minocycline (as minocycline hydrochloride) 100 MG Oral Capsule

Generic Name: MINOCYCLINE HYDROCHLORIDE
Brand Name: Minocycline Hydrochloride
  • Substance Name(s):
  • MINOCYCLINE HYDROCHLORIDE

WARNINGS

MINOCYCLINE, 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 .) If renal impairment exists, even usual oral or parenteral doses may lead to systemic accumulation of the drug and possible liver toxicity.

DOSAGE AND ADMINISTRATION Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines.

This has been reported with minocycline.

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.

associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including minocycline, 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 Clostridium difficile C.

difficile.

produces toxins A and B which contribute to the development of CDAD.

Hypertoxin producing strains of 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.

C.

difficile C.

difficile If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued.

Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of and surgical evaluation should be instituted as clinically indicated.

C.

difficile C.

difficile,

DRUG INTERACTIONS

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 .) PRECAUTIONS Increased risk of ergotism when ergot alkaloids or their derivatives are given with tetracyclines.

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.

DESCRIPTION

Minocycline hydrochloride 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.

Its structural formula is: C H N O •HCl M.W.

493.95 23 27 3 7 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: D&C Red No.

28, D&C Yellow No.

10, gelatin, silicon dioxide, sodium lauryl sulfate and titanium dioxide.

The 100 mg capsule shell also contains black iron oxide.

Structural formula of Minocycline Hydrochloride

HOW SUPPLIED

NDC:68151-2299-5 in a PACKAGE of 1 CAPSULES

GERIATRIC USE

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

INDICATIONS AND USAGE

Minocycline hydrochloride capsules 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 Chlamydia psittaci.

Trachoma caused by , although the infectious agent is not always eliminated, as judged by immunofluorescence.

Chlamydia trachomatis Inclusion conjunctivitis caused by Chlamydia trachomatis.

Nongonococcal urethritis, endocervical, or rectal infections in adults caused by or 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 species (in conjunction with streptomycin).

Brucella Bartonellosis due to Bartonella bacilliformis.

Granuloma inguinale caused by Calymmatobacterium 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.

species.

Shigella species.

Acinetobacter Respiratory tract infections caused by Haemophilus influenzae.

Respiratory tract and urinary tract infections caused by species.

Klebsiella 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: Upper respiratory tract infections caused by .

Streptococcus pneumoniae Skin and skin structure infections caused by (Note: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.) Staphylococcus aureus.

When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections: Uncomplicated urethritis in men due to and for the treatment of other gonococcal infections.

Neisseria gonorrhoeae Infections in women caused by .

Neisseria gonorrhoeae Syphilis caused by subspecies Treponema pallidum pallidum.

Yaws caused by subspecies 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 species Clostridium .

In acute minocycline may be a useful adjunct to amebicides.

intestinal amebiasis, In severe minocycline may be useful adjunctive therapy.

acne, Oral minocycline is indicated in the treatment of asymptomatic carriers of 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.

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 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 modifying antibacterial therapy.

In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

PEDIATRIC USE

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

PREGNANCY

Pregnancy Teratogenic Effects (See .) Pregnancy Category D.

WARNINGS 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 (See .) WARNINGS

NUSRING MOTHERS

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

INFORMATION FOR PATIENTS

Information for Patients 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 who experience central nervous system symptoms should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy.

(See .) WARNINGS Concurrent use of tetracycline with oral contraceptives may render oral contraceptives less effective.

(See .) Drug Interactions 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.

Unused supplies of tetracycline antibiotics should be discarded by the expiration date.

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 capsules 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 capsules should be swallowed whole.

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 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.

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.

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.

Mycobacterium marinum Uncomplicated urethral, endocervical, or rectal infection in adults caused by or 100 mg orally, every 12 hours for at least 7 days.

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 (CL CR <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