Tuesday, June 19, 2012

Mucopolysaccharidosis Type II Medications


Drugs associated with Mucopolysaccharidosis Type II

The following drugs and medications are in some way related to, or used in the treatment of Mucopolysaccharidosis Type II. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.





Drug List:

Friday, June 15, 2012

Mucous Plugging in Lung Disease Medications


There are currently no drugs listed for "Mucous Plugging in Lung Disease".





Drug List:

Sunday, June 10, 2012

Zinc-220


Generic Name: zinc supplement (Oral route, Parenteral route)


Commonly used brand name(s)

In the U.S.


  • Galzin

  • M2 Zinc 50

  • Orazinc 110

  • Orazinc 220

  • Zinc-220

  • Zinc Chelated

  • Zn Plus Protein

In Canada


  • Prostavan

Available Dosage Forms:


  • Tablet

  • Capsule

  • Tablet, Extended Release

Uses For Zinc-220


Zinc supplements are used to prevent or treat zinc deficiency.


The body needs zinc for normal growth and health. For patients who are unable to get enough zinc in their regular diet or who have a need for more zinc, zinc supplements may be necessary. They are generally taken by mouth but some patients may have to receive them by injection.


Zinc supplements may be used for other conditions as determined by your health care professional.


Lack of zinc may lead to poor night vision and wound-healing, a decrease in sense of taste and smell, a reduced ability to fight infections, and poor development of reproductive organs.


  • Acrodermatitis enteropathica (a lack of absorption of zinc from the intestine)

  • Alcoholism

  • Burns

  • Type 2 diabetes mellitus

  • Down's syndrome

  • Eating disorders

  • Intestine diseases

  • Infections (continuing or chronic)

  • Kidney disease

  • Liver disease

  • Pancreas disease

  • Sickle cell disease

  • Skin disorders

  • Stomach removal

  • Stress (continuing)

  • Thalassemia

  • Trauma (prolonged)

In addition, premature infants may need additional zinc.


Increased need for zinc should be determined by your health care professional.


Claims that zinc is effective in preventing vision loss in the elderly have not been proven. Zinc has not been proven effective in the treatment of porphyria.


Injectable zinc is given by or under the supervision of a health care professional. Other forms of zinc are available without a prescription.


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


  • Wilson's disease (a disease of too much copper in the body)

Importance of Diet


For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.


Zinc is found in various foods, including lean red meats, seafood (especially herring and oysters), peas, and beans. Zinc is also found in whole grains; however, large amounts of whole-grains have been found to decrease the amount of zinc that is absorbed. Additional zinc may be added to the diet through treated (galvanized) cookware. Foods stored in uncoated tin cans may cause less zinc to be available for absorption from food.


The daily amount of zinc needed is defined in several different ways.


  • For U.S.—

  • Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy).

  • Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs).

  • For Canada—

  • Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Normal daily recommended intakes in milligrams (mg) for zinc are generally defined as follows:


























PersonsU.S. (mg)Canada (mg)
Infants and children birth to

3 years of age
5–102–4
Children 4 to 6 years of age105
Children 7 to 10 years of age107–9
Adolescent and adult males159–12
Adolescent and adult females129
Pregnant females1515
Breast-feeding females16–1915

Before Using Zinc-220


If you are taking a dietary supplement without a prescription, carefully read and follow any precautions on the label. For these supplements, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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


Problems in children have not been reported with intake of normal daily recommended amounts.


Geriatric


Problems in older adults have not been reported with intake of normal daily recommended amounts. There is some evidence that the elderly may be at risk of becoming deficient in zinc due to poor food selection, decreased absorption of zinc by the body, or medicines that decrease absorption of zinc or increase loss of zinc from the body.


Pregnancy


It is especially important that you are receiving enough vitamins and minerals when you become pregnant and that you continue to receive the right amount of vitamins and minerals throughout your pregnancy. The healthy growth and development of the fetus depend on a steady supply of nutrients from the mother. There is evidence that low blood levels of zinc may lead to problems in pregnancy or defects in the baby. However, taking large amounts of a dietary supplement in pregnancy may be harmful to the mother and/or fetus and should be avoided.


Breast Feeding


It is important that you receive the right amounts of vitamins and minerals so that your baby will also get the vitamins and minerals needed to grow properly. However, taking large amounts of a dietary supplement while breast-feeding may be harmful to the mother and/or baby and should be avoided.


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 any of these dietary supplements, 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 dietary supplements in this class 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.


  • Amygdalin

  • Deferoxamine

  • Eltrombopag

Interactions with Food/Tobacco/Alcohol


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


Other Medical Problems


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


  • Copper deficiency—Zinc supplements may make this condition worse.

Proper Use of zinc supplement

This section provides information on the proper use of a number of products that contain zinc supplement. It may not be specific to Zinc-220. Please read with care.


Zinc supplements are most effective if they are taken at least 1 hour before or 2 hours after meals. However, if zinc supplements cause stomach upset, they may be taken with a meal. You should tell your health care professional if you are taking your zinc supplement with meals.


Dosing


The dose medicines in this class 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 these medicines. If your dose is different, do not change it unless your doctor tells you to do so.


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


  • For oral dosage forms (capsules, lozenges, tablets, extended-release tablets):
    • To prevent deficiency, the amount taken by mouth is based on normal daily recommended intakes (Note that the normal daily recommended intakes are expressed as an actual amount of zinc. The dosage form [e.g., zinc gluconate, zinc sulfate] has a different strength):
      • For the U.S

      • Adult and teenage males—15 milligrams (mg) per day.

      • Adult and teenage females—12 mg per day.

      • Pregnant females—15 mg per day.

      • Breast-feeding females—16 to 19 mg per day.

      • Children 4 to 10 years of age—10 mg per day.

      • Children birth to 3 years of age—5 to 10 mg per day.

      • For Canada

      • Adult and teenage males—9 to 12 mg per day.

      • Adult and teenage females—9 mg per day.

      • Pregnant females—15 mg per day.

      • Breast-feeding females—15 mg per day.

      • Children 7 to 10 years of age—7 to 9 mg per day.

      • Children 4 to 6 years of age—5 mg per day.

      • Children birth to 3 years of age—2 to 4 mg per day.


    • To treat deficiency:
      • Adults, teenagers, and children—Treatment dose is determined by prescriber for each individual based on severity of deficiency.



Missed Dose


If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


If you miss taking zinc supplements for one or more days there is no cause for concern, since it takes some time for your body to become seriously low in zinc. However, if your health care professional has recommended that you take zinc, try to remember to take it as directed every day.


Storage


Keep out of the reach of children.


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


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using Zinc-220


When zinc combines with certain foods it may not be absorbed into your body and it will do you no good. If you are taking zinc, the following foods should be avoided or taken 2 hours after you take zinc:


  • Bran

  • Fiber-containing foods

  • Phosphorus-containing foods such as milk or poultry

  • Whole-grain breads and cereals

Do not take zinc supplements and copper, iron, or phosphorus supplements at the same time. It is best to space doses of these products 2 hours apart, to get the full benefit from each dietary supplement.


Zinc-220 Side Effects


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


Check with your doctor as soon as possible if any of the following side effects occur:


Rare - With large doses
  • Chills

  • continuing ulcers or sores in mouth or throat

  • fever

  • heartburn

  • indigestion

  • nausea

  • sore throat

  • unusual tiredness or weakness

Symptoms of overdose
  • Chest pain

  • dizziness

  • fainting

  • shortness of breath

  • vomiting

  • yellow eyes or skin

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.



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Monday, June 4, 2012

vinblastine


Generic Name: vinblastine (vin BLAS teen)

Brand Names: Velban


What is vinblastine?

Vinblastine is cancer medication that interferes with the growth of cancer cells and slows their spread in the body.


Vinblastine is used to treat Hodgkin's disease, certain types of lymphoma, testicular cancer, breast cancer, choriocarcinoma (a type of uterine cancer), Kaposi's sarcoma, and Letterer-Siwe disease.


Vinblastine is often used in combination with other cancer medications.


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


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


You should not use this medication if you are allergic to it, or if you have severely low white blood cell counts, or an untreated or uncontrolled bacterial infection. Do not use vinblastine if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Before you receive vinblastine, tell your doctor if you have liver disease, wasting syndrome, skin ulcers, coronary artery disease, a history of blood clot or stroke, or cancer that has spread to your bone marrow.


Vinblastine is often used in combination with other cancer medications.


Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when vinblastine is injected.

Vinblastine can lower blood cells that help your body fight infections. Avoid being near people who have colds, the flu, or other contagious illnesses. Your blood will need to be tested on a regular basis. Do not miss any scheduled appointments. Contact your doctor at once if you develop signs of infection.


Do not receive a "live" vaccine while you are being treated with vinblastine, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you.

What should I discuss with my healthcare provider before receiving vinblastine?


You should not use this medication if you are allergic to it, or if you have:

  • severely low white blood cell counts; or




  • an untreated or uncontrolled bacterial infection.



If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:


  • liver disease;


  • wasting syndrome (decreased weight with loss of muscle tissue);




  • skin ulcers, bed sores;




  • coronary artery disease, a history of blood clot or stroke (including "mini-stroke"); or




  • cancer than has spread to your bone marrow.




FDA pregnancy category D. Vinblastine can cause harm to an unborn baby or cause birth defects. Before you receive vinblastine, tell your doctor if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. It is not known whether vinblastine passes into breast milk or if it could harm a nursing baby. Before you receive this medication, tell your doctor if you are breast-feeding a baby.

How is vinblastine given?


Vinblastine is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion.


Vinblastine is usually given once every 7 days. Follow your doctor's instructions.


Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when the medicine is injected.

Vinblastine can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your cancer treatments may be delayed based on the results of these tests. Do not miss any scheduled visits to your doctor.


What happens if I miss a dose?


Call your doctor for instructions if you miss an appointment for your vinblastine injection.


What happens if I overdose?


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

Overdose symptoms may include severe forms of the serious side effects listed in this medication guide.


What should I avoid while receiving vinblastine?


Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.


Do not receive a "live" vaccine while you are being treated with vinblastine, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), oral polio, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

Talk to your doctor about ways to avoid constipation while being treated with vinblastine.


Vinblastine side effects


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

  • signs of infection such as fever, chills, sore throat, mouth pain, white patches or sores inside your mouth or on your lips;




  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;




  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;




  • numbness, burning, pain, or tingly feeling;




  • bronchospasm (wheezing, chest tightness, trouble breathing);




  • severe constipation;




  • problems with vision, hearing, speech, balance, or daily activities;




  • sudden numbness or weakness on one side of the body, sudden headache or confusion;




  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or




  • pain, burning, redness, swelling, or skin changes where the IV needle was placed.



Less serious side effects may include:



  • temporary hair loss;




  • jaw pain;




  • tumor pain, bone pain;




  • missed menstrual periods;




  • nausea, vomiting, loss of appetite; or




  • feeling weak or tired.



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.


Vinblastine Dosing Information


Usual Adult Dose for Breast Cancer:

Initial Dose: 3.7 mg/m2 intravenously over approximately one minute, once.

Because of the variation in the depth of the leukopenic response following therapy, the manufacturer recommends that vinblastine not be given more frequently than once every 7 days. However, there are several multiple day regimens where the dose is split into several consecutive days.

The manufacturer outlines the following conservative incremental approach to dosage at weekly intervals for adults. Therapy may be continued at 5.5 mg/m2 for the second dose, 7.4 mg/m2 for the third dose, 9.25 mg/m2 for the fourth dose, and 11.1 mg/m2 for the fifth dose. This progression may be followed up to a maximum dosage of 18.5 mg/m2. Dosage regimens may vary in clinical practice according to the disease being treated and the combination of antineoplastic agents being used.

White blood cell counts should be obtained just prior to dosage administration. The nadir in the white blood cell count is generally observed from 5 to 10 days following the dosage. Recovery to pretreatment levels is usually observed from 7 to 14 days after treatment. If a dose reduces the white cell count to approximately 3,000 cells/mm3, the next dose should not be given until the white cell count has returned to at least 4,000/mm3. The previous dosage increment may then be administered at weekly intervals for maintenance. In some cases, oncolytic activity may be encountered before leukopenic effect. When this occurs, there is no need to increase subsequent doses.

The manufacturer states that the use of small amounts of vinblastine daily for long periods of time is not advisable and that strict adherence to the recommended dosage schedule is very important.

The duration of maintenance therapy varies according to the disease being treated and the combination of antineoplastic agents being used. Prolonged chemotherapy for maintaining remissions involves several risks, including life-threatening infectious diseases, sterility and the appearance of other cancers through suppression of immune surveillance. These risks must be balanced with potential benefits of therapy.

Usual Adult Dose for Kaposi's Sarcoma:

Initial Dose: 3.7 mg/m2 intravenously over approximately one minute, once.

Because of the variation in the depth of the leukopenic response following therapy, the manufacturer recommends that vinblastine not be given more frequently than once every 7 days. However, there are several multiple day regimens where the dose is split into several consecutive days.

The manufacturer outlines the following conservative incremental approach to dosage at weekly intervals for adults. Therapy may be continued at 5.5 mg/m2 for the second dose, 7.4 mg/m2 for the third dose, 9.25 mg/m2 for the fourth dose, and 11.1 mg/m2 for the fifth dose. This progression may be followed up to a maximum dosage of 18.5 mg/m2. Dosage regimens may vary in clinical practice according to the disease being treated and the combination of antineoplastic agents being used.

White blood cell counts should be obtained just prior to dosage administration. The nadir in the white blood cell count is generally observed from 5 to 10 days following the dosage. Recovery to pretreatment levels is usually observed from 7 to 14 days after treatment. If a dose reduces the white cell count to approximately 3,000 cells/mm3, the next dose should not be given until the white cell count has returned to at least 4,000/mm3. The previous dosage increment may then be administered at weekly intervals for maintenance. In some cases, oncolytic activity may be encountered before leukopenic effect. When this occurs, there is no need to increase subsequent doses.

The manufacturer states that the use of small amounts of vinblastine daily for long periods of time is not advisable and that strict adherence to the recommended dosage schedule is very important.

The duration of maintenance therapy varies according to the disease being treated and the combination of antineoplastic agents being used. Prolonged chemotherapy for maintaining remissions involves several risks, including life-threatening infectious diseases, sterility and the appearance of other cancers through suppression of immune surveillance. These risks must be balanced with potential benefits of therapy.

Usual Adult Dose for Testicular Cancer:

Initial Dose: 3.7 mg/m2 intravenously over approximately one minute, once.

Because of the variation in the depth of the leukopenic response following therapy, the manufacturer recommends that vinblastine not be given more frequently than once every 7 days. However, there are several multiple day regimens where the dose is split into several consecutive days.

The manufacturer outlines the following conservative incremental approach to dosage at weekly intervals for adults. Therapy may be continued at 5.5 mg/m2 for the second dose, 7.4 mg/m2 for the third dose, 9.25 mg/m2 for the fourth dose, and 11.1 mg/m2 for the fifth dose. This progression may be followed up to a maximum dosage of 18.5 mg/m2. Dosage regimens may vary in clinical practice according to the disease being treated and the combination of antineoplastic agents being used.

White blood cell counts should be obtained just prior to dosage administration. The nadir in the white blood cell count is generally observed from 5 to 10 days following the dosage. Recovery to pretreatment levels is usually observed from 7 to 14 days after treatment. If a dose reduces the white cell count to approximately 3,000 cells/mm3, the next dose should not be given until the white cell count has returned to at least 4,000/mm3. The previous dosage increment may then be administered at weekly intervals for maintenance. In some cases, oncolytic activity may be encountered before leukopenic effect. When this occurs, there is no need to increase subsequent doses.

The manufacturer states that the use of small amounts of vinblastine daily for long periods of time is not advisable and that strict adherence to the recommended dosage schedule is very important.

The duration of maintenance therapy varies according to the disease being treated and the combination of antineoplastic agents being used. Prolonged chemotherapy for maintaining remissions involves several risks, including life-threatening infectious diseases, sterility and the appearance of other cancers through suppression of immune surveillance. These risks must be balanced with potential benefits of therapy.

Usual Adult Dose for Hodgkin's Disease:

Initial Dose: 3.7 mg/m2 intravenously over approximately one minute, once.

Because of the variation in the depth of the leukopenic response following therapy, the manufacturer recommends that vinblastine not be given more frequently than once every 7 days. However, there are several multiple day regimens where the dose is split into several consecutive days.

The manufacturer outlines the following conservative incremental approach to dosage at weekly intervals for adults. Therapy may be continued at 5.5 mg/m2 for the second dose, 7.4 mg/m2 for the third dose, 9.25 mg/m2 for the fourth dose, and 11.1 mg/m2 for the fifth dose. This progression may be followed up to a maximum dosage of 18.5 mg/m2. Dosage regimens may vary in clinical practice according to the disease being treated and the combination of antineoplastic agents being used.

White blood cell counts should be obtained just prior to dosage administration. The nadir in the white blood cell count is generally observed from 5 to 10 days following the dosage. Recovery to pretreatment levels is usually observed from 7 to 14 days after treatment. If a dose reduces the white cell count to approximately 3,000 cells/mm3, the next dose should not be given until the white cell count has returned to at least 4,000/mm3. The previous dosage increment may then be administered at weekly intervals for maintenance. In some cases, oncolytic activity may be encountered before leukopenic effect. When this occurs, there is no need to increase subsequent doses.

The manufacturer states that the use of small amounts of vinblastine daily for long periods of time is not advisable and that strict adherence to the recommended dosage schedule is very important.

The duration of maintenance therapy varies according to the disease being treated and the combination of antineoplastic agents being used. Prolonged chemotherapy for maintaining remissions involves several risks, including life-threatening infectious diseases, sterility and the appearance of other cancers through suppression of immune surveillance. These risks must be balanced with potential benefits of therapy.

Usual Adult Dose for Mycosis Fungoides:

Initial Dose: 3.7 mg/m2 intravenously over approximately one minute, once.

Because of the variation in the depth of the leukopenic response following therapy, the manufacturer recommends that vinblastine not be given more frequently than once every 7 days. However, there are several multiple day regimens where the dose is split into several consecutive days.

The manufacturer outlines the following conservative incremental approach to dosage at weekly intervals for adults. Therapy may be continued at 5.5 mg/m2 for the second dose, 7.4 mg/m2 for the third dose, 9.25 mg/m2 for the fourth dose, and 11.1 mg/m2 for the fifth dose. This progression may be followed up to a maximum dosage of 18.5 mg/m2. Dosage regimens may vary in clinical practice according to the disease being treated and the combination of antineoplastic agents being used.

White blood cell counts should be obtained just prior to dosage administration. The nadir in the white blood cell count is generally observed from 5 to 10 days following the dosage. Recovery to pretreatment levels is usually observed from 7 to 14 days after treatment. If a dose reduces the white cell count to approximately 3,000 cells/mm3, the next dose should not be given until the white cell count has returned to at least 4,000/mm3. The previous dosage increment may then be administered at weekly intervals for maintenance. In some cases, oncolytic activity may be encountered before leukopenic effect. When this occurs, there is no need to increase subsequent doses.

The manufacturer states that the use of small amounts of vinblastine daily for long periods of time is not advisable and that strict adherence to the recommended dosage schedule is very important.

The duration of maintenance therapy varies according to the disease being treated and the combination of antineoplastic agents being used. Prolonged chemotherapy for maintaining remissions involves several risks, including life-threatening infectious diseases, sterility and the appearance of other cancers through suppression of immune surveillance. These risks must be balanced with potential benefits of therapy.

Usual Adult Dose for Choriocarcinoma:

Initial Dose: 3.7 mg/m2 intravenously over approximately one minute, once.

Because of the variation in the depth of the leukopenic response following therapy, the manufacturer recommends that vinblastine not be given more frequently than once every 7 days. However, there are several multiple day regimens where the dose is split into several consecutive days.

The manufacturer outlines the following conservative incremental approach to dosage at weekly intervals for adults. Therapy may be continued at 5.5 mg/m2 for the second dose, 7.4 mg/m2 for the third dose, 9.25 mg/m2 for the fourth dose, and 11.1 mg/m2 for the fifth dose. This progression may be followed up to a maximum dosage of 18.5 mg/m2. Dosage regimens may vary in clinical practice according to the disease being treated and the combination of antineoplastic agents being used.

White blood cell counts should be obtained just prior to dosage administration. The nadir in the white blood cell count is generally observed from 5 to 10 days following the dosage. Recovery to pretreatment levels is usually observed from 7 to 14 days after treatment. If a dose reduces the white cell count to approximately 3,000 cells/mm3, the next dose should not be given until the white cell count has returned to at least 4,000/mm3. The previous dosage increment may then be administered at weekly intervals for maintenance. In some cases, oncolytic activity may be encountered before leukopenic effect. When this occurs, there is no need to increase subsequent doses.

The manufacturer states that the use of small amounts of vinblastine daily for long periods of time is not advisable and that strict adherence to the recommended dosage schedule is very important.

The duration of maintenance therapy varies according to the disease being treated and the combination of antineoplastic agents being used. Prolonged chemotherapy for maintaining remissions involves several risks, including life-threatening infectious diseases, sterility and the appearance of other cancers through suppression of immune surveillance. These risks must be balanced with potential benefits of therapy.

Usual Adult Dose for Lymphoma:

Initial Dose: 3.7 mg/m2 intravenously over approximately one minute, once.

Because of the variation in the depth of the leukopenic response following therapy, the manufacturer recommends that vinblastine not be given more frequently than once every 7 days. However, there are several multiple day regimens where the dose is split into several consecutive days.

The manufacturer outlines the following conservative incremental approach to dosage at weekly intervals for adults. Therapy may be continued at 5.5 mg/m2 for the second dose, 7.4 mg/m2 for the third dose, 9.25 mg/m2 for the fourth dose, and 11.1 mg/m2 for the fifth dose. This progression may be followed up to a maximum dosage of 18.5 mg/m2. Dosage regimens may vary in clinical practice according to the disease being treated and the combination of antineoplastic agents being used.

White blood cell counts should be obtained just prior to dosage administration. The nadir in the white blood cell count is generally observed from 5 to 10 days following the dosage. Recovery to pretreatment levels is usually observed from 7 to 14 days after treatment. If a dose reduces the white cell count to approximately 3,000 cells/mm3, the next dose should not be given until the white cell count has returned to at least 4,000/mm3. The previous dosage increment may then be administered at weekly intervals for maintenance. In some cases, oncolytic activity may be encountered before leukopenic effect. When this occurs, there is no need to increase subsequent doses.

The manufacturer states that the use of small amounts of vinblastine daily for long periods of time is not advisable and that strict adherence to the recommended dosage schedule is very important.

The duration of maintenance therapy varies according to the disease being treated and the combination of antineoplastic agents being used. Prolonged chemotherapy for maintaining remissions involves several risks, including life-threatening infectious diseases, sterility and the appearance of other cancers through suppression of immune surveillance. These risks must be balanced with potential benefits of therapy.

Usual Adult Dose for Histiocytosis:

Initial Dose: 3.7 mg/m2 intravenously over approximately one minute, once.

Because of the variation in the depth of the leukopenic response following therapy, the manufacturer recommends that vinblastine not be given more frequently than once every 7 days. However, there are several multiple day regimens where the dose is split into several consecutive days.

The manufacturer outlines the following conservative incremental approach to dosage at weekly intervals for adults. Therapy may be continued at 5.5 mg/m2 for the second dose, 7.4 mg/m2 for the third dose, 9.25 mg/m2 for the fourth dose, and 11.1 mg/m2 for the fifth dose. This progression may be followed up to a maximum dosage of 18.5 mg/m2. Dosage regimens may vary in clinical practice according to the disease being treated and the combination of antineoplastic agents being used.

White blood cell counts should be obtained just prior to dosage administration. The nadir in the white blood cell count is generally observed from 5 to 10 days following the dosage. Recovery to pretreatment levels is usually observed from 7 to 14 days after treatment. If a dose reduces the white cell count to approximately 3,000 cells/mm3, the next dose should not be given until the white cell count has returned to at least 4,000/mm3. The previous dosage increment may then be administered at weekly intervals for maintenance. In some cases, oncolytic activity may be encountered before leukopenic effect. When this occurs, there is no need to increase subsequent doses.

The manufacturer states that the use of small amounts of vinblastine daily for long periods of time is not advisable and that strict adherence to the recommended dosage schedule is very important.

The duration of maintenance therapy varies according to the disease being treated and the combination of antineoplastic agents being used. Prolonged chemotherapy for maintaining remissions involves several risks, including life-threatening infectious diseases, sterility and the appearance of other cancers through suppression of immune surveillance. These risks must be balanced with potential benefits of therapy.

Usual Pediatric Dose for Malignant Disease:

Hodgkin's disease: 2.5 to 6 mg/m2/day once every one to two weeks for three to six weeks. The maximum weekly dose is 12.5 mg/m2.

Histiocytosis: 0.4 mg/kg once every seven to ten days.

Germ cell tumor: 0.2 mg/kg on days one and two of the cycle every three weeks for four cycles.


What other drugs will affect vinblastine?


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



  • conivaptan (Vaprisol);




  • diclofenac (Arthrotec, Cataflam, Voltaren, Flector Patch, Solareze);




  • imatinib (Gleevec);




  • isoniazid (for treating tuberculosis);




  • phenytoin (Dilantin);




  • an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or telithromycin (Ketek);




  • antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);




  • an antidepressant such as nefazodone;




  • heart or blood pressure medication such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;




  • cancer medicines such as cisplatin (Platinol), carboplatin (Paraplatin), mitomycin (Mutamycin), or oxaliplatin (Elixatin);




  • HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir).



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



More vinblastine resources


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


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

  • Velban Monograph (AHFS DI)

  • Vinblastine Prescribing Information (FDA)

  • Vinblastine MedFacts Consumer Leaflet (Wolters Kluwer)



Compare vinblastine with other medications


  • Breast Cancer
  • Cancer
  • Choriocarcinoma
  • Histiocytosis
  • Hodgkin's Lymphoma
  • Kaposi's Sarcoma
  • Lymphoma
  • Mycosis Fungoides
  • Testicular Cancer


Where can I get more information?


  • Your doctor or pharmacist can provide more information about vinblastine.

See also: vinblastine side effects (in more detail)


Sunday, June 3, 2012

D-GAM, Solution for Injection 1,500 and 2,500iu vials





1. Name Of The Medicinal Product



D-GAM ®, Human Anti-D Immunoglobulin, 1,500 and 2,500 IU, solution for injection.


2. Qualitative And Quantitative Composition



Each vial contains either 1500 IU or 2500 IU human Anti-D immunoglobulin



One mL contains 1250 IU/mL human Anti-D immunoglobulin.



*100 micrograms of human anti-D immunoglobulin correspond to 500 international units (IU).



Human protein content 20 - 180 g/L of which at least 95% is IgG.



For excipients see 6.1.



3. Pharmaceutical Form



A solution for injection.



4. Clinical Particulars



4.1 Therapeutic Indications



Prevention of RhD immunisation in RhD negative women:



i. Pregnancy/delivery of a RhD positive baby.



ii. Abortion/threatened abortion, ectopic pregnancy or hydatidiform mole.



iii. After ante-partum haemorrhage (APH), amniocentesis, chorionic biopsy or obstetric manipulative procedure e.g. external version, or abdominal trauma, which may cause transplacental haemorrhage (TPH).



Treatment of RhD negative patients after transfusions of RhD positive blood or other products containing RhD positive red blood cells (e.g. platelets).



4.2 Posology And Method Of Administration



Posology



a) Post-Natal Dosage:



The recommended dose is 500 IU.



For postnatal use, the product should be administered as soon as possible within 72 hours of delivery.



If a large fetomaternal haemorrhage is suspected, its extent should be determined by a suitable method and additional doses of anti-D should be administered as indicated.



b) Ante-Natal Prophylaxis:



A single dose of 1,500 IU at 28 weeks of gestation, or



500 IU given at both 28 and 34 weeks of gestation.



c) Following a Potentially Sensitising Event During Pregnancy:



D-GAM ® should be administered as soon as possible and no later than 72 hours after the event.



Up to 20 weeks gestation: recommended dose is 250 IU per incident.



After 20 weeks gestation: recommended dose is 500 IU per incident. A test for the size of the FMH should be performed when anti-D is given after 20 weeks and additional doses of anti-D should be administered as indicated.



d) Prevention of Immunisation in RhD Negative Patients Given Blood Components Containing RhD Positive Cells:



Recommended doses: 125 IU per mL of transfused RhD positive red cells; 250 IU per three adult doses of platelets.



Method of administration



For intramuscular use (preferably into the deltoid muscle).



D-GAM ® vials are for single use only.



In the case of haemorrhagic disorders, where intramuscular injections are contra-indicated, Anti-D immunoglobulin may be administered subcutaneously. Careful manual pressure with a compress should be applied to the site after injection.



If large total doses (>5 mL) are required, it is advisable to administer them in divided doses at different sites.



4.3 Contraindications



Hypersensitivity to any of the components.



4.4 Special Warnings And Precautions For Use



Do not administer this product intravenously (risk of shock).



In the case of post-partum use, the product is intended for maternal administration. It should not be given to the newborn infant.



The product is not intended for use in RhD positive individuals.



Patients should be observed for at least 20 minutes after administration.



If symptoms of allergic or anaphylactic type reactions occur, immediate discontinuation of the administration is required.



True hypersensitivity reactions are rare but allergic type responses to Anti-D immunoglobulin may occur. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. The treatment required depends on the nature and severity of the side effect. In case of shock, the current medical standards for shock treatment should be observed.



D-GAM ® contains a small quantity of IgA. Although anti-D immunoglobulin has been used successfully to treat selected IgA deficient individuals, the attending physician must weigh the benefit against the potential risks of hypersensitivity reactions. Individuals deficient in IgA have a potential for development of IgA antibodies and anaphylactic reactions after administration of blood components containing IgA.



Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.



The viral removal/inactivation procedures may be of limited value against non-enveloped viruses such as hepatitis A virus or parvovirus B19.



In the interest of patients, it is recommended that, whenever possible, every time that D-GAM ® is administered to them, the name and batch number of the product is registered.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



Active immunisation with live virus vaccines (e.g. measles, mumps or rubella) should be postponed until 3 months after the administration of Anti-D immunoglobulin, as the efficacy of the live virus vaccine may be impaired. If Anti-D immunoglobulin needs to be administered within 2-4 weeks of a live virus vaccination, then the efficacy of such a vaccination may be impaired.



After injection of immunoglobulin, the transitory rise of the various passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing.



The results of blood typing and antibody testing, including the Coombs' or antiglobulin test, are significantly affected by the administration of anti-D immunoglobulin.



4.6 Pregnancy And Lactation



This medicinal product is used in pregnancy.



4.7 Effects On Ability To Drive And Use Machines



No effects on ability to drive and use machines have been observed.



4.8 Undesirable Effects



Local pain and tenderness can be observed at the injection site; this can be prevented by dividing larger doses over several injection sites.



The following side effects are known to be associated with Anti-D (the incidence has not been quantified): Occasionally fever, malaise, headache, cutaneous reactions and chills occur. In rare cases: nausea, vomiting, hypotension, tachycardia and allergic or anaphylactic type reactions, including dyspnoea and shock, are reported, even when the patient has shown no hypersensitivity to previous administration.



For information on viral safety see 4.4.



4.9 Overdose



No data are available on overdosage. RhD negative patients who are given RhD positive blood or other products containing RhD positive red blood cells and receive anti-D immunoglobulin should be monitored clinically and by biological parameters, because of the risk of haemolytic reaction.



In other RhD negative individuals, overdosage should not lead to more frequent or more severe undesirable effects than the normal dose.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Pharmacotherapeutic group: immune sera and immunoglobulins: Anti-D (Rh) immunoglobulin. ATC code: J06B B01.



Anti-D immunoglobulin contains specific antibodies (IgG) against the RhD antigen of human erythrocytes.



5.2 Pharmacokinetic Properties



Measurable levels of antibodies are obtained approximately 8 hours after intramuscular injection. Peak serum levels are usually achieved 2 to 4 days later.



The half-life in the circulation of individuals with normal IgG levels is 3 to 5 weeks.



IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.



5.3 Preclinical Safety Data



D-GAM ® is a preparation of human plasma proteins, so safety testing in animals is not particularly relevant to the safety of use in man. Acute toxicity studies in rat and mouse showed species specific reactions, which bear no relevance to administration in humans.



Repeated dose safety testing is impracticable due to the induction of and interference with antibodies to human protein. Clinical experience provides no sign of tumourigenic and mutagenic effects.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Sodium chloride



Glycine



Sodium acetate trihydrate



Sodium hydroxide



6.2 Incompatibilities



This medicinal product must not be mixed with other medicinal products.



6.3 Shelf Life








Stored at 2° - 8°C:




2 years.




Stored at 25°C:




1 week.



6.4 Special Precautions For Storage



D-GAM ® should be stored in the original container at 2°C to 8°C. Storage for up to one week at ambient temperatures (25°C) in the original container is not detrimental. DO NOT FREEZE.



The condition of date-expired, or incorrectly stored product cannot be guaranteed. Such product may be unsafe, and should not be used.



6.5 Nature And Contents Of Container



Neutral borosilicate glass vial (Type I Ph.Eur.) with overseal consisting of a halobutyl rubber wad (Type I Ph.Eur.), clear lacquered aluminium skirt and flip-off polypropylene cap.



6.6 Special Precautions For Disposal And Other Handling



The product should be brought to room or body temperature before use.



The solution should be clear or slightly opalescent. Do not use solutions which are cloudy or have deposits.



Any unused product or waste material should be disposed of in accordance with local requirements.



7. Marketing Authorisation Holder



Bio Products Laboratory



Dagger Lane



Elstree



Hertfordshire



WD6 3BX



United Kingdom.



8. Marketing Authorisation Number(S)



PL 08801/0049 - 1,500 IU and 2,500 IU dose sizes.



9. Date Of First Authorisation/Renewal Of The Authorisation



31 July 2000



10. Date Of Revision Of The Text








11th August 2011




Version Code: SDS5C




POM




 



 


Epi-Stat


Generic Name: barium sulfate (Oral route, Rectal route)


BAR-ee-um SUL-fate


Commonly used brand name(s)

In the U.S.


  • Bar-Test

  • E-Z-Disk

  • Readi-Cat

  • Volumen

In Canada


  • Acb

  • Baro-Cat

  • Barosperse Enema

  • Colobar-100

  • Epi-C

  • Epi-Stat

  • Esobar

  • Esopho-Cat Esophageal Cream

  • E-Z-Cat

  • E-Z-Hd

  • E-Z-Jug

  • E-Z-Paque

Available Dosage Forms:


  • Kit

  • Suspension

  • Powder for Suspension

  • Enema

  • Paste

  • Tablet

  • Liquid

Therapeutic Class: Diagnostic Agent, Radiological Contrast Media


Uses For Epi-Stat


Barium sulfate is a radiopaque agent. Radiopaque agents are used to help diagnose certain medical problems. Since radiopaque agents are opaque to (block) x-rays, the areas of the body in which they are localized will appear white on the x-ray film. This creates the needed distinction, or contrast, between one organ and other tissues. The contrast will help the doctor see any special conditions that may exist in that organ or part of the body.


Barium sulfate is taken by mouth or given rectally by enema. If taken by mouth, it makes the esophagus, the stomach, and/or the small intestine opaque to the x-rays so that they can be "photographed". If it is given by enema, the colon and/or the small intestine can be seen and photographed by x-rays.


The dose of barium sulfate will be different for different patients and depends on the type of test. The strength of the suspension and tablet is determined by how much barium they contain. Different tests will require a different strength and amount of suspension (some may require the tablet form), depending on the age of the patient, the contrast needed, and the x-ray equipment used.


Barium sulfate is to be used only by or under the direct supervision of a doctor.


Before Using Epi-Stat


In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, the following should be considered:


Allergies


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


Pediatric


Although there is no specific information comparing use of barium sulfate in children with use in other age groups, this agent is not expected to cause different side effects or problems in children than it does in adults.


Geriatric


This contrast agent has been used in older people and has not been shown to cause different side effects or problems in them than it does in younger adults.


Interactions with Medicines


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


Interactions with Food/Tobacco/Alcohol


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


Other Medical Problems


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


  • Asthma, hay fever, or other allergies (history of)—If you have a history of these conditions, the risk of having a reaction, such as an allergic reaction to the additives in the barium sulfate preparation, is greater

  • Cystic fibrosis—The risk of blockage in the small bowel is greater

  • Dehydration—Barium sulfate may cause severe constipation

  • Intestinal blockage or perforation—Barium sulfate may make this condition worse

Proper Use of barium sulfate

This section provides information on the proper use of a number of products that contain barium sulfate. It may not be specific to Epi-Stat. Please read with care.


Dosing


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


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


Precautions While Using Epi-Stat


Make sure to drink plenty of liquids after the test. Otherwise, barium sulfate may cause severe constipation.


Epi-Stat 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:


Rare
  • Bloating

  • constipation (severe, continuing)

  • cramping (severe)

  • nausea or vomiting

  • stomach or lower abdominal pain

  • tightness in chest or troubled breathing

  • wheezing

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
  • Constipation or diarrhea

  • cramping

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: Epi-Stat side effects (in more detail)



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


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


More Epi-Stat resources


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


Compare Epi-Stat with other medications


  • Computed Tomography

Saturday, June 2, 2012

Femcon Fe Chewable Tablets


Pronunciation: nor-ETH-in-drone/ETH-i-nil ES-tra-DYE-ol/FER-us FUE-ma-rate
Generic Name: Norethindrone/Ethinyl Estradiol
Brand Name: Femcon Fe

Smoking cigarettes while using Femcon Fe Chewable Tablets increases your chance of having heart problems. Do not smoke while using Femcon Fe Chewable Tablets. The risk of heart problems increases with age and with frequent smoking. Women older than 35 years old and women who smoke 15 or more cigarettes per day are at a greater risk for heart problems.





Femcon Fe Chewable Tablets are used for:

Preventing pregnancy. It may be used for other conditions as determined by your doctor.


Femcon Fe Chewable Tablets are a combination progesterone and estrogen birth control pill. It works by preventing ovulation, altering the cervical mucus, and changing the lining of the uterus.


Do NOT use Femcon Fe Chewable Tablets if:


  • you are allergic to any ingredient in Femcon Fe Chewable Tablets

  • you are pregnant or think you may be pregnant

  • you have a history of blood clotting problems, severe blood clots (eg, in the lungs, legs, eyes), certain blood vessel problems (eg, bleeding in the brain, heart attack, stroke), or breast cancer

  • you are at risk for developing severe blood clots or have certain heart problems (eg, certain heart valve problems, certain types of irregular heartbeat)

  • you have chest pain caused by angina; certain types of headaches or migraines with aura; severe or uncontrolled high blood pressure; endometrial, cervical, or vaginal cancer; estrogen-dependent growths; undiagnosed abnormal vaginal bleeding; diabetes that affects circulation

  • you have liver disease, liver tumors or cancer, or a history of yellowing of the eyes or skin caused by pregnancy or prior birth control use

  • you have had surgery and are or will be confined to a bed or a chair for an extended period of time

  • you are older than 35 years old and you smoke 15 or more cigarettes per day

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



Before using Femcon Fe Chewable Tablets:


Some medical conditions may interact with Femcon Fe Chewable Tablets. 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 endometriosis, growths in the uterus, abnormal mammogram, irregular menstrual periods, or a lump in the breast

  • if you have heart problems, diabetes, headaches or migraines, gallbladder problems, high blood cholesterol or lipid levels, high blood pressure, kidney problems, blood problems (eg, porphyria), blood in the urine, depression or other mental/mood problems, lupus, chorea, high blood calcium levels, yellowing of the eyes or skin, pancreas problems (eg, pancreatitis), seizures (eg, epilepsy), or a history of cancer

  • if you are overweight, you have not yet had your first menstrual period, or you use tobacco

  • if you have given birth or otherwise ended a pregnancy within the past 4 weeks

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


  • Atorvastatin or troleandomycin because they may increase the risk of Femcon Fe Chewable Tablets's side effects

  • Acitretin, aprepitant, azole antifungals (eg, itraconazole, ketoconazole), barbiturates (eg, phenobarbital), bosentan, carbamazepine, dexamethasone, felbamate, griseofulvin, HIV protease inhibitors (eg, ritonavir), hydantoins (eg, phenytoin), modafinil, nevirapine, oxcarbazepine, penicillins (eg, amoxicillin), phenylbutazone, primidone, rifabutin, rifampin, rufinamide, St. John's wort, tetracyclines (eg, doxycycline), topiramate, or troglitazone because they may decrease Femcon Fe Chewable Tablets's effectiveness, resulting in breakthrough bleeding or pregnancy

  • Beta-blockers (eg, propranolol), corticosteroids (eg, prednisolone), cyclosporine, or theophylline because the risk of their side effects may be increased by Femcon Fe Chewable Tablets

  • Clofibric acid, lamotrigine, morphine, salicylic acid, temazepam, or valproic acid because their effectiveness may be decreased by Femcon Fe Chewable Tablets

  • Penicillamine or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by the ferrous fumarate tablets in Femcon Fe Chewable Tablets

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


Use Femcon Fe Chewable Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • An extra patient leaflet is available with Femcon Fe Chewable Tablets. Talk to your pharmacist if you have questions about this information.

  • Take Femcon Fe Chewable Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

  • Femcon Fe Chewable Tablets may be swallowed whole or chewed and swallowed. If you chew Femcon Fe Chewable Tablets, drink a full glass of water (8 oz/240 mL) right after you swallow it.

  • If you also take a bisphosphonate (eg, alendronate), do not take Femcon Fe Chewable Tablets within 2 hours after you take it.

  • If you also take cefdinir, eltrombopag, methyldopa, quinolone antibiotics (eg, levofloxacin), or tetracyclines (eg, doxycycline), you may need to separate them from the ferrous fumarate tablets. Ask your doctor or pharmacist how you should take them with Femcon Fe Chewable Tablets.

  • Begin taking Femcon Fe Chewable Tablets on the first Sunday following the start of your period, unless otherwise directed by your doctor. If your period begins on a Sunday, begin taking Femcon Fe Chewable Tablets on that day. Try to take Femcon Fe Chewable Tablets at the same time every day, not more than 24 hours apart. After taking the last pill in the pack, start taking the first pill from a new pack the very next day.

  • Femcon Fe Chewable Tablets may not be effective for up to 7 days after you begin taking the first cycle of pills. Use a back-up method of birth control for the first 7 days after you start Femcon Fe Chewable Tablets.

  • For Femcon Fe Chewable Tablets to be effective it must be taken every day. Do not skip doses.

  • If you vomit within 3 to 4 hours after you take Femcon Fe Chewable Tablets, follow the instructions for what to do if you miss a pill. If you have diarrhea, use a back-up method of birth control and talk with your doctor.

  • If you miss a dose of Femcon Fe Chewable Tablets and remember it on the same day, take it as soon as possible and go back to your regular dosing schedule. If you do not remember until the next day or if you miss more than 1 dose of Femcon Fe Chewable Tablets, see the additional patient information leaflet that comes with Femcon Fe Chewable Tablets or contact your doctor for further instructions. You may need to use an extra form of birth control (eg, condoms). If you are not sure about how to handle missed doses of Femcon Fe Chewable Tablets, use an extra form of birth control (eg, condoms) and talk with your doctor.

Ask your health care provider any questions you may have about how to use Femcon Fe Chewable Tablets.



Important safety information:


  • Femcon Fe Chewable Tablets may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Femcon Fe Chewable Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Follow your doctor's instructions for examining your own breasts, and report any lumps immediately.

  • If you will be having surgery or will be confined to a bed or chair for a long period of time (such as a long plane flight), notify your doctor 3 to 4 weeks ahead of time. Special precautions may need to be taken in these circumstances while taking Femcon Fe Chewable Tablets.

  • You should usually not take Femcon Fe Chewable Tablets within 4 weeks after giving birth. or otherwise ending a pregnancy. Discuss any questions or concerns with your doctor.

  • Femcon Fe Chewable Tablets may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or wear protective clothing when exposed to the sun, sunlamps, or tanning booths.

  • Use of Femcon Fe Chewable Tablets will not protect against HIV infection or prevent the spread of sexually transmitted diseases (STDs).

  • Bleeding or spotting may occur while taking Femcon Fe Chewable Tablets. Do not stop taking Femcon Fe Chewable Tablets if this occurs. If bleeding or spotting continues for more than 7 days or is heavy, contact your doctor.

  • Smoking while using Femcon Fe Chewable Tablets may increase your risk of stroke, heart attack, blood clots, high blood pressure, or other diseases of the heart and blood vessels.

  • Femcon Fe Chewable Tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Femcon Fe Chewable Tablets.

  • Taking certain antibiotics, anticonvulsants, or other medicines, as listed in the interactions section, while you are using Femcon Fe Chewable Tablets may decrease the effectiveness of Femcon Fe Chewable Tablets. To prevent pregnancy, use an extra form of birth control (eg, condoms) until your next period.

  • If you wear contact lenses and you develop problems with them, contact your doctor.

  • If you miss your period, call your doctor immediately. A missed period may indicate that you are pregnant.

  • Femcon Fe Chewable Tablets may take time to wear off after your last dose. You may not be able to become pregnant for several months after stopping Femcon Fe Chewable Tablets. Discuss any concerns with your doctor or pharmacist.

  • Lab tests, such as Pap tests, may be performed while you use Femcon Fe Chewable Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Femcon Fe Chewable Tablets should not be used in CHILDREN who have not had their first menstrual period; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY AND BREAST-FEEDING: Do not use Femcon Fe Chewable Tablets if you are pregnant. If you think you may be pregnant, contact your doctor right away. Femcon Fe Chewable Tablets are found in breast milk. Do not breast-feed while taking Femcon Fe Chewable Tablets.


Possible side effects of Femcon Fe Chewable Tablets:


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:



Breast tenderness or enlargement; changes in appetite; changes in weight; dizziness; hair loss; headache; nausea; stomach cramps or bloating; unusual spotting or bleeding; 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; unusual hoarseness); breast discharge; breast lumps; calf or leg pain, swelling, or tenderness; change in amount of urine produced; change in vaginal secretions; changes in vision or speech; confusion; coughing of blood; crushing chest pain or heaviness in the chest; dark-colored urine; depression; difficulty wearing contact lenses; fainting; fever; fluid retention (swelling of the fingers and ankles); light-colored bowel movements; mental or mood changes; missed menstrual period; numbness of an arm or leg; one-sided weakness; persistent or new headache or migraines; persistent or recurrent abnormal vaginal bleeding; persistent or severe dizziness; severe pain or tenderness in the stomach; shortness of breath; sudden partial or complete loss of vision; sudden severe headache or vomiting; unusual or persistent tiredness, lack of energy, or trouble sleeping; vaginal irritation or discharge; weakness; yellowing of the skin or eyes.



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


See also: Femcon Fe 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 nausea; vaginal bleeding; vomiting.


Proper storage of Femcon Fe Chewable Tablets:

Store Femcon Fe Chewable Tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Femcon Fe Chewable Tablets out of the reach of children and away from pets.


General information:


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

  • Femcon Fe Chewable Tablets are 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 Femcon Fe Chewable Tablets. 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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