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Logo TRIOMIN 50 (Capsules)
TRIOMIN 100 (Capsules)

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

TRIOMIN 50 (Capsules)
TRIOMIN 100 (Capsules)

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

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

PHARMACOLOGICAL ACTION:
Tetracyclines are bacteriostatic antibiotics which inhibit bacterial growth by binding to the 30S ribosomal sub unit with consequent misreading of information for protein synthesis. They are effective in vitro against the following organisms:
In vitroactivity does not necessarily imply in vivoefficacy.
Vibrio cholerae, Ureaplasma urealyticum, Mycoplasma pneumoniae, Chlamydia trachomatis, Chlamydia psittaci, Borrelia recurrentis, Calymmatobacterium granulomatis, Borrelia burgdorferi, Penicillin-sensitive Neisseria gonorrhoeae and Rickettsiae.
Tetracyclines are also effective against the following organisms in vitro:
Haemophilus ducreyi, Actinomyces isrealii, Francisella tularensis
and Treponema pertenue.
Resistant Pathogens:
Many of the following strains are resistant:
Staphylococci
Enterococci
Proteus vulgaris
Fungi and yeast (except actinomyces)
Pseudomonas aeroginosa (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) caused byChlamydia trachomatis, lymphogranuloma venereum, chancroid, granuloma inguinale, gonococcal salpingitis, epididymitis and acute epididymo-orchitis caused byNeisseria gonorrhoeae.
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:
Patients with impaired renal function.
Hypersensitivity or allergy to any tetracycline.
Minocycline is contra-indicated in pregnancy as it crosses the placenta and is deposited in foetal bones and teeth.
Pregnant women are particularly susceptible to severe minocycline-induced liver damage.
Minocycline should not be given to lactating women or to children younger than 12 years of age as permanent discoloration of the child's teeth may occur. This is more common during the long-term use of minocycline, but has been observed following repeated short-term courses. Enamel hypoplasia has been reported.
Minocycline should not be given to patients with systemic lupus erythematosus.

WARNINGS:
Use with care in patients with liver function impairment.
Frail or elderly patients are susceptible to the hepatotoxic and anti-anabolic 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.
Tetracyclines have anti-anabolic action, which may cause a rise in blood urea. In patients with severe renal insufficiency, the reduction of dosage, if necessary, and monitoring of renal function is advisable.
Central nervous system side-effects including lightheadedness, headache, dizziness or vertigo have been reported. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy. These symptoms may disappear during therapy and always disappear rapidly when the medicine is discontinued.

DOSAGE AND DIRECTIONS FOR USE:
Adults:
The usual dosage of minocycline hydrochloride is 200 mg initially, followed by 100 mg every 12 hours.
Alternatively, if more frequent doses are preferred two or four 50 mg capsules may be given initially followed by one 50 mg capsule four times daily.
Treatment of acne: TRIOMIN 50 - One capsule (50 mg) twice daily.
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.
Unlike earlier tetracyclines, absorption of minocycline is not significantly impaired by food or moderate amounts of milk.
Therapy should be continued for at least 24-48 hours after symptoms and fever have subsided.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
Gastro-intestinal:
Nausea, vomiting, diarrhoea, dry mouth, glossitis, dysphagia related to oesophagitis, 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; Pseudomembranous colitis due to Clostridium difficile may occur; 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 aneamia, oesinophilia, neutropenia, thrombocytopenia.
Vitamin deficiencies may occur.
Allergic (hypersensitivity) reactions:
Urticaria, maculopapular and erythematous rashes, exfoliative dermatitis, exacerbation of systemic lupus erythematosus, pericarditis, Henoch-Schönlein purpura (anaphylactoid purpura), angioneurotic oedema, anaphylaxis.
Precautions:
Photosensitivity of the skin and nails: onycholysis and nail discolouration may occur.
Minocycline has been associated with pigmentation of the skin and other tissues. Pigmentation may occur as blue-black macules occurring in areas of inflammation and scarring and possibly due to an iron chelate of minocycline within macrophages, as blue-grey macules or hyperpigmentation affecting normal skin and which may be due to a break-down product of minocycline or as a greyish-brown discolouration occurring particularly in sun-exposed areas of the skin ('muddy skin syndrome') apparently due to melanin deposition. Skin pigmentation appears to resolve slowly on discontinuing the medicine.
A Jarisch-Herxheimer-like reaction has been reported in patients with relapsing fever treated with minocycline.
The use of expired minocycline may lead to a Fanconi-type syndrome which is characterised by polyuria and polydipsia with nausea, vomiting, proteinuria, glucosuria, acidosis, aminoaciduria, hypophosphatemia and hypocalcaemia.
Minocycline may cause vestibular toxicity (dizziness, ataxia, vomiting).
In the elderly a negative nitrogen balance may be induced.
In venereal diseases, when coexistent syphilis is suspected, darkfield examinations should be done before treatment is started and the blood serology repeated monthly for at least 4 months.
Because minocycline has been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.
In long-term therapy, periodic laboratory evaluation of organ systems, including haematopoietic, renal and hepatic studies should be performed.
Interactions:
Absorption of minocycline is diminished by alkalis antacids containing aluminum 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.
Penicillin should not be given concomitantly with minocycline as antagonism in action may occur. Minocycline may diminish the effectiveness of oral contraceptives and an increase in the incidence of breakthrough bleeding has been reported.
Methoxyflurane: Serious nephrotoxicity may follow concomitant use.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF TREATMENT:
See Side-effects and Special precautions.
Treatment is symptomatic and supportive.

IDENTIFICATION:
TRIOMIN 50 : Size 3, hard gelatin opaque yellow capsule, with imprint DAN 5694 in black on the body and Minocycline 50 on the cap. The capsule contains a light yellow powder.
TRIOMIN 100 : Size 2 hard gelatin capsule with an opaque grey cap with minocycline 100 imprinted in black and an opaque yellow body with DAN 5695 imprinted in black. The capsule contains a light yellow powder.

PRESENTATION:
TRIOMIN 50 : White plastic jars with white plastic screw caps containing 60 capsules.
TRIOMIN 100 : White plastic jars with white plastic screw caps containing 30 capsules.

STORAGE INSTRUCTIONS:
Store below 25°C in a tightly closed container.
Protect from moisture and light.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBERS:
TRIOMIN 50 : 30/20.1.1/0413
TRIOMIN 100 : 30/20.1.1/0414

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Triomed (Pty) Ltd
Gardener Place
Cnr. Howard Drive & Gardener way
Pinelands
7405

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
May 1997

        PS 059/B
        02/02
        Britepak

Updated on this site: June 2003
Source: Community Pharmacy

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