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Undesirable effects
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What are the possible side effects of Xtralite?
Applies to Xtralite / Hydroquinone (Xtralite) / Tretinoin (Xtralite) topical: topical application cream
In addition to its needed effects, some unwanted effects may be caused by Xtralite / Hydroquinone (Xtralite) / Tretinoin (Xtralite) topical. In the event that any of these side effects do occur, they may require medical attention.
Major Side Effects
You should check with your doctor immediately if any of these side effects occur when taking Xtralite / Hydroquinone (Xtralite) / Tretinoin (Xtralite) topical:
More common:
- Redness, peeling, drying, itching, or burning of the skin
Less common: - Darkening of normal skin color
- irritated skin
- rash
Incidence not known: - Blistering, crusting, or flaking of the skin
- burning and itching of the skin with pinhead-sized red blisters
- lightening of normal skin color
- redness and scaling around the mouth
- severe redness, soreness, or scaling of the skin
- thinning of the skin with easy bruising
Minor Side Effects
Some of the side effects that can occur with Xtralite / Hydroquinone (Xtralite) / Tretinoin (Xtralite) topical may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:
Less common:
- Blemishes on the skin
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- pimples
- raised, dark red, wart-like spots on the skin
Therapeutic indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
Xtralite, Hydroquinone (Xtralite), and Tretinoin (Xtralite) topical is a combination of medicines used to treat moderate to severe melasma (skin discoloration) of the face. Melasma usually happens with hormone changes in women.
Xtralite is a corticosteroid (steroid medicine), Hydroquinone (Xtralite) is a bleaching agent, and Tretinoin (Xtralite) is a retinoid (related to vitamin A).
Xtralite, Hydroquinone (Xtralite), and Tretinoin (Xtralite) is available only with your doctor's prescription.
- Avoid getting Xtralite in your eyes, nose, or mouth. If you get Xtralite in your eyes, rinse thoroughly with water.
- Do not use Xtralite on open wounds.
- Xtralite may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths while you are using Xtralite. Use a sunscreen (minimum SPF 30) and wear a wide-brimmed hat or other protective clothing if you must be outside for more than a short time.
- Talk with your doctor before you use any other medicines or products on your skin. Avoid using other topical medication, medicated or abrasive soaps, or other products that have a strong drying effect or a high alcohol content. While you are using Xtralite, you may use cosmetics and/or moisturizers.
- Do not apply Xtralite to skin that is sunburned. Wait until the burn is fully healed before using Xtralite.
- Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Hormonal contraceptives (eg, birth control pills) may cause or worsen melasma. If you are using hormonal contraception, talk with your doctor about the use of an alternative form of birth control.
- Do not use Xtralite for any condition other than that for which it was prescribed.
- Weather extremes, such as windy or cold weather, may irritate your skin more while you are using Xtralite.
- Xtralite may cause a gradual blue-black darkening of the skin. Black patients may be at higher risk for this side effect. Contact your doctor immediately if you develop this symptom.
- Some of these products contain sulfites. Sulfites may cause an allergic reaction in some patients (eg, asthma patients). If you have ever had an allergic reaction to sulfites, ask your pharmacist if your product has sulfites in it.
- Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Xtralite.
- PREGNANCY and BREAST-FEEDING: It is not known if Xtralite may cause harm to the fetus after topical use. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Xtralite while you are pregnant. It is not known if Xtralite is found in breast milk after topical use. If you are or will be breast-feeding while you use Xtralite, check with your doctor. Discuss any possible risks to your baby.
Name of the medicinal product
Xtralite
Special warnings and precautions for use
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
Use Xtralite as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Xtralite. Talk to your pharmacist if you have questions about this information.
- Xtralite is for external use only.
- Apply Xtralite at least 30 minutes before bedtime.
- Wash your hands before and after using Xtralite.
- Gently wash your face and neck with a mild cleanser. Rinse and pat the skin dry. Apply a thin film of medicine to the areas of melasma, including about ½ inch of normal-appearing skin surrounding each lesion. Rub lightly until the medicine is evenly distributed.
- Do not cover or bandage the treated area unless otherwise directed by your doctor.
- You may apply moisturizers and cosmetics during the day.
- If you miss a dose of Xtralite, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Xtralite.
Dosage (Posology) and method of administration
Usual Adult Dose for Melasma
Apply thin film to hyperpigmented areas and 1/2 inch of surrounding skin once daily at night, at least 30 minutes before bedtime.
Wash face and neck and pat skin dry before applying.
Duration: Treatment may continue intermittently for up to 6 months of cumulative drug exposure.
Renal Dose Adjustments
No adjustment recommended
Liver Dose Adjustments
No adjustment recommended
Precautions
Do not apply occlusive dressings.
Sodium metabisulfite ingredient may cause severe allergic reactions or asthmatic episodes in sensitive patients.
Avoid contact with eyes, mouth, mucous membranes, and open wounds.
Do not apply if skin is sunburned. Avoid exposure to sunlight and sunlamps. Apply an SPF 30 sunscreen during the day and wear protective clothing.
Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).
Dialysis
No adjustment recommended
Other Comments
May apply moisturizers and cosmetics during the day.
