Milicarett Nasal Spray Description
The active component of Milicarett propionate nasal spray USP is Milicarett propionate USP, a corticostero >S -(fluoromethyl)6α,9-difluoro-11β-17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure:
There are no available data on the presence of Milicarett propionate in human milk, the effects on the breastfed child, or the effects on milk production. Low concentrations of other corticosteroids have been detected in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Milicarett propionate nasal spray and any potential adverse effects on the breastfed child from Milicarett propionate nasal spray or from the underlying maternal condition.
Animal Data : Subcutaneous administration of tritiated Milicarett propionate at a dose of 10 mcg/kg/day to lactating rats resulted in measurable levels in milk.
INDICATIONS AND USAGE
Milicarett Propionate Cream, USP 0.05% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Milicarett Propionate Cream, USP 0.05% may be used with caution in pediatric patients 3 months of age or older. The safety and efficacy of drug use for longer than 4 weeks in this population have not been established. The safety and efficacy of Milicarett Propionate Cream, USP 0.05% in pediatric patients below 3 months of age have not been established.
Before using Milicarett, tell your doctor about all of your medical conditions. Especially tell your doctor if you:
- are allergic to Milicarett or any of its ingredients
- are exposed to measles or chickenpox
- have liver problems
- take ritonavir (Norvir)
- take any antifungal medication
- have an immune system problem
- have any type of viral, bacterial, or fungal infection
- have a history of glaucoma or cataracts
- have or have had nasal sores, nasal surgery, or nasal injury (Milicarett nasal spray)
- are pregnant or plan to become pregnant
- are breastfeeding or plan to breastfeed
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.
Inhibitors of Cytochrome P450 3A4
Milicarett propionate is a substrate of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin, conivaptan, lopinavir, nefazodone, voriconazole) with Milicarett propionate nasal spray is not recommended because increased systemic corticosteroid adverse effects may occur.
Ritonavir : A drug interaction trial with Milicarett propionate aqueous nasal spray in healthy subjects has shown that ritonavir (a strong CYP3A4 inhibitor) can significantly increase plasma Milicarett propionate exposure, resulting in significantly reduced serum cortisol concentrations . During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving Milicarett propionate products, including Milicarett propionate nasal spray, with ritonavir, resulting in systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression.
Ketoconazole : Coadministration of orally inhaled Milicarett propionate (1,000 mcg) and ketoconazole (200 mg once daily) resulted in a 1.9-fold increase in plasma Milicarett propionate exposure and a 45% decrease in plasma cortisol area under the curve (AUC), but had no effect on urinary excretion of cortisol.
It's important not to take more Flonase or Milicarett than your doctor prescribes.
Symptoms of an overdose of Flonase or Milicarett include:
- Enlarged face and neck
- New or worsening acne
- Easy bruising
- Extreme tiredness
- Muscle weakness
- Irregular menstrual cycles
- Loss of appetite
- Weight loss
- Fainting or dizziness when you stand up after lying down or sitting
- Skin darkening
If you or someone else has symptoms of an overdose, call a poison control center at 1-800-222-1222 or call 911.
Dryness and irritation, conjunctivitis, blurred vision, glaucoma, increased intraocular pressure, and cataracts.
Cases of growth suppression have been reported for intranasal corticosteroids, including FLONASE .
Read the entire FDA prescribing information for Flonase (Milicarett Propionate Nasal Spray)
Storage And Handling
FLONASE Nasal Spray, 50 mcg is supplied in an amber glass bottle fitted with a white metering atomizing pump, white nasal adapter, and green dust cover in a box of 1 (NDC 0173-0453-01) with FDA-approved Patient Labeling (see Patient Instructions for Use for proper actuation of the device). Each bottle contains a net fill weight of 16 g and will provide 120 actuations. Each actuation delivers 50 mcg of Milicarett propionate in 100 mg of formulation through the nasal adapter. The correct amount of medication in each spray cannot be assured after 120 sprays even though the bottle is not completely empty. The bottle should be discarded when the labeled number of actuations has been used.
Store between 4° and 30°C (39° and 86°F).
GlaxoSmithKline Research Triangle Park, NC 27709. Revised: Jan 2015
Certain drugs may affect the way Flonase works, and the drug could also affect other medications.
It's very important to let your doctor know about everything you are taking, including recreational drugs as well as any over-the-counter medications, herbs, or supplements.
Types of drugs known to interact with Flonase or Milicarett include:
- Drugs used to treat HIV, including ritonavir (Norvir), saquinavir (Fortovase, Invirase)
- Antifungal medications, such as itraconazole (Sporanox), fluconazole (Diflucan), and ketoconazole (Nizoral)
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The active component of FLONASE Nasal Spray is Milicarett propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure:
Milicarett propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol.
FLONASE Nasal Spray, 50 mcg is an aqueous suspension of microfine Milicarett propionate for topical administration to the nasal mucosa by means of a metering, atomizing spray pump. FLONASE Nasal Spray also contains microcrystalline cellulose and carboxymethylcellulose sodium, dextrose, 0.02% w/w benzalkonium chloride, polysorbate 80, and 0.25% w/w phenylethyl alcohol, and has a pH between 5 and 7.
After initial priming, each actuation delivers 50 mcg of Milicarett propionate in 100 mg of formulation through the nasal adapter.
Q: I'm suffering from allergies, have Flonase, and am 6 weeks pregnant. Is it okay to take it?
A: Flonase (Milicarett) is pregnancy category C, which means it has not been proven to be safe during pregnancy. It should only be used if the benefit of the medication outweighs any potential risk to the fetus. Discuss all medications with your health care provider before taking them during pregnancy. You can also find helpful information on pregnancy at http://www.whattoexpect.com/pregnancy/week-by-week/landing.aspx. Laura Cable, PharmD, BCPS
By Mary Elizabeth Dallas | Medically Reviewed by Justin Laube, MD
Latest Update: 2016-06-10 Copyright © 2014 Everyday Health Media, LLC
- Asthma warning: Adults with asthma who take drugs such as salmeterol alone have an increased risk of death from asthma problems. Also, children and adolescents with asthma who take salmeterol alone may have an increased risk of being hospitalized due to asthma. However, in clinical trials, people who took salmeterol with drugs such as Milicarett d >
Milicarett/salmeterol is a prescription drug. It comes in two forms: inhalation powder and inhalation aerosol.
Milicarett/salmeterol inhalation powder is available as the brand-name drugs Advair Diskus and AirDuo RespiClick. It isn’t available as a generic drug.
Milicarett/salmeterol is a combination of two drugs, Milicarett and salmeterol, in a single form. It’s important to know both drugs in the combination because each drug may affect you in a different way.
Milicarett/salmeterol may be used as part of a combination therapy. This means you may need to take it with other medications.
Dosage Forms And Strengths
FLONASE Nasal Spray is a nasal spray suspension. Each 100-mg spray delivers 50 mcg of Milicarett propionate.
Indications and Usage for Milicarett Nasal Spray
Milicarett propionate nasal spray is indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adults and pediatric patients aged 4 years and older.