Clobetasol (Clobetasol Propionate Topical) - Indications and Dosage

INDICATIONS AND USAGE

FLOVENT DISKUS is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 4 years of age and older. It is also indicated for patients requiring oral corticosteroid therapy for asthma. Many of these patients may be able to reduce or eliminate their requirement for oral corticosteroids over time.

FLOVENT DISKUS is NOT indicated for the relief of acute bronchospasm.

DOSAGE AND ADMINISTRATION

FLOVENT DISKUS should be administered by the orally inhaled route only in patients 4 years of age and older. Individual patients will experience a variable time to onset and degree of symptom relief. Maximum benefit may not be achieved for 1 to 2 weeks or longer after starting treatment.

After asthma stability has been achieved, it is always desirable to titrate to the lowest effective dosage to reduce the possibility of side effects. For patients who do not respond adequately to the starting dosage after 2 weeks of therapy, higher dosages may provide additional asthma control. The safety and efficacy of FLOVENT DISKUS when administered in excess of recommended dosages have not been established.

The recommended starting dosage and the highest recommended dosage of FLOVENT DISKUS, based on prior asthma therapy, are listed in Table 2.

Table 2. Recommended Dosages of FLOVENT DISKUS^*

NOTE: In all patients, it is desirable to titrate to the lowest effective dosage once asthma stability is achieved.
Previous Therapy	Recommended Starting Dosage	Highest Recommended Dosage
Adults and Adolescents
Bronchodilators alone	100 mcg twice daily	500 mcg twice daily
Inhaled corticosteroids	100-250 mcg twice daily	500 mcg twice daily
Oral corticosteroids†	500-1,000 mcg twice daily‡	1,000 mcg twice daily
Children 4 to 11 Years
Bronchodilators alone	50 mcg twice daily	100 mcg twice daily
Inhaled corticosteroids	50 mcg twice daily	100 mcg twice daily

^*Starting dosages above 100 mcg twice daily for adults and adolescents and 50 mcg twice daily for children 4 to 11 years of age may be considered for patients with poorer asthma control or those who have previously required doses of inhaled corticosteroids that are in the higher range for that specific agent.

^† For Patients Currently Receiving Chronic Oral Corticosteroid Therapy: Prednisone should be reduced no faster than 2.5 mg/day on a weekly basis, beginning after at least 1 week of therapy with FLOVENT DISKUS. Patients should be carefully monitored for signs of asthma instability, including serial objective measures of airflow, and for signs of adrenal insufficiency (see WARNINGS). Once prednisone reduction is complete, the dosage of fluticasone propionate should be reduced to the lowest effective dosage.

^‡The choice of starting dosage should be made on the basis of individual patient assessment. A controlled clinical study of 111 oral corticosteroid-dependent patients with asthma showed few significant differences between the 2 doses of FLOVENT DISKUS on safety and efficacy endpoints. However, inability to decrease the dose of oral corticosteroids further during corticosteroid reduction may be indicative of the need to increase the dose of fluticasone propionate up to the maximum of 1,000 mcg twice daily.

Pediatric Use

Because individual responses may vary, children previously maintained on other inhaled corticosteroids may require dosage adjustments upon transfer to FLOVENT DISKUS.

Geriatric Use

In studies where geriatric patients (65 years of age or older, see PRECAUTIONS: Geriatric Use) have been treated with fluticasone propionate inhalation powder, efficacy and safety did not differ from that in younger patients. Based on available data for FLOVENT DISKUS, no dosage adjustment is recommended.

Directions for Use

Illustrated Patient’s Instructions for Use accompany each package of FLOVENT DISKUS.

HOW SUPPLIED

FLOVENT DISKUS 50 mcg is supplied as a disposable orange inhalation unit containing 60 blisters. The drug product is packaged within an orange, plastic-coated, moisture-protective foil pouch (NDC 0173-0600-02).

Store at controlled room temperature (see USP), 20° to 25°C (68° to 77°F) in a dry place away from direct heat or sunlight. Keep out of reach of children. The DISKUS inhalation device is not reusable. The device should be discarded 6 weeks after removal from the moisture-protective foil pouch or after all blisters have been used (when the dose indicator reads “0”), whichever comes first. Do not attempt to take the device apart.

GlaxoSmithKline

Research Triangle Park, NC 27709

©2008, GlaxoSmithKline. All rights reserved.

March 2008 FLD:2PI

Patient's Instructions for Use

FOR ORAL INHALATION ONLY

Read this leaflet carefully before you start to take your medicine. It provides a summary of information about your medicine. Keep it for future use. Read the leaflet every time you refill your prescription because there may be new information.

For more information ask your doctor or pharmacist.

What Is FLOVENT DISKUS?

FLOVENT DISKUS contains a medicine called fluticasone propionate, which is a synthetic corticosteroid. Corticosteroids are natural substances found in the body that help fight inflammation. Corticosteroids are used to treat asthma because they reduce airway inflammation.

When inhaled regularly, corticosteroids also help to prevent symptoms of asthma.

Children should use FLOVENT DISKUS under adult supervision, as instructed by the patient's doctor.

Important Points to Remember About Using FLOVENT DISKUS

1. TELL YOUR DOCTOR BEFORE YOU START TAKING THIS MEDICINE if you are:

• pregnant or planning to become pregnant;
• breastfeeding a baby;
• allergic to FLOVENT DISKUS, any other medicines, or food products;
• taking a medicine containing ritonavir (commonly used to treat HIV infection or AIDS); or
• taking other medicines, especially any other orally inhaled corticosteroid, over-the-counter medicines, and herbal products.

In some circumstances, this medicine may not be suitable for you, and your doctor may wish to give you a different medicine.

2. It is important that you inhale each dose as your doctor has advised. The prescription label provided by your pharmacist will usually tell you what dose to take and how often. If it doesn’t, or if you are not sure, ask your doctor or pharmacist. DO NOT inhale more doses or use your FLOVENT DISKUS more often than your doctor advises.

3. FLOVENT DISKUS delivers your dose of medicine as a very fine powder that most, but not all, patients can taste or feel. Whether or not you are able to taste or feel your dose of medicine, you should not exceed the recommended dosage. If you are not sure you are receiving your dose of FLOVENT DISKUS, contact your doctor or pharmacist.

4. It may take 1 to 2 weeks or longer for this medicine to work, and it is VERY IMPORTANT THAT YOU USE IT REGULARLY. DO NOT STOP TREATMENT EVEN IF YOU ARE FEEL ING BETTER unless told to do so by your doctor.

5. If you miss a dose, just take your next scheduled dose when it is due. DO NOT DOUBLE the dose.

6. This medicine is NOT intended to provide rapid relief of your breathing difficulties during an asthma attack. It must be taken at regular intervals as recommended by your doctor, and not as an emergency measure.

7. Your doctor may prescribe additional medication (such as bronchodilators) for emergency relief if an acute asthma attack occurs. Please contact your doctor if:

• an asthma attack does not respond to the additional medication or
• you require more of the additional medication than usual.

8. Long-term use of inhaled corticosteroids, including fluticasone propionate, may increase the risk of some eye problems (cataracts or glaucoma). Regular eye examinations should be considered.

9. If you also use another medicine by inhalation, you should consult your doctor for instructions on when to use it in relation to using FLOVENT DISKUS.

10. Do not use FLOVENT DISKUS with a spacer device.

How to Use Your FLOVENT DISKUS

Follow the instructions below. If you have any questions, ask your doctor or pharmacist.

When you take the FLOVENT DISKUS out of the box and foil overwrap pouch, write the “Pouch opened” and “Use by” dates on the label in the spaces provided on the DISKUS^® inhalation unit. The “Use by” date is 6 weeks from date of opening of the pouch.

The DISKUS will be in the closed position when the pouch is opened.

The dose indicator on the top of the DISKUS tells you how many doses are left. The dose indicator number will decrease each time you use the DISKUS. After the DISKUS has delivered 55 doses(23 doses from the sample pack), numbers 5 to 0 will appear in red to warn you that there are only a few doses left (see Figure 1).

Figure 1

Taking a dose of FLOVENT DISKUS requires the following 3 simple steps: Open, Click, Inhale.

1 OPEN: Hold the DISKUS in one hand and put the thumb of your other hand on the thumbgrip. Push your thumb away from you as far as it will go until the mouthpiece appears and the outer case snaps into position (see Figure 2).

Figure 2

2 CLICK: Hold the DISKUS in a level, horizontal position with the mouthpiece towards you. Slide the lever away from you as far as it will go until it clicks (see Figure 3). The DISKUS is now ready to use.

Figure 3

Every time the lever is pushed back, a dose is ready to be inhaled. This is shown by a decrease in numbers on the dose counter. To avoid releasing or wasting doses once the DISKUS is ready:

• Do not close the DISKUS.
• Do not tilt the DISKUS.
• Do not play with the lever.
• Do not advance the lever more than once.

3 INHALE: Before inhaling your dose of FLOVENT DISKUS, breathe out as far as is comfortable, holding the DISKUS level and away from your mouth (see Figure 4). Remember, never breathe out into the DISKUS mouthpiece.

Figure 4

Put the mouthpiece to your lips (see Figure 5). Breathe in quickly and deeply through the DISKUS, not through your nose.

Figure 5

Remove the DISKUS from your mouth. Hold your breath for about 10 seconds, or for as long as is comfortable. Breathe out slowly.

CLOSE THE DISKUS when you are finished taking a dose so that the DISKUS will be ready for you to take your next dose. Put your thumb on the thumbgrip and slide the thumbgrip back towards you as far as it will go (see Figure 6). The DISKUS will click shut. The lever will automatically return to its original position. The DISKUS is now ready for you to take your next scheduled dose. (Repeat steps 1 through 3.)

Figure 6

REMEMBER:

• Never exhale into the DISKUS.
• Never attempt to take the DISKUS apart.
• Always activate and use the DISKUS in a level, horizontal position.
• After you finish taking your dose, rinse your mouth  with water and spit it out. Do not swallow.
• Never wash the mouthpiece or any part of the DISKUS. KEEP IT DRY.
• Always keep the DISKUS in a dry place.
• Never take an extra dose, even if you feel you did not receive a dose.

Storing Your FLOVENT DISKUS

Store at controlled room temperature, 20° to 25°C (68° to 77°F), in a dry place away from direct heat or sunlight. Keep out of reach of children. The DISKUS is not reusable. FLOVENT DISKUS should be discarded 6 weeks after removal from the moisture-protective foil overwrap pouch or after all blisters have been used (when the dose indicator reads “0”), whichever comes first. Do not attempt to take the DISKUS apart.

REMEMBER: This medicine has been prescribed for you by your doctor. DO NOT give this medicine to anyone else.

Further Information

This leaflet does not contain the complete information about your medicine. If you have any questions, or are not sure about something, then you should ask your doctor or pharmacist.

You may want to read this leaflet again. Please DO NOT THROW IT AWAY until you have finished your medicine.

Your doctor has determined that this product is likely to help your personal health. USE THIS PRODUCT AS DIRECTED, UNLESS INSTRUCTED TO DO OTHERWISE BY YOUR DOCTOR. If you have any questions about alternatives, consult with your doctor.

GlaxoSmithKline

Research Triangle Park, NC 27709

©2008, GlaxoSmithKline. All rights reserved.

March 2008 FLD:2PIL