INTERNATIONAL NONPROPRIETARY NAME -Doxycycline
Each tablet contains:
Drug substance: doxycycline hyclate 115.4 mg equivalent to doxycycline anhydrous 100 mg.
excipients: microcrystalline cellulose, calcium phosphate dibasic, crospovidone, magnesium stearate, maize starch, sodium starch glycolate, talc, sodium lauryl sulfate, silica colloidal hydrated.
Antibacterial for systemic use.
Infections from Gram-positive and Gram-negative germs sensitive to tetracycline.
Hypersensitivity to tetracyclines or to any of the excipients.
Esophageal obstructive disorders, such as tightening or achalasia.
The product is not recommended to pregnant women or children under eight years of age (see Special Warnings).
PRECAUTIONS FOR USE
The administration of doxycycline in large doses and for therapies that last more than two weeks may cause disorders of liver function that must therefore be monitored and the treatment should be discontinued in case of abnormal reactions.
Photosensitivity manifested by an exaggerated sunburn reaction to sunlight and ultraviolet light exposure can be observed in some individuals taking tetracycline drugs. Patients should be advised that this reaction can occur with tetracycline drugs; they should avoid exposure to direct sunlight and treatment should be discontinued at the first evidence of skin erythema. The excretion of doxycycline is not modified in subjects with impaired renal
functions. In these patients it is nonetheless advisable to proceed with caution and with a downward adjustment of the dose, whenever necessary.
In patients with renal impairment, the administration of tetracyclines at the usual recommended dose may lead to an excessive accumulation in blood, with the possibility of hepatic damages. According to the renal functionality, dosage adjustment is recommended and blood tests (levels should never exceed 15 mg/ml) and liver function tests should be carried out. It should also be remembered that tetracyclines perform an antianabolic
action that may worsen impaired renal function.
Instances of esophagitis and esophageal ulcerations (some of which severe) have been reported.
Patients should be reminded to take the drug with much water, also during meals, and to remain in an upright position for at least an hour after administration. The drug should not be administered immediately before lying down.
In case of appearance of symptoms such as dysphagia or retrosternal pain, the administration of the drug should be immediately discontinued and the eventuality of performing appropriate examinations should be evaluated by the doctor.
Patients suffering from ascertained esophageal reflux should also consider alternative therapies.
The concomitant administration of tetracycline and penicillin drugs should be avoided, due to possible interference between their antibacterial activity.
Because tetracyclines have been shown to depress prothrombin activity, patients who are on anticoagulant therapy may require an adjustment of their anticoagulant dosage.
Oral absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, dairy products and iron salts containing preparations. It is therefore advisable to avoid concurrent administration of these substances. Barbiturates, carbamazepine and phenytoin decrease the half-life of doxycycline.
Following the concurrent administration of tetracyclines, rare instances of an increase of concentrations of lithium, methrotrexate, digoxin and ergot derivatives in the blood plasma have been reported in literature. Concurrent use of tetracyclines may render oral contraceptives less effective.
As with other antibiotic preparations, the use of tetracycline drugs may result in superinfection caused by resistant bacterial agents or fungi. The possibility of enterocolitis induced by resistant staphylococcus should be considered.
During gonococcal infection treatment, there is the risk that symptoms of a coexistent syphilis might pass unnoticed: in this case, serological controls are recommended for at least 4 months.
In cycles of long-term treatment, periodic controls of blood counts, renal and hepatic function should be performed.
Tetracycline may form a stable calcium complex in any bone-forming tissue, although no particular hazardous effects have been highlighted in man so far. The use of drugs of the tetracycline class during tooth development (last half of pregnancy, infancy and early childhood) may cause permanent pigmentation of the teeth (yellowbrown).
This adverse reaction is more common during long-term use of the drugs but it has also been observed following repeated short-term courses.
As Doxycicline potentially weakens a neuromuscular transmission, this medicine should be prescribed to the patients with muscular weakness with care Doxycicline can lead to acute condition of systemlupus erythematosis.
KEEP THE MEDICINAL PRODUCT OUT OF THE REACH AND SIGHT OF CHILDREN
PREGNANCY AND BREAST-FEEDING
Administration of the drug is contraindicated during pregnancy and nursingbecause doxycycline crosses the placenta and it is found in human milk.
POSOLOGY AND METHOD OF ADMINISTRATION
Two tablets as a single dose on the first day of treatment, followed by a maintenance dose of one tablet per day. In case of severe infections strictly follow the instructions of the physician. In all Group A beta hemolytic streptococcus infections, treatment should be continued for at least ten days.
Each dose must be taken during meals with a full glass of water. Patients should take the medicinal product in an upright position at least an hour before lying down (see Precautions for Use).
The duration of the treatment will depend on the evolution of the infection: in any case the therapy should not be discontinued until disappearance of fever and clinical symptoms.
In order to obtain maximum therapeutic safety it will anyway be appropriate to perform an antibiogram to ascertain that the strain of germs responsible for the infection to be treated is sensitive to the action of tetracycline.
In case of overdosage proceed to gastric irrigation.
In order to obtain clarifications on the use of the medicinal product, it is advisable to consult your physician or chemist.
In case of tetracycline-based therapy, the following side effects may occur:
- Digestive system: nausea, epigastralgia, vomiting, diarrhea, lack of appetite glossitis and other forms of mucositis, enterocolitis, candidiasis in the anogenital region (infection caused by microscopic fungi).
- Dysphagia, esophagitis, esophageal ulcerations (see Precautions for Use), in particular in patients receiving the medicinal drug immediately before lying down and/or not with enough water.
- Skin: maculopapular and erythematous rashes.
- Hypersensitivity reactions: urticaria, anaphylactoid purpura, angioneurotic edema; rare cases of Stevens-Johnson syndrome have been reported.
- Hematological alterations: very rare instances of hematological alterations (hemolytic anemia, neutropenia, thrombocytopenia and eosinophilia) have been reported.
Following the instructions of this leaflet will reduce the risk of side effects.
PHARMACEUTICAL FORM AND CONTENTS
Pack of 10 tablets of 100 mg.
EXPIRY DATE AND STORAGE
The expiry date stated on the package refers to the product properly stored.
Store below 25°C.
Do not take the medicine after the expiry date stated on the box.
PHARMACY PURCHASING TERMS
MANUFACTURER AND FINAL SUPERVISOR
Laboratorio Farmacologico Milanese Srl, Caronno Pertusella (Va) – Italy.
Last revision of the Italian Ministry of Health: 25/10/11
MARKETING AUTHORIZATION HOLDER
Laboratorio Farmacologico Milanese Srl, via Monterosso 273, 21042 Caronno Pertusella (Va) – Italy.