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Licensed to fill prescriptions for patients in RI, MA, CT, NJ, NH, FL, ME and PA. New York patients are served on a limited basis while nonresident registration is pending.
Prepared to a prescriber's order for one patient. Not FDA-approved.
This is a compounded nasal spray containing azelastine hydrochloride, prepared to a prescriber's order for one patient. Compounded preparations are not FDA-approved.
These listings cover every salt or ester form of each drug in the FDA National Drug Code Directory.
FDA-approved products containing azelastine are listed as nasal sprays and as eye drops.
This dose form is water-containing (aqueous). Under USP <795>, aqueous preparations carry shorter default beyond-use dates than nonaqueous ones, and a preservative in the base allows a longer date than no preservative. The date printed on the label is the one to follow.
Azelastine hydrochloride is an antihistamine sold as a nasal spray and as eye drops that a pharmacy may compound when a prescriber orders it.
Azelastine hydrochloride is a phthalazinone derivative that blocks the action of histamine, a substance in the body that causes allergy symptoms, at H1 receptors. Laboratory and clinical studies also show effects on other inflammatory mediators such as leukotrienes. Prescription azelastine hydrochloride nasal spray is FDA-approved for symptoms of seasonal allergic rhinitis and of vasomotor (nonallergic) rhinitis. Azelastine hydrochloride ophthalmic solution is approved for itching of the eye from allergic conjunctivitis. Astepro Allergy is an over-the-counter nasal spray labeled for hay fever and other upper respiratory allergy symptoms. A prescriber might order azelastine compounded when a needed strength or form is not manufactured, when a patient needs a preparation free of a particular inactive ingredient, or as part of a combination. Compounded preparations are not FDA-approved and require a prescription.
Azelastine labels carry no boxed warning, and the prescription nasal spray label lists no contraindications. Do not use it if you have had an allergic reaction to it or its ingredients. It can cause drowsiness, so be careful driving or operating machinery, and avoid alcohol, sedatives and other central nervous system depressants, which add to it. Ask first if you have had a recent nose ulcer, nose surgery or a nose injury that has not healed. In the nasal spray label, limited data from decades of postmarketing use in pregnancy have not identified a drug-associated risk of birth defects or miscarriage. LactMed says small occasional doses of the nasal spray are not expected to harm a breastfed infant, but larger or prolonged use may cause infant drowsiness or reduce milk supply, the bitter taste may lead an infant to refuse the breast, and oral nonsedating antihistamines are preferred alternatives. Eye drops are not expected to affect a breastfed infant. Side effects can include bitter taste, nasal burning, headache and nosebleeds; if they are severe or do not go away, talk to your prescriber or pharmacist.
Azelastine is a racemic phthalazinone H1-receptor antagonist; its major metabolite, desmethylazelastine, also has H1 antagonist activity. A 2007 review, based on literature searches run by the manufacturer, reports in vitro and in vivo activity against leukotrienes, kinins and platelet-activating factor and downregulation of ICAM-1 in patients with rhinitis (Bernstein 2007). After intranasal use, systemic bioavailability is about 40%, with peak plasma levels in 2 to 3 hours. Plasma protein binding is about 88% for azelastine and 97% for desmethylazelastine. Azelastine is oxidized by cytochrome P450 enzymes (specific isoforms not identified); the elimination half-life is about 22 hours, and most of an oral dose is excreted in feces. Renal insufficiency raised Cmax and AUC in single-dose oral studies. Labeled uses: azelastine hydrochloride nasal spray for seasonal allergic rhinitis and vasomotor rhinitis; azelastine hydrochloride ophthalmic solution for ocular itching of allergic conjunctivitis; Astepro Allergy (OTC) for hay fever symptoms. Other uses are not FDA-approved indications, and compounded preparations are not FDA-approved. Dosing is per prescriber. Counsel on somnolence and avoidance of alcohol and CNS depressants. In lactation, monitor the infant for milk rejection, per the label.
Wash your hands and blow your nose gently. Prime the pump if your label says to. Keep your head upright, close one nostril with a finger, insert the tip into the other nostril and breathe in slowly while pressing the pump the number of times on your label. Repeat in the other nostril if directed. Wipe the nozzle, recap, and wash your hands. Do not share the bottle.
Nasal sprays are aqueous. Under USP <795>, a preserved spray usually carries a beyond-use date of up to 35 days at room temperature or refrigerated, and an unpreserved one 14 days refrigerated. Follow the storage line on your label, keep out of reach of children, and discard after the beyond-use date.
This formulation is compounded by Bayview Pharmacy on a prescriber's order for an individual patient. It is not an FDA-approved drug product, and the FDA has not evaluated it for safety, effectiveness, or manufacturing quality.
A valid prescription is required. Availability depends on Bayview's licensure in your state. This page is general information, not medical advice. Discuss your situation with a licensed healthcare provider.
Search by NCPDP 4106882, or by name and ZIP: Bayview Pharmacy, Warwick, RI 02886. Select it as the destination pharmacy and save it as a favorite. Click any value to copy it.
Compounded preparations have no NDC, so this formula will not appear in your EHR's drug search. Use your system's compound, non-formulary, or free-text prescription entry and name the preparation exactly as written in step 3. If your EHR forces you to pick a listed drug, pick the closest entry for the active ingredient and put the full formula in the prescription body (the Sig or directions field), not in Notes to Pharmacy.
Compounded preparations have no NDC and will not appear in your drug search. For EPCS to validate, select a drug entry your EHR recognizes as controlled, usually the bulk powder entry for the active ingredient (for example Ketamine (bulk) powder, not a branded product), then put the full formula from step 3 in the prescription body. A free-text entry that does not validate as controlled will be rejected by your EPCS module.
Quantity and directions are starting points for this dose form, not treatment recommendations. Dosing remains the prescriber's responsibility.
Transmit from your EHR. For this non-controlled preparation we also accept fax to (401) 284-4506 and phoned orders at (401) 284-4505. Order forms are on the formulation pages and in the prescriber portal.
Transmit with two-factor authentication through your EPCS-enabled EHR. No order form is offered for this preparation; e-prescribing guides for our controlled preparations are on the formulation pages.
Licensed to dispense in RI, MA, CT, NJ, NH, FL, ME, and PA; New York is served on a limited basis while nonresident registration is pending. Compounded preparations are not FDA-approved. A valid prescription is required. Full guide, including steps by EHR: How to e-prescribe to Bayview. Questions about this formula: call (401) 284-4505.
Inhale intranasally
