      • Adults?One 500-mg suppository, inserted into the rectum atbedtime. The suppository is usually used only at night by people who takean oral dosage form (tablets, oral suspension, or delayed-release tablets)during the day. Usually, no more than a total of 1500 mg of naproxen shouldbe used in a day from all dosage forms combined.
      • Children?The suppositories are too strong for use in children.
  • For naproxen sodium (e.g., Aleve, Anaprox) tablet dosage form:
    • For arthritis:
      • Adults?At first, 275 or 550 mg two times a day, in the morningand evening, or 275 mg in the morning and 550 mg in the evening. Your doctormay increase the dose, if necessary, up to a total of 1650 mg a day. Afteryour condition improves your doctor may direct you to take a lower dose.
      • Children?Naproxen sodium tablets are too strong for most children.Naproxen (e.g., Naprosyn) tablets or oral suspension are usually used forchildren.
    • For bursitis and tendinitis:
      • Adults?550 mg for the first dose, then 275 mg every six toeight hours as needed.
      • Children?Use and dose must be determined by your doctor. Naproxensodium tablets are too strong for most children.
    • For gout:
      • Adults?825 mg for the first dose, then 275 mg every eight hoursuntil the attack is relieved.
      • Children?Use and dose must be determined by your doctor. Naproxensodium tablets are too strong for most children.
    • For pain, fever, and menstrual cramps:
      • Adults and children 12 years of age or older?For nonprescription(over-the-counter [OTC]) use: 220 mg (one tablet) every eight to twelve hoursas needed. Some people may get better relief if they take 440 mg (two tablets)for the first dose, then 220 mg twelve hours later on the first day only.If you are taking this medicine without a prescription from your health careprofessional, do not take more than three 220-mg tablets a day. If you areolder than 65 years of age, do not take more than two 220-mg tablets a day.Your health care professional may direct you to take larger doses.
      • Children up to 12 years of age?Use and dose must be determinedby your doctor.
    For oxaprozin
  • For oral dosage form (tablets):
    • For arthritis:
      • Adults?At first, 600 milligrams (mg) once or twice a day, or1200 mg once a day. Some people may need a larger amount for the first doseonly. Your doctor may increase the dose, if necessary, up to 1800 mg a day.This large dose should always be divided into smaller amounts that are takentwo or three times a day. After your condition improves your doctor may directyou to take a lower dose.
      • Children?Use and dose must be determined by your doctor.
    For phenylbutazone
  • For oral dosage forms (capsules, tablets,and buffered tablets):
    • For severe arthritis:
      • Adults and teenagers 15 years of age and older?At first, 100milligrams (mg) three or four times a day. Some people may need a higher doseof 200 mg three times a day. After your condition improves your doctor maydirect you to take a lower dose for a while before stopping treatment completely.This medicine should not be taken for longer than a few weeks.
      • Children up to 15 years of age?Use is not recommended.
    • For gout:
      • Adults?400 mg for the first dose, then 100 mg every four hoursfor one week or less.
      • Children up to 15 years of age?Use is not recommended.
    For piroxicam
  • For oral dosage form (capsules):
    • For arthritis:
      • Adults?20 milligrams (mg) once a day or 10 mg twice a day.
      • Children?Dose must be determined by your doctor.
    • For menstrual cramps:
      • Adults?40 mg once a day for one day only, then 20 mg once aday if needed.
      • Children?Dose must be determined by your doctor.
  • For rectal dosage form (suppositories):
    • For arthritis:
      • Adults?20 mg once a day or 10 mg twice a day.
      • Children?Dose must be determined by your doctor.
    For sulindac
  • For oral dosage form (tablets):
    • For arthritis:
      • Adults?At first, 150 or 200 milligrams (mg) twice a day. Afteryour condition improves, your doctor may direct you to take a lower dose.
      • Children?Use and dose must be determined by your doctor.
    • For gout, bursitis, or tendinitis:
      • Adults?At first, 200 mg twice a day. After the pain is relieved,your doctor may direct you to take a lower dose for a while before treatmentis stopped completely.
      • Children?Use and dose must be determined by your doctor.
    For tenoxicam
  • For oral dosage form (tablets):
    • For arthritis:
      • Adults and teenagers 16 years of age and older?At first, 20milligrams (mg) once a day, at the same time each day. For some people, asmaller dose of 10 mg (one-half tablet) a day may be enough.
      • Children and teenagers up to 16 years of age?Dose must be determinedby your doctor.
    For tiaprofenic acid
  • For oral tablet dosage form:
    • For arthritis:
      • Adults?At first, 200 milligrams (mg) three times a day or 300mg twice a day. After your condition improves, your doctor may direct youto take a lower dose.
      • Children?Use and dose must be determined by your doctor.
  • For extended-release capsule dosage form:
    • For arthritis:
      • Adults?600 mg (two capsules) once a day, at the same time eachday.
      • Children?Use and dose must be determined by your doctor.
    For tolmetin
  • For oral dosage forms (capsules or tablets):
    • For arthritis:
      • Adults?At first, 400 milligrams (mg) three times a day. Yourdoctor may increase the dose, if necessary, up to a total of 1800 mg a day.After your condition improves, your doctor may direct you to take a lowerdose.
      • Children 2 years of age and older?The dose is based on bodyweight. At first, 20 mg per kilogram (kg) (about 9 mg per pound) of body weighta day, divided into smaller amounts that are taken three or four times a day.Your doctor may increase the dose, if necessary, up to 30 mg per kg (about13.5 mg per pound) of body weight a day. After your condition improves, yourdoctor may direct you to take a lower dose.
      • Children up to 2 years of age?Dose must be determined by yourdoctor.

Missed dose?If your health care professional has ordered youto take this medicine according to a regular schedule, and you miss a dose,take it as soon as you remember. However, if it is almost time for your nextdose, skip the missed dose and go back to your regular dosing schedule. (Forlong-acting medicines or extended-release dosage forms that are only takenonce or twice a day, take the missed dose only if you remember within an houror two after the dose should have been taken. If you do not remember untillater, skip the missed dose and go back to your regular dosing schedule.)Do not double doses.

Storage?To store this medicine:

  • Keep out of the reach of children.
  • Store away from heat and direct light.
  • Do not store tablets or capsules in the bathroom, near the kitchensink, or in other damp places. Heat or moisture may cause the medicine tobreak down.
  • Keep liquid and suppository forms of this medicine from freezing.
  • Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

If you will be taking this medicine for a long time, as forarthritis (rheumatism), your doctor should check your progress at regularvisits. Your doctor may want to do certain tests to find out if unwantedeffects are occurring, especially if you are taking phenylbutazone. The testsare very important because serious side effects, including ulcers, bleeding,or blood problems, can occur without any warning.

Stomach problems may be more likely to occur if you drink alcoholic beverageswhile being treated with this medicine. Also, alcohol may add to the depressantside effects of phenylbutazone.

If you consume 3 or more alcoholic beverages per day,check with your doctor before taking this medicine.

Taking two or more of the nonsteroidal anti-inflammatory drugs togetheron a regular basis may increase the chance of unwanted effects. Also, takingacetaminophen, aspirin or other salicylates, or ketorolac (e.g., Toradol)regularly while you are taking a nonsteroidal anti-inflammatory drug may increasethe chance of unwanted effects. The risk will depend on how much of each medicineyou take every day, and on how long you take the medicines together. If yourhealth care professional directs you to take these medicines together on aregular basis, follow his or her directions carefully. However, do not take acetaminophen or aspirin or other salicylates together with thismedicine for more than a few days, and do not take any ketorolac (e.g., Toradol)while you are taking this medicine, unless your doctor has directed you todo so and is following your progress.

Serious side effects can occur during treatment with this medicine. Sometimesserious side effects can occur without any warning. However, possible warningsigns often occur, including swelling of the face, fingers, feet, and/or lowerlegs; severe stomach pain, black, tarry stools, and/or vomiting of blood ormaterial that looks like coffee grounds; unusual weight gain; and/or skinrash. Also, signs of serious heart problems could occur such as chest pain,tightness in chest, fast or irregular heartbeat, or unusual flushing or warmthof skin. Stop taking this medicine and check with yourdoctor immediately if you notice any of these warning signs.

Before having any kind of surgery (including dental surgery), tell themedical doctor or dentist in charge that you are taking this medicine. Ifpossible, this should be done when your surgery is first being planned. Someof the nonsteroidal anti-inflammatory drugs can increase the chance of bleedingduring and after surgery. It may be necessary for you to stop treatment fora while, or to change to a different nonsteroidal anti-inflammatory drug thatis less likely to cause bleeding.

This medicine may cause some people to become confused, drowsy, dizzy,lightheaded, or less alert than they are normally. It may also cause blurredvision or other vision problems in some people. Makesure you know how you react to this medicine before you drive, use machines,or do anything else that could be dangerous if you are confused, dizzy, ordrowsy, or if you are not alert and able to see well. If these reactionsare especially bothersome, check with your doctor.

For patients taking the buffered form of phenylbutazone(e.g., Alka-Butazolidin):

  • This medicine contains antacids that can keep other medicines fromworking properly if the 2 medicines are taken too close together. Always take this medicine:
    • At least 6 hours before or 2 hours after takingciprofloxacin (e.g., Cipro) or lomefloxacin (e.g., Maxaquin).
    • At least 8 hours before or 2 hours after takingenoxacin (e.g., Penetrex).
    • At least 2 hours after taking itraconazole (e.g.,Sporanox).
    • At least 3 hours before or after taking ketoconazole(e.g., Nizoral).
    • At least 2 hours before or after taking norfloxacin(e.g., Noroxin) or ofloxacin (e.g., Floxin).
    • At least 1 to 3 hours before or after takinga tetracycline antibiotic by mouth.
    • At least 1 or 2 hours bef