Rinosone

Rinosone

  • Active Ingredient: Fluticasone
  • 50mcg
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What is Rinosone?

The active ingredient of Rinosone brand is fluticasone. Fluticasone propionate has a molecular weight of 500.6. It is a white to off-white powder and is insoluble in water. Each gram of Fluticasone Propionate Cream, USP 0.05% contains Fluticasone propionate 0.5 mg in a base of propylene glycol, mineral oil, cetostearyl alcohol, Ceteth-20, isopropyl myristate, dibasic sodium phosphate, citric acid, purified water, and methylparaben as preservative.

Used for

Rinosone is used to treat diseases such as: Asthma, Maintenance, Bronchopulmonary Dysplasia, Eosinophilic Esophagitis.

Side Effect

Possible side effects of Rinosone include: lower abdominal or stomach pain; high blood pressure; muscle soreness, sprain, or strain; headache, severe and throbbing; fruit-like breath odor; unusual tiredness or weakness; bruising.

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Pharmacodynamics

HPA Axis Effect : The potential systemic effects of Rinosone propionate nasal spray on the HPA axis were evaluated. Rinosone propionate nasal spray given as 200 mcg once daily or 400 mcg twice daily was compared with placebo or oral prednisone 7.5 or 15 mg given in the morning. Rinosone propionate nasal spray at either dosage for 4 weeks did not affect the adrenal response to 6-hour cosyntropin stimulation, while both dosages of oral prednisone significantly reduced the response to cosyntropin.

Cardiac Electrophysiology : A study specifically designed to evaluate the effect of Rinosone propionate nasal spray on the QT interval has not been conducted.

Why it's used

Rinosone/salmeterol contains two drugs that work in different ways to treat asthma and chronic obstructive pulmonary disease (COPD).

COMMON BRAND(S): Xhance

GENERIC NAME(S): Rinosone Propionate

Rinosone is used to treat certain growths in the nose (nasal polyps). It belongs to a class of drugs known as corticosteroids. Rinosone works by reducing swelling (inflammation) in the nasal passages. This can help decrease symptoms such as stuffy nose.

Generic Name: Rinosone propionate Dosage Form: cream

Medically reviewed by Drugs.com. Last updated on Sep 1, 2018.

Q: Can I use Flonase for hay fever?

A: According to drug information, Flonase (Rinosone) is approved by the U.S. Food and Drug Administration (FDA) for the management of seasonal and perennial allergic rhinitis and nonallergic rhinitis. Therefore, yes it is used for hay fever allergies. For additional information regarding allergies. //www.everydayhealth.com/allergies/guide/ Jen Marsico, RPh

QUESTION

DRUG INTERACTIONS: This drug should not be used with the following medications because very serious interactions may occur: aldesleukin, mifepristone. If you are currently using any of these medications, tell your doctor or pharmacist before starting Rinosone. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: oral corticosteroids (e.g., prednisone, dexamethasone), drugs affecting the removal of Rinosone from your system (potent CYP 3A4 inhibitors such as ketoconazole, ritonavir). Do not start or stop any medicine without doctor or pharmacist approval.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: Do not share this medication with others. Learn to use a peak flow meter. Use it daily and promptly report worsening asthma (such as readings in the yellow or red range, or increased use of quick-relief inhalers). Tell your doctor or pharmacist if you need to use 4 or more puffs daily for 2 or more consecutive days or more than 1 inhaler (200 puff canister) every 8 weeks of your quick-relief inhaler. Make sure all of your doctors know that you are using this medication or have used it in the past. Laboratory and/or medical tests (e.g., cortisol levels, lung function, eye exam) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store the US product at room temperature between 36-86 degrees F (2-30 degrees C). Store the Canadian product at room temperature between 59-86 degrees F (15-30 degrees C). Store the medication away from light and moisture. Avoid freezing. Do not puncture or expose this medication to high heat or open flame. Keep all medicines away from children and pets.

Precautions

Before using Rinosone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: recent nose problems (such as injury, ulcers, surgery), infections (including tuberculosis, herpes eye infection), certain eye problems (glaucoma, cataracts), liver disease.

Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Rarely, using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months.

Though it is unlikely, this medication may slow down a child's growth if used for a long time. The effect on final adult height is unknown. See the doctor regularly so your child's height can be checked.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Pregnancy

There are insufficient data on the use of Rinosone propionate nasal spray in pregnant women to inform a drug-associated risk. In animals, teratogenicity characteristic of corticostero >2 basis, respectively. ( See Animal Data. ) However, Rinosone propionate administered via nose-only inhalation to rats decreased fetal body weight, but d >2 basis. ( See Animal Data. ) Experience with oral corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroids than humans.

The estimated risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Human Data: Following inhaled administration, Rinosone propionate was detected in the neonatal cord blood after delivery.

Animal Data: In embryofetal development studies with pregnant rats and mice dosed by the subcutaneous route throughout the period of organogenesis, Rinosone propionate was teratogenic in both species. Omphalocele, decreased body weight, and skeletal variations were observed in rat fetuses, in the presence of maternal toxicity, at a dose approximately 5 times the MRHD >2 basis with a maternal subcutaneous dose of 100 mcg/kg/day). The rat no observed adverse effect level (NOAEL) was observed at approximately equivalent to the MRHD >2 basis with a maternal subcutaneous dose of 30 mcg/kg/day). Cleft palate and fetal skeletal variations were observed in mouse fetuses at a dose approximately equivalent to the MRHD >2 basis with a maternal subcutaneous dose of 45 mcg/kg/day). The mouse NOAEL was observed with a dose approximately 0.3 times the MRHD >2 basis with a maternal subcutaneous dose of 15 mcg/kg/day).

In an embryofetal development study with pregnant rats dosed by the nose-only inhalation route throughout the period of organogenesis, Rinosone propionate produced decreased fetal body weights and skeletal variations, in the presence of maternal toxicity, at a dose approximately equivalent to the MRHD >2 basis with a maternal nose-only inhalation dose of 25.7 mcg/kg/day); however, there was no ev >2 basis with a maternal nose-only inhalation dose of 5.5 mcg/kg/day).

In an embryofetal development study in pregnant rabbits that were dosed by the subcutaneous route throughout organogenesis, Rinosone propionate produced reductions of fetal body weights, in the presence of maternal toxicity, at doses approximately 0.06 times the MRHD >2 basis with a maternal subcutaneous dose of 0.57 mcg/kg/day). Teratogenicity was ev >2 basis with a maternal subcutaneous dose of 4 mcg/kg/day). The NOAEL was observed in rabbit fetuses with a dose approximately 0.01 times the MRHD >2 basis with a maternal subcutaneous dose of 0.08 mcg/kg/day).

Rinosone propionate crossed the placenta following subcutaneous administration to mice and rats and oral administration to rabbits.

In a pre- and post-natal development study in pregnant rats dosed from late gestation through delivery and lactation (Gestation Day 17 to Postpartum Day 22), Rinosone propionate was not associated with decreases in pup body weight, and had no effects on developmental landmarks, learning, memory, reflexes, or fertility at doses up to 2 times the MRHD >2 basis with maternal subcutaneous doses up to 50 mcg/kg/day).

Pharmacokinetics

The activity of FLONASE Nasal Spray is due to the parent drug, Rinosone propionate. Due to the low bioavailability by the intranasal route, the majority of the pharmacokinetic data was obtained via other routes of administration.


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