Saturday, 7 July 2012

Salflex


Generic Name: salicylate (Oral route, Rectal route)


Commonly used brand name(s)

In the U.S.


  • Amigesic

  • Asacol

  • Azulfidine

  • Azulfidine Entabs

  • Bayer

  • Canasa

  • Colazal

  • Dipentum

  • Doan's Extra Strength

  • Doan's Regular

  • Dolobid

  • Ecotrin

  • Kaopectate

  • Pepto Bismol

  • Salflex

  • Tricosal

  • Trilisate

In Canada


  • Alti-Sulfasalazine

  • Arthropan

  • Asacol 800

  • Bismuth Extra Strength

  • Bismuth Original Formula

  • Mesasal

  • Pentasa

  • Pepto-Bismol

  • Pms-Asa Suppository Adult

  • Pms-Asa Suppository Children

  • Salazopyrin

  • Salofalk

Available Dosage Forms:


  • Tablet, Enteric Coated

  • Tablet, Extended Release

  • Suppository

  • Tablet

  • Capsule

  • Tablet, Chewable

  • Tablet, Effervescent

  • Capsule, Delayed Release

  • Gum

  • Tablet, Delayed Release

  • Enema

  • Capsule, Extended Release

  • Liquid

  • Solution

  • Suspension

Uses For Salflex


Aspirin may also be used to lessen the chance of heart attack, stroke, or other problems that may occur when a blood vessel is blocked by blood clots. Aspirin helps prevent dangerous blood clots from forming. However, this effect of aspirin may increase the chance of serious bleeding in some people. Therefore, aspirin should be used for this purpose only when your doctor decides, after studying your medical condition and history, that the danger of blood clots is greater than the risk of bleeding. Do not take aspirin to prevent blood clots or a heart attack unless it has been ordered by your doctor.


Salicylates may also be used for other conditions as determined by your doctor.


The caffeine present in some of these products may provide additional relief of headache pain or faster pain relief.


Some salicylates are available only with your medical doctor's or dentist's prescription. Others are available without a prescription; however, your medical doctor or dentist may have special instructions on the proper dose of these medicines for your medical condition.


Importance of Diet


Make certain your health care professional knows if you are on a low-sodium diet. Regular use of large amounts of sodium salicylate (as for arthritis) can add a large amount of sodium to your diet. Sodium salicylate contains 46 mg of sodium in each 325-mg tablet and 92 mg of sodium in each 650-mg tablet.


Before Using Salflex


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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


Do not give aspirin or other salicylates to a child or a teenager with a fever or other symptoms of a virus infection, especially flu or chickenpox, without first discussing its use with your child's doctor. This is very important because salicylates may cause a serious illness called Reye's syndrome in children and teenagers with fever caused by a virus infection, especially flu or chickenpox.


Some children may need to take aspirin or another salicylate regularly (as for arthritis). However, your child's doctor may want to stop the medicine for a while if a fever or other symptoms of a virus infection occur. Discuss this with your child's doctor, so that you will know ahead of time what to do if your child gets sick.


Children who do not have a virus infection may also be more sensitive to the effects of salicylates, especially if they have a fever or have lost large amounts of body fluid because of vomiting, diarrhea, or sweating. This may increase the chance of side effects during treatment.


Geriatric


Elderly people are especially sensitive to the effects of salicylates. This may increase the chance of side effects during treatment.


Pregnancy


Salicylates have not been shown to cause birth defects in humans. Studies on birth defects in humans have been done with aspirin but not with other salicylates. However, salicylates caused birth defects in animal studies.


Some reports have suggested that too much use of aspirin late in pregnancy may cause a decrease in the newborn's weight and possible death of the fetus or newborn infant. However, the mothers in these reports had been taking much larger amounts of aspirin than are usually recommended. Studies of mothers taking aspirin in the doses that are usually recommended did not show these unwanted effects. However, there is a chance that regular use of salicylates late in pregnancy may cause unwanted effects on the heart or blood flow in the fetus or in the newborn infant.


Use of salicylates, especially aspirin, during the last 2 weeks of pregnancy may cause bleeding problems in the fetus before or during delivery or in the newborn infant. Also, too much use of salicylates during the last 3 months of pregnancy may increase the length of pregnancy, prolong labor, cause other problems during delivery, or cause severe bleeding in the mother before, during, or after delivery. Do not take aspirin during the last 3 months of pregnancy unless it has been ordered by your doctor.


Studies in humans have not shown that caffeine (present in some aspirin products) causes birth defects. However, studies in animals have shown that caffeine causes birth defects when given in very large doses (amounts equal to those present in 12 to 24 cups of coffee a day).


Breast Feeding


Salicylates pass into the breast milk. Although salicylates have not been reported to cause problems in nursing babies, it is possible that problems may occur if large amounts are taken regularly, as for arthritis (rheumatism).


Caffeine passes into the breast milk in small amounts.


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 any of these medicines, 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 medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.


  • Influenza Virus Vaccine, Live

  • Ketorolac

  • Pentoxifylline

Using medicines in this class 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

  • Acenocoumarol

  • Alteplase, Recombinant

  • Anisindione

  • Ardeparin

  • Argatroban

  • Beta Glucan

  • Bivalirudin

  • Certoparin

  • Cilostazol

  • Citalopram

  • Clopidogrel

  • Clovoxamine

  • Dabigatran Etexilate

  • Dalteparin

  • Danaparoid

  • Desirudin

  • Desvenlafaxine

  • Dicumarol

  • Dipyridamole

  • Duloxetine

  • Enoxaparin

  • Eptifibatide

  • Escitalopram

  • Femoxetine

  • Flesinoxan

  • Fluoxetine

  • Fluvoxamine

  • Fondaparinux

  • Ginkgo

  • Heparin

  • Ketoprofen

  • Lepirudin

  • Methotrexate

  • Milnacipran

  • Nadroparin

  • Naproxen

  • Nefazodone

  • Parnaparin

  • Paroxetine

  • Pemetrexed

  • Phenindione

  • Phenprocoumon

  • Protein C

  • Reteplase, Recombinant

  • Reviparin

  • Riluzole

  • Rivaroxaban

  • Sertraline

  • Sibutramine

  • Tacrolimus

  • Ticlopidine

  • Tinzaparin

  • Tirofiban

  • Varicella Virus Vaccine

  • Venlafaxine

  • Vilazodone

  • Warfarin

  • Zimeldine

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.


Other Medical Problems


The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:


  • Anemia or

  • Overactive thyroid or

  • Stomach ulcer or other stomach problems—Salicylates may make your condition worse.

  • Asthma, allergies, and nasal polyps (history of) or

  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency or

  • High blood pressure (hypertension) or

  • Kidney disease or

  • Liver disease—The chance of side effects may be increased.

  • Gout—Salicylates can make this condition worse and can also lessen the effects of some medicines used to treat gout.

  • Heart disease—The chance of some side effects may be increased. Also, the caffeine present in some aspirin products can make some kinds of heart disease worse.

  • Hemophilia or other bleeding problems—The chance of bleeding may be increased, especially with aspirin.

Proper Use of salicylate

This section provides information on the proper use of a number of products that contain salicylate. It may not be specific to Salflex. Please read with care.


Take this medicine after meals or with food (except for enteric-coated capsules or tablets and aspirin suppositories) to lessen stomach irritation.


Take tablet or capsule forms of this medicine with a full glass (8 ounces) of water. Also, do not lie down for about 15 to 30 minutes after swallowing the medicine. This helps to prevent irritation that may lead to trouble in swallowing.


For patients taking aspirin (including buffered aspirin and/or products containing caffeine):


  • Do not use any product that contains aspirin if it has a strong, vinegar-like odor. This odor means the medicine is breaking down. If you have any questions about this, check with your health care professional.

  • If you are to take any medicine that contains aspirin within 7 days after having your tonsils removed, a tooth pulled, or other dental or mouth surgery, be sure to swallow the aspirin whole. Do not chew aspirin during this time.

  • Do not place any medicine that contains aspirin directly on a tooth or gum surface. This may cause a burn.

  • There are several different forms of aspirin or buffered aspirin tablets. If you are using:
    • chewable aspirin tablets, they may be chewed, dissolved in liquid, crushed, or swallowed whole.

    • delayed-release (enteric-coated) aspirin tablets, they must be swallowed whole. Do not crush them or break them up before taking.

    • extended-release (long-acting) aspirin tablets, check with your pharmacist as to how they should be taken. Some may be broken up (but must not be crushed) before swallowing if you cannot swallow them whole. Others should not be broken up and must be swallowed whole.


To use aspirin suppositories:


  • If the suppository is too soft to insert, chill it in the refrigerator for 30 minutes or run cold water over it before removing the foil wrapper.

  • To insert the suppository: First remove the foil wrapper and moisten the suppository with cold water. Lie down on your side and use your finger to push the suppository well up into the rectum.

To take choline and magnesium salicylates (e.g., Trilisate) oral solution:


  • The liquid may be mixed with fruit juice just before taking.

  • Drink a full glass (8 ounces) of water after taking the medicine.

To take enteric-coated sodium salicylate tablets:


  • The tablets must be swallowed whole. Do not crush them or break them up before taking.

Unless otherwise directed by your medical doctor or dentist:


  • Do not take more of this medicine than recommended on the label, to lessen the chance of side effects.

  • Children up to 12 years of age should not take this medicine more than 5 times a day.

When used for arthritis (rheumatism), this medicine must be taken regularly as ordered by your doctor in order for it to help you. Up to 2 to 3 weeks or longer may pass before you feel the full effects of this medicine.


Dosing


The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For aspirin

  • For oral dosage forms (short-acting tablets, chewable tablets, and delayed-release [enteric-coated] tablets):
    • For pain or fever:
      • Adults and teenagers—325 to 500 milligrams (mg) every three or four hours, 650 mg every four to six hours, or 1000 mg every six hours as needed.

      • Children 11 to 12 years of age—320 to 480 mg every four hours as needed.

      • Children 9 to 11 years of age—320 to 400 mg every four hours as needed.

      • Children 6 to 9 years of age—320 to 325 mg every four hours as needed.

      • Children 4 to 6 years of age—240 mg every four hours as needed.

      • Children 2 to 4 years of age—160 mg every four hours as needed.

      • Children up to 2 years of age—Dose must be determined by your doctor.


    • For arthritis:
      • Adults and teenagers—A total of 3600 to 5400 mg a day, divided into several smaller doses.

      • Children—A total of 80 to 100 mg per kilogram (kg) (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.


    • For preventing a heart attack, stroke, or other problems caused by blood clots:
      • Adults—Most people will take 81, 162.5, or 325 mg a day or 325 mg every other day. Some people taking aspirin to prevent a stroke may need as much as 1000 mg a day.

      • Children—Use and dose must be determined by your doctor.



  • For oral dosage form (chewing gum):
    • For pain:
      • Adults and teenagers—2 tablets every four hours as needed.

      • Children 6 to 12 years of age—1 or 2 tablets (227 mg each) up to four times a day.

      • Children 3 to 6 years of age—1 tablet (227 mg) up to three times a day.

      • Children up to 3 years of age—Dose must be determined by your doctor.



  • For long-acting oral dosage form (extended-release tablets):
    • For pain:
      • Adults and teenagers—1 or 2 tablets twice a day.

      • Children—The long-acting aspirin tablets are too strong for use in children.


    • For arthritis:
      • Adults and teenagers—1 or 2 tablets twice a day, at first. Your doctor will then adjust your dose as needed.

      • Children—The long-acting aspirin tablets are too strong for use in children.



  • For rectal dosage form (suppositories):
    • For pain or fever:
      • Adults and teenagers—325 to 650 mg every four hours as needed.

      • Children 11 to 12 years of age—325 to 480 mg every four hours as needed.

      • Children 9 to 11 years of age—325 to 400 mg every four hours as needed.

      • Children 6 to 9 years of age—325 mg every four hours as needed.

      • Children 4 to 6 years of age—240 mg every four hours as needed.

      • Children 2 to 4 years of age—160 mg every four hours as needed.

      • Children up to 2 years of age—Dose must be determined by your doctor.


    • For arthritis:
      • Adults and teenagers—A total of 3600 to 5400 mg a day, divided into several smaller doses.

      • Children—A total of 80 to 100 mg per kilogram (kg) (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.



  • For aspirin and caffeine

  • For oral dosage forms (capsule):
    • For pain or fever:
      • Adults and teenagers—325 to 500 milligrams (mg) of aspirin every three or four hours, 650 mg of aspirin every four to six hours, or 1000 mg of aspirin every six hours as needed.

      • Children 9 to 12 years of age—325 to 400 mg every four hours as needed.

      • Children 6 to 9 years of age—325 mg every four hours as needed.

      • Children up to 6 years of age—Aspirin and caffeine capsules are too strong for use in children up to 6 years of age


    • For preventing a heart attack, stroke, or other problems caused by blood clots:
      • Adults—325 mg a day or every other day. People who take smaller doses of aspirin will have to use a different product. Some people taking aspirin to prevent a stroke may need as much as 1000 mg a day.

      • Children—Use and dose must be determined by your doctor.



  • For oral dosage form (tablets):
    • For pain or fever:
      • Adults and teenagers—325 to 500 mg of aspirin every three or four hours, 650 mg of aspirin every four to six hours, or 1000 mg of aspirin every six hours as needed.

      • Children 9 to 12 years of age—325 to 400 mg every four hours as needed.

      • Children up to 9 years of age—Aspirin and caffeine tablets are too strong for use in children up to 9 years of age.


    • For arthritis:
      • Adults and teenagers—A total of 3600 to 5400 mg of aspirin a day, divided into several smaller doses.

      • Children—A total of 80 to 100 mg per kg (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.


    • For preventing a heart attack, stroke, or other problems caused by blood clots:
      • Adults—325 mg a day or every other day. People who take smaller doses of aspirin will have to use a different product. Some people taking aspirin to prevent a stroke may need as much as 1000 mg a day.

      • Children—Use and dose must be determined by your doctor.



  • For buffered aspirin

  • For oral dosage forms (tablets):
    • For pain or fever:
      • Adults and teenagers—325 to 500 milligrams (mg) of aspirin every three or four hours, 650 mg of aspirin every four to six hours, or 1000 mg of aspirin every six hours as needed.

      • Children 11 to 12 years of age—One or one and one-half 325-mg tablets every four hours as needed.

      • Children 9 to 11 years of age—One or one and one-fourth 325-mg tablets every four hours as needed.

      • Children 6 to 9 years of age—One 325-mg tablet every four hours as needed.

      • Children 4 to 6 years of age—Three-fourths of a 325-mg tablet every four hours as needed.

      • Children 2 to 4 years of age—One-half of a 325-mg tablet every four hours as needed.

      • Children up to 2 years of age—Dose must be determined by your doctor.


    • For arthritis:
      • Adults and teenagers—A total of 3600 to 5400 mg of aspirin a day, divided into several smaller doses.

      • Children—A total of 80 to 100 mg per kilogram (kg) (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.


    • For preventing a heart attack, stroke, or other problems caused by blood clots:
      • Adults—325 mg a day or every other day. People who take smaller doses of aspirin will have to use a different product. Some people taking aspirin to prevent a stroke may need as much as 1000 mg a day.

      • Children—Use and dose must be determined by your doctor.



  • For buffered aspirin and caffeine

  • For oral dosage form (tablets):
    • For pain or fever:
      • Adults and teenagers—325 or 421 milligrams (mg) of aspirin every three or four hours, 650 mg of aspirin every four to six hours, or 842 mg of aspirin every six hours as needed.

      • Children 11 to 12 years of age—One or one and one-half 325-mg tablets, or one 421-mg tablet, every four hours as needed.

      • Children 9 to 11 years of age—One or one and one-fourth 325-mg tablets every four hours as needed.

      • Children 6 to 9 years of age—One 325-mg or 421-mg tablet every four hours as needed.

      • Children 4 to 6 years of age—Three-fourths of a 325-mg tablet every four hours as needed.

      • Children 2 to 4 years of age—One-half of a 325-mg tablet every four hours as needed.

      • Children up to 2 years of age—Dose must be determined by your doctor.


    • For arthritis:
      • Adults and teenagers—A total of 3600 to 5400 mg of aspirin a day, divided into several smaller doses.

      • Children—A total of 80 to 100 mg per kilogram (kg) (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.


    • For preventing a heart attack, stroke, or other problems caused by blood clots:
      • Adults—162.5 or 325 mg (one-half or one 325-mg tablet) a day or 325 mg every other day. People who need smaller doses of aspirin will have to use a different product. Some people taking aspirin to prevent a stroke may need as much as 1000 mg a day.

      • Children—Use and dose must be determined by your doctor.



  • For choline salicylate

  • For oral dosage form (oral solution):
    • For pain or fever:
      • Adults and teenagers—One-half or three-fourths of a teaspoonful every three hours, one-half or one teaspoonful every four hours, or one or one and one-half teaspoonfuls every six hours as needed.

      • Children 11 to 12 years of age—2.5 to 3.75 mL (one-half to three-fourths of a teaspoonful) every four hours as needed. This amount should be measured by a special measuring spoon.

      • Children 6 to 11 years of age—2.5 mL (one-half of a teaspoonful) every four hours as needed. This amount should be measured by a special measuring spoon.

      • Children 4 to 6 years of age—1.66 mL every four hours as needed. This amount should be measured by a special dropper or measuring spoon.

      • Children 2 to 4 years of age—1.25 milliliters (mL) (one-fourth of a teaspoonful) every four hours as needed. This amount should be measured by a special dropper or measuring spoon.

      • Children up to 2 years of age—Dose must be determined by your doctor.


    • For arthritis:
      • Adults—A total of five and one-half to eight teaspoonfuls a day, divided into several smaller doses.

      • Children—A total of 0.6 to 0.7 mL per kilogram (kg) (0.25 to 0.28 mL per pound) of body weight a day, divided into several smaller doses.



  • For choline and magnesium salicylates

  • For oral dosage forms (oral solution or tablets):
    • For pain or fever:
      • Adults and teenagers—A total of 2000 to 3000 milligrams (mg) a day, divided into two or three doses.

      • Children weighing more than 37 kg (90 pounds or more)—2200 mg a day, divided into two doses.

      • Children weighing up to 37 kilograms (kg) (about 89 pounds)—A total of 50 mg per kg (20 mg per pound) of body weight a day, divided into two doses.



  • For magnesium salicylate

  • For oral dosage form (tablets):
    • For pain:
      • Adults and teenagers—2 regular-strength tablets every four hours, up to a maximum of 12 tablets a day, or 2 extra-strength tablets every eight hours, up to a maximum of 8 tablets a day.

      • Children—Dose must be determined by your doctor.



  • For salsalate

  • For oral dosage forms (capsules or tablets):
    • For arthritis:
      • Adults and teenagers—500 to 1000 milligrams (mg) two or three times a day, to start. Your doctor will then adjust your dose as needed.

      • Children—Dose must be determined by your doctor.



  • For sodium salicylate

  • For oral dosage forms (tablets or delayed-release [enteric-coated] tablets):
    • For pain or fever:
      • Adults and teenagers—325 or 650 milligrams (mg) every four hours as needed.

      • Children 6 years of age and older—325 mg every four hours as needed.

      • Children up to 6 years of age—This medicine is too strong for use in children younger than 6 years of age.


    • For arthritis:
      • Adults and teenagers—A total of 3600 to 5400 mg a day, divided into several smaller doses.

      • Children—A total of 80 to 100 mg per kilogram (kg) (32 to 40 mg per pound) of body weight a day, divided into several smaller doses.



Missed Dose


If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Keep out of the reach of children.


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using Salflex


Check the labels of all nonprescription (over-the-counter [OTC]) and prescription medicines you now take. If any contain aspirin or other salicylates (including bismuth subsalicylate [e.g., Pepto-Bismol] or any shampoo or skin medicine that contains salicylic acid or any other salicylate), check with your health care professional. Taking or using them together with this medicine may cause an overdose.


If you will be taking salicylates for a long time (more than 5 days in a row for children or 10 days in a row for adults) or in large amounts, your doctor should check your progress at regular visits.


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


Check with your medical doctor or dentist:


  • If you are taking this medicine to relieve pain and the pain lasts for more than 10 days (5 days for children) or if the pain gets worse, if new symptoms occur, or if redness or swelling is present. These could be signs of a serious condition that needs medical or dental treatment.

  • If you are taking this medicine to bring down a fever, and the fever lasts for more than 3 days or returns, if the fever gets worse, if new symptoms occur, or if redness or swelling is present. These could be signs of a serious condition that needs treatment.

  • If you are taking this medicine for a sore throat, and the sore throat is very painful, lasts for more than 2 days, or occurs together with or is followed by fever, headache, skin rash, nausea, or vomiting.

  • If you are taking this medicine regularly, as for arthritis (rheumatism), and you notice a ringing or buzzing in your ears or severe or continuing headaches. These are often the first signs that too much salicylate is being taken. Your doctor may want to change the amount of medicine you are taking every day.

For patients taking aspirin to lessen the chance of heart attack, stroke, or other problems caused by blood clots:


  • Take only the amount of aspirin ordered by your doctor. If you need a medicine to relieve pain, a fever, or arthritis, your doctor may not want you to take extra aspirin. It is a good idea to discuss this with your doctor, so that you will know ahead of time what medicine to take.

  • Do not stop taking this medicine for any reason without first checking with the doctor who directed you to take it.

Taking certain other medicines together with a salicylate may increase the chance of unwanted effects. The risk will depend on how much of each medicine you take every day, and on how long you take the medicines together. If your doctor directs you to take these medicines together on a regular basis, follow his or her directions carefully. However, do not take any of the following medicines together with a salicylate for more than a few days, unless your doctor has directed you to do so and is following your progress:


  • Acetaminophen (e.g., Tylenol)

  • Diclofenac (e.g., Voltaren)

  • Diflunisal (e.g., Dolobid)

  • Etodolac (e.g., Lodine)

  • Fenoprofen (e.g., Nalfon)

  • Floctafenine (e.g., Idarac)

  • Flurbiprofen, oral (e.g., Ansaid)

  • Ibuprofen (e.g., Motrin)

  • Indomethacin (e.g., Indocin)

  • Ketoprofen (e.g., Orudis)

  • Ketorolac (e.g., Toradol)

  • Meclofenamate (e.g., Meclomen)

  • Mefenamic acid (e.g., Ponstel)

  • Nabumetone (e.g., Relafen)

  • Naproxen (e.g., Naprosyn)

  • Oxaprozin (e.g., Daypro)

  • Phenylbutazone (e.g., Butazolidin)

  • Piroxicam (e.g., Feldene)

  • Sulindac (e.g., Clinoril)

  • Tenoxicam (e.g., Mobiflex)

  • Tiaprofenic acid (e.g., Surgam)

  • Tolmetin (e.g., Tolectin)

For diabetic patients:


  • False urine sugar test results may occur if you are regularly taking large amounts of salicylates, such as:
    • Aspirin: 8 or more 325-mg (5-grain), or 4 or more 500-mg or 650-mg (10-grain), or 3 or more 800-mg (or higher strength), doses a day.

    • Buffered aspirin or

    • Sodium salicylate: 8 or more 325-mg (5-grain), or 4 or more 500-mg or 650-mg (10-grain), doses a day.

    • Choline salicylate: 4 or more teaspoonfuls (each teaspoonful containing 870 mg) a day.

    • Choline and magnesium salicylates: 5 or more 500-mg tablets or teaspoonfuls, 4 or more 750-mg tablets, or 2 or more 1000-mg tablets, a day.

    • Magnesium salicylate: 7 or more regular-strength, or 4 or more extra-strength, tablets a day.

    • Salsalate: 4 or more 500-mg doses, or 3 or more 750-mg doses, a day.


  • Smaller doses or occasional use of salicylates usually will not affect urine sugar tests. However, check with your health care professional (especially if your diabetes is not well-controlled) if:
    • you are not sure how much salicylate you are taking every day.

    • you notice any change in your urine sugar test results.

    • you have any other questions about this possible problem.


Do not take aspirin for 5 days before any surgery, including dental surgery, unless otherwise directed by your medical doctor or dentist. Taking aspirin during this time may cause bleeding problems.


For patients taking buffered aspirin, choline and magnesium salicylates (e.g., Trilisate), or magnesium salicylate (e.g., Doan's):


  • Buffered aspirin, choline and magnesium salicylates, or magnesium salicylate can keep many other medicines, especially some medicines used to treat infections, from working properly. This problem can be prevented by not taking the 2 medicines too close together. Ask your health care professional how long you should wait between taking a medicine for infection and taking buffered aspirin, choline and magnesium salicylates, or magnesium salicylate.

If you are taking a laxative containing cellulose, take the salicylate at least 2 hours before or after you take the laxative. Taking these medicines too close together may lessen the effects of the salicylate.


For patients taking this medicine by mouth:


  • Stomach problems may be more likely to occur if you drink alcoholic beverages while being treated with this medicine, especially if you are taking it in high doses or for a long time. Check with your doctor if you have any questions about this.

For patients using aspirin suppositories:


  • Aspirin suppositories may cause irritation of the rectum. Check with your doctor if this occurs.

Salicylates may interfere with the results of some medical tests. Before you have any medical tests, tell the doctor in charge if you have taken any of these medicines within the past week. If possible, it is best to check with the doctor first, to find out whether the medicine may be taken during the week before the test.


For patients taking one of the products that contain caffeine:


  • Caffeine may interfere with the result of a test that uses adenosine (e.g., Adenocard) or dipyridamole (e.g., Persantine) to help find out how well your blood is flowing through certain blood vessels. Therefore, you should not have any caffeine for at least 8 to 12 hours before the test.

If you think that you or anyone else may have taken an overdose, get emergency help at once. Taking an overdose of these medicines may cause unconsciousness or death. Signs of overdose include convulsions (seizures), hearing loss, confusion, ringing or buzzing in the ears, severe drowsiness or tiredness, severe excitement or nervousness, and fast or deep breathing.


Salflex 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.


Get emergency help immediately if any of the following side effects occur:


Symptoms of overdose in children
  • Changes in behavior

  • drowsiness or tiredness (severe)

  • fast or deep breathing

  • Any loss of hearing

  • bloody urine

  • confusion

  • convulsions (seizures)

  • diarrhea (severe or continuing)

  • difficulty in swallowing

  • dizziness, lightheadedness, or feeling faint (severe)

  • drowsiness (severe)

  • excitement or nervousness (severe)

  • fast or deep breathing

  • flushing, redness, or other change in skin color

  • hallucinations (seeing, hearing, or feeling things that are not there)

  • increased sweating

  • increased thirst

  • nausea or vomiting (severe or continuing)

  • shortness of breath, troubled breathing, tightness in chest, or wheezing

  • stomach pain (severe or continuing)

  • swelling of eyelids, face, or lips

  • unexplained fever

  • uncontrollable flapping movements of the hands (especially in elderly patients)

  • vision problems

Check with your doctor as soon as possible if any of the following side effects occur:


Less common or rare
  • Abdominal or stomach pain, cramping, or burning (severe)

  • bloody or black, tarry stools

  • headache (severe or continuing)

  • ringing or buzzing in ears (continuing)

  • skin rash, hives, or itching

  • unusual tiredness or weakness

  • vomiting of blood or material that looks like coffee grounds

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
  • Abdominal or stomach cramps, pain, or discomfort (mild to moderate)

  • heartburn or indigestion

  • nausea or vomiting

Less common
  • Trouble in sleeping, nervousness, or jitters (only for products containing caffeine)

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.



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

Friday, 6 July 2012

Febuxostat


Class: Antigout Agents
VA Class: MS400
Chemical Name: 2-[3-cyano-4-(2-methylpropoxy) phenyl]-4-methylthiazole-5-carboxylic acid
Molecular Formula: C16H16N2O3S
CAS Number: 144060-53-7
Brands: Uloric

Introduction

Xanthine oxidase inhibitor.1 2 3 4 5 6 8


Uses for Febuxostat


Gout


Long-term management of hyperuricemia in patients with gout.1 2 3 4 5 6 7


Goal in management of gout is reduction in serum urate concentrations to levels below the limit of urate solubility (about 6.8 mg/dL).2 4


Not recommended for the management of asymptomatic hyperuricemia.1


Febuxostat Dosage and Administration


General



  • Acute gout attacks (gout flare) may occur after initiation of febuxostat.1 Consider gout flare prophylaxis with an NSAIA or colchicine; start these agents when febuxostat therapy is initiated.1 Gout flare prophylaxis may be beneficial for up to 6 months.1 During these acute attacks, continue febuxostat and manage the gout flare as appropriate.1




  • Testing for target serum urate concentrations can be performed after 2 weeks of febuxostat therapy.1



Administration


Oral Administration


Administered orally without regard to meals or antacids.1 10


Dosage


Adults


Gout

Oral

Initial dosage is 40 mg once daily.1 Increase dosage to 80 mg once daily in patients who do not achieve serum urate concentrations of <6 mg/dL after 2 weeks of therapy with febuxostat 40 mg once daily.1


Special Populations


Dosage adjustment is not needed in patients with mild to moderate renal or hepatic impairment.1 8


Cautions for Febuxostat


Contraindications



  • Concomitant therapy with azathioprine, mercaptopurine, or theophylline.1 (See Interactions.)



Warnings/Precautions


Acute Gout


Febuxostat initiation may increase frequency of acute gout attacks (gout flare).1 Consider gout flare prophylaxis with an NSAIA or colchicine; start these agents when febuxostat therapy is initiated.1


Cardiovascular Events


Higher rate of cardiovascular thromboembolic events (cardiovascular deaths, nonfatal MI, nonfatal stroke) in patients receiving febuxostat than in patients receiving allopurinol.1 Causal relationship not established.1 Monitor for signs and symptoms of MI and stroke.1


Hepatic Effects


Elevations of serum transaminase concentrations reported.1 Perform liver function tests during therapy (e.g., at month 2 and 4 of therapy and then periodically).1


Specific Populations


Pregnancy

Category C.1


Lactation

Distributed into milk in rats; not known whether distributed into human milk.1 Use with caution in nursing women.1


Pediatric Use

Safety and efficacy have not been established in pediatric patients <18 years of age.1


Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity of some older patients cannot be ruled out.1


Dosage adjustment based on age not needed.1 3


Hepatic Impairment

Not studied in patients with severe hepatic impairment (Child-Pugh class C); caution if used in these individuals.1 Dosage adjustment not needed in patients with mild to moderate hepatic impairment (Child-Pugh class A or B).1 8


Renal Impairment

Insufficient date in patients with severe renal impairment (Clcr <30 mL/minute); caution if used in these individuals.1 Dosage adjustment not needed in patients with mild to moderate renal impairment (Clcr 30–89 mL/minute).1


Not studied in individuals with end-stage renal disease who are undergoing dialysis.1


Secondary Hyperuricemia

Not evaluated in patients with secondary hyperuricemia.1 Not recommended in patients whose rate of urate formation is greatly increased.1


Common Adverse Effects


Liver function abnormalities, nausea, arthralgia, rash.1


Interactions for Febuxostat


Febuxostat does not inhibit cytochrome P-450 (CYP) isoenzymes 1A2, 2C9, 2C19, or 3A4; febuxostat is a weak inhibitor of CYP2D6.1 Febuxostat does not induce CYP1A2, 2B6, 2C9, 2C19, 3A4.1


Febuxostat is metabolized by conjugation by glucuronosyltransferase (uridine diphosphoglucuronosyltransferase, UDP-glucuronate β-D-glucuronosyltransferase [acceptor-unspecific], UGT) enzymes, including UGT1A1, UGT1A3, UGT1A9, and UGT2B7, as well as by oxidation by CYP isoenzymes, including CYP1A2, 2C8, and 2C9, and non-CYP enzymes.1 Relative contribution of each enzyme isoform to the drug's metabolism is not clear.1


Drugs Affecting Hepatic Microsomal or Other Enzymes


Drug interactions generally are not expected between febuxostat and inhibitors or inducers of particular enzyme isoforms.1


Drugs Metabolized by Hepatic Microsomal Enzymes


Pharmacokinetic interactions are unlikely between febuxostat and substrates of these isoenzymes.1


Drugs Metabolized by Xanthine Oxidase


Inhibition of xanthine oxidase by febuxostat may increase plasma concentrations of drugs metabolized by the enzyme if administered concomitantly, resulting in toxicity.1 (See Contraindications.)


Specific Drugs




































Drug



Interaction



Comments



Antacids



Pharmacokinetic interaction unlikely1 10



Antineoplastic agents



Not evaluated1


Mercaptopurine: Inhibition of mercaptopurine metabolism; possible increase in toxic effects1



No information on safety of concomitant use1


Mercaptopurine: Concomitant use contraindicated1



Azathioprine



Inhibition of azathioprine metabolism; possible increase in toxic effects1



Concomitant use contraindicated1



Colchicine



Clinically important pharmacokinetic interaction unlikely1



Dosage adjustment not needed



Desipramine



Pharmacokinetic interaction not considered clinically important1



Dosage adjustment not expected to be necessary1



Hydrochlorothiazide



Clinically important pharmacokinetic interaction unlikely1



Dosage adjustment not needed



Indomethacin



Clinically important pharmacokinetic interaction unlikely1



Dosage adjustment not needed



Naproxen



Clinically important pharmacokinetic interaction unlikely1



Dosage adjustment not needed



Theophylline



Inhibition of theophylline metabolism; possible increase in toxic effects1



Concomitant use contraindicated1



Warfarin



Pharmacokinetic interaction unlikely1



Dosage adjustment not needed


Febuxostat Pharmacokinetics


Absorption


Bioavailability


Peak plasma concentrations of febuxostat are reached in 1–1.5 hours.1 3


Food


Administration with food decreases the rate and extent of absorption of febuxostat; not considered clinically important.1 10


Distribution


Plasma Protein Binding


99.2%.1


Elimination


Metabolism


Febuxostat is metabolized by uridine diphosphate-glucuronosyltransferase (UGT) 1A1, 1A3, 1A9, 2B7, CYP 1A2, 2C8, 2C9, and other enzymes.1


Elimination Route


Excreted in urine (49%) and feces (45%), principally as metabolites.1


Half-life


5–8 hours.1


Special Populations


Pharmacokinetic values in geriatric adults similar to those in younger adults.1 3


Extent of absorption and half-life increased in individuals with renal impairment; not considered clinically important.1


Extent of absorption increased in individuals with mild to moderate hepatic impairment; not considered clinically important.1 8


Stability


Storage


Oral


Tablets

25°C (may be exposed to 15–30°C).1


ActionsActions



  • Febuxostat inhibits xanthine oxidase, the enzyme that catalyzes the conversion of hypoxanthine to xanthine and xanthine to uric acid.1 3 By blocking uric acid production, febuxostat decreases serum concentrations of uric acid.1 2 3




  • Febuxostat has minimal effects on other enzymes involved in purine and pyrimidine synthesis and metabolism.1 2



Advice to Patients



  • Possibility of gout flares, liver function abnormalities, and cardiovascular events.1




  • Importance of informing clinician of rash, chest pain, shortness of breath, or symptoms suggestive of stroke.1




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal products and any concomitant illnesses.1




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1




  • Importance of advising patients of other important precautionary information.1 (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.


















Febuxostat

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Tablets



40 mg



Uloric



Takeda



80 mg



Uloric



Takeda



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions February 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References



1. Takeda Pharmaceuticals America. Uloric (febuxostat) tablets prescribing information. Deerfield, Il; 2009 Feb.



2. Becker MA, Schumacher HR, Wortmann RL et al. Febuxostat compared with allopurinol in patients with hyperuricemia and gout. N Engl J Med. 2005; 353:2450-61. [PubMed 16339094]



3. Khosravan R, Kukulka MJ, Wu J-T et al. The effect of age and gender on pharmacokinetics, pharmacodynamics, and safety of febuxostat, a novel nonpurine selective inhibitor of xanthine oxidase. J Clin Pharmacol. 2008; 48:1014-24. [PubMed 18635756]



4. Schumacher HR, Becker MA, Wortmann RL et al. Effects of febuxostat versus allopurinol and placebo in reducing serum urate in subjects with hyperuricemia and gout: a 28-week, phase III, randomized, double-blind, parallel-group trial. Arthritis Rheum. 2008; 59:1540-8. [PubMed 18975369]



5. Becker MA, Schumacher HR, MacDonald PA et al. Clinical efficacy and safety of successful longterm urate lowering with febuxostat or allopurinol in subjects with gout. J Rheumatol. 2009; 36:1273-82. [PubMed 19286847]



6. Anon. Febuxostat (Uloric) for chronic treatment of gout. Med Lett Drugs Ther. 2009; 51:37-8.



7. Becker M, Schumacher HR, Espinoza L et al. A phase 3 randomized, controlled, multicenter, double-blind trial (RCT) comparing efficacy and safety of daily febuxostat (FEB) and allopurinol (ALLO) in subjects with gout. 2008 annual meeting American College of Rheumatology, San Francisco.



8. Khosravan R, Grabowski BA, Mayer MD et al. The effect of mild and moderate hepatic impairment on pharmacokinetics, pharmacodynamics, and safety of febuxostat, a novel nonpurine selective inhibitor of xanthine oxidase. J Clin Pharmacol. 2006; 46:88-102. [PubMed 16397288]



9. Khosravan R, Wu J-T, Joseph-Ridge N et al. Pharmacokinetic interactions of concomitant administration of febuxostat and NSAIDs. J Clin Pharmacol. 2006; 46:855-66. [PubMed 16855070]



10. Khosravan R, Grabowski B, Wu J-T et al. Effect of food or antacid on pharmacokinetics and pharmacodynamics of febuxostat in healthy subjects. Br J Clin Pharmacol. 2007; 65:355-63. [PubMed 17953718]



More Febuxostat resources


  • Febuxostat Side Effects (in more detail)
  • Febuxostat Dosage
  • Febuxostat Use in Pregnancy & Breastfeeding
  • Febuxostat Drug Interactions
  • Febuxostat Support Group
  • 6 Reviews for Febuxostat - Add your own review/rating


  • Febuxostat MedFacts Consumer Leaflet (Wolters Kluwer)

  • Febuxostat Professional Patient Advice (Wolters Kluwer)

  • febuxostat Advanced Consumer (Micromedex) - Includes Dosage Information

  • Uloric Prescribing Information (FDA)

  • Uloric Consumer Overview



Compare Febuxostat with other medications


  • Gout

HAD


Generic Name: benzocaine (Oral route, Oromucosal route)

BEN-zoe-kane

Commonly used brand name(s)

In the U.S.


  • Anbesol

  • Babee Teething

  • Benzodent

  • Benz-O-Sthetic

  • Bi-Zets/Benzo-Troches

  • Dentemp's

  • Dent-O-Kain/20

  • Detane

  • Gumsol

  • HAD

  • Hurricaine

  • Hurricane Spray Kit

  • Kank-A Soft Brush

  • Larynex

  • Miradyne-3

  • Mycinette

  • Orabase-B

  • Oracaine

  • Ora film

  • Orajel

  • OraMagic Plus

  • Orasol

  • Red Cross Canker Sore

  • Thorets

  • Trocaine

  • Zetts

  • Zilactin

  • Zilactin-B

In Canada


  • Anbesol Extra Strength

  • Anbesol Liquid

  • Baby Anbesol

  • Baby Orajel

  • Baby Orajel Liquid

  • Maximum Strength Orajel Pm

  • Orajel Extra Strength

Available Dosage Forms:


  • Liquid

  • Gel/Jelly

  • Solution

  • Lozenge/Troche

  • Film

  • Lotion

  • Ointment

  • Powder for Suspension

  • Cream

  • Tablet, Disintegrating

  • Swab

  • Spray

  • Gum

  • Paste

Therapeutic Class: Anesthetic, Local


Chemical Class: Amino Ester


Uses For HAD


Benzocaine lozenges are used to relieve pain and irritation caused by sore throat, sore mouth, or canker sores.


This medicine is available without a prescription; however, your doctor may have special instructions on the proper use and dose for your medical problem.


Before Using HAD


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


No information is available on the relationship of age to the effects of benzocaine lozenges in the pediatric population. Safety and efficacy have not been established in children below 5 years of age.


Geriatric


No information is available on the relationship of age to the effects of benzocaine in geriatric patients.


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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.


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.


Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Infection in or around your mouth or

  • Large sores in or around your mouth—The chance of side effects may be increased.

Proper Use of benzocaine

This section provides information on the proper use of a number of products that contain benzocaine. It may not be specific to HAD. Please read with care.


Use this medicine exactly as directed by your doctor. Do not use more of this medicine, do not use it more often, and do not use it for a longer time than directed. To do so may increase the chance of absorption into the body and the risk of side effects.


This medicine should be used only for problems being treated by your doctor or conditions listed in the package directions. Check with your doctor before using it for other problems, especially if you think that an infection may be present.


Do not use this medicine for more than 2 days without checking first with your doctor.


Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For oral dosage form (lozenges):
    • For sore throat and mouth pain:
      • Adults, teenagers, and children 5 years of age and older—One lozenge, dissolved slowly in the mouth every 2 hours as needed.

      • Children younger than 5 years of age—Use is not recommended.



Missed Dose


If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using HAD


If your condition does not improve within 7 days, or if it becomes worse, check with your doctor.


Call your doctor right away if you start to have a severe sore throat or sore throat that occurs with a high fever, headache, nausea, or vomiting. These maybe signs of an infection.


HAD 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:


Incidence not known
  • Headache

  • high fever

  • nausea

  • vomiting

  • worsening of pain, redness, swelling, or irritation in or around the mouth

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.



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More HAD resources


  • HAD Use in Pregnancy & Breastfeeding
  • HAD Support Group
  • 6 Reviews for HAD - Add your own review/rating


Compare HAD with other medications


  • Anal Itching
  • Anesthesia
  • Aphthous Ulcer
  • Burns, External
  • Cold Sores
  • Hemorrhoids
  • Oral and Dental Conditions
  • Pain
  • Pruritus
  • Sunburn
  • Tonsillitis/Pharyngitis

Tuesday, 3 July 2012

hydrocortisone valerate Topical application



hye-droe-KOR-ti-sone VAL-er-ate


Commonly used brand name(s)

In the U.S.


  • Westcort

In Canada


  • Hydroval

  • Tarocort

Available Dosage Forms:


  • Ointment

  • Cream

Therapeutic Class: Corticosteroid, Intermediate


Pharmacologic Class: Hydrocortisone


Uses For hydrocortisone valerate


Hydrocortisone valerate topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. hydrocortisone valerate is a corticosteroid (cortisone-like medicine or steroid).


hydrocortisone valerate is available only with your doctor's prescription.


Before Using hydrocortisone valerate


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 hydrocortisone valerate, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to hydrocortisone valerate 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 hydrocortisone valerate topical in the pediatric population. However, because of hydrocortisone valerate's toxicity, it should be used with caution. Children and teenagers who must use hydrocortisone valerate should be checked often by their doctor since hydrocortisone valerate topical may be absorbed through the skin and can affect growth or cause other unwanted effects. Safety and effectiveness have not been established.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hydrocortisone valerate topical in the elderly.


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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.


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.


Other Medical Problems


The presence of other medical problems may affect the use of hydrocortisone valerate. Make sure you tell your doctor if you have any other medical problems, especially:


  • Cushing's syndrome (adrenal gland disorder) or

  • Diabetes or

  • Hyperglycemia (high blood sugar) or

  • Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

  • Infection at or near the place of application or

  • Large sores, broken skin, or severe injury at the area of application—The chance of side effects may be increased.

Proper Use of hydrocortisone valerate


Use hydrocortisone valerate exactly as directed by your doctor. Do not use it for any other condition without first checking with your doctor. hydrocortisone valerate may cause unwanted effects if it is used too much, because more of it is absorbed into the body through the skin.


Wash your hands with soap and water before and after using hydrocortisone valerate.


Be very careful not to get hydrocortisone valerate in your eyes. Wash your hands after using your finger to apply the medicine. If you accidentally get hydrocortisone valerate in your eyes, flush them with water.


Apply a thin layer of hydrocortisone valerate to the affected area of the skin. Rub it in gently.


Unless otherwise directed by your doctor, do not apply hydrocortisone valerate to open wounds, burns, or broken or inflamed skin.


hydrocortisone valerate should only be used for problems being treated by your doctor. Check with your doctor before using it for other problems, especially if you think that an infection may be present. hydrocortisone valerate should not be used to treat certain kinds of skin infections or serious problems, such as severe burns.


Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.


If your doctor has ordered an occlusive dressing (airtight covering, such as kitchen plastic wrap or a special patch) to be applied over hydrocortisone valerate, make sure you know how to apply it. Since occlusive dressings increase the amount of medicine absorbed through your skin and the possibility of side effects, use them only as directed. If you have any questions about this, check with your doctor.


Do not use hydrocortisone valerate on the face, groin, or underarms unless directed to do so by your doctor.


Dosing


The dose of hydrocortisone valerate will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of hydrocortisone valerate. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For topical dosage forms (cream and ointment):
    • For redness, itching, and swelling of the skin:
      • Adults—Apply to the affected area of the skin two or three times a day.

      • Children—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of hydrocortisone valerate, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using hydrocortisone valerate


It is very important that your doctor check your or your child's progress at regular visits for any problems or unwanted effects that may be caused by hydrocortisone valerate.


If your symptoms do not improve within 2 weeks, or if it become worse, check with your doctor.


After applying hydrocortisone valerate to the skin of your child, watch the child carefully to make sure that he or she does not get any of the medicine in the eyes or mouth. hydrocortisone valerate can cause serious side effects, especially in children, if it gets into the mouth and is swallowed.


Using too much of hydrocortisone valerate or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and for patients who use large amounts for a long time. Talk to your doctor if you or your child have more than one of these symptoms while you are using hydrocortisone valerate: blurred vision; dizziness or fainting; fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.


Stop using hydrocortisone valerate and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.


Avoid using tight-fitting diapers or plastic pants on a child if hydrocortisone valerate is being used on the child's diaper area. Plastic pants and tight-fitting diapers may increase the chance of absorption of the medicine through the skin and the chance of side effects.


Do not use cosmetics or other skin care products on the treated skin areas.


hydrocortisone valerate 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:


More common
  • Skin rash, encrusted, scaly, and oozing

  • stinging

Less common
  • Burning, itching, redness, skin rash, swelling, or soreness at the application site

  • cough or hoarseness

  • dry skin

  • fever or chills

  • itching in the genital or other skin areas

  • lower back or side pain

  • painful or difficult urination

  • rash

  • rash with flat lesions or small raised lesions on the skin

  • skin irritation

Incidence not known
  • Blistering, burning, crusting, dryness, or flaking of the skin

  • itching, scaling, severe redness, soreness, or swelling of the skin

  • redness and scaling around the mouth

  • thinning of the skin with easy bruising, especially when used on facial or intertriginous areas

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:


Less common
  • Diarrhea

  • indigestion

  • loss of appetite

  • nausea or vomiting

  • passing of gas

  • stomach pain, fullness, or discomfort

Incidence not known
  • Acne or pimples

  • burning and itching of the skin with pinhead-sized red blisters

  • burning, itching, and pain in hairy areas, or pus at the root of the hair

  • increased hair growth on the forehead, back, arms, and legs

  • lightening of normal skin color

  • lightening of treated areas of dark skin

  • reddish purple lines on the arms, face, legs, trunk, or groin

  • softening of the skin

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.



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More hydrocortisone valerate Topical application resources


  • Hydrocortisone valerate Topical application Use in Pregnancy & Breastfeeding
  • Hydrocortisone valerate Topical application Drug Interactions
  • Hydrocortisone valerate Topical application Support Group
  • 15 Reviews for Hydrocortisone valerate Topical application - Add your own review/rating


Compare hydrocortisone valerate Topical application with other medications


  • Anal Itching
  • Aphthous Stomatitis, Recurrent
  • Atopic Dermatitis
  • Dermatitis
  • Eczema
  • Gingivitis
  • Hemorrhoids
  • Proctitis
  • Pruritus
  • Psoriasis
  • Seborrheic Dermatitis
  • Skin Rash
  • Ulcerative Colitis, Active

Sunday, 1 July 2012

Topcare Ibuprofen Oral Suspension




Generic Name: ibuprofen

Dosage Form: oral suspension
Topco Children's Ibuprofen Oral Suspension Drug Facts

Active ingredient (in each 5 mL = 1 teaspoonful)


Ibuprofen 100 mg (NSAID)*


*nonsteroidal anti-inflammatory drug



Purpose


Pain reliever/fever reducer



Uses


temporarily:


  • relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache

  • reduces fever


Warnings


Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:


  • hives

  • facial swelling

  • asthma (wheezing)

  • shock

  • skin reddening

  • rash

  • blisters

If an allergic reaction occurs, stop use and seek medical help right away.


Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding.


The chance is higher if your child


  • has had stomach ulcers or bleeding problems

  • takes a blood thinning (anticoagulant) or steroid drug

  • takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

  • takes more or for a longer time than directed

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.



Do not use


  • if the child has ever had an allergic reaction to any other pain reliever/fever reducer

  • right before or after heart surgery


Ask a doctor before use if


  • the stomach bleeding warning applies to your child

  • child has a history of stomach problems, such as heartburn

  • child has not been drinking fluids

  • child has lost a lot of fluid due to vomiting or diarrhea

  • child has high blood pressure, heart disease, liver cirrhosis, or kidney disease

  • child has asthma

  • child is taking a diuretic


Ask a doctor or pharmacist before use if the child is


  • under a doctor’s care for any serious condition

  • taking any other drug


When using this product


  • give with food or milk if stomach upset occurs

  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed


Stop use and ask a doctor if


  • child experiences any of the following signs of stomach bleeding:

  • feels faint

  • vomits blood

  • has bloody or black stools

  • has stomach pain that does not get better

  • the child does not get any relief within first day (24 hours) of treatment

  • fever or pain gets worse or lasts more than 3 days

  • redness or swelling is present in the painful area

  • any new symptoms appear


Keep out of reach of children.


In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)



Directions


  • this product does not contain directions or complete warnings for adult use

  • do not give more than directed

  • do not give longer than 10 days, unless directed by a doctor (see Warnings)

  • shake well before using

  • find right dose on chart. If possible, use weight to dose; otherwise use age.

  • use only enclosed measuring cup

  • if needed, repeat dose every 6-8 hours

  • do not use more than 4 times a day

  • replace original bottle cap to maintain child resistance

  • wash dosage cup after each use























Dosing Chart
Weight (lb)Age(yrs)Dose (teaspoonful or mL)
under 2 yearsask a doctor
24-35 lbs2-3 years1 tsp or 5 mL
36-47 lbs4-5 years1 ½ tsp or 7.5 mL
48-59 lbs6-8 years2 tsp or 10 mL
60-71 lbs9-10 years2 ½ tsp or 12.5 mL
72-95 lbs11 years3 tsp or 15 mL

Other information


  • each teaspoon contains: sodium 2 mg

  • do not use if printed neckband is broken or missing

  • store at 20-25°C (68-77°F)

  • see bottom panel for lot number and expiration date


Inactive ingredients


anhydrous citric acid, butylparaben, D&C red #33, FD&C yellow #6, flavor, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, xanthan gum



Questions or comments?


1-888-423-0139



Principal Display Panel


See New Warnings Information


For Ages 2 to 11


Children’s


Ibuprofen Oral Suspension


100 mg per 5 mL (teaspoonful)


Pain Reliever/Fever Reducer (NSAID)


Lasts up to 8 hours


Alcohol Free


Berry Flavor


Compare to Children’s Motrin® Berry Flavor active ingredient


Children's Ibuprofen Oral Suspension Carton










TOPCARE IBUPROFEN 
ibuprofen  suspension










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)36800-897
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN)IBUPROFEN100 mg  in 5 mL





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorORANGEScore    
ShapeSize
FlavorBERRYImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
136800-897-261 BOTTLE In 1 CARTONcontains a BOTTLE
1120 mL In 1 BOTTLEThis package is contained within the CARTON (36800-897-26)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07493712/31/1998


Labeler - Topco Associates LLC (006935977)
Revised: 04/2010Topco Associates LLC




More Topcare Ibuprofen Oral Suspension resources


  • Topcare Ibuprofen Oral Suspension Side Effects (in more detail)
  • Topcare Ibuprofen Oral Suspension Use in Pregnancy & Breastfeeding
  • Drug Images
  • Topcare Ibuprofen Oral Suspension Drug Interactions
  • Topcare Ibuprofen Oral Suspension Support Group
  • 51 Reviews for Topcare Ibuprofen - Add your own review/rating


Compare Topcare Ibuprofen Oral Suspension with other medications


  • Aseptic Necrosis
  • Back Pain
  • Costochondritis
  • Cystic Fibrosis
  • Diffuse Idiopathic Skeletal Hyperostosis
  • Dysautonomia
  • Fever
  • Frozen Shoulder
  • Gout, Acute
  • Headache
  • Muscle Pain
  • Osteoarthritis
  • Pain
  • Patent Ductus Arteriosus
  • Period Pain
  • Rheumatoid Arthritis
  • Sciatica
  • Spondylolisthesis
  • Temporomandibular Joint Disorder