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Minocycline Hydrochloride 105 mg Tablet, Film Coated, Extended Release, 30-count — NDC 67877-0438-30 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Minocycline Hydrochloride 105 mg Tablet, Film Coated, Extended Release, 30-count — NDC 67877-438-30 (Billing 67877-0438-30)

by Ascend Laboratories, LLC · 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

This is a package of 30 tablets of Minocycline Hydrochloride 105 mg Tablet, Film Coated, Extended Release from Ascend Laboratories, LLC, marketed since Sep 2016 and currently FDA-listed; retail pharmacies pay about $1.73 per tablet (NADAC). It is the main listing for this product, which comes in 4 package sizes.

NDC 67877-0438-30
🏷️ FDA NDC (as labeled) 67877-438-30 billing pads the product segment with a zero
This package
Contains30-count Cost per ea$1.73 NADAC Per package$52.03 / 30 tablets Pack sizes4 compare ↓
Also priced by: Part D plans $14.43/unit — full pricing hub ↓
Main listing for product 67877-438 · Also comes in: 14 tablets 67877-438-14 100 tablets 67877-438-01 500 tablets 67877-438-05
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

🚨
Active recall for this product.
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
Lots / codes: Lot# 25141635, Exp 4/30/2028 · reported Jun 17, 2026
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 67877-438-30
Product NDC 67877-438
11-digit billing NDC 67877043830
NCPDP billing unit EA — each (per item)
RxCUI 629695, 629697, 629699, 858062, 858372, 1013659, 1013662, 1013665
UNII 0020414E5U
Application # ANDA204453
SPL Set ID a8f95207-b259-4f50-87f2-3652d9268890
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 2016-09-30
Route ORAL
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Substance MINOCYCLINE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 04000040107533
GPI class Minocycline HCl ER
GCN Seq No 066685
GCN 29045
HICL code 004015
Ingredient (HICL) Minocycline Hcl
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1C
Therapeutic class — specific (HIC3) Tetracycline Antibiotics
AHFS code 08:12.24.00
AHFS class Tetracycline Antibiotics
FDB label name MINOCYCLINE ER 105 MG TABLET
FDB brand name Minocycline Hcl Er
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 066685
  • GCN: 29045
  • GPI-14 (Medi-Span): 04000040107533
  • HICL (First Databank): 004015
  • AHFS class code: 08:12.24.00
  • RxCUI (RxNorm): 629695
Why two NDCs? The FDA registers this code as 67877-438-30 — 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 → 67877-0438-30. 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.

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.

Clinical

Label name MINOCYCLINE ER 105 MG TABLET Ingredient Minocycline Hcl
📖 What it is MedlinePlus · NLM

Minocycline is used to treat infections caused by bacteria and certain other infections spread by ticks, lice, mites, and infected animals. It is also used to treat acne and rosacea (a skin disease that causes redness, flushing, and pimples on the face). Minocycline is in a class of medications called tetracycline antibiotics. It works to treat infections by preventing the growth and spread of bacteria. It works to treat acne and rosacea by killing the bacteria that infects pores and by lowering the amount of oil on your skin that can cause acne. Antibiotics such as minocycline will not work f...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Capsules, tablets and IV minocycline treat certain bacterial infections. Extended-release tablets and Amzeeq foam treat inflammatory acne. Zilxi foam and...
  • Minocycline capsules and regular tablets can be taken with or without food. Swallow them whole with a full glass of water. Avoid taking them right before lying down, since that is...
  • Nausea, vomiting, diarrhea, headache and dizziness are possible. You may also sunburn more easily, so limit sun and tanning beds. Call your doctor if you have severe diarrhea, visi...
  • These products can reduce how much minocycline your body absorbs. Ask me or your prescriber how to space them out. Also tell us if you take blood thinners, penicillin or isotretino...
📖 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.

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 eaPer package
Retail pharmacies payNADAC · weekly $1.734 $52.03 / 30 tablets
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 $14.43 $433.04 / 30 tablets
NADAC price history (per ea) — tap or hover for the price & month
Jul 2025 $1.734 $1.734
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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
67877-0438-01 67877-438-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE — — 2016-09-30 — Active
67877-0438-05 67877-438-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE — — 2016-09-30 — Active
67877-0438-14 67877-438-14 10 BLISTER PACK in 1 CARTON / 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK — — 2016-09-30 — Active
67877-0438-30 You're viewing this Main listing 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE $1.73 / ea $52.03 2016-09-30 — Active

Pack size FAQ

What quantity is in this package?
This is a 30-count package — 30 tablet, film coated, extended release in 1 bottle.
How does this package differ from NDC 67877-0438-01?
Both are Minocycline Hydrochloride 105 mg Tablet, Film Coated, Extended Release — the drug itself is identical. This page's package is the 30-count one, while NDC 67877-0438-01 is the 100 tablets package.
What NDC number is used to bill for this package of Minocycline Hydrochloride 105 mg Tablet, Film Coated, Extended Release?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Minocycline Hydrochloride 105 mgthis 67877-0438-30 Ascend 30 tablets $1.734 AB Availability likely —
Minocycline Hydrochloride 105 mg 63629-9208-01 Bryant 30 tablets — AB FDA listed —
Minocycline Hydrochloride 105 mg 65862-0885-01 Aurobindo 100 tablets — AB FDA listed —
minocycline hydrochloride 105 mg 68382-0552-01 Zydus 100 tablets — — FDA listed —
minocycline hydrochloride 105 mg 70771-1157-00 Zydus 1000 tablets — — FDA listed —
Minocycline Hydrochloride 105 mg 71335-2904-01 Bryant 30 tablets — AB FDA listed —
Minocycline Hydrochloride 105 mg 72162-1840-03 Bryant 30 tablets — AB FDA listed —
Minocycline Hydrochloride 105 mg 72789-0528-30 PD-Rx 30 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

🏛️
2016
On the market since
Sep 2016
📍
2026
Currently FDA-listed
10 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.

What it looks like

Color Gray / Yellow / Pink / Blue / Green / Purple
ShapeCapsule
Imprint105
Size14 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 LMI26O6933
    Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
  • 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 H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII 39J80LT57T
    Hypromellose 2208 is a plant-derived thickening agent used as a binder and film-coating material. It helps hold tablet ingredients together and creates a protective coating on pills to control how quickly medicine dissolves.
  • UNII 1IVH67816N
    Hypromellose 2910 is a plant-derived cellulose compound used as a thickener and film-former in medicines. It helps control how quickly the medication dissolves and creates protective coatings on tablets or capsules.
  • 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.

11 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.

Manufacturer & labeler

LabelerAscend Laboratories, LLC
Application holderALKEM LABORATORIES LTD
FDA applicationANDA204453 (ANDA)
Labeler code67877
First marketedSep 2016
Product typeHuman Prescription Drug
Portfolio349 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 171 words ▾

1 INDICATIONS & USAGE Minocycline hydrochloride extended-release tablets is 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 is 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 206 words ▾

2 DOSAGE & ADMINISTRATION 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. Table 1: Dosing Table for Minocycline hydrochloride extended-release tablets 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 )]. The recommended dosage of Minocycline hydrochloride extended-release tablets is approximately 1 mg/kg once daily for 12 weeks.

( 2 )

💊 Dosage Forms and Strengths 197 words ▾

3 DOSAGE FORMS & STRENGTHS 45 mg extended-release tablets: grey coloured capsule shaped film coated tablets, debossed with “45” on one side, plain on other side. 55 mg extended-release tablets: Pink coloured capsule shaped film coated tablets, debossed with "55" on one side, plain on other side. 65 mg extended-release tablets: blue coloured capsule shaped film coated tablets, debossed with “65” on one side, plain on other side.

80 mg extended-release tablets: Greyish brown coloured capsule shaped film coated tablets, debossed with "80'' on one side, plain on other side. 90 mg extended-release tablets: yellow coloured capsule shaped film coated tablets, debossed with “90” on one side, plain on other side. 105 mg extended-release tablets: Purple coloured capsule shaped film coated tablets, debossed with "105'' on one side, plain on other side.

115 mg extended-release tablets: green coloured capsule shaped film coated tablets, debossed with “115” on one side, plain on other side. 135 mg extended-release tablets: pink (orange-brown) coloured capsule shaped film coated tablets, debossed with “135” on one side, plain on other side Extended-release tablets: 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg ( 3 )

⛔ Contraindications 38 words ▾

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

⚠️ Warnings and Cautions ~2 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 8 years 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 hydrochloride extended-release tablets 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, minocycline hydrochloride extended-release tablets should be discontinued immediately.

Fixed drug eruptions have occurred with minocycline and other tetracyclines. Worsening severity upon subsequent administrations, including generalized bullous fixed drug eruption, has been observed with other tetracyclines [see ADVERSE REACTIONS ( 6.2 )] . If severe skin/hypersensitivity reactions occur, discontinue minocycline hydrochloride extended-release tablets and institute appropriate therapy.

5.2Tooth Discoloration and Enamel Hypoplasia The use of tetracycline-class drugs, including minocycline hydrochloride extended-release tablets, 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-graybrown). 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 hydrochloride extended-release tablets is not recommended during tooth development. Advise the patient of the potential risk to the fetus if minocycline hydrochloride extended-release tablets 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 hydrochloride extended-release tablets, 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 hydrochloride extended-release tablets, form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human infants given ora… [Excerpted — this section continues on DailyMed.]

🤒 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 Ascend Laboratories, LLC at 1-877-272-7901 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. Table 2: Selected Treatment-Emergent Adverse Reactions in at Least 1% of Clinical Trial Subjects 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 108 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 extended-release tablets 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 hydrochloride extended-release tablets 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 hydrochloride extended-release tablets, 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, 10, 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… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Tetracycline class drugs, including minocycline hydrochloride extended-release tablets 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 hydrochloride extended-release tablets, 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, 10, 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 115 words ▾

8.4Pediatric Use The safety and effectiveness of minocycline hydrochloride extended-release tablets 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 hydrochloride extended-release tablets 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 39 words ▾

10 OVERDOSAGE Minocycline is not removed in significant quantities by hemodialysis or peritoneal dialysis. In case of overdosage, discontinue minocycline hydrochloride extended-release tablets, 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 to 4.0 hours as compared to a non-modified release reference minocycline product (T max at 2.25 to 3 hours). At steady-state (Day 6), the mean AUC (0–24) 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 doseproportional 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 are supplied as aqueous film coated tablets containing Minocycline hydrochloride equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg or 135 mg minocycline, are supplied as follows. The 45 mg extended-release tablets are grey coloured capsule shaped film coated tablets, debossed with “45” on one side, plain on other side. Each tablet contains Minocycline hydrochloride equivalent to 45 mg minocycline, supplied as follows: NDC 67877-578-14 Carton of 140 (10 x 14 unit-dose) NDC 67877-578-30 Bottle of 30 NDC 67877-578-01 Bottle of 100 NDC 67877-578-05 Bottle of 500 The 55 mg extended-release tablets are Pink colored capsule shaped film coated tablets, debossed with "55" on one side, plain on other side.

Each tablet contains Minocycline hydrochloride equivalent to 55 mg minocycline, supplied as follows: NDC 67877-436-14 Carton of 140 (10 x 14 unit-dose) NDC 67877-436-30 Bottle of 30 NDC 67877-436-01 Bottle of 100 NDC 67877-436-05 Bottle of 500 The 65 mg extended-release tablets are blue coloured capsule shaped film coated tablets, debossed with “65” on one side, plain on other side. Each tablet contains Minocycline hydrochloride equivalent to 65 mg minocycline, supplied as follows: NDC 67877-643-14 Carton of 140 (10 x 14 unit-dose) NDC 67877-643-30 Bottle of 30 NDC 67877-643-01 Bottle of 100 NDC 67877-643-05 Bottle of 500 The 80 mg extended-release tablets are Greyish brown colored capsule shaped film coated tablets, debossed with "80'' on one side, plain on other side.

Each tablet contains Minocycline hydrochloride equivalent to 80 mg minocycline, supplied as follows: NDC 67877-437-14 Carton of 140 (10 x 14 unit-dose) NDC 67877-437-30 Bottle of 30 NDC 67877-437-01 Bottle of 100 NDC 67877-437-05 Bottle of 500 The 90 mg extended-release tablets are yellow coloured capsule shaped film coated tablets, debossed with “90” on one side, plain on other side. Each tablet contains Minocycline hydrochloride equivalent to 90 mg minocycline, supplied as follows: NDC 67877-576-14 Carton of 140 (10 x 14 unit-dose) NDC 67877-576-30 Bottle of 30 NDC 67877-576-01 Bottle of 100 NDC 67877-576-05 Bottle of 500 The 105 mg extended-release tablets are Purple colored capsule shaped film coated tablets, debossed with "105'' on one side, plain on other side.

Each tablet contains Minocycline hydrochloride equivalent to 105 mg minocycline, supplied as follows: NDC 67877-438-14 Carton of 140 (10 x 14 unit-dose) NDC 67877-438-30 Bottle of 30 NDC 67877-438-01 Bottle of 100 NDC 67877-438-05 Bottle of 500 The 115 mg extended-release tablets are green coloured capsule shaped film coated tablets, debossed with “115” on one side, plain on other side. Each tablet contains Minocycline hydrochloride equivalent to 115 mg minocycline, supplied as follows: NDC 67877-644-14 Carton of 140 (10 x 14 unit-dose) NDC 67877-644-30 Bottle of 30 NDC 67877-644-01 Bottle of 100 NDC 67877-644-05 Bottle of 500 The 135 mg extended-release tablets are pink (orange brown) coloured capsule shaped film coated tablets, debossed with “135” on one side, plain on other side.

Each tablet contains Minocycline hydrochloride equivalent to 135 mg minocycline, supplied as follows: NDC 67877-577-14 Carton of 140 (10 x 14 unit-dose) NDC 67877-577-30 Bottle of 30 NDC 67877-577-01 Bottle of 100 NDC 67877-577-05 Bottle of 500 Storage Store at 20˚ to 25˚C (68˚ to 77˚ F) [See USP Controlled Room Temperature]. Handling Keep out of reach of children. Protect from light, moisture, and excessive heat.

Dispense in tight, light-resistant container with child-resistant closure.

📋 Description ~1 min read ▾

11 DESCRIPTION Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4 S -(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 monohydrochloride. The structural formula is represented below: C 23 H 27 N 3 O 7 •HCl M. W.

493.95 Minocycline hydrochloride extended-release tablets, USP for oral administration contain minocycline hydrochloride USP equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg of minocycline. In addition, 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg tablets contain the following inactive ingredients: lactose monohydrate, hypromellose type 2910, hypromellose type 2208, colloidal silicon dioxide, magnesium stearate, titanium dioxide and triacetin. The 45 mg tablets also contain iron oxide black.

The 65 mg tablets also contain FD&C blue #1/brilliant blue FCF aluminium lake, polyethylene glycol 3350, FD&C blue #2/indigo carmine aluminum lake and D&C yellow #10 aluminum lake. The 55 mg tablets also contain macrogol, FD&C RED #40. The 80 mg tablets also contain macrogol, FD&C blue #2, FD&C red #40, FD&C yellow #6.

The 90 mg tablets also contain iron oxide yellow and polyethylene glycol 3350. The 105 mg tablets also D&C red #27, macrogol, FD&C blue #1. The 115 mg tablets also contain D&C yellow #10 aluminum lake, FD&C blue #1/brilliant blue FCF aluminium lake and FD&C blue #2/indigo carmine aluminum lake.

The 135 mg tablets also contain polyethylene glycol 3350 and iron oxide red. The USP Dissolution Test is pending. mino-struc

💬 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 hydrochloride 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 hydrochloride 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 hydrochloride extended-release tablets use in pregnancy may cause permanent tooth discoloration of deciduous teeth.

Advise patients to discontinue minocycline hydrochloride 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 hydrochloride 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 hydrochloride extended-release tablets use in pregnancy may cause inhibition of fetal bone growth.

Advise patients to discontinue minocycline hydrochloride extended-release tablets 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 SOLODYN. 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 hydrochloride extended-release tablets [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 hydrochloride extended-release tablets 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 som… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics 198 words ▾

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 to 4.0 hours as compared to a non-modified release reference minocycline product (T max at 2.25 to 3 hours). At steady-state (Day 6), the mean AUC (0–24) 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 doseproportional 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.

🧬 Pharmacodynamics 16 words ▾

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

🔬 Clinical Studies ~1 min read ▾

14 CLINICAL STUDIES The safety and efficacy of minocycline hydrochloride extended-release tablets in the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris was assessed in two 12-week, multi-center, randomized, double-blind, placebo-controlled trials in adult and pediatric subjects 12 years of age and older (Trial 1 and Trial 2). A total of 924 subjects with non-nodular moderate to severe acne vulgaris received minocycline hydrochloride extended-release tablets or placebo for a total of 12 weeks.

The mean age of subjects was 20 years and subjects were from the following racial groups: White (73%), Hispanic (13%), Black (11%), Asian/Pacific Islander (2%), and Other (2%). The two primary efficacy endpoints were: 1) Mean percent change in inflammatory lesion counts from Baseline to 12 weeks. 2) Percentage of subjects with an Evaluator's Global Severity Assessment (EGSA) of clear or almost clear at 12 weeks.

Efficacy results are presented in Table 4. Table 4: Efficacy Results at Week 12 in Subjects with Non-nodular Moderate to Severe Acne Vulgaris in Trial 1 and Trial 2 Trial 1 Trial 2 Minocycline hydrochloride extended-release tablets (1 mg/kg) N = 300 Placebo N = 151 Minocycline hydrochloride extended-release tablets (1 mg/kg) N = 315 Placebo N = 158 Mean Percent Improvement in Inflammatory Lesions 43.1% 31.7% 45.8% 30.8% No. (%) of Subjects Clear or Almost Clear on the EGSA* 52 (17.3%) 12 (7.9%) 50 (15.9%) 15 (9.5%) * Evaluator's Global Severity Assessment Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory lesions (benefit or worsening).

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis & Mutagenesis & Impairment Of Fertility In a carcinogenicity study in which minocycline HCl was orally administered to male and female rats once daily for up to 104 weeks at dosages up to 200 mg/kg/day, minocycline HCl was associated in both sexes with follicular cell tumors of the thyroid gland, including increased incidences of adenomas, carcinomas and the combined incidence of adenomas and carcinomas in males, and adenomas and the combined incidence of adenomas and carcinomas in females. In a carcinogenicity study in which minocycline HCl was orally administered to male and female mice once daily for up to 104 weeks at dosages up to 150 mg/kg/day, exposure to minocycline HCl did not result in a significantly increased incidence of neoplasms in either males or females.

Minocycline was not mutagenic in vitro in a bacterial reverse mutation assay (Ames test) or CHO/HGPRT mammalian cell assay in the presence or absence of metabolic activation. Minocycline was not clastogenic in vitro using human peripheral blood lymphocytes or in vivo in a mouse micronucleus test. Male and female reproductive performance in rats was unaffected by oral doses of minocycline of up to 300 mg/kg/day (40 times the MRHD on an AUC comparison basis).

However, oral administration of 100 or 300 mg/kg/day of minocycline to male rats (15 to 40 times the MRHD on an AUC comparison basis) adversely affected spermatogenesis. Effects observed at 300 mg/kg/day included a reduced number of sperm cells per gram of epididymis, an apparent reduction in the percentage of sperm that were motile, and (at 100 and 300 mg/kg/day) increased numbers of morphologically abnormal sperm cells. Morphological abnormalities observed in sperm samples included absent heads, misshapen heads, and abnormal flagella.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis & Mutagenesis & Impairment Of Fertility In a carcinogenicity study in which minocycline HCl was orally administered to male and female rats once daily for up to 104 weeks at dosages up to 200 mg/kg/day, minocycline HCl was associated in both sexes with follicular cell tumors of the thyroid gland, including increased incidences of adenomas, carcinomas and the combined incidence of adenomas and carcinomas in males, and adenomas and the combined incidence of adenomas and carcinomas in females. In a carcinogenicity study in which minocycline HCl was orally administered to male and female mice once daily for up to 104 weeks at dosages up to 150 mg/kg/day, exposure to minocycline HCl did not result in a significantly increased incidence of neoplasms in either males or females.

Minocycline was not mutagenic in vitro in a bacterial reverse mutation assay (Ames test) or CHO/HGPRT mammalian cell assay in the presence or absence of metabolic activation. Minocycline was not clastogenic in vitro using human peripheral blood lymphocytes or in vivo in a mouse micronucleus test. Male and female reproductive performance in rats was unaffected by oral doses of minocycline of up to 300 mg/kg/day (40 times the MRHD on an AUC comparison basis).

However, oral administration of 100 or 300 mg/kg/day of minocycline to male rats (15 to 40 times the MRHD on an AUC comparison basis) adversely affected spermatogenesis. Effects observed at 300 mg/kg/day included a reduced number of sperm cells per gram of epididymis, an apparent reduction in the percentage of sperm that were motile, and (at 100 and 300 mg/kg/day) increased numbers of morphologically abnormal sperm cells. Morphological abnormalities observed in sperm samples included absent heads, misshapen heads, and abnormal flagella.

📄 Package Label / Principal Display Panel 100 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 67877-578-30 Minocycline Hydrochloride Extended-Release Tablets, USP 45 mg 30 Tablets NDC 67877-436-30 Minocycline Hydrochloride Extended-Release Tablets, USP 55 mg 30 Tablets NDC 67877-643-30 Minocycline Hydrochloride Extended-Release Tablets, USP 65 mg 30 Tablets NDC 67877-437-30 Minocycline Hydrochloride Extended-Release Tablets, USP 80 mg 30 Tablets NDC 67877-576-30 Minocycline Hydrochloride Extended-Release Tablets, USP 90 mg 30 Tablets NDC 67877-438-30 Minocycline Hydrochloride Extended-Release Tablets, USP 105 mg 30 Tablets NDC 67877-644-30 Minocycline Hydrochloride Extended-Release Tablets, USP 115 mg 30 Tablets NDC 67877-577-30 Minocycline Hydrochloride Extended-Release Tablets, USP 135 mg 30 Tablets mino-45-30-count-a mino-55mg-30s-a mino-65-30-count-a mino-80mg-30s-a mino-90-30-count-a mino-105mg-30s-a mino-115-30-count-a mino-135-30-count-a

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 67877-0437-01 · Ascend 67877-0439-05 · Ascend →
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