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Minocycline Hydrochloride 50 mg Capsule, 90-count

by A-S Medication Solutions · 90 CAPSULE in 1 BOTTLE (50090-5710-3)
NDC 50090-5710-03
🏷️ FDA NDC (as labeled) 50090-5710-3 billing pads the package segment with a zero
This package
Contains90-count Pack sizes2 compare ↓
Also comes in: 60 capsules 50090-5710-00
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Minocycline Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jun 1, 2026 — Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis (Ascend Laboratories, LLC) · FDA recall D-0597-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 50090-5710-3
Product NDC 50090-5710
11-digit billing NDC 50090571003
NCPDP billing unit EA — each (per item)
UNII 0020414E5U
Application # ANDA090867
SPL Set ID 1229c84c-5627-4992-bb8a-7874b215c543
Established class (EPC) Tetracycline-class Drug
Physiologic effect Decreased Prothrombin Activity
Chemical class Tetracyclines
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-05-13
Route ORAL
Dosage form CAPSULE
Substance MINOCYCLINE HYDROCHLORIDE
GCN Seq No 009227
GCN 40411
HICL code 004015
Ingredient (HICL) Minocycline Hcl
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1C
Therapeutic class — specific (HIC3) Tetracycline Antibiotics
AHFS code 08:12.24.00
AHFS class Tetracycline Antibiotics
FDB label name MINOCYCLINE 50 MG CAPSULE
FDB brand name Minocycline Hcl
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 50090-5710-3 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 50090-5710-03. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerA-S Medication Solutions
Application holderSUN PHARMACEUTICAL INDUSTRIES INC
FDA applicationANDA090867 (ANDA)
Labeler code50090
First marketedMay 2013
Product typeHuman Prescription Drug
Portfolio2,774 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name MINOCYCLINE 50 MG CAPSULE Ingredient Minocycline Hcl
📖 What it is MedlinePlus · NLM

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 ↗
📗 Our plain-language guide HelloPharmacist
  • 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?
📖 Read our full Minocycline guide →
11
Nutrient depletion considerations

Minocycline Hydrochloride may be associated with lower levels of 11 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Minocycline Hydrochloride nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 60 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Minocycline Hydrochloride 50 mg 13668-0482-01 Torrent 100 capsules $0.180 AB Availability likely —
Minocycline hydrochloride 50 mg 68382-0316-01 Zydus 100 capsules $0.180 AB Availability likely —
Minocycline Hydrochloride 50 mg 00591-5694-01 Actavis 100 capsules $0.180 AB Discontinued —
Minocycline Hydrochloride 50 mg 65862-0209-01 Aurobindo 100 capsules $0.180 AB Availability likely —
Minocycline hydrochloride 50 mg 63187-0450-20 Proficient 20 capsules — AB FDA listed —
Minocycline Hydrochloride 50 mg 71205-0086-20 Proficient 20 capsules — AB FDA listed —
Minocycline Hydrochloride 50 mg 71335-0682-01 Bryant 90 capsules — AB FDA listed —
Minocycline Hydrochloride 50 mgthis 50090-5710-03 A-S 90 capsules — — FDA listed —
Minocycline hydrochloride 50 mg 51655-0753-20 Northwind 20 capsules — AB FDA listed —
Minocycline Hydrochloride 50 mg 71335-1237-01 Bryant 90 capsules — AB Discontinued —
Minocycline Hydrochloride 50 mg 68071-3635-03 NuCare 30 capsules — AB FDA listed —
Minocycline Hydrochloride 50 mg 50090-2971-00 A-S 60 capsules — AB FDA listed —
Minocycline Hydrochloride 50 mg 57664-0851-13 Sun 500 capsules — — Discontinued —
Minocycline hydrochloride 50 mg 70771-1426-01 Zydus 100 capsules — AB FDA listed —
Minocycline Hydrochloride 50 mg 50090-3016-00 A-S 60 capsules — AB FDA listed —
Minocycline Hydrochloride 50 mg 55289-0202-30 PD-Rx 30 capsules — AB FDA listed —
Minocycline Hydrochloride 50 mg 72162-2573-01 Bryant 100 capsules — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2013
On the market since
May 2013
📍
2026
Currently FDA-listed
13 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Minocycline Hydrochloride — the ingredient across all brands.

Top reported reactions

Drug Intolerance969
Pain957
Rheumatoid Arthritis930
Nausea845
Rash821
Arthralgia811
Drug Hypersensitivity800

Age at onset

Neonate34
Infant2
Child8
Adolescent33
Adult772
Elderly332

Reporter sex

5,809 reports
Male · 30%
Female · 69%
Unknown · 2%

Serious outcomes

Life-threatening1,430
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 741 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
50090-5710-00 60 CAPSULE in 1 BOTTLE (50090-5710-0) 2021-09-24 Active
50090-5710-03 You're viewing this 90 CAPSULE in 1 BOTTLE (50090-5710-3) 2021-09-24 Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 50090-5710-03?
NDC 50090-5710-03 is a 90-count package — 90 capsule in 1 bottle.
What is the difference between NDC 50090-5710-03 and NDC 50090-5710-00?
Both are Minocycline Hydrochloride 50 mg Capsule — the drug itself is identical. NDC 50090-5710-03 is the 90-count package, while NDC 50090-5710-00 is the 60 capsules package.
What NDC number is used to bill for this package of Minocycline Hydrochloride 50 mg Capsule?
Bill NDC 50090-5710-03 — the 11-digit billing format is 50090571003. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 50090-5710-3, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 50090-5710-03, written without dashes as 50090571003. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 50090-5710-03, the first segment (50090) is the labeler code FDA assigned to A-S Medication Solutions; the middle segment (5710) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by A-S Medication Solutions. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 60 capsules (50090-5710-00). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
A-S Medication Solutions is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🔄 Drug / Laboratory Test Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🎯 Indications and Usage ~3 min read ▾

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. • Enterobacter 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 ca…

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE & ADMINISTRATION THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF MINOCY‑CLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS. Minocycline hydrochloride capsules USP 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 USP 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 infec‑tions 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 ).

⛔ Contraindications 26 words ▾

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 ~3 min read ▾

WARNINGS Tooth Development Minocycline hydrochloride capsules, 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. Dermatologic Reaction Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) including fatal cases have been reported with minocycline use.

If this syndrome is recognized, the drug should be discontinued immediately. 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 accumulations 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 light-headedness, 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 the 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 antibiotic use.

Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment…

🤒 Adverse Reactions ~2 min read ▾

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 report‑ed. Lesions occurring on the glans penis have caused balanitis.

Erythema multiforme and Stevens-Johnson syndrome have been reported. Photosensitivity is discussed above (See WARNINGS ). 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 stiff‑ness, 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 PRECAUTIONS - General ). Headache has also been reported. Other: Thyroid cancer has been reported in the post-marketing 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 ) and also, in adults has been reported. Oral cavity discoloration (including tongue, lip, and gum) have been reported. Tinnitus and decreased hearing have been reported in patients on minocycline hydrochloride capsules.

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 syndrome consisting of positive antinuclear…

🔄 Drug Interactions 133 words ▾

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.

The concurrent use of tetracyclines and methoxyflurane has been reported to result in fatal renal toxicity. 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 19 words ▾

Drug /Laboratory Test Interactions False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

🤰 Pregnancy 121 words ▾

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 post-marketing 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 28 words ▾

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 74 words ▾

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 , DOSAGE AND ADMINISTRATION ).

🆘 Overdosage 45 words ▾

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 ~2 min read ▾

CLINICAL PHARMACOLOGY Following a single dose of two 100 mg capsules of minocycline hydrochloride 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 one hour when administered with food, compared to dosing under fasting conditions. Minocycline 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 gonorrhoeae 1 Neisseria meningitidis 1 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 1 When penicillin is contraindicated, tetracyclines are alternative drugs in the treatment of infections caused by the cited microorganisms.

Susceptibility Test Methods For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.

📦 How Supplied / Storage and Handling 18 words ▾

HOW SUPPLIED Product: 50090-5710 NDC: 50090-5710-0 60 CAPSULE in a BOTTLE NDC: 50090-5710-3 90 CAPSULE in a BOTTLE

📋 Description 153 words ▾

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 and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, povidone, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, titanium dioxide, gelatin, D&C Yellow #10 aluminum lake, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, black iron oxide, propylene glycol and shellac.

In addition 50 mg capsules contains D&C Red #33 aluminum lake, FD&C Red #3 aluminum lake and FD&C Yellow #6 aluminum lake; 75 mg capsules contains FDA/E172 black iron oxide and 100 mg capsules contains D&C Red #28 aluminum lake, FD&C Blue #1 aluminum lake, FD&C Red #40 aluminum lake and FDA/E172 red iron oxide. structure

💬 Information for Patients ~1 min read ▾

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 tetracyclines 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.

💬 Medication Guide ~3 min read ▾

PATIENT INFORMATION PATIENT INFORMATION Minocycline Hydrochloride Capsules, USP (mye-no-SYE-kleen) Hydrochloride Capsules 50 mg, 75 mg, and 100 mg Rx Only Read the Patient Information that comes with minocycline hydrochloride capsules, USP before you or a family member starts taking them and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your doctor about your medical condition or treatment.

What are Minocycline Hydrochloride Capsules, USP? Minocycline hydrochloride capsules, USP are a tetracycline class antibiotic medicine. Minocycline hydrochloride capsules, USP are used to treat certain infections caused by bacteria.

These include infections of the skin, respiratory tract, urinary tract, some sexually transmitted diseases, and others. Minocycline hydrochloride capsules, USP may be used along with other treatments for severe acne. Sometimes, other germs, called viruses cause infections.

The common cold is a virus. Minocycline hydrochloride capsules, USP, like other antibiotics, do not treat viruses. Who should not use Minocycline Hydrochloride Capsules, USP?

Do not take minocycline hydrochloride capsules, USP if you are allergic to minocycline or other tetracycline antibiotics. Ask your doctor or pharmacist for a list of these medications if you are not sure. See the end of this leaflet for a complete list of ingredients in minocycline hydrochloride capsules, USP.

Minocycline hydrochloride capsules, USP are not recommended for pregnant women or children up to 8 years old because: 1. Minocycline hydrochloride capsules, USP may harm an unborn baby. 2.

Minocycline hydrochloride capsules, USP may permanently turn a baby’s or child’s teeth yellow-gray-brown during tooth development . Tooth development happens in the last half of pregnancy and birth to age 8 years. What should I tell my doctor before starting Minocycline Hydrochloride Capsules, USP?

Tell your doctor about all of your medical conditions, including if you: • have liver or kidney problems • are pregnant or planning to become pregnant . Minocycline hydrochloride capsules, USP may harm your unborn baby. Stop taking minocycline hydrochlo‑ride capsules, USP and call your doctor if you become pregnant while taking them. • are breast feeding .

Minocycline passes into your milk and may harm your baby. You should decide whether to use minocycline hydrochloride capsules, USP or breastfeed, but not both. Tell your doctor about all the medicines you are taking including prescription and non-prescription medications, vitamins, and herbal supplements.

Minocycline hydrochloride capsules, USP and other medicines may interact. Especially tell your doctor if you take: • birth control pills. Minocycline hydrochloride capsules, USP may make your birth control pills less effective • a blood thinner medicine.

The dose of your blood thinner may have to be lowered. • a penicillin antibiotic medicine . Minocycline hydrochloride capsules, USP and penicillins should not be used together. • migraine medicines called ergot alkaloids • an acne medicine called isotretinoin (Accutane, Amnesteem, Claravis, Sotret) • antacids that contain aluminum, calcium, or magnesium, or iron-containing products. Know the medicines you take, keep a list of them to show your doctor and pharmacist each time you get a new medicine.

How should I take Minocycline Hydrochloride Capsules, USP? • Take minocycline hydrochloride capsules, USP exactly as your doctor tells you to take them. Skipping doses or not taking all your minocycline hydrochloride capsules, USP may: o Decrease the effectiveness of the treatment o Increase the chance that bacteria will develop resistance to minocycline hydrochloride capsules, USP • Take minocycline hydrochloride capsules, USP with a full glass of liquid. Taking minocycline hydrochloride capsules, USP with enough liquid may lower your chance of getting irritation or ulcers in your esophagus.

Your esophagus is the tube that con…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.