Doxycycline hydrochloride equivalent to doxycycline 50 mg.
PHARMACOLOGICAL CLASSIFICATION: A.20.1.1 Broad and medium spectrum antibiotics
PHARMACOLOGICAL ACTION: Doxycycline hydrochloride is a tetracycline which is a broad-spectrum antibiotic. It is bacteriostatic against susceptible strains of a wide range of gram-positive and gram-negative organisms. Doxycycline is well absorbed. Absorption is diminished by the presence of iron, aluminium, calcium and magnesium.
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. It is clear that with conventional doses doxycycline is not excreted in the urine to the same extent as the other tetracyclines and it does not accumulate in the blood of the patients with renal failure. It also has less impact on the intestinal microflora.
INDICATIONS: Doxycycline is indicated in the treatment of acne.
CONTRA-INDICATIONS: Doxycycline should not be used in pregnancy. When administered to women during the latter half of pregnancy, to nursing mothers or during childhood up to the age of 12 years, permanent discoloration of the child's teeth may occur.
Doxycycline should not be given to patients with a known sensitivity to tetracyclines. Should be avoided in patients with systemic lupus erythematosus.
Potentially hepatotoxic drugs should not be given with doxycycline.
WARNING: KEEP OUT OF REACH OF CHILDREN.
DOSAGE AND DIRECTIONS FOR USE: 50 mg (1 capsule) daily.
Doxycyl may be taken with food or milk, but not with antacids containing calcium or other di/tri valence metals.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Gastro-intestinal side-effects including nausea, vomiting, and diarrhoea are common, especially with high doses. Oesophageal ulceration has also been reported. Oral candidiasis, vulvovaginitis, and pruritis ani can occur due to overgrowth of overgrowth of Candida albicans. Oral candidiasis results in soreness, redness and thrush in the mouth, which may extend into the trachea and bronchi. There may also be overgrowth of resistant coliform organisms, such as Pseudomonas spp. and Proteus spp., causing diarrhoea. More serious superinfection with resistant staphylococci causing enterocolitis, and also pseudomembranous colitis due Clostridium difficile have been reported.
Severe and sometimes fatal hepatotoxicity has been reported in patients with renal impairment and in those given high doses. Tetracyclines are deposited in deciduous and permanent teeth, causing discolouration and enamel hypoplasia. 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, eosinophylia, thrombocytopenia have been reported. Vitamin deficiency may occur.
Doxycycline has an anti-anabolic action which may cause a rise in blood urea.
Allergic reactions to doxycycline has been reported, usually as skin reactions; cross-sensitisation between tetracyclines is common.
Photosensitivity of the skin and nails has occurred, and onycholysis may be associated with nail discolouration.
A Jarisch-Herxheimer-like reaction has been reported in patients with relapsing fever treated with tetracycline.
Special precautions: Care must be taken when liver function is impaired.
Symptoms of myasthenia gravis may be exacerbated by tetracyclines.
It is recommended not to take doxycycline and penicillin concomitantly, especially when a rapid bactericidal action is necessary, because of the possible antagonism of the action. Doxycyl may decrease the efficacy of oral contraceptives.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: In the event of sensitivity reactions, treatment should be withdrawn. Symptoms should be treated symptomatically.
IDENTIFICATION: A yellow granular powder encapsulated within a no. 4 opaque capsule, with a red cap and brown body.
PRESENTATION: Blister packs of 30.
STORAGE INSTRUCTIONS: Store below 25°C in airtight containers. Protect from light.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER: 27/20.1.1/0495
NAME AND BUSINESS ADDRESS OF THE APPLICANT Lennon Limited, 7 Fairclough Road, PORT ELIZABETH 6001