Summary of product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1. Trade Name of the medical product
2. Qualitative and quantitative composition
Doxycycline hydrochloride equivalent to Doxycycline 100mg, Microcrystalline
cellulose 245mg, Lactose 174mg, Sodium starch glycolate 48mg, Povidone
3mg, Polyethylene glycol 6000 6mg, Colloidal silicon dioxide 3mg,
Yellow film coating suspension per gram: Hydroxypropylmethylcellulose 2910
11.3mg, Polyethylene glycol 400 1.4mg, Titanium dioxide 1.4mg, Riboflavine
3. Pharmaceutical form
4. Clinical information
4.1 Therapeutic Indications
DOXAT has been found clinically effective in the treatment of a variety of
infections caused by susceptible strains of Gram-positive and Gram-negative
bacteria and certain other micro-organisms.
Respiratory tract infections
Pneumonia and other lower respiratory tract
infections due to susceptible strains of Streptococcus pneumoniae
, Klebsiella pneumoniae
and other organisms.
pneumonia. Treatment of chronic bronchitis,
Urinary tract infections
caused by susceptible strains of Klebsiella species,
Enterobacter species, Escherichia coli, Streptococcus faecalis
Sexually transmitted diseases
Infections due to Chlamydia trachomatis
including uncomplicated urethral, endocervical or rectal infections. Non-
gonococcal urethritis caused by Ureaplasma urealyticum
DOXAT is also indicated in chancroid, granuloma inguinale and
lymphogranuloma venereum. DOXAT is an alternative drug in the treatment of
Acne vulgaris, when antibiotic therapy is considered
Since DOXAT is a member of the tetracycline series of antibiotics, it may be
expected to be useful in the treatment of infections which respond to other
Due to susceptible strains of gonococci,
staphylococci and Haemophilus influenzae
. Trachoma, although the infectious
agent, as judged by immunofluorescence, is not always eliminated. Inclusion
conjunctivitis may be treated with oral DOXAT alone or in combination with
Rocky Mountain spotted fever, typhus group, Q fever,
Psittacosis, brucellosis (in combination with streptomycin),
cholera, bubonic plague, louse and tick-borne relapsing fever, tularaemia
glanders, melioidosis, chloroquine-resistant falciparum malaria and acute
intestinal amoebiasis (as an adjunct to amoebicides).
DOXAT is an alternative drug in the treatment of leptospirosis, gas gangrene
DOXAT is indicated for prophylaxis in the following conditions: Scrub typhus,
travellers' diarrhoea (enterotoxigenic Escherichia coli),
malaria. Prophylaxis of malaria should be used in accordance to current
guidelines, as resistance is an ever changing problem.
4.2 Posology and method of administration
The usual dosage of DOXAT for the treatment of acute infections in adults is
200mg on the first day (as a single dose or in divided doses) followed by a
maintenance dose of 100mg/day. In the management of more severe
infections, 200mg daily should be given throughout treatment.
Dispersible Tablets are for oral administration only.
DOXAT-D tablets are administered by drinking a suspension of the tablets in
This should be done in the sitting or standing position and well before retiring
at night to reduce the risk of oesophageal irritation and ulceration. If gastric
irritation occurs, it is recommended that DOXAT be given with food or milk.
Studies indicate that the absorption of DOXAT is not notably influenced by
Exceeding the recommended dosage may result in an increased incidence of
side effects. Therapy should be continued for at least 24 to 48 hours after
When used in streptococcal infections, therapy should be continued for 10
days to prevent the development of rheumatic fever or glomerulonephritis.
Dosage recommendations in specific infections:
50mg daily with food or fluid for 6 to 12 weeks.
Sexually transmitted diseases
100mg twice daily for 7 days is
recommended in the following infections: uncomplicated gonococcal
infections (except anorectal infections in men); uncomplicated urethral,
endocervical or rectal infection caused by Chlamydia trachomatis
gonococcal urethritis caused by Ureaplasma urealyticum
. Acute epididymo-
orchitis caused by Chlamydia trachomatis
or Neisseria gonorrhoea
twice daily for 10 days. Primary and secondary syphilis: Non-pregnant
penicillin-allergic patients who have primary or secondary syphilis can be
treated with the following regimen: doxycycline 200mg orally twice daily for
two weeks, as an alternative to penicillin therapy.
Louse and tick-borne relapsing fevers
A single dose of 100 or 200mg
Treatment of chloroquine-resistant falciparum malaria
200mg daily for at
least 7 days. Due to the potential severity of the infection, a rapid-acting
schizonticide such as quinine should always be given in conjunction with
DOXAT; quinine dosage recommendations vary in different areas.
Prophylaxis of malaria
100mg daily in adults and children over the age of 12
years. Prophylaxis can begin 1-2 days before travel to malarial areas. It
should be continued daily during travel in the malarial areas and for 4 weeks
after the traveller leaves the malarial area. For current advice on geographical
resistance patterns and appropriate chemoprophylaxis, current guidelines or
the Malaria Reference Laboratory should be consulted, details of which can
be found in the British National Formulary (BNF).
For the prevention of scrub typhus
200mg as a single dose.
For the prevention of travellers' diarrhoea in adults
200mg on the first day
of travel (administered as a single dose or as 100mg every 12 hours) followed
by 100mg daily throughout the stay in the area. Data on the use of the drug
prophylactically are not available beyond 21 days.
For the prevention of leptospirosis
200mg once each week throughout the
stay in the area and 200mg at the completion of the trip. Data on the use of
the drug prophylactically are not available beyond 21 days.
Use for children
See under “Contra-indications”.
Use in the elderly
DOXAT may be prescribed in the elderly in the usual
dosages with no special precautions. No dosage adjustment is necessary in
the presence of renal impairment. The DOXAT-D dispersible tablet may be
preferred for the elderly since it is less likely to be associated with
Use in patients with impaired hepatic function
See under “Special
Use in patients with renal impairment
Studies to date have indicated that
administration of DOXAT at the usual recommended doses does not lead to
accumulation of the antibiotic in patients with renal impairment see under
“Special warnings and precautions for use”.
Persons who have shown hypersensitivity to doxycycline, any of its inert
ingredients or to any of the tetracyclines.
The use of drugs of the tetracycline class during tooth development
(pregnancy, infancy and childhood to the age of 12 years) may cause
permanent discolouration of the teeth (yellow-grey-brown). This adverse
reaction is more common during long-term use of the drugs but has been
observed following repeated short-term courses. Enamel hypoplasia has also
been reported. DOXAT is therefore contra-indicated in these groups of
DOXAT is contra-indicated in pregnancy. It appears that the risks
associated with the use of tetracyclines during pregnancy are predominantly
due to effects on teeth and skeletal development. (See above about use
Tetracyclines are excreted into milk and are therefore
contra-indicated in nursing mothers. (See above about use during tooth
DOXAT is contra-indicated in children under the age of 12 years. As
with other tetracyclines, DOXAT forms a stable calcium complex in any bone-
forming tissue. A decrease in the fibula growth rate has been observed in
prematures given oral tetracyclines in doses of 25mg/kg every 6 hours. This
reaction was shown to be reversible when the drug was discontinued. (See
above about use during tooth development).
4.4 Special warnings and precautions for use
Use in patients with impaired hepatic function
DOXAT should be
administered with caution to patients with hepatic impairment or those
receiving potentially hepatotoxic drugs.
Abnormal hepatic function has been reported rarely and has been caused by
both the oral and parenteral administration of tetracyclines, including
Use in patients with renal impairment
Excretion of doxycycline by the
kidney is about 40%/72 hours in individuals with normal renal function. This
percentage excretion may fall to a range as low as 1-5%/72 hours in
individuals with severe renal insufficiency (creatinine clearance below
10ml/min). Studies have shown no significant difference in the serum half-life
of doxycycline in individuals with normal and severely impaired renal function.
Haemodialysis does not alter the serum half-life of doxycycline. The anti-
anabolic action of the tetracyclines may cause an increase in blood urea.
Studies to date indicate that this anti-anabolic effect does not occur with the
use of DOXAT in patients with impaired renal function.
Photosensitivity manifested by an exaggerated sunburn
reaction has been observed in some individuals taking tetracyclines, including
doxycycline. Patients likely to be exposed to direct sunlight or ultraviolet light
should be advised that this reaction can occur with tetracycline drugs and
treatment should be discontinued at the first evidence of skin erythema.
The use of antibiotics may occasionally result in
the overgrowth of non-susceptible organisms including Candida. If a resistant
organism appears, the antibiotic should be discontinued and appropriate
Pseudomembranous colitis has been reported with nearly all antibacterial
agents, including doxycycline, and has ranged in severity from mild to life-
threatening. It is important to consider this diagnosis in patients who present
with diarrhoea subsequent to the administration of antibacterial agents.
Instances of oesophagitis and oesophageal ulcerations have
been reported in patients receiving capsule and tablet forms of drugs in the
tetracycline class, including doxycycline. Most of these patients took
medications immediately before going to bed or with inadequate amounts of
in infants and benign intracranial hypertension in
juveniles and adults have been reported in individuals receiving full
therapeutic dosages. These conditions disappeared rapidly when the drug
There have been rare reports of porphyria in patients receiving
When treating venereal disease, where co-existent syphilis
is suspected, proper diagnostic procedures including dark-field examinations
should be utilised. In all such cases monthly serological tests should be made
Beta-haemolytic streptococci infections
Infections due to group A beta-
haemolytic streptococci should be treated for at least 10 days.
Due to a potential for weak neuromuscular blockade, care
should be taken in administering tetracyclines to patients with myasthenia
Systemic lupus erythematosus
Tetracyclines can cause exacerbation of
Caution is advised in administering tetracyclines with
4.5 Interactions with other medications and other forms of
The absorption of doxycycline may be impaired by concurrently administered
antacids containing aluminium, calcium, magnesium or other drugs containing
these cations; oral zinc, iron salts or bismuth preparations. Dosages should
Since bacteriostatic drugs may interfere with the bactericidal action of
penicillin, it is advisable to avoid giving DOXAT in conjunction with penicillin.
There have been reports of prolonged prothrombin time in patients taking
warfarin and doxycycline. Tetracyclines depress plasma prothrombin activity
and reduced doses of concomitant anticoagulants may be necessary.
The serum half-life of doxycycline may be shortened when patients are
concurrently receiving barbiturates, carbamazepine or phenytoin. An increase
in the daily dosage of DOXAT should be considered.
Alcohol may decrease the half-life of doxycycline.
A few cases of pregnancy or breakthrough bleeding have been attributed to
the concurrent use of tetracycline antibiotics with oral contraceptives.
Doxycycline may increase the plasma concentration of cyclosporin. Co-
administration should only be undertaken with appropriate monitoring.
The concurrent use of tetracyclines and methoxyflurane has been reported to
result in fatal renal toxicity. See section 4.4
Laboratory test interactions
False elevations of urinary catecholamine levels may occur due to
interference with the fluorescence test.
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
The effect of doxycycline on the ability to drive or operate heavy machinery
has not been studied. There is no evidence to suggest that doxycycline may
4.8 Undesirable effects
The following adverse reactions have been observed in patients receiving
Autonomic nervous system
Body as a whole
Hypersensitivity reactions, including anaphylactic shock,
anaphylaxis, anaphylactoid reaction, anaphylactoid purpura, hypotension,
pericarditis, angioneurotic oedema, exacerbation of systemic lupus
erythematosus, dyspnoea, serum sickness, peripheral oedema, tachycardia
Central and Peripheral nervous system
Headache. Bulging fontanelles in
infants and benign intracranial hypertension in juveniles and adults have been
reported in individuals receiving full therapeutic dosages of tetracyclines. In
relation to benign intracranial hypertension, symptoms included blurring of
vision, scotomata and diplopia. Permanent visual loss has been reported.
Gastro-intestinal symptoms are usually mild and seldom
necessitate discontinuation of treatment. Abdominal pain, anorexia, nausea,
vomiting, diarrhoea, dyspepsia and rarely dysphagia. Oesophagitis and
oesophageal ulceration have been reported in patients receiving DOXAT. A
significant proportion of these occurred with the hyclate salt in the capsule
form. (See 'Special warnings and precautions for use' section).
porphyria, and eosinophilia have been reported with tetracyclines.
Transient increases in liver function tests, hepatitis, jaundice,
hepatic failure and pancreatitis have been reported rarely.
Arthralgia and myalgia.
Rashes including maculopapular and erythematous rashes, exfoliative
dermatitis, erythema multiforme, Steven-Johnson syndrome and toxic
epidermal necrolysis. Photosensitivity skin reactions (see 'Special warnings
As with all antibiotics, overgrowth of non-susceptible
organisms may cause candidiasis, glossitis, staphylococcal enterocolitis,
pseudomembranous colitis (with Clostridium difficile
inflammatory lesions (with candidal overgrowth) in the anogenital region.
Similarly there have been reports for products in the tetracycline class of
Increased blood urea. (See 'Special warnings and
When given over prolonged periods, tetracyclines have been reported
to produce brown-black microscopic discolouration of thyroid tissue. No
abnormalities of thyroid function are known to occur.
Tetracyclines may cause discoloration of teeth and enamel hypoplasia, but
Acute overdosage with antibiotics is rare. In the event of overdosage, gastric
lavage and other supportive measures are indicated.
Dialysis does not alter serum half-life and thus would not be of benefit in treating
5. Pharmacological properties
5.1 Pharmacodynamic properties
DOXAT is primarily bacteriostatic and is believed to exert its antimicrobial
effect by the inhibition of protein synthesis. DOXAT is active against a wide
range of Gram-positive and Gram-negative bacteria and certain other micro-
5.2 Pharmacokinetic properties
Tetracyclines are readily absorbed and are bound to plasma proteins in
varying degrees. They are concentrated by the liver in the bile and excreted in
the urine and faeces at high concentrations and in a biologically active form.
Doxycycline is virtually completely absorbed after oral administration. Studies
reported to date indicate that the absorption of doxycycline, unlike certain
other tetracyclines, is not notably influenced by the ingestion of food or milk.
Following a 200mg dose, normal adult volunteers averaged peak serum levels
of 2.6 micrograms/ml of doxycycline at 2 hours decreasing to 1.45
micrograms/ml at 24 hours. Doxycycline has a high degree of lipid solubility
and a low affinity for calcium. It is highly stable in normal human serum.
Doxycycline will not degrade into an epianhydro form.
6. Pharmaceutical information
6.1 List of excipients
Microcrystalline cellulose, Lactose, Sodium starch glycolate, Povidone,
Polyethylene glycol 6000, Colloidal silicon dioxide, Magnesium stearate.
Hydroxypropylmethylcellulos 2910, Polyethylene glycol 400, Titanium dioxide
6.4 Special precautions for storage
Store in a dry place protected from light, below 25ºC.
6.5 Nature and contents of container
6.6 Instructions for use/handling
7. Marketing authorization holder
Aegis Ltd, Ergates Ind. Area P.O. Box 28629, 2081 Nicosia, CYPRUS,
8. Marketing authorization number
9. Date of first authorization/renewal of authorization
10. Date of partial revision of the text
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Medical and Dental History Patient Name_____________________________________ Date of Birth_______________ Please fill out the form completely to the best of your ability. Health problems that you may have, or medication(s) that you may be taking may have an important interrelationship with the dental care you receive. Thank you. Name of Primary care physician ________________________