Minocycline

Minocycline is a prescription antibiotic used to treat bacterial infections such as pneumonia, urinary tract infections, gonorrhea, chlamydia, and acne. Minocycline belongs to a group of drugs tetracycline antibiotics. It works by preventing the growth and spread of bacteria.

This medication comes as a capsule, tablet, or dental powder. It is usually taken one to four times a day. Refer to your healthcare provider's instructions for the specific minocycline product you are taking as some products are best when taken without food, at least one hour before or two hours after a meal.

Common side effects include nausea, vomiting, headache, tiredness, and dizziness.

Minocycline is part of the drug class:

• TETRACYCLINES

Tell your doctor about all the other medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Minocycline may affect the way other medicines work, and other medicines may affect how minocycline works.

Especially tell your doctor if you take:

• birth control pills. Minocycline may make your birth control pills less effective. You could become pregnant. You should use a second form of birth control while taking minocycline.
• a blood thinner medicine.
• a penicillin antibiotic medicine. Minocycline and penicillins should not be used together.
• antacids that contain aluminum, calcium, or magnesium or iron-containing products.
• an acne medicine that contains isotretinoin (Amnesteem, Claravis, Sotret). Minocycline and isotretinoin should not be used together.

Ask your doctor or pharmacist if you are not sure if your medicine is one that is listed above.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist.

Tell your doctor if you are pregnant or plan to become pregnant. Minocycline may harm your unborn baby. Taking minocycline while you are pregnant may cause serious side effects on the growth of bone and teeth of your baby. Talk to your doctor before taking minocycline if you plan to become pregnant, or if you are already taking minocycline and plan to become pregnant. Stop taking minocycline and call your doctor right away if you become pregnant while taking minocycline.

Minocycline may make your birth control pills less effective. You could become pregnant. You should use a second form of birth control while taking minocycline.

If you are a male, and you and your female partner are trying to conceive a baby. You should not take minocycline.

Minocycline is a tetracycline antibiotic that fights bacteria in the body.

Minocycline is used to treat many different bacterial infections, such as urinary tract infections, respiratory infections, skin infections, severe acne, gonorrhea, tick fever, chlamydia, and others.

Minocycline may also be used for purposes not listed in this medication guide.

You should not take this medicine if you are allergic to minocycline or to similar antibiotics such as demeclocycline, doxycycline, or tetracycline.

If you are using minocycline to treat gonorrhea, your doctor may test you to make sure you do not also have syphilis, another sexually transmitted disease.

To make sure minocycline is safe for you, tell your doctor if you have:

• liver disease;

• kidney disease; or

• asthma or sulfite allergy.

You should not use minocycline if you are pregnant. It could harm the unborn baby or cause permanent tooth discoloration later in life. Tell your doctor right away if you become pregnant during treatment.

Minocycline can make birth control pills less effective. Ask your doctor about using a non hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while using minocycline.

Minocycline passes into breast milk and may affect bone and tooth development in a nursing baby. You should not breast-feed while you are taking minocycline.

Do not give this medicine to a child without medical advice. Minocycline can cause permanent yellowing or graying of the teeth in children younger than 8 years old.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take this medicine with a full glass of water.

You may take minocycline with or without food.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Minocycline will not treat a viral infection such as the flu or a common cold.

If you use this medicine long-term, you may need frequent medical tests.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using minocycline.

Store at room temperature away from moisture, heat, and light.

Throw away any minocycline not used before the expiration date on the medicine label. Using expired minocycline can cause damage to your kidneys.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include dizziness, nausea, or vomiting.

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Avoid exposure to sunlight or tanning beds. Minocycline can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

For 2 hours before or after you take minocycline, avoid taking antacids, laxatives, multivitamins, or supplements that contain calcium or iron. These other medicines can make it harder for your body to absorb minocycline.

Take minocycline 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. minocycline is not for long-term use.

minocycline 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 minocycline with or without food. Taking minocycline 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 minocycline for the full time of treatment, even if you begin to feel better after a few days. If you stop taking minocycline too soon, your symptoms may return.

Dosing

The dose of minocycline 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 minocycline. 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 minocycline, 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.

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 minocycline 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 minocycline, 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.

minocycline 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 minocycline. 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.

minocycline 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 minocycline affects you.

minocycline 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 minocycline:

• 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.

minocycline 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 minocycline. The results of some tests may be affected by minocycline.

If you plan to have children, talk with your doctor before using minocycline. minocycline 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.

Following a single dose of two Minocycline hydrochloride capsules, 100 mg administered to 18 normal fasting adult volunteers, maximum serum concentrations were attained in 1 to 4 hours (average 2.1 hours) and ranged from 2.1 to 5.1 mcg/mL (average 3.5 mcg/mL). The serum half-life in the normal volunteers ranged from 11.1 to 22.1 hours (average 15.5 hours).

When Minocycline hydrochloride capsules were given concomitantly with a high-fat meal, which included dairy products, the extent of absorption of Minocycline hydrochloride capsules was unchanged compared to dosing under fasting conditions. The mean Tmax was delayed by one hour when administered with food, compared to dosing under fasting conditions. Minocycline hydrochloride capsules may be administered with or without food.

In previous studies with other Minocycline dosage forms, the Minocycline serum half-life ranged from 11 to 16 hours in 7 patients with hepatic dysfunction, and from 18 to 69 hours in 5 patients with renal dysfunction. The urinary and fecal recovery of Minocycline when administered to 12 normal volunteers was one-half to one-third that of other tetracyclines.

Microbiology

Mechanism of Action

The tetracyclines are primarily bacteriostatic and are thought to exert their antimicrobial effect by the inhibition of protein synthesis. The tetracyclines, including Minocycline, have a similar antimicrobial spectrum of activity against a wide range of gram-positive and gram-negative organisms. Cross-resistance of these organisms to tetracycline is common.

Antimicrobial Activity

Minocycline has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section:

Gram-positive Bacteria

Bacillus anthracis
Listeria monocytogenes
Staphylococcus aureus
Streptococcus pneumoniae

Gram-negative Bacteria

Bartonella bacilliformis
Brucella species
Klebsiella granulomatis
Campylobacter fetus
Francisella tularensis
Haemophilus ducreyi
Vibrio cholerae
Yersinia pestis
Acinetobacter species
Enterobacter aerogenes
Escherichia coli
Haemophilus influenzae
Klebsiella species
Neisseria gonorrhoeae1
Neisseria meningitidis1
Shigella species

Other Microorganisms

Actinomyces species
Borrelia recurrentis
Chlamydophila psittaci
Chlamydia trachomatis
Clostridium species
Entamoeba species
Fusobacterium nucleatum subspecies fusiforme
Mycobacterium marinum
Mycoplasma pneumoniae
Propionibacterium acnes
Rickettsiae
Treponema pallidum subspecies pallidum
Treponema pallidum subspecies pertenue
Ureaplasma urealyticum

Susceptibility Test Methods

When available, the clinical microbiology laboratory should provide cumulative reports of in vitro susceptibility test results for antimicrobial drugs used in local hospitals and practice areas to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting an antibacterial drug for treatment.

Dilution Techniques

Quantitative methods are used to determine antimicrobial minimal inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized test method (broth or agar) or equivalent with standardized inoculum concentrations and standardized concentrations of tetracycline (class) or Minocycline powder.1,2  The MIC values should be interpreted according to the criteria provided in Table 1.

Diffusion Techniques

Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. The zone size provides an estimate of the susceptibility of bacteria to antimicrobial compounds. The zone size should be determined using a standardized method.2,3 This procedure uses paper disks impregnated with   30 mcg tetracycline (class disk) or 30 mcg Minocycline to test the susceptibility of microorganisms to Minocycline. The disk diffusion interpretive criteria are provided in Table 1. 

  A report of Susceptible (S) indicates that the antimicrobial drug is likely to inhibit growth of the microorganism if the antimicrobial drug reaches the concentration usually achievable at the site of infection. A report of  Intermediate (I) indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of Resistant (R) indicates that the antimicrobial drug is not likely to inhibit growth of the microorganism, if the antimicrobial drug reaches the concentrations usually achievable at the infection site; other therapy should be selected.

Quality Control

Standardized susceptibility test procedures require the use of laboratory controls to monitor and ensure the accuracy and precision of supplies and reagents used in the assay, and the techniques of the individuals performing the test.1-3  Standard tetracycline (class compound) or Minocycline powder should provide the following range of MIC values noted in Table 2. For the disc diffusion technique, using the 30 mcg tetracycline or 30 mcg Minocycline disk, the criteria in Table 2 should be achieved.

Minocycline hydrochloride has been observed to cause a dark discoloration of the thyroid in experimental animals (rats, minipigs, dogs, and monkeys). In the rat, chronic treatment with Minocycline hydrochloride has resulted in goiter accompanied by elevated radioactive iodine uptake and evidence of thyroid tumor production. Minocycline hydrochloride has also been found to produce thyroid hyperplasia in rats and dogs.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Minocin: 50 mg, 75 mg [DSC], 100 mg [contains brilliant blue fcf (fd&c blue #1), fd&c yellow #10 (quinoline yellow)]

Generic: 50 mg, 75 mg, 100 mg

Kit, Combination:

Minocin: 50 mg [DSC], 100 mg [DSC] [contains brilliant blue fcf (fd&c blue #1), disodium edta, fd&c yellow #10 (quinoline yellow), sodium benzoate]

Solution Reconstituted, Intravenous:

Minocin: 100 mg (1 ea)

Tablet, Oral:

Generic: 50 mg, 75 mg, 100 mg

Tablet Extended Release 24 Hour, Oral:

Solodyn: 55 mg [contains fd&c red #40]

Solodyn: 65 mg [contains brilliant blue fcf (fd&c blue #1), fd&c blue #2 (indigotine), fd&c yellow #10 (quinoline yellow)]

Solodyn: 80 mg [contains fd&c blue #2 (indigotine), fd&c red #40, fd&c yellow #6 (sunset yellow)]

Solodyn: 105 mg [contains brilliant blue fcf (fd&c blue #1)]

Solodyn: 115 mg [contains brilliant blue fcf (fd&c blue #1), fd&c blue #2 (indigotine), fd&c yellow #10 (quinoline yellow)]

Generic: 45 mg, 90 mg, 135 mg

May cause interference with fluorescence test for urinary catecholamines (false elevations)

Concerns related to adverse effects:

• Autoimmune syndromes: Lupus-like, hepatitis, and vasculitis autoimmune syndromes (including serum sickness [eg fever, arthralgia, and malaise]) have been reported; discontinue if symptoms occur and assess liver function tests, ANA, and CBC.

• Benign intracranial hypertension (eg, pseudotumor cerebri [PTC]): Intracranial hypertension (headache, blurred vision, diplopia, vision loss, and/or papilledema) has been associated with use. Women of childbearing age who are overweight or have a history of intracranial hypertension are at greater risk. Concomitant use of isotretinoin (known to cause PTC) and minocycline should be avoided. Intracranial hypertension typically resolves after discontinuation of treatment; however, permanent visual loss is possible. If visual symptoms develop during treatment, prompt ophthalmologic evaluation is warranted. Intracranial pressure can remain elevated for weeks after drug discontinuation; monitor patients until they stabilize.

• CNS effects: Lightheadedness, dizziness, and vertigo may occur; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving). Symptoms usually disappear with continued therapy and when the drug is discontinued.

• Hepatotoxicity: Serious liver injury, including irreversible drug induced hepatitis and fulminant hepatic failure (sometimes fatal) have been reported with use for acne treatment.

• Hyperpigmentation: Hyperpigmentation may occur in nails, bone, skin (including scar and injury sites), eyes, sclerae, thyroid, oral cavity, visceral tissue, and heart valves; skin and oral hyperpigmentation are independent of dose or administration duration.

• Hypersensitivity: Anaphylaxis has been reported; discontinue drug immediately and institute supportive measures.

• Increased BUN: May be associated with increases in BUN secondary to antianabolic effects; use caution in patients with renal impairment as this may lead to azotemia, hyperphosphatemia, acidosis, and possibly to drug accumulation and potential hepatotoxicity.

• Photosensitivity: May cause photosensitivity; discontinue if skin erythema occurs. Use skin protection and avoid prolonged exposure to sunlight; avoid use of use tanning equipment or UVA/B treatment.

• Skin rash: Rash, erythema multiforme, Stevens Johnson syndrome or eosinophilia, fever, and organ failure (Drug Rash with Eosinophilia and Systemic Symptoms [DRESS] syndrome), may occur; onset of symptoms may be delayed up to several weeks; fatal in up to 10% of cases; discontinue treatment immediately if DRESS syndrome is suspected.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

Disease-related concerns:

• Hepatic impairment: Hepatotoxicity has been reported; use with caution in patients with hepatic impairment or in conjunction with other hepatotoxic drugs.

• Renal impairment: Use with caution in patients with renal impairment (CrCl <80 mL/minute).

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Pediatric: May cause tissue hyperpigmentation, tooth enamel hypoplasia, or permanent tooth discoloration; more common with long-term use, but observed with repeated, short courses; use of tetracyclines should be avoided during tooth development (infancy and children ≤8 years of age) unless other drugs are not likely to be effective or are contraindicated.

• Pregnancy: Do not use during pregnancy. In addition to affecting tooth development, tetracycline use has been associated with retardation of skeletal development and reduced bone growth.

Dosage form specific issues:

• Magnesium content: Parenteral (IV) formulation contains magnesium; monitor serum magnesium in patients with renal impairment and signs of magnesium intoxication (eg, flushing, sweating, hypotension, depressed reflexes, flaccid paralysis, hypothermia, circulatory collapse, cardiac and CNS depression leading to respiratory paralysis). Also use with caution and closely monitor patients with heart block or myocardial damage.

Other warnings/precautions:

• Appropriate use: Acne: The American Academy of Dermatology acne guidelines recommends minocycline be used as adjunctive treatment for moderate and severe acne and forms of inflammatory acne that are resistant to topical treatments. Concomitant topical therapy with benzoyl peroxide or a retinoid is recommended should be administered with systemic antibiotic therapy (eg, minocycline) and continued for maintenance after the antibiotic course is completed (AAD [Zaenglein 2016]).