Drugs List

Therapeutic Indications

Uses

Acne vulgaris
Antibiotic sensitive infections
Brucellosis (in combination with streptomycin)
Syphilis - chancre (initial therapy)
Syphilis - secondary
Treatment of rosacea

Respiratory tract infections
Treatment of pneumonia, whooping cough and other lower respiratory tract infections due to susceptible strains of Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae, Mycoplasma pneumoniae and other organisms. Treatment of chronic bronchitis (including the prophylaxis of acute exacerbations).

Urinary tract infections
Treatment of urinary tract infections caused by susceptible strains of Klebsiella species, Enterobacter species, Escherichia coli, Streptococcus faecalis and other organisms.

Sexually transmitted diseases
Treatment of infections due Chlamydial trachomatis including uncomlicated urethral, endocervical or rectal infections. Non-gonococcal urethritis caused by Ureaplasma urealyticum. Oxytetracycline is also indicated in chancroid, granuloma inguinale and lymphogranuloma venereum. Oxytetracycline is an alternative drug in the treatment of gonorrhoea and syphilis.

Skin infections
Treatment of Acne vulgaris when antibiotic therapy is considered necessary and severe rosacea.

Ophthalmological infections
Treatment of trachoma, although the infectious agent, as judged by immunofluorescence, is not always eliminated. Inclusion conjunctivitis may be treated with oral oxytetracycline alone or in combination with topical agents.

Rickettsial infections
Treatment of Rocky mountain spotted fever, typhus group, Q fever and coxiella endocarditis and tick fevers.

Antibiotic sensitive infections
Treatment of stagnant loop syndrome. Psittacosis, brucellosis (in combination with streptomycin), cholera, bubonic plague, louse and tick-borne relapsing fever, tularaemia, glanders, melioidosis and acute intestinal ameobiasis (as an adjunct to amoebicides).

Oxytetracycline is an alternative drug in the treatment of leptospirosis, gas-gangrene and tetanus.

Contraindications

Children under 12 years
Breastfeeding
Galactosaemia
Porphyria
Pregnancy
Systemic lupus erythematosus

Precautions and Warnings

Elderly
Glucose-galactose malabsorption syndrome
Hepatic impairment
Lactose intolerance
Myasthenia gravis
Renal impairment

Consult national/regional policy on the use of anti-infectives
Contains lactose
Haematological monitoring required in long term use
Monitor hepatic function on long term therapy
Monitor renal function on long term therapy
Patients with gonorrhoea should be tested for syphilis
Prolonged use may result in superinfection with non-susceptible organisms
Discontinue if overgrowth of resistant organisms occurs
Discontinue if severe skin reaction occurs
Discontinue if signs of raised intracranial pressure
Advise avoid milk/antacid/mineral supplements 2 hours before or after dose
Dairy products may impair absorption
Avoid direct exposure to sunlight

Tetracycline drugs may cause permanent tooth discoluration (yellow-grey-brown), if administered during tooth development, in the last half of pregnancy and in infancy up to 12 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.

Absorption is adversely affected by milk, antacids and aluminium, calcium, iron, magnesium and zinc salts.

When treating venereal disease, where co-existent syphilis is suspected, proper diagnostic procedures should be utilised. In all such cases, monthly serological tests should be made for at least 4 months.

Pregnancy and Lactation

Pregnancy

Oxytetracycline is contraindicated in pregnancy.

Tetracyclines cross the placenta and bind strongly to calcium ions, and therefore are deposited in developing tooth and bone structures. The use of tetracyclines in the 1950's resulted in many reports of brown discoloured teeth in the children who were prenatally exposed to tetracyclines. A report which examined the relationship between oral oxytetracycline and congenital defects between 1980 and 1996, found that 0.9% of offspring with congenital defects were born to mothers who had taken oxytetracycline whilst pregnant. This compared to 0.6% of newborns with congenital defects who were born to mothers who had not taken oxytetracycline. These defects included neural tube defects, cleft palate and cardiovascular malformations. However, these results were based on a very small number of cases. In the past the use of tetracyclines have been associated with severe maternal hepatotoxicity (Schaefer, 2007). Schaefer (2007) have contraindicated tetracyclines after the 15th week of gestation and consider them to be second line therapy in the first trimester, but doxycycline should be preferred in such cases. Inadvertent use of tetracyclines, even after the 15th week, is not an indication for termination of pregnancy or for invasive diagnostic procedures.

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 ).

Lactation

Oxytetracycline is contraindicated in breastfeeding.

Oxytetracycline is excreted into human milk, but in very low concentrations. Theoretically, the staining of teeth and inhibition of bone growth could occur in breastfed infants whose mothers were taking oxytetracycline, but this is very unlikely due to the low milk concentrations.

Three potential problems may exist for the nursing infant even though no reports describing these have been found: Modification of bowel flora, direct effects on the infant, and interference with the interpretation of culture results if a fever workup is required. Because of the reasons stated above and the potential for serious adverse effects on the newborn, the use of tetracycline should be avoided during breast feeding.

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

Side Effects

Abdominal discomfort
Abdominal pain
Acidosis
Agranulocytosis
Altered liver function tests
Anaphylactoid purpura
Anaphylaxis
Angioedema
Angioneurotic oedema
Anorexia
Antibiotic-associated colitis
Aplastic anaemia
Asthma
Azotaemia
Benign intracranial hypertension
Blood dyscrasias
Brown-black microscopic discolouration of thyroid tissue
Bulging fontanelles in infants
Candidiasis (mouth or throat)
Diarrhoea
Drug fever
Dry mouth
Dysphagia
Enamel hypoplasia
Enterocolitis
Eosinophilia
Erythema
Exfoliative dermatitis
Fixed drug eruption
Fungal superinfection
Glossitis
Haemolytic anaemia
Headache
Hepatic failure
Hepatitis
Hepatotoxicity
Hyperphosphataemia
Hypersensitivity reactions
Hypoprothrombinaemia
Increase in blood urea nitrogen
Jaundice
Nausea
Neutropenia
Oesophageal ulceration
Oesophagitis
Onycholysis
Overgrowth by non-susceptible organisms
Pancreatitis
Papilloedema
Paraesthesia
Pericarditis
Photosensitivity
Pigmentation of nails
Pruritus
Pseudomembranous colitis
Rash
Rectal irritation
Reduction in serum vitamin B concentrations
Stomatitis
Thrombocytopenia
Toxic epidermal necrolysis
Uraemia
Urticaria
Vaginal candidiasis
Vaginitis
Visual disturbances
Vomiting
Worsening of lupus erythematosus
Yellowish-brown discolouration of teeth

Presentation

Tablets containing oxytetracycline

Drugs List

Therapeutic Indications

Uses

Acne vulgaris
Antibiotic sensitive infections
Brucellosis (in combination with streptomycin)
Syphilis - chancre (initial therapy)
Syphilis - secondary
Treatment of rosacea

Respiratory tract infections
Treatment of pneumonia, whooping cough and other lower respiratory tract infections due to susceptible strains of Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae, Mycoplasma pneumoniae and other organisms. Treatment of chronic bronchitis (including the prophylaxis of acute exacerbations).

Urinary tract infections
Treatment of urinary tract infections caused by susceptible strains of Klebsiella species, Enterobacter species, Escherichia coli, Streptococcus faecalis and other organisms.

Sexually transmitted diseases
Treatment of infections due Chlamydial trachomatis including uncomlicated urethral, endocervical or rectal infections. Non-gonococcal urethritis caused by Ureaplasma urealyticum. Oxytetracycline is also indicated in chancroid, granuloma inguinale and lymphogranuloma venereum. Oxytetracycline is an alternative drug in the treatment of gonorrhoea and syphilis.

Skin infections
Treatment of Acne vulgaris when antibiotic therapy is considered necessary and severe rosacea.

Ophthalmological infections
Treatment of trachoma, although the infectious agent, as judged by immunofluorescence, is not always eliminated. Inclusion conjunctivitis may be treated with oral oxytetracycline alone or in combination with topical agents.

Rickettsial infections
Treatment of Rocky mountain spotted fever, typhus group, Q fever and coxiella endocarditis and tick fevers.

Antibiotic sensitive infections
Treatment of stagnant loop syndrome. Psittacosis, brucellosis (in combination with streptomycin), cholera, bubonic plague, louse and tick-borne relapsing fever, tularaemia, glanders, melioidosis and acute intestinal ameobiasis (as an adjunct to amoebicides).

Oxytetracycline is an alternative drug in the treatment of leptospirosis, gas-gangrene and tetanus.

Dosage

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

Adults

Elderly

Children

Patients with Renal Impairment

Contraindications

Children under 12 years
Breastfeeding
Galactosaemia
Porphyria
Pregnancy
Systemic lupus erythematosus

Precautions and Warnings

Elderly
Glucose-galactose malabsorption syndrome
Hepatic impairment
Lactose intolerance
Myasthenia gravis
Renal impairment

Consult national/regional policy on the use of anti-infectives
Contains lactose
Haematological monitoring required in long term use
Monitor hepatic function on long term therapy
Monitor renal function on long term therapy
Patients with gonorrhoea should be tested for syphilis
Prolonged use may result in superinfection with non-susceptible organisms
Discontinue if overgrowth of resistant organisms occurs
Discontinue if severe skin reaction occurs
Discontinue if signs of raised intracranial pressure
Advise avoid milk/antacid/mineral supplements 2 hours before or after dose
Dairy products may impair absorption
Avoid direct exposure to sunlight

Tetracycline drugs may cause permanent tooth discoluration (yellow-grey-brown), if administered during tooth development, in the last half of pregnancy and in infancy up to 12 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.

Absorption is adversely affected by milk, antacids and aluminium, calcium, iron, magnesium and zinc salts.

When treating venereal disease, where co-existent syphilis is suspected, proper diagnostic procedures should be utilised. In all such cases, monthly serological tests should be made for at least 4 months.

Pregnancy and Lactation

Pregnancy

Oxytetracycline is contraindicated in pregnancy.

Tetracyclines cross the placenta and bind strongly to calcium ions, and therefore are deposited in developing tooth and bone structures. The use of tetracyclines in the 1950's resulted in many reports of brown discoloured teeth in the children who were prenatally exposed to tetracyclines. A report which examined the relationship between oral oxytetracycline and congenital defects between 1980 and 1996, found that 0.9% of offspring with congenital defects were born to mothers who had taken oxytetracycline whilst pregnant. This compared to 0.6% of newborns with congenital defects who were born to mothers who had not taken oxytetracycline. These defects included neural tube defects, cleft palate and cardiovascular malformations. However, these results were based on a very small number of cases. In the past the use of tetracyclines have been associated with severe maternal hepatotoxicity (Schaefer, 2007). Schaefer (2007) have contraindicated tetracyclines after the 15th week of gestation and consider them to be second line therapy in the first trimester, but doxycycline should be preferred in such cases. Inadvertent use of tetracyclines, even after the 15th week, is not an indication for termination of pregnancy or for invasive diagnostic procedures.

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 ).

Lactation

Oxytetracycline is contraindicated in breastfeeding.

Oxytetracycline is excreted into human milk, but in very low concentrations. Theoretically, the staining of teeth and inhibition of bone growth could occur in breastfed infants whose mothers were taking oxytetracycline, but this is very unlikely due to the low milk concentrations.

Three potential problems may exist for the nursing infant even though no reports describing these have been found: Modification of bowel flora, direct effects on the infant, and interference with the interpretation of culture results if a fever workup is required. Because of the reasons stated above and the potential for serious adverse effects on the newborn, the use of tetracycline should be avoided during breast feeding.

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

Side Effects

Abdominal discomfort
Abdominal pain
Acidosis
Agranulocytosis
Altered liver function tests
Anaphylactoid purpura
Anaphylaxis
Angioedema
Angioneurotic oedema
Anorexia
Antibiotic-associated colitis
Aplastic anaemia
Asthma
Azotaemia
Benign intracranial hypertension
Blood dyscrasias
Brown-black microscopic discolouration of thyroid tissue
Bulging fontanelles in infants
Candidiasis (mouth or throat)
Diarrhoea
Drug fever
Dry mouth
Dysphagia
Enamel hypoplasia
Enterocolitis
Eosinophilia
Erythema
Exfoliative dermatitis
Fixed drug eruption
Fungal superinfection
Glossitis
Haemolytic anaemia
Headache
Hepatic failure
Hepatitis
Hepatotoxicity
Hyperphosphataemia
Hypersensitivity reactions
Hypoprothrombinaemia
Increase in blood urea nitrogen
Jaundice
Nausea
Neutropenia
Oesophageal ulceration
Oesophagitis
Onycholysis
Overgrowth by non-susceptible organisms
Pancreatitis
Papilloedema
Paraesthesia
Pericarditis
Photosensitivity
Pigmentation of nails
Pruritus
Pseudomembranous colitis
Rash
Rectal irritation
Reduction in serum vitamin B concentrations
Stomatitis
Thrombocytopenia
Toxic epidermal necrolysis
Uraemia
Urticaria
Vaginal candidiasis
Vaginitis
Visual disturbances
Vomiting
Worsening of lupus erythematosus
Yellowish-brown discolouration of teeth

Overdosage

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 ).

Further Information

Last Full Review Date: July 2014

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press https://www.medicinescomplete.com Accessed on July 15, 2014.

Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications https://www.medicinescomplete.com Accessed on July 15, 2014.

Summary of Product Characteristics: Oxytetracycline tablets BP 250mg. Actavis UK Ltd. Revised May 2010.

Summary of Product Characteristics: Oxytetracycline tablets 250mg. Intrapharm Laboratories Ltd. Revised October 2015.

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
Oxytetracycline Last revised: September 7, 2013
Last accessed: July 15, 2014