COMPOSITION:
Each capsule contains Oxytetracycline Hydrochloride equivalent to 250 mg Oxytetracycline.
PHARMACOLOGICAL CLASSIFICATION:
Broad and medium spectrum antibiotics.
PHARMACOLOGICAL ACTION:
Oxytetracycline is a bacteriostatic antibiotic and inhibits bacterial protein synthesis(30S ribosomes). In vitro activity does not necessarily imply in vivo efficacy.
It is particularly effective in vitro against the following organisms:
Vibrio cholerae, Ureaplasma urealyticum, Mycoplasma pneumoniae, Chlamydia trachomatis, Chlamydia psittaci, Borrelia burgdorferi, penicillin - sensitive Neisseria gonorrhoeae and Rickettsiae;
Oxytetracycline is also effective against the following organisms in vitro:
Clostridium tetani, Listeria monocytogenes, Haemophilus ducreyi, Campylobacter jejuni, Leptospira, Actinomyecs israelii, Bacillus anthracis, Pasteurella multocida, Streptobacillus moniliformis, Erysipelothrix rhusopathiae.
INDICATIONS:
Infections caused by susceptible strains of pathogens:
Upper and lower respiratory tract: Sinusitis pharyngitis, pneumonia and psittacosis Genito-urinary tract; Non-specific urethritis , Iymphogranuloma venereum , chancroid and granuloma inguinale , gonorrhoea, gonococcal salpingitis , epididymitis , acute epididymo-orchitis , endocervical infections and syphillis ( in cases of penicillin allergy).
Sott tissue:
Acne Ophthalmic:
Trachoma and indusion conjunctivitis; Intestinal:
Cholera, Whipple's disease, ana tropical sprue; Miscellaneous:
Rickettsial infections, brucellosis, tularemia, actinomycosis, Lyme disease, yaws, relapsing fever,
Leptospirosis , during the early infective phase.
CONTRA-INDICATIONS:
In patients with renal impairment.
Hypersensitivity to any tetracycline.
Oxytetracycline should not be given in pregnancy, lactation and in young children.
WARNINGS:
Use with care in patients with liver function impairment;
Do not use concomitantly with hepatotoxic medicines;
Tooth discolouration , enamel hypoplasia and retarded bone growth may occur in children under the age of 12 years. These effects may also occur in the foetus if given to prenant women;
Symptoms of myasthenia may be aggravated;
Photosensitivity may occur (see " Side effects and Special Precautions");
Pseudotumor cerebri may occur.
DOSAGE AND DIRECTIONS FOR USE:
Oxytetracycline should be taken either one hour before meals or two hours after meals. The maximum dose for oxytetracyline should not exceed 3g daily for adults and 50mg/kg bodymass/day for children.
The usual dose for oxytetracycline for the commonly occurring infection , depending on the severity is 250 to 500 mg every six hours.
For acne , the adult dosage is as follows: 250mg twice daily
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Oxytetracycline is not indicated for treating commonly occurring infections in children under 12 years of age.
Gastro-intestinal: Nausea, Vomiting , Diarrhea , Glossitis , Dysphagia related to oesophagitis.
Secondary fungal overgrowth (Candida Albicans): Oral candidiasis, Vulvovaginitis, pruritus ani
Secondary bacterial overgrowth infections may occur.
Resisitant coliform organisms such as Proteus spp. may cause diarrhea.
Supper-infection due to resistant staphylococci may cause fulminating enteritis.
Increased severity of uraemia and hepatotoxicity in patient with renal disease given high doses.
Blood abnormalities: Haemolytic anaemia, Eosinophilia, Neutropenia,
Thrombocytopenia
Vitamin deficiencies may occur.
Allergic (hypersensitivity) reactions : Urticaria, Maculopapular & Erythematous rashes, Exfoliative dermatitis, Exacerbation of systemic lupus erythematosus pericarditis , henoch-Schonlein purpura (anaphylactoid purpura) , Angioneurotic oedema , Anaphylaxis
Photosensitivity of the skin and nails; onycholysis and nail discolouration may occur.
The use of expired oxytetracycline may lead to the Fanconi-type syndrome which is characterised by polyuria and polydipsia with nausea , vomiting , proteinuria, glucosuria, acidosis and aminoaciduria.
Raised intracranial pressure ( pseudotumor cerebri).
INTERACTIONS:
Absorption of oxytetracycline is diminished by milk , alkalis , aluminium hydroxide and other and trivalent caution such as calcium iron and magnesium if they are give concomitantly.
Doses of anticoagulants may need to be reduced if given concomitantly with oxytetracycline.
Penicillin should not be given concomitantly with oxytetracycline as antagonism in action may occur.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "side effects and special precautions". Treatment is symptomatic and supportive.
IDENTIFICATION:
A hard gelatin capsule (Size 0) with dark green cap and light green body.
STORAGE INSTRUCTIONS:
Store in a cool dry place away from light.
KEEP OUT OF REACH OF CHILDREN.
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