Oxytetracycline Tablets 250mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oxytetracycline Tablets 250mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg Oxytetracycline Dihydrate.
Also contains Sunset yellow E110, for a full list of excipients see 6.1
3 PHARMACEUTICAL FORM
Film coated tablet
Pale yellow film coated biconvex tablets marked MP10 on one side
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Oxytetracycline is a bacteriostatic broad-spectrum antibiotic, active against a wide variety of Gram-positive and Gram-negative organisms.
Infections caused by oxytetracycline-sensitive organisms include:
1. Respiratory tract infections: Pneumonia, whooping cough and other lower respiratory tract infections due to susceptible strains of Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae and other organisms. Mycoplasma pneumoniae pneumonia. Treatment of chronic bronchitis, (including the prophylaxis of acute exacerbations)
2. Urinary tract infections: caused by susceptible strains of the Klebsiella species. Enterobacter species, Escherichia coli, Streptococcus faecalis and other organisms
3. Sexually transmitted diseases. Infections due to Chlamydia trachomatis including uncomplicated urethral, endocervical or rectal infections. Non-gonococcal urethritis caused by Ureaplasma urealyticum: Oxytetracycline is also indicated in chancroid, granuloma inguinale and lymphogranuloma venereum. Oxytetracycline is an alternative drug in the treatment of gonorrhoea and syphilis
4. Skin Infections: Acne vulgaris when antibiotic therapy is considered necessary and severe rosacea
5. Ophthalmic infections: Trachoma, although the infectious agent, as judged by immunofluorescence, is not always eliminated. Inclusion conjunctivitis may be treated with oral oxytetracycline alone or in combination with topical agents
6. Rickettsial infections: Rocky Mountain spotted fever, typhus group, Q fever and Coxiella endocarditis and tick fevers
7. Other infections: Stagnant loop syndrome, Psittacosis, brucellosis (in combination with streptomycin), cholera, bubonic plague, louse and tick-borne relapsing fever, tularaemia, glanders, melioidosis and acute intestinal amoebiasis (as an adjunct to amoebicides)
Oxytetracycline is an alternative drug in the treatment of leptospirosis, gasgangrene and tetanus.
4.2 Posology and method of administration
Posology:
Oxytetracycline Tablets are best taken on an empty stomach (one hour before food or two hours after), since food and some dairy products interfere with absorption. If gastric irritation occurs, tablets should be taken with food. Tablets should be taken well before going to bed. Therapy should be continued for up to three days after symptoms have subsided.
All infections due to Group A beta-haemolytic streptococci should be treated for at least 10 days.
Adults and children over 12 years:
The minimum recommended dosage is 250 mg every six hours. Therapeutic levels are attained more rapidly by the administration of 500 mg initially, followed by 250 mg every six hours. In severe infections; the dosage may be increased to 500 mg every six hours.
Children under 12 years:
Contraindicated in this age group
Elderly:
May be given at the usual adult dosage. The possibility of sub-clinical renal insufficiency should be kept in mind, as it may lead to drug accumulation.
Renal impairment:
In general, tetracyclines are contraindicated in renal impairment and the dosing recommendations only apply if use of this class of drug is deemed absolutely essential. Total dosage should be decreased by reduction of recommended individual doses and/or by extending time intervals between doses.
Dosage Recommendations in Specific Infections:
Skin infections: 250-500 mg daily in single or divided doses should be administered for at least 3 months in the treatment of acne vulgaris and severe rosacea.
Streptococcal infections: A therapeutic dose of oxytetracycline should be administered for at least 10 days.
Brucellosis: 500 mg four times daily accompanied by streptomycin.
Sexually transmitted diseases: 500 mg four times daily for 7 days is recommended in the following infections: uncomplicated gonococcal infections (except anorectal infections in men); uncomplicated urethra; endocervical or rectal infection caused by Chlamydia trachomatis; nongonoccocal urethritis caused by Ureaplasma urealyticum.
Acute epididymo-orchitis caused by Chlamydia trachomatis, or Neisseria gonorroeae: 500 mg four times daily for 10 days.
Primary and Secondary syphilis: 500 mg four times daily for 15 days. Syphilis of more than one year’s duration, (latent syphilis of uncertain or more than one year’s duration, cardiovascular or late benign syphilis) except neurosyphilis, should be treated with 500 mg four times daily for 30 days. Patient compliance with this regimen may be difficult so care should be taken to encourage optimal compliance. Close follow-up including laboratory tests, is recommended.
Method of administration:
Oral
4.3 Contraindications
• Known hypersensitivity to Oxytetracycline (or any other tetracycline), or to any of the excipients
• Children under 12 years of age
• Pregnant or breast-feeding women
• Renal impairment
• Patients receiving vitamin A or retinoid therapy
• Systemic lupus erythematosus
4.4 Special warnings and precautions for use
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.
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.
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.
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.
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.
The anti-anabolic action of tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired renal function, higher serum levels of oxytetracycline may lead to azotaemia, hyperphosphataemia and acidosis.
Care is advised when administering to patients with myasthenia gravis as this may cause increased muscle weakness.
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.
Sunset yellow E110 contained in these tablets can cause allergic-type reactions including asthma. Allergy is more common in those people who are allergic to aspirin.
4.5 Interaction with other medicinal products and other forms of interaction
Antacids containing aluminium, calcium iron, magnesium or zinc may impair absorption of oxytetracycline. Allow two to three hours between doses of oxytetracycline and antacids.
Food and some dairy products also interfere with absorption.
The absorption of oxytetracycline is reduced by strontium ranelate and concomitant use should be avoided.
There is an increased risk of ergotism when tetracyclines are given with ergotamine.
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. Oxytetracycline may prolong the action of coumarin anticoagulants.
Anti-diarrhoeal preparations such as kaolin-pectin and bismuth subsalicylate hinder absorption of tetracyclines.
Combination of tetracyclines with diuretics may be detrimental to renal function.
Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracyclines in conjunction with penicillin.
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.
There have been reports of nephrotoxicity (increased blood urea nitrogen and serum creatinine) and death in some cases when oxytetracycline therapy has been combined with methoxyflurane.
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.
4.6 Pregnancy and lactation
Pregnancy:
The product should not be used in pregnancy unless absolutely essential.
Animal studies have shown that tetracyclines cross the placenta and may have toxic effects on foetal tissues, particularly on skeletal development, (see section 4.4).
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.
Breast-feeding:
Tetracyclines are also excreted in breast milk and are therefore contraindicated in nursing mothers.
Use in newborns, infants and children:
All tetracyclines form a stable calcium complex in any bone-forming tissue.
A decrease in fibula growth rate has been observed in premature infants given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was reversed when drug was discontinued.
Use in children under 12 years of age is contraindicated.
4.7. Effects on Ability to Drive and Use Machines
Not applicable
4.8 Undesirable effects
Common
Uncommon
Rare
Very rare
Very common
(>1/10)
(>1/100 to <1/10)
(>1/1,000 to <1/100) (>1/10,000 to <1/1,000) (<1/10,000)
Frequency not known (cannot be estimated from the available data)
Blood and lymphatic disorders:
Frequency not known: haemolytic anaemia, thrombocytopenia, neutropenia, eosinophilia
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, benign intracranial hypertension (Treatment should cease if evidence of raised intracranial pressure develops)
Cardiac disorders:
Frequency not known: pericarditis
Gastrointestinal disorders:
Frequency not known: gastrointestinal irritations giving rise to nausea, abdominal discomfort, vomiting, diarrhoea, anorexia, 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
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.)
Hepatobiliary system disorders:
Frequency not known: hepatotoxicity (hepatitis, jaundice and hepatic failure), fatty liver degeneration
Skin and subcutaneous tissue disorders:
Uncommon: exfoliative dermatitis
Frequency not known: Macropapular and erythematous rashes, photoerythema
(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
Renal and urinary disorders:
Frequency not known: renal dysfunction
4.9. Overdose
Although overdosage with antibiotics is rare, if it should occur gastric lavage plus appropriate supportive therapy and control of plasma electrolytes is indicated.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Oxytetracycline is primarily a bacteriostatic antibiotic and has a similar spectrum of activity to other tetracyclines.
Oxytetracycline is a broad spectrum antibiotic to sensitive organisms.
5.2. Pharmacokinetic Properties
Oxytetracycline is absorbed irregularly to the extent of about 60% of an oral dose, absorption occurring in the stomach and upper small intestine.
Peak plasma concentrations achieved 2-4 hours after an oral dose.
The mean plasma half-life is 9.2 hours. The plasma/protein bind is 27-35%. The drug is eliminated largely unchanged mostly in the urine, with some in the faeces. A small amount is metabolised in the liver.
5.3. Preclinical Safety Data
No relevant information additional to that contained elsewhere in the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Maize starch
Pregelatinised maize starch Povidone
Sodium starch glycollate Sodium lauryl sulphate Magnesium stearate
Opaspray K-IF-3048 contains Titanium dioxide E171 Quinoline Yellow Lake E104 Hydroxypropyl Cellulose E463 FD&CYellow#6/Sunset Yellow FCF Lake E110
Hypromellose
Ethylcellulose
Diethylphthalate
6.2.
Incompatibilities
Not Applicable
Shelf Life
6.3.
Container: 36 months Blister pack: 48 months
6.4. Special Precautions for Storage
Container: Do not store above 25°C. Keep the container tightly closed. Blister pack: Do not store above 25°C. Store in the original package.
6.5. Nature and Contents of Container
Conatainer: High density polystyrene or polypropylene containers with polypropylene or polythene lids and polyurethane/polythene inserts Blister pack: 250pm PVC and 20pm Aluminium foil coated with heat resistant print primer on one side and heat-seal lacquer on the other.
Pack sizes: 28, 30, 50, 56, 60, 84, 100, 250, 500, 1000 tablets
6.6. Instruction for Use/Handling Not Applicable
7 MARKETING AUTHORISATION HOLDER
Metwest Pharmaceuticals Limited 15 Runnelfield Harrow on the Hill Middlesex HA1 3NY United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 17521/0010
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
8 January 2001
10 DATE OF REVISION OF THE TEXT
09/07/2014