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

Logo DOXITAB

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

DOXITAB
TABLETS

COMPOSITION
Each tablet contains: Doxycycline hydrochloride equivalent to
doxycycline 100 mg

PHARMACOLOGICAL CLASSIFICATION:
A.20.1.1 Broad and medium spectrum antibiotics.

PHARMACOLOGICAL ACTION:
Doxycycline is a bacteriostatic antibiotic that inhibits bacterial protein synthesis (30S ribosomes). It is effective in vitro against the following organisms (in vitro sensitivity does not necessarily imply in vivo efficacy): Vibrio cholera, Ureaplasma urealyticum, Mycoplasma pneumoniae, Chlamydia trachomatis, Chlamydia psittaci, Borrelia recurrencis, Calymmatobacterium granulomatis, Borrelia burgdorferi, penicillin-sensitive Neisseria gonorrhoeae and Rickettsiae.
Doxycycline is also effective against the following organisms in vitro:
Clostridium tetani, Listeria monocytogenes, Haemophilus ducreyi, Campylobacter jejuni, Leptospira, Actinomyces israelii, Bacillus anthracis*, Pasteurella multocida, Streptobacillus moniliformis, Erysipelothrix rhusiopathiae, Francisella tularensis, Treponema pertenue and Plasmodium falciparum.
Doxycycline may also show some effect against the following organisms:
Bacteroides species and Fusobacterium nucleatum.
* = in vitro sensitivity tests must be performed.
Resistant pathogens:
Many strains of the following are resistant:
Staphylococci, Enterococci, Proteus vulgaris, Fungi and Yeasts (except Actinomyces), Pseudomonas aeruginosa (all strains), E. coli, Shigella, Strep. pneumoniae.
Doxycycline is well absorbed. After an oral dose of 200 mg of Doxycycline, plasma concentrations of the medicine reach a maximum of 3 micrograms/mL at 2 hours and are well maintained, and thus dosage once daily is usually adequate.
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.

INDICATIONS:
Infections caused by susceptible strains.
Upper and lower respiratory tract:
Sinusitis, pharyngitis, pneumonia (Legionella and Mycoplasma), psittacosis and chronic bronchitis.
Genito-urinary tract:
Non-specific urethritis (only if the strain is sensitive), lymphogranuloma venereum, chancroid and granuloma inguinale, gonorrhoea, gonococcal salpingitis, epididymitis, acute epididymo-orchitis, endocervical infections and syphilis (in cases of penicillin allergy).
Soft tissue infections:
Acne vulgaris.
Ophthalmic:
Trachoma and inclusion conjunctivitis.
Intestinal:
Cholera, Whipple’s disease, and tropical sprue.
Malaria prophylaxis:
For short-term prophylaxis of malaria in short-term travelers (<4 months) going to areas where a high level of chloroquine resistance has been reported and the traveler cannot tolerate Mefloquine or other relevant agents for the prophylaxis of malaria.
Miscellaneous:
Rickettsial infections, brucellosis, tularemia, actinomycosis, Lyme disease, yaws, relapsing fever, Leptospirosis during the early phase.

CONTRA-INDICATIONS
Hypersensitivity to any tetracycline.
Doxycycline should not be used during pregnancy, lactation and in children under the age of 12 years, or until calcification of the permanent teeth.
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 Doxycycline. Patients with systemic lupus erythematosus.

WARNINGS:
Use with care in patients with impaired hepatic function and avoid concomitant use with hepatotoxic medicines. Frail and elderly patients are especially susceptible to the hepatotoxic and anti-anabolic effects of Doxycycline.
Photosensitivity, manifested by an exaggerated sunburn reaction, may occur. Patients or travelers likely to be exposed to direct sunlight or UV light should be advised of this.
Raised intracranial pressure may occur, particularly in infants and especially if Vitamin A or other retinoids are taken concomitantly.
The symptoms of myasthenia gravis may be aggravated.
KEEP OUT OF REACH OF CHILDREN.

Patient Information in the case of Malaria Prophylaxis:
Because no form of malaria prophylaxis, including Doxycycline, guarantees full protection, it is imperative to also prevent mosquito bites. The following preventative measures should therefore be taken:
it is preferable to visit endemic areas when rainfall is low or during the dry season;
the following high risk individuals should avoid malaria areas if at all possible:
- babies and young children less than 5 years old,
- pregnant women,
- immunocompromised patients e.g. those on longterm steroids or chemotherapy, patients with cancer or AIDS and those who have had a splenectomy;
remain indoors between dusk and dawn, when mosquitoes are at their most active;
apply insect repellant to exposed skin and clothing;
wear long sleeves and trousers at night;
use mosquito nets, screens, coils or pads.
Should flu-like symptoms appear at any time, the patient must inform his doctor that he has been to a malaria area.

DOSAGE AND DIRECTIONS FOR USE:
Usual dose: 2 tablets on 1st day (single dose or 100 mg twice daily), thereafter 1 tablet (100 mg) a day, 1 hour before or 2 hours after meals, with adequate liquid (at least half a glass of water) and one hour or more before retiring to bed to avoid esophageal irritation and ulceration.
Severe infections: 200 mg daily throughout treatment period.
Medication should be taken for at least 24 - 48 hours after fever and other symptoms have disappeared.
For malaria prophylaxis:
ADULTS AND TEENAGERS: 100 mg (1 tablet) daily
CHILDREN OVER 8 YEARS: 2 mg/kg, once daily, up to 100 mg daily.
  (Contra-indicated under 8 years)
Start prophylaxis one to two days before entry into the potential malaria area, continue daily dosage while in malaria area and for four weeks after the last possible exposure to mosquito bites.
Trachoma: 100 mg daily for 40 days.
Nonspecific urethritis: 100 mg (1 tablet) twice daily for 7 days.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Doxycycline is not indicated for treating commonly occurring infections in children less than 12 years of age.
In the case of malaria prophylaxis DOXITAB is contra-indicated in children under 8 years of age.
The side-effects of doxycycline hydrochloride include nausea, vomiting, diarrhoea, and symptoms resulting from the overgrowth of non-susceptible organisms.
Doxycycline is deposited in calcifying areas in bone, nails and in teeth, causing permanent discoloration and malformation; when given in therapeutic doses to young infants or to pregnant women, tetracyclines interfere with the growth of bones and teeth in infants.
Use in pregnancy, potentially during breast-feeding, and in childhood up to the age of 12 years, may result in impaired bone growth and permanent discoloration of the child’s teeth.
An increase in intracranial pressure with headache, visual disturbances and papilloedema, which may be associated with a bulging fontanelle in infants, has been reported in patients given doxycycline.
Other effects that have been reported include dry mouth, glossitis and discoloration of the tongue, stomatitis and dysphagia.
Oral candidiasis, vulvovaginitis, and pruritus ani occur mainly due to overgrowth with Candida albicans and there may be overgrowth of resistant coliform organisms, such as Pseudomonas spp. and Proteus spp. causing diarrhoea.
Severe and sometimes fatal hepatotoxicity associated with fatty changes in the liver and pancreatitis has been reported in pregnant women with renal impairment or those given high doses.
Oesophageal ulceration may be a particular problem if doxycycline is taken with insufficient fluid or in a recumbent posture.
Hypersensitivity reactions including rashes, fixed drug eruptions, exfoliative dermatitis, toxic epidermal necrolysis, drug fever, pericarditis, angioedema, urticaria, and asthma have been reported and anaphylaxis has occurred less frequently.
Photosensitivity appears to be phototoxic rather than photoallergic in nature. Patients who may be exposed to direct sunlight must be warned of the risk of photosensitivity. Paraesthesia may be an early sign of impending phototoxicity.
Nail discoloration and onycholysis may occur.
Abnormal pigmentation of the skin and eye has occurred.
A Jarisch-Herxheimer-like reaction has been reported in patients with relapsing fever treated with doxycycline.
Haemolytic anaemia, eosinophilia, neutropenia, and thrombocytopenia have been reported.
Reductions in serum vitamin B concentrations, including folate deficiency and concomitant megaloblastic anaemia can occur.
The use of out-of-date or deteriorated tetracyclines has been associated with the development of a reversible Fanconi-type syndrome characterized by polyuria and polydipsia with nausea, glycosuria, aminoaciduria, hypophosphataemia, hypokalaemia, and hyperuricaemia with acidosis, and proteinuria.
Other adverse effects include myopathy, increased muscle weakness in patients with myasthenia gravis, and provocation of lupus erythematosus.
Special precautions:
Care should be taken if doxycycline is given to patients with impaired liver function and high doses should be avoided.
Cross-sensitisation between different tetracyclines is common.
The risk of photosensitivity should be emphasized to patients, or travelers to malaria areas, who may be exposed to direct sunlight.
If long term therapy is necessary, periodic laboratory evaluation of haemopoietic, renal and hepatic organ systems should be done.
Interactions:
Doses of anticoagulants may need to be reduced when doxycycline is given due to depression of plasma prothrombin activity.
The half-life of doxycycline is decreased from 20 hours to 7 hours when given concomitantly with phenobarbitone and diphenylhydantoin.
Alcohol and carbamazepine also reduces the half-life of doxycycline.
Efficacy of estrogen containing oral contraceptives may be decreased.
The administration of doxycycline and penicillin concomitantly is to be avoided, especially when a rapid bactericidal action is required, due to the possible antagonism of actions.
The absorption of doxycycline is reduced by di- and trivalent cations such as aluminium, bismuth, calcium, iron, magnesium and zinc contained in antacids, sucralfate, iron preparations, alkalis, bismuth salts, milk and other diary products.
The nephrotoxic effects of doxycycline may be exacerbated by diuretics.
Doxycycline may increase the concentrations of lithium and digoxin and may also increase the toxic effects of ergot alkaloids and methotrexate.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULRS OF ITS TREATMENT:
See “Side-effects and Special Precautions”.
Treatment is symptomatic and supportive.

IDENTIFICATION:
White, film coated biconvex tablets, cross-scored on one side and plain on the other side.

PRESENTATION:
Tablets: 10 and 100 tablets in blister packs.

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
29/20.1.1/0298

NAME AND BUSINESS ADDRESS OF APPLICANT:
CIPLA MEDPRO (PTY) LTD.
Rosen Heights, Pasita Street,
Rosen Park Bellville 7530 R.S.A.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
January 2001

5365 D

Updated on this site: January 2017
Source: Pharmaceutical Industry
http://www.cipla.co.za/wp-content/uploads/2013/10/sep_doxitab.pdf

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