Alphatrex

Alphatrex is used to help relieve redness, itching, swelling or other discomfort caused by skin conditions.

This medication is a corticosteroid (cortisone-like medication or steroid) and is only available with your doctor’s prescription.

This medication is available in the following forms:

• Cream
• Lotion
• Spray
• Ointment

As with all medicines, the risks of using Alphatrex must be compared to how much this medication will help you. This is a decision that you and your doctor will make together.

For this medication, there are many things that need to be considered:

• Allergies: Inform your doctor if you have ever had an allergic reaction to any other medications. It is also important to inform your doctor of any non-medicine allergies such as foods, dyes, preservatives or animals.
• Pediatric: Up-to-date Pediatric Appropriate studies have not indicated any problems that would limit the use of this medication. Because of this medication’s toxicity, it should be used with caution. Use in children 12 years of age and younger is not recommended.
• Geriatric: Up-to-date studies have not shown any problems specific to the elderly that would limit the use of this medication in the elderly population.
• Pregnancy: This medication is listed as Pregnancy Category C. This means that animal studies have shown an adverse effect and no studies have been performed on pregnant women OR there are no adequate studies on pregnant animals and pregnant women.
• Breastfeeding: There are no up-to-date studies in women for determining infant risk when using this medication while breastfeeding. Weigh the potential risks with the benefits before taking this medication while breastfeeding.
• Drug Interactions: Certain medications should not be used together. However, in certain cases, two medications may be used together, even if an interaction might occur. In these cases, your doctor may want to change your dose or take other precautions. When taking this medication, it is important that you inform your doctor if you are taking any over the counter or prescription medications.
• Other Interactions: Certain medications should not be used while eating, or while eating certain foods in case of negative interactions. Using alcohol or tobacco with certain medications may also cause negative interactions. Talk with your doctor about the use of your medication with food, alcohol or tobacco.
• Other Medical Problems: Pre-existing medical problems may affect the use of this medication.Be sure to tell your doctor if you have any other medical problems, especially:

• • Cushing's syndrome (adrenal gland disorder)
  • Diabetes
  • Hyperglycemia (high blood sugar)
  • Intracranial hypertension (increased pressure in the head) - Use with caution. May make these conditions worse.
  • Infection of the skin at or near the place of application
  • Large sores, broken skin, or severe skin injury at the place of application
  • Liver failure - The chance of side effects may be increased.
  • Perioral dermatitis (skin problem)
  • Rosacea (skin problem) - The gel should not be used in patients with these conditions.

Only take Alphatrex as directed by your doctor. Do not take more, less or for a longer or shorter period of time than your doctor tells you.

This medication is for the skin only. Do not get it in your eyes, mouth or vagina. Do not use it on areas with cuts, scrapes or burns. If this medication gets on these areas, rinse if off immediately with water.

This medication is only to be used for skin conditions that your doctor is treating. Ask your doctor before using it with other conditions, especially if you think that a skin infection may be present.

This medication should not be used to treat certain kinds of skin infections or conditions such as severe burns.

In order to help resolve the problem completely, it is important that you use this medication for the full length of treatment, even if your symptoms begin to clear up after a few days. Do not miss any doses.

Do not use the ointment on the face, groin or underarms unless directed to do so by your doctor.

To use:

• Wash your hands with soap and water before and after using this medication.
• Apply a thin layer of this medication to the affected area and rub it in gently.
• With the lotion, protect the skin from water, clothing or anything that causes rubbing until it has dried completely.
• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.
• If this medication is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.
• If your doctor ordered an occlusive dressing or airtight covering to be applied over the medication, be sure you know how to apply it. Occlusive dressings increase the amount of medication absorbed through the skin, so it is important to only use them as directed. If you have any questions, be sure to ask your doctor.

Dosing

Different patients will be given a different dose of this medication based on the strength of the medication. The number of doses you take each day, the time between doses and the length of time you take this medication depends on the reason you are taking this medication.

The following information only includes the average dose of this medication. If your dose is different, do not change it without first speaking to your doctor.

• Adults and teenagers - Apply to the affected area of the skin 1-2 times per day.
• Children 12 years of age and under - Use is not recommended.

Missed Dose

If you miss a dose of this medication, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and resume your normal dosing schedule. Do not double dose.

Storage

Store this medication in a closed container at room temperature. Keep it away from heat, moisture, and direct light. Do not freeze.

Keep out of the reach of children. Do not keep expired medication or medication you no longer need. Ask your doctor how to dispose of any medication you do not use.

It is very important that your doctor checks in with you often while you are receiving Alphatrex to make sure that it is working properly.

If your symptoms do not improve within two weeks or become worse, inform your doctor.

Using too much medication or using it for too long of a period may increase your risk of adrenal gland problems. The risk is greater for children and patients who use a large dose for an extended period of time.

Inform your doctor immediately if you experience blurred vision, dizziness or fainting (syncope), a fast, irregular or pounding heartbeat (tachycardia, arrhythmias, palpitations), increased thirst or urination (polydipsia, polyuria), irritability or unusual fatigue or weakness.

Inform your doctor immediately if you have a skin rash, blistering, burning, crusting, dryness, flaking of the skin, itching, scaling, severe redness, stinging, swelling or irritation on the skin.

Do not use cosmetics or other skin care products on the treated areas.

Alphatrex may produce unwanted effects along with the intended effects. Although not all of these side-effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if you experience any of the following side-effects:

More Common

• Burning or stinging

Less Common

• Blistering, burning, crusting, dryness, or flaking of the skin
• Cracking or tightening of the skin
• Dry skin
• Flushing or redness of the skin
• Irritation
• Itching, scaling, severe redness, soreness, or swelling of the skin
• Thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (eg, between the fingers)
• Unusually warm skin

Some side effects that may occur do not normally need medical attention. These may leave as your body becomes accustomed to treatment. Ask your doctor about ways to prevent or reduce some of these side effects.

Talk to your doctor if any of the following side effects continue or are bothersome, or if you have questions:

Less Common

• Raised, dark red or wart-like spots on the skin, especially when used on the face

Rare

• Burning, itching and pain in hairy areas or pus at the root of the hair.

Some patients may experience other side effects that are not listed. Check with your doctor if you notice any other side effects.

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