Wednesday, 25 April 2012

Childrens Kaopectate


Generic Name: bismuth subsalicylate (BIZ muth sub sa LISS i late)

Brand Names: Bismarex, Bismatrol, Bismatrol Maximum Strength, Kao-Tin Bismuth Subsalicylate Formula, Kaopectate, Maalox Total Stomach Relief, Peptic Relief, Pepto-Bismol, Pepto-Bismol Maximum Strength, Pink Bismuth


What is Childrens Kaopectate (bismuth subsalicylate)?

Bismuth subsalicylate is an antacid and anti-diarrhea medication.


Bismuth subsalicylate is used to treat diarrhea, nausea, heartburn, indigestion, and upset stomach.


Bismuth subsalicylate may also be used for purposes not listed in this medication guide.


What is the most important information I should know about Childrens Kaopectate (bismuth subsalicylate)?


This medication should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Salicylates can cause a serious and sometimes fatal condition called Reye's syndrome in children. You should not use bismuth subsalicylate if you have a stomach ulcer, a recent history of stomach or intestinal bleeding, or if you are allergic to salicylates such as aspirin, Doan's Extra Strength, Salflex, Tricosal, and others.

Do not take more than 8 doses in one day (24 hours).


Bismuth subsalicylate can cause you to have a black or darkened tongue. This is a harmless side effect.


This medication can also cause unusual results with certain medical tests, thyroid scans, or stomach x-rays. Tell any doctor who treats you that you have recently taken bismuth subsalicylate.


What should I discuss with my health care provider before taking Childrens Kaopectate (bismuth subsalicylate)?


This medication should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Subsalicylate can cause a serious and sometimes fatal condition called Reye's syndrome in children. You should not use bismuth subsalicylate if you are allergic to it, or if you have:

  • a stomach ulcer;




  • a recent history of stomach or intestinal bleeding; or




  • if you are allergic to salicylates such as aspirin, Doan's Extra Strength, Salflex, Tricosal, and others.



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



  • fever;




  • mucus in your stools;




  • diabetes;




  • arthritis; or




  • gout.




Do not take bismuth subsalicylate without medical advice if you are pregnant. Bismuth subsalicylate can pass into breast milk and may harm a nursing baby. Do not use this medication without medical advice if you are breast-feeding a baby.

How should I take Childrens Kaopectate (bismuth subsalicylate)?


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


Do not take more than 8 doses in one day (24 hours). Shake the liquid medicine well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

The chewable tablet must be chewed before you swallow it.


Bismuth subsalicylate can cause you to have a black or darkened tongue. This is a harmless side effect.


This medication can also cause unusual results with certain medical tests, thyroid scans, or stomach x-rays. Tell any doctor who treats you that you have recently taken bismuth subsalicylate.


Store at room temperature away from moisture and heat. Do not freeze.

What happens if I miss a dose?


Since bismuth subsalicylate is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose. Do not take more than 8 doses in one day (24 hours).


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include increased thirst, anxiety, muscle spasm, ringing in your ears, dizziness, confusion, severe headache, problems with speech or vision, severe stomach pain, or worsening diarrhea or vomiting.


What should I avoid while taking Childrens Kaopectate (bismuth subsalicylate)?


Ask your doctor or pharmacist before taking other antacids or diarrhea medications together with bismuth subsalicylate.


Childrens Kaopectate (bismuth subsalicylate) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking this medicine and call your doctor at once if you have a serious side effect such as:

  • hearing loss or ringing in your ears;




  • diarrhea lasting longer than 2 days; or




  • worsened stomach symptoms.



Less serious side effects include:



  • constipation;




  • dark colored stools; or




  • black or darkened tongue.



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 Childrens Kaopectate (bismuth subsalicylate)?


Ask a doctor or pharmacist if it is safe for you to use bismuth subsalicylate if you are also using any of the following drugs:



  • a blood thinner such as warfarin (Coumadin, Jantoven);




  • insulin or oral diabetes medications;




  • probenecid (Benemid);




  • an antibiotic such as doxycycline (Doryx, Oracea, Periostat, Vibramycin), minocycline (Dynacin, Minocin, Solodyn), or tetracycline (Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap);




  • medication used to prevent blood clots, such as alteplase (Activase), tenecteplase (TNKase), urokinase (Abbokinase); or




  • other salicylates such as aspirin, Nuprin Backache Caplet, Kaopectate, KneeRelief, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate, and others.



This list is not complete and other drugs may interact with bismuth subsalicylate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More Childrens Kaopectate resources


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


  • Bismuth Subsalicylate Professional Patient Advice (Wolters Kluwer)

  • Bismuth Subsalicylate MedFacts Consumer Leaflet (Wolters Kluwer)

  • Bismatrol Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Bismatrol Advanced Consumer (Micromedex) - Includes Dosage Information



Compare Childrens Kaopectate with other medications


  • Diarrhea
  • Diarrhea, Chronic
  • Helicobacter Pylori Infection
  • Indigestion
  • Lymphocytic Colitis


Where can I get more information?


  • Your pharmacist can provide more information about bismuth subsalicylate.

See also: Childrens Kaopectate side effects (in more detail)


Sunday, 22 April 2012

Mitomycin


Pronunciation: mye-toe-MYE-sin
Generic Name: Mitomycin
Brand Name: Mutamycin

Mitomycin may cause bone marrow suppression, which may cause severe blood problems such as low platelet levels (thrombocytopenia) and low white blood cell levels (leukopenia). These blood problems may increase your risk of developing severe bleeding or a severe and possibly fatal infection. Mitomycin may also increase your risk of developing hemolytic uremic syndrome (HUS), which may cause problems such as hemolytic anemia, low platelet count, and permanent kidney failure. HUS may occur at any time during treatment. Higher doses may increase your risk for developing this side effect. Blood transfusions may make the symptoms of this syndrome worse. Notify your doctor immediately if you develop symptoms of an infection (eg, fever, chills, persistent sore throat), fatigue, unusual bleeding or bruising, or a change in the amount of urine produced.





Mitomycin is used for:

Treating cancer of the stomach or pancreas in combination with other medicines. It may also be used to reduce the severity of these cancers when they have not responded to other treatments. It may also be used for other conditions as determined by your doctor.


Mitomycin is an antibiotic that has been shown to have action against tumors. It works by blocking growth of the cancer cell.


Do NOT use Mitomycin if:


  • you are allergic to or have had an unusual reaction to any ingredient in Mitomycin

  • you have low blood platelet levels (thrombocytopenia), low white blood cell levels (leukopenia), blood clotting problems, or bleeding problems

  • you have active severe bleeding

  • you have shingles or chickenpox

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



Before using Mitomycin:


Some medical conditions may interact with Mitomycin. 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 kidney problems, breathing problems, or bone marrow problems

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


  • Vinca alkaloids (eg, vincristine) or other cancer medicines because lung problems, such as severe shortness of breath, may occur

  • Tamoxifen because risk of anemia, low blood platelet levels, or hemolytic uremic syndrome may be increased

  • Doxorubicin because risk of heart failure may be increased

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


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


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

  • If nausea, vomiting, or loss of appetite occur, ask your doctor or pharmacist for ways to lessen these effects.

  • Mitomycin may cause a serious reaction if it comes in contact with your skin. If this happens, wash the area with soap and water for approximately 15 minutes. Contact your doctor as soon as possible. The use of gloves while handling Mitomycin is recommended.

  • If Mitomycin 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 Mitomycin, contact your doctor immediately.

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



Important safety information:


  • Mitomycin may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.

  • Mitomycin may lower your body's ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection, including fever, sore throat, rash, or chills. Do not touch your eyes or the inside of your nose unless you have thoroughly washed your hands first.

  • Avoid vaccinations with live virus vaccines (eg, measles, mumps, oral polio) while you are taking Mitomycin. Talk to your doctor before having any vaccinations while you are using Mitomycin.

  • Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Mitomycin.

  • LAB TESTS, including platelet count, complete blood cell count, and kidney function tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.

  • Use Mitomycin with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: It is unknown if Mitomycin can cause harm to the fetus. If you become pregnant while taking Mitomycin, discuss with your doctor the benefits and risks of using Mitomycin during pregnancy. It is unknown if Mitomycin is excreted in breast milk. Do not breast-feed while taking Mitomycin.


Possible side effects of Mitomycin:


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:



Hair loss; loss of appetite; nausea; vomiting.



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); chest pain; decreased urination; dizziness; dry cough; fever, chills, or sore throat; pain, redness, or swelling at the injection site; shortness of breath; sores or swelling of the mouth, lips, hands, or feet; unusual bruising or bleeding; unusual tiredness or weakness.



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.



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 Mitomycin:

Mitomycin is usually handled and stored by a health care provider. If you are using Mitomycin at home, store Mitomycin as directed by your pharmacist or health care provider.


General information:


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

  • Mitomycin 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 Mitomycin. 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 Mitomycin resources


  • Mitomycin Use in Pregnancy & Breastfeeding
  • Mitomycin Drug Interactions
  • Mitomycin Support Group
  • 0 Reviews for Mitomycin - Add your own review/rating


  • Mitomycin Professional Patient Advice (Wolters Kluwer)

  • Mitomycin Monograph (AHFS DI)

  • Mitomycin Prescribing Information (FDA)

  • Mutamycin Prescribing Information (FDA)

  • mitomycin Concise Consumer Information (Cerner Multum)

  • mitomycin Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information



Compare Mitomycin with other medications


  • Bladder Cancer
  • Pancreatic Cancer
  • Stomach Cancer

Thursday, 19 April 2012

sunitinib


soo-NI-ti-nib MAL-ate


Oral route(Capsule)

Hepatotoxicity has been observed in clinical trials and postmarketing experience. This hepatotoxicity may be severe, and deaths have been reported .



Commonly used brand name(s)

In the U.S.


  • Sutent

Available Dosage Forms:


  • Capsule

Therapeutic Class: Antineoplastic Agent


Pharmacologic Class: Sunitinib


Uses For sunitinib


Sunitinib belongs to the group of medicines known as antineoplastics. It is used to treat a gastrointestinal stromal tumor (GIST) after a medicine called imatinib did not work very well. It may also be used when patients are not able to take imatinib. GIST is a group of cancer cells that start growing in the wall of the stomach, intestines, or rectum. Sunitinib is also used to treat advanced (late-stage) kidney cancer.


Sunitinib is also used to treat a type of pancreatic cancer called pancreatic neuroendocrine tumor (pNET), that cannot be surgically removed and is locally advanced or metastatic (cancer that has spread).


Sunitinib interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by sunitinib, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.


Before you begin treatment with sunitinib, you and your doctor should talk about the benefits sunitinib will do as well as the risks of using it.


sunitinib is available only with your doctor's prescription.


Before Using sunitinib


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 sunitinib, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to sunitinib 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 sunitinib 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 sunitinib in the elderly.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersDStudies 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. When you are taking sunitinib, 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 sunitinib 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.


  • Dronedarone

  • Fluconazole

  • Mesoridazine

  • Pimozide

  • Posaconazole

  • Sparfloxacin

  • Thioridazine

Using sunitinib 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.


  • Alfuzosin

  • Amiodarone

  • Amitriptyline

  • Amoxapine

  • Apomorphine

  • Arsenic Trioxide

  • Asenapine

  • Astemizole

  • Atazanavir

  • Azithromycin

  • Boceprevir

  • Bretylium

  • Carbamazepine

  • Chloroquine

  • Chlorpromazine

  • Ciprofloxacin

  • Cisapride

  • Citalopram

  • Clarithromycin

  • Clomipramine

  • Clozapine

  • Conivaptan

  • Crizotinib

  • Dasatinib

  • Desipramine

  • Dexamethasone

  • Disopyramide

  • Dofetilide

  • Dolasetron

  • Droperidol

  • Erythromycin

  • Flecainide

  • Gatifloxacin

  • Gemifloxacin

  • Granisetron

  • Halofantrine

  • Haloperidol

  • Ibutilide

  • Iloperidone

  • Imipramine

  • Indinavir

  • Itraconazole

  • Ketoconazole

  • Lapatinib

  • Levofloxacin

  • Lopinavir

  • Lumefantrine

  • Mefloquine

  • Methadone

  • Mitotane

  • Moxifloxacin

  • Nefazodone

  • Nelfinavir

  • Nilotinib

  • Norfloxacin

  • Nortriptyline

  • Octreotide

  • Ofloxacin

  • Ondansetron

  • Paliperidone

  • Pazopanib

  • Perflutren Lipid Microsphere

  • Phenobarbital

  • Phenytoin

  • Procainamide

  • Prochlorperazine

  • Promethazine

  • Propafenone

  • Protriptyline

  • Quetiapine

  • Quinidine

  • Quinine

  • Ranolazine

  • Rifabutin

  • Rifampin

  • Rifapentine

  • Ritonavir

  • Salmeterol

  • Saquinavir

  • Sodium Phosphate

  • Sodium Phosphate, Dibasic

  • Sodium Phosphate, Monobasic

  • Solifenacin

  • Sorafenib

  • Sotalol

  • St John's Wort

  • Telavancin

  • Telithromycin

  • Terfenadine

  • Tetrabenazine

  • Toremifene

  • Trazodone

  • Trifluoperazine

  • Trimipramine

  • Vandetanib

  • Vardenafil

  • Vemurafenib

  • Voriconazole

  • Ziprasidone

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.


Other Medical Problems


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


  • Bleeding problems or

  • Bradycardia (very slow heart beat), history of or

  • Congestive heart failure, history of or

  • Heart disease (e.g., cardiomyopathy), history of or

  • Heart rhythm problems (e.g., QT prolongation), history of or

  • Hypertension (high blood pressure) or

  • Hyperthyroidism (overactive thyroid) or

  • Hypothyroidism (underactive thyroid) or

  • Kidney problems (other than cancer) or

  • Liver problems or

  • Seizures or

  • Stomach ulcers—Use with caution. May make these conditions worse.

  • Hypokalemia (low potassium in the blood) or

  • Hypomagnesemia (low magnesium in the blood)—May cause side effects to become worse.

  • Infection, severe or

  • Surgery or

  • Trauma—These conditions may cause adrenal gland problems.

Proper Use of sunitinib


Your doctor will tell you how much of sunitinib to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.


You may take sunitinib with or without food. Do not open the capsules.


sunitinib comes with a Medication Guide and a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.


Dosing


The dose of sunitinib 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 sunitinib. If your dose is different, do not change it unless your doctor tells you to do so.


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


  • For oral dosage form (capsules):
    • For the treatment of GIST and kidney cancer:
      • Adults—50 milligrams (mg) once a day for 4 weeks. This is followed by 2 weeks without medicine. Your doctor may tell you to repeat this cycle.

      • Children—Use and dose must be determined by your doctor.


    • For advanced pancreatic cancer or pancreatic neuroendocrine tumor (pNET):
      • Adults—37.5 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 50 mg per day.

      • Children—Use and dose must be determined by your doctor.



Missed Dose


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


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 sunitinib


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


If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting sunitinib treatment.


Using sunitinib while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.


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


Cancer medicines can cause nausea or vomiting in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these unwanted effects.


Sunitinib can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:


  • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

  • Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.

  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.

  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.

  • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.

  • Avoid contact sports or other situations where bruising or injury could occur.

Check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.


Check with your doctor right away if you are rapidly gaining weight or have shortness of breath; chest pain or discomfort; extreme tiredness or weakness; irregular breathing; uneven heartbeats; or excessive swelling of the hands, wrist, ankles, or feet. These may be symptoms of a heart problem.


sunitinib can cause changes in the heart rhythm, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or dizziness. Call your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.


sunitinib may also increase your risk of bleeding and cause delay in wound healing. Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.


Make sure any doctor or dentist who treats you knows that you are using sunitinib. You may need to stop using sunitinib several days before having surgery or medical tests.


Grapefruit and grapefruit juice may cause you to have too much of sunitinib in the blood. You should not eat grapefruit or drink grapefruit juice while you are taking sunitinib.


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 (e.g., St. John's Wort) or vitamin supplements.


sunitinib 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
  • Bleeding gums

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

  • blurred vision

  • chest pain

  • chills

  • confusion

  • coughing up blood

  • cracked lips

  • decreased urination

  • decreased urine output

  • diarrhea

  • difficulty with breathing or swallowing

  • dilated neck veins

  • dizziness

  • dry mouth

  • extreme fatigue

  • fainting

  • fast, slow, or irregular heartbeat

  • fever

  • headache

  • increase in heart rate

  • increased menstrual flow or vaginal bleeding

  • irregular breathing

  • labored breathing

  • lightheadedness

  • nervousness

  • nosebleeds

  • paralysis

  • pounding in the ears

  • prolonged bleeding from cuts

  • rapid breathing

  • rapid weight gain

  • red or black, tarry stools

  • red or dark brown urine

  • shortness of breath

  • sores, ulcers, or white spots on the lips, tongue, or inside the mouth

  • sunken eyes

  • swelling or inflammation of the mouth

  • thirst

  • tightness in the chest

  • tingling of the hands or feet

  • troubled breathing

  • unusual tiredness or weakness

  • unusual weight gain or loss

  • wheezing

  • wrinkled skin

  • yellow eyes or skin

Less common
  • Constipation

  • depressed mood

  • dry skin and hair

  • feeling cold

  • hair loss

  • hoarseness or husky voice

  • indigestion

  • loss of appetite

  • muscle cramps and stiffness

  • nausea

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

  • pain in the stomach, side, or abdomen, possibly radiating to the back

  • severe, sudden headache

  • slurred speech

  • sudden loss of coordination

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

  • sudden, unexplained shortness of breath

  • vision changes

  • vomiting

Rare
  • Back pain

  • chest discomfort

  • cloudy or bloody urine

  • convulsions

  • darkening of the skin

  • drowsiness

  • general feeling of tiredness or weakness

  • irregular or slow heart rate

  • light-colored stools

  • mental depression

  • skin rash

  • stomach pain, continuing

  • swelling of the face, feet, or lower legs

Incidence not known
  • Cough

  • dark-colored urine

  • decreased frequency or amount of urine

  • increased thirst

  • lower back or side pain

  • muscle cramps or spasms

  • muscular pain, tenderness, wasting, or weakness

  • painful or difficult urination

  • pale skin

  • sore throat

  • sudden, severe chest pain

  • unusual bleeding or bruising

  • weight gain

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


More common
  • Abdominal or stomach pain

  • acid or sour stomach

  • belching

  • blistering, peeling, redness, or swelling of the palms, hands, or bottoms of the feet

  • change in color of the treated skin

  • change in taste

  • difficulty with moving

  • discouragement

  • excess air or gas in the stomach or intestines

  • feeling sad or empty

  • full feeling

  • hair color changes

  • hair loss or thinning of the hair

  • heartburn

  • irritability

  • joint pain

  • lack of appetite

  • lack or loss of strength

  • loss of interest or pleasure

  • muscle aches or pains

  • numbness, pain, tingling, or unusual sensations in the palms of the hands or bottoms of the feet

  • pain or burning in the throat

  • passing gas

  • sleeplessness

  • stomach discomfort, upset, or pain

  • swollen joints

  • trouble concentrating

  • trouble sleeping

  • unable to sleep

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: sunitinib 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.


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  • sunitinib Concise Consumer Information (Cerner Multum)

  • Sunitinib MedFacts Consumer Leaflet (Wolters Kluwer)

  • Sunitinib Malate Monograph (AHFS DI)

  • Sutent Prescribing Information (FDA)



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Monday, 16 April 2012

Kerol AD



urea emulsion

Dosage Form: emulsion
Kerol™ AD

(45% urea emulsion)

Accu-Dose

In a zinc undecylenate and lactic acid vehicle

For external use only. Not for ophthalmic use.


Rx only



DESCRIPTION


Each mL of KerolTM AD contains 45% urea in a formulation consisting of: propylene glycol, caprylic/capric triglycerides, polyethylene glycol 300, purified water, trolamine, vitamin E acetate, lactic acid, glycerin, polysorbate-60, linoleic acid, sorbitan monostearate, zinc undecylenate, titanium dioxide, cetyl alcohol, EDTA disodium, hydroxyethyl cellulose and xanthan gum.


Urea is a diamide of carbonic acid with the following chemical structure:




CLINICAL PHARMACOLOGY


Urea gently dissolves the intercellular matrix, which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas.



PHARMACOKINETICS


The mechanism of action of topically applied Urea is not yet known.



INDICATIONS AND USES


For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses.



CONTRAINDICATIONS


Known hypersensitivity to any of the listed ingredients.



WARNINGS


For external use only. Avoid contact with eyes, lips or mucous membranes.



PRECAUTIONS


This medication is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use.



PREGNANCY


Pregnancy Category B. Animal reproduction studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, KerolTM AD should be given to a pregnant woman only if clearly needed.



NURSING MOTHERS


It is not known whether or not this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when KerolTM AD is administered to a nursing woman.


KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.



Adverse Reactions


Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.



DOSAGE AND ADMINISTRATION


Apply KerolTM AD to affected skin twice per day, or as directed by a physician. Rub in until completely absorbed.



HOW SUPPLIED


KerolTM AD (45% urea emulsion) is supplied as:


240 mL bottle, NDC 10337-643-24


Store at 15˚-30˚ C (59˚- 86˚ F).


Protect from freezing.


Mfd. for:

PharmaDerm®

A division of Nycomed US Inc.

Melville, NY 11747 USA

www.pharmaderm.com


Mfd. by:

Pegasus Laboratories, Inc.

Pensacola, FL 32514


IF643

R5/09



How to use


Rx only

Kerol™ AD

(45% urea emulsion)

Accu-Dose

In a zinc undecylenate and lactic acid vehicle


Steps for using Kerol AD to treat dry skin conditions including psoriasis, xerosis, ichthyosis, keratosis pilaris, keratosis palmaris, keratoderma, dermatitis, pruritus, eczema, corns and calluses.


Kerol AD can be applied directly to the treatment area(s) without pouring from a bottle or squeezing from a tube. The pump is designed to consistently deliver a precise amount of Kerol AD with each use once the pump has been primed and medication is delivered to the spout. To begin using Kerol AD:


  1. Remove the cap.

  2. With the first use, prime the chamber by pushing the pump top all the way down and then release. Repeat this four to six times until the chamber inside is filled and the Kerol AD passes through the spout.*

  3. To use after the chamber is filled, push the pump top all the way down to dispense one dose of Kerol AD. A precise amount of Kerol AD will be consistently delivered with each use.

  4. Apply Kerol AD to the affected area(s).

  5. Gently massage Kerol AD into the affected area twice a day or as directed by your physician. Keep Kerol AD away from the eyes, lips or mucous membranes.

  6. Replace the cap.

* Sample bottles of Kerol AD have a different fill ratio and will need to be pumped eight to ten times to prime the chamber and get the Kerol AD to pass through the spout.



PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 240 mL CONTAINER LABEL


NDC 10337-643-24


PharmaDerm®


NDC 10337-643-24


Rx only


KEROL™ AD

(45% urea emulsion)

Accu-Dose


In a zinc undecylenate and lactic acid vehicle


For Topical Use Only


Net Content 240 mL




PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 240 mL CARTON


PharmaDerm®


NDC 10337-643-24


Rx only


KEROL™ AD

(45% urea emulsion)

Accu-Dose


In a zinc undecylenate and

lactic acid vehicle


For Topical

Use Only


Net Content 240 mL










Kerol AD 
urea  emulsion










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)10337-643
Route of AdministrationTOPICALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
urea (urea)urea0.45 mL  in 1 mL


































Inactive Ingredients
Ingredient NameStrength
propylene glycol 
polyethylene glycol 300 
water 
trolamine 
alpha-tocopherol acetate 
lactic acid 
glycerin 
polysorbate 60 
linoleic acid 
sorbitan monostearate 
zinc undecylenate 
titanium dioxide 
cetyl alcohol 
edetate disodium 
xanthan gum 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
110337-643-241 BOTTLE In 1 CARTONcontains a BOTTLE
1240 mL In 1 BOTTLEThis package is contained within the CARTON (10337-643-24)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved other09/15/2009


Labeler - PharmaDerm, A division of Nycomed US Inc. (043838424)

Registrant - Nycomed US Inc. (043838424)
Revised: 09/2009PharmaDerm, A division of Nycomed US Inc.

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  • Dermatological Disorders
  • Dry Skin
  • Pityriasis rubra pilaris

Indivina





Indivina 1 mg/2.5 mg tablets


Indivina 1 mg/5 mg tablets


Indivina 2 mg/5 mg tablets


estradiol /medroxyprogesterone



Read all of this leaflet carefully before you start taking this medicine


  • Keep this leaflet. You may need to read it again.

  • If you have any further questions, ask your doctor or pharmacist.

  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.



In this leaflet:


1. What Indivina is and what it is used for

2. Before you take Indivina

3. How to take Indivina

4. Possible side effects of Indivina

5. How to store Indivina

6. Further information





What Indivina Is And What It Is Used For


The name of your medicine is Indivina. It is a hormone replacement therapy (HRT) used to treat some of the symptoms which occur when the oestrogen levels decline and the periods stop (menopause) by replacing the oestrogen that your body is no longer producing. The tablets contain oestrogen and progestogen. Indivina is only recommended for women whose periods stopped more than three years ago and who still have their womb.


Indivina can also be used to help to prevent osteoporosis (thinning of the bones) if you are at an increased risk of fractures due to osteoporosis but are unable to take other treatments or if other therapies prove to be ineffective. Your doctor should discuss all the available options with you.


There is only limited experience of treating women older than 65 years with Indivina.




Before You Take Indivina



Medical check-ups


Before you start taking Indivina, your doctor will inform you about the risks and benefits of the treatment (see also section 4, “Other side effects of combined HRT”). Before you start treatment and regularly during treatment, your doctor will evaluate whether Indivina is the right treatment for you. Your doctor will tell you how often you should go for periodic check-ups, taking into account your general state of health. If you have any close relative (mother, sister, maternal or paternal grandmother), who has suffered from serious illness, e.g. blood clot or breast cancer, you might be at increased risk. You should therefore always tell your doctor about any close relative suffering from serious illness, and you should also tell your doctor about any changes, you might find in your breasts.


As well as regular check-ups with your doctor, be sure to:


  • Regularly check your breasts for any changes, such as dimpling or sinking of the skin, changes in the nipple, or any lumps you can see or feel.

  • Go for regular breast screening (mammography) and cervical smear tests.

    • While you are receiving this medication, you should see your doctor regularly, at least every six to twelve months
    • If you have unusual symptoms such as unexplained pains in the chest, abdomen or legs you must consult your doctor immediately.
    • If you have a family history of breast cancer you should use this medication with great caution.



Do not take Indivina, if:


  • you are allergic (hypersensitive) to estradiol valerate or medroxyprogesterone acetate or any of the other ingredients of Indivina (see section 6: Further information)

  • you have or have had breast cancer in the past

  • you have or have had an oestrogen-dependent tumour such as endometrial cancer (cancer of the lining of the womb)

  • you have unusual vaginal bleeding that has not been checked by a doctor

  • you have endometrial hyperplasia (abnormal growth of the lining of the womb) that is not being treated

  • you have had a recent blood clot of an artery (leading to chest pain or heart attack)

  • you have had liver disease and have been told by your doctor that your liver function has not yet returned to normal

  • you have or have had a blood clot in a vein in your leg or anywhere else (a “deep vein thrombosis or pulmonary embolism”)

  • you have porphyria (a genetic disorder).



Take special care with Indivina


As well as benefits, HRT has some risks which you need to consider when you are deciding whether to take it, or whether to carry on taking it. Tell your doctor if you have any of the following as you may need more frequent check ups’ if:


  • you think you might be at risk of oestrogen dependent tumors such as breast cancer or endometrial cancer (see the section below on effects on your risk of developing cancer)

  • you have had endometrial hyperplasia (thickening of the lining of the womb)

  • you have uterine fibroids or endometriosis

  • you feel you might be at risk of developing blood clots (see section below on blood clots)

  • you have liver, kidney or heart problems

  • you have gallstones

  • you have asthma, epilepsy or diabetes

  • you have high blood pressure

  • you have otosclerosis (hearing problems due to bone overgrowth in the ear)

  • you have been told that you have an intolerance to some sugars

  • you have systemic lupus erythematosus (SLE)

  • you have migraine or severe headaches

  • you have been told you have high cholesterol or fat levels in your blood

  • you are going to have surgery, make sure your doctor knows about it. You may need to stop taking HRT about 4 to 6 weeks before the operation, to reduce the risk of a blood clot. Your doctor will tell you when you can start taking HRT again.

HRT may change the results of some laboratory tests. If you are going to have any laboratory tests, tell your doctor/nurse that you are taking Indivina.




Taking other medicines


Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.


In particular tell your doctor if you are taking any of the following:


  • antibiotics such as rifampicin, rifabutin

  • anti-epileptic medicines such as phenytoin, phenobarbital and carbamazepine

  • HIV medicines such as nelfinavir, ritonavir, nevirapine and efavirenz

  • the herbal preparation St. Johns Wort.

If you are in any doubt about taking other medicines with Indivina, talk to your doctor or your pharmacist.




Taking Indivina with food and drink


Indivina can be swallowed with a glass of water at the same time each day.




Pregnancy and breast-feeding


  • Pregnancy – Do not take Indivina if you are pregnant, think you are pregnant or planning to become pregnant

  • Breast feeding – Do not take Indivina if you are breast feeding.

Ask your doctor or pharmacist for advice before taking any medicine.




Driving and using machines


Indivina should not affect your ability to drive or operate machinery.




Important information about some ingredients of Indivina


This medicine contains lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.





How To Take Indivina


Always take Indivina as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.


Take one Indivina tablet every day, preferably at about the same time each day. Calendar days are printed on the blister sheet to help you follow your daily tablet intake. Swallow the tablet whole with a drink if necessary. You will normally start on the lowest dose of Indivina and this will be increased, if necessary. Your doctor should aim to prescribe the lowest dose for the shortest time that gives you relief from your symptoms. Talk to your doctor if your symptoms are not better after three months. If you feel that the effect of Indivina is too strong or too weak, do not change the dose or stop taking the tablets yourself, but ask your doctor for advice.


If you are not having periods and you have not previously taken HRT or you are changing from another continuous combined HRT product, treatment with Indivina may be started on any day.


If you switch from a cyclic HRT regimen, start Indivina treatment one week after taking the last tablet of the cyclic HRT. Talk to your doctor or pharmacist if you are unsure.



Whilst taking this medicine


When you first start taking Indivina you may get some bleeding at odd times for a few months (Please also refer to the section above on Endometrial cancer). However, if this is still happening after a few months or if you experience heavy bleeding tell your doctor.



If you take more Indivina than you should:


If you or somebody else has taken too many Indivina tablets, talk to your doctor or pharmacist. An overdose of Indivina could make you feel sick or make you get a headache or uterine bleeding.




If you forget to take Indivina:


It is best to take the tablet at the same time each day. If you forget to take a tablet leave the forgotten tablet. You should then continue by taking the next tablet at your usual time. Missing a tablet or irregular use of Indivina tablets may cause breakthrough bleeding or spotting.


If you have any further questions on the use of this product, ask your doctor or pharmacist.




If you stop taking Indivina


If you want to stop taking Indivina, talk to your doctor first. He/she will explain the effects of stopping treatment and discuss other possibilities with you.





Indivina Side Effects


Like all medicines, Indivina may cause side effects although not everybody gets them, particularly early on (in the first few months of treatment), for example irregular bleeding may occur. These often disappear with continued treatment.


There are a number of situations in which you may have to stop taking Indivina. Tell your doctor immediately if you develop any of the following conditions:



Common (affecting more than 1 person in 100):


  • feeling sick, stomach pain

  • headache

  • breast tenderness, breast enlargement, breakthrough bleeding

  • weight increase or decrease

  • changes in mood including anxiety and depressive mood, changes in libido

  • increase in size of uterine muscle lumps (fibroids)

  • swelling caused by fluid retention


Uncommon (affecting more than 1 in 1,000 but less than 1 in 100)


  • dizziness, migraine

  • leg cramps

  • increased blood pressure

  • vaginal thrush (candidiasis)

  • indigestion/heartburn

  • wind, vomiting

  • gall bladder disease and/or gallstones


Rare (affecting more than 1 in 10,000 but less than 1 in 1,000)


  • skin rash, itching

  • blood clots

  • hair loss, excessive hair growth (hirsutism)


Other side effects of combined HRT


The following side effects have been reported after taking other oestrogen/progestagen products:


Oestrogen dependent tumours, heart attack, stroke, disorders of skin and underlying tissues.



Endometrial hyperplasia and endometrial cancer


In women with an intact uterus, the risk of excessive growth of the womb lining (endometrial hyperplasia) is increased. Treatment with unopposed oestrogens for long periods of time increases the risk of cancer of the lining of the womb (endometrial cancer). Adding a progestagen, which Indivina contains, greatly reduces this increased risk.




Compare


Looking at women who still have a uterus and who are not taking HRT, on average, 5 in 1000 will be diagnosed with endometrial cancer between the ages of 50 and 65. For women who take oestrogen-only HRT the number will be 2 to 12 times higher, depending on the dose and how long you take it. The addition of progestogen to oestrogen-only HRT substantially reduces the risk of endometrial cancer.




Breast cancer


Every woman is at risk of getting breast cancer whether or not she takes HRT. There is a small increase in this risk for women who have been using HRT compared with women of the same age who have never used HRT. This risk increases with the duration of intake of HRT, but returns to normal within a few (at most five) years of having stopped HRT. The risk seems to be higher for women who use oestrogen in combination with progestagen as compared to oestrogen alone.




Compare:


Looking at women aged 50 who are not taking HRT – on average, 32 in 1000 will be diagnosed with breast cancer by the time they reach the age of 65.


For women who start taking oestrogen-only HRT at age 50 and take it for 5 years, the figure will be between 33 and 34 in 1000 (i.e. an extra 1-2 cases).


If they take oestrogen-only HRT for 10 years, the figure will be, 37 in 1000 (i.e. an extra 5 cases). For women who start taking oestrogen plus progestogen HRT at age 50 and take it for 5 years, the figure will be 38 in 1000 (i.e. an extra 6 cases).


If they take oestrogen plus progestogen HRT for 10 years, the figure will be 51 in 1000 (i.e. an extra 19 cases).


To be able to detect a breast tumour as early as possible, it’s important to regularly check your breasts for any changes and to discuss any changes with your doctor. Also go for regular health check, including mammography. If you are anxious about the risk of developing breast cancer, you should talk to your doctor about the risks and benefits of hormone replacement therapy.



Blood clots in the deep veins


Every woman is at risk of getting a blood clot whether or not she takes HRT.


HRT may increase the risk of blood clots in the veins up to3 times, especially in the first year of taking it.


If you suspect you are suffering from a blood clot, seek immediate medical attention.


You are also more likely to get a blood clot:


  • If you are very overweight

  • If you have had a blood clot before, or have had any blood clotting problem that needs treatment with a medicine such as Warfarin

  • If any of your close family has had blood clots

  • If you have had a miscarriage

  • If you are off your feet for a long time through surgery, injury or illness

  • If you have Systemic Lupus Erythematosus ((SLE) – an autoimmune disease)



Compare


Looking at women in their 50’s who are not taking HRT – on average, over a 5 year period, 3 in 1000 would be expected to get a blood clot.


For women in their 50s who are taking HRT, the figure would be 7 in 1000.


Looking at women in their 60s who are not taking HRT – on average, over a 5 year period, 8 in 1000 would be expected to get a blood clot.


For women in their 60’s who are taking HRT, the figure would be 17 in 1000.



Symptoms that may be indicative of blood clots:


  • Pain and swelling in your leg

  • Sudden chest pain

  • Difficulty breathing.


Seek immediate medical help. Stop taking HRT until your doctor says you can.



Heart disease


If you ever have had angina or heart attack, you should talk to your doctor about the risks and benefits of hormone replacement therapy.


There is no evidence from clinical trials of beneficial effects on the risks of cardiovascular disease with hormone replacement therapy in the menopause. Results from two large clinical studies showed that women, who used another type of oestrogen/progestagen combination, had a slightly increased risk of heart disease in the first year of use.


For other HRT products there are only very limited data from trials examining the effects on the risk of cardiovascular disease.



Stroke


There may be a slightly higher chance of having a stroke if you are taking HRT.


Other things that also increase the risk of stroke are:


  • Getting older

  • High blood pressure

  • Smoking

  • Drinking too much alcohol

  • An irregular heartbeat.



Compare


Looking at women in their 50’s who are not taking HRT - on average, over a 5 year period, 3 in 1000 would be expected to have a stroke.


For women in their 50s who are taking HRT, the figure would be 4 in 1000.


Looking at women in their 60s who are not taking HRT - on average, over a 5 year period, 11 in 1000 would be expected to have a stroke.


For women in their 60’s who are taking HRT, the figure would be 15 in 1000.


If you get:


  • Unexplained migraine-type headaches, with or without disturbed vision.


See a doctor as soon as possible. Stop taking HRT until your doctor says you can.



Ovarian cancer


Long-term (at least 5 or 10 years) use of oestrogen-only HRTs and oestrogen plus progestogen HRTs has been associated with an increased risk of ovarian cancer in some epidemiological studies.



Dementia



HRT will not prevent memory loss. In one study of women who started using combined HRT after the age of 65, a small increase in the risk of dementia was observed.



Effects on the skin


Brown patches in the face (chloasma), skin rashes including red inflammation on the hands or the legs (erythema multiforme), formation of tender, red nodules on the front of the legs/knees (erythema nodosum) or a bruise-like rash (vascular purpura).



If you notice any side effects not listed in this leaflet or if any of the side effects mentioned gets serious please tell your doctor or pharmacist.




How To Store Indivina


Keep out of the reach and sight of children. Do not use Indivina after the expiry date which is stated on the pack. Do not store above 30 ºC. Store in the original package in order to protect from moisture. Medicines should not be disposed via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.




Further Information



What Indivina contains:


The active ingredients of Indivina tablets are estradiol valerate and medroxyprogesterone acetate. Three different strengths of tablets are available.


Indivina 1 mg/2.5 mg tablets contain 1 mg of estradiol valerate and 2.5 mg medroxyprogesterone acetate.


Indivina 1 mg/5 mg tablets contain 1 mg of estradiol valerate and 5 mg medroxyprogesterone acetate.


Indivina 2 mg/5 mg tablets contain 2 mg of estradiol valerate and 5 mg medroxyprogesterone acetate.


The other ingredients of all Indivina tablets are lactose monohydrate, maize starch, gelatin, and magnesium stearate




What Indivina looks like and contents of the pack:


Indivina 1 mg/2.5 mg tablets are white, round, bevelled-edge, diameter 7 mm, flat tablets with a code ‘1 + 2.5’on one side.


Indivina 1 mg/5 mg tablets are white, round, bevelled-edge, diameter 7 mm, flat tablets with a code ‘1 + 5’on one side.


Indivina 2 mg/5 mg tablets are white, round, bevelled-edge, diameter 7 mm, flat tablets with a code ‘2 + 5’on one side.


The tablets are packed in a PVC/PVDC-aluminium blister of 28 tablets. The pack sizes available are 1 x 28 tablets and 3 x 28 tablets for all three strengths. All pack sizes may not be available in your country.




Marketing Authorisation Holder:



Orion Corporation

Orionintie 1

FIN-02200 Espoo

FINLAND




Manufactured by:



Orion Corporation

Tengströminkatu 8

FIN-20360 Turku

FINLAND




This medicinal product is authorised in the Member States of the EEA under the following names:


Indivina, Duova




This leaflet was last revised: June 2010





insulin lispro


Generic Name: insulin lispro (IN soo lin LISS pro)

Brand Names: HumaLOG, HumaLOG Cartridge, HumaLOG KwikPen, HumaLOG Pen


What is insulin lispro?

Insulin is a hormone that is produced in the body. It works by lowering levels of glucose (sugar) in the blood. Insulin lispro is a fast-acting form of insulin.


Insulin lispro is used to treat type 1 (insulin-dependent) diabetes in adults. It is usually given together with another long-acting insulin.


Insulin lispro is also used together with oral (taken by mouth) medications to treat type 2 (non insulin-dependent) diabetes in adults.


Insulin lispro may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about insulin lispro?


Insulin lispro is a fast-acting insulin that begins to work very quickly. If you use this medication with meal, use it within 15 minutes before or just after you eat.


Take care to keep your blood sugar from getting too low, causing hypoglycemia. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, or trouble concentrating. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar. Also be sure your family and close friends know how to help you in an emergency.


Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. Check your blood sugar levels and ask your doctor how to adjust your insulin doses if needed.


Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

Insulin lispro is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.


What should I discuss with my healthcare provider before using insulin lispro?


Do not use this medication if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).

Before using insulin lispro, tell your doctor if you have liver or kidney disease.


Tell your doctor about all other medications you use, including any oral (by mouth) diabetes medications.


Insulin lispro is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.


Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.


FDA pregnancy category B. This medication is not expected to 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 insulin lispro 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 should I use insulin lispro?


Use this medication exactly as it was prescribed for you. Do not use it in larger amounts or for longer than recommended by your doctor. Follow the directions on your prescription label.


Insulin lispro is given as an injection (shot) under your skin, using a needle and syringe or an insulin pump. Your doctor, nurse, or pharmacist will give you specific instructions on how and where to inject this medicine. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.


Insulin lispro is a fast-acting insulin that begins to work very quickly. If you use this medication with meal, use it within 15 minutes before or just after you eat.

Insulin lispro should be thin, clear, and colorless. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.


Choose a different place in your injection skin area each time you use this medication. Do not inject into the same place two times in a row.


If you use this medication with an insulin pump, do not mix or dilute insulin lispro with any other insulin. Call your doctor at once if you think your infusion pump is not working properly.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.


Some insulin needles can be used more than once, depending on needle brand and type. But a reused needle must be properly cleaned, recapped, and inspected for bending or breakage. Reusing needles also increases your risk of infection. Ask your doctor or pharmacist whether you are able to reuse your insulin needles.


Infusion pump tubing, catheters, and the needle location on your skin should be changed every 48 hours. Throw away any medication leftover in the reservoir.


Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, or skip meals. These things can affect your glucose levels and your insulin dose needs may also change.


Watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. Check your blood sugar levels and ask your doctor how to adjust your insulin doses if needed.


Ask your doctor how to adjust your insulin lispro dose if needed. Do not change your dose without first talking to your doctor. Carry an ID card or wear a medical alert bracelet stating that you have diabetes, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are diabetic. Storing unopened vials, cartridges, or injection pens: Keep in the carton and store in a refrigerator, protected from light. Throw away any insulin not used before the expiration date on the medicine label. Unopened vials, cartridges, or injection pens may also be stored at room temperature for up to 28 days, away from heat and bright light. Throw away any insulin not used within 28 days. Storing after your first use: You may keep "in-use" vials in the refrigerator, protected from light. Use within 28 days. Do not refrigerate an in-use cartridge or injection pen. Keep it at room temperature and use within 28 days.

Do not freeze insulin lispro, and throw away the medication if it has become frozen.


What happens if I miss a dose?


Since insulin lispro is used before meals, you may not be on a timed dosing schedule. Whenever you use insulin lispro, be sure to eat a meal within 15 minutes. Do not use extra insulin lispro to make up a missed dose.


It is important to keep insulin lispro on hand at all times. Get your prescription refilled before you run out of medicine completely.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine. An insulin overdose can cause life-threatening hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, seizure (convulsions), or coma.


What should I avoid while using insulin lispro?


Do not change the brand of insulin lispro or syringe you are using without first talking to your doctor or pharmacist. Avoid drinking alcohol. Your blood sugar may become dangerously low if you drink alcohol while using insulin lispro. Do not expose insulin lispro to high heat.

Insulin lispro side effects


Get emergency medical help if you have any of these signs of insulin allergy: itching skin rash over the entire body, wheezing, trouble breathing, fast heart rate, sweating, or feeling like you might pass out.

Hypoglycemia, or low blood sugar, is the most common side effect of insulin lispro. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, trouble concentrating, confusion, or seizure (convulsions). Watch for signs of low blood sugar. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.


Insulin lispro can also cause hypokalemia (low potassium levels in the blood). Call your doctor at once if you have symptoms such as dry mouth, increased thirst, increased urination, uneven heartbeats, muscle pain or weakness, leg pain or discomfort, or confusion.

Tell your doctor if you have itching, swelling, redness, or thickening of the skin where you inject insulin lispro.


This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.


Insulin lispro Dosing Information


Usual Adult Dose for Diabetes Mellitus Type I:

Insulin lispro is a rapid-acting insulin and is given 2 to 5 times daily within 15 minutes before meals or as a continuous subcutaneous infusion via external insulin pump.

Insulin dosage should be individualized to achieve/maintain a target blood glucose level and is determined by various factors including body weight, body fat, physical activity, insulin sensitivity, blood glucose levels, and target blood glucose.

Conventional regimen: The total daily insulin dose is administered as a mixture of rapid/short-acting and intermediate-acting insulins in 1 to 2 injections. Twice daily injections are preferred for better glycemic control. With the 2-injection regimen, generally two-thirds of the daily dose is given before breakfast and one-third is given before the evening meal.

Intensive regimen: The total daily dose is administered as 3 or more injections or by continuous subcutaneous infusion to cover basal and pre-meal bolus insulin requirements. The basal requirement is approximately 30 to 50% of the total dose, given as intermediate or long-acting insulin (NPH, zinc, extended zinc, lispro-protamine, glargine), 1 to 2 times daily. Meal boluses are approximately 50 to 70% of the total dose, given as rapid/short-acting insulin (regular, aspart, lispro) 2 to 5 times daily before meals. Common regimens include injections of rapid/short acting insulin before each meal along with injections of intermediate or long-acting insulin in the morning and/or evening. Dosage adjustments are made to achieve target blood glucose levels and are based on frequent blood glucose measurements, diet and exercise levels.

Total daily insulin requirements:
Initial dose: 0.5 to 0.8 unit/kg/day subcutaneously
Honeymoon phase: 0.2 to 0.5 unit/kg/day subcutaneously
Split dose therapy: 0.5 to 1.2 unit/kg/day subcutaneously
Insulin resistance: 0.7 to 2.5 units/kg/day subcutaneously

Usual Adult Dose for Diabetes Mellitus Type II:

Insulin lispro is a rapid-acting insulin and should be given within 15 minutes before meals or as a continuous subcutaneous infusion via external insulin pump. It may be given without an intermediate or long-acting insulin when used in combination with a sulfonylurea.

Diet and lifestyle modifications are recommended as initial treatment for type II diabetes, followed by oral agents. Insulin may be considered if patients are very hyperglycemic or symptomatic and/or not controlled with oral agents. Insulin may exacerbate obesity, further increase insulin resistance, and increase the frequency of hypoglycemia.

Insulin dosage should be individualized to achieve/maintain a target blood glucose level and is determined by various factors including body weight, body fat, physical activity, insulin sensitivity, blood glucose levels, and target blood glucose.

Conventional regimen:
Initial dose, adjunct: Lispro insulin has been given 3 times daily before meals as an adjunct to sulfonylureas (average study dose: 0.3 unit/kg/day).

Initial dose, monotherapy: Total insulin requirement: 0.1 unit/kg/day. When insulin is used alone, twice daily injections are recommended for better glycemic control. The total daily insulin dose is administered as a mixture of rapid/short-acting and intermediate-acting insulins in 1 to 2 injections. With the 2-injection regimen, generally two-thirds of the daily dose is given before breakfast and one-third is given before the evening meal. Once daily injections are sometimes used in children with suboptimal compliance; however, this may lead to more nocturia, fasting hyperglycemia, morning glucosuria, and a risk of ketoacidosis if the doses are missed.
Maintenance dose, monotherapy: Total daily insulin requirements may progress to 1.5 to 2.5 units/kg or higher in patients with obesity and insulin resistance.

Intensive regimen:
The necessity for and efficacy of intensive insulin therapy in type II diabetes has been controversial. The total daily dose is administered as 3 or more injections or by continuous subcutaneous infusion to cover basal and pre-meal bolus insulin requirements. This method may be appropriate for closely supervised and highly motivated older children or adolescents who are able to inject their insulin, monitor their blood glucose, and recognize hypoglycemia. The basal requirement is approximately 30 to 50% of the total dose, given as intermediate or long-acting insulin (NPH, zinc, extended zinc, lispro-protamine, glargine), 1 to 2 times daily. Meal boluses are approximately 50 to 70% of the total dose, given as rapid/short-acting insulin (regular, aspart, lispro) 2 to 5 times daily before meals. Common regimens include injections of rapid/short acting insulin before each meal along with injections of intermediate or long-acting insulin in the morning and/or evening. Dosage adjustments are made to achieve target blood glucose levels and are based on frequent blood glucose measurements, diet and exercise levels.
Initial dose, monotherapy: 0.5 to 1.5 unit/kg/day subcutaneously.
Maintenance dose, monotherapy: Total daily insulin requirements may progress to 2.5 units/kg or higher in patients with obesity and insulin resistance.

Usual Pediatric Dose for Diabetes Mellitus Type I:

Insulin lispro is a rapid-acting insulin and is given 2 to 5 times daily within 15 minutes before meals or as a continuous subcutaneous infusion via external insulin pump.

Insulin dosage should be individualized to achieve/maintain a target blood glucose level and is determined by various factors including body weight, body fat, physical activity, insulin sensitivity, blood glucose levels, and target blood glucose.

Conventional regimen: The total daily insulin dose is administered as a mixture of rapid/short-acting and intermediate-acting insulins in 1 to 2 injections. Twice daily injections are recommended for better glycemic control. With the 2-injection regimen, generally two-thirds of the daily dose is given before breakfast and one-third is given before the evening meal. Once daily injections are sometimes used in children with suboptimal compliance; however, this may lead to more nocturia, fasting hyperglycemia, morning glucosuria, and a risk of ketoacidosis if the doses are missed.

Intensive regimen: The total daily dose is administered as 3 or more injections or by continuous subcutaneous infusion to cover basal and pre-meal bolus insulin requirements. This method may be appropriate for closely supervised and highly motivated older children or adolescents who are able to inject their insulin, monitor their blood glucose, and recognize hypoglycemia. The basal requirement is approximately 30 to 50% of the total dose, given as intermediate or long-acting insulin (NPH, zinc, extended zinc, glargine), 1 to 2 times daily. Meal boluses are approximately 50 to 70% of the total dose, given as rapid/short-acting insulin (regular, lispro) 2 to 5 times daily before meals. Common regimens include injections of rapid/short acting insulin before each meal along with injections of intermediate or long-acting insulin in the morning and/or evening. Dosage adjustments are made to achieve target blood glucose levels and are based on frequent blood glucose measurements, diet and exercise levels.

Total daily insulin requirements:
Initial dose: 0.5 to 0.8 unit/kg/day subcutaneously
Honeymoon phase: 0.2 to 0.5 unit/kg/day subcutaneously
Split dose therapy: 0.5 to 1.2 unit/kg/day subcutaneously
Adolescents during growth spurts. 0.8 to 1.5 units/kg/day subcutaneously

Usual Pediatric Dose for Diabetes Mellitus Type II:

Insulin lispro is a rapid-acting insulin and should be given within 15 minutes before meals or as a continuous subcutaneous infusion via external insulin pump.

Diet and lifestyle modifications are recommended as initial treatment for type II diabetes, followed by oral agents (metformin). Insulin may be considered if children are very hyperglycemic or symptomatic and/or not controlled with oral agents. Insulin may exacerbate obesity, further increase insulin resistance, and increase the frequency of hypoglycemia.

Insulin dosage should be individualized to achieve/maintain a target blood glucose level and is determined by various factors including body weight, body fat, physical activity, insulin sensitivity, blood glucose levels, and target blood glucose.

Conventional regimen:
Initial dose, monotherapy: Total insulin requirement: 0.1 unit/kg/day. When insulin is used alone, twice daily injections are recommended for better glycemic control. The total daily insulin dose is administered as a mixture of rapid/short-acting and intermediate-acting insulins in 1 to 2 injections. With the 2-injection regimen, generally two-thirds of the daily dose is given before breakfast and one-third is given before the evening meal. Once daily injections are sometimes used in children with suboptimal compliance; however, this may lead to more nocturia, fasting hyperglycemia, morning glucosuria, and a risk of ketoacidosis if the doses are missed.
Maintenance dose, monotherapy: Total daily insulin requirements may progress to 1.5 to 2.5 units/kg or higher in patients with obesity and insulin resistance.

Intensive regimen:
The necessity for and efficacy of intensive insulin therapy in type II diabetes has been controversial. The total daily dose is administered as 3 or more injections or by continuous subcutaneous infusion to cover basal and pre-meal bolus insulin requirements. This method may be appropriate for closely supervised and highly motivated older children or adolescents who are able to inject their insulin, monitor their blood glucose, and recognize hypoglycemia. The basal requirement is approximately 30 to 50% of the total dose, given as intermediate or long-acting insulin (NPH, zinc, extended zinc, glargine), 1 to 2 times daily. Meal boluses are approximately 50 to 70% of the total dose, given as rapid/short-acting insulin (regular, lispro) 2 to 5 times daily before meals. Common regimens include injections of rapid/short acting insulin before each meal along with injections of intermediate or long-acting insulin in the morning and/or evening. Dosage adjustments are made to achieve target blood glucose levels and are based on frequent blood glucose measurements, diet and exercise levels.
Initial dose, monotherapy: 0.5 to 1.5 unit/kg/day subcutaneously.
Maintenance dose, monotherapy: Total daily insulin requirements may progress to 2.5 units/kg or higher in patients with obesity and insulin resistance.


What other drugs will affect insulin lispro?


Using certain medicines can make it harder for you to tell when you have low blood sugar. Tell your doctor if you use any of the following:



  • albuterol (Proventil, Ventolin);




  • clonidine (Catapres);




  • reserpine;




  • guanethidine (Ismelin); or




  • beta-blockers such as atenolol (Tenormin), bisoprolol (Zebeta), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), timolol (Blocadren), and others.




There are many other medicines that can increase or decrease the effects of insulin lispro on lowering your blood sugar. 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. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

More insulin lispro resources


  • Insulin lispro Use in Pregnancy & Breastfeeding
  • Insulin lispro Drug Interactions
  • Insulin lispro Support Group
  • 4 Reviews for Insulin lispro - Add your own review/rating


  • insulin lispro Subcutaneous Advanced Consumer (Micromedex) - Includes Dosage Information

  • Insulin Lispro Monograph (AHFS DI)

  • Insulin Lispro Cartridges MedFacts Consumer Leaflet (Wolters Kluwer)

  • Humalog Prescribing Information (FDA)

  • Humalog Consumer Overview



Compare insulin lispro with other medications


  • Diabetes, Type 1
  • Diabetes, Type 2


Where can I get more information?


  • Your pharmacist can provide more information about insulin lispro.