COMPOSITION:
Capsules: Each capsule contains:
Doxycycline hydrochloride equivalent to doxycycline 100 mg.
PHARMACOLOGICAL CLASSIFICATION:
A.20.1.1 Broad and medium spectrum antibiotics
PHARMACOLOGICAL ACTION:
Doxycycline hydrochloride is a tetracycline which is a broad spectrum antibiotic. It is bacteriostatic against susceptible strains of a wide range of Gram-positive and Gram-negative organisms. Doxycycline is useful in infections caused by
Haemophilus ducreyi, Brucella (in conjunction with streptomycin),
Vibrio cholerae, Pseudomonas (actinobacillus)
mallei and
pseudomallei, and
Calyminatobacterium (Danovania)
granulomatis. Doxycycline also inhibits the growth of
Yersinia (Pasteurella)
pestis, Francisella (Past.)
tularensis and
Past. multocida. More variable success is achieved with infections due to
Escherichia coli, Klebsiella, Enterobacter (Aerobacter),
Bacteroides, H. influenzae and indole-producing strains of Proteus. Doxycycline is effective against certain rickettsiae and larger viruses responsible for Rocky Mountain spotted fever, murine typhus, epidemic typhus, scrub typhus, rickettsial pox and Q fever. Doxycycline is also effective in relapsing fever (
Borrelia recurrentis) and is a valuable secondary agent against the spirochetes
Treponema pallidum, T. pertenue, and
Leptospira interogans. High concentrations inhibit the growth of the protozoan
Entamoeba histolytica. Certain organisms known to have been sensitive may have lost their sensitivity to tetracycline. Many strains of staphylococci and enterococci and nearly all strains of proteus vulgaris and pseudomonas aeruginosa are relatively resistant.
Doxycycline is well absorbed. After an oral dose of 200 mg of doxycycline, plasma concentrations of the drug reach a maximum of 3 µg/mL at 2 hours and are well maintained, and thus dosage once daily is usually adequate. Absorption is diminished by the presence of iron, aluminium, calcium and magnesium.
Doxycycline is widely distributed into pleural and peritoneal fluid, saliva, semen and prostatic fluid. It passes the placental barrier readily and is also present in the milk of lactating patients. It is concentrated by the liver and excreted, by way of the bile, into the intestine from which it is partially reabsorbed. It is clear that with conventional doses doxycycline is not excreted in the urine to the same extent as the other tetracyclines and it does not accumulate in the blood of the patients with renal failure. Extrarenal infections in such individuals may be treated with doxycycline when indicated. It also has less impact on the intestinal microflora.
INDICATIONS:
Infectious diseases caused by susceptible organisms, including Rocky Mountain spotted fever, murine typhus, recrudescent epidemic typhus, scrub typhus, Q fever, lymphogranuloma venereum, psittacosis, tularemia, brucellosis (in conjunction with Streptomycin). Doxycycline may be used in the treatment of gonorrhoea, syphilis and anthrax in cases where the patient is hypersensitive to penicillin.
Doxycycline may be used in the initial treatment of moderate to severe acne.
CONTRA-INDICATIONS:
Doxycycline should not be used during pregnancy and in children under the age of 12 years. Doses of anticoagulants may need to be reduced when doxycycline is given. As preparations containing iron, aluminium, calcium or magnesium decrease the absorption of tetracycline, do not give to patients receiving antacid therapy, milk or calcium containing foods. Potentially hepatotoxic drugs should not be given with doxycycline.
DOSAGE AND DIRECTIONS FOR USE:
Capsules: 2 capsules on first day, then 1 capsule a day, after food.
Medication should be carried out for at least 24 - 48 hours after fever and other symptoms have disappeared.
Initial treatment of acne: one capsule (100 mg doxycycline) daily. The dosage must be reduced as soon as possible to the maintenance dosage of 50 mg doxycycline daily.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
In the event of sensitivity reactions, treatment should be withdrawn. Symptoms should be treated symptomatically.
PRESENTATION:
Capsules: Containers of 100 capsules.
STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.
for Export use only
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