AH-Chew Chewable Tablets

Pronunciation: KLOR-fen-IR-a-meen/FEN-il-EF-rin/METH-skoe-POL-a-meen
Generic Name: Chlorpheniramine/Phenylephrine/Methscopolamine
Brand Name: Examples include AH-Chew and Extendryl

AH-Chew Chewable Tablets are used for:

Relieving congestion, sneezing, runny nose, and itchy, watery eyes due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

AH-Chew Chewable Tablets are an antihistamine, decongestant, and anticholinergic combination. It works by blocking histamine, a substance in the body that causes sneezing, runny nose, and watery eyes. It also relieves nasal congestion by shrinking the nasal mucous membranes, which promotes nasal drainage, and dries the chest by decreasing lung secretions.

Do NOT use AH-Chew Chewable Tablets if:

• you are allergic to any ingredient in AH-Chew Chewable Tablets


• you are pregnant or breast-feeding


• you take sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days


• you are taking or have taken medicine for high blood pressure or depression in the last 14 days


• you have a history of narrow-angle glaucoma, blockage in the stomach or intestines, peptic ulcer disease, intestinal or bowel problems, difficulty urinating, inflammation of the esophagus from reflux disease, difficulty swallowing, or uncontrolled bleeding


• you have severe heart disease or severe high blood pressure

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

Before using AH-Chew Chewable Tablets:

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

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have diabetes, an enlarged prostate, a history of bladder or kidney problems, high blood pressure, diarrhea, asthma, nerve problems, heart problems, blood clots, a hiatal hernia, an adrenal gland tumor, glaucoma, breathing problems during sleep, myasthenia gravis (muscle weakness), or an overactive thyroid

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

• Alpha-blockers (eg, guanethidine, methyldopa, prazosin), beta-blockers (eg, atenolol), diuretics (eg, furosemide, hydrochlorothiazide), furazolidone, or MAOIs (eg, phenelzine) because the risk of high or low blood pressure may be increased


• Alkalizers (eg, calcium or magnesium antacids), anticholinergics (eg, atropine, benztropine, dicyclomine), carbonic anhydrase inhibitors (eg, acetazolamide), ergotamine, sodium bicarbonate, or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of AH-Chew Chewable Tablets's side effects


• Bromocriptine, catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), certain stimulants (eg, doxapram, pseudoephedrine), cocaine, digoxin, droxidopa, potassium chloride, or sodium oxybate (GHB) because the risk of their side effects may be increased by AH-Chew Chewable Tablets


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by AH-Chew Chewable Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if AH-Chew Chewable Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use AH-Chew Chewable Tablets:

Use AH-Chew Chewable Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

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


• Do not take AH-Chew Chewable Tablets at the same time as antacids, certain medicines for diarrhea (eg, attapulgite, bismuth, kaolin, pectin), or ketoconazole. Take these medicines 2 or 3 hours before or after you take AH-Chew Chewable Tablets.


• Chew thoroughly before swallowing. Follow with a glass of water.


• If you miss a dose of AH-Chew Chewable Tablets and you are taking it regularly, 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 AH-Chew Chewable Tablets.

Important safety information:

• AH-Chew Chewable Tablets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use AH-Chew Chewable Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using AH-Chew Chewable Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• If your symptoms do not get better within 7 days or if they get worse or you develop a high fever or persistent headache, check with your doctor.


• AH-Chew Chewable Tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know that you are taking AH-Chew Chewable Tablets.


• AH-Chew Chewable Tablets may cause dry mouth. To relieve dry mouth, suck on sugarless hard candy or ice chips, chew sugarless gum, drink water, or use a saliva substitute.


• AH-Chew Chewable Tablets may make your eyes more sensitive to sunlight. It may help to wear sunglasses.


• AH-Chew Chewable Tablets may reduce sweating. Do not become overheated in hot weather or while you are being active; heatstroke may occur.


• Do not take diet or appetite control medicines while you are taking AH-Chew Chewable Tablets without checking with your doctor.


• If you have trouble sleeping, ask your doctor or pharmacist about the best time of day to take AH-Chew Chewable Tablets.


• Diabetes patients - AH-Chew Chewable Tablets may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Use AH-Chew Chewable Tablets with caution in the ELDERLY; they may be more sensitive to its effects.


• AH-Chew Chewable Tablets should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Do not use AH-Chew Chewable Tablets if you are pregnant. If you think you may be pregnant, contact your doctor right away. Do not use AH-Chew Chewable Tablets during labor or delivery because it could cause harm to the fetus. AH-Chew Chewable Tablets are found in breast milk. Do not breast-feed while taking AH-Chew Chewable Tablets.

Possible side effects of AH-Chew Chewable Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; clumsiness; constipation; dizziness; drowsiness; dry mouth, nose, or throat; excitability or irritability (especially in children); flushing; giddiness; headache; lack of energy; nausea; nervousness; tearing; trouble sleeping; unusual tiredness or 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); difficulty swallowing; mental or mood changes; pounding in the chest; unusual bleeding or bruising; urinary retention; vomiting.

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: AH-Chew 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 convulsions; deep sleep or loss of consciousness; hot or cool skin; irregular heartbeat; irritability, anxiety, or panic; large pupils; numbness or tingling in the arms or legs; seizures; slowed or shallow breathing; vomiting.

Proper storage of AH-Chew Chewable Tablets:

Store AH-Chew Chewable Tablets in a tightly closed container 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 AH-Chew Chewable Tablets out of the reach of children and away from pets.

General information:

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


• AH-Chew Chewable Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.


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


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

This information is a summary only. It does not contain all information about AH-Chew Chewable Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More AH-Chew resources

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

Compare AH-Chew with other medications

• Nasal Congestion
• Rhinitis

Flector Patch

Generic Name: diclofenac transdermal (dye KLOE fen ak)

Brand Names: Flector Patch

What is Flector Patch (diclofenac transdermal)?

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body.

Diclofenac transdermal skin patch is used to treat pain caused by minor sprains, strains, or bruising.

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

What is the most important information I should know about Flector Patch (diclofenac transdermal)?

Do not use this medication if you have ever had asthma or a severe allergic reaction caused by aspirin, diclofenac (Cataflam, Voltaren), or another non-steroidal anti-inflammatory drug (NSAID). Do not use diclofenac just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have heart disease, congestive heart failure, high blood pressure, a history of heart attack or stroke, a history of stomach ulcer or bleeding, liver or kidney disease, a blood clotting disorder, asthma or polyps in your nose, or if you smoke.

While the risk of absorbing diclofenac transdermal into your bloodstream is low, an NSAID may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term.

Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are using diclofenac transdermal, especially in older adults.

Call your doctor at once if you have symptoms of stomach bleeding such as black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

What should I discuss with my healthcare provider before using Flector Patch (diclofenac transdermal)?

While the risk of absorbing diclofenac transdermal into your bloodstream is low, an NSAID can cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term.

This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are using diclofenac transdermal, especially in older adults.

Do not use this medication if you have ever had asthma or a severe allergic reaction caused by aspirin, diclofenac (Cataflam, Voltaren), or another NSAID. Do not use diclofenac just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

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

• 
  

  a history of drug allergies;

  
  


• 
  

  a history of heart attack, stroke, or blood clot;

  
  


• 
  

  heart disease, congestive heart failure, high blood pressure;

  
  


• 
  

  a history of stomach ulcer or bleeding;

  
  


• liver or kidney disease;


• 
  

  a bleeding or blood clotting disorder;

  
  


• 
  

  asthma;

  
  


• 
  

  polyps in your nose; or

  
  


• 
  

  if you smoke.

  
  

FDA pregnancy category C. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Using diclofenac during the last 3 months of pregnancy may harm the unborn baby. Do not use this medication during pregnancy unless your doctor has told you to. It is not known whether diclofenac transdermal passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use Flector Patch (diclofenac transdermal)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Using extra skin patches will not make the medication more effective. Follow the directions on your prescription label.

Apply the skin patch directly to the area of pain. The skin patch can be worn for up to 12 hours and then removed. Apply a new patch at that time if pain continues. Do not wear a skin patch while taking a bath or shower or while swimming.

Do not apply diclofenac transdermal on an open skin wound, or on areas of eczema, infection, skin rash, or burn injury. Wash your hands after applying or removing a skin patch.

If the patch falls off, try sticking it back on, or use medical tape to hold it on.

After removing a skin patch fold it in half, sticky side in, and throw it away in a place where children or pets cannot get to it. Keep both used and unused skin patches out of the reach of children or pets.

If you use this medication long-term, your blood may need to be tested often. Your blood pressure may also need to be checked. Visit your doctor regularly.

The diclofenac transdermal patch may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the patch before undergoing such a test. Store at room temperature away from moisture and heat. Do not take a skin patch out of the patch envelope until you are ready to use it. Reseal the envelope for storage.

What happens if I miss a dose?

Apply a skin patch as soon as you remember, and wear it for 12 hours before applying a new one. Do not use extra patches to make up the missed dose. Do not wear a diclofenac skin patch for longer than 12 hours.

What happens if I overdose?

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

What should I avoid while using Flector Patch (diclofenac transdermal)?

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Avoid taking aspirin, oral (pill form) diclofenac (Cataflam, Voltaren), or other NSAIDs without your doctor's advice. This includes ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), indomethacin, piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine), and others.

Ask a doctor or pharmacist before using any over-the-counter cold, allergy, or pain medicine. Many combination medicines contain aspirin or other medicines similar to diclofenac (such as ibuprofen, ketoprofen, or naproxen). Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, or naproxen. Avoid getting this medication near your eyes. If this does happen, rinse with water and call your doctor if you have eye irritation that lasts longer than 1 hour.

Flector Patch (diclofenac transdermal) 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.

Although the risk of serious side effects is low when diclofenac is applied to the skin, you should be aware of side effects that can occur if the medication is absorbed into your bloodstream.

Stop using this medicine and call your doctor at once if you have a serious side effect such as:

• 
  

  chest pain, slurred speech, problems with vision or balance, and feeling weak or short of breath;

  
  


• 
  

  bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

  
  


• 
  

  fever, chills, body aches, flu symptoms;

  
  


• 
  

  pale or yellowed skin, dark colored urine, confusion;

  
  


• 
  

  swelling or rapid weight gain;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  
  


• 
  

  skin rash, bruising, severe tingling, numbness, pain, muscle weakness;

  
  


• 
  

  fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or

  
  


• 
  

  the first sign of any skin rash, no matter how mild.

  
  

Less serious side effects may include:

• 
  

  mild nausea, vomiting;

  
  


• 
  

  diarrhea, constipation;

  
  


• 
  

  upset stomach, heartburn, gas;

  
  


• 
  

  dizziness; or

  
  


• 
  

  mild itching, burning, redness, or other skin irritation where the patch was worn.

  
  

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 Flector Patch (diclofenac transdermal)?

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

• 
  

  a blood thinner such as warfarin (Coumadin);

  
  


• 
  

  cyclosporine (Gengraf, Neoral, Sandimmune);

  
  


• 
  

  lithium (Eskalith, Lithobid);

  
  


• 
  

  methotrexate (Rheumatrex, Trexall);

  
  


• 
  

  a diuretic (water pill);

  
  


• 
  

  steroids (prednisone and others); or

  
  


• 
  

  heart or blood pressure medication such as benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace), and others.

  
  

It is not likely that other drugs you take orally or inject will have an effect on topically applied diclofenac. But many drugs can interact with each other. 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 Flector Patch resources

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

Compare Flector Patch with other medications

• Pain

Where can I get more information?

• Your pharmacist can provide more information about diclofenac transdermal.

See also: Flector side effects (in more detail)

Extina

ketoconazole

Dosage Form: aerosol, foam
FULL PRESCRIBING INFORMATION

Indications and Usage for Extina

Extina® (ketoconazole) Foam, 2% is indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older. Safety and efficacy of Extina® Foam for treatment of fungal infections have not been established.

Extina Dosage and Administration

Extina® Foam should be applied to the affected area(s) twice daily for four weeks.

Hold the container upright, and dispense Extina® Foam into the cap of the can or other cool surface in an amount sufficient to cover the affected area(s). Dispensing directly onto hands is not recommended, as the foam will begin to melt immediately upon contact with warm skin. Pick up small amounts of Extina® Foam with the fingertips, and gently massage into the affected area(s) until the foam disappears. For hair-bearing areas, part the hair, so that Extina® Foam may be applied directly to the skin (rather than on the hair).

Avoid contact with the eyes and other mucous membranes. Extina® Foam is not for ophthalmic, oral or intravaginal use.

Dosage Forms and Strengths

Extina® Foam contains 2% ketoconazole in a thermolabile hydroethanolic foam, and is provided in 50 g and 100 g aluminum containers.

Contraindications

None

Warnings and Precautions

Contact Sensitization

Extina® Foam may result in contact sensitization, including photoallergenicity. [See Adverse Reactions (6.2)]

Flammable Contents

The contents of Extina® Foam include alcohol and propane/butane, which are flammable. Avoid fire, flame and/or smoking during and immediately following application. Do not puncture and/or incinerate the containers. Do not expose containers to heat and/or store at temperatures above 120°F (49°C).

Systemic Effects

Hepatitis has been seen with orally administered ketoconazole (1:10,000 reported incidence). Lowered testosterone and ACTH–induced corticosteroid serum levels have been seen with high doses of orally administered ketoconazole. These effects have not been seen with topical ketoconazole.

Adverse Reactions

Adverse Reactions in Clinical Trials

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse reactions that appear to be related to drug use and for approximating rates.

The safety data presented in Table 1 (below) reflect exposure to Extina® Foam in 672 subjects, 12 years and older with seborrheic dermatitis. Subjects applied Extina® Foam or vehicle foam twice daily for 4 weeks to affected areas on the face, scalp, and/or chest. Adverse reactions occurring in > 1% of subjects are presented in

Table 1.

Table 1: Adverse Reactions Reported by > 1% Subjects in Clinical Trials

Adverse Reactions	Extina® Foam N = 672 n (%)	Vehicle Foam N = 497 n (%)
Subjects with an Adverse Reaction	188 (28%)	122 (25%)
Application site burning	67 (10%)	49 (10%)
Application site reaction	41 (6%)	24 (5%)

Application site reactions that were reported in < 1% of subjects were dryness, erythema, irritation, paresthesia, pruritus, rash and warmth.

Dermal Safety Studies

In a photoallergenicity study, 9 of 53 subjects (17%) had reactions during the challenge period at both the irradiated and non-irradiated sites treated with Extina® Foam. Extina® Foam may cause contact sensitization.

USE IN SPECIFIC POPULATIONS

Pregnancy

Teratogenic Effects, Pregnancy Category C

Ketoconazole has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given orally in the diet at 80 mg/kg/day (4.8 times the maximum expected human topical dose based on a mg/m2 comparison, assuming 100% absorption from 8 g of foam). However, these effects may be partly related to maternal toxicity, which was also observed at this dose level. [See Pharmacokinetics (12.3)]

No reproductive studies in animals have been performed with Extina® Foam. There are no adequate and well-controlled studies of Extina® Foam in pregnant women.

Extina® Foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether Extina® Foam administered topically could result in sufficient systemic absorption to produce detectable quantities in breast milk. Because many drugs are excreted in human milk, caution should be exercised when Extina® Foam is administered to women who are breastfeeding.

Pediatric Use

The safety and effectiveness of Extina® Foam in pediatric patients less than 12 years of age have not been established.

Of the 672 subjects treated with Extina® Foam in the clinical trials, 44 (7%) were from 12 to 17 years of age. [See Clinical Studies (14)]

Geriatric Use

Of the 672 subjects treated with Extina® Foam in the clinical trials, 107 (16%) were 65 years and over.

Extina Description

Extina® Foam contains 2% ketoconazole USP, an antifungal agent, in a thermolabile hydroethanolic foam for topical application.

The chemical name for ketoconazole is piperazine, 1-acetyl-4-[4-[[2-(2,4-dichlorophenyl) -2-(1H-imidazol-l-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-, cis- with the molecular formula C26H28Cl2N4O4 and a molecular weight of 531.43. The following is the chemical structure:

Extina® Foam contains 20 mg ketoconazole per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol, citric acid, ethanol (denatured with tert-butyl alcohol and brucine sulfate) 58%, polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant.

Extina - Clinical Pharmacology

Mechanism of Action

The mechanism of action of ketoconazole in the treatment of seborrheic dermatitis is not known.

Pharmacodynamics

The pharmacodynamics of Extina® Foam has not been established.

Pharmacokinetics

In a bioavailability study, 12 subjects with moderate to severe seborrheic dermatitis applied 3 g of Extina® Foam twice daily for 4 weeks. Circulating plasma levels of ketoconazole were < 6 ng/mL for a majority of subjects (75%), with a maximum level of 11 ng/mL observed in one subject.

Microbiology

Ketoconazole is an antifungal agent which inhibits the in vitro synthesis of ergosterol, a key sterol in the cell membrane of Malassezia furfur. The clinical significance of antifungal activity in the treatment of seborrheic dermatitis is not known.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic or photo-carcinogenic potential of Extina® Foam.

In oral carcinogenicity studies in mice (18-months) and rats (24-months) at dose levels of 5, 20 and 80 mg/kg/day ketoconazole was not carcinogenic. The high dose in these studies was approximately 2.4 to 4.8 times the expected topical dose in humans based on a mg/m2 comparison. In a bacterial reverse mutation assay, ketoconazole did not express any mutagenic potential. In three in vivo assays (sister chromatid exchange in humans, dominant lethal and micronucleus tests in mice), ketoconazole did not exhibit any genotoxic potential.

At oral dose levels of 75 mg/kg/day (4.5 times the expected topical human dose in mg/m2), ketoconazole impaired reproductive performance and fertility when administered to male rats (increased abnormal sperm, decreased sperm mobility and decreased pregnancy in mated females).

Clinical Studies

The safety and efficacy of Extina® Foam were evaluated in a randomized, double-blind, vehicle-controlled study in subjects 12 years and older with mild to severe seborrheic dermatitis. In the study, 427 subjects received Extina® Foam and 420 subjects received vehicle foam. Subjects applied Extina® Foam or vehicle foam twice daily for 4 weeks to affected areas on the face, scalp, and/or chest. The overall disease severity in terms of erythema, scaling, and induration was assessed at Baseline and week 4 on a 5-point Investigator’s Static Global Assessment (ISGA) scale.

Treatment success was defined as achieving a Week 4 (end of treatment) ISGA score of 0 (clear) or 1 (majority of lesions have individual scores for scaling, erythema, and induration that averages 1 [minimal or faint]) and at least two grades of improvement from baseline. The results are presented in Table 2. The database was not large enough to assess whether there were differences in effects in age, gender, or race subgroups.

Table 2: Efficacy Results

Number of Subjects	Extina® Foam N = 427 n (%)	Vehicle Foam N = 420 n (%)
Subjects Achieving Treatment Success	239 (56%)	176 (42%)

How Supplied/Storage and Handling

Extina® Foam, 2% is supplied in 50 g (NDC 63032-051-50) and 100 g (NDC 63032-051-00) aluminum containers.

Store at controlled room temperature 68° to 77°F (20° to 25°C). Do not store under refrigerated conditions. Do not expose containers to heat, and/or store at temperatures above 120°F (49°C). Do not store in direct sunlight.

Contents are flammable.

Contents under pressure. Do not puncture and/or incinerate container.

Keep out of reach of children.

Patient Counseling Information

See FDA-approved patient labeling. (17.3)

Instructions for Use

• Avoid fire, flame and/or smoking during and immediately following application.

• Do not apply Extina® Foam directly to hands. Dispense onto a cool surface, and apply to the affected areas using the fingertips.

Local Reactions

• Extina® Foam may cause skin irritation (application site burning and/or reactions)

• Extina® Foam may cause contact sensitization.

• As with any topical medication, patients should wash their hands after application.

• Inform a physician if the area of application shows signs of increased irritation and report any signs of adverse reactions.

Patient Package Insert

-See below-

EXT:2PI

PATIENT INFORMATION

Extina® (ex-TEEN-ah) Foam (ketoconazole, 2%)

IMPORTANT: For skin use only. Do not use in the eyes, mouth or vagina.

Read the Patient Information that comes with Extina® Foam before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treatment.

What is Extina® Foam?

Extina® Foam is used on the skin (topical) to treat a skin condition called seborrheic dermatitis in patients 12 years and older. Seborrheic dermatitis can cause areas of flaky skin (scales) on the scalp, face, ears, chest or upper back.

Extina® Foam has not been studied in children less than 12 years old.

What should I tell my doctor before using Extina® Foam?

For female patients, tell your doctor if you:

• are pregnant or become pregnant. It is not known if Extina® Foam can harm a fetus (unborn baby).

• breastfeeding. It is not known if Extina® Foam passes into breast milk.

How should I use Extina® Foam?

• Apply Extina® Foam exactly as prescribed. Extina® Foam is usually applied to the affected skin areas two times a day (once in the morning and once at night) for 4 weeks. Talk to your doctor if your skin does not improve after 4 weeks of treatment with Extina® Foam.

• Keep the Extina® Foam can away from and do not spray it near fire, open flame, or direct heat. Extina® Foam is flammable. Never throw the Extina® Foam can into a fire, even if the can is empty.

Instructions for applying Extina® Foam

	1. Hold the can at an upright angle. 2. Push the button to spray Extina® Foam directly into the cap of the can or other cool surface. Spray only the amount of Extina® Foam that you will need to cover your affected skin. Do not spray Extina®Foam directly onto your affected skin or your hands because the foam will begin to melt right away when it touches your skin. 3. If your fingers are warm, rinse them in cold water first. Be sure to dry them well before handling the Extina® Foam. If the Extina® Foam can seems warm or the foam seems runny, place the can under cool running water for a few minutes.
	4. Using your fingertips, gently massage Extina® Foam into the affected areas until the foam disappears.
	5. If you are treating skin areas with hair such as your scalp, move any hair away so that the foam can be applied to the affected skin. 6. Do not get Extina® Foam in your eyes, mouth or vagina. If any Extina® Foam gets in your eyes, mouth or vagina, rinse areas well with water. 7. Wash your hands well after applying Extina® Foam.

What are the possible side effects of Extina® Foam?

The most common side effects of Extina® Foam are reaction or burning on treated skin areas. Tell your doctor if you have any reaction on your treated skin such as redness, itching, or a rash. These are not all the side effects of Extina® Foam. Ask your doctor or pharmacist for more information.

How should I store Extina® Foam?

• Extina® Foam is flammable.

• Do not spray Extina® Foam near fire or direct heat. Never throw the can into a fire, even if the can is empty.

• Store the can of Extina® Foam at room temperature, 68° to 77°F (20°-25°C). Do not place the Extina® Foam can in the refrigerator or freezer. 

• Keep the Extina® Foam can away from all sources of fire and heat. Do not leave the Extina® Foam can in direct sunlight.

• Do not smoke while holding the Extina® Foam can or while spraying or applying the foam. 

• Do not pierce or burn the Extina® Foam can.

• Keep Extina® Foam and all medicines out of the reach of children.

General information about Extina® Foam

Medicines are sometimes prescribed for conditions that are not mentioned in Patient Information leaflets. Do not use Extina® Foam for any other condition for which it was not prescribed. Do not give Extina® Foam to other people, even if they have the same condition that you have. It may harm them.

This leaflet summarizes the most important information about Extina® Foam. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Extina® Foam that is written for health professionals.

If you have questions about Extina® Foam you can also call: 1-888-784-3335 (STIEFEL) (this is a toll-free number) between 6:00 a.m. and 4:00 p.m. Pacific Standard Time, Monday through Friday.

What are the ingredients in Extina® Foam?

Active ingredients: ketoconazole

Inactive Ingredients: cetyl alcohol, citric acid, ethanol (denatured with tert-butyl alcohol and brucine sulfate) 58%, polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant.

Rx Only

This Patient Information leaflet has been approved by the U.S. Food and Drug Administration.

The Patient Information leaflet was last revised: November 2008


EXT:2PIL

Manufactured for

Stiefel Laboratories, Inc.

Research Triangle Park, NC 27709

Extina is a registered trademark of Stiefel Laboratories, Inc.

©2011 Stiefel Laboratories, Inc.

Principal Display Panel

NDC 63032-051-00

Extina®

(ketoconazole) Foam, 2%

100 g Rx only

FOR TOPICAL USE ONLY

NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE.

Hold the can at an upright angle and then press firmly to dispense

Description: Extina® (ketoconazole) Foam, 2% contains 20 mg ketoconazole per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol, citric acid, ethanol (denatured with tert-butyl alcohol and brucine sulfate) 58%, polysorbate 60, potassium citrate, propylene glycol, purified water, stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant.

Dosage: Use only as prescribed by your physician. See package insert for full prescribing information.

Warning: FLAMMABLE. AVOID FIRE, FLAME, OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION.

Contents under pressure. Do not puncture and/or incinerate container. Do not exposecontainers to heat, and/or store at temperatures above 120oF (49oC). Do not store in direct sunlight.

Avoid contact with eyes. Keep out of reach of children.

Do not store in the refrigerator. Store at controlled room temperature, 68o – 77oF (20o - 25oC).

CFC FREE

Manufactured for

Stiefel Laboratories, Inc.

Research Triangle Park

NC 27709

For additional information:

1-888-784-3335 (STIEFEL)

or visit www.Extina.com

©2011 Stiefel Laboratories, Inc.

Extina is a registered trademark of Stiefel Laboratories, Inc.

111682

10000000092304

Extina  ketoconazole  aerosol, foam

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63032-051 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KETOCONAZOLE (KETOCONAZOLE) KETOCONAZOLE 20 mg  in 1 g

Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL   CITRIC ACID MONOHYDRATE   ALCOHOL   POLYSORBATE 60   POTASSIUM CITRATE   PROPYLENE GLYCOL   WATER   STEARYL ALCOHOL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 63032-051-50 50 g In 1 CAN None 2 63032-051-00 100 g In 1 CAN None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021738	07/01/2007

Labeler - Stiefel Laboratories Inc (808842343)

Revised: 04/2011Stiefel Laboratories Inc

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

• Extina Foam MedFacts Consumer Leaflet (Wolters Kluwer)


• Extina Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Extina Consumer Overview


• Kuric Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Nizoral A-D Shampoo MedFacts Consumer Leaflet (Wolters Kluwer)


• Xolegel Consumer Overview


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Compare Extina with other medications

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• Seborrheic Dermatitis
• Tinea Corporis
• Tinea Cruris
• Tinea Pedis
• Tinea Versicolor

Plan B Oral, Implantation, Parenteral

Generic Name: progestin contraceptives (Oral route, Parenteral route)

Commonly used brand name(s)

In the U.S.

• Aygestin


• Camila


• Errin


• Jolivette


• Next Choice


• Nora-BE


• Nor-QD


• Ortho Micronor


• Ovrette


• Plan B


• Plan B One-Step


• Provera

Available Dosage Forms:

• Tablet

Uses For Plan B

Progestins are hormones.

The low-dose progestins for contraception are used to prevent pregnancy. Other names for progestin-only oral contraceptives are minipills and progestin-only pills (POPs). Progestins can prevent fertilization by preventing a woman's egg from fully developing.

Also, progestins cause changes at the opening of the uterus, such as thickening of the cervical mucus. This makes it hard for the partner's sperm to reach the egg. The fertilization of the woman's egg with her partner's sperm is less likely to occur while she is taking, receiving, or using a progestin, but it can occur. Even so, the progestins make it harder for the fertilized egg to become attached to the walls of the uterus, making it difficult to become pregnant.

No contraceptive method is 100 percent effective. Studies show that fewer than 1 of each 100 women become pregnant during the first year of use after correctly receiving the injection on time. Fewer than 10 of each 100 women who take progestins correctly by mouth for contraception become pregnant during the first year of use. Methods that do not work as well include condoms, diaphragms, or spermicides. Discuss with your doctor what your options are for birth control.

Progestin contraceptives are available only with your doctor's prescription.

Importance of Diet

Make certain your doctor knows if you are on any special diet, such as a low-sodium or low-sugar diet.

Before Using Plan B

Allergies

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

Pediatric

Progestins have been used by teenagers and have not been shown to cause different side effects or problems than they do in adults. You must take progestin-only oral contraceptives every day in order for them to work. Progestins do not protect against sexually transmitted diseases, a risk factor for teenagers. It is not known if Depo-Provera Contraceptive Injection causes problems with bone development and growth in teenagers and young women. It is important that your doctor check you regularly for growth problems, especially if you have been using this medicine for 2 years or longer.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Use of progestin-only contraceptives during pregnancy is not recommended. Doctors should be told if pregnancy is suspected. When accidently used during pregnancy, progestins used for contraception have not caused problems.

Breast Feeding

Although progestins pass into the breast milk, the low doses of progestins used for contraception have not been shown to cause problems in nursing babies. Progestins used for contraception are recommended for nursing mothers when contraception is desired.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Isotretinoin


• Theophylline


• Tizanidine


• Tranexamic Acid

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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma or


• Epilepsy, or history of or


• Heart or circulation problems or


• Kidney disease, severe or


• Migraine headaches—May cause fluid buildup and make these conditions worse.

• Bleeding problems, undiagnosed, such as blood in the urine or changes in vaginal bleeding—May make diagnosis of these problems more difficult.

• Breast disease (e.g., breast lumps or cysts), history of—May make this condition worse in certain types of diseases that do not react to progestins in a positive way.

• Central nervous system (CNS) disorders (e.g., depression), or history of or


• High blood cholesterol or


• Osteoporosis (brittle bones), or a family history of—May cause these conditions to occur or make these conditions worse.

• Diabetes mellitus—May cause a mild increase in blood sugar and a need to monitor blood sugar more often.

• Liver disease—The effects of some progestins may be increased. May make this condition worse.

Proper Use of progestin contraceptives

This section provides information on the proper use of a number of products that contain progestin contraceptives. It may not be specific to Plan B. Please read with care.

To make the use of a progestin as safe and reliable as possible, you should understand how and when to take it and what effects may be expected. Progestins for contraception usually come with patient directions. Read them carefully before taking or using this medicine.

Progestins do not protect a woman from sexually transmitted diseases (STDs), including human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS). The use of latex (rubber) condoms or abstinence is recommended for protection from these diseases.

Take this medicine only as directed by your doctor. Do not take more of it and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects. Try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.

When using levonorgestrel tablet dosage form for emergency contraception:

• The tablets may be taken at any time during the menstrual cycle.

When using medroxyprogesterone injection dosage form for contraception:

• Your injection is given by a health care professional every 3 months.


• To stop using medroxyprogesterone injection for contraception, simply do not have another injection.


• Full protection from pregnancy begins immediately if you receive the first injection within the first 5 days of your menstrual period or within 5 days after delivering a baby if you will not be breast-feeding. If you are going to breast-feed, you may have to wait for 6 weeks from your delivery date before receiving your first injection. If you follow this schedule, you do not need to use another form of birth control. Protection from that one injection ends at 3 months. You will need another injection every 3 months to have full protection from becoming pregnant. However, if the injection is given later than 5 days from the first day of your last menstrual period, you will need to use another method of birth control as directed by your doctor.

When using an oral progestin dosage form:

• Take a tablet every 24 hours each day of the year. Taking the medicine at the same time each day helps to reduce the possibility of side effects and makes it work as expected. Taking your tablet 3 hours late is the same as missing a dose and can cause the medicine to not work properly.


• Keep the tablets in the container in which you received them to help you to keep track of your dosage schedule.


• When switching from estrogen and progestin oral contraceptives, you should take the first dose of the progestin-only contraceptive the next day after the last active pill of the estrogen and progestin oral contraceptive has been taken. This means you will not take the last 7 days (placebo or nonactive pills) of a 28-day cycle of the estrogen and progestin oral contraceptive pack. You will begin a new pack of progestin-only birth control pills on the 22nd day.


• Also, when switching, full protection from pregnancy begins after 48 hours if the first dose of the progestin-only contraceptive is taken on the first day of the menstrual period. If the birth control is begun on other days, full protection may begin 3 weeks after you begin taking the medicine for the first time. You should use a second method of birth control for at least the first 3 weeks to ensure full protection. You are not fully protected if you miss pills. The chances of your getting pregnant are greater with each pill that is missed.

Follow your doctor's orders to schedule the proper time to receive an injection of progestins for contraception.

Dosing

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

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

• For levonorgestrel


• For oral dosage form (tablets):
  
  • For emergency contraception for preventing pregnancy:
    
    • Adults and teenagers—The first dose of 0.75 milligram should be taken as soon as possible within 72 hours of intercourse. The second dose must be taken 12 hours later.
    
    
  
  

• For medroxyprogesterone


• For muscular injection dosage form
  
  • For preventing pregnancy:
    
    • Adults and teenagers—150 milligrams injected into a muscle in the upper arm or in the buttocks every three months (13 weeks).
    
    
  
  


• For subcutaneous injection dosage form
  
  • For preventing pregnancy:
    
    • Adults and teenagers—104 milligrams injected under the skin of the anterior thigh or abdomen every three months (12 to 14 weeks).
    
    
  
  

• For norethindrone


• For oral dosage form (tablets):
  
  • For preventing pregnancy:
    
    • Adults and teenagers—0.35 milligrams every 24 hours, beginning on the first day of your menstrual cycle whether menstrual bleeding begins or not. The first day of your menstrual cycle can be figured out by counting 28 days from the first day of your last menstrual cycle.
    
    
  
  

• For norgestrel


• For oral dosage form (tablets):
  
  • For preventing pregnancy:
    
    • Adults and teenagers—75 micrograms every 24 hours, beginning on the first day of your menstrual cycle whether menstrual bleeding occurs or not. The first day of your menstrual cycle can be figured out by counting 28 days from the first day of your last menstrual cycle.
    
    
  
  

Missed Dose

Call your doctor or pharmacist for instructions.

For oral dosage form (tablets):

• When you miss 1 day's dose of oral tablets or are 3 hours or more late in taking your dose, many doctors recommend that you take the missed dose immediately, continue your normal schedule, and use another method of contraception for 2 days. This is different from what is done after a person misses a dose of birth control tablets that contain more than one hormone.

For injection dosage form:

• If you miss having your next injection and it has been longer than 13 weeks since your last injection, your doctor may want you to stop receiving the medicine. Use another method of birth control until your period begins or until your doctor determines that you are not pregnant.


• If your doctor has other directions, follow that advice. Any time you miss a menstrual period within 45 days after a missed or delayed dose you will need to be tested for a possible pregnancy.

Storage

Keep out of the reach of children.

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

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Plan B

It is very important that your doctor check your progress at regular visits. This will allow your dosage to be adjusted to your changing needs, and will allow any unwanted effects to be detected. These visits are usually every 12 months when you are taking progestins by mouth for birth control.

• If you are receiving the medroxyprogesterone injection for contraception, a physical exam is needed only every 12 months, but you need an injection every 3 months. Your doctor will also want to check you for any bone development or growth problems, especially if you are a teenager or young adult.

Progestins may cause dizziness in some people. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

It is possible that certain doses of progestins may cause a temporary thinning of the bones by changing your hormone balance. It is important that your doctor know if you have an increased risk of osteoporosis. Some things that can increase your risk for osteoporosis include cigarette smoking, abusing alcohol, taking or drinking large amounts of caffeine, and having a family history of osteoporosis or easily broken bones. Some medicines, such as steroids (cortisone-like medicines) or anticonvulsants (seizure medicines), can also cause thinning of the bones. It is especially important that you tell your doctor about any of these risk factors if you are taking Depo-Provera® Contraceptive Injection or Depo-SubQ Provera® 104. These contraceptives may cause a loss of bone mineral density. Your doctor may replace these contraceptives with a different one.

Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is not unusual and does not mean you should stop the medicine. This is sometimes called spotting when the bleeding is slight, or breakthrough bleeding when it is heavier. If this occurs, continue on your regular dosing schedule. Check with your doctor:

• If vaginal bleeding continues for an unusually long time.


• If your menstrual period has not started within 45 days of your last period.

Missed menstrual periods may occur. If you suspect a pregnancy, you should call your doctor immediately.

If you are scheduled for any laboratory tests, tell your doctor that you are taking a progestin. Progestins can change certain test results.

The following medicines might reduce the effectiveness of progestins for contraception:

• Aminoglutethimide (e.g., Cytadren®)


• Carbamazepine (e.g., Tegretol®)


• Phenobarbital


• Phenytoin (e.g., Dilantin®)


• Rifabutin (e.g., Mycobutin®)


• Rifampin (e.g., Rifadin®)

Sometimes your doctor may use these medicines with progestins for contraception, but the doctor will give you special directions to follow to make sure your progestin is working properly. In order to prevent pregnancy, use a second method of birth control together with the progestin when you also use a medicine that could reduce the effectiveness of the progestin. If you are using medroxyprogesterone injection for contraception, continue using a back-up method of birth control until you have your next injection, even if the medicine that affects contraceptives is discontinued. If you are using the oral tablets, continue using a back-up method of birth control for a full cycle (or 4 weeks), even if the medicine that affects contraceptives is discontinued.

If you vomit your oral progestin-only contraceptive for any reason within a few hours after taking it, do not take another dose. Return to your regular dosing schedule and use an additional back-up method of birth control for 48 hours.

If you are receiving levonorgestrel tablets for emergency contraception and vomiting occurs within 1 hour after taking either dose of the medicine, contact your physician to discuss whether the dose should be repeated.

Plan B Side Effects

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

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

More common

• Changes in uterine bleeding (increased amounts of menstrual bleeding occurring at regular monthly periods


• heavier uterine bleeding between regular monthly periods


• lighter uterine bleeding between menstrual periods


• or stopping of menstrual periods

Less common

• Mental depression


• skin rash


• unexpected or increased flow of breast milk

Incidence not known - for patients taking Depo-Provera Contraceptive Injection

• Cough


• decrease in height


• difficulty swallowing


• fast heartbeat


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


• pain in back, ribs, arms, or legs


• pain or swelling in arms or legs without any injury


• shortness of breath


• skin rash


• tightness in chest


• wheezing

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

More common

• Abdominal pain or cramping


• diarrhea


• dizziness


• fatigue


• mild headache


• mood changes


• nausea


• nervousness


• pain or irritation at the injection site


• swelling of face, ankles, or feet


• unusual tiredness or weakness


• vomiting


• weight gain

Less common

• Acne


• breast pain or tenderness


• brown spots on exposed skin, possibly long-lasting


• hot flashes


• loss or gain of body, facial, or scalp hair


• loss of sexual desire


• trouble in sleeping

Not all of the side effects listed above have been reported for each of these medicines, but they have been reported for at least one of them. All of the progestins are similar, so any of the above side effects may occur with any of these medicines.

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time, check with your doctor if you notice any of the following side effects:

• Delayed return to fertility


• stopping of menstrual periods


• unusual menstrual bleeding (continuing)

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.

Femoston 1 / 10mg and 2 / 10mg

femoston


1/10 mg

femoston


2/10 mg

film-coated tablets

estradiol/dydrogesterone

What you should know about Femoston

Please read this leaflet before you take your medicine, and keep it safe because you may want to read it again. If you have any questions or are not sure about anything, ask your doctor or a pharmacist.

What is in Femoston?

Femoston belongs to a group of medicines known as Hormone Replacement Therapy or HRT.

Each pack of Femoston tablets contains two different types of tablets.

Femoston 1/10: the white tablets contain 1 mg of estradiol (as hemihydrate) and the grey tablets contain 1 mg of estradiol (as hemihydrate) and 10 mg of dydrogesterone.

Femoston 2/10: the brick-red tablets contain 2 mg of estradiol (as hemihydrate) and the yellow tablets contain 2 mg of estradiol (as hemihydrate) and 10 mg of dydrogesterone.

All of the tablets can be recognised by the following markings: 'a letter S above a triangle’ on one side and ‘379’ on the other side.

The estradiol in the tablets is made from plant materials. The tablets also contain lactose, hypromellose, maize starch, colloidal anhydrous silica, magnesium stearate and titanium dioxide (E171).

In addition, the white tablets contain macrogol 400; the grey tablets contain macrogol 3350, iron oxides (E172), talc and polyvinylalcohol; the yellow tablets and the red tablets contain macrogol 400, talc and iron oxides (E172).

Femoston is available as a three month pack (84 tablets) containing 3 strips of 28 tablets each or in a one month pack (28 tablets) containing one strip of 28 tablets. The strips are marked with the days of the week to help you remember to take your tablets. The arrows marked 1 and 2 show you which order to take the tablets in. All pack sizes may not be marketed.

The marketing authorisation holder is

Solvay Healthcare Limited

Southampton

SO18 3JD

UK

Femoston is made by

Solvay Biologicals BV

8121 AA Olst

The Netherlands

What is Femoston for?

Femoston 1/10 and 2/10 are continuous sequential HRTs for peri and postmenopausal women, used to treat the symptoms of the menopause (change of life). These symptoms vary from woman to woman, and can include hot flushes, night sweats, sleeping difficulties, dryness of the vagina and urinary problems.

Femoston may also be used to prevent osteoporosis (thinning of the bones) in women who are at an increased risk of fractures but who are unable to take other medicines for osteoporosis prevention or if these have proved to be ineffective. Your doctor should discuss all the available options with you. Osteoporosis can accelerate after the menopause as estrogen levels fall. If your doctor has prescribed Femoston for treatment of menopausal symptoms, you will not need to take another medicine to prevent osteoporosis whilst you are taking Femoston. Femoston is suitable for peri and postmenopausal women who may or may not still be having their periods and women switching from standard (cyclic or sequential) HRT on the advice of their doctor.

Femoston 1/10 and Femoston 2/10 are not contraceptives. If you need contraception you should use a non-hormonal method.

How does Femoston work?

Femoston contains estradiol and dydrogesterone. These hormones replace the estradiol and progesterone you produce in your ovaries from puberty until the menopause. Your body’s natural estrogen is also called estradiol. Dydrogesterone is a manufactured form of progesterone which is very similar to a woman’s own progesterone.

Estradiol replaces your body’s natural estrogen, controlling your menopausal symptoms and giving protection against osteoporosis. Women who still have a womb should normally take some form of progesterone (a progestagen), because estrogen alone can cause problems due to a build up of the womb lining. Taking dydrogesterone for part of each monthly cycle (as in Femoston) helps prevent a build up of the womb lining by inducing a regular monthly bleed (see ‘Endometrial cancer’).

Before taking Femoston

Before you take your medicine, you should make sure that it is safe for you to do so. If you answer yes to any of the following questions, do not take Femoston:

• Are you allergic to any of the tablet ingredients?


• Do you have, have you had, or does your doctor think you might have, breast cancer?


• Have you had or does your doctor think that you might have a tumour which is made worse by estrogens (e.g., endometrial cancer)?


• Have you had or does your doctor think that you might have a tumour which is made worse by progestagens (e.g. meningioma)?


• Do you have undiagnosed vaginal bleeding that is not associated with your period?


• Do you have or are you being treated for a blood clot in an artery or in a vein in your leg or any
  where else (a deep vein thrombosis), or a blood clot that has travelled to your lung or other parts of your body (an embolus)? Have you had one of these conditions in the past?


• Do you have angina, or have you ever had a heart attack or stroke?


• Do you have acute liver disease or has your liver function not returned to normal after a liver disease?


• Has your doctor told you that you have porphyria (a metabolic disorder)?


• Are you pregnant or do you think that you might be pregnant?

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

If any of the following apply to you, you should check with your doctor before you start taking Femoston:

• you have or have had serious liver disease; or


• you have irregular or unusually heavy periods; or


• you have or have had endometrial hyperplasia.

Medical check-ups

Before you start taking HRT, your doctor should ask about your own and your family’s medical history.

Your doctor may decide to examine your breasts and/or your abdomen, and may do an internal examination - but only if these examinations are necessary for you, or if you have any special concerns.

Once you’ve started on HRT, you should see your doctor for regular check-ups (at least once a year).

At these check-ups, your doctor may discuss with you the benefits and risks of continuing to take HRT.

Be sure to:

go for regular breast screening and cervical smear tests

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

If you have (or had in the past, or are at risk of getting) any of the following conditions, your doctor may want
to see you more often for check-ups:

• fibroids or endometriosis


• blood clots in the legs or lungs


• tumours related to estrogens


• high blood pressure


• liver complaints


• sugar diabetes


• gall stones


• migraine or severe headache


• systemic lupus erythematosus (SLE) (a disease which affects the skin and major organs)


• epilepsy (fits)


• asthma


• otosclerosis (a type of deafness)

Safety of HRT

As well as benefits, HRT has some risks which you need to consider when you’re deciding whether to take it, or whether to carry on taking it.

Effects on your heart or circulation

Heart disease

HRT is not recommended for women who have heart disease, or have had heart disease recently. If you have had heart disease, talk to your doctor to see if you should take HRT.

HRT will not help to prevent heart disease.

Studies with one type of HRT (containing conjugated estrogen plus the progestagen MPA), have shown that women may be slightly more likely to get heart disease during the first year of taking the medication. For other types of HRT, the risk is likely to be similar, although this is not yet certain.

If you get:

• a pain in your chest that spreads to your arm or neck

• 
  See a doctor as soon as possible and do not take any more HRT until your doctor says you can. This pain could be a sign of heart disease.

Stroke

Recent research suggests that HRT slightly increases the risk of having a stroke. Other things that can increase the risk of stroke include:

• getting older


• high blood pressure


• smoking


• drinking too much alcohol


• an irregular heartbeat

If you are worried about any of these things,
or if you have had a stroke in the past, talk to your doctor to see if you should take HRT.

Compare

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

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

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

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

If you get:

• unexplained migraine-type headaches, with or without disturbed vision

• 
  See a doctor as soon as possible and do not take any more HRT until your doctor says you can. These headaches may be an early warning sign of a stroke.

Blood clots

HRT may increase the risk of blood clots in the veins (also called deep vein thrombosis, or DVT), especially during the first year of taking it.

These blood clots are not always serious, but if one travels to the lungs, it can cause chest pain,
breathlessness, collapse or even death.

This condition is called pulmonary embolism, or PE.

DVT and PE are examples of a condition called venous thromboembolism, or VTE.

You are more likely to get a blood clot:

• if you are seriously overweight


• if you have had a blood clot before


• if any of your close family have had blood clots


• if you have had one or more miscarriages


• if you have any blood clotting problem that needs treatment with a medicine such as warfarin


• if you’re off your feet for a long time because of major surgery, injury or illness


• if you have a rare condition called SLE

If any of these things apply to you
, talk to your doctor to see if you should take HRT.

Compare

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

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

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

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

If you get:

• painful swelling in your leg


• sudden chest pain


• difficulty breathing

• 
  See a doctor as soon as possible and do not take any more HRT until your doctor says you
  can. These may be signs of a blood clot.

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

Effects on your risk of developing cancer

Breast cancer

Women who have breast cancer, or have had breast cancer in the past, should not take HRT.

Taking HRT slightly increases the risk of breast cancer; so does having a later menopause. The risk for a post-menopausal woman taking estrogen-only HRT for 5 years is about the same as for a woman of the same age who’s still having periods over that time and not taking HRT. The risk for a woman who is taking estrogen plus progestagen HRT is higher than for estrogen-only HRT (but estrogen plus progestagen HRT is beneficial for the endometrium, see ‘Endometrial cancer’ below).

For all kinds of HRT, the extra risk of breast cancer goes up the longer you take it, but returns to normal
within about 5 years after stopping.

Your risk of breast cancer is also higher:

• if you have a close relative (mother, sister or grandmother) who has had breast cancer


• if you are seriously overweight

Compare

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

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

If they take estrogen-only HRT for 10 years, the figure will be 37 in 1000 (an extra 5 cases).

For women who start taking estrogen plus progestagen HRT at age 50 and take it for 5 years, the figure will be 38 in 1000 (ie an extra 6 cases).

If they take estrogen plus progestagen HRT for 10 years, the figure will be 51 in 1000 (ie an extra 19
cases).

If you notice
any changes in your breast, such as:

• dimpling of the skin


• changes in the nipple


• any lumps you can see or feel

• 
  Make an appointment to see your doctor as soon as possible.

Endometrial cancer (cancer of the lining of the womb)

Taking estrogen-only HRT for a long time can increase the risk of cancer of the lining of the womb (the endometrium). Taking a progestagen as well as the estrogen helps to lower the extra risk.

If you still have your womb, your doctor may prescribe a progestagen as well as estrogen.

If so, these may be prescribed separately, or as a combined HRT product.

If you have had your womb removed (a hysterectomy), your doctor will discuss with you whether you can safely take estrogen without a progestagen.

If you’ve had your womb removed because of endometriosis, any endometrium left in your body may be at risk. So your doctor may prescribe HRT that includes a progestagen as well as an estrogen.

Your product, Femoston contains a progestagen

Compare

Looking at women who still have a uterus and who are not taking HRT – on average 5 in 1000 will be
diagnosed with endometrial cancer between the ages of 50 and 65.

For women who take estrogen-only HRT the number will be 2 to 12 times higher, depending on the dose and how long you take it.

The addition of a progestagen to estrogen-only HRT substantially reduces the risk of endometrial cancer.

If you get breakthrough bleeding or spotting, it’s usually nothing to worry about, especially during the first few months of taking HRT.

But if the bleeding or spotting:

• carries on for more than the first few months


• starts after you’ve been on HRT for a while


• carries on even after you’ve stopped taking HRT

• 
  Make an appointment to see your doctor. It could be a sign that your endometrium has become thicker.

Ovarian cancer

Ovarian cancer (cancer of the ovaries) is very rare, but it is serious. It can be difficult to diagnose, because
there are often no obvious signs of the disease. Some studies have indicated that taking estrogen-only HRT for more than 5 years may increase the risk of ovarian cancer. It is not yet known whether other kinds of HRT increase the risk in the same way.

Are you taking any of these other medicines?

If you are taking anticonvulsants (eg. phenobarbital, phenytoin, carbamezapine), anti-infectives (e.g. rifampicin, rifabutin, nevirapine, efavirenz), ritonavir, nelfinavir or herbal preparations containing St John’s wort (Hypericum perforatum), talk to your doctor or a pharmacist. These other medicines may stop Femoston working properly.

How to take Femoston

Generally your doctor will start you on Femoston 1/10 mg. Your doctor will aim to give you the lowest dose for the shortest time to treat your symptoms. The dose can then be increased, by your doctor, if necessary. Take one tablet every day, without a break between packs. Swallow the tablet with water, with or without food.

If you are having regular periods you should start taking Femoston within five days of the start of bleeding. If you are not having regular periods and are not taking any other HRT preparations, or you are switching from a combined continuous HRT product, you can start taking Femoston on any convenient day.

If you are currently using a ‘cyclic’ or ‘sequential’ HRT preparation (which involves taking an estrogen tablet
or patch for part of the month, followed by both estrogen and progestagen tablet or patch for up to 14 days) start taking Femoston the day after you finish the pack i.e. at the end of the progestagen phase. If you forget to take a tablet, take the next one as soon as you remember. If it is more than 12 hours since you took the last one, take the next dose without taking the forgotten tablet. If you miss a tablet, it is more likely that you will have irregular bleeds.

Overdose

If you (or someone else, e.g. a child) take too many Femoston tablets, they are unlikely to do any harm. Nausea, vomiting, sleepiness and dizziness may occur. No treatment is necessary, but if you are worried, contact your doctor for advice.

Possible side effects

Some women may have side effects when taking Femoston, but they usually disappear after the first few months. In the list of possible side effects given below, we give an indication of how likely it is that you will get these side effects: ‘common’ means less than one in ten patients may experience this side effect; ‘uncommon’ means less than one in a hundred; ‘rarely’ means less than one in a thousand; and ‘very rarely’ means less than one in ten thousand patients.

Infections: Symptoms of cystitis; thrush; (uncommon)

Tumours: Breast cancer; fibroids get bigger; (uncommon)

Blood changes: Anaemia (iron deficiency); (very rare)

Mental problems: Depression; change in sex drive; nervousness; (uncommon)

Nervous system: Headache; migraine; (common). Dizziness; (uncommon). Chorea (muscle twitches); (very rare)

Eye changes: Intolerance to contact lenses; change in the surface of the eye; (rare)

Heart: Heart attack; (very rare)

Blood vessels: High blood pressure; peripheral vascular disease; varicose veins; venous thromboembolism (blood clots in the legs, pelvis or lungs); (uncommon). Stroke; (very rare)

Gut complaints: Nausea; abdominal pain; flatulence (wind); (common). Indigestion; (uncommon). Vomiting; (very rare)

Liver complaints: Gall bladder disease; (uncommon). Liver function changes (e.g. jaundice); (rare)

Skin complaints: Allergic skin reactions (including rash or itching); (uncommon). Skin discolouration; bruise like swellings on the shins; swelling of the throat or face; (very rare)

Muscle and bone: Leg cramps; (common). Back pain; (uncommon)

Reproductive system: Tender breasts; irregular bleeds and spotting; pelvic pain; (common). Vaginal discharge; painful periods; heavy or irregular periods; (uncommon). Swollen breasts; pre-menstrual tension (PMT); (rare)

Inherited conditions: Porphyria (a metabolic disorder) gets worse; (very rare)

General complaints: Asthenia (feeling weak); (common). Fluid retention (i.e. swollen ankles); (uncommon)

Investigations: Weight changes (up or down); (common).

Tumours related to estrogens (both benign and malignant) have been associated with HRT (see ‘Effects on your risk of developing cancer’ above)

An increase in the size of progestagen dependant tumours (e.g. meningioma) has been associated with estrogen/dydrogesterone treatment.

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

Usually, side effects are not common and do not usually last long. If any of these side effects do last for a long time or you notice any other side effects and you are worried about them, please contact your doctor or a pharmacist for advice.

You should stop taking Femoston and contact your doctor if:

• you develop any of the conditions listed in the ‘Before taking Femoston’ section; or


• you develop a blood clot (see ‘Blood clots’); or


• you get sudden problems with your vision, severe headaches or migraines (see ‘Stroke’); or


• you develop jaundice (yellowing of the skin); or


• you become pregnant; or


• your blood pressure increases.

How to store your medicine

Do not store above 30°C. Store in the original container in order to protect from light. Do not take the tablets after the expiry date shown on the pack.

Store all medicines where children cannot see or reach them.

Take any unused tablets back to a pharmacy (chemist).

This leaflet was approved in October 2009.

Remember

This medicine is for you. Please do not offer it to your family and friends, even if they have the same symptoms as you.

For more advice about osteoporosis contact the following organisation:

National Osteoporosis Society

PO Box 10

Radstock

Bath

BA3 3YB

Tel.:(01761) 471771

Helpline:0845 450 0230

registered trade mark

1069708