Minocin Information
Minocin (Minocycline hcl)
Minocin (Minocycline hcl) Description
Minocin (Minocycline hcl) , minocycline for injection, a sterile formulation of 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.
Its structural formula is:
CHNO•HCl M.W. 493.94
Each vial, dried by cryodesiccation, contains minocycline HCl equivalent to 100 mg minocycline. When reconstituted with 5 mL of Sterile Water for Injection USP the pH ranges from 2.0 to 2.8.
Minocin (Minocycline hcl) Clinical Pharmacology
Following a single dose of Minocin (Minocycline hcl) 200 mg administered intravenously to 10 healthy male subjects, serum concentrations of minocycline ranged from 2.52 to 6.63 mcg/mL (average 4.18 mcg/mL) at the end of infusion and 0.82 to 2.64 mcg/mL (average 1.38 mcg/mL) after 12 hours. In a group of 5 healthy male subjects, serum concentrations of minocycline ranged from 1.4 to 1.8 mcg/mL at the end of the dosing interval following administration of Minocin (Minocycline hcl) 100 mg every 12 hours for three days. When Minocin (Minocycline hcl) 200 mg once daily was administered for three days, serum concentrations of minocycline were approximately 1 mcg/mL at 24 hours. The serum elimination half-life of minocycline following administration of either Minocin (Minocycline hcl) 100 mg every 12 hours or 200 mg once daily was not significantly different and ranged from 15 to 23 hours.
The serum elimination half-life of minocycline ranged from 11 to 16 hours in subjects with hepatic impairment (n=7) and 18 to 69 hours in subjects with renal impairment (n=5). In comparison, the serum elimination half-life of minocycline ranged from 11 to 17 hours following a single dose of oral minocycline 200 mg in healthy subjects (n=12).
Minocin (Minocycline hcl) Indications And Usage
Minocin (Minocycline hcl) Intravenous is indicated in the treatment of the following infections due to susceptible isolates of the designated bacteria:
Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae.Respiratory tract infections caused by .Lymphogranuloma venereum caused by .Psittacosis (Ornithosis) due to .Trachoma caused by , although the infectious agent is not always eliminated, as judged by immunofluorescence.Inclusion conjunctivitis caused by .Nongonococcal urethritis, endocervical, or rectal infections in adults caused by or .Relapsing fever due to .Plague due to .Tularemia due to .Cholera caused by .Campylobacter fetus infections caused by .Brucellosis due to species (in conjunction with streptomycin).Bartonellosis due to .Granuloma inguinale caused by .
Minocycline is indicated for the treatment of infections caused by the following Gram-negative bacteria when bacteriologic testing indicates appropriate susceptibility to the drug:
Minocin (Minocycline hcl) Intravenous is indicated for the treatment of infections caused by the following Gram-positive bacteria when bacteriologic testing indicates appropriate susceptibility to the drug:
Upper respiratory tract infections caused by .Skin and skin structure infections caused by (Note: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.)
When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections:
Meningitis due to .Syphilis caused by subspecies .Yaws caused by subspecies .Listeriosis due to .Anthrax due to .Vincent's infection caused by .Actinomycosis caused by .Infections caused by species.
In , minocycline may be a useful adjunct to amebicides.
In severe , minocycline may be useful adjunctive therapy.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Minocin (Minocycline hcl) (minocycline) Injection and other antibacterial drugs, Minocin (Minocycline hcl) (minocycline) Injection 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.
Minocin (Minocycline hcl) 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.
Minocin (Minocycline hcl) Warnings
This adverse reaction is more common during long-term use of the drugs but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported.
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 (See ). 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. 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.
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.
Minocin (Minocycline hcl) Precautions
As with other antibiotic preparations, use of this drug may result in overgrowth of nonsusceptible 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 soon 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 hcl) Injection 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.
Patients should be counseled that antibacterial drugs including Minocin (Minocycline hcl) (minocycline) Injection should only be used to treat bacterial infections. They do not treat viral infections (eg, the common cold). When Minocin (Minocycline hcl) (minocycline) Injection is 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 hcl) (minocycline) Injection or other antibacterial drugs in the future.
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.
Periodic laboratory evaluation of organ systems, including hematopoietic, renal and hepatic studies should be performed.
All patients with gonorrhea should have a serologic test for syphilis at the time of diagnosis. Patients treated with minocycline should have a follow-up serologic test for syphilis after 3 months.
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 tetracyclines in conjunction with penicillin.
The concurrent use of tetracyclines 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 ).
Increased risk of ergotism when ergot alkaloids or their derivatives are given with tetracyclines.
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.
Clinical studies of intravenous 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 , ).
Minocin (Minocycline hcl) IV (sterile minocycline hydrochloride, USP) does not contain sodium.
Minocin (Minocycline hcl) Adverse Reactions
The following adverse reactions have been observed in patients receiving tetracyclines.
Tooth discoloration in pediatric patients less than 8 years of age (see ) and 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 (Minocycline hcl) (minocycline for injection).
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.
Minocin (Minocycline hcl) 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.
Minocin (Minocycline hcl) Dosage And Administration
Note: Rapid administration is to be avoided. Parenteral therapy is indicated only when oral therapy is not adequate or tolerated. Oral therapy should be instituted as soon as possible. If intravenous therapy is given over prolonged periods of time, thrombophlebitis may result.
Minocin (Minocycline hcl) How Supplied
Minocin (Minocycline hcl) (minocycline for injection) Intravenous is supplied as 100 mg vials of sterile cryodesiccated powder.
Product No. NDC 14290-545-92
Minocin (Minocycline hcl) 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.
Minocin (Minocycline hcl) References
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By Patheon Italia S.p.AMonza (Milan), Italy
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