Minocin

• Compumed Pharmaceuticals, Inc.

• Lederle Labs

• Onset Dermatologics, LLC

• Rempex Pharmaceuticals, Inc.

• Triax Pharmaceuticals, LLC

Minocin is part of the drug class:

• TETRACYCLINES

Minocycline may cause serious side effects. See "Drug Precautions" section.

The most common side effects of minocycline include:

• nausea
• fever
• diarrhea
• vomiting
• headache
• tiredness
• dizziness or spinning feeling
• itching

Call your doctor if you have a side effect that bothers you or that does not go away. Your doctor may do tests to check you for side effects during treatment with minocycline.

These are not all the side effects with minocycline. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant. Minocycline may harm your unborn baby. Taking minocycline while you are pregnant may cause serious side effects on the growth of bone and teeth of your baby. Talk to your doctor before taking minocycline if you plan to become pregnant, or if you are already taking minocycline and plan to become pregnant. Stop taking minocycline and call your doctor right away if you become pregnant while taking minocycline.

Minocycline may make your birth control pills less effective. You could become pregnant. You should use a second form of birth control while taking minocycline.

If you are a male, and you and your female partner are trying to conceive a baby. You should not take minocycline.

If you take too much minocycline, call your doctor or poison control center right away. 

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Black, tarry stools
• blistering, peeling, or loosening of the skin
• blood in the urine or stools
• blurred or double vision
• bulging soft spot on the head of an infant
• chest pain, possibly moving to the left arm, neck, or shoulder
• confusion
• diarrhea
• dizziness or lightheadedness
• eye pain
• fast heartbeat
• general feeling of discomfort or illness
• general tiredness and weakness
• hives, itching, or skin rash
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• nausea or vomiting
• red skin lesions, often with a purple center
• severe headache
• severe stomach pain
• sores, ulcers, or white spots on the lips or in the mouth
• troubled breathing
• unusual bleeding or bruising
• upper right abdominal or stomach pain
• yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Continuing ringing or buzzing or other unexplained noise in the ears
• difficulty with moving
• hearing loss
• hives or welts
• muscle stiffness
• redness of the skin
• sleepiness or unusual drowsiness

• Bloating
• discoloration of the tooth
• increased sensitivity of the skin to sunlight
• indigestion
• severe sunburn

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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 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 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.

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 PRECAUTIONS - Drug Interactions).

Patients should be counseled that antibacterial drugs including Minocin Pellet-Filled Capsules should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Minocin 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 Pellet-Filled Capsules or other antibacterial drugs in the future.

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

Rx Only

NDC 16781-403-60

Minocin®

(minocycline HCl)

Pellet-Filled Capsules

60 Capsules

100

mg

Applies to minocycline: intravenous powder for injection, oral capsule, oral suspension, oral tablet, oral tablet extended release, oral and topical kit

Nervous system

Headache, dizziness, vertigo. and ataxia have been reported. These side effects were reversible within 3 to 48 hours of stopping therapy and occurred less often with low doses.

Pseudotumor cerebri, bulging fontanels (infants), and decreased hearing have also been reported during postmarketing experience.[Ref]

Very common (10% or more): Headache (up to 23%)
Common (1% to 10%): Dizziness (lightheadedness), somnolence, tinnitus, vertigo
Rare (0.01% to 0.1%): Hypoesthesia, paresthesia, intracranial hypertension, impaired/decreased hearing
Very rare (less than 0.01%): Bulging fontanels (in infants)
Frequency not reported: Convulsions, sedation, ataxia, benign intracranial hypertension (pseudotumor cerebri), vestibular reactions[Ref]

Dermatologic

Hyperpigmentation of various body sites (including the skin, nails, teeth, oral mucosa, bones, thyroid, eyes [including sclera, conjunctiva], breast milk, lacrimal secretions, perspiration) has been reported. This blue/black/grey or muddy-brown discoloration was localized or diffuse. The most common site was the skin. Pigmentation often reversed when the drug was discontinued; however, resolution took several months or persisted in some cases. The generalized muddy-brown skin pigmentation sometimes persisted, especially in areas exposed to sun.

Biopsies of pigmented tissue have shown granules within the cells which stained positive for iron. This pigmentation faded over time after drug discontinuation.

DRESS syndrome (including fatal cases) has been reported. DRESS syndrome with persistent myocarditis has been reported in at least 3 cases.

Fixed drug eruptions, erythema multiforme, Stevens-Johnson syndrome, and photosensitivity have also been reported during postmarketing experience.[Ref]

Common (1% to 10%): Pruritus, urticaria
Rare (0.01% to 0.1%): Alopecia, erythema multiforme, erythema nodosum, fixed drug eruptions, hyperpigmentation (brownish or bluish-black pigmentation) of skin, photosensitivity, rash, vasculitis
Very rare (less than 0.01%): Angioedema, exfoliative dermatitis, hyperpigmentation of nails/nail beds, Stevens-Johnson syndrome, toxic epidermal necrolysis
Frequency not reported: Hyperpigmentation of various body sites (including bones, mucous membranes, teeth, oral mucosa, tongue, thyroid, eyes [including sclera, conjunctiva], breast milk, lacrimal secretions, structures of inner organs), maculopapular rash, erythematous rash, discolored perspiration, Sweet's syndrome (acute febrile neutrophilic dermatosis)
Postmarketing reports: Anaphylactoid purpura, pigmentation of skin and mucous membranes, angioneurotic edema, drug rash with eosinophilia and systemic symptoms (DRESS)[Ref]

Gastrointestinal

Pancreatitis has rarely been associated with use of this drug. In 2 case reports, cystic fibrosis patients experienced pancreatitis during treatment with this drug for acute bacterial exacerbations of respiratory disease. The authors suggested that cystic fibrosis patients, as a result of the disease process, may be more susceptible to drug-induced pancreatitis. Additionally, in at least 1 case, multiple concomitant medications were taken; therefore, a temporal relationship between this drug and pancreatitis could not be proven conclusively.

Esophagitis and esophageal ulcerations have been reported in patients taking the capsule or tablet formulations of tetracycline-class antibiotics. Most of these patients took the drug immediately before going to bed.

Enterocolitis, pancreatitis, glossitis, dysphagia, and tooth discoloration have also been reported during postmarketing experience.[Ref]

Common (1% to 10%): Dry mouth
Rare (0.01% to 0.1%): Diarrhea, nausea, stomatitis, discoloration of teeth, vomiting
Very rare (less than 0.01%): Oral and anogenital candidiasis, dyspepsia, dysphagia, enamel hypoplasia, enterocolitis, esophagitis, esophageal ulcerations, glossitis, pancreatitis, pseudomembranous colitis
Frequency not reported: Antibiotic-associated colitis, oral cavity discoloration (including buccal mucosa, tongue, lip, gum), abdominal cramping, inflammatory lesions (with monilial overgrowth) in the oral and anogenital regions[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, myalgia
Rare (0.01% to 0.1%): Lupus-like syndrome (consisting of positive antinuclear antibody [ANA], arthralgia, arthritis, joint stiffness/swelling, and at least 1 of the following: fever, myalgia, hepatitis, rash, vasculitis)
Very rare (less than 0.01%): Arthritis, bone discoloration, systemic lupus erythematosus (SLE), exacerbation of SLE, joint stiffness, joint swelling, joint discoloration, myopathy, hypersensitivity-associated rhabdomyolysis
Postmarketing reports: Polyarthralgia, exacerbation of systemic lupus, transient lupus-like syndrome[Ref]

Lupus-like reactions induced by this drug have commonly presented with arthralgia or arthritis, myalgia or malaise, and positive ANA titer. Patients with highly positive anti-double stranded DNA (anti-dsDNA) antibodies have rarely been reported. All patients recovered after the drug was discontinued; however, several required short courses of corticosteroids.

Severe acute myopathy associated with this drug (100 mg orally per day) occurred in a 17-year-old male after strenuous exercise. His laboratory values were as follows: ESR 33 mm/hr, CRP 0.84 mg/dL, creatine kinase 87,297 units/L, AST 1307 units/L, ALT 311 units/L, LDH 4935 units/L, aldolase 12.6 units/L, alkaline phosphatase 145 units/L, GGT 66 units/L. Muscle enzyme levels normalized and his symptoms resolved 1 month after this drug was discontinued.

IV minocycline plus quinupristin-dalfopristin were associated with myalgia and arthralgia in 36% of neutropenic cancer patients (n=56).[Ref]

Other

Common (1% to 10%): Fatigue, malaise
Uncommon (0.1% to 1%): Fever
Very rare (less than 0.01%): Discoloration of secretions

Injection:
-Frequency not reported: Magnesium intoxication (including flushing, sweating, hypotension, depressed reflexes, flaccid paralysis, hypothermia, circulatory collapse, cardiac and CNS depression, respiratory paralysis)[Ref]

Psychiatric

Common (1% to 10%): Mood alteration

Hypersensitivity

Death has been reported in some cases involving hypersensitivity syndrome, serum sickness-like syndrome, and lupus-like syndrome.

Pulmonary infiltrates, night sweats, fever, and eosinophilia have developed in several patients receiving this drug. These effects were thought to be due to drug hypersensitivity.

Case reports have described a severe CNS -pulmonary hypersensitivity syndrome requiring high-dose corticosteroid therapy. Signs and symptoms have included dry cough, fever, ataxia, muscle weakness, numbness, visual abnormalities, abnormal brain MRI, seizures, pulmonary infiltrates, elevated serum IgE, elevated erythrocyte sedimentation rate (ESR), and eosinophilia.

Eosinophilic pneumonia with relapsing acute respiratory failure requiring mechanical ventilation and corticosteroids has been reported in a 54-year-old woman. Initial symptoms included dry cough, low-grade fever, fatigue, and dyspnea. Eosinophilia, elevated leukocytes, and C-reactive protein (CRP) were noted. At 14 days after being discharged and resuming this drug, the patient developed rapidly progressive respiratory failure again requiring mechanical ventilation.

Late-onset drug fever (associated with fever, sore throat, abdominal pain, weakness, loose bloody stools, fatigue, 40-pound weight loss, ESR 99 mm/hr, CRP 5 mg/dL, and mild increases in liver enzymes) has been reported in a 15-year-old boy after using this drug for 24 months for acne. After 1 year of therapy, at least 1 other case of late-onset drug fever occurred. Other reported cases of drug fever generally occurred after 2 to 4 weeks of drug exposure.[Ref]

Rare (0.01% to 0.1%): Anaphylaxis/anaphylactoid reaction (including shock, fatalities)
Frequency not reported: Hypersensitivity, hypersensitivity syndrome (consisting of cutaneous reaction [e.g., rash, exfoliative dermatitis], eosinophilia, and at least 1 of the following: hepatitis, pneumonitis, nephritis, myocarditis, pericarditis; with or without fever, lymphadenopathy), serum sickness-like syndrome (consisting of fever, urticaria/rash, arthralgia, arthritis, joint stiffness/swelling, lymphadenopathy; with or without eosinophilia), autoimmune vasculitis, drug fever, eosinophilic pneumonitis, drug hypersensitivity (e.g., pulmonary infiltrates, night sweats, fever, eosinophilia), serum sickness, serum sickness-like reactions, severe central nervous system (CNS)-pulmonary hypersensitivity syndrome
Postmarketing reports: Hypersensitivity reactions, anaphylaxis[Ref]

Immunologic

Frequency not reported: Positive antineutrophil cytoplasmic antibody (ANCA) titers, polyarteritis nodosa, ANCA-positive crescentic glomerulonephritis, ANCA-positive vasculitis, autoimmune hepatitis, necrotizing vasculitis and systemic reactions[Ref]

Rare cases of necrotizing vasculitis and systemic reactions have been reported, characterized by lymphadenopathy, eosinophilia, increased liver function enzyme levels, and dermatologic involvement. In each case, this drug was discontinued and in some cases, corticosteroid therapy was necessary to assist in the resolution of symptoms.[Ref]

Hepatic

Some hepatic reactions had an autoimmune basis and occurred after several months of therapy.

In 1 case, a patient developed rapidly progressing liver failure after using this drug for 4 weeks for acne. The patient had stopped this drug 2 weeks prior to onset of malaise. Liver transplantation was considered, but the patient slowly recovered without significant intervention.

Other reports of immunologically-mediated progressive liver dysfunction have rarely occurred. In 1 case, a patient received a liver transplant after fulminant hepatic failure which was thought to be related to a 3-year history of daily therapy to treat acne. The dose of this drug ranged from 50 to 200 mg/day. A second patient had been using this drug to treat acne for 1 year just prior to seeking medical attention for an "influenza-like" syndrome. Upon hospitalization, it was determined that the patient was experiencing an autoimmune-mediated hepatitis, most probably related to this drug. Resolution of symptoms occurred in both of these cases after therapy was discontinued and each patient had received appropriate supportive medical care.

Hepatitis and liver failure have also been reported during postmarketing experience.[Ref]

Rare (0.01% to 0.1%): Increased liver enzymes, hepatitis, autoimmune hepatitis/hepatotoxicity
Very rare (less than 0.01%): Hepatic cholestasis, hepatic failure (including fatalities), hyperbilirubinemia, jaundice
Frequency not reported: Autoimmune hepatitis with lupus-like symptoms, increased liver function test values, acute hepatic failure, liver injury, acute hypersensitivity hepatitis associated with eosinophilia and dermatitis[Ref]

Renal

Rare (0.01% to 0.1%): Increased BUN/serum urea, interstitial nephritis, acute renal failure
Postmarketing reports: Reversible acute renal failure

Tetracyclines:
-Frequency not reported: Aggravation of preexisting renal failure, azotemia/uremia, nephrotoxicity (associated with acute fatty liver), renal tubular damage, Fanconi-like syndrome[Ref]

Nephrotoxicity associated with acute fatty liver has been reported with high tetracycline doses. High serum levels of tetracyclines have been associated with azotemia, hyperphosphatemia, and acidosis in patients with renal dysfunction.

Degraded tetracycline may cause renal tubular damage and a Fanconi-like syndrome.[Ref]

Hematologic

Rare (0.01% to 0.1%): Eosinophilia, leukopenia, neutropenia, thrombocytopenia
Very rare (less than 0.01%): Hemolytic anemia, pancytopenia
Frequency not reported: Agranulocytosis, antineutrophil cytoplasmic antibody (ANCA)-positive vasculitis[Ref]

Hemolytic anemia, thrombocytopenia, and eosinophilia have also been reported during postmarketing experience.[Ref]

Respiratory

Rare (0.01% to 0.1%): Cough, dyspnea, pulmonary infiltration
Very rare (less than 0.01%): Bronchospasm, exacerbation of asthma, pulmonary eosinophilia
Frequency not reported: Pneumonitis, hypersensitivity pneumonitis, pulmonary lupus, eosinophilic pneumonia, pleural effusions, relapsing acute respiratory failure
Postmarketing reports: Pulmonary infiltrates with eosinophilia[Ref]

Cardiovascular

Rare (0.01% to 0.1%): Myocarditis, pericarditis[Ref]

Metabolic

High serum levels of tetracyclines have been associated with azotemia, hyperphosphatemia, and acidosis in patients with renal dysfunction.[Ref]

Rare (0.01% to 0.1%): Anorexia

Tetracyclines:
-Frequency not reported: Hyperphosphatemia, acidosis[Ref]

Endocrine

Very rare (less than 0.01%): Abnormal thyroid function, brown-black microscopic thyroid discoloration
Frequency not reported: Discolored breast secretions[Ref]

A condition characterized by dark pigmentation (brown-black microscopic discoloration) of the thyroid gland has been reported; however, there was no clinical or laboratory evidence of thyroid dysfunction (unknown clinical implications).

Brown-black microscopic thyroid discoloration and abnormal thyroid function have also been reported during postmarketing experience.[Ref]

Genitourinary

Very rare (less than 0.01%): Balanitis (due to lesions on the glans penis), vulvovaginitis
Postmarketing reports: Deleterious effects on spermatogenesis[Ref]

Balanitis has also been reported during postmarketing experience.[Ref]

Local

Frequency not reported: Injection site erythema, injection site pain[Ref]

Oncologic

Frequency not reported: Papillary thyroid cancer
Postmarketing reports: Thyroid cancer

Ocular

Frequency not reported: Discoloration of conjunctiva, discoloration of lacrimal secretions, grey scleral pigmentation, macular pigmentation[Ref]

Cases of grey scleral pigmentation and macular pigmentation have been reported in elderly patients after chronic use of this drug (5 to 12 years).[Ref]

Some side effects of Minocin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.