- ANTI-INFECTIVE DRUGS
- Pharmaceutical Form : Capsules
- Composition : Doxycyclin ( Monohydrate ) 100 mg / Cap
- Active Substance : Doxycyclin
Doxycycline is a broad-spectrum antibiotic synthetically derived from Oxytetracycline.
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. Doxycycline is virtually completely absorbed after oral administration. The tetracyclines are primarily bacteriostatic and are thought to exert their antimicrobial effect by the inhibition of protein synthesis.
INDICATIONS AND USAGE
Doxycycline is indicated for the treatment of the following infections:
-Rocky mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae.
-Respiratory tract infections caused by Mycoplasma pneumoniae.
-Lymphogranuloma venereum caused by Chlamydia trachomatis.
-Psittacosis (ornithosis) caused by Chlamydia psittaci.
-Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence.
-Inclusion conjunctivitis caused by Chlamydia trachomatis.
-Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis.
-Nongonococcal urethritis caused by Ureaplasma urealyticum.
-Relapsing fever due to Borrelia recurrentis
Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms:
– Chancroid caused by Haemophilus ducreyi.
– Plague due to Yersinia pestis (formerly Pasteurella pestis ).
– Cholera caused by Vibrio cholerae (formerly Vibrio comma ).
– Brucellosis due to Brucella species (in conjunction with streptomycin).
– Bartonellosis due to Bartonella bacilliformis.
– Granuloma inguinale caused by Calymmatobacterium granulomatis.
Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended.
Doxycycline is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug:
– Escherichia coli
– Enterobacter aerogenes (formerly Aerobacter aerogenes )
– Shigella species
– Acinetobacter species (formerly Mima species and Herellea species)
– Respiratory tract infections caused by Haemophilus influenzae.
– Respiratory tract and urinary tract infections caused by Klebsiella species.
Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:
– Upper respiratory infections caused by Streptococcus pneumoniae (formerly Diplococcus pneumoniae ).
– Skin and skin structure infections caused by Staphylococcus aureus.
Doxycycline is not the drug of choice in the treatment of any type of staphylococcal infections.
When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections:
– Uncomplicated gonorrhea caused by Neisseria gonorrhoeae.
– Syphilis caused by Treponema pallidum.
– Yaws caused by Treponema pertenue.
– Listeriosis due to Listeria monocytogenes.
– Anthrax due to Bacillus anthracis.
– In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides.
– In severe acne, doxycycline may be useful adjunctive therapy.
This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
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 drugs but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported.
Tetracycline drugs, therefore, should not be used in this age group 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 given oral tetracycline in doses of 25 mg/kg every six hours. This reaction was shown to be reversible when the drug was discontinued.
Pregnancy Category D:
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).
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
Tetracyclines are present in the milk of lactating women who are taking a drug in this class. 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
Tetracycline drugs, therefore, should not be used in this age group( under 8 years ) unless other drugs are not likely to be effective or are contraindicated
Impaired renal function:
The anti anabolic action of the tetracyclines may cause an increase in BUN.
Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with monilial overgrowth) in the anogenital region. These reactions have been caused by both the oral and parenteral administration of tetracyclines. Skin: Maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon.
Renal toxicity: Rise in BUN has been reported and is apparently dose related.
Hypersensitivity reactions: Urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, pericarditis, and exacerbation of systemic lupus erythematosus.
Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia
DOSAGE AND ADMINISTRATION :
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. The maintenance dose may be administered as a single dose. In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended.
For pediatric patients above eight years of age: The recommended dosage schedule for pediatric patients weighing 45 kg or less is 0.9 mg/kg of body weight divided into two doses on the first day of treatment, followed by 0.45 mg/kg of body weight given as a single daily dose or divided into two doses, on subsequent days. For more severe infections, up to 2 mg/lb of body weight may be used. For pediatric patients over 45 kg the usual adult dose should be used.
Uncomplicated gonococcal infections in adults (except anorectal infections in men): 100 mg by, mouth, twice a day for 7 days. As an alternate single visit dose, administer 300 mg stat followed in one hour by a second 300 mg dose.
Acute epididymo-orchitis caused by N. gonorrhoeae : 100 mg, by mouth, twice a day for at least 10 days.
Primary and secondary syphilis: 300 mg a day in divided doses for at least 10 days.
Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis : 100 mg, by mouth, twice a day for at least 7 days
Nongonococcal urethritis caused by C. trachomatis and U. urealyticum: 100 mg, by mouth, twice a day for at least 7 days.
Acute epididymo-orchitis caused by C. trachomatis: 100 mg, by mouth, twice a day for at least 10 days.
When used in streptococcal infections, therapy should be continued for 10 days.
In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Dialysis does not alter serum half-life, and it would not be of benefit in treating cases of overdosage.
How should I store DOXYCYCLIN – MEDICO 100?
Store DOXYCYCLIN – MEDICO 100 Capsules at room temperature, under 30°C.
Keep DOXYCYCLIN – MEDICO 100 Capsules out of the reach of children.
PACKING: Box of 20 capsules.