Patient Medication Information: uses, side effects, how to take - Prevex B
ABOUT THIS MEDICATION
What the medication is used for:
PREVEX® B is used to help relieve the redness and itchiness of certain skin problems for up to 4 weeks in patients 1 year of age and older.
What it does: PREVEX® B contains betamethasone valerate which belongs to a group of medicines called steroids. Steroids help to reduce redness, swelling and irritation of the skin.
When it should not be used: Do not use PREVEX® B if you:
- are allergic to betamethasone valerate, other corticosteroids, or to any of the other ingredients in PREVEX® B (see What the nonmedicinal ingredients are).
- have bacterial, fungal, parasitic, viral skin infections (e.g. herpes simplex, chicken pox), tuberculosis or syphilis skin lesions, or a skin reaction following a recent vaccination.
- have acne, rosacea (a facial skin condition where the nose, cheeks, chin, forehead or entire face are unusually red, with or without tiny visible blood vessels, bumps (papules) or pus-filled bumps (pustules)), rashes around the mouth, itchy skin which is not inflamed, itchy skin around the anus or genitals.
Do not apply in or near the eye.
Do not use on children under 1 year of age.
If you think any of these apply to you, don’t use PREVEX® B until you have checked with your doctor or pharmacist.
What the medicinal ingredient is: betamethasone valerate, USP
What the nonmedicinal ingredients are: petrolatum, dimethicone, trisiloxane and microcrystalline wax.
What dosage forms it comes in: PREVEX® B cream comes in a sample size 2 g tube and a trade size 30 g tube. Each 1 g of PREVEX® B cream contains 1.22 mg of betamethasone valerate equivalent to 1 mg (0.1% w/w) betamethasone.
WARNINGS AND PRECAUTIONS
Topical corticosteroids when used over large areas, on sensitive areas such as the face, in skin-fold areas like the armpit and groin, on broken skin, for prolonged periods or under an airtight dressing are more likely to be absorbed into the bloodstream and cause side effects. Apply only enough to cover the affected areas. PREVEX® B should not be applied over large areas unless advised by a physician.
Only use PREVEX® B for as long as your doctor recommends.
Inform your doctor if you have previously used corticosteroids.
Before using PREVEX® B, talk to your doctor or pharmacist if:
You are pregnant or planning to become pregnant.
- You are breastfeeding. If you do use PREVEX® B when breastfeeding, do not use on your breast area to ensure that the baby does not accidentally get it in their mouth.
- You have other inflammatory skin diseases in the leg as a result of impaired circulation (such as stasis dermatitis).
- You have problems with your kidney or liver. You may need to use a smaller amount of PREVEX® B or use it less often.
While using PREVEX® B, talk to your doctor or pharmacist if:
- you develop any skin infection
- you have an allergic reaction
- you develop significant skin irritation
- you experience skin thinning or softening
- your condition worsens or you develop raised bumps with pus under the skin
While using PREVEX® B:
- PREVEX® B should be used with caution on the face, or in skin fold areas, such as the groin or the armpit.
- Avoid PREVEX® B from getting in the eye, or other mucous membranes. Absorption in the body may cause increased pressure in the eye (glaucoma), or a cloudy lens in the eye (cataracts).
- Do not use occlusive dressings such as a bandage, nor cover the treated areas tightly.
- If you are over 65 years of age, use PREVEX® B with caution.
- Children absorb larger amounts of topical corticosteroids and therefore, may be more likely to develop side effects.
- If you have any skin disease around a leg ulcer, use of a topical corticosteroid may increase the risk of an allergic reaction or an infection around the ulcer.
INTERACTIONS WITH THIS MEDICATION
Some medicines may affect how PREVEX® B works or make it more likely that you’ll have side effects. Examples of these medicines include:
- Ritonavir (for HIV)
- Itraconazole (for fungal infections)
Tell your doctor or pharmacist about all other medications you are taking, including medicines that you bought without prescription, and natural health products.
PROPER USE OF THIS MEDICATION
Usual dose:
Use PREVEX® B once or twice a day for a maximum of 4 weeks. The number of times you use your medicine may be reduced as your skin gets better or your doctor may prescribe a weaker steroid for you to use instead. It is important to not stop using PREVEX® B suddenly or your skin condition could flare up again. If your condition does not improve within 2-4 weeks of treatment, speak to your doctor or pharmacist.
If you use PREVEX® B regularly make sure you talk to your doctor before you stop using it.
How to Apply PREVEX® B:
- Apply a thin layer and gently rub in, using only enough to cover the entire affected area.
- Wash your hands after use unless treating the hands.
A moisturizer should be used as maintenance therapy. If you are also using an emollient
- (moisturising) preparation allow time for PREVEX® B to be absorbed after each application before applying the emollient.
- This medicine should not be used every day for more than four weeks at a time.
PREVEX® B should be used for the minimum amount of time required to achieve the desired results, but always use PREVEX® B exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Overdose:
| In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
If you apply a large amount of PREVEX® B or accidentally swallow a lot of PREVEX® B, it could make you ill. If you do swallow a large amount of PREVEX® B rinse your mouth out with plenty of water and contact your doctor, pharmacist or local poison control centre for advice.
Missed Dose: If you forget to use PREVEX® B apply it as soon as you remember. If it is close to the time scheduled to apply your next dose, wait and apply your next scheduled dose and then continue as before.
Do not apply extra PREVEX® B to make up for missed doses.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Side effects will affect your skin and may affect other parts of your body if a sufficient quantity of medicine is absorbed through the skin and enters your blood stream.
If your skin condition gets worse or your skin becomes swollen during treatment, you may be allergic to the medicine, have an infection or need other treatment. Stop using PREVEX® B and tell your doctor as soon as possible
Common side effects
- itchy skin
- local skin burning or pain
Very rare side effects
Use of PREVEX® B for a long period of time, over a large body surface, or use under an airtight dressing, may cause the following symptoms:
- increased weight
- moon face/rounding of the face, obesity
- skin thinning (this may cause stretch marks), skin wrinkling, skin dryness, the appearance of blood vessels under the surface of your skin (telangiectasia), changes to the colour of your skin, skin infection
- increased body hair, hair loss/lack of hair growth/damaged looking hair
- allergic reaction, irritation or pain at the site of application
- worsening of condition
- redness, rash or hives
- secondary infection
- allergic contact dermatitis/dermatitis (a type of eczema)
If you have psoriasis you may get raised bumps with pus under the skin. This can happen very rarely during or after treatment and is known as pustular psoriasis.
In children also look out for the following symptoms:
- delayed weight gain
- slow growth
Other symptoms that may only show in blood tests or when your doctor gives you a medical examination are: decreased hormone cortisol levels in your blood, increased sugar levels in your blood or urine, high blood pressure, cloudy lens in the eye (cataract), increased pressure in the eye (glaucoma), as well as weakening of the bones through gradual mineral loss (osteoporosis) and additional tests may be needed after your medical examination to confirm whether you have osteoporosis.
If any of the side effects listed becomes severe or troublesome, tell your doctor or pharmacist.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||
|---|---|---|---|
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | |
| Only if severe | In all cases | ||
| Allergic reactions: rash, hives, swelling of the skin. | ✓ | ||
| Cushing's syndrome: weight gain, moon face / rounding of the face and obesity | ✓ | ||
This is not a complete list of side effects. For any unexpected effects while taking PREVEX® B, contact your doctor or pharmacist.
HOW TO STORE IT
Store PREVEX® B between 15°C to 25°C. Do not freeze. Keep out of the reach and sight of children.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways: -------------------------------------------------------------------------- Report online at www.healthcanada.gc.ca/medeffect Call toll-free at 1-866-234-2345 Complete a Canada Vigilance Reporting Form and:
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect. NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice. |
MORE INFORMATION
This document plus the full prescribing information, prepared for health professionals can be found at:
http://www.stiefel.ca or by contacting the sponsor,
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
1-800-387-7374
Last revised: March 26, 2014
© 2014 GlaxoSmithKline Inc. All Rights Reserved.
® PREVEX is a registered trade-mark, used under license by GlaxoSmithKline Inc.