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Logo DOXYHEXAL 100 (tablets)

DXAP1

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

DOXYHEXAL 100 (tablets)

COMPOSITION
Each tablet contains 104,1 mg Doxycycline as the monohydrate, equivalent to 100,0 mg
Doxycycline.

PHARMACOLOGICAL CLASSIFICATION
A 20.1.1 Broad spectrum antibiotics

PHARMACOLOGICAL ACTION
Doxycycline is a tetracycline type antibiotic. Tetracyclines are bacteriostatic antibiotics which bind to the 30S ribosomal subunit thereby causing misreading of the information for protein synthesis.
Doxycycline is effective in vitro against the following organisms (in vitro activity does not necessarily imply in vivo efficacy).
Vibrio cholerae, Ureaplasma urealyticum, Mycoplasma pneumoniae, Chlamydia trachomatis, Chlamydia psittaci, Borrelia recurrentis, Calymmatobacterium granulomatis, Borrelia burgdorferi, penicillin sensitive Neisseria gonorrhoeae and Rickettsiae
Doxycycline is also effective against the following organisms in vitro:
Haemophilus ducreyi, Actinomyces israelii, Francisella tubarensis, Treponema pertenue.

Resistant pathogens
Many of the following strains are resistant
- Staphylococci
- Enterococci
- Proteus vulgaris
- Fungi and yeasts (except Actinomyces)
- Pseudomonas aeroginosa (all strains)
- E. coli
- Shigella
- Streptococcus

Doxycycline is highly lipid soluble and has a low affinity for calcium binding.
It is virtually completely absorbed following oral administration.

INDICATIONS
Doxycycline is indicated for the treatment of infections caused by susceptible organisms.
Upper and lower respiratory tract infections:
Sinusitis, pharyngitis, Mycoplasma pneumonia, psittacosis, and chronic bronchitis.
Genito-urinary tract infections:
Non specific urethritis (only if the strain is sensitive), lymphogranuloma venereum, chancroid, and granuloma inguinale, gonococcal salpingitis, epididymitis, acute epididymo-orchitus, endocervical infections, syphilis and gonorrhoea (in cases of penicillin allergy)
Soft tissue:
Acne
Ophthalmic:
Trachoma and inclusion conjunctivitis
Intestinal:
Cholera, Whipple’s disease and tropical sprue.
Miscellaneous:
Rickettsial infections, brucellosis, tularaemia, actinomycosis, Lyme’s disease, yaws, relapsing fever, leptospirosis during the early infective phase.

CONTRA-INDICATIONS
Hypersensitivity to doxycycline or any of the other tetracyclines.
Do not administer doxycycline during pregnancy. Doxycycline crosses the placenta and is deposited in foetal bones and teeth and may lead to permanent grey-yellow-brown discolouration of the teeth.
Pregnant women are particularly susceptible to severe doxycycline induced liver damage.
Do not administer to lactating women or to children younger than 12 years of age as permanent discolouration of the child’s teeth may occur.
Do not give to patients suffering from systemic lupus erythematosus.

WARNINGS
Use with care in patients with impaired liver function.
Frail or elderly patients are susceptible to the hepatotoxic and anti-anabolic effects of doxycycline
Do not use concomitantly with hepatotoxic medicines.
Symptoms of Myasthenia gravis may be aggravated.
Photosensitivity may occur (see side effects and special precautions)
Raised intracranial pressure may occur, particularly in infants and especially if Vitamin A or other retinoids are given concomitantly.

DOSAGE AND DIRECTIONS FOR USE
The tablets should be swallowed with adequate liquid to avoid lodging of the tablets in the distal oesophagus as this may result in local corrosive initiation and ulceration.
For the treatment of acne
Half a tablet (50 mg) twice daily with meals and followed by adequate water.
For the treatment of other doxycycline responsive infections
100 mg (1 tablet) twice daily.
The tablets should be taken with a meal and should be followed by adequate water ingestion.
At the normal doses, renally impaired patients, do not seem to accumulate excessive amounts of the medicine.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
The following have been observed
Gastro-intestinal - anorexia, nausea, vomiting, diarrhoea, glossitis, dysphagia (related to oesophagitis), enterocolitis.
Secondary fungal overgrowth (candida albicans) - oral candidiasis, vulvovaginitis, pruritis ani.
Secondary bacterial overgrowth infections may occur: resistant coliform organisms such as Proteus spp. may cause diarrhoea; Pseudomembranous colitis due to Clostridium difficile may occur; super-infection due to resistant Staphylococci may cause fulminating enteritis.
Photosensitivity of the skin and nails ; onycholysis and nail discolouration may occur.
Hypersensitivity reactions - urticaria, macropapular and erythematous rashes, exfoliative dermatitis, exacerbation of systemic lupus erythematosus angioneurotic oedema, anaphylaxis, anaphalactoid purpura and pericarditis.
Following full therapeutic doses, bulging fontanelles have been reported in infants and raised intra-cranial pressure in adults. These signs disappear when the drug is withdrawn.
Blood - haemolytic anaemia, thrombocytopenia, neutropenia and eosinophilia have been reported.
Vitamin deficiencies may occur.
Local irritation after intravenous administration, has occurred and thrombophlebitis may follow.
A Jarisch-Herxheimer-like reaction has been reported in patients with relapsing fever, treated with doxycycline.
The use of expired tetracyclines may lead to a Fanconi type syndrome which is characterized by polyuria and polydipsia with nausea, vomiting, proteinuria, glucosuria, acidosis, aminoaciduria, hypophosphataemia and hypocalcaemia
In the elderly a negative nitrogen balance may be induced.

Interactions
Absorption of doxycycline is diminished by milk, alkalis, aluminium hydroxide and other di- and trivalent cations such as calcium, iron and magnesium , if they are given concomitantly.
Doses of anticoagulants may need to be reduced if given concomitantly.
Penicillin should not be given concomitantly with doxycycline as antagonism of antibacterial action may occur.
Doxycycline may diminish the effectiveness of the oral contraceptive.
Methoxyflurane: serious nephrotoxicity may follow concomitant use.
Phenobarbitone and Diphenylhydantoin - half life of doxycycline is reduced from approximately 20 hours to approximately 7 hours.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
See side effects and special precautions
Treatment is supportive and symptomatic.

IDENTIFICATION
Dull, yellow, round biplane tablets, with a single sided score notch
8,0 mm +0,1 mm (d) X 2,8 mm –3,3 mm (h)

PRESENTATION
PP securitainers containing 100 tablets.

STORAGE INSTRUCTION
Store in an airtight container below 25°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER
32/20.1.1/0117

NAME AND BUSINESS OF ADDRESS OF APPLICANT
Hexal Pharma (SA) (PTY) Ltd
Unit A, 10 Fangio road
Mahogany Ridge
Westmead
3610

DATE OF PUBLICATION OF THIS PACKAGE INSERT
31 March 2000

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