Nydrazid

Pronunciation: EYE-soe-NYE-a-zid
Generic Name: Isoniazid
Brand Name: Nydrazid

Nydrazid may cause severe and sometimes fatal liver problems (eg, hepatitis). The risk of liver problems is greater in patients older than 35 years old. It may also be increased by daily use of alcohol, long-term liver problems, or unsanitary injectable drug use. Women, especially those who are black, are Hispanic, or have just had a baby, may also be at increased risk. Hepatitis can develop at any time during treatment, but usually occurs during the first 3 months. Your doctor will monitor your liver function and discuss your progress every month.

Contact your doctor right away if you develop unusual fatigue, weakness or fever that lasts longer than 3 days, general feeling of discomfort, loss of appetite, nausea, vomiting, numbness or tingling of the hands or feet, dark urine, yellowing of the skin or eyes, or stomach pain or tenderness. Your doctor may decide to slowly restart isoniazid after these symptoms disappear and lab tests return to normal.

Patients with active liver problems should not use Nydrazid.

Nydrazid is used for:

Treating or preventing tuberculosis (TB). If you are using Nydrazid to treat TB, it should always be used along with another medicine.

Nydrazid is an antibacterial. It works by killing TB organisms.

Do NOT use Nydrazid if:

• you are allergic to any ingredient in Nydrazid or have had severe side effects from isoniazid, such as drug fever, chills, or arthritis


• you have severe liver damage, active liver disease, or liver damage from previous use of Nydrazid


• you have a history of hepatitis caused by any medicine

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

Before using Nydrazid:

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

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


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


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


• if you have diabetes, kidney problems, nerve problems (eg, neuropathy) or risk of nerve problems, HIV, or a history of liver problems


• if you have a history of alcohol or other substance abuse, have unsanitary injectable drug habits, or drink alcohol daily


• if you are older than 35 years old, you have recently given birth, or you have previously taken Nydrazid

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

• Acetaminophen, anticoagulants (eg, warfarin), carbamazepine, hydantoins (eg, phenytoin), rifampin, theophylline, or valproic acid because the risk of their side effects may be increased by Nydrazid


• Ketoconazole because its effectiveness may be decreased by Nydrazid

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

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

• Nydrazid is usually given as an injection at your doctor's office, hospital, or clinic.


• Do not use Nydrazid if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• Continue to use Nydrazid even if you feel well. Do not miss any doses.


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

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

Important safety information:

• Check with your doctor before drinking alcohol while using Nydrazid. Alcohol may increase the risk of liver problems. If you have a history of alcohol abuse, you may also be at increased risk of developing nerve problems from Nydrazid. Notify your doctor if you notice any unusual tingling or numbness in your hands or feet.


• If you have a history of diabetes, alcohol abuse, or poor nutrition, your doctor may recommend that you also take vitamin B₆ while you are taking Nydrazid. This may help to decrease your risk of nerve problems. Discuss any questions with your doctor.


• Do not eat foods high in tyramine while you use Nydrazid. Eating foods high in tyramine (eg, aged cheeses, red wines, beer, certain meats and sausages, liver, sour cream, soy sauce, raisins, bananas, avocados) while you use Nydrazid may cause severe high blood pressure. Seek medical attention at once if symptoms of severe high blood pressure occur. These may include severe headache, fast or irregular heartbeat, sore or stiff neck, nausea, vomiting, sweating, enlarged pupils, or sensitivity to light.


• Do not eat foods high in histamine while you use Nydrazid. Eating foods high in histamine (eg, skipjack, tuna, tropical fish) while you use Nydrazid may cause low blood pressure, irregular heartbeat, headache, sweating, or flushing. Contact your doctor at once if any of these symptoms occur.


• Ask your health care provider for a complete list of all foods you should avoid while you are using Nydrazid.


• Nydrazid only works against TB bacteria; it does not treat viral infections (eg, the common cold).


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


• Diabetes patients - Nydrazid may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. You may also be at increased risk of developing nerve problems from Nydrazid. Contact your doctor if you notice any unusual tingling in your hands or feet.


• Lab tests, including liver function and eye exams, may be performed while you use Nydrazid. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Nydrazid with caution in BLACK and HISPANIC WOMEN; they may have a greater risk of severe liver problems from Nydrazid.


• Use Nydrazid with caution in patients older than 35 years old; they may have a greater risk of severe liver problems from Nydrazid.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Nydrazid while you are pregnant. Nydrazid is found in breast milk. If you are or will be breast-feeding while you use Nydrazid, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Nydrazid:

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:

Mild stomach upset.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in vision; chills or fever; dark urine; general feeling of discomfort; increased thirst or urination; joint pain or swelling; loss of appetite; memory problems; mental or mood changes; nausea; seizures; stomach pain or tenderness; symptoms of low vitamin B₆ levels (eg, confusion, cracks in the corners of the mouth, irritability, mouth redness or soreness, scaly rash); tingling or numbness in the hands or feet; unusual bruising or bleeding; unusual tiredness or weakness; vomiting; yellowing of the 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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Nydrazid side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; dizziness; hallucinations; loss of consciousness; nausea; seizures; slurred speech; symptoms of high blood sugar (eg, confusion, increased thirst or urination, rapid breathing, unusual drowsiness); very slow breathing; vomiting.

Proper storage of Nydrazid:

Nydrazid is usually handled and stored by a health care provider. If you are using Nydrazid at home, store Nydrazid as directed by your pharmacist or health care provider. Keep Nydrazid out of the reach of children and away from pets.

General information:

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


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


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


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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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Nyamyc

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.

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Nyaderm Vaginal Cream

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.

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Nuvigil

Generic Name: armodafinil (Oral route)

ar-moe-DAF-i-nil

Commonly used brand name(s)

In the U.S.

• Nuvigil

Available Dosage Forms:

• Tablet

Therapeutic Class: CNS Stimulant

Chemical Class: Amphetamine Related

Uses For Nuvigil

Armodafinil is used to help people who have narcolepsy, obstructive sleep apnea (also called hypopnea syndrome), or shift work sleep disorders to stay awake during the day. This medicine does not cure these conditions and will only work as long as you continue to take it.

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

Before Using Nuvigil

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

Allergies

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

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of armodafinil in children younger than 17 years of age. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of armodafinil have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of armodafinil in the elderly. However, elderly patients may have a slower removal of this medicine from the body, which may require an adjustment in the dose for patients receiving armodafinil.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

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

Interactions with Medicines

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

Using this medicine with any of the following medicines 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.

• Midazolam


• Omeprazole

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:

• Alcohol abuse, history of or


• Drug abuse or dependence, history of—Dependence may be more likely to develop.

• Angina (severe chest pain), unstable or


• Heart attack, recent—Use with caution. May cause side effects to become worse.

• Depression, history of or


• Hypertension (high blood pressure) or


• Mania, history of or


• Psychosis (mental illness), history of—Use with caution. May make these conditions worse.

• Left ventricular hypertrophy (heart disease), history of or


• Mitral valve prolapse (heart disease)—Should not be used in patients with these conditions.

• Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of Nuvigil

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor if you have any questions.

If you have sleep apnea and use a continuous positive airway pressure (CPAP) machine at night, continue using this machine with the medicine.

Take this medicine at the same time each day. Do not change your schedule without talking to your doctor.

You may take this medicine with or without food.

Dosing

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

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

• For oral dosage form (tablets):
  
  • For narcolepsy or obstructive sleep apnea:
    
    • Adults and teenagers 17 years of age and older—150 or 250 milligrams (mg) once a day in the morning.
    
    
    • Teenagers and children younger than 17 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For shift work sleep disorder:
    
    • Adults and teenagers 17 years of age and older—150 milligrams (mg) one hour before you begin working.
    
    
    • Teenagers and children younger than 17 years of age—Use and 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.

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

Precautions While Using Nuvigil

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

This medicine does not take the place of getting enough sleep. It should not be used for occasional sleepiness that has not been diagnosed as narcolepsy, sleep apnea, or a shift work sleep problem. Ask your doctor for advice about good sleep habits.

This medicine may cause serious types of allergic reactions, including anaphylaxis and angioedema. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop taking this medicine and call your doctor right away if you have a skin rash, itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Stop taking this medicine and check with your doctor right away if you have more than one of these symptoms: chest pain or discomfort; fever and chills; dark urine; a headache; a rash; stomach pain; unusual bleeding or bruising; unusual tiredness; or yellow eyes or skin. These may be signs of a serious allergic reaction.

Serious skin reactions can occur during treatment with this medicine. Stop using this medicine and check with your doctor right away if you have any of the following symptoms: blistering, peeling, or loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat; sores, ulcers, or white spots in your mouth or lips; or unusual tiredness or weakness.

Hormonal birth control pills, implants, patches, shots, vaginal rings, or IUDs may not work as well while you are using armodafinil. To keep from getting pregnant, use a second form of birth control together with your pills, implant, patch, shot, vaginal ring, or IUD while you are using this medicine. Continue using the second form of birth control for one month after your last dose. Other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies.

If you do become pregnant while you are taking this medicine, tell your doctor right away. Your doctor may want you to join a pregnancy registry for pregnant patients who are taking this medicine.

Until you know how this medicine affects you, do not drive, use machines, or do anything else that could be dangerous if you are not alert.

Armodafinil may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you notice any of these side effects, tell your doctor right away.

Check with your doctor if you have been taking this medicine for a long time and feel that it is not working as well as before. Do not increase your dose without talking to your doctor. Some people can become mentally or physically dependent on this medicine. If you have questions, talk with your doctor.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Nuvigil Side Effects

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

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

Less common

• Blistering, burning, crusting, dryness, or flaking of the skin


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• difficult or labored breathing


• fast, irregular, pounding, or racing heartbeat or pulse


• fever


• frequent urination


• headache, severe and throbbing


• increased volume of pale, dilute urine


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


• rash


• shakiness in the legs, arms, hands, or feet


• shortness of breath


• tightness in the chest


• trembling or shaking of the hands or feet


• wheezing

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

Symptoms of overdose

• Anxiety


• blurred vision


• chest pain or discomfort


• confusion about identity, place, and time


• diarrhea


• dry mouth


• headache


• hyperventilation


• irritability


• lightheadedness, dizziness, or fainting


• nausea


• nervousness


• pounding in the ears


• restlessness


• seeing, hearing, or feeling things that are not there


• sleeplessness


• slow heartbeat


• trouble sleeping


• unable to sleep


• unusual tiredness or weakness

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

• Acid or sour stomach


• belching


• chills


• cough


• depression


• difficulty having a bowel movement (stool)


• discouragement


• feeling sad or empty


• general feeling of discomfort or illness


• heartburn


• indigestion


• joint pain


• loss of appetite


• loss of interest or pleasure


• mood or mental changes


• muscle aches and pains


• runny nose


• shivering


• sore throat


• stomach discomfort, upset, or pain


• sweating


• thirst


• tiredness


• trouble concentrating


• vomiting


• weight loss

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.

See also: Nuvigil side effects (in more detail)

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

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

More Nuvigil resources

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

• Nuvigil Prescribing Information (FDA)


• Nuvigil Consumer Overview


• Nuvigil Monograph (AHFS DI)


• Nuvigil MedFacts Consumer Leaflet (Wolters Kluwer)


• Armodafinil Professional Patient Advice (Wolters Kluwer)

Compare Nuvigil with other medications

• Bipolar Disorder
• Chronic Fatigue Syndrome
• Depression
• Fibromyalgia
• Hypersomnia
• Jet Lag
• Narcolepsy
• Obstructive Sleep Apnea/Hypopnea Syndrome
• Shift Work Sleep Disorder

NuZon

Generic Name: hydrocortisone topical (hye droe KOR ti sone)

Brand Names: Ala-Cort, Ala-Scalp HP, Aquanil HC, Beta HC, Caldecort, Cortaid, Cortaid Intensive Therapy, Cortaid Maximum Strength, Cortaid with Aloe, Cortalo with Aloe, Corticaine, Cortizone for Kids, Cortizone-10, Cortizone-10 Intensive Healing Formula, Cortizone-10 Plus, Cortizone-5, Dermarest Dricort, Dermarest Eczema Medicated, Dermarest Plus Anti-Itch, Dermtex HC, Genasone/Aloe, Gly-Cort, Gynecort Maximum Strength, Hycort, Hydrocortisone 1% In Absorbase, Hydrocortisone with Aloe, Hydrocortisone-Aloe, Hytone, Instacort, Itch-X Lotion, Locoid, Locoid Lipocream, Locoid Lotion, Massengill Medicated Soft Cloth, MD Hydrocortisone, Neutrogena T-Scalp, NuCort with Aloe, NuZon, Pandel, Recort Plus, Rederm, Sarnol-HC, Scalacort, Texacort, U-Cort, Westcort

What is NuZon (hydrocortisone topical)?

Hydrocortisone is a topical steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Hydrocortisone topical is used to treat inflammation of the skin caused by a number of conditions such as allergic reactions, eczema, or psoriasis.

Hydrocortisone topical may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about NuZon (hydrocortisone topical)?

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

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

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Avoid using this medication on your face, near your eyes, or on body areas where you have skin folds or thin skin.

Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of hydrocortisone topical.

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days.

What should I discuss with my healthcare provider before using NuZon (hydrocortisone topical)?

Do not use this medication if you are allergic to hydrocortisone.

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

FDA pregnancy category C. It is not known whether hydrocortisone topical is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether hydrocortisone topical 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. Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of hydrocortisone topical.

How should I use NuZon (hydrocortisone topical)?

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

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

Wash your hands before and after each application, unless you are using hydrocortisone topical to treat a hand condition.

Apply a small amount to the affected area and rub it gently into the skin.

Avoid using this medication on your face, near your eyes or mouth, or on body areas where you have skin folds or thin skin.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions. Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days. It is important to use hydrocortisone topical regularly to get the most benefit. Store hydrocortisone topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use 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, or if anyone has accidentally swallowed it. An overdose of hydrocortisone topical applied to the skin is not expected to produce life-threatening symptoms.

What should I avoid while using NuZon (hydrocortisone topical)?

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water. Do not use hydrocortisone topical on sunburned, windburned, irritated, or broken skin. Also avoid using this medication in open wounds.

Avoid using skin products that can cause irritation, such as harsh soaps or shampoos or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

NuZon (hydrocortisone topical) 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 hydrocortisone topical and call your doctor at once if you have any of these serious side effects:

• 
  

  blurred vision, or seeing halos around lights;

  
  


• 
  

  uneven heartbeats;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  weight gain, puffiness in your face; or

  
  


• 
  

  feeling tired.

  
  

Less serious side effects may include:

• 
  

  skin redness, burning, itching, or peeling;

  
  


• 
  

  thinning of your skin;

  
  


• 
  

  blistering skin; or

  
  


• 
  

  stretch marks.

  
  

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 NuZon (hydrocortisone topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied hydrocortisone. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More NuZon resources

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

• Ala-Cort Advanced Consumer (Micromedex) - Includes Dosage Information


• Anusol-HC Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Carmol HC Prescribing Information (FDA)


• Carmol HC MedFacts Consumer Leaflet (Wolters Kluwer)


• Cortizone-10 Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Hydrocortisone Acetate Monograph (AHFS DI)


• Hydrocortisone with Aloe Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Hytone Prescribing Information (FDA)


• Instacort Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Locoid Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Locoid Lipocream Prescribing Information (FDA)


• Locoid Lotion Prescribing Information (FDA)


• Nutracort Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• Pandel Prescribing Information (FDA)


• Pediaderm HC Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• ProctoCream-HC Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Proctocort Prescribing Information (FDA)


• Texacort Prescribing Information (FDA)


• U-cort Prescribing Information (FDA)


• Westcort Prescribing Information (FDA)

Compare NuZon with other medications

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

Where can I get more information?

• Your pharmacist can provide more information about hydrocortisone topical.

See also: NuZon side effects (in more detail)

Nupercainal

Generic Name: dibucaine (Topical application route)

DYE-bue-kane

Commonly used brand name(s)

In the U.S.

• Nupercainal

Available Dosage Forms:

• Cream


• Ointment

Therapeutic Class: Anesthetic, Local

Chemical Class: Amino Amide

Uses For Nupercainal

Dibucaine is used to relieve pain and itching caused by conditions such as sunburn or other minor burns, insect bites or stings, poison ivy, poison oak, poison sumac, minor cuts, or scratches.

Dibucaine belongs to a group of medicines known as topical local anesthetics. It deadens the nerve endings in the skin. This medicine does not cause unconsciousness as general anesthetics do when used for surgery.

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

Before Using Nupercainal

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

Allergies

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

Pediatric

Appropriate studies on the relationship of age to the effects of dibucaine have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in children are not expected.

Geriatric

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Infection at or near the place of application or


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

Proper Use of Nupercainal

Use this medicine exactly as directed by your doctor or as directed in the package instructions. Do not use it for any other reason without first checking with your doctor. This medicine may cause unwanted effects if it is used too much, because more of it is absorbed into the body through the skin.

Wash your hands with soap and water before and after using this medicine.

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

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

Be careful not to get any of this medicine in your nose, mouth, and especially in your eyes, because it can cause severe eye irritation. If any of the medicine does get on these areas, wash the area with water for at least 15 minutes and check with your doctor right away.

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 form (ointment):
  
  • For pain and itching caused by minor skin conditions:
    
    • Adults—Apply to the affected area three or four times a day as needed. The largest amount that may be used in a 24-hour period is 30 grams (g), but much smaller amounts are usually enough.
    
    
    • Children 2 years of age and older—Apply to the affected area three or four times a day as needed. Do not use more than 7.5 g in a 24-hour period.
    
    
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Nupercainal

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

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

Stop using this medicine and check with your doctor right away if you have a skin rash, burning, stinging, swelling, or irritation of your skin.

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

Nupercainal Side Effects

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

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

Incidence not known

• Chest pain


• fast or irregular heartbeat


• tightness in the chest


• unusual warmth or flushing of skin

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:

Incidence not known

• Diarrhea


• eye irritation


• nausea


• skin irritation


• vomiting

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

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

See also: Nupercainal side effects (in more detail)

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

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

More Nupercainal resources

• Nupercainal Side Effects (in more detail)
• Nupercainal Use in Pregnancy & Breastfeeding
• Nupercainal Support Group
• 1 Review for Nupercainal - Add your own review/rating

• Nupercainal topical Concise Consumer Information (Cerner Multum)


• Nupercainal Monograph (AHFS DI)


• Nupercainal Ointment MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Nupercainal with other medications

• Anal Itching
• Burns, External
• Hemorrhoids
• Local Anesthesia

Nuflor Gold

Dosage Form: FOR ANIMAL USE ONLY
NuflorGold™

(florfenicol)

Injectable Solution, An Antimicrobial

300 mg/mL

For subcutaneous use in beef and non-lactating dairy cattle only

Not for use in female dairy cattle 20 months of age or older or in calves to be processed for veal

PRODUCT

INFORMATION

CAUTION

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Nuflor Gold Description

Nuflor Gold™ is an injectable solution of the synthetic antibiotic florfenicol. Each milliliter of sterile Nuflor Gold™ contains 300 mg of florfenicol, 300 mg of 2-pyrrolidone, and triacetin qs.

INDICATION

Nuflor Gold™ is indicated for treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis in beef and non-lactating dairy cattle.

Nuflor Gold Dosage and Administration

Nuflor Gold™ should be administered once by subcutaneous injection at a dose rate of 40 mg florfenicol/kg body weight (6 mL/100 lb). Do not administer more than 15 mL at each site. The injection should be given only in the neck. Injection sites other than the neck have not been evaluated.

Nuflor Gold™ Dosage Guide
ANIMAL WEIGHT (lb)	DOSAGE (mL)
100	6.0	Recommended Injection Location:
200	12.0
300	18.0
400	24.0
500	30.0
600	36.0
700	42.0
800	48.0
900	54.0
1000	60.0

Contraindications

Do not use in animals that have shown hypersensitivity to florfenicol.

Warnings

NOT FOR HUMAN USE. KEEP OUT OF REACH OF CHILDREN. This product contains materials that can be irritating to skin and eyes. Avoid direct contact with skin, eyes, and clothing. In case of accidental eye exposure, flush with water for 15 minutes. In case of accidental skin exposure, wash with soap and water. Remove contaminated clothing. Consult a physician if irritation persists. Accidental injection of this product may cause local irritation. Consult a physician immediately. The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information.

For customer service, to report suspected adverse reactions, or to obtain a copy of the MSDS, call 1-800-211-3573.

Precautions

Not for use in animals intended for breeding purposes. The effects of florfenicol on bovine reproductive performance, pregnancy, and lactation have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy.

Subcutaneous injection in cattle can cause a transient local tissue reaction that may result in trim loss of edible tissue at slaughter.

RESIDUE WARNINGS

Animals intended for human consumption must not be slaughtered within 44 days of treatment. Do not use in female dairy cattle 20 months of age or older. Use of florfenicol in this class of cattle may cause milk residues. A withdrawal period has not been established in pre-ruminating calves. Do not use in calves to be processed for veal.

Adverse Reactions

Transient inappetence, diarrhea, decreased water consumption, and injection site swelling have been associated with the use of florfenicol in cattle. In addition, anaphylaxis and collapse have been reported post-approval with the use of another formulation of florfenicol in cattle.

Nuflor Gold - Clinical Pharmacology

The pharmacokinetic disposition of Nuflor Gold™ was evaluated in feeder calves following a single subcutaneous injection at a dose rate of 40 mg florfenicol/kg body weight. Administration of Nuflor Gold™ resulted in florfenicol plasma concentrations of 2 µg (mcg)/mL within two hours of injection.

Table 1. Pharmacokinetic Parameter Values for Florfenicol Following a Single Subcutaneous Injection of Nuflor Gold™ at a Dose Rate of 40 mg Florfenicol/kg Body Weight to Feeder Calves (n=24).

	Cmax (µg/mL)	Tmax (hr)	AUClast (µg*hr/mL)	T½ (hr)
Cmax: Maximum observed plasma concentration Tmax: Time at which Cmax was observed AUClast: Area under the plasma-concentration-time curve from time zero to the last quantifiable concentration that is equal to or greater than the limit of quantification of the validated analytical method T½: Terminal elimination half-life % CV: Percent coefficient of variance
* T½ value could not be accurately estimated for one calf † Tmax is presented as the median value or range of observed values (minimum to maximum)
n	24	24	24	23*
Mean	5.93	5†	150	37.7
% CV	38.3	2-12†	20.9	27.3

Figure 1. Mean Florfenicol Plasma Concentration versus Time Following a Single Subcutaneous Injection of Nuflor Gold™ at a Dose Rate of 40 mg Florfenico/kg Body Weight in Feeder Calves (Mean ± Standard Error of the Mean)

MICROBIOLOGY

Florfenicol is a synthetic, broad-spectrum antibiotic active against many Gram-negative and Gram-positive bacteria isolated from domestic animals. It acts by binding to the 50S ribosomal subunit and inhibiting bacterial protein synthesis. Florfenicol is generally considered a bacteriostatic drug, but it exhibits bactericidal activity against certain bacterial species. In vitro studies demonstrate that florfenicol is active against the BRD pathogens M. haemolytica, P. multocida, H. somni, and M. bovis and that florfenicol exhibits bactericidal activity against strains of M. haemolytica and H. somni.

The minimum inhibitory concentrations (MICs) of florfenicol were determined for BRD isolates obtained from calves enrolled in BRD field studies in the U.S. in 2006 using methods recommended by the Clinical and Laboratory Standards Institute (M31-A2). Isolates were obtained from pre-treatment nasal swabs from all calves enrolled at all four sites, post-treatment nasal swabs from treatment failures in the Nuflor Gold Injectable Solution and saline control treatment groups at three sites, and lung tissue from one calf that died in the saline control treatment group. The results are shown below in Table 2.

Table 2. Florfenicol MIC values* of indicated pathogens isolated from cattle with naturally-occurring BRD

Indicated pathogens	Year of isolation	No. of isolates	MIC50† (µg/mL)	MIC90† (µg/mL)	MIC range (µg/mL)
* The correlation between in vitro susceptibility data and clinical effectiveness is unknown. † The lowest MIC to encompass 50% and 90% of the most susceptible isolates, respectively.
Mannheimia haemolytica	2006	158	1.0	1.0	0.5 to 32
Pasteurella multocida	2006	103	0.5	0.5	≤ 0.125 to 16
Histophilus somni	2006	85	≤ 0.125	≤ 0.125	≤ 0.125 to 0.25

ANIMAL SAFETY

A target animal safety study was conducted to evaluate the effects of Nuflor Gold™ when administered to feeder cattle by subcutaneous injection at 1X, 3X, or 5X the labeled dose for three consecutive days (3X the labeled duration). Decreased feed consumption (inappetence), decreased water consumption, and injection site swelling were observed in the 1X, 3X, and 5X groups.

A separate injection site study conducted in cattle demonstrated that Nuflor Gold™ may induce a transient local reaction in the subcutaneous tissue and underlying muscle tissue.

STORAGE INFORMATION

Store between 2°-30°C (36°-86°F). Use within 28 days of first use. Refrigeration is not required. The solution is light yellow to straw colored. Color does not affect potency.

How is Nuflor Gold Supplied

Nuflor Gold™ is packaged in 100 mL (NDC 0061-5327-01), 250 mL (NDC 0061-5327-02), and 500 mL (NDC 0061-5327-03) glass sterile multiple-dose vials.

Made in Germany

Intervet Inc., Roseland, NJ 07068

© 2009, Intervet Inc.

All rights reserved.

B-31331005   7/09

F-31331005

NADA 141-265, Approved by FDA.

PRINCIPAL DISPLAY PANEL - 100 mL vial label

NuflorGOLD™

(florfenicol)

Injectable Solution, An Antimicrobial

For subcutaneous use in beef and non-lactating dairy

cattle only

Not for use in female dairy cattle 20 months of age or

older or in calves to be processed for veal

Caution: Federal law restricts this drug to use by or on

the order of a licensed veterinarian

NADA 141-265, Approved by FDA

Intervet

Schering-Plough Animal Health

NDC 0061-5327-01

100 mL Multiple Dose Vial • 300 mg/mL • Sterile

PRINCIPAL DISPLAY PANEL - 100 mL vial carton

NuflorGOLD™

(florfenicol)

Injectable Solution,

An Antimicrobial

Caution: Federal law restricts this drug to use by or

on the order of a licensed veterinarian

NADA 141-265, Approved by FDA

NDC 0061-5327-01

Intervet

Schering-Plough Animal Health

100 mL Multiple Dose Vial • 300 mg/mL • Sterile

PRINCIPAL DISPLAY PANEL - 250 mL vial label

NuflorGOLD™

(florfenicol)

Injectable Solution, An Antimicrobial

For subcutaneous use in beef and non-lactating dairy

cattle only

Not for use in female dairy cattle 20 months of age or

older or in calves to be processed for veal

Caution: Federal law restricts this drug to use by

or on the order of a licensed veterinarian

NADA 141-265, Approved by FDA

Intervet

Schering-Plough Animal Health

NDC 0061-5327-02

250 mL Multiple Dose Vial • 300 mg/mL • Sterile

PRINCIPAL DISPLAY PANEL - 500 mL vial label

NuflorGOLD™

(florfenicol)

Injectable Solution, An Antimicrobial

For subcutaneous use in beef and non-lactating dairy

cattle only

Not for use in female dairy cattle 20 months of age or older

or in calves to be processed for veal

Caution: Federal law restricts this drug to use by

or on the order of a licensed veterinarian

NADA 141-265, Approved by FDA

Intervet

Schering-Plough Animal Health

NDC 0061-5327-03

500 mL Multiple Dose Vial • 300 mg/mL • Sterile

Nuflor Gold  florfenicol  injection

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 0061-5327 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Florfenicol (Florfenicol) Florfenicol 300 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength Triacetin

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0061-5327-01 1 VIAL In 1 CARTON contains a VIAL, MULTI-DOSE 1 100 mL In 1 VIAL, MULTI-DOSE This package is contained within the CARTON (0061-5327-01) 2 0061-5327-02 250 mL In 1 VIAL, MULTI-DOSE None 3 0061-5327-03 500 mL In 1 VIAL, MULTI-DOSE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141265	09/18/2009

Labeler - Schering Corporation (001317601)

Establishment
Name	Address	ID/FEI	Operations
Essex Animal Health Friesoythe		330363511	ANALYSIS, MANUFACTURE

Revised: 09/2009Schering Corporation