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 capsules may be taken with or without food.<br/>For Pediatric Patients Above 8 Years of Age: The usual dosage of minocycline hydrochloride capsules is 4 mg/kg initially followed by 2 mg/kg every 12 hours.<br/>Adults: The usual dosage of minocycline hydrochloride 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 four 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 four 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 five days is recommended. For the treatment of syphilis, the usual dosage of minocycline hydrochloride capsules 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 five days. Mycobacterium marinum infections: Although optimal doses have not been established, 100 mg every 12 hours for 6 to 8 weeks have been used successfully in a limited number of cases. Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis or Ureaplasma urealyticum: 100 mg orally, every 12 hours for at least seven days. 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. In patients with renal impairment , the total dosage should be decreased by either reducing the recommended individual doses and/or by extending the time intervals between doses.
Minocycline hydrochloride, a semisynthetic derivative of tetracycline, is 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: CHNO.HCl M. W. 493.94 Each minocycline hydrochloride capsule, 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: magnesium stearate and starch (corn). The 50 mg, 75 mg and 100 mg capsule shells contain: gelatin, silicon dioxide, sodium lauryl sulfate and titanium dioxide. The 75 mg and 100 mg capsule shells also contain: black iron oxide.
Following oral administration of minocycline hydrochloride capsules, absorption from the gastrointestinal tract is rapid. Maximum serum concentrations following a single dose of minocycline hydrochloride to normal fasting adult volunteers were attained in 1 to 4 hours. The serum half-life in normal volunteers ranges from approximately 11 hours to 22 hours. When minocycline hydrochloride capsules were given concomitantly with a meal which included dairy products, the extent of absorption of minocycline hydrochloride capsules was not noticeably influenced. The peak plasma concentrations were slightly decreased and delayed by one hour when administered with food, compared to dosing under fasting conditions. 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 is one-half to one-third that of other tetracyclines.<br/>Microbiology: 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 tetracyclines is common. Minocycline has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section: AEROBIC GRAM-POSITIVE MICROORGANISMS 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. AEROBIC GRAM-NEGATIVE MICROORGANISMS Because many strains of the following groups of gram-negative microorganisms have been shown to be resistant to tetracyclines, culture and susceptibility tests are especially recommended: "OTHER" MICROORGANISMS When penicillin is contraindicated, tetracyclines are alternative drugs in the treatment of infections caused by the cited microorganisms.<br/>Susceptibility tests: Susceptibility testing should be performed with tetracycline since it predicts susceptibility to minocycline. However, certain organisms (e.g., some staphylococci, and Acinetobacter ssp.) may be more susceptible to minocycline and doxycycline than to tetracycline. Dilution techniques 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(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: Diffusion techniques Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedurerequires the use of standardized inoculum concentrations. This procedure uses paper disks impregnated with 30��g tetracycline (class disk) or 30��g minocycline to test the susceptibility of microorganisms to minocycline. Reports from the laboratory providing results of the standard single-disk susceptibility test with a 30��g tetracycline or minocycline disk should be interpreted according to the following criteria: For testing aerobic gram-negative microorganisms (Enterobacteriaceae) Acinetobacter ssp. and Staphylococcus aureus: For testing Haemophilus influenzae: These zone diameter standards are applicable only to susceptibility testing with Haemophilus influenzae using Haemophilus Test Medium and a 30��g tetracycline disk. For testing Neisseria gonorrhoeae: These interpretative standards are applicable only to disk diffusion testing using GC agar and 1% growth supplements, and a 30��g tetracycline disk. For testing Streptococcus pneumoniae: These interpretative standards are applicable only to disk diffusion testing using Muller-Hinton agar adjusted with 5% sheep blood and a 30��g tetracycline disk. For testing Vibrio cholerae: These interpretative standards are applicable only to disk diffusion testing performed with a 30��g tetracycline disk. Interpretation should be as stated above for results using dilution techniques. Interpretation involves correlation of the diameter obtained in the disk test with the MIC for tetracycline. 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��g tetracycline or minocycline disk should provide the following zone diameters in these laboratory test quality control strains:
This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
DYNACIN (MINOCYCLINE HCl CAPSULES, USP) equivalent to 50 mg minocycline are opaque white capsules imprinted "0487" and "DYNACIN 50 mg" and are supplied as follows: NDC 99207-487-10 Bottles of 100 NDC 99207-487-11 Bottle of 1000. DYNACIN (MINOCYCLINE HCl CAPSULES, USP) equivalent to 75 mg minocycline are light gray opaque capsules imprinted "0489" and "DYNACIN 75 mg" and are supplied as follows: NDC 99207-489-10 Bottles of 100 NDC 99207-489-11 Bottle of 1000. DYNACIN (MINOCYCLINE HCl CAPSULES, USP) equivalent to 100 mg minocycline are opaque dark gray and opaque white capsules imprinted "0488" and "DYNACIN 100 mg" and are supplied as follows: NDC 99207-488-05 Bottles of 50 NDC 99207-488-11 Bottle of 1000. Dispense in tight, light-resistant container with child-resistant closure. Store at 20�����25��C (68�����77��F). [See USP Controlled Room Temperature]. Protect from light, moisture and excessive heat.
In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Minocycline is not removed in significant quantities by hemodialysis or peritoneal dialysis.
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.<br/>Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, pancreatitus, inflammatory lesions (with monilial overgrowth) in the anogenital region, and increases in liver enzymes have been reported. Rarely, hepatitis and liver failure have been reported. These reactions have been causedby both the oral and the parenteral administration of tetracyclines. Rare 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 .<br/>Skin: Maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Fixed drug eruptions have been rarely reported. Lesions occurring on the glans penis have caused balanitis. Erythema multiforme and rarely Stevens-Johnson syndrome have been reported. Photosensitivity is discussed above . Pigmentation of the skin and mucous membranes has been reported.<br/>Renal toxicity: Elevations in BUN have been reported and are apparently dose related . Acute renal failure has been rarely reported and, in most cases, has been reversible.<br/>Hypersensitivity reactions: Urticaria, angioneurotic edema, polyarthralgia, anaphylaxis, anaphylactoid purpura, pericarditis, exacerbation of systemic lupus erythematosus and rarely pulmonary infiltrates with eosinophilia have been reported. A lupus-like syndrome and serum sickness-like reactions also have been reported.<br/>Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported.<br/>Central Nervous System: Bulging fontanels in infants and benign intracranial hypertension (pseudotumor cerebri) in adults have been reported. Headache has also been reported.<br/>Other: When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of the thyroid glands. Very rare cases of abnormal thyroid function have been reported. Tooth discoloration in pediatric patients less than 8 years of age and also, rarely, in adults has been reported. Tinnitus and decreased hearing have been rarely reported in patients on minocycline hydrochloride.
Minocycline Hydrochloride Capsules are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: Minocycline is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug: Minocycline hydrochloride capsules are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections: In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. In severe acne, minocycline may be useful adjunctive therapy. 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 susceptibilitytesting, 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. 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 capsules and other antibacterial drugs, minocycline hydrochloride capsules 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 modifyingantibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.