Fluorescite

Dosage Form: injection, solution
Fluorescite®

(fluorescein injection, USP) 10%

Sterile

DESCRIPTION

Fluorescite® (fluorescein injection, USP) 10% contains fluorescein sodium (equivalent to fluorescein 10% w/v). It is a sterile solution for use intravenously as a diagnostic aid. Its chemical name is spiro[isobenzofuran-1(3H), 9'-[9H]xanthene]-3-one, 3'6'-dihydroxy,disodium salt. The active ingredient is represented by the chemical structure:

Fluorescite® (fluorescein injection, USP) 10% is supplied as a sterile, unpreserved, single-use aqueous solution, that has a pH of 8.0 - 9.8 and an osmolality of 572-858 mOsm/kg.

Active ingredient: fluorescein sodium

Inactive Ingredients

Sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection.

CLINICAL PHARMACOLOGY

Mechanism of Action

Fluorescein sodium responds to electromagnetic radiation and light between the wavelengths of 465-490 nm and fluoresces, i.e., emits light at wavelengths of 520-530 nm. Thus, the hydrocarbon is excited by blue light and emits light that appears yellowish-green. Following intravenous injection of fluorescein sodium in an aqueous solution, the unbound fraction of the fluorescein can be excited with a blue light flash from a fundus camera as it circulates through the ocular vasculature, and the yellowish green fluorescence of the dye is captured by the camera. In the fundus, the fluorescence of the dye demarcates the retinal and/or choroidal vasculature under observation, distinguishing it from adjacent areas/structures.

Pharmacokinetics

Distribution:

Within 7 to 14 seconds after IV administration into antecubital vein, fluorescein usually appears in the central artery of the eye. Within a few minutes of IV administration of fluorescein sodium, a yellowish discoloration of the skin occurs, which begins to fade after 6 to 12 hours of dosing. Various estimates of volume of distribution indicate that fluorescein distributes well into interstitial space (0.5 L/kg).

Metabolism:

Fluorescein undergoes rapid metabolism to fluorescein monoglucuronide. After IV administration of fluorescein sodium (14 mg/kg) to 7 healthy subjects, approximately 80% of fluorescein in plasma was converted to glucuronide conjugate after a period of 1 hour post dose, indicating relatively rapid conjugation.

Excretion:

Fluorescein and its metabolites are mainly eliminated via renal excretion. After IV administration, the urine remains slightly fluorescent for 24 to 36 hours. A renal clearance of 1.75 mL/min/kg and a hepatic clearance (due to conjugation) of 1.50 mL/min/kg have been estimated. The systemic clearance of fluorescein was essentially complete by 48 to 72 hours after administration of 500 mg fluorescein.

INDICATIONS AND USAGE:

Fluorescite® (fluorescein injection, USP) 10% is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.

CONTRAINDICATIONS

Fluorescite® (fluorescein injection, USP) 10% is contraindicated in patients with known hypersensitivity to fluorescein sodium or any other ingredients in this product.

WARNINGS

FOR INTRAVENOUS USE

Care must be taken to avoid extravasation during injection as the high pH of fluorescein solution can result in severe local tissue damage. The following complications resulting from extravasation of fluorescein have been noted to occur: Sloughing of the skin, superficial phlebitis, subcutaneous granuloma, and toxic neuritis along the median curve in the antecubital area. Complications resulting from extravasation can cause severe pain in the arm for up to several hours. When significant extravasation occurs, the injection should be discontinued and conservative measures to treat damaged tissue and to relieve pain should be implemented. Rare cases of death due to anaphylaxis have been reported (See PRECAUTIONS).

PRECAUTIONS

General

Caution is to be exercised in patients with a history of allergy or bronchial asthma. An emergency tray should be available in the event of possible reaction to Fluorescite® (fluorescein injection, USP) 10%. Use only if the container is undamaged.

Information for Patients

Skin will attain a temporary yellowish discoloration. Urine attains a bright yellow color. Discoloration of the skin usually fades in 6 to 12 hours and usually fades in urine in 24 to 36 hours.

Laboratory Information

If a potential allergy is suspected, an intradermal skin test may be performed prior to intravenous administration, i.e., 0.05 mL injected intradermally to be evaluated 30 to 60 minutes following injection. Given the sensitivity and specificity of skin testing, a negative skin test is not proof that a patient is not allergic to fluorescein.

Carcinogenesis, Mutagenesis, Impairment of Fertility

There have been no long-term studies done using fluorescein in animals to evaluate carcinogenic potential.

Pregnancy

Teratogenic Effects: Pregnancy Category C

Adequate animal reproduction studies have not been conducted with fluorescein sodium. It is also not known whether fluorescein sodium can cause fetal harm when administered to a pregnant woman. Fluorescein sodium should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Fluorescein sodium has been demonstrated to be excreted in human milk. Caution should be exercised when fluorescein sodium is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have been established.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

ADVERSE REACTIONS (see WARNINGS and PRECAUTIONS)

Nausea, vomiting, gastrointestinal distress, headache, syncope, hypotension, and symptoms and signs of hypersensitivity have occurred. Cardiac arrest, basilar artery ischemia, severe shock, convulsions, thrombophlebitis at the injection site, and rare cases of death have been reported. Extravasation of the solution at the injection site causes intense pain at the site and a dull aching pain in the injected arm (see WARNINGS). Generalized hives and itching, bronchospasm and anaphylaxis have been reported. A strong taste may develop after injection.

DOSAGE AND ADMINISTRATION

The normal adult dose of Fluorescite® (fluorescein injection, USP) 10% is 500 mg (100 mg/mL) via intravenous administration.

For children, the dose should be calculated on the basis of 35 mg for each ten pounds of body weight (7.7 mg/kg body weight).

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not mix or dilute with other solutions or drugs. Flush intravenous cannulas before and after drugs are injected to avoid physical incompatibility reactions.

Inject the dose rapidly (1 mL per second is normally recommended) into the antecubital vein, after taking precautions to avoid extravasation. A syringe, filled with Fluorescite® (fluorescein injection, USP) 10%, may be attached to transparent tubing and a 23 gauge butterfly needle for injection. Insert the needle and draw the patient's blood to the hub of the syringe so that a small air bubble separates the patient's blood in the tubing from the fluorescein. With the room lights on, slowly inject the blood back into the vein while watching the skin over the needle tip. If the needle has extravasated, the patient's blood will be seen to bulge the skin and the injection should be stopped before any fluorescein is injected. When assured that extravasation has not occurred, the room light may be turned off and the fluorescein injection completed. Luminescence usually appears in the retina and choroidal vessels in 7 to 14 seconds and can be observed by standard viewing equipment.

Reduction in dose from 5 ml to 2 ml of Fluorescite® (fluorescein injection, USP) 10% may be appropriate in cases when a highly sensitive imaging system e.g., scanning laser ophthalmoscope is used.

HOW SUPPLIED

Fluorescite® (fluorescein injection, USP) 10% is supplied in a single-use 5 mL glass vial with a gray FluroTec coated chlorobutyl (latex free) stopper and purple flip-off aluminum seal. It contains a sterile, red-orange solution of fluorescein sodium.

NDC 0065-0092-65

Storage

Store at 2°- 25°C (36°- 77°F).

Do Not Freeze

Rx Only

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA

Printed in USA

© 2006, 2009 Alcon, Inc.

9004433-0209

PRINCIPAL DISPLAY PANEL

NDC 0065-0092-65              1 Dozen 5 mL Vials

Fluorescite® 10%

(fluorescein injection, USP) 10%

STERILE

100 mg/ml Fluorescein

Rx Only

FOR INTRAVENOUS USE

Store at 2° - 25° C (36° - 77°F)

Do Not Freeze

  

Alcon®

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA

  

©2000-2009 Alcon, Inc.              H11427 - 1009

     

Fluorescite  fluorescein sodium  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0065-0092 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FLUORESCEIN SODIUM (FLUORESCEIN) FLUORESCEIN SODIUM 100 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM HYDROXIDE   HYDROCHLORIC ACID   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0065-0092-05 5 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021980	09/15/1972

Labeler - Alcon, Inc. (008018525)

Registrant - Alcon, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Operations
Alcon Research Ltd.		008018525	MANUFACTURE

Revised: 07/2011Alcon, Inc.

More Fluorescite resources

• Fluorescite Support Group
• 0 Reviews · Be the first to review/rate this drug

Fabrazyme

Pronunciation: ay-GAL-si-dase
Generic Name: Agalsidase Beta
Brand Name: Fabrazyme

Fabrazyme is used for:

Treating Fabry disease.

Fabrazyme is a glycoprotein. It works by providing the enzyme alpha-galactosidase A to the body.

Do NOT use Fabrazyme if:

• you are allergic to any ingredient in Fabrazyme

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

Before using Fabrazyme:

Some medical conditions may interact with Fabrazyme. 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 are or have recently been ill


• if you have heart or lung problems

Some MEDICINES MAY INTERACT with Fabrazyme. However, no specific interactions with Fabrazyme are known at this time.

Ask your health care provider if Fabrazyme 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 Fabrazyme:

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

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


• Do not use Fabrazyme 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 Fabrazyme even if you feel well. Do not miss any doses.


• If you miss a dose of Fabrazyme, contact your doctor right away.

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

Important safety information:

• Fabrazyme may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Fabrazyme with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Many patients may experience a reaction while they are receiving their dose of Fabrazyme. Some reactions may be severe. Tell your doctor right away if you develop fever, chills, headache, rash, hives, itching, swelling, stomach pain, nausea, vomiting, muscle pain, dizziness, chest pain or tightness, fast heartbeat, throat tightness, or shortness of breath while you are receiving your dose. Discuss any questions or concerns with your doctor.


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


• Fabrazyme should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fabrazyme while you are pregnant. It is not known if Fabrazyme is found in breast milk. If you are or will be breast-feeding while you are using Fabrazyme, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Fabrazyme:

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:

Dizziness; headache; nausea; runny or stuffy nose; sore throat; 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); bone pain; chest pain or tightness; chills; confusion; decreased hearing or hearing loss; decreased or painful urination; fainting; fast, slow, or irregular heartbeat; fever; joint pain; loss of coordination; mental or mood changes (eg, anxiety, depression); muscle pain or weakness; numbness or pain of an arm or leg; one-sided weakness; severe headache, dizziness, or nausea; shortness of breath; slurred speech; stomach pain; sudden vision changes; swelling (eg, hands, legs, feet, lips, ears); throat tightness; unusual tiredness or weakness; unusually pale skin; vomiting.

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: Fabrazyme side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Fabrazyme:

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

General information:

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


• Fabrazyme 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 Fabrazyme. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Fabrazyme resources

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

• Fabrazyme Prescribing Information (FDA)


• Fabrazyme Consumer Overview


• Fabrazyme Monograph (AHFS DI)


• Fabrazyme Advanced Consumer (Micromedex) - Includes Dosage Information


• Agalsidase Beta Professional Patient Advice (Wolters Kluwer)

Compare Fabrazyme with other medications

• Fabry Disease

Factrel

Pronunciation: goe-nad-oh-RELL-in
Generic Name: Gonadorelin
Brand Name: Factrel

Factrel is used for:

Evaluating how well the hypothalamus and pituitary glands are working. It may also be used for other conditions as determined by your doctor.

Factrel is a gonadotropin-releasing hormone. It works by causing the pituitary gland to release other hormones (luteinizing hormone and follicle-stimulating hormone) that control development in children and fertility in adults.

Do NOT use Factrel if:

• you are allergic to any ingredient in Factrel

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

Before using Factrel:

Some medical conditions may interact with Factrel. 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 breastfeeding


• 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 or have a history of cancer or abnormal growths or lumps


• if you have a cyst on your ovary or ovarian hyperstimulation

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

• Other infertility medicines (eg, clomiphene) because the risk of side effects may be increased

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

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

• Factrel is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Factrel at home, carefully follow the injection procedures taught to you by your health care provider.


• If Factrel contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.


• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.


• If you miss a dose of Factrel, contact your doctor immediately.

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

Important safety information:

• LAB TESTS, including blood samples, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• Factrel is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Factrel during pregnancy. It is unknown if Factrel is excreted in breast milk. If you are or will be breastfeeding while you are using Factrel, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Factrel:

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:

Headache; lightheadedness.

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); fast pulse; flushing; hoarseness; shortness of breath; swelling, pain, and redness at the injection site.

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: Factrel side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Factrel:

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

General information:

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


• Factrel 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 Factrel. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Factrel resources

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

• Factrel injectable Concise Consumer Information (Cerner Multum)


• Factrel Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Factrel with other medications

• Amenorrhea
• Gonadotropin Deficiency

Flumadine

Generic Name: rimantadine (Oral route)

ri-MAN-ta-deen

Commonly used brand name(s)

In the U.S.

• Flumadine

Available Dosage Forms:

• Tablet


• Syrup

Therapeutic Class: Antiviral

Chemical Class: Adamantane

Uses For Flumadine

Rimantadine is used to prevent or treat certain influenza (flu) infections (type A) in adults (17 years of age and older). It is also used to prevent flu infection (type A) in children (1 to 16 years of age). It may be given alone or along with flu shots.

Rimantadine is an antiviral. It will not work for colds, other types of flu, or other virus infections.

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

Before Using Flumadine

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of rimantadine in children. However, safety and efficacy have not been established in children younger than 1 year of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rimantadine in the elderly. However, elderly patients are more likely to have unwanted side effects (e.g., anxiety, dizziness, nausea, vomiting, stomach pain), which may require caution and an adjustment in the dose for patients receiving rimantadine.

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. 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:

• Epilepsy or seizures, history of—Use with caution. May make these conditions worse.

• Kidney disease, severe or


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

Proper Use of Flumadine

Talk to your doctor about the possibility of getting a flu shot if you have not had one yet.

This medicine is best taken before exposure, or as soon as possible after exposure, to people who have the flu.

To help keep yourself from getting the flu, keep taking this medicine for the full time of treatment.

If you already have the flu, continue taking this medicine for the full time of treatment even if you begin to feel better after a few days. This will help to clear up your infection completely. If you stop taking this medicine too soon, your symptoms may return. This medicine should be taken for at least 5 to 7 days.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times day and night.

Shake the oral liquid well before each use. Measure the medicine with 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.

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 (suspension or tablets):
  
  • For treatment of flu:
    
    • Adults and teenagers 17 years of age and older—100 milligrams (mg) two times a day for 7 days.
    
    
    • Older adults—100 mg once a day.
    
    
    • Children up to 16 years of age—Use is not recommended.
    
    
  
  
  • For prevention of flu:
    
    • Adults and teenagers 17 years of age and older—100 milligrams (mg) two times a day.
    
    
    • Older adults—100 mg once a day.
    
    
    • Children 10 to 16 years of age—100 mg two times a day.
    
    
    • Children 1 to 9 years of age—Dose is based on body weight and must be determined by your doctor. The dose is 5 milligrams (mg) per kilogram (kg) of body weight once a day. Children in this age group should not receive more than 150 mg per day.
    
    
    • Children younger than 1 year 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

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.

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

Store the oral liquid at room temperature for 14 days.

Precautions While Using Flumadine

It is important that your doctor check the progress of you or your child at regular visits to allow changes in your dose and to check for any unwanted effects.

This medicine may cause some people to become dizzy or confused, or to have trouble concentrating. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or confused. If these reactions are especially bothersome, check with your doctor.

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

While you are being treated with rimantadine, do not have any immunizations (vaccinations) without your doctor's approval. Live virus vaccinations should not be given for 2 days after stopping rimantadine, and this medicine should be not be given 2 weeks after receiving live vaccines.

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.

Flumadine 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

• Difficult or labored breathing


• shortness of breath


• tightness in the chest


• wheezing

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

Symptoms of overdose

• Anxiety


• chest pain or discomfort


• dizziness


• dry mouth


• fainting


• fast, slow, or irregular heartbeat


• hyperventilation


• irregular heartbeats


• irritability


• lightheadedness


• nervousness


• pounding or rapid pulse


• restlessness


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


• shaking


• trouble with sleeping

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Abdominal or stomach pain


• acid or sour stomach


• belching


• continuing ringing or buzzing or other unexplained noise in the ears


• diarrhea


• difficulty with concentrating


• headache


• hearing loss


• heartburn


• impaired concentration


• indigestion


• lack or loss of strength


• loss of appetite


• nausea


• rash


• shakiness and unsteady walk


• sleepiness or unusual drowsiness


• stomach discomfort, upset, or pain


• unsteadiness, trembling, or other problems with muscle control or coordination


• unusual tiredness or weakness


• 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: Flumadine 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 Flumadine resources

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

• Flumadine Prescribing Information (FDA)


• Flumadine MedFacts Consumer Leaflet (Wolters Kluwer)


• Flumadine Concise Consumer Information (Cerner Multum)


• Flumadine Monograph (AHFS DI)


• Rimantadine Prescribing Information (FDA)

Compare Flumadine with other medications

• Influenza A
• Influenza Prophylaxis

Febuxostat

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

Introduction

Xanthine oxidase inhibitor.^{1 2 3 4 5 6 8}

Uses for Febuxostat

Gout

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

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

Not recommended for the management of asymptomatic hyperuricemia.¹

Febuxostat Dosage and Administration

General

• 
  

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

  
  


• 
  

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

  
  

Administration

Oral Administration

Administered orally without regard to meals or antacids.^{1 10}

Dosage

Adults

Gout

Oral

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

Special Populations

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

Cautions for Febuxostat

Contraindications

• 
  

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

  
  

Warnings/Precautions

Acute Gout

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

Cardiovascular Events

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

Hepatic Effects

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

Specific Populations

Pregnancy

Category C.¹

Lactation

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

Pediatric Use

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

Geriatric Use

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

Dosage adjustment based on age not needed.^{1 3}

Hepatic Impairment

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

Renal Impairment

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

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

Secondary Hyperuricemia

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

Common Adverse Effects

Liver function abnormalities, nausea, arthralgia, rash.¹

Interactions for Febuxostat

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

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

Drugs Affecting Hepatic Microsomal or Other Enzymes

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

Drugs Metabolized by Hepatic Microsomal Enzymes

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

Drugs Metabolized by Xanthine Oxidase

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

Specific Drugs

Drug	Interaction	Comments
Antacids	Pharmacokinetic interaction unlikely1 10
Antineoplastic agents	Not evaluated1 Mercaptopurine: Inhibition of mercaptopurine metabolism; possible increase in toxic effects1	No information on safety of concomitant use1 Mercaptopurine: Concomitant use contraindicated1
Azathioprine	Inhibition of azathioprine metabolism; possible increase in toxic effects1	Concomitant use contraindicated1
Colchicine	Clinically important pharmacokinetic interaction unlikely1	Dosage adjustment not needed
Desipramine	Pharmacokinetic interaction not considered clinically important1	Dosage adjustment not expected to be necessary1
Hydrochlorothiazide	Clinically important pharmacokinetic interaction unlikely1	Dosage adjustment not needed
Indomethacin	Clinically important pharmacokinetic interaction unlikely1	Dosage adjustment not needed
Naproxen	Clinically important pharmacokinetic interaction unlikely1	Dosage adjustment not needed
Theophylline	Inhibition of theophylline metabolism; possible increase in toxic effects1	Concomitant use contraindicated1
Warfarin	Pharmacokinetic interaction unlikely1	Dosage adjustment not needed

Febuxostat Pharmacokinetics

Absorption

Bioavailability

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

Food

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

Distribution

Plasma Protein Binding

99.2%.¹

Elimination

Metabolism

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

Elimination Route

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

Half-life

5–8 hours.¹

Special Populations

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

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

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

Stability

Storage

Oral

Tablets

25°C (may be exposed to 15–30°C).¹

ActionsActions

• 
  

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

  
  


• 
  

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

  
  

Advice to Patients

• 
  

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

  
  


• 
  

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

  
  


• 
  

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

  
  


• 
  

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

  
  


• 
  

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

  
  

Preparations

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

Febuxostat

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	40 mg	Uloric	Takeda
		80 mg	Uloric	Takeda

Disclaimer

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

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

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

References

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

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

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

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

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

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

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

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

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

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

More Febuxostat resources

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

• Febuxostat MedFacts Consumer Leaflet (Wolters Kluwer)


• Febuxostat Professional Patient Advice (Wolters Kluwer)


• febuxostat Advanced Consumer (Micromedex) - Includes Dosage Information


• Uloric Prescribing Information (FDA)


• Uloric Consumer Overview

Compare Febuxostat with other medications

• Gout

Flagyl Vaginal

Generic Name: metronidazole (Vaginal route)

met-roe-NYE-da-zole

Commonly used brand name(s)

In the U.S.

• Metrogel-Vaginal


• Vandazole

In Canada

• Flagyl


• Neo-Metric


• Nidagel

Available Dosage Forms:

• Suppository


• Gel/Jelly


• Cream

Therapeutic Class: Antibacterial

Chemical Class: Nitroimidazole

Uses For Flagyl

Metronidazole vaginal is used to treat women with vaginal infections (e.g., bacterial vaginosis).

Metronidazole belongs to the class of medicines known as antibiotics. It works by killing the bacteria or preventing their growth. However, this medicine will not work for vaginal fungus or yeast infections.

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

Before Using Flagyl

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:

In deciding whether to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For vaginal metronidazole, 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 metronidazole vaginal gel have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in teenagers are not expected. This medicine may be used for bacterial vaginosis in teenage females but should not be used before the start of menstruation.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of metronidazole vaginal gel in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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

• Amprenavir


• Disulfiram

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.

• Amiodarone


• Busulfan


• Fluorouracil


• Mycophenolate Mofetil


• Warfarin

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.

• Carbamazepine


• Cholestyramine


• Cyclosporine


• Lithium


• Milk Thistle


• Tacrolimus

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. 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 is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

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:

• Aseptic meningitis, history of or


• Encephalopathy (brain disorder), history of or


• Leukopenia (low white blood cells), history of or


• Optic neuropathy (eye disease with vision changes), history of or


• Peripheral neuropathy (nerve disease with pain, numbness, or tingling), history of or


• Seizures or epilepsy, history of—Use with caution. May make these conditions worse.

• Liver disease, severe—Patients with severe liver disease may have an increase in side effects.

Proper Use of metronidazole

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

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

This medicine is to be used only in the vagina. Use it at bedtime, unless your doctor tells you otherwise.

Do not get it in your eyes, nose, mouth, or skin. If this medicine does get into your eyes, wash them out right away with large amounts of cool tap water. If your eyes still burn or are painful, check with your doctor.

This medicine usually come with patient directions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

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

Metronidazole vaginal gel is in a tube. You will use an applicator to put the gel into your vagina. The applicator has a plastic tube called a barrel that is open at one end and has a plunger (another piece of plastic that can move inside the barrel) at the other end.

• To fill the applicator:
  
  • For cream or gel dosage forms:
    
    • Break the metal seal at the opening of the tube by using the point on the top of the cap.
    
    
    • Screw the applicator onto the tube.
    
    
    • Squeeze the medicine into the applicator slowly until it is full.
    
    
    • Remove the applicator from the tube. Replace the cap on the tube.
    
    
  
  
  • For vaginal tablet dosage form:
    
    • Place the vaginal tablet into the applicator. Wet the vaginal tablet with water for a few seconds.
    
    
  
  


• To insert vaginal metronidazole using the applicator
  
  • For all dosage forms:
    
    • Relax while lying on your back with your knees bent (or in any position that you feel comfortable).
    
    
    • Hold the full applicator in one hand. Insert it slowly into the vagina. Stop before it becomes uncomfortable.
    
    
    • Slowly press the plunger until it stops.
    
    
    • Withdraw the applicator. The medicine will be left behind in the vagina.
    
    
    • Remove the applicator from your vagina. Use each applicator only once, and then throw it away.
    
    
  
  

To help clear up your infection completely, it is very important that you keep using this medicine for the full time of treatment, even if your symptoms begin to clear up after a few days. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses. Also, continue using this medicine even if your menstrual period starts during the time of treatment.

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 bacterial vaginal infections:
  
  • For vaginal dosage form (cream):
    
    • Adults and teenagers—One applicatorful (500 milligrams [mg]), inserted into the vagina. Use the medicine one or two times a day for 10 or 20 days.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For vaginal dosage form (gel):
    
    • Adults and teenagers—One applicatorful (5000 milligrams [mg]) inserted into the vagina once a day (at bedtime) for 5 days. Each applicatorful contains 37.5 mg of metronidazole.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For vaginal dosage form (tablets):
    
    • Adults and teenagers—One 500 milligram (mg) tablet, inserted high into the vagina. Use the medicine once a day in the evening for 10 or 20 days.
    
    
    • Children—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 Flagyl

It is important that your doctor check your progress after you finish using this medicine. This is to make sure that the infection is cleared up.

If your symptoms do not improve within a few days after you start this medicine or if they become worse, check with your doctor.

You should not use this medicine if you have taken disulfiram (Antabuse®) within the last 2 weeks. Disulfiram is used to help people who have a drinking problem. If these 2 medicines are taken close together, serious unwanted effects may occur.

Drinking alcoholic beverages while using this medicine may cause stomach pain, nausea, vomiting, headache, or flushing or redness of the face. Alcohol-containing medicines (e.g., elixirs, cough syrups, tonics) may also cause problems. The chance of these problems occurring may continue for at least a day after you stop using metronidazole. You should not drink alcoholic beverages or take other alcohol-containing medicines while you are using this medicine and for at least 3 days after stopping it.

Stop using this medicine and check with your doctor right away if you have dizziness, problems with muscle control or coordination, shakiness or an unsteady walk, slurred speech, or trouble with speaking. These may be symptoms of a serious brain condition called encephalopathy.

Stop using this medicine and call your doctor right away if you have confusion, drowsiness, fever, a general feeling of illness, a headache, loss of appetite, nausea, a stiff neck or back, or vomiting. These could be symptoms of a serious condition called aseptic meningitis.

Stop using this medicine and check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

This medicine may cause some people to become dizzy or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert. If these reactions are especially bothersome, check with your doctor.

Vaginal medicines usually leak out of the vagina during treatment. To keep the medicine from getting on your clothing, wear a mini-pad or sanitary napkin. Do not use tampons (like those used for menstrual periods) since they may soak up the medicine.

To help clear up your infection completely and to help make sure it does not return, good health habits are also required.

• Wear cotton panties (or panties or pantyhose with cotton crotches) instead of synthetic (e.g., nylon or rayon) panties.


• Wear only freshly washed panties daily.

Do not have sexual intercourse while you are using this medicine. Having sexual intercourse may reduce the strength of the medicine. This may keep the medicine from working properly. Also, oils in the cream and vaginal tablets (but not the vaginal gel) may damage latex (rubber) contraceptive devices (e.g., cervical caps, condoms, or diaphragms), causing them to leak, wear out sooner, or not work properly.

Avoid using douches or other vaginal products unless your doctor tells you to.

Many vaginal infections (e.g., trichomoniasis) are spread by having sexual intercourse. You can give the infection to your sexual partner, and the infection could be given back to you. Your partner may also need to be treated for some infections. Until you are sure that the infection is completely cleared up after your treatment with this medicine, your partner should wear a condom during sexual intercourse . If you have any questions about this, check with your doctor.

Before you have any medical tests, tell the medical doctor in charge that you are using 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.

Flagyl 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

• Itching in the vagina


• pain during sexual intercourse


• thick, white vaginal discharge with no odor or with a mild odor

Less common

• Abdominal or stomach cramping or pain


• burning on urination or need to urinate more often


• burning or irritation of penis of sexual partner


• itching, stinging, or redness of the genital area

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


• dizziness or lightheadedness


• dryness of the mouth


• feeling of a furry tongue


• headache


• loss of appetite


• metallic taste or other change in taste sensation


• nausea


• vomiting

Metronidazole may cause your urine to become dark. This is harmless and will go away when you stop using this medicine.

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Any vaginal or genital irritation or itching


• pain during sexual intercourse


• thick, white vaginal discharge not present before treatment, with no odor or with a mild odor

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.

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More Flagyl Vaginal resources

• Flagyl Vaginal Use in Pregnancy & Breastfeeding
• Flagyl Vaginal Drug Interactions
• Flagyl Vaginal Support Group
• 15 Reviews for Flagyl Vaginal - Add your own review/rating

Compare Flagyl Vaginal with other medications

• Bacterial Vaginitis
• Perioral Dermatitis
• Rosacea

Faslodex

Generic Name: fulvestrant (Intramuscular route)

ful-VES-trant

Commonly used brand name(s)

In the U.S.

• Faslodex

Available Dosage Forms:

• Solution

Therapeutic Class: Antiestrogen

Uses For Faslodex

Fulvestrant injection is used to treat metastatic breast cancer (cancer that has spread) that is hormone-receptor positive in women who have already stopped menstruating (postmenopausal). It is used for women who have breast cancer that has not improved after using other cancer medicines.

Many of the breast cancer tumors will grow when estrogen is available in the body. This medicine blocks the effects of the estrogen hormone in the body. As a result, the amount of estrogen that the tumor is exposed to is reduced, which will limit the growth of the tumor.

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

Before Using Faslodex

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 fulvestrant injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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

• Bleeding problems or


• Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.

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

Proper Use of Faslodex

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine. This medicine is given as a shot into one of your buttocks muscles.

Fulvestrant injection comes with patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Precautions While Using Faslodex

It is very important that your doctor check your progress at regular visits to make sure that the medicine is working properly. Blood tests may be needed to check for unwanted effects.

It is unlikely that a postmenopausal woman may become pregnant. But, you should know that using this medicine while you are pregnant could harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

This medicine may cause you to have bleeding from the vagina, especially when you first start using it. If the bleeding continues or is bothersome, check with your doctor right away.

Cancer medicines can cause nausea or vomiting, even after receiving medicines to prevent it. If you have nausea and vomiting after receiving this medicine, talk to your doctor or nurse about ways to control these effects.

Faslodex 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 or nurse immediately if any of the following side effects occur:

More common

• Bloating or swelling of the face, arms, hands, lower legs, or feet


• rapid weight gain


• tingling of the hands or feet


• unusual weight gain or loss

Less common

• Difficult or labored breathing


• shortness of breath


• tightness in the chest


• wheezing

Incidence not known

• Black, tarry stools


• chest pain


• chills


• cough


• fever


• flushing or redness of the skin


• hives or welts


• itching


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• pain in the chest, groin, or legs, especially the calves


• painful or difficult urination


• severe and sudden headache


• skin rash


• slurred speech


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• sudden loss of coordination


• sudden and severe weakness or numbness in the arm or leg


• sudden unexplained shortness of breath


• swollen glands


• unusual bleeding or bruising


• unusual tiredness or weakness


• vaginal bleeding


• vision changes

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

• Back pain


• bladder pain


• bloody or cloudy urine


• body aches or pain


• bone pain


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


• depression


• diarrhea


• difficulty having a bowel movement (stool)


• difficulty with moving


• dizziness


• dryness or soreness of the throat


• feeling faint, dizzy, or lightheaded


• feeling of warmth or heat


• feeling sad or empty


• frequent urge to urinate


• general feeling of discomfort or illness


• headache


• hoarseness


• irritability


• joint pain


• lack or loss of appetite


• lack or loss of strength


• loss of interest or pleasure


• lower back or side pain


• muscle aches and pains


• muscle stiffness


• nausea


• pain at the injection site


• pain in the arms or legs


• pelvic pain


• shivering


• skin rash


• stomach pain


• sudden sweating


• tender, swollen glands in the neck


• trouble concentrating


• trouble with swallowing


• unable to sleep


• voice changes


• vomiting


• weight loss

Less common

• Nervousness


• pain, swelling, or redness in the joints


• pale skin

Incidence not known

• Dizziness or lightheadedness


• feeling of constant movement of self or surroundings


• sensation of spinning

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: Faslodex 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 Faslodex resources

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

• Faslodex Prescribing Information (FDA)


• Faslodex Consumer Overview


• Faslodex Monograph (AHFS DI)


• Faslodex MedFacts Consumer Leaflet (Wolters Kluwer)


• Fulvestrant Professional Patient Advice (Wolters Kluwer)

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