Minocycline hydrochloride

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# Overview
Minocycline hydrochloride is a tetracycline antibiotic that is FDA approved for the {{{indicationType}}} of acne vulgaris, bacterial infectious disease, amebic dysentery; adjunct, anthrax, chlamydia trachomatis infection, disease caused by rickettsiae, periodontitis; adjunct, respiratory tract infection, syphilis, ureaplasma urealyticum infection, urinary tract infectious disease.   Common adverse reactions include tooth discoloration, dizziness, headache, fatigue.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae.
- The usual dosage of MINOCIN Pellet-Filled Capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg pellet-filled capsules may be given initially followed by one 50 mg capsule 4 times daily.
- Respiratory tract infections caused by Mycoplasma pneumoniae.
- The usual dosage of MINOCIN Pellet-Filled Capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg pellet-filled capsules may be given initially followed by one 50 mg capsule 4 times daily.
- Caused by Chlamydia trachomatis.
- The usual dosage of MINOCIN Pellet-Filled Capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg pellet-filled capsules may be given initially followed by one 50 mg capsule 4 times daily.
- Caused by Chlamydia psittaci.
- The usual dosage of MINOCIN Pellet-Filled Capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg pellet-filled capsules may be given initially followed by one 50 mg capsule 4 times daily.
- Caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence.
- The usual dosage of MINOCIN Pellet-Filled Capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg pellet-filled capsules may be given initially followed by one 50 mg capsule 4 times daily.
- Caused by Chlamydia trachomatis.
- The usual dosage of MINOCIN Pellet-Filled Capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg pellet-filled capsules may be given initially followed by one 50 mg capsule 4 times daily.
- Caused by Ureaplasma urealyticum or Chlamydia trachomatis.
- The usual dosage of MINOCIN Pellet-Filled Capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg pellet-filled capsules may be given initially followed by one 50 mg capsule 4 times daily.
- Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis or Ureaplasma urealyticum: 100 mg orally, every 12 hours for at least 7 days.
- Caused by Borrelia recurrentis.
- The usual dosage of MINOCIN Pellet-Filled Capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg pellet-filled capsules may be given initially followed by one 50 mg capsule 4 times daily.
- Caused by Haemophilus ducreyi.
- The usual dosage of MINOCIN Pellet-Filled Capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg pellet-filled capsules may be given initially followed by one 50 mg capsule 4 times daily.
- Caused by Yersinia pestis.
- The usual dosage of MINOCIN Pellet-Filled Capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg pellet-filled capsules may be given initially followed by one 50 mg capsule 4 times daily.
- Caused by Francisella tularensis.
- The usual dosage of MINOCIN Pellet-Filled Capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg pellet-filled capsules may be given initially followed by one 50 mg capsule 4 times daily.
- Caused by Vibrio cholerae.
- The usual dosage of MINOCIN Pellet-Filled Capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg pellet-filled capsules may be given initially followed by one 50 mg capsule 4 times daily.
- Caused by Campylobacter fetus
- The usual dosage of MINOCIN Pellet-Filled Capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg pellet-filled capsules may be given initially followed by one 50 mg capsule 4 times daily.
- Caused by Brucella species (in conjunction with streptomycin).
- The usual dosage of MINOCIN Pellet-Filled Capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg pellet-filled capsules may be given initially followed by one 50 mg capsule 4 times daily.
- Due to Bartonella bacilliformis.
- The usual dosage of MINOCIN Pellet-Filled Capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg pellet-filled capsules may be given initially followed by one 50 mg capsule 4 times daily.
- Caused by Calymmatobacterium granulomatis.
- The usual dosage of MINOCIN Pellet-Filled Capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg pellet-filled capsules may be given initially followed by one 50 mg capsule 4 times daily.
- MINOCIN Pellet-Filled Capsules are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:
- Caused by Streptococcus pneumoniae.
- The usual dosage of MINOCIN Pellet-Filled Capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg pellet-filled capsules may be given initially followed by one 50 mg capsule 4 times daily.
- Caused by Staphylococcus aureus. (Note: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.)
- The usual dosage of MINOCIN Pellet-Filled Capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg pellet-filled capsules may be given initially followed by one 50 mg capsule 4 times daily.
- When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections:
- In men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections.
- 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.
- The usual dosage of MINOCIN Pellet-Filled Capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg pellet-filled capsules may be given initially followed by one 50 mg capsule 4 times daily.
- Caused by Treponema pallidum subspecies pallidum.
- The usual dosage of MINOCIN Pellet-Filled Capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg pellet-filled capsules may be given initially followed by one 50 mg capsule 4 times daily.
- 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.
- Caused by Treponema pallidum subspecies pertenue.
- The usual dosage of MINOCIN Pellet-Filled Capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg pellet-filled capsules may be given initially followed by one 50 mg capsule 4 times daily.
- Due to Listeria monocytogenes.
- The usual dosage of MINOCIN Pellet-Filled Capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg pellet-filled capsules may be given initially followed by one 50 mg capsule 4 times daily.
- Due to Bacillus anthracis.
- The usual dosage of MINOCIN Pellet-Filled Capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg pellet-filled capsules may be given initially followed by one 50 mg capsule 4 times daily.
- Caused by Fusobacterium fusiforme.
- The usual dosage of MINOCIN Pellet-Filled Capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg pellet-filled capsules may be given initially followed by one 50 mg capsule 4 times daily.
- Caused by Actinomyces israelii.
- The usual dosage of MINOCIN Pellet-Filled Capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg pellet-filled capsules may be given initially followed by one 50 mg capsule 4 times daily.
- Caused by Clostridium species.
- The usual dosage of MINOCIN Pellet-Filled Capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg pellet-filled capsules may be given initially followed by one 50 mg capsule 4 times daily.
- Minocycline may be a useful adjunct to amebicides.
- The usual dosage of MINOCIN Pellet-Filled Capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg pellet-filled capsules may be given initially followed by one 50 mg capsule 4 times daily.
- Minocycline may be useful adjunctive therapy.
- The usual dosage of MINOCIN Pellet-Filled Capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg pellet-filled capsules may be given initially followed by one 50 mg capsule 4 times daily.
- In the treatment of meningococcal carrier state, the recommended dosage is 100 mg every 12 hours for 5 days.
- 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.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Minocycline hydrochloride in adult patients.

### NonGuideline-Supported Use
- Dosing Information
- Minocycline at a dosage of 200 mg orally daily for 5 days.
- Dosing Information
- Minocycline (100 mg once daily).
- Dosing Information
- Minocycline 100 mg twice daily.
- Dosing Information
- 100 mg of minocycline.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
- Usual pediatric dose: 4 mg/kg initially followed by 2 mg/kg every 12 hours, not to exceed the usual adult dose.
- Minocycline is not recommended for the use in children below 8 years of age unless the expected benefits of therapy outweigh the risks.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Minocycline hydrochloride in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Minocycline hydrochloride in pediatric patients.

# Contraindications
- 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.

# Warnings
- MINOCIN, 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.
- 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.
- 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. If renal impairment exists, even usual oral or parenteral doses may lead to systemic accumulation of the drug and possible liver toxicity.
- 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.
- Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including MINOCIN, 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.

### Precautions
- 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.
- Hepatotoxicity has been reported with minocycline; therefore, minocycline should be used with caution in patients with hepatic dysfunction and in conjunction with other hepatotoxic drugs.
- Incision and drainage or other surgical procedures should be performed in conjunction with antibiotic therapy when indicated.
- Prescribing MINOCIN (minocycline hydrochloride) Pellet-Filled 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.

# Adverse Reactions

## Clinical Trials Experience
- Due to oral minocyclines 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.
Fever, and discoloration of secretions.
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.
Vulvovaginitis.
Hyperbilirubinemia, hepatic cholestasis, increases in liver enzymes, fatal hepatic failure, and jaundice. Hepatitis, including autoimmune hepatitis, and liver failure have been reported.
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. Pigmentation of the skin and mucous membranes has been reported.
Cough, dyspnea, bronchospasm, exacerbation of asthma, and pneumonitis.
Interstitial nephritis. Elevations in BUN have been reported and are apparently dose related. Reversible acute renal failure has been reported.
Arthralgia, arthritis, bone discoloration, myalgia, joint stiffness, and joint swelling.
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.
Agranulocytosis, hemolytic anemia, thrombocytopenia, leukopenia, neutropenia, pancytopenia, and eosinophilia have been reported.
Convulsions, dizziness, hypesthesia, paresthesia, sedation, and vertigo. Bulging fontanels in infants and benign intracranial hypertension (pseudotumor cerebri) in adults have been reported. Headache has also been reported.
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.
- Tooth discoloration in children less than 8 years of age and also, in adults has been reported.
- Oral cavity discoloration (including tongue, lip, and gum) have been reported.
- Tinnitus and decreased hearing have been reported in patients on MINOCIN.
- 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. Eosinophilia may be present.

## Postmarketing Experience
There is limited information regarding Postmarketing Experience of Minocycline hydrochloride in the drug label.

# 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.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA):
- Pregnancy Category D
- 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.
Pregnancy Category (AUS):
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Minocycline hydrochloride in women who are pregnant.

### Labor and Delivery
- The effect of tetracyclines on labor and delivery is unknown.

### 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.

### 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.

### Geriatic 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.

### Gender
There is no FDA guidance on the use of Minocycline hydrochloride with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Minocycline hydrochloride with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Minocycline hydrochloride in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Minocycline hydrochloride in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Minocycline hydrochloride in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Minocycline hydrochloride in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Oral

### Monitoring
There is limited information regarding Monitoring of Minocycline hydrochloride in the drug label.

# IV Compatibility
There is limited information regarding IV Compatibility of Minocycline hydrochloride in the drug label.

# Overdosage

## Acute Overdose

### Signs and Symptoms
- The adverse events more commonly seen in overdose are dizziness, nausea, and vomiting.

### Management
- 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.

## Chronic Overdose
There is limited information regarding Chronic Overdose of Minocycline hydrochloride in the drug label.

# Pharmacology

## 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 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.

## Structure
- MINOCIN 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:
- MINOCIN Pellet-Filled Capsules for oral administration contain pellets of minocycline HCl equivalent to 50 mg or 100 mg of minocycline in microcrystalline cellulose.
- The capsule shells contain the following inactive ingredients: Blue 1, Gelatin, Titanium Dioxide and Yellow 10. The 50 mg capsule shells also contain Black and Yellow Iron Oxides.

## Pharmacodynamics
There is limited information regarding Pharmacodynamics of Minocycline hydrochloride in the drug label.

## Pharmacokinetics
- Following a single dose of two MINOCIN 100 mg pellet-filled capsules 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 g/mL (average 3.5 g/mL). The serum half-life in the normal volunteers ranged from 11.1 to 22.1 hours (average 15.5 hours).
- When MINOCIN Pellet-Filled Capsules were given concomitantly with a high-fat meal, which included dairy products, the extent of absorption of MINOCIN Pellet-Filled 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. MINOCIN   Pellet-Filled 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.

## Nonclinical Toxicology
- 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 (ie, adrenal and pituitary tumors). Likewise, although mutagenicity studies of minocycline have not been conducted, positive results in in vitro mammalian cell assays (ie, 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.

# Clinical Studies
There is limited information regarding Clinical Studies of Minocycline hydrochloride in the drug label.

# How Supplied
- MINOCIN Pellet-Filled Capsules are supplied as capsules containing minocycline hydrochloride equivalent to 100 mg and 50 mg minocycline.
- 100 mg, two-piece, hard-shell capsule with an opaque light green cap and a transparent green body, printed in white ink with Onset over M0100 on one half and Onset over 100 mg on the other half. Each capsule contains pellets of minocycline HCl equivalent to 100 mg of minocycline, supplied as follows:
- NDC 16781-403-50: Bottle of 50
- 50 mg, two-piece, hard-shell capsule with an opaque yellow cap and a transparent green body, printed in black ink with Onset over M050 on one half and Onset over 50 mg on the other half. Each capsule contains pellets of minocycline HCl equivalent to 50 mg of minocycline, supplied as follows:
- NDC 16781-400-96: Bottle of 100
- Store at controlled room temperature 20 to 25C (68 to 77F).
- Protect from light, moisture, and excessive heat.
- Dispense in a tight, light-resistant container as defined in the USP.

## Storage
There is limited information regarding Minocycline hydrochloride Storage in the drug label.

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
- 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 MINOCIN (minocycline hydrochloride) Pellet-Filled Capsules should only be used to treat bacterial infections. They do not treat viral infections (eg, the common cold). When MINOCIN (minocycline hydrochloride) Pellet-Filled 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 MINOCIN (minocycline hydrochloride) Pellet-Filled Capsules or other antibacterial drugs in the future.
- Unused supplies of tetracycline antibiotics should be discarded by the expiration date.

# Precautions with Alcohol
- Alcohol-Minocycline hydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- MINOCIN

# Look-Alike Drug Names
- Dynacin  Dynacirc

# Drug Shortage Status

# Price