measles and rubella virus vaccine live Intramuscular, Injection

MEE-zuls VYE-rus VAX-een, lyve, roo-BELL-a VYE-rus VAX-een, lyve

Commonly used brand name(s)

In Canada

• Eolarix

Available Dosage Forms:

• Injectable


• Powder for Solution

Therapeutic Class: Vaccine

Uses For measles and rubella virus vaccine live

Measles and rubella virus vaccine live is an active immunizing agent used to prevent infection by the measles and rubella viruses. It works by causing your body to produce its own protection (antibodies) against the viruses.

Measles (also known as coughing measles, hard measles, morbilli, red measles, rubeola, and 10-day measles) is an infection that is easily spread from one person to another. Infection with measles can cause serious problems, such as pneumonia, ear infections, sinus problems, convulsions (seizures), brain damage, and possibly death. The risk of serious complications and death is greater for adults and infants than for children and teenagers.

Rubella (also known as German measles) is a serious infection that causes miscarriages, stillbirths, or birth defects in unborn babies when pregnant women get the disease.

While immunization against measles and rubella is recommended for all persons 12 months of age and older, it is especially important for women of childbearing age and persons traveling outside the U.S.

If measles and rubella vaccine is to be given to a child, the child should be at least 12 months of age. This is to make sure the measles vaccine is effective. In a younger child, antibodies from the mother may prevent the vaccine from working.

This vaccine should be administered only by or under the supervision of your doctor or other health care professional.

Before Using measles and rubella virus vaccine live

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to measles and rubella virus vaccine live 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

Use of this vaccine is not recommended for infants younger than 12 months of age, unless the risk of measles infection is high. Waiting until children are at least 12 months of age is important because antibodies that infants receive from their mothers before birth may interfere with the effectiveness of the vaccine. In addition, there may be special reasons why children between 6 months and 12 months of age also may require measles vaccination.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during 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 this vaccine, 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.

Receiving this vaccine 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.

• Aclarubicin


• Adalimumab


• Aldesleukin


• Alemtuzumab


• Altretamine


• Amonafide


• Amsacrine


• Asparaginase


• Azacitidine


• Azathioprine


• Bleomycin


• Broxuridine


• Busulfan


• Capecitabine


• Carboplatin


• Carmustine


• Certolizumab Pegol


• Chlorambucil


• Cisplatin


• Cladribine


• Cyclophosphamide


• Cytarabine


• Cytarabine Liposome


• Dacarbazine


• Dactinomycin


• Daunorubicin


• Daunorubicin Citrate Liposome


• Decitabine


• Docetaxel


• Doxifluridine


• Doxorubicin Hydrochloride


• Doxorubicin Hydrochloride Liposome


• Edatrexate


• Eflornithine


• Epirubicin


• Estramustine


• Etanercept


• Etoposide


• Everolimus


• Fingolimod


• Floxuridine


• Fludarabine


• Fluorouracil


• Fotemustine


• Gallium Nitrate


• Gemcitabine


• Golimumab


• Hydroxyurea


• Idarubicin


• Ifosfamide


• Irinotecan


• Lomustine


• Mechlorethamine


• Melphalan


• Meningococcal Vaccine


• Mercaptopurine


• Methotrexate


• Mitolactol


• Mitomycin


• Mitotane


• Mitoxantrone


• Mycophenolic Acid


• Oxaliplatin


• Paclitaxel


• Pegaspargase


• Pentostatin


• Pipobroman


• Pirarubicin


• Plicamycin


• Procarbazine


• Raltitrexed


• Rilonacept


• Rituximab


• Sirolimus


• Streptozocin


• Tacrolimus


• Teceleukin


• Tegafur


• Temsirolimus


• Teniposide


• Thioguanine


• Thiotepa


• Topotecan


• Treosulfan


• Trimetrexate


• Trofosfamide


• Uracil Mustard


• Ustekinumab


• Vinblastine


• Vincristine


• Vincristine Liposome


• Vindesine


• Vinorelbine

Receiving this vaccine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abatacept


• Cytomegalovirus Immune Globulin, Human


• Hepatitis B Immune Globulin


• Immune Globulin


• Leflunomide


• Rabies Immune Globulin


• Respiratory Syncytial Virus Immune Globulin, Human


• Rho(D) Immune Globulin


• Tetanus Immune Globulin


• Vaccinia Immune Globulin, Human


• Varicella-Zoster Immune Globulin

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Immune deficiency condition (or family history of)—Condition may increase the chance and severity of side effects of the vaccine and/or may decrease the useful effects of the vaccine

• Severe illness with fever—The symptoms of the condition may be confused with the possible side effects of the vaccine

Proper Use of measles and rubella virus vaccine live

Dosing

The dose of measles and rubella virus vaccine live 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 measles and rubella virus vaccine live. 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 injection dosage form:
  
  • For prevention of measles and rubella:
    
    • Adults and children 12 months of age and older—One dose injected under the skin.
    
    
    • Children up to 12 months of age—Use is not recommended.
    
    
  
  

Precautions While Using measles and rubella virus vaccine live

Do not become pregnant for 3 months after receiving measles and rubella vaccine without first checking with your doctor. There may be a chance that this vaccine can cause birth defects.

Tell your doctor that you have received this vaccine:

• If you are to receive a tuberculin skin test within 4 to 6 weeks after receiving this vaccine. The results of the test may be affected by this vaccine.


• If you are to receive blood products or immune globulins within 14 days of receiving this vaccine.


• If you are to receive this vaccine within 3 to 11 months of receiving blood products or immune globulins

measles and rubella virus vaccine live Side Effects

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

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

Symptoms of allergic reaction - rare

• Difficulty in breathing or swallowing


• hives


• itching, especially of feet or hands


• reddening of skin, especially around ears


• swelling of eyes, face, or inside of nose


• unusual tiredness or weakness (sudden and severe)

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

More common

• Fever over 103 °F (39.4 °C)

Less common

• Pain or tenderness of eyes

Rare

• Bruising or purple spots on skin


• confusion


• convulsions (seizures)


• double vision


• headache (severe or continuing)


• irritability


• pain, numbness, or tingling of hands, arms, legs, or feet


• stiff neck


• vomiting

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

• Burning or stinging at place of injection


• fever between 100 and 103 °F (37.7 and 39.4 °C)


• skin rash


• swelling of glands in neck

Less common

• Aches or pain in joints


• headache (mild)


• itching, swelling, redness, tenderness, or hard lump at place of injection


• nausea


• runny nose


• sore throat


• vague feeling of bodily discomfort

The above side effects (especially aches or pain in joints) are more likely to occur in adults, particularly women.

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.

Flurox Ophthalmic Solution

Dosage Form: ophthalmic solution
Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4%

DESCRIPTION:

Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% is disclosing agent with rapid anesthetic action and short duration.

CLINICAL PHARMACOLOGY:

Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% is the combination of a disclosing agent with a rapidly acting anesthetic of short duration. 

INDICATIONS AND USAGE:

For procedures requiring a disclosing agent in combination with a topical ophthalmic anesthetic agent such as tonometry, gonioscopy, removal of corneal foreign bodies and other short corneal or conjunctival procedures.

CONTRAINDICATIONS:

Known hypersensitivity to any component of this product.

WARNINGS:

NOT FOR INJECTION-FOR TOPICAL OPHTHALMIC USE ONLY.

Prolonged use of a topical ocular anesthetic is not recommended.  It may product permanent corneal opacification with accompanying visual loss.

PRECAUTIONS:

Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% should be used cautiously and sparingly in patients with known allergies, cardiac disease, or hyperthyroidism.  The long-term toxicity is unknown; prolonged use may possibly delay wound healing.  Although exceedingly rare with ophthalmic application of local anesthetics, it should be borne in the mind that systemic toxicity manifested by central nervous system stimulation followed by depression may occur.  Protection of the eye from irritation chemicals, foreign bodies and rubbing during the period of anesthesia is very important.  Tonometers soaked in sterilizing or detergent solutions should be thoroughly rinsed with sterile distilled water prior to use.  Patients should be advised to avoid touching the eye until the anesthesia has worn off. 

Pregnancy:

Pregnancy Category C. Animal reproduction studies have not been conducted with Fluorescein Sodium Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4%.  It is also not known whether Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.  Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% should be given to a pregnant woman only if clearly needed.  

Nursing Mothers:

Caution should be exercised when Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% is administered to a nursing women. 

Pediatric Use:

Safety and effectiveness in pediatric patients have not been established.

ADVERSE REACTIONS:

Occasional temporary stinging, burning, and conjunctival redness have been reported after use of ocular anesthetics, as well as a rare, severe, immediate-type, apparent hyper-allergic corneal reaction, with acute, intense and diffuse epithelial keratitis, a gray, ground glass appearance, sloughing of large areas of necrotic epithelium, corneal filaments and sometimes, iritis with descemetitis. 


Allergic contact dermatitis with drying and fissuring of the fingertips has been reported.

DOSAGE and ADMINISTRATION:

Usual Dosage: Removal of foreign bodies and sutures and for tonometry, 1 t0 2 drops (in single instillations) in each eye before operating.

HOW SUPPLIED:

Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% is supplied in a glass bottle with a sterilized dropper in the following size:

5 mL-Prod.No.30107

Storage:

Store in a refrigerator at 2o-8oC (36o-46oF).

User may store at room temperature up to one month.

Keep tightly closed.

DO NOT USE IF IMPRINTED BODY SEAL IS NOT INTACT.

KEEP OUT OF REACH OF CHILDREN.

FLUROX  fluorescein sodium and benoxinate hydrochloride ophthalmic solution  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 54799-506 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Fluorescein Sodium (FLUORESCEIN) Fluorescein Sodium 2.5 mg  in 1 mL BENOXINATE HYDROCHLORIDE (BENOXINATE) BENOXINATE HYDROCHLORIDE 4 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength Povidone   Boric Acid   WATER   Chlorobutanol   Hydrochloric Acid

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 54799-506-05 5 mL In 1 BOTTLE, DROPPER None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/30/2006	02/29/2012

Labeler - OCuSOFT Inc. (174939207)

Registrant - OCuSOFT Inc. (174939207)

Establishment
Name	Address	ID/FEI	Operations
Bausch & Lomb Incorporated		807927397	manufacture

Revised: 09/2011OCuSOFT Inc.

More Flurox Ophthalmic Solution resources

• Flurox Ophthalmic Solution Side Effects (in more detail)
• Flurox Ophthalmic Solution Support Group
• 0 Reviews · Be the first to review/rate this drug

Striant

Generic Name: testosterone buccal system (tes TOSS ter one)

Brand Names: Striant

What is testosterone buccal system?

Testosterone is a naturally occurring "male" sex hormone necessary for many processes in the body.

Testosterone buccal system is used to treat men with low testosterone levels.

Testosterone buccal system may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about testosterone buccal system?

Notify your doctor if you experience nausea; vomiting; swelling of the ankles; changes in skin color; too frequent or prolonged erections; breathing disturbances, including those associated with sleep; yellowing of the skin or eyes; dark colored urine; or problems with urination. Notify your doctor if a female partner experiences male-pattern baldness, excessive body hair growth, an increase in acne, menstrual irregularities, or signs of masculinity.

Regularly inspect the gum where the testosterone buccal system is applied. Promptly report any changes to your doctor or dentist.

What should I discuss with my healthcare provider before using testosterone buccal system?

Do not use testosterone buccal system if you have cancer of the breast or prostate. Testosterone may worsen some cancers of these types.

Before using testosterone buccal system, tell your doctor if you have

• 
  

  had a previous allergic reaction to testosterone;

  
  


• 
  

  diabetes;

  
  


• 
  

  sleep apnea (brief periods of not breathing during sleep) or if you have risk factors for sleep apnea (e.g., obesity, chronic lung disease);

  
  


• 
  

  difficulty with urination due to enlargement of the prostate;

  
  


• 
  

  heart disease; or

  
  


• liver disease or kidney disease.

You may not be able to use testosterone buccal system, or you may need a dosage adjustment or special monitoring if you have any of the conditions listed above.

Testosterone buccal system is not approved for use by women and must not be used by women. Testosterone buccal system is in the FDA pregnancy category X. This means that testosterone is known to cause birth defects in an unborn baby. Do not use testosterone buccal system if you are pregnant or could become pregnant during treatment. Testosterone buccal system is not approved for use by women and must not be used by women. It is not known whether testosterone from the buccal system will pass into breast milk.Do not use testosterone buccal system if you are breast-feeding a baby. Men over 65 years of age that use testosterone buccal system may be at increased risk for the development of prostatic enlargement or cancer. You may not be able to use buccal system testosterone, or you may require a lower dose or special monitoring.

How should I use testosterone buccal system?

Use testosterone buccal system exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

To use the testosterone buccal system (Striant):

• 
  

  Hold one buccal system with the flat side on your fingertip. Place the curved side onto your gum, as high as possible above the left or right incisor tooth. Hold your finger on the outside of your lip over the system for 30 seconds to ensure the system is attached to the gum. If the system sticks to the cheek and not the gum, this is acceptable.

  
  


• 
  

  The buccal system should remain in place for 12 hours. To remove the system, move it slightly toward the back or front of the mouth then slide it toward the teeth from removal. With each new application, rotate to alternate sides of the mouth. This avoids scratching the gum. Check to see that the system is in place after eating, drinking, brushing the teeth, or using mouthwash.

  
  


• 
  

  As the buccal system absorbs moisture from the mouth, it will begin to soften and will mold to the shape of the gum. The system does not dissolve completely, but will remain in place. It will not move until you remove it.

  
  


• 
  

  If a buccal system falls off before 8 hours of use, remove it and replace it with a new system in the same place.

  
  


• 
  

  Change the buccal system and alternate sides of the mouth 12 hours after application of the original system. If a buccal system falls off after 8 hours but before 12 hours of use, remove the system and replace it with a new system above the opposite incisor. This will serve as the second dose for the day.

  
  


• 
  

  Do not chew or swallow the testosterone buccal system.

  
  


• 
  

  Regularly inspect the gum where the testosterone buccal system is applied. Promptly report any changes to your doctor or dentist.

  
  

Your doctor may want to perform tests to monitor the amount of testosterone in the body, liver function, prostate function, cholesterol levels, or other factors during treatment with testosterone buccal system.

It is important to use testosterone buccal system regularly to get the most benefit.

Dispose of all used systems properly, out of the reach of children and pets.

Store testosterone buccal system at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the next system as soon as you remember. Do not use two doses simultaneously, unless otherwise directed by your doctor.

What happens if I overdose?

An overdose of testosterone buccal system is not likely to threaten life. If you do suspect an overdose, or if a system has been ingested, call an emergency room or poison control center for advice.

What should I avoid while using testosterone buccal system?

Regularly inspect the gum where the testosterone buccal system is applied. Promptly report any changes to your doctor or dentist.

Testosterone buccal system side effects

If you experience any of the following serious side effects, stop using testosterone buccal system and seek emergency medical attention or contact your doctor immediately:

• 
  

  an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

  
  


• 
  

  nausea or vomiting;

  
  


• 
  

  changes in skin color;

  
  


• 
  

  swelling of the ankles or legs;

  
  


• 
  

  breathing disturbances, including those associated with sleep;

  
  


• 
  

  too frequent or prolonged erections;

  
  


• 
  

  liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, or severe fatigue); or

  
  


• 
  

  dark colored urine or problems with urination.

  
  

Other, less serious side effects may be more likely to occur. Continue to use testosterone buccal system and talk to your doctor if you experience

• 
  

  irritation or changes in the gum at the system application site;

  
  


• 
  

  bitter or unusual taste in the mouth;

  
  


• 
  

  headache;

  
  


• 
  

  emotional changes;

  
  


• 
  

  increased blood pressure;

  
  


• 
  

  decreased interest in sex;

  
  


• 
  

  changes in blood cholesterol or number of red blood cells (detected by blood tests);

  
  


• 
  

  prostate changes or difficulty urinating;

  
  


• 
  

  enlarged, swollen or tender breasts; or

  
  


• 
  

  acne.

  
  

Notify your doctor if a female partner experiences male-pattern baldness, excessive body hair growth, an increase in acne, menstrual irregularities, or signs of masculinity.

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

What other drugs will affect testosterone buccal system?

Before using testosterone buccal system, tell your doctor if you are taking any of the following medicines:

• 
  

  warfarin (Coumadin);

  
  


• 
  

  insulin or an oral diabetes medication such as glipizide (Glucotrol), glyburide (Diabeta, Micronase, Glynase), repaglinide (Prandin), rosiglitazone (Avandia), pioglitazone (Actos), and others;

  
  


• 
  

  propranolol (Inderal, Inderal LA, others); or

  
  


• 
  

  a corticosteroid such as hydrocortisone (Cortef, Hydrocortone, Solu-Cortef), dexamethasone (Decadron, Hexadrol others), methylprednisolone (Depo-Medrol, Medrol, Solu-Medrol), prednisolone (Prelone, Pediapred), prednisone (Deltasone, Orasone, others), and others.

  
  

You may not be able to use testosterone buccal system, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with testosterone buccal system. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

More Striant resources

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

• Striant MedFacts Consumer Leaflet (Wolters Kluwer)


• Striant Advanced Consumer (Micromedex) - Includes Dosage Information


• Striant Consumer Overview


• Striant Prescribing Information (FDA)


• Testosterone Monograph (AHFS DI)


• Testosterone Prescribing Information (FDA)


• Testosterone Professional Patient Advice (Wolters Kluwer)


• AndroGel Prescribing Information (FDA)


• AndroGel Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Androderm Advanced Consumer (Micromedex) - Includes Dosage Information


• Androderm Patch MedFacts Consumer Leaflet (Wolters Kluwer)


• Androderm Prescribing Information (FDA)


• Androgel Consumer Overview


• Androgel Advanced Consumer (Micromedex) - Includes Dosage Information


• Axiron Prescribing Information (FDA)


• Axiron Consumer Overview


• Axiron Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Delatestryl Prescribing Information (FDA)


• Delatestryl MedFacts Consumer Leaflet (Wolters Kluwer)


• Depo-Testosterone Prescribing Information (FDA)


• Depo-Testosterone MedFacts Consumer Leaflet (Wolters Kluwer)


• Fortesta Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Fortesta Consumer Overview


• Testim Prescribing Information (FDA)


• Testim Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Testosterone Cypionate Prescribing Information (FDA)


• Testosterone Enanthate Prescribing Information (FDA)

Compare Striant with other medications

• Hypogonadism, Male

Where can I get more information?

• Your pharmacist has additional information about testosterone buccal system written for health professionals that you may read.

See also: Striant side effects (in more detail)

Sodium Sulfacetamide Medicated Pads

Sodium Sulfacetamide

Medicated Pads 10%

in a Urea Vehicle

Topical Antibacterial Therapy

FOR DERMATOLOGICAL USE ONLY. NOT FOR OPHTHALMIC USE.

DESCRIPTION: 10% Sodium Sulfacetamide Medicated Pads contain 10% sodium sulfacetamide. Inactive ingredients: purified water, sodium thiosulfate, trisodium EDTA, and urea.

Sodium sulfacetamide is a sulfonamide with antibacterial activity. Chemically, sodium sulfacetamide is C8H9N2Na03S•H20, with a molecular weight of 254.24. Chemically it is Acetamide, N- [(4 aminophenyl) sulfonyl]-, monosodium salt and monohydrate, with the following structural formula:

CLINICAL PHARMACOLOGY: Sodium sulfacetamide exerts a bacteriostatic effect against sulfonamide-sensitive gram-positive and gram-negative microorganisms including Propionibacterium acnes commonly isolated from secondary cutaneous pyogenic infections.

The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth. While absorption through intact skin in humans has not been determined, sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine largely unchanged. The biological half-life has variously been reported as 7 to 12.8 hours.

INDICATIONS AND USAGE: 10% Sodium Sulfacetamide Medicated Pads are indicated for the treatment of bacterial infections of the skin due to organisms susceptible to sulfonamides including Propionibacterium acnes. They are also intended for topical control of seborrheic dermatitis of the face and scalp.

CONTRAINDICATIONS: 10% Sodium Sulfacetamide Medicated Pads are contraindicated in persons with known or suspected hypersensitivity to sulfonamides or to any of the ingredients of the preparation. 10% Sodium Sulfacetamide Medicated Pads are not to be used by patients with kidney disease.

WARNINGS: Although rare, sensitivity to sodium sulfacetamide may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice, and contact dermatitis indicate hypersensitivity to sulfonamides. Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the topical use of sodium sulfacetamide. Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide have also been reported.

PRECAUTIONS: General: Nonsusceptible organisms, including fungi, may proliferate with the use of this preparation. Hypersensitivity reactions may recur when a sulfonamide is readministered, irrespective of the route of administration, and cross hypersensitivity between different sulfonamides may occur. If 10% Sodium Sulfacetamide Medicated Pads produce signs of hypersensitivity or other untoward reactions, discontinue use of the preparation. Systemic absorption of topical sulfonamides is greater following application to large, infected, abraded, denuded, or severely burned areas. Under these circumstances, any of the adverse effects produced by the systemic administration of these agents could potentially occur, and appropriate observations and laboratory determinations should be performed.

Information For Patients: Avoid contact with eyes, eyelids, lips, and mucous membranes. If accidental contact occurs, rinse with water. Patients should discontinue the use of 10% Sodium Sulfacetamide Medicated Pads if the condition becomes worse, or if a rash develops in the area being treated or elsewhere. 10% Sodium Sulfacetamide Medicated Pads also should be discontinued promptly and the physician notified if any arthritis, fever, or sores in the mouth develop.

Drug Interactions: 10% Sodium Sulfacetamide Medicated Pads are incompatible with silver preparations.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term animal studies for carcinogenic potential have not been performed on 10% Sodium Sulfacetamide Medicated Pads.

Pregnancy Category C: Animal reproduction studies have not been conducted with 10% Sodium Sulfacetamide Medicated Pads. It also is not known whether 10% Sodium Sulfacetamide Medicated Pads can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 10% Sodium Sulfacetamide Medicated Pads should be used by a pregnant woman only if clearly needed.

Nursing Mothers: It is not known whether this drug is excreted in human milk following topical use of 10% Sodium Sulfacetamide Medicated Pads. Because many drugs are excreted in human milk, caution should be exercised when 10% Sodium Sulfacetamide Medicated Pads are administered to a nursing woman.

Pediatric Use: Safety and effectiveness in children below the age of 12 years have not been established.

ADVERSE REACTIONS: Reports of irritation and hypersensitivity to sodium sulfacetamide are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sodium sulfacetamide, are noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity, which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome has been reported (see WARNINGS.)

Call your doctor for medical advice about side effects.

DOSAGE AND ADMINISTRATION: Cutaneous Bacterial Infection - Gently apply 10% Sodium Sulfacetamide Medicated Pads to the affected areas 1 to 2 times daily or as directed by a physician until the infection has cleared.

Seborrheic dermatitis - Gently apply 10% Sodium Sulfacetamide Medicated Pads to the skin or scalp 1 to 2 times daily or as directed by a physician.

Dispense in accordance with applicable state law. This product has not been approved by the FDA, is not listed in the Orange Book, and has not been approved or rated for therapeutic equivalence with any other product.

HOW SUPPLIED: 10% Sodium Sulfacetamide Medicated Pads, NDC 42808-0101-30.

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature. Protect from freezing.

Note: 10% Sodium Sulfacetamide Medicated Pads may darken after prolonged storage. Slight discoloration does not impair the efficacy or safety of the product.

Rx Only

Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747

00-0101-30-205-00

Iss:5/11

PACKAGE LABEL -30 foil pouches

For External Use Only

NDC 42808-0101-30        Rx Only

Sodium Sulfacetamide

(In a Urea Vehicle)

10%

PADS

Exact-Rx.

INCORPORATED

Contains (30) foil pouches

each with a single-use 2.5 mL medicated pad

SODIUM SULFACETAMIDE  sodium sulfacetamide  swab

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 42808-101 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFACETAMIDE SODIUM (SULFACETAMIDE) SULFACETAMIDE SODIUM 100 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength WATER   SODIUM THIOSULFATE   EDETATE TRISODIUM   UREA

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 42808-101-30 30 POUCH In 1 BOX contains a POUCH 1 2.5 mL In 1 POUCH This package is contained within the BOX (42808-101-30)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/01/2011

Labeler - Exact-Rx, Inc. (137953498)

Revised: 08/2011Exact-Rx, Inc.

More Sodium Sulfacetamide Medicated Pads resources

• Sodium Sulfacetamide Medicated Pads Use in Pregnancy & Breastfeeding
• Sodium Sulfacetamide Medicated Pads Support Group
• 0 Reviews for Sodium Sulfacetamide - Add your own review/rating

Compare Sodium Sulfacetamide Medicated Pads with other medications

• Seborrheic Dermatitis
• Secondary Cutaneous Bacterial Infections

Avita Cream

tretinoin

Dosage Form: cream

Avita Cream Description

AVITA® Cream, a topical retinoid, contains tretinoin 0.025% by weight in a hydrophilic cream vehicle of stearic acid, polyolprepolymer-2, isopropyl myristate, polyoxyl 40 stearate, propylene glycol, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. Chemically, tretinoin is all-transretinoic acid (C20H2802; molecular weight 300.44 vitamin A acid) and has the following structural formula:

Avita Cream - Clinical Pharmacology

Although the exact mode of action of tretinoin is unknown, current evidence suggests that topical tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedo formation. Additionally, tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells causing extrusion of the comedones.

Pharmacokinetics

In vitro and in vivo pharmacokinetic studies with AVITA® Cream indicate that less than 0.3% of the topically applied dose is bioavailable. Circulating plasma levels of both tretinoin and isotretinoin are only slightly elevated above those found in healthy normal controls.

Clinical Studies

In one vehicle-controlled clinical trial, AVITA® (tretinoin cream) Cream 0.025%, applied once daily was more effective than vehicle in the treatment of facial acne vulgaris of mild to moderate severity. Percent reductions in lesion count after treatment for 12 weeks in this study are shown in the following table:

	Avita® Cream, 0.025%	Vehicle Cream
	N = 75	N = 58
Noninflammatory Lesions	45%	27%
Inflammatory Lesions	46%	32%
Total Lesions	46%	28%
N = Number of Subjects

Indications and Usage for Avita Cream

AVITA® Cream is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of this product in the treatment of other disorders have not been established.

Contraindications

The product should not be used if there is hypersensitivity to any of the ingredients.

Precautions

General

If a reaction suggesting sensitivity or chemical irritation occurs, use of the medication should be discontinued. Exposure to sunlight, including sunlamps, should be minimized during the use of AVITA® Cream, and patients with sunburn should be advised not to use the product until fully recovered because of heightened susceptibility to sunlight as a result of the use of tretinoin. Patients who may be required to have considerable sun exposure due to occupation and those with inherent sensitivity to the sun should exercise particular caution. Use of sunscreen products and protective clothing over treated areas is recommended when exposure cannot be avoided. Weather extremes, such as wind or cold, also may be irritating to patients under treatment with tretinoin.

AVITA® (tretinoin cream) Cream, 0.025% should be kept away from the eyes, the mouth, the paranasal creases, and mucous membranes. Topical use may induce severe local erythema and peeling at the site of application. If the degree of local irritation warrants, patients should be directed to temporarily use the medication less frequently, discontinue use temporarily, or discontinue use altogether. Efficacy at reduced frequencies of application has not been established. Tretinoin has been reported to cause severe irritation on eczematous skin and should be used with utmost caution in patients with this condition.

Information for Patients

See attached Patient Package Insert.

Drug Interactions

Concomitant topical medication, medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices or lime should be used with caution because of possible interaction with tretinoin. Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid with AVITA® Cream. It also is advisable to “rest” a patient’s skin until the effects of such preparations subside before use of AVITA® Cream is begun.

Carcinogenesis, Mutagenesis and Impairment of Fertility

In a life-time dermal study in CD-1 mice with another tretinoin cream, at 100 and 200 times the average recommended human topical clinical dose, a few skin tumors in the female mice and liver tumors in male mice were observed. The biological significance of these findings is not clear because they occurred at doses that exceeded the dermal maximally tolerated dose (MTD) of tretinoin and because they were within the background natural occurrence rate for these tumors in this strain of mice. There was no evidence of carcinogenic potential when tretinoin was administered topically at a dose five times the average recommended human topical clinical dose. For purposes of comparisons of the animal exposure to human exposure, the “recommended human topical clinical dose” is defined as 1.0 g of 0.025% AVITA® Cream applied daily to a 50 kg person. In a chronic, two-year bioassay of vitamin A acid in mice performed by Tsubura and Yamamoto, generalized amyloid deposition was reported in all vitamin A treated groups in the basal layer of the skin. In CD-1 mice, a similar study reported hyalinization at the treated skin sites and the incidence of this finding was 0/50, 3/50, 3/50, and 2/50 in male mice and 1/50, 0/50, 4/50, and 2/50 in female mice from the vehicle control, 0.25 mg/kg, 0.5 mg/kg, and 1 mg/kg groups, respectively.

Studies in hairless albino mice suggest that tretinoin may enhance the tumorigenic potential of carcinogenic doses of UVB and UVA light from a solar simulator. In other studies, when lightly pigmented hairless mice treated with tretinoin were exposed to carcinogenic doses of UVA/UVB light, the incidence and rate of development of skin tumors were either reduced or no effect was seen. Due to significantly different experimental conditions, no strict comparison of these disparate data is possible at this time. Although the significance of these studies to humans is not clear, patients should minimize exposure to sun.

The mutagenic potential of tretinoin was evaluated in the Ames assay and in the in vivo mouse micronucleus assay, both of which were negative.

Dermal Segment I and III studies with AVITA® Cream have not been performed in any species. In oral Segment I and Segment III studies in rats with tretinoin, decreased survival of neonates and growth retardation were observed at doses in excess of 2 mg/kg/day (> 400 times the average recommended human topical clinical dose).

Pregnancy: Pregnancy Category C.

Teratogenic Effects

Oral tretinoin has been shown to be teratogenic in rats, mice, rabbits, hamsters, and subhuman primates. It was teratogenic and fetotoxic in rats when given orally in doses 1000 times the average recommended human topical clinical dose. However, variations in teratogenic doses among various strains of rats have been reported. In the cynomolgus monkey, which metabolically is closer to humans for tretinoin than other species examined, fetal malformations were reported at oral doses of 10 mg/kg/day or greater, but none were observed at 5 mg/kg/day (1000 times the average recommended human topical clinical dose), although increased skeletal variations were observed at all doses. Dose-related increased embryolethality and abortion were reported. Similar results have also been reported in pigtail macaques.

Topical tretinoin in animal teratogenicity tests has generated equivocal results. There is evidence for teratogenicity (shortened or kinked tail) of topical tretinoin in Wistar rats at doses greater than 1 mg/kg/day (200 times the recommended human topical clinical dose). Anomalies (humerus: short 13%, bent 6%; os parietal incompletely ossified 14%) have also been reported in rats when 10 mg/kg/day was dermally applied.

Topical tretinoin (AVITA® Cream, 0.1%) has been shown to be teratogenic in rabbits when given in doses 91 times the topical human dose for cream (assuming a 50 kg adult applies 1.0 g of 0.1% cream topically). In this study, increased incidence of cleft palate and hydrocephaly was reported in the tretinoin-treated animals.

There are other reports, in New Zealand White rabbits with doses of approximately 80 times the recommended human topical clinical dose, of an increased incidence of domed head and hydrocephaly, typical of retinoid-induced fetal malformations in this species.

When given subcutaneously to rabbits, tretinoin was teratogenic at 2 mg/kg/day but not at 1 mg/kg/day. These doses are approximately 400 and 200 times, respectively, the human topical dose of tretinoin cream, 0.025% (assuming a 50 kg adult applies 1.0 g of 0.025% cream topically).

In contrast, several well-controlled animal studies have shown that dermally applied tretinoin was not teratogenic at doses of 100 and 200 times the recommended human topical clinical dose, in rats and rabbits, respectively.

With widespread use of any drug, a small number of birth defect reports associated temporally with the administration of the drug would be expected by chance alone. Thirty cases of temporally associated congenital malformations have been reported during two decades of clinical use of another formulation of topical tretinoin (Retin-A). Although no definite pattern of teratogenicity and no causal association have been established from these cases, five of the reports describe the rare birth defect category, holoprosencephaly (defects associated with incomplete midline development of the forebrain). The significance of these spontaneous reports in terms of risk to the fetus is not known.

Nonteratogenic Effects

Dermal tretinoin has been shown to be fetotoxic in rabbits when administered in doses 100 times the recommended topical human clinical dose. Oral tretinoin has been shown to be fetotoxic in rats when administered in doses 500 times the recommended topical human clinical dose. There are, however, no adequate and well-controlled studies in pregnant women. AVITA® (tretinoin cream) Cream, 0.025% should not be used during pregnancy.

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 AVITA® Cream is administered to a nursing woman.

Adverse Reactions

The skin of certain sensitive individuals may become excessively red, edematous, blistered, or crusted. If these effects occur, the medication should either be discontinued until the integrity of the skin is restored, or the medication dosing frequency should be adjusted temporarily to a level the patient can tolerate. However, efficacy has not been established for lower dosing frequencies. True contact allergy to topical tretinoin is rarely encountered. Temporary hyper- or hypopigmentation has been reported with repeated application of AVITA® Cream. Some individuals have been reported to have heightened susceptibility to sunlight while under treatment with AVITA® Cream. Adverse effects of AVITA® Cream have been reversible upon discontinuation of therapy (see Dosage and Administration Section).

Overdosage

If medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling, or discomfort may occur. Oral ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of vitamin A.

Avita Cream Dosage and Administration

AVITA® Cream should be applied once a day, in the evening, to the skin where acne lesions appear, using enough to cover the entire affected area lightly. Application may cause a transient feeling of warmth or slight stinging. In cases where it has been necessary to temporarily discontinue therapy or reduce the frequency of application, therapy may be resumed or frequency of application increased when the patients become able to tolerate the treatment. Alterations of dose frequency should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance. Efficacy has not been established for less than once-daily dosing frequencies.

During the early weeks of therapy, an apparent increase in number and exacerbation of inflammatory acne lesions may occur. This is due, in part, to the action of the medication on deep, previously unseen lesions and should not be considered a reason to discontinue therapy. Therapeutic results should be noticed after two to three weeks but more than six weeks of therapy may be required before definite beneficial effects are seen. Patients treated with AVITA® Cream may use cosmetics, but the areas to be treated should be cleansed thoroughly before the medication is applied (see Precautions Section).

How is Avita Cream Supplied

AVITA® (tretinoin cream) Cream, 0.025% is supplied as:

NDC Code	Strength	Quantity
0378-6141-44	0.025%	20 g
0378-6141-45	0.025%	45 g

Storage Conditions: Store below 30°C (86°F). Avoid freezing.

Rx Only

Mylan Pharmaceuticals Inc.

Morgantown, WV 26505

Revised February 2009

023.4

Patent #’s: 5,700,483 and 5,650,171

  

 Remove this portion before dispensing

AVITA®

(tretinoin cream)

CREAM, 0.025%

PATIENT INSTRUCTIONS

Acne Treatment

IMPORTANT

Read Directions Carefully

Before Using

THIS LEAFLET TELLS YOU ABOUT AVITA® (TRETINOIN) CREAM ACNE TREATMENT AS PRESCRIBED BY YOUR PHYSICIAN. THIS PRODUCT IS TO BE USED ONLY ACCORDING TO YOUR DOCTOR’S INSTRUCTIONS, AND IT SHOULD NOT BE APPLIED TO OTHER AREAS OF THE BODY OR TO OTHER GROWTHS OR LESIONS. THE SAFETY AND EFFECTIVENESS OF THIS PRODUCT IN OTHER DISORDERS HAVE NOT BEEN EVALUATED. IF YOU HAVE ANY QUESTIONS, BE SURE TO ASK YOUR DOCTOR.

PRECAUTIONS

The effects of the sun on your skin: As you know, overexposure to natural sunlight or the artificial sunlight of a sunlamp can cause sunburn. Overexposure to the sun over many years may cause premature aging of the skin and even skin cancer. The chances of these effects occurring will vary depending on skin type, the climate and the care taken to avoid overexposure to the sun. Therapy with AVITA® Cream may make your skin more susceptible to sunburn and other adverse effects of the sun, so unprotected exposure to natural or artificial sunlight should be minimized.

Laboratory findings: When laboratory mice are exposed to artificial sunlight, they often develop skin tumors. These sunlight-induced tumors may appear more quickly and in greater number if the mouse is also topically treated with the active ingredient in AVITA® Cream, tretinoin. In some studies, under different conditions, however, when mice treated with tretinoin were exposed to artificial sunlight, the incidence and rate of development of skin tumors was reduced. There is no evidence to date that tretinoin alone will cause the development of skin tumors in either laboratory animals or humans. However, investigations in this area are continuing.

Use caution in the sun: When outside, even on hazy days, areas treated with AVITA® Cream should be protected. An effective sunscreen should be used any time you are outside (consult your physician for a recommendation of an SPF level which will provide you with the necessary high level of protection). For extended sun exposure, protective clothing, like a hat, should be worn. Do not use artificial sunlamps while you are using AVITA® (tretinoin cream) Cream, 0.025%. If you do become sunburned, stop your therapy with AVITA® Cream until your skin has recovered.

Avoid excessive exposure to wind or cold: Extremes of climate tend to dry or burn normal skin. Skin treated with AVITA® Cream may be more vulnerable to these extremes.Your physician can recommend ways to manage your acne treatment under such conditions.

Possible problems: The skin of certain sensitive individuals may become excessively red, swollen, blistered, or crusted. If you are experiencing severe or persistent irritation, discontinue the use of AVITA® Cream and consult your physician.

There have been reports that, in some patients, areas treated with AVITA® Cream developed a temporary increase or decrease in the amount of skin pigment (color) present.

Use other medication only on your physician’s advice: Only your physician knows which other medications may be helpful during treatment and will recommend them to you if necessary. Follow the physician’s instructions carefully. In addition, you should avoid preparations that may dry or irritate your skin. These preparations may include certain astringents, toiletries containing alcohol, spices or lime, or certain medicated soaps, shampoos, and hair permanent solutions. Do not allow anyone else to use this medication.

Do not use other medications with AVITA® Cream which are not recommended by your doctor. The medications you have used in the past might cause unnecessary redness or peeling.

If you are pregnant, think you are pregnant, or are nursing an infant: No studies have been conducted in humans to establish the safety of AVITA® Cream in pregnant women. If you are pregnant, think you are pregnant, or are nursing a baby, consult your physician before using this medication.

AND WHILE YOU’RE ON AVITA® THERAPY

Use a mild non-medicated soap. Avoid frequent washings and harsh scrubbing. Acne isn’t caused by dirt, so no matter how hard you scrub, you can’t wash it away. Washing too frequently or scrubbing too roughly may at times actually make your acne worse.Wash your skin gently with a mild, bland soap. Two or three times a day should be sufficient. Pat skin dry with a towel. Let the face dry 20 to 30 minutes before applying AVITA® (tretinoin cream) Cream, 0.025%. Remember, excessive irritation such as rubbing, too much washing, use of other medications not suggested by your physician, etc., may worsen your acne.

HOW TO USE AVITA® (TRETINOIN) CREAM

To get the best results with AVITA® Cream therapy, it is necessary to use it properly. Forget about the instructions given for other products and the advice of friends. Just stick to the special plan your doctor has laid out for you and be patient. Remember, when AVITA® Cream is used properly, many users see improvement by 12 weeks. AGAIN, FOLLOW INSTRUCTIONS - BE PATIENT - DON’T START AND STOP THERAPY ON YOUR OWN - IF YOU HAVE QUESTIONS, ASK YOUR DOCTOR.

To help you use the medication correctly, keep these simple instructions in mind.

• AVITA® Cream should be applied once a day, in the evening, or as directed by your physician, to the skin where acne lesions appear, using enough to cover the entire affected area lightly. First, wash with a mild soap and dry your skin gently.WAIT 20 to 30 MINUTES BEFORE APPLYING MEDICATION; it is important for skin to be completely dry in order to minimize possible irritation.


• It is better not to use more than the amount suggested by your physician or to apply more frequently than instructed. Too much may irritate the skin, waste medication, and won’t give faster or better results.


• Keep the medication away from the corners of the nose, mouth, eyes, and open wounds. Spread away from these areas when applying.


• Cream: Squeeze about a half inch or less of medication onto the fingertip. While that should be enough for your whole face, after you have had some experience with the medication you may find you need slightly more or less to do the job. The medication should become invisible almost immediately. If it is still visible, you are using too much. Cover the affected area lightly with AVITA® Cream by first dabbing it on your forehead, chin, and both cheeks, then spreading it over the entire affected area. Smooth gently into the skin.


• If needed, you may apply a moisturizer or a moisturizer with sunscreen that will not aggravate your acne (noncomedogenic) in the morning after you wash.

WHAT TO EXPECT WITH YOUR NEW TREATMENT

AVITA® (tretinoin cream) Cream, 0.025% works deep inside your skin and this takes time. You cannot make AVITA® Cream work any faster by applying more than one dose each day, but an excess amount of AVITA® Cream may irritate your skin. Be patient.

There may be some discomfort or peeling during the early days of treatment. Some patients also notice that their skin begins to take on a blush.

These reactions do not happen to everyone. If they do, it is just your skin adjusting to AVITA® Cream and this usually subsides within two to four weeks. These reactions can usually be minimized by following instructions carefully. Should the effects become excessively troublesome, consult your doctor.

BY THREE TO SIX WEEKS, some patients notice an appearance of new blemishes (papules and pustules). At this stage, it is important to continue using AVITA® Cream.

If AVITA® Cream is going to have a beneficial effect for you, you should notice an improvement in your appearance by 6 to 12 weeks of therapy. Don’t be discouraged if you see no immediate improvement. Don’t stop treatment at the first signs of improvement.

Once your acne is under control, you should continue regular application of AVITA® Cream until your physician instructs otherwise.

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

Mylan Pharmaceuticals Inc.

Morgantown, WV 26505

Revised February 2009

Printed in U.S.A

023.4PL

Patent #’s: 5,700,483 and 5,650,171

PRINCIPAL DISPLAY PANEL - 0.025%

NDC 0378-6141-44

AVITA®

(tretinoin) Cream 0.025%

20 g

For Topical Use Only

Rx only

Mylan Pharmaceuticals Inc., Morgantown, WV 26505

Patent #'s: 5,700,483 and 5,650,171

Contains: Tretinoin 0.025% in a cream vehicle of stearic acid, polyolprepolymer-2,

isopropyl myristate, polyoxyl 40 stearate, propylene glycol, stearyl alcohol,

xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water.

Usual Dosage: See accompanying package insert

for full prescribing information.

Store below 30°C (86°F).

Avoid freezing.

See crimp of tube for lot number

and expiration date.

934.5

AVITA  tretinoin  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0378-6141 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRETINOIN (TRETINOIN) TRETINOIN 0.25 mg  in 1 g

Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYTOLUENE   ISOPROPYL MYRISTATE   NITROGEN   POLYOXYL 40 STEARATE   PROPYLENE GLYCOL   SORBIC ACID   STEARIC ACID   STEARYL ALCOHOL   XANTHAN GUM   WATER

Product Characteristics Color WHITE Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0378-6141-44 20 g In 1 TUBE None 2 0378-6141-45 45 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020404	05/20/2011

Labeler - Mylan Pharmaceuticals Inc. (059295980)

Revised: 02/2009Mylan Pharmaceuticals Inc.

More Avita Cream resources

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

Compare Avita Cream with other medications

• Acne
• Lichen Sclerosus
• Necrobiosis Lipoidica Diabeticorum
• Photoaging of the Skin

polyethylene glycol electrolyte solution

Generic Name: polyethylene glycol electrolyte solution (pall ee ETH il een GLYE kol ee LEK troe lyte)

Brand names: Colyte, Colyte with Flavor Packs, GoLYTELY, MoviPrep, NuLYTELY, NuLYTELY Cherry, NuLYTELY Lemon Lime, NuLYTELY Orange, NuLYTELY with Flavor Packs, PEG-3350 with Electolytes, TriLyte with Flavor Packs, ...show all 19 brand names.Colonic Lavage Solution, Go-Evac, Co-Lav, MiraLax (obsolete), Colyte Flavored, GaviLyte-N, GaviLyte-C, GaviLyte-G

What is polyethylene glycol electrolyte solution?

Polyethylene glycol electrolyte solution is a laxative solution that increases the amount of water in the intestinal tract to stimulate bowel movements. This medication also contains potassium, sodium, and other minerals to replace electrolytes that are passed from the body in the stool.

Polyethylene glycol electrolyte solution is used to clean the bowel before colonoscopy, a barium x-ray, or other intestinal procedures.

Polyethylene glycol electrolyte solution may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about polyethylene glycol electrolyte solution?

Do not use this medication if you are allergic to polyethylene glycol or any other electrolyte solutions (such as Pedialyte or Gatorade).

You should also not take polyethylene glycol electrolyte solution if you have a perforated bowel, a bowel obstruction or severe constipation, or colitis or toxic megacolon. If you have any these conditions, you could have dangerous or life-threatening side effects from polyethylene glycol electrolyte solution.

People with eating disorders (such as anorexia or bulimia) should not take polyethylene glycol electrolyte solution without the advice of a doctor.

Talk to your healthcare provider if you are not able to consume all of the solution. Incomplete cleansing of the bowel may affect the scheduled procedure.

What should I discuss with my health care provider before taking polyethylene glycol electrolyte solution?

Do not use this medication if you are allergic to polyethylene glycol or any other electrolyte solutions (such as Pedialyte or Gatorade), or if you have:

• 
  

  a perforated bowel;

  
  


• 
  

  a bowel obstruction or severe constipation; or

  
  


• 
  

  colitis or toxic megacolon.

  
  

If you have any these conditions, you could have dangerous or life-threatening side effects from polyethylene glycol electrolyte solution.

People with eating disorders (such as anorexia or bulimia) should not use this medication without the advice of a doctor.

Before taking polyethylene glycol electrolyte solution, tell your doctor if you are allergic to any drugs, or if you have:

• 
  

  nausea or vomiting;

  
  


• 
  

  trouble swallowing; or

  
  


• 
  

  a history of bowel obstruction, diverticulitis, ulcerative colitis, or other chronic bowel disease.

  
  

If you have any of these conditions, you may need a dose adjustment or special tests to safely take polyethylene glycol electrolyte solution.

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

Older adults may be more likely to have serious side effects from this medicine.

How should I take polyethylene glycol electrolyte solution?

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

Do not take polyethylene glycol electrolyte solution if it has been less than 2 hours since you last ate solid food. For best results, take the medicine 3 to 4 hours after you last ate.

Do not add any flavorings to this medicine, such as sugar, honey, artificial sweetener, fruit juices, or other beverages.

Chilling the medicine in a refrigerator may make it taste better. Shake the liquid well just before you measure a dose. Drink this medicine in the exact portions at the exact time intervals prescribed by your doctor.

Polyethylene glycol electrolyte solution will produce watery diarrhea. Keep taking the medicine until your stool is watery and clear. In most cases, at least 3 liters of polyethylene glycol electrolyte solution is needed for the full effect.

The usual dose of the medication is 8 ounces every 10 minutes. Drink each portion as quickly as possible, rather than sipping it slowly. The first watery stool should appear within 1 hour after you start drinking polyethylene glycol electrolyte solution.

You may be instructed not to drink or eat anything before your medical test or procedure. Follow your doctor's instructions about the type and amount of liquids you should drink for at least 24 hours before and after your test or procedure.

Throw away any polyethylene glycol electrolyte solution you have not used within 48 hours after it was mixed.

What happens if I miss a dose?

Talk to your doctor if you cannot drink all of the medication prescribed for you. Your test or procedure may need to be rescheduled if your bowel is not completely cleansed.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine at one time.

An overdose of this medication is not expected to produce life-threatening symptoms.

What should I avoid while taking polyethylene glycol electrolyte solution?

Avoid taking other medications, vitamins, or mineral supplements within 1 hour before drinking polyethylene glycol electrolyte solution. Any medications you take just before a bowel cleansing will not be properly absorbed into your body.

Do not use other laxatives while using polyethylene glycol electrolyte solution unless your doctor has told you to.

Polyethylene glycol electrolyte solution side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor if you have any of these serious side effects:

• 
  

  severe stomach pain or bloating;

  
  


• 
  

  no bowel movement within 2 hours after use; or

  
  


• 
  

  gagging, choking, or vomiting.

  
  

If you have any of these side effects, you may need to drink the medication more slowly, or stop using it for a short time.

Less serious side effects may include:

• 
  

  mild stomach cramps, gas, or bloating;

  
  


• 
  

  rectal pain or irritation;

  
  


• 
  

  nausea; or

  
  


• 
  

  passing gas.

  
  

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

Polyethylene glycol electrolyte solution Dosing Information

Usual Adult Dose for Bowel Preparation:

240 mL (8 fluid ounces) orally every 10 minutes until 4 liters are consumed or rectal effluent is clear. In cases requiring nasogastric administration, a rate of 20 to 30 mL per minute is recommended.

Usual Adult Dose for Gastrointestinal Decontamination:

1 to 2 liters per hour orally or via nasogastric tube until the effluent is clear. Polyethylene glycol electrolyte solution is sometimes administered in combination with activated charcoal, however, charcoal adsorption may occur.

Usual Adult Dose for Constipation -- Chronic:

240 to 480 mL (8 to 16 fluid ounces) orally once a day.

What other drugs will affect polyethylene glycol electrolyte solution?

There may be other drugs that can interact with polyethylene glycol electrolyte solution. 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 polyethylene glycol electrolyte solution resources

• Polyethylene glycol electrolyte solution Use in Pregnancy & Breastfeeding
• Polyethylene glycol electrolyte solution Support Group
• 39 Reviews for Polyethylene glycol electrolyte solution - Add your own review/rating

Compare polyethylene glycol electrolyte solution with other medications

• Bowel Preparation
• Constipation, Chronic
• Gastrointestinal Decontamination

Where can I get more information?

• Your pharmacist can provide more information about polyethylene glycol electrolyte solution.

Salicylic Acid Pads

Pronunciation: sal-ih-SILL-ik AS-id
Generic Name: Salicylic Acid
Brand Name: Examples include Dr. Scholl's Zino Soft Corn Remover and Tinamed Plantar

Salicylic Acid Pads are used for:

Removing corns, calluses, and warts. It may also be used for other conditions as determined by your doctor.

Salicylic Acid Pads are a topical salicylate. It works by causing the skin to swell, soften, and then slough or peel in areas where it is applied.

Do NOT use Salicylic Acid Pads if:

• you are allergic to any ingredient in Salicylic Acid Pads


• you have diabetes or poor blood circulation

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

Before using Salicylic Acid Pads:

Some medical conditions may interact with Salicylic Acid Pads. 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 had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to aspirin or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, naproxen, celecoxib)


• if you have liver or kidney problems, a skin infection, or skin irritation

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

• Anticoagulants, (eg, heparin, warfarin), aspirin, methotrexate, or sulfonylureas (eg, glipizide) because the risk of side effects may be increased by Salicylic Acid Pads

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

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

• First soak the affected area in warm water for about 5 minutes. Dry thoroughly. Apply according to instructions from your doctor or on the packaging. Unless your hands are being treated, be sure to wash your hands after each use.


• If you miss a dose of Salicylic Acid Pads, 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 Salicylic Acid Pads.

Important safety information:

• Salicylic Acid Pads are for external use only. Avoid getting Salicylic Acid Pads in your eyes, nose, or mouth, or on the genitals. If contact with your eyes occurs, flush with water for 15 minutes. Do not inhale the vapors of Salicylic Acid Pads.


• Do not use Salicylic Acid Pads longer or more often than recommended by your doctor or on the package label.


• Check with your doctor before use if you have a condition that covers a large area of the body.


• Be sure to apply Salicylic Acid Pads only to the affected area and not to normal healthy skin.


• Do not use Salicylic Acid Pads on skin that is irritated, infected, or reddened.


• Do not use Salicylic Acid Pads on open skin wounds, moles, birthmarks, genital warts, warts on the face, or warts growing hair.


• Do not use any other medicines or drying products on your skin unless your doctor instructs you otherwise.


• Salicylic Acid Pads may interfere with certain lab test results. Make sure your doctor and lab personnel know you are using Salicylic Acid Pads.


• Salicylic Acid Pads are extremely flammable. Do not store or use Salicylic Acid Pads near a fire or other open flame.


• Salicylic Acid Pads may be harmful if swallowed. If you may have taken Salicylic Acid Pads by mouth, contact your local poison control center or emergency room immediately.


• Salicylic Acid Pads contains a salicylate, which has been linked to Reye syndrome. Do not use Salicylic Acid Pads on children or teenagers during or after chickenpox, flu, or other viral infections without checking with your doctor or pharmacist.


• Caution is advised when using Salicylic Acid Pads in CHILDREN because they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Salicylic Acid Pads during pregnancy. It is unknown if Salicylic Acid Pads are excreted in breast milk. If you are or will be breast-feeding while you are using Salicylic Acid Pads, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Salicylic Acid Pads:

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:

Dry, peeling, red, or scaling skin.

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); severe irritation.

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

See also: Salicylic Acid side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include agitation; diarrhea; dizziness; loss of appetite; loss of hearing; mental disturbances; nausea; rapid or difficult breathing; ringing in the ears; seizures; sluggishness; vomiting; yellowing of the skin or eyes.

Proper storage of Salicylic Acid Pads:

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

General information:

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


• Salicylic Acid Pads are to be used only by the patient for whom it is prescribed. Do not share it with other people.


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


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

This information is a summary only. It does not contain all information about Salicylic Acid Pads. 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 Salicylic Acid resources

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

Compare Salicylic Acid with other medications

• Acne
• Dermatological Disorders
• Warts