Product info: Antibiotics - Doxycycline
Doxycycline: Doxycycline (VIBRAMYCIN) is a tetracycline antibiotic. It works by preventing the growth and spread of bacteria. Antibiotics will not work for colds, flu, or other viral infections. It fights bacteria in the body, including pneumonia and other respiratory tract infections. Doxycycline is used to treat many different bacterial infections, such as urinary tract infections, acne, gonorrhea, chlamydia, periodontitis (gum disease), and anthrax (after inhalational exposure) and others. Doxycycline may also be used for other purposes not listed in this medication guide.
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Doxycycline Monohydrate
Generic Name: Doxycycline Monohydrate
Dosage Form: capsules
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doxycycline Monohydrate capsules and other antibacterial drugs, Doxycycline Monohydrate capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Doxycycline Monohydrate Description
Doxycycline is a broad-spectrum antibiotic synthetically derived from oxytetracycline. Doxycycline Monohydrate capsules 100 mg and 50 mg contain Doxycycline Monohydrate equivalent to 100 mg or 50 mg of doxycycline for oral administration. The chemical designation of the light-yellow crystalline powder is alpha-6-deoxy-5-oxytetracycline.
Structural formula:
C22H24N2O8 • H2O M.W.=462.45
Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form.
Inert ingredients: colloidal silicon dioxide; hard gelatin capsule which contains black iron oxide, red iron oxide, titanium dioxide, and yellow iron oxide for the 100 mg strength, titanium dioxide and yellow iron oxide for the 50 mg strength; magnesium stearate; microcrystalline cellulose; and sodium starch glycolate.
Doxycycline Monohydrate - Clinical Pharmacology
Tetracyclines are readily absorbed and are bound to plasma proteins in varying degrees. They are concentrated by the liver in the bile and excreted in the urine and feces at high concentrations in a biologically active form. Doxycycline is virtually completely absorbed after oral administration.
Following a 200 mg dose of Doxycycline Monohydrate, 24 normal adult volunteers averaged the following serum concentration values:
Time(hr): 0.5 1.0 1.5 2.0 3.0 4.0 8.0 12.0 24.0 48.0 72.0
Conc. 1.02 2.26 2.67 3.01 3.16 3.03 2.03 1.62 0.95 0.37 0.15 (mcg/mL)
Average Observed Values
Maximum Concentration 3.61 mcg/mL (± 0.9 sd)
Time of Maximum Concentration 2.60 hr (± 1.10 sd)
Elimination Rate Constant 0.049 per hr (± 0.030 sd)
Half-Life 16.33 hr (± 4.53 sd)
Excretion of doxycycline by the kidney is about 40%/72 hours in individuals with normal function (creatinine clearance about 75 mL/min). This percentage excretion may fall as low as 1-5%/72 hours in individuals with severe renal insufficiency (creatinine clearance below 10 mL/min). Studies have shown no significant difference in serum half-life of doxycycline (range 18-22 hours) in individuals with normal and severely impaired renal function.
Hemodialysis does not alter serum half-life.
Microbiology:
The tetracyclines are primarily bacteriostatic and are thought to exert their antimicrobial effect by the inhibition of protein synthesis. The tetracyclines, including doxycycline, have a similar antimicrobial spectrum of activity against a wide range of gram-positive and gram-negative microorganisms. Cross-resistance of these microorganisms to tetracyclines is common.
Doxycycline 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.
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