INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
DOXYCYL 100 CAPSULES

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

DOXYCYL 100 CAPSULES

COMPOSITION:
Each capsule 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 by binding to the 30S ribosomal subunit with subsequent misreading of information for protein synthesis. It is bacteriostatic against strains of a wide range of gram-positive and gram-negative organisms.
It is effective in vitro against the following oganisms: (in vitro activity does not necessarily imply in vivo efficacy)
Vibrio cholerae, Ureaplasma urealyticum, Mycoplasma pneumoniae, Chlamydia trachomatis, Chlamydia psittaci, Borrelia recurrensis, 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 israelli, Bacillus anthracis*, Pasteurella multocida, Streptobacillus moniliformis, Erysipelothrix rhusiopathiae, Francisella tularensis, Treponema pertenue and Plasmodium falciparum.
* = 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, Streptococcus.

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, 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
	Malaria:
	For short-term prophylaxis of malaria due to Plasmodium faiciparum in short-term travellers (<4 months) going to areas where a high level of chloroquine resistance and/or pyrimethamine-sulfadoxine resistant strains have been reported and the traveller cannot tolerate mefloquine or other agents for the prophylaxis of malaria.
•	Miscellaneous:
	Rickettsial infections, brucellosis, tularemia, actinomycosis, Lyme disease, yaws, relapsing fever, Leptospirosis during the early infective phase

CONTRA-INDICATIONS:
Doxycycline should not be used in pregnancy, as it crossses the placenta and is deposited in foetal bones and teeth. Pregnant women and the developing foetus are particularly susceptible to severe doxycycline-induced liver damage.
When administered to women during the latter half of pregnancy, to nursing mothers, or during childhood up to the age of 12 years, permanent discolouration of the child's teeth may occur, as well as impaired bone growth.
Doxycycline should not be given to patients with a known allergy to tetracyclines, since cross sensitivity may occur.
Should be avoided in patients with systemic lupus erythematosus.
Doxycycline should not be given to patients receiving antacid therapy, milk or calcium containing foods.
Potentially hepatotoxic medication should not be given with doxycycline.
The administration of Doxycyl is contra-indicated in patients with porphyria.

WARNING:
Do not use concomitantly with hepatotoxic medicines.
Photosensitivity may occur (see "Side Effects and Special Precautions)
Raised intracranial pressure may occur, particularly in infants and especially if Vitamin A or other retiniods are given concomitantly.
Doxycyl may interfere with some diagnostic tests including determination of urinary catecholamines or glucose.
Use with care in patients with liver impairment.
Special care should be taken in frail or elderly patients as they are susceptible to the hepatotxic and anti-anabolic effects of doxycycline.
Care is advisable in patients with symptoms of myasthenia gravis as this may be aggravated in patients with this problem.
KEEP OUT OF REACH OF CHILDREN.

WHEN USED FOR MALARIA PROPHYLAXIS:
Because no form of prophylaxis is fully effective, the prevention of mosquito bites should be the mainstay of malaria prophylaxis. The following preventative measures to prevent mosquito bites should be taken:

i)	Endemic areas should preverable be visited during the dry season or when rainful is low;
ii)	High risk persons should avoid malaria areas altogether. These include
-	babies and young children less than 5 years old
-	pregnant women
-	immunocompromised individuals such as those on long-term steriods, cancer patients and those on chemotherapy, AIDS patients and those who had their spleens removed;
iii)	- Not going outside between dusk and dawn, when mosquitos are most active.
iv)	- Applying insect repellant to exposed skin and clothing;
v)	- Wearing long sleeves and trousers at night;
vi)	- Using mosquito nets, screens, coils or pads.

Should flu-like symptoms appear, the patient must inform the doctor that he has been to a malarious area.

DOSAGE AND DIRECTIONS FOR USE:
Doxycyl is administered once daily, and may be taken one hour before or two hours after meals. It should be taken with adequate liquid to avoid lodging of capsules in the distal oesophagus, as this may result in local corrosive irritation and ulceration.

ADULTS:	200 mg (2 capsules) during the first 24 hours as a single dose, followed by 100 mg (1 capsule) daily during the following days.
CHILDREN:	(<50 kg): 4 mg per kg body mass during the first 24 hours, and thereafter 2 mg per kg body mass daily during the following days. Should only be used for children under 8 years of age on very stong indications and the effect of tetracyclines on teeth and bones should be considered.

In severe infections the initial dosage is maintained throughout the course of treatment. Medication should be carried out for at least 24 - 48 hours after fever and other symptoms have disappeared.
For short-term malaria prophylaxis:

ADULTS AND TEENAGERS:	100 mg (1 capsule) daily
CHILDREN:	Above 8 years old: 2 mg/kg, once a day, up to 100 mg daily.

Contra-indicated for children under 8 years
To be started one or two days before departure to the area where malaria may occur, and continue taking the medicine every day throughout travel, and for four weeks after the last possible exposure to infection.
TRACHOMA:
100 mg (1 capsule) daily for 40 days.
NONSPECIFIC URETHRITIS:
A dose of 100 mg of Doxycycline (1 capsule) every 12 hours for 7 days.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Doxycycline are not indicated for treating commonly occurring infections in children under 12 years of age. For malaria prophylaxis, DOXYCYL is contra- indicated for children under 8 years of age.
Gastro-intestinal side-effects including nausea, vomiting, and diarrhoea are common, especially with high doses.
Dry mouth, glossitis, discolouration of the tongue, stomatitis and dysphagia have been reported.
Oesophageal ulceration has also been reported after ingestion of capsules with insufficient water, at bedtime. Enterocolitis have also been reported.
Oral candidiasis, vaginal candidiasis, vulvovaginitis, and pruritis ani can occur due to overgrowth of Candida albicans. Oral candidiasis results in soreness, redness and thrush in the mouth, which may extend into the trachea and bronchi. There may also be an overgrowth of resistant coliform organisms, such as Pseudomonas spp. and Proteus spp., causing diarrhoea. More serious superinfection with resistant staphylococci causing enterocolitis, and also pseudomembranous colitis due to Clostridium difficile have been reported.
Super-infection due to resistant staphylococci may cause fulminating enteritis.
These complications are rare, except after abdominal surgery, especially gastrectomy.
Usual therapeutic doses given to patients with renal disease increase the severity of ureamia with increased excretion of nitrogen and losses of sodium, accompanied by acidosis and hyperphosphataemia. These effects are related to the dose and severity of renal impairment and are due to the anti-anabolic effects of doxycyclines.
Severe and sometimes fatal hepatotoxicity has been reported in patients with renal impairment and in those given high doses. Doxycycline are deposited in deciduous and permanent teeth, causing discolouration and enamel hypoplasia, although doxycycline causes less tooth discolouration than other tetracyclines. 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 doxycycline. Vitamin deficiency may occur.
Doxycycline has an anti-anabolic action which may cause a rise in blood urea.
Allergic reactions to doxycycline has been reported, usually as skin reactions.
Allergic (hypersensitivity) reactions: urticaria, maculopapular & erythematous rashes, exfoliative dermatitis, exacerbation of systemic lupus erythematosus, pericarditis, Henoch-Schönlein purpura (anaphylactoid purpura), angioneurotic oedema, fixed drug eruptions, toxic epidermal necrolysis, drug fever, angiodema, asthma, anaphylaxis.
Blood abnormalities:
haemolytic anaemia, eosinophilia, neutropenia and thrombocytopenia may occur.
In the elderly a negative nitrogen balance may be induced.

•	The use of expired doxycycline may lead to the Fanconi-type syndrome which is characterised by polyuria and polydipsia with nausea, vomiting, proteinuria, glucosuria, acidosis, amino-aciduria, hypophosphataemia and hypocalcaemia, hypokalaemia and hyperuricaemia.

Cross-sensitisation between tetracyclines is common.
Photosensitivity of the skin and nails has occurred, and onycholysis may be associated with nail discolouration.
A Jarisch-Herxheimer-like reaction has been reported in patients with relapsing fever treated with doxycycline.

SPECIAL PRECAUTIONS:
Cross-sensitisation between tetracyclines are common.
Patients who may be exposed to direct sunlight should be warned of the risk of photosensitivity.
Care must be taken when liver function is impaired.
Symptoms of myasthenia gravis may be exacerbated by doxycyclines.
It is recommended not to take doxycycline and penicillin concomitantly, especially when a rapid bactericidal action is necessary, because of the possible antagonism of the action.

INTERACTIONS:
The absorption of doxycycline is reduced by divalent and trivalent cations such as aluminium, bismuth, calcium, iron, magnesium and zinc, and therefore concomitant administration of doxycycline with antacids, sucralfate, iron preparations, some foods such as milk and dairy products, or other preparations containing such cations may result in subtherapeutic serum concentrations of Doxycyl.
Sodium bicarbonate and colestipol are reported to reduce doxycycline absorption.
Doses of anticoagulants may need to be reduced if given concomitantly with doxycycline. The nephrotoxic effects of doxycycline may be exacerbated by diuretics.
Doxycycline may produce increased concentrations of lithium, digoxin.
It has been reported that doxycycline increases the toxic effects of ergot alkaloids and methotrexate.
Penicillin should not be given concomitantly with doxycycline as antagonism in action may occur, especially when a rapid bactericidal action is necessary.
Doxycyl may diminish the effectiveness of oral contraceptives. Alternative methods of contraception are advisable in women receiving Doxycyl therapy.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See “side-effects and special precautions”
In the event of sensitivity reactions, treatment should be withdrawn. Symptoms should be treated symptomatically.

IDENTIFICATION:
Blue/clear hard gelatin capsules, filled with a pale yellow powder.

PRESENTATION:
Blister packs of 6 capsules.
Securitainers of 30, 100, 500 and 1000 capsules.

STORAGE INSTRUCTIONS:
Store below 25°C in airtight containers. Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
28/20.1.1/0059

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited
7 Fairclough Road
PORT ELIZABETH
6020

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
05/05/1993

D664
A&S PRINTERS

Updated on this site: March 2005
Source: Community Pharmacy
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