Doxycycline

Doxycycline hyclate

De secties hieronder zijn geciteerd uit de Engelstalige productinformatie, want dat is het document dat de goedkeuring draagt. Waar een Europese instantie dezelfde informatie in het Nederlands publiceert, staat de link bij de bronnen. Wij vertalen regelgevende teksten niet zelf: een vertaalfout in een contra-indicatie is gevaarlijker dan een regel in een vreemde taal.

01Goedgekeurde toepassingen

• Uncomplicated urethral, endocervical or rectal infections caused by Chlamydia trachomatis.
• Nongonococcal urethritis caused by Ureaplasma urealyticum.
• Lymphogranuloma venereum caused by Chlamydia trachomatis.
• Granuloma inguinale caused by Klebsiella granulomatis.
• Uncomplicated gonorrhea caused by Neisseria gonorrhoeae.
• Respiratory tract infections caused by Mycoplasma pneumoniae.

02Vormen en sterktes

• Each tablet contains specially coated pellets of doxycycline hyclate USP equivalent to 75 mg of doxycycline.
• Doxycycline hyclate delayed-release tablets USP, 100 mg having functional scoring are white, oval tablets containing yellow specks, debossed with "L242" on one side and score line on the other side.

03Hoe het wordt ingenomen

• Dosage in Adult Patients: The usual dosage is 200 mg on the first day of treatment (administered 100 mg every 12 hours) followed by a maintenance dose of 100 mg daily.; In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended.
• Dosage in Pediatric Patients: For all pediatric patients weighing less than 45 kg with severe or life -threatening infections (e.g., anthrax, Rocky Mountain spotted fever), the recommended dose is 2.2 mg per kg of body weight administered every 12 hours. Pediatric patients weighing 45 kg or more should receive the adult dose.;

04Mag niet worden gebruikt bij

• Doxycycline hyclate delayed-release tablets are contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

05Interacties

• Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage
• Avoid co-administration of tetracyclines with penicillin
• Absorption of tetracyclines, including doxycycline hyclate delayed-release tablets, is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron-containing preparations
• Concurrent use of tetracyclines, including doxycycline hyclate delayed-release tablets, may render oral contraceptives less effective
• Barbiturates, carbamazepine and phenytoin decrease the half-life of doxycycline

06Waarschuwingen en voorzorgen

• The use of drugs of the tetracycline-class during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown).
• Clostridiodes difficile -associated diarrhea (CDAD) has been reported: Evaluate patients if diarrhea occurs.
• Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Limit sun exposure.
• Overgrowth of non-susceptible organisms, including fungi, may occur. If such infections occur, discontinue use and institute appropriate therapy.

07Vaak voorkomende bijwerkingen

• Most commonly reported adverse reactions in both treatment groups were nausea, vomiting, diarrhea, and bacterial vaginitis, Table 1.

08Zwangerschap

There are no adequate and well-controlled studies on the use of doxycycline in pregnant women. The vast majority of reported experience with doxycycline during human pregnancy is short-term, first trimester exposure. There are no human data available to assess the effects of long-term therapy of doxycycline in pregnant women such as that proposed for the treatment of anthrax exposure.

09Werkingsmechanisme

Doxycycline is a tetracycline-class antimicrobial drug.

Deze sectie geeft de goedgekeurde productinformatie weer. De formulering is ingedikt uit de samenvatting van de toezichthouder zelf, en het volledige document staat bij de bronnen.