MONODOX® (doxycycline monohydrate) Capsules may be useful as adjunctive therapy in severe acne.
Click here for Full Prescribing Information for MONODOX® Capsules.Important Safety Information Regarding MONODOX® (doxycycline monohydrate) Capsules, 100 mg and 75 mg
- MONODOX® Capsules are contraindicated in persons who have shown any sensitivity to any of the tetracyclines.
- Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.
- Patients receiving tetracyclines have been observed to have an exacerbation of systemic lupus erythematosus, and adult patients receiving tetracyclines have been reported to experience intracranial hypertension.
- Adverse reactions that have been observed in patients receiving tetracyclines include the following: anorexia, nausea, vomiting, diarrhea, rashes, rise in BUN, urticaria, angioneurotic edema, anaphylaxis, hemolytic anemia, thrombocytopenia, neutropenia, eosinophilia, and intracranial hypertension. Additional common side effects include the following: renal toxicity (rise in BUN) and hypersensitivity reactions.
- The use of drugs of the tetracycline class during tooth development (last half of pregnancy, infancy, and childhood to 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown).
- Patients are advised to drink fluids liberally along with doxycycline to reduce the risk of esophageal irritation and ulceration.
- Photosensitivity manifested by an exaggerated sunburn has been observed in some individuals taking tetracyclines.
- Concurrent use of tetracycline may render oral contraceptives less effective.
- MONODOX® Capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
- Women of childbearing age who are overweight or have a history of Intracranial Hypertension (IH, pseudotumor cerebri) are at greater risk for developing tetracycline-associated IH. Concomitant use of isotretinoin and MONODOX® Capsules should be avoided because isotretinoin is also known to cause pseudotumor cerebri.
- Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus.
- Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including MONODOX® Capsules, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against Clostridium difficile may need to be discontinued.
Click here for Full Prescribing Information for MONODOX® Capsules.
To report SUSPECTED ADVERSE REACTIONS, contact Aqua Pharmaceuticals at 1-866-665-2782, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.