INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo NUCOTET

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

NUCOTET

COMPOSITION:
Each NUCOTET capsule contains:
Oxytetracycline hydrochloride equivalent to
Oxytetracycline 250 mg

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.1 Broad and medium spectrum antibiotics

PHARMACOLOGICAL ACTION:
NUCOTET is a bacteriostic antibiotic and inhabits bacterial protein synthesis (30S ribosomes). It is particularly effective in vitro against the following organisms:
Vibrio cholerae, Ureaplasma urealyticum, Mycoplasma pneumonia, chlamydia trachomatis (see also below), chlamydia psittaci, Borrelia recurrentis, Calymmatobacterium granulomatis, Borrelia burgdorferi, penicillin-sensitive Neisseria gonorrhoeae and Rickettsiae.
NUCOTET is also effective against the following organisms in vitro:
Clostridium tetani, Listeria monocytogenes, Haemophilus ducreyi, Campylobacter jejuni, Leptospira, Actinomyces israelli, Bacillus anthracis*, Pasteurella multocida, Streptobacillus moniliformis, Erysipelothrix rhusiopathiae.
NUCOTET may also show some effect against the following organisms:
Bacteroides species and Fusobacterium nucleatum.
* = In vitro sensitivity tests must be performed.

Resistant pathogens:
Many strains of the following are resistant:
  Staphylococci Pseudomonas aeruginosa (all strains)
  Enterococci E. coli
  Proteus vulgaris Shigella
  Fungi and Yeasts
(except Actinomyces)
Streptococcus pneumoniae

INDICATIONS:
Infections caused by susceptible strains of pathogens:
Upper and lower respiratory tracts:
Sinusitis, Pharyngitis, Pneumonia (Legionella and Mycoplasma) and psittacosis;
Genito-urinary tract:
Non-specific urethritis, Lymphogranuloma venereum, chancroid and granuloma inguinal, gonorrhoea, gonococcal salpingitis, epididymitis, acute epididymo-orchitis, endocervical infections and syphilis (in cases of penicillin allergy);
Soft Tissue:
Acne
Ophthalmic:
Trachoma and inclusion conjunctivitis;
Intestinal:
Cholera, Whipple’s disease, and 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.
NUCOTET 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 discoloration, 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 pregnant 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
NUCOTET should be taken either one hour before meals or two hours after meals. The maximum dose for tetracycline should not exceed 3 g daily for adults and 50 mg/kg body mass/day for children.
The usual dosage for the commonly occurring infections is as follows, depending on the severity of the infection: 250 to 500 mg every six hours.
For acne, the adult dosage is as follows: 250 mg twice daily.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Tetracyclines are not indicated for treating commonly occurring infections in children under 12 years of age.
Gastro-intestinal: Nausea, Glossitis, Vomiting, Dysphagia related to oesophagitis, Diarrhoea, Enterocolitis
Secondary fungal overgrowth (Candida albicans): Oral candidiasis, Vulvovaginitis, Pruritus ani
Secondary bacterial overgrowth infections may occur: Resistant coliform organisms such as Proteus spp. may cause diarrhoea;
Super-infection due to resistant staphylococci may cause fulminating enteritis;
Increased severity of uraemia and hepatotoxicity in patients with renal disease given high doses;
Blood abnormalities: Haemolytic anaemia, Eosinophila, 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 discoloration may occur.
The use of expired tetracyclines may lead to the Fanconi-type syndrome, which is characterized by polyuria and polydipsia with nausea, vomiting, proteinuria, glucosuria, acidosis and aminoaciduria.
Raised intracranial pressure may occur.
In the elderly a negative nitrogen balance may be induced.

INTERACTIONS:
Absorption of tetracyclines is diminished by milk, alkalis, aluminium hydroxide and other di- and trivalent cations such as calcium, iron and magnesium if they are given concomitantly; Doses of anticoagulants may need to be reduced if given concomitantly with tetracyclines.
Penicillin should not be given concomitantly with tetracyclines 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:
Light green opaque capsules.

PRESENTATION:
Plastic containers containing 1000 capsules.

STORAGE INSTRUCTIONS:
Store below 25ºC in a dry place.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
Z/20.1.1/0246

NAME AND ADDRESS OF THE APPLICANT:
GULF DRUG COMPANY (PTY) LTD.
22 BURNSIDE DRIVE
OLD MILL INDUSTRIAL PARK
MOUNT EDGECOMBE
4300

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
04 JUNE 1991

New addition to this site: July 2010
Source: Pharmaceutical Industry

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2010