Myrac (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 them from growing. 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 allows your doctor to see if the medicine is working correctly and to decide if you should continue taking it. Blood and urine tests may be needed to check for unwanted effects.

If your or your child's symptoms do not improve or get worse after 12 weeks of treatment, contact your doctor.

Using this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If you become pregnant while using this medicine, tell your doctor immediately.

Birth control pills may not work as well while you are using minocycline. To prevent pregnancy, 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, which can be severe in some cases. 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 it worse or last longer. If you or your child have any questions about this, or if mild diarrhea continues or worsens, consult your doctor.

Contact your doctor immediately 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 signs of a serious liver problem.

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

This medicine may increase pressure in your head, which can lead to permanent vision loss. Contact 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 you experience fever, rash, joint pain, or tiredness. These could be signs of an autoimmune syndrome where the body attacks itself.

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

• Stay out of 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 product with a higher SPF, especially if they have a fair complexion. If you have questions about this, consult 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, consult your doctor.

This medicine may cause serious allergic reactions, including anaphylaxis, which 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 skin color on the face, very fast but irregular heartbeat, hive-like swellings on the skin, and puffiness around the eyelids or eyes. If these side effects occur, seek emergency help immediately.

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

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

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

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This decision should be made between you and your doctor. For this medicine, 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, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Research conducted so far has not shown any specific problems that would limit the use of minocycline extended-release capsules and tablets in children aged 12 years and older. However, safety and effectiveness have not been established for children younger than 12 years old.

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

Geriatric

Research conducted so far has not shown any specific problems that would limit the use of minocycline in elderly patients. However, older adults are more likely to have kidney, liver, or heart problems, which may require caution and a dose adjustment for these patients taking minocycline.

Breast Feeding

Studies suggest that this medication may change milk production or its composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and ensure they are getting enough milk.

Interactions with Medicines

While some medicines should not be used together at all, in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may adjust the dose or may need to take other precautions. 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 have been chosen for their potential importance and are not necessarily all-inclusive.

Using this medicine with any of the following is not recommended. Your doctor may choose not to treat you with this medication or may change some of the other medicines you are taking.

• Acitretin

Using this medicine with any of the following is usually not recommended but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or how often you take one or both 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
• Temocillin
• Tretinoin

Using this medicine with any of the following may increase the risk of certain side effects, but using both medicines may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or how often you take 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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around the time of eating certain foods, as interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions have been chosen for their potential importance and are not necessarily all-inclusive.

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

• Dairy Food

Other Medical Problems

Having other medical problems may affect how this medicine works. Be sure to inform your doctor if you have any other medical issues, 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. The 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. 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.

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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