Minocycline Hydrochloride 100 mg Capsule, 500-count
Other active recalls for Minocycline Hydrochloride (different manufacturers) — 1 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Tetracycline-class Drug class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Minocycline is used to treat infections caused by bacteria and certain other infections spread by ticks, lice, mites, and infected animals. It is also used to treat acne and rosacea (a skin disease that causes redness, flushing, and pimples on the face). Minocycline is in a class of medications called tetracycline antibiotics. It works to treat infections by preventing the growth and spread of bacteria. It works to treat acne and rosacea by killing the bacteria that infects pores and by lowering the amount of oil on your skin that can cause acne. Antibiotics such as minocycline will not work f...
Read the full MedlinePlus article ↗- Good news — standard minocycline oral capsules and tablets can be taken with or without food, so you have flexibility there. The most important thing is to take it with a full glas...
- Can I take my minocycline capsule or tablet with food, or does it have to be on an empty stomach?
- The extended-release tablets for acne are typically taken once daily for 12 weeks. As with most acne treatments, you likely won't see dramatic results overnight — it takes time for...
- I've been prescribed the extended-release minocycline tablets for acne. How long does it take to work, and how long do I take it?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Minocycline Hydrochloride — tap one for details:
Minocycline Hydrochloride may be associated with lower levels of 11 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
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UNII 5138Q19F1X
Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
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UNII 8PJ61P6TS3
Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
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UNII 767IP0Y5NH
A synthetic red colorant used to give medicines their color. It helps patients identify their medication and makes the product visually appealing.
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UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
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UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
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UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
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UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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UNII ND2M416302
Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII WZH3C48M4T
Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
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UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
17 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.353 | $176.70 / 500 capsules |
| Medicaid paysCMS SDUD · 12 mo | $0.5235 | $261.75 / 500 capsules |
| Medicare drug plans payPart D · Q2 2026 | $0.3275 | $163.75 / 500 capsules |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Minocycline Hydrochloride 100 mg 00591-5695-50 | Actavis | 50 capsules | $0.353 | AB | Availability likely | — |
| Minocycline Hydrochloride 100 mg 00904-6888-06 | Major | 50 capsules | $0.353 | AB | Availability likely | — |
| Minocycline Hydrochloride 100 mg 13668-0484-05 | Torrent | 500 capsules | $0.353 | AB | Availability likely | — |
| Minocycline Hydrochloride 100 mg 60687-0336-65 | American | 50 capsules | $0.353 | AB | Availability likely | — |
| Minocycline Hydrochloride 100 mgthis 65862-0211-05 | Aurobindo | 500 capsules | $0.353 | AB | Availability likely | — |
| Minocycline hydrochloride 100 mg 68382-0318-18 | Zydus | 50 capsules | $0.353 | AB | Availability likely | — |
| Minocycline Hydrochloride 100 mg 43063-0736-14 | PD-Rx | 14 capsules | — | AB | FDA listed | — |
| Minocycline Hydrochloride 100 mg 50090-2579-00 | A-S | 60 capsules | — | AB | FDA listed | — |
| Minocycline Hydrochloride 100 mg 51655-0004-20 | Northwind | 20 capsules | — | AB | FDA listed | — |
| Minocycline Hydrochloride 100 mg 55289-0201-14 | PD-Rx | 14 capsules | — | AB | FDA listed | — |
| Minocycline Hydrochloride 100 mg 57664-0853-13 | Sun | 500 capsules | — | — | Discontinued | — |
| Minocycline hydrochloride 100 mg 63187-0036-20 | Proficient | 20 capsules | — | AB | FDA listed | — |
| Minocycline Hydrochloride 100 mg 63187-0850-20 | Proficient | 20 capsules | — | AB | FDA listed | — |
| Minocycline Hydrochloride 100 mg 68071-2225-08 | NuCare | 28 capsules | — | AB | FDA listed | — |
| Minocycline Hydrochloride 100 mg 68071-2866-06 | NuCare | 60 capsules | — | AB | FDA listed | — |
| Minocycline Hydrochloride 100 mg 68788-7052-01 | Preferred | 14 capsules | — | AB | FDA listed | — |
| Minocycline Hydrochloride 100 mg 70518-1336-01 | REMEDYREPACK | 30 capsules | — | AB | FDA listed | — |
| Minocycline Hydrochloride 100 mg 70518-4565-00 | REMEDYREPACK | 28 capsules | — | AB | FDA listed | — |
| Minocycline hydrochloride 100 mg 70771-1428-07 | Zydus | 50 capsules | — | AB | FDA listed | — |
| Minocycline Hydrochloride 100 mg 71205-0272-20 | Proficient | 20 capsules | — | AB | FDA listed | — |
| Minocycline Hydrochloride 100 mg 71205-0511-30 | Proficient | 30 capsules | — | — | FDA listed | — |
| Minocycline Hydrochloride 100 mg 71335-0046-00 | Bryant | 50 capsules | — | AB | FDA listed | — |
| Minocycline Hydrochloride 100 mg 71335-1045-00 | Bryant | 50 capsules | — | AB | FDA listed | — |
| Minocycline Hydrochloride 100 mg 71335-1123-00 | Bryant | 50 capsules | — | AB | FDA listed | — |
| Minocycline Hydrochloride 100 mg 72162-2574-02 | Bryant | 50 capsules | — | AB | FDA listed | — |
| Minocycline hydrochloride 100 mg 80425-0314-01 | Advanced | 30 capsules | — | AB | FDA listed | — |
| Minocycline Hydrochloride 100 mg 80425-0390-01 | Advanced | 30 capsules | — | AB | FDA listed | — |
| Minocycline hydrochloride 100 mg 82868-0017-60 | Northwind | 60 capsules | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 65862-0211-05 You're viewing this | 500 CAPSULE in 1 BOTTLE (65862-211-05) | $0.3534 / ea | $176.68 | 2008-03-11 | Active |
| 65862-0211-50 | 50 CAPSULE in 1 BOTTLE (65862-211-50) | $0.3534 / ea | $17.67 | 2008-03-11 | Active |
| 65862-0211-99 | 1000 CAPSULE in 1 BOTTLE (65862-211-99) | — | — | 2008-03-11 | Active |
| 65862-0211-22 | 2000 CAPSULE in 1 BAG (65862-211-22) | — | — | — | Active |
You're viewing one of 4 pack sizes for this product.
This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.3534 NADAC).
This pack accounts for about 34% of this product's recent Medicaid fills; most go to the 50 capsules pack. See all packs ↓
Pack size FAQ
What quantity is in NDC 65862-0211-05?
What is the difference between NDC 65862-0211-05 and NDC 65862-0211-50?
What NDC number is used to bill for this package of Minocycline Hydrochloride 100 mg Capsule?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Minocycline hydrochloride capsules, USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae . Lymphogranuloma venereum caused by Chlamydia trachomatis .
Psittacosis (Ornithosis) due to Chlamydophila psittaci . Trachoma caused by Chlamydia trachomatis , although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis .
Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis . Relapsing fever due to Borrelia recurrentis . Chancroid caused by Haemophilus ducreyi .
Plague due to Yersinia pestis . Tularemia due to Francisella tularensis . Cholera caused by Vibrio cholerae .
Campylobacter fetus infections caused by Campylobacter fetus . Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis .
Granuloma inguinale caused by Klebsiella granulomatis . Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: Escherichia coli. Klebsiella aerogenes Shigella species.
Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae . Respiratory tract and urinary tract infections caused by Klebsiella species.
Minocycline hydrochloride capsules, USP are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: Upper respiratory tract infections caused by Streptococcus pneumoniae . Skin and skin structure infections caused by Staphylococcus aureus . (NOTE: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.) When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections: Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections.
Infections in women caused by Neisseria gonorrhoeae . Syphilis caused by Treponema pallidum subspecies pallidum . Yaws caused by Treponema pallidum subspecies pertenue.
Listeriosis due to Listeria monocytogenes . Anthrax due to Bacillus anthracis . Vincent's infection caused by Fusobacterium fusiforme .
Actinomycosis caused by Actinomyces israelii . Infections caused by Clostridium species. In acute intestinal amebiasis , minocycline may be a useful adjunct to amebicides.
In severe acne , minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment.
It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection . Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum .
To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules, USP and other antibacterial drugs, minocycline hydrochloride capsules, USP should be used only to treat or prevent infections…
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF MINOCYCLINE DIFFER FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS. Minocycline hydrochloride capsules may be taken with or without food (see CLINICAL PHARMACOLOGY ).
Ingestion of adequate amounts of fluids along with capsule and tablet forms of drugs in the tetracycline-class is recommended to reduce the risk of esophageal irritation and ulceration. The capsules should be swallowed whole. For Pediatric Patients above 8 Years of Age Usual pediatric dose: 4 mg/kg initially followed by 2 mg/kg every 12 hours, not to exceed the usual adult dose.
Adults The usual dosage of minocycline hydrochloride capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg capsules may be given initially followed by one 50 mg capsule 4 times daily. Uncomplicated gonococcal infections other than urethritis and anorectal infections in men: 200 mg initially, followed by 100 mg every 12 hours for a minimum of 4 days, with post-therapy cultures within 2 to 3 days.
In the treatment of uncomplicated gonococcal urethritis in men, 100 mg every 12 hours for 5 days is recommended. For the treatment of syphilis, the usual dosage of minocycline hydrochloride should be administered over a period of 10 to 15 days. Close follow-up, including laboratory tests, is recommended.
In the treatment of meningococcal carrier state, the recommended dosage is 100 mg every 12 hours for 5 days. Mycobacterium marinum infections: Although optimal doses have not been established, 100 mg every 12 hours for 6 to 8 weeks have been used successfully in a limited number of cases. Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis or Ureaplasma urealyticum : 100 mg orally, every 12 hours for at least 7 days.
Ingestion of adequate amounts of fluids along with capsule and tablet forms of drugs in the tetracycline class is recommended to reduce the risk of esophageal irritation and ulceration. The pharmacokinetics of minocycline in patients with renal impairment (CL CR <80 mL/min) have not been fully characterized. Current data are insufficient to determine if a dosage adjustment is warranted.
The total daily dosage should not exceed 200 mg in 24 hours. However, due to the antianabolic effect of tetracyclines, BUN and creatinine should be monitored (see WARNINGS-Antianabolic Action ).
⛔ Contraindications ▾
CONTRAINDICATIONS This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or to any of the components of the product formulation.
⚠️ Warnings ▾
WARNINGS Tooth Development Minocycline hydrochloride, like other tetracycline-class antibiotics, can cause fetal harm when administered to a pregnant woman. If any tetracycline is used during pregnancy or if the patient becomes pregnant while taking these drugs, the patient should be apprised of the potential hazard to the fetus. The use of drugs of the tetracycline class during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown).
This adverse reaction is more common during long-term use of the drug but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. Tetracycline drugs, therefore, should not be used during tooth development unless other drugs are not likely to be effective or are contraindicated.
Skeletal Development All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in the fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every six hours. This reaction was shown to be reversible when the drug was discontinued.
Use in Pregnancy Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity has been noted in animals treated early in pregnancy. The safety of minocycline hydrochloride for use during pregnancy has not been established.
Dermatologic Reaction Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) including fatal cases has been reported with minocycline use. Fixed drug eruptions have occurred with minocycline and other tetracyclines. Worsening severity upon subsequent administrations, including generalized bullous fixed drug eruption, has been observed with other tetracyclines (see ADVERSE REACTIONS ).
If severe skin reactions occur, discontinue minocycline hydrochloride immediately and institute appropriate therapy. Antianabolic Action The antianabolic action of the tetracyclines may cause an increase in blood urea nitrogen (BUN). While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline may lead to azotemia, hyperphosphatemia, and acidosis.
Under such conditions, monitoring of creatinine and BUN is recommended, and the total daily dosage should not exceed 200 mg in 24 hours (see DOSAGE AND ADMINISTRATION ). If renal impairment exists, even usual oral or parenteral doses may lead to systemic accumulation of the drug and possible liver toxicity. Photosensitivity Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines.
This has been reported with minocycline. Central Nervous System Central nervous system side effects including lightheadedness, dizziness, or vertigo have been reported with minocycline therapy. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy.
These symptoms may disappear during therapy and usually disappear rapidly when the drug is discontinued. Clostridium difficile -Associated Diarrhea Clostridium difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including minocycline hydrochloride, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile .
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin- producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Due to oral minocycline's virtually complete absorption, side effects to the lower bowel, particularly diarrhea, have been infrequent. The following adverse reactions have been observed in patients receiving tetracyclines: Body as a whole: Fever and discoloration of secretions. Gastrointestinal : Anorexia, nausea, vomiting, diarrhea, dyspepsia, stomatitis, glossitis, dysphagia, enamel hypoplasia, enterocolitis, pseudomembranous colitis, pancreatitis, inflammatory lesions (with monilial overgrowth) in the oral and anogenital regions.
Instances of esophagitis and esophageal ulcerations have been reported in patients taking the tetracycline-class antibiotics in capsule and tablet form. Most of these patients took the medication immediately before going to bed (see DOSAGE AND ADMINISTRATION ). Genitourinary: Vulvovaginitis.
Hepatic toxicity : Hyperbilirubinemia, hepatic cholestasis, increases in liver enzymes, fatal hepatic failure, and jaundice. Hepatitis, including autoimmune hepatitis, and liver failure have been reported (see PRECAUTIONS ). Skin: Alopecia, erythema nodosum, hyperpigmentation of nails, pruritus, toxic epidermal necrolysis, vasculitis, maculopapular rash and erythematous rash.
Exfoliative dermatitis has been reported. Fixed drug eruptions have been reported. Lesions occurring on the glans penis have caused balanitis.
Erythema multiforme and Stevens-Johnson syndrome have been reported. Photosensitivity is discussed above (see WARNINGS-Photosensitivity ). Pigmentation of the skin and mucous membranes has been reported.
Respiratory: Cough, dyspnea, bronchospasm, exacerbation of asthma, and pneumonitis. Renal toxicity: Interstitial nephritis. Elevations in BUN have been reported and are apparently dose related (see WARNINGS ).
Reversible acute renal failure has been reported. Musculoskeletal: Arthralgia, arthritis, bone discoloration, myalgia, joint stiffness, and joint swelling. Hypersensitivity reactions: Urticaria, angioneurotic edema, polyarthralgia, anaphylaxis/anaphylactoid reaction (including shock and fatalities), anaphylactoid purpura, myocarditis, pericarditis, exacerbation of systemic lupus erythematosus and pulmonary infiltrates with eosinophilia have been reported.
A transient lupus-like syndrome and serum sickness-like reactions also have been reported. Blood: Agranulocytosis, hemolytic anemia, thrombocytopenia, leukopenia, neutropenia, pancytopenia, and eosinophilia have been reported. Central Nervous System: Convulsions, dizziness, hypesthesia, paresthesia, sedation, and vertigo.
Bulging fontanels in infants and benign intracranial hypertension (pseudotumor cerebri) in adults have been reported (see WARNINGS-Intracranial Hypertension ). Headache has also been reported. Other: Thyroid cancer has been reported in the postmarketing setting in association with minocycline products.
When minocycline therapy is given over prolonged periods, monitoring for signs of thyroid cancer should be considered. When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of the thyroid gland. Cases of abnormal thyroid function have been reported.
Tooth discoloration in children less than 8 years of age (see WARNINGS-Tooth Development ) and also in adults has been reported. Oral cavity discoloration (including tongue, lip, and gum) has been reported. Tinnitus and decreased hearing have been reported in patients on minocycline hydrochloride.
The following syndromes have been reported. In some cases, involving these syndromes, death has been reported. As with other serious adverse reactions, if any of these syndromes are recognized, the drug should be discontinued immediately: Hypersensitivity syndrome consisting of cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more of the following: hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis.
Fever and lymphadenopathy may be present. Lupus-like syndrom…
🔄 Drug Interactions ▾
Drug Interactions Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin. Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron-containing preparations.
Concurrent use of tetracyclines with oral contraceptives may render oral contraceptives less effective. Administration of isotretinoin should be avoided shortly before, during, and shortly after minocycline therapy. Each drug alone has been associated with pseudotumor cerebri (see WARNINGS ).
Increased risk of ergotism when ergot alkaloids or their derivatives are given with tetracyclines.
🔄 Drug / Laboratory Test Interactions ▾
Drug/Laboratory Test Interactions False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.
🤰 Pregnancy ▾
Pregnancy Risk Summary All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. There are no adequate and well-controlled studies on the use of minocycline in pregnant women. Minocycline, like other tetracycline-class antibiotics, crosses the placenta and may cause fetal harm when administered to a pregnant woman.
Rare spontaneous reports of congenital anomalies including limb reduction have been reported in postmarketing experience. Only limited information is available regarding these reports; therefore, no conclusion on causal association can be established. If minocycline is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Nonteratogenic Effects: (see WARNINGS .)
🧒 Pediatric Use ▾
Pediatric Use Minocycline is not recommended for the use in children below 8 years of age unless the expected benefits of therapy outweigh the risks (see WARNINGS ).
🧓 Geriatric Use ▾
Geriatric Use Clinical studies of oral minocycline did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy (see WARNINGS and DOSAGE AND ADMINISTRATION ).
🆘 Overdosage ▾
OVERDOSAGE The adverse events more commonly seen in overdose are dizziness, nausea, and vomiting. No specific antidote for minocycline is known. In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures. Minocycline is not removed in significant quantities by hemodialysis or peritoneal dialysis.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY 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 T max was delayed by 1 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 (see INDICATIONS AND USAGE ). Gram-positive Bacteria Bacillus anthracis Listeria monocytogenes Staphylococcus aureus Streptococcus pneumoniae Gram-negative Bacteria Acinetobacter species Bartonella bacilliformis Brucella species Campylobacter fetus Escherichia coli Francisella tularensis Haemophilus ducreyi Haemophilus influenzae Klebsiella aerogenes Klebsiella granulomatis Klebsiella species Neisseria gonorrhoeae Neisseria meningitidis Shigella species Yersinia pestis Vibrio cholerae 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 Testing For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by the FDA for this drug, please see https://www.fda.gov/STIC.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Minocycline hydrochloride capsules USP contains minocycline hydrochloride USP equivalent to minocycline 50 mg, 75 mg and 100 mg. Minocycline Hydrochloride Capsules USP, 50 mg are Pink/Pink size ‘3’ hard gelatin capsule filled with yellow granular powder and imprinted with ‘C’ on Pink cap and ‘76’ on Pink body with black ink. Bottles of 100 NDC 65862-209-01 Bottles of 500 NDC 65862-209-05 Bottles of 1,000 NDC 65862-209-99 Minocycline Hydrochloride Capsules USP, 75 mg are White/Grey size ‘3’ hard gelatin capsule filled with yellow granular powder and imprinted with ‘C’ on White cap and ‘77’ on Grey body with black ink.
Bottles of 100 NDC 65862-210-01 Bottles of 500 NDC 65862-210-05 Bottles of 1,000 NDC 65862-210-99 Minocycline Hydrochloride Capsules USP, 100 mg are Maroon/Pink size ‘2’ hard gelatin capsule filled with yellow granular powder and imprinted with ‘C’ on Maroon cap and ‘78’ on Pink body with black ink. Bottles of 50 NDC 65862-211-50 Bottles of 500 NDC 65862-211-05 Bottles of 1,000 NDC 65862-211-99 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Protect from light, moisture, and excessive heat. Dispense in a tight, light-resistant container as defined in the USP.
📋 Description ▾
DESCRIPTION Minocycline hydrochloride, USP, is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is: C 23 H 27 N 3 O 7 •HCl M.W. 493.94 Minocycline hydrochloride capsules, USP for oral administration contain minocycline hydrochloride, USP equivalent to 50 mg, 75 mg or 100 mg of minocycline.
The capsule also contains the following inactive ingredients: corn starch and magnesium stearate. The empty hard gelatin capsule shells contain titanium dioxide, sodium lauryl sulfate, and gelatin. In addition, the 50 mg capsule shells contain FD&C Red #3, D&C Red #33, and FD&C Yellow #6; the 75 mg capsule shells contain black iron oxide; and the 100 mg capsule shells contain FD&C Blue #1, D&C Red #28, FD&C Red #40, and red iron oxide.
The capsules are printed with edible ink containing shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide. Chemical Structure
💬 Information for Patients ▾
Information for Patients Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema. This reaction has been reported with use of minocycline.
Patients who experience central nervous system symptoms should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy (see WARNINGS ). Concurrent use of tetracycline with oral contraceptives may render oral contraceptives less effective (see PRECAUTIONS - Drug Interactions ). Patients should be counseled that antibacterial drugs including minocycline hydrochloride capsules should only be used to treat bacterial infections.
They do not treat viral infections (e.g., the common cold). When minocycline hydrochloride capsules are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by minocycline hydrochloride capsules or other antibacterial drugs in the future.
Unused supplies of tetracycline antibiotics should be discarded by the expiration date.