Fluxal

Fluxal

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

The active ingredient of Fluxal 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

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

Side Effect

Possible side effects of Fluxal include: fast heartbeat; flushed, dry skin; bone fractures; ear ache; Diarrhea; impotence in males.

How to Buy Fluxal online?

To buy Fluxal online - just click on the "Buy Now" button from the top and follow on to our store. Payment and Order takes a couple of minutes, and all steps are obvious. We do not take a medical prescription plus also we have many procedures of payment. Considering all the details of fast shipping and confidentiality, then you may read on the applicable pages on the hyperlinks from the top menu.

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CONTRAINDICATIONS

FLONASE (Fluxal propionate) Nasal Spray is contraindicated in patients with a hypersensitivity to any of its ingredients.

Pregnancy

There are insufficient data on the use of Fluxal 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, Fluxal 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, Fluxal 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, Fluxal 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, Fluxal 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, Fluxal 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).

Fluxal 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), Fluxal 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).

Dosage Forms and Strengths

Fluxal propionate nasal spray USP is an aqueous suspension. Each 100 mg spray delivers 50 mcg of Fluxal propionate USP.

How it works

Fluxal belongs to a class of drugs called inhaled corticosteroids. Salmeterol belongs to a class of drugs called long-acting beta-adrenergic agonists. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

Fluxal helps decrease inflammation in your lungs to help you breathe better.

Salmeterol helps the muscles around the airways in your lungs stay relaxed. This prevents symptoms such as wheezing, cough, chest tightness, and shortness of breath. This can help you breathe better.

Lactation

There are no available data on the presence of Fluxal 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 Fluxal propionate nasal spray and any potential adverse effects on the breastfed child from Fluxal propionate nasal spray or from the underlying maternal condition.

Animal Data : Subcutaneous administration of tritiated Fluxal propionate at a dose of 10 mcg/kg/day to lactating rats resulted in measurable levels in milk.

Pregnancy Category C. There are no adequate and well-controlled trials with FLONASE Nasal Spray in pregnant women. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Because animal reproduction studies are not always predictive of human response, FLONASE Nasal Spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Women should be advised to contact their physicians if they become pregnant while taking FLONASE Nasal Spray.

Mice and rats at Fluxal propionate doses approximately 1 and 4 times, respectively, the maximum recommended human daily intranasal dose (MRHDID) for adults (on a mg/m² basis at maternal subcutaneous doses of 45 and 100 mcg/kg/day, respectively) showed fetal toxicity characteristic of potent corticosteroid compounds, including embryonic growth retardation, omphalocele, cleft palate, and retarded cranial ossification. No teratogenicity was seen in rats at doses up to 3 times the MRHDID (on a mg/m² basis at maternal inhalation doses up to 68.7 mcg/kg/day).

In rabbits, fetal weight reduction and cleft palate were observed at a Fluxal propionate dose approximately 0.3 times the MRHDID for adults (on a mg/m² basis at a maternal subcutaneous dose of 4 mcg/kg/day). However, no teratogenic effects were reported at Fluxal propionate doses up to approximately 20 times the MRHDID for adults (on a mg/m² basis at a maternal oral dose up to 300 mcg/kg/day). No Fluxal propionate was detected in the plasma in this study, consistent with the established low bioavailability following oral administration .

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

Experience with oral corticosteroids since their introduction in pharmacologic, as opposed to physiologic, doses suggests that rodents are more prone to teratogenic effects from corticosteroids than humans. In addition, because there is a natural increase in corticosteroid production during pregnancy, most women will require a lower exogenous corticosteroid dose and many will not need corticosteroid treatment during pregnancy.

Inhibitors of Cytochrome P450 3A4

Fluxal 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 Fluxal propionate nasal spray is not recommended because increased systemic corticosteroid adverse effects may occur.

Ritonavir : A drug interaction trial with Fluxal propionate aqueous nasal spray in healthy subjects has shown that ritonavir (a strong CYP3A4 inhibitor) can significantly increase plasma Fluxal propionate exposure, resulting in significantly reduced serum cortisol concentrations . During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving Fluxal propionate products, including Fluxal propionate nasal spray, with ritonavir, resulting in systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression.

Ketoconazole : Coadministration of orally inhaled Fluxal propionate (1,000 mcg) and ketoconazole (200 mg once daily) resulted in a 1.9-fold increase in plasma Fluxal propionate exposure and a 45% decrease in plasma cortisol area under the curve (AUC), but had no effect on urinary excretion of cortisol.

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Inhalational:

  • Common side effects of Fluxal inhalational include
    • upper airway infection or inflammation
    • throat irritation
    • sinus infection
    • hoarse voice
    • candidiasis
    • cough
    • headache

Topical:

  • Common side effects of Fluxal nasal spray include
    • headache
    • nosebleeds
    • irritated or burning nose
    • runny nose
    • cough
    • nausea
    • stomach pain
    • vomiting
    • diarrhea
    • dizziness

Stinging or sneezing may occur for a few seconds right after use of Fluxal nasal spray.

  • Common s >abnormal amount of hair growth over the body (hypertrichosis)

This is not a complete list of Fluxal side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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COMMON BRAND(S): Xhance

GENERIC NAME(S): Fluxal Propionate

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

home drugs a-z list Flonase(Fluxal Propionate Nasal Spray) side effects drug center

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Flonase (Fluxal) is a synthetic steroid of the glucocorticoid family of drugs and is prescribed for the control of symptoms of allergic and non-allergic rhinitis. Flonase is available as a generic drug, and dosing is usually administered as two sprays in each nostril once daily, or one spray in each nostril twice daily. The most common side effects of Flonase (Fluxal) include:

  • headache,
  • back pain,
  • sore throat,
  • sneezing,
  • cough,
  • nausea,
  • vomiting,
  • menstrual problems,
  • loss of interest in sex,
  • nosebleeds,
  • sinus pain, and
  • sores or white patches inside mouth or around your nose.

Flonase has also been associated with hypersensitivity reactions (for example, skin rash, itching, facial swelling, and anaphylaxis).

The recommended starting dosage of Flonase in adults is 2 sprays (50 mcg of Fluxal propionate each) in each nostril once daily (total daily dose, 200 mcg). Drug interactions and warnings include Norvir (ritonavir) and Nizoral (ketoconazole). Taking either one of these drugs with Flonase may increase the blood concentrations of Flonase and potentially increase its side effects. Flonase should only be used during pregnancy when it is absolutely necessary. There have not been adequate studies of Flonase and concentrations in breast milk; therefore, Flonase should be avoided while breastfeeding unless it is absolutely necessary.

Our Flonase Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Pharmacodynamics

HPA Axis Effect : The potential systemic effects of Fluxal propionate nasal spray on the HPA axis were evaluated. Fluxal 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. Fluxal 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 Fluxal propionate nasal spray on the QT interval has not been conducted.


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