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

Logo APO-MINOCYCLINE 50 mg capsules
APO-MINOCYCLINE 100 mg capsules

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

APO-MINOCYCLINE 50 mg capsules
APO-MINOCYCLINE 100 mg capsules

COMPOSITION:
APO-MINOCYCLINE 50 mg: Each capsule contains
minocycline hydrochloride equivalent to 50 mg minocycline.
APO-MINOCYCLINE 100 mg: Each capsule contains minocycline hydrochloride equivalent to 100 mg minocycline.

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.1 Antimicrobial (chemotherapeutic) agents. Broad and medium spectrum antibiotics.

PHARMACOLOGICAL ACTION:
Minocycline is a bacteriostatic antibiotic that inhibits bacterial growth by binding to the 30S ribosomal subunit with consequent misreading of information for protein synthesis. It is in vitro effective against the following organisms (in vitro activity does not necessarily imply in vivo efficacy):
Vibrio cholerae, Ureaplasma urealyticum, Mycoplasma pneumoniae, Chlamydia trachomatis, Chlamydia psittaci, Borrelia recurrentis, Calymmatobacterium granulomatis, Borrelia burgdorferi, penicillin-sensitive Neisseria gonorrhoeae and Rickettsiae.
Minocycline is also in vitro effective against the following organisms:
Haemophilus ducreyi,Actinomyces israelii, Francisella tularensis, Treponema pertenue.
Resistant pathogens:
Many of the following strains are resistant:
Staphylococci
Enterococci
Proteus vulgaris
Fungi and yeasts (except Actinomyces)
Pseudomonas aeruginosa (all strains)
E. coli
Shigella
Streptococcus

INDICATIONS:
Infections caused by susceptible strains of pathogens.
Upper and lower respiratory tract infections
Sinusitis, pharyngitis, Mycoplasma pneumonia, psittacosis and chronic bronchitis.
Genito-urinary tract infections
Non-specific urethritis (only if the strain is sensitive), lymphogranuloma venereum, chancroid and granuloma inguinale, gonococcal salpingitis, epididymitis, acute epididymo-orchitis.
Soft tissue
Acne
Ophthalmic
Trachoma and inclusion conjunctivitis.
Intestinal
Cholera, Whipples disease and tropical sprue.
Miscellaneous
Rickettsial infections, brucellosis, tularaemia, actinomycosis, Lyme disease, yaws, relapsing fever, leptospirosis during the early infective phase.

CONTRA-INDICATIONS:
In patients with impaired renal function.
Allergy to any tetracycline.
Minocycline should not be given in pregnancy. Minocycline crosses the placenta and is deposited in foetal bones and teeth.
Pregnant women are particularly susceptible to severe minocycline-induced liver damage.
Should not be given to lactating women or to children younger than 12 years of age as permanent discolouration of the childs teeth may occur.
Should not be given to patients with systemic lupus erythematosus.

WARNING:
Use with care in patients with liver function impairment.
Frail or elderly patients are susceptible to the hepatotoxic and antianabolic effects of minocycline.
Do not use concomitantly with hepatotoxic medicines.
Symptoms of myasthenia gravis may be aggravated.
Photosensitivity may occur (see SIDE-EFFECTS AND SPECIAL PRECAUTIONS).
Raised intracranial pressure may occur particularly in infants and especially if Vitamin A or other retinoids are given concomitantly.
Minocycline should not be given to patients with systemic lupus erythematosus.

DOSAGE AND DIRECTIONS FOR USE:
Adults:
Acne: 50 mg twice daily.
Other indications: 200 mg initially then 100 mg every twelve hours or 100 mg or 200 mg initially then 50 mg every six hours.
Absorption is not significantly affected by food or moderate amounts of milk.
APO-MINOCYCLINE should be taken with adequate liquid to avoid lodging of capsules in the distal oesophagus as this may result in local corrosive irritation and ulceration.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Gastro-intestinal effects include nausea, vomiting and diarrhoea.
Other effects include dry-mouth, glossitis and discolouration of the tongue, stomatitis and dysphagia.
Oesophageal ulceration has occurred if taken at bedtime with too little water.
Oral candidiasis, vulvovaginitis and pruritis ani occur mainly due to overgrowth with Candida.
Superinfections with resistant staphylococci causing enterocolitis and pseudomembranous colitis due to Clostridium difficile have occurred.
Patients with renal disease may experience an increase in uraemia with increased excretion of nitrogen and loss of sodium, accompanied by acidosis and hyperphosphataemia.
Hepatotoxicity may occur in patients given high doses or with renal impairment.
Discolouration of the teeth, enamel hypoplasia and interference with bone growth in the infant may occur when given to infants or to pregnant women.
Increased intracranial pressure with headache, visual disturbances and papiloedema has been reported; it may cause bulging fontanelle in infants.
Treatment should be discontinued immediately in these cases.
Hypersensitivity reactions include rashes, fixed drug eruptions, exfoliative dermatitis, toxic epidermal necrolysis, drug fever, pericarditis, angioedema, urticaria and asthma.
Anaphylaxis has occurred rarely.
Photosensitivity has occurred.
Nail discolouration and onycholysis, and abnormal pigmentation of the skin and eye have occurred rarely.
Permanent discolouration of the cornea in infants born to mothers given high doses of tetracycline in pregnancy has occurred. Myopia may be due to transient hydration of the lens.
Blood dyscrasias such as haemolytic anaemia, eosinophilia, neutropenia, thrombocytopenia, hypoprothombinemia, folate deficiency and megaloblastic anaemia have occurred.
Expired or deteriorated tetracyclines may cause a reversible Fanconi-type syndrome characterised by polyuria, polydipsia, nausea, glycosuria, aminoaciduria, hypophosphatemia, hypokalaemia and hyperuricaemia with acidosis and proteinuria.
Other side-effects occasionally reported include myopathy, increased muscle weakness in patients with myasthenia gravis, and provocation of lupus erythematosus.
Vestibular effects include dizziness or vertigo. Patients should be advised not to drive or operate machinery if affected.
Pigmentation of the skin and other tissues may occur, which slowly resolves on discontinuation of the medicine.
A Jarisch-Herxheimer reaction has been reported in patients with relapsing fever treated with minocycline.
INTERACTIONS:
Absorption is reduced by divalent and trivalent cations such as aluminium, bismuth, calcium, iron, magnesium and zinc and should therefore not be taken with antacids, iron preparations and some foods such as milk and dairy products.
Nephrotoxic effects may be increased with diuretics.
Benign intracranial pressure is increased with retinoids.
Minocycline may increase the concentrations of lithium, digoxin, theophylline and oral anti-coagulants.
Minocycline increases toxic effects of ergot alkaloids and methotrexate.
It may decrease the effectiveness of oral contraceptives.
Because of possible antagonism of the action of penicillins, it is recommended that these two antibiotics are not taken concomitantly.
May interfere with some diagnostic tests such as urinary catecholamines and glucose.
Doses of anti-coagulants may need to be reduced if given concomitantly.
Methoxyflurane: Serious nephrotoxicity may follow concomitant use.

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

IDENTIFICATION:
APO-MINOCYCLINE 50 mg:
Hard gelatine capsules with orange opaque body and orange opaque cap, imprinted "APO 50". Yellow powder fill.
APO-MINOCYCLINE 100 mg: Hard gelatine capsules with orange opaque body and purple opaque cap, imprinted "APO 100". Yellow powder fill.

PRESENTATION:
APO-MINOCYCLINE 50 mg:
White plastic bottles containing 60, 100, 250, 500 or 1000 capsules.
APO-MINOCYCLINE 100 mg: White plastic bottles containing 100, 250, 500 or 1000 capsules

STORAGE INSTRUCTIONS:
Store in well closed containers below 25°C, protected from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
MINOCYCLINE 50 mg:
31/20.1.1/0130
MINOCYCLINE 100 mg: 31/20.1.1/0131

NAME AND BUSINESS ADDRESS OF APPLICANT:
APOTEX S.A.
PHARMACEUTICAL INNOVATION
APOTEX S.A. (Pty) Ltd
Corner Watt and Fleming Streets
Meadowdale Ext. 1

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
11 June 1998

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