Doxycycline

These indications are based on manufacturer information for both originator and generic products. For product specific registered indications, please refer to product specific manufacturer information

Registered South African indications: 

• Upper and lower respiratory tract infections: Sinusitis, pharyngitis, pneumonia (Legionella and Mycoplasma), psittacosis and chronic bronchitis
• Genito-urinary tract infections: Non-specific urethritis (only if the strain is sensitive), Lymphogranuloma venereum, chancroid, and Granuloma inguinale, Gonococcal salpingitis, epididymitis, acute Epididymo-orchitis, endocervical infections, syphilis and gonorrhoea (in cases of penicillin allergy)
• Soft tissue infections: Acne vulgaris
• Ophthalmic: Trachoma and inclusion conjunctivitis
• Intestinal: Cholera, Whipple’s disease and tropical sprue
• Miscellaneous: Rickettsial infections, brucellosis, tularaemia, actinomycosis, Lyme’s disease, yaws, relapsing fever, leptospirosis during the early infective phase
• Malaria prophylaxis: For short-term prophylaxis of malaria due to Plasmodium falciparum 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

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Doxycycline should not be given to patients with a known allergy to tetracyclines, since cross sensitivity may occur
• Pregnancy
  - Pregnant woman and the developing foetus are particularly susceptible to severe doxycycline-induced liver damage
• Breastfeeding
• When administered during childhood up to the age of 12 years, permanent discolouration of the child's teeth may occur, as well as impaired bone growth
• Should be avoided in patients with systemic lupus erythematosus
• Potentially hepatotoxic medication should not be given with doxycycline (cap)
• The administration of doxycycline is contraindicated in patients with porphyria (cap)

Contraindications registered in other jurisdictions

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to tetracyclines
• Pregnancy
• Breastfeeding

• Hepatic impairment
• Porphyria (Recommendations in other jurisdictions) 
• Exposed to direct sunlight or ultraviolet light
• Taking doxycycline immediately before going to bed or with inadequate amounts of fluid
• Venereal disease (when co-existent syphilis is suspected)
• Myasthenia gravis
• Systemic lupus erythematosus
• Spirochete infections
• Coadministration with hepatotoxic agents
• Coadministration with methoxyflurane
• Coadministration with isotretinoin or other systemic retinoids
• May impair ability to drive and operate machinery

Forms avail. in SA and covered in this monograph: cap, tab

Dosages below include:

• South African Standard Treatment Guideline indications and dosages
• South African registered indications and dosages
• South African National Guideline for Malaria recommendations

Infections caused by: Vibrio cholerae, Ureaplasma urealyticum, Mycoplasma pneumoniae, Chlamydia trachomatis, Chlamydia psittaci, Borrelia recurrensis, Calymmatobacterium granulomatis, Borrelia burgdorferi, penicillin-sensitive Neisseria gonorrhoeae and Rickettsiae

Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

South African Standard Treatment Guideline indications and dosages

Brucellosis (Additional agent required)

• Oral (cap, tab): 100mg, 12hrly; Treatment duration: 6 weeks 
  (STG, Adult 2019)

Bubo

• Oral (cap, tab): 100mg, 12hrly; Treatment duration: 21 days 
  (STG, Adult 2019)

- For laboratory-confirmed diagnosis of lymphogranuloma venereum (LGV)

• Oral (cap, tab): 100mg, 12hrly; Treatment duration: >21 days may be required for complete resolution of disease 
  (STG, Adult 2019)

Tick bite fever

• Oral (cap, tab): 100mg, 12hrly; Treatment duration: For at least 3 days after the fever subsides with clinical improvement; Total treatment duration: 7 days
  (STG, Adult 2019; PHC 2020)

Chronic obstructive pulmonary disease - acute exacerbation of chronic bronchitis
- Severe penicillin allergy

• Oral (cap, tab): 100mg, 12hrly; Treatment duration: 5 days
  (STG, Adult 2019; PHC 2020)

Acne vulgaris - moderate

• Oral (cap, tab): 100mg, dly; Treatment duration: 3 months
  (STG, PHC 2020)

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Review: After month 3

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Oral (tab, cap): Should be taken with meals
Not to be taken together with iron preparations and antacids

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Genital ulcer syndrome (GUS) 

• Oral (cap, tab): 100mg, 12hrly; Treatment duration: 14 days
  (STG, PHC 2020)

- Treatment of partners (asymptomatic and symptomatic)

• Oral (cap, tab): 100mg, 12hrly; Treatment duration: 14 days
  (STG, PHC 2020)

Early syphilis 
- If penicillin-allergic or if benzathine benzylpenicillin is unavailable

• Oral (cap, tab): 100mg, 12hrly; Treatment duration: 14 days
  (STG, PHC 2020)

Late/late latent syphilis
- If penicillin-allergic or if benzathine benzylpenicillin is unavailable

• Oral (cap, tab): 100mg, 12hrly; Treatment duration: 30 days
  (STG, PHC 2020)

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South African registered indications and dosages

Acne vulgaris

• Oral (cap): 50mg, twice dly

Commonly occurring infections (usual dose)

• Oral (cap, tab): Initial: 200mg, dly OR 100mg, 12hrly on the first day; Maintenance: 100mg, dly with adequate liquid; In severe infections: Maintain initial dose throughout the course of treatment; Treatment duration: 24-48hrs after the symptoms and fever have subsided

Uncomplicated gonorrhoea
Non-gonococcal urethral
Endocervical and rectal infections 
Nonspecific urethritis

• Oral (cap, tab): 100mg, 12hrly; Treatment duration: 7 days

Malaria prophylaxis
- For short-term prophylaxis of malaria due to Plasmodium falciparum 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

• Oral (cap, tab): 100mg, dly, started 1-2 days before travel to malaria areas and continued daily throughout travel and for 4 weeks after the last possible exposure to infection

Trachoma

• Oral (cap, tab): 100mg, dly; Treatment duration: 40 days

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Take 1 hour before or 2 hours after meals

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Should be taken with adequate liquid with the patient in an upright position to avoid lodging of tablet or capsules in the distal oesophagus as this may result in local corrosive irritation and ulceration

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Doxycycline should be given with plenty of fluid. It may be given with food if gastric irritation occurs

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South African National Guideline for Malaria recommendations

Malaria treatment - uncomplicated (additional agent required)

• Oral (cap, tab): 100mg, 12hrly; Treatment duration: ≥7 days

Paed. forms avail. in SA and covered in this monograph: cap, tab

Paed. dosages below include:

• South African Standard Treatment Guideline recommendations
• South African manufacturer recommendations
• South African National Guideline for Malaria recommendations

Infections caused by: Vibrio cholerae, Ureaplasma urealyticum, Mycoplasma pneumoniae, Chlamydia trachomatis, Chlamydia psittaci, Borrelia recurrensis, Calymmatobacterium granulomatis, Borrelia burgdorferi, penicillin-sensitive Neisseria gonorrhoeae and Rickettsiae

Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

South African Standard Treatment Guideline indications and dosages

Acne (Additional agent required)
- For inflammatory acne

• Oral (cap, tab): 100mg, dly; Max duration: 3 months
  (STG, Paed. 2023)

Malaria prophylaxis

Older than 8 years

• Oral (cap, tab): 2.2mg/kg, dly beginning 2 days before travel, and continued daily during travel, and for 4 weeks after leaving the area

Tick bite fever - severe disease

• <50kg: Oral (cap, tab): Day 1: 4mg/kg/24hrs in 2 divided doses; Day 2: 2mg/kg/24hrs in 2 divided doses; Then switch to azithromycin: IV/oral, 10mg/kg daily for 3 days
  (STG, Paed. 2023)
• >50kg: Oral (cap, tab): 100mg, 12hrly for 2 days; Then switch to azithromycin: IV/oral, 10mg/kg daily for 3 days
  (STG, Paed. 2023)

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South African registered indications and dosages

Malaria prophylaxis 
- For short-term prophylaxis of malaria due to Plasmodium falciparum 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

Younger than 8 years

• Contraindicated

Older than 8 years

• Oral (cap, tab): 2mg/kg, dly, started 1-2 days before travel to malaria areas and continued daily throughout travel and for 4 weeks after the last possible exposure to infection; Max: 100mg/24hrs 

Commonly occurring infections (usual dose)

Younger than 12 years

• Contraindicated

Older than 12 years

• <50kg: Oral (cap): Initial: 4mg/kg body mass during the first 24hrs, Then: 2mg/kg body mass, dly during the following days taken 1hr before or 2hrs after meals, with adequate liquid; Treatment duration: 24-48hrs after the symptoms and fever have subsided

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Doxycycline should only be used for children under 8 years of age on very strong indications and the effect of tetracyclines on teeth and bones should be considered

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South African National Guideline for Malaria recommendations

Uncomplicated malaria (Additional agent required)

Younger than 8 years

• Avoid use

Older than 8 years

• Oral (cap, tab): 2.2mg/kg, 12hrly; Treatment duration: ≥7 days

Pregnancy

South African recommendations

• Contraindicated
• Doxycycline should not be used in pregnancy, as it crosses the placenta and is deposited in foetal bones and teeth
• Pregnant woman and the developing foetus are particularly susceptible to severe doxycycline-induced liver damage. When administered to women during the latter half of pregnancy, permanent discolouration of the child's teeth may occur, as well as impaired bone growth

Recommendations in other jurisdictions

• Contraindicated
• Doxycycline is contraindicated during pregnancy. It appears that the risks associated with the use of tetracyclines during pregnancy are predominantly due to effects on teeth and skeletal development

Breastfeeding

South African recommendations

• Contraindicated
• Doxycycline is contraindicated in nursing mothers. When administered to nursing mothers, permanent discolouration of the child's teeth may occur, as well as impaired bone growth

Recommendations in other jurisdictions

• Contraindicated
• Tetracyclines are excreted into milk and are therefore contraindicated in nursing mothers

Fertility

Recommendations below are applicable to South Africa and other jurisdictions

• No information available

• No dose adjustment recommended

• Caution; no dose adjustment recommended

• No dose adjustment recommended

Central Nervous System Disorders

• Headache
• Bulging fontanelle
• Anxiety
• Benign intracranial hypertension (pseudotumor cerebri)

Cardiovascular Disorders

• Tachycardia
• Pericarditis
• Hypotension
• Flushing

Respiratory Disorders

• Dyspnoea

Gastrointestinal Disorders

• Pseudomembranous colitis
• Clostridium difficile colitis
• Abdominal pain
• Stomatitis
• Nausea and vomiting
• Diarrhoea
• Dyspepsia
  - Heartburn
  - Gastritis
• Pancreatitis
• Dysphagia
• Oesophagitis
• Oesophageal ulceration
• Enterocolitis
• Inflammatory lesions (with monilial overgrowth) in the anogenital region
• Glossitis
• Discolouration of teeth
• Enamel hypoplasia

Hepatobiliary Disorders

• Hepatitis
• Hepatoxicity
• Jaundice
• Abnormal hepatic function
• Hepatic failure

Genitourinary Disorders

• Increased blood urea
• Vaginal infection

Endocrine and Metabolic Disorders

• Brown-black microscopic discolouration of thyroid glands
• Decreased appetite

Musculoskeletal Disorders

• Arthralgia
• Myalgia

Skin and Subcutaneous Tissue Disorders

• Rash
• Maculopapular and erythematous rash
• Exfoliative dermatitis
• Erythema multiforme
• Henoch-Schonlein purpura
• Urticaria
• Stevens-Johnson syndrome
• Toxic epidermal necrolysis
• Photo-onycholysis
• Photosensitivity
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
• Skin hyperpigmentation

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions
• Anaphylactic shock
• Anaphylactic reaction
• Anaphylactoid reaction
• Jarisch-Herxheimer reaction
• Exacerbation of systemic lupus erythematosus
• Serum sickness
• Peripheral oedema
• Candida infection
• Haemolytic anaemia
• Thrombocytopenia
• Neutropenia
• Porphyria
• Eosinophilia
• Angioedema

Sensory Disorders

• Tinnitus
• Blurring of vision
• Scotomata
• Diplopia
• Permanent visual loss

• Antacids
• Cation-containing agents
• Aluminium
• Calcium
• Magnesium
• Oral zinc
• Bismuth preparations
• Iron salts
• Penicillins
• Anticoagulants
• Warfarin
• Barbiturates
• Phenytoin
• Carbamazepine
• Oral contraceptives
• Ciclosporin
• Methoxyflurane
• Isotretinoin
• Systemic retinoids
• Rifampicin
• Ergotamine
• Methotrexate
• Quinapril

Other interactions

• Alcohol
• Laboratory test interactions
• Fluorescence test

None routine. Specific cases may require

• Full blood count
• Hepatic function
• Renal function
• Intracranial pressure

Drug levels

• Plasma concentration of ciclosporin (when coadministered)
• Plasma concentration of doxycycline (when coadministered with hepatic enzyme inducers)

 

The main mechanism of action of doxycycline is on protein synthesis. Doxycycline passes directly through the lipid bilayer of the bacterial cell wall and an energy dependent active transport system pumps the drug through the inner cytoplasmic membrane. Once inside the cell doxycycline inhibits protein synthesis by binding to 30S ribosomes and prevents the addition of amino acids to the growing peptide chain. Doxycycline will impair protein synthesis in mammalian cells at very high concentrations but these cells lack the active transport system found in bacteria. Doxycycline is clinically effective in the treatment of a variety of infections caused by a wide range of gram-negative and gram-positive bacteria, as well as certain other micro-organisms.

Spectrum of activity: Arcanobacter sp, B. burgdoferi, Bartonella sp, C. burnetii, C. trachomatis, Chlamydophila sp, Ehrlichia, Anaplas, F. tularensis, K. granulomatis, Leptospira sp, Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae,M. pneumoniae, R. ricketsii, U. urealyticum,Klebsiella species, Enterobacter species, Escherichia coli, enterotoxigenic Escherichia coli, Streptococcus faecalis, Coxiella endocarditis, Yersinia sp (susceptible strains), Brucella sp, Clostridium sp, Francisella tularensis, falciparum malaria (chloroquine-resistant)

Capsule 50mg

• Doxycyl (Pharmacare)
• Dumoxin (Pharmacare) originator

Capsule 100mg

• A-Lennon doxycycline  (Pharmacare)
• Cyclidox (Trinity Pharma)
• Doxycyl (Pharmacare)
• Doxytet (Medicine Dev)

Tablet 100mg

• Doxycycline biotech (Biotech)
• Doxyhexal (Sandoz)
• Doximal (Cipla)
• Doxitab (Cipla)