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Minolira Extended Release Minocycline Hydrochloride 135 mg Tablet, 30-count

by EPI Health, Inc · 1 BOTTLE in 1 CARTON (71403-102-30) / 30 TABLET in 1 BOTTLE
NDC 71403-0102-30
🏷️ FDA NDC (as labeled) 71403-102-30 billing pads the product segment with a zero
This package
Contains30-count Pack sizes2 compare ↓
Also comes in: 5 tablets 71403-0102-05
Rx only Brand Discontinued Non-controlled ⚠ Inactivated by FDA
🗂️ Data synced Jul 16, 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 ↗
⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2023. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 71403-102-30
Product NDC 71403-102
11-digit billing NDC 71403010230
NCPDP billing unit EA — each (per item)
Application # NDA209269
SPL Set ID 523856a4-530b-4a23-a80a-d72ab08e2c08
Chemical class Tetracycline-class Drug [EPC], Tetracyclines
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2023)
Route ORAL
Dosage form TABLET
Substance MINOCYCLINE HYDROCHLORIDE
GCN Seq No 077553
GCN 43598
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 MINOLIRA ER 135 MG TABLET
FDB brand name Minolira Er
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 71403-102-30 — a 5-3-2 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 product segment → 71403-0102-30. 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

LabelerEPI Health, Inc
Application holderEPI HEALTH LLC
FDA applicationNDA209269 (NDA)
Labeler code71403
Product typeHuman Prescription Drug
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 MINOLIRA ER 135 MG TABLET Ingredient Minocycline Hcl
📗 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: 5 tablets
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
Minolira Extended Release 135 mgthis 71403-0102-30 EPI 30 tablets — — Discontinued —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2017
First FDA approval
May 2017
📍
2026
Currently FDA-listed
9 years listed
🛡️
2036
Latest patent/protection listed
not a guaranteed launch date
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Apr 2036. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved May 8, 2017 RLD RS ⏳ ~9.5 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 11103517 — drug product
US 11103517 — drug product
2017 2019 2021 2023 2025 2027 2029 2031 2033 2035
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (2)
PatentTypeUse codeExpires
US 11103517 ↗ Drug product — Apr 7, 2036
US 11103517 ↗ Drug product — Apr 7, 2036
Common questions
Is there a generic version of MINOLIRA ER 135 MG TABLET?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for MINOLIRA ER 135 MG TABLET. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
71403-0102-05 1 BOTTLE in 1 CARTON (71403-102-05) / 5 TABLET in 1 BOTTLE 2019-03-15 Inactivated by FDA
71403-0102-30 You're viewing this 1 BOTTLE in 1 CARTON (71403-102-30) / 30 TABLET in 1 BOTTLE 2019-03-15 Inactivated by FDA

Pack size FAQ

What quantity is in NDC 71403-0102-30?
NDC 71403-0102-30 is a 30-count package — 1 bottle in 1 carton / 30 tablet in 1 bottle.
What is the difference between NDC 71403-0102-30 and NDC 71403-0102-05?
Both are Minolira Extended Release Minocycline Hydrochloride 135 mg Tablet — the drug itself is identical. NDC 71403-0102-30 is the 30-count package, while NDC 71403-0102-05 is the 5 tablets package.
What NDC number is used to bill for this package of Minolira Extended Release Minocycline Hydrochloride 135 mg Tablet?
Bill NDC 71403-0102-30 — the 11-digit billing format is 71403010230. 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 No longer marketed (per FDA listing data)
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 ✓ Available
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 71403-102-30, 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: 71403-0102-30, written without dashes as 71403010230. 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 71403-0102-30, the first segment (71403) is the labeler code FDA assigned to EPI Health, Inc; the middle segment (0102) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 5 tablets (71403-0102-05). 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?
EPI Health, Inc 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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 151 words ▾

1 INDICATIONS AND USAGE MINOLIRA is indicated to treat the inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. MINOLIRA is a tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. ( 1 ) Limitations of Use This formulation of minocycline has not been evaluated in the treatment of infections.

To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, MINOLIRA should be used only as indicated [see Warnings and Precautions (5.13) ]. Limitations of Use This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, MINOLIRA should be used only as indicated [see Warnings and Precautions (5.13) ] .

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION The recommended dosage of MINOLIRA is approximately 1 mg/kg once daily for 12 weeks. Higher doses have not shown to be of additional benefit in the treatment of inflammatory lesions of acne, and may be associated with more acute vestibular side effects. The 105 mg and 135 mg tablets may be split on the score line for dosing of patient weight ranges of 45-59 kg and 60-89 kg, respectively (see Table 1 ).

Table 1: Dosing Table for MINOLIRA Patient's Weight (kg) Daily Dose Tablet Strength and Size to Administer Actual Dose (mg/kg) 45 – 59 52.5 half of the 105 mg tablet 1.16 –0.88 60 – 89 67.5 half of the 135 mg tablet 1.13 – 0.76 90 – 125 105 one 105 mg tablet 1.17 – 0.84 126 – 136 135 one 135 mg tablet 1.07 –

0.99MINOLIRA may be taken with or without food [see Clinical Pharmacology (12.3) ] . Ingestion of food along with MINOLIRA may help reduce the risk of esophageal irritation and ulceration. MINOLIRA tablets should not be chewed or crushed.

In patients with renal impairment, the total dosage should be decreased by either reducing the recommended individual doses and/or by extending the time intervals between doses [see Warnings and Precautions (5.6) ] . Recommended dosage: Approximately 1 mg/kg once daily for 12 weeks. ( 2 )

💊 Dosage Forms and Strengths 121 words ▾

3 DOSAGE FORMS AND STRENGTHS MINOLIRA extended-release tablets are white to off-white, functionally scored, rectangular tablets with brown or gold color speckles and a single score line on both surfaces. MINOLIRA are available in the following two strengths. 105 mg extended-release tablets: ‘M1’debossed on one surface, where ‘M’ and ‘1’ are on either side of the score line.

Each tablet contains 105 mg minocycline, equivalent to 113.4 mg of minocycline hydrochloride. 135 mg extended-release tablets: ‘M3’ is debossed on one surface, where ‘M’ and ‘3’ are on either side of the score line. Each tablet contains 135 mg minocycline, equivalent to 145.8 mg of minocycline hydrochloride.

Extended- release tablets: 105 mg and 135 mg of minocycline, functionally scored ( 3 )

⛔ Contraindications 41 words ▾

4 CONTRAINDICATIONS MINOLIRA is contraindicated in patients who have shown hypersensitivity to any of the tetracyclines [see Serious Skin/Hypersensitivity Reactions (5.11) ] . This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS The use of MINOLIRA during the second and third trimesters of pregnancy, infancy and childhood up to the age of 8 years may cause permanent discoloration of the teeth (yellow-gray-brown) and reversible inhibition of bone growth. ( 5.1 , 5.2 , 5.3 , 8.1 , 8.4 ) If pseudomembranous colitis occurs, discontinue MINOLIRA. ( 5.4 ) If liver injury is suspected, discontinue MINOLIRA.

( 5.5 ) If renal impairment exists, MINOLIRA doses may need to be adjusted to avoid excessive systemic accumulations of the drug and possible liver toxicity. ( 5.6 ) Minocycline may cause central nervous system side effects including lightheadedness, dizziness, or vertigo. ( 5.7 ) Minocycline may cause intracranial hypertension in adults and adolescents.

Discontinue MINOLIRA if symptoms occur. ( 5.8 ) Minocycline has been associated with autoimmune syndromes; discontinue MINOLIRA immediately if symptoms occur. ( 5.9 ) Minocycline has been associated with anaphylaxis, serious skin reactions, erythema multiforme, and DRESS syndrome.

Discontinue MINOLIRA immediately if symptoms occur. ( 5.11 )

5.1Teratogenic Effects Avoid MINOLIRA use during pregnancy. MINOLIRA, like other tetracycline-class drugs, can cause fetal harm when administered to a pregnant woman. MINOLIRA, like other tetracycline-class drugs, may cause permanent discoloration of the teeth and inhibit bone growth when administered during pregnancy.

Based on animal data, tetracyclines cross the placenta, are found in fetal tissues, and can cause skeletal malformation and retardation of skeletal development on the developing fetus. Evidence of embryotoxicity has been noted in animals treated early in pregnancy. If MINOLIRA is used during pregnancy, advise the patient of the potential risk to the fetus and discontinue treatment [see Use in Specific Populations (8.1) ] .

5.2Tooth Discoloration The use of tetracycline class drugs during tooth development (second and third trimesters of pregnancy, infancy, and childhood up 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 tetracycline but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported.

Use of tetracycline drugs is not recommended during tooth development. The safety and effectiveness of MINOLIRA have not been established in pediatric patients less than 12 years of age.

5.3Inhibition of Bone Growth All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued.

The safety and effectiveness of MINOLIRA have not been established in patients less than 12 years of age [see Use in Specific Populations (8.1 , 8.4) ] . Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can cause retardation of skeletal development on the developing fetus. Evidence of embryotoxicity has been noted in animals treated early in pregnancy [see Use in Specific Populations (8.1) ] .

5.4Pseudomembranous Colitis Clostridium difficile associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, including minocycline, 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 ove…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The most commonly observed adverse reactions (incidence ≥5%) are headache, fatigue, dizziness, and pruritus. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact EPI Health, LLC at 1-800-499-4468 or www.epihealth.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in practice. The following table summarizes selected adverse reactions reported in clinical trials at a rate of ≥1% for minocycline hydrochloride extended release tablets. Table 2: Selected Treatment-Emergent Adverse Reactions in at least 1% of Clinical Trial Adverse Reactions Minocycline Hydrochloride Extended-Release Tablets (1 mg/kg) N = 674 (%) Placebo N = 364 (%) At least one treatment emergency event 379 (56) 197 (54) Headache 152(23) 83(23) Fatigue 62 (9) 24 (7) Dizziness 59 (9) 17 (5) Pruritus 31 (5) 16 (4) Malaise 26 (4) 9 (3) Mood alteration 17 (3) 9 (3) Somnolence 13 (2) 3 (1) Urticaria 10 (2) 1 (0) Tinnitus 10 (2) 5 (1) Arthralgia 9 (1) 2 (0) Vertigo 8 (1) 3 (1) Dry Mouth 7 (1) 5 (1) Myalgia 7 (1) 4 (1)

6.2Postmarketing Experience Adverse reactions that have been reported with minocycline hydrochloride use in a variety of indications include: Skin and hypersensitivity reactions: fixed drug eruptions, balanitis, erythema multiforme, Stevens-Johnson syndrome, anaphylactoid purpura, photosensitivity, pigmentation of skin and mucous membranes, hypersensitivity reactions, angioneurotic edema, anaphylaxis, DRESS syndrome [see Warnings and Precautions (5.11) ]. Autoimmune conditions: polyarthralgia, pericarditis, exacerbation of systemic lupus, pulmonary infiltrates with eosinophilia, transient lupus-like syndrome.

Central nervous system: pseudotumor cerebri, bulging fontanels in infants, decreased hearing. Endocrine: brown-black microscopic thyroid discoloration, abnormal thyroid function. Oncology: thyroid cancer.

Oral: glossitis, dysphagia, tooth discoloration. Gastrointestinal: enterocolitis, pancreatitis, hepatitis, liver failure. Genitourinary: Preliminary studies suggest that use of minocycline may have deleterious effects on human spermatogenesis [see Nonclinical Toxicoloty (13.1) ] .

Renal: reversible acute renal failure. Hematology: hemolytic anemia, thrombocytopenia, eosinophilia.

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. ( 7.1 ) To avoid contraceptive failure, female patients are advised to use a second form of contraception during treatment with minocycline. ( 7.4 )

7.1Anticoagulants Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

7.2Penicillin Because bacteriostatic drugs may interfere with the bactericidal action of penicillin, to avoid giving tetracycline-class drugs in conjunction with penicillin.

7.3Antacids and Iron Preparations Absorption of tetracyclines is impaired by antacids containing aluminum, calcium or magnesium and iron-containing preparations.

7.4Low Dose Oral Contraceptives In a multi-center study to evaluate the effect of minocycline extended release tablets on low dose oral contraceptives, hormone levels over one menstrual cycle with and without minocycline extended release tablets 1 mg/kg once-daily were measured. Based on the results of this trial, minocycline-related changes in estradiol, progestinic hormone, FSH and LH plasma levels, of breakthrough bleeding, or of contraceptive failure, cannot be ruled out. To avoid contraceptive failure during treatment with minocycline, advise patients of reproductive potential to use a second form of contraception in addition to low-dose oral contraceptives.

7.5Drug/Laboratory Test Interactions False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Minocycline like other tetracycline-class drugs can cause fetal harm when administered to a pregnant woman. The use of drugs of the tetracycline class during tooth development may cause permanent discoloration of teeth. ( 5.1 , 5.2 , 8.1 , 8.4 ) Lactation: Breastfeeding is not recommended. ( 8.2 )

8.1Pregnancy Risk Summary MINOLIRA, like tetracycline class drugs, may cause permanent discoloration of teeth and reversible inhibition of bone growth when administered during pregnancy [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4) ] . Post-marketing cases of minocycline use in pregnant women report congenital anomalies such as limb reductions. The limited data are not sufficient to inform a drug-associated risk for birth defects or miscarriage.

In animal reproduction studies, minocycline induced skeletal malformations in fetuses when orally administered to pregnant rats and rabbits during the period of organogenesis at systemic exposure of approximately 3 times and 2 times, respectively, the systemic exposure to minocycline observed in patients administered MINOLIRA (see Data ) . If a patient becomes pregnant while taking this drug, advise the patient of the risk to the fetus and discontinue treatment. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Human Data The use of tetracycline during tooth development (second and third trimesters of pregnancy) may cause permanent discoloration of deciduous teeth.

This adverse reaction is more common during long-term use of the drug but has been observed following repeated short-term courses. Animal Data Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can cause retardation of skeletal development of the developing fetus. [see Warnings and Precautions (5.1) ] . Minocycline induced skeletal malformations (bent limb bones) in fetuses when administered to pregnant rats and rabbits during the period of organogenesis at doses of 30 mg/kg/day and 100 mg/kg/day, respectively, (resulting in approximately 3 times and 2 times, respectively, the systemic exposure to minocycline observed in patients administered MINOLIRA).

Reduced mean fetal body weight was observed when minocycline was administered to pregnant rats during the period of organogenesis at a dose of 10 mg/kg/day (which resulted in approximately the same level of systemic exposure to minocycline as that observed in patients administered MINOLIRA). Minocycline was assessed for effects on peri- and post-natal development of rats in a study that involved oral administration to pregnant rats during the period of organogenesis through lactation , at doses of 5, 10, or 50 mg/kg/day.

In this study, body weight gain was significantly reduced in pregnant females that received 50 mg/kg/day (resulting in approximately 2.5 times the systemic exposure to minocycline observed in patients administered MINOLIRA). No effects of treatment on the duration of the gestation period or the number of live pups born per litter were observed. Gross external anomalies observed in F1 pups (offspring of animals that received minocycline) included reduced body size, improperly rotated forelimbs, and reduced size of extremites.

No effects were observed on the physical development, behavior, learning ability, or reproduction of F1 pups, and there was no effect on gross appearance of F2 pups (offspring of F1 animals).

8.2Lactation Risk Summary Tetracycline-class drugs including minocycline are present in breast milk. It is not known whether minocycline has an effect on the breastfed infant or on milk production. Because of the potential f…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary MINOLIRA, like tetracycline class drugs, may cause permanent discoloration of teeth and reversible inhibition of bone growth when administered during pregnancy [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4) ] . Post-marketing cases of minocycline use in pregnant women report congenital anomalies such as limb reductions. The limited data are not sufficient to inform a drug-associated risk for birth defects or miscarriage.

In animal reproduction studies, minocycline induced skeletal malformations in fetuses when orally administered to pregnant rats and rabbits during the period of organogenesis at systemic exposure of approximately 3 times and 2 times, respectively, the systemic exposure to minocycline observed in patients administered MINOLIRA (see Data ) . If a patient becomes pregnant while taking this drug, advise the patient of the risk to the fetus and discontinue treatment. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Human Data The use of tetracycline during tooth development (second and third trimesters of pregnancy) may cause permanent discoloration of deciduous teeth.

This adverse reaction is more common during long-term use of the drug but has been observed following repeated short-term courses. Animal Data Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can cause retardation of skeletal development of the developing fetus. [see Warnings and Precautions (5.1) ] . Minocycline induced skeletal malformations (bent limb bones) in fetuses when administered to pregnant rats and rabbits during the period of organogenesis at doses of 30 mg/kg/day and 100 mg/kg/day, respectively, (resulting in approximately 3 times and 2 times, respectively, the systemic exposure to minocycline observed in patients administered MINOLIRA).

Reduced mean fetal body weight was observed when minocycline was administered to pregnant rats during the period of organogenesis at a dose of 10 mg/kg/day (which resulted in approximately the same level of systemic exposure to minocycline as that observed in patients administered MINOLIRA). Minocycline was assessed for effects on peri- and post-natal development of rats in a study that involved oral administration to pregnant rats during the period of organogenesis through lactation , at doses of 5, 10, or 50 mg/kg/day.

In this study, body weight gain was significantly reduced in pregnant females that received 50 mg/kg/day (resulting in approximately 2.5 times the systemic exposure to minocycline observed in patients administered MINOLIRA). No effects of treatment on the duration of the gestation period or the number of live pups born per litter were observed. Gross external anomalies observed in F1 pups (offspring of animals that received minocycline) included reduced body size, improperly rotated forelimbs, and reduced size of extremites.

No effects were observed on the physical development, behavior, learning ability, or reproduction of F1 pups, and there was no effect on gross appearance of F2 pups (offspring of F1 animals).

🧒 Pediatric Use 84 words ▾

8.4Pediatric Use The safety and effectiveness of MINOLIRA have been established in pediatric patients 12 years of age and older for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris [see Pharmacokinetics (12.3) and Clinical Studies (14) ] . Tooth discoloration and inhibition of bone growth have been observed in pediatric patients [see Warnings and Precautions (5.2 , 5.3) ] . The safety and effectiveness of MINOLIRA have not been established in pediatric patients less than 12 years of age.

🧓 Geriatric Use 83 words ▾

8.5Geriatric Use Clinical studies of MINOLIRA did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. 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 concomitant disease or other drug therapy.

🆘 Overdosage 27 words ▾

10 OVERDOSAGE In case of over dosage, discontinue medication, treat symptomatically and institute supportive measures. Minocycline is not removed in significant quantities by hemodialysis or peritoneal dialysis.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of MINOLIRA for the treatment of acne is unknown.

12.2Pharmacodynamics The pharmacodynamics of MINOLIRA for the treatment of acne are unknown.

12.3Pharmacokinetics The pharmacokinetics of minocycline following oral administration of a single dose of MINOLIRA (135 mg) was investigated in 77 healthy male and female adult subjects under fasting conditions. The pharmacokinetic parameters of minocycline under fasting conditions are presented in Table 3. Table 3 : Pharmacokinetic Parameters of Minocycline Following Administration of a Single Dose of MINOLIRA (135 mg) under Fasting Conditions (N = 77) C max (ng/mL) T max (hr) Median (Min-Max) AUC 0-t (ng∙hr/mL) T 1/2 (hr) Mean ± SD 700 ± 261 2.0 (1.0 – 4.5) 10874 ± 3717 15.6 ±

2.46In a separate trial, a single dose of MINOLIRA (135 mg) was administered orally with a high-fat, high-calorie meal that included dairy products to 36 healthy male and female adult subjects. The estimated calorie content of the meal was 848 Kcal, consisting of 145 Kcal from protein, 250 Kcal from carbohydrates, and 453 Kcal from fat. The pharmacokinetic parameters of minocycline under fed conditions are presented in Table 4.

Table 4 : Pharmacokinetic Parameters of Minocycline Following Administration of a Single Dose of MINOLIRA (135 mg) under Fed Conditions (N = 36) C max (ng/mL) T max (hr) Median (Min-Max) AUC 0-t (ng∙hr/mL) T 1/2 (hr) Mean ± SD 707 ± 190 3.5 (1.5 – 6.0) 12000 ± 2967 17.1 ±

3.03Minocycline is lipid soluble and distributes into the skin and sebum.

🧬 Mechanism of Action 17 words ▾

12.1Mechanism of Action The mechanism of action of MINOLIRA for the treatment of acne is unknown.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied MINOLIRA is supplied as functionally scored extended-release tablets containing minocycline hydrochloride equivalent to 105 mg and 135 mg of minocycline. The 105 mg extended-release tablets are white to off-white, rectangular, with brown or gold color speckles. The tablets have a single score line on both surfaces and are debossed with ‘M1’ on one surface.

On the face with debossing, ‘M’ and ‘1’ are on either side of the score line. Each tablet contains 26.25 mg of minocycline as immediate release beads and 78.75 mg of minocycline as extended release beads. The 105 mg tablets are supplied as follows: NDC 71403-101-30 Bottle of 30 The 135 mg extended-release tablets are white to off-white, rectangular with brown or gold color speckles.

The tablets have a single score line on both surfaces and are debossed with ‘M3’ on one surface. On the face with debossing, ‘M’ and ‘3’ are on either side of the score line. Each tablet contains 33.75 mg of minocycline as immediate release beads and 101.25 of minocycline as extended release beads.

The 135 mg tablets are supplied as follows: NDC 71403-102-30 Bottle of 30 Storage Store at 20°C - 25°C (68°F - 77°F); excursions are permitted to 15°C-30°C (59°-86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Handling Dispense in tight, light-resistant container as defined in USP with child-resistant closure.

📦 Storage and Handling 38 words ▾

Storage Store at 20°C - 25°C (68°F - 77°F); excursions are permitted to 15°C-30°C (59°-86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Handling Dispense in tight, light-resistant container as defined in USP with child-resistant closure.

📋 Description 151 words ▾

11 DESCRIPTION Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S (4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is representated below: C 23 H 27 N 3 O 7 ∙HCl M. W.

493.95 MINOLIRA (minocycline hydrochloride) extended-release tablets for oral administration contain 105 mg or 135 mg of minocycline, equivalent to 113.4 mg or 145.8 mg of minocycline hydrochloride, respectively. MINOLIRA extended-release tablets, 105 mg and 135 mg, contain 25% of minocycline as immediate release beads and 75% of minocycline as extended release beads. In addition, 105 mg and 135 mg tablets contain the following inactive ingredients: ethyl cellulose NF, hypromellose USP, isopropyl alcohol USP, microcrystalline cellulose NF, polytheylene glycol 400 NF, purified water USP, silicified microcrystalline cellulose NF, sodium stearyl fumarate NF, talc USP, triethyl citrate NF.

Both 105 mg and 135 mg tablets also contain Opadry clear which contains hydroxyl propyl cellulose NF and hypromellose USP. Chemical Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instruction for Use). Advise patients of the following: Teratogenic effects Advise patients to avoid use of MINOLIRA during pregnancy. Advise patients that MINOLIRA use during pregnancy may cause inhibition of fetal bone growth.

Advise patients that MINOLIRA use during pregnancy may cause discoloration of deciduous teeth. Advise patients to discontinue MINOLIRA during pregnancy. Tooth Discoloration Advise caregivers of pediatric patients that MINOLIRA use may cause permanent discoloration of deciduous and permanent teeth.

Lactation Advise a woman that breast feeding is not recommended during MINOLIRA therapy. Contraception Advise patients of reproductive potential that MINOLIRA may reduce the effectiveness of low-dose oral contraceptives. Advise patients of reproductive potential not rely on low-dose oral contraceptives as an effective contraceptive method and to use an additional method of contraception during treatment with MINOLIRA.

Infertility Advise males of reproductive potential that MINOLIRA may impair fertility. Tissue Hyperpigmentation Inform patients that MINOLIRA may cause discoloration of skin, scars, teeth or gums. Pseudomembranous Colitis Advise patients that pseudomembranous colitis can occur with minocycline therapy, including MINOLIRA.

Advise patients to seek medical attention if they develop watery or bloody stools. Hepatotoxicity Inform patients about the possibility of hepatotoxicity. Advise patients to seek medical advice if they experience symptoms or signs of hepatotoxicity, including loss of appetite, tiredness, diarrhea, jaundice, increased bleeding tendencies, confusion, and sleepiness.

Central Nervous System Effects Inform patients that central nervous system adverse reactions including dizziness or vertigo have been reported with minocycline therapy. Caution patients about driving vehicles or using hazardous machinery if they experience such symptoms while on MINOLIRA. Intracranial Hypertension Inform patients that intracranial hypertension can occur with minocycline therapy.

Advise patients to seek medical attention if they develop unusual headache, visual symptoms, such as blurred vision, diplopia, and vision loss. Inform patients that autoimmune syndromes, including drug-induced lupus-like syndrome, autoimmune hepatitis, vasculitis and serum sickness have been observed with tetracycline-class drugs, including minocycline. Symptoms may be manifested by arthralgia, fever, rash and malaise.

Advise patients who experience such symptoms to stop the drug immediately and seek medical help. Photosensitivity Inform patients that photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines, including minocycline. Advise patients to minimize or avoid exposure to natural or artificial UV light (tanning beds or UVA/B treatment) while using MINOLIRA.

Discuss other sun protection measures, if patients need to be outdoors while using MINOLIRA. Advise patients to discontinue treatment at the first evidence of sunburn. Important Administration Instructions Inform patients to take MINOLIRA as directed.

Missing doses or not completing the full course of therapy may decrease the effectiveness of the current treatment course and increase the likelihood that bacteria will develop resistance and will not be treatable by other antibacterial drugs in the future. Advise patient not to chew or crush the tablet. Advise patients to split MINOLIRA tablet across the score line, if required depending on patient's body weight.

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.