Drugs List

Therapeutic Indications

Uses

Treatment of infections caused by susceptible strains of Gram-positive and Gram-negative bacteria.

Types of infections include:

Respiratory tract infections
Pneumonia and other lower respiratory tract infections due to susceptible strains of Streptococcuspneumoniae , Haemophilus influenzae , Klebsiella pneumoniae and other organisms, Mycoplasma pneumoniae , treatment of chronic bronchitis, and prophylaxis of acute exacerbations of chronic bronchitis, treatment of whooping cough.

Urinary tract infections
Due to susceptible strains of Klebsiella species, Enterobacter species, Escherichia coli, Streptococcus faecalis and other organisms

Sexually transmitted infections
Due to Chlamydia trachomatis including uncomplicated urethral, endocervical or rectal infections. Non-gonococcal urethritis caused by Ureaplasma urealyticum . Chancroid granuloma inguinale and lymphogranuloma venereum and as an alternative drug in the treatment of penicillin resistant gonorrhoea and syphilis.

Skin infections
Acne vulgaris when antibiotic therapy is considered necessary, and severe rosacea

Ophthalmic infections
Trachoma (although the infectious agent is not eliminated). Inclusion conjunctivitis.

Rickettsial infections
Rocky mountain spotted fever, typhus, Q fever, Coxiella endocarditis and tick fevers.

Other infections
Stagnant loop syndrome, Psittacosis, brucellosis (in combination with streptomycin), cholera, bubonic plague, louse and tick-borne relapsing fever, tularaemia, glanders, melioidosis, acute intestinal amoebiasis (as an adjunct to amoebicides), leptospirosis, gas gangrene and tetanus.

Unlicensed Uses

Management of diabetic diarrhoea in autonomic neuropathy.

Administration

For oral administration.

Tablets should be swallowed whole with plenty of fluid while sitting or standing.

Tetracycline should be administered 1 hour before or 2 hours after meals. Food and some dairy products may impair absorption.
If gastric irritation occurs, the tablets should be taken with food.

Absorption of tetracyclines is impaired by antacids containing calcium, magnesium, aluminium, and products containing iron or zinc. Advise patient to avoid milk, antacids and mineral supplements 2 hours before or after dose.

Contraindications

Children under 12 years
Renal impairment
Chronic hepatic impairment
Systemic lupus erythematosus
Pregnancy - see Pregnancy section
Breastfeeding - see Lactation section

Precautions and Warnings

In the treatment of syphilis, optimal compliance should be encouraged and close follow up, including laboratory tests, is recommended.

Patients should be advised not to self medicate due to the potential of some drugs to interact with tetracycline. This includes anti-diarrhoeal products and vitamin A supplements. Concurrent administration of tetracycline and vitamin A may cause benign intracranial hypertension.

Tetracyclines may cause permanent tooth discolouration if administered during tooth development in children under 12 or during the last half of pregnancy. Enamel hypoplasia has also been reported. This reaction is more common during prolonged use of tetracycline but has also been observed following repeated short term courses.

Patients with renal impairment - See Dosage; Renal impairment. Use with caution in elderly patients as renal impairment in these patients may cause drug accumulation.

Patients with hepatic impairment - See Dosage; Hepatic impairment

In long-term therapy, laboratory evaluation of organ systems, including haematopoietic, renal and hepatic function, should be monitored periodically.

In patients with a venereal disease where syphilis is also suspected, proper diagnostic procedures should be followed. This includes monthly serological tests for at least 4 months.

The use of tetracycline may result in the overgrowth of non-susceptible organisms, such as candida. The patients should be observed closely and if this effect occurs, tetracycline should be discontinued and appropriate therapy initiated.

Use with caution and avoid high doses in patients with acute hepatic impairment.

High doses of tetracycline have been associated with a syndrome involving fatty liver degeneration and pancreatitis.

If patients present with severe and persistent diarrhoea after treatment with tetracycline, consider pseudomembranous colitis. If clostridium difficile is suspected or confirmed tetracycline should be discontinued and appropriate treatment initiated. Anti-peristaltic drugs are contraindicated in this situation.

Photosensitivity reactions may occur in hypersensitive persons. Patients should be warned to avoid direct exposure to natural or artificial sunlight and to discontinue therapy at the first sign of skin discomfort.

Bulging fontanelles in infants and benign intracranial hypertension in juveniles and adults has been reported. Symptoms include headache, visual disturbances, blurred vision, scotomata, and diplopia. Permanent loss of vision has been reported. If evidence of raised intracranial pressure develops, tetracycline should be discontinued.

Systemic lupus erythematosus can be exacerbated by the use of tetracyclines.

Use with caution in patients with myasthenia gravis. Tetracyclines may increase muscle weakness in these patients.

Absorption of tetracyclines is impaired by milk, antacids containing calcium, magnesium, aluminium, and products containing iron or zinc.

If gastric irritation occurs, the tablets should be taken with food.

The Faculty of Sexual and Reproductive Health has issued revised guidance concerning additional contraceptive cover when antibiotics are prescribed to patients taking combined oral contraceptives in January 2011. With the exception of the enzyme-inducing antibiotics rifampicin and rifabutin, it is no longer necessary to advise the patient to take additional contraceptive precautions while also taking an antibiotic.

Advise the patient that if vomiting occurs, she should follow the guidance for the oral contraceptive in respect of additional doses or contraceptive precautions.

Pregnancy and Lactation

Pregnancy

Contraindicated. Tetracycline should not be used during pregnancy unless essential to the welfare of the patient.

Tetracyclines cross the placenta and may have toxic effects on the foetal tissues, especially on skeletal development.

If used during pregnancy, or if the patient becomes pregnant during treatment, the potential risks to the foetus should be discussed with the patient.

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 14-17 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

Contraindicated.

Tetracycline is excreted in human breast milk. There is a theoretical risk of dental staining and inhibition of bone growth in breastfed infants.

Hale (2010) concludes, short-term exposure (less than 3 weeks) to tetracycline is not contraindicated however long-term exposure could cause problems. The drugs and lactation database (LactMed) suggests as a theoretical precaution, avoid prolonged or repeated courses during breastfeeding. Monitor the infant for rash and for possible effects on the gastrointestinal flora, such as diarrhoea or candidiasis.

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

Gastric irritation
Nausea
Abdominal discomfort
Vomiting
Diarrhoea
Anorexia
Dysphagia
Overgrowth by non-susceptible organisms
Candidiasis
Glossitis
Rectal irritation
Vaginal irritation
Perianal inflammation
Urogenital lesions
Enterocolitis
Altered liver function tests
Hepatitis
Jaundice
Hepatic failure
Pseudomembranous colitis
Pericarditis
Haemolytic anaemia
Thrombocytopenia
Neutropenia
Eosinophilia
Benign intracranial hypertension
Headache
Visual disturbances
Blurred vision
Scotomata
Diplopia
Loss of vision
Maculopapular rash
Erythematous rash
Exfoliative dermatitis
Hypersensitivity reactions
Urticaria
Angioedema
Anaphylaxis
Anaphylactoid purpura
Exacerbation of systemic lupus erythematosus
Brown-black microscopic discolouration of thyroid tissue
Oesophagitis
Oesophageal ulceration
Antibiotic-associated colitis
Hepatotoxicity
Pancreatitis
Photosensitivity
Stevens-Johnson syndrome
Acute renal failure
Skin discolouration
Increase in blood urea nitrogen
Exacerbation of myasthenia gravis
Stomatitis
Agranulocytosis
Aplastic anaemia
Fixed drug eruption
Bulging fontanelles in infants
Dizziness
Tinnitus
Enamel hypoplasia
Staining of teeth
Pruritus
Bullous dermatoses
Nephritis
Serum urea increased
Renal impairment

Presentation

Tablets containing 250mg tetracycline hydrochloride

Drugs List

Therapeutic Indications

Uses

Treatment of infections caused by susceptible strains of Gram-positive and Gram-negative bacteria.

Types of infections include:

Respiratory tract infections
Pneumonia and other lower respiratory tract infections due to susceptible strains of Streptococcuspneumoniae , Haemophilus influenzae , Klebsiella pneumoniae and other organisms, Mycoplasma pneumoniae , treatment of chronic bronchitis, and prophylaxis of acute exacerbations of chronic bronchitis, treatment of whooping cough.

Urinary tract infections
Due to susceptible strains of Klebsiella species, Enterobacter species, Escherichia coli, Streptococcus faecalis and other organisms

Sexually transmitted infections
Due to Chlamydia trachomatis including uncomplicated urethral, endocervical or rectal infections. Non-gonococcal urethritis caused by Ureaplasma urealyticum . Chancroid granuloma inguinale and lymphogranuloma venereum and as an alternative drug in the treatment of penicillin resistant gonorrhoea and syphilis.

Skin infections
Acne vulgaris when antibiotic therapy is considered necessary, and severe rosacea

Ophthalmic infections
Trachoma (although the infectious agent is not eliminated). Inclusion conjunctivitis.

Rickettsial infections
Rocky mountain spotted fever, typhus, Q fever, Coxiella endocarditis and tick fevers.

Other infections
Stagnant loop syndrome, Psittacosis, brucellosis (in combination with streptomycin), cholera, bubonic plague, louse and tick-borne relapsing fever, tularaemia, glanders, melioidosis, acute intestinal amoebiasis (as an adjunct to amoebicides), leptospirosis, gas gangrene and tetanus.

Unlicensed Uses

Management of diabetic diarrhoea in autonomic neuropathy.

Dosage

Therapy should be continued for up to three days after symptoms have resolved.

Adults

Elderly

Children

Patients with Renal Impairment

Patients with Hepatic Impairment

Administration

For oral administration.

Tablets should be swallowed whole with plenty of fluid while sitting or standing.

Tetracycline should be administered 1 hour before or 2 hours after meals. Food and some dairy products may impair absorption.
If gastric irritation occurs, the tablets should be taken with food.

Absorption of tetracyclines is impaired by antacids containing calcium, magnesium, aluminium, and products containing iron or zinc. Advise patient to avoid milk, antacids and mineral supplements 2 hours before or after dose.

Contraindications

Children under 12 years
Renal impairment
Chronic hepatic impairment
Systemic lupus erythematosus
Pregnancy - see Pregnancy section
Breastfeeding - see Lactation section

Precautions and Warnings

In the treatment of syphilis, optimal compliance should be encouraged and close follow up, including laboratory tests, is recommended.

Patients should be advised not to self medicate due to the potential of some drugs to interact with tetracycline. This includes anti-diarrhoeal products and vitamin A supplements. Concurrent administration of tetracycline and vitamin A may cause benign intracranial hypertension.

Tetracyclines may cause permanent tooth discolouration if administered during tooth development in children under 12 or during the last half of pregnancy. Enamel hypoplasia has also been reported. This reaction is more common during prolonged use of tetracycline but has also been observed following repeated short term courses.

Patients with renal impairment - See Dosage; Renal impairment. Use with caution in elderly patients as renal impairment in these patients may cause drug accumulation.

Patients with hepatic impairment - See Dosage; Hepatic impairment

In long-term therapy, laboratory evaluation of organ systems, including haematopoietic, renal and hepatic function, should be monitored periodically.

In patients with a venereal disease where syphilis is also suspected, proper diagnostic procedures should be followed. This includes monthly serological tests for at least 4 months.

The use of tetracycline may result in the overgrowth of non-susceptible organisms, such as candida. The patients should be observed closely and if this effect occurs, tetracycline should be discontinued and appropriate therapy initiated.

Use with caution and avoid high doses in patients with acute hepatic impairment.

High doses of tetracycline have been associated with a syndrome involving fatty liver degeneration and pancreatitis.

If patients present with severe and persistent diarrhoea after treatment with tetracycline, consider pseudomembranous colitis. If clostridium difficile is suspected or confirmed tetracycline should be discontinued and appropriate treatment initiated. Anti-peristaltic drugs are contraindicated in this situation.

Photosensitivity reactions may occur in hypersensitive persons. Patients should be warned to avoid direct exposure to natural or artificial sunlight and to discontinue therapy at the first sign of skin discomfort.

Bulging fontanelles in infants and benign intracranial hypertension in juveniles and adults has been reported. Symptoms include headache, visual disturbances, blurred vision, scotomata, and diplopia. Permanent loss of vision has been reported. If evidence of raised intracranial pressure develops, tetracycline should be discontinued.

Systemic lupus erythematosus can be exacerbated by the use of tetracyclines.

Use with caution in patients with myasthenia gravis. Tetracyclines may increase muscle weakness in these patients.

Absorption of tetracyclines is impaired by milk, antacids containing calcium, magnesium, aluminium, and products containing iron or zinc.

If gastric irritation occurs, the tablets should be taken with food.

The Faculty of Sexual and Reproductive Health has issued revised guidance concerning additional contraceptive cover when antibiotics are prescribed to patients taking combined oral contraceptives in January 2011. With the exception of the enzyme-inducing antibiotics rifampicin and rifabutin, it is no longer necessary to advise the patient to take additional contraceptive precautions while also taking an antibiotic.

Advise the patient that if vomiting occurs, she should follow the guidance for the oral contraceptive in respect of additional doses or contraceptive precautions.

Pregnancy and Lactation

Pregnancy

Contraindicated. Tetracycline should not be used during pregnancy unless essential to the welfare of the patient.

Tetracyclines cross the placenta and may have toxic effects on the foetal tissues, especially on skeletal development.

If used during pregnancy, or if the patient becomes pregnant during treatment, the potential risks to the foetus should be discussed with the patient.

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 14-17 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

Contraindicated.

Tetracycline is excreted in human breast milk. There is a theoretical risk of dental staining and inhibition of bone growth in breastfed infants.

Hale (2010) concludes, short-term exposure (less than 3 weeks) to tetracycline is not contraindicated however long-term exposure could cause problems. The drugs and lactation database (LactMed) suggests as a theoretical precaution, avoid prolonged or repeated courses during breastfeeding. Monitor the infant for rash and for possible effects on the gastrointestinal flora, such as diarrhoea or candidiasis.

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

Effects on Ability to Drive and Operate Machinery

None known

Counselling

Advise patients to take tetracycline 1 hour before or 2 hours after food.

Advise patient to avoid milk, antacids and mineral supplements 2 hours before or after dose.

Advise patients to avoid direct exposure to natural or artificial sunlight and to discontinue therapy at the first sign of skin discomfort.

Side Effects

Gastric irritation
Nausea
Abdominal discomfort
Vomiting
Diarrhoea
Anorexia
Dysphagia
Overgrowth by non-susceptible organisms
Candidiasis
Glossitis
Rectal irritation
Vaginal irritation
Perianal inflammation
Urogenital lesions
Enterocolitis
Altered liver function tests
Hepatitis
Jaundice
Hepatic failure
Pseudomembranous colitis
Pericarditis
Haemolytic anaemia
Thrombocytopenia
Neutropenia
Eosinophilia
Benign intracranial hypertension
Headache
Visual disturbances
Blurred vision
Scotomata
Diplopia
Loss of vision
Maculopapular rash
Erythematous rash
Exfoliative dermatitis
Hypersensitivity reactions
Urticaria
Angioedema
Anaphylaxis
Anaphylactoid purpura
Exacerbation of systemic lupus erythematosus
Brown-black microscopic discolouration of thyroid tissue
Oesophagitis
Oesophageal ulceration
Antibiotic-associated colitis
Hepatotoxicity
Pancreatitis
Photosensitivity
Stevens-Johnson syndrome
Acute renal failure
Skin discolouration
Increase in blood urea nitrogen
Exacerbation of myasthenia gravis
Stomatitis
Agranulocytosis
Aplastic anaemia
Fixed drug eruption
Bulging fontanelles in infants
Dizziness
Tinnitus
Enamel hypoplasia
Staining of teeth
Pruritus
Bullous dermatoses
Nephritis
Serum urea increased
Renal impairment

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 ).

Shelf Life and Storage

Store at or below 25 degrees C
Protect from light.

Further Information

Last Full Review Date: November 2012

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

Summary of Product Characteristics: Tetracycline Tablets BP 250mg. Actavis UK Ltd. Revised May 2011.

Faculty of Sexual and Reproductive Healthcare
https://www.ffprhc.org.uk/pdfs/CEUGuidanceDrugInteractionsHormonal.pdf
Last accessed 31 May 2011

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 04 September 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
Tetracycline. Last revised: October 2, 2012
Last accessed: November 12, 2012