Description
Minocycline topical foam is used to treat moderate to severe acne vulgaris. This medicine also treats inflammatory lesions (pimples and red bumps) caused by rosacea.
Minocycline belongs to the class of medicines known as tetracycline antibiotics. However, this medicine is not used to prevent or treat infections.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Foam
Before Using
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 minocycline topical foam to treat acne vulgaris in children 9 years of age and older. However, safety and efficacy have not been established in children younger than 9 years of age to treat acne vulgaris, and have not been established in children to treat inflammatory lesions of rosacea.
Minocycline may cause permanent discoloration of the 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
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of minocycline topical foam in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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:
- Diarrhea or
- Eye or vision problems—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—The chance of side effects may be increased.
- Kidney disease or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
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.
- For inflammatory lesions caused by rosacea:
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.
Precautions
It is very important that your doctor 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 become worse, check with your doctor.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.
Minocycline may cause diarrhea, and in some cases it can be severe. It may occur 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 make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.
Tell your doctor right away if you have confusion, diarrhea, loss of appetite, sleepiness, tiredness, unusual bleeding, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may cause dizziness, lightheadedness, or spinning feeling. 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 occur in women of childbearing age who are overweight. Tell your doctor right away if you have a headache, blurred vision, or other 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 cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for short periods of time, may cause skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:
- Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
- Wear protective clothing, including a hat. Also, wear sunglasses.
- Apply a sunblock product that has a sun protection factor (SPF) number of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your doctor.
- Do not use a sun lamp or tanning bed or booth.
- If you have a severe reaction from the sun, check with 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 of the 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, trouble breathing or swallowing, or yellow eyes or skin.
Check with your doctor right away if you have 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 you have medical tests.
Do not use cosmetics or other skin care products on the treated areas.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
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
- 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.
CON-XXXXXXXX
