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minocycline hydrochloride 135 mg Tablet, Extended Release, 1,000-count — NDC 70771-1167-00 package photo

minocycline hydrochloride 135 mg Tablet, Extended Release, 1,000-count

by Zydus Lifesciences Limited · 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1167-0)
NDC 70771-1167-00
🏷️ FDA NDC (as labeled) 70771-1167-0 billing pads the package segment with a zero
This package
Contains1,000-count Pack sizes6 compare ↓
Also priced by: Part D plans $22.27/unit — full pricing hub ↓
Also comes in: 10 tablets 70771-1167-07 30 tablets 70771-1167-03 90 tablets 70771-1167-09 100 tablets 70771-1167-01 500 tablets 70771-1167-05
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) 70771-1167-0
Product NDC 70771-1167
11-digit billing NDC 70771116700
RxCUI 629695, 629697, 629699, 858062, 858372, 1013659, 1013662, 1013665
UNII 0020414E5U
UPC 0370771115419, 0370771115310, 0370771115617, 0370771115518 +4 more
Application # ANDA203553
SPL Set ID 8bf9cf23-8ffc-401f-981d-4878d694a468
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 2018-03-07
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance MINOCYCLINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 70771-1167-0 — 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 → 70771-1167-00. 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.

🏷️ RxNorm drug class

This medicine belongs to the Tetracycline-class Drug class.

Pharmacologic class Tetracycline-class Drug
Drug family (ATC) Antiinfectives and antiseptics for local oral treatment, Antiinfectives for treatment of acne, Tetracyclines
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerZydus Lifesciences Limited
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA203553 (ANDA)
Labeler code70771
First marketedMar 2018
Product typeHuman Prescription Drug
Portfolio717 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

📖 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.

💊 What it looks like

Color Gray / Yellow / Blue / Green / Pink
ShapeCapsule
Imprint535
Size16 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 2LRS185U6K
    D&C Red No. 27 is a synthetic red colorant used in medicines and cosmetics. It gives tablets, capsules, or liquids their red or reddish color so products are visually identifiable.
  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII L06K8R7DQK
    A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII G2M7P15E5P
    Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.

10 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

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 · Q2 2026 $22.27 $22,270.00 / 1000 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
Minocycline Hydrochloride 135 mg 63629-9210-01 Bryant 30 tablets — AB FDA listed —
Minocycline Hydrochloride 135 mg 65862-0558-01 Aurobindo 100 tablets — — FDA listed —
Minocycline Hydrochloride 135 mg 67877-0577-01 Ascend 100 tablets — AB FDA listed —
minocycline hydrochloride 135 mg 68382-0535-01 Zydus 100 tablets — — FDA listed —
minocycline hydrochloride 135 mgthis 70771-1167-00 Zydus 1000 tablets — — FDA listed —
Minocycline Hydrochloride 135 mg 72162-1853-03 Bryant 30 tablets — AB FDA listed —
Minocycline Hydrochloride 135 mg 72789-0530-30 PD-Rx 30 tablets — AB FDA listed —
Minocycline Hydrochloride 135 mg 68180-0381-01 Lupin 100 tablets — 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

🏛️
2018
On the market since
Mar 2018
📍
2026
Currently FDA-listed
8 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
70771-1167-00 You're viewing this 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1167-0) 2018-03-07 Active
70771-1167-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1167-1) 2018-03-07 Active
70771-1167-03 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1167-3) 2018-03-07 Active
70771-1167-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1167-5) 2018-03-07 Active
70771-1167-07 10 BLISTER PACK in 1 CARTON (70771-1167-7) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 2018-03-07 Active
70771-1167-09 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1167-9) 2018-03-07 Active

Pack size FAQ

What quantity is in NDC 70771-1167-00?
NDC 70771-1167-00 is a 1,000-count package — 1000 tablet, extended release in 1 bottle.
What is the difference between NDC 70771-1167-00 and NDC 70771-1167-03?
Both are minocycline hydrochloride 135 mg Tablet, Extended Release — the drug itself is identical. NDC 70771-1167-00 is the 1,000-count package, while NDC 70771-1167-03 is the 30 tablets package.
What NDC number is used to bill for this package of minocycline hydrochloride 135 mg Tablet, Extended Release?
Bill NDC 70771-1167-00 — the 11-digit billing format is 70771116700. 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 ✓ Available
Inactive ingredients (structured) ✓ 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 70771-1167-0, 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: 70771-1167-00, written without dashes as 70771116700. 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 70771-1167-00, the first segment (70771) is the labeler code FDA assigned to Zydus Lifesciences Limited; the middle segment (1167) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) 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 Zydus Lifesciences Limited. 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 5 other package presentations of this same product, including 10 tablets (70771-1167-07), 30 tablets (70771-1167-03), 90 tablets (70771-1167-09). 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?
Zydus Lifesciences Limited 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 📋 Description 💬 Information for Patients
🎯 Indications and Usage 169 words ▾

1 INDICATIONS AND USAGE Minocycline hydrochloride extended-release tablets are indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Limitations of Use Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions. This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies (14) ] .

To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, use minocycline hydrochloride extended-release tablets only as indicated [see Warnings and Precautions (5.12) ] . Minocycline hydrochloride extended-release tablets are a tetracycline-class drug indicated to treat 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 and to maintain the effectiveness of other antibacterial drugs, use minocycline hydrochloride extended-release tablets only as indicated. ( 1 )

⏱️ Dosage and Administration 196 words ▾

2 DOSAGE AND ADMINISTRATION The recommended dosage of minocycline hydrochloride extended-release tablets are approximately 1 mg/kg once daily for 12 weeks. (2) The recommended dosage of minocycline hydrochloride extended-release tablets is approximately 1 mg/kg once daily for 12 weeks. Table 1 provides the recommended minocycline hydrochloride extended-release tablets dosage based upon weight ranges.

Patient's Weight (kg) Recommended Dosage (mg/day) 45 to 49 45 50 to 59 55 60 to 71 65 72 to 84 80 85 to 96 90 97 to 110 105 111 to 125 115 126 to 136 135 Higher dosages have not shown to be of additional benefit in the treatment of inflammatory lesions of acne and may be associated with more acute vestibular adverse reactions. Swallow tablets whole. Do not chew, crush, or split the extended-release tablets.

Administer minocycline hydrochloride extended-release tablets with or without food [see Clinical Pharmacology (12.3) ] . Ingestion of food along with minocycline hydrochloride extended-release tablets may help reduce the risk of esophageal irritation and ulceration. In patients with renal impairment, decrease the daily dosage by either reducing the recommended individual doses and/or by extending the time intervals between doses [see Warnings and Precautions (5.9 )] .

💊 Dosage Forms and Strengths ~1 min read ▾

3 DOSAGE FORMS AND STRENGTHS Extended-release tablets: 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg and 135 mg (3) 45 mg extended-release tablets are grey colored, modified capsule shaped, biconvex, coated tablets, debossed with "531" on one side and plain on other side. 55 mg extended-release tablets are yellow colored, modified capsule shaped, biconvex, coated tablets, debossed with "550" on one side and plain on other side. 65 mg extended-release tablets are blue colored, modified capsule shaped, biconvex, coated tablets, debossed with "532" on one side and plain on other side.

80 mg extended-release tablets are whitish blue colored, modified capsule shaped, biconvex, coated tablets, debossed with "551" on one side and plain on other side. 90 mg extended-release tablets are light yellow colored, modified capsule shaped, biconvex, coated tablets, debossed with "533" on one side and plain on other side. 105 mg extended-release tablets are light blue colored, modified capsule shaped, biconvex, coated tablets, debossed with "552" on one side and plain on other side.

115 mg extended-release tablets are green colored, modified capsule shaped, biconvex, coated tablets, debossed with "534" on one side and plain on other side. 135 mg extended-release tablets are light pink colored, modified capsule shaped, biconvex, coated tablets, debossed with "535" on one side and plain on other side.

⛔ Contraindications 36 words ▾

4 CONTRAINDICATIONS Known hypersensitivity to any of the tetracyclines. (4) Minocycline hydrochloride extended-release tablet is contraindicated in patients with history of a hypersensitivity reaction to any of the tetracyclines [see Warnings and Precautions (5.1) ] .

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Serious Skin/Hypersensitivity Reactions: Minocycline has been associated with anaphylaxis, serious skin reactions, erythema multiforme, and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome. Discontinue immediately if symptoms occur. ( 5.1 ) Tooth Discoloration and Enamel Hypoplasia: Use during the second and third trimesters of pregnancy, infancy, and childhood up to the age of 8years may cause permanent discoloration of the teeth (yellow-gray-brown).

( 5.2 , 8.1 , 8.4 ) Inhibition of Bone Growth: Use during the second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years may cause reversible inhibition of bone growth. ( 5.3 , 8.1 , 8.4 ) Clostridioides difficile-Associated Diarrhea (Antibiotic-Associated Colitis) : Discontinue if Clostridioides difficile-associated diarrhea (antibiotic-associated colitis) occurs. ( 5.4 ) Hepatotoxicity: Discontinue if liver injury is suspected.

( 5.5 ) Central Nervous System Effects: May cause central nervous system side effects including light-headedness, dizziness, or vertigo. ( 5.6 ) Idiopathic Intracranial Hypertension: May cause idiopathic intracranial hypertension in adults and adolescents. Discontinue if symptoms occur.

( 5.7 ) Autoimmune Syndromes: Minocycline has been associated with autoimmune syndromes; discontinue immediately if symptoms occur. ( 5.8 ) Metabolic Effects: If renal impairment exists, reduce minocycline dosage. ( 5.9 )

5.1Serious Skin/Hypersensitivity Reactions Cases of anaphylaxis, serious skin reactions (e.g., Stevens-Johnson syndrome), erythema multiforme, and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been reported postmarketing with minocycline use in patients with acne. DRESS syndrome consists of cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more of the following visceral complications such as: hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis.

Fever and lymphadenopathy may be present. In some cases, death has been reported. If this syndrome is recognized, discontinue minocycline immediately.

5.2Tooth Discoloration and Enamel Hypoplasia The use of tetracycline-class drugs, including minocycline, 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). Permanent discoloration of the teeth is more common during long-term use of tetracycline-class drugs but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported.

Use of minocycline is not recommended during tooth development. Advise the patient of the potential risk to the fetus if minocycline is used during the second or third trimester of pregnancy [see Use in Specific Populations ( 8.1 , 8.4 )].

5.3Inhibition of Bone Growth The use of tetracycline-class drugs, including minocycline, during the second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years may cause reversible inhibition of bone growth. All tetracyclines, including minocycline, 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. Advise the patient of the potential risk to the fetus if minocycline is used during the second or third trimester of pregnancy [see Use in Specific Populations ( 8.1 , 8.4 )].

5.4Clostridioides difficile -Associated Diarrhea (Antibiotic-Associated Colitis) Clostridioides 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. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strain…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Skin/Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Clostridioides difficile -Associated Diarrhea (Antibiotic-Associated Colitis) [see Warnings and Precautions ( 5.4 )] Hepatotoxicity [see Warnings and Precautions ( 5.5 )] Central Nervous System Effects [see Warnings and Precautions ( 5.6 )] Idiopathic Intracranial Hypertension [see Warnings and Precautions ( 5.7 )] The most commonly observed adverse reactions (incidence > 5%) are headache, fatigue, dizziness, and pruritus.

(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 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 and higher than placebo. Adverse Reactions Minocycline Hydrochloride Extended-Release Tablets (1 mg/kg) N = 674 (%) PLACEBO N = 364 (%) At least one treatment-emergent event 379 (56) 197 (54) Fatigue 62 (9) 24 (7) Dizziness 59 (9) 17 (5) Pruritus 31 (5) 16 (4) Malaise 26 (4) 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)

6.2Postmarketing Experience The following adverse reactions have been reported with minocycline hydrochloride use in a variety of indications. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Skin and hypersensitivity reactions: anaphylaxis, angioedema, DRESS syndrome, erythema multiforme, Stevens-Johnson syndrome, acute febrile neutrophilic dermatosis (Sweet's syndrome), fixed drug eruptions, balanitis, anaphylactoid purpura, photosensitivity, pigmentation of skin and mucous membranes.

Autoimmune conditions: polyarthralgia, pericarditis, exacerbation of systemic lupus, pulmonary infiltrates with eosinophilia, lupus-like syndrome. Central nervous system: idiopathic intracranial hypertension, 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.

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

🔄 Drug Interactions 106 words ▾

7 DRUG INTERACTIONS Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. ( 7.1 )

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, avoid giving minocycline hydrochloride 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.

7.4Drug/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 Lactation: Breastfeeding is not recommended. ( 8.2 ).

8.1Pregnancy Risk Summary Tetracycline class drugs, including minocycline may cause permanent discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy [see Warnings and Precautions ( 5.2 , 5.3 ) and Use in Specific Populations ( 8.4 )]. A few postmarketing cases of limb reductions have been reported over decades of use; however, the association is unclear. The limited data from postmarketing reports are not sufficient to inform a drug-associated risk for birth defects or miscarriage.

In animal reproduction studies conducted in pregnant rats and rabbits, fetuses with bent limb bones were observed following oral administration of minocycline during organogenesis at systemic exposures 3 and 2 times, respectively, the exposure associated with the maximum recommended human dose (MRHD) (see Data) . If a patient becomes pregnant while taking this drug, advise the patient of the risk to the fetus and to discontinue treatment. The 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 to 4% and 15 to 20%, respectively. Data Human Data The use of tetracycline class drugs, including minocycline, during tooth development (second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of deciduous teeth (yellow-gray-brown).

Permanent discoloration of the teeth is more common during long-term use of the drug but has been observed following repeated short-term courses [see Warnings and Precautions ( 5.2 )] . Animal Data Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can cause delayed skeletal development in the developing fetus. Evidence of embryotoxicity has been noted in animals treated early in pregnancy [see Warnings and Precautions ( 5.3 )].

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 (3 times the MRHD and 2 times the MRHD on an AUC comparison basis, respectively). Reduced mean fetal body weight was observed in studies in which minocycline was administered to pregnant rats at an oral dose of 10 mg/kg/day (approximately equal to the MRHD on an AUC comparison basis). 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 dosages of 5 mg/kg/day, 10 mg/kg/day, or 50 mg/kg/day.

In this study, body weight gain was significantly reduced in pregnant females that received 50 mg/kg/day (2.5 times the MRHD on an AUC comparison basis). 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 offspring of animals that received minocycline included reduced body size, improperly rotated forelimbs, and reduced size of extremities.

No effects were observed on the physical development, behavior, learning ability, or reproduction of the offspring of animals that received minocycline.

8.2Lactation Risk Summary Tetracycline-class antibiotics, including minocycline, are present in breast milk following oral administration. There are no data on the effects of minocycline on milk production. Because of the potential for serious adverse reactions, including tooth discoloration and inhibition of bone growth, advise patients that breastfeeding is not recommended during minocycline therapy and for 4 day…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Tetracycline class drugs, including minocycline may cause permanent discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy [see Warnings and Precautions ( 5.2 , 5.3 ) and Use in Specific Populations ( 8.4 )]. A few postmarketing cases of limb reductions have been reported over decades of use; however, the association is unclear. The limited data from postmarketing reports are not sufficient to inform a drug-associated risk for birth defects or miscarriage.

In animal reproduction studies conducted in pregnant rats and rabbits, fetuses with bent limb bones were observed following oral administration of minocycline during organogenesis at systemic exposures 3 and 2 times, respectively, the exposure associated with the maximum recommended human dose (MRHD) (see Data) . If a patient becomes pregnant while taking this drug, advise the patient of the risk to the fetus and to discontinue treatment. The 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 to 4% and 15 to 20%, respectively. Data Human Data The use of tetracycline class drugs, including minocycline, during tooth development (second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of deciduous teeth (yellow-gray-brown).

Permanent discoloration of the teeth is more common during long-term use of the drug but has been observed following repeated short-term courses [see Warnings and Precautions ( 5.2 )] . Animal Data Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can cause delayed skeletal development in the developing fetus. Evidence of embryotoxicity has been noted in animals treated early in pregnancy [see Warnings and Precautions ( 5.3 )].

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 (3 times the MRHD and 2 times the MRHD on an AUC comparison basis, respectively). Reduced mean fetal body weight was observed in studies in which minocycline was administered to pregnant rats at an oral dose of 10 mg/kg/day (approximately equal to the MRHD on an AUC comparison basis). 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 dosages of 5 mg/kg/day, 10 mg/kg/day, or 50 mg/kg/day.

In this study, body weight gain was significantly reduced in pregnant females that received 50 mg/kg/day (2.5 times the MRHD on an AUC comparison basis). 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 offspring of animals that received minocycline included reduced body size, improperly rotated forelimbs, and reduced size of extremities.

No effects were observed on the physical development, behavior, learning ability, or reproduction of the offspring of animals that received minocycline.

🧒 Pediatric Use 110 words ▾

8.4Pediatric Use The safety and effectiveness of minocycline hydrochloride 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 Clinical Studies ( 14 )] . Tooth discoloration and inhibition of bone growth have been observed in pediatric patients [see Warnings and Precaution ( 5.2 , 5.3 )] . Use of tetracycline-class antibiotics below the age of 8 is not recommended due to the potential for tooth discoloration [see Warnings and Precautions ( 5.2 )] .

Safety and effectiveness of minocycline have not been established in pediatric patients younger than 12 years of age.

🧓 Geriatric Use 85 words ▾

8.5Geriatric Use Clinical studies of minocycline hydrochloride extended-release tablets did not include sufficient numbers of subjects aged 65 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 37 words ▾

10 OVERDOSAGE Minocycline is not removed in significant quantities by hemodialysis or peritoneal dialysis. In case of overdosage, discontinue minocycline, treat symptomatically, and institute supportive measures. Call Poison Control Center at 1-800 222-1222 for the latest recommendations.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of minocycline hydrochloride extended-release tablets for the treatment of acne is unknown.

12.2Pharmacodynamics The pharmacodynamics of minocycline hydrochloride extended-release tablets for the treatment of acne are unknown.

12.3Pharmacokinetics Minocycline hydrochloride extended-release tablets are not bioequivalent to non-modified release minocycline products. Based on pharmacokinetic studies in healthy adults, minocycline hydrochloride extended-release tablets produce a delayed T max at 3.5 hours to 4 hours as compared to a non-modified release reference minocycline product (T max at 2.25 hours to 3 hours). At steady-state (Day 6), the mean AUC (0 to 24) and C max were 33.32 mcg×hr/mL and 2.63 mcg/mL for minocycline hydrochloride extended-release tablets and 46.35 mcg×hr/mL and 2.92 mcg/mL for minocycline hydrochloride capsules, respectively.

These parameters are based on dose adjusted to 135 mg/day for both products. A single-dose, four-way crossover study demonstrated that minocycline hydrochloride extended-release tablets used in the study (45 mg, 90 mg, 135 mg) exhibited dose-proportional pharmacokinetics. In another single-dose, five-way crossover pharmacokinetic study, minocycline hydrochloride extended-release tablets 55 mg, 80 mg, and 105 mg were shown to be dose-proportional to minocycline hydrochloride extended-release tablets 90 mg and 135 mg.

When minocycline hydrochloride extended-release tablets were administered concomitantly with a meal that included dairy products, the extent and timing of absorption of minocycline did not differ from that of administration under fasting conditions. Minocycline is lipid soluble and distributes into the skin and sebum.

🧬 Mechanism of Action 20 words ▾

12.1Mechanism of Action The mechanism of action of minocycline hydrochloride extended-release tablets for the treatment of acne is unknown.

📦 How Supplied / Storage and Handling ~3 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Minocycline Hydrochloride Extended-release Tablets, USP 45 mg are grey colored, modified capsule shaped, biconvex, coated tablets, debossed with "531" on one side and plain on other side and are supplied as follows: NDC 68382-531-06 in bottles of 30 tablets with child resistance closure NDC 68382-531-16 in bottles of 90 tablets with child resistance closure NDC 68382-531-01 in bottles of 100 tablets with child resistance closure NDC 68382-531-05 in bottles of 500 tablets NDC 68382-531-10 in bottles of 1000 tablets NDC 68382-531-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Minocycline Hydrochloride Extended-release Tablets, USP 55 mg are yellow colored, modified capsule shaped, biconvex, coated tablets, debossed with "550" on one side and plain on other side and are supplied as follows: NDC 68382-550-06 in bottles of 30 tablets with child resistance closure NDC 68382-550-16 in bottles of 90 tablets with child resistance closure NDC 68382-550-01 in bottles of 100 tablets with child resistance closure NDC 68382-550-05 in bottles of 500 tablets NDC 68382-550-10 in bottles of 1000 tablets NDC 68382-550-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Minocycline Hydrochloride Extended-release Tablets, USP 65 mg are blue colored, modified capsule shaped, biconvex, coated tablets, debossed with "532" on one side and plain on other side and are supplied as follows: NDC 68382-532-06 in bottles of 30 tablets with child resistance closure NDC 68382-532-16 in bottles of 90 tablets with child resistance closure NDC 68382-532-01 in bottles of 100 tablets with child resistance closure NDC 68382-532-05 in bottles of 500 tablets NDC 68382-532-10 in bottles of 1000 tablets NDC 68382-532-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Minocycline Hydrochloride Extended-release Tablets, USP 80 mg are whitish blue colored, modified capsule shaped, biconvex, coated tablets, debossed with "551" on one side and plain on other side and are supplied as follows: NDC 68382-551-06 in bottles of 30 tablets with child resistance closure NDC 68382-551-16 in bottles of 90 tablets with child resistance closure NDC 68382-551-01 in bottles of 100 tablets with child resistance closure NDC 68382-551-05 in bottles of 500 tablets NDC 68382-551-10 in bottles of 1000 tablets NDC 68382-551-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Minocycline Hydrochloride Extended-release Tablets, USP 90 mg are light yellow colored, modified capsule shaped, biconvex, coated tablets, debossed with "533" on one side and plain on other side and are supplied as follows: NDC 68382-533-06 in bottles of 30 tablets with child resistance closure NDC 68382-533-16 in bottles of 90 tablets with child resistance closure NDC 68382-533-01 in bottles of 100 tablets with child resistance closure NDC 68382-533-05 in bottles of 500 tablets NDC 68382-533-10 in bottles of 1000 tablets NDC 68382-533-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Minocycline Hydrochloride Extended-release Tablets, USP 105 mg are light blue colored, modified capsule shaped, biconvex, coated tablets, debossed with "552" on one side and plain on other side and are supplied as follows: NDC 68382-552-06 in bottles of 30 tablets with child resistance closure NDC 68382-552-16 in bottles of 90 tablets with child resistance closure NDC 68382-552-01 in bottles of 100 tablets with child resistance closure NDC 68382-552-05 in bottles of 500 tablets NDC 68382-552-10 in bottles of 1000 tablets NDC 68382-552-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Minocycline Hydrochloride Extended-release Tablets, USP 115 mg are green colored, modified capsule shaped, biconvex, coated tablets, debossed with "534" on one side and plain on other side and are supplied as follows: NDC 68382-534-06 in bottles of 30 tablets with child resistance closure NDC 68382-534-16 in bottles o…

📋 Description ~1 min read ▾

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 represented below: C 23 H 27 N 3 O 7 •HCl M. W.

493.95 Each minocycline hydrochloride extended-release tablet, USP intended for oral administration contains minocycline hydrochloride equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg or 135 mg of minocycline. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol (55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg and 135 mg only), titanium dioxide and triacetin. Additionally, the 45 mg tablets contain ferric oxide black and ferric oxide yellow; the 55 mg tablets contain ferric oxide red and ferric oxide yellow; the 65 mg tablets contain FD & C blue #2 aluminum lake; the 80 mg tablets contain FD & C blue #2 aluminum lake and FD & C red #40 aluminum lake; the 90 mg tablets contain D & C yellow #10 aluminum lake, ferric oxide red and ferric oxide yellow; the 105 mg tablets contain FD & C blue #2 aluminum lake and FD & C red #40 aluminum lake; the 115 mg tablets contain FD & C blue #2 aluminum lake and ferric oxide yellow; the 135 mg tablets contain D & C red #27 aluminum lake, D & C yellow #10 aluminum lake and FD & C blue #2 aluminum lake.

USP dissolution test-8 used. USP organic impurities procedure pending. figure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Patients taking minocycline hydrochloride extended-release tablets should receive the following information and instructions: Administration Instructions Minocycline hydrochloride extended-release tablets should be taken exactly as directed. Advise patients to swallow minocycline extended-release tablets whole and not to chew, crush, or split the tablets [see Dosage and Administration ( 2 )] Serious Skin/Hypersensitivity Reactions Inform patients that serious skin reactions have occurred with the minocycline use in patients with acne.

Advise patients to discontinue use of minocycline extended-release tablets and contact their healthcare provider immediately at the first evidence of skin erythema [see Warnings and Precautions ( 5.1 )]. Tooth Discoloration and Enamel Hypoplasia Advise patients that minocycline extended-release tablets use in pregnancy may cause permanent tooth discoloration of deciduous teeth. Advise patients to discontinue minocycline extended-release tablets during pregnancy and to inform their healthcare provider right away if they become pregnant during treatment [see Warnings and Precautions ( 5.2 ), Use in Specific Populations ( 8.1 )] .

Advise caregivers of pediatric patients that minocycline extended-release tablets use may cause permanent discoloration of deciduous and permanent teeth [see Warnings and Precautions ( 5.2 ), Use in Specific Populations ( 8.4 )] . Inhibition of Bone Growth Advise patients that minocycline use in pregnancy may cause inhibition of fetal bone growth. Advise patients to discontinue minocycline during pregnancy and to inform their healthcare provider right away if they become pregnant during treatment [see Warnings and Precautions ( 5.3 ), Use in Specific Populations ( 8.1 )].

Clostridioides difficile- Associated Diarrhea (Antibiotic-Associated Colitis) Advise patients that Clostridioides difficile -associated diarrhea (antibiotic-associated colitis) can occur with minocycline therapy, including minocycline extended-release tablets. If patients develop watery or bloody stools, advise patients to seek medical attention [see Warnings and Precautions ( 5.4 )] . Hepatotoxicity Inform patients about the possibility of hepatotoxicity.

Advise patients to seek medical advice if they experience signs or symptoms of hepatotoxicity, including loss of appetite, tiredness, diarrhea, jaundice, bleeding easily, confusion, and sleepiness [see Warnings and Precautions ( 5.5 )] . Central Nervous System Effects Inform patients that central nervous system adverse reactions including dizziness or vertigo have been reported with oral minocycline therapy. Caution patients about driving vehicles or using hazardous machinery if they experience such symptoms while on minocycline [see Warnings and Precautions ( 5.6 )] .

Idiopathic Intracranial Hypertension Inform patients that idiopathic 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 [see Warnings and Precautions ( 5.7 )] . Autoimmune Syndromes 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 immediately discontinue minocycline and seek medical help [see Warnings and Precautions ( 5.8 )] . 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 sunlight (i.e., tanning beds or UVA/B treatment) while using minocycli…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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