Oxytetracycline 250 Mg Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oxytetracycline 250 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg Oxytetracycline.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Yellow, biconvex, film-coated tablets, engraved 1C5 or BERK 1C5 on one side with a plain reverse.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Oxytetracycline tablets are indicated for the treatment of infections caused by oxytetracycline sensitive organisms including acute and chronic bronchitis, pneumonia, urinary tract infections, brucellosis, pertussis, rickettsial fevers and psittacosis.
4.2 Posology and method of administration
For oral administration
Adults and children over 12 years of age:
250 - 500 mg four times a day depending on the severity of the condition.
The tablets should be taken with adequate amounts of fluid to reduce the risk of oesophageal irritation and ulceration.
Treatment should continue for at least 24 to 48 hours after symptoms and fever have subsided.
Tetracyclines should be given one hour before or two hours after meals as food, milk and some dairy products interfere with absorption.
Children under 12 years of age:
Oxytetracycline tablets should not be used in children under 12 years of age. Elderly:
The recommended adult dose is appropriate. Caution should be observed as subclinical renal insufficiency may lead to drug accumulation.
4.3 Contraindications
Oxytetracycline is contra-indicated in persons who have shown hypersensitivity to any of the tetracyclines, in pregnancy and lactation, and in children under 12 years of age. Oxytetracycline is contra-indicated in children under 12 years of age as the use of tetracycline during the period of tooth development, (including pregnancy), can cause permanent discolouration of the teeth and enamel hypoplasia. This reaction has been observed during both long-term administration of the drug and following repeated short-term treatment. Tetracyclines also form a stable calcium complex in any bone-forming tissue. In premature infants given oral tetracyclines in doses of 25 mg/kg every six hours a decrease in fibula growth rate was seen. This was reversible on discontinuation of the drug.
Oxytetracycline should not be given to patients with renal dysfunction or failure unless its use is considered essential.
4.4 Special warnings and precautions for use
Oxytetracycline is considered unsafe in patients with acute porphyrias.
Tetracyclines may increase muscle weakness in patients with myasthenia gravis.
As with all tetracyclines, oxytetracycline should be used with caution in patients with renal or hepatic dysfunction, or those receiving potentially hepatotoxic drugs. In patients with renal impairment, administration of the usual doses may lead to excessive systemic accumulation of oxytetracycline and liver toxicity. A rise in blood urea has been reported with tetracyclines; this is not a problem in patients with normal renal function, but in patients with significant renal impairment higher levels of tetracycline may lead to azotaemia, hyperphosphataemia and acidosis.
Phototoxicity manifested as an exaggerated sunburn reaction may occur in patients receiving tetracyclines and who are exposed to direct sunlight or ultraviolet light. Treatment should be discontinued at the first sign of skin erythema.
Intestinal overgrowth of resistant organisms (candida albicans in particular) may occur. In this case, treatment should be discontinued and appropriate therapy initiated.
In the treatment of venereal disease, if co-existing syphilis is suspected proper diagnostic procedures should be used and monthly serological tests carried out for at least four months.
In long term treatment, laboratory evaluation of organ systems, including haematopoietic, renal and hepatic studies should be carried out periodically.
Group A beta-haemolytic streptococci infections should be treated for at least 10 days.
4.5 Interaction with other medicinal products and other forms of interaction
Milk or antacids containing aluminium, magnesium or calcium, zinc or iron salts may interfere with the absorption of oxytetracycline.
In long term treatment, patients receiving anticoagulant therapy may require downward adjustment of anticoagulant dosage due to depression of plasma prothrombin activity.
Oxytetracycline should not be administered concomitantly with bactericidal drugs such as penicillins.
The concomitant use of tetracyclines and methoxyflurane has been reported to result in fatal renal toxicity.
Tetracyclines may decrease the efficacy of oral contraceptives.
Kaolin reduces the absorption of tetracyclines.
Ace inhibitors - quinapril tablets containing magnesium carbonate as an excipient in the formulation reduce absorption of tetracyclines.
Atovaquone - concomitant use of atovaquone with tetracyclines leads to a reduced plasma concentration of atovaquone.
Cytotoxics - tetracyclines increase the risk of methotrexate toxicity.
Ergot alkaloids - there is an increased risk of ergotism if ergotamine or methysergide are taken concurrently with tetracyclines.
Retinoids - there is a possible increased risk of benign intracranial hypertension if taken concurrently with tetracyclines.
Strontium ranelate - the absorption of tetracyclines is reduced by strontium ranelate.
Ulcer healing drugs - ranitidine, bismuth citrate; sucralfate and tripotassium dicitrobismuthate reduce the absorption of tetracyclines.
4.6 Pregnancy and lactation
Oxytetracycline is contra-indicated in pregnancy and lactation. Animal studies have indicated that tetracyclines cross the placenta, are found in foetal tissue and can have toxic effects on the embryo and foetus. The risks associated with using tetracyclines during pregnancy are mainly due to effects on bone and teeth development. Tetracyclines are excreted in breast milk.
4.7 Effects on ability to drive and use machines
None known
4.8 Undesirable effects
Gastro-intestinal: Like all tetracyclines, oxytetracycline may produce gastrointestinal irritations giving rise to anorexia, nausea, vomiting and diarrhoea. Glossitis, dysphagia, enterocolitis and inflammatory lesions (with candidial overgrowth) in the anogenital regions have also been reported. Oesophagitis and oesophageal ulceration have been reported rarely in patients receiving tablet and capsule forms of tetracyclines. In most cases the patient took the medication immediately before going to bed.
Pancreatitis has been reported with tetracyclines.
Hypersensitivity reactions: Urticaria, angioneurotic oedema, anaphylaxis, anaphylactoid purpura, pericarditis and exacerbation of systemic lupus erythematosus may occur.
Blood: Haemolytic anaemia, thrombocytopenia, eosinophilia and neutropenia have been reported with tetracyclines.
Skin: Maculopapular and erythematous rashes, including Stevens-Johnson syndrome, may occur. Exfoliative dermatitis has been reported but is uncommon. Photosensitivity reactions may occur. (See Special Warnings and Precautions for Use).
Renal: Rise in blood urea has been reported and is apparently dose related.
Hepatic: Hepatotoxicity has been reported with tetracyclines.
Prolonged treatment with tetracyclines has been reported to produce brown-black microscopic discolouration of thyroid tissue but no known abnormal thyroid function occurs.
Bulging fontanelles in infants have been reported. Headache and visual disturbances may indicate benign intracranial hypertension in adults. Treatment should cease if evidence of raised intracranial pressure develops.
Reporting of suspected adverse reactions
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.
4.9 Overdose
Serious symptoms are unlikely. Gastric lavage might be beneficial in the first
hours after ingestion followed by conservative management. Milk will reduce absorption.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC code: J01A A06 (antibacterials for systemic use)
Oxytetracycline is a tetracycline antibiotic and possesses a wide range of antimicrobial activity against Gram-positive and Gram-negative bacteria. It is also effective against some micro-organisms e.g. Rickettsiae, Mycoplasma, Chlamydia, some atypical mycobacteria and amoebae, which are resistant to agents that exert their effects on the bacterial cell wall. The site of action of tetracyclines is the bacterial ribosome and they are mainly bacteriostatic. Many aerobic Gram-negative bacilli are now relatively resistant.
5.2 Pharmacokinetic properties
Oxytetracycline is incompletely but adequately absorbed from the gastro-intestinal tract (60 - 80% when the stomach is empty). The percentage that is not absorbed rises as the dose increases. Absorption is impaired by milk products, aluminium hydroxide gels, sodium bicarbonate, calcium and magnesium salts, and iron preparations. After a single oral dose, peak plasma concentrations are reached in 2 -4 hours (20 - 40% is bound to plasma protein). The half life is 6 - 12 hours and the
drug is frequently administered 2 - 4 times daily (250 mg every six hours produces peak plasma concentrations of approximately 3 qg/ml).
Tetracyclines are excreted in the urine (40 - 70%) and faeces via the bile. Decreased hepatic or renal function can cause persistence in the blood.
5.3 Preclinical safety data
Preclinical information has not been included because the safety profile of
oxytetracycline has been established after many years of clinical use. Please refer to section 4.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Tablet contains:
Lactose Monohydrate Maize Starch
Pregelatinised Maize Starch Sodium Starch Glycollate (Type A)
Magnesium Stearate (E572)
Anhydrous Colloidal Silica Sodium Lauryl Sulphate
Coating contains:
Hypromellose (E464),
Polyethylene glycol 4000,
Purified talc (E553(b))
Tartrazine (E102)
Titanium Dioxide (E171).
The tablet is polished with Carnauba Wax (E903).
6.2 Incompatibilities
None known
6.3 Shelf life
Blisters:
24 months.
6.4 Special precautions for storage
None
6.5 Nature and contents of container
PVDC coated PVC film with hard temper aluminium foil (blister pack) in packs of 7, 10, 14,
21, 28, 30, 56, 60, 84, 90, 100, 110, 112, 120, 150, 160 and 168 tablets.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
TEVA UK Limited,
Brampton Road,
Hampden Park,
Eastbourne,
ENGLAND,
BN22 9AG.
Trading address: Leeds, LS27 0JG, England
8 MARKETING AUTHORISATION NUMBER(S)
PL 0289/0167
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
06 September 1991 / 12 June 2006
10 DATE OF REVISION OF THE TEXT
03/11/2015