Elite Iron

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

Commonly used brand name(s)

In the U.S.

• Beef,Iron & Wine


• Bifera


• Elite Iron


• Femiron


• Feosol


• Fergon


• Ferrex 150


• Hemocyte

In Canada

• Fer-In-Sol


• Palafer


• Pms-Ferrous Sulfate

Available Dosage Forms:

• Tablet, Chewable


• Liquid


• Tablet


• Capsule


• Solution


• Tablet, Enteric Coated


• Tablet, Extended Release


• Suspension


• Syrup


• Capsule, Extended Release


• Elixir


• Capsule, Liquid Filled

Uses For Elite Iron

Iron is a mineral that the body needs to produce red blood cells. When the body does not get enough iron, it cannot produce the number of normal red blood cells needed to keep you in good health. This condition is called iron deficiency (iron shortage) or iron deficiency anemia.

Although many people in the U.S. get enough iron from their diet, some must take additional amounts to meet their needs. For example, iron is sometimes lost with slow or small amounts of bleeding in the body that you would not be aware of and which can only be detected by your doctor. Your doctor can determine if you have an iron deficiency, what is causing the deficiency, and if an iron supplement is necessary.

Lack of iron may lead to unusual tiredness, shortness of breath, a decrease in physical performance, and learning problems in children and adults, and may increase your chance of getting an infection.

Some conditions may increase your need for iron. These include:

• Bleeding problems


• Burns


• Hemodialysis


• Intestinal diseases


• Stomach problems


• Stomach removal


• Use of medicines to increase your red blood cell count

In addition, infants, especially those receiving breast milk or low-iron formulas, may need additional iron.

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

Injectable iron is administered only by or under the supervision of your health care professional. Other forms of iron are available without a prescription; however, your health care professional may have special instructions on the proper use and dose for your condition.

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.

Iron is found in the diet in two forms—heme iron, which is well absorbed, and nonheme iron, which is poorly absorbed. The best dietary source of absorbable (heme) iron is lean red meat. Chicken, turkey, and fish are also sources of iron, but they contain less than red meat. Cereals, beans, and some vegetables contain poorly absorbed (nonheme) iron. Foods rich in vitamin C (e.g., citrus fruits and fresh vegetables), eaten with small amounts of heme iron-containing foods, such as meat, may increase the amount of nonheme iron absorbed from cereals, beans, and other vegetables. Some foods (e.g., milk, eggs, spinach, fiber-containing, coffee, tea) may decrease the amount of nonheme iron absorbed from foods. Additional iron may be added to food from cooking in iron pots.

The daily amount of iron 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 iron are generally defined as follows (Note that the RDA and RNI are expressed as an actual amount of iron, which is referred to as “elemental”' iron. The product form [e.g., ferrous fumarate, ferrous gluconate, ferrous sulfate] has a different strength):

Persons	U.S. (mg)	Canada (mg)
Infants birth to 3 years of age	6–10	0.3–6
Children 4 to 6 years of age	10	8
Children 7 to 10 years of age	10	8–10
Adolescent and adult males	10	8–10
Adolescent and adult females	10–15	8–13
Pregnant females	30	17–22
Breast-feeding females	15	8–13

Before Using Elite Iron

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. Iron supplements, when prescribed by your health care professional, are not expected to cause different side effects in children than they do in adults. However, it is important to follow the directions carefully, since iron overdose in children is especially dangerous.

Studies on sodium ferric gluconate have shown that this supplement is safe to use in children ages 6 to 15 years. The safety of sodium ferric gluconate has not been determined in patients who are younger than 6 years of age.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts. Elderly people sometimes do not absorb iron as easily as younger adults and may need a larger dose. If you think you need to take an iron supplement, check with your health care professional first. Only your health care professional can decide if you need an iron supplement and how much you should take.

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. Healthy fetal growth and development depend on a steady supply of nutrients from mother to fetus. During the first 3 months of pregnancy, a proper diet usually provides enough iron. However, during the last 6 months, in order to meet the increased needs of the developing baby, an iron supplement may be recommended by your health care professional.

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 especially 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. Iron normally is present in breast milk in small amounts. When prescribed by a health care professional, iron preparations are not known to cause problems during breast-feeding. However, nursing mothers are advised to check with their health care professional before taking iron supplements or any other medication. Taking large amounts of a dietary supplement while breast-feeding may be harmful to the mother and/or infant 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.

• Altretamine


• Amygdalin


• Deferoxamine


• Digoxin


• Eltrombopag


• Rilpivirine

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:

• Alcohol abuse (or history of) or


• Blood transfusions (with high red blood cell iron content) or


• Kidney infection or


• Liver disease or


• Porphyria cutaneous tarda—Higher blood levels of the iron supplement may occur, which may increase the chance of side effects.

• Arthritis (rheumatoid) or


• Asthma or allergies or


• Heart disease—The injected form of iron may make these conditions worse.

• Colitis or other intestinal problems or


• Iron overload conditions (e.g., hemochromatosis, hemosiderosis, hemoglobinopathies) or


• Stomach ulcer—Iron supplements may make these conditions worse.

• Other anemias—Iron supplements may increase iron to toxic levels in anemias not associated with iron deficiency.

Proper Use of iron supplement

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

After you start using this dietary supplement, continue to return to your health care professional to see if you are benefiting from the iron. Some blood tests may be necessary for this.

Iron is best absorbed when taken on an empty stomach, with water or fruit juice (adults: full glass or 8 ounces; children: ½ glass or 4 ounces), about 1 hour before or 2 hours after meals. However, to lessen the possibility of stomach upset, iron may be taken with food or immediately after meals.

For safe and effective use of iron supplements:

• Follow your health care professional's instructions if this dietary supplement was prescribed.


• Follow the manufacturer's package directions if you are treating yourself. If you think you still need iron after taking it for 1 or 2 months, check with your health care professional.

Liquid forms of iron supplement tend to stain the teeth. To prevent, reduce, or remove these stains:

• Mix each dose in water, fruit juice, or tomato juice. You may use a drinking tube or straw to help keep the iron supplement from getting on the teeth.


• When doses of liquid iron supplement are to be given by dropper, the dose may be placed well back on the tongue and followed with water or juice.


• Iron stains on teeth can usually be removed by brushing with baking soda (sodium bicarbonate) or medicinal peroxide (hydrogen peroxide 3%).

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, tablets, oral solution):
  
  • To prevent deficiency, the amount taken by mouth is based on normal daily recommended intakes:
    
    • For the U.S.
    
    
    • Adult and teenage males—10 milligrams (mg) per day.
    
    
    • Adult and teenage females—10 to 15 mg per day.
    
    
    • Pregnant females—30 mg per day.
    
    
    • Breast-feeding females—15 mg per day.
    
    
    • Children 7 to 10 years of age—10 mg per day.
    
    
    • Children 4 to 6 years of age—10 mg per day.
    
    
    • Children birth to 3 years of age—6 to 10 mg per day.
    
    
    • For Canada
    
    
    • Adult and teenage males—8 to 10 mg per day.
    
    
    • Adult and teenage females—8 to 13 mg per day.
    
    
    • Pregnant females—17 to 22 mg per day.
    
    
    • Breast-feeding females—8 to 13 mg per day.
    
    
    • Children 7 to 10 years of age—8 to 10 mg per day.
    
    
    • Children 4 to 6 years of age—8 mg per day.
    
    
    • Children birth to 3 years of age—0.3 to 6 mg per day.
    
    
  
  
  • To treat deficiency:
    
    • Adults, teenagers, and children— The dose will be determined by your doctor, based on your condition.
    
    
  
  


• For injection dosage forms:
  
  • Adults, teenagers, and children— The dose will be determined by your doctor, based on your condition.
  
  

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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 Elite Iron

When iron is combined with certain foods it may lose much of its value. If you are taking iron, the following foods should be avoided, or only taken in very small amounts, for at least 1 hour before or 2 hours after you take iron:

• Cheese and yogurt


• Eggs


• Milk


• Spinach


• Tea or coffee


• Whole-grain breads and cereals and bran

Do not take iron supplements and antacids or calcium supplements at the same time. It is best to space doses of these 2 products 1 to 2 hours apart, to get the full benefit from each medicine or dietary supplement.

If you are taking iron supplements without a prescription:

• Do not take iron supplements by mouth if you are receiving iron injections. To do so may result in iron poisoning.


• Do not regularly take large amounts of iron for longer than 6 months without checking with your health care professional. People differ in their need for iron, and those with certain medical conditions can gradually become poisoned by taking too much iron over a period of time. Also, unabsorbed iron can mask the presence of blood in the stool, which may delay discovery of a serious condition.

If you have been taking a long-acting or coated iron tablet and your stools have not become black, check with your health care professional. The tablets may not be breaking down properly in your stomach, and you may not be receiving enough iron.

It is important to keep iron preparations out of the reach of children. Keep a 1-ounce bottle of syrup of ipecac available at home to be taken in case of an iron overdose emergency when a doctor, poison control center, or emergency room orders its use.

If you think you or anyone else has taken an overdose of iron medicine:

• Call your doctor, a poison control center, or the nearest hospital emergency room at once. Always keep these phone numbers readily available.


• Follow any instructions given to you. If syrup of ipecac has been ordered and given, do not delay going to the emergency room while waiting for the ipecac syrup to empty the stomach, since it may require 20 to 30 minutes to show results


• Go to the emergency room without delay


• Take the container of iron with you.

Early signs of iron overdose may not appear for up to 60 minutes or more. Do not delay going to the emergency room while waiting for signs to appear.

Elite Iron Side Effects

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

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

More common - with injection only

• Backache , groin, side, or muscle pain


• chest pain


• chills


• dizziness


• fainting


• fast heartbeat


• fever with increased sweating


• flushing


• headache


• metallic taste


• nausea or vomiting


• numbness, pain, or tingling of hands or feet


• pain or redness at injection site


• redness of skin


• skin rash or hives


• swelling of mouth or throat


• troubled breathing

More common - when taken by mouth only

• Abdominal or stomach pain


• cramping (continuing) or soreness

Less common or rare - with injection only

• Double vision


• general unwell feeling


• weakness without feeling dizzy or faint

Less common or rare - when taken by mouth only

• Chest or throat pain, especially when swallowing


• stools with signs of blood (red or black color)

Early symptoms of iron overdose

Symptoms of iron overdose may not occur for up to 60 minutes or more after the overdose was taken. By this time you should have had emergency room treatment. Do not delay going to emergency room while waiting for signs to appear.

• Diarrhea (may contain blood)


• fever


• nausea


• stomach pain or cramping (sharp)


• vomiting, severe (may contain blood)

Late symptoms of iron overdose

• Bluish-colored lips, fingernails, and palms of hands


• convulsions (seizures)


• pale, clammy skin


• shallow and rapid breathing


• unusual tiredness or weakness


• weak and fast heartbeat

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


• diarrhea


• leg cramps


• nausea


• vomiting

Less common

Stools commonly become dark green or black when iron preparations are taken by mouth. This is caused by unabsorbed iron and is harmless. However, in rare cases, black stools of a sticky consistency may occur along with other side effects such as red streaks in the stool, cramping, soreness, or sharp pains in the stomach or abdominal area. Check with your health care professional immediately if these side effects appear.

If you have been receiving injections of iron, you may notice a brown discoloration of your skin. This color usually fades within several weeks or months.

• Darkened urine


• heartburn


• stained teeth

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

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

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

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

Nandrolone

Generic Name: Nandrolone (NAN-drole-ohn)
Brand Name: Generic only. No brands available.

Nandrolone may cause liver tumors or bloody cysts in the liver and spleen. If they occur, they will usually go away once you stop taking Nandrolone. However, you may not know that you have one of these tumors or cysts until severe, possibly life-threatening bleeding occurs in the abdomen.

Nandrolone may also cause a decrease in good cholesterol (HDL) and an increase in bad cholesterol (LDL). These changes in cholesterol may be severe and may seriously increase your risk of developing hardening of the arteries and heart disease.

Nandrolone is used for:

Managing anemia caused by kidney problems. It may also be used to treat other conditions as determined by your doctor.

Nandrolone is an anabolic steroid. It works by increasing the growth of certain tissues in the body and has been shown to improve the oxygen-carrying ability of blood by increasing hemoglobin and the size of red blood cells.

Do NOT use Nandrolone if:

• you are allergic to any ingredient in Nandrolone


• you are pregnant or planning to become pregnant


• you have prostate cancer or breast cancer, breast cancer with high calcium levels, or severe kidney damage

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

Before using Nandrolone:

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

• if you 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 an enlarged prostate, liver or heart disease, diabetes, swelling of the feet or ankles, or high blood calcium levels

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

• Anticoagulants (eg, warfarin) or carbamazepine because actions and side effects may be increased by Nandrolone

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

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

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


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

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

Important safety information:

• Do not use Nandrolone to enhance physical appearance or athletic performance. This is dangerous and illegal.


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


• Diabetes patients - If you have diabetes, Nandrolone may affect your blood sugar. Check your blood sugar level closely and ask your doctor before adjusting the dose of your diabetes medicine.


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


• Nandrolone may cause bones in CHILDREN to mature quickly without the child growing taller. This may cause abnormal stature when your child reaches adulthood. Bone growth should be monitored every 6 months while your child on taking Nandrolone. Use Nandrolone with extreme caution in NEWBORNS and CHILDREN younger than 9 years of age. Safety and effectiveness in these age groups have not been confirmed.


• Men should contact their doctor if any of the following occurs: frequent or painful erections; acne.


• Women who use Nandrolone should contact their doctor if they notice increased body or facial hair growth, enlarged clitoris, acne, menstrual changes, or deepening of the voice.


• PREGNANCY and BREAST-FEEDING: Do not use Nandrolone if you are pregnant. If you suspect that you could be pregnant, contact your doctor immediately. It is unknown if Nandrolone is excreted in breast milk. Do not breast-feed while taking Nandrolone.

Possible side effects of Nandrolone:

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:

Ankle swelling; baldness; breast growth; change in skin color; diarrhea; excitement; increase or decrease in sex drive; nausea; sleeplessness; swelling of the feet or ankles; vomiting.

After puberty: bladder irritation; fertility problems; inability to achieve an erection; testicle problems.

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); acne, especially in women; behavior or emotional changes; dark urine; deepening of the voice in women; difficulty breathing, especially when lying down; enlarged sex organ (clitoris); increase in facial or body hair in women; menstrual changes; pain, redness, or swelling at the injection site; tenderness or swelling in the abdomen; yellowing of the skin or eyes.

Before puberty: increased frequency of erections; penile enlargement.

After puberty: frequent, painful erections.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

See also: Nandrolone 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 (http://www.aapcc.org/DNN/), or emergency room immediately.

Proper storage of Nandrolone:

Store Nandrolone at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly-closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Nandrolone out of the reach of children and away from pets.

General information:

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


• Nandrolone 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.

This information is a summary only. It does not contain all information about Nandrolone. 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 Nandrolone resources

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

• Nandrolone Prescribing Information (FDA)

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Elestat

Dosage Form: ophthalmic solution
FULL PRESCRIBING INFORMATION

Indications and Usage for Elestat

Elestat® ophthalmic solution is indicated for the prevention of itching associated with allergic conjunctivitis.

Elestat Dosage and Administration

The recommended dosage is one drop in each eye twice a day.

Treatment should be continued throughout the period of exposure (i.e., until the pollen season is over or until exposure to the offending allergen is terminated), even when symptoms are absent.

Dosage Forms and Strengths

Solution containing 0.5 mg/mL epinastine HCl

Contraindications

None

Warnings and Precautions

Contamination of Tip and Solution

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

Bottle should be kept tightly closed when not in use.

Use with Contact Lenses

Patients should be advised not to wear a contact lens if their eye is red. Elestat® ophthalmic solution should not be used to treat contact lens-related irritation.

The preservative in Elestat®, benzalkonium chloride, may be absorbed by soft contact lenses. Contact lenses should be removed prior to instillation of Elestat® ophthalmic solution and may be reinserted after 10 minutes following its administration.

Topical Ophthalmic Use Only

Elestat® is for topical ophthalmic use only and not for injection or oral use.

Adverse Reactions

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

The most frequently reported ocular adverse reactions occurring in approximately 1-10% of patients were burning sensation in the eye, folliculosis, hyperemia, and pruritus.

The most frequently reported non-ocular adverse reactions were infection (cold symptoms and upper respiratory infections), seen in approximately 10% of patients, and headache, rhinitis, sinusitis, increased cough, and pharyngitis, seen in approximately 1 - 3% of patients.

Some of these reactions were similar to the underlying disease being studied.

Postmarketing Experience

The following reactions have been identified during postmarketing use of Elestat® in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to Elestat®, or a combination of these factors, include: lacrimation increased.

USE IN SPECIFIC POPULATIONS

Pregnancy

Teratogenic Effects

Pregnancy Category C

In an embryofetal developmental study in pregnant rats, maternal toxicity with no embryofetal effects was observed at an oral dose that was approximately 150,000 times the maximum recommended ocular human dose (MROHD) of 0.0014 mg/kg/day on a mg/kg basis. Total resorptions and abortion were observed in an embryofetal study in pregnant rabbits at an oral dose that was approximately 55,000 times the MROHD. In both studies, no drug-induced teratogenic effects were noted.

Epinastine reduced pup body weight gain following an oral dose to pregnant rats that was approximately 90,000 times the MROHD.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Elestat® ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

A study in lactating rats revealed excretion of epinastine in the breast milk. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Elestat® ophthalmic solution is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 2 years have not been established.

Geriatric Use

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

Elestat Description

Elestat® (epinastine HCl ophthalmic solution) 0.05% is a clear, colorless, sterile isotonic solution containing epinastine HCl, an antihistamine and an inhibitor of histamine release from the mast cell for topical administration to the eyes.

Epinastine HCl is represented by the following structural formula:

Chemical Name:

3-Amino-9,13b-dihydro-1H-dibenz[c,f]imidazo[1,5-a]azepine hydrochloride

Each mL contains: Active: Epinastine HCl 0.05% (0.5 mg/mL) equivalent to epinastine 0.044% (0.44 mg/mL); Preservative: Benzalkonium chloride 0.01%; Inactives: Edetate disodium; purified water; sodium chloride; sodium phosphate, monobasic; and sodium hydroxide and/or hydrochloric acid (to adjust pH). Elestat® has a pH of approximately 7 and an osmolality range of 250 to 310 mOsm/kg.

Elestat - Clinical Pharmacology

Mechanism of Action

Epinastine is a topically active, direct H1-receptor antagonist and an inhibitor of the release of histamine from the mast cell. Epinastine is selective for the histamine H1-receptor and has affinity for the histamine H2-receptor. Epinastine also possesses affinity for the α1, α 2-, and 5-HT2–receptors.

Pharmacokinetics

Fourteen subjects, with allergic conjunctivitis, received one drop of Elestat® ophthalmic solution in each eye twice daily for 7 days. On day 7, average maximum epinastine plasma concentrations of 0.04±0.014 ng/ml were reached after about two hours indicating low systemic exposure. While these concentrations represented an increase over those seen following a single dose, the day 1 and day 7 Area Under the Curve (AUC) values were unchanged indicating that there is no increase in systemic absorption with multiple dosing. Epinastine is 64% bound to plasma proteins. The total systemic clearance is approximately 56 L/hr and the terminal plasma elimination half-life is about 12 hours. Epinastine is mainly excreted unchanged. About 55% of an intravenous dose is recovered unchanged in the urine with about 30% in feces. Less than 10% is metabolized. The renal elimination is mainly via active tubular secretion.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

In 18-month or 2-year dietary carcinogenicity studies in mice or rats, respectively, epinastine was not carcinogenic at doses up to 40 mg/kg [approximately 30,000 times higher than the MROHD, assuming 100% absorption in humans and animals].

Epinastine in newly synthesized batches was negative for mutagenicity in the Ames/Salmonella assay and in vitro chromosome aberration assay using human lymphocytes. Positive results were seen with early batches of epinastine in two in vitro chromosomal aberration studies conducted in 1980s with human peripheral lymphocytes and with V79 cells, respectively. Epinastine was negative in the in vivo clastogenicity studies, including the mouse micronucleus assay and chromosome aberration assay in Chinese hamsters. Epinastine was also negative in the cell transformation assay using Syrian hamster embryo cells, V79/HGPRT mammalian cell point mutation assay, and in vivo/in vitro unscheduled DNA synthesis assay using rat primary hepatocytes.

Epinastine had no effect on fertility of male rats. Decreased fertility in female rats was observed at an oral dose up to approximately 90,000 times the MROHD.

Clinical Studies

Epinastine HCl 0.05% has been shown to be significantly superior to vehicle for improving ocular itching in patients with allergic conjunctivitis in clinical studies using two different models: (1) conjunctival antigen challenge (CAC) where patients were dosed and then received antigen instilled into the inferior conjunctival fornix; and (2) environmental field studies where patients were dosed and evaluated during allergy season in their natural habitat. Results demonstrated a rapid onset of action for epinastine HCl 0.05% within 3 to 5 minutes after conjunctival antigen challenge. Duration of effect was shown to be 8 hours, making a twice daily regimen suitable. This dosing regimen was shown to be safe and effective for up to 8 weeks, without evidence of tachyphylaxis.

How Supplied/Storage and Handling

Elestat® (epinastine HCl ophthalmic solution) 0.05% is supplied sterile in opaque white LDPE plastic bottles with dropper tips and white high impact polystyrene (HIPS) caps as follows:

5 mL in 10 mL bottle                  NDC 0023-9201-05

Storage: Store at 15º-25ºC (59º-77ºF). Keep bottle tightly closed and out of the reach of children.

Patient Counseling Information

Sterility of Dropper Tip

Patients should be advised not to touch dropper tip to any surface, as this may contaminate the contents (see WARNINGS AND PRECAUTIONS, 5.1).

Concomitant Use of Contact Lenses

Patients should be advised not to wear a contact lens if their eye is red. Patients should be advised that Elestat® should not be used to treat contact lens-related irritation. Patients should also be advised to remove contact lenses prior to instillation of Elestat®. The preservative in Elestat®, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of Elestat®.

Topical Ophthalmic Use Only

For topical ophthalmic administration only.

Rx only

© 2012 Allergan, Inc.

Irvine, CA 92612, U.S.A.

Allergan corporate signature logo is a registered trademark of Allergan, Inc.

Elestat is a registered trademark of Boehringer Ingelheim International GmbH and is licensed to Allergan, Inc.

Made in the U.S.A.

72499US10

ALLERGAN NDC 0023-9201-05

Elestat®

(epinastine HCI

ophthalmic solution) 0.05%

5 mL Rx only sterile

ALLERGAN

NDC 0023-9201-05

Elestat®

(epinastine HCl

ophthalmic solution) 0.05%

Rx Only

5 mL sterile

Elestat  epinastine hydrochloride  solution/ drops

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0023-9201 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength epinastine hydrochloride (epinastine) epinastine hydrochloride 0.5 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength benzalkonium chloride   edetate disodium   water   sodium chloride   sodium phosphate, monobasic   sodium hydroxide   hydrochloric acid

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0023-9201-05 1 BOTTLE In 1 CARTON contains a BOTTLE, DROPPER 1 5 mL In 1 BOTTLE, DROPPER This package is contained within the CARTON (0023-9201-05)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021565	01/19/2004

Labeler - Allergan, Inc. (144796497)

Establishment
Name	Address	ID/FEI	Operations
Allergan, Inc.		362898611	MANUFACTURE

Revised: 12/2011Allergan, Inc.

Flunisolide

Class: Adrenals
ATC Class: R03BA03
VA Class: NT200
Chemical Name: (6α,11β,16α) - 6 - fluoro - 11,21 - dihydroxy - 16,17 - [(1 - methylethylidene)bis(oxy)] - pregna - 1,4 - diene - 3,20 - dione hemihydrate
Molecular Formula: C₂₄H₃₁FO₆½H₂O
CAS Number: 77326-96-6
Brands: AeroBid

Introduction

Synthetic fluorinated glucocorticoid.^a

Uses for Flunisolide

Asthma

Long-term prevention of bronchospasm in patients with asthma.^{102 104 105}

In corticosteroid-dependent patients, may permit a substantial reduction in the daily maintenance dosage of the systemic corticosteroid or gradual discontinuance of systemic corticosteroid maintenance dosages.¹⁰⁵

Oral inhalation should not be used for the treatment of nonasthmatic bronchitis or for rapid relief of bronchospasm.¹⁰⁵

Flunisolide Dosage and Administration

General

• 
  

  Adjust dosage carefully according to individual requirements and response.¹⁰⁵

  
  


• 
  

  After a satisfactory response is obtained, decrease dosage gradually to the lowest possible dosage that maintains an adequate clinical response.^b Achieve the lowest effective dosage, particularly in children, since inhaled corticosteroids have the potential to affect growth.^c (See Pediatric Use under Cautions.)

  
  

Conversion to Orally Inhaled Therapy in Patients Receiving Systemic Corticosteroids

• 
  

  When switching from systemic corticosteroids to orally inhaled flunisolide, asthma should be reasonably stable before initiating treatment with the oral inhalation.^b

  
  


• 
  

  Initially, administer oral inhalation concurrently with the maintenance dosage of the systemic corticosteroid.^b After about 1 week, gradually withdraw the systemic corticosteroid.^{a b}

  
  


• 
  

  Decrements usually should not exceed 2.5 mg of prednisone (or its equivalent) every 1–2 weeks in patients receiving the oral inhalation. ^{b c}

  
  


• 
  

  During withdrawal of oral therapy, symptoms of systemic corticosteroid withdrawal may occur despite maintenance or even improvement in pulmonary function; continue oral inhalation therapy but monitor for objective signs of adrenal insufficiency.^b If evidence of adrenal insufficiency occurs, increase systemic corticosteroid dosage temporarily and continue withdrawal more slowly.^b

  
  


• 
  

  Death has occurred in some individuals in whom systemic corticosteroids were withdrawn too rapidly.¹⁰⁵ (See Withdrawal of Systemic Corticosteroid Therapy under Cautions.)

  
  


• 
  

  If exacerbations of asthma occur after transfer to oral inhalation therapy, administer short courses of systemic corticosteroids, then taper dosage as symptoms subside.^a Supplemental systemic corticosteroid therapy may also be required during periods of stress.^b

  
  

Administration

Oral Inhalation

Administer by oral inhalation using an oral aerosol inhaler.^{a b}

Administer twice daily in the morning and evening.¹⁰⁵

Shake well immediately prior to use and hold inhaler upright prior to actuation.¹⁰⁶ Exhale out as completely as possible and place the mouthpiece of the inhaler well into the mouth with lips closed firmly around it.¹⁰⁶ Inhale slowly through the mouth while pressing the metal canister down with the forefinger.¹⁰⁶ After holding the breath for as long as possible, remove the mouthpiece and exhale slowly.¹⁰⁶ If additional inhalations are required, wait 1 minute between inhalations, shake the inhaler again, and repeat the procedure.¹⁰⁶

Following each treatment, rinse mouth thoroughly with water or mouthwash to remove drug deposited in the oropharyngeal area.¹⁰⁶

Clean inhaler every few days by removing canister from the inhaler and rinsing plastic cap and inhaler in warm water; allow to dry thoroughly.¹⁰⁶

Dosage

Available as flunisolide hemihydrate; dosage expressed in terms of flunisolide.¹⁰⁵

Oral inhalation aerosol delivers 250 mcg of flunisolide from the actuator (mouthpiece) per metered spray.¹⁰⁵ The inhaler system delivers at least 100 metered sprays.¹⁰⁵

Pediatric Patients

Asthma

Oral

Children 6–15 years of age: 500 mcg (2 inhalations) twice daily.¹⁰⁵

Adults

Asthma

Oral

Initially, 500 mcg (2 inhalations) twice daily.¹⁰⁵ If required, dosage may be increased to 1 mg (4 inhalations) twice daily.¹⁰⁵ Higher dosages have been recommended by some clinicians for patients with severe persistent asthma.^{104 105}

Prescribing Limits

Pediatric Patients

Oral

Dosages >500 mcg (2 inhalations) twice daily not evaluated.¹⁰⁵

Adults

Oral

Manufacturer recommends maximum 1 mg (4 inhalations) twice daily (2 mg total daily dosage).^{104 105}

Special Populations

No special population dosage recommendations at this time.^b

Cautions for Flunisolide

Contraindications

• 
  

  Primary treatment of severe acute asthmatic attacks or status asthmaticus when intensive measures (e.g., oxygen, parenteral bronchodilators, IV corticosteroids) are required.^{102 104 105}

  
  


• 
  

  Known hypersensitivity to flunisolide or any ingredient in the formulation.^b

  
  

Warnings/Precautions

Warnings

Withdrawal of Systemic Corticosteroid Therapy

Possible corticosteroid withdrawal symptoms (e.g., joint pain, muscular pain, lassitude, depression);^{b c} acute adrenal insufficiency;^{b c} pulmonary infiltrates with eosinophilia;^b or symptomatic exacerbation of allergic conditions if prolonged systemic corticosteroid therapy is replaced with oral inhalation corticosteroid therapy.^b

Taper the dosage of the systemic corticosteroid, and carefully monitor patients during dosage reduction for objective signs of adrenal insufficiency (e.g., hypotension, weight loss).^c

Immunosuppressed Patients

Increased susceptibility to infections in patients who are taking immunosuppressant drugs compared with healthy individuals.^b Certain infections (e.g., varicella [chickenpox], measles) can have a more serious or even fatal outcome in such patients,^b particularly in children.^c

Exposure to varicella and measles should be avoided in previously unexposed patients.^b If exposure to varicella (chickenpox) or measles occurs in susceptible patients, consider administering varicella zoster immune globulin (VZIG) or pooled immune globulin (IG), respectively.^b Consider treatment with an antiviral agent if varicella develops.^b

Concomitant Therapy

Concomitant use with prednisone in an alternate-day regimen could increase the likelihood of HPA-axis suppression compared with therapeutic dosages of either drug alone.^b

Resume systemic corticosteroids during periods of stress (e.g., infection, trauma, surgery) or a severe asthma exacerbation in patients who were attempting a switch from systemic to orally inhaled corticosteroid therapy.^b

Infections

Localized fungal infections (Candida albicans or Aspergillus niger) of the mouth, pharynx, and occasionally the larynx reported.^b If infection occurs, appropriate local or systemic treatment and/or discontinuance of therapy may be required.^b

Use with caution, if at all, in patients with Mycobacterium tuberculosis infections of the respiratory tract; untreated systemic fungal, bacterial, or parasitic infections; or ocular herpes simplex or untreated, systemic viral infections.^{b c}

General Precautions

Systemic Corticosteroid Effects

Administration of higher than recommended dosages of orally inhaled flunisolide may result in manifestations of hypercorticism and suppression of hypothalamic-pituitary-adrenal (HPA) function.^{b c} Periodically monitor patients receiving long-term therapy at a maximum daily dosage for effects on the HPA axis.¹⁰⁵

Carefully monitor patients during periods of stress (e.g., infections, trauma, surgery) for manifestations of hypoadrenalism.^{b c}

Monitor adrenal function to assess the risk of adrenal insufficiency in emergency situations.^b Normal morning plasma cortisol concentrations (>10 mcg/dL) indicate basal pituitary-adrenal function is adequate.^c

Ocular Effects

Glaucoma, increased intraocular pressure, and cataracts reported rarely.

Other Effects

Unknown long-term local and systemic effects of the drug in humans, particularly developmental or immunologic processes in the mouth, pharynx, trachea, and lung.^b

Specific Populations

Pregnancy

Category C.^b

Lactation

Not known whether flunisolide is distributed into milk; however, other corticosteroids are distributed into milk.^{b c} Caution if used in nursing women.^b

Pediatric Use

Safety and efficacy not established in children <6 years of age.^b

Periodically monitor children receiving prolonged therapy for adverse effects on growth and development.^{105 b}

Common Adverse Effects

Diarrhea,^b nausea,^b vomiting,^b flu,^b sore throat,^b headache,^b nasal congestion,^b upper respiratory infection,^b unpleasant taste,^b cold symptoms,^b upset stomach.^b

Interactions for Flunisolide

Specific Drugs

Drug	Interaction	Comments
Antidiabetic agents	May increase blood glucose concentrations in patients with diabetes mellitus	Adjust insulin and/or oral hypoglycemic dosages as needed
Vaccines and toxoids	May cause a diminished response to toxoids and live or inactivated vaccinesc May potentiate replication of some organisms contained in live, attenuated vaccines c	May undertake immunization procedures in patients receiving nonimmunosuppressive doses of glucocorticoidsc

Flunisolide Pharmacokinetics

Absorption

Bioavailability

Following oral inhalation, total systemic availability is 40%.^b

Onset

1–4 weeks of continuous therapy may be required for optimum effectiveness.^b

Distribution

Extent

Placental distribution in humans is unknown, but flunisolide apparently crosses the placenta in animals.^d

Distribution into milk is unknown, but other corticosteroids are distributed into milk.^{c d}

Plasma Protein Binding

At a plasma concentration of 1–20,000 ng/mL, about 50% bound to plasma albumin.^d No binding to corticosteroid-binding globulin.^d

Elimination

Metabolism

Rapidly and extensively metabolized in the liver.^b

Elimination Route

Excretion pathway is unknown when inhaled; however when given systemically, metabolites are excreted in roughly equal portions in feces and urine.^d

Half-life

Approximately, 1.8 hours. ^b

Stability

Storage

Oral Inhalation

Aerosol

25°C;^e protect from excessive heat (>49°C).^b

ActionsActions

• 
  

  Potent glucocorticoid and minimal mineralocorticoid activity.^d

  
  


• 
  

  Demonstrates marked anti-inflammatory and antiallergic activity. ^b

  
  


• 
  

  Improves lung function (e.g., forced expiratory volume in 1 second [FEV₁], morning peak expiratory flow).¹⁰⁰

  
  


• 
  

  Principal sites of action are the bronchi and bronchioles; minimal systemic activity at recommended doses. ^b

  
  


• 
  

  May reduce the number of mediator cells (basophil leukocytes and mast cells) at the epithelial level, number of eosinophils, sensitivity of sensory nerves to mechanical stimuli, secretory response to cholinergic receptor stimulation, and fibroblast activity.^d

  
  


• 
  

  May inhibit capillary dilation and permeability, and stabilize lysosomal membranes and subsequent prevention of release of proteolytic enzymes.^d

  
  

Advice to Patients

• 
  

  Importance of instructing patient in the use of the oral inhaler and providing a copy of the manufacturer's information and/or medication guide.^b

  
  


• 
  

  Importance of adequate understanding of proper storage, preparation, and administration techniques.^b

  
  


• 
  

  Importance of rinsing mouth after oral inhalation. ^b

  
  


• 
  

  Importance of informing clinician if mouth becomes sore or develops a rash.^b

  
  


• 
  

  Importance of advising patient that flunisolide oral inhalation must be used at regular intervals to be therapeutically effective.^b

  
  


• 
  

  Importance of not exceeding the recommended dosage and of contacting a clinician immediately if asthma symptoms that are not responsive to bronchodilators occur.^b

  
  


• 
  

  Importance of not using orally inhaled flunisolide as a bronchodilator and for emergency use (e.g., relief of acute bronchospasm).^{b c}

  
  


• 
  

  Advise patients being transferred from systemic corticosteroids to flunisolide oral inhalation therapy to carry special identification (e.g., card, bracelet) indicating the need for supplementary systemic corticosteroids during periods of stress.^b

  
  


• 
  

  Advise patients receiving orally inhaled flunisolide therapy who are currently being withdrawn from systemic corticosteroids to immediately resume full therapeutic dosages of systemic corticosteroids and to contact their clinician for further instructions during stressful periods (e.g., severe infection, severe asthmatic attack).

  
  


• 
  

  Importance of immunosuppressed patients avoiding exposure to chickenpox or measles, and if exposed, of immediately consulting their clinician.^b

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.^b

  
  


• 
  

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

  
  


• 
  

  Importance of informing patients of other precautionary information.^b (See Cautions.)

  
  

Preparations

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

Flunisolide Hemihydrate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral Inhalation	Aerosol	250 mcg (of flunisolide) per metered spray	AeroBid Inhaler System (with chlorofluorohydrocarbon propellants and sorbitan trioleate)	Forest
			AeroBid-M Inhaler System (with chlorofluorohydrocarbon propellants, menthol, and sorbitan trioleate)	Forest

Disclaimer

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

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

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions September 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

100. National Asthma Education and Prevention Program. Expert panel report II: guidelines for the diagnosis and management of asthma. Bethesda, MD: National Institutes of Health; 1997 Feb.

101. National Asthma Education Program. Executive summary: guidelines for the diagnosis and management of asthma. NIH Publication No. 94-3042A. Washington, DC: US Governement Printing Office; 1994 Jul.

102. National Institutes of Health, National Heart, Lung, and Blood Institute. Global initiative for asthma: global strategy for asthma management and prevention NHLBI/WHO Workshop Report. Bethesda, MD: National Institutes of Health. 2002 Feb. NIH/NHLBI Publication No. 02-3659. Available at http://www.ginasthma.com. Accessed Sep. 26, 2002.

103. British Thoracic Society. Guidelines on the management of asthma. Thorax. 1993; 48(Suppl 2):S1-24.

104. National Asthma Education and Prevention Program. Expert panel report: guidelines for the diagnosis and management of asthma. Update on selected topics-2002. Bethesda, Md: National Heart, Lung, and Blood Institute, National Asthma Education and Prevention Program Coordinating Committee; 2003 Jun. Available from National Heart, Lung, and Blood Institute Information Center, NIH Publication No. 02-5074. Also available at . Accessed 2006 Jan. 5.

105. Forest Pharmaceuticals. AeroBID/AeroBID-M (flunisolide) inhaler system prescribing information. St. Louis, MO; 2002 Mar.

106. Forest Pharmaceuticals. Aerobid/Aerobid-M (flunisolide) inhaler system directions for use. St. Louis, MO; 2002 Mar.

a. AHFS drug information 2007. McEvoy GK, ed. Flunisolide. Bethesda, MD: American Society of Health-System Pharmacists; 2007:3048-9.

b. Forest Pharmaceuticals, Inc. Aerobid and Aerobid-M (flunisolide) aerosol, metered prescribing information. St. Louis, MO; 2006 Dec.

c. AHFS drug information 2007. McEvoy GK, ed. Corticosteroids General Statement. Bethesda, MD: American Society of Health-System Pharmacists; 2007: 3024-37.

d. AHFS drug information 2007. McEvoy GK, ed. Flunisolide. Bethesda, MD: American Society of Health-System Pharmacists; 2007:2821-3.

e. Sinha, N (Forest Pharmaceuticals, Inc. St. Louis, MO): Personal communication; 2007 Jun.

More Flunisolide resources

• Flunisolide Dosage
• Flunisolide Use in Pregnancy & Breastfeeding
• Flunisolide Drug Interactions
• Flunisolide Support Group
• 1 Review for Flunisolide - Add your own review/rating

• Flunisolide Prescribing Information (FDA)


• Flunisolide Aerosol Inhaler MedFacts Consumer Leaflet (Wolters Kluwer)


• Flunisolide Professional Patient Advice (Wolters Kluwer)


• AeroBid Concise Consumer Information (Cerner Multum)


• Aerobid Prescribing Information (FDA)

Compare Flunisolide with other medications

• Asthma

Etoposide Oral, Intravenous

e-TOE-poe-side

Intravenous route(Solution)

Severe myelosuppression with resulting infection or bleeding may occur with etoposide .

Intravenous route(Powder for Solution)

Severe myelosuppression with resulting infection or bleeding may occur with etoposide phosphate .

Commonly used brand name(s)

In the U.S.

• Etopophos


• Vepesid

In Canada

• Dom-Etoposide


• Eposin


• Etoposide


• Pms-Etoposide

Available Dosage Forms:

• Solution


• Powder for Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Mitotic Inhibitor

Uses For etoposide

Etoposide injection (also known as VP-16) is used in combination with other cancer medicines to treat cancer of the testicles and small cell lung cancer. It is also sometimes used to treat some other kinds of cancer in both males and females.

Etoposide belongs to the group of medicines known as antineoplastic agents. The exact way that etoposide acts against cancer is not known. However, it seems to interfere with the growth of the cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by etoposide, 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 until months or years after the medicine is used.

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

etoposide is to be administered only by or under the immediate supervision of your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, etoposide is used in certain patients with the following medical conditions:

• Autoimmune deficiency syndrome (AIDS)—associated Kaposi's sarcoma (a type of cancer of the skin and mucous membranes that is more common in patients with AIDS).


• Cancer in the bone.


• Cancer of the adrenal cortex (the outside layer of the adrenal gland).


• Cancer of the endometrium.


• Cancer of the lung (a certain type of lung cancer usually associated with prior smoking, passive smoking, or radon exposure).


• Cancer of the lymph system (a part of the body's immune system) that affects the skin.


• Cancer of the ovaries (a type of cancer found in the egg-making cells).


• Cancer of the stomach.


• Cancer of unknown primary site.


• Cancers of the blood and lymph system.


• Cancers of the soft tissues of the body, including the muscles, connective tissues (tendons), vessels that carry blood or lymph, or fat.


• Ewing's sarcoma (a type of cancer found in the bone).


• Gestational trophoblastic tumors (tumors in the uterus or womb).


• Hepatoblastoma (a certain type of liver cancer that occurs in children).


• Multiple myeloma (a certain type of cancer of the blood).


• Myelodysplastic syndromes (MDS).


• Neuroblastoma (a cancer of the nerves that usually occurs in children).


• Retinoblastoma (a cancer of the eye that usually occurs in children).


• Thymoma (a cancer of the thymus, which is a small organ that lies under the breastbone).


• Tumors in the brain.


• Wilms' tumor (a cancer of the kidney that usually occurs in children).

Before Using etoposide

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 etoposide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to etoposide 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 etoposide injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of etoposide injection in the elderly. However, elderly patients are more likely to have unwanted side effects (e.g., infection, nausea and vomiting, hair loss), and have age-related kidney, liver, or heart problems, which may require caution in elderly patients receiving etoposide injection.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving etoposide, 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 etoposide 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.

• Rotavirus Vaccine, Live

Using etoposide 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.

• Adenovirus Vaccine Type 4, Live


• Adenovirus Vaccine Type 7, Live


• Aprepitant


• Bacillus of Calmette and Guerin Vaccine, Live


• Cyclosporine


• Fosaprepitant


• Glucosamine


• Influenza Virus Vaccine, Live


• Measles Virus Vaccine, Live


• Mumps Virus Vaccine, Live


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Smallpox Vaccine


• St John's Wort


• Typhoid Vaccine


• Valspodar


• Varicella Virus Vaccine


• Warfarin


• Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using etoposide with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use etoposide, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

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

• Low serum albumin (protein in the blood)—May experience increased side effects.

• Infection—Etoposide may decrease your body's ability to fight infection.

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

Proper Use of etoposide

A nurse or other trained health professional will give you etoposide in a hospital or cancer treatment center. etoposide is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for 30 to 60 minutes.

Etoposide is sometimes given together with certain other medicines. If you are using a combination of medicines, make sure that you take each one at the proper time and do not mix them. If you are taking some of these medicines by mouth, ask your doctor to help you plan a way to remember to take your medicines at the right times.

Etoposide often causes nausea, vomiting, and loss of appetite, which may be severe. However, it is very important that you continue to receive the medicine, even if you begin to feel ill. Ask your doctor for ways to lessen these effects.

Precautions While Using etoposide

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

Using etoposide 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.

Etoposide can temporarily lower the number of white blood cells in your blood, increasing the chance of your 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 have 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.

etoposide may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have chills; fever; lightheadedness, dizziness, or fainting; fast, pounding heartbeat; swelling of the face, tongue, and throat; or trouble with breathing after you receive the medicine.

Injection site reactions may occur while you are receiving etoposide. Tell your doctor right away if you notice swelling, pain, or redness at the injection site.

etoposide may cause leukemia (cancer of the blood or bone marrow) in rare cases. Talk with your doctor about any concerns you have about this.

Talk with your doctor before getting flu shots or other vaccines while you are receiving etoposide because there are certain vaccines that you should not receive.

etoposide Side Effects

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

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

More common

• Black, tarry stools


• bleeding gums


• blood in the urine or stools


• chest pain


• chills


• cough


• fever


• painful or difficult urination


• pale skin


• pinpoint red spots on the skin


• shortness of breath


• sore throat


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


• swollen glands


• troubled breathing with exertion


• unusual bleeding or bruising


• unusual tiredness or weakness

Less common

• Blurred vision


• confusion


• cough or hoarseness, accompanied by fever or chills


• difficulty with swallowing


• dizziness


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• face is warm or hot to touch


• fast heartbeat


• headache


• hives


• itching


• lower back or side pain, accompanied by fever or chills


• nervousness


• numbness or tingling in the fingers or toes


• pain or redness at the site of injection


• pale skin at the site of injection


• pounding in the ears


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• redness to face


• skin rash


• slow or fast heartbeat


• sweating


• tightness in the chest


• wheezing

Rare

• Back pain


• difficulty with walking


• loss of consciousness


• swelling of the face or tongue


• tightness in the throat

Incidence not known

• Abdominal or stomach pain, severe


• blindness


• blistering, peeling, or loosening of the skin


• blue-yellow color blindness


• dark urine


• decreased vision


• difficult with breathing


• eye pain


• joint or muscle pain


• loss of appetite


• nausea or vomiting


• red, irritated eyes


• red skin lesions, often with a purple center


• seizures


• yellow eyes or skin

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

More common

• Bad, unusual, or unpleasant (after) taste


• change in taste


• constipation


• cracked lips


• hair loss or thinning of the hair


• lack or loss of strength


• swelling or inflammation of the mouth


• weight loss

etoposide often causes a temporary loss of hair. After treatment with etoposide has ended, normal hair growth should return.

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: etoposide Oral, Intravenous side effects (in more detail)

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More etoposide Oral, Intravenous resources

• Etoposide Oral, Intravenous Side Effects (in more detail)
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• Drug Images
• Etoposide Oral, Intravenous Drug Interactions
• Etoposide Oral, Intravenous Support Group
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