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

Logo NORITET 100 mg CAPSULES
SCHEDULING STATUS
S4

PROPRIETARY NAME
(and dosage form)

NORITET 100 mg CAPSULES

COMPOSITION
Per capsule:
Doxycycline hydrochloride
equivalent to doxycycline base 100 mg

PHARMACOLOGICAL CLASSIFICATION
A 20.1.1 Broad and medium spectrum antibiotics

PHARMACOLOGICAL ACTION
NORITET (doxycycline hydrochloride) is a bacteriostatic tetracycline antibiotic and inhibits bacterial protein synthesis (30 S ribosomes). It is particularly effective in vitro against the following organisms: (in vitro activity does not necessarily imply in vivo efficacy.)
Vibrio cholerae, Ureaplasma urealyticum, Mycoplasma pneumoniae, Chlamydia trachomatis (see also below), Chlamydia psittaci, Borrelia recurrensis, Calymmatobacterium granulomatis, Borrelia burgdorferi, penicillin-sensitive Neisseria gonorrhoeae and Rickettsiae. NORITET 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.
NORITET 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, Enterococci, Proteus vulgaris, Fungi and yeasts (except Actinomyces), Pseudomonas aeruginosa (all strains), E. Coli, Shigella, Streptococcus pneumoniae.

INDICATIONS
Infections caused by susceptible strains of pathogens:
•- Upper and lower respiratory tract: Sinusitis, pharyngitis, pneumonia (Legionella and Mycoplasma) and psittacosis.
• Genito-urinary tract: Non-specific urethritis, lymphogranuloma venereum, chancroid and granuloma inguinale, gonorrhoea, gonococcal salpingitis, epididymitis, acute epididymo-orchitis, endocervical infections and syphilis (in cases of penicillin allergy).
• Soft tissue: Acne.
• Ophthalmic: Trachoma (including conjunctivitis).
• Intestinal: Cholera, tropical sprue.
• Miscellaneous: Rickettsial infections, brucellosis, tularemia, actinomycosis, Lyme disease, yaws, relapsing fever, Leptospirosis, during the early infective phase.

CONTRA-INDICATIONS
NORITET is contra-indicated in persons who have shown sensitivity to any of the tetracyclines.
Pregnancy and lactation
Patients with systemic lupus erythematosus.

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 pregnant women).
• Symptoms of myasthenia may be aggravated.
• Photosensitivity may occur (see side-effects and special precautions).
• Pseudotumour cerebri may occur.

DOSAGE AND DIRECTIONS FOR USE
Adults:
Two capsules (200 mg) on the first day of treatment as a single dose or one capsule (100 mg) every 12 hours.
Maintenance dose:
One capsule (100 mg) per day as a single dose except in more severe infections, where two capsules (200 mg) daily should be given throughout the treatment period.
Administration of adequate amounts of fluid with the capsules is recommended to reduce the risk of oesophageal irritation and ulceration.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Side-effects:
Gastro-intestinal effects including nausea, vomiting, diarrhoea, glossitis and enterocolitis are common, especially with high doses and most are attributed to irritation of the mucosa. Oesophageal ulceration has also been reported, particularly after ingestion of the capsules with insufficient water at bedtime. More serious super infection with resistant Staphylococci causing enterocolitis, and also pseudomembranous colitis have been reported. Doxycycline hydrochloride is deposited in calcifying areas in bone, teeth and nails. When given in therapeutic doses to young infants or women during the late stages of pregnancy tetracyclines interfere with bone growth. Discolouration of teeth and enamel hypoplasia.
An increase in intracranial pressure, has been reported.
Skin:
Allergic reactions including urticaria, maculopapular and erythematous rashes, exfoliative dermatitis, exacerbation of systemic lupus erythematosus, pericarditis, Henoch-Schönlein purpura, angioneurotic oedema and anaphylaxis have been reported. Cross-sensitisation between tetracyclines is common.
Photosensitivity of the skin and nails have occurred.
Blood:
Haemolytic anaemia, eosinophilia, neutropenia, and thrombocytopenia have been reported. A negative nitrogen balance may be induced in the elderly.
Special precautions:
Care must be taken when liver functions are impaired. Potentially hepatotoxic drugs should not be given with NORITET nor should compounds such as methoxyflurane which can be nephrotoxic.
Symptoms of myasthenia gravis may be exacerbated by tetracyclines. The use of expired or deteriorated tetracyclines has been associated with the development of a reversible Fanconi-type syndrome characterised by polyuria and polydipsia with nausea, proteinuria, glycosuria, acidosis, amino-aciduria, hypophosphataemia, and hypokalaemia.
Interactions:
Absorption of NORITET is diminished by milk, alkali, aluminium hydroxide and other di- and trivalent cations such as calcium, iron and magnesium when given concomitantly. Since bacteriostatic agents may interfere with the bactericidal action of penicillin, it is advisable to avoid giving NORITET in conjunction with penicillin. NORITET may interfere with some diagnostic tests including determination of urine catecholamines or glucose.
Doses of anticoagulants may need to be reduced if given concomitantly with NORITET.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
See “SIDE-EFFECTS AND SPECIAL PRECAUTIONS”.
Treatment is symptomatic and supportive.

IDENTIFICATION
No. 2, hard gelatin capsule with an opaque dark green cap and an opaque dark green body, containing a fine, yellow powder.

PRESENTATION
6' and 30’in blister packs and 100' in securitainers.

STORAGE INSTRUCTIONS
Store below 25°C and protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
Y/20.1.1/225

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Quatromed Limited
10 Lindley Street
Bethlehem
9701

DATE OF PUBLICATION OF THIS PACKAGE INSERT
25 July 1995

                Pro-print PNO 04928/02-99

Updated on this site: May 2000

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