COMPOSITION: Each capsule contains: Doxycycline hyclate equivalent to 200 mg doxycycline.
PHARMACOLOGICAL CLASSIFICATION: A.20.1.1 Broad and medium spectrum antibiotics
PHARMACOLOGICAL ACTION: CYCLIDOX EC is bacteriostatic against susceptible strains of a wide range of Gram-positive and Gram-negative bacteria.
CYCLIDOX EC is particularly effective in vitro against the following organisms: (in vitro activity does not necessarily imply in vivo activity).
penicillin-sensitive Neisseria gonorrhoeae and Rickettsiae.
CYCLIDOX EC is also effective against the following organisms in vitro:
CYCLIDOX EC may also show some effect against the following organisms:
Bacteroides species and Fusobacterium nucleatum.
*= in vitro sensitivity tests must be performed.
Many strains of the following are resistant:
Fungi and yeasts (except Actinomyces)
Pseudomonas aeruginosa (all strains)
Doxycycline 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 reabsorbed. Conventional doses of doxycycline are not excreted in the urine to the same extent as other tetracyclines and it does not accumulate significantly in the blood of patients with renal failure. Extrarenal infections in individuals may be treated with doxycycline when indicated. Doxycycline is excreted in the faeces, largely as an inactive conjugate or chelate.
INDICATIONS: For the treatment of Brucellosis, trachoma, urinary tract infections, sensitive gonococcal infections.
CONTRA-INDICATIONS: Pregnancy and lactation and in young children. Sensitivity to any tetracycline. As preparations containing iron, aluminium, calcium or magnesium decrease the absorption of doxycycline, do not give to patients receiving antacid therapy, milk or calcium containing foods. Potentially hepatotoxic medicine should not be given with CYCLIDOX EC.
WARNINGS: Use with care in liver function impairment. Symptoms of myasthenia gravis may be aggravated. Photosensitivity may occur. (See side-effects and special precautions).
DOSAGE AND DIRECTIONS FOR USE: CYCLIDOX EC should be taken one hour before meals or two hours after meals.
Adults: one capsule every 24 hours.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Gastro-intestinal:
dysphagia related to oesophagitis
Secondary fungal overgrowth (Candida albicans);
oral candidiasis, with soreness, redness and thrush which may extend into the trachea and bronchi.
Secondary bacterial overgrowth infections may occur:
resistant coliform organisms such as Proteus spp may cause diarrhoea
super-infection due to staphylococci may cause fulminating enteritis.
Increased severity of uraemia and hepatotoxicity in patients with renal disease given high doses.
Vitamin deficiencies may occur.
Allergic (sensitivity) reactions:
maculopapular and erythematous rashes
exacerbation of systemic lupus erythematosus pericarditis
Henoch-Schönlein purpura (anaphylactoid purpura)
Photosensitivity of the skin and nails; onycholysis and nail discoloration may occur.
The use of Doxycycline beyond the indicated date of expiry may lead to the Fanconi type syndrome which is characterised by polyuria and polydipsia with nausea, vomiting, proteinuria, glucosuria, acidosis and aminoaciduria. Raised intracranial pressure has been reported. CYCLIDOX EC has anti-anabolic action which may cause a rise in blood urea. In the elderly a negative nitrogen balance may be induced. Interactions: Absorption of CYCLIDOX EC is diminished by milk, alkalis, aluminium 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 with CYCLIDOX EC. Doxycycline may decrease the efficacy of oral contraceptives. Penicillin should not be given concomitantly with CYCLIDOX EC as antagonism in action may occur.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: See Side-Effects and Special Precautions. Treatment is symptomatic and supportive.
IDENTIFICATION: Size 1 gelatin capsule with opaque white cap and body.
Contains yellow or yellowish spherical microgranules.
PRESENTATION: Available in boxes of 10 capsules in blister packs.
STORAGE CONDITIONS: Store below 25°C and protect from light.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER: 28/20.1.1/0006.
NAME AND BUSINESS ADDRESS OF THE APPLICANT: TRIOMED (Pty) Ltd
2 Bella Rosa Street
DATE OF PUBLICATION OF THIS PACKAGE INSERT: 31 March 1995