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Primary Axillary Hyperhidrosis
Sweating is a part of life, but for the millions who sweat excessively, sweating may seem like the focus of their life. That’s because of a medical condition called hyperhidrosis. People diagnosed with hyperhidrosis under the arms (that is not due to another condition or a side effect of medication) have primary axillary hyperhidrosis.
Important Safety Information for QBREXZA® (glycopyrronium) cloth
What is QBREXZA?
QBREXZA is a prescription medication used on the skin to treat excessive underarm sweating (primary axillary hyperhidrosis) in people 9 years of age and older.
What is the most important information I should know about QBREXZA?
Who should not use QBREXZA?
Do not use QBREXZA if you have certain medical conditions that can be made worse by taking an anticholinergic medicine such as glaucoma, severe ulcerative colitis (UC) or certain other serious bowel problems associated with UC, myasthenia gravis, and Sjogren’s syndrome.
What should I tell my healthcare provider before using QBREXZA?
- Tell your healthcare provider about all your medical conditions, including if you have prostate, bladder or kidney problems or problems passing urine; if you are pregnant or breastfeeding, or plan to become pregnant or breastfeed. It is not known if QBREXZA will harm your unborn baby or pass into breastmilk.
- Tell your healthcare provider and pharmacist about all the medicines you take, including prescription and over-the-counter medicines and especially any anticholinergic medicines.
What are the possible side effects of QBREXZA?
Serious side effects may include:
- New or worsened urinary retention: People who use QBREXZA may develop new or worse urinary retention. Urinary retention can result from a blockage in your bladder or a larger than normal prostate. Stop using QBREXZA and call your healthcare provider right away if you experience any of the following symptoms: difficulty urinating; urinating frequently; urinating in a weak stream or drips; full bladder or difficulty emptying your bladder.
- Problems with control of your body temperature: QBREXZA can cause you to have decreased sweating in areas other than the underarm leading to overheating and the development of heat illness when in hot or very warm temperatures. Stop using QBREXZA and call your healthcare provider right away if you experience any of the following symptoms: lack of sweating on your body; hot or red skin; decreased alertness or passing out; fast, weak pulse; fast, shallow breathing; increased body temperature.
- Blurred Vision: Stop using QBREXZA and call your healthcare provider if you develop blurred vision. Do not drive, operate machinery, or do hazardous work until your vision is clear.
The most common side effects of QBREXZA in clinical studies were dry mouth; dilation of the pupils; sore throat; skin redness, burning/stinging or itching in underarm area; headache; problems with urination; blurred vision; nasal, throat, eye, and skin dryness; and constipation. These are not all the possible side effects of QBREXZA. Call your healthcare provider for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
QBREXZA is for use on the skin in the underarm only. Wash your hands right away after you apply QBREXZA and have thrown away the cloth.
Please see full Prescribing Information, including Patient Product Information.
QBREXZA is a prescription medication used on the skin to treat excessive underarm sweating (primary axillary hyperhidrosis) in people 9 years of age and older.
Do not use QBREXZA if you have certain medical conditions that can be made worse by taking an anticholinergic medicine such as glaucoma, severe ulcerative colitis (UC) or certain other serious bowel problems associated with UC, myasthenia gravis, and Sjogren’s syndrome.
Sweating helps to regulate your body’s temperature. But people with axillary hyperhidrosis sweat more under their arms than the body requires. And the results can range from noticeable pit stains to fully drenched shirts.
Severe Recalcitrant Nodular Acne
Severe recalcitrant nodular acne is another way of saying severe acne with large, painful bumps that don’t go away with other acne medicines. Patients with severe recalcitrant nodular acne are at higher risk of scarring.
Important Safety Information for Accutane® (Isotretinoin Capsules USP)
What is the most important information I should know about Accutane?
Accutane is used to treat a type of severe acne (nodular acne) that has not been helped by other treatments, including antibiotics.
Accutane can harm your unborn baby, including birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births. Patients who are pregnant or who plan to become pregnant must not take Accutane.
Patients must not get pregnant:
- for 1 month before starting Accutane
- while taking Accutane
- for 1 month after stopping Accutane
If you get pregnant while taking Accutane, stop taking it right away and call your healthcare provider.
Accutane is only for patients who can understand and agree to follow all the instructions in the iPLEDGE® Program. Patients taking Accutane must register in the iPLEDGE® Pregnancy Registry at 1-866-495-0654 or www.ipledgeprogram.com. See your healthcare provider for further information.
Accutane can cause serious mental health problems, including:
- depression
- psychosis (seeing or hearing things that are not real)
- suicide. Some patients taking Accutane have had thoughts about hurting themselves or suicide. Consult your healthcare provider if you have such thoughts.
Stop Accutane and call your doctor right away if you or a family member notices that you have any of the following signs and symptoms of depression or psychosis:
- start to feel sad or have crying spells
- lose interest in activities you once enjoyed
- sleep too much or have trouble sleeping
- become more irritable, angry, or aggressive than usual (for example, temper outbursts, thoughts of violence)
- have a change in your appetite or body weight
- have trouble concentrating
- withdraw from your friends or family
- feel like you have no energy
- have feelings of worthlessness or guilt
- start having thoughts about hurting yourself or taking your own life (suicidal thoughts)
- start acting on dangerous impulses
- start seeing or hearing things that are not real
After stopping Accutane, you may also need follow-up mental health care if you had any of these symptoms.
Who should not take Accutane?
- Do not take Accutane if you are pregnant, plan to become pregnant, or become pregnant during Accutane treatment. Accutane causes severe birth defects. See What is the most important information I should know about Accutane?
- Do not take Accutane if you are allergic to anything in it. See the end of the Medication Guide for a complete list of ingredients in Accutane. Accutane contains parabens as the preservatives.
What should I tell my doctor before taking Accutane?
Tell your doctor if you or a family member has any of the following health conditions:
- mental problems
- asthma
- liver disease
- diabetes
- heart disease
- bone loss (osteoporosis) or weak bones
- an eating problem called anorexia nervosa (where people eat too little)
- food or medicine allergies
Tell your doctor if you are pregnant or breastfeeding. Accutane must not be used by women who are pregnant or breastfeeding.
Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Accutane and certain other medicines can interact with each other, sometimes causing serious side effects. Especially tell your doctor if you take:
- Vitamin A supplements. Vitamin A in high doses has many of the same side effects as Accutane. Taking both together may increase your chance of getting side effects.
- Tetracycline antibiotics. Tetracycline antibiotics taken with Accutane can increase the chances of getting increased pressure in the brain.
- Progestin-only birth control pills (mini-pills). They may not work while you take Accutane. Ask your doctor or pharmacist if you are not sure what type you are using.
- Dilantin (phenytoin). This medicine taken with Accutane may weaken your bones.
- Corticosteroid medicines. These medicines taken with Accutane may weaken your bones.
- St. Johns Wort. This herbal supplement may make birth control pills work less effectively.
These medicines should not be used with Accutane unless your doctor tells you it is okay.
Know the medicines you take. Keep a list of them to show to your doctor and pharmacist. Do not take any new medicine without talking with your doctor.
What should I avoid while taking Accutane?
- Do not get pregnant while taking Accutane and for one month after stopping Accutane. See What is the most important information I should know about Accutane?
- Do not breastfeed while taking Accutane and for one month after stopping Accutane. We do not know if Accutane can pass through your milk and harm the baby.
- Do not give blood while you take Accutane and for one month after stopping Accutane. If someone who is pregnant gets your donated blood, their baby may be exposed to Accutane and may be born with birth defects.
- Do not take other medicines or herbal products with Accutane unless you talk to your doctor. See What should I tell my doctor before taking Accutane?
- Do not drive at night until you know if Accutane has affected your vision. Accutane may decrease your ability to see in the dark.
- Do not have cosmetic procedures to smooth your skin, including waxing, dermabrasion, or laser procedures, while you are using Accutane and for at least 6 months after you stop. Accutane can increase your chance of scarring from these procedures. Check with your doctor for advice about when you can have cosmetic procedures.
- Avoid sunlight and ultraviolet lights as much as possible. Tanning machines use ultraviolet lights. Accutane may make your skin more sensitive to light.
- Do not share Accutane with other people. It can cause birth defects and other serious health problems.
What are the possible side effects of Accutane?
- Accutane can harm your unborn baby, including birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births.
- Accutane can cause serious mental health problems.
- Serious brain problems. Accutane can increase the pressure in your brain. This can lead to permanent loss of eyesight and, in rare cases, death. Stop taking Accutane and call your healthcare provider right away if you get any of these signs of increased brain pressure:
- bad headache
- blurred vision
- dizziness
- nausea or vomiting
- seizures (convulsions)
- stroke
- Skin problems. Skin rash can occur in patients taking Accutane. In some patients a rash can be serious. Stop using Accutane and call your healthcare provider immediately if you develop:
- conjunctivitis (red or inflamed eyes, like pink eye)
- rash with a fever
- blisters on legs, arms or face and/or sores in your mouth, throat, nose, eyes
- skin begins to peel
- Stomach area (abdomen) problems. Certain symptoms may mean your internal organs are being damaged, such as the liver, pancreas, bowel (intestines), and esophagus (connection between mouth and stomach). If your organs are damaged, they may not get better even after you stop taking Accutane. Stop Accutane and call your healthcare provider if you get:
- severe stomach, chest or bowel pain
- trouble swallowing or painful swallowing
- new or worsening heartburn
- diarrhea
- rectal bleeding
- yellowing of your skin or eyes
- dark urine
- Bone or muscle problems. Accutane may affect your bones, muscles, and ligaments and cause pain in your joints and muscles. Tell your healthcare provider if you plan hard physical activity during treatment or get back or joint pain or broken bones. Stop Accutane and call your healthcare provider immediately if you have muscle weakness. Muscle weakness with or without pain can be a sign of serious muscle damage. Accutane may stop long bone growth in teenagers who are still growing.
- Hearing problems. Stop using Accutane and call your healthcare provider if your hearing gets worse or if you have ringing in your ears. Your hearing loss may be permanent.
- Vision problems. Accutane may affect your ability to see in the dark. Stop taking Accutane and call your healthcare provider right away if you have problems with your vision or dryness of the eyes that is painful or constant. If you wear contact lenses, you may have trouble wearing them during and after you stop treatment with Accutane.
- Lipid (fats and cholesterol in blood) problems. Accutane can raise the level of fats and cholesterol in your blood. This can be a serious problem. Return to your doctor for blood tests to check your lipids and to get any needed treatment. These problems usually go away when Accutane treatment is finished.
- Serious allergic reactions. Stop taking Accutane and get emergency care right away if you develop hives, a swollen face or mouth, or have trouble breathing. Stop taking Accutane and call your healthcare provider if you get a fever, rash, or red patches or bruises on your legs.
- Blood sugar problems. Accutane may cause blood sugar problems including diabetes. Tell your healthcare professional if you are very thirsty or urinate a lot.
- Decreased red or white blood cells. Call your healthcare professional if you have trouble breathing, faint, or feel weak.
- The common, less serious side effects of Accutane include:
- Dry skin
- Chapped lips
- Dry eyes
- Dry nose that may lead to nosebleeds
These are not all of the possible side effects of Accutane. Call your healthcare professional for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or JG Pharma, Inc. at 1-844-325-3350.
Accutane is used to treat a type of severe acne (nodular acne) that has not been helped by other treatments, including antibiotics.
Accutane can harm your unborn baby, including birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births. Patients who are pregnant or who plan to become pregnant must not take Accutane. Accutane can cause serious mental health problems, including depression, psychosis, and suicide.
Please see the Medication Guide and full Prescribing Information here for Boxed Warning, Contraindications, other important Warnings and Precautions, Drug Interactions, Use in Specific Populations, and other Adverse Reactions.
There are four main causes of the development of severe nodular acne: excess oils, slower skin cell turnover, bacterial growth and inflammation.
Excess oils: the oily substance that protects your skin can contribute to acne when too much is produced.
Slower skin cell turnover: dead skin cells that normally just fall off can get stuck in skin oils instead and clog your pores.
Bacterial growth: a specific bacteria that is normally harmless begins to multiply if it gets trapped in a clogged pore.
Inflammation: multiplying bacteria trigger inflammation that results in red, swollen, painful and pus-filled pimples.
Acne
Acne is the most common skin condition in the United States and can affect up to 50 million Americans every year. By the age of 21, more than 90% of males and 80% of females will have experienced acne, and the condition can continue into adulthood.
Important Safety Information for Targadox® (doxycycline hyclate USP) Tablets
Indications and Usage
What is Targadox?
TARGADOX (doxycycline hyclate USP) 50mg tablets is a tetracycline-class antimicrobial indicated as adjunctive therapy for severe acne. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of TARGADOX and other antibacterial drugs, TARGADOX should be used only as indicated. There are no adequate and well-controlled studies on the use of doxycycline in pregnant women.
Important Risk Information
Who Should Not Take Targadox?
This drug should not be used by persons who have shown hypersensitivity to any of the tetracyclines.
What Are Possible Side Effects of Targadox?
- TARGADOX tablets should not be used by persons who have shown hypersensitivity to any of the tetracyclines.
- The use of tetracycline class drugs during tooth development (last half of pregnancy, infancy, and childhood to 8 years) may cause permanent discoloration of the teeth and should not be used in this group (except for anthrax).
- Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, including doxycycline, and may range from mild diarrhea to fatal colitis.
- Photosensitivity can occur with tetracycline-class drugs.
- TARGADOX patients should minimize or avoid excessive exposure to natural or artificial sunlight and consider using sunscreen or sunblock. Patients should discontinue therapy at the first evidence of skin redness.
- Intracranial Hypertension (IH) has been associated with the use of tetracyclines.
- Concurrent use of tetracycline may render oral contraceptives less effective.
- Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate, and iron-containing preparations.
- Esophagitis has been associated with the use of tetracyclines so patients should drink fluids liberally along with doxycycline.
- Adverse reactions observed in patients receiving tetracyclines include anorexia, nausea, vomiting, diarrhea, rash, photosensitivity, urticaria, hemolytic anemia, toxic epidermal necrolysis, Stevens-Johnson syndrome, increased blood urea nitrogen (BUN) and hypersensitivity reactions.
To report SUSPECTED ADVERSE REACTIONS, contact Journey Medical Corporation at 1-855-531-1859, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Important Safety Information for Ximino® (minocycline hydrochloride) Extended-Release Capsules
Indications and Usage
What Is Ximino?
XIMINO (minocycline hydrochloride) is a tetracycline-class drug used to treat pimples and red bumps (non-nodular inflammatory lesions) that happen with moderate to severe acne vulgaris in people 12 years and older.
XIMINO is not effective for acne that is not red-looking (this means acne that is not inflammatory). It is not known whether Ximino is: safe for use longer than 12 weeks, safe and effective for the treatment of infections, or safe and effective in children under the age of 12 years.
Important Risk Information
Who Should Not Take Ximino?
Do not take XIMINO if you are allergic to tetracycline class medicines. Ask your doctor or pharmacist for a list of these medicines if you are not sure.
What Should I Tell My Doctor Before Taking Ximino?
Before you take XIMINO, tell your doctor if you have kidney or liver problems, diarrhea or watery stools, vision problems, plan to have surgery with general anesthesia, or have any other medical conditions.
You should not take XIMINO if you are a male, and you and your female partner are trying to conceive a baby.
You should not take XIMINO if you are pregnant or plan to become pregnant. XIMINO may harm your unborn baby. Taking XIMINO while you are pregnant may cause serious side effects on the growth of bone and teeth of your baby. Talk to your doctor before taking XIMINO if you plan to become pregnant or if you are already taking XIMINO and plan to become pregnant. Stop taking XIMINO and call your doctor right away if you become pregnant while taking XIMINO.
You should not take XIMINO if you are breastfeeding or plan to breastfeed. XIMINO passes into your milk and may harm your baby. You and your doctor should decide if you will take XIMINO or breastfeed. You should not do both.
Tell your doctor about all the other medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. XIMINO may affect the way other medicines work, and other medicines may affect how XIMINO works. Especially tell your doctor if you take birth control pills, blood thinner medicine, penicillin antibiotic medicine, antacids that contain aluminum, calcium, or magnesium, iron-containing products, or an acne medication that contains isotretinoin. XIMINO and penicillins should not be used together. XIMINO should not be taken with an acne medication that contains isotretinoin. XIMINO and isotretinoin should not be used together. Ask your doctor or pharmacist if you are not sure if your medicine is one that is listed above.
What Are Possible Side Effects of Ximino?
Ximino May Cause Serious Side Effects, Including:
- Harm to an unborn baby.
- Permanent teeth discoloration. XIMINO may permanently turn a baby or child’s teeth yellow-grey-brown during tooth development. XIMINO should not be used during tooth development. Tooth development happens in the last half of pregnancy, and from birth to 8 years of age.
- Intestine infection (pseudomembranous colitis). Pseudomembranous colitis can happen with most antibiotics, including XIMINO. Call your doctor right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools. You may have stomach cramps and a fever. Pseudomembranous colitis can happen 2 or more months after you have finished your medication.
- Serious liver problems. Stop taking XIMINO and call your doctor right away if you get any of the following symptoms of liver problems:
- loss of appetite
- tiredness
- diarrhea
- yellowing of your skin or the whites of your eyes
- unexplained bleeding
- confusion
- sleepiness
- Central nervous system effects. Central nervous system effects such as light headedness, dizziness, and a spinning feeling (vertigo) may go away during your treatment with XIMINO or if treatment is stopped. Call your doctor if you get headaches that do not go away or blurred vision.
- Benign intracranial hypertension, also called pseudotumor cerebri. This is a condition where there is high pressure in the fluid around the brain. This swelling may lead to vision changes and permanent vision loss. Stop taking XIMINO and tell your doctor right away if you have blurred vision, vision loss, or unusual headaches.
- Immune system reactions including a lupus-like syndrome, hepatitis, and inflammation of blood or lymph vessels (vasculitis). Using XIMINO for a long time to treat acne may cause immune system reactions. Tell your doctor right away if you get a fever, rash, joint pain, or body weakness. Your doctor may do tests to check your blood for immune system reactions.
- Serious rash and allergic reactions. XIMINO may cause a serious rash and allergic reactions that may affect parts of your body such as your liver, lungs, kidneys and heart. Sometimes these can lead to death.
- Stop taking XIMINO and get medical help right away if you have any of these symptoms:
- skin rash, hives, sores in your mouth, or your skin blisters and peels
- swelling of your face, eyes, lips, tongue, or throat
- trouble swallowing or breathing
- blood in your urine
- fever, yellowing of the skin or the whites of your eyes, dark colored urine
- pain on the right side of the stomach area (abdominal pain)
- chest pain or abnormal heartbeats
- swelling in your legs, ankles, and feet
- darkening of your nails, skin, eyes, scars, teeth, and gums
- Stop taking XIMINO and get medical help right away if you have any of these symptoms:
What Should I Avoid While Taking Ximino?
- Avoid sunlight, sunlamps, and tanning beds. XIMINO can make your skin sensitive to the sun and the light from sunlamps and tanning beds. You could get severe sunburn.
- Wear loose-fitting clothes that protect your skin from sun exposure. Talk to your doctor about other ways to protect your skin while out in sunlight.
- You should not drive or operate dangerous machinery until you know how XIMINO affects you. XIMINO may cause you to feel dizzy or lightheaded, or have a spinning feeling (vertigo).
The most common side effects of XIMINO were headache, tiredness, dizziness or spinning feeling and itching.
Call your doctor if you have a side effect that bothers you or that does not go away. Your doctor may do tests to check you for side effects during treatment with XIMINO.
These are not all the side effects with XIMINO. Ask your doctor or pharmacist for more information. Call your doctor for medical advice about side effects.
To report SUSPECTED ADVERSE REACTIONS, contact Journey Medical Corporation at 1-855-531-1859, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Important Safety Information for Amzeeq® (minocycline) topical foam, 4%
Indications and Usage
What Is AMZEEQ?
AMZEEQ® (minocycline) topical foam, 4% is a prescription medicine used on the skin (topical) for the treatment of pimples and red bumps (non-nodular inflammatory lesions) of moderate to severe acne in patients 9 years of age and older.
AMZEEQ should not be used for the treatment of infections. It is not known if AMZEEQ is safe and effective in children under 9 years of age. AMZEEQ is for use on skin only (topical use). AMZEEQ is not for use in your mouth, eyes or vagina.
Important Risk Information
Who Should Not Take AMZEEQ?
- Do not use AMZEEQ if you are allergic to AMZEEQ or any tetracycline medicine. Stop using AMZEEQ right away and call your doctor if you get a rash or other allergic symptom.
- Before using AMZEEQ, tell your doctor about all of your medical conditions and the medicines you take. Do not use AMZEEQ if you are pregnant, may become pregnant or are nursing. If you become pregnant while using AMZEEQ, talk to your doctor. Tetracycline medicine when taken by mouth during pregnancy, infancy and/or childhood up to the age of 8 years may permanently discolor teeth (yellow-gray-brown) and may slow the growth of bones.
- AMZEEQ is flammable. Avoid fire, flame, and smoking when applying and right after you apply AMZEEQ.
- Protect your skin from the sun while using AMZEEQ. Avoid sunlight or artificial sunlight such as sunlamps or tanning beds. Stop using AMZEEQ if you get a sunburn.
- When taken by mouth, minocycline may cause feelings of lightheadedness, dizziness or spinning. You should not drive or operate dangerous machinery if you have these symptoms.
What Are Possible Side Effects of Amzeeq?
The most common side effect of AMZEEQ is headache.
AMZEEQ is a topical foam that contains minocycline, a tetracycline medicine. It is not taken by mouth. However, tetracyclines, when taken by mouth (capsules or tablets), may cause serious side effects, including: diarrhea which may be caused by an infection and can cause watery or bloody stools; loss of appetite; tiredness; yellowing of your skin or eyes (jaundice); bleeding more easily than normal; confusion; sleepiness; vision changes, including blurred vision, double vision, or permanent vision loss; unusual headaches; fever; rash; joint pain; body weakness; discoloration or darkening of your skin, scars, teeth, or gums. Call your doctor right away if these side effects occur.
These are not all of the possible side effects with AMZEEQ. Call your doctor for medical advice about side effects.
Please see full Prescribing Information and Patient Information.
To report SUSPECTED ADVERSE REACTIONS, contact Journey Medical Corporation at 1-855-531-1859, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information and Patient Information.
TARGADOX is a tetracycline-class antimicrobial indicated as adjunctive therapy for severe acne.
To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of TARGADOX and other antibacterial drugs, TARGADOX should be used only as indicated.
TARGADOX should not be used by persons who have shown hypersensitivity to any of the tetracyclines.
AMZEEQ® (minocycline) topical foam, 4% is a prescription medicine used on the skin (topical) for the treatment of pimples and red bumps (non-nodular inflammatory lesions) of moderate to severe acne in patients 9 years of age and older.
AMZEEQ should not be used for the treatment of infections. It is not known if AMZEEQ is safe and effective in children under 9 years of age. AMZEEQ is for use on skin only (topical use). AMZEEQ is not for use in your mouth, eyes or vagina.
XIMINO is a tetracycline-class drug used to treat pimples and red bumps (non-nodular inflammatory lesions) that happen with moderate to severe acne vulgaris in people 12 years and older.
XIMINO is not effective for acne that is not red-looking (this means acne that is not inflammatory). It is not known whether Ximino is: safe for use longer than 12 weeks, safe and effective for the treatment of infections, or safe and effective in children under the age of 12 years
Do not take XIMINO if you are allergic to tetracycline class medicines. Ask your doctor or pharmacist for a list of these medicines if you are not sure.
Acne occurs when hair follicles are clogged with oils and dead skin cells. Hormones play a central role in the development of acne, which could be further aggravated by stress, environmental factors, over-washing or using harsh skin products, excessive touching of the face and diet. Acne can appear on the face, forehead, shoulders, back and chest in the form of whiteheads, blackheads or pimples and is often accompanied by oily skin.
Rosacea
Rosacea is a common inflammatory skin condition estimated to affect 16 million Americans. Common symptoms can include facial redness, and pimples and bumps (also called inflammatory lesions).
Important Safety Information for Zilxi® (minocycline) topical foam, 1.5%
Indications and Usage
What Is ZILXI?
ZILXI® (minocycline) topical foam, 1.5% is a prescription medicine used on the skin (topical) to treat adults with pimples and bumps caused by a condition called rosacea.
ZILXI should not be used for the treatment of infections. It is not known if ZILXI is safe and effective in children. ZILXI is for use on the skin only (topical use). ZILXI is not for use in your mouth, eyes, or vagina.
Important Risk Information
Who Should Not Take ZILXI?
- Do not use ZILXI if you are allergic to ZILXI or any tetracycline medicine. Stop using ZILXI right away and call your doctor if you get a rash or other allergic symptom.
- Before using ZILXI, tell your doctor about all of your medical conditions and the medicines you take. Do not use ZILXI if you are pregnant, may become pregnant or are nursing. If you become pregnant while using ZILXI, talk to your doctor. Tetracycline medicine when taken by mouth during pregnancy, infancy, and/or childhood up to the age of 8 years may permanently discolor teeth (yellow-gray-brown) and may slow the growth of bones.
- ZILXI is flammable. Avoid fire, flames, and smoking when applying and right after you apply ZILXI.
- Protect your skin from the sun while using ZILXI. Avoid sunlight or artificial sunlight such as sunlamps or tanning beds. Stop using ZILXI if you get a sunburn.
- When taken by mouth, minocycline may cause feelings of lightheadedness, dizziness or spinning. You should not drive or operate dangerous machinery if you have these symptoms.
What Are Possible Side Effects of ZILXI?
ZILXI is a topical foam that contains minocycline, a tetracycline medicine. It is not taken by mouth. However, tetracyclines, when taken by mouth (capsules or tablets), may cause serious side effects, including: diarrhea which may be caused by an infection and can cause watery or bloody stools; loss of appetite; tiredness; yellowing of your skin or eyes (jaundice); bleeding more easily than normal; confusion; sleepiness; vision changes, including blurred vision, double vision, or permanent vision loss; unusual headaches; fever; rash; joint pain; body weakness; discoloration or darkening of your skin, scars, teeth, or gums. Call your doctor right away if these side effects occur.
The most common side effect of ZILXI is diarrhea.
These are not all of the possible side effects with ZILXI. Call your doctor for medical advice about side effects.
Please see Patient Information.
To report SUSPECTED ADVERSE REACTIONS, contact Journey Medical Corporation at 1-855-531-1859, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
ZILXI® (minocycline) topical foam, 1.5% is a prescription medicine used on the skin (topical) to treat adults with pimples and bumps caused by a condition called rosacea.
ZILXI should not be used for the treatment of infections. It is not known if ZILXI is safe and effective in children. ZILXI is for use on the skin only (topical use). ZILXI is not for use in your mouth, eyes or vagina.
Important Safety Information
There are a number of foods and situations that can trigger rosacea symptoms, such as alcohol, hot or spicy foods, sweat, sun exposure and extreme temperatures.
Although your rosacea may not be affected by every trigger, it’s important to be aware of them. Make a note of your activities on the days you experience flare-ups to help pinpoint which rosacea triggers to avoid in the future.
Emotional stress can also be a cause and a symptom of rosacea. Feeling embarrassed, frustrated, or anxious regarding your rosacea is natural. Know that you are not alone. There are resources and support for you and for the millions in the U.S. like you who have rosacea.
Fungal Skin Infections
Fungal skin infections are caused by pathogenic fungi, which affect structures such as the hair and skin, and are usually accompanied with itching.
Important Safety Information for Exelderm® (sulconazole nitrate, USP) Cream & Solution, 1.0%
Indications and Usage
What Is Exelderm?
Exelderm (sulconazole nitrate) Cream and Solution, 1.0% are antifungal agents indicated for the treatment of tinea cruris and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis,* and for the treatment of tinea versicolor. *Efficacy for this organism in the organ system was studied in fewer than 10 infections. EXELDERM Cream is also indicated for the treatment of tinea pedis (athlete’s foot). Effectiveness of EXELDERM Solution has not been proven in tinea pedis.
Important Risk Information
Who Should Not Take Exelderm?
EXELDERM (sulconazole nitrate) Cream and Solution,1.0% are contraindicated in patients who have a history of hypersensitivity to any of its ingredients.
What Should I Avoid While Using Exelderm?
Use EXELDERM (sulconazole nitrate) Cream and Solution, as directed by your physician only. EXELDERM (sulconazole nitrate) Cream and Solution, 1.0% are for external use only. Avoid contact with the eyes. If irritation develops, the cream or solution should be discontinued and appropriate therapy instituted.
There are no adequate and well-controlled studies in pregnant women. Sulconazole nitrate should be used during pregnancy only if clearly needed. Sulconazole nitrate has been shown to be embryotoxic in rats when given in doses of 125 times the adult human dose (in mg/kg). The drug was not teratogenic in rats or rabbits at oral doses of 50 mg/kg/day. Sulconazole nitrate given orally to rats at a dose 125 times the human dose resulted in prolonged gestation and dystocia. Several females died during the prenatal period, most likely due to labor complications.
It is not known whether sulconazole nitrate is excreted in human milk. Caution should be exercised when sulconazole nitrate is administered to a nursing woman.
Safety and effectiveness in children have not been established.
What Are Possible Side Effects of Exelderm?
There were no systemic effects and only infrequent cutaneous adverse reactions in 1185 patients treated with sulconazole nitrate cream in controlled clinical trials. Approximately 3% of these patients reported itching, 3% burning or stinging, and 1% redness. These complaints did not usually interfere with treatment.
There were no systemic effects and only infrequent cutaneous adverse reactions in 370 patients treated with sulconazole nitrate solution in controlled clinical trials. Approximately 1% of these patients reported itching and 1% burning or stinging. These complaints did not usually interfere with treatment.
These preparations are not for ophthalmic, oral, or intravaginal use.
For topical use only. Please see Full Prescribing Information.
To report SUSPECTED ADVERSE REACTIONS, contact Journey Medical Corporation at 1-855-531-1859, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Click here for full prescribing information.
References: 1. Drugs & medications—EXELDERM TOP. WebMD (website). http://www.webmd.com/drugs/mono-593-SULCONAZOLE+CREAM+-+TOPICAL.aspx?drugid=6792&drugname=EXELDERM+top. Accessed January 29, 2014. 2. EXELDERM [prescribing information]. Scottsdale, AZ: Journey Medical Inc.; October 2018.
EXELDERM Cream and Solution are contraindicated in patients who have a history of hypersensitivity to any of its ingredients. Use EXELDERM Cream and Solution as directed by your physician only.
Important Safety Information
Athlete’s Foot
Athlete’s foot, also known as tinea pedis, is a common fungal infection affecting the superficial skin of the foot. Up to 25% of Americans are affected by this condition at any one time. The infection most often starts in the space between the toes and can be accompanied by redness, itching, cracked skin and bad odors. It can be spread through contact with infected skin flakes or contact with fungi in damp areas such as public showers, pool areas or locker rooms, and can be exacerbated by wearing restrictive footwear and/or sweaty socks.
Jock Itch
Jock itch, also known as tinea cruris, affects the skin of the groin, buttocks and upper thighs, especially in athletes. These areas are particularly susceptible to infection due to the presence of sweat and moisture, which creates perfect conditions for fungal growth. Jock itch presents as a highly visible, scaly plaque with a raised edge, with symptoms including an uncomfortable, itchy rash on the groin, which may be painful if the skin is breaking down due to excess moisture.
Ringworm
Ringworm, also known as tinea corporis, is a fungal infection affecting the trunk, neck, arms and legs, and does not have anything to do with worms. In the United States, 1 in 5 cases of these fungal skin infections are due to ringworm. Ringworm typically presents with a visible, itchy, red rash and single or multiple lesions with raised borders that spread from a core, giving it the characteristic ring shape.
Pityriasis
Pityriasis, also known as tinea versicolor, is caused by yeasts, which are a type of fungi that causes the skin to appear lighter, darker or redder than surrounding unaffected skin. It most commonly occurs on the chest and back, but other affected areas include upper arms, neck and face. Pityriasis is most noticeable during the summer months, when the affected areas do not tan as easily as normal skin. Symptoms include patches of discolored skin, mild itching and scaling of skin. It is not contagious or painful.
Wounds, Abrasions, Skin Ulcers, Sunburn & Donor Site Wounds
Minor cuts and scrapes, superficial wounds and abrasions are a common part of everyday life. It only takes one false move with a potato peeler to cut yourself or a stumble off of a curb to scrape your knee. Though these conditions may not seem very serious, they can cause redness, irritation, inflammation and pain, and become infected if left untreated. Proper wound care and application of topical treatments can reduce the risk of scarring. It takes three months for the wounded area to almost achieve pre-trauma strength; however, the entire healing process could take a few years.
Important Safety Information for Luxamend® Wound Cream
Indications and Usage
What Is Luxamend?
Luxamend is indicated for use in:
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- Full Thickness Wounds, Pressure Sores, Dermal Ulcers including Lower Leg Ulcers
- Superficial Wounds
- 1st and 2nd Degree Burns, including Sunburns
- Dermal Donor and Graft Site Management
- Radiation Dermatitis
- Minor Abrasions
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Important Risk Information
Who Should Not Use Luxamend?
Luxamend is contraindicated for use on bleeding wounds, skin rashes related to food or medicine allergies, and when an allergy to one of the ingredients is known.
What Should I Know While Using Luxamend?
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- In radiation therapy, Luxamend may be applied as directed by the treating physician. Do not apply 4 hours prior to a radiation session.
- Do not apply Luxamend to dermal grafts until after the graft has successfully taken.
- Keep out of the reach of children.
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What Should I Avoid While Using Luxamend?
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- For the treatment of any dermal wound, consult a physician. Use Luxamend only as directed.
- Luxamend is non-toxic; it is for topical use only and should not be ingested or taken internally.
- Luxamend does not contain a sunscreen and should not be used prior to extended exposure to the sun.
- The use of Luxamend on skin rashes due to allergies has not been studied sufficiently and therefore is not recommended.
- Following the application of Luxamend, a temporary tingling sensation may occur (10–15 minutes).
- If clinical signs of infection are present, appropriate treatment should be initiated. If clinically indicated, use of Luxamend may be continued during the anti-infective therapy.
- If condition does not improve within 10–14 days, consult a physician.
- Luxamend may dissolve fuchsin when this dye is used to define the margins of the radiation fields to be treated.
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Call your doctor for medical advice about side effects.
To report SUSPECTED ADVERSE REACTIONS, contact Journey Medical Corporation at 1-855-531-1859, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Luxamend Wound Cream is indicated for the treatment of full thickness and superficial wounds, pressure sores, dermal ulcers, 1st and 2nd degree burns, dermal donor and graft site management, radiation dermatitis, and minor abrasions.
Luxamend is contraindicated for use on bleeding wounds, skin rashes related to food or medicine allergies, and when an allergy to one of the ingredients is known.
Sunburn remains one of the most common and preventable skin injuries. It is caused by overexposure to ultraviolet radiation (UVR) through indoor tanning beds or outdoor sunlight. Symptoms include mild to severe redness, skin warmth and tenderness, blistering, swelling and pain. Treatment of sunburn should begin as soon as you notice the symptoms.
Skin ulcers are caused by factors affecting the normal healing of the skin such as problems with blood circulation or injury/pressure. Some of the symptoms include pain, bleeding, discharge, bad odor and itching. With inadequate treatment, skin ulcers can deteriorate and develop complications such as infections, pain and sepsis.