MINOCYCLINE- minocycline hydrochloride_tablet, film coated

CLINICAL PHARMACOLOGY
Following a single dose of two minocycline hydrochloride 100 mg tablets administered to 18 normal fasting adult volunteers, maximum serum concentrations were attained in 1 to 4 hours (average 2. 1 hours) and ranged from 2. 1 mcg/mL (average 3. The serum half-life in the normal volunteers ranged from 11. 1 hours (average 15. When minocycline hydrochloride tablets were given concomitantly with a high-fat meal, which included dairy products, the extent of absorption of minocycline hydrochloride tablets was unchanged compared to dosing under fasting conditions. The mean Tmax was delayed by one hour when administered with food, compared to dosing under fasting conditions. Minocycline tablets may be administered with or without food. In previous studies with other minocycline dosage forms, the minocycline serum half-life ranged from 11 to 16 hours in 7 patients with hepatic dysfunction, and from 18 to 69 hours in 5 patients with renal dysfunction. The urinary and fecal recovery of minocycline when administered to 12 normal volunteers was one-half to one-third that of other tetracyclines. Mechanism of Action The tetracyclines are primarily bacteriostatic and are thought to exert their antimicrobial effect by the inhibition of protein synthesis. The tetracyclines, including minocycline, have similar antimicrobial spectrum of activity against a wide range of gram-positive and gram-negative organisms. Cross-resistance of these organisms to tetracycline is common. Antimicrobial Activity Minocycline has been shown to be active against most strains of the following microorganisms, both in vitro INDICATIONS AND USAGE Gram-positive Bacteria Bacillus anthracis Listeria monocytogenes Staphylococcus aureu Streptococcus pneumonia Gram-negative Bacteria Bartonella bacilliformi Brucella Klebsiella granulomati Campylobacter fetu Francisella tularensi Haemophilus ducrey Vibrio cholera Yersinia pesti Acinetobacter Enterobacter aerogene Escherichia coli Haemophilus influenza Klebsiella Neisseria gonorrhoeae 1 Neisseria meningitidis 1 Shigella species Other Microorganisms Actinomyces Borrelia recurrentis Chlamydophila psittaci Chlamydia trachomatis Clostridium Entamoeba Fusobacterium nucleatum fusiforme Mycobacterium marinum Mycoplasma pneumonia Propionibacterium acne Rickettsia Treponema pallidum pallidum Treponema pallidum pertenue Ureaplasma urealyticum _____________________________________________________________________________________ dagger Susceptibility Test Methods For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.
Microbiology
Mechanism of Action The tetracyclines are primarily bacteriostatic and are thought to exert their antimicrobial effect by the inhibition of protein synthesis. The tetracyclines, including minocycline, have similar antimicrobial spectrum of activity against a wide range of gram-positive and gram-negative organisms. Cross-resistance of these organisms to tetracycline is common. Antimicrobial Activity Minocycline has been shown to be active against most strains of the following microorganisms, both in vitro INDICATIONS AND USAGE Gram-positive Bacteria Bacillus anthracis Listeria monocytogenes Staphylococcus aureu Streptococcus pneumonia Gram-negative Bacteria Bartonella bacilliformi Brucella Klebsiella granulomati Campylobacter fetu Francisella tularensi Haemophilus ducrey Vibrio cholera Yersinia pesti Acinetobacter Enterobacter aerogene Escherichia coli Haemophilus influenza Klebsiella Neisseria gonorrhoeae 1 Neisseria meningitidis 1 Shigella species Other Microorganisms Actinomyces Borrelia recurrentis Chlamydophila psittaci Chlamydia trachomatis Clostridium Entamoeba Fusobacterium nucleatum fusiforme Mycobacterium marinum Mycoplasma pneumonia Propionibacterium acne Rickettsia Treponema pallidum pallidum Treponema pallidum pertenue Ureaplasma urealyticum _____________________________________________________________________________________ dagger Susceptibility Test Methods For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC
ANIMAL PHARMACOLOGY AND TOXICOLOGY
Minocycline hydrochloride has been observed to cause a dark discoloration of the thyroid in experimental animals (rats, minipigs, dogs, and monkeys). In the rat, chronic treatment with minocycline hydrochloride has resulted in goiter accompanied by elevated radioactive iodine uptake and evidence of thyroid tumor production. Minocycline hydrochloride has also been found to produce thyroid hyperplasia in rats and dogs. All brand names listed are the registered trademarks of their respective owners. This product’s label may have been updated. For current package insert and further product information, please call Sun Pharmaceutical Industries, Inc. by calling at 1-800-818-4555. Manufactured by: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharma City, Selaqui Industrial Area Dehradun, 248197, Uttarakhand, India. P2081004 M. L. No.: 41/UA/SC/P-2007 Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 USA 5816T03 Rev. 05/18

Minocycline hydrochloride tablets, USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae Respiratory tract infections caused by Mycoplasma pneumoniae Lymphogranuloma venereum caused by Chlamydia trachomatis Psittacosis (Ornithosis) due to Chlamydophila psittaci Trachoma caused by Chlamydia trachomatis Inclusion conjunctivitis caused by Chlamydia trachomatis Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum Chlamydia trachomatis. Relapsing fever due to Borrelia recurrentis Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella Bartonellosis due to Bartonella bacilliformis Granuloma inguinale caused by Klebsiella granulomatis. Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: Escherichia coli. Enterobacter aerogenes Shigella Acinetobacter Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Kiebsiella Minocycline hydrochloride tablets, USP are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: Upper respiratory tract infections caused by Streptococcus pneumoniae. Skin and skin structure infections caused by Staphylococcus aureus When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections: Uncomplicated urethritis in men due to Neisseria gonorrhoeae Infections in women caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum pallidum Yaws caused by Treponema pallidum pertenue Listeriosis due to Listeria monocytogenes Anthrax due to Bacillus anthracis Vincent’s infection caused by Fusobacterium fusiforme Actinomycosis caused by Actinomyces israelii Infections caused by Clostridium In acute intestinal amebiasis In severe acne Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis Oral minocycline is not indicated for the treatment of meningococcal infection Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride tablets, USP and other antibacterial drugs, minocycline hydrochloride tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

DOSAGE AND ADMINISTRATION
THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF MINOCYCLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS. Minocycline hydrochloride tablets, USP may be taken with or without food (see CLINICAL PHARMACOLOGY Ingestion of adequate amounts of fluids along with capsule and tablet forms of drugs in the tetracycline-class is recommended to reduce the risk of esophageal irritation and ulceration. The tablets should be swallowed whole. Usual pediatric dose: 4 mg/kg initially followed by 2 mg/kg every 12 hours, not to exceed the usual adult dose. The usual dosage of minocycline hydrochloride tablets is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg tablets may be given initially followed by one 50 mg capsule 4 times daily. Uncomplicated gonococcal infections other than urethritis and anorectal infections in men: 200 mg initially, followed by 100 mg every 12 hours for a minimum of 4 days, with post-therapy cultures within 2 to 3 days. In the treatment of uncomplicated gonococcal urethritis in men, 100 mg every 12 hours for 5 days is recommended. For the treatment of syphilis, the usual dosage of minocycline hydrochloride should be administered over a period of 10 to 15 days. Close follow-up, including laboratory tests, is recommended. In the treatment of meningococcal carrier state, the recommended dosage is 100 mg every 12 hours for 5 days. Mycobacterium marinum infections Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis Ureaplasma urealyticum Ingestion of adequate amounts of fluids along with capsule and tablet forms of drugs in the tetracycline-class is recommended to reduce the risk of esophageal irritation and ulceration. The pharmacokinetics of minocycline in patients with renal impairment (CLCR <80 mL/min) have not been fully characterized. Current data are insufficient to determine if a dosage adjustment is warranted. The total daily dosage should not exceed 200 mg in 24 hours. However, due to the anti-anabolic effect of tetracyclines, BUN and creatinine should be monitored (see WARNINGS.
For Pediatric Patients above 8 Years of Age
Usual pediatric dose: 4 mg/kg initially followed by 2 mg/kg every 12 hours, not to exceed the usual adult dose.
Adults
The usual dosage of minocycline hydrochloride tablets is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg tablets may be given initially followed by one 50 mg capsule 4 times daily. Uncomplicated gonococcal infections other than urethritis and anorectal infections in men: 200 mg initially, followed by 100 mg every 12 hours for a minimum of 4 days, with post-therapy cultures within 2 to 3 days. In the treatment of uncomplicated gonococcal urethritis in men, 100 mg every 12 hours for 5 days is recommended. For the treatment of syphilis, the usual dosage of minocycline hydrochloride should be administered over a period of 10 to 15 days. Close follow-up, including laboratory tests, is recommended. In the treatment of meningococcal carrier state, the recommended dosage is 100 mg every 12 hours for 5 days. Mycobacterium marinum infections Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis Ureaplasma urealyticum Ingestion of adequate amounts of fluids along with capsule and tablet forms of drugs in the tetracycline-class is recommended to reduce the risk of esophageal irritation and ulceration. The pharmacokinetics of minocycline in patients with renal impairment (CLCR <80 mL/min) have not been fully characterized. Current data are insufficient to determine if a dosage adjustment is warranted. The total daily dosage should not exceed 200 mg in 24 hours. However, due to the anti-anabolic effect of tetracyclines, BUN and creatinine should be monitored (see WARNINGS

Due to oral minocycline’s virtually complete absorption, side effects to the lower bowel, particularly diarrhea, have been infrequent. The following adverse reactions have been observed in patients receiving tetracyclines: Body as a whole: Gastrointestinal: DOSAGE AND ADMINISTRATION Genitourinary: Hepatic toxicity: PRECAUTIONS Skin: WARNINGS Respiratory: Renal toxicity: WARNINGS Musculoskeletal: Hypersensitivity reactions: Blood: Central Nervous System: PRECAUTIONS General Other: Tooth discoloration in children less than 8 years of age and also in adults have been reported. (see WARNINGS Oral cavity discoloration (including tongue, lip, and gum) have been reported. Tinnitus and decreased hearing have been reported in patients on minocycline hydrochloride. The following syndromes have been reported. In some cases involving these syndromes, death has been reported. As with other serious adverse reactions, if any of these syndromes are recognized, the drug should be discontinued immediately: Hypersensitivity syndrome consisting of cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more of the following: hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis. Fever and lymphadenopathy may be present. Lupus-like syndrome consisting of positive antinuclear antibody; arthralgia, arthritis, joint stiffness, or joint swelling; and one or more of the following: fever, myalgia, hepatitis, rash, and vasculitis. Serum sickness-like syndrome consisting of fever; urticaria or rash; and arthralgia, arthritis, joint stiffness, or joint swelling and lymphadenopathy. Eosinophilia may be present. To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or to any of the components of the product formulation.

Pregnancy
Risk Summary All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. There are no adequate and well-controlled studies on the use of minocycline in pregnant women. Minocycline, like other tetracycline-class antibiotics, 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 in post-marketing experience. Only limited information is available regarding these reports; therefore, no conclusion on causal association can be established. If minocycline is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Nonteratogenic Effects: WARNINGS
Nursing Mothers
Tetracyclines are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from the tetracyclines, 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
Pediatric Use
Minocycline is not recommended for the use in children below 8 years of age unless the expected benefits of therapy outweigh the risks (see WARNINGS
Geriatric Use
Clinical studies of oral minocycline did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 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 of concomitant disease or other drug therapy (see WARNINGS DOSAGE AND ADMINISTRATION

Drug Interactions
Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin. Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron-containing preparations. The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity. Concurrent use of tetracyclines with oral contraceptives may render oral contraceptives less effective. Administration of isotretinoin should be avoided shortly before, during, and shortly after minocycline therapy. Each drug alone has been associated with pseudotumor cerebri (see WARNINGS Increased risk of ergotism when ergot alkaloids or their derivatives are given with tetracyclines.
Drug/Laboratory Test Interactions
False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

WARNINGS
Tooth Development Minocycline hydrochloride tablets, like other tetracycline-class antibiotics, 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. The use of drugs of the tetracycline class during tooth development (last half of pregnancy, infancy, and childhood 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 unless other drugs are not likely to be effective or are contraindicated. Skeletal Development All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in the fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every six hours. This reaction was shown to be reversible when the drug was discontinued. Use in Pregnancy Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity has been noted in animals treated early in pregnancy. Dermatologic Reaction Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) including fatal cases have been reported with minocycline use. If this syndrome is recognized, the drug should be discontinued immediately. Antianabolic Action The antianabolic action of the tetracyclines may cause an increase in blood urea nitrogen (BUN). While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline may lead to azotemia, hyperphosphatemia, and acidosis. Under such conditions, monitoring of creatinine and BUN is recommended, and the total daily dosage should not exceed 200 mg in 24 hours (see DOSAGE AND ADMINISTRATION Photosensitivity Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. This has been reported with minocycline. Central Nervous System Central nervous system side effects including light-headedness, dizziness, or vertigo have been reported with minocycline therapy. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy. These symptoms may disappear during therapy and usually disappear rapidly when the drug is discontinued. Clostridium difficile Associated Diarrhea Clostridium difficile C. difficile C. difficile C. difficile If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile C. difficile Intracranial Hypertension Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines including minocycline hydrochloride tablets. Clinical manifestations of IH 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 IH are at greater risk for developing tetracycline-associated IH. Concomitant use of isotretinoin and minocycline hydrochloride tablets should be avoided because isotretinoin is also known to cause pseudotumor cerebri. Although IH typically resolves after discontinuation of treatment, the possibility for permanent visual loss exists. If visual disturbance occurs during treatment, prompt ophthalmologic evaluation is warranted. Since intracranial pressure can remain elevated for weeks after drug cessation, patients should be monitored until they stabilize.
Carcinogenesis,Mutagenesis, Impairment of Fertility
Dietary administration of minocycline in long-term tumorigenicity studies in rats resulted in evidence of thyroid tumor production. Minocycline has also been found to produce thyroid hyperplasia in rats and dogs. In addition, there has been evidence of oncogenic activity in rats in studies with a related antibiotic, oxytetracycline (i.e., adrenal and pituitary tumors). Likewise, although mutagenicity studies of minocycline have not been conducted, positive results in in vitro mammalian cell assays (i.e., mouse lymphoma and Chinese hamster lung cells) have been reported for related antibiotics (tetracycline hydrochloride and oxytetracycline). Segment I (fertility and general reproduction) studies have provided evidence that minocycline impairs fertility in male rats.
Labor and Delivery
The effect of tetracyclines on labor and delivery is unknown.
OVERDOSAGE
The adverse events more commonly seen in overdose are dizziness, nausea, and vomiting. No specific antidote for minocycline is known. In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures. Minocycline is not removed in significant quantities by hemodialysis or peritoneal dialysis.
PATIENT INFORMATION
Minocycline hydrochloride tablets, USP (mye-no-SYE-kleen) Hydrochloride Tablets 50 mg, 75 mg, and 100 mg Rx Only Read the Patient Information that comes with Minocycline hydrochloride tablets, USP before you or a family member starts taking them and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your doctor about your medical condition or treatment. What are Minocycline hydrochloride tablets, USP? Minocycline hydrochloride tablets are a tetracycline-class antibiotic medicine. Minocycline hydrochloride tablets, USP are used to treat certain infections caused by bacteria. These include infections of the skin, respiratory tract, urinary tract, some sexually transmitted diseases, and others. Minocycline hydrochloride tablets, USP may be used along with other treatments for severe acne. Sometimes, other germs, called viruses cause infections. The common cold is a virus. Minocycline hydrochloride tablets, USP, like other antibiotics, does not treat viruses. Who should not use Minocycline hydrochloride tablets, USP? Do not take Minocycline hydrochloride tablets, USP if you are allergic to minocycline or other tetracycline antibiotics. Ask your doctor or pharmacist for a list of these medications if you are not sure. See the end of this leaflet for a complete list of ingredients in Minocycline hydrochloride tablets, USP. Minocycline hydrochloride tablets, USP are not recommended for pregnant women or children up to 8 years old because: Minocycline hydrochloride tablets, USP may harm an unborn baby. Minocycline hydrochloride tablets, USP may permanently turn a baby’s or child’s teeth yellow-gray-brown during tooth development. What should I tell my doctor before starting Minocycline hydrochloride tablets, USP? Tell your doctor about all of your medical conditions, including if you: have liver or kidney problems. are pregnant or planning to become pregnant. Stop taking Minocycline hydrochloride tablets, USP and call your doctor if you become pregnant while taking them. are breast feeding. Tell your doctor about all the medicines you are taking including prescription and non-prescription medications, vitamins, and herbal supplements. Minocycline hydrochloride tablets, USP and other medicines may interact. Especially tell your doctor if you take: birth control pills. a blood thinner medicine. a penicillin antibiotic medicine. migraine medicines called ergot alkaloids. an acne medicine called isotretinoin (Accutane, Amnesteem, Claravis, Sotret). antacids that contain aluminum, calcium, or magnesium, or iron-containing products. Know the medicines you take, keep a list of them to show your doctor and pharmacist each time you get a new medicine. How should I take minocycline hydrochloride tablets, USP? Take minocycline hydrochloride tablets, USP exactly as your doctor tells you to take them. Decrease the effectiveness of the treatment. Increase the chance that bacteria will develop resistance to Minocycline hydrochloride tablets, USP. Take minocycline hydrochloride tablets, USP with a full glass of liquid. Minocycline hydrochloride tablets, USP may be taken with or without food. If you take too much Minocycline hydrochloride tablets, USP, call your doctor or poison control center right away. What are the possible side effects of Minocycline hydrochloride tablets, USP? Minocycline hydrochloride tablets, USP may cause serious side effects. Stop Minocycline hydrochloride tablets, USP and call your doctor if you have: watery diarrhea bloody stools stomach cramps unusual headaches blurred vision fever rash joint pain feeling very tired swollen lymph nodes Minocycline hydrochloride tablets, USP may also cause: central nervous system effects. sun sensitivity (photosensitivity). These are not all the side effects with Minocycline hydrochloride tablets, USP. Ask your doctor or pharmacist for more information. CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088. How should I store minocycline hydrochloride, USP tablets? Store Minocycline hydrochloride tablets, USP at room temperature and away from excess heat and moisture. Throw away any Minocycline hydrochloride tablets, USP that is outdated or no longer needed. Keep Minocycline hydrochloride tablets, USP and all medicines out of the reach of children. General advice about Minocycline hydrochloride tablets, USP Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Minocycline hydrochloride tablets, USP for a condition for which they were not prescribed. Do not give Minocycline hydrochloride tablets, USP to other people, even if they have the same symptoms you have. It may harm them. This Patient Information leaflet summarizes the most important information about minocycline hydrochloride tablets, USP. If you would like more information, talk with your doctor. Your doctor or pharmacist can give you information about Minocycline hydrochloride tablet that is written for healthcare professionals. For more information, you can also contact Sun Pharmaceutical Industries, Inc. by calling 1-800-818-4555. What are the ingredients in Minocycline hydrochloride tablets, USP? Active ingredient: Inactive ingredients: All product/brand names are the trademarks of their respective owners. P2081004 M. L. No.: 41/UA/SC/P-2007 Manufactured by: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharma City, Selaqui Industrial Area Dehradun, 248197, Uttarakhand, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 5816T03 Rev. 05/18

Sun Pharmaceutical Industries, Inc.

MINOCYCLINE- minocycline hydrochloride_tablet, film coated Product manual source documgent