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DOXITAB

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

DOXITAB
TABLETS

COMPOSITION:
Each tablet contains: Doxycycline hydrochloride equivalent to doxycycline 100 mg

PHARMACOLOGICAL CLASSIFICATION:
A.20.1.1 Broad and medium spectrum antibiotics.

PHARMACOLOGICAL ACTION:
Doxycycline is a bacteriostatic antibiotic and inhibits bacterial protein synthesis (305 ribosomes). It is effective in vitro against the following organisms (in vitro sensitivity does not necessarily imply in vivo efficacy) Vibrio cholera, Ureaplasma urealyticum, Mycoplasma pneumoniae, Chlamydia trachomatis, Chlamydia psittaci, Borrelia recurrencis Calymmatobacterium granulomatis, Borrelia burgdorferi, penicillin-sensitive Neisseria gonorrhoeae and Rickettsiae.
Doxycycline is also effective against the following organisms in vitro: Clostridium tetani, Listeria monocytogenes, Haemophilus ducreyi, Campylobacter jejuni, Leptospira, Actinomyces israelii, Bacillus anthracis*, Pasteurella multocida, Streptobacillus moniliformis, Erysipelothrix rhusiopathiae.
Doxycycline may also show some effect against the following organisms: Bacteroides species and Fusobacterium nucleatum.
* = in vitro sensitivity tests must be performed.
Resistant pathogens:
Many strains of the following are resistant:
Staphylococci, Enterococci, Proteus vulgaris, Fungi and Yeasts (except Actinomyces), Pseudomonas aeruginosa (all strains), E. coli, Shigella, Strep pneumoniae.
Doxycycline is well absorbed. After an oral dose of 200 mg of doxycycline, plasma concentrations of the medicine 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.

INDICATIONS:
Infections caused by susceptible strains.

*	Upper and lower respiratory tract: Sinusitis, pharyngitis, pneumonia (Legionella and Mycoplasma) and psittacosis;
*	Genito-urinary tract: Non-specific urethritis (only if the strain is sensitive), lymphogranuloma venereum, chancroid and granuloma inguinale, gonorrhoea, gonococcal salpingitis, epididymitis acute epididymo-orchitis, endocervical infections and syphilis (in cases of penicillin allergy)
*	Ophthalmic: Trachoma and inclusion conjunctivitis.
*	Intestinal: Cholera, Whipple's disease, and tropical sprue.
*	Miscellaneous: Rickettsial infections, brucellosis, tularemia, actinomycosis, Lyme disease, yaws, relapsing fever, Leptospirosis during the early phase.

CONTRA-INDICATIONS:
Hypersensitivity to any tetracycline.
Doxycycline should not be used during pregnancy, lactation and in children under the age of 12 years, or until calcification of the permanent teeth.
As preparations containing iron, aluminium, calcium or magnesium decrease the absorption of doxycycline, do not give to patients receiving antacid therapy, milk or calcium containing foods. Potentially hepatotoxic medicine should not be given with doxycycline. Patients with systemic lupus erythematosus.

DOSAGE AND DIRECTIONS FOR USE:
Tablets: 2 tablets on 1st day, thereafter 1 tablet a day after food with at least half a glass of water and one hour or more before retiring to bed. Medication should be taken for at least 24 - 48 hours after fever and other symptoms have disappeared.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Interaction:
Doses of anticoagulants may need to be reduced when doxycycline is given.
The side-effects of doxycycline hydrochloride include nausea, vomiting, diarrhoea, and symptoms resulting from the overgrowth of non-susceptible organisms.
Doxycycline is deposited in calcifying areas in bone, nails and in teeth, causing permanent discoloration and malformation; when given in therapeutic doses to young infants or to pregnant women, tetracycline interferes with the growth of bones and teeth in the infants. Use in pregnancy, potentially during breast-feeding, and in childhood up to the age of 12 years, may result in impaired bone growth and permanent discoloration of the child's teeth. An increase in intracranial pressure with headache, visual disturbances and papilloedema, which may be associated with a bulging fontanelle in infants, has been reported in patients given doxycycline.
Other effects that have been reported include dry mouth, glossitis and discoloration of the tongue, stomatitis and dysphagia. Oral candidiasis, vulvovaginitis, and pruritus ani occur mainly due to overgrowth with Candida albicans and there may be overgrowth of resistant coliform organisms, such as Pseudomonas spp. and Proteus spp. causing diarrhoea. Severe and sometimes fatal hepatotoxicity associated with fatty changes in the liver and pancreatitis has been reported in pregnant women with renal impairment or those given high doses.
Oesophageal ulceration may be a particular problem if doxycycline is taken with insufficient fluid or in a recumbent posture.
Hypersensitivity reactions including rashes, fixed drug eruptions, exfoliative dermatitis, toxic epidermal necrolysis, drug fever pericarditis, angioedema, urticaria, and asthma have been reported and anaphylaxis has occurred less frequently.
Photosensitivity appears to be phototoxic rather than photoallergic in nature. Patients who may be exposed to direct sunlight must be warned of the risk of photosensitivity.
Paraesthesia may be an early sign of impending phototoxicity. Nail discoloration and onycholysis may occur. Abnormal pigmentation of the skin and eye has occurred.
A Jarisch-Herxheimer-like reaction has been reported in patients with relapsing fever treated with doxycycline. Haemolytic anaemia, eosinophilia, neutropenia, and thrombocytopenia have been reported.
Reductions in serum vitamin B concentrations, including folate deficiency and concomitant megaloblastic anaemia can occur.
The use of out-of-date or deteriorated tetracyclines has been associated with the development of a reversible Fanconi-type syndrome characterised by polyuria and polydipsia with nausea, glycosuria, aminoaciduria, hypophosphataemia, hypokalaemia, and hyperuricaemia with acidosis, and proteinuria.
When administered together with phenobarbitone and diphenylhydantoin the half-life of doxycycline is decreased from 20 hours to 7 hours. Other adverse effects include myopathy, increased muscle weakness in patients with myasthenia gravis, and provocation of lupus erythematosus. Care should be taken if doxycycline is given to patients with impaired liver function and high doses should be avoided. Efficacy of oestrogen containing contraceptives may be decreased.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-effects and Special Precautions". Treatment is symptomatic and supportive.

IDENTIFICATION:
White, film coated biconvex tablets with perpendicular score on one side and other side plain.

PRESENTATION:
Tablets: 10 and 100 tablets in blister packs

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

REGISTRATION NUMBER:
29/20.1.1/0298

NAME AND BUSINESS ADDRESS OF APPLICANT:
Medpro Pharmaceutica (Pty) Ltd.
Rosen Heights
Pasita Street
ROSENPARK

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
March 1998

5365 A
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