Doxycycline monohydrate oral standard release
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Standard release oral formulations containing doxycycline as doxycycline monohydrate.
Antibiotic sensitive infections
Malaria - prophylaxis
Prophylaxis of leptospirosis
Prophylaxis of scrub typhus
Prophylaxis of travellers' diarrhoea(enterotoxigenic E. coli)
Treatment of chloroquine resistant malaria
Treatment of louse and tick-borne fevers (Rickettsia, Babesia, Borrelia)
Treatment of sexually transmitted infections
Treatment of infections caused by susceptible strains of Gram-positive and Gram-negative bacteria and certain other micro-organisms.
Types of infections include:
Respiratory tract infections
Chronic bronchitis, sinusitis, pneumonia and other lower respiratory tract infections due to susceptible strains of Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae and other organisms including Mycobacteria pneumoniae.
Urinary tract infections
Susceptible strains of Klebsiella species, Enterobacter species, Escherichia coli, Streptococcus faecalis and other organisms.
Sexually transmitted infections
Chlamydia trachomatis including uncomplicated urethral, endocervical or rectal infections. Non-gonococcal urethritis caused by Ureaplasma urealyticum (T-mycoplasma). Chancroid, granuloma inguinale and lymphogranuloma venereum and as an alternative drug in the treatment of gonorrhoea and syphilis.
Acne vulgaris when antibiotic therapy is considered necessary.
Susceptible strains of gonococci, staphylococci and Haemophilus influenzae. Trachoma (although the infectious agent is not always eliminated). Inclusion conjunctivitis used alone or with topical agents.
Rocky mountain spotted fever, typhus, Q fever, Coxiella endocarditis and tick fevers.
Psittacosis, brucellosis (in combination with streptomycin), cholera, bubonic plague, louse and tick-borne relapsing fever, tularaemia glanders, melioidosis, chloroquine-resistant falciparum malaria, acute amoebiasis (as an adjunct to amoebicides), and as an alternative treatment of leptospirosis, gas gangrene and tetanus.
Prophylaxis against the following infections
Scrub typhus, travellers' diarrhoea, leptospirosis and malaria.
For up to date advice on geographical resistance patterns and appropriate prophylaxis, current guidelines should be consulted.
Guidelines for Malaria Prevention from the Health Protection Agency specifically developed for travellers from the United Kingdom may be obtained from the Public Health England website: https://www.gov.uk/government/publications/malaria-prevention-guidelines-for-travellers-from-the-uk
Recurrent aphthous ulceration
Treatment and prophylaxis of anthrax
Treatment of rosacea
Initial dose: 200mg on the first day (as a single or in divided doses).
Maintenance dose: 100mg daily (up to 200mg daily in severe infections).
Continue for 24 to 48 hours after symptoms have resolved.
When used to treat streptococcal infections, therapy should be continued for 10 days to prevent the development of rheumatic fever or glomerulonephritis.
Dose regimes in specific infections
50mg daily with food or fluid for six to twelve weeks.
Sexually transmitted diseases
100mg twice daily for seven days.
Primary or secondary syphilis (non-pregnant, penicillin-allergic patients only)
100mg to 200mg twice daily for fourteen days.
Louse and tick-borne relapsing fevers
100mg to 200mg (single dose) according to severity.
Chloroquine resistant falciparum malaria treatment
200mg daily for at least seven days. A rapid acting schizonticide such as quinine should be given in conjunction with doxycycline.
Prophylaxis of malaria
100mg daily. Prophylaxis can begin one to two 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.
Scrub typhus prevention
200mg as a single dose.
Traveller's diarrhoea prevention
200mg on the first day of travel (as a single dose or as 100mg every 12 hours), followed by 100mg daily throughout the stay in the area.
200mg once weekly throughout stay in the area and 200mg on completion of the trip.
200mg twice daily for twenty eight days.
Late latent syphilis
100mg twice daily for twenty eight days.
Pelvic inflammatory disease
100mg twice daily for fourteen days.
Anthrax prophylaxis and treatment (unlicensed)
100mg twice daily.
Lyme disease (unlicensed)
100mg twice daily for ten to fourteen days for early Lyme disease (twenty eight days in Lyme arthritis).
Periodontitis, as an adjunct to gingival scaling and root planing (unlicensed)
20mg twice daily for three months.
Rosacea treatment (unlicensed)
100mg once daily.
Treatment of recurrent aphthous ulceration (unlicensed)
100mg dispersible tablets, rinse in mouth for 2 to 3 minutes, four times daily for three days. Avoid swallowing.
Children aged over 12 years: (See Dosage; Adult).
Doxycycline may cause permanent discolouration of the teeth and enamel hypoplasia.
Children aged 1 months to 12 years (unlicensed)
Treatment or prophylaxis of anthrax
2.5mg/kg twice daily (maximum 100mg twice daily).
Patients with Hepatic Impairment
Doxycycline should be administered with caution to patients with hepatic impairment or to those receiving hepatotoxic drugs.
Abnormal hepatic function has been reported rarely with the use of oral administration of tetracyclines including doxycycline.
Children under 12 years
Precautions and Warnings
May exacerbate or activate systemic lupus erythematosus
Drugs for malaria prophylaxis are not prescribable on the NHS
If visual disturbances occur, perform ophthalmic evaluation
Consider C. difficile if diarrhoea occurs within 2 months of treatment
Consider pseudomembranous colitis if patient presents with diarrhoea
May cause tooth discolouration during tooth development
Prolonged use may result in superinfection with non-susceptible organisms
May affect results of some laboratory tests
Discontinue at first signs of skin erythema
Discontinue if overgrowth of resistant organisms occurs
Discontinue if photosensitivity occurs
Discontinue if severe skin reaction occurs
Discontinue if signs of raised intracranial pressure
Advise patient not to take St John's wort concurrently
Advise to avoid antacids/mineral supplements 2 hours before or after dose
Advise patient to avoid alcohol during treatment
Advise patient that photosensitivity possible
Avoid excessive exposure to sunlight
Avoid excessive exposure to UV light
When treating venereal disease, where syphilis is also suspected, appropriate diagnostic procedures (including dark-field examinations) should be conducted. In these cases, monthly serological tests should be made for at least four months.
The use of the tetracycline class during tooth development (pregnancy, infancy and children under 12 years) may cause permanent discolouration of the teeth (yellow-grey-brown). This is more common after long-term use however this side effect has also be seen after short term use.
Pregnancy and Lactation
Doxycycline is contraindicated in pregnancy.
Schaefer suggests tetracyclines are contraindicated after the fifteenth week of gestation. If used in the first trimester they are considered second-line however doxycycline would be the preferred choice. Use of tetracyclines is not an indication for termination of pregnancy or for invasive diagnostic procedures. Briggs suggests tetracyclines should be used with caution, if at all, in pregnancy and contraindicates use in the second and third trimesters. If travel to a malarious area is unavoidable in pregnancy, doxycycline can be used if other regimens have been deemed unsuitable, and if the entire treatment course can be completed before 15 weeks' gestation. The manufacturers contraindicate the use of doxycycline in pregnancy.
The risks associated with tetracyclines in pregnancy are effects on teeth and skeletal development in the foetus. Enamel hypoplasia has been reported.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Doxycycline is contraindicated in breastfeeding.
The Drugs and Lactation Database (LactMed) suggests short-term use of doxycycline is unlikely to be harmful as absorption by the infant is inhibited by the calcium in breast milk and milk levels are low. Prolonged or repeated treatment courses should be avoided. Briggs suggest that tetracyclines can cause discolouration in teeth and inhibit bone growth however the risk seems remote. Use with a similar antibiotic, tetracycline, showed serum levels were undetectable in exposed infants. Schaefer suggests doxycycline can be given if the antibiotics of choice are not expected to work. The manufacturer suggest doxycycline is contraindicated in breastfeeding.
Tetracyclines are excreted in breast milk, however absorption and discolouration of teeth in the infant is probably prevented by chelation with calcium in the milk.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Advise patient the doxycycline dispersible tablets should be allowed to disperse in a small amount of water and the suspension swallowed.
Advise patient doxycycline should be taken with adequate amounts of fluid in a sitting or standing position well before retiring at night to minimise the risks of oesophageal irritation and ulceration. If gastric irritation occurs, the dose should be taken with food or milk.
Advise patient to avoid excessive exposure to sunlight or ultraviolet light.
Advise patients that they should not consume alcohol while taking doxycycline. Alcohol may decrease the half-life of doxycycline.
Advise patient to avoid antacids and mineral supplements for 2 hours before or after dose.
Advise patient to avoid taking St John's wort concurrently.
Advise patient that photosensitivity is possible and to avoid prolonged exposure to sunlight and UV rays during treatment. Discontinue if skin erythema occurs.
Abnormal liver function tests
Benign intracranial hypertension
Blood urea increased
Brown-black microscopic discolouration of thyroid tissue
Bulging fontanelles in infants
Drug rash with eosinophilia and systemic symptoms (DRESS)
Exacerbation of systemic lupus erythematosus
Loss of vision
Toxic epidermal necrolysis
Yellowish-brown discolouration of teeth
Effects on Laboratory Tests
False elevations of urinary catecholamines levels may occur due to interference with the fluorescence test.
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: September 2016
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Products Characteristics: Vibramycin-D Dispersible Tablets 100 mg. Pfizer Limited. Revised February 2020.
NICE - Evidence Services
Available at: www.nice.org.uk
Last accessed: 29 June 2017.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Doxycycline. Last revised: 10 March 2015.
Last accessed: 09 September 2016.
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