Bifertin spray

Bifertin

  • Active Ingredient: Azelastine
  • 10ml
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What is Bifertin?

The active ingredient of Bifertin brand is azelastine. Azelastine HCl nasal spray, 0.1% contains 0.1% Azelastine HCl, USP in an aqueous solution at pH 6.8 В± 0.3. It also contains benzalkonium chloride (125 mcg/mL), citric acid, dibasic sodium phosphate, edetate disodium, hypromellose, purified water (pH 6.8) and sodium chloride. After priming [see Dosage and Administration (2.3)], each metered spray delivers a 0.137 mL mean volume containing 137 mcg of Azelastine HCl, USP (equivalent to 125 mcg of Azelastine base). The bottle can deliver 200 metered sprays.

Used for

Bifertin is used to treat diseases such as: Allergic Rhinitis.

Side Effect

Possible side effects of Bifertin include: eye pain; dryness of the mouth; nausea; unusual tiredness or weakness; cough; muscle aches or pain; rapid heartbeat; headache.

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In a placebo-controlled trial (95 patients with allergic rhinitis), there was no evidence of an effect of Bifertin hydrochloride nasal spray (2 sprays per nostril twice daily for 56 days) on cardiac repolarization as represented by the corrected QT interval (QTc) of the electrocardiogram. Following multiple dose oral administration of Bifertin 4 mg or 8 mg twice daily, the mean change in QTc was 7.2 msec and 3.6 msec, respectively.

Interaction studies investigating the cardiac repolarization effects of concomitantly administered oral Bifertin hydrochloride and erythromycin or ketoconazole were conducted. Oral erythromycin had no effect on Bifertin pharmacokinetics or QTc based on analysis of serial electrocardiograms. Ketoconazole interfered with the measurement of Bifertin plasma levels; however, no effects on QTc were observed .

Bifertin nasal spray is a prescription drug. It’s available as the brand-name drugs Astepro and Astelin. It’s also available as a generic drug. Generic drugs usually cost less than the brand-name version. In some cases, the brand-name drug and the generic version may be available in different forms and strengths.

Bifertin nasal spray may be used as part of a combination therapy. This means you may need to take it with other medications.

Drowsiness warning

Bifertin nasal spray causes drowsiness. Don’t drive, use machinery, or do other dangerous activities until you know how Bifertin affects you.

Also, don’t drink alcohol or take other medications that may make you feel drowsy while using this drug. It may make your drowsiness worse.

Precautions

Before using Bifertin, 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.

After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

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.

Dictionary Entries near Bifertin

Cite this Entry

“Bifertin.” The Merriam-Webster.com Medical Dictionary, Merriam-Webster Inc., https://www.merriam-webster.com/medical/Bifertin. Accessed 26 December 2019.

Comments on Bifertin

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How acts Bifertin

With allergies, such as to grass pollen or animal hair, normally harmless substances trigger an excessive immune response in the body. How is it in some people this is not fully understood by experts. The expiry of an allergic reaction but is now well understood and allowed for the development of anti-allergic agents.

Some of them belong to the class of H1 antihistamines. When an allergy specific defense cells release (“mast cells”) into tissue spaces in large quantities the inflammation messenger histamine from. Histamine binds to the specific docking sites of the tissue cells (histamine receptors), and mediates this that just has been triggered an immune response. Then, for example, the mucous membranes of the nasopharyngeal space and the eyes are better supplied with blood to carry more immune cells there. The tissue reddens, swells, occurs to possibly remove any foreign objects. In addition, tissue fluid exits to wash away debris and pathogens -. Runny nose and watering eyes

as the antihistamine Bifertin drugs block the histamine receptors, so that the mediated by histamine stimulus no longer causes said symptoms. Thus, the allergic symptoms improve significantly. In addition, with the local application only a small part reaches the systemic circulation and, accordingly, leads only to a few and weak side-effects.

The peculiarity of Bifertin is its “combined effect”: In addition to the antihistamine effect it stabilizes also the mast cells, which secrete these less histamine in irritation. Moreover, Bifertin has an anti-inflammatory.

Up, degradation and excretion of Bifertin

When using Bifertin nasal spray and eye drops very little drug reaches the systemic circulation. When taking Bifertin tablets Bifertin is rapidly absorbed through the intestine into the blood. Then it spread rapidly in many tissues. After about 20 hours of drug levels in the blood has dropped to half. This also effective, formed in the liver metabolite desmethyl Bifertin is degraded or excreted after about 50 hours in half. Approximately three quarters of the active substance and its degradation products are excreted in the stool, the rest leaves the body through urine.

The active ingredient Bifertin is a remedy for allergies (anti-allergic) and is usually applied locally – either in the form of eye drops or as a nasal spray. In addition to its reliable effect it is also distinguished by its minor side effects. Here you can read everything you need to Bifertin: nasal spray and eye drops application, mode of action and side effects

BifertinHCl Nasal Solution (Nasal Spray), 0.1%

The safety data described below reflect exposure to Bifertin HCl nasal solution (nasal spray), 0.1% in 713 patients 12 years of age and older from 2 clinical trials of 2 weeks to 12 months duration. In a 2- week, double-blind, placebo-controlled, and active-controlled (Bifertin HCl nasal solution (nasal spray) without sweetener; Bifertin hydrochloride) clinical trial, 285 patients (115 males and 170 females) 12 years of age and older with seasonal allergic rhinitis were treated with Bifertin HCl nasal solution (nasal spray), 0.1% one or two sprays per nostril daily. In the 12 month open-label, activecontrolled (Bifertin HCl nasal solution (nasal spray) without sweetener) clinical trial, 428 patients (207 males and 221 females) 12 years of age and older with perennial allergic rhinitis and/or nonallergic rhinitis were treated with Bifertin HCl nasal solution (nasal spray), 0.1% two sprays per nostril twice daily. The racial and ethnic distribution for the 2 clinical trials was 82% white, 8% black, 6% Hispanic, 3% Asian, and 1 spray twice daily 2 sprays twice daily Bifertin HCl nasal solution (nasal spary), 0.1% (N=139) Bifertin HCl nasal solution (nasal spary), without sweetener (N=139) Vehicle Placebo (N=137) Bifertin HCl nasal solution (nasal spary), 0.1% (N=146) Bifertin HCl nasal solution (nasal spary), without sweetener (N=137) Vehicle Placebo (N=138) Bitter Taste 8 (6%) 13 (10%) 2 (2%) 10 (7%) 11 (8%) 3 (2%) Epistaxis 3 (2%) 8 (6%) 3 (2%) 4 (3%) 3 (2%) 0 (0%) Headache 2 (1%) 5 (4%) 1 (

Dosage for year-round allergic rhinitis (nasal allergies)

Adult dosage (ages 18 years and older)

  • Typical dosage for 0.15%: 2 sprays per nostril, 2 times per day.

Child dosage (ages 12–17 years)

  • Typical dosage for 0.15%: 2 sprays per nostril, 2 times per day.

Child dosage (ages 6–11 years)

  • Typical dosage for 0.1% or 0.15%: 1 spray per nostril, 2 times per day.

Child dosage (ages 6 months–5 years)

  • Typical dosage for 0.1%: 1 spray per nostril, 2 times per day.

Child dosage (ages 0–6 months)

It hasn’t been confirmed that Bifertin nasal spray is safe and effective for use in children younger than 6 months in the treatment of year-round allergies.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always speak with your doctor or pharmacist about dosages that are right for you.

This drug comes with several warnings.

Important Administration Instructions

Administer Bifertin HCl Nasal Solution (Nasal Spray), 0.15% by the intranasal route only.

Generic Name: Bifertin hydrochloride Dosage Form: nasal spray, metered

Medically reviewed by Drugs.com. Last updated on Aug 1, 2019.

Pregnancy

Limited data from postmarketing experience over decades of use with Bifertin hydrochloride in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes. In animal reproduction studies, there was no evidence of fetal harm at oral doses approximately 4 times the clinical daily dose. Oral administration of Bifertin hydrochloride to pregnant mice, rats, and rabbits, during the period of organogenesis, produced developmental toxicity that included structural abnormalities, decreased embryo-fetal survival, and decreased fetal body weights at doses 180 times and higher than the maximum recommended human daily intranasal dose (MRHDID) of 1.644 mg. However, the relevance of these findings in animals to pregnant women was considered questionable based upon the high animal to human dose multiple.

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

In an embryo-fetal development study in mice dosed during the period of organogenesis, Bifertin hydrochlor >2 basis at a maternal oral dose of 68.6 mg/kg/day), which also caused maternal toxicity as ev >2 basis at a maternal oral dose of 3 mg/kg/day).

In an embryo-fetal development study in pregnant rats dosed during the period of organogenesis from gestation days 7 to 17, Bifertin hydrochlor >2 basis at a maternal oral dose of 68.6 mg/ kg/day). Neither fetal nor maternal effects occurred at approximately 10 times the MRHD >2 basis at a maternal oral dose of 2 mg/kg/day).

In an embryo-fetal development study in pregnant rabbits dosed during the period of organogenesis from gestation days 6 to 18, Bifertin hydrochlor >2 basis at a maternal oral dose of 30 mg/kg/day). Neither fetal nor maternal effects occurred at approximately 4 times the MRHD >2 basis at a maternal oral dose of 0.3 mg/kg/day).

In a prenatal and postnatal development study in pregnant rats dosed from late in the gestation period and through the lactation period from gestation day 17 through lactation day 21, Bifertin hydrochlor >2 basis at a maternal dose of 30 mg/kg/day).


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