TARGADOX- doxycycline hyclate tablet
Journey Medical Corporation
To reduce the development of drug-resistant bacteria and maintain the effectiveness of TARGADOX� and other antibacterial drugs, TARGADOX� should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
DESCRIPTION
Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate tablets for oral administration. The chemical designation of doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate.
with a molecular formula of (C22 H24 N2 O8 HCl)2 C2 H6 OH2 O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water.
Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form.
Active Ingredient: Doxycycline hyclate USP equivalent to 50 mg of doxycycline USP.
Inactive Ingredient: Microcrystalline cellulose and magnesium stearate.
Tablet coating contains hypromellose, titanium dioxide, polyethylene glycol, FD&C yellow #6, polysorbate 80 and FD&C blue #2.
CLINICAL PHARMACOLOGY
Tetracyclines are readily absorbed and are bound to plasma proteins in varying degree. They are concentrated by the liver in the bile, and excreted in the urine and feces at high concentrations and in a biologically active form. Doxycycline is virtually completely absorbed after oral administration.
Microbiology
Mechanism of Action
Doxycycline inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit. Doxycycline has bacteriostatic activity against a broad range of Gram-positive and Gram-negative bacteria. Cross resistance with other tetracyclines is common.
Doxycycline has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section of the package insert for TARGADOX�.
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain effectiveness of TARGADOX� and other antibacterial drugs, TARGADOX� 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.
Information for Patients
Patients taking doxycycline for malaria prophylaxis should be advised:
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that no present-day antimalarial agent, including doxycycline, guarantees protection against malaria.
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to avoid being bitten by mosquitoes by using personal protective measures that help avoid contact with mosquitoes, especially from dusk to dawn (e.g., staying in well-screened areas, using mosquito nets, covering the body with clothing, and using an effective insect repellent).
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that doxycycline prophylaxis:
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should begin 1 to 2 days before travel to the malarious area,
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should be continued daily while in the malarious area and after leaving the malarious area,
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should be continued for 4 further weeks to avoid development of malaria after returning from an endemic area,
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should not exceed 4 months.
All patients taking doxycycline should be advised:
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to avoid excessive sunlight or artificial ultraviolet light while receiving doxycycline and to discontinue therapy if phototoxicity (e.g., skin eruption, etc.) occurs. Sunscreen or sunblock should be considered. (See WARNINGS.)
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to drink fluids liberally along with doxycycline to reduce the risk of esophageal irritation and ulceration. (See ADVERSE REACTIONS.)
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that the absorption of tetracyclines is reduced when taken with foods, especially those which contain calcium. However, the absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk. (See DRUG INTERACTIONS.)
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that the absorption of tetracyclines is reduced when taking bismuth subsalicylate. (See DRUG INTERACTIONS.)
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that the use of doxycycline might increase the incidence of vaginal candidiasis.
Patients should be counseled that antibacterial drugs, including doxycycline hyclate tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When doxycycline hyclate tablets 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 doxycycline hyclate tablets or other antibacterial drugs in the future.
Diarrhea is a common problem caused by antibacterial drugs, which usually ends when the antibacterials are discontinued. Sometimes after starting treatment with antibacterial drugs, 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 antibacterial drug. If this occurs, patients should contact their physician as soon as possible.
DOSAGE AND ADMINISTRATION
Other dosage forms of doxycycline may be more appropriate to meet some of the dosing recommendations listed below.
The usual dosage and frequency of administration of doxycycline differs from that of the other tetracyclines. Exceeding the recommended dosage may result in an increased incidence of side effects.
Adults:
The usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours) followed by a maintenance dose of 100 mg/day.
In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended.
Pediatric Patients:
For all pediatric patients weighing less than 45 kg with severe or life-threatening infections (e.g., anthrax, Rocky Mountain spotted fever), the recommended dosage is 2.2 mg/kg of body weight administered every 12 hours. Children weighing 45 kg or more should receive the adult dose. (See WARNINGS and PRECAUTIONS.) For pediatric patients with less severe disease (greater than 8 years of age and weighing less than 45 kg), the recommended dosage schedule is 4.4 mg/kg of body weight divided into two doses on the first day of treatment, followed by a maintenance dose of 2.2 mg/kg of body weight (given as a single daily dose or divided into twice daily doses). For pediatric patients weighing over 45 kg, the usual adult dose should be used.
The therapeutic antibacterial serum activity will usually persist for 24 hours following recommended dosage.
When used in streptococcal infections, therapy should be continued for 10 days.
