Description and Brand NamesBefore UsingProper UsePrecautionsSide Effects Brand Name : Dermovate cream Descriptions Clobetasol topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. The solution and foam are used for scalp problems, the cream, lotion, and spray are used for moderate to severe plaque psoriasis, and the shampoo is used for moderate to severe scalp psoriasis. This medicine is a corticosteroid (cortisone-like medicine or steroid). This medicine is available only with your doctor’s prescription. This product is available in the following dosage forms: • Cream • Ointment • Gel/Jelly • Spray • Solution • Foam • Emollient Cream • Lotion • Shampoo In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered: Allergies Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of clobetasol topical cream, foam, gel, ointment, or scalp solution in children 12 years of age and older. However, because of this medicine’s toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor’s instructions very carefully. Safety and efficacy have not been established in children younger than 12 years of age and the use of clobetasol topical cream, foam, gel, ointment, or scalp solution is not recommended. The safety and efficacy of clobetasol topical lotion, shampoo, or spray have not been established in children and use is not recommended. Geriatric Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of clobetasol topical in the elderly. However, elderly patients are more likely to have unwanted effects, which may require caution in patients receiving clobetasol topical cream. Pregnancy Information about this clobetasol-topical-application-route Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breastfeeding There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. Drug Interactions 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 this medicine, 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 this medicine 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. • Pixantrone Other Interactions 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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially: • Acne vulgaris (skin problem) or • Perioral dermatitis (skin problem) or • Rosacea (skin problem)—Should not be used in patients with these conditions. • Cushing’s syndrome (adrenal gland disorder) or • Diabetes or • Hyperglycemia (high blood sugar) or • 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 or • Large sores, broken skin, or severe skin injury at the place of application or Liver failure—The chance of side effects may be increased. It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation. This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water. To help clear up your skin or scalp problem completely, it is very important that you keep using this medicine for the full time of treatment. Do not miss any doses. This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns. Do not use this medicine on the face, groin, or underarms unless directed to do so by your doctor. To use the cream, foam, gel, lotion, ointment, or spray: • Wash your hands with soap and water before and after using this medicine. • Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently. • With the lotion, protect the skin from water, clothing, or anything that causes rubbing until the medicine has dried. Also, shake the lotion well before using it. • Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor. To use the foam, scalp solution, or shampoo: • Wash your hands with soap and water before and after using this medicine. • Apply a thin layer of this medicine to the affected area of the scalp. Rub it in gently. • Do not cover the scalp (eg, shower cap, bathing cap) while it is being treated. • With the shampoo, do not wet your hair before using it. And if the shampoo gets on any part of your body other than your scalp, rinse the area well with water. • Do not use the shampoo for more than 4 weeks, the foam and scalp solution for more than 2 weeks unless your doctor has told you to. This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions. Dosing The dose of this medicine 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 this medicine. 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 redness, itching, and swelling of the skin: For topical dosage forms (cream, gel, or ointment): Adults—Apply to the affected area of the skin two times per day. Children 12 to 17 years of age—Apply to the affected area of the skin two times per day. Children younger than 12 years of age—Use is not recommended. For topical dosage form (lotion): Adults—Apply to the affected area of the skin two times per day. Children—Use is not recommended. • For plaque psoriasis: For topical dosage form (cream): Adults—Apply to the affected area of the skin two times per day. Children younger than 16 years of age—Use is not recommended. For topical dosage form (foam): Adults—Apply to the affected area of the skin two times per day, once in the morning and once at night. Children 12 to 17 years of age—Apply to the affected area of the skin two times per day, once in the morning and once at night. Children younger than 12 years of age—Use is not recommended. For topical dosage form (spray): Adults—Spray to the affected area of the skin two times per day. Children—Use is not recommended. • For scalp problems: For topical dosage forms (foam or scalp solution): Adults—Apply to the affected area of the scalp two times per day, once in the morning and once at night. Children 12 to 17 years of age—Apply to the affected area of the scalp two times per day, once in the morning and once at night. Children younger than 12 years of age—Use is not recommended. For topical dosage form (shampoo): Adults—Apply to the affected area of the scalp once a day. Children—Use is not recommended. Missed Dose If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Storage Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Store the foam can at room temperature, away from heat and direct light. Do not keep this medicine inside a car where it could be exposed to extreme heat. Do not poke holes in the canister or throw it into a fire, even if the canister is empty. Store the Temovate® E cream at room temperature, away from heat, moisture, and direct light. Do not refrigerate. Keep from freezing. It is very important that your doctor check the progress of you or your child at regular visits for any unwanted effects that may be caused by this medicine. If your or your child’s symptoms do not improve within a few days, or if they become worse, check with your doctor. Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision, dizziness or fainting, a fast, irregular, or pounding heartbeat, increased thirst or urination, irritability, or unusual tiredness or weakness. Check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin. Make sure your doctor knows that you are using clobetasol cream or gel. You may need to stop using this medicine several days before having surgery. Do not use clobetasol together with other topical corticosteroid-containing medicines, such as betamethasone, hydrocortisone, triamcinolone, Cortaid®, or Lotrisone®. Using these medicines together may cause serious unwanted effects. Do not use cosmetics or other skin care products on the treated areas. 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 immediately if any of the following side effects occur: More common • Burning or stinging at the application site Less common • Burning sensation of the skin • dry skin • flushing or redness of the skin • itching, scaling, severe redness, soreness, or swelling of the skin • skin irritation • skin rash, encrusted, scaly and oozing • thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (eg, between the fingers) Incidence not known • Burning, itching, and pain in hairy areas, or pus at the root of the hair • hair loss • redness and scaling around the mouth • thinning of the hair • thinning, weakness, or wasting away of the skin 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 • Cough • sore throat Less common • Body aches or pain • changes in skin coloring • congestion or cough • dryness or soreness of the throat • headache • raised, dark red, wart-like spots on the skin, especially when used on the face • skin discomfort • stuffy or runny nose • tender, swollen glands in the neck • trouble swallowing • unusual tiredness or weakness • voice changes Incidence not known • Acne or pimples • burning and itching of the skin with pinhead-sized red blisters • increased hair growth on the forehead, back, arms, and legs • lightening of normal skin color • lightening of treated areas of dark skin • reddish purple lines on the arms, face, legs, trunk, or groin • softening of the skin Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.