INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
DOXYMYCIN®–100 CAPSULES
DOXYMYCIN®–100 TABLETS

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

DOXYMYCIN^®–100 CAPSULES
DOXYMYCIN^®–100 TABLETS

COMPOSITION:
Capsules Each capsule contains:
        Doxycycline hydrochloride equivalent to 100 mg doxycycline.
Tablets Each tablet contains:
        Doxycycline hydrochloride equivalent to 100 mg doxycycline.

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 interrogans. High concentrations inhibit the growth of the protozoen 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 micrograms/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 other tetracyclines and it does not accumulate in the blood of 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 gonorrhea, syphilis and anthrax in cases where the patient is hypersensitive to penicillin.

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 1st day, then 1 capsule a day after meals.
Tablets	2 Tablets on 1st day, then 1 tablet a day after meals.

Medication should be carried out for at least 24 - 48 hours after fever and other symptoms have disappeared.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The side-effects of doxycycline hydrochloride 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 in the 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, eosinophilia, 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.

CONDITIONS OF REGISTRATION:
May be advertised to the professions only.

IDENTIFICATION:

Capsules	Blue/clear hard gelatin capsules, filled with a pale yellow powder.
Tablets	White film-coated tablets.

PRESENTATION:

Capsules	Containers of 5, 25 and 100 capsules.
Tablets	Containers of 5, 25 and 100 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C and protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:

Capsules	M/20.1.1/506;
Tablets	N/20.1.1/144.

NAME AND BUSINESS ADDRESS OF APPLICANT:
Lennon Limited
7 Fairclough Road
PORT ELIZABETH 6001

For: Continental Ethicals
1 Corlett Drive
ILLOVO, 2116

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
14.09.1979.

        P737

First displayed on this site December 1995
Current: September 2004
Source: Pharmaceutical Industry

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