Demeclocycline oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of demeclocycline hydrochloride.
Drugs List
Therapeutic Indications
Uses
Antibiotic sensitive infections
Hyponatraemia due to syndrome of inappropriate ADH secretion (SIADH)
Treatment of infections caused by tetracycline-sensitive organisms including the treatment of severe acne vulgaris.
Treatment of chronic hyponatraemia associated with the syndrome of inappropriate secretion of antidiuretic hormone (SIADH) secondary to malignant disease.
Dosage
Adults
Treatment of tetracycline-sensitive infections
600mg daily in two or four divided doses.
For primary atypical pneumonia, the average daily dose is 900mg in 3 divided doses for 6 days.
Treatment should continue for 1 to 3 days after symptoms of fever have resolved.
The occurrence of rheumatic fever or glomerulonephritis following streptococcal infections suggests that treatment of these infections should be continued for 8 days (even after resolution of symptoms).
Treatment of chronic hyponatraemia associated with SIADH
Initial dose of 900mg to 1200g daily to be given in divided doses.
Maintenance dose of 600mg to 900mg daily to be given in divided doses.
Treatment should not be withdrawn without starting other methods of control for this condition.
Children
Children 12 to 18 years
See Dosage; Adult.
Children under 12 years
Contraindicated.
Patients with Renal Impairment
Avoid demeclocycline use in renal impairment if possible.
Lower doses are indicated in cases of renal impairment to avoid excessive systemic accumulation and if therapy is prolonged, serum level determinations are advisable.
The Renal Drug Handbook suggests the following doses:
Glomerular filtration rate 20 to 50ml/minute
See Dosage; Adult.
Glomerular filtration rate 10 to 20ml/minute
600mg every 24 to 48 hours.
Glomerular filtration rate below 10ml/minute
600mg every 24 to 48 hours.
Patients with Hepatic Impairment
Patients with hepatic impairment should not receive more than 1g daily.
Contraindications
Children under 12 years
Acute porphyria
Breastfeeding
Pregnancy
Precautions and Warnings
Elderly
Photosensitivity
Hepatic impairment
Myasthenia gravis
Renal impairment
Systemic lupus erythematosus
Reduce dose in patients with renal impairment
Advise ability to drive/operate machinery may be affected by side effects
Advise patient to have no food for 2 hours before and 1 hour after dose
Haematological monitoring required in long term use
Monitor hepatic function on long term therapy
Monitor renal function on long term therapy
Prolonged use may lead to nephrotoxicity
Discontinue if overgrowth of resistant organisms occurs
Discontinue if photosensitivity occurs
Advise avoid milk/antacid/mineral supplements 2 hours before or after dose
Dairy products may impair absorption
Advise patient that photosensitivity possible
Avoid excessive exposure to sunlight or sunlamps
Use with caution in patients with hepatic impairment and in patients receiving concurrent hepatotoxic or nephrotoxic drugs.
High doses of demeclocycline administered for long periods can increase the risk of nephrotoxicity and photoallergic reactions.
Pregnancy and Lactation
Pregnancy
Demeclocycline is contraindicated during pregnancy.
The manufacturer does not recommend the use of demeclocycline during pregnancy.
Tetracycline administration during tooth development in the second half of pregnancy can result in permanent tooth discolouration. This reaction is more common during long term use but has been observed following repeated short term administration. Enamel hypoplasia in the child has also been reported.
Animal studies have demonstrated that tetracycline cross the placenta, are found in foetal tissue and can have foetotoxic effects, including impaired skeletal development. Embryotoxicity has also been observed.
Lactation
Demeclocycline is contraindicated during breastfeeding.
The manufacturer does not recommend breastfeeding whilst taking demeclocycline.
Tetracyclines have been found in human breast milk. This may result in permanent tooth discolouration and enamel hypoplasia in the breastfeeding infant.
Counselling
Advise patients to be take an hour before or two hours after a meal as food will impair the absorption of demeclocycline.
Advise patients to avoid milk, antacids and mineral supplements for 2 hours before or after demeclocycline dose.
Advise patients to avoid direct exposure to natural or artificial sunlight and to discontinue therapy at the first sign of skin discomfort.
Advise patients to discontinue therapy and seek medical advice if severe or persistent headache or blurred vision are noted (possible raised intracranial pressure).
Advise patients that side effects including headache, dizziness, visual disturbances, and hearing impairment may affect their ability to drive and operate machinery.
Side Effects
Acute renal failure
Agranulocytosis
Altered liver function tests
Anaphylactoid purpura
Anaphylaxis
Angioedema
Antibiotic-associated colitis
Aplastic anaemia
Benign intracranial hypertension
Blurred vision
Brown-black microscopic discolouration of thyroid tissue
Bulging fontanelles in infants
Bullous dermatoses
Candidiasis
Diabetes insipidus
Diarrhoea
Dizziness
Dysphagia
Enterocolitis
Eosinophilia
Erythematous rash
Exacerbation of systemic lupus erythematosus
Exfoliative dermatitis
Glossitis
Haemolytic anaemia
Headache
Hearing disturbances
Hepatic failure
Hepatitis
Hepatotoxicity
Hypersensitivity reactions
Increase in blood urea nitrogen
Jaundice
Maculopapular rash
Myasthenia
Nausea
Nephritis
Neutropenia
Oesophageal ulceration
Oesophagitis
Pancreatitis
Pericarditis
Photosensitivity
Pruritus
Pseudomembranous colitis
Renal impairment
Serum creatinine increased
Skin discolouration
Stevens-Johnson syndrome
Stomatitis
Thrombocytopenia
Urticaria
Vaginitis
Visual disturbances
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: May 2019
Reference Sources
The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.
Summary of Product Characteristics: Demeclocycline Hydrochloride 150 mg Capsules. ADVANZ Pharma. Revised January 2019.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 10 May 2019
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