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Minocycline Hydrochloride 55 mg Tablet, Extended Release, 100-count — NDC 68180-0460-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Minocycline Hydrochloride 55 mg Tablet, Extended Release, 100-count — NDC 68180-460-01 (Billing 68180-0460-01)

by Lupin Pharmaceuticals, Inc. · 100 TABLET, EXTENDED RELEASE in 1 BOTTLE

This is a package of 100 tablets of Minocycline Hydrochloride 55 mg Tablet, Extended Release from Lupin Pharmaceuticals, Inc., marketed since Feb 2019 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 68180-0460-01
🏷️ FDA NDC (as labeled) 68180-460-01 billing pads the product segment with a zero
This package
Contains100-count Pack sizes2 compare ↓
Main listing for product 68180-460 · Also comes in: 30 tablets 68180-460-06
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

⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68180-460-01
Product NDC 68180-460
11-digit billing NDC 68180046001
RxCUI 629695, 629697, 629699, 1013662
UNII 0020414E5U
UPC 0368180460060
Application # ANDA091424
SPL Set ID 3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b
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 2019-02-22
Route ORAL
Dosage form TABLET, 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 04000040107522
GPI class Minocycline HCl ER
Quick answers
  • GPI-14 (Medi-Span): 04000040107522
  • RxCUI (RxNorm): 629695
Why two NDCs? The FDA registers this code as 68180-460-01 — 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 → 68180-0460-01. 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

📗 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 30 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
68180-0460-01 You're viewing this Main listing 100 TABLET, EXTENDED RELEASE in 1 BOTTLE 2019-02-22 — Active
68180-0460-06 68180-460-06 30 TABLET, EXTENDED RELEASE in 1 BOTTLE 2019-02-22 — Discontinued by firm

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

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 tablet, extended release in 1 bottle.
How does this package differ from NDC 68180-0460-06?
Both are Minocycline Hydrochloride 55 mg Tablet, Extended Release — the drug itself is identical. This page's package is the 100-count one, while NDC 68180-0460-06 is the 30 tablets package.
What NDC number is used to bill for this package of Minocycline Hydrochloride 55 mg Tablet, 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Minocycline Hydrochloride 55 mg 63629-9212-01 Bryant 30 tablets — AB FDA listed —
Minocycline Hydrochloride 55 mg 65862-0883-01 Aurobindo 100 tablets — AB FDA listed —
Minocycline Hydrochloride 55 mg 67877-0436-01 Ascend 100 tablets — AB FDA listed —
minocycline hydrochloride 55 mg 68382-0550-01 Zydus 100 tablets — — FDA listed —
minocycline hydrochloride 55 mg 70771-1153-00 Zydus 1000 tablets — — FDA listed —
Minocycline Hydrochloride 55 mg 72162-1838-03 Bryant 30 tablets — AB FDA listed —
Minocycline Hydrochloride 55 mg 72789-0526-30 PD-Rx 30 tablets — AB FDA listed —
Minocycline Hydrochloride 55 mgthis 68180-0460-01 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

🏛️
2019
On the market since
Feb 2019
📍
2026
Currently FDA-listed
7 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 Pink / Yellow / Brown / Green
ShapeRound
ImprintF26;LU
Size7 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.

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerLupin Pharmaceuticals, Inc.
Application holderLUPIN LTD
FDA applicationANDA091424 (ANDA)
Labeler code68180
First marketedFeb 2019
Product typeHuman Prescription Drug
Portfolio404 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 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 154 words ▾

1 INDICATIONS AND USAGE Minocycline hydrochloride extended-release tablets USP are tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. ( 1 )

1.1Indication Minocycline hydrochloride extended-release tablets USP are indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.

1.2Limitations of Use Minocycline hydrochloride extended-release tablets USP did not demonstrate any effect on non-inflammatory acne lesions. Safety of minocycline hydrochloride extended-release tablets USP have not been established beyond 12 weeks of use. 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, minocycline hydrochloride extended-release tablets USP should be used only as indicated [see WARNINGS AND PRECAUTIONS ( 5.11 )]

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION The recommended dosage of minocycline hydrochloride extended-release tablets USP are approximately 1 mg/kg once daily for 12 weeks. ( 2 ) The recommended dosage of minocycline hydrochloride extended-release tablet USP are approximately 1 mg/kg once daily for 12 weeks. Higher doses have not shown to be of additional benefit in the treatment of inflammatory lesions of acne, and may be associated with more acute vestibular side effects.

The following table shows tablet strength and body weight to achieve approximately 1 mg/kg. Table 1: Dosing Table for Minocycline Hydrochloride Extended-release Tablets USP Patient's Weight ( lbs .) Patient's Weight ( kg ) Tablet Strength ( mg ) Actual mg / kg Dose 99 - 109 45 - 49 45 1 - 0.92 110 - 131 50 - 59 55 1.10 - 0.93 132 - 157 60 - 71 65 1.08 - 0.92 158 - 186 72 - 84 80 1.11 - 0.95 187 - 212 85 - 96 90 1.06 - 0.94 213 - 243 97 - 110 105 1.08 - 0.95 244 - 276 111 - 125 115 1.04 - 0.92 277 - 300 126 - 136 135 1.07 -

0.99Minocycline hydrochloride extended-release tablets USP may be taken with or without food [see CLINICAL PHARMACOLOGY (12.3) ]. Ingestion of food along with minocycline hydrochloride extended-release tablets USP may help reduce the risk of esophageal irritation and ulceration. In patients with renal impairment, the total dosage should be decreased by either reducing the recommended individual doses and/or by extending the time intervals between doses [see WARNINGS AND PRECAUTIONS (5.4) ] .

💊 Dosage Forms and Strengths 112 words ▾

3 DOSAGE FORMS AND STRENGTHS Extended release tablets: 45, 55 mg, 90, and 135 mg ( 3 ) 45 mg extended-release tablets: pink colored, round shaped, biconvex, film-coated tablets debossed with "F21" on one side and "LU" on the other side. 55 mg extended release tablets: green colored, round shaped, biconvex, film-coated tablets debossed with "F26" on one side and "LU" on the other side. 90 mg extended-release tablets: pale yellow colored, round shaped, biconvex, film-coated tablets debossed with "F22" on one side and "LU" on the other side.

135 mg extended-release tablets: brown colored, capsule shaped, biconvex, film-coated tablets debossed with "F23" on one side and "LU" on the other side.

⛔ Contraindications 35 words ▾

4 CONTRAINDICATIONS This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. ( 4 ) This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS The use of minocycline hydrochloride extended-release tablets during tooth development (last half of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). ( 5.1 ) If pseudomembranous colitis occurs, discontinue minocycline hydrochloride extended-release tablets. ( 5.2 ) If liver injury is suspected, discontinue minocycline hydrochloride extended-release tablets.

( 5.3 ) If renal impairment exists, minocycline hydrochloride extended-release tablets doses may need to be adjusted to avoid excessive systemic accumulations of the drug and possible liver toxicity. ( 5.4 ) Minocycline may cause central nervous system side effects including light-headedness, dizziness, or vertigo. Advise patients.

( 5.5 ) Minocycline may cause pseudotumor cerebri (benign intracranial hypertension) in adults and adolescents. Discontinue minocycline hydrochloride extended-release tablets if symptoms occur. ( 5.6 ) Minocycline has been associated with autoimmune syndromes; discontinue minocycline hydrochloride extended-release tablets immediately if symptoms occur.

( 5.7 ) Minocycline has been associated with anaphylaxis, serious skin reactions, erythema multiforme, and DRESS syndrome. Discontinue minocycline hydrochloride extended-release tablets immediately if symptoms occur. ( 5.9 ).

5.1Teratogenic Effects A. MINOCYCLINE, LIKE OTHER TETRACYCLINE-CLASS DRUGS, CAN CAUSE FETAL HARM WHEN ADMINISTERED TO A PREGNANT WOMAN. IF ANY TETRACYCLINE IS USED DURING PREGNANCY OR IF THE PATIENT BECOMES PREGNANT WHILE TAKING THESE DRUGS, THE PATIENT SHOULD BE APPRISED OF THE POTENTIAL HAZARD TO THE FETUS.

Minocycline hydrochloride extended-release tablets should not be used during pregnancy or by individuals of either gender who are attempting to conceive a child [see NONCLINICAL TOXICOLOGY (13.1) and USE IN SPECIFIC POPULATIONS (8.1) ]. B. THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY, AND CHILDHOOD UP TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH (YELLOW-GRAY-BROWN).

This adverse reaction is more common during long-term use of the drug but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED DURING TOOTH DEVELOPMENT.

C. All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/ kg every 6 hours.

This reaction was shown to be reversible when the drug was discontinued. Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can cause retardation of skeletal development on the developing fetus. Evidence of embryotoxicity has been noted in animals treated early in pregnancy [see USE IN SPECIFIC POPULATIONS (8.1) ].

5.2Pseudomembranous Colitis Clostridium difficile associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, including minocycline, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD.

Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, an… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The most commonly observed adverse reactions (incidence ≥ 5%) are headache, fatigue, dizziness, and pruritus. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in practice. The following table summarizes selected adverse reactions reported in clinical trials at a rate of ≥1% for minocycline hydrochloride extended-release tablets. Table 2: Selected Treatment-Emergent Adverse Reactions in at least 1% of Clinical Trial Subjects 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) Headache 152 (23) 83 (23) Fatigue 62 (9) 24 (7) Dizziness 59 (9) 17 (5) Pruritus 31 (5) 16 (4) Malaise 26 (4) 9 (3) Mood alteration 17 (3) 9 (3) Somnolence 13 (2) 3 (1) Urticaria 10 (2) 1 (0) Tinnitus 10 (2) 5 (1) Arthralgia 9 (1) 2 (0) Vertigo 8 (1) 3 (1) Dry mouth 7 (1) 5 (1) Myalgia 7 (1) 4 (1)

6.2Postmarketing Experience Adverse reactions that have been reported with minocycline hydrochloride use in a variety of indications include: Skin and hypersensitivity reactions: fixed drug eruptions, balanitis, erythema multiforme, Stevens-Johnson syndrome, anaphylactoid purpura, photosensitivity, pigmentation of skin and mucous membranes, hypersensitivity reactions, angioneurotic edema, anaphylaxis, DRESS syndrome [see WARNINGS AND PRECAUTIONS ( 5.9 ) ]. Autoimmune conditions: polyarthralgia, pericarditis, exacerbation of systemic lupus, pulmonary infiltrates with eosinophilia, transient lupus-like syndrome.

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

Oral: glossitis, dysphagia, tooth discoloration. Gastrointestinal: enterocolitis, pancreatitis, hepatitis, liver failure. Renal: reversible acute renal failure.

Hematology: hemolytic anemia, thrombocytopenia, eosinophilia. Preliminary studies suggest that use of minocycline may have deleterious effects on human spermatogenesis [see NONCLINICAL TOXICOLOGY ( 13.1 ) ].

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. ( 7.1 ) The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity. ( 7.3 ) To avoid contraceptive failure, female patients are advised to use a second form of contraceptive during treatment with minocycline. ( 7.5 )

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 Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin.

7.3Methoxyflurane The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.

7.4Antacids and Iron Preparations Absorption of tetracyclines is impaired by antacids containing aluminum, calcium or magnesium and iron-containing preparations.

7.5Low Dose Oral Contraceptives In a multi-center study to evaluate the effect of minocycline hydrochloride extended-release tablets on low dose oral contraceptives, hormone levels over one menstrual cycle with and without minocycline hydrochloride extended-release tablets 1 mg/kg once-daily were measured. Based on the results of this trial, minocycline-related changes in estradiol, progestinic hormone, FSH and LH plasma levels, of breakthrough bleeding, or of contraceptive failure, can not be ruled out. To avoid contraceptive failure, female patients are advised to use a second form of contraceptive during treatment with minocycline.

7.6Drug/Laboratory Test Interactions False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Minocycline like other tetracycline-class drugs can cause fetal harm when administered to a pregnant woman. ( 5.1 , 8.1 ) The use of drugs of the tetracycline class during tooth development may cause permanent discoloration of teeth. ( 5.1 , 8.4 )

8.1Pregnancy Teratogenic Effects: Pregnancy Category D [see WARNINGS AND PRECAUTIONS (5.1) ] Minocycline hydrochloride extended-release tablets should not be used during pregnancy. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus and stop treatment immediately. There are no adequate and well-controlled studies on the use of minocycline in pregnant women.

Minocycline, like other tetracycline-class drugs, crosses the placenta and may cause fetal harm when administered to a pregnant woman. Rare spontaneous reports of congenital anomalies including limb reduction have been reported with minocycline use in pregnancy in post-marketing experience. Only limited information is available regarding these reports; therefore, no conclusion on causal association can be established.

Minocycline induced skeletal malformations (bent limb bones) in fetuses when administered to pregnant rats and rabbits in doses of 30 mg/ kg/day and 100 mg/kg/day, respectively, (resulting in approximately 3 times and 2 times, respectively, the systemic exposure to minocycline observed in patients as a result of use of minocycline hydrochloride extended-release tablets). Reduced mean fetal body weight was observed in studies in which minocycline was administered to pregnant rats at a dose of 10 mg/kg/day (which resulted in approximately the same level of systemic exposure to minocycline as that observed in patients who use minocycline hydrochloride extended-release tablets).

Minocycline was assessed for effects on peri- and post-natal development of rats in a study that involved oral administration to pregnant rats from day 6 of gestation through the period of lactation (postpartum day 20), 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 (resulting in approximately 2.5 times the systemic exposure to minocycline observed in patients as a result of use of minocycline hydrochloride extended-release tablets).

No effects of treatment on the duration of the gestation period or the number of live pups born per litter were observed. Gross external anomalies observed in F1 pups (offspring of animals that received minocycline) included reduced body size, improperly rotated forelimbs, and reduced size of extremities. No effects were observed on the physical development, behavior, learning ability, or reproduction of F1 pups, and there was no effect on gross appearance of F2 pups (offspring of F1 animals).

8.3Nursing Mothers Tetracycline-class antibiotics are excreted in human milk. Because of the potential for serious adverse effects on bone and tooth development in nursing infants from the tetracycline-class antibiotics, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother [see WARNINGS AND PRECAUTIONS (5.1) ].

8.4Pediatric Use Minocycline hydrochloride extended-release tablets are indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years and older. Safety and effectiveness in pediatric patients below the age of 12 has not been established. Use of tetracycline-class antibiotics below the age of 8 is not recommended due to the potential for tooth discoloration [see WARNINGS AND PRECAUTIONS (5.1) ].

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 resp… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Teratogenic Effects: Pregnancy Category D [see WARNINGS AND PRECAUTIONS (5.1) ] Minocycline hydrochloride extended-release tablets should not be used during pregnancy. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus and stop treatment immediately. There are no adequate and well-controlled studies on the use of minocycline in pregnant women.

Minocycline, like other tetracycline-class drugs, crosses the placenta and may cause fetal harm when administered to a pregnant woman. Rare spontaneous reports of congenital anomalies including limb reduction have been reported with minocycline use in pregnancy in post-marketing experience. Only limited information is available regarding these reports; therefore, no conclusion on causal association can be established.

Minocycline induced skeletal malformations (bent limb bones) in fetuses when administered to pregnant rats and rabbits in doses of 30 mg/ kg/day and 100 mg/kg/day, respectively, (resulting in approximately 3 times and 2 times, respectively, the systemic exposure to minocycline observed in patients as a result of use of minocycline hydrochloride extended-release tablets). Reduced mean fetal body weight was observed in studies in which minocycline was administered to pregnant rats at a dose of 10 mg/kg/day (which resulted in approximately the same level of systemic exposure to minocycline as that observed in patients who use minocycline hydrochloride extended-release tablets).

Minocycline was assessed for effects on peri- and post-natal development of rats in a study that involved oral administration to pregnant rats from day 6 of gestation through the period of lactation (postpartum day 20), 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 (resulting in approximately 2.5 times the systemic exposure to minocycline observed in patients as a result of use of minocycline hydrochloride extended-release tablets).

No effects of treatment on the duration of the gestation period or the number of live pups born per litter were observed. Gross external anomalies observed in F1 pups (offspring of animals that received minocycline) included reduced body size, improperly rotated forelimbs, and reduced size of extremities. No effects were observed on the physical development, behavior, learning ability, or reproduction of F1 pups, and there was no effect on gross appearance of F2 pups (offspring of F1 animals).

🧒 Pediatric Use 67 words ▾

8.4Pediatric Use Minocycline hydrochloride extended-release tablets are indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years and older. Safety and effectiveness in pediatric patients below the age of 12 has not been established. Use of tetracycline-class antibiotics below the age of 8 is not recommended due to the potential for tooth discoloration [see WARNINGS AND PRECAUTIONS (5.1) ].

🧓 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 26 words ▾

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

🧬 Clinical Pharmacology ~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 µg × 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 Minocin ® capsules, respectively.

These parameters are based on dose adjusted to 135 mg per 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 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 ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Minocycline hydrochloride extended-release tablets USP are supplied as aqueous film coated tablets containing minocycline hydrochloride USP equivalent to 45 mg, 55 mg, 90 mg, or 135 mg minocycline. The 45 mg extended-release tablets are pink colored, round shaped, biconvex, film-coated tablets debossed with "F21" on one side and "LU" on the other side. Each tablet contains minocycline hydrochloride USP equivalent to 45 mg minocycline, supplied as follows: NDC 68180-379-06 Bottle of 30 NDC 68180-379-01 Bottle of 100 The 55 mg extended-release tablets are green colored, round shaped, biconvex, film-coated tablets debossed with "F26" on one side and "LU" on the other side.

Each tablet contains minocycline hydrochloride equivalent to 55 mg minocycline, supplied as follows: NDC 68180-460-06 Bottle of 30 NDC 68180-460-01 Bottle of 100 The 90 mg extended-release tablets are pale yellow colored, round shaped, biconvex, film-coated tablets debossed with "F22" on one side and "LU" on the other side. Each tablet contains minocycline hydrochloride USP equivalent to 90 mg minocycline, supplied as follows: NDC 68180-380-06 Bottle of 30 NDC 68180-380-01 Bottle of 100 The 135 mg extended-release tablets are brown colored, capsule shaped, biconvex, film-coated tablets debossed with "F23" on one side and "LU" on the other side.

Each tablet contains minocycline hydrochloride USP equivalent to 135 mg minocycline, supplied as follows: NDC 68180-381-06 Bottle of 30 NDC 68180-381-01 Bottle of 100

16.2Storage Store at 25°C (77°F); excursions are permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

16.3Handling Keep out of reach of children. Protect from light, moisture, and excessive heat. Dispense in tight, light-resistant container with child-resistant closure.

📋 Description 138 words ▾

11 DESCRIPTION Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [ 4S -(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is represented below: Minocycline hydrochloride extended-release tablets USP for oral administration contain minocycline hydrochloride USP equivalent to 45 mg, 55 mg, 90 mg or 135 mg of minocycline. In addition, 45 mg, 55 mg, 90 mg, and 135 mg tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide.

The 45 mg tablets also contain iron oxide red, 55 mg tablets also contain D&C yellow # 10, FD&C blue # 1, FD&C red #40 and polysorbate 80, the 90 mg tablets also contain iron oxide yellow and talc, and 135 mg tablets also contain iron oxide red and iron oxide yellow. Drug Product meets USP Dissolution Test 3. Minocycline Hydrochloride

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION [See FDA-Approved Patient Labeling (Patient Labeling) ] Patients taking Minocycline hydrochloride (minocycline HCl, USP) extended-release tablets should receive the following information and instructions: Minocycline hydrochloride extended-release tablets should not be used by pregnant women or women attempting to conceive a child [see USE IN SPECIFIC POPULATIONS (8.1) , NONCLINICAL TOXICOLOGY (13.1) ]. It is recommended that minocycline hydrochloride extended-release tablets not be used by men who are attempting to father a child [see NONCLINICAL TOXICOLOGY (13.1) ].

Patients should be advised that pseudomembranous colitis can occur with minocycline therapy. If patients develop watery or bloody stools, they should seek medical attention. Patients should be counseled about the possibility of hepatotoxicity.

Patients should seek medical advice if they experience symptoms which can include loss of appetite, tiredness, diarrhea, skin turning yellow, bleeding easily, confusion, and sleepiness. Patients who experience central nervous system symptoms [see WARNINGS AND PRECAUTIONS (5.5) ] should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy. Patients should seek medical help for persistent headaches or blurred vision.

Concurrent use of tetracycline may render oral contraceptives less effective [see DRUG INTERACTIONS (7.5) ]. 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.

Patients who experience such symptoms should be cautioned to stop the drug immediately and seek medical help. Patients should be counseled about discoloration of skin, scars, teeth or gums that can arise from minocycline therapy. Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines, including minocycline.

Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UV A/B treatment) while using minocycline. If patients need to be outdoors while using minocycline, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician. Treatment should be discontinued at the first evidence of skin erythema.

Minocycline hydrochloride extended-release tablets should be taken exactly as directed. Skipping doses or not completing the full course of therapy may decrease the effectiveness of the current treatment course and increase the likelihood that bacteria will develop resistance and will not be treatable by other antibacterial drugs in the future. Patients should be advised to swallow minocycline hydrochloride extended-release tablets whole and not to chew, crush, or split the tablets. ® Minocin is a registered trademark of Triax Pharmaceuticals, LLC.

Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States Manufactured by: Lupin Limited MADE IN INDIA Revised: December 2018 ID#: 257323

🍼 Nursing Mothers 60 words ▾

8.3Nursing Mothers Tetracycline-class antibiotics are excreted in human milk. Because of the potential for serious adverse effects on bone and tooth development in nursing infants from the tetracycline-class antibiotics, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother [see WARNINGS AND PRECAUTIONS (5.1) ].

🧬 Pharmacokinetics 199 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 µg × 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 Minocin ® capsules, respectively.

These parameters are based on dose adjusted to 135 mg per 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 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.

🧬 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 subjects ≥ 12 years. 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%). In two efficacy and safety trials, 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, according to the following dose assignments.

Table 3: Clinical Studies Dosing Table Subject's Weight ( lbs .) Subject's Weight ( kg ) Available Tablet Strength ( mg ) Actual mg / kg Dose 99 - 131 45 - 59 45 1 - 0.76 132 - 199 60 - 90 90 1.5 - 1 200 - 300 91 - 136 135 1.48 -

0.99The 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 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 Evaluator's Global Severity Assessment 52 (17.3%) 12 (7.9%) 50 (15.9%) 15 (9.5%) Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory lesions (benefit or worsening).

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis-In a carcinogenicity study in which minocycline hydrochloride was orally administered to male and female rats once daily for up to 104 weeks at dosages up to 200 mg/kg/day, minocycline hydrochloride was associated in both genders 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 hydrochloride 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 hydrochloride did not result in a significantly increased incidence of neoplasms in either males or females. Mutagenesis-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.

Impairment of Fertility-Male and female reproductive performance in rats was unaffected by oral doses of minocycline of up to 300 mg/kg/day (which resulted in up to approximately 40 times the level of systemic exposure to minocycline observed in patients as a result of use of minocycline hydrochloride extended-release tablets). However, oral administration of 100 or 300 mg/kg/day of minocycline to male rats (resulting in approximately 15 to 40 times the level of systemic exposure to minocycline observed in patients as a result of use of minocycline hydrochloride extended-release tablets) 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. Limited human studies suggest that minocycline may have a deleterious effect on spermatogenesis.

Minocycline hydrochloride extended-release tablets should not be used by individuals of either gender who are attempting to conceive a child.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis-In a carcinogenicity study in which minocycline hydrochloride was orally administered to male and female rats once daily for up to 104 weeks at dosages up to 200 mg/kg/day, minocycline hydrochloride was associated in both genders 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 hydrochloride 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 hydrochloride did not result in a significantly increased incidence of neoplasms in either males or females. Mutagenesis-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.

Impairment of Fertility-Male and female reproductive performance in rats was unaffected by oral doses of minocycline of up to 300 mg/kg/day (which resulted in up to approximately 40 times the level of systemic exposure to minocycline observed in patients as a result of use of minocycline hydrochloride extended-release tablets). However, oral administration of 100 or 300 mg/kg/day of minocycline to male rats (resulting in approximately 15 to 40 times the level of systemic exposure to minocycline observed in patients as a result of use of minocycline hydrochloride extended-release tablets) 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. Limited human studies suggest that minocycline may have a deleterious effect on spermatogenesis.

Minocycline hydrochloride extended-release tablets should not be used by individuals of either gender who are attempting to conceive a child.

📄 Patient Package Insert ~3 min read ▾

Patient Information Minocycline Hydrochloride Extended-release Tablets USP (mye no SYE kleen) Rx only Read this patient information leaflet that comes with minocycline hydrochloride extended-release tablets before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treatment.

What are minocycline hydrochloride extended-release tablets? Minocycline hydrochloride is a tetracycline class drug. Minocycline hydrochloride extended-release tablets are prescription medicine used to treat pimples and red bumps (non-nodular inflammatory lesions) that happen with moderate to severe acne vulgaris in people 12 years and older.

Minocycline hydrochloride extended-release tablets are not effective for acne that is not red-looking (this means acne that is not inflammatory). It is not known if Minocycline hydrochloride extended-release tablets are: safe for use longer than 12 weeks. safe and effective for the treatment of infections. safe and effective in children under the age of 12 years. Who should not take minocycline hydrochloride extended-release tablets?

Do not take minocycline hydrochloride extended-release tablets if you are allergic to tetracycline-class drugs. Ask your doctor or pharmacist for a list of these medicines if you are not sure. What should I tell my doctor before taking minocycline hydrochloride extended-release tablets?

Before you take minocycline hydrochloride extended-release tablets , tell your doctor if you: have kidney problems. Your doctor may prescribe a lower dose of medicine for you. have liver problems. have diarrhea or watery stools. have any vision problems. plan to have surgery with general anesthesia. have any other medical conditions. are a male, and you and your female partner are trying to conceive a baby. You should not take minocycline hydrochloride extended-release tablets. are pregnant or plan to become pregnant.

Minocycline hydrochloride extended-release tablets may harm your unborn baby. Taking minocycline hydrochloride extended-release tablets while you are pregnant may cause serious side effects on the growth of bone and teeth of your baby. Talk to your doctor before taking minocycline hydrochloride extended-release tablets if you plan to become pregnant or if you are already taking minocycline hydrochloride extended-release tablets and plan to become pregnant.

Stop taking minocycline hydrochloride extended-release tablets and call your doctor right away if you become pregnant while taking minocycline hydrochloride extended-release tablets. are breastfeeding or plan to breastfeed. Minocycline hydrochloride passes into your milk and may harm your baby. You and your doctor should decide if you will take minocycline hydrochloride extended-release tablets or breastfeed.

You should not do both. Tell your doctor about all the other medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Minocycline hydrochloride extended-release tablets may affect the way other medicines work, and other medicines may affect how minocycline hydrochloride extended-release tablets work.

Especially tell your doctor if you take: birth control pills. Minocycline hydrochloride extended-release tablets may make your birth control pills less effective. You could become pregnant.

You should use a second form of birth control while taking minocycline hydrochloride extended-release tablets. a blood thinner medicine. a penicillin antibiotic medicine. Minocycline hydrochloride extended-release tablets and penicillins should not be used together. antacids that contain aluminum, calcium, or magnesium or iron-containing products. an acne medicine that contains isotretinoin (Amnesteem, Claravis, Sotret). Minocycline hydrochloride extended-release tablets and isotretinoin should not be used together.

Ask your doctor or pharmacist if you are not sure if your medicine is on… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 64 words ▾

PRINCIPAL DISPLAY PANEL MINOCYCLINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS Rx Only 45 mg* NDC 68180-379-06 30 TABLETS MINOCYCLINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS Rx Only 55 mg* NDC 68180-460-06 30 TABLETS MINOCYCLINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS Rx Only 90 mg* NDC 68180-380-06 30 TABLETS MINOCYCLINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS Rx Only 135 mg* NDC 68180-381-01 100 TABLETS 45 mg - 30s img 90 mg - 30s 125 mg - 30s

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

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