Doxycycline Hyclate Tablets
Item info. These highlights do not include all the info. needed to use ACTICLATE safely and effectively. See full prescribing info. for ACTICLATE . ACTICLATE (doxycycline hyclate USP) Tablets for oral use Initial U.S. Approval: 1967 -INDICATIONS AND USAGE ACTICLATE is tetracycline-class antimicrobial indicated for: Rickettsial infections 1.1 Sexually transmitted infections 1.2 Respiratory tract infections 1.3 Specific bacterial infections 1.4 Ophthalmic infections 1.5 Anthrax, including inhalational anthrax (post-exposure) 1.6 Alternative treatment for se lected infections when pe nicillin is contraindicated 1.7 Adjunctive therapy in acu te intestinal amebiasis and severe acne 1.8 Prophylaxis of malaria 1.9 To reduce the development of drug-resistant acteria and maintain the effectiveness of doxycycline hyclate and other antimicrobi al drugs, ACTICLATE Tablets should be used only to treat or prevent infections th at are proven or strongly suspected to be caused by bacteria. 1 --DOSAGE AND ADMINISTRATION Adults: the usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours) followed by 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. 2.1 For children above eight years of age: The recommended dosage schedule for children weighing 45 kg or less is 4.4 mg per kg of body weight divided into two doses on the first day of treatment, followe by 2.2 mg per kg of body weight given as single daily dose or divided into tw doses on subsequent days. For more severe infections, up to 4.4 mg per kg of body weight may be used. For children over 45 kg, the usual adult dose should be used. 2.1 DOSAGE FORMS AND STRENGTHS -- Tablets, 75 mg and 150 mg (functionally scored) 3 CONTRAINDICATIONS Doxycycline is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. 4 --WARNINGS AND PRECAUTIONS The use of drugs of the tetracycline-cla ss during tooth development (last half of pregnancy, infancy and childhood to the age of years) may cause permanent discoloration of the teeth (yellow-gray-brown). 5.1 Clostridium difficile -associated diarrhea: Evaluate patients if diarrhea occurs. 5.2 Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Limit sun exposure. 5.3 Overgrowth of non-susceptible organisms, including fungi, may occur. Reevaluate therapy if superinfection occurs. 5.4 ADVERSE REACTIONS Adverse reactions observed in patients receivi ng tetracyclines include anorexia, nausea, vomiting, diarrhea, rash, photosensitivity urticaria, and hemolytic anemia. 6 To report SUSPECTED ADVERSE REACTIO NS, contact Aqua Pharmaceuticals at 1-866-665-2782, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage 7.1 Avoid coadministration of tetr acyclines with penicillin 7.2 Absorption of tetracyclines is impair ed by antacids containing aluminum, calcium, or magnesium, bismuth subsalic ylate and iron-containing preparations 7.3 Concurrent use of tetracycline may rende oral contraceptives less effective 7.4 Barbiturates, carbamazepine and phenytoin decrease the half-life of doxycycline 7.5 --USE IN SPECIFIC POPULATIONS Tetracycline-class drugs can cause fetal ha rm when administered to pregnant woman, but data for doxycycline are limited. (5.6, 8.1 Tetracyclines are excreted in human milk however, the extent of absorption of doxycycline in the breastfed infant is not known. Doxycycline use during nursing should be avoided if possible. 8.3 See 17 for PATIENT COUNSELING info. Revised: 07/2014
