What happens if I overdose Mecloma-F?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately.
Proper storage of Mecloma-F cream:
Store Mecloma-F cream at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Mecloma-F cream out of the reach of children and away from pets.
Overdose of Mecloma-F in details
There are no data available on the effects of acute or chronic overdosage with Mecloma-F nasal spray 50 mcg. Because of low systemic bioavailability, and an absence of acute drug-related systemic findings in clinical studies, overdose is unlikely to require any therapy other than observation. Intranasal administration of 1600 mcg (4 times the recommended dose of Mecloma-F nasal spray 50 mcg for the treatment of nasal polyps in patients 18 years of age and older) daily for 29 days, to healthy human volunteers, showed no increased incidence of adverse events. Single intranasal doses up to 4000 mcg and oral inhalation doses up to 8000 mcg have been studied in human volunteers with no adverse effects reported. Chronic over dosage with any corticosteroid may result in signs or symptoms of hypercorticism. Acute overdosage with this dosage form is unlikely since one bottle of Mecloma-F nasal spray 50 mcg contains approximately 8500 mcg of Mecloma-F.
What should I avoid while taking Mecloma-F?
Mecloma-F topical should not be used to treat any skin condition your doctor has not prescribed it for.
Avoid using Mecloma-F topical to treat skin on your face, underarms, or groin area without your doctor's advice.
Avoid getting this medication in your eyes. If contact does occur, rinse with water. Do not use Mecloma-F topical on broken or infected skin. Also avoid using this medication in open wounds.
Mecloma-F warnings
Local Nasal Effects
Epistaxis
In clinical studies, epistaxis was observed more frequently in patients with allergic rhinitis with Mecloma-F nasal spray than those who received placebo.
Candida Infection
In clinical studies with Mecloma-F nasal spray 50 mcg, the development of localized infections of the nose and pharynx with Candida albicans has occurred. When such an infection develops, use of Mecloma-F nasal spray 50 mcg should be discontinued and appropriate local or systemic therapy instituted, if needed.
Nasal Septum Perforation
Instances of nasal septum perforation have been reported following the intranasal application of corticosteroids. As with any long-term topical treatment of the nasal cavity, patients using Mecloma-F nasal spray 50 mcg over several months or longer should be examined periodically for possible changes in the nasal mucosa.
Impaired Wound Healing
Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal septum ulcers, nasal surgery, or nasal trauma should not use a nasal corticosteroid until healing has occurred.
Glaucoma and Cataracts
Nasal and inhaled corticosteroids may result in the development of glaucoma and/or cataracts. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.
Glaucoma and cataract formation was evaluated in one controlled study of 12 weeks' duration and one uncontrolled study of 12 months' duration in patients treated with Mecloma-F nasal spray, 50 mcg at 200 mcg/day, using intraocular pressure measurements and slit lamp examination. No significant change from baseline was noted in the mean intraocular pressure measurements for the 141 Mecloma-F nasal spray-treated patients in the 12-week study, as compared with 141 placebo-treated patients. No individual Mecloma-F nasal spray-treated patient was noted to have developed a significant elevation in intraocular pressure or cataracts in this 12-week study. Likewise, no significant change from baseline was noted in the mean intraocular pressure measurements for the 139 Mecloma-F nasal spray-treated patients in the 12-month study and again, no cataracts were detected in these patients. Nonetheless, nasal and inhaled corticosteroids have been associated with the development of glaucoma and/or cataracts.
Hypersensitivity Reactions
Hypersensitivity reactions including instances of wheezing may occur after the intranasal administration of Mecloma-F monohydrate. Discontinue Mecloma-F nasal spray if such reactions occur.
Immunosuppression
Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in nonimmune children or adults on corticosteroids. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. If chickenpox develops, treatment with antiviral agents may be considered.
Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculous infection of the respiratory tract, or in untreated fungal, bacterial, systemic viral infections, or ocular herpes simplex because of the potential for worsening of these infections.
Hypothalamic-Pituitary-Adrenal Axis Effect
Hypercorticism and Adrenal Suppression
When intranasal steroids are used at higher than recommended dosages or in susceptible individuals at recommended dosages, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. If such changes occur, the dosage of Mecloma-F nasal spray should be discontinued slowly, consistent with accepted procedures for discontinuing oral corticosteroid therapy.
Effect on Growth
Corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth routinely of pediatric patients receiving Mecloma-F nasal spray. To minimize the systemic effects of intranasal corticosteroids, including Mecloma-F nasal spray, titrate each patient's dose to the lowest dosage that effectively controls his/her symptoms.
What should I discuss with my healthcare provider before taking Mecloma-F?
Some medical conditions may interact with Mecloma-F cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have chickenpox, shingles, measles, or tuberculosis (TB), or have had a positive TB skin test or a recent vaccination
- if you have had a skin infection, thinning of the skin (atrophy), or a certain type of severe acne (rosacea)
- if you are taking an oral corticosteroid (eg, prednisone)
Some MEDICINES MAY INTERACT with Mecloma-F cream. Because little, if any, of Mecloma-F cream is absorbed into the blood, the risk of it interacting with another medicine is low.
This may not be a complete list of all interactions that may occur. Ask your health care provider if Mecloma-F cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Mecloma-F precautions
General: Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.
Patients applying a topical steroid to a large surface area or areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests.
In a study evaluating the effects of Mecloma-F ointment on the hypothalamicpituitary-adrenal (HPA) axis, 15 grams were applied twice daily for 7 days to six adult patients with psoriasis or atopic dermatitis. The ointment was applied without occlusion to at least 30% of the body surface. The results show that the drug caused a slight lowering of adrenal corticosteroid secretion.
If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur requiring supplemental systemic corticosteroids. For information on systemic supplementation, see Prescribing Information for those products.
Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios.
If irritation develops, Mecloma-F (Mecloma-F ointment) should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.
If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Mecloma-F (Mecloma-F ointment) should be discontinued until the infection has been adequately controlled.
Laboratory Tests: The following tests may be helpful in evaluating patients for HPA axis suppression:
ACTH stimulation test
A.M. plasma cortisol test
Urinary free cortisol test
Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential of ELOCON (Mecloma-F ointment) Ointment. Long-term carcinogenicity studies of Mecloma-F were conducted by the inhalation route in rats and mice. In a 2-year carcinogenicity study in Sprague-Dawley rats, Mecloma-F demonstrated no statistically significant increase of tumors at inhalation doses up to 67 mcg/kg (approximately 0.04 times the estimated maximum clinical topical dose from Mecloma-F (Mecloma-F ointment) on a mcg/m basis).
There are no adequate and well-controlled studies of teratogenic effects from topically applied corticosteroids in pregnant women. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Mecloma-F (Mecloma-F ointment) is administered to a nursing woman.
Pediatric Use: Mecloma-F (Mecloma-F ointment) may be used with caution in pediatric patients 2 years of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established. Use of Mecloma-F (Mecloma-F ointment) is supported by results from adequate and well-controlled studies in pediatric patients with corticosteroid-responsive dermatoses. Since safety and efficacy of Mecloma-F (Mecloma-F ointment) have not been adequately established in pediatric patients below 2 years of age, its use in this age group is not recommended.
Mecloma-F (Mecloma-F ointment) caused HPA axis suppression in approximately 27% of pediatric patients ages 6 to 23 months, who showed normal adrenal function by Cortrosyn test before starting treatment, and were treated for approximately 3 weeks over a mean body surface area of 39% (range 15% to 99%). The criteria for suppression were: basal cortisol level of δ5 mcg/dL, 30- minute post-stimulation level of δ18 mcg/dL, or an increase of < 7 mcg/dL. Follow-up testing 2 to 4 weeks after stopping treatment, available for 8 of the patients, demonstrated suppressed HPA axis function in 3 patients, using these same criteria. Long-term use of topical corticosteroids has not been studied in this population..
Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are, therefore, also at greater risk of glucocorticosteroid insufficiency during and/or after withdrawal of treatment. Pediatric patients may be more susceptible than adults to skin atrophy, including striae, when they are treated with topical corticosteroids. Pediatric patients applying topical corticosteroids to greater than 20% of body surface are at higher risk of HPA axis suppression.
HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids.
Manifestations of adrenal suppression in children include low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
ELOCON (Mecloma-F ointment) Ointment, 0.1%, should not be used in the treatment of diaper dermatitis.
Geriatrics Use: Clinical studies of Mecloma-F (Mecloma-F ointment) included 310 subjects who were 65 years of age and over and 57 subjects who were 75 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out.
What happens if I miss a dose of Mecloma-F?
Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.
References
- DailyMed. "FORMOTEROL FUMARATE; MOMETASONE FUROATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DrugBank. "fusidic acid". http://www.drugbank.ca/drugs/DB02703 (accessed September 17, 2018).
- DrugBank. "Mometasone". http://www.drugbank.ca/drugs/DB00764 (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
