Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Minocycline Hydrochloride Extended-Release Tablets USP, 45 mg are gray colored, round shaped, biconvex, film-coated tablets debossed with ‘I’ on one side and ‘95’ on the other side. Bottles of 30 NDC 65862-554-30 Bottles of 100 NDC 65862-554-01 Bottles of 1,000 NDC 65862-554-99 Minocycline Hydrochloride Extended-Release Tablets USP, 55 mg are pink colored, round shaped, biconvex, film-coated tablets debossed with ‘K’ on one side and ‘6’ on the other side. Bottles of 30 NDC 65862-883-30 Bottles of 100 NDC 65862-883-01 Bottles of 500 NDC 65862-883-05 Bottles of 1,000 NDC 65862-883-99 Minocycline Hydrochloride Extended-Release Tablets USP, 65 mg are blue colored, modified capsule shaped, biconvex, film-coated tablets debossed with ‘I’ on one side and ‘26’ on the other side. Bottles of 30 NDC 65862-555-30 Bottles of 1,000 NDC 65862-555-99 Minocycline Hydrochloride Extended-Release Tablets USP, 80 mg are grey colored, modified capsule shaped, biconvex, film-coated tablets debossed with ‘K’ on one side and ‘7’ on the other side. Bottles of 30 NDC 65862-884-30 Bottles of 100 NDC 65862-884-01 Bottles of 500 NDC 65862-884-05 Bottles of 1,000 NDC 65862-884-99 Minocycline Hydrochloride Extended-Release Tablets USP, 90 mg are yellow colored, modified capsule shaped, biconvex, film-coated tablets debossed with ‘I’ on one side and ‘27’ on the other side. Bottles of 30 NDC 65862-556-30 Bottles of 100 NDC 65862-556-01 Bottles of 1,000 NDC 65862-556-99 Minocycline Hydrochloride Extended-Release Tablets USP, 105 mg are purple colored, modified capsule shaped, biconvex, film-coated tablets debossed with ‘K’ on one side and ‘8’ on the other side. Bottles of 30 NDC 65862-885-30 Bottles of 100 NDC 65862-885-01 Bottles of 500 NDC 65862-885-05 Bottles of 1,000 NDC 65862-885-99 Minocycline Hydrochloride Extended-Release Tablets USP, 115 mg are green colored, capsule shaped, biconvex, film-coated tablets debossed with ‘F81’ on one side and plain on the other side. Bottles of 30 NDC 65862-557-30 Bottles of 1,000 NDC 65862-557-99 Minocycline Hydrochloride Extended-Release Tablets USP, 135 mg are red colored, modified capsule shaped, biconvex, film-coated tablets debossed with ‘I’ on one side and ‘93’ on the other side. Bottles of 30 NDC 65862-558-30 Bottles of 100 NDC 65862-558-01 Bottles of 1,000 NDC 65862-558-99 Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Handling Protect from light, moisture, and excessive heat. Dispense in tight, light-resistant container with child-resistant closure.; PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 45 mg (30 Tablets Bottle) NDC 65862-554-30 Rx only Minocycline Hydrochloride Extended-Release Tablets, USP 45 mg* AUROBINDO 30 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 45 mg (30 Tablets Bottle); PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 55 mg (30 Tablets Bottle) NDC 65862-883-30 Rx only Minocycline Hydrochloride Extended-Release Tablets, USP 55 mg* AUROBINDO 30 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 55 mg (30 Tablets Bottle); PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 65 mg (30 Tablets Bottle) NDC 65862-555-30 Rx only Minocycline Hydrochloride Extended-Release Tablets, USP 65 mg* AUROBINDO 30 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 65 mg (30 Tablets Bottle); PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 80 mg (30 Tablets Bottle) NDC 65862-884-30 Rx only Minocycline Hydrochloride Extended-Release Tablets, USP 80 mg* AUROBINDO 30 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 80 mg (30 Tablets Bottle); PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 90 mg (30 Tablets Bottle) NDC 65862-556-30 Rx only Minocycline Hydrochloride Extended-Release Tablets, USP 90 mg* AUROBINDO 30 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 90 mg (30 Tablets Bottle); PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 105 mg (30 Tablets Bottle) NDC 65862-885-30 Rx only Minocycline Hydrochloride Extended-Release Tablets, USP 105 mg* AUROBINDO 30 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 105 mg (30 Tablets Bottle); PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 115 mg (30 Tablets Bottle) NDC 65862-557-30 Rx only Minocycline Hydrochloride Extended-Release Tablets, USP 115 mg* AUROBINDO 30 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 115 mg (30 Tablets Bottle); PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 135 mg (30 Tablets Bottle) NDC 65862-558-30 Rx only Minocycline Hydrochloride Extended-Release Tablets, USP 135 mg* AUROBINDO 30 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 135 mg (30 Tablets Bottle)
- 16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Minocycline Hydrochloride Extended-Release Tablets USP, 45 mg are gray colored, round shaped, biconvex, film-coated tablets debossed with ‘I’ on one side and ‘95’ on the other side. Bottles of 30 NDC 65862-554-30 Bottles of 100 NDC 65862-554-01 Bottles of 1,000 NDC 65862-554-99 Minocycline Hydrochloride Extended-Release Tablets USP, 55 mg are pink colored, round shaped, biconvex, film-coated tablets debossed with ‘K’ on one side and ‘6’ on the other side. Bottles of 30 NDC 65862-883-30 Bottles of 100 NDC 65862-883-01 Bottles of 500 NDC 65862-883-05 Bottles of 1,000 NDC 65862-883-99 Minocycline Hydrochloride Extended-Release Tablets USP, 65 mg are blue colored, modified capsule shaped, biconvex, film-coated tablets debossed with ‘I’ on one side and ‘26’ on the other side. Bottles of 30 NDC 65862-555-30 Bottles of 1,000 NDC 65862-555-99 Minocycline Hydrochloride Extended-Release Tablets USP, 80 mg are grey colored, modified capsule shaped, biconvex, film-coated tablets debossed with ‘K’ on one side and ‘7’ on the other side. Bottles of 30 NDC 65862-884-30 Bottles of 100 NDC 65862-884-01 Bottles of 500 NDC 65862-884-05 Bottles of 1,000 NDC 65862-884-99 Minocycline Hydrochloride Extended-Release Tablets USP, 90 mg are yellow colored, modified capsule shaped, biconvex, film-coated tablets debossed with ‘I’ on one side and ‘27’ on the other side. Bottles of 30 NDC 65862-556-30 Bottles of 100 NDC 65862-556-01 Bottles of 1,000 NDC 65862-556-99 Minocycline Hydrochloride Extended-Release Tablets USP, 105 mg are purple colored, modified capsule shaped, biconvex, film-coated tablets debossed with ‘K’ on one side and ‘8’ on the other side. Bottles of 30 NDC 65862-885-30 Bottles of 100 NDC 65862-885-01 Bottles of 500 NDC 65862-885-05 Bottles of 1,000 NDC 65862-885-99 Minocycline Hydrochloride Extended-Release Tablets USP, 115 mg are green colored, capsule shaped, biconvex, film-coated tablets debossed with ‘F81’ on one side and plain on the other side. Bottles of 30 NDC 65862-557-30 Bottles of 1,000 NDC 65862-557-99 Minocycline Hydrochloride Extended-Release Tablets USP, 135 mg are red colored, modified capsule shaped, biconvex, film-coated tablets debossed with ‘I’ on one side and ‘93’ on the other side. Bottles of 30 NDC 65862-558-30 Bottles of 100 NDC 65862-558-01 Bottles of 1,000 NDC 65862-558-99 Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Handling Protect from light, moisture, and excessive heat. Dispense in tight, light-resistant container with child-resistant closure.
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 45 mg (30 Tablets Bottle) NDC 65862-554-30 Rx only Minocycline Hydrochloride Extended-Release Tablets, USP 45 mg* AUROBINDO 30 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 45 mg (30 Tablets Bottle)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 55 mg (30 Tablets Bottle) NDC 65862-883-30 Rx only Minocycline Hydrochloride Extended-Release Tablets, USP 55 mg* AUROBINDO 30 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 55 mg (30 Tablets Bottle)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 65 mg (30 Tablets Bottle) NDC 65862-555-30 Rx only Minocycline Hydrochloride Extended-Release Tablets, USP 65 mg* AUROBINDO 30 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 65 mg (30 Tablets Bottle)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 80 mg (30 Tablets Bottle) NDC 65862-884-30 Rx only Minocycline Hydrochloride Extended-Release Tablets, USP 80 mg* AUROBINDO 30 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 80 mg (30 Tablets Bottle)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 90 mg (30 Tablets Bottle) NDC 65862-556-30 Rx only Minocycline Hydrochloride Extended-Release Tablets, USP 90 mg* AUROBINDO 30 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 90 mg (30 Tablets Bottle)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 105 mg (30 Tablets Bottle) NDC 65862-885-30 Rx only Minocycline Hydrochloride Extended-Release Tablets, USP 105 mg* AUROBINDO 30 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 105 mg (30 Tablets Bottle)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 115 mg (30 Tablets Bottle) NDC 65862-557-30 Rx only Minocycline Hydrochloride Extended-Release Tablets, USP 115 mg* AUROBINDO 30 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 115 mg (30 Tablets Bottle)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 135 mg (30 Tablets Bottle) NDC 65862-558-30 Rx only Minocycline Hydrochloride Extended-Release Tablets, USP 135 mg* AUROBINDO 30 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 135 mg (30 Tablets Bottle)
Overview
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: 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: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, titanium dioxide, and triacetin. The 45 mg extended-release tablets also contain iron oxide black. The 55 mg extended-release tablets also contain FD&C Red # 40/Allura Red AC aluminum lake and polyethylene glycol. The 65 mg extended-release tablets also contain D&C Yellow #10 aluminum lake, FD&C Blue #1/Brilliant blue FCF aluminum lake, FD&C Blue #2/Indigo caramine aluminum lake, and polyethylene glycol. The 80 mg extended-release tablets also contain FD&C Blue #2 indigo caramine aluminum lake, FD&C Red # 40/Allura Red AC aluminum lake, FD&C Yellow #6/Sunset yellow FCF aluminum lake and polyethylene glycol. The 90 mg extended-release tablets also contain iron oxide yellow and polyethylene glycol. The 105 mg extended-release tablets also contain D&C Red #27/Phloxine aluminum lake, FD&C Blue #1/Brilliant blue FCF aluminum lake and polyethylene glycol. The 115 mg extended-release tablets also contain D&C Yellow #10 aluminum lake, FD&C Blue #1/Brilliant blue FCF aluminum lake and FD&C Blue #2/Indigo caramine aluminum lake. The 135 mg extended-release tablets also contain iron oxide red and polyethylene glycol. Meets USP dissolution test 2 for 45 mg, 90 mg and 135 mg. FDA approved dissolution test specifications differ from USP for 55 mg, 65 mg, 80 mg, 105 mg and 115 mg. Chemical Structure
Indications & Usage
Minocycline hydrochloride extended-release tablets are indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Limitations of Use Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions. This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies (14) ]. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, use minocycline hydrochloride extended-release tablets only as indicated [see Warnings and Precautions (5.12) ] . Minocycline hydrochloride is a tetracycline-class drug indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. ( 1 ) Limitations of Use This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria and to maintain the effectiveness of other antibacterial drugs, use minocycline hydrochloride extended-release tablets only as indicated. ( 1 )
Dosage & Administration
The recommended dosage of minocycline hydrochloride extended-release tablets is approximately 1 mg/kg once daily for 12 weeks. Table 1 provides the recommended minocycline hydrochloride extended-release tablets dosage based upon weight ranges. Table 1: Dosing Table for Minocycline Hydrochloride Extended-Release Tablets Patient’s Weight (kg) Recommended Dosage (mg/day) 45 to 49 45 50 to 59 55 60 to 71 65 72 to 84 80 85 to 96 90 97 to 110 105 111 to 125 115 126 to 136 135 Higher dosages have not shown to be of additional benefit in the treatment of inflammatory lesions of acne and may be associated with more acute vestibular adverse reactions. Swallow tablets whole. Do not chew, crush, or split the extended-release tablets. Administer minocycline hydrochloride extended-release tablets with or without food [see Clinical Pharmacology (12.3) ] . Ingestion of food along with minocycline hydrochloride extended-release tablets may help reduce the risk of esophageal irritation and ulceration. In patients with renal impairment, decrease the daily dosage by either reducing the recommended individual doses and/or by extending the time intervals between doses [see Warnings and Precautions (5.9) ]. The recommended dosage of minocycline hydrochloride extended-release tablets is approximately 1 mg/kg once daily for 12 weeks. (2)
Warnings & Precautions
Serious Skin/Hypersensitivity Reactions : Minocycline has been associated with anaphylaxis, serious skin reactions, erythema multiforme, and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome. Discontinue immediately if symptoms occur. ( 5.1 ) Tooth Discoloration and Enamel Hypoplasia: Use during the second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years may cause permanent discoloration of the teeth (yellow-gray-brown). ( 5.2 , 8.1 , 8.4 ) Inhibition of Bone Growth: Use during the second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years may cause reversible inhibition of bone growth. ( 5.3 , 8.1 , 8.4 ) Clostridioides difficile-Associated Diarrhea (Antibiotic-Associated Colitis): Discontinue if Clostridioides difficile -associated diarrhea (antibiotic-associated colitis) occurs. ( 5.4 ) Hepatotoxicity : Discontinue if liver injury is suspected. ( 5.5 ) Central Nervous System Effects: May cause central nervous system side effects including light-headedness, dizziness, or vertigo. ( 5.6 ) Idiopathic Intracranial Hypertension: May cause idiopathic intracranial hypertension in adults and adolescents. Discontinue if symptoms occur. ( 5.7 ) Autoimmune Syndromes : Minocycline has been associated with autoimmune syndromes; discontinue immediately if symptoms occur. ( 5.8 ) Metabolic Effects : If renal impairment exists, reduce minocycline hydrochloride extended-release tablets dosage. ( 5.9 ) 5.1 Serious Skin/Hypersensitivity Reactions Cases of anaphylaxis, serious skin reactions (e.g., Stevens-Johnson syndrome), erythema multiforme, and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been reported postmarketing with minocycline use in patients with acne. DRESS syndrome consists of cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more of the following visceral complications such as: hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis. Fever and lymphadenopathy may be present. In some cases, death has been reported. If this syndrome is recognized, minocycline hydrochloride extended-release tablets should be discontinued immediately. Fixed drug eruptions have occurred with minocycline and other tetracyclines. Worsening severity upon subsequent administrations, including generalized bullous fixed drug eruption, has been observed with other tetracyclines [see ADVERSE REACTIONS (6.2) ] . If severe skin/hypersensitivity reactions occur, discontinue minocycline hydrochloride extended-release tablets and institute appropriate therapy. 5.2 Tooth Discoloration and Enamel Hypoplasia The use of tetracycline-class drugs, including minocycline hydrochloride extended-release tablets, during tooth development (second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-graybrown). Permanent discoloration of the teeth is more common during long-term use of tetracycline-class drugs but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. Use of minocycline hydrochloride extended-release tablets are not recommended during tooth development. Advise the patient of the potential risk to the fetus if minocycline hydrochloride extended-release tablets are used during the second or third trimester of pregnancy [see Use in Specific Populations (8.1 , 8.4) ]. 5.3 Inhibition of Bone Growth The use of tetracycline-class drugs, including minocycline hydrochloride extended-release tablets, during the second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years may cause reversible inhibition of bone growth. All tetracyclines, including minocycline hydrochloride extended-release tablets, form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human infants given 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 are used during the second or third trimester of pregnancy [see Use in Specific Populations (8.1 , 8.4) ]. 5.4 Clostridioides difficile Associated Diarrhea (Antibiotic Associated Colitis) Clostridioides difficile -associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, including minocycline, and may range in severity from mild diarrhea to fatal colitis. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing 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. 5.5 Hepatotoxicity 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. 5.6 Central Nervous System Effects 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 are discontinued. 5.7 Idiopathic Intracranial Hypertension 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. 5.8 Autoimmune Syndromes 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. 5.9 Metabolic Effects 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. 5.10 Photosensitivity 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. 5.11 Tissue Hyperpigmentation 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. 5.12 Development of Drug-Resistant Bacteria 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. 5.13 Superinfection 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. 5.14 Laboratory Monitoring Perform periodic laboratory evaluations of organ systems, including hematopoietic, renal, and hepatic studies.
Contraindications
Minocycline hydrochloride extended-release tablets are contraindicated in patients with history of a hypersensitivity reaction to any of the tetracyclines [see Warnings and Precautions (5.1) ] . Known hypersensitivity to any of the tetracyclines. (4)
Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Skin/Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Clostridioides difficile -Associated Diarrhea (Antibiotic-Associated Colitis) [see Warnings and Precautions (5.4) ] Hepatotoxicity [see Warnings and Precautions (5.5) ] Central Nervous System Effects [see Warnings and Precautions (5.6) ] Idiopathic Intracranial Hypertension [see Warnings and Precautions (5.7) ] The most commonly observed adverse reactions (incidence ≥5%) are headache, fatigue, dizziness, and pruritus. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following table summarizes selected adverse reactions reported in clinical trials at a rate of ≥1% for minocycline hydrochloride extended-release tablets and higher than placebo. Table 2: Selected Treatment-Emergent Adverse Reactions in at Least 1% of Clinical Trial Subjects and Higher than Placebo Adverse Reactions Minocycline Hydrochloride Extended-Release Tablets (1 mg/kg) N = 674 (%) Placebo N = 364 (%) At least one treatment-emergent event 379 (56) 197 (54) Fatigue 62 (9) 24 (7) Dizziness 59 (9) 17 (5) Pruritus 31 (5) 16 (4) Malaise 26 (4) 9 (3) Somnolence 13 (2) 3 (1) Urticaria 10 (2) 1 (0) Tinnitus 10 (2) 5 (1) Arthralgia 9 (1) 2 (0) Vertigo 8 (1) 3 (1) 6.2 Postmarketing Experience The following adverse reactions have been reported with minocycline hydrochloride use in a variety of indications. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Skin and hypersensitivity reactions: anaphylaxis, angioedema, DRESS syndrome, erythema multiforme, Stevens-Johnson syndrome, acute febrile neutrophilic dermatosis (Sweet’s syndrome), fixed drug eruptions, balanitis, anaphylactoid purpura, photosensitivity, pigmentation of skin and mucous membranes. Autoimmune conditions: polyarthralgia, pericarditis, exacerbation of systemic lupus, pulmonary infiltrates with eosinophilia, lupus-like syndrome. Central nervous system: idiopathic intracranial hypertension, bulging fontanels in infants, decreased hearing. Endocrine: brown-black microscopic thyroid discoloration, abnormal thyroid function. Oncology: thyroid cancer. Oral: glossitis, dysphagia, tooth discoloration. Gastrointestinal: enterocolitis, pancreatitis, hepatitis, liver failure. Renal: acute renal failure. Hematology: hemolytic anemia, thrombocytopenia, eosinophilia.
Drug Interactions
Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. ( 7.1 ) 7.1 Anticoagulants Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. 7.2 Penicillin Because bacteriostatic drugs may interfere with the bactericidal action of penicillin, avoid giving minocycline hydrochloride extended-release tablets in conjunction with penicillin. 7.3 Antacids and Iron Preparations Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium and iron-containing preparations. 7.4 Drug/Laboratory Test Interactions False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.
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