Minolira (Oral)

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

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

Minocycline is part of a group of medicines called tetracycline antibiotics. It works by killing bacteria or stopping their growth. However, this medicine will not work for colds, flu, or other viral infections.

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

It is very important for your doctor to check the progress of you or your child during regular visits. This will help your doctor see if the medicine is working properly and decide if you should keep taking it. Blood and urine tests may be needed to check for side effects.

If your or your child's symptoms do not improve or get worse after 12 weeks of treatment, talk to 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 partner becomes pregnant. If you become pregnant while using this medicine, tell your doctor immediately.

Birth control pills may not work as well when you are using minocycline. To prevent pregnancy, use an additional form of birth control with your pills. Other options 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 to your doctor if you or your child have any concerns.

Minocycline may cause diarrhea, which can be severe in some cases. It may happen 2 months or more after you stop taking this medicine. Do not take any medicine for diarrhea without checking with your doctor first. Diarrhea medicines may worsen the diarrhea or make it last longer. If you or your child have questions about this or if mild diarrhea continues or worsens, talk to your doctor.

Contact your doctor immediately if you or your child experience pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellowing of the eyes or skin. These could be signs of a serious liver problem.

This medicine may cause some people to feel dizzy or lightheaded. Make sure you know how this medicine affects you before driving, using machines, or doing anything that could be dangerous.

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

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

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

• Avoid direct sunlight, especially between 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Use a sunblock product with a sun protection factor (SPF) of at least 15. Some patients may need a higher SPF, especially if they have fair skin. If you have questions about this, talk to your doctor.
• Use a sunblock lipstick with 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 to the sun, talk to your doctor.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis needs immediate medical attention. The most serious signs include very fast or irregular breathing, gasping for breath, or fainting. Other signs may include changes in skin color on the face, very fast but irregular heartbeat, hives, and swelling of the eyelids or around the eyes. If these side effects happen, seek emergency help right away.

Before any medical tests, inform the doctor in charge that you or your child are taking this medicine. Some test results may be affected by this medicine.

If you plan to have children, discuss this with your doctor before using this medicine. It may affect sperm cell formation in males.

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

In deciding to use a medicine, it's important to think about the risks and the benefits. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

Let your doctor know if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also inform your healthcare professional if you have other types of allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Studies so far have not shown any specific problems in children 12 years and older that would limit the use of minocycline extended-release capsules and tablets. However, safety and effectiveness have not been proven in children younger than 12 years.

Minocycline can cause permanent tooth discoloration and may slow down bone growth. This medicine should not be given to children younger than 8 years old unless directed by their doctor.

Geriatric

Studies have not shown any specific problems in older adults that would limit the usefulness of minocycline. However, older patients are more likely to have kidney, liver, or heart problems, which may require careful monitoring and possibly adjusting the dose for those taking minocycline.

Breast Feeding

Research suggests that this medication may affect milk production or composition. If you are not given a different medication, you should watch the infant for side effects and ensure they are getting enough milk.

Interactions with Medicines

Some medicines should not be taken together. In other cases, two different medicines may be used together even if there might be an interaction. In these situations, your doctor may want to change the dose, or other precautions may be necessary. When taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are based on 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 prescribe this medication or change some of the other medicines you are taking.

• Acitretin

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medications.

• 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
• Temocillin
• Tretinoin

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be necessary for your treatment. If both are prescribed together, your doctor may adjust the dose or frequency of one or both medications.

• 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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions are based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may increase the risk of certain side effects, but this may be unavoidable in some cases. If used together, your doctor may adjust the dose or frequency of this medicine, or provide special instructions about food, alcohol, or tobacco use.

• Dairy Food

Other Medical Problems

Other medical issues may affect the use of this medicine. Be sure to inform your doctor if you have any other medical problems, especially:

• Diarrhea or
• Increased pressure in the head or
• Infection (e.g., fungi) or any other type of
• Liver disease—Use with caution. May worsen these conditions.

• Kidney disease—Use with caution. Effects may be increased due to slower removal of the medicine from the body.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, you 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. Your health care professional may also be able to tell you 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.

In the U.S.

• Cleeravue-M
• Dynacin
• Minocin
• Minolira
• Myrac
• Solodyn
• Ximino

Available Dosage Forms:

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

Therapeutic Class: Antibiotic

Chemical Class: Tetracycline (class)

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.

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