Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Intrapharm Laboratories Limited, The Courtyard Barns, Choke Lane, Cookham Dean, Maidenhead, Berkshire, SL6 6PT
Must not be given to children below 12 years.
Known hypersensitivity to any of the tetracyclines or any of the other ingredients in the formulation, renal or hepatic impairment, systemic lupus erythematosus, pregnancy and breastfeeding women, porphyria, patients receiving vitamin A or retinoid therapy.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine as this product contains lactose and sucrose.
Tetracycline drugs may cause permanent tooth discoloration (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.
The anti-anabolic action of tetracyclines may cause an increase in BUN. While this is not a function, higher serum levels of Oxytetracycline may lead to azotaemia, hyperphosphataemia and acidosis.
Absorption is adversely affected by milk, antacids and aluminium, calcium, iron, magnesium and zinc salts.
Tetracyclines depress plasma prothrombin activity, therefore reduced dosages of concurrent anticoagulants may be required.
The use of tetracyclines in general is contraindicated in renal impairment due to excessive systemic accumulation and used with caution in patients with hepatic impairment or those receiving drugs which may have hepatotoxic effects; high doses should be avoided.
Special care should be taken when treating the elderly.
In long-term therapy, periodic laboratory evaluation of organ systems, including haematopoietic, renal and hepatic studies should be performed.
High doses of tetracyclines have been associated with a syndrome involving fatty liver degeneration and pancreatitis.
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.
Care is advised when administering to patients with myasthenia gravis.
Treatment should cease if symptoms of benign intracranial hypertension (e.g. headache and visual disturbance) develop.
Photosensitivity reactions may occur in hypersensitive persons and such patients should be warned to avoid direct exposure to natural or artificial sunlight and to discontinue therapy at the first sign of skin discomfort.
The use of antibiotics may occasionally result in the overgrowth of non susceptible organisms including Candida. If a resistant organism appears, the antibiotic should be discontinued and appropriate therapy instituted.
Antidiarrhoeal preparations such as kaolin-pectin and bismuth subsalicylate hinder absorption of tetracyclines.
Since Oxytetracycline has been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require a downward adjustment of their anticoagulant dosage.
Antacids containing aluminium, calcium, iron, magnesium or zinc may impair absorption of oxytetracycline. Allow two to three hours between doses of oxytetracycline and antacids.
Oxytetracycline may potentiate action of some anti-coagulants.
Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving oxytetracycline in conjunction with penicillin.
The nephrotoxic effects of tetracyclines may be exacerbated by co-administration of diuretics, methoxyflurane or other drugs known to be nephrotoxic.
Dairy products and food may interfere with absorption.
Oxytetracycline may increase the hypoglycaemic effects of insulin and sulphonylureas in patients with diabetes mellitus.
Benign intracranial hypertension has been reported following the concomitant use of tetracyclines and vitamin A or retinoids and therefore concurrent use is contraindicated.
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.
The product 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. (See section 4.4) The use of tetracycline compounds during pregnancy has been associated with reports of maternal liver toxicity.
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. Tetracyclines are also excreted in breast milk and are therefore contraindicated in nursing mothers.
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 every 6 hours. This reaction was reversed when the drug was discontinued.
None known.
Very common (1/10); common (1/100 to <1/10); uncommon ≥1/1,000 to <1/100); rare ≥1/10,000 to <1/1,000); very rare (<1/10,000); Frequency not known (cannot be estimated from the available data).
Frequency not known: Haemolytic anaemia, thrombocytopenia, neutropenia, eosinophilia.
Frequency not known: brown-black microscopic discoloration of thyroid tissue in use over prolonged periods (No abnormalities of thyroid function are known to occur).
Frequency not known: bulging fontanelles in infants, benign intracranial hypertension.
(Treatment should cease if evidence of raised intracranial pressure develops.)
Frequency not known: Pericarditis.
Rare: oesophagitis, oesophageal ulceration
(Reported in patients receiving capsule and tablet forms of drugs in the tetracycline class. Most of these patients took medication immediately before going to bed.)
Frequency not known: Gastrointestinal irritations giving rise to nausea, abdominal discomfort, vomiting, diarrhoea, anorexia and dysphagia (If gastric irritation occurs, tablets should be taken with food.). Pseudomembranous colitis, intestinal overgrowth of resistant organisms (Candida albicans, in particular), may occur and cause glossitis, rectal and vaginal irritation and inflammatory lesions (with candidial overgrowth) in the anogenital regions. Similarly, resistant staphylococci may cause enterocolitis. Tooth discolouration, pancreatitis.
Frequency not known: Hepatotoxicity (hepatitis, jaundice and hepatic failure), fatty liver degeneration.
Uncommon: Exfoliative dermatitis
Frequency not known: Macropapular and erythematous rashes, photo-erythema. - (Patients exposed to direct sunlight or ultraviolet light should be advised to discontinue treatment if any skin reaction occurs).
Hypersensitivity reactions: urticaria, angioneurotic oedema, anaphylaxis, anaphylactoid purpura, pericarditis, exacerbation of systemic lupus erythematosus.
Frequency not known: Renal dysfunction.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
May potentiate action of some anticoagulants, antacids, iron and zinc salts and dairy products may reduce absorption. Slight risk of adverse effect on action of oral contraceptives.
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