INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
VIBRAMYCIN Capsules 100 mg

        Doxycycline
        VIBRAMYCIN ^®
        Capsules 100 mg

                S4
                Prescription
                Required

SCHEDULING STATUS:
Schedule 4

PROPRIETARY NAME
(and dosage form):

VIBRAMYCIN Capsules 100 mg

COMPOSITION:
Vibramycin brand of doxycycline is a broad spectrum antibiotic synthetically derived from oxytetracycline and is available as Vibramycin Hyclate (doxycycline hydrochloride hemiethanolate hemihydrate). The chemical designation of this light yellow crystalline powder is alpha-6-deoxy-5-oxytetracycline. Doxycycline will not degrade into an epianhydro form.
Each Vibramycin Capsule 100 mg contains doxycycline hyclate equivalent to 100 mg doxycycline base.
Vibramycin Capsules contain the following inert ingredients: starch, lactose, alginic acid, magnesium stearate, sodium lauryl sulphate and a hard capsule shell of gelatin and Patent blue, Quinolene yellow and Titanium dioxide.

PHARMACOLOGICAL CLASSIFICATION:
A.20.1.1. Broad and Medium Spectrum Antibiotics

PHARMACOLOGICAL ACTION:
Doxycycline is primarily bacteriostatic and is believed to exert its anti-microbial effect by the inhibition of protein synthesis by binding to the 30S ribosomal subunit.
Doxycycine is readily absorbed and bound to plasma proteins. It is concentrated by the liver in the bile. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is virtually completely absorbed after oral administration.
Haemodialysis does not alter the serum half-life of doxycycline.
Doxycycline is 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, Chlamydia psittaci, Borrelia recurrentis, Calymmatobacterium granulomatis, Borrelia burgdorferi, penicillin-sensitive Neisseria gonorrhoeae and Rickettsiae.
Doxycycline is also effective against the following organisms in vitro:
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
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, endocervical infections, syphilis and gonorrhoea (in cases of penicillin allergy).
Soft tissue infections: Acne vulgaris.
Ophthalmic infections: Trachoma and inclusion conjunctivitis.
Intestinal infections: Cholera, Wipple's disease and tropical sprue.
Miscellaneous: Rickettsial infections, brucellosis, tularemia, actinomycosis, Lyme disease, yaws, relapsing fever, leptospirosis during the early infective phase.
Malaria prophylaxis: For short-term prophylaxis of malaria in areas where a high level of chloroquine resistance has been reported and the traveler cannot tolerate mefloquine or other agents for the prophylaxsis of malaria.

CONTRA-INDICATIONS:
Vibramycin is contra-indicated in persons who have shown hyper-sensitivity to doxycycline or any of the tetracyclines.
Doxycycline should not be given to patients with systemic lupus erythematosus (see Side Effects and Special Precautions).
Use in pregnancy:
Should not be used in pregnant women.
Doxycycline crosses the placenta and is deposited in foetal bones and teeth
Pregnant women are particularly susceptible to severe doxycycline-induced liver damage.
Doxycycline is present in the milk of lactating women and therefore should be avoided in nursing mothers.
The use of doxycycline during tooth development (last half of pregnancy, infancy and childhood to the age of 12 years) may cause permanent discoloration of the teeth (yellow-grey-brown). Enamel hypoplasia has also been reported.

WARNINGS:
Use with care in patients with liver function impairment. Frail or elderly patients are susceptible to the hepatotoxic effects of doxycycline.
Do not use concomitantly with hepatotoxic medicines.
Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking doxycycline. Patients likely to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur and treatment should be discontinued at the first evidence of skin erythema.
Raised intracranial pressure may occur particularly in infants and especially if Vitamin A or other retinoids are given concurrently (see Side Effects and Special Precautions).
Symptoms of Myasthenia gravis may be aggravated.
Information for patients - Malaria prophylaxis:
No present-day antimalarial agent, including doxycycline, guarantees protection against malaria. Should flu-like symptoms appear, the patient must inform the doctor that he has been in a malarious area.
The prevention of mosquito bites should form the mainstay of malaria prophylaxis. The following preventative measures to prevent mosquito bites should be taken:

-	endemic areas should preferably be visited during the dry season or in years when rainfall is low;
-	high risk patients should avoid malaria areas altogether.
	High risk persons include:         babies and young children less than 5 years of age;         pregnant women         immunocompromised individuals such as those on long term steroids, cancer patients and those on chemotherapy, AIDS patients and those who have had their spleens removed;
-	not going outside between dusk and dawn, when mosquitoes are most active;
-	applying insect repellent to exposed skin and clothing
-	wearing long sleeves and trousers at night
-	using mosquito nets, screens, coils and pads

DOSAGE AND DIRECTIONS FOR USE:
Exceeding the recommended dosage may result in an increased incidence of side effects.
The usual dose of Vibramycin in adults is 200 mg on the first day of treatment (administered as a single dose or as 100 mg every 12 hours), followed by a maintenance dose of 100 mg per day (administered as a single dose or as 50 mg every 12 hours). In the management of more severe infections 200 mg daily should be given throughout the treatment period.
Malaria prophylaxis: For adults, the recommended dose is 100 mg daily. For children over 8 years of age, the recommended dose is 2 mg/kg given once daily up to the adult dose. Prophylaxis should begin 1-2 days before travel to the malarious area. Prophylaxis should be continued daily during travel in the malarious area and for 4 weeks after the traveler leaves the malarious area.
Directions for Use:
Should be taken either 1 hour before meals or 2 hours after meals.
Should be taken with adequate amounts of liquid and at least an hour before retiring to bed to reduce the risk of oesophageal irritation and ulceration.

Concomitant therapy: antacids containing aluminium, calcium or magnesium impair absorption and should not be given to patients taking doxycycline.
The absorption of Vibramycin (doxycycline), is not notably influenced by the ingestion of food or milk.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Doxycycline is not indicated for treating commonly occurring infections in children under 12 years of age.
Gastro-intestinal: anorexia, nausea, vomiting, diarrhoea, glossitis, dysphagia and enterocolitis. Instances of oesophagitis and oesophageal ulceration may be a particular problem if capsules are taken with insufficient fluid or in a recumbent position.
Hypersensitivity reactions: urticaria, angioneurotic oedema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, and exacerbation of systemic lupus erythematosus.
Maculopapular and erythematous rashes. Exfoliative dermatitis has been reported.
Photosensitivity of the skin and nails; onycholysis and nail discoloration may occur.
Bulging fontanels have been reported in young infants following full therapeutic dose and increased intracranial pressure has been reported in adults.
Blood: haemolytic anaemia, thrombocytopenia, neutropenia, and oeosinophilia may occur.
Increased severity of uraemia and hepatotoxicity in patients with renal disease given high doses.
A Jarisch-Herxheimer like reaction has been reported in patients with relapsing fever treated with doxycycline.
When given over prolonged periods, doxycycline has been reported to produce brown-black microscopic discoloration of thyroid glands. No abnormalities of thyroid function studies are known to occur.
Vitamin deficiencies may occur.
The use of expired doxycycline may lead to a Fanconi-type syndrome which is characterised by polyuria and polydipsia with nausea, vomiting, proteinuria, glucosuria, acidosis, aminoaciduria, hypophosphatemia and hypocalcaemia.
Secondary fungal overgrowth (Candida albicans) may occur: oral candidiasis, vulvovaginitis and pruritis ani.
Secondary bacterial overgrowth infections may occur: resistant coliform organisms such as Proteus spp. may cause diarrhoea; Pseudomembranous colitis due to Clostridium difficile; super-infection due to resistant staphylococci may cause fulminating enteritis.
Special Precautions:
Constant observation of the patient is essential. If a resistant organism appears, the antibiotic should be discontinued and appropriate therapy instituted.
When treating gonorrhoea when co-existent syphilis is suspected, proper diagnostic procedures, including dark-field examinations, should be utilized. In all such cases, monthly serological tests should be made for at least four months.
In long term therapy, periodic laboratory evaluation of organ systems, including haematopoietic, renal, and hepatic studies should be performed.
Interactions:
Absorption of doxycycline is diminished by milk, alkalis, bismuth salts, aluminium hydroxide and other di and trivalent cations such as calcium, iron and magnesium if they are given concomitantly.
Concomitant therapy: antacids containing aluminium, calcium or magnesium impair absorption and should not be given to patients taking doxycycline.
Because doxycycline has been shown to depress plasma prothrombin activity, patients who are on anti-coagulant therapy may require downward adjustment of their anti-coagulant dosage.
Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving doxycycline in conjunction with penicillin.
Alcohol, barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.
When administered together with phenobarbitone and diphenylhydantoin the half life of doxycycline is decreased from 20 hours to 7 hours.
Doxycycline may diminish the effectiveness of oral contraceptives.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF TREATMENT
See side-effects and special precautions.
Treatment is symptomatic and supportive.

IDENTIFICATION:
Vibramycin Capsules 100 mg are green, opaque No 2, hard gelatin capsules. The capsules are imprinted with "VBM 100" and the Pfizer logo.

PRESENTATION:
Vibramycin Capsules 100 mg are available in blister packs of 5, 25 and 100.

STORAGE INSTRUCTIONS:
Store below 30°C. Keep out of reach of children.

REGISTRATION NUMBER:
Vibramycin Capsules 100 mg: A/20.1.1/70

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pfizer Laboratories (Pty) Ltd
102 Rivonia Road
SANDTON
2196

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
12 January 1996

Updated on this site: April 2002
Source: Pharmaceutical Industry
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