(and dosage form):
Capsules: Each capsule contains: Doxycycline hydrochloride equivalent to doxycycline 100 mg.
A.20.1.1 Broad and medium spectrum antibiotics
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.
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.
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.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The side-effects of doxycycline include nausea, diarrhoea, and symptoms resulting from the overgrowth of non-susceptible organisms. Overgrowth of Candida albicans in the mouth causes soreness, redness and thrush, which may extend into the trachea and bronchi; overgrowth of C. albicans in the bowel results in pruritus ani and there may be overgrowth of resistant coliform organisms, such as Pseudomonas spp. and Proteus spp., causing diarrhoea. The most serious supra-infection is by resistant staphylococci, causing a fulminating enteritis with dehydration and, occasionally, death; this complication is rare, except after abdominal surgery, especially gastrectomy.
Occasionally severe and sometimes fatal liver damage has occurred in pregnant women treated with a tetracycline for pyelonephritis, especially when large doses have been given intravenously. Tetracyclines are deposited in calcifying areas in bone and in teeth, causing permanent discolouration and malformation; when given in therapeutic doses to young infants or to women during the late stages of pregnancy, tetracycline interferes with the growth of bones and teeth of infants. Milk teeth are affected if given to children 3 months to six years, and permanent teeth if given to children up, to 12 years. An increase in intracranial pressure, which may be associated with a bulging fontanelle in infants, has been reported in patients given tetracyclines. Haemolytic anaemia, eosinophylia, thrombocytopenia have been reported. Vitamin deficiency may occur.
Doxycycline has an anti-anabolic action which may cause a rise in blood urea. Allergic reactions to tetracycline and its analogues have been reported on rare occasions; photosensitivity has occurred.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
In the event of sensitivity reactions, treatment should be withdrawn. Symptoms should be treated symptomatically.
Capsules: Opaque white hard capsules printed "Cyclidox" in red.
Capsules: Containers of 6, 30, 100 and 1000 capsules.
Store below 25°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF THE APPLICANT
Triomed (Pty) Limited
Building No 3
Parc du cap
Corner Mispel Road and Willie van Schoor Road
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
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