Thursday, September 22, 2016

Feocyte


Generic Name: multivitamin with iron (MUL tee VYE ta mins with i ron)

Brand Names:


What is Feocyte (multivitamin with iron)?

Multivitamin are a combination of many different vitamins that are normally found in foods and other natural sources.


Iron is normally found in foods like red meat. In the body, iron becomes a part of your hemoglobin (HEEM o glo bin) and myoglobin (MY o glo bin). Hemoglobin carries oxygen through your blood to tissues and organs. Myoglobin helps your muscle cells store oxygen.


Multivitamin and iron are used to provide vitamins and iron that are not taken in through the diet. They are also used to treat iron or vitamin deficiencies caused by illness, pregnancy, poor nutrition, digestive disorders, and many other conditions.


Multivitamin and iron may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about Feocyte (multivitamin with iron)?


Never take more than the recommended dose of a multivitamin. Avoid taking any other multivitamin product within 2 hours before or after you take multivitamin with iron. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects. Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects. Iron and other minerals contained in a multivitamin can also cause serious overdose symptoms if you take too much.

Overdose symptoms may include severe stomach pain, vomiting, bloody diarrhea, coughing up blood, constipation, loss of appetite, hair loss, peeling skin, warmth or tingly feeling, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine or stools, black and tarry stools, pale skin, easy bruising or bleeding, weakness, shallow breathing, weak and rapid pulse, pale skin, blue lips, and seizure (convulsions).


Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin with iron.

What should I discuss with my healthcare provider before taking Feocyte (multivitamin with iron)?


Iron and certain vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.

If you have any medical conditions, ask your doctor before taking a multivitamin with iron. If you have certain conditions, you may need a certain vitamin formulation or special tests while taking this product.


Do not take multivitamin with iron without telling your doctor if you are pregnant or plan to become pregnant. Some vitamins and minerals can harm an unborn baby if taken in large doses. You may need to use a prenatal vitamin specially formulated for pregnant women. Multivitamin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Feocyte (multivitamin with iron)?


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


Never take more than the recommended dose of multivitamin with iron. Avoid taking any other multivitamin product within 2 hours before or after you take multivitamin with iron. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Many multivitamin products also contain minerals such as calcium, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.


Take your multivitamin with a full glass of water. You may take the multivitamin with food if it upsets your stomach.

The chewable tablet must be chewed or allowed to dissolve in the mouth before swallowing.


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


Liquid multivitamin may sometimes be mixed with water, fruit juice, or infant formula (but not milk or other dairy products). Follow the directions on the medicine label.


Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow the pill whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

It is important to take multivitamin with iron regularly to get the most benefit.


Store this medication at room temperature away from moisture and heat. Keep the liquid medicine from freezing.

Store multivitamin in their original container. Storing multivitamin in a glass container can ruin the medication.


What happens if I miss a dose?


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


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects. Iron and other minerals contained in a multivitamin can also cause serious overdose symptoms.

Overdose symptoms may include severe stomach pain, vomiting, bloody diarrhea, coughing up blood, constipation, loss of appetite, hair loss, peeling skin, warmth or tingly feeling, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine or stools, black and tarry stools, pale skin, easy bruising or bleeding, weakness, shallow breathing, weak and rapid pulse, pale skin, blue lips, and seizure (convulsions).


What should I avoid while taking Feocyte (multivitamin with iron)?


Avoid taking any other multivitamin product within 2 hours before or after you take multivitamin with iron. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.


Avoid taking an antibiotic medicine within 2 hours before or after you take multivitamin with iron. This is especially important if you are taking an antibiotic such as ciprofloxacin (Cipro), demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), levofloxacin (Levaquin), lomefloxacin (Maxaquin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), norfloxacin (Noroxin), ofloxacin (Floxin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).


Certain foods can also make it harder for your body to absorb iron. Avoid taking this multivitamin within 1 hour before or 2 hours after eating fish, meat, liver, and whole grain or "fortified" breads or cereals.


Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin.

Feocyte (multivitamin with iron) 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. Call your doctor if you have serious side effects such as:

  • bright red blood in your stools; or




  • pain in your chest or throat when swallowing a ferrous fumarate tablet.



When taken as directed, multivitamin are not expected to cause serious side effects. Less serious side effects may include:



  • constipation, diarrhea;




  • nausea, vomiting, heartburn;




  • stomach pain, upset stomach;




  • black or dark-colored stools or urine;




  • temporary staining of the teeth;




  • headache; or




  • unusual or unpleasant taste in your mouth.



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 Feocyte (multivitamin with iron)?


Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking multivitamin with iron, tell your doctor if you also use:



  • acetohydroxamic acid (Lithostat);




  • cimetidine (Tagamet);




  • deferoxamine (Desferal);




  • etidronate (Didronel);




  • diuretics (water pills);




  • heart or blood pressure medications;




  • tretinoin (Vesanoid);




  • isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);




  • dimercaprol (an injection used to treat poisoning by arsenic, lead, or mercury);




  • penicillamine (Cuprimine);




  • pancrelipase (Cotazym, Creon, Ilozyme, Pancrease, Ultrase);




  • trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Septra, TMP/SMX); or




  • an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), and others.



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



More Feocyte resources


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


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Compare Feocyte with other medications


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Where can I get more information?


  • Your pharmacist can provide more information about multivitamin with iron.

See also: Feocyte side effects (in more detail)


Fludara


Pronunciation: floo-DAYR-a-been
Generic Name: Fludarabine
Brand Name: Fludara

Some patients who received high doses of Fludara to treat acute leukemia developed severe nervous system side effects, including blindness, coma, and death. Similar nervous system side effects, including coma, seizures, agitation, and confusion, have occurred in patients at doses recommended for the treatment of chronic lymphocytic leukemia. Discuss any questions or concerns with your doctor. Contact your doctor right away if any of these effects occur.


Fludara may severely decrease bone marrow function. This can lower your body's ability to fight infection and reduce the ability of your blood to clot properly. Some patients have developed severe and sometimes fatal blood problems (eg, hemolytic anemia, autoimmune thrombocytopenia, hemophilia) while using Fludara. Your doctor will need to monitor you closely for these conditions. Tell your doctor right away if you develop signs or symptoms of an infection (eg, swollen glands, sore throat, fever, chills), bleeding problems (eg, easy bruising; black, tarry stools; bleeding from the gums), or hemolytic anemia (eg, yellowing of the eyes or skin, dark urine, severe tiredness or weakness). Be sure to keep all doctor and laboratory appointments.


Fatal lung problems have been reported in patients receiving Fludara along with pentostatin. Fludara is not recommended for use with pentostatin.





Fludara is used for:

Treating patients with certain types of leukemia who have not responded to other therapy or whose disease has progressed during treatment with other medicines. It may also be used for other conditions as determined by your doctor.


Fludara is an antimetabolite. It works by preventing the cancer cell from reproducing, which results in death of the cell.


Do NOT use Fludara if:


  • you are allergic to any ingredient in Fludara

  • you are taking pentostatin

  • you have severely decreased kidney function

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



Before using Fludara:


Some medical conditions may interact with Fludara. 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 a history of bone marrow problems (eg, low blood platelet levels, anemia), blood or bleeding problems, kidney problems, immune system problems, nervous system problems, infections, skin cancer, autoimmune hemolytic anemia, or a positive Coombs test

  • if you receive other chemotherapy, radiation therapy, or you have received radiation or chemotherapy in the past

  • if you have developed an autoimmune reaction (eg, hemolytic anemia) after receiving Fludara

  • if you will be having a blood transfusion

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


  • Pentostatin because the risk of fatal lung problems may be increased

  • Digoxin because its effectiveness may be decreased by Fludara

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


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


  • Fludara is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Fludara at home, a health care provider will teach you how to use it. Be sure you understand how to use Fludara. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.

  • Avoid contact with skin and mucous membranes (eg, mouth, nose). If Fludara accidentally spills on your skin, wash it off immediately with soap and water. If it gets in your eyes, rinse thoroughly with plain tap water.

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

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

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



Important safety information:


  • Fludara may cause drowsiness, dizziness, tiredness, weakness, vision problems, confusion, agitation, or seizures. Some of these effects may be worse if you use it with alcohol or certain medicines. Use Fludara with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.

  • Fludara may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.

  • Fludara may lower the ability of your body to fight infection and may increase the risk of severe and sometimes fatal infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.

  • Do not receive a live vaccine (eg, measles, mumps) during or after treatment with Fludara. Talk with your doctor before you receive any vaccine.

  • New or worsening skin cancer has been reported with Fludara. Tell your doctor if you have a history of skin cancer. Contact your doctor right away if you notice a change in the appearance of a mole, new growth on the skin, or any unusual skin change.

  • Serious bone marrow problems (myelodysplastic syndrome [MDS]) and a type of leukemia (acute myeloid leukemia [AML]) have been reported with Fludara. Most reports were in patients who had also been treated with certain other chemotherapy medicines or radiation. Tell your doctor if you have ever received other chemotherapy or radiation treatments. Contact your doctor if you have questions about this information.

  • A severe and possibly fatal nervous system problem (progressive multifocal leukoencephalopathy [PML]) has been reported in patients who use Fludara. This has been reported to develop between a few weeks and as long as about 1 year after starting treatment. Many of these patients were also taking other chemotherapy or had received other chemotherapy in the past. Contact your doctor right away if you develop signs of PML, such as trouble walking or talking, confusion, vision problems, or vision loss.

  • Men who may father a child and women who may become pregnant must use an effective form of birth control (eg, condoms) while using Fludara and for 6 months after stopping treatment. If you have questions about effective birth control, talk with your doctor.

  • Fludara may cause infertility in men that is sometimes permanent. Discuss any questions or concerns with your doctor.

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

  • Use Fludara with caution in the ELDERLY; they may be more sensitive to its effects.

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

  • PREGNANCY and BREAST-FEEDING: Fludara has been shown to cause harm to the fetus. Avoid becoming pregnant while you use it and for 6 months after you stop treatment. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fludara while you are pregnant. It is not known if Fludara is found in breast milk. Do not breast-feed while using Fludara.


Possible side effects of Fludara:


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:



Diarrhea; general body discomfort; loss of appetite; muscle pain; nausea; tiredness; vomiting; weakness.



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); abnormal thinking; black, tarry, or bloody stools; bloody or dark urine; changes in strength or the way you walk; chest pain; confusion; coughing or vomiting blood; difficult, decreased, or painful urination; fainting; hearing loss; irregular heartbeat; lower back or side pain; mental or mood changes (eg, agitation); muscle weakness or cramps; numbness or tingling in the hands or feet; red, swollen, blistered, or peeling skin; seizures; severe or persistent tiredness or weakness; shortness of breath; signs of infection (eg, fever, chills, cough, or sore throat); skin changes; swelling of the fingers, hands, or feet; swelling or sores of the mouth, lips, or tongue; unusual bruising or bleeding; vision changes or blindness; vomit that looks like coffee grounds; yellowing of the eyes or skin.



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


See also: Fludara 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 bleeding; blindness; coma; infection.


Proper storage of Fludara:

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


General information:


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

  • Fludara 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 Fludara. 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 Fludara resources


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


  • Fludara Prescribing Information (FDA)

  • Fludara Monograph (AHFS DI)

  • Fludara Advanced Consumer (Micromedex) - Includes Dosage Information

  • Fludarabine Prescribing Information (FDA)

  • fludarabine Advanced Consumer (Micromedex) - Includes Dosage Information

  • Oforta Prescribing Information (FDA)

  • Oforta Consumer Overview



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Flurandrenolide Cream


Pronunciation: FLUR-an-DREN-oh-lide
Generic Name: Flurandrenolide
Brand Name: Examples include Cordran SP and Cordran


Flurandrenolide Cream is used for:

Treating inflammation and itching due to certain skin conditions. It may also be used for other conditions as determined by your doctor.


Flurandrenolide Cream is a topical adrenocortical steroid. It works by reducing skin inflammation (redness, swelling, itching, and irritation) in a way that is not clearly understood.


Do NOT use Flurandrenolide Cream if:


  • you are allergic to any ingredient in Flurandrenolide Cream

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



Before using Flurandrenolide Cream:


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


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

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

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

  • if you have any kind of skin infection, cuts, scrapes, or lessened blood flow to your skin

  • if you have had a recent vaccination; have measles, tuberculosis (TB), chickenpox, or shingles; or have had a positive TB test

  • if you are taking prednisone or similar medicines

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


This may not be a complete list of all interactions that may occur. Ask your health care provider if Flurandrenolide Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Flurandrenolide Cream:


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


  • Apply a small amount of medicine to the affected area. Gently rub the medicine in until it is evenly distributed. Wash your hands after applying Flurandrenolide Cream, unless your hands are part of the treated area.

  • Do not bandage or cover the treated skin area unless directed by your doctor. If your doctor instructs you to bandage or cover the treated area, closely follow the instructions provided by your doctor or other health care provider.

  • If you miss a dose of Flurandrenolide Cream, apply 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 apply 2 doses at once.

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



Important safety information:


  • Flurandrenolide Cream is for external use only. Do not get Flurandrenolide Cream in your eyes, nose, or mouth. If you get it in any of these areas, rinse immediately with tap water.

  • Do not use Flurandrenolide Cream on the face, underarms, or groin area unless your doctor tells you otherwise.

  • If Flurandrenolide Cream is applied to the diaper area, apply a very small amount and do not use tight-fitting diapers or plastic pants.

  • Do NOT take more than the recommended dose, use for longer than prescribed, or apply Flurandrenolide Cream over a large area without checking with your doctor.

  • If your symptoms do not get better within 2 weeks or if they get worse, check with your doctor.

  • Talk with your doctor before you use any other medicines or cleansers on your skin.

  • Check with your doctor before having vaccinations while using Flurandrenolide Cream.

  • Do not use Flurandrenolide Cream for other skin conditions at a later time.

  • Flurandrenolide Cream has a corticosteroid in it. Before you start any new medicine, check the label to see if it has a corticosteroid in it too. If it does or if you are not sure, check with your doctor or pharmacist.

  • Serious side effects may occur if too much of Flurandrenolide Cream is absorbed through the skin. This may be more likely to occur if you use Flurandrenolide Cream over a large area of the body. It may also be more likely if you wrap or bandage the area after you apply Flurandrenolide Cream. The risk is greater in children. Do not use more than the prescribed dose. Contact your doctor right away if you develop unusual weight gain (especially in the face), muscle weakness, increased thirst or urination, confusion, unusual drowsiness, severe or persistent headache, or vision changes. Discuss any questions or concerns with your doctor.

  • Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Flurandrenolide Cream.

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


Possible side effects of Flurandrenolide Cream:


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



Dryness; itching.



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); acne-like rash; burning, cracking, irritation, or peeling not present before you began using Flurandrenolide Cream; excessive hair growth; inflamed hair follicles; inflammation around the mouth; muscle weakness; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.



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: Flurandrenolide 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 increased thirst or urination; muscle weakness; unusual weight gain, especially in the face.


Proper storage of Flurandrenolide Cream:

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


General information:


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

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

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

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

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



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Flurandrenolide resources


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


Compare Flurandrenolide with other medications


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flumazenil


Generic Name: flumazenil (floo MAZ e nil)

Brand Names: Romazicon


What is flumazenil?

Flumazenil reverses the effects of certain types of sedatives from the benzodiazepine (ben-zo-dye-AYZ-e-peen) group of drugs. This includes Valium, Xanax, Tranxene, Librium, ProSom, Dalmane, Ativan, Restoril, Halcion, and others.


Flumazenil is used to reverse the sedative effects of a benzodiazepine when used during surgery or other medical procedure. Flumazenil is also used to treat benzodiazepine overdose.


Flumazenil may also be used for purposes other than those listed in this medication guide.


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


You should not receive this medication if you are allergic to flumazenil or any type of benzodiazepine sedative, or if you have taken an overdose of antidepressant medication such as Elavil, Janimine, Tofranil, Norpramin, Desyrel, Ascendin, Anafranil, Sinequan, Pamelor, Vivactil, or Surmontil.

Before receiving flumazenil, tell your doctor if you have a seizure disorder, liver disease, a history of head injury, uncontrolled muscle twitches, a breathing disorder, anxiety or panic disorder, or a history of drug or alcohol addiction.



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You may have temporary amnesia while you are coming out of sedation after a surgery. You may not remember everything going on around you during this time.


Flumazenil can cause side effects that may impair your thinking or reactions. For at least 18 hours after you leave the hospital or surgery center, do not drive or do anything else that requires you to be awake and alert. Continue to limit these activities until you no longer feel sedated (weak, drowsy, or dizzy).

Even though you may feel alert after waking up from sedation, your judgment or reactions may still be impaired. Follow your caregivers' instructions about limiting activities after receiving flumazenil.


Do not drink alcohol for at least 18 hours after receiving flumazenil, or if you still feel sedated.

What should I discuss with my health care provider before receiving flumazenil?


You should not receive this medication if you are allergic to flumazenil or any type of benzodiazepine sedative, or if you have taken an overdose of antidepressant medication such as Elavil, Janimine, Tofranil, Norpramin, Desyrel, Ascendin, Anafranil, Sinequan, Pamelor, Vivactil, or Surmontil.

Before receiving flumazenil, tell your doctor if you are allergic to any drugs, or if you have:



  • epilepsy or other seizure disorder;




  • liver disease;




  • a history of head injury;




  • uncontrolled muscle twitches;




  • asthma or other breathing disorder;




  • panic or anxiety disorder; or




  • a history of drug or alcohol addiction.



If you have any of these conditions, you may not be able to use flumazenil, or you may need dosage adjustments or special tests during treatment.


FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether flumazenil 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.

How is flumazenil given?


Flumazenil is given as an injection through a needle placed into a vein. You will receive this injection in a hospital or surgical clinic.


Flumazenil is usually effective in reversing sedation within 2 hours.


You may have temporary amnesia while you are coming out of sedation after a surgery. You may not remember everything going on around you during this time.


What happens if I miss a dose?


Since this medication is given as needed by a healthcare professional, it is not likely that you will miss a dose.


What happens if I overdose?


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

Overdose symptoms may include feeling anxious or agitated, muscle tightness, or seizure (convulsions).


What should I avoid while receiving flumazenil?


Flumazenil can cause side effects that may impair your thinking or reactions. For at least 18 hours after you leave the hospital or surgery center, do not drive or do anything else that requires you to be awake and alert. Continue to limit these activities until you no longer feel sedated (weak, drowsy, or dizzy).

Even though you may feel alert after waking up from sedation, your judgment or reactions may still be impaired. Follow your caregivers' instructions about limiting activities after receiving flumazenil.


Do not drink alcohol for at least 18 hours after receiving flumazenil, or if you still feel sedated.

Flumazenil 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. Call your doctor at once if you have any of these serious side effects:

  • seizures (convulsions);




  • weak or shallow breathing;




  • continued drowsiness for longer than 2 hours after receiving flumazenil;




  • confusion, fear, panic attack; or




  • fast or uneven heart rate.



Less serious side effects include:



  • pain or irritation where the medicine was injected;




  • agitation or tremors (shaking);




  • warmth, redness, or tingly feeling under your skin;




  • dizziness;




  • sweating or shivering;




  • headache;




  • blurred vision; or




  • ringing in your ears.



Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.


Flumazenil Dosing Information


Usual Adult Dose for Reversal of Sedation:

Initial dose: 0.2 mg IV one time over 15 seconds.
Repeated doses: 0.2 mg may be given every minute until the desired level of consciousness is achieved.
Maximum total dose 1 mg.
Most patients respond to 0.6 to 1 mg.
Resedation doses: 0.2 mg every minute to a total of 1 mg/dose and 3 mg/hour.

Usual Adult Dose for Benzodiazepine Overdose:

Initial dose: 0.2 mg IV one time over 30 seconds.
Repeated doses: 0.5 mg may be given every minute.
Maximum total dose 3 mg. Patients responding partially at 3 mg may receive additional doses up to 5 mg.
Most patients respond to 1 to 3 mg.
Resedation doses: 0.5 mg every 20 minutes to a total of 1 mg/dose and 3 mg/hour.

Usual Pediatric Dose for Reversal of Sedation:

IV:
Infants and Children:
Benzodiazepine reversal when used in conscious sedation or general anesthesia:
Initial dose: 0.01 mg/kg (maximum dose: 0.2 mg) given over 15 seconds; may repeat 0.01 mg/kg (maximum dose: 0.2 mg) after 45 seconds, and then every minute to a maximum total cumulative dose of 0.05 mg/kg or 1 mg, whichever is lower; usual total dose: 0.08 to 1 mg (mean: 0.65 mg)
Management of benzodiazepine overdose: Minimal information available; initial dose: 0.01 mg/kg (maximum dose: 0.2 mg) with repeat doses of 0.01 mg/kg (maximum dose: 0.2 mg) given every minute to a maximum total cumulative dose of 1 mg; as an alternative to repeat bolus doses, follow up continuous infusions of 0.005 to 0.01 mg/kg/hour have been used; further studies are needed.

Usual Pediatric Dose for Benzodiazepine Overdose:

1 to 17 years:
Initial dose: 0.01 mg/kg IV over 15 seconds.
Repeat doses: 0.01 mg/kg given over 15 seconds; may repeat 0.01 mg/kg after 45 seconds, then every minute to a maximum total cumulative dose of 0.05 mg/kg.

Continuous IV infusion: 0.005 to 0.01 mg/kg/hr was used in a premature neonate (gestational age: 32 weeks) exposed to high doses of diazepam intrapartum.
Myoclonus, benzodiazepine induced: IV: 0.078 mg/kg once was effective in a single full-term neonate who was receiving continuous infusion midazolam.


What other drugs will affect flumazenil?


Before receiving flumazenil, tell your doctor if you have recently drank an alcoholic beverage, or if you are using any of the following drugs:



  • seizure medication;




  • eszopiclone (Lunesta);




  • antidepressants such as amitriptyline (Elavil, Etrafon), amoxapine (Ascendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil); or




  • diazepam (Valium) or similar medicines such as alprazolam (Xanax), chlordiazepoxide (Librium), clorazepate (Tranxene), estazolam (ProSom), flurazepam (Dalmane), lorazepam (Ativan), midazolam (Versed), temazepam (Restoril), triazolam (Halcion), and others.



If you are using any of these drugs, you may not be able to use flumazenil, or you may need dosage adjustments or special tests during treatment.


There may be other drugs not listed that can affect flumazenil. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.



More flumazenil resources


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


  • Flumazenil Professional Patient Advice (Wolters Kluwer)

  • Flumazenil Monograph (AHFS DI)

  • Flumazenil MedFacts Consumer Leaflet (Wolters Kluwer)

  • Romazicon Prescribing Information (FDA)



Compare flumazenil with other medications


  • Benzodiazepine Overdose
  • Reversal of Sedation


Where can I get more information?


  • Your doctor or pharmacist has information about flumazenil written for health professionals that you may read.

See also: flumazenil side effects (in more detail)


Fludeoxyglucose F 18




FULL PRESCRIBING INFORMATION

Indications and Usage for Fludeoxyglucose F 18




Fludeoxyglucose F18 Injection is indicated for positron emission tomography (PET) imaging in the following settings:

Oncology




For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer.

Cardiology




For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.

Neurology


For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.



Fludeoxyglucose F 18 Dosage and Administration


Fludeoxyglucose F18 Injection emits radiation.  Use procedures to minimize radiation exposure.  Calculate the final dose from the end of synthesis (EOS) time using proper radioactive decay factors.  Assay the final dose in a properly calibrated dose calibrator before administration to the patient [ see Description (11.2)].



Recommended Dose for Adults


Within the oncology, cardiology and neurology settings, the recommended dose for adults is 5 – 10 mCi (185 – 370 MBq) as an intravenous injection.



Recommended Dose for Pediatric Patients


Within the neurology setting, the recommended dose for pediatric patients is 2.6 mCi, as an intravenous injection.  The optimal dose adjustment on the basis of body size or weight has not been determined [ see Use in Special Populations (8.4)].



Patient Preparation


  • To minimize the radiation absorbed dose to the bladder, encourage adequate hydration.Encourage the patient to drink water or other fluids (as tolerated) in the 4 hours before their PET study.

  • Encourage the patient to void as soon as the imaging study is completed and as often as possible thereafter for at least one hour.

  • Screen patients for clinically significant blood glucose abnormalities by obtaining a history and/or laboratory tests [ see Warnings and Precautions (5.2)]. Prior to Fludeoxyglucose F 18 PET imaging in the oncology and neurology settings, instruct patient to fast for 4 – 6 hours prior to the drug’s injection.

  • In the cardiology setting, administration of glucose-containing food or liquids (e.g., 50 – 75 grams) prior to Fludeoxyglucose F 18 Injection facilitates localization of cardiac ischemia.


Radiation Dosimetry


The estimated human absorbed radiation doses (rem/mCi) to a newborn (3.4 kg), 1-year old (9.8 kg), 5-year old (19 kg), 10-year old (32 kg), 15-year old (57 kg), and adult (70 kg) from intravenous administration of Fludeoxyglucose F 18 Injection are shown in Table 1. These estimates were calculated based on human2 data and using the data published by the International Commission on Radiological Protection4 for Fludeoxyglucose 18F. The dosimetry data show that there are slight variations in absorbed radiation dose for various organs in each of the age groups. These dissimilarities in absorbed radiation dose are due to developmental age variations (e.g., organ size, location, and overall metabolic rate for each age group). The identified critical organs (in descending order) across all age groups evaluated are the urinary bladder, heart, pancreas, spleen, and lungs.


























































































































































































Table 1. Estimated Absorbed Radiation Doses (rem/mCi) After Intravenous Administration of Fludeoxyglucose F 18 Injectiona
Organ
Newborn

(3.4kg)
1-year old

(9.8kg)
5-year old

(19kg)
10-year old

(32kg)
15-year old

(57kg)
Adult

(70kg)
Bladder wallb4.3
1.7
0.93
0.60
0.40
0.32
Heart wall
2.4
1.2
0.70
0.44
0.29
0.22
Pancreas
2.2
0.68
0.33
0.25
0.13
0.096
Spleen
2.2
0.84
0.46
0.29
0.19
0.14
Lungs
0.96
0.38
0.20
0.13
0.092
0.064
Kidneys
0.81
0.34
0.19
0.13
0.089
0.074
Ovaries
0.80
0.8
0.19
0.11
0.058
0.053
Uterus
0.79
0.35
0.19
0.12
0.076
0.062
LLI wall*
0.69
0.28
0.15
0.097
0.060
0.051
Liver
0.69
0.31
0.17
0.11
0.076
0.058
Gallbladder wall
0.69
0.26
0.14
0.093
0.059
0.049
Small intestine
0.68
0.29
0.15
0.096
0.060
0.047
ULI wall**
0.67
0.27
0.15
0.090
0.057
0.046
Stomach wall
0.65
0.27
0.14
0.089
0.057
0.047
Adrenals
0.65
0.28
0.15
0.095
0.061
0.048
Testes
0.64
0.27
0.14
0.085
0.052
0.041
Red marrow
0.62
0.26
0.14
0.089
0.057
0.047
Thymus
0.61
0.26
0.14
0.086
0.056
0.044
Thyroid
0.61
0.26
0.13
0.080
0.049
0.039
Muscle0.058
0.25
0.13
0.078
0.049
0.039
Bone surface0.57
0.24
0.12
0.079
0.052
0.041
Breast0.54
0.22
0.11
0.068
0.043
0.034
Skin0.49
0.20
0.10
0.060
0.037
0.030
Brain0.29
0.13
0.09
0.078
0.072
0.070
Other tissues0.59
0.25
0.13
0.083
0.052
0.042

aMIRDOSE 2 software was used to calculate the radiation absorbed dose. Assumptions on the biodistribution based on data from Gallagher et al.1 and Jones et al.2bThe dynamic bladder model with a uniform voiding frequency of 1.5 hours was used.

*LLI = lower large intestine; **ULI = upper large intestine

Radiation Safety – Drug Handling


  • Use waterproof gloves, effective radiation shielding, and appropriate safety measures when handling Fludeoxyglucose F18 Injection to avoid unnecessary radiation exposure to the patient, occupational workers, clinical personnel and other persons.

  • Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides.

  • Calculate the final dose from the end of synthesis (EOS) time using proper radioactive decay factors.  Assay the final dose in a properly calibrated dose calibrator before administration to the patient [ see Description (11.2)].

  • The dose of Fludeoxyglucose F18 used in a given patient should be minimized consistent with the objectives of the procedure, and the nature of the radiation detection devices employed.


Drug Preparation and Administration


  • Calculate the necessary volume to administer based on calibration time and dose.

  • Aseptically withdraw Fludeoxyglucose F18 Injection from its container.

  • Inspect Fludeoxyglucose F18 Injection visually for particulate matter and discoloration before administration, whenever solution and container permit.

  • Do not administer the drug if it contains particulate matter or discoloration; dispose of these unacceptable or unused preparations in a safe manner, in compliance with applicable regulations.

  • Use Fludeoxyglucose F 18 Injection within 12 hours from the EOS.


Imaging Guidelines


  • Initiate imaging within 40 minutes following Fludeoxyglucose F 18 Injection administration.

  • Acquire static emission images 30 – 100 minutes from the time of injection.


Dosage Forms and Strengths


Multiple-dose glass vial containing 0.74 - 11.1GBq (20 - 300 mCi/mL) of Fludeoxyglucose F 18 Injection and 4.5 mg of sodium chloride in citrate buffer (approximately 16 - 17 mL volume) for intravenous administration.



Contraindications


None.



Warnings and Precautions



Radiation Risks


Radiation-emitting products, including Fludeoxyglucose F 18 Injection, may increase the risk for cancer, especially in pediatric patients.  Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker [ see Dosage and Administration (2.5)].



Blood Glucose Abnormalities


In the oncology and neurology setting, suboptimal imaging may occur in patients with inadequately regulated blood glucose levels.  In these patients, consider medical therapy and laboratory testing to assure at least two days of normoglycemia prior to Fludeoxyglucose F 18 Injection administration.



Adverse Reactions


Hypersensitivity reactions with pruritus, edema and rash have been reported in the post-marketing setting.  Have emergency resuscitation equipment and personnel immediately available.



Drug Interactions


The possibility of interactions of Fludeoxyglucose F 18 Injection with other drugs taken by patients undergoing PET imaging has not been studied.



USE IN SPECIAL POPULATIONS



Pregnancy


Pregnancy Category C


Animal reproduction studies have not been conducted with Fludeoxyglucose F 18 Injection. It is also not known whether Fludeoxyglucose F 18 Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.  Consider alternative diagnostic tests in a pregnant woman; administer Fludeoxyglucose F 18 Injection only if clearly needed.



Nursing Mothers


It is not known whether Fludeoxyglucose F 18 Injection is excreted in human milk. Consider alternative diagnostic tests in women who are breast-feeding.  Use alternatives to breast feeding (e.g., stored breast milk or infant formula) for at least 10 half-lives of radioactive decay, if Fludeoxyglucose F 18 Injection is administered to a woman who is breast-feeding.



Pediatric Use


The safety and effectiveness of Fludeoxyglucose F 18 Injection in pediatric patients with epilepsy is established on the basis of studies in adult and pediatric patients. In pediatric patients with epilepsy, the recommended dose is 2.6 mCi. The optimal dose adjustment on the basis of body size or weight has not been determined.


In the oncology or cardiology settings, the safety and effectiveness of Fludeoxyglucose F 18 Injection have not been established in pediatric patients.



Fludeoxyglucose F 18 Description



Chemical Characteristics


Fludeoxyglucose F 18 Injection is a positron emitting radiopharmaceutical that is used for diagnostic purposes in conjunction with positron emission tomography (PET) imaging. The active ingredient 2-deoxy-2-[18F]fluoro-D-glucose has the molecular formula of C6H1118FO5 with a molecular weight of 181.26, and has the following chemical structure:



Fludeoxyglucose F 18 Injection is provided as a ready to use sterile, pyrogen free, clear, colorless citrate buffered solution. Each mL contains between 0.740 to 11.1GBq (20.0-300 mCi) of 2-deoxy-2-[18F]fluoro-D-glucose at the EOS, 4.5 mg of sodium chloride in citrate buffer. The pH of the solution is between 4.5 and 7.5. The solution is packaged in a multiple-dose glass vial and does not contain any preservative.



Physical Characteristics


Fluorine F 18 has a physical half-life of 109.7 minutes and decays to Oxygen O 18 (stable) by positron decay. The principal photons useful for imaging are the dual 511 keV “annihilation” gamma photons that are produced and emitted simultaneously in opposite directions when the positron interacts with an electron (Table 2).













Table 2. Principal Radiation Emission Data for Fluorine F 18
Radiation/Emission% Per DisintegrationMean Energy
Positron(β+)96.73249.8 keV
Gamma(±)*193.46511.0 keV

*Produced by positron annihilation


From: Kocher, D.C. Radioactive Decay Tables DOE/TIC-I 1026, 89 (1981)


The specific gamma ray constant (point source air kerma coefficient) for fluorine F 18 is 5.7 R/hr/mCi (1.35 x 10 -6 Gy/hr/kBq) at 1 cm. The half-value layer (HVL) for the 511 keV photons is 4 mm lead (Pb). The range of attenuation coefficients for this radionuclide as a function of lead shield thickness is shown in Table 3. For example, the interposition of an 8 mm thickness of Pb, with a coefficient of attenuation of 0.25, will decrease the external radiation by 75%.




















Table 3. Radiation Attenuation of 511 keV Photons by lead (Pb) shielding
Shield thickness (Pb) mmCoefficient of attenuation
0
0.00
4
0.50
8
0.25
13
0.10
26
0.01
39
0.001
52
0.0001

For use in correcting for physical decay of this radionuclide, the fractions remaining at selected intervals after calibration are shown in Table 4.



















Table 4. Physical Decay Chart for Fluorine F 18
MinutesFraction Remaining
0*
1.000
15
0.909
30
0.826
60
0.683
110
0.500
220
0.250

*calibration time



Fludeoxyglucose F 18 - Clinical Pharmacology



Mechanism of Action


Fludeoxyglucose F 18 is a glucose analog that concentrates in cells that rely upon glucose as an energy source, or in cells whose dependence on glucose increases under pathophysiological conditions. Fludeoxyglucose F 18 is transported through the cell membrane by facilitative glucose transporter proteins and is phosphorylated within the cell to [18F] FDG-6-phosphate by the enzyme hexokinase. Once phosphorylated it cannot exit until it is dephosphorylated by glucose-6-phosphatase. Therefore, within a given tissue or pathophysiological process, the retention and clearance of Fludeoxyglucose F 18 reflect a balance involving glucose transporter, hexokinase and glucose-6-phosphatase activities. When allowance is made for the kinetic differences between glucose and Fludeoxyglucose F 18 transport and phosphorylation (expressed as the ''lumped constant'' ratio), Fludeoxyglucose F 18 is used to assess glucose metabolism.


In comparison to background activity of the specific organ or tissue type, regions of decreased or absent uptake of Fludeoxyglucose F 18 reflect the decrease or absence of glucose metabolism. Regions of increased uptake of Fludeoxyglucose F 18 reflect greater than normal rates of glucose metabolism.



Pharmacodynamics


Fludeoxyglucose F 18 Injection is rapidly distributed to all organs of the body after intravenous administration. After background clearance of Fludeoxyglucose F 18 Injection, optimal PET imaging is generally achieved between 30 to 40 minutes after administration.


In cancer, the cells are generally characterized by enhanced glucose metabolism partially due to (1) an increase in activity of glucose transporters, (2) an increased rate of phosphorylation activity, (3) a reduction of phosphatase activity or, (4) a dynamic alteration in the balance among all these processes. However, glucose metabolism of cancer as reflected by Fludeoxyglucose F 18 accumulation shows considerable variability. Depending on tumor type, stage, and location, Fludeoxyglucose F 18 accumulation may be increased, normal, or decreased. Also, inflammatory cells can have the same variability of uptake of Fludeoxyglucose F 18.


In the heart, under normal aerobic conditions, the myocardium meets the bulk of its energy requirements by oxidizing free fatty acids. Most of the exogenous glucose taken up by the myocyte is converted into glycogen. However, under ischemic conditions, the oxidation of free fatty acids decreases, exogenous glucose becomes the preferred myocardial substrate, glycolysis is stimulated, and glucose taken up by the myocyte is metabolized immediately instead of being converted into glycogen. Under these conditions, phosphorylated Fludeoxyglucose F 18 accumulates in the myocyte and can be detected with PET imaging.


In the brain, cells normally rely on aerobic metabolism. In epilepsy, the glucose metabolism varies. Generally, during a seizure, glucose metabolism increases. Interictally, the seizure focus tends to be hypometabolic.



Pharmacokinetics


Distribution: In four healthy male volunteers, receiving an intravenous administration of 30 seconds in duration, the arterial blood level profile for Fludeoxyglucose F 18 decayed triexponentially. The effective half-life ranges of the three phases were 0.2-0.3 minutes, 10-13 minutes with a mean and standard deviation (STD) of 11.6 (±) 1.1 min, and 80-95 minutes with a mean and STD of 88 (±) 4 min.


Plasma protein binding of Fludeoxyglucose F 18 has not been studied.


Metabolism: Fludeoxyglucose F 18 is transported into cells and phosphorylated to [18F]-FDG-6- phosphate at a rate proportional to the rate of glucose utilization within that tissue. [F 18]-FDG-6-phosphate presumably is metabolized to 2-deoxy-2-[F 18]fluoro-6-phospho-D-mannose([F 18]FDM-6-phosphate).


Fludeoxyglucose F 18 Injection may contain several impurities (e.g., 2-deoxy-2-chloro-D-glucose (ClDG)). Biodistribution and metabolism of ClDG are presumed to be similar to Fludeoxyglucose F 18 and would be expected to result in intracellular formation of 2-deoxy-2-chloro-6-phospho-D-glucose (ClDG-6-phosphate) and 2-deoxy-2-chloro-6-phospho-D-mannose (ClDM-6-phosphate). The phosphorylated deoxyglucose compounds are dephosphorylated and the resulting compounds (FDG, FDM, ClDG, and ClDM) presumably leave cells by passive diffusion. Fludeoxyglucose F 18 and related compounds are cleared from non-cardiac tissues within 3 to 24 hours after administration. Clearance from the cardiac tissue may require more than 96 hours. Fludeoxyglucose F 18 that is not involved in glucose metabolism in any tissue is then excreted in the urine.


Elimination: Fludeoxyglucose F 18 is cleared from most tissues within 24 hours and can be eliminated from the body unchanged in the urine. Three elimination phases have been identified in the reviewed literature. Within 33 minutes, a mean of 3.9% of the administrated radioactive dose was measured in the urine. The amount of radiation exposure of the urinary bladder at two hours post-administration suggests that 20.6% (mean) of the radioactive dose was present in the bladder.


Special Populations: The pharmacokinetics of Fludeoxyglucose F 18 Injection have not been studied in renally-impaired, hepatically impaired or pediatric patients. Fludeoxyglucose F 18 is eliminated through the renal system. Avoid excessive radiation exposure to this organ system and adjacent tissues.


The effects of fasting, varying blood sugar levels, conditions of glucose intolerance, and diabetes mellitus on Fludeoxyglucose F 18 distribution in humans have not been ascertained [ see Warnings and Precautions (5.2)].



Nonclinical Toxicology



Carcinogenesis, Mutagenesis, Impairment of Fertility


Animal studies have not been performed to evaluate the Fludeoxyglucose F 18 Injection carcinogenic potential, mutagenic potential or effects on fertility.



Clinical Studies





Oncology


The efficacy of Fludeoxyglucose F 18 Injection in positron emission tomography cancer imaging was demonstrated in 16 independent studies. These studies prospectively evaluated the use of Fludeoxyglucose F 18 in patients with suspected or known malignancies, including non-small cell lung cancer, colo-rectal, pancreatic, breast, thyroid, melanoma, Hodgkin's and non-Hodgkin's lymphoma, and various types of metastatic cancers to lung, liver, bone, and axillary nodes.  All these studies had at least 50 patients and used pathology as a standard of truth. The Fludeoxyglucose F 18 Injection doses in the studies ranged from 200 MBq to 740 MBq with a median and mean dose of 370 MBq.


In the studies, the diagnostic performance of Fludeoxyglucose F 18 Injection varied with the type of cancer, size of cancer, and other clinical conditions.  False negative and false positive scans were observed.  Negative Fludeoxyglucose F 18 Injection PET scans do not exclude the diagnosis of cancer.  Positive Fludeoxyglucose F 18 Injection PET scans can not replace pathology to establish a diagnosis of cancer.  Non-malignant conditions such as fungal infections, inflammatory processes and benign tumors have patterns of increased glucose metabolism that may give rise to false-positive scans.  The efficacy of Fludeoxyglucose F 18 Injection PET imaging in cancer screening was not studied.



Cardiology


The efficacy of Fludeoxyglucose F 18 Injection for cardiac use was demonstrated in ten independent, prospective studies of patients with coronary artery disease and chronic left ventricular systolic dysfunction who were scheduled to undergo coronary revascularization.  Before revascularization, patients underwent PET imaging with Fludeoxyglucose F 18 Injection (74 – 370 MBq, 2 – 10 mCi) and perfusion imaging with other diagnostic radiopharmaceuticals. Doses of Fludeoxyglucose F 18 Injection ranged from 74-370 MBq (2-10 mCi).  Segmental, left ventricular, wall-motion assessments of asynergic areas made before revascularization were compared in a blinded manner to assessments made after successful revascularization to identify myocardial segments with functional recovery.


Left ventricular myocardial segments were predicted to have reversible loss of systolic function if they showed Fludeoxyglucose F 18 accumulation and reduced perfusion (i.e., flow-metabolism mismatch). Conversely, myocardial segments were predicted to have irreversible loss of systolic function if they showed reductions in both Fludeoxyglucose F 18 accumulation and perfusion (i.e., matched defects).


Findings of flow-metabolism mismatch in a myocardial segment may suggest that successful revascularization will restore myocardial function in that segment.  However, false-positive tests occur regularly, and the decision to have a patient undergo revascularization should not be based on PET findings alone.  Similarly, findings of a matched defect in a myocardial segment may suggest that myocardial function will not recover in that segment, even if it is successfully revascularized.  However, false-negative tests occur regularly, and the decision to recommend against coronary revascularization, or to recommend a cardiac transplant, should not be based on PET findings alone.  The reversibility of segmental dysfunction as predicted with Fludeoxyglucose F 18 PET imaging depends on successful coronary revascularization. Therefore, in patients with a low likelihood of successful revascularization, the diagnostic usefulness of PET imaging with Fludeoxyglucose F 18 Injection is more limited.



Neurology


In a prospective, open label trial, Fludeoxyglucose F 18 Injection was evaluated in 86 patients with epilepsy.  Each patient received a dose of Fludeoxyglucose F 18 Injection in the range of 185-370 MBq (5-10 mCi).  The mean age was 16.4 years (range: 4 months - 58 years; of these, 42 patients were less than 12 years and 16 patients were less than 2 years old). Patients had a known diagnosis of complex partial epilepsy and were under evaluation for surgical treatment of their seizure disorder.  Seizure foci had been previously identified on ictal EEGs and sphenoidal EEGs.  Fludeoxyglucose F 18 Injection PET imaging confirmed previous diagnostic findings in 16% (14/87) of the patients; in 34% (30/87) of the patients, Fludeoxyglucose F 18 Injection PET images provided new findings.  In 32% (27/87), imaging with Fludeoxyglucose F 18 Injection was inconclusive. The impact of these imaging findings on clinical outcomes is not known.


Several other studies comparing imaging with Fludeoxyglucose F 18 Injection results to subsphenoidal EEG, MRI and/or surgical findings supported the concept that the degree of hypometabolism corresponds to areas of confirmed epileptogenic foci.  The safety and effectiveness of Fludeoxyglucose F 18 Injection to distinguish idiopathic epileptogenic foci from tumors or other brain lesions that may cause seizures have not been established.



REFERENCES


  1. Gallagher B.M., Ansari A.,  Atkins H., Casella V., Christman D.R., Fowler J.S., Ido T., MacGregor R.R., Som P., Wan C.N., Wolf A.P., Kuhl D.E., and Reivich M.  “Radiopharmaceuticals XXVII. 18F-labeled 2-deoxy-2-fluoro-d-glucose as a radiopharmaceutical for measuring regional myocardial glucose metabolism in vivo: tissue distribution and imaging studies in animals,” J Nucl Med, 1977; 18, 990-6.

  2. Jones S.C., Alavi, A., Christman D., Montanez, I., Wolf, A.P., and Reivich M. “The radiation dosimetry of 2 [F-18] fluoro-2-deoxy-D-glucose in man,” J Nucl Med, 1982; 23, 613-617.

  3. Kocher, D.C. “Radioactive Decay Tables:  A handbook of decay data for application to radiation dosimetry and radiological assessments,” 1981, DOE/TIC-I 1026, 89.

  4. ICRP Publication 53, Volume 18, No. l-4,1987, pages 75-76.


How Supplied/Storage and Handling


Fludeoxyglucose F 18 Injection is supplied in a multi-dose, capped 20 mL glass vial containing between 0.740 – 11.1GBq/mL (20 - 300 mCi/mL), of no carrier added 2-deoxy-2-[F 18] fluoro-D-glucose, at end of synthesis, in approximately 16 - 17 mL.  The contents of each vial are sterile, pyrogen-free and preservative-free.


NDC 13267-123 -23


This radiopharmaceutical is licensed by the State of New York, Department Of Health, Bureau of Environmental Radiation Protection, for distribution to persons licensed pursuant to New York's Regulatory Code for Radioactive material specified in Chapter 1-Part 16 of the State Sanitary Code, as appropriate, or under equivalent licenses of an Agreement State or Licensing State.


Store the Fludeoxyglucose F 18 Injection vial upright in a lead shielded container at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).


Store and dispose of Fludeoxyglucose F 18 Injection in accordance with the regulations and a general license, or its equivalent, of an Agreement State or a Licensing State.


The expiration date and time are provided on the container label. Use Fludeoxyglucose F 18 Injection within 12 hours from the EOS time.



Patient Counseling Information


Instruct patients in procedures that increase renal clearance of radioactivity. Encourage patients to


  • drink water or other fluids (as tolerated) in the 4 hours before their PET study.

  • void as soon as the imaging study is completed and as often as possible thereafter for at least one hour.










FLUDEOXYGLUCOSE F18 
fludeoxyglucose f18  injection










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)13267-123
Route of AdministrationINTRAVENOUSDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FLUDEOXYGLUCOSE F-18 (FLUDEOXYGLUCOSE F-18)FLUDEOXYGLUCOSE F-18300 mCi  in 1 mL





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
113267-123-2317 mL In 1 VIAL, GLASSNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02187008/19/2005


Labeler - THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH (110565913)
Revised: 01/2012THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH

Fluphenazine Decanoate


Pronunciation: floo-FEN-a-zeen
Generic Name: Fluphenazine Decanoate
Brand Name: Generic only. No brands available.

Fluphenazine Decanoate is an antipsychotic. It may increase the risk of death when used to treat mental problems caused by dementia in elderly patients. Most of the deaths were linked to heart problems or infection. Fluphenazine Decanoate is not approved to treat mental problems caused by dementia. Discuss any questions or concerns with your doctor.





Fluphenazine Decanoate is used for:

Long-acting treatment of certain mental or mood disorders (eg, schizophrenia). It may also be used for other conditions as determined by your doctor.


Fluphenazine Decanoate is a phenothiazine. It is not known exactly how it works.


Do NOT use Fluphenazine Decanoate if:


  • you are allergic to any ingredient in Fluphenazine Decanoate or to other phenothiazines (eg, thioridazine)

  • you have certain types of brain damage, liver damage, severe drowsiness, or blood problems

  • you have recently taken large amounts of alcohol or medicines that may cause drowsiness, such as barbiturates (eg, phenobarbital) or narcotic pain medicines (eg, codeine)

  • you are taking astemizole, cabergoline, cisapride, metoclopramide, pergolide, terfenadine, or tramadol

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



Before using Fluphenazine Decanoate:


Some medical conditions may interact with Fluphenazine Decanoate. 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 developed severe side effects (eg, blood problems, yellowing of the skin or eyes) while taking another phenothiazine (eg, thioridazine)

  • if you have a history of heart problems (eg, angina, mitral valve problems), high or low blood pressure, blood problems (eg, anemia), bone marrow problems (eg, low white blood cell count), diabetes, liver problems (eg, cirrhosis), kidney problems, neuroleptic malignant syndrome (NMS), tardive dyskinesia (TD), an enlarged prostate gland, seizures, trouble urinating, mental or mood problems (eg, depression), or an adrenal gland tumor (eg, pheochromocytoma)

  • if you have asthma, a lung infection, or other lung or breathing problems (eg, emphysema); or increased pressure in the eyes or glaucoma, or if you are at risk of glaucoma

  • if you have Alzheimer disease, dementia, Parkinson disease, or Reye syndrome

  • if you have had high blood prolactin levels or a history of certain types of cancer (eg, breast, pancreas, pituitary, brain), or if you are at risk of breast cancer

  • if you are in poor health or are regularly exposed to extreme heat or certain insecticides (organophosphorus insecticides)

  • if you have a history of alcohol abuse, drink alcohol, or are in alcohol withdrawal

  • if you take any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat

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


  • Many prescription and nonprescription medicines (eg, used for allergies, blood clotting problems, cancer, infections, inflammation, aches and pains, heart problems, high blood pressure, high cholesterol, irregular heartbeat, mental or mood problems, nausea or vomiting, Parkinson disease, seizures, stomach or bowel problems, overactive bladder), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, gingko, St. John's wort) may interact with Fluphenazine Decanoate. Ask your doctor if you are unsure if any of your medicines may interact with Fluphenazine Decanoate

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


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


  • Fluphenazine Decanoate is a long-acting injection. Closely follow the dosing schedule provided by your doctor.

  • Fluphenazine Decanoate is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Fluphenazine Decanoate at home, a health care provider will teach you how to use it. Be sure you understand how to use Fluphenazine Decanoate. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.

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

  • Do not suddenly stop using Fluphenazine Decanoate. You may have an increased risk of side effects. If you need to stop Fluphenazine Decanoate, your doctor will gradually lower your dose.

  • 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 Fluphenazine Decanoate even if you feel well. Do not miss any doses.

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

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



Important safety information:


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

  • Fluphenazine Decanoate may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.

  • Do NOT take more than the recommended dose without checking with your doctor.

  • Do not drink alcohol while you are using Fluphenazine Decanoate.

  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Fluphenazine Decanoate; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

  • Do not become overheated in hot weather or while you are being active; heatstroke may occur.

  • Fluphenazine Decanoate may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Fluphenazine Decanoate. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

  • Fluphenazine Decanoate may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.

  • Some patients who take Fluphenazine Decanoate may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take Fluphenazine Decanoate in higher doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking Fluphenazine Decanoate.

  • Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by Fluphenazine Decanoate. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.

  • Tell your doctor or dentist that you take Fluphenazine Decanoate before you receive any medical or dental care, emergency care, or surgery.

  • Fluphenazine Decanoate may increase the amount of a certain hormone (prolactin) in your blood. Symptoms may include enlarged breasts, missed menstrual period, decreased sexual ability, or nipple discharge. Contact your doctor right away if you experience any of these symptoms.

  • Diabetes patients - Fluphenazine Decanoate may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

  • Fluphenazine Decanoate may cause the results of some pregnancy tests to be wrong. Check with your doctor if you have questions or concerns about your pregnancy test results.

  • Fluphenazine Decanoate may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Fluphenazine Decanoate.

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

  • Use Fluphenazine Decanoate with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion; dizziness or light-headedness, especially upon standing; drowsiness; fainting; trouble urinating; uncontrolled muscle movements; and constipation.

  • Fluphenazine Decanoate should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these 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 Fluphenazine Decanoate while pregnant. Using Fluphenazine Decanoate during the third trimester may result in uncontrolled muscle movements or withdrawal symptoms in the newborn. Discuss any questions or concerns with your doctor. Fluphenazine Decanoate is found in breast milk. Do not breast-feed while taking Fluphenazine Decanoate.

If you suddenly stop taking Fluphenazine Decanoate, you may experience WITHDRAWAL symptoms, including nausea, vomiting, dizziness, stomach upset, and tremors.



Possible side effects of Fluphenazine Decanoate:


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:



Agitation; constipation; dizziness; drowsiness; dry mouth; enlarged pupils; headache; jitteriness; loss of appetite; nausea; stuffy nose.



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 or throat; swelling of the mouth, face, lips, or tongue; unusual hoarseness; wheezing); chest pain; confusion; decreased coordination; drooling; fainting; fast, slow, or irregular heartbeat; mask-like face; muscle spasms of the face, neck, or back; muscle weakness; new or worsening mental or mood problems; numbness of an arm or leg; prolonged or painful erection; restlessness; seizures; severe or persistent constipation; severe or persistent dizziness, drowsiness, or headache; shuffling walk; sleeplessness; stiff or rigid muscles; sudden shortness of breath or vomiting; swelling of the hands, ankles, or feet; symptoms of infection (eg, fever, chills, persistent sore throat); symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, stomach pain, or loss of appetite); tremors; trouble urinating; twisting or twitching movements; uncontrolled muscle movements (eg, twitching of the face or tongue; loss of balance; uncontrolled movements of arms or legs; trouble speaking, breathing, or swallowing); unusual bruising or bleeding; unusual eye movements or inability to move eyes; unusual or excessive sweating; unusual tiredness or weakness; unusually pale skin; vision changes (eg, blurred vision).



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: Fluphenazine Decanoate 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 agitation; coma; confusion; difficulty breathing; fainting; fast, slow, or irregular heartbeat; loss of consciousness; muscle spasms or uncontrolled muscle movements; restlessness; seizures; severe constipation or stomach pain; severe drowsiness or dizziness; tremors; or trouble urinating.


Proper storage of Fluphenazine Decanoate:

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


General information:


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

  • Fluphenazine Decanoate 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 Fluphenazine Decanoate. 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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