Nydrazid

30/06/10

Generic Name: isoniazid (Oral route, Intramuscular route)

eye-soe-NYE-a-zid

Intramuscular routeSolution

Severe and sometimes fatal hepatitis associated with isoniazid therapy has been reported and may occur or may develop even after many months of treatment. The risk of developing hepatitis is age related. Approximate case rates by age are: less than 1 per 1,000 for persons under 20 years of age, 3 per 1,000 for persons in the 20 year to 34 year age group, 12 per 1,000 for persons in the 35 year to 49 year age group, 23 per 1,000 for persons in the 50 year to 64 year age group, and 8 per 1,000 for persons over 65 years of age. The risk of hepatitis is increased with daily consumption of alcohol. Precise data to provide fatality rate for isoniazid-related hepatitis is not available; however, in a U.S. Public Health Service Surveillance Study of 13,838 persons taking isoniazid, there were 8 deaths among 174 cases of hepatitis.

Therefore, patients given isoniazid should be carefully monitored and interviewed at monthly intervals. For persons 35 and older, in addition to monthly symptom reviews, hepatic enzymes (specifically, AST and ALT (formerly SGOT and SGPT, respectively)) should be measured prior to starting isoniazid therapy and periodically throughout treatment. Isoniazid-associated hepatitis usually occurs during the first three months of treatment. Usually, enzyme levels return to normal despite continuance of drug, but in some cases progressive liver dysfunction occurs. Other factors associated with an increased risk of hepatitis include daily use of alcohol, chronic liver disease and injection drug use. A recent report suggests an increased risk of fatal hepatitis associated with isoniazid among women, particularly black and Hispanic women. The risk may also be increased during the post partum period. More careful monitoring should be considered in these groups, possibly including more frequent laboratory monitoring. If abnormalities of liver function exceed three to five times the upper limit of normal, discontinuation of isoniazid should be strongly considered. Liver function tests are not a substitute for a clinical evaluation at monthly intervals or for the prompt assessment of signs or symptoms of adverse reactions occurring between regularly scheduled evaluations. Patients should be instructed to immediately report signs or symptoms consistent with liver damage or other adverse effects. These include any of the following: unexplained anorexia, nausea, vomiting, dark urine, icterus, rash, persistent paresthesias of the hands and feet, persistent fatigue, weakness or fever of greater than 3 days duration and/or abdominal tenderness, especially right upper quadrant discomfort. If these symptoms appear or if signs suggestive of hepatic damage are detected, isoniazid should be discontinued promptly, since continued use of the drug in these cases has been reported to cause a more severe form of liver damage.

Patients with tuberculosis who have hepatitis attributed to isoniazid should be given appropriate treatment with alternative drugs. If isoniazid must be reinstituted, it should be reinstituted only after symptoms and laboratory abnormalities have cleared. The drug should be restarted in very small and gradually increasing doses and should be withdrawn immediately if there is any indication of recurrent liver involvement.

Preventive treatment should be deferred in persons with acute hepatic diseases .

Severe and sometimes fatal hepatitis has been reported with isoniazid therapy and may occur even after many months of treatment. The risk for hepatitis increases with advancing age and alcohol use. Patients given isoniazid should be carefully monitored and interviewed at monthly intervals. For persons 35 and older, in addition to monthly symptom reviews, hepatic enzymes (specifically, AST and ALT (formerly SGOT and SGPT, respectively) should be measured prior to starting isoniazid therapy and periodically throughout treatment. An increased risk of fatal hepatitis associated with isoniazid has been reported in women, particularly black and Hispanic women. The risk may also be increased during the post partum period. More careful monitoring should be considered in these groups, possibly including more frequent laboratory monitoring .

Oral routeTabletSyrup

Severe and sometimes fatal hepatitis associated with isoniazid therapy has been reported and may occur or may develop even after many months of treatment. The risk of developing hepatitis is age related. Approximate case rates by age are: less than 1 per 1,000 for persons under 20 years of age, 3 per 1,000 for persons in the 20 year to 34 year age group, 12 per 1,000 for persons in the 35 year to 49 year age group, 23 per 1,000 for persons in the 50 year to 64 year age group, and 8 per 1,000 for persons over 65 years of age. The risk of hepatitis is increased with daily consumption of alcohol. Precise data to provide fatality rate for isoniazid-related hepatitis is not available; however, in a U.S. Public Health Service Surveillance Study of 13,838 persons taking isoniazid, there were 8 deaths among 174 cases of hepatitis.

Therefore, patients given isoniazid should be carefully monitored and interviewed at monthly intervals. For persons 35 and older, in addition to monthly symptom reviews, hepatic enzymes (specifically, AST and ALT (formerly SGOT and SGPT, respectively)) should be measured prior to starting isoniazid therapy and periodically throughout treatment. Isoniazid-associated hepatitis usually occurs during the first three months of treatment. Usually, enzyme levels return to normal despite continuance of drug, but in some cases progressive liver dysfunction occurs. Other factors associated with an increased risk of hepatitis include daily use of alcohol, chronic liver disease and injection drug use. A recent report suggests an increased risk of fatal hepatitis associated with isoniazid among women, particularly black and Hispanic women. The risk may also be increased during the post partum period. More careful monitoring should be considered in these groups, possibly including more frequent laboratory monitoring. If abnormalities of liver function exceed three to five times the upper limit of normal, discontinuation of isoniazid should be strongly considered. Liver function tests are not a substitute for a clinical evaluation at monthly intervals or for the prompt assessment of signs or symptoms of adverse reactions occurring between regularly scheduled evaluations. Patients should be instructed to immediately report signs or symptoms consistent with liver damage or other adverse effects. These include any of the following: unexplained anorexia, nausea, vomiting, dark urine, icterus, rash, persistent paresthesias of the hands and feet, persistent fatigue, weakness or fever of greater than 3 days duration and/or abdominal tenderness, especially right upper quadrant discomfort. If these symptoms appear or if signs suggestive of hepatic damage are detected, isoniazid should be discontinued promptly, since continued use of the drug in these cases has been reported to cause a more severe form of liver damage.

Patients with tuberculosis who have hepatitis attributed to isoniazid should be given appropriate treatment with alternative drugs. If isoniazid must be reinstituted, it should be reinstituted only after symptoms and laboratory abnormalities have cleared. The drug should be restarted in very small and gradually increasing doses and should be withdrawn immediately if there is any indication of recurrent liver involvement.

Preventive treatment should be deferred in persons with acute hepatic diseases .

Severe and sometimes fatal hepatitis has been reported with isoniazid therapy and may occur even after many months of treatment. The risk for hepatitis increases with advancing age and alcohol use. Patients given isoniazid should be carefully monitored and interviewed at monthly intervals. For persons 35 and older, in addition to monthly symptom reviews, hepatic enzymes (specifically, AST and ALT (formerly SGOT and SGPT, respectively) should be measured prior to starting isoniazid therapy and periodically throughout treatment. An increased risk of fatal hepatitis associated with isoniazid has been reported in women, particularly black and Hispanic women. The risk may also be increased during the post partum period. More careful monitoring should be considered in these groups, possibly including more frequent laboratory monitoring .

Commonly used brand name(s):

In the U.S.

  • Nydrazid

In Canada

  • Pms-Isoniazid

Available Dosage Forms:

  • Syrup
  • Tablet
  • Solution

Therapeutic Class: Antitubercular

Chemical Class: Isonicotinic Acid

Uses For Nydrazid

Isoniazid is used to treat tuberculosis (TB) or prevent its return (reactivation). It may be given alone, or in combination with other medicines, to treat TB or to prevent its return (reactivation). This medicine may also be used for other problems as determined by your doctor.

This medicine may cause some serious side effects, including damage to the liver. Liver damage is more likely to occur in patients over 50 years of age. You and your doctor should talk about the good this medicine will do, as well as the risks of taking it.

If you are being treated for active tuberculosis (TB): To help clear up your TB infection completely, you must keep taking this medicine for the full time of treatment, even if you begin to feel better. This is very important. It is also important that you do not miss any doses.

Isoniazid is available only with your doctor’s prescription.


Before Using Nydrazid

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

Isoniazid can cause serious side effects in any patient. Therefore, it is especially important that you discuss with the child’s doctor the good that this medicine may do as well as the risks of using it.

Geriatric

Hepatitis may be especially likely to occur in patients over 50 years of age, who are usually more sensitive than younger adults to the effects of isoniazid.

Breast Feeding

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

Interactions with Medicines

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

  • Itraconazole
  • Levodopa
  • Rifampin

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

  • Acetaminophen
  • Aminosalicylic Acid
  • Carbamazepine
  • Diazepam
  • Disulfiram
  • Enflurane
  • Ethionamide
  • Fosphenytoin
  • Ketoconazole
  • Meperidine
  • Phenytoin
  • Warfarin

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.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Ethanol

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Tyramine Containing Food

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:

  • Alcohol abuse (or history of) or
  • Liver disease—There may be an increased chance of hepatitis with daily drinking of alcohol or in patients with liver disease
  • Kidney disease (severe)—There may be an increased chance of side effects in patients with severe kidney disease
  • Seizure disorders such as epilepsy—There may be an increased chance of seizures (convulsions) in some patients




Proper Use of isoniazid

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

Make certain your health care professional knows if you are on a low-sodium, low-sugar, or any other special diet. Most medicines contain more than just the active ingredient, and many liquid medicines contain alcohol.

If you are taking isoniazid by mouth and it upsets your stomach, take it with food. Antacids may also help. However, do not take aluminum-containing antacids within 1 hour of taking isoniazid. They may keep this medicine from working properly.

For patients taking the oral liquid form of isoniazid:

  • Use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.

To help clear up your tuberculosis (TB) completely, it is very important that you keep taking this medicine for the full time of treatment, even if you begin to feel better after a few weeks. You may have to take it every day for as long as 6 months to 2 years. It is important that you do not miss any doses.

Your doctor may also want you to take pyridoxine (e.g., Hexa-Betalin, vitamin B 6) every day to help prevent or lessen some of the side effects of isoniazid. This is not usually needed in children, who receive enough pyridoxine in their diet. If it is needed, it is very important to take pyridoxine every day along with this medicine. Do not miss any doses.

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 forms (tablets, syrup):
    • For preventing the return (reactivation) of tuberculosis:
      • Adults and teenagers—300 milligrams (mg) once a day.
      • Children—Dose is based on body weight. The usual dose is 10 mg per kilogram (kg) (4.5 mg per pound) of body weight, up to 300 mg, once a day.
    • For treatment of tuberculosis:
      • Adults and teenagers—300 mg once a day; or 15 mg per kg (6.8 mg per pound) of body weight, up to 900 mg, two times a week or three times a week, depending on the schedule your doctor chooses for you.
      • Children—Dose is based on body weight. The usual dose is 10 to 20 mg per kg (4.5 to 9.1 mg per pound) of body weight, up to 300 mg, once a day; or 20 to 40 mg per kg (9.1 to 18.2 mg per pound) of body weight, up to 900 mg, two times a week or three times a week, depending on the schedule your doctor chooses for you.
  • For injection dosage form:
    • For preventing the return (reactivation) of tuberculosis:
      • Adults and teenagers—300 mg once a day.
      • Children—Dose is based on body weight. The usual dose is 10 mg per kg (4.5 mg per pound) of body weight, up to 300 mg, once a day.
    • For treatment of tuberculosis:
      • Adults and teenagers—300 mg once a day; or 15 mg per kg (6.8 mg per pound) of body weight, up to 900 mg, two times a week or three times a week, depending on the schedule your doctor chooses for you.
      • Children—Dose is based on body weight. The usual dose is 10 to 20 mg per kg (4.5 to 9.1 mg per pound) of body weight, up to 300 mg, once a day; or 20 to 40 mg per kg (9.1 to 18.2 mg per pound) of body weight, up to 900 mg, two times a week or three times a week, depending on the schedule your doctor chooses for you.

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.


Precautions While Using Nydrazid

It is very important that your doctor check your progress at regular visits. Also, check with your doctor immediately if blurred vision or loss of vision, with or without eye pain, occurs during treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

If your symptoms do not improve within 2 to 3 weeks, or if they become worse, check with your doctor.

Certain foods such as cheese (Swiss or Cheshire) or fish (tuna, skipjack, or Sardinella) may rarely cause reactions in some patients taking isoniazid. Check with your doctor if redness or itching of the skin, hot feeling, fast or pounding heartbeat, sweating, chills or clammy feeling, headache, or lightheadedness occurs while you are taking this medicine.

Liver problems may be more likely to occur if you drink alcoholic beverages regularly while you are taking this medicine. Also, the regular use of alcohol may keep this medicine from working properly. Therefore, you should strictly limit the amount of alcoholic beverages you drink while you are taking this medicine.

If this medicine causes you to feel very tired or very weak; or causes clumsiness; unsteadiness; a loss of appetite; nausea; numbness, tingling, burning, or pain in the hands and feet; or vomiting, check with your doctor immediately. These may be early warning signs of more serious liver or nerve problems that could develop later.

  • For diabetic patients:
  • This medicine may cause false test results with some urine sugar tests. Check with your doctor before changing your diet or the dosage of your diabetes medicine.

Nydrazid 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

  • Clumsiness or unsteadiness
  • dark urine
  • loss of appetite
  • nausea or vomiting
  • numbness, tingling, burning, or pain in hands and feet
  • unusual tiredness or weakness
  • yellow eyes or skin

Rare

  • Blurred vision or loss of vision, with or without eye pain
  • convulsions (seizures)
  • fever and sore throat
  • joint pain
  • mental depression
  • mood or other mental changes
  • skin rash
  • unusual bleeding or bruising

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

  • Diarrhea
  • stomach pain

For injection form

  • Irritation at the place of injection

Dark urine and yellowing of the eyes or skin (signs of liver problems) are more likely to occur in patients over 50 years of age.

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.

 

NYE-li-drin

Available Dosage Forms:

  • Tablet

Therapeutic Class: Peripheral Vasodilator

Uses For nylidrin

Nylidrin belongs to the group of medicines called vasodilators. Vasodilators increase the size of blood vessels. Nylidrin is used to treat problems due to poor blood circulation.

Nylidrin was available only with your doctor’s prescription.

Nylidrin is no longer available in the United States.


Before Using nylidrin

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 nylidrin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to nylidrin 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.

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 nylidrin in the elderly with use in other age groups. However, nylidrin may reduce tolerance to cold temperatures in elderly patients.

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. 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 nylidrin. Make sure you tell your doctor if you have any other medical problems, especially:

  • Angina (chest pain) or
  • Fast heartbeat or
  • Heart attack (recent) or other heart disease or
  • Overactive thyroid gland or
  • Stomach ulcer—May make these conditions worse.




Proper Use of nylidrin

Nylidrin may cause you to have a fast or pounding heartbeat. To keep this from affecting your sleep, do not take the last dose of the day at bedtime. Instead, it is best to plan your dose or doses according to a schedule that will least affect your sleep. Ask your health care professional to help you plan the best time to take nylidrin.

Dosing

The dose of nylidrin 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 nylidrin. 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 (tablets):
    • Adults: 3 to 12 milligrams (mg) three or four times a day.

Missed Dose

If you miss a dose of nylidrin, 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.


Precautions While Using nylidrin

It may take some time for nylidrin to work. If you feel that the medicine is not working, do not stop taking it on your own. Instead, check with your doctor.

The helpful effects of nylidrin may be decreased if you smoke. If you have any questions about this, check with your doctor.

nylidrin 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 as soon as possible if any of the following side effects occur:

Less common

  • Dizziness
  • fast or irregular heartbeat
  • weakness or tiredness (continuing)

Signs and symptoms of overdose

  • Blurred vision
  • chest pain
  • decrease in urination or inability to urinate
  • fever
  • metallic taste

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

  • Chilliness
  • flushing or red face
  • headache
  • nausea and vomiting
  • nervousness
  • trembling

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.

 

NyQuil Liquid

30/06/10

Generic Name: Acetaminophen/Dextromethorphan/Doxylamine/Pseudoephedrine (a-seet-a-MIN-oh-fen/dex-troe-meth-OR-fan/dox-IL-a-meen/sue-do-eh-FED-rin)
Brand Name: Examples include NyQuil and Tylenol NightTime Cold & Flu

NyQuil Liquid is used for:

Relieving symptoms of pain, sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

NyQuil Liquid is a decongestant, antihistamine, cough suppressant, and analgesic combination. It works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms, such as watery eyes and sneezing. The analgesic and cough suppressant work in the brain to decrease pain and to reduce dry or unproductive cough.

Do NOT use NyQuil Liquid if:

  • you are allergic to any ingredient in NyQuil Liquid
  • you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems
  • you are unable to urinate or are having an asthma attack
  • you take sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

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

Before using NyQuil Liquid:

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

  • if you are pregnant, plan 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 a fast, slow, or irregular heartbeat
  • if you have a history of adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your bladder, stomach, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; an overactive thyroid; liver problems; or if you consume more than 3 alcohol-containing drinks per day
  • if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if cough occurs with large amounts of mucus

Some MEDICINES MAY INTERACT with NyQuil Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, isoniazid, MAO inhibitors (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects of NyQuil Liquid may be increased
  • Anticoagulants (eg, warfarin), digoxin, or droxidopa because risk of bleeding, irregular heartbeat or heart attack may be increased
  • Bromocriptine or hydantoins (eg, phenytoin) because side effects may be increased by NyQuil Liquid
  • Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by NyQuil Liquid

This may not be a complete list of all interactions that may occur. Ask your health care provider if NyQuil Liquid 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 NyQuil Liquid:

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

  • NyQuil Liquid may be taken with or without food.
  • Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
  • If you miss a dose of NyQuil Liquid, take 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 take 2 doses at once.

Ask your health care provider any questions you may have about how to use NyQuil Liquid.

Important safety information:

  • NyQuil Liquid may cause dizziness, drowsiness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to NyQuil Liquid. Using NyQuil Liquid alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
  • Do not take diet or appetite control medicines while you are taking NyQuil Liquid without checking with your doctor.
  • NyQuil Liquid contains acetaminophen and pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains acetaminophen or pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.
  • Do NOT exceed the recommended dose or take NyQuil Liquid for longer than prescribed without checking with your doctor.
  • If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.
  • NyQuil Liquid may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to NyQuil Liquid. Use a sunscreen or protective clothing if you must be outside for a prolonged period.
  • NyQuil Liquid may cause liver damage. If you consume 3 or more alcohol-containing drinks every day, ask your doctor if you should take NyQuil Liquid or other pain relievers/fever reducers. Alcohol use combined with NyQuil Liquid may increase your risk for liver damage.
  • If you are scheduled for allergy skin testing, do not take NyQuil Liquid for several days before the test because it may decrease your response to the skin tests.
  • Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using NyQuil Liquid.
  • Use NyQuil Liquid with caution in the ELDERLY because they may be more sensitive to its effects.
  • Caution is advised when using NyQuil Liquid in CHILDREN because they may be more sensitive to its effects.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant while taking NyQuil Liquid, discuss with your doctor the benefits and risks of using NyQuil Liquid during pregnancy. It is unknown if NyQuil Liquid is excreted in breast milk. Do not breast-feed while taking NyQuil Liquid.

Possible side effects of NyQuil Liquid:

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:

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; stomach pain; tremor; trouble sleeping; vision changes; yellowing of skin or eyes.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; and vomiting.

Proper storage of NyQuil Liquid:

Store NyQuil Liquid at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep NyQuil Liquid out of the reach of children and away from pets.

General information:

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

This information is a summary only. It does not contain all information about NyQuil Liquid. 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: May 5, 2010
Database Edition 10.2.1.002
Copyright © 2010 Wolters Kluwer Health, Inc.
 

Nyaderm Ointment

30/06/10

Generic Name: nystatin (Topical route)

nye-STAT-in

Commonly used brand name(s):

In the U.S.

  • Mycostatin
  • Nystop
  • Pedi-Dri

In Canada

  • Mycostatin Cream
  • Mycostatin Ointment
  • Mycostatin Powder
  • Nadostine
  • Nilstat Topical Cream
  • Nilstat Topical Ointment
  • Nyaderm Cream
  • Nyaderm Ointment

Available Dosage Forms:

  • Powder
  • Cream
  • Ointment

Therapeutic Class: Antifungal

Chemical Class: Polyene

Uses For Nyaderm Ointment

Nystatin belongs to the group of medicines called antifungals. Topical nystatin is used to treat some types of fungus infections of the skin.

Nystatin is available in the U.S. only with your doctor’s prescription.


Before Using Nyaderm Ointment

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

Although there is no specific information comparing use of topical nystatin in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does 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 topical nystatin in the elderly with use in other age groups.

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.




Proper Use of nystatin

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

Topical nystatin should not be used in the eyes.

Apply enough nystatin to cover the affected area.

For patients using the powder form of this medicine on the feet:

  • Sprinkle the powder between the toes, on the feet, and in socks and shoes.

The use of any kind of occlusive dressing (airtight covering, such as kitchen plastic wrap) over this medicine may increase the chance of irritation. Therefore, do not bandage, wrap, or apply any occlusive dressing over this medicine unless directed to do so by your doctor. When using this medicine on the diaper area of children, avoid tight-fitting diapers and plastic pants.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your condition has improved. Do not miss any doses.

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 topical dosage forms (cream or ointment):
    • For fungus infections:
      • Adults and children—Apply to the affected area(s) of the skin two times a day.
  • For topical dosage form (powder):
    • For fungus infections:
      • Adults and children—Apply to the affected area(s) of the skin two or three times a day.

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.

Nyaderm Ointment 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 as soon as possible if any of the following side effects occur:

  • Skin irritation not present before use of this medicine

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.

 

Generic Name: nystatin (Vaginal route)

nye-STAT-in

Commonly used brand name(s):

In Canada

  • Mycostatin
  • Mycostatin Vaginal Cream
  • Nadostine
  • Nilstat Vaginal Cream
  • Nilstat Vaginal Tablet
  • Nyaderm Vaginal Cream

Available Dosage Forms:

  • Cream
  • Tablet

Therapeutic Class: Antifungal

Chemical Class: Polyene

Uses For Nyaderm Vaginal Cream

Nystatin belongs to the group of medicines called antifungals. Vaginal nystatin is used to treat fungus infections of the vagina. Nystatin vaginal cream or tablets may also be used for other problems as determined by your doctor.

Nystatin is available only with your doctor’s prescription.


Before Using Nyaderm Vaginal Cream

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

Studies on this medicine have been done only in adults, and there is no specific information comparing use of vaginal nystatin in children with use in other age groups.

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 the use of vaginal nystatin in the elderly with use in other age groups.

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.




Proper Use of nystatin

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

Nystatin usually comes with patient directions. Read them carefully before using this medicine.

This medicine is usually inserted into the vagina with an applicator. However, if you are pregnant, check with your doctor before using the applicator to insert the vaginal tablet.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your condition has improved. Also, keep using this medicine even if you begin to menstruate during the time of treatment. Do not miss any doses.

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 treating fungus (yeast) infections:
    • For vaginal cream dosage form:
      • Adults and teenagers—One 100,000-unit applicatorful inserted into the vagina one or two times a day for two weeks. Or, your doctor may want you to insert one 500,000-unit applicatorful into the vagina once a day.
      • Children—Dose must be determined by your doctor.
    • For vaginal tablet dosage form:
      • Adults and teenagers—One 100,000-unit tablet inserted into the vagina one or two times a day for two weeks.
      • Children—Dose must be determined by your doctor.

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.


Precautions While Using Nyaderm Vaginal Cream

To help cure the infection and to help prevent reinfection, good health habits are required.

  • Wear cotton panties (or panties or pantyhose with cotton crotches) instead of synthetic (for example, nylon, rayon) underclothes.
  • Wear freshly laundered underclothes.

If you have any questions about this, check with your health care professional.

If you have any questions about douching or intercourse during the time of treatment with nystatin, check with your doctor.

Since there may be some vaginal drainage while you are using this medicine, a sanitary napkin may be worn to protect your clothing.

Nyaderm Vaginal Cream 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 as soon as possible if any of the following side effects occur:

Rare

  • Vaginal burning or itching not present before use of this medicine

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.

 

Nyamyc

30/06/10

Generic Name: nystatin
Dosage Form: topical powder, USP

100,000 units per gram
Rx only

FOR TOPICAL USE ONLY • NOT FOR OPHTHALMIC USE

Nyamyc Description

Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei.

Structural formula:

Nystatin

Nyamyc™ (Nystatin Topical Powder, USP) is for dermatologic use.

Nyamyc™ (Nystatin Topical Powder, USP) contains 100,000 USP nystatin units per gram dispersed in talc.

Nyamyc – Clinical Pharmacology

Pharmacokinetics

Nystatin is not absorbed from intact skin or mucous membrane.

Microbiology

Nystatin is an antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi, including Candida albicans, C. parapsilosis, C. tropicalis, C. guilliermondi, C. pseudotropicalis, C. krusei, Torulopsis glabrata, Tricophyton rubrum, T. mentagrophytes.

Nystatin acts by binding to sterols in the cell membrane of susceptible species resulting in a change in membrane permeability and the subsequent leakage of intracellular components. On repeated subculturing with increasing levels of nystatin, Candida albicans does not develop resistance to nystatin. Generally, resistance to nystatin does not develop during therapy. However, other species of Candida (C. tropicalis, C. guilliermondi, C. krusei, and C. stellatoides) become quite resistant on treatment with nystatin and simultaneously become cross resistant to amphotericin as well. This resistance is lost when the antibiotic is removed.

Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.

Indications and Usage for Nyamyc

Nyamyc™ (Nystatin Topical Powder, USP) is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species.

This preparation is not indicated for systemic, oral, intravaginal or ophthalmic use.





Contraindications

Nyamyc™ (Nystatin Topical Powder, USP) is contraindicated in patients with a history of hypersensitivity to any of its components.

Precautions

General

Nyamyc™ (Nystatin Topical Powder, USP) should not be used for the treatment of systemic, oral, intravaginal or ophthalmic infections.

If irritation or sensitization develops, treatment should be discontinued and appropriate measures taken as indicated. It is recommended that KOH smears, cultures, or other diagnostic methods be used to confirm the diagnosis of cutaneous or mucocutaneous candidiasis and to rule out infection caused by other pathogens.

INFORMATION FOR THE PATIENT

Patients using this medication should receive the following information and instructions:

  1. The patient should be instructed to use this medication as directed (including the replacement of missed doses). This medication is not for any disorder other than that for which it is prescribed.
  2. Even if symptomatic relief occurs within the first few days of treatment, the patient should be advised not to interrupt or discontinue therapy until the prescribed course of treatment is completed.
  3. If symptoms of irritation develop, the patient should be advised to notify the physician promptly.

Laboratory Tests

If there is a lack of therapeutic response, KOH smears, cultures, or other diagnostic methods should be repeated.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin. No studies have been performed to determine the mutagenicity of nystatin or its effects on male or female fertility.

Pregnancy: Teratogenic Effects

Category C. Animal reproduction studies have not been conducted with any nystatin topical preparation. It also is not known whether these preparations can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nystatin topical preparations should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.

Nursing Mothers

It is not known whether nystatin is excreted in human milk. Caution should be exercised when nystatin is prescribed for a nursing woman.

Pediatric Use

Safety and effectiveness have been established in the pediatric population from birth to 16 years. (See DOSAGE AND ADMINISTRATION.)

Geriatric Use

Clinical studies with nystatin topical powder did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Adverse Reactions

The frequency of adverse events reported in patients using nystatin topical preparations is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application. (See PRECAUTIONS: General.)

Nyamyc Dosage and Administration

Very moist lesions are best treated with the topical dusting powder.

Nyamyc™ (Nystatin Topical Powder, USP)
Adults and Pediatric Patients
(Neonates and Older):

Apply to candidal lesions two or three times daily until healing is complete. For fungal infection of the feet caused by Candida species, the powder should be dusted on the feet, as well as, in all foot wear.

How is Nyamyc Supplied

Nyamyc™ (Nystatin Topical Powder, USP): 100,000 units nystatin per gram in 15 g (NDC 0832-0465-15) and 30 g (NDC-0832-0465-30) plastic squeeze bottles.

STORAGE

Nyamyc™ (Nystatin Topical Powder, USP): Store at 20-25°C (68-77°F) and excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Avoid excessive heat (40°C/104°F). Keep tightly closed. Keep out of reach of children.

Rev. 0105

Manufactured by:
UPSHER-SMITH LABORATORIES, INC.
Minneapolis, MN 55447

Nyamyc 
nystatin  powder
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0832-0465
Route of Administration CUTANEOUS DEA Schedule     
INGREDIENTS
Name (Active Moiety) Type Strength
Nystatin (Nystatin) Active 100000 UNITS  In 1 GRAM
talc Inactive  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0832-0465-15 15 g (GRAM) In 1 BOTTLE, PLASTIC None
2 0832-0465-30 30 g (GRAM) In 1 BOTTLE, PLASTIC None

Revised: 06/2008UPSHER-SMITH LABORATORIES, INC.

 

Nycoff

30/06/10

Generic Name: dextromethorphan (Oral route)

dex-troe-meth-OR-fan

Commonly used brand name(s):

In the U.S.

  • Babee Cof Syrup
  • Benylin Pediatric Formula
  • Children’s Pedia Care
  • Creomulsion
  • Creo-Terpin
  • Delsym
  • Dexalone
  • ElixSure Cough Children’s
  • Father John’s Medicine
  • Miltuss
  • Nycoff
  • Pediacare
  • Pediacare Long-Acting Cough
  • Robafen Cough
  • Robitussin
  • Silphen DM
  • Simply Cough
  • St. Joseph
  • Vicks 44 Cough Relief

Available Dosage Forms:

  • Suspension, Extended Release
  • Solution
  • Capsule
  • Syrup
  • Lozenge/Troche
  • Liquid
  • Tablet
  • Capsule, Liquid Filled
  • Suspension

Therapeutic Class: Antitussive

Uses For Nycoff

Dextromethorphan is used to relieve coughs due to colds or influenza (flu). It should not be used for chronic cough that occurs with smoking, asthma, or emphysema or when there is an unusually large amount of mucus or phlegm (flem) with the cough.

Dextromethorphan relieves cough by acting directly on the cough center in the brain.

This medicine is available without a prescription.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .


Before Using Nycoff

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

Although there is no specific information comparing use of dextromethorphan in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children 4 years of age and older than it does in adults.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

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 dextromethorphan in the elderly with use in other age groups.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

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

  • Clorgyline
  • Iproniazid
  • Isocarboxazid
  • Moclobemide
  • Nialamide
  • Pargyline
  • Phenelzine
  • Procarbazine
  • Rasagiline
  • Selegiline
  • Toloxatone
  • Tranylcypromine

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

  • Fluoxetine
  • Linezolid
  • Paroxetine
  • Sibutramine

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

  • Haloperidol
  • Quinidine

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:

  • Asthma—Since dextromethorphan decreases coughing, it makes it difficult to get rid of the mucus that collects in the lungs and airways during asthma
  • Diabetes (sugar diabetes)—Some products contain sugar and may affect control of blood glucose monitoring
  • Liver disease—Dextromethorphan may build up in the body and cause unwanted effects
  • Chronic bronchitis or
  • Emphysema or
  • Mucus or phlegm with cough—Since dextromethorphan decreases coughing, it makes it difficult to get rid of the mucus that may collect in the lungs and airways with some diseases
  • Slowed breathing—Dextromethorphan may slow the rate of breathing even further




Proper Use of dextromethorphan

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

Make certain your health care professional knows if you are on a low-sodium, low-sugar, or any other special diet. Most medicines contain more than their active ingredient, and many liquid medicines contain alcohol.

Use this medicine only as directed by your doctor or the directions on the label. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor or the label says. Although this effect has happened only rarely, dextromethorphan has become habit-forming (causing mental or physical dependence) in some persons who used too much for a long time.

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 lozenge dosage form:
    • For cough:
      • Adults and children 12 years of age and older—5 to 15 mg every two to four hours, as needed.
      • Children 6 to 12 years of age—5 to 15 mg every two to six hours, as needed.
      • Children 4 to 6 years of age—5 mg every four hours, as needed.
      • Children and infants up to 4 years of age—Use is not recommended .
  • For syrup dosage form:
    • For cough:
      • Adults and children 12 years of age and older—30 mg every six to eight hours, as needed.
      • Children 6 to 12 years of age—7 mg every four hours or 15 mg every six to eight hours, as needed.
      • Children 4 to 6 years of age—3.5 mg every four hours or 7.5 mg every six to eight hours, as needed.
      • Children and infants up to 4 years of age—Use is not recommended .
  • For extended-release oral suspension dosage form :
    • For cough:
      • Adults and children 12 years of age and older—60 mg every twelve hours, as needed.
      • Children 6 to 12 years of age—30 mg every twelve hours, as needed.
      • Children 4 to 6 years of age—15 mg every twelve hours, as needed.
      • Children and infants up to 4 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.


Precautions While Using Nycoff

If your cough has not improved after 7 days, if sore throat has not improved after 2 days, if you have a high fever, skin rash, or continuing headache with the cough, or if asthma or high blood pressure is present, check with your doctor. These signs may mean that you have other medical problems.

Dissolve lozenges in the mouth with caution, to lessen the risk of choking.

Nycoff 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 as soon as possible if any of the following side effects occur:

Symptoms of overdose

  • Blurred vision
  • confusion
  • difficulty in urination
  • drowsiness or dizziness
  • nausea or vomiting (severe)
  • shakiness and unsteady walk
  • slowed breathing
  • unusual excitement, nervousness, restlessness, or irritability (severe)

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 or rare

  • Confusion
  • constipation
  • dizziness (mild)
  • drowsiness (mild)
  • headache
  • nausea or vomiting
  • stomach pain

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.

 

Ny-Tannic

30/06/10

Generic Name: chlorpheniramine and phenylephrine (KLOR fen IR a meen and FEN il EFF rin)
Brand Names: Allan Tannate Pediatric, Allerest PE, AlleRx, BP Allergy JR, C Phen, C Phen Drops, Cardec, Cardec Drops, Ceron, Ceron Drops, Chlor-Mes Jr, ChlorTan D, Cold & Allergy Relief, CP Dec, CP Dec Drops, Dallergy Drops, Dallergy-JR, Ed A-Hist, Ed ChlorPed D, Histadec, Nasohist Pediatric, NoHist, Ny-Tannic, PD-Hist D, PD-Hist D Drops, PediaTan D, Phenchlor Tannate Pediatric, R-Tanna, Relera, Rescon-Jr, Rinate Pediatric, Rondec, Rondec Drops, Rondex, Rondex Drops, Ry-Tann, Rynatan, Rynatan Pediatric, Sildec-PE, Sildec-PE Drops, Sinus & Allergy Maximum Strength, Sinus & Allergy PE, Sonahist, Sudafed PE Sinus & Allergy, Tanahist-D, Tannate Pediatric, Triaminic Cold & Allergy

What is Ny-Tannic (chlorpheniramine and phenylephrine)?

Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of chlorpheniramine and phenylephrine is used to treat symptoms of the common cold or seasonal allergies, including sneezing, runny or stuffy nose, and itchy, watery eyes.

Chlorpheniramine and phenylephrine may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about Ny-Tannic (chlorpheniramine and phenylephrine)?

There are many brands and forms of this medication available and not all brands are listed on this leaflet.

Do not use chlorpheniramine and phenylephrine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Dangerous side effects may occur if you take chlorpheniramine and phenylephrine before the MAO inhibitor has cleared from your body. Do not use this medication if you are allergic to chlorpheniramine or phenylephrine, or if you have severe high blood pressure or coronary artery disease, narrow-angle glaucoma, a stomach ulcer, or if you are unable to urinate.

Do not use this medication during an asthma attack.

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of chlorpheniramine and phenylephrine. Older adults may be more likely to have side effects from this medicine. Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Contact your doctor if your symptoms do not improve or if they get worse after taking this medicine for 7 days.


What should I discuss with my healthcare provider before taking Ny-Tannic (chlorpheniramine and phenylephrine)?

Do not use chlorpheniramine and phenylephrine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Dangerous side effects may occur if you take chlorpheniramine and phenylephrine before the MAO inhibitor has cleared from your body. Do not use this medication if you are allergic to chlorpheniramine or phenylephrine, or if you have:

  • severe or uncontrolled high blood pressure;

  • severe coronary artery disease;

  • narrow angle glaucoma;

  • a stomach ulcer; or

  • if you are unable to urinate.

Do not use this medication during an asthma attack.

Ask a doctor or pharmacist if it is safe for you to take this medication if you have:

  • kidney disease;
  • liver disease;
  • diabetes;

  • glaucoma;

  • circulation problems;

  • heart disease or high blood pressure;

  • overactive thyroid;

  • a seizure disorder such as epilepsy;

  • asthma, emphysema or chronic bronchitis; or

  • urination problems or an enlarged prostate.

FDA pregnancy category C. It is not known whether chlorpheniramine and phenylephrine is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether chlorpheniramine and phenylephrine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medicine.


How should I take Ny-Tannic (chlorpheniramine and phenylephrine)?

Use this medication as directed on the label, or as your doctor has prescribed. Do not use the medication in larger amounts or for longer than recommended.

Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Take this medicine with a full glass of water. Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time.

The chewable tablet must be chewed before swallowing.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Contact your doctor if your symptoms do not improve or if they get worse after taking this medicine for 7 days.

Store chlorpheniramine and phenylephrine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.


What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose can cause nausea, vomiting, diarrhea, stomach pain, problems with balance or coordination, headache, urination problems, dizziness, feeling excited or irritable, hallucinations (seeing things), metallic taste in your mouth, tremors, fever, flushed face, and seizure (convulsions).

What should I avoid while taking Ny-Tannic (chlorpheniramine and phenylephrine)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of chlorpheniramine and phenylephrine.

Avoid using other medicines that may cause restlessness (such as caffeine, stimulants, diet pills, and decongestants contained in over-the-counter cold medicines). They can add to the stimulant effects of phenylephrine.


Ny-Tannic (chlorpheniramine and phenylephrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using chlorpheniramine and phenylephrine and call your doctor at once if you have any of these serious side effects:

  • fast or uneven heart beats;

  • feeling light-headed, fainting;

  • seizure (convulsions);

  • hallucinations (seeing things that are not there); or

  • tremors.

Less serious side effects may include:

  • heartburn, nausea, vomiting, diarrhea, loss of appetite;

  • dry nose or mouth;

  • drowsiness, dizziness, weakness, headache;

  • dry eyes, blurred vision;

  • painful or difficult urination;

  • sleep problems (insomnia);

  • feeling nervous or excited (especially in children).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Ny-Tannic (chlorpheniramine and phenylephrine)?

Sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by chlorpheniramine. Tell your doctor if you regularly use any of these medicines, or any other cold or allergy medications..

Tell your doctor about all other medications you use, especially:

  • mecamylamine (Inversine);

  • methyldopa (Aldomet);

  • reserpine;

  • a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;

  • a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or

  • an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others.

This list is not complete and there may be other drugs that can interact with chlorpheniramine and phenylephrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about chlorpheniramine and phenylephrine.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 7.03. Revision Date: 11/19/2009 11:50:43 AM.

 

Nyaderm

30/06/10

Generic Name: nystatin (Oral route)

nye-STAT-in

Commonly used brand name(s):

In the U.S.

  • Bio-Statin

In Canada

  • Mycostatin Suspension
  • Nadostine
  • Nadostine Sucrose-Free
  • Nilstat Drops
  • Nilstat Powder
  • Nyaderm
  • Pms-Nystatin

Available Dosage Forms:

  • Capsule
  • Tablet
  • Suspension

Therapeutic Class: Antifungal

Chemical Class: Polyene

Uses For Nyaderm

Nystatin belongs to the group of medicines called antifungals. The dry powder, lozenge (pastille), and liquid forms of this medicine are used to treat fungus infections in the mouth.

Nystatin is available only with your doctor’s prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, nystatin is used in certain patients with the following medical condition:

  • Candidiasis, oral (fungus infection of the mouth) (prevention)


Before Using Nyaderm

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

This medicine has been tested in children and has not been reported to cause different side effects or problems in children than it does in adults. However, since children up to 5 years of age may be too young to use the lozenges (pastilles) or tablets safely, the oral suspension dosage form is best for this age group.

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 oral nystatin in the elderly with use in other age groups.

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.




Proper Use of nystatin

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

For patients taking the dry powder form of nystatin:

  • Add about ⅛ teaspoonful of dry powder to about 4 ounces of water immediately before taking. Stir well.
  • After it is mixed, take this medicine by dividing the whole amount (4 ounces) into several portions. Hold each portion of the medicine in your mouth or swish it around in your mouth for as long as possible, gargle, and swallow. Be sure to use all the liquid to get the full dose of medicine.

For patients taking the lozenge (pastille) form of nystatin:

  • Nystatin lozenges (pastilles) should be held in the mouth and allowed to dissolve slowly and completely. This may take 15 to 30 minutes. Also, the saliva should be swallowed during this time. Do not chew or swallow the lozenges whole.
  • Do not give nystatin lozenges (pastilles) to infants or children up to 5 years of age. They may be too young to use the lozenges safely.

For patients taking the oral liquid form of nystatin :

  • This medicine is to be taken by mouth even if it comes in a dropper bottle. If it does come in a dropper bottle, use the specially marked dropper to measure each dose accurately.
  • Take this medicine by placing one-half of the dose in each side of your mouth. Hold the medicine in your mouth or swish it around in your mouth for as long as possible, then gargle and swallow.

Patients with full or partial dentures may need to soak their dentures nightly in nystatin for oral suspension to eliminate the fungus from the dentures. In rare cases when this does not eliminate the fungus, it may be necessary to have new dentures made.

To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if your condition has improved. Do not miss any doses.

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 the lozenge (pastille) and tablet dosage forms:
    • Adults and children 5 years of age and older: 1 or 2 lozenges or tablets three to five times a day for up to fourteen days.
    • Children up to 5 years of age: Children this young may not be able to use the lozenges or tablets safely. The oral suspension is better for this age group.
  • For the suspension dosage form:
    • Adults and children 5 years of age and older: 4 to 6 milliliters (mL) (about 1 teaspoonful) four times a day.
    • For older infants: 2 mL four times a day.
    • For premature and low-birth-weight infants: 1 mL four times a day.

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.

Store the lozenge (pastille) form in the refrigerator.

Nyaderm 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.

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
  • nausea or vomiting
  • stomach pain

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.

 

Nyaderm Cream

30/06/10

Generic Name: nystatin (Topical route)

nye-STAT-in

Commonly used brand name(s):

In the U.S.

  • Mycostatin
  • Nystop
  • Pedi-Dri

In Canada

  • Mycostatin Cream
  • Mycostatin Ointment
  • Mycostatin Powder
  • Nadostine
  • Nilstat Topical Cream
  • Nilstat Topical Ointment
  • Nyaderm Cream
  • Nyaderm Ointment

Available Dosage Forms:

  • Powder
  • Cream
  • Ointment

Therapeutic Class: Antifungal

Chemical Class: Polyene

Uses For Nyaderm Cream

Nystatin belongs to the group of medicines called antifungals. Topical nystatin is used to treat some types of fungus infections of the skin.

Nystatin is available in the U.S. only with your doctor’s prescription.


Before Using Nyaderm Cream

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

Although there is no specific information comparing use of topical nystatin in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does 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 topical nystatin in the elderly with use in other age groups.

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.




Proper Use of nystatin

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

Topical nystatin should not be used in the eyes.

Apply enough nystatin to cover the affected area.

For patients using the powder form of this medicine on the feet:

  • Sprinkle the powder between the toes, on the feet, and in socks and shoes.

The use of any kind of occlusive dressing (airtight covering, such as kitchen plastic wrap) over this medicine may increase the chance of irritation. Therefore, do not bandage, wrap, or apply any occlusive dressing over this medicine unless directed to do so by your doctor. When using this medicine on the diaper area of children, avoid tight-fitting diapers and plastic pants.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your condition has improved. Do not miss any doses.

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 topical dosage forms (cream or ointment):
    • For fungus infections:
      • Adults and children—Apply to the affected area(s) of the skin two times a day.
  • For topical dosage form (powder):
    • For fungus infections:
      • Adults and children—Apply to the affected area(s) of the skin two or three times a day.

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.

Nyaderm Cream 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 as soon as possible if any of the following side effects occur:

  • Skin irritation not present before use of this medicine

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.

 

 

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