16.1 How Supplied Minocycline hydrochloride extended-release tablets, USP are supplied as aqueous film coated tablets containing Minocycline hydrochloride. 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 72162-1838-3: 3...
www.fda.gov/medwatchMinocycline 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
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)].
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)].
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.
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)].
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 oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued.
Advise the patient of the potential risk to the fetus if minocycline hydrochloride extended-release tablets is used during the second or third trimester of pregnancy [see Use in Specific Populations (8.1, 8.4)].
Clostridioides difficile-associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, including minocycline, and may range in severity from mild diarrhea to fatal colitis.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing 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, discontinue minocycline hydrochloride extended-release tablets.
Postmarketing cases of serious liver injury, including irreversible drug-induced hepatitis and fulminant hepatic failure (sometimes fatal), have been reported with minocycline use in the treatment of acne. Discontinue minocycline hydrochloride extended-release tablets if liver injury is suspected.
Central nervous system side effects including light-headedness, dizziness, or vertigo have been reported with minocycline therapy. Caution patients who experience these symptoms about driving vehicles or using hazardous machinery while on minocycline hydrochloride extended-release tablets. These symptoms may disappear during therapy and usually rapidly disappear when minocycline hydrochloride extended-release tablets is discontinued.
Idiopathic intracranial hypertension has been associated with the use of tetracycline-class drugs, including minocycline hydrochloride extended-release tablets. Clinical manifestations of idiopathic intracranial hypertension include headache, blurred vision, diplopia, and vision loss; papilledema can be found on fundoscopy. Women of childbearing age who are overweight or have a history of idiopathic intracranial hypertension are at a greater risk for developing idiopathic intracranial hypertension. Avoid concomitant use of isotretinoin and minocycline hydrochloride extended-release tablets because isotretinoin, a systemic retinoid, is also known to cause idiopathic intracranial hypertension.
Permanent visual loss may exist, even after the medication is discontinued. If visual disturbance occurs during treatment, prompt ophthalmologic evaluation is warranted. Because intracranial pressure can remain elevated for weeks after drug cessation, monitor patients until they stabilize.
Tetracyclines have been associated with the development of autoimmune syndromes. The long-term use of minocycline in the treatment of acne has been associated with drug-induced lupus-like syndrome, autoimmune hepatitis, and vasculitis. Sporadic cases of serum sickness have presented shortly after minocycline use. Symptoms may be manifested by fever, rash, arthralgia, and malaise. Evaluate symptomatic patients. If symptoms occur, immediately discontinue use of minocycline hydrochloride extended-release tablets.
The anti-anabolic action of the tetracyclines, including minocycline hydrochloride extended-release tablets, may cause an increase in blood urea nitrogen (BUN). In patients with significantly impaired renal function, higher serum levels of tetracycline-class drugs may lead to azotemia, hyperphosphatemia, and acidosis. If renal impairment exists, lower the total doses of minocycline hydrochloride extended-release tablets, and if therapy is prolonged, monitor serum levels minocycline hydrochloride extended-release tablets.
Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines, including minocycline. Advise patients to minimize or avoid exposure to natural or artificial sunlight (e.g., tanning beds or UVA/B treatment) while using minocycline hydrochloride extended-release tablets. Instruct patients to use sunscreen products and wear protective apparel (e.g., hat) when exposure to sun cannot be avoided.
Tetracycline-class antibiotics are known to cause hyperpigmentation. Tetracycline therapy may induce hyperpigmentation in many organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity (e.g., teeth, mucosa, alveolar bone), sclerae, and heart valves. Skin and oral pigmentation has been reported to occur independently of time or amount of drug administration, whereas other tissue pigmentation has been reported to occur upon prolonged administration. Skin pigmentation includes diffuse pigmentation as well as over sites of scars or injury.
Bacterial resistance to tetracyclines may develop in patients using minocycline hydrochloride extended-release tablets. Because of the potential for drug-resistant bacteria to develop during the use of minocycline hydrochloride extended-release tablets, it should be used only as indicated.
Use of minocycline hydrochloride extended-release tablets may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue minocycline hydrochloride extended-release tablets and institute appropriate therapy.
Perform periodic laboratory evaluations of organ systems, including hematopoietic, renal, and hepatic studies.
The following clinically significant adverse reactions are described elsewhere in the labeling:
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) |
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.
Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.
Because bacteriostatic drugs may interfere with the bactericidal action of penicillin, avoid giving minocycline hydrochloride extended-release tablets in conjunction with penicillin.
Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium and iron-containing preparations.
False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.
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.
Risk Summary
Tetracycline-class antibiotics, including minocycline, are present in breast milk following oral administration. There are no data on the effects of minocycline on milk production. Because of the potential for serious adverse reactions, including tooth discoloration and inhibition of bone growth, advise patients that breastfeeding is not recommended during minocycline hydrochloride extended-release tablets therapy and for 4 days after the final dose [see Warnings and Precautions (5.2, 5.3)].
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.
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.
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.
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 monohydrochloride.
The structural formula is represented below:
C23H27N3O7•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.
The mechanism of action of minocycline hydrochloride extended-release tablets for the treatment of acne is unknown.
The pharmacodynamics of minocycline hydrochloride extended-release tablets for the treatment of acne are unknown.
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 Tmax at 3.5 to 4.0 hours as compared to a non-modified release reference minocycline product (Tmax at 2.25 to 3 hours). At steady-state (Day 6), the mean AUC (0–24) and Cmax 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.
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.
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).
16.1 How Supplied
Minocycline hydrochloride extended-release tablets, USP are supplied as aqueous film coated tablets containing Minocycline hydrochloride.
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 72162-1838-3: 30 Tablets in a Bottle
16.2 Storage
Store at 20˚ to 25˚C (68˚ to 77˚ F) [See USP Controlled Room Temperature].
16.3 Handling
Keep out of reach of children.
Protect from light, moisture, and excessive heat.
Dispense in tight, light-resistant container with child-resistant closure.
Repackaged/Relabeled by:
Bryant Ranch Prepack
Burbank, CA 91504
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
Serious Skin/Hypersensitivity Reactions
Tooth Discoloration and Enamel Hypoplasia
Inhibition of Bone Growth
Clostridioides difficile-Associated Diarrhea (Antibiotic-Associated Colitis)
Hepatotoxicity
Central Nervous System Effects
Idiopathic Intracranial Hypertension
Autoimmune Syndromes
Photosensitivity
Tissue Hyperpigmentation
Lactation
Manufactured by:
Alkem Laboratories Ltd.,
Mumbai - 400 013, INDIA.
Distributed by:
Ascend Laboratories, LLC
Bedminster, NJ 07921
Minocycline hydrochloride
(min-oh-sye-kleen hye-droe-KLOR-ide)
extended-release tablets
What is minocycline hydrochloride extended-release tablets?
Minocycline hydrochloride extended-release tablets is a 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 of age and older.
Minocycline hydrochloride extended-release tablets is not effective for acne that is not red-looking (non-inflammatory acne).
It is not known if minocycline hydrochloride extended-release tablets is:
Who should not take minocycline hydrochloride extended-release tablets?
Do not take minocycline hydrochloride extended-release tablets if you are allergic to any tetracycline medicines. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.
Before taking minocycline hydrochloride extended-release tablets, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the other medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Minocycline hydrochloride extended-release tablets and other medicines may affect each other and can cause serious side effects. Minocycline hydrochloride extended-release tablets may affect the way other medicines work, and other medicines may affect how minocycline hydrochloride extended-release tablets works.
Especially tell your healthcare provider if you take:
Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist.
How should I take minocycline hydrochloride extended-release tablets?
If you take too much minocycline hydrochloride extended-release tablets, stop taking minocycline hydrochloride extended-release tablets and call your healthcare provider or go to the nearest hospital emergency room, or contact a poison control center right away at 1-800-222-1222.
What should I avoid while taking minocycline hydrochloride extended-release tablets?
What are possible side effects of minocycline hydrochloride extended-release tablets?
Minocycline hydrochloride extended-release tablets may cause serious side effects, including:
The most common side effects of minocycline hydrochloride extended-release tablets include:
Your healthcare provider may do blood tests and check you for side effects during treatment with minocycline hydrochloride extended-release tablets and may lower your dose or stop treatment if you develop certain side effects.
These are not all of the possible side effects of minocycline hydrochloride extended-release tablets.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Bausch Health US, LLC at 1-800-321-4576.
How should I store minocycline hydrochloride extended-release tablets?
Keep minocycline hydrochloride extended-release tablets and all medicines out of the reach of children.
General information about the safe and effective use of minocycline hydrochloride extended-release tablets.
Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use minocycline hydrochloride extended-release tablets for a condition for which it was not prescribed. Do not give minocycline hydrochloride extended-release tablets to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about minocycline hydrochloride extended-release tablets that is written for health professionals.
What are the ingredients in minocycline hydrochloride extended-release tablets?
Active ingredient: minocycline hydrochloride
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.
Manufactured by:
Alkem Laboratories Ltd.,
Mumbai - 400 013, INDIA.
Distributed by:
Ascend Laboratories, LLC
Bedminster, NJ 07921
For more information, call 1-877-272-7901.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised: October 2025
PT 3278-04
Minocycline HCL 55 mg ER tab#30
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|---|---|---|---|---|---|---|
| 72162-1838-3 | Minocycline Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | 102 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72162-1838-3 | EA - Each | 72162-1838 | bfd062ed-f8be-44c1-8800-759499f33884 | 1 | 2024-04-05 |
| 67877-436-30 | EA - Each | 67877-436 | e38b5e5b-7258-4ad5-b553-8cad4e537c53 | 1 | 2020-05-08 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 72162-1838 | 72162-1838-3 |
| 67877-436 |
Every source-derived ingredient row is available through these pages.
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204453-001 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 45MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | |
| A204453-002 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 80MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | |
| A204453-003 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 90MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | |
| A204453-004 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 105MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | |
| A204453-005 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 135MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2016-09-28 |
| A204453-006 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 65MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-16 | |
| A204453-007 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 115MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2018-03-16 |
| A204453-008 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 55MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-12-19 |
| Application-product | TE code |
|---|---|
| A204453-001 | AB |
| A204453-002 | AB |
| A204453-003 | AB |
| A204453-004 | AB |
| A204453-005 | AB |
| A204453-006 | AB |
| A204453-007 | AB |
| A204453-008 | AB |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A204453-001 | MINOCYCLINE HYDROCHLORIDE | EQ 45MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A204453-002 | MINOCYCLINE HYDROCHLORIDE | EQ 80MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A204453-003 | MINOCYCLINE HYDROCHLORIDE | EQ 90MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A204453-004 | MINOCYCLINE HYDROCHLORIDE | EQ 105MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A204453-005 | MINOCYCLINE HYDROCHLORIDE | EQ 135MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2016-09-28 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A204453-006 | MINOCYCLINE HYDROCHLORIDE | EQ 65MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A204453-007 | MINOCYCLINE HYDROCHLORIDE | EQ 115MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2018-03-16 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A204453-008 | MINOCYCLINE HYDROCHLORIDE | EQ 55MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-12-19 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A204453-001 | MINOCYCLINE HYDROCHLORIDE | EQ 45MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204453-002 | MINOCYCLINE HYDROCHLORIDE | EQ 80MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204453-003 | MINOCYCLINE HYDROCHLORIDE | EQ 90MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204453-004 | MINOCYCLINE HYDROCHLORIDE | EQ 105MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204453-005 | MINOCYCLINE HYDROCHLORIDE | EQ 135MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2016-09-28 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204453-006 | MINOCYCLINE HYDROCHLORIDE | EQ 65MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204453-007 | MINOCYCLINE HYDROCHLORIDE | EQ 115MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2018-03-16 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204453-008 | MINOCYCLINE HYDROCHLORIDE | EQ 55MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-12-19 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204453-001 | MINOCYCLINE HYDROCHLORIDE | EQ 45MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204453-002 | MINOCYCLINE HYDROCHLORIDE | EQ 80MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204453-003 | MINOCYCLINE HYDROCHLORIDE | EQ 90MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204453-004 | MINOCYCLINE HYDROCHLORIDE | EQ 105MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204453-005 | MINOCYCLINE HYDROCHLORIDE | EQ 135MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2016-09-28 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204453-006 | MINOCYCLINE HYDROCHLORIDE | EQ 65MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204453-007 | MINOCYCLINE HYDROCHLORIDE | EQ 115MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2018-03-16 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204453-008 | MINOCYCLINE HYDROCHLORIDE | EQ 55MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-12-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204453-001 | MINOCYCLINE HYDROCHLORIDE | EQ 45MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204453-002 | MINOCYCLINE HYDROCHLORIDE | EQ 80MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204453-003 | MINOCYCLINE HYDROCHLORIDE | EQ 90MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204453-004 | MINOCYCLINE HYDROCHLORIDE | EQ 105MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204453-005 | MINOCYCLINE HYDROCHLORIDE | EQ 135MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2016-09-28 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204453-006 | MINOCYCLINE HYDROCHLORIDE | EQ 65MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204453-007 | MINOCYCLINE HYDROCHLORIDE | EQ 115MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2018-03-16 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204453-008 | MINOCYCLINE HYDROCHLORIDE | EQ 55MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-12-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204453-001 | MINOCYCLINE HYDROCHLORIDE | EQ 45MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204453-002 | MINOCYCLINE HYDROCHLORIDE | EQ 80MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204453-003 | MINOCYCLINE HYDROCHLORIDE | EQ 90MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204453-004 | MINOCYCLINE HYDROCHLORIDE | EQ 105MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204453-005 | MINOCYCLINE HYDROCHLORIDE | EQ 135MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2016-09-28 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204453-006 | MINOCYCLINE HYDROCHLORIDE | EQ 65MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204453-007 | MINOCYCLINE HYDROCHLORIDE | EQ 115MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2018-03-16 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204453-008 | MINOCYCLINE HYDROCHLORIDE | EQ 55MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-12-19 | 6a471c1ec25d… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A204453-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A204453-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A204453-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A204453-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A204453-005 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A204453-006 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A204453-007 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A204453-008 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A204453-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204453-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204453-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204453-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204453-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204453-006 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204453-007 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204453-008 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A204453-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204453-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204453-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204453-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204453-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204453-006 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204453-007 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204453-008 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204453-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204453-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204453-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204453-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204453-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204453-006 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204453-007 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204453-008 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A204453-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204453-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204453-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204453-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204453-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204453-006 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204453-007 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204453-008 | AB | 1 | 6a471c1ec25d… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | 493bdeac-e073-4ec2-a481-85e6a6d3cb58 | 2026-03-25 | Warnings, Adverse reactions | 72162-1838-3 72162-1838 72162183803 4f5ed703-75b8-4f24-a709-0eb5ed6c4bba 493bdeac-e073-4ec2-a481-85e6a6d3cb58 |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Ascend Laboratories, LLC | a8f95207-b259-4f50-87f2-3652d9268890 | 2025-12-18 | Warnings, Adverse reactions | 67877-436 |
Adverse event summaries are temporarily unavailable. Other product information remains available.