Urocit-K 5

Generic Name: citrate (Oral route)

Commonly used brand name(s)

In the U.S.

• Citra pH


• Cytra-K


• Cytra-K Crystals


• Liqui-DualCitra


• Polycitra-K


• Polycitra-K Crystals


• Urocit-K 10


• Urocit-K 15


• Urocit-K 5

In Canada

• Pms-Dicitrate

Available Dosage Forms:

• Tablet


• Solution


• Tablet, Extended Release


• Syrup


• Powder for Suspension

Uses For Urocit-K 5

Citrates are used to make the urine more alkaline (less acid). This helps prevent certain kinds of kidney stones. Citrates are sometimes used with other medicines to help treat kidney stones that may occur with gout. They are also used to make the blood more alkaline in certain conditions

Citrates are available only with your doctor's prescription.

Before Using Urocit-K 5

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

Although there is no specific information comparing use of citrates in children with use in other age groups, these medicines are not expected to cause different side effects or problems in children than they do in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of citrates in the elderly with use in other age groups.

Pregnancy

Studies on effects in pregnancy have not been done in either humans or animals.

Breast Feeding

Although it is not known whether citrates pass into the breast milk, this medicine has not been reported to cause problems in nursing babies.

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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Addison's disease (underactive adrenal glands) or


• Type 2 diabetes mellitus or


• Kidney disease—The potassium in potassium-containing citrates may worsen or cause heart problems in patients with these conditions.

• Diarrhea (chronic)—Treatment with citrates may not be effective; a change in dose of citrate may be needed.

• Edema (swelling of the feet or lower legs) or


• High blood pressure or


• Toxemia of pregnancy—The sodium in sodium-containing citrates may cause the body to retain (keep) water.

• Heart disease—The sodium in sodium-containing citrates may cause the body to retain (keep) water; the potassium in potassium-containing citrates may make heart disease worse.

• Intestinal or esophageal blockage—Potassium citrate tablets may cause irritation of the stomach or intestines.

• Stomach ulcer or other stomach problems—Potassium citrate–containing products may make these conditions worse.

• Urinary tract infection—Citrates may make conditions worse.

Proper Use of citrate

This section provides information on the proper use of a number of products that contain citrate. It may not be specific to Urocit-K 5. Please read with care.

For patients taking the tablet form of this medicine:

• Swallow the tablets whole. Do not crush, chew, or suck the tablet.


• Take with a full glass (8 ounces) of water.


• If you have trouble swallowing the tablets or they seem to stick in your throat, check with your doctor at once. If this medicine is not completely swallowed and not properly dissolved, it can cause severe irritation.

For patients taking the liquid form of this medicine:

• Dilute with a full glass (6 ounces) of water or juice and drink; follow with additional water, if desired.


• Chill, but do not freeze, this medicine before taking it, for a better taste.

For patients taking the crystals form of this medicine:

• Add the contents of one packet to at least 6 ounces of cool water or juice.


• Stir well to make sure the crystals are completely dissolved.


• Drink all the mixture to be sure you are taking the correct dose. Follow with additional water or juice, if desired.

Take each dose immediately after a meal or within 30 minutes after a meal or bedtime snack. This helps prevent the medicine from causing stomach pain or a laxative effect.

Drink at least a full glass (8 ounces) of water or other liquid (except milk) every hour during the day (about 3 quarts a day), unless otherwise directed by your doctor. This will increase the flow of urine and help prevent kidney stones.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important if you are also taking a diuretic (water pill) or digitalis medicine for your heart.

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 potassium citrate


• For oral dosage form (tablets):
  
  • To make the urine more alkaline (less acidic) and to prevent kidney stones:
    
    • Adults—At first, 1.08 to 2.16 grams three times a day with meals. Some people may take 1.62 grams four times a day with meals or within thirty minutes after a meal or bedtime snack. Your doctor may change your dose if needed. However, most people usually will not take more than 10.8 grams a day.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For potassium citrate and citric acid


• For oral dosage form (solution):
  
  • To make the urine or blood more alkaline (less acidic) and to prevent kidney stones:
    
    • Adults—At first, 2 to 3 teaspoonfuls of solution, mixed with water or juice, four times a day, after meals and at bedtime. Your doctor may change the dose if needed.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  
  • To make the urine more alkaline (less acidic):
    
    • Children—At first, 1 to 3 teaspoonfuls of solution, mixed with water or juice, four times a day after meals and at bedtime. Your doctor may change the dose if needed.
    
    
  
  


• For oral dosage form (crystals for solution):
  
  • To make the urine or blood more alkaline (less acidic) and to prevent kidney stones:
    
    • Adults—At first, 3.3 grams of potassium citrate, mixed with water or juice, four times a day, after meals and at bedtime. Your doctor may change the dose if needed.
    
    
    • Children—Use is not recommended.
    
    
  
  

• For potassium citrate and sodium citrate


• For oral dosage form (tablets):
  
  • To make the urine more alkaline (less acidic) and to prevent kidney stones:
    
    • Adults—At first, 1 to 4 tablets after meals and at bedtime.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For sodium citrate and citric acid


• For oral dosage form (solution):
  
  • To make the urine and blood more alkaline (less acidic) and to prevent kidney stones:
    
    • Adults—At first, 2 to 6 teaspoonfuls of solution four times a day, after meals and at bedtime. The solution should be mixed in one to three ounces of water. Your doctor may change the dose if needed. However, most people will usually not take more than five ounces a day.
    
    
  
  
  • To make the blood more alkaline (less acidic):
    
    • Adults—1 to 2 tablespoonfuls as a single dose. You may mix it in one to two tablespoonfuls of water.
    
    
  
  
  • To make the contents of the stomach less acidic before surgery:
    
    • Children—At first, 1 to 3 teaspoonfuls of solution four times a day, after meals and at bedtime. The solution should be mixed in one to three ounces of water. Your doctor may change the dose if needed.
    
    
  
  

• For tricitrates


• For oral dosage form (solution):
  
  • To make the urine and blood more alkaline (less acidic) and to prevent kidney stones:
    
    • Adults—At first, 1 to 2 tablespoonfuls of solution four times a day, after meals and at bedtime. Your doctor may change the dose if needed.
    
    
  
  
  • To make the contents of the stomach less acidic before surgery:
    
    • Adults—1 tablespoonful as a single dose. You should mix the solution in one tablespoonful of water.
    
    
  
  
  • To make the urine or blood more alkaline (less acidic):
    
    • Children—At first, 5 to 10 mL four times a day after meals and at bedtime. Your doctor may change the dose if needed.
    
    
  
  

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 Urocit-K 5

It is important that your doctor check your progress at regular visits. This is to make sure the medicine is working properly and to check for unwanted effects.

Do not eat salty foods or use extra table salt on your food while you are taking citrates. This will help prevent kidney stones and unwanted effects.

Check with your doctor before starting any strenuous physical exercise, especially if you are out of condition and are taking any other medication. Exercise and certain medications may increase the amount of potassium in the blood.

For patients taking potassium citrate–containing medicines:

• Do not use salt substitutes and low-salt milk unless told to do so by your doctor. They may contain potassium.


• Check with your doctor at once if you are taking the tablet form and notice black, tarry stools or other signs of stomach or intestinal bleeding.


• Do not be alarmed if you notice what appears to be a whole tablet in the stool after taking potassium citrate tablets. Your body has received the proper amount of medicine from the tablet and has expelled the tablet shell. However, it is a good idea to check with your doctor also.


• If you are on a potassium-rich or potassium-restricted diet, check with your health care professional. Potassium citrate–containing medicines contain a large amount of potassium.

For patients taking sodium citrate–containing medicines:

• If you are on a sodium-restricted diet, check with your health care professional. Sodium citrate–containing medicines contain a large amount of sodium.

Urocit-K 5 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.

Stop taking this medicine and get emergency help immediately if any of the following effects occur:

Rare

• Abdominal or stomach pain or cramping (severe)


• black, tarry stools


• vomiting (severe), sometimes with blood

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

• Confusion


• convulsions (seizures)


• dizziness


• high blood pressure


• irregular or fast heartbeat


• irritability


• mood or mental changes


• muscle pain or twitching


• nervousness or restlessness


• numbness or tingling in hands, feet, or lips


• shortness of breath, difficult breathing, or slow breathing


• swelling of feet or lower legs


• unexplained anxiety


• unpleasant taste


• unusual tiredness or weakness


• weakness or heaviness of legs

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

• Abdominal or stomach soreness or pain (mild)


• diarrhea or loose bowel movements


• nausea or vomiting

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.

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Pentasa Oral, Rectal

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 Pentasa

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 Pentasa

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 Pentasa. 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 Pentasa

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.

Pentasa 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.

Nizoral Cream

Pronunciation: kee-toe-KOE-na-zole
Generic Name: Ketoconazole
Brand Name: Kuric and Nizoral

Nizoral Cream is used for:

Treating certain fungal infections of the skin.

Nizoral Cream is an imidazole antifungal. It works by killing sensitive fungi by interfering with the formation of the fungal cell membrane and weakening it. The weakened cell membrane allows the cell contents to leak out and results in the death of the fungus.

Do NOT use Nizoral Cream if:

• you are allergic to any ingredient in Nizoral Cream

Contact your doctor or health care provider right away if any of these apply to you.

Before using Nizoral Cream:

Some medical conditions may interact with Nizoral Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have low blood sugar levels, liver disease, or porphyria (a blood disease), sulfite sensitivity, or you drink more than 3 alcohol-containing drinks a day

Some MEDICINES MAY INTERACT with Nizoral Cream. Because little, if any, of Nizoral Cream is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Nizoral Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Nizoral Cream:

Use Nizoral Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Clean the affected area with soap and water and dry thoroughly. Apply enough medicine to cover the affected area. Rub in gently. Do not cover unless directed otherwise by your doctor. Wash your hands immediately after using Nizoral Cream, unless your hands are part of the treated area.


• Keep Nizoral Cream out of your eyes, nose, and mouth. If this occurs, wash with water and contact your doctor, nurse, or pharmacist.


• To clear up your infection completely, use Nizoral Cream for the full course of treatment. Keep using it even if you feel better in a few days.


• If you miss a dose of Nizoral Cream, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Nizoral Cream.

Important safety information:

• Be sure to use Nizoral Cream for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• If you use topical products too often, your condition may become worse.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Some of these products contain sulfites. Sulfites may cause an allergic reaction in some patients (eg, asthma patients). If you have ever had an allergic reaction to sulfites, ask your pharmacist if your product has sulfites in it.


• Talk to your doctor before you take Nizoral Cream if you drink more than 3 drinks with alcohol per day.


• Nizoral Cream should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Nizoral Cream while you are pregnant. It is not known if Nizoral Cream is found in breast milk. Do not breast-feed while using Nizoral Cream.

Possible side effects of Nizoral Cream:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Itching; mild irritation or stinging.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); reddening, blistering, peeling, itching, or burning of your skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Nizoral side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Nizoral Cream:

Store Nizoral Cream between 59 and 77 degrees F (15 and 25 degrees C). Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Nizoral Cream out of the reach of children and away from pets.

General information:

• If you have any questions about Nizoral Cream, please talk with your doctor, pharmacist, or other health care provider.


• Nizoral Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Nizoral Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Nizoral resources

• Nizoral Side Effects (in more detail)
• Nizoral Use in Pregnancy & Breastfeeding
• 2 Reviews for Nizoral - Add your own review/rating

Compare Nizoral with other medications

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• Dandruff
• Seborrheic Dermatitis
• Tinea Corporis
• Tinea Cruris
• Tinea Pedis
• Tinea Versicolor

Zarontin

ethosuximide

Dosage Form: oral solution
Zarontin ®

(Ethosuximide)

ORAL SOLUTION

Zarontin Description

Zarontin (ethosuximide) is an anticonvulsant succinimide, chemically designated as alpha-ethyl-alpha-methyl-succinimide, with the following structural formula:

Each teaspoonful (5 mL), for oral administration, contains 250 mg ethosuximide, USP. Also contains citric acid, anhydrous, USP; FD&C red No. 40; FD&C yellow No. 6; flavor; glycerin, USP; purified water, USP; saccharin sodium, USP; sodium benzoate, NF; sodium citrate, USP; sucrose, NF.

Zarontin - Clinical Pharmacology

Ethosuximide suppresses the paroxysmal three cycle per second spike and wave activity associated with lapses of consciousness which is common in absence (petit mal) seizures. The frequency of epileptiform attacks is reduced, apparently by depression of the motor cortex and elevation of the threshold of the central nervous system to convulsive stimuli.

Indications and Usage for Zarontin

Zarontin is indicated for the control of absence (petit mal) epilepsy.

Contraindications

Ethosuximide should not be used in patients with a history of hypersensitivity to succinimides.

Warnings

Blood dyscrasias

Blood dyscrasias, including some with fatal outcome, have been reported to be associated with the use of ethosuximide; therefore, periodic blood counts should be performed. Should signs and/or symptoms of infection (eg, sore throat, fever) develop, blood counts should be considered at that point.

Effects on Liver and Kidneys

Ethosuximide is capable of producing morphological and functional change in the animal liver. In humans, abnormal liver and renal function studies have been reported. Ethosuximide should be administered with extreme caution to patients with known liver or renal disease. Periodic urinalysis and liver function studies are advised for all patients receiving the drug.

Systemic Lupus Erythematosus

Cases of systemic lupus erythematosus have been reported with the use of ethosuximide. The physician should be alert to this possibility.

Suicidal Behavior and Ideation

Antiepileptic drugs (AEDs), including Zarontin, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.

The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.

The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5–100 years) in the clinical trials analyzed.

Table 1 shows absolute and relative risk by indication for all evaluated AEDs.

Table 1 Risk by indication for antiepileptic drugs in the pooled analysis

Indication	Placebo Patients with Events Per 1000 Patients	Drug Patients with Events Per 1000 Patients	Relative Risk: Incidence of Events in Drug Patients/Incidence in Placebo Patients	Risk Difference: Additional Drug Patients with Events Per 1000 Patients
Epilepsy	1.0	3.4	3.5	2.4
Psychiatric	5.7	8.5	1.5	2.9
Other	1.0	1.8	1.9	0.9
Total	2.4	4.3	1.8	1.9

The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.

Anyone considering prescribing Zarontin or any other AED must balance the risk of suicidal thoughts and behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.

Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.

Usage in Pregnancy

Ethosuximide crosses the placenta.

Reports suggest an association between the use of anticonvulsant drugs by women with epilepsy and an elevated incidence of birth defects in children born to these women. Data are more extensive with respect to phenytoin and phenobarbital, but these are also the most commonly prescribed anticonvulsants; less systematic or anecdotal reports suggest a possible similar association with the use of all known anticonvulsant drugs.

Cases of birth defects have been reported with ethosuximide. The reports suggesting an elevated incidence of birth defects in children of drug-treated epileptic women cannot be regarded as adequate to prove a definite cause and effect relationship. There are intrinsic methodologic problems in obtaining adequate data on drug teratogenicity in humans; the possibility also exists that other factors, eg, genetic factors or the epileptic condition itself, may be more important than drug therapy in leading to birth defects. The great majority of mothers on anticonvulsant medication deliver normal infants. It is important to note that anticonvulsant drugs should not be discontinued in patients in whom the drug is administered to prevent major seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life. In individual cases where the severity and frequency of the seizure disorder are such that the removal of medication does not pose a serious threat to the patient, discontinuation of the drug may be considered prior to and during pregnancy, although it cannot be said with any confidence that even minor seizures do not pose some hazard to the developing embryo or fetus.

The prescribing physician will wish to weigh these considerations in treating or counseling epileptic women of childbearing potential.

Ethosuximide is excreted in human breast milk. Because the effects of ethosuximide on the nursing infant are unknown, caution should be exercised when ethosuximide is administered to a nursing mother. Ethosuximide should be used in nursing mothers only if the benefits clearly outweigh the risks.

Precautions

General

Ethosuximide, when used alone in mixed types of epilepsy, may increase the frequency of grand mal seizures in some patients.

As with other anticonvulsants, it is important to proceed slowly when increasing or decreasing dosage, as well as when adding or eliminating other medication. Abrupt withdrawal of anticonvulsant medication may precipitate absence (petit mal) status.

Information for Patients

Inform patients of the availability of a Medication Guide, and instruct them to read the Medication Guide prior to taking Zarontin. Instruct patients to take Zarontin only as prescribed.

Ethosuximide may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a motor vehicle or other such activity requiring alertness; therefore, the patient should be cautioned accordingly.

Patients taking ethosuximide should be advised of the importance of adhering strictly to the prescribed dosage regimen.

Patients should be instructed to promptly contact their physician when they develop signs and/or symptoms suggesting an infection (eg, sore throat, fever).

Patients, their caregivers, and families should be counseled that AEDs, including Zarontin, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.

Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This Registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334 (see PRECAUTIONS: Pregnancy section).

Drug Interactions

Since Zarontin (ethosuximide) may interact with concurrently administered antiepileptic drugs, periodic serum level determinations of these drugs may be necessary (eg, ethosuximide may elevate phenytoin serum levels and valproic acid has been reported to both increase and decrease ethosuximide levels).

Pregnancy

To provide information regarding the effects of in utero exposure to Zarontin, physicians are advised to recommend that pregnant patients taking Zarontin enroll in the (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888- 233-2334, and must be done by patients themselves. Information on the registry can also be found at the website: http://www.aedpregnancyregistry.org/.

See WARNINGS.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 3 years have not been established. (See DOSAGE AND ADMINISTRATION section.)

Adverse Reactions

Body As A Whole: Allergic reaction.

Gastrointestinal System: Gastrointestinal symptoms occur frequently and include anorexia, vague gastric upset, nausea and vomiting, cramps, epigastric and abdominal pain, weight loss, and diarrhea. There have been reports of gum hypertrophy and swelling of the tongue.

Hemopoietic System: Hemopoietic complications associated with the administration of ethosuximide have included leukopenia, agranulocytosis, pancytopenia, with or without bone marrow suppression, and eosinophilia.

Nervous System: Neurologic and sensory reactions reported during therapy with ethosuximide have included drowsiness, headache, dizziness, euphoria, hiccups, irritability, hyperactivity, lethargy, fatigue, and ataxia.

Psychiatric or psychological aberrations associated with ethosuximide administration have included disturbances of sleep, night terrors, inability to concentrate, and aggressiveness.

These effects may be noted particularly in patients who have previously exhibited psychological abnormalities. There have been rare reports of paranoid psychosis, increased libido, and increased state of depression with overt suicidal intentions.

Integumentary System: Dermatologic manifestations which have occurred with the administration of ethosuximide have included urticaria, Stevens-Johnson syndrome, systemic lupus erythematosus, pruritic erythematous rashes, and hirsutism.

Special Senses: Myopia.

Genitourinary System: Vaginal bleeding, microscopic hematuria.

Overdosage

Acute overdoses may produce nausea, vomiting, and CNS depression including coma with respiratory depression. A relationship between ethosuximide toxicity and its plasma levels has not been established. The therapeutic range of serum levels is 40 mcg/mL to 100 mcg/mL, although levels as high as 150 mcg/mL have been reported without signs of toxicity.

Treatment

Treatment should include emesis (unless the patient is or could rapidly become obtunded, comatose, or convulsing) or gastric lavage, activated charcoal, cathartics, and general supportive measures. Hemodialysis may be useful to treat ethosuximide overdose. Forced diuresis and exchange transfusions are Ineffective.

Zarontin Dosage and Administration

Zarontin is administered by the oral route. The initial dose for patients 3 to 6 years of age is one teaspoonful (250 mg) per day; for patients 6 years of age and older, 2 teaspoonfuls (500 mg) per day. The dose thereafter must be individualized according to the patient's response. Dosage should be increased by small increments. One useful method is to increase the daily dose by 250 mg every four to seven days until control is achieved with minimal side effects. Dosages exceeding 1.5 g daily, in divided doses, should be administered only under the strictest supervision of the physician. The optimal dose for most pediatric patients is 20 mg/kg/day. This dose has given average plasma levels within the accepted therapeutic range of 40 to 100 mcg/mL. Subsequent dose schedules can be based on effectiveness and plasma level determinations.

Zarontin may be administered in combination with other anticonvulsants when other forms of epilepsy coexist with absence (petit mal). The optimal dose for most pediatric patients is 20 mg/kg/day.

How is Zarontin Supplied

Zarontin is supplied as:

NDC 0071-2418-23-1 pint bottles. Each 5 mL of oral solution contains 250 mg ethosuximide in a raspberry flavored base.

Store at 20°–25° (68° – 77°F); [see USP Controlled Room Temperature]

Preserve in tight containers. Protect from freezing and light.

LAB-0093-6.0

April 2011

MEDICATION GUIDE

Zarontin, (Ză rŏn' tĭn)

(ethosuximide)

Capsules, Oral Solution

Read this Medication Guide before you start taking Zarontin and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. If you have any questions about Zarontin, ask your healthcare provider or pharmacist.

What is the most important information I should know about Zarontin?

Do not stop taking Zarontin without first talking to your healthcare provider.

Stopping Zarontin suddenly can cause serious problems.

Zarontin can cause serious side effects, including:

1. Rare but serious blood problems that may be life-threatening. Call your healthcare provider right away if you have:
   
   • fever, swollen glands, or sore throat that come and go or do not go away
   
   
   • frequent infections or an infection that does not go away
   
   
   • easy bruising
   
   
   • red or purple spots on your body
   
   
   • bleeding gums or nose bleeds
   
   
   • severe fatigue or weakness
   
   


2. Systematic Lupus Erythematosus. Call your healthcare provider right away if you have any of these symptoms:
   
   • joint pain and swelling
   
   
   • muscle pain
   
   
   • fatigue
   
   
   • low-grade fever
   
   
   • pain in the chest that is worse with breathing
   
   
   • unexplained skin rash
   
   


3. Like other antiepileptic drugs, Zarontin may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
   
   Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
   
   • thoughts about suicide or dying
   
   
   • attempts to commit suicide
   
   
   • new or worse depression
   
   
   • new or worse anxiety
   
   
   • feeling agitated or restless
   
   
   • panic attacks
   
   
   • trouble sleeping (insomnia)
   
   
   • new or worse irritability
   
   
   • acting aggressive, being angry, or violent
   
   
   • acting on dangerous impulses
   
   
   • an extreme increase activity and talking (mania)
   
   
   • other unusual changes in behavior or mood
   
   
   
   How can I watch for early symptoms of suicidal thoughts and actions?
   
   • Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
   
   
   • Keep all follow-up visits with your healthcare provider as scheduled.
   
   
   
   Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
   
   Do not stop Zarontin without first talking to a healthcare provider.
   
   • Stopping Zarontin suddenly can cause serious problems.
   
   
   • Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).
   
   
   
   
   Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

What is Zarontin?

Zarontin is a prescription medicine used to treat absence (petit mal) seizures.

Who should not take Zarontin?

Do not take Zarontin if you are allergic to succinimides (methsuximide or ethosuximide), or any of the ingredients in Zarontin. See the end of this Medication Guide for a complete list of ingredients in Zarontin.

What should I tell my healthcare provider before taking Zarontin?

Before you take Zarontin, tell your healthcare provider if you:

• have or had liver problems


• have or have had depression, mood problems or suicidal thoughts or behavior


• have any other medical conditions


• are pregnant or plan to become pregnant. It is not known if Zarontin can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking Zarontin. You and your healthcare provider should decide if you should take Zarontin while you are pregnant.
  
  • If you become pregnant while taking Zarontin, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy. You can enroll in this registry by calling 1-888-233-2334.
  
  


• are breast-feeding or plan to breast-feed. It is not known if Zarontin can pass into breast milk. You and your healthcare provider should decide how you will feed your baby while you take Zarontin.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Taking Zarontin with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

Know the medicines you take. Keep a list of them with you to show your healthcare provider and pharmacist when you get a new medicine.

How should I take Zarontin?

• Take Zarontin exactly as prescribed. Your healthcare provider will tell you how much Zarontin to take.


• Your healthcare provider may change your dose. Do not change your dose of Zarontin without talking to your healthcare provider.


• If you take too much Zarontin, call your healthcare provider or your local Poison Control Center right away.

What should I avoid while taking Zarontin?

• Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking Zarontin without first talking to your healthcare provider. Zarontin taken with alcohol or medicines that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
  
  • Do not drive, operate heavy machinery, or do other dangerous activities until you know how Zarontin affects you. Zarontin can slow your thinking and motor skills.
  
  

What are the possible side effects of Zarontin?

• See "What is the most important information I should know about Zarontin?"

Zarontin may cause other serious side effects, including:

• Serious allergic reactions. Call your healthcare provider right away if you have any of these symptoms:
  
  • skin rash
  
  
  • hives
  
  
  • sores in your mouth
  
  
  • blistering or peeling skin
  
  


• Changes in thinking, mood, or behavior. Some patients may get abnormally suspicious thoughts, hallucinations (seeing or hearing things that are not there), or delusions (false thoughts or beliefs).


• Grand mal seizures can happen more often or become worse

Call your healthcare provider right away, if you have any of the symptoms listed above.

The most common side effects of Zarontin include

• nausea or vomiting


• indigestion, stomach pain


• diarrhea


• weight loss


• loss of appetite


• hiccups


• fatigue


• dizziness or lightheadedness


• unsteadiness when walking


• headache


• loss of concentration

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the possible side effects with Zarontin. For more information, ask your healthcare provider or pharmacist.

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

How should I store Zarontin?

• Store Zarontin capsules at room temperature, between 59°F to 86°F (15°C to 30°C).


• Store Zarontin syrup (oral solution) at 20°–25°C (68°–77°F). Preserve in tight containers. Protect from freezing and light.

Keep Zarontin and all medicines out of the reach of children.

General information about Zarontin

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Zarontin for a condition for which it was not prescribed. Do not give Zarontin to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about Zarontin. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Zarontin that is written for healthcare professionals.

For more information, go to www.pfizer.com or call 1-800-438-1985.

What are the ingredients in Zarontin?

Active ingredient: ethosuximide

Capsules

Inactive ingredients: Polyethylene glycol 400, NF; D&C yellow No. 10; FD&C red No. 3; gelatin, NF; glycerin, USP; and sorbitol.

Oral Solution

Inactive ingredients: Each 5 ml (teaspoonful) of oral solution contains 250 mg ethosuximide in a raspberry flavored base. Also contains citric acid, anhydrous, USP; FD&C red No. 40; FD&C yellow No. 6; flavor; glycerin, USP; purified water, USP; saccharin sodium, USP; sodium benzoate, NF; Sodium Citrate, USP; sucrose, NF.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

LAB-403-1.0

September 2010

PRINCIPAL DISPLAY PANEL - 474 mL Bottle Label

NDC 0071-2418-23

1 Pint (474 mL)

Rx only

Zarontin®

(Ethosuximide)

ORAL SOLUTION

250 mg per 5 mL

Pfizer

Distributed by

Parke-Davis

Division of Pfizer Inc, NY, NY 10017

Zarontin  ethosuximide  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0071-2418 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ethosuximide (Ethosuximide) Ethosuximide 250 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength citric acid monohydrate   FD&C red No. 40   FD&C yellow No. 6   glycerin   water   saccharin sodium   sodium benzoate   sodium citrate   sucrose

Product Characteristics Color      Score      Shape Size Flavor RASPBERRY Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0071-2418-23 473 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA080258	02/27/2002

Labeler - Parke-Davis Div of Pfizer Inc (829076962)

Establishment
Name	Address	ID/FEI	Operations
Katwijk Chemie B.V.		416984441	Manufacture

Establishment
Name	Address	ID/FEI	Operations
McNeil PPC		801375143	Manufacture

Establishment
Name	Address	ID/FEI	Operations
Pharmacia and Upjohn Company		829076566	Manufacture

Revised: 05/2011Parke-Davis Div of Pfizer Inc

More Zarontin resources

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

• Zarontin Concise Consumer Information (Cerner Multum)


• Zarontin MedFacts Consumer Leaflet (Wolters Kluwer)


• Zarontin Monograph (AHFS DI)


• Zarontin Advanced Consumer (Micromedex) - Includes Dosage Information


• Ethosuximide Professional Patient Advice (Wolters Kluwer)

Compare Zarontin with other medications

• Seizures