Label: MINOCYCLINE HYDROCHLORIDE capsule
Contains inactivated NDC Code(s)
NDC Code(s): 63304-694-01, 63304-694-05, 63304-695-01, 63304-695-05, view more63304-696-05, 63304-696-50
- Packager: Ranbaxy Pharmaceuticals Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
Updated May 19, 2014
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MINOCYCLINE HYDROCHLORIDE CAPSULES, USP
To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules, USP and other antibacterial drugs, minocycline hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Minocycline hydrochloride, USP, is a semisynthetic derivative of tetracycline, 4,7-Bis (dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride.
Each minocycline hydrochloride capsule, USP for oral administration, contains the equivalent of 50 mg, 75 mg or 100 mg of minocycline. In addition each capsule contains the following inactive ingredients: corn starch and magnesium stearate.
Following a single dose of two minocycline hydrochloride capsules, 100 mg 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 to 5.1 mcg/mL (average 3.5 mcg/mL). The serum half-life in the normal volunteers ranged from 11.1 to 22.1 hours (average 15.5 hours).
When minocycline hydrochloride capsules were given concomitantly with a high-fat meal, which included dairy products, the extent of absorption of minocycline hydrochloride capsules 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 hydrochloride capsules 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.
The tetracyclines are primarily bacteriostatic and are thought to exert their antimicrobial effect by the inhibition of protein synthesis. The tetracyclines, including minocycline, have a 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.
Because many strains of the following gram-positive microorganisms have been shown to be resistant to tetracyclines, culture and susceptibility testing are especially recommended. Tetracycline antibiotics should not be used for streptococcal diseases unless the organism has been demonstrated to be susceptible. Tetracyclines are not the drug of choice in the treatment of any type of staphylococcal infection.
Susceptibility testing should be performed with tetracycline since it predicts susceptibility to minocycline. However, certain organisms (e.g., some staphylococci, and Acinetobacter species) may be more susceptible to minocycline and doxycycline than to tetracycline.
Quantitative methods are used to determine antimicrobial minimal inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized procedure. Standardized procedures are based on a dilution method (Ref1, Ref3) (broth or agar) or equivalent with standardized inoculum concentrations and standardized concentrations of tetracycline powder. The MIC values should be interpreted according to the following criteria:
MIC (mcg/mL) Interpretation ≤ 4 Susceptible (S) 8 Intermediate (I) ≥ 16 Resistant (R) MIC (mcg/mL) Interpretation ≤ 2 Susceptible (S) 4 Intermediate (I) ≥ 8 Resistant (R) MIC (mcg/mL) Interpretation ≤ 0.25 Susceptible (S) 0.5 to 1 Intermediate (I) ≥ 2 Resistant (R)
A report of “Susceptible” indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable. A report of “Intermediate” indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of “Resistant” indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.
Standardized susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures. Standard tetracycline powder should provide the following MIC values:
Microorganism MIC Range (mcg/mL) Escherichia coli ATCC 25922 0.5 to 2 Staphylococcus aureus ATCC 29213 0.12 to 1 Haemophilus influenzae ATCC 49247 4 to 32 Streptococcus pneumoniae ATCC 49619 0.06 to 0.5 Neisseria gonorrhoeae ATCC 49226 0.25 to 1
Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure Ref2,Ref3 requires the use of standardized inoculum concentrations. This procedure uses paper disks impregnated with 30 mcg tetracycline (class disk) or 30 mcg minocycline to test the susceptibility of microorganisms to minocycline.
Zone Diameter (mm) Interpretation MIC (mcg/mL) ≥ 16 Susceptible (S) ≤ 4 13 to 15 Intermediate (I) - ≤ 12 Resistant (R) ≥ 16 Zone Diameter (mm) Interpretation MIC (mcg/mL) ≥ 19 Susceptible (S) ≤ 4 15 to 18 Intermediate (I) - ≤ 14 Resistant (R) ≥ 16 Zone Diameter (mm) Interpretation MIC (mcg/mL) ≥ 29 Susceptible (S) ≤ 2 26 to 28 Intermediate (I) - ≤ 25 Resistant (R) ≥ 8 Zone Diameter (mm) Interpretation MIC (mcg/mL) ≥ 38 Susceptible (S) ≤ 0.25 31 to 37 Intermediate (I) - ≤ 30 Resistant (R) ≥ 2 Zone Diameter (mm) Interpretation MIC (mcg/mL) ≥ 23 Susceptible (S) ≤ 2 19 to 22 Intermediate (I) - ≤ 18 Resistant (R) ≥ 8
As with standardized dilution techniques, diffusion methods require the use of laboratory control microorganisms that are used to control the technical aspects of the laboratory procedures. For the diffusion technique, the 30 mcg tetracycline or minocycline disk should provide the following zone diameters in these laboratory test quality control strains:
Microorganism ZoneDiameterRange(mm) Tetracycline Minocycline Escherichia coli ATCC 25922 18 to 25 19 to 25 Staphylococcus aureus ATCC 25923 24 to 30 25 to 30 Haemophilus influenzae ATCC 49247 14 to 22 - Neisseria gonorrhoeae ATCC 49226 30 to 42 - Streptococcus pneumoniae ATCC 49619 27 to 31 -
INDICATIONS AND USAGE
Minocycline hydrochloride capsules, USP are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:
Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high.
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 capsules, USP and other antibacterial drugs, minocycline hydrochloride capsules, 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.
MINOCYCLINE HYDROCHLORIDE, 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.
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.
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.
The anti-anabolic action of the tetracyclines may cause an increase in 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). If renal impairment exists, even usual oral or parenteral doses may lead to systemic accumulation of the drug and possible liver toxicity.
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 (CDAD) has been reported with use of nearly all antibacterial agents, including minocycline hydrochloride, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
As with other antibiotic preparations, use of this drug may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, the antibiotic should be discontinued and appropriate therapy instituted.
Pseudotumor cerebri (benign intracranial hypertension) in adults has been associated with the use of tetracyclines. The usual clinical manifestations are headache and blurred vision. Bulging fontanels have been associated with the use of tetracyclines in infants. While both of these conditions and related symptoms usually resolve after discontinuation of the tetracycline, the possibility for permanent sequelae exists.
Prescribing minocycline hydrochloride capsules in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema. This reaction has been reported with use of minocycline.
Patients should be counseled that antibacterial drugs including minocycline hydrochloride capsules should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When minocycline hydrochloride capsules are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by minocycline hydrochloride capsules or other antibacterial drugs in the future.
Drug/Laboratory Test Interactions
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.
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 postmarketing 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.
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).
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).
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.
Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, dyspepsia, stomatitis, glossitis, dysphagia, enamel hypoplasia, enterocolitis, pseudomembranous colitis, pancreatitis, inflammatory lesions (with monilial overgrowth) in the oral and anogenital regions. Instances of esophagitis and esophageal ulcerations have been reported in patients taking the tetracycline-class antibiotics in capsule and tablet form. Most of these patients took the medication immediately before going to bed (see DOSAGE AND ADMINISTRATION).
Hepatic Toxicity: Hyperbilirubinemia, hepatic cholestasis, increases in liver enzymes, fatal hepatic failure, and jaundice. Hepatitis, including autoimmune hepatitis, and liver failure have been reported (see PRECAUTIONS).
Skin: Alopecia, erythema nodosum, hyperpigmentation of nails, pruritus, toxic epidermal necrolysis, and vasculitis. Maculopapular and erythematous rashes. Exfoliative dermatitis has been reported. Fixed drug eruptions have been reported. Lesions occurring on the glans penis have caused balanitis. Erythema multiforme and Stevens-Johnson syndrome have been reported. Photosensitivity is discussed above (see WARNINGS). Pigmentation of the skin and mucous membranes has been reported.
Hypersensitivity Reactions: Urticaria, angioneurotic edema, polyarthralgia, anaphylaxis/anaphylactoid reaction (including shock and fatalities), anaphylactoid purpura, myocarditis, pericarditis, exacerbation of systemic lupus erythematosus and pulmonary infiltrates with eosinophilia have been reported. A transient lupus-like syndrome and serum sickness-like reactions also have been reported.
Central Nervous System: Convulsions, dizziness, hypesthesia, paresthesia, sedation, and vertigo. Bulging fontanels in infants and benign intracranial hypertension (pseudotumor cerebri) in adults have been reported (see PRECAUTIONS, General). Headache has also been reported.
Other: Thyroid cancer has been reported in the post-marketing setting in association with minocycline products. When minocycline therapy is given over prolonged periods, monitoring for signs of thyroid cancer should be considered. When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of the thyroid gland. Cases of abnormal thyroid function have been reported.
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.
DOSAGE AND ADMINISTRATION
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 capsules should be swallowed whole.
The usual dosage of minocycline hydrochloride capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg capsules 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.
The pharmacokinetics of minocycline in patients with renal impairment (CLCR < 80mL/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).
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.
Ref1. Clinical and Laboratory Standards Institute. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard-Ninth Edition; Document M07-A9, Vol. 32, No. 2, CLSI, Wayne, PA, January, 2012
Ref2. Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard-Eleventh Edition; Document M02-A11, Vol. 32, No. 1, CLSI, Wayne, PA, January, 2012
Ref3. Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Second Informational Supplement. Document M100-S22, Vol. 32, No. 3, CLSI, Wayne, PA, January, 2012
PATIENT INFORMATION ABOUT MINOCYCLINE HYDROCHLORIDE CAPSULES, USP
Read the Patient Information that comes with minocycline hydrochloride capsules, 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.
Minocycline hydrochloride capsules, USP are a tetracycline-class antibiotic medicine. Minocycline hydrochloride capsules, 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 capsules, USP may be used along with other treatments for severe acne.
- Minocycline hydrochloride capsules, USP may harm an unborn baby
- Minocycline hydrochloride capsules, USP may permanently turn a baby’s or child’s teeth yellow-gray-brown during tooth development. Tooth development happens in the last half of pregnancy and birth to age 8 years.
- have liver or kidney problems
- are pregnant or planning to become pregnant. Minocycline hydrochloride capsules, USP may harm your unborn baby. Stop taking minocycline hydrochloride capsules, USP and call your doctor if you become pregnant while taking them.
- are breast feeding. Minocycline passes into your milk and may harm your baby. You should decide whether to use minocycline hydrochloride capsules, USP or breastfeed, but not both.
Tell your doctor about all the medicines you are taking including prescription and non prescription medications, vitamins, and herbal supplements. Minocycline hydrochloride capsules, USP and other medicines may interact. Especially tell your doctor if you take:
- birth control pills. Minocycline hydrochloride capsules, USP may make your birth control pills less effective
- a blood thinner medicine. The dose of your blood thinner may have to be lowered.
- a penicillin antibiotic medicine. Minocycline hydrochloride capsules, USP and penicillins should not be used together.
- 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.
Take minocycline hydrochloride capsules, USP exactly as your doctor tells you to take them. Skipping doses or not taking all your minocycline hydrochloride capsules, USP may:
- Decrease the effectiveness of the treatment
- Increase the chance that bacteria will develop resistance to minocycline hydrochloride capsules, USP
- Take minocycline hydrochloride capsules, USP with a full glass of liquid. Taking minocycline hydrochloride capsules, USP with enough liquid may lower your chance of getting irritation or ulcers in your esophagus. Your esophagus is the tube that connects your mouth to your stomach.
- Minocycline hydrochloride capsules, USP may be taken with or without food. If you forget to take minocycline hydrochloride capsules, USP, take them as soon as you remember.
- If you take too many minocycline hydrochloride capsules, USP, call your doctor or poison control center right away.
- watery diarrhea
- bloody stools
- stomach cramps
- unusual headaches
- blurred vision
- joint pain
- feeling very tired
- central nervous system effects. Symptoms include light-headedness, dizziness, and a spinning feeling (vertigo). You should not drive or operate machines if you have these symptoms.
- sun sensitivity (photosensitivity). You may get a worse sunburn with minocycline hydrochloride capsules, USP. Avoid sun exposure and the use of sunlamps or tanning beds. Protect your skin while out in the sunlight. Stop minocycline hydrochloride capsules, USP and call your doctor if your skin turns red.
- Store minocycline hydrochloride capsules, USP at room temperature and away from excess heat and moisture.
- Throw away any minocycline hydrochloride capsules, USP that are outdated or no longer needed.
- Keep minocycline hydrochloride capsules, USP and all medicines out of the reach of children.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use minocycline hydrochloride capsules, USP for a condition for which they were not prescribed. Do not give minocycline hydrochloride capsules, USP to other people, even if they have the same symptoms you have. It may harm them.
Your doctor or pharmacist can give you information about minocycline hydrochloride capsules, USP that is written for health care professionals. For more information, you can also call Ranbaxy Pharmaceuticals Inc. at 1-800-406-7984.
PACKAGE LABEL. PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
minocycline hydrochloride capsule
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-694 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINOCYCLINE HYDROCHLORIDE (UNII: 0020414E5U) (MINOCYCLINE - UNII:FYY3R43WGO) MINOCYCLINE 50 mg Inactive Ingredients Ingredient Name Strength GELATIN (UNII: 2G86QN327L) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) STARCH, CORN (UNII: O8232NY3SJ) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white (to off-white, opaque) Score no score Shape CAPSULE Size 14mm Flavor Imprint Code RX694 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63304-694-01 100 in 1 BOTTLE 2 NDC:63304-694-05 500 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065062 12/22/2000 MINOCYCLINE HYDROCHLORIDE
minocycline hydrochloride capsule
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-695 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINOCYCLINE HYDROCHLORIDE (UNII: 0020414E5U) (MINOCYCLINE - UNII:FYY3R43WGO) MINOCYCLINE 75 mg Inactive Ingredients Ingredient Name Strength GELATIN (UNII: 2G86QN327L) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) STARCH, CORN (UNII: O8232NY3SJ) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color gray (opaque) Score no score Shape CAPSULE Size 16mm Flavor Imprint Code RX695 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63304-695-01 100 in 1 BOTTLE 2 NDC:63304-695-05 500 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065062 12/22/2000 MINOCYCLINE HYDROCHLORIDE
minocycline hydrochloride capsule
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-696 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINOCYCLINE HYDROCHLORIDE (UNII: 0020414E5U) (MINOCYCLINE - UNII:FYY3R43WGO) MINOCYCLINE 100 mg Inactive Ingredients Ingredient Name Strength GELATIN (UNII: 2G86QN327L) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) STARCH, CORN (UNII: O8232NY3SJ) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color gray (gray opaque cap, white opaque body) Score no score Shape CAPSULE Size 18mm Flavor Imprint Code RX696 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63304-696-50 50 in 1 BOTTLE 2 NDC:63304-696-05 500 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065062 12/22/2000 Labeler - Ranbaxy Pharmaceuticals Inc. (937890044) Registrant - Ranbaxy Pharmaceuticals Inc. (937890044) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 051565745 FDF MANUFACTURE(63304-694, 63304-695, 63304-696) , pack(63304-694, 63304-695, 63304-696) Establishment Name Address ID/FEI Business Operations Euticals SpA dba Prime European Therapeuticals SpA 430253557 api manufacture(63304-694, 63304-695, 63304-696)