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5365d

Scheduling Status: S4
Malaria prophylaxis:
Special precautions:
Proprietary name (and Dosage Form):
For short-term prophylaxis of malaria in short-term Care should be taken if doxycycline is given to patients travelers (< 4 months) going to areas where a high level Start prophylaxis one to two days before entry into the with impaired liver function and high doses should be of chloroquine resistance has been reported and the potential malaria area, continue daily dosage while in traveler cannot tolerate Mefloquine or other relevant malaria area and for four weeks after the last possible Cross-sensitisation between different tetracyclines is agents for the prophylaxis of malaria.
Miscellaneous:
Trachoma:
The risk of photosensitivity should be emphasized to Rickettsial infections, br ucellosis, tularemia, patients, or travelers to malaria areas, who may be exposed Nonspecific urethritis:
COMPOSITION
actinomycosis, Lyme disease, yaws, relapsing fever, Each tablet contains: Doxycycline hydrochloride equivalent Leptospirosis during the early phase.
If long term therapy is necessary, periodic laboratory SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
CONTRA-INDICATIONS
evaluation of haemopoietic, renal and hepatic organ Doxycycline is not indicated for treating commonly occurring PHARMACOLOGICAL CLASSIFICATION:
Hypersensitivity to any tetracycline.
infections in children less than 12 years of age. In the case A.20.1.1 Broad and medium spectrum antibiotics.
Doxycycline should not be used during pregnancy, lactation Interactions:
of malaria prophylaxis DOXITAB is contra-indicated in PHARMACOLOGICAL ACTION:
and in children under the age of 12 years, or until Doses of anticoagulants may need to be reduced when Doxycycline is a bacteriostatic antibiotic that inhibits calcification of the permanent teeth.
doxycycline is given due to depression of plasma The side-effects of doxycycline hydrochloride include bacterial protein synthesis (30S ribosomes). It is effective As preparations containing iron, aluminium, calcium or nausea, vomiting, diarrhoea, and symptoms resulting from in vitro against the following organisms (in vitro sensitivity magnesium decrease the absorption of Doxycycline, do not The half-life of doxycycline is decreased from 20 hours to the overgrowth of non-susceptible organisms.
does not necessarily imply in vivo efficacy): Vibrio cholera, give to patients receiving antacid therapy, milk or calcium 7 hours when given concomitantly with phenobarbitone and Doxycycline is deposited in calcifying areas in bone, nails Ureaplasma urealyticum, Mycoplasma pneumoniae, containing foods. Potentially hepatotoxic medicine should and in teeth, causing per manent discoloration and Chlamydia trachomatis, Chlamydia psittaci, Borrelia not be given with Doxycycline. Patients with systemic lupus Alcohol and carbamazepine also reduces the half-life of malformation; when given in therapeutic doses to young recurrencis, Calymmatobacterium granulomatis, Borrelia infants or to pregnant women, tetracyclines interfere with burgdorferi, penicillin-sensitive Neisseria gonorrhoeae and WARNINGS:
Efficacy of estrogen containing oral contraceptives may be the growth of bones and teeth in infants. Use in pregnancy, Use with care in patients with impaired hepatic function potentially during breast-feeding, and in childhood up to Doxycycline is also effective against the following organisms and avoid concomitant use with hepatotoxic medicines. Frail The administration of doxycycline and penicillin the age of 12 years, may result in impaired bone growth and elderly patients are especially susceptible to the concomitantly is to be avoided, especially when a rapid and permanent discoloration of the child’s teeth. An Clostridium tetani, Listeria monocytogenes, Haemophilus hepatotoxic and anti-anabolic effects of Doxycycline.
bactericidal action is required, due to the possible increase in intracranial pressure with headache, visual ducreyi, Campylobacter jejuni, Leptospira, Actinomyces Photosensitivity, manifested by an exaggerated sunburn disturbances and papilloedema, which may be associated israelii, Bacillus anthracis*, Pasteurella multocida, reaction, may occur. Patients or travelers likely to be The absorption of doxycycline is reduced by di- and trivalent with a bulging fontanelle in infants, has been reported in Streptobacillus moniliformis, Erysipelothrix rhusiopathiae, exposed to direct sunlight or UV light should be advised of cations such as aluminium, bismuth, calcium, iron, Francisella tularensis, Treponema per tenue and magnesium and zinc contained in antacids, sucralfate, iron Other effects that have been reported include dry mouth, Raised intracranial pressure may occur, particularly in preparations, alkalis, bismuth salts, milk and other diary glossitis and discoloration of the tongue, stomatitis and Doxycycline may also show some effect against the infants and especially if Vitamin A or other retinoids are dysphagia. Oral candidiasis, vulvovaginitis, and pruritus The nephrotoxic effects of doxycycline may be exacerbated ani occur mainly due to overgrowth with Candida albicans Bacteroides species and Fusobacterium nucleatum.
The symptoms of myasthenia gravis may be aggravated.
and there may be overgrowth of resistant coliform * = in vitro sensitivity tests must be performed.
Doxycycline may increase the concentrations of lithium and organisms, such as Pseudomonas spp. and Proteus spp.
digoxin and may also increase the toxic effects of ergot Patient Information in the case of Malaria Prophylaxis:
causing diarrhoea. Severe and sometimes fatal Many strains of the following are resistant: Because no for m of malaria prophylaxis, including hepatotoxicity associated with fatty changes in the liver and Staphylococci, Enterococci, Proteus vulgaris, Fungi and KNOWN SYMPTOMS OF OVERDOSAGE AND
Doxycycline, guarantees full protection, it is imperative to pancreatitis has been reported in pregnant women with Yeasts (except Actinomyces), Pseudomonas aeruginosa PARTICULRS OF ITS TREATMENT:
also prevent mosquito bites. The following preventative renal impairment or those given high doses.
(all strains), E.coli, Shigella, Strep. pneumoniae.
See “Side-effects and Special Precautions”. Treatment is Oesophageal ulceration may be a particular problem if Doxycycline is well absorbed. After an oral dose of 200 it is preferable to visit endemic areas when rainfall is doxycycline is taken with insufficient fluid or in a recumbent mg of Doxycycline, plasma concentrations of the medicine IDENTIFICATION:
reach a maximum of 3µg/ml at 2 hours and are well the following high risk individuals should avoid malaria Hypersensitivity reactions including rashes, fixed drug White, film coated biconvex tablets, cross-scored on one maintained, and thus dosage once daily is usually adequate.
eruptions, exfoliative dermatitis, toxic epidermal necrolysis, Absorption is diminished by the presence of iron, aluminium, babies and young children less than 5 years old, drug fever, pericarditis, angioedema, urticaria, and asthma PRESENTATION:
have been reported and anaphylaxis has occurred less Tablets: 10 and 100 tablets in blister packs.
Doxycycline is widely distributed into pleural and peritoneal immunocompromised patients e.g. those on longterm fluid, saliva, semen and prostatic fluid. It passes the STORAGE INSTRUCTIONS:
steroids or chemotherapy, patients with cancer or Photosensitivity appears to be phototoxic rather than placental barrier readily and is also present in the milk of Store below 25°C. Protect from light.
AIDS and those who have had a splenectomy; photoallergic in nature. Patients who may be exposed to lactating patients. It is concentrated by the liver and remain indoors between dusk and dawn, when direct sunlight must be warned of the risk of photosensitivity.
excreted, by way of the bile, into the intestine from which it REGISTRATION NUMBER: 29/20.1.1/0298
Paraesthesia may be an ear ly sign of impending apply insect repellant to exposed skin and clothing; phototoxicity. Nail discoloration and onycholysis may occur.
NAME AND BUSINESS ADDRESS OF APPLICANT:
INDICATIONS:
Abnormal pigmentation of the skin and eye has occurred.
Infections caused by susceptible strains.
use mosquito nets, screens, coils or pads.
A Jarisch-Herxheimer-like reaction has been reported in Upper and lower respiratory tract:
Should flu-like symptoms appear at any time, the patient patients with relapsing fever treated with doxycycline.
Sinusitis, pharyngitis, pneumonia (Legionella and must inform his doctor that he has been to a malaria area.
Haemolytic anaemia, eosinophilia, neutropenia, and DATE OF PUBLICATION OF THIS PACKAGE INSERT:
Mycoplasma), psittacosis and chronic bronchitis.
thrombocytopenia have been reported.
DOSAGE AND DIRECTIONS FOR USE:
Genito-urinary tract:
Reductions in serum vitamin B concentrations, including Usual dose: 2 tablets on 1st day (single dose or 100mg twice Non-specific urethritis (only if the strain is sensitive), folate deficiency and concomitant megaloblastic anaemia daily), thereafter 1 tablet (100mg) a day, 1 hour before or 2 lymphogranuloma venereum, chancroid and granuloma hours after meals, with adequate liquid (at least half a glass inguinale, gonorrhoea, gonococcal salpingitis, The use of out-of-date or deteriorated tetracyclines has of water) and one hour or more before retiring to bed to epididymitis, acute epididymo-orchitis, endocervical been associated with the development of a reversible avoid esophageal irritation and ulceration.
infections and syphilis (in cases of penicillin allergy).
Fanconi-type syndrome characterized by polyuria and Severe infections: 200mg daily throughout treatment period.
Soft tissue infections:
polydipsia with nausea, glycosuria, aminoacidur ia, Medication should be taken for at least 24 - 48 hours after hypophosphataemia, hypokalaemia, and hyperuricaemia fever and other symptoms have disappeared.
Ophthalmic:
For malaria prophylaxis:
Trachoma and inclusion conjunctivitis.
Other adverse effects include myopathy, increased muscle ADULTS AND TEENAGERS: 100mg (1 tablet) daily Intestinal:
weakness in patients with myasthenia gravis, and CHILDREN OVER 8 YEARS: 2mg/kg, once daily, up to Cholera, Whipple’s disease, and tropical sprue.

Source: http://www.ciplamedsa.co.za/media/55781/sep_doxitab.pdf

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