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
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
of malaria prophylaxis DOXITAB is contra-indicated in
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
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
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
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
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
weakness in patients with myasthenia gravis, and
CHILDREN OVER 8 YEARS: 2mg/kg, once daily, up to
Cholera, Whipple’s disease, and tropical sprue.
One-year Results of Photorefractive Keratectomy With and Without Surface Smoothing Using the Technolas 217C Laser Sebastiano Serrao, MD, PhD; Marco Lombardo, MD ABSTRACT PURPOSE: To assess the efficacy, predictability, Several factors can affect smoothness of the stability, and safety of a smoothing technique in patients with myopia immediately after photore- laser beam diameter1, l
Progetti di ricerca in corso nell’ U.O. di Virologia Direttore: Prof. Ceccherini-Nelli Luca INTRODUZIONE Il virus erpetico ottavo umano (HHV-8), noto anche come virus erpetico associato al sarcoma di Kaposi (KSHV) è stato isolato per la prima volta nel 1994 da una biopsia di un sarcoma di Kaposi (SK) associato ad AIDS. E’ un virus a DNA a doppio filamento dotato di pericapside e con sim