Oxytetracycline

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: Sinusitis, pharyngitis, pneumonia (legionella and mycoplasma) and psittacosis
• Genitourinary tract: Non-specific urethritis, lymphogranuloma venereum, chancroid and granuloma inguinal, gonorrhoea, gonococcal salpingitis, epididymitis, acute epididymo-orchitis, endocervical infections and syphilis (in cases of penicillin allergy)
• Soft tissue: Acne
• Ophthalmic: Trachoma and inclusion conjunctivitis
• Intestinal: Cholera, Whipple’s disease, and tropical sprue
• Miscellaneous: Rickettsial infections, brucellosis, tularemia, actinomycosis, Lyme disease, yaws, relapsing fever, leptospirosis (during the early infective phase)

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Systemic lupus erythematosus
• Porphyria
• Coadministration with vitamin A or retinoid therapy
• Children <12 years

Cautions

• Elderly
• Venereal disease with co-existent syphilis
• Myasthenia gravis
• Direct exposure to natural or artificial sunlight
• Prolonged use
• Diabetes mellitus
• High doses (particularly when coadministered with hepatotoxic agents)
• Galactose intolerance (certain formulations)
• Total lactase deficiency (certain formulations)
• Glucose-galactose malabsorption (certain formulations)
• Fructose intolerance (certain formulations)
• Glucose-galactose malabsorption (certain formulations)
• Sucrase-isomaltase insufficiency (certain formulations)

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

Dosages below include:

• International manufacturer recommendations
• South African manufacturer recommendations

Infections caused by: Activity against a large number of gram-positive and gram-negative bacteria; Clostridium tetani, Listeria monocytogenes, Haemophilus ducreyi, Campylobacter jejuni, Leptospira, Actinomyces israelli, Bacillus anthracis (In vitro sensitivity tests must be performed), Pasteurella multocida, Streptobacillus moniliformis, Erysipelothrix rhusiopathiae M. pneumoniae, Vibrio cholerae, Ureaplasma urealyticum, Mycoplasma pneumonia, Chlamydia trachomatis, chlamydia psittaci, Borrelia recurrentis, Calymmatobacterium granulomatis, Borrelia burgdorferi, penicillin-sensitive Neisseria gonorrhoeae and Rickettsiae

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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

International manufacturer recommendations

Respiratory tract infections
- Pneumonia, whooping cough and other lower respiratory tract infections due to susceptible strains of Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae and other organisms
- Mycoplasma pneumoniae pneumonia
Treatment of chronic bronchitis
- Including the prophylaxis of acute exacerbations
Urinary tract infections 
- caused by susceptible strains of the Klebsiella species, Enterobacter species, Escherichia coli, Streptococcus faecalis and other organisms
Ophthalmic infections
- Trachoma
- Inclusion conjunctivitis
Rickettsial infections
- Rocky Mountain spotted fever
- Typhus group
- Q fever
- Coxiella endocarditis
- Tick fevers
Alternative agent in the treatment of leptospirosis, gas-gangrene and tetanus
Stagnant loop syndrome
Psittacosis
Cholera
Bubonic plague
Louse and tick-borne relapsing fever
Tularaemia
Glanders
Melioidosis
Acute intestinal amoebiasis (as an adjunct to amoebicides)

• Oral (cap): 250-500mg, 6hrly

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Therapeutic levels are attained more rapidly by the administration of 500mg initially, followed by 250mg, 6hrly. For severe infections, the dosage may be increased to 500mg, 6hrly

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All infections due to Group A beta-haemolytic streptococci should be treated for ≥10 days

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Brucellosis (additional agent required)

• Oral (cap): 500mg, 6hrly

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Brucellosis treatment should be coadministered with streptomycin

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Skin infections
- Acne vulgaris
- Severe rosacea

• Oral (cap): 250-500mg, dly or in divided doses; Treatment duration: ≥3 months

Sexually transmitted diseases
- Uncomplicated urethral infection
- Endocervical or rectal infections caused by Chlamydia trachomatis 
- Non-gonococcal urethritis caused by Ureaplasma urealyticum
- Uncomplicated gonococcal infections (except anorectal infections in men)
- Chancroid, granuloma inguinale and lymphogranuloma venereum

• Oral (cap): 500mg, 6hrly; Treatment duration: 7 days

- Acute epididymo-orchitis caused by Chlamydia trachomatis, or Neisseria gonorroeae

• Oral (cap): 500mg, 6hrly; Treatment duration: 10 days

- Syphilis

- Primary
- Secondary

• Oral (cap): 500mg, 6hrly; Treatment duration: 15 days

- Latent syphilis of uncertain or >1 year duration
- Cardiovascular syphilis
- Late benign syphilis (except neurosyphilis)

• Oral (cap): 500mg, 6hrly; Treatment duration: 30 days

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International manufacturer doses are based on a tablet formulation and have been translated to the South African available formulation (cap) for the purposes of this medicine monograph

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Patient compliance with this regimen may be difficult so care should be taken to encourage optimal compliance. Close follow-up including laboratory tests, is recommended

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All indications:
- Best taken on an empty stomach 1hr before food or 2hrs after
- If gastric irritation occurs, the oral formulation should be taken with food and should be taken well before going to bed
- Therapy should be continued for up to 3 days after symptoms have subsided

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South African manufacturer recommendations

Upper and lower respiratory tract
- Sinusitis
- Pharyngitis
- Pneumonia (legionella and mycoplasma)
- Psittacosis
Genitourinary tract infections
- Non-specific urethritis
- Lymphogranuloma venereum, chancroid and granuloma inguinal
- Gonorrhoea
- Gonococcal salpingitis
- Epididymitis
- Acute epididymo-orchitis
- Endocervical infections
-Syphilis (in cases of penicillin allergy)
Ophthalmic infections
- Trachoma
- Inclusion conjunctivitis
Intestinal infections
- Cholera
- Whipple’s disease
- Tropical sprue
Rickettsial infections
Brucellosis
Tularemia
Actinomycosis
Lyme disease
Yaws
Relapsing fever
Leptospirosis - early infective phase

• Oral (cap): 250-500mg, 6hrly; Max: 2g/24hrs 

Soft tissue infections
- Acne

• Oral (cap): 250mg, 12hrly

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Should be taken on an empty stomach 1hr before food or 2hrs after meals

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

Paed. dosages below include:

• International manufacturer recommendations
• South African manufacturer recommendations

Infections caused by: Activity against a large number of gram-positive and gram-negative bacteria; Clostridium tetani, Listeria monocytogenes, Haemophilus ducreyi, Campylobacter jejuni, Leptospira, Actinomyces israelli, Bacillus anthracis (In vitro sensitivity tests must be performed), Pasteurella multocida, Streptobacillus moniliformis, Erysipelothrix rhusiopathiae M. pneumoniae, Vibrio cholerae, Ureaplasma urealyticum, Mycoplasma pneumonia, Chlamydia trachomatis, chlamydia psittaci, Borrelia recurrentis, Calymmatobacterium granulomatis, Borrelia burgdorferi, penicillin-sensitive Neisseria gonorrhoeae and Rickettsiae

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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

International manufacturer recommendations

Respiratory tract infections
- Pneumonia, whooping cough and other lower respiratory tract infections due to susceptible strains of Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae and other organisms
- Mycoplasma pneumoniae pneumonia
Treatment of chronic bronchitis
- Including the prophylaxis of acute exacerbations
Urinary tract infections 
- caused by susceptible strains of the Klebsiella species, Enterobacter species, Escherichia coli, Streptococcus faecalis and other organisms
Ophthalmic infections
- Trachoma
- Inclusion conjunctivitis
Rickettsial infections
- Rocky Mountain spotted fever
- Typhus group
- Q fever
- Coxiella endocarditis
- Tick fevers
Alternative agent in the treatment of leptospirosis, gas-gangrene and tetanus
Stagnant loop syndrome
Psittacosis
Cholera
Bubonic plague
Louse and tick-borne relapsing fever
Tularaemia
Glanders
Melioidosis
Acute intestinal amoebiasis (as an adjunct to amoebicides)
Brucellosis (additional agent required)
Skin Infections
- Acne vulgaris
- Severe rosacea
Sexually transmitted diseases
-Uncomplicated urethral, endocervical or rectal infections caused by Chlamydia trachomatis
- Non-gonococcal urethritis caused by Ureaplasma urealyticum
- Uncomplicated gonococcal infections (except anorectal infections in men)
- Chancroid, granuloma inguinale and lymphogranuloma venereum
-  Acute epididymo-orchitis  caused by Chlamydia trachomatis, or Neisseria gonorroeae
- Syphilis

- Primary
- Secondary
- Latent syphilis of uncertain or >1 year duration
- Cardiovascular
- Late benign syphilis

Younger than 12 years

• Contraindicated

Older than 12 years

• See adult dosage

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Take either 1hr before meals or 2hrs after meals

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South African manufacturer recommendations

Upper and lower respiratory tract
- Sinusitis
- Pharyngitis
- Pneumonia (legionella and mycoplasma)
- Psittacosis
Genitourinary tract infections
- Non-specific urethritis
- Lymphogranuloma venereum, chancroid and granuloma inguinal
- Gonorrhoea
- Gonococcal salpingitis
- Epididymitis
- Acute epididymo-orchitis
- Endocervical infections
-Syphilis (in cases of penicillin allergy)
Ophthalmic infections
- Trachoma
- Inclusion conjunctivitis
Intestinal infections
- Cholera
- Whipple’s disease
- Tropical sprue
Rickettsial infections
Brucellosis
Tularemia
Actinomycosis
Lyme disease
Yaws
Relapsing fever
Leptospirosis - early infective phase
Soft tissue
- Acne

Younger than 8 years 

• Not established for use

Older than 8 years

• Oral (cap): Max: 50mg/kg/day

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Tetracyclines are not indicated for treating commonly occurring infections in children <12 years. Tooth discoloration, enamel hypoplasia and retarded bone growth may occur in children <12 years

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Should be taken on an empty stomach 1hr before food or 2hrs after meals

Pregnancy

• Contraindicated; positive evidence of risk
• Oxytetracycline should not be used in pregnancy unless absolutely essential
• Tetracyclines cross the placenta and may have toxic effects on foetal tissues, particularly on skeletal development. The use of tetracycline compounds during pregnancy has been associated with reports of maternal liver toxicity
• Tetracycline drugs may cause permanent tooth discoloration (yellow-grey-brown), if administered during tooth development in the last half of pregnancy
• If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the foetus

Breastfeeding

• Contraindicated
• Tetracyclines are excreted in breast milk and are therefore contraindicated in breastfeeding mothers

Renal Impairment

• Contraindicated
  In general, tetracyclines are contraindicated in renal impairment due to excessive systemic accumulation and the dosing recommendations only apply if use of this class of drug is deemed absolutely essential
• Total dosage should be decreased by reduction of recommended individual doses and/or by extending time intervals between doses

Hepatic Impairment

• Contraindicated

Elderly            

• Caution; no dose adjustment recommended
  Caution should be observed as subclinical renal insufficiency may lead to drug accumulation

Newborns, infants and children

• All tetracyclines form a stable calcium complex in any bone-forming tissue
• A decrease in the fibula growth rate has been observed in premature infants given oral tetracycline in doses of 25mg/kg, 6hrly. This reaction was reversed when the drug was discontinued

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Bulging fontanelles (in infants)
• Benign intracranial hypertension

Cardiovascular Disorders

• Pericarditis

Gastrointestinal Disorders

• Oesophagitis
• Oesophageal ulceration
• Nausea and vomiting
• Abdominal discomfort
• Diarrhoea
• Anorexia  
• Dysphagia
• Pseudomembranous colitis
• Intestinal overgrowth of resistant organisms
• Glossitis
• Rectal irritation
• Enterocolitis
• Tooth discolouration (yellow-grey-brown)
• Enamel hypoplasia
• Pancreatitis

Hepatobiliary Disorders

• Hepatotoxicity
  - Hepatitis
  - Jaundice
  - Hepatic failure
• Fatty liver degeneration

Genitourinary Disorders

• Vaginal irritation
• Renal dysfunction
• Inflammatory lesions (with candidal overgrowth) in the anogenital regions

Endocrine and Metabolic Disorders

• Brown-black microscopic discoloration of thyroid tissue (prolonged use)

Skin and Subcutaneous Tissue Disorders

• Exfoliative dermatitis
• Maculopapular rash 
• Erythematous rash
• Photo-erythema
• Photosensitivity

Immune, Blood and Lymphatic System Disorders

• Haemolytic anaemia
• Thrombocytopenia
• Neutropenia
• Eosinophilia
• Hypersensitivity reactions
  - Anaphylaxis
  - Urticaria
  - Angioneurotic oedema
  - Anaphylactoid purpura
  - Pericarditis
  - Exacerbation of systemic lupus erythematosus
• Azotaemia
• Acidosis
• Hyperphosphataemia

• Vitamin A
• Retinoids
• Antidiarrhoeal preparations
• Kaolin-pectin
• Bismuth subsalicylate
• Anticoagulants
• Antacids containing aluminium, calcium, iron, magnesium or zinc (See additional prescribing points)
• Penicillin
• Diuretics
• Methoxyflurane
• Nephrotoxic agents
• Insulin
• Sulphonylureas
• Oral contraceptives (See additional prescribing points)
• Lithium/ lithium-containing medications

Other interactions

• Dairy products
• Food

None routine. Specific cases may require

• Blood urea nitrogen (BUN)
• Renal function
• Hepatic function
• Full blood count
• Prothrombin time

Use in paediatrics

• Tetracycline agents may cause permanent tooth discolouration (yellow-grey-brown) if administered during tooth development, in the last half of pregnancy and in infancy up to twelve years of age
• Enamel hypoplasia has also been reported. This adverse reaction is more common during long-term use of the drug but has been observed following repeated short-term courses

Coadministration with antacids

• Antacids containing aluminium, calcium, iron, magnesium or zinc may impair absorption of oxytetracycline. Allow two to three hours between doses of oxytetracycline and antacids

Coadministration with oral contraception

• There is a slight risk of adverse effect on oral contraception. A few cases of pregnancy or breakthrough bleeding have been attributed to the concurrent use of oxytetracycline with oral contraceptives and alternative contraceptive advice should be sought where necessary

Oxytetracycline is a broad-spectrum tetracycline antibiotic and acts by interfering with bacterial protein synthesis.

Spectrum of activity: Activity against a large number of gram-positive and gram-negative bacteria; Clostridium tetani, Listeria monocytogenes, Haemophilus ducreyi, Campylobacter jejuni, Leptospira, Actinomyces israelli, Bacillus anthracis (In vitro sensitivity tests must be performed), Pasteurella multocida, Streptobacillus moniliformis, Erysipelothrix rhusiopathiae M. pneumoniae, Vibrio cholerae, Ureaplasma urealyticum, Mycoplasma pneumonia, Chlamydia trachomatis, chlamydia psittaci, Borrelia recurrentis, Calymmatobacterium granulomatis, Borrelia burgdorferi, penicillin-sensitive Neisseria gonorrhoeae and Rickettsiae

Capsule 250mg

• Adco Roxy (Adcock Ingram)
• Be-Oxytet (Be Tabs)
• Dynoxytet (Thebe Medicare)
• Nucotet (Gulf Drug)
• Oxypan (Adcock Ingram)
• Oxy 250 (Innovata)
• O-4 Cycline (Pharmacare)
• Pharmatet (Dezzo Trading)