Description
Minocycline is used to treat moderate to severe acne vulgaris. This medicine is also used to treat inflammatory lesions (pimples and red bumps) caused by rosacea.
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 Ximino® extended-release capsules and Solodyn® extended-release 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.
Appropriate studies have not been performed on the relationship of age to the effects of Emrosi® extended-release capsules in the pediatric population. Safety and efficacy have not been established.
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
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
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.
- Acenocoumarol
- Aluminum Carbonate, Basic
- Aluminum Hydroxide
- Aluminum Phosphate
- Amoxicillin
- Ampicillin
- Apixaban
- Ardeparin
- Argatroban
- Atazanavir
- Azathioprine
- Bacampicillin
- Bemiparin
- Betrixaban
- Bexarotene
- Bivalirudin
- Calcium Carbonate
- Calcium Silicate
- Certoparin
- Cholera Vaccine, Live
- Cloxacillin
- Dabigatran Etexilate
- Dalteparin
- Danaparoid
- Desirudin
- Desogestrel
- Dicloxacillin
- Dienogest
- Digoxin
- Dihydroxyaluminum Aminoacetate
- Dihydroxyaluminum Sodium Carbonate
- Drospirenone
- Edoxaban
- Enoxaparin
- Estradiol
- Ethinyl Estradiol
- Ethynodiol
- Etretinate
- Fondaparinux
- Gestodene
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.
- Aminolevulinic Acid
- Iron
- 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 throat irritation and ulcers.
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 infections:
- For oral dosage forms (Ximino® extended-release capsules or Solodyn® extended-release 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 once a day for 12 weeks.
- Weighing 126 kilograms (kg) to 136 kg—135 milligram (mg) once a day for 12 weeks.
- Weighing 111 kg to 125 kg—115 mg once a day for 12 weeks.
- Weighing 97 kg to 110 kg—105 mg once a day for 12 weeks.
- Weighing 85 kg to 96 kg—90 mg once a day for 12 weeks.
- Weighing 72 kg to 84 kg—80 mg once a day for 12 weeks.
- Weighing 60 kg to 71 kg—65 mg once a day for 12 weeks.
- Weighing 50 kg to 59 kg—55 mg once a day for 12 weeks.
- Weighing 45 kg to 49 kg—45 mg once a 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.
- 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 once a day for 12 weeks.
- For treatment of acne vulgaris:
- For oral dosage form (Emrosi® extended-release capsules):
- For inflammatory lesions caused by rosacea:
- Adults—40 milligrams (mg) or one capsule once a day.
- Children—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, 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 your or your child's progress at regular visits to see if the medicine is working properly. 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. 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.
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.
Serious skin reactions, including erythema multiforme, Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), and fixed drug eruption (FDE) can occur with this medicine. Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills ,cough, fever, painful or difficult urination, sore throat, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness while using this medicine.
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 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 increased pressure inside the head (intracranial hypertension). This is more likely to occur in females of childbearing age who have overweight or have a history of intracranial hypertension. Tell your doctor right away if you have a headache, blurred vision, or changes 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 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, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, fast heartbeat, hives, itching, skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness.
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
- Anxiety
- back, leg, or stomach pains
- black, tarry stools
- bleeding gums
- blistering, peeling, or loosening of the skin
- bloating
- blood in the urine or stools
- blue or pale skin
- blurred or double vision
- bulging soft spot on the head of an infant
- change in ability to see colors, especially blue or yellow
- chest pain, possibly moving to the left arm, neck, or shoulder
- chest pain or tightness
- chills
- confusion
- constipation
- cough
- darkened urine
- diarrhea
- difficulty swallowing
- dizziness or lightheadedness
- eye pain
- fast heartbeat
- fever
- general feeling of discomfort or illness
- headache
- hives, itching, or skin rash
- increased blood pressure
- increased thirst
- indigestion
- joint or muscle pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- light-colored stools
- loss of appetite
- lower back or side pain
- nausea or vomiting
- nosebleeds
- painful or difficult urination
- pains in stomach, side, or abdomen, possibly radiating to the back
- pale skin
- pinpoint red spots on the skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red skin lesions, often with a purple center
- severe headache
- severe stomach pain
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swelling of the face, fingers, or lower legs
- swollen glands
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- upper right abdominal or stomach pain
- weight gain
- 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
- muscle stiffness
- redness of the skin
- sleepiness or unusual drowsiness
Incidence not known
- 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.
DRG-20075715
