Brand Name

    US Brand Name

    Cleeravue-M

    Dynacin

    Minocin

    Minolira

    Myrac

    Solodyn

    Ximino


    Description

    Minocycline is used to treat pimples and red bumps (non-nodular inflammatory lesions) that occur with moderate to severe acne vulgaris in patients 12 years of age and older.

    Minocycline capsules are used to treat bacterial infections in many different parts of the body. It is also used to treat anthrax infection and other infections in patients who cannot receive penicillins.

    Minocycline belongs to the class of medicines known as tetracycline antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

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

    This product is available in the following dosage forms:

    • Capsule, Extended Release
    • Tablet
    • Tablet, Extended Release
    • Capsule

    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 extended-release capsules and tablets in children 12 years of age and older. However, safety and efficacy have not been established in children younger than 12 years of age.

    Minocycline may cause permanent discoloration of the teeth and slow down the growth of bones. This medicine should not be given to children younger than 8 years of age 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 in the elderly. However, elderly patients are more likely to have kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving minocycline.

    Breastfeeding

    Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

    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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

    • Acitretin

    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.

    • Amoxicillin
    • Ampicillin
    • Atazanavir
    • Bacampicillin
    • Bexarotene
    • Cholera Vaccine, Live
    • Cloxacillin
    • Desogestrel
    • Dicloxacillin
    • Dienogest
    • Digoxin
    • Drospirenone
    • Estradiol
    • Ethinyl Estradiol
    • Ethynodiol
    • Etretinate
    • Gestodene
    • Isotretinoin
    • Levoketoconazole
    • Levonorgestrel
    • Magnesium Sulfate
    • Mestranol
    • Methicillin
    • Methotrexate
    • Methoxyflurane
    • Nafcillin
    • Nomegestrol
    • Norethindrone
    • Norgestimate
    • Norgestrel
    • Oxacillin
    • Palovarotene
    • Penicillin G
    • Penicillin G Benzathine
    • Penicillin G Procaine
    • Penicillin V
    • Piperacillin
    • Pivampicillin
    • Porfimer
    • Sultamicillin

    Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Aluminum Carbonate, Basic
    • Aluminum Hydroxide
    • Aluminum Phosphate
    • Aminolevulinic Acid
    • Calcium
    • Dihydroxyaluminum Aminoacetate
    • Dihydroxyaluminum Sodium Carbonate
    • Iron
    • Magaldrate
    • Magnesium Carbonate
    • Magnesium Hydroxide
    • Magnesium Oxide
    • Magnesium Trisilicate
    • Vitamin A

    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. 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 may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

    • Dairy Food

    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
    • Increased pressure in the head or
    • Infection (eg, fungi), any other type of or
    • Liver disease—Use with caution. May make these conditions worse.
    • Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

    Proper Use

    Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects. This medicine is not for long-term use.

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

    Swallow the capsule, extended-release capsule, or tablet whole with water. Do not, crush, break, or chew it.

    You may take this medicine with or without food. Taking this medicine with food may lower your chances of irritation or ulcers in your esophagus (tube that connects mouth to the stomach).

    To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your symptoms may return.

    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 oral dosage form (capsules):
      • For infections:
        • Adults—At first, 200 milligrams (mg) followed by 100 mg every 12 hours. Some patients may start at 2 or 4 capsules of 50 mg followed by one 50 mg capsule 4 times a day.
        • Children 8 years of age and older—Dose is based on body weight and must be determined by your doctor. The initial dose is usually 4 milligram (mg) per kilogram (kg) of body weight followed by 2 mg per kg of body weight every 12 hours. However, the dose should not be more than the usual adult dose.
        • Children younger than 8 years of age—Use is not recommended.
    • For oral dosage forms (extended-release capsules or tablets):
      • For treatment of acne vulgaris:
        • Adults and children 12 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 1 milligram (mg) per kilogram (kg) of body weight per day for 12 weeks.
        • Children 8 to 12 years of age—Use and dose must be determined by your doctor.
        • Children younger than 8 years of age—Use is not recommended.

    Missed Dose

    If you miss a dose of this medicine, take 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. Do not double doses.

    Storage

    Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

    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.


    Precautions

    It is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

    If your or your child's symptoms do not improve or if they become worse after 12 weeks of treatment, check with your doctor.

    Using this medicine while you are pregnant can harm your unborn baby. The medicine may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If a pregnancy occurs while you are using this medicine, tell your doctor right away.

    Birth control pills may not work as well while you are using minocycline. To keep from getting pregnant, use an additional form of birth control with your pills. Other forms include condoms, a diaphragm, or contraceptive foam or jelly.

    This medicine may darken the color of your skin, nails, eyes, teeth, gums, or scars. Talk with your doctor if you or your child have any concerns.

    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 or your child have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

    Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

    This medicine may cause some people to become dizzy or lightheaded. Make sure you know how you react to this combination of medicines before you drive, use machines, or do anything else that could be dangerous until you know how this medicine affects you.

    This medicine may cause an increased pressure in your head which can lead to permanent vision loss. Check with your doctor right away if you or your child has severe headache, blurred vision, or any vision changes.

    Contact your doctor immediately if fever, rash, joint pain, or tiredness occurs. These could be symptoms of an autoimmune syndrome where the body attacks itself.

    Minocycline may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a 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.
    • Apply a sunblock lipstick that has an SPF of at least 15 to protect your lips.
    • Do not use a sun lamp or tanning bed or booth.

    If you have a severe reaction from the sun, check with your doctor.

    This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, or fainting. Other signs may include changes in color of the skin of the face, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, and puffiness or swellings of the eyelids or around the eyes. If these side effects occur, get emergency help at once.

    Before you have any medical tests, tell the medical doctor in charge that you or your child are taking this medicine. The results of some tests may be affected by this medicine.

    If you plan to have children, talk with your doctor before using this medicine. This medicine may affect the process of sperm cell formation in males.

    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:

    Incidence not known

    • Black, tarry stools
    • blistering, peeling, or loosening of the skin
    • blood in the urine or stools
    • blurred or double vision
    • bulging soft spot on the head of an infant
    • chest pain, possibly moving to the left arm, neck, or shoulder
    • confusion
    • diarrhea
    • dizziness or lightheadedness
    • eye pain
    • fast heartbeat
    • general feeling of discomfort or illness
    • general tiredness and weakness
    • hives, itching, or skin rash
    • joint or muscle pain
    • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
    • loss of appetite
    • nausea or vomiting
    • red skin lesions, often with a purple center
    • severe headache
    • severe stomach pain
    • sores, ulcers, or white spots on the lips or in the mouth
    • troubled breathing
    • unusual bleeding or bruising
    • upper right abdominal or stomach pain
    • yellow eyes and 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:

    Less common

    • Continuing ringing or buzzing or other unexplained noise in the ears
    • difficulty with moving
    • hearing loss
    • hives or welts
    • muscle stiffness
    • redness of the skin
    • sleepiness or unusual drowsiness

    Incidence not known

    • Bloating
    • discoloration of the tooth
    • increased sensitivity of the skin to sunlight
    • indigestion
    • severe sunburn

    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.






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