Iopox may be available in the countries listed below.
Ingredient matches for Iopox
Povidone Iodine
Povidone-Iodine is reported as an ingredient of Iopox in the following countries:
- Argentina
International Drug Name Search
Monday, September 10, 2012
Thursday, September 6, 2012
Iron/L-Methylfolate/Vitamin B12/Vitamin C
Pronunciation: EYE-urn/meth-ill-FOE-late/VYE-ta-min
Generic Name: Iron/L-Methylfolate/Vitamin B12/Vitamin C
Brand Name: Maxaron Forte
Accidental overdose of products that contain iron is a leading cause of fatal poisoning in children younger than 6 years old. Keep this and all medicines out of the reach of children. In case of accidental ingestion, call the poison control center or a doctor right away.
Iron/L-Methylfolate/Vitamin B12/Vitamin C is used for:
Preventing and treating certain types of anemia (eg, caused by low blood iron levels, poor nutrition). It may also be used for other conditions as determined by your doctor.
Iron/L-Methylfolate/Vitamin B12/Vitamin C is a vitamin, folic acid, and iron combination. It works by providing vitamins, folic acid, and iron to the body.
Do NOT use Iron/L-Methylfolate/Vitamin B12/Vitamin C if:
- you are allergic to any ingredient in Iron/L-Methylfolate/Vitamin B12/Vitamin C
- you have certain iron metabolism problems (eg, hemosiderosis, hemochromatosis) or you have high levels of iron in your blood
Contact your doctor or health care provider right away if any of these apply to you.
Before using Iron/L-Methylfolate/Vitamin B12/Vitamin C:
Some medical conditions may interact with Iron/L-Methylfolate/Vitamin B12/Vitamin C. 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 another type of anemia (eg, hemolytic anemia, pernicious anemia) or other blood problems (eg, porphyria, thalassemia)
- if you have stomach or bowel problems (eg, colitis, Crohn disease, diverticulitis, peptic ulcer)
- if you have glucose-6-phosphate dehydrogenase (G6PD) deficiency
- if you have had multiple blood transfusions
Some MEDICINES MAY INTERACT with Iron/L-Methylfolate/Vitamin B12/Vitamin C. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Doxycycline, hydantoins (eg, phenytoin), penicillamine, or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Iron/L-Methylfolate/Vitamin B12/Vitamin C
This may not be a complete list of all interactions that may occur. Ask your health care provider if Iron/L-Methylfolate/Vitamin B12/Vitamin C 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 Iron/L-Methylfolate/Vitamin B12/Vitamin C:
Use Iron/L-Methylfolate/Vitamin B12/Vitamin C as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Iron/L-Methylfolate/Vitamin B12/Vitamin C by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- If you also take an antacid, a bisphosphonate (eg, alendronate), cefdinir, eltrombopag, methyldopa, penicillamine, a quinolone antibiotic (eg, ciprofloxacin), or a tetracycline antibiotic (eg, minocycline), ask your doctor or pharmacist how to take it with Iron/L-Methylfolate/Vitamin B12/Vitamin C.
- If you miss a dose of Iron/L-Methylfolate/Vitamin B12/Vitamin C, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Iron/L-Methylfolate/Vitamin B12/Vitamin C.
Important safety information:
- Do NOT take more than the recommended dose without checking with your doctor.
- Do not take large doses of vitamins (megadoses or megavitamin therapy) while you use Iron/L-Methylfolate/Vitamin B12/Vitamin C unless your doctor tells you to.
- Iron/L-Methylfolate/Vitamin B12/Vitamin C has folic acid and iron in it. Before you start any new medicine, check the label to see if it also has folic acid or iron in it too. If it does or if you are not sure, check with your doctor or pharmacist.
- Iron/L-Methylfolate/Vitamin B12/Vitamin C has iron in it. Iron overdose is a leading cause of fatal poisoning in children younger than 6 years old. In case of an overdose, call a doctor or poison control center right away.
- Iron/L-Methylfolate/Vitamin B12/Vitamin C may darken the stools. This is normal and not cause for concern.
- Iron/L-Methylfolate/Vitamin B12/Vitamin C may interfere with certain lab tests, including tests used to check for blood in the stool. Be sure your doctor and lab personnel know you are taking Iron/L-Methylfolate/Vitamin B12/Vitamin C.
- Lab tests, including hematocrit, hemoglobin levels, and blood iron levels, may be performed while you use Iron/L-Methylfolate/Vitamin B12/Vitamin C. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Iron/L-Methylfolate/Vitamin B12/Vitamin C should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Iron/L-Methylfolate/Vitamin B12/Vitamin C while you are pregnant. Iron/L-Methylfolate/Vitamin B12/Vitamin C is found in breast milk. If you are or will be breast-feeding while you use Iron/L-Methylfolate/Vitamin B12/Vitamin C, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Iron/L-Methylfolate/Vitamin B12/Vitamin C:
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:
Constipation; dark stools; diarrhea; nausea; stomach pain; 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); black, tarry, or bloody stools; severe or persistent nausea, vomiting, or stomach pain.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include black, tarry, or bloody stools; blue or unusually pale skin; drowsiness or dizziness; fainting; fast heartbeat; increased thirst or urination; seizures; severe or persistent nausea, vomiting, diarrhea, or stomach pain; sluggishness; vomiting blood; weakness.
Proper storage of Iron/L-Methylfolate/Vitamin B12/Vitamin C:
Store Iron/L-Methylfolate/Vitamin B12/Vitamin C 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 Iron/L-Methylfolate/Vitamin B12/Vitamin C out of the reach of children and away from pets.
General information:
- If you have any questions about Iron/L-Methylfolate/Vitamin B12/Vitamin C, please talk with your doctor, pharmacist, or other health care provider.
- Iron/L-Methylfolate/Vitamin B12/Vitamin C is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information is a summary only. It does not contain all information about Iron/L-Methylfolate/Vitamin B12/Vitamin C. 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 Iron/L-Methylfolate/Vitamin B12/Vitamin C resources
- Iron/L-Methylfolate/Vitamin B12/Vitamin C Use in Pregnancy & Breastfeeding
- Drug Images
- Iron/L-Methylfolate/Vitamin B12/Vitamin C Drug Interactions
- Iron/L-Methylfolate/Vitamin B12/Vitamin C Support Group
- 11 Reviews for Iron/L-Methylfolate/Vitamin B12/Vitamin C - Add your own review/rating
Compare Iron/L-Methylfolate/Vitamin B12/Vitamin C with other medications
- Anemia
- Vitamin/Mineral Supplementation and Deficiency
Wednesday, September 5, 2012
Atralin
Generic Name: tretinoin topical (TRET in oin)
Brand Names: Altinac, Atralin, Avita, Renova, Retin A Micro Gel, Retin-A, Tretin-X
What is tretinoin topical?
Tretinoin is a topical (applied to the skin) form of vitamin A that helps the skin renew itself.
The Retin-A and Avita brands of tretinoin are used to treat acne. The Renova brand of tretinoin is used to reduce the appearance of fine wrinkles and mottled skin discoloration, and to make rough facial skin feel smoother.
Tretinoin topical may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about tretinoin topical?
Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Tretinoin topical can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun. Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water. Do not use tretinoin topical on sunburned, windburned, dry, chapped, irritated, or broken skin. Also avoid using this medication in wounds or on areas of eczema. Wait until these conditions have healed before using tretinoin topical. Use this medication for as many days as it has been prescribed for you even if you think it is not working. It may take weeks or months of use before you notice improvement in your skin. If you are using tretinoin topical to treat acne, your condition may get slightly worse for a short time when you first start using the medication. Call your doctor if skin irritation becomes severe or if your acne does not improve within 8 to 12 weeks.
What should I discuss with my healthcare provider before using tretinoin topical?
FDA pregnancy category C. It is not known whether tretinoin topical is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Tretinoin topical can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
How should I use tretinoin topical?
Use tretinoin topical exactly as your doctor has prescribed it for you. Using more medicine or applying it more often than prescribed will not make it work any faster, and may increase side effects. Do not use this medication for longer than your doctor has prescribed.
Wash your hands before and after applying tretinoin topical. Before applying, clean and dry the skin area to be treated.
Applying tretinoin topical to wet skin may cause skin irritation. If you use Renova, wait at least 20 minutes after washing your face before applying a thin layer of the medication.
Do not wash the treated area for at least 1 hour after applying tretinoin topical. Avoid the use of other skin products on the treated area for at least 1 hour following application of tretinoin topical.
Applying an excessive amount of tretinoin gel may result in "pilling" of the medication. If this occurs, use a thinner layer of gel with the next application.
Tretinoin topical should be used as part of a complete skin care program that includes avoiding sunlight and using an effective sunscreen and protective clothing.
Use this medication for as many days as it has been prescribed for you even if you think it is not working. It may take weeks or months of use before you notice improvement in your skin. If you are using tretinoin topical to treat acne, your condition may get slightly worse for a short time when you first start using the medication. Call your doctor if skin irritation becomes severe or if your acne does not improve within 8 to 12 weeks. Store tretinoin topical at room temperature away from moisture and heat. The gel formulations of Retin-A are flammable, keep them away from open flame.
What happens if I miss a dose?
Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not apply extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Tretinoin topical is not expected to cause overdose symptoms.
What should I avoid while using tretinoin topical?
Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Tretinoin topical can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun. Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water. Do not use tretinoin topical on skin that is sunburned, windburned, dry, chapped, or irritated. Also avoid using this medication in wounds or on areas of eczema. Wait until these conditions have healed before using tretinoin topical.
Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medication skin products unless your doctor has told you to.
Your skin may be more sensitive to weather extremes such as cold and wind while using this medicine.
Tretinoin topical side effects
Stop using this medication and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Less serious side effects may include burning, warmth, stinging, tingling, itching, redness, swelling, dryness, peeling, irritation, or discolored skin.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect tretinoin topical?
Do not use skin products that contain benzoyl peroxide, sulfur, resorcinol, or salicylic acid unless otherwise directed by your doctor. These products can cause severe skin irritation if used with tretinoin topical.
The following drugs can interact with tretinoin topical, which can make your skin more sensitive to natural and artificial sunlight. Before using this medication, tell your doctor if you are using any of these:
a diuretic (water pill);
tetracycline (Sumycin, Panmycin, Robitet), minocycline (Minocin), doxycycline (Doryx, Vibramycin), demeclocycline (Declomycin), and others;
an antibiotic such as ciprofloxacin (Cipro), ofloxacin (Floxin), and others;
a sulfa drug such as Bactrim, Septra, Cotrim, and others; or
chlorpromazine (Thorazine), prochlorperazine (Compazine), fluphenazine (Permitil, Prolixin), promethazine (Phenergan, Promethegan), perphenazine (Trilafon), and others.
This list is not complete and there may be other drugs that can affect tretinoin topical. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
More Atralin resources
- Atralin Side Effects (in more detail)
- Atralin Use in Pregnancy & Breastfeeding
- Atralin Drug Interactions
- Atralin Support Group
- 24 Reviews for Atralin - Add your own review/rating
- Atralin Topical Advanced Consumer (Micromedex) - Includes Dosage Information
- Atralin Consumer Overview
- Avita Prescribing Information (FDA)
- Avita Cream MedFacts Consumer Leaflet (Wolters Kluwer)
- Refissa Prescribing Information (FDA)
- Renova Emollient Cream MedFacts Consumer Leaflet (Wolters Kluwer)
- Renova Consumer Overview
- Retin-A Prescribing Information (FDA)
- Tretin-X Cream MedFacts Consumer Leaflet (Wolters Kluwer)
Compare Atralin with other medications
- Acne
- Photoaging of the Skin
Where can I get more information?
- Your pharmacist can provide more information about tretinoin topical.
See also: Atralin side effects (in more detail)
Tuesday, September 4, 2012
Timolol
Pronunciation: TIM-oh-lole
Generic Name: Timolol
Brand Name: Blocadren
Do not suddenly stop taking Timolol. Sharp chest pain, irregular heartbeat, and sometimes heart attack may occur if you suddenly stop Timolol. The risk may be greater if you have certain types of heart disease. Your doctor should slowly lower your dose over several weeks if you need to stop taking it. This should be done even if you only take Timolol for high blood pressure. Heart disease is common and you may not know you have it. Limit physical activity while you are lowering your dose. If new or worsened chest pain or other heart problems occur, contact your doctor right away. You may need to start taking Timolol again.
Timolol is used for:
Treating high blood pressure. It is also used to help prevent a second heart attack in patients who have survived a first heart attack and are stable and to prevent migraines. It may also be used for other conditions as determined by your doctor.
Timolol is a beta-blocker. It works by interfering with body chemicals that shrink blood vessels and interfere with normal heart contractions.
Do NOT use Timolol if:
- you are allergic to any ingredient in Timolol or to similar medicines
- you have asthma, a history of asthma, or severe chronic obstructive pulmonary disease (COPD)
- you have severe slow heartbeat or rapid heartbeat; heart blockage, failure, or shock; or low systolic blood pressure
- you are taking mibefradil, theophyllines (eg, aminophylline), cocaine, or sympathomimetics (eg, epinephrine)
Contact your doctor or health care provider right away if any of these apply to you.
Before using Timolol:
Some medical conditions may interact with Timolol. 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 heart disease, heart failure, blood flow problems, bronchitis or another lung problem, tumors on your adrenal gland, diabetes mellitus, an overactive thyroid, or you are suffering from an allergic reaction, or you will be having surgery
Some MEDICINES MAY INTERACT with Timolol. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Indomethacin and derivatives, ibuprofen, naproxen, phenylpropanolamine, sulfinpyrazone, or sulindac because they may decrease Timolol's effectiveness
- Anticholinesterases (eg, pyridostigmine), cimetidine, diltiazem, disopyramide, flecainide, ketanserin, lithium, mefloquine, mibefradil, nifedipine and derivatives, propafenone, quinidine, reserpine, serotonin reuptake inhibitors (eg, fluoxetine), or verapamil and derivatives because side effects, such as low blood pressure and slowed heart rate, may occur
- Bupivacaine, carbonic anhydrase inhibitors (eg, acetazolamide), cocaine, disopyramide, sympathomimetics (eg, epinephrine), ergot alkaloids (eg, ergotamine), flecainide, insulin, ketanserin, mefloquine, meglitinide antidiabetics (eg, repaglinide), methyldopa, nifedipine and derivatives, quinazolines (eg, imatinib), serotonin reuptake inhibitors (eg, fluoxetine), or verapamil and derivatives because the risk of their side effects may be increased by Timolol
- Glucagon, meglitinide antidiabetics (eg, repaglinide), phenformin, sympathomimetics (eg, pseudoephedrine, albuterol), or theophyllines (eg, aminophylline) because the their effectiveness may be decreased by Timolol
- Clonidine because when it is discontinued it may cause rebound high blood pressure
This may not be a complete list of all interactions that may occur. Ask your health care provider if Timolol 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 Timolol:
Use Timolol as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Timolol by mouth with or without food.
- If you miss a dose of Timolol, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Timolol.
Important safety information:
- Timolol may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Timolol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Additional monitoring of your dose or condition may be needed if you are taking prazosin.
- Tell your doctor or dentist that you take Timolol before you receive any medical or dental care, emergency care, or surgery.
- If you have high blood pressure, do not use nonprescription products that contain stimulants. These products may include diet pills or cold medicines. Contact your doctor if you have any questions or concerns.
- Diabetes patients - Timolol may hide signs of low blood sugar, such as a rapid heartbeat. Be sure to watch for other signs of low blood sugar. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your vision change; give you a headache, chills, or tremors; or make you more hungry. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.
- If your doctor has instructed you to check your blood pressure and heart rate regularly, be sure to do so.
- Timolol should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Timolol while you are pregnant. Timolol is found in breast milk. Do not breast-feed while taking Timolol.
Possible side effects of Timolol:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Dizziness; fatigue/tiredness; lightheadedness; mild drowsiness; slow heartbeat; unusual weakness.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breathing problems; chest pain; irregular heart rhythms.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include difficult or slowed breathing; fainting; low blood pressure; severe dizziness; very slow heart rate; weakness.
Proper storage of Timolol:
Store Timolol at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Timolol out of the reach of children and away from pets.
General information:
- If you have any questions about Timolol, please talk with your doctor, pharmacist, or other health care provider.
- Timolol is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information is a summary only. It does not contain all information about Timolol. 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 Timolol resources
- Timolol Dosage
- Timolol Use in Pregnancy & Breastfeeding
- Drug Images
- Timolol Drug Interactions
- Timolol Support Group
- 0 Reviews for Timolol - Add your own review/rating
- Timolol Prescribing Information (FDA)
- Timolol eent Monograph (AHFS DI)
- timolol Concise Consumer Information (Cerner Multum)
- timolol Advanced Consumer (Micromedex) - Includes Dosage Information
- Blocadren Prescribing Information (FDA)
- Timolol Maleate Monograph (AHFS DI)
Compare Timolol with other medications
- Angina
- Heart Attack
- High Blood Pressure
- Migraine Prevention
Monday, September 3, 2012
Trichophyton
Dosage Form: injection for intradermal skin testing
ALLERGENIC EXTRACT Trichophyton for Intradermal Skin Testing
Warnings
This product is intended for use by physicians who are experienced in the administration of allergenic extracts or for use under the guidance of an allergy specialist. Skin tests should be performed after the patient's physical well being and allergic history have been evaluated. Patients should be instructed to recognize adverse reaction symptoms and cautioned to contact the physician if symptoms occur. As with all allergenic extracts, severe systemic reactions may occur, and in certain individuals these reactions may cause death. Patients should be observed for at least 20 minutes after skin tests have been completed. Emergency measures as well as personnel trained in their use should be immediately available in the event of a life threatening reaction.
This product should never be injected intravenously (see DOSAGE AND ADMINISTRATION). Also, see WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and OVERDOSE Sections below.
Trichophyton Description
Trichophyton extract for diagnostic skin testing is a sterile solution that is prepared by extracting allergenic source material of equal parts of Trichophyton mentagrophytes and Trichophyton rubrum with an aqueous solution of 0.25% sodium chloride, 0.125% sodium bicarbonate and 50% glycerol v/v. Phenol is added at 0.4% w/v as a preservative. Extract for intradermal administration is diluted with the above solution without glycerol.
WEIGHT BY VOLUME (W/V) Weight by volume refers to the weight of raw product added to a measured volume of extraction solution. A 1:500 w/v extract contains 1 gram of source material in 500 mL of solution. The w/v designation refers to concentration rather than potency. Extract labeled w/v has no U.S. Standard of Potency.
Trichophyton - Clinical Pharmacology
In sensitive persons, allergenic extract elicits immediate-type skin reactions consisting of erythema and edema at the test site. This allergic inflammatory response is thought to begin with the reaction of allergen with immunoglobulin E (IgE) on the surface of the mast cell. This antigen-antibody reaction initiates a series of biochemical events that result in the release of histamine and other mediators from the mast cell. These mediators are responsible for the characteristic wheal and flare response associated with a positive skin test. The initial antigen-antibody reaction appears to be a specific response that is dependent upon the presence of allergen-specific IgE attached to the mast cell2,3.
Delayed-type reactions occur in some individuals following the intradermal administration of Trichophyton extract. This response is due to the presence of sensitized lymphocytes. The reaction is characterized by erythema and induration that peaks between 24 and 48 hours after skin testing4.
Indications and Usage for Trichophyton
Intradermal skin tests with Trichophyton extract are indicated for use in persons who are suspected of having Type I hypersensitivity (i.e. allergy) to the fungus.
Contraindications
Conditions under which the administration of allergenic extract may be contraindicated, depending upon individual circumstances, include: EXTREME SENSITIVITY TO AN ALLERGEN - Determined from the allergic history, or from previous anaphylaxis following skin testing or subcutaneous injection; MYOCARDIAL INFARCTION - Patients who have experienced a recent myocardial infarction may be less able to tolerate the life-threatening effects of a serious adverse reaction. ASTHMA - Patients with highly unstable asthma are at greater risk of fatal reactions from skin tests than are patients without asthma, especially during seasonal exacerbations of the disease. Also, the combination of unstable asthma and treatment with B-adrenergic blockers appears to increase this risk5. Allergenic extract should be temporarily withheld from patients if any of the following conditions exist: 1) severe symptoms of hay fever and/or asthma; 2) infection or flu accompanied by fever; and 3) exposure to excessive amounts of clinically relevant allergen(s) prior to skin testing.
Warnings
Physicians who use allergenic extracts should have a knowledge and practical understanding of allergy skin testing as described in the published literature6,7,8.
Allergenic extracts are manufactured to assure high potency and therefore have the ability to cause serious local and systemic reactions, including death in highly sensitive patients5. Patients should be informed of the risks of skin testing and instructed in the recognition of symptoms of an adverse allergic reaction (see PRECAUTIONS and ADVERSE REACTIONS below).
Excessively large local reactions or systemic reactions are more likely to occur if the patient is skin tested shortly after exposure to allergens to which he or she is sensitive.
Precautions
GENERAL It is recommended that the device used to perform skin tests be disposable to prevent the possibility of accidental transfer of serum hepatitis, HIV and other infectious agents from one person to another. Injectable epinephrine should be available when skin tests are administered (see ADVERSE REACTIONS).
PATIENT INFORMATION Skin tests with allergenic extracts are usually safe and effective in the diagnosis of allergic diseases when used properly and when interpreted in conjunction with the allergic history and clinical findings. Patients should be observed in the office for 20 minutes after skin tests have been completed9 and instructed to return to the office or emergency room if symptoms of an allergic reaction or shock occur. The risk of a serious adverse reaction is always present. However, it is minimized by the use of the prick-puncture procedure as the initial method of testing. In a study of 16,204 persons in the United States between 6 and 74 years of age, no anaphylactic reactions were observed after prick-puncture skin testing with eight different allergenic extracts. The authors concluded that the risk of adverse reactions to prick-puncture skin tests is low and similar to other routine medical procedures, such as venipuncture10.
Since drugs may affect the reactivity of the skin, patients should be instructed to avoid medications, particularly antihistamines and sympathomimetic drugs prior to skin testing (see DRUG INTERACTION below).
DRUG INTERACTION Treatment with beta-blocking drugs may make patients refractory to the usual dose of epinephrine, in the event epinephrine is required to control an adverse reaction11.
Since drugs may affect the reactivity of the skin, patients should be instructed to avoid medications, particularly antihistamines and sympathomimetic drugs for at least 24 hours prior to skin testing. Non-sedating antihistamine suppresses the erythema/edema response for longer periods and should be withheld according to information included in the package insert. Adrenal corticosteroids and ACTH do not alter the immediate hypersensitivity reaction of the skin but do reduce delayed-type reactions associated with cellular hypersensitivity.
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY Long-term studies in animals have not been conducted with allergenic extracts to determine their potential for carcinogenicity, mutagenicity or impairment of fertility.
PREGNANCY CATEGORY C Allergenic Extracts. Animal reproduction studies have not been conducted with allergenic extracts. It is also not known whether allergenic extracts can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Allergenic extracts should be given to a pregnant woman only if clearly needed. Since studies indicate no increased risk to the fetus or to the mother who is treated cautiously with immunotherapy during a normal pregnancy, it is unlikely that extract administered by skin test will be harmful. However, on the basis of histamine's known ability to contract uterine muscle, extensive testing with its possibility of histamine release should be avoided during pregnancy. Also, immunologic suppressive action can occur during pregnancy and for this reason it is possible that the results of allergy skin tests may not accurately reflect the allergic state of the pregnant patient12.
NURSING MOTHERS 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 allergenic extract is administered to a nursing woman.
PEDIATRIC USE The procedures and precautions that are observed in skin testing adults should be observed with children13.
Adverse Reactions
LOCAL REACTIONS Large, persistent local reactions or minor exacerbations of the patient's allergic symptoms may be treated by local cold applications and/or the use of oral anti-histamines.
SYSTEMIC REACTIONS Allergenic extracts are highly potent and in highly sensitive individuals can cause systemic symptoms, including anaphylaxis. It cannot be overemphasized that anaphylactic shock is always a possibility under certain unpredictable combinations of circumstances. Other possible systemic reaction symptoms may include fainting, pallor, bradycardia, hypotension, angioedema, cough, wheezing, conjunctivitis, rhinitis and urticaria. Therefore, it is imperative that physicians administering skin tests understand and be prepared to treat severe allergic reactions.
If a systemic or anaphylactic reaction occurs during or following skin testing, the patient should be treated with 1:1000 epinephrine hydrochloride. The recommended dose: infants to 2 years of age 0.05 to 0.1 mL, children 2 to 6 years, 0.15 mL, children 6 to 12 years, 0.2 mL, adults 0.3 - 0.5 mL. If necessary, treatment may be repeated up to three times every 10 - 15 minutes.
After administration of epinephrine, profound shock or vasomotor collapse should be treated with intravenous fluids and possibly vasoactive drugs. Oxygen should be given by mask. Intravenous antihistamine, aminophylline, inhaled bronchodilators or adrenal corticosteroids may be used if necessary after adequate epinephrine and circulatory support have been given. Emergency resuscitation measures and personnel trained in their use should be available immediately. The physician should be prepared in advance for all contingencies. Promptness in beginning emergency treatment is of utmost importance14.
Serious adverse reactions should be reported to MedWatch: The FDA Safety Information and Adverse Event Reporting Program, Office Of The Center Director, Center for Drug Evaluation and Research, 5515 Security Lane, Suite 5100, Rockville, MD 20852, Telephone (800) 332-1088.
Overdosage
The signs and symptoms of overdosage are the same as those listed under ADVERSE REACTIONS, paragraphs 1 and 2.
The treatment of a systemic allergic reaction resulting from skin tests should include the following:
- The patient should be placed in the recumbent position to maintain blood flow to the head.
- Aqueous epinephrine 1:1,000 should be administered subcutaneously. See ADVERSE REACTIONS for dose and other supportive measures.
- Reassurance should be provided.
The above steps should be performed nearly simultaneously and as soon as possible after the reaction begins. Persistent wheezing may necessitate treatment with intravenous aminophylline and inhaled bronchodilators. For profound shock and hypotension, intravenous fluids, vasopressors and oxygen also may be needed. Maintenance of an open airway is critical if upper airway obstruction is present. Corticosteroids may provide benefit if symptoms are prolonged or recurrent.
Trichophyton Dosage and Administration
Prior to administering skin tests, the skin should be cleaned with alcohol and allowed to dry completely. The tests should be placed on the volar surface of the forearm and four rows may be placed on the back.
INTRADERMAL TEST The intradermal test is performed by administering 0.1 mL of extract into the skin. The injection should be given as superficially as possible creating a distinct bleb approximately 5 mm in diameter. The tests should be examined after 15 - 20 minutes and read as negative or positive. Test sites that show a wheal and flare response should be measured and reported in mm of edema and erythema or scored as 1+ to 4+ based on a mm reference scale. Induration after 24 - 48 hours can occur in some individuals and also may be recorded in mm.
How is Trichophyton Supplied
One mL of extract for intradermal skin testing is supplied in 2 mL sealed multidose vials. Each vial contains enough extract for 10 tests.
STORAGE
Extract should be stored at 2°C to 8°C, since higher temperatures may adversely affect the stability of allergens. Do not freeze.
REFERENCES
- Turkeltaub, P.C., The allergy unit - clinical relevance: Issues in allergen standardization, In: Lockey, R.F., S.C. Bukantz (Eds), Allergen Immunotherapy, Marcel Dekkar, New York, 171, 1991.
- Ting, S., E.H. Dunsky, R.M. Lavker, et al., Patterns of mast cell alterations and in vivo mediator release in human allergic skin reactions, J. Allergy Clin. Immunol., 66:417, 1980.
- Zweiman, B., Mediators of allergic inflammation in the skin, Clin. Allergy, 18:419, 1988.
- Askenase, Philip W., Effector and regulatory mechanisms in delayed-type hypersensitivity, Allergy Principles and Practice, vol.1, p. 264, third edition, C.V. Mosby, St. Louis, 1988.
- Lockey, R.F., L.M. Benedict, P.C. Turkeltaub, S.C. Buicantz, Fatalities from immunotherapy (IT) and skin testing (ST), J. Allergy and Clinical Immunol., 79:660, 1987.
- Nelson, H.S., Diagnostic procedures in allergy: I. Allergy skin testing, Ann. Allergy, 51: 411, 1983.
- Bierman, C.W., D.S. Pearlman, G.G. Shapiro, W.W. Busse (Eds), Allergic disease from infancy to adulthood, Third edition, W.B. Saunders Co., Philadelphia, 1996.
- Middleton, E., Jr., C.E. Reed, E.F. Ellis, N.F. Adkinson, J.W. Yunginger (Eds), Allergy principles and practice, Fourth edition, C.V. Mosby, St. Louis, 1993.
- Executive Committee, The American Academy of Allergy and Clinical Immunology, Position Statement, The waiting period after allergen skin testing and immunotherapy, J. Allergy Clin. Immunol., 85:526, 1990.
- Turkeltaub, P.C., P.J. Gergen, The risk of adverse reactions from percutaneous prick-puncture allergen skin testing, venipuncture and body measurements: data from the second National Health and Nutrition Examination Survey (NHANES II) 1976-1980, J. Allergy Clin. Immunol., 84:886, 1989.
- Jacobs, Robert L., Goeffrey W. Rake, Jr., et al., Potentiated anaphylaxis in patients with drug-induced beta-adrenergic blockade, J. Allergy and Clinical Immunol., 68:125, 1981.
- Weinstein, A.M., D.B. Dubin, W. K. Podleski, L.L. Spector, R.S. Farr, Asthma and pregnancy, JAMA 134: 1161, 1979.
- Sly, M.R., Pediatric allergy, Medical Examination Publishing Co., Inc., Second edition, p.352, 1981.
- Executive Committee, The American Academy of Allergy and Clinical Immunology, Position Statement, Personnel and equipment to treat systemic reactions caused by immunotherapy with allergenic extracts. J. Allergy and Clinical Immunol., 77:271, 1986.
| Trichophyton FOR INTRADERMAL SKIN TESTING Trichophyton mentagrophytes and Trichophyton rubrum injection | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| BLA | BLA102211 | 08/15/2007 | |
| Labeler - Allermed Laboratories, Inc. (073364531) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Allermed Laboratories, Inc. | 073364531 | manufacture | |
More Trichophyton resources
- Trichophyton Side Effects (in more detail)
- Trichophyton Drug Interactions
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Sunday, September 2, 2012
Atacand
Generic Name: candesartan (kan de SAR tan)
Brand Names: Atacand
What is candesartan?
Candesartan is an angiotensin II receptor antagonist. Candesartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.
Candesartan is used to treat high blood pressure (hypertension). It is sometimes given together with other blood pressure medications.
Candesartan is also used to treat kidney problems caused by type 2 diabetes.
Candesartan may also be used for purposes not listed in this medication guide.
What is the most important information I should know about candesartan?
Do not use candesartan if you are pregnant. Stop using this medication and tell your doctor right away if you become pregnant. Candesartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control while taking candesartan. You should not use this medication if you are allergic to candesartan. Drinking alcohol can further lower your blood pressure and may increase certain side effects of candesartan.
Do not use potassium supplements or salt substitutes while you are taking candesartan, unless your doctor has told you to.
Your blood pressure will need to be checked often. Visit your doctor regularly.
If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.
In rare cases, candesartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.
What should I discuss with my healthcare provider before taking candesartan?
You should not use this medication if you are allergic to candesartan.
To make sure you can safely take candesartan, tell your doctor if you have any of these other conditions:
- kidney disease;
- liver disease;
congestive heart failure;
an electrolyte imbalance; or
if you are dehydrated.
FDA pregnancy category D. Do not use candesartan if you are pregnant. Stop using this medication and tell your doctor right away if you become pregnant. Candesartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control while taking candesartan.
If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.
It is not known whether candesartan passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
How should I take candesartan?
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Your doctor may occasionally change your dose to make sure you get the best results.
You may take candesartan with or without food.
Your blood pressure will need to be checked often. Visit your doctor regularly.
It may take 2 to 4 weeks of using this medicine before your blood pressure is under control. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 4 weeks of treatment.
If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.
If you need surgery, tell the surgeon ahead of time that you are using candesartan. You may need to stop using the medicine for a short time. Store at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include fast or slow heartbeat, dizziness, or feeling like you might pass out.
What should I avoid while taking candesartan?
Drinking alcohol can further lower your blood pressure and may increase certain side effects of candesartan. Do not use potassium supplements or salt substitutes while you are taking candesartan, unless your doctor has told you to. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.
Candesartan side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. In rare cases, candesartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine. Call your doctor at once if you have any other serious side effect, such as:
feeling like you might pass out;
chest pain;
swelling in your hands or feet; or
slow heart rate, weak pulse, tingly feeling.
Less serious side effects may include:
runny or stuffy nose, sore throat, cough;
back pain;
joint pain;
stomach pain, diarrhea;
headache, dizziness; or
tired feeling.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect candesartan?
Tell your doctor about all other medicines you use, especially:
a diuretic (water pill);
lithium (Eskalith, LithoBid, Lithonate); or
an NSAID (non-steroidal anti-inflammatory drug) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others.
This list is not complete and other drugs may interact with candesartan. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
More Atacand resources
- Atacand Side Effects (in more detail)
- Atacand Use in Pregnancy & Breastfeeding
- Drug Images
- Atacand Drug Interactions
- Atacand Support Group
- 4 Reviews for Atacand - Add your own review/rating
- Atacand Prescribing Information (FDA)
- Atacand Monograph (AHFS DI)
- Atacand Advanced Consumer (Micromedex) - Includes Dosage Information
- Atacand MedFacts Consumer Leaflet (Wolters Kluwer)
- Atacand Consumer Overview
Compare Atacand with other medications
- Heart Failure
- High Blood Pressure
Where can I get more information?
- Your pharmacist can provide more information about candesartan.
See also: Atacand side effects (in more detail)
Thursday, August 30, 2012
Flunisolide
Flunisolide Nasal Solution USP, 0.025% is intended for administration as a spray to the nasal mucosa. Flunisolide, the active component of Flunisolide nasal solution, is an anti-inflammatory steroid.
Flunisolide is represented by the following structural formula:
C24H31FO6 • 1/2H2O
Mol. Wt. 443.52
6α-fluoro-11β 16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone (USAN).
Flunisolide is a white to creamy white crystalline powder. It is soluble in acetone, sparingly soluble in chloroform, slightly soluble in methanol, and practically insoluble in water. It has a melting point of about 245°C.
After initial priming (5 to 6 sprays) each spray of the unit delivers a metered droplet spray of 100 mg formulation containing 25 mcg of Flunisolide.
The size of the droplets produced by the unit is in excess of 8 microns to facilitate deposition on the nasal mucosa. The contents of one nasal spray bottle delivers 200 sprays.
Each mL Contains: ACTIVE: Flunisolide 0.25 mg (0.025%); INACTIVES: Propylene Glycol, Polyethylene Glycol 3350, Butylated Hydroxyanisole, Edetate Disodium, Sodium Citrate, Citric Acid and Purified Water. Sodium Hydroxide and/or Hydrochloric Acid may be added to adjust pH (5.1 – 5.4). PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.
Clinical Pharmacology
Flunisolide has demonstrated potent glucocorticoid and weak mineralocorticoid activity in classical animal test systems. As a glucocorticoid it is several hundred times more potent than the cortisol standard. Clinical studies with Flunisolide have shown therapeutic activity on nasal mucous membranes with minimal evidence of systemic activity at the recommended doses.
A study in approximately 100 patients that compared the recommended dose of Flunisolide nasal solution with an oral dose providing equivalent systemic amounts of Flunisolide has shown that the clinical effectiveness of Flunisolide nasal solution, when used topically as recommended, is due to its direct local effect and not to an indirect effect through systemic absorption.
Following administration of Flunisolide to man, approximately half of the administered dose is recovered in the urine and half in the stool: 65 to 70% of the dose recovered in urine is the primary metabolite, which has undergone loss of the 6α fluorine and addition of a 6β hydroxy group. Flunisolide is well absorbed but is rapidly converted by the liver to the much less active primary metabolite and to glucuronate and/or sulfate conjugates. Because of first-pass liver metabolism, only 20% of the Flunisolide reaches the systemic circulation when it is given orally whereas 50% of the Flunisolide administered intranasally reaches the systemic circulation unmetabolized. The plasma half-life of Flunisolide is 1 to 2 hours.
The effects of Flunisolide on hypothalamic-pituitary-adrenal (HPA) axis function have been studied in adult volunteers. Flunisolide was administered intranasally as a spray in total doses over 7 times the recommended dose (2200 mcg, equivalent to 88 sprays/day) in 2 subjects for 4 days, about 3 times the recommended dose (800 mcg, equivalent to 32 sprays/day) in 4 subjects for 4 days, and over twice the recommended dose (700 mcg, equivalent to 28 sprays/day) in 6 subjects for 10 days. Early morning plasma cortisol concentrations and 24-hour urinary 17-ketogenic steroids were measured daily. There was evidence of decreased endogenous cortisol production at all three doses.
In controlled studies, Flunisolide nasal solution was found to be effective in reducing symptoms of stuffy nose, runny nose and sneezing in most patients. These controlled clinical studies have been conducted in 488 adult patients at doses ranging from 8 to 16 sprays (200-400 mcg) per day and 127 pediatric patients at doses ranging from 6 to 8 sprays (150 to 200 mcg) per day for periods as long as 3 months. In 170 patients who had cortisol levels evaluated at baseline and after 3 months or more of Flunisolide treatment, there was no unequivocal Flunisolide-related depression of plasma cortisol levels.
Clinical studies have shown that improvement is usually apparent within a few days after starting Flunisolide nasal solution.
The mechanisms responsible for the anti-inflammatory action of corticosteroids and for the activity of the aerosolized drug on the nasal mucosa are unknown.
Indications and Usage
Flunisolide nasal solution is indicated for the treatment of the nasal symptoms of seasonal or perennial rhinitis. Flunisolide nasal solution should not be used in the presence of untreated localized infection involving nasal mucosa.
Contraindications
Hypersensitivity to any of the ingredients.
Warnings
The replacement of a systemic corticosteroid with a topical corticoid can be accompanied by signs of adrenal insufficiency, and in addition some patients may experience symptoms of withdrawal, e.g., joint and/or muscular pain, lassitude and/or depression. Patients previously treated for prolonged periods with systemic corticosteroids and transferred to Flunisolide should be carefully monitored to avoid acute adrenal insufficiency in response to stress.
When transferred to Flunisolide, careful attention must be given to patients previously treated for prolonged periods with systemic corticosteroids. This is particularly important in those patients who have associated asthma or other clinical conditions, where too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of their symptoms.
The use of Flunisolide with alternate-day prednisone systemic treatment could increase the likelihood of HPA suppression compared to a therapeutic dose of either one alone. Therefore, Flunisolide treatment should be used with caution in-patients already on alternate-day prednisone regimens for any disease.
Persons who are on drugs that suppress the immune system are more susceptible to infections than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in non-immune pediatric patients or adults on corticosteroids. In such pediatric patients or adults who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If a nonimmune patient is exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package insert for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.
Precautions
General
Intranasal corticosteroids may also cause a reduction in growth velocity when administered to pediatric patients (see PRECAUTIONS, Pediatric Use section).
Symptomatic relief may not occur in some patients for as long as 2 weeks. Although systemic effects are minimal at recommended doses, Flunisolide should not be continued beyond 3 weeks in the absence of significant symptomatic improvement. In clinical studies with Flunisolide administered intranasally, the development of localized infections of the nose and pharynx with Candida albicans has occurred only rarely. When such an infection develops it may require treatment with appropriate local therapy or discontinuance of treatment with Flunisolide.
Flunisolide is absorbed into the circulation. Use of excessive doses of Flunisolide may suppress hypothalamic-pituitary-adrenal function. Flunisolide should be used with caution, if at all, in-patients with active or quiescent tuberculosis infection of the respiratory tract or in untreated fungal, bacterial or systemic viral infections or ocular herpes simplex.
Because of the inhibitory effect of corticosteroids on wound healing, in patients who have experienced recent nasal septal ulcers, recurrent epistaxis, nasal surgery or trauma, a nasal corticosteroid should be used with caution until healing has occurred.
Although systemic effects have been minimal with recommended doses, this potential increases with excessive dosages. Therefore, larger than recommended doses should be avoided.
Information for patients
Patients should use Flunisolide at regular intervals since its effectiveness depends on its regular use. The patient should take the medication as directed. It is not acutely effective and the prescribed dosage should not be increased. Instead, nasal vasoconstrictors or oral antihistamines may be needed until the effects of Flunisolide are fully manifested. One to 2 weeks may pass before full relief is obtained. The patient should contact the physician if symptoms do not improve, or if the condition worsens, or if sneezing or nasal irritation occurs.
Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.
For the proper use of this unit and to attain maximum improvement, the patient should read and follow the accompanying Patient Instructions carefully.
Patients should be advised to clear their nasal passages of secretions prior to use.
Carcinogenesis, mutagenesis, impairment of fertility
In mice, Flunisolide at an oral dose of 500 mcg/kg/day (approximately 6 times the maximum recommended daily intranasal dose in adults and children on a mg/m2 basis) for 21 months was negative for carcinogenic effects. In rats, administration of Flunisolide at an oral dose of 2.5 mcg/kg/day (less than the maximum recommended daily intranasal dose in adults and children on a mg/m2 basis) for 24 months resulted in an increased incidence of mammary gland adenoma and islet cell adenoma of the pancreas in females. There were no significant increases in the incidence of any tumor type in rats at an oral dose of 1.0 mcg/kg (less than the maximum recommended daily intranasal dose in adults and children on a mg/m2 basis).
Flunisolide showed no mutagenic activity in in vitro test systems including the Ames Assay and the Rec-Assay, and no clastogenic activity in either the in vitro chromosomal aberration assay in Chinese hamster lung fifibroblast cells or the in vivo mouse bone marrow chromosomal aberration assay.
Flunisolide, at an oral dose of 200 mcg/kg/day (approximately 4 times the maximum recommended daily intranasal dose in adults on a mg/m2 basis) produced impaired fertility in female rats, but was devoid of such effect at oral doses less than or equal to 40 mcg/kg/day (approximately equal to the maximum recommended daily intranasal dose in adults on a mg/m2 basis).
Pregnancy
Pregnancy Category C. As with other corticosteroids, Flunisolide has been shown to be teratogenic and fetotoxic in rabbits and rats at oral doses of 40 and 200 mcg/kg/day respectively (approximately 2 and 4 times, respectively, the maximum recommended daily intranasal dose in adults on a mg/m2 basis). There are no adequate and well-controlled studies in pregnant women. Flunisolide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing mothers
It is not known whether this drug is excreted in human milk. Because other corticosteroids are excreted in human milk, caution should be exercised when Flunisolide is administered to nursing women.
Pediatric use
Flunisolide nasal solution is not recommended for use in pediatric patients less than 6 years of age as safety and efficacy, have not been assessed in this age group. Controlled clinical studies have shown that intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. This effect has been observed in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The long-term effects of this reduction in growth velocity associated with intranasal corticosteroids, including the impact on final adult height, are unknown. The potential for “catch up” growth following discontinuation of treatment with intranasal corticosteroids has not been adequately studied. The growth of pediatric patients receiving intranasal corticosteroids, including Flunisolide nasal solution, should be monitored routinely (e.g., via stadiometry). The potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of safe and effective noncorticosteroid treatment alternatives. To minimize the systemic effects of intranasal corticosteroids, including Flunisolide nasal solution, each patient should be titrated to the lowest dose that effectively controls his/her symptoms.
Geriatric use
Clinical studies of Flunisolide nasal solution did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose reduction for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting a greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Adverse Reactions
Adverse reactions reported in controlled clinical trials and long-term open studies in 595 patients treated with Flunisolide nasal solution are described below. Of these patients, 409 were treated for 3 months or longer, 323 for 6 months or longer, 259 for 1 year or longer, and 91 for 2 years or longer.
In general, side effects elicited in the clinical studies have been primarily associated with the nasal mucous membranes. The most frequent complaints were those of mild transient nasal burning and stinging, which were reported in approximately 45% of the patients treated with Flunisolide nasal solution in placebo-controlled and long-term studies. These complaints do not usually interfere with treatment; in only 3% of patients was it necessary to decrease dosage or stop treatment because of these symptoms. Approximately the same incidence of mild transient nasal burning and stinging was reported in patients on placebo as was reported in patients treated with Flunisolide nasal solution in controlled studies, implying that these complaints may be related to the vehicle or the delivery system. The incidence of complaints of nasal burning and stinging decreased with increasing duration of treatment.
Other side effects reported at a frequency of 5% or less were: nasal congestion, sneezing, epistaxis and/or bloody mucous, nasal irritation, watery eyes, sore throat, nausea and/or vomiting, and headaches. As with other nasally inhaled corticosteroids, nasal septal perforations have been reported in rare instances with the use of Flunisolide nasal solutions. Temporary or permanent loss of the sense of smell and taste have also been reported with the use of Flunisolide nasal solutions.
Systemic corticosteroid side effects were not reported during the controlled clinical trials. If recommended doses are exceeded, or if individuals are particularly sensitive, symptoms of hypercorticism, i.e., Cushing’s syndrome, could occur. Cases of growth suppression have been reported for intranasal corticosteroids (including Flunisolide nasal solution) (see PRECAUTIONS, Pediatric Use section).
Overdosage
Flunisolide, infused intravenously, at doses up to 4 mg/kg in mice, rats and dogs (approximately 45, 300 and 90 times, respectively, the maximum recommended daily intranasal dose in adults and children on a mg/m2 basis) was without lethality.
Dosage and Administration
Adults: The recommended starting dose of Flunisolide nasal solution is 2 sprays (50 mcg) in each nostril 2 times a day (total dose 200 mcg/day). If needed, this dose may be increased to 2 sprays in each nostril 3 times a day (total dose 300 mcg/day).
Pediatric Patients 6 to 14 years: The recommended starting dose of Flunisolide nasal solution is 1 spray (25 mcg) in each nostril 3 times a day or 2 sprays (50 mcg) in each nostril 2 times a day (total dose 150 to 200 mcg/day). Flunisolide nasal solution is not recommended for use in pediatric patients less than 6 years of age as safety and efficacy studies, including possible adverse effects on growth, have not been conducted.
Maximum total daily doses should not exceed 8 sprays in each nostril for adults (total dose 400 mcg/day) and 4 sprays in each nostril for pediatric patients under 14 years of age (total dose 200 mcg/day). Since there is no evidence that exceeding the maximum recommended dosage is more effective and increased systemic absorption would occur, higher doses should be avoided.
After the desired clinical effect is obtained, the maintenance dose should be reduced to the smallest amount necessary to control the symptoms. Approximately 15% of patients with perennial rhinitis may be maintained on as little as 1 spray in each nostril per day.
For priming and repriming the nasal spray unit after storage: The patient should remove the dust cover. Put two fingers on “shoulders” of pump unit, and place thumb on bottom of bottle. Push bottle with thumb FIRMLY and QUICKLY 5-6 times or until fine spray appears. Now your pump is primed. The patient must prime the pump unit again if it has not been used for 5 days or more, or if it has been disassembled for cleaning.
How Supplied
Flunisolide Nasal Solution USP, 0.025% is supplied in a nasal pump dispenser with dust cover and with patient instructions in the following size:
25 mL bottles - Prod. No. 34454
Each 25 mL Flunisolide nasal solution spray bottle contains 6.25 mg (0.25 mg/mL), 200 sprays of Flunisolide.
Directions For Use
A patient leaflet of instructions accompanies each package of Flunisolide nasal solution.
Warning
Do not spray in eyes.
Storage
Store between 15°-30°C (59°-86°F).
KEEP OUT OF REACH OF CHILDREN.
Rx only
FOR INTRANASAL USE ONLY
Manufacturer Information
Bausch & Lomb Incorporated
Tampa, FL 33637
©Bausch & Lomb Incorporated
Revised January 2008
9116400
Patient Instructions
PHARMACIST — DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT
Flunisolide Nasal Solution USP, 0.025%
– HOW TO USE YOUR NASAL PUMP UNIT –
Your nasal spray unit with the pump requires no assembly. Just follow the simple instructions below.
IMPORTANT INFORMATION ON Flunisolide NASAL SOLUTION:
1. You should use Flunisolide nasal solution at regular intervals since its effectiveness depends on its regular use (see below).
2. It may take 1-2 weeks before full relief is obtained.
3. You should contact your physician if symptoms do not improve, if the condition worsens, or if sneezing, nasal irritation, or bleeding occurs.
4. You should contact your physician if you know you have been exposed to chickenpox or measles.
TO PRIME:
1. Remove the dust cover. Put two fingers on “shoulders” of pump unit, and place thumb on bottom of bottle. Push bottle with thumb FIRMLY and QUICKLY 5-6 times or until a fine spray appears. Now your pump is primed. You must prime the pump unit again if you have not used it for 5 days or more, or if you have disassembled it for cleaning.
2. If the solution is delivered in a stream of liquid, it may fail to provide maximum benefit and cause some discomfort. A fine mist can be produced only by a rapid and firm pumping action.
3. Once your pump is primed, it‘s ready to use.
NOTE: Keep dust cover on the pump unit when not in use.
PHARMACIST — DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT
TO USE:
1. Gently blow nose to clear nostrils. If nose is blocked, use medicine your doctor has recommended to open nasal passages.
2. Remove the dust cover. Be sure the pump unit is primed.
3. Place the spray tip into one nostril (tip should not reach far into nose).
Bend head forward so spray will aim toward the back of the nose.
4. Hold pump as shown, resting back of index finger against upper lip.
BE CAREFUL THAT FINGERS DO NOT SLIP OFF THE PUMP AS YOU SPRAY.
5. Point the tip toward the BACK and OUTER SIDE of the nose. Close other nostril with finger. Pump the spray by pushing bottle with thumb FIRMLY and QUICKLY and sniff gently at the same time. Your doctor will tell you whether to pump once or twice in each nostril.
6. After spraying in nostril, remove unit from nose and bend head back for a few seconds to let spray spread over back of nose.
7. Repeat Steps 5 and 6 in other nostril. You may feel brief burning or stinging after using the spray.
8. Keep dust cover on the pump unit when not in use.
TO CLEAN:
1. If spray nozzle becomes clogged, DO NOT ATTEMPT TO CLEAR IT USING A POINTED OBJECT. Remove the pump unit from bottle.
2. Soak only the pump unit in warm water. Squirt several times while holding under water.
3. Make sure the pump unit is dry. Assemble as before with 5 or 6 sprays before use.
Bausch & Lomb Incorporated
Tampa, FL 33637
©Bausch & Lomb Incorporated
Revised January 2008
9116400
Principal Display Panel
NDC 24208-344-25
Flunisolide Nasal Solution USP, 0.025%
Rx only
[icon-nose] [icon 0.025%] [icon pump spray] [icon 25 mL]
200 Metered Sprays
Bausch & Lomb
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA074805 | 02/20/2002 | |
| Labeler - Bausch & Lomb Incorporated (196603781) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Bausch & Lomb Incorporated | 807927397 | MANUFACTURE | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Teva-Sicor SpA | 429369713 | API MANUFACTURE | |
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