Cleeravue-M (Topical application)

Minocycline topical foam is used to treat moderate to severe acne vulgaris. It also treats inflammatory lesions (pimples and red bumps) caused by rosacea.

Minocycline is part of a group of medicines called tetracycline antibiotics. However, this medicine is not used to prevent or treat infections.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your or your child's progress at regular visits to see if the medicine is working properly. Blood tests may be needed to check for unwanted effects.

If your or your child's symptoms do not improve within a few days, or if they get worse, contact your doctor.

Using this medicine while you are pregnant can harm your unborn baby. Use effective birth control to prevent pregnancy. If you think you may be pregnant while using this medicine, tell your doctor right away.

Minocycline may cause diarrhea, and sometimes it can be severe. This can happen 2 months or more after you stop taking this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or last longer. If you have questions about this or if mild diarrhea continues or worsens, contact your doctor.

Tell your doctor right away if you experience confusion, diarrhea, loss of appetite, sleepiness, tiredness, unusual bleeding, or yellow eyes or skin. These could be signs of a serious liver problem.

This medicine may cause dizziness, lightheadedness, or a spinning sensation. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may cause intracranial hypertension (increased pressure in the head). This is more likely to happen in women of childbearing age who are overweight. Tell your doctor right away if you have a headache, blurred vision, or any change in vision.

Autoimmune syndromes (including drug-induced lupus-like syndrome, autoimmune hepatitis, vasculitis, and serum sickness) may occur while using this medicine. Call your doctor right away if you or your child have a fever, rash, joint pain, or body weakness while using this medicine.

Minocycline may make your skin more sensitive to sunlight than usual. Exposure to sunlight, even for short periods, may cause a rash, itching, redness or other discoloration of the skin, or severe sunburn. When you start taking this medicine:

• Stay out of direct sunlight, especially from 10:00 a.m. to 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sunblock with a sun protection factor (SPF) of at least 15. Some patients may need a product with a higher SPF, especially if they have a fair complexion. If you have questions about this, consult your doctor.
• Do not use a sun lamp or tanning bed or booth.
• If you have a severe reaction to the sun, contact your doctor right away.

Serious skin or allergic reactions, which can be life-threatening, may occur during treatment with this medicine. Call your doctor right away if you have blistering or peeling skin, chest pain, dark urine, fever, hives, irregular heartbeat, skin rash, sores in the mouth, stomach pain, swelling in the legs, ankles, or feet, swelling of the face, eyes, lips, tongue, or throat, or trouble breathing or swallowing, or yellow eyes or skin.

Contact your doctor right away if you notice darkening of the skin, scars, teeth, or gums.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having medical tests.

Do not use cosmetics or other skin care products on the treated areas.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription and nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to think about the risks and benefits. For this medicine, please consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, tell your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not shown any specific problems that would limit the use of minocycline topical foam to treat acne vulgaris in children 9 years of age and older. However, safety and effectiveness have not been established for children younger than 9 years of age for treating acne vulgaris, and have not been established for children for treating inflammatory lesions of rosacea.

Minocycline may cause permanent discoloration of teeth and slow down bone growth. This medicine should not be given to children 8 years of age and younger unless directed by the child's doctor.

Geriatric

Studies have not shown any specific problems that would limit the use of minocycline topical foam in elderly patients. However, older adults may be more sensitive to the effects of this medicine than younger adults.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there could be an interaction. In such cases, your doctor may adjust the dose, or other precautions might be needed. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around mealtime or with certain types of food due to potential interactions. Drinking alcohol or using tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

• Diarrhea or
• Eye or vision problems—Use with caution. May worsen these conditions.

• Infection of the skin at or near the application site or
• Large sores, broken skin, or severe skin injury at the application site—This may increase the chance of side effects.

• Kidney disease or
• Liver disease—Use with caution. The effects may be stronger due to slower removal of the medicine from the body.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Redness, dryness, itching, peeling, or discoloration of the treated skin

Less common

• Diarrhea

Incidence not known

• Blurred vision
• change in ability to see colors, especially blue or yellow
• fever
• general feeling of discomfort or illness
• headache
• increased sensitivity of the skin to sunlight
• itching or skin rash
• joint or muscle pain
• loss of appetite
• redness or other discoloration of the skin
• severe abdominal or stomach cramps and pain
• severe sunburn
• unusual tiredness or weakness
• vomiting
• watery and severe diarrhea, which may also be bloody

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

• Burning, darkening, dryness, flushing, itching, peeling, redness, or stinging on the skin, especially when used on the face
• raised, dark red, wart-like spots on the skin, especially when used on the face

Less common

• Headache

Incidence not known

• Darkening of the skin, teeth, or gums
• dizziness or lightheadedness
• feeling of constant movement of self or surroundings
• sensation of spinning

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Amzeeq
• Cleeravue-M
• Zilxi

Available Dosage Forms:

• Foam

Therapeutic Class: Antiacne Antibacterial

Chemical Class: Tetracycline (class)

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 comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

This medicine is for use on the skin only. Do not get it into 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 condition 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 first 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.

To use the topical foam:

• Wash your hands with soap and water before and after using this medicine.
• Allow the foam can to warm to room temperature before using it for the first time. Shake it well.
• Apply a thin layer of this medicine to the affected area of the skin. For acne: Rub Amzeeq™ foam gently into the acne-affected parts of the face and other parts of the body (eg, neck, shoulders, arms, back, chest). For rosacea: Gently rub Zilxi™ foam over all areas of the face. You may need to use additional foam to make sure the entire face is treated.
• Apply it at the same time each day at least 1 hour before bedtime.
• Do not bathe, shower, or swim for at least 1 hour after application.

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 topical dosage form (foam): For inflammatory lesions caused by rosacea: Adults—Apply to the affected area of the skin once a day, at least 1 hour before bedtime. Children—Use and dose must be determined by your doctor. For moderate to severe acne: Adults and children 9 years of age and older—Apply to the affected area of the skin once a day, at least 1 hour before bedtime. Children younger than 9 years of age—Use and dose must be determined by your doctor.

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 for 90 days, away from heat, flames, smoke, and direct light. Do not store in the refrigerator.

The foam can is flammable. 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.