Drugs List

Therapeutic Indications

Uses

Acne vulgaris
Infections sensitive to tetracycline

Treatment of acne.

As a broad spectrum antibiotic, it is also recommended for the treatment of infections caused by tetracycline-sensitive organisms such as:
Ear, nose and throat infections
Acute and chronic bronchitis (also for prophylaxis)
Gastro-intestinal tract infections
Urinary tract infections
Chlamydial infections such as non-gonococcal urethritis and trachoma
Rickettsial fevers
Soft tissue infections

Contraindications

Children under 8 years
Breastfeeding
Pregnancy
Raised intracranial pressure
Severe renal impairment

Precautions and Warnings

Children aged 8 to 12 years
Hepatic impairment
Myasthenia gravis
Renal impairment
Systemic lupus erythematosus

May exacerbate myasthenia gravis
May exacerbate or activate systemic lupus erythematosus
Consult national/regional policy on the use of anti-infectives
Prolonged use may result in infection due to resistant organisms
Discontinue at first signs of skin erythema
Discontinue if signs of raised intracranial pressure
Advise to avoid antacids/mineral supplements 2 hours before or after dose
Advise patient to avoid exposure to sunlight and UV rays during treatment

Pregnancy and Lactation

Pregnancy

Lymecycline is contraindicated in pregnancy.

Schaefer suggests tetracyclines are contraindicated after the fifteenth week of gestation. 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. The manufacturers contraindicate the use of lymecycline in pregnancy.

Tetracyclines readily cross the placental barrier and are selectively absorbed by growing bones and teeth.

Lymecycline 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 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

Lymecycline is contraindicated in breastfeeding.

The Drugs and Lactation Database (LactMed) suggests a number of sources contraindicate the use of tetracyclines in breastfeeding due to discolouration of teeth and bone deposition. Hale and Briggs suggest that tetracyclines can cause discolouration in teeth and inhibit bone growth. Schaefer suggests tetracyclines can be given if the antibiotics of choice are not expected to work. The manufacturer suggest lymecycline 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

Side Effects

Abdominal pain
Anaphylaxis
Angioedema
Benign raised intracranial pressure
Blood disorders
Dental discolouration
Diarrhoea
Dizziness
Dysphagia
Enterocolitis
Erythematous rash
Exfoliative dermatitis
Glossitis
Headache
Hepatic failure
Hepatitis
Hypersensitivity reactions
Increase in alkaline phosphatase
Increase in serum transaminases
Jaundice
Nausea
Oesophageal ulceration
Oesophagitis
Pancreatitis
Pericarditis
Photosensitivity
Pruritus
Pseudomembranous colitis
Pyrexia
Rash
Serum bilirubin increased
Stevens-Johnson syndrome
Superinfections
Urticaria
Visual disturbances
Visual impairment (irreversible)
Vomiting

Presentation

Oral formulations of lymecycline

Drugs List

Therapeutic Indications

Uses

Acne vulgaris
Infections sensitive to tetracycline

Treatment of acne.

As a broad spectrum antibiotic, it is also recommended for the treatment of infections caused by tetracycline-sensitive organisms such as:
Ear, nose and throat infections
Acute and chronic bronchitis (also for prophylaxis)
Gastro-intestinal tract infections
Urinary tract infections
Chlamydial infections such as non-gonococcal urethritis and trachoma
Rickettsial fevers
Soft tissue infections

Dosage

Adults

Children

Patients with Renal Impairment

Contraindications

Children under 8 years
Breastfeeding
Pregnancy
Raised intracranial pressure
Severe renal impairment

Precautions and Warnings

Children aged 8 to 12 years
Hepatic impairment
Myasthenia gravis
Renal impairment
Systemic lupus erythematosus

May exacerbate myasthenia gravis
May exacerbate or activate systemic lupus erythematosus
Consult national/regional policy on the use of anti-infectives
Prolonged use may result in infection due to resistant organisms
Discontinue at first signs of skin erythema
Discontinue if signs of raised intracranial pressure
Advise to avoid antacids/mineral supplements 2 hours before or after dose
Advise patient to avoid exposure to sunlight and UV rays during treatment

Pregnancy and Lactation

Pregnancy

Lymecycline is contraindicated in pregnancy.

Schaefer suggests tetracyclines are contraindicated after the fifteenth week of gestation. 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. The manufacturers contraindicate the use of lymecycline in pregnancy.

Tetracyclines readily cross the placental barrier and are selectively absorbed by growing bones and teeth.

Lymecycline 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 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

Lymecycline is contraindicated in breastfeeding.

The Drugs and Lactation Database (LactMed) suggests a number of sources contraindicate the use of tetracyclines in breastfeeding due to discolouration of teeth and bone deposition. Hale and Briggs suggest that tetracyclines can cause discolouration in teeth and inhibit bone growth. Schaefer suggests tetracyclines can be given if the antibiotics of choice are not expected to work. The manufacturer suggest lymecycline 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

Side Effects

Abdominal pain
Anaphylaxis
Angioedema
Benign raised intracranial pressure
Blood disorders
Dental discolouration
Diarrhoea
Dizziness
Dysphagia
Enterocolitis
Erythematous rash
Exfoliative dermatitis
Glossitis
Headache
Hepatic failure
Hepatitis
Hypersensitivity reactions
Increase in alkaline phosphatase
Increase in serum transaminases
Jaundice
Nausea
Oesophageal ulceration
Oesophagitis
Pancreatitis
Pericarditis
Photosensitivity
Pruritus
Pseudomembranous colitis
Pyrexia
Rash
Serum bilirubin increased
Stevens-Johnson syndrome
Superinfections
Urticaria
Visual disturbances
Visual impairment (irreversible)
Vomiting

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: August 2016

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.

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.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 15 November 2018

Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.

Summary of Product Characteristics: Tetralysal 300. Galderma (U.K) Ltd. Revised March 2018.