Patient Medication Information: uses, side effects, how to take - Sandoz Clobetasol
What is Sandoz Clobetasol used for?
Sandoz Clobetasol is used in adults for the treatment of plaque type psoriasis.
How does Sandoz Clobetasol work?
Sandoz Clobetasol contains the medicinal ingredient clobetasol propionate. It belongs to a group of medicines called topical corticosteroids or topical steroids. Topical corticosteroids reduce inflammation by decreasing the body’s immune response. This can relieve symptoms such as redness, scaling, and itching. Sandoz Clobetasol is not to be used for more than 4 weeks.
What are the ingredients in Sandoz Clobetasol?
Medicinal ingredient: clobetasol propionate
Non-medicinal ingredients: alcohol, isopropyl myristate, sodium lauryl sulphate, and undecylenic acid
Sandoz Clobetasol comes in the following dosage form:
Spray, 0.05% w/w
Do not use Sandoz Clobetasol:
- if you are allergic to clobetasol propionate, any other corticosteroids or to any of the other ingredients in Sandoz Clobetasol.
- if you have skin areas affected by a bacterial, mycobacterial (including tuberculosis of the skin), parasitic or fungal infection.
- if you have a viral infection (such as herpes simplex, chickenpox or vaccinia).
- on wounds that have become ulcers.
in children under 2 years of age.
- on or near the eyes or eyelids (risk of glaucoma or cataracts).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you use Sandoz Clobetasol. Talk about any health conditions or problems you may have, including if you:
- have a weak immune response. Tell your healthcare professional if you suspect an infection has occurred as corticosteroids can make infections more likely and may mask their signs.
- have rosacea or acne.
- have plaques around your mouth, underarms, anus, or genitals.
- think you have a fungal or bacterial infection. Tell your healthcare professional before you use Sandoz Clobetasol, because you may need other medicines to treat the infection.
- have liver problems.
- have diabetes.
- have eye problems, such as glaucoma or cataracts.
- have adrenal gland problems. Sandoz Clobetasol can affect how your adrenal glands work.
- use other oral or topical medication containing corticosteroids or medication intended to suppress your immune system (e.g. for autoimmune disease or after an organ transplant). Combining Sandoz Clobetasol with these medicines may result in serious infections.
- are less than 18 years of age. Children are at a greater risk of side effects, including adrenal suppression and may experience a decrease in the speed of their growth.
are pregnant or trying to become pregnant.
- are breastfeeding or planning to breastfeed.
Other warnings you should know about:
- Do not use Sandoz Clobetasol for more than 4 weeks.
Adrenal Suppression:
- Too much Sandoz Clobetasol passing through your skin can shut down your adrenal glands (adrenal suppression). This may happen if you use too much Sandoz Clobetasol or if you use it for too long, but it can happen with correct use. Using Sandoz Clobetasol for longer than 4 weeks, over large areas of skin, on broken skin or on the face, underarms or groin can also increase your chances of developing adrenal suppression.
- If your adrenal glands shut down, they may not start working right away after you stop using Sandoz Clobetasol, which will make it hard for your body to respond properly to stress or illness. It can also cause the symptoms of Cushing’s syndrome. This is due to too much cortisol (a hormone) in your blood. It has also caused high levels of blood sugar (hyperglycemia) and high levels of sugar in the urine. Your healthcare professional may do special blood and urine tests to check your adrenal gland function, hormone levels and sugar levels while you are using Sandoz Clobetasol.
- Covering the treated area can increase the amount of medicine absorbed through your skin. This may increase your chance of developing adrenal suppression. You should not cover the treated skin area with a bandage or other covering unless your healthcare professional tells you to.
Immunosuppression: Sandoz Clobetasol can suppress your immune system. This may:
- hide symptoms of infections
- reactivate dormant infections
- cause infections due to lowered body resistance
Tell your healthcare professional if you suspect an infection has occurred while you are using Sandoz Clobetasol.
- Surgery: Before you have any surgery, including at the dentist’s office, tell your healthcare professional that you are using Sandoz Clobetasol.
- Vision Problems: If you experience symptoms such as increased eye pressure, blurred vision, or other visual disturbances, tell your healthcare professional. Corticosteroids, like Sandoz Clobetasol, can cause eye problems.
- Allergic Contact Dermatitis: You may develop contact dermatitis (allergic skin reaction) while using Sandoz Clobetasol. Tell your healthcare professional if your skin condition is not healing or gets worse.
Tell your healthcare professional about all the medicines you take and skin products you use, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
There are no known interactions with this medication.
How to use Sandoz Clobetasol:
- Use Sandoz Clobetasol only as directed by your healthcare professional in order to avoid serious side effects. Do not use more of it; do not use it more often, or for a longer period of time than your healthcare professional has told you.
- Do not use Sandoz Clobetasol for longer than 4 weeks. If your skin condition has not improved in 2 weeks, talk to your healthcare professional.
- As with other corticosteroids, stop using Sandoz Clobetasol once your plaques have healed.
- Sandoz Clobetasol is for external, topical use only.
- Before applying Sandoz Clobetasol, wash the area to be treated with a mild cleanser, pat dry, and wait several minutes.
- Do not apply Sandoz Clobetasol to your face, groin or armpits.
- Do not cover the treated skin area with a bandage or other covering unless your healthcare professional tells you to.
- Do not get Sandoz Clobetasol on or near your lips. If you get Sandoz Clobetasol on your lips, rinse your face with cold water right away. If you accidentally swallow Sandoz Clobetasol, call your regional poison control centre immediately.
- Do not use Sandoz Clobetasol near your eyes or eyelids (risk of glaucoma and cataracts). If you get Sandoz Clobetasol in your eye, flush it with cold water right away. If your eyes keep stinging after rinsing them well with water, tell your healthcare professional right away.
- Sandoz Clobetasol is flammable. Avoid using it near sources of heat or open flame.
Usual dose:
Adults: Apply to the affected skin areas twice daily, once in the morning and once at night. Rub in gently and completely. Use only enough to cover the affected areas.
Maximum single dose: ¾ tsp or 23 sprays. Do not cover more than 20% of your body surface area.
Maximum weekly dose: 50 mL (one bottle).
How to apply Sandoz Clobetasol:
Please read the following instructions before using Sandoz Clobetasol. The terms described in the figure below (Fig.1) will help you understand these instructions.
When you receive Sandoz Clobetasol, the Directional Spray Nozzle is in the “locked” position (see Fig. 2).
To use Sandoz Clobetasol follow Steps 1 through 3.
Step 1: Grip the sides of the Pump Top with one hand and use your second hand to point the Directional Spray Nozzle where you want the spray to go (see Fig. 3). The spray will be delivered through the nozzle opening at the end of the Directional Spray Nozzle.
Step 2: Push down on the Pump Top to spray Sandoz Clobetasol (see Fig.4).
Step 3: Spray only enough to cover affected area (see Fig. 5). Rub in gently to ensure even coverage. Wash your hands after applying Sandoz Clobetasol.
Overdose:
| If you think you, or a person you are caring for, have used too much Sandoz Clobetasol, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
|---|
Missed dose:
If you forget to apply Sandoz Clobetasol at the scheduled time, use it as soon as you remember. Then go back to your regular schedule. If it is about time for your next dose, apply just that one dose, and continue with your regular schedule the next day. Do not make up the missed dose. If you miss several doses, tell your healthcare professional.
What are possible side effects from using Sandoz Clobetasol?
These are not all possible side effects you may have when using Sandoz Clobetasol. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- burning, pain
- dry skin, skin irritation
- itching, rash, redness
- thinning of the skin
- swelling of the skin
- darkening of the skin around the plaque being treated
- inflammation and infection of the hair follicles (folliculitis)
- spider veins
- stretch marks
- acne
- excessive hair growth
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | ||||
|---|---|---|---|---|---|---|
| Only if severe | In all cases | |||||
| UNCOMMON | ||||||
| Adrenal suppression: dizziness, nausea, vomiting, fever, chest pain, can lead to death | √ | |||||
| Osteoporosis or Osteonecrosis (thin, fragile bones): bone/joint pain, broken bones, back pain that gets worse when standing or walking | √ | |||||
| Vision problems (glaucoma or cataracts): failing eyesight, blurred vision, eye pain, increased pressure in your eye | √ | |||||
| Infections: raised temperature and feeling unwell | √ | |||||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | ||||
|---|---|---|---|---|---|---|
| Only if severe | In all cases | |||||
| Worsening of psoriasis or Pustular psoriasis: red, scaly, thick patches of skin, clearly defined raised bumps filled with a white, thick fluid | √ | |||||
| Wounds that are slow to heal | √ | |||||
| Immunosuppression: get sick or have infections often, purplish spots on skin or in the mouth and/or throat, swollen lymph nodes | √ | |||||
| Cushing’s syndrome: weight gain in the upper body, puffy face, skin problems, hirsutism (excessive hair growth in females, acne, irregular periods), infections | √ | |||||
| Hyperglycemia (high levels of sugar in the blood): increased thirst/hunger, frequent urination, dizziness, sweating | √ | |||||
| Allergic reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | √ | |||||
| Allergic contact dermatitis: red rash, itching, dry, scaly skin, oozing and crusting, swelling, tenderness | √ | |||||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
|---|
Storage:
Store at room temperature (15 - 30°C). Do not refrigerate. Keep tightly closed. The spray is flammable, and must be kept away from heat or flame.
Keep out of reach and sight of children.
If you want more information about Sandoz Clobetasol:
Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html ; the manufacturer's website https://www.sandoz.ca/ , or by calling 1-800-361-3062.