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Cordran Lotion and Cordran Cream 0.05% are both indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Important Safety Information Regarding Both Cordran Lotion and Cream 0.05%
- Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, Cushing's syndrome, hyperglycemia, and glucosuria.
- Increased absorption may occur with the use of more potent steroids, use over large surface areas or with occlusive dressings, prolonged use, or use in pediatric patients.
- Patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression using urine free cortisol and ACTH stimulation tests.
- Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than do adults because of a larger skin surface area to body weight ratio.
- Local adverse reactions are reported infrequently with topical corticosteroids but may occur more frequently with the use of occlusive dressings.
- The most common adverse events with both Cordran Lotion and Cordran Cream 0.05% were burning, itching, irritation, and dryness.
- The following adverse reactions have been identified during post-approval use of Cordran Lotion: hypersensitivity, contact dermatitis, skin discoloration, skin striae and skin atrophy.
Indication for Verdeso (desonide) Foam, 0.05%
VERDESO® (desonide) Foam, 0.05% is a corticosteroid indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older.
Important Safety Information Regarding Verdeso (desonide) Foam, 0.05%
Treatment should not exceed 4 consecutive weeks as the safety and efficacy of Verdeso Foam has not been established beyond 4 weeks of use. Verdeso Foam has been shown to produce reversible HPA axis suppression. Systemic effects of topical corticosteroids may also include manifestations of Cushing's syndrome, hyperglycemia, facial swelling, glycosuria, withdrawal syndrome, and growth retardation in children. Pediatric patients are at greater risk for HPA-axis suppression and Cushing's syndrome when treated with topical steroids. The most common adverse reactions observed in clinical trials were upper respiratory tract infection, cough, application site burning, headache, viral infection, and increased blood pressure. In post-marketing reports, the most common adverse reactions were application site irritation followed by application site erythema. Do not dispense directly on the face. Avoid contact with the eyes or other mucous membranes. The propellant in Verdeso Foam is flammable. Avoid fire, flame, or smoking during and immediately following application.
Indication for XOLEGEL® (ketoconazole) Gel 2%
XOLEGEL® (ketoconazole) Gel 2% is an azole antifungal indicated for topical treatment of seborrheic dermatitis in immunocompetent adults and children 12 years of age and older.
Safety and efficacy of XOLEGEL Gel for treatment of fungal infections have not been established.
Important Safety Information Regarding XOLEGEL® (ketoconazole) Gel 2%
XOLEGEL Gel is for topical use only. XOLEGEL Gel is flammable. Avoid using near fire, flame, or smoking during and immediately following application of XOLEGEL Gel. XOLEGEL Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether XOLEGEL Gel is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when XOLEGEL Gel is administered to a nursing woman. Safety and effectiveness of XOLEGEL Gel in children below the age of 12 have not been established. The most common treatment-related adverse reaction was application site burning (4%). Treatment-related application site reactions that were reported in less than 1% of subjects were: dermatitis, discharge, dryness, erythema, irritation, pain, pruritus, and pustules. Adverse events identified during post approval use with XOLEGEL Gel include burning sensation, pain, skin irritation, and erythema.
Indication for FLUOROPLEX® (fluorouracil) 1% Topical Cream
FLUOROPLEX® (fluorouracil) 1% Topical Cream is indicated for the topical treatment of multiple actinic (solar) keratoses.
Important Safety Information Regarding FLUOROPLEX® (fluorouracil) 1% Topical Cream
FLUOROPLEX Topical Cream should not be used by women who are or may become pregnant. FLUOROPLEX Topical Cream may cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. FLUOROPLEX Topical Cream should not be used by patients who are allergic to any of its components. There exists the potential for a delayed hypersensitivity reaction to FLUOROPLEX Topical Cream. Patch testing to prove hypersensitivity may be inconclusive. The patient should avoid prolonged exposure to sunlight or other forms of ultraviolet irradiation during treatment with FLUOROPLEX Topical Cream, as the intensity of the reaction may be increased. It is not known whether FLUOROPLEX Topical Cream is excreted in human milk. Because many drugs are excreted in human milk, and because there is some systemic absorption of FLUOROPLEX Cream after topical administration, mothers should not nurse their infants while receiving this drug. Safety and effectiveness in pediatric patients have not been established. Pain, pruritus, burning, irritation, inflammation, allergic contact dermatitis and telangiectasia have been reported with use of FLUOROPLEX Topical Cream. Occasionally, hyperpigmentation and scarring have also been reported.
Important Safety Information Regarding Monodox
- 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 benign 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 bulging fontanels in infants. Additional common side effects: 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 should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
- 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, 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.