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

Logo CYCLIMYCIN-50 CAPSULES
CYCLIMYCIN-100 CAPSULES

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

CYCLIMYCIN-50 CAPSULES
CYCLIMYCIN-100 CAPSULES

COMPOSITION:
Each capsule contains:
Minocycline hydrochloride equivalent to minocycline 50 or 100 mg.

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.1 Broad and medium spectrum antibiotics.

PHARMACOLOGICAL ACTION’
Cyclimycin is a bacteriostatic antibiotic and inhibits bacterial protein synthesis (30S ribosomes). It is particularly effective in vitro against the following organisms:
  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.
Cyclimycin 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,
Neisseria meningitidis contacts.Cyclimycin 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
Strep. pneumoniaeMinocycline is well absorbed and its half-life is long (16-18 hours). Plasma concentrations at the usual dosage range are between 1-3 µg/mL.
Minocycline is widely distributed into pleural and peritoneal fluid, saliva semen and prostatic fluid. It passes the placental barrier readily and is also present in the milk of lactating patients. It is concentrated by the liver and excreted, by way of the bile, into the intestine from which it is partially re-absorbed.
Minocycline is recoverable from both urine and faeces and it appears to be metabolized to a considerable extent. Renal clearance of minocycline is low. The drug persists in the body after its administration is stopped; this may be due to retention in fatty tissues.

INDICATIONS:
Infectious diseases caused by susceptible organisms including Rocky Mountain spotted fever, murine typhus, recrudescent epidemic typhus, scrub typhus. Q fever, lymphogranuloma venereum, psittacosis, tularaemia, brucellosis.
Cyclimycin may be used in the treatment of gonorrhoea, syphilis and anthrax in cases where the patient is hypersensitive to penicillin.
In severe acne, Cyclimycin may be useful adjunctive therapy.

CONTRA-INDICATIONS:
Cyclimycin should not be used during pregnancy, by nursing mothers or in children under the age of 12 years. Doses of anticoagulants may need to be reduced when minocycline is given.
Hypersensitivity to any tetracycline.
Do not give minocycline to patients receiving antacids containing calcium, magnesium and aluminium salts or preparations containing iron salts as these ions decrease the absorption of tetracyclines.
Potentially hepatotoxic drugs should not be given with minocycline.

WARNING:
Vestibular side-effects including dizziness or vertigo occur with minocycline and patients should be advised not to drive or operate machinery.
Use with care in patients with liver function impairment.
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”);
Pseudotumor cerebri may occur.

DOSAGE AND DIRECTIONS FOR USE:
Adults:
200 mg initially followed by 100 mg every 12 hours.
Acne: Initially 50 - 100 mg (1-2 50 mg capsules) twice daily, followed by a maintenance dose of 50 mg (1 50 mg capsule) twice daily.
Children: 4 mg/kg initially, followed by a 2 mg/kg every 12 hours.
Unlike earlier tetracyclines, absorption of minocycline is not significantly impaired by food or moderate amounts of milk.
Medication should be carried out for at least 24 - 48 hours after fever and other symptoms have disappeared.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The side-effects of Cyclimycin include nausea, vomiting, diarrhoea, and other symptoms resulting from the overgrowth of non-susceptible organisms.
Overgrowth of Candida albicans in the mouth causes soreness redness and thrush which may extend into the trachea and bronchi; overgrowth of C. albicans in the bowel results in pruritis ani and vulvovaginitis.
There may be overgrowth of resistant coliform organisms such as Pseudomonas spp. and Proteus spp., causing diarrhoea. The most serious super-infection is caused by resistant staphylococci causing a fulminating enteritis with dehydration and, occasionally death, especially after abdominal surgery, particularly gastrectomy.
Glossitis, dysphagia related to oesophagitis and enterocolitis may also occur.
Tetracyclines are deposited in calcifying areas in bone and teeth, causing permanent discolouration and malformation, when given in therapeutic doses to young infants or to women during the late stages of pregnancy, tetracycline interferes with the growth of bones and teeth in infants. Milk teeth are affected if given to children 3 months to six years, and permanent teeth if given to children up to 12 years. An increase in intracranial pressure, which may be associated with a bulging fontanelle in infants has been reported in patients given tetracyclines. Haemolytic anaemia, neutropenia, eosinophilia thrombocytopenia have been reported. Vitamin deficiency may occur.
The use of expired tetracyclines may lead to the Fanconi-type syndrome which is characterised by polyuria and polydipsia with nausea, vomiting, proteinuria, glucosuria, acidosis and aminoaciduria.
Minocycline has an anti-anabolic action which may cause a rise in blood urea.
Allergic (hypersensitivity) reactions that may occur are:
  urticaria
maculopapular and erythematous rashes
exfoliative dermatitis
exacerbation of systemic lupus erythematosus
pericarditis
Henoch-Schönlein purpura (anaphylactoid purpura)
angioneurotic oedema
anaphylaxis
Photosensitivity of the skin and nails, onycholysis and nail discolouration may occur.
In the elderly a negative nitrogen balance may be induced.
INTERACTIONS:
Absorption of minocycline is impaired by the concomitant administration of iron salts and by antacids containing calcium, magnesium and aluminium salts.
Doses of anticoagulants may need to be reduced if given, concomitantly.
Penicillins should not be given concomitantly with tetracyclines as antagonism in action may occur.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
In the event of sensitivity reactions, treatment should be withdrawn. Symptoms should be treated symptomatically and supportively.

IDENTIFICATION:
50 mg:
A No. 3 capsule with an opaque orange cap and body containing a pale yellow powder.
100 mg: A No. 2 capsule with an opaque purple cap and an opaque orange body, containing a pale yellow powder.

PRESENTATION:
50 mg:
Blister packs of 60 and 100.
100 mg: Blister packs of 10 and 100 capsules.

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

REGISTRATION NUMBERS:
50 mg:
W/20.1.1/442.
100 mg: W/20.1.1/443.

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited
7 Fairclough Road
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
23.5.90.

                        G450A
                        KOHLER C&P P.E.

Current: September 2004
Source: Community Pharmacy & Industry

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