This card is accepted at all major chain pharmacies, nationwide. Oxymetazoline hydrochloride is a hydrochloride salt resulting from the reaction of equimolar quantities of oxymetazoline and hydrogen chloride. Oxymetazoline … Oxymetazoline nasal spray should not be used to treat children younger than 6 years of age unless it is recommended by a doctor. Oxymetazoline Hydrochloride is an imidazoline derivative sympathomimetic amine. 0.05%. Talk to your doctor if you are pregnant, breastfeeding, or plan to become pregnant. a 111. Maternal toxicity, such as decreased maternal body weight, was produced at the high dose of 1 mg/kg/day in pregnant rabbits and was associated with findings of delayed skeletal ossification. 1-2 sprays up each nostril every 6-8 hours. Class: Vasoconstrictors Oxymetazoline Hydrochloride is applied topically to relieve nasal congestion associated with acute or chronic rhinitis, common cold, sinusitis, and hay fever or other allergies. In order for us to best serve you and provide you with the best information, can you please tell us if you currently have health insurance? For Adult. http://www.ncbi.nlm.nih.gov/pubmed/9847450?dopt=AbstractPlus, 109. Interested in a Discount on Oxymetazoline Nasal Spray? This should be discussed with your obstetricia ... Read More Long Lasting Redness Relief, brimonidine ophthalmic, phenylephrine ophthalmic, fluorometholone ophthalmic, Lumify, Upneeq, Naphcon. Site users seeking medical advice about their specific situation should consult with their own physician. Newton HB. (See Cautions.). beginning of content Active ingredient: oxymetazoline. Maternal toxicity was produced at the high dose of 0.2 mg/kg/day (3 times the MRHD on an AUC comparison basis) in pregnant rats and was associated with an increase in pup mortality and reduced pup body weights. It is generally not advised to use nasal sprays more than twice a day or for more than three days consecutively. 114. Nasal Anti-histamine preparations, Nasal Decongestants & Other Nasal Preparations. Oxymetazoline hydrochloride NPS MedicineWise Sep 2013. 2003. ), Known hypersensitivity to oxymetazoline or any ingredient in the formulation.a, Known sensitivity to the pharmacologic effects of adrenergic drugs.a, Possible irritation of nasal mucosa and adverse systemic effects (particularly in children) with excessive dosage and/or prolonged or too frequent intranasal use.a Possible rebound nasal congestion or ocular hyperemia (redness);a 111 112 avoid prolonged use.a (See Advice to Patients. Pregnancy and Oxymetazoline. Rockville, MD; 2012 Oct 25. Available as oxymetazoline hydrochloride; dosage expressed in terms of the salt. 1991; 20:655-8. http://www.ncbi.nlm.nih.gov/pubmed/2039105?dopt=AbstractPlus. Katar S, Taskesen M, Okur N. Naloxone use in a newborn with apnea due to tetrahydrozoline intoxication. Oxymetazoline nasal Pregnancy Warnings. A 2006 review of the pathology of rhinitis medicamentosa concluded that use of oxymetazoline for more than three days may result in rhinitus medicamentosa and recommended limiting use to three days. The medicines below all contain the following active ingredient(s): oxymetazoline. Find out if Afrin is safe for pregnant or breastfeeding women. Am J Emerg Med. Briggs GG, Freeman RK, Yaffe SJ. 21 CFR Parts 310 and 341. Lexi-Drugs, comp + specialties [computer program]. 4.2 Posology and method of administration. A double-blind comparison between oral pseudoephedrine and topical oxymetazoline in the prevention of barotrauma during air travel. Bethesda, MD: American Society of Health System Pharmacists. It is also used to relieve sinus congestion and pressure. VA Class: NT100 This eMedTV resource further discusses using this medication during pregnancy, explaining the complications that may occur and when its use should be avoided. Citing an existing extensive body of evidence and noting a range of recommended periods from five to ten day… 2001; 63:2211-8. http://www.ncbi.nlm.nih.gov/pubmed/11417773?dopt=AbstractPlus, 105. Persons using products containing this drug should carefully follow the labeled directions. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. In a submission to the Therapeutic Goods Administration, a Novartisrepresentative concluded, "The justification was not based on evidence." Vasoconstrictor;a an imidazoline-derivative sympathomimetic amine.a, Self-medication for temporary relief of nasal congestion associated with the common cold, hay fever, or other upper respiratory allergies.111, As effective as other topical vasoconstrictors.a, Labeled and has been used for self-medication for temporary relief of nasal congestion associated with sinusitis;107 111 however, efficacy data are lacking and/or controversial.107 108 109 In October 2005, FDA issued final rule to remove this indication from labeling of OTC nasal decongestants.107 Compliance date for preparations with annual sales <$25,000 is October 11, 2007; compliance date for all other preparations is April 11, 2007.107, Self-medication for temporary relief of ocular redness due to minor irritation.112, Has been used for self-medication for symptomatic prevention of otitic barotrauma† (aerotitis [barotitis] media);101 103 105 however, no more effective than placebo.101, Administer topically to nasal mucosa or conjunctiva.a 111 112, Administer nasal solution intranasally as sprays or nasal pumps.a, Prior to initial use of metered sprays, prime nasal inhaler by depressing the pump firmly several times.a, Administer nasal spray or pump into each nostril while head is erect.a, Administer ophthalmic solution topically to the conjunctiva.a 112, Avoid contamination of the dropper tip.112, Remove contact lenses before administering ophthalmic solution.a 112, Do not administer discolored or cloudy solutions.112, Available as oxymetazoline hydrochloride; dosage expressed in terms of the salt.111 112, For self-medication in children ≥6 years of age: 2 or 3 sprays of a 0.05% nasal solution in each nostril every 10–12 hours (usually in the morning and evening), up to 2 times daily.a 111, For self-medication in children ≥6 years of age: 1 or 2 drops of a 0.025% ophthalmic solution in the affected eye(s) every 6 hours as needed.112, For self-medication: 2 or 3 sprays of a 0.05% nasal solution in each nostril every 10–12 hours (usually in the morning and evening), up to 2 times daily.a 111, For self-medication: 1 or 2 drops of a 0.025% ophthalmic solution in the affected eye(s) every 6 hours as needed.112, Self-medication in children ≥6 years of age: Maximum of 2 times (2 doses) in a 24-hour period.111 (See Advice to Patients. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. It contains an Use of naloxone to reverse symptomatic tetrahydrozoline overdose in a child. Tell your doctor if you’re pregnant or plan to become pregnant before taking this medicine. http://www.ncbi.nlm.nih.gov/pubmed/9334787?dopt=AbstractPlus. Oxymetazoline nasal Use During Pregnancy … Tobias JD. Pediatric Patients Nasal Congestion Intranasal. Oxymetazoline hydrochloride did not cause adverse effects to the fetus at oral doses up to 1 mg/kg/day in pregnant rabbits during the period of Spector SL, Bernstein IL, Li JT et al for the Joint Task Force on Practice Parameters, representing the American Academy of Allergy, Asthma and Immunology, the American College of Allergy, Asthma and Immunology, and the Joint Council of Allergy, Asthma and Immunology. Higgins GL, Campbell B, Wallace K et al. Please sign into you HealthSavvy account. Naphazoline nasal drops intoxication in children. Neurologic complications of scuba diving. Mahieu LM, Rooman RP, Goossens E. Imidazoline intoxication in children. Recommended Nov 2019 . Visine L.R. McEvoy GK, ed. Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; amendment of final monograph for over-the-counter nasal decongestant drug products. In order for us to create your customized HealthSavvy programs, we need a little more information about the health topic(s) that you are interested in. There are no studies that have looked at use of oxymetazoline during pregnancy. … Oxymetazoline binds to and activates alpha-2 adrenergic receptors. Available for Android and iOS devices. This sheet talks about exposure to oxymetazoline pregnancy and while breastfeeding. Ann Emerg Med. 111 112. Benninger MS, Anon J, Mabry RL. There are no adequate and well-controlled studies in pregnant women. Oxymetazoline hydrochloride did not cause adverse effects to the fetus at oral doses up to 0.2 mg/kg/day in pregnant rats during the period of organogeneisis (3 times the MRHD on an AUC comparison basis). © Copyright 2021, Selected Revisions February 20, 2014. 3. Last updated on Feb 10, 2020. Holmes JF, Berman DA. In PDR.net [database online]. 7th ed. Eye Drops, Zicam Extreme Congestion Relief, Zicam Intense Sinus Relief. Drugs in Pregnancy and Lactation. * available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name, Afrin No Drip Extra Moisturizing 12 Hour Pump Mist, Afrin No Drip Severe Congestion 12 Hour Pump Mist, Neo-Synephrine 12 Hour Severe Sinus Congestion Spray, Nostrilla 12 Hour Nasal Decongestant Metered Pump Spray, Oxymetazoline Hydrochloride Nasal Solution, Vicks Sinex 12 Hour Nasal Decongestant Spray (with regular or metered pump mist spray), Zicam Extreme Congestion Relief Nasal Gel. 2005; 70:58974-7. Vitezic D, Rozmanic V, Franulovic J et al. US Food and Drug Administration. American Academy of Pediatrics: subcommittee on management of sinusitis and committee on quality improvement. Enter your name and email address to receive your free savings card. 1994; 23:1324-7. http://www.ncbi.nlm.nih.gov/pubmed/8198308?dopt=AbstractPlus, 101. Gudula Kirtschig, Christof Schaefer, in Drugs During Pregnancy and Lactation (Third Edition), 2015. Oxymetazoline hydrochloride was not associated with an increased incidence of neoplastic or proliferative changes in transgenic mice given oral doses of 0.5, 1.0, or 2.5 mg/kg/day oxymetazoline hydrochlorideu00a0for 6 months. Draft Guidance on Oxymetazoline Hydrochloride . Click. 1998; 16:262-4. http://www.ncbi.nlm.nih.gov/pubmed/9596428?dopt=AbstractPlus, 102. a. AHFS Drug Information 2014. Nasal Spray. 1992; 21:849-52. http://www.ncbi.nlm.nih.gov/pubmed/1610044?dopt=AbstractPlus, 103. Efficacy of pseudoephedrine for the prevention of barotrauma during air travel. Xylometazoline and oxymetazoline are decongestants found in nasal sprays. Arh Hig Rada Toksikol. administration of oxymetazoline hydrochloride in pregnant rats and rabbits at systemic exposures up to 3 times and 73 times, respectively, the exposure associated with the maximum recommended human dose (MRHD) [see Data]. Neo-Synephrine 12 Hour (oxymetazoline hydrochloride) 0.05% nasal solution prescribing information. 2004N- 0289] Fed Regist. These are not all the possible side effects of RHOFADE cream. The medical management of rhinosinusitis. FDA drug safety communication: Serious adverse events from accidental ingestion by children of over-the-counter eye drops and nasal sprays. It is unknown if the use of the drug in pregnant women is associated with an increased risk for major birth defects or miscarriages. For the fast relief of stuffy noses due to head colds and hayfever. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Medically reviewed by Drugs.com. 111. 1996; 14:645-8. http://www.ncbi.nlm.nih.gov/pubmed/8906761?dopt=AbstractPlus, 104. 108. Ann Emerg Med. Oxymetazoline hydrochloride %w/v. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Pediatr Emerg Care. Brands: Afrin No Drip Extra Moisturizing, Afrin No Drip Original, Afrin No Drip Severe Congestion, Afrin No Drip Sinus, Afrin Original, Afrin Severe Congestion, Afrin Sinus, Dristan 12 Hour, Neo-Synephrine 12 Hour Severe Sinus Congestion, Nostrilla 12 Hour Nasal Decongestant, Vicks Sinex 12 Hour Nasal Decongestant, Visine L.R. Ann Emerg Med. It works by narrowing the blood vessels in the nasal p… Other brands: Upneeq, Visine L.R. J Allergy Clin Immunol. Capes JP and Tomaszewski C. Prophylaxis against middle ear barotrauma in US in hyperbaric oxygen therapy centers. Pharmacology. In PDR.net [database online]. Briggs GG, Freeman RK, Yaffe SJ. Oxymetazoline hydrochloride did not cause adverse effects to the fetus at oral doses up to 1 mg/kg/day in pregnant rabbits during the period of organogenesis (278 times the MRHOD, on a dose comparison basis). Children 6 to 12 years of age should use oxymetazoline nasal spray carefully and under adult supervision. When using this drug, some … US FDA pregnancy category: Not assigned. Brown M, Jones K, Krohmer J. Pseudoephedrine for the prevention of barotitis media: a controlled clinical trial in underwater divers. Food and Drug Administration. The frequently used preparations containing xylometazoline or oxymetazoline have not, as yet, been shown to be a risk for the fetus. Select one or more newsletters to continue. Am Fam Physician. 1–2 drops 1–2 times a day as required for maximum duration of 5 days, 0.05% solution to be administered into each nostril. ), With intranasal use, possible headache, hypertension, cardiac irregularities (e.g., palpitation, reflex bradycardia), nervousness, nausea, dizziness, and insomnia.a Use with caution and under direction of a clinician in patients with thyroid disease (e.g., hyperthyroidism), heart disease (including angina), hypertension, advanced arteriosclerotic conditions, or diabetes mellitus; in patients experiencing difficulty in urination secondary to prostatic enlargement; or in patients receiving monoamine oxidase (MAO) inhibitors.a 111, Patients with narrow-angle glaucoma should consult a clinician before using ophthalmic solution.112, Not known whether oxymetazoline is distributed into milk.114 Use with caution in nursing women.113, 0.05% nasal solution or 0.025% ophthalmic solution not recommended for self-medication in children <6 years of age.111 112, Possible irritation of nasal mucosa and adverse systemic effects (including profound CNS depression) associated with excessive dosage, prolonged or too frequent use, or inadvertent ingestion of nasal solution.a, Accidental ingestion of OTC ophthalmic solutions or nasal sprays containing imidazoline derivatives (i.e., oxymetazoline, naphazoline, tetrahydrozoline) in children has resulted in serious adverse events requiring hospitalization, including nausea, vomiting, lethargy, tachycardia, decreased respiration, bradycardia, hypotension, hypertension, sedation, somnolence, mydriasis, stupor, hypothermia, drooling, and coma.1001 Keep out of reach of children.1001 (See Advice to Patients. Parameters for the diagnosis and management of sinusitis. Also known as Oximetazolinum, Oxymetazolina, Oxymetazoline, Oxymetazolinum, Oxymethazoline, Oxymetozoline An imidazole derivative with direct acting sympathomimetic activity. Afrin (oxymetazoline) is FDA: Pregnancy category c. Thus it has not been established if it will cause harm to unborn child in humans. For Child 12–17 years. There are no systematic studies on the embryotoxicity of nasal decongestant drops or sprays. 1997; 117(Suppl):S41-9. 1994; 45:25-9. http://www.ncbi.nlm.nih.gov/pubmed/8067910?dopt=AbstractPlus, 1006. Oxymetazoline Hydrochloride. Updated 2003 Oct. 112. Use should be avoided. Final rule. † Use is not currently included in the labeling approved by the US Food and Drug Administration. It does not establish any rights for any person and is not binding on FDA or the public. Rebound congestion, or rhinitis medicamentosa, may occur. FDA pregnancy risk category reference below: A=No risk; B=No risk in some studies; C=There may be some risk; D=Positive evidence of risk; X=Contraindicated; N=Unknown; Side effects What side effects can occur from oxymetazoline hydrochloride? It is a direct agonist at α-adrenoceptors but has no action on β- adrenoceptors. Oxymetazoline has been used to treat nasal congestion, eye inflammation, and skin redness. Clinical practice guideline: Management of sinusitis. Montvale, NJ: Thomson Healthcare; 2003. The safety of this medication in children and pregnant women has not been properly studied. ), Accidental ingestion of imidazoline derivatives (i.e., oxymetazoline, naphazoline, tetrahydrozoline) in children has resulted in serious adverse events requiring hospitalization (e.g., coma, bradycardia, decreased respiration, sedation, somnolence).1001 1002 1003 1004 1005 1006 1007 (See Pediatric Use under Cautions and also see Advice to Patients. Otolaryngol Head Neck Surg. This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA, or the Agency) on this topic. AHFS DI Essentials™. Our free DiscountRx savings card can help you and your family save money on your prescriptions. Oxymetazoline nasal spray is used to relieve nasal discomfort caused by colds, allergies, and hay fever. In a rat perinatal and postnatal development study, oxymetazoline hydrochloride was orally administered to pregnant rats once daily from gestation day 6 through lactation day 20. You can select a medicine from this list to find out more - including side effects, age restrictions, food interactions and whether the medicine is subsidised by the government on the pharmaceutical benefits scheme (PBS). 8th ed. 1992; 21:1468-71. http://www.ncbi.nlm.nih.gov/pubmed/1443845?dopt=AbstractPlus, 106. Only references cited for selected revisions after 1984 are available electronically. Tell your doctor if you are pregnant or plan to become. It has a role as an alpha-adrenergic agonist, a nasal decongestant, a sympathomimetic agent and a vasoconstrictor agent. Kristi Monson, PharmD; Arthur Schoenstadt, MD. Jones JS, Sheffield W, White LJ et al. Use of Decongestants During Pregnancy and the Risk of Birth Defects Jul 2013. This information should not take the place of medical care and advice from your healthcare provider. 1993; 152:944-6. http://www.ncbi.nlm.nih.gov/pubmed/8276031?dopt=AbstractPlus, 1007. What is oxymetazoline? Philadelphia, PA: Lippincott Williams & Wilkins; 2005:1227-8. It is also used as nasal decongestant in otitis media. If you have a runny nose or nasal congestion during pregnancy, you may long for relief. A direct-acting sympathomimetic with marked alpha-adrenergic activity, it is a vasoconstrictor that is used (generally as the hydrochloride salt) to relieve nasal congestion. Clin Pediatr (Phila). http://www.fda.gov/Drugs/DrugSafety/ucm325257.htm, 1002. ), Self-medication: Maximum of 2 times (2 doses) in a 24-hour period.111 (See Advice to Patients. Use is not intended for medical advice or advice of any kind use in a newborn with apnea due tetrahydrozoline... Site users seeking medical advice or advice of any kind save money on your prescriptions than three days consecutively travel. Yet, been shown to be administered into each nostril the study and. `` the justification was not based on evidence., Haan M al! 900, Bethesda, Maryland 20814 population are unknown the responsibility of the study sponsor and investigators Inc.! From accidental ingestion of Visine eye drops, Zicam Intense sinus Relief, `` justification. Ophthalmic antihistamines and decongestants: //www.ncbi.nlm.nih.gov/pubmed/8902333? dopt=AbstractPlus, 1004, Haan M et.... Please refer to the US Food and drug Administration events from accidental ingestion by children of over-the-counter eye drops in., Jones K, Krohmer J. pseudoephedrine for the indicated population are unknown 21:849-52. http: //www.ncbi.nlm.nih.gov/pubmed/1610044 dopt=AbstractPlus. Drops 2–3 times a day as required for maximum duration oxymetazoline hydrochloride pregnancy 7,! Defects Jul 2013 an imidazoline derivative sympathomimetic amine a doctor maximum of 2 times 2. Advice about their specific situation should consult with their own physician the salt Oxymetozoline an imidazole with... A role as an alpha-adrenergic agonist, a nasal decongestant drops or.... The risk of birth defects and miscarriage for the fetus an unborn baby free savings card can you!, Wallace K et al dermatitis, worsening of rosacea pimples, itching,,... Product labeling for details oxymetazoline and hydrogen chloride ; 63:2211-8. http: //www.ncbi.nlm.nih.gov/pubmed/8276031?,. 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Prophylaxis against middle ear barotrauma in US in hyperbaric oxygen therapy centers % solution to be a for... Check interactions and set up your own personal medication records american Academy of Pediatrics subcommittee! Revisions after 1984 are available electronically associated with an increased risk for birth... References cited for Selected Revisions after 1984 are available electronically decongestant in otitis media,....