Oxytetracycline Tablets Bp 250mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oxytetracycline Tablets BP 250 mg.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Oxytetracycline 250.0 mg (as dihydrate).
For excipients, see 6.1.
3. PHARMACEUTICAL FORM Coated tablet.
Round, yellow, sugar coated tablets.
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
Treatment of infections due to Chlamydia, Brucella, Mycoplasma, Rickettsia, and other sensitive organisms. May also be used for prophylaxis and treatment of chronic bronchitis, non-gonococcal urethritis, gonorrhoea, syphilis, other urinary tract infections and severe acne vulgaris.
4.2. Posology and method of administration
For oral administration. The tablets should preferably be taken on an empty stomach (1 hour before food or 2 hours after).
Adults, the elderly and children over 12 years: Normal dose is 250 - 500 mg every 6 hours (4 times a day). This may be increased in severe infections.
For acne the dose is usually 250 mg three times a day for 4 weeks, but this may be prolonged if necessary.
Children under 12 years of age: Not to be given.
4.3. Contraindications
Must not be given to children under 12 years. Known hypersensitivity, renal impairment, pregnancy, breastfeeding, porphyria, systemic lupus erythematosus (SLE).
4.4. Special warnings and precautions for use
Oxytetracycline should be administered with caution to patients with hepatic impairment or those receiving potentially hepatotoxic drugs.
Oxytetracycline may increase muscle weakness in patients with myasthenia gravis.
The use of antibiotics may occasionally result in the overgrowth of nonsusceptible
oganisms including Candida. Constant observation of the patients is essential. If a resistant organism appears, the antibiotic should be discontinued and appropriate therapy instituted.
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 four months.
In long term therapy, periodic laboratory evaluation of organ systems, including haematopoietic, renal and hepatic studies should be performed.
All infections due to Group A beta-haemolytic streptococci should be treated for at least 10 days.
Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that the potential exists for photosensitivity reactions.
Patients with rare hereditary problems of fructose or galactose intolerance, the LAPP lactase deficiency. glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Use in the elderly: Oxytetracycline may be given in the usual adult dosage. The possibility of sub-clinical renal insufficiency should be kept in mind, as it may lead to drug accumulation.
4.5 Interaction with other medicinal products and other forms of interaction
The absorption of oxytetracycline is reduced by the following:
Antacids - allow two to three hours between doses of oxytetracycline and antacids; preparations containing aluminium, bismuth, calcium, iron, magnesium, kaolin or zinc; some foods such as milk and dairy products; sodium bicarbonate; colestipol, colestyramine, quinapril tablets, strontium ranelate, ranitidine bismuth citrate, sucralfate and tripotassium dicitratobismuthate.
The absorption of zinc and oral iron is reduced by oxytetracycline.
The nephrotoxic effects of oxytetracycline may be exacerbated by diuretics, methoxyflurane, or other potentially nephrotoxic drugs.
Oxytetracycline increases concentrations of lithium, digoxin, halofantrine, and theophylline (although these interactions are not strongly established) and may enhance the anticoagulant effect of coumarins and phenindione and patients may require a downward adjustment of their anticoagulant dose. Oxytetracycline increases the toxic effects of ergot alkaloids. Ocular inflammation has occurred following the use of ocular preparations preserved with thiomersal in some patients receiving tetracyclines.
An increased incidence of benign intracranial hypertension has been reported when retinoids and tetracyclines are used concomitantly and therefore concurrent use is contrainidicated.
Tetracyclines may decrease the effectiveness of oral contraceptives.
Oxytetracycline should not be given concurrently with bactericidal drugs such as penicillins.
Oxytetracycline may increase the hypoglycaemic effects of insulin and sulphonylureas in patients with diabetes mellitus.
4.6. Pregnancy and lactation
Should not be used during pregnancy and lactation unless absolutely essential, as use of tetracyclines during teeth development may bring about permanent discolouration.
4.7. Effects on ability to drive and use machines
No or negligible influence.
4.8 Undesirable effects
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)
Blood and lymphatic disorders:
Frequency not known: agranulocytosis, aplastic anaemia, haemolytic anaemia, thrombocytopenia, neutropenia and eosinophilia. Hypoprothrombinaemia may occur. Tetracyclines have also been associated with reductions in serum-vitamin B concentrations, including a case of folate deficiency and concomitant megaloblastic anaemia.
Endocrine disorders:
Frequency not known: brown-black microscopic discoloration of thyroid tissue in use over prolonged periods. (No abnormalities of thyroid function are known to occur).
Nervous system disorders:
Frequency not known: bulging fontanelles in infants. Headache, visual disturbances and papilloedema may indicate benign intracranial hypertension. If raised intracranial pressure occurs treatment with oxytetracycline should be stopped.
Cardiac disorders:
Frequency not known: pericarditis.
Respiratory, thoracic and mediastinal disorders:
Frequency not known: asthma.
Gastro-intestinal disorders:
Rare: oesophagitis and oesophageal ulceration have been reported in patients particularly after ingestion of capsules or tablets with insufficient water at bedtime.
Frequency not known: nausea, vomiting, diarrhoea (antibiotic-associated colitis reported occasionally), dry mouth, glossitis and discoloration of the tongue, stomatitis and dysphagia.
Oral candidiasis, vulvovaginitis, and pruritis ani occur mainly due to overgrowth with Candida albicans. Enterocolitis and pseudomembranous colitis have occasionally been reported. Tooth discolouration, pancreatitis.
Hepatobiliary disorders:
Frequency not known: increases in liver enzyme values have been reported with tetracyclines. In some cases severe and sometimes fatal hepatotoxicity, associated with fatty changes in the liver has occurred in patients with renal impairment or those given high doses.
Skin and subcutaneous tissue disorders:
Uncommon: exfoliative dermatitis.
Frequency not known: rashes, fixed drug eruptions, toxic epidermal necrolysis, drug fever, angioedema, Stevens Johnson syndrome, urticaria, anaphylaxis, exacerbation of systemic lupus erythematosus. Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patients likely to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracyclines and treatment should be discontinued at the first evidence of skin erythema.
Renal and urinary disorders:
Frequency not known: renal dysfunction has been reported with tetracyclines, and particularly exacerbation of dysfunction in those with pre-existing renal impairment. Usual therapeutic doses given to patients with renal disease increase the severity of uraemia with increased excretion of nitrogen and losses of sodium, accompanied by acidosis and hyperphosphataemia. These effects are related to the dose and the severity of renal impairment. Acute renal failure and nephritis have occurred rarely.
Tetracyclines are deposited in deciduous and permanent teeth during their formation, causing discoloration and enamel hypoplasia. They are also deposited in calcifying areas in bone and the nails and interfere with bone growth when given in therapeutic doses to young infants or pregnant women. Onycholysis and nail discoloration may occur. Abnormal pigmentation of the skin and eye has occurred rarely. Myopia which may be due to transient hydration of the lens has occurred.
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
There are no specific overdose problems or symptoms. Gastric lavage and administration of milk or antacids may be employed.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
J01A A06 - Antibacterials for systemic use, tetracylines
Oxytetracycline is a broad spectrum tetracycline antibiotic with activity against a large number of gram positive and gram negative bacteria. It acts by interfering with bacterial protein synthesis.
5.2. Pharmacokinetic properties
Oxytetracycline is absorbed irregularly and incompletely from the GI tract. Absorption may be affected by food, drink and other medicines. It should preferably be given before food and milk drinks, and antacids and iron containing medicines should be avoided.
In circulation, oxytetracycline is bound to plasma proteins (20-35%) and it is also widely distributed in body tissues and fluids. The biological half life is in the order of 91/2 hours and excretion is in the urine and faeces.
5.3. Preclinical safety data
No data of relevance which is additional to that already included in other sections of the SPC.
6 Pharmaceutical particulars
6.1 List of Excipients
Lactose
Pregelatinised Maize Starch Sodium Laurilsulfate Gelatin
Magnesium Stearate
Talc
Sucrose
Titanium Dioxide E171
Yellow colour containing Dried Aluminium Hydroxide & Tartrazine (E102).
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Tablet containers: Do not store above 25°C. Keep the container tightly closed. Blister packs: Do not store above 25°C. Store in the original package.
6.5.
Nature and contents of container
HDPE tablet containers with LDPE caps of 1000 tablets. Al/PVC blisters enclosed in an outer carton.
Pack Sizes: 28, 56 tablets.
6.6. Instruction for use, handling and disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Dalkeith Laboratories Ltd
2 Park Street
Woburn
Bedfordshire
MK17 9PG
8. MARKETING AUTHORISATION NUMBER
PL 17496/0003
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
13/01/2006
10 DATE OF REVISION OF THE TEXT
11/01/2016