Skip to Content

OXYMYCIN-OXYTETRACYCLINE CAPSULES 250MG

Active substance(s): OXYTETRACYCLINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
OXYMYCN/Oxytetracycline Capsules 250 mg

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Oxytetracycline Hydrochloride BP 265 mg

3

PHARMACEUTICAL FORM
Capsule

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Infections caused by oxytetracycline-sensitive organisms. These include acute
and chronic bronchitis, pneumonia, urinary tract infections, brucellosis,
pertussis, rickettsial fevers and psittacosis.

4.2

Posology and method of administration
Capsules should be swallowed whole with water one hour before or two hours
after a meal.
Adults and
children of
12 years
and above

250 mg every six hours. Dosage may be increased in severe infections to
250 mg every three hours after an initial loading dose of 1 g.

Children:

Not recommended for children under 12years of age.

Elderly:

May be given at the usual adult dosage. The possibility of sub-clinical
renal insufficiency should be kept in mind, as it may lead to drug
accumulation.

Therapy should be continued for at least 24 - 48 hours after symptoms and
fever have subsided.

4.3

Contraindications
Known hypersensitivity to tetracyclines. Renal impairment. Children under
12 years of age. Use during pregnancy or lactation.

4.4

Special warnings and precautions for use
Medicines and foods containing di-/tri-valent cations interfere with the
absorption of oxetetracycline and doses should be maximally seperated.. If
however, gastric irritation occurs the medicine should be taken with food.
OXYMYCIN should be used with caution in patients with hepatic or renal
dysfunction, or in conjunction with other potentially hepatotoxic or
nephrotoxic drugs.
OXYMYCIN should not be administered to children during the period of
tooth development because of the likelihood of staining of teeth and deposition
in the epiphysis.
Intestinal overgrowth of resistant organisms (candida albicans in particular)
may occur.
Photosensitivity reactions can sometimes occur. Susceptible patients should
avoid direct exposure to natural or artificial sunlight and discontinue therapy at
the first sign of skin discomfort.
Weak neuromuscular blockade mat occur in patients suffering from
Myasthenia Gravis.
Exacerbation of SLE (systemic lupus erythematosus) may occur.
OXYMYCIN is unsafe in acute porphyrias.

4.5

Interaction with other medicinal products and other forms of interaction
Tetracyclines bind to di-/tri-valent cations. Absorption from the
gastrointestinal tract is impaired by the concomitant administration of iron,
calcium,aluminium, magnesium, bismuth and zinc salts(interactions with
specified salts, antacids Bismuth containing ulcer-healing drugs, quinapril
which may contain a magnesium carbonate excipienta). Dosages should be
maximally separated.
Absorption of tetracyclines is impaired by food, milk and milk products.
The concomitant use of tetracycline mat reduce the efficacy of oral
contraceptives and the concomitant use of retinoids may increase the risk of
benign intracranial nypertension. It is advisable to avoid giving tetracyclines
in conjunction with penicillin.
Patients reciving concurrent anti-coagulant therapy should have the doses of
those drugs reduced because tetracycline depresses plasma prothrombin
activity.
Atovaquone plasma concentration is reduced by teracycline.
Diuretics may aggravate nephrotoxicity by volume depletion.

4.6

Pregnancy and lactation
Do not use in pregnancy unless there are compelling reasons.

4.7

Effects on ability to drive and use machines
Does not affect ability to drive and use machines.

4.8

Undesirable effects
Nausea, vomiting, diarrhoea, anorexia and on rare occasions dysphagia have
been reported.
Skin reactions have been occasionally occurred. The most common reaction is
photosensitivity. Erythematous, and macro-papular rashes, pruritis, bullous
dermatoses and exfoliative dermatitis have also been reported.

A few cases of pancreatitis and antibiotic-associated colitis have beeb
reported. Oesophagitis and oesophageal ulceration have been reported,
usually when taken beforw bed or without inadequate fluids.
Hypersensitivity reactions reactions include rash, exfoliative dermatitis,
urticaria, angioedema, anaphylaxis, pericarditis and exacerbation of systemic
lupus erythematosus.
Teeth discolouration has occurred, but is usually only obvious after repeated
doses.
Bulging fontanelles and benign intracranial hypertension in juveniles and
adults have been reported indicated by headache and visual disturbances
including blurring of vision, scotomata and diplopia. Permanent visual loss
has been reported.
Overgrowth of resistant organisms may cause candidiasis,
pseudomembrananous colitis (Clostridium difficile overgrowth), glossitis,
stomatitis, vaginitis and staphylococcal entero-colitis.
On rare occasions transient increases in liver function tests, hepatitis, jaundice
and hepatic failure have been reported. Blood dycrasias have also occurred.

4.9

Overdose
Although overdosage with antibiotics is rare, if it should occur gastric lavage
supportive therapy and control of plasma electrolytes is indicated.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Oxytetracycline is primarily a bacteriostatic antibiotic and has a similar
spectrum of activity to other tetracyclines.
Oxytetracycline is a broad spectrum antibiotic to sensitive organisms.

5.2

Pharmacokinetic properties
Oxytetracydline is absorbed irregularly to the extent of about 60% of an oral
dose, absorption occurring in the stomach and upper small intestine.

Peak plasma concentrations achieved 2-4 hours after an oral dose.
The mean plasma half-life is 9.2 hours. The plasma/protein bind is 27-35%.
The drug is eliminated largely unchanged mostly in the urine, with some in the
faeces. A small amount is metabolised in the liver.

5.3

Preclinical safety data
Not applicable.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Talc
Alginic acid
Stearic acid
Sodium lauryl sulphate
Capsule shell size 1:
Gelatin
Titanium dioxide
Yellow iron oxide

6.2

Incompatibilities
Antacids containing aluminium, magnesium or calcium, interfere with the
absorption of oxytetracycline as does the calcium content of milk.

6.3

Shelf life
36 Months.

6.4

Special precautions for storage
Store below 25°C in a dry place. Keep containers well closed.
Protect from light.

6.5

Nature and contents of container
High density polystyrene or polypropylene containers with polypropylene or
polythene lids and polyurethane/polythene inserts.
Pack sizes: 100 and 500 capsules

6.6

Special precautions for disposal
Not applicable.

7

MARKETING AUTHORISATION HOLDER
Chelonia Healthcare Limited
Boumpoulinas 11, 3rd Floor
NICOSIA
CYPRUS
P.C. 1060
CYPRUS

8

MARKETING AUTHORISATION NUMBER(S)
PL 33414/0074

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION

June 1972

10

19/06/1996

DATE OF REVISION OF THE TEXT
10/01/1996

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide