Azeflo

Azeflo hydrochloride nasal solution (nasal spray) is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older.

Azeflo (Azeflo) is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Azeflo Nasal Spray prevents sneezing, itching, runny nose, and other nasal symptoms of allergies. This medicine is for seasonal allergies in adults and children who are at least 2 years old, and for year-round allergies in adults and children as young as 6 months old.

Azeflo may also be used for purposes not listed in this medication guide.

Seasonal Allergic Rhinitis

The recommended dosage of Azeflo Nasal Spray in adults and adolescent patients 12 years and older with seasonal allergic rhinitis is one or two sprays per nostril twice daily. The recommended dosage of Azeflo Nasal Spray in pediatric patients 5 years to 11 years of age is one spray per nostril twice daily.

Vasomotor Rhinitis

The recommended dosage of Azeflo Nasal Spray in adults and adolescent patients 12 years and older with vasomotor rhinitis is two sprays per nostril twice daily.

Important Administration Instructions

Administer Azeflo Nasal Spray by the intranasal route only.

Priming: Prime Azeflo Nasal Spray before initial use by releasing 4 sprays or until a fine mist appears. When Azeflo Nasal Spray has not been used for 3 or more days, reprime with 2 sprays or until a fine mist appears. Avoid spraying Azeflo Nasal Spray into the eyes.

How supplied

Dosage Forms And Strengths

Azeflo Nasal Spray is a nasal spray solution. Each spray of Azeflo Nasal Spray delivers a volume of 0.137 mL solution containing 137 mcg of Azeflo hydrochloride.

Storage And Handling

Azeflo (Azeflo hydrochloride) Nasal Spray, 137 mcg is supplied as a 30-mL package (NDC 0037-0241-30) delivering 200 metered sprays in a high-density polyethylene (HDPE) bottle fitted with a metered-dose spray pump unit. The spray pump unit consists of a nasal spray pump fitted with a blue safety clip and a blue plastic dust cover. The net content of the bottle is 30 mL (net weight 30 gm of solution). Each bottle contains 30 mg (1 mg/mL) of Azeflo hydrochloride. After priming, each spray delivers a fine mist containing a mean volume of 0.137 mL solution containing 137 mcg of Azeflo hydrochloride. The correct amount of medication in each spray cannot be assured before the initial priming and after 200 sprays have been used, even though the bottle is not completely empty. The bottle should be discarded after 200 sprays have been used. Azeflo Nasal Spray should not be used after the expiration date “EXP” printed on the medicine label and carton.

Storage

Store at controlled room temperature 20° to 25°C (68° to 77°F). Protect from freezing.

Manufactured by: MEDA Pharmaceuticals Somerset, NJ 08873-4120. Revised: 10/2014

See also:
What is the most important information I should know about Azeflo?

Before using Azeflo nasal, tell your doctor about all of your medical conditions.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Before using Azeflo, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by Azeflo.

Drinking alcohol can increase certain side effects of Azeflo.

Call your doctor if your symptoms do not improve, or if they get worse while using Azeflo.

Stop using Azeflo and call your doctor at once if you have fast or uneven heartbeats, tightness in your chest, or if you feel short of breath.

Use Azeflo spray as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Azeflo spray. Talk to your pharmacist if you have questions about this information.
• Azeflo spray is for the nose only. Do not get it in your eyes or mouth. If you get Azeflo spray in your eyes, rinse with cool tap water at once.
• Prime the spray pump before the first use of a new bottle. Remove the blue dust cover over the tip of the bottle and the blue safety clip. To prime the pump, point the spray pump away from you and others. Spray rapidly and firmly several times until a fine mist appears (6 sprays or less).
• Gently blow your nose to clear your nostrils.
• Keep your head tilted downward. Place the spray tip ¼ to ½ inch into the nostril. Hold bottle upright, allowing spray tip to aim toward the back of the nose. Close the other nostril with one finger.
• Spray rapidly and firmly once and sniff gently at the same time. Repeat in the other nostril as directed.
• Breathe in gently. Do not tilt your head back after using Azeflo spray. This will help you to avoid the bitter taste that may be caused by Azeflo spray.
• After using Azeflo spray, wipe the spray tip with a clean tissue or cloth. Keep the dust cover and safety clip on the bottle when it is not in use.
• If 3 or more days have passed since the last use of this bottle, reprime the pump with 2 sprays or until a fine mist appears.
• If the nozzle becomes clogged, do NOT clean it by using a pointed object. Remove the spray pump from the bottle. Soak it in warm water, squirting it several times while under water. Dry the spray pump completely. Attach the spray pump to the bottle and reprime.
• Throw away any medicine that is left in the bottle after you have used 200 sprays. You may no longer receive the correct amount of medicine with each spray.
• If you miss a dose of Azeflo spray, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Azeflo spray.

Azeflo is an antihistamine (antiallergic) medication used for the treatment of hay fever, and allergy symptoms including runny nose, sneezing, and itchy nose and eye allergies (allergic conjunctivitis).

See also:
What other drugs will affect Azeflo?

Central Nervous System Depressants

Concurrent use of Azeflo Nasal Spray with alcohol or other central nervous system depressants should be avoided because reductions in alertness and impairment of central nervous system performance may occur.

See also:
What are the possible side effects of Azeflo?

Use of Azeflo Nasal Spray has been associated with somnolence.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect rates observed in practice.

Seasonal Allergic Rhinitis

Azeflo Nasal Spray Two Sprays Per Nostril Twice Daily

Adverse experience information for Azeflo Nasal Spray is derived from six placebo-and active-controlled, 2-day to 8-week clinical trials which included 391 patients, 12 years of age and older, with seasonal allergic rhinitis who received Azeflo Nasal Spray at a dose of 2 sprays per nostril twice daily. In placebo-controlled efficacy trials, the incidence of discontinuation due to adverse reactions in patients receiving Azeflo Nasal Spray and vehicle placebo was 2.2% and 2.8%, respectively.

Table 1 contains adverse reactions that were reported with frequencies ≥ 2% in the Azeflo Nasal Spray 2 sprays per nostril twice daily treatment group and more frequently than placebo.

Table 1: Adverse Reactions Reported in ≥ 2% Incidence in Placebo-Controlled Trials in Patients with Seasonal Allergic Rhinitis [n (%)]

Azeflo Nasal Spray One Spray Per Nostril Twice Daily

Adverse experience information for Azeflo Nasal Spray at a dose of one spray per nostril twice daily is derived from two placebo-controlled 2-week clinical studies which included 276 patients 12 years of age and older with seasonal allergic rhinitis. The incidence of discontinuation due to adverse reactions in patients receiving Azeflo Nasal Spray and vehicle placebo was 0.0% and 0.8%, respectively. Bitter taste was reported in 8.3% of patients compared to none in the placebo group. Somnolence was reported in 0.4% of patients compared to none in the placebo group.

A total of 176 patients 5 to 11 years of age were exposed to Azeflo Nasal Spray at a dose of 1 spray each nostril twice daily in 3 placebo-controlled studies. In these studies, adverse reactions that occurred more frequently in patients treated with Azeflo Nasal Spray than with placebo, and that were not represented in the adult adverse reactions table above include rhinitis/cold symptoms (17.0% vs. 9.5%), cough (11.4% vs. 8.3%), conjunctivitis (5.1% vs. 1.8%), and asthma (4.5% vs. 4.1%).

Adverse Reactions < 2% in Azeflo Nasal Spray One or Two Sprays Per Nostril Twice Daily

The following reactions were observed infrequently ( < 2% and exceeding placebo incidence) in patients who received Azeflo Nasal Spray dosed at 1 or 2 sprays per nostril twice daily in U.S. clinical trials.

Cardiovascular: flushing, hypertension, tachycardia.

Dermatological: contact dermatitis, eczema, hair and follicle infection, furunculosis, skin laceration.

Digestive: constipation, gastroenteritis, glossitis, ulcerative stomatitis, vomiting, increased SGPT, aphthous stomatitis, diarrhea, toothache.

Metabolic and Nutritional: increased appetite.

Musculoskeletal: myalgia, temporomandibular dislocation, rheumatoid arthritis.

Neurological: hyperkinesia, hypoesthesia, vertigo.

Psychological: anxiety, depersonalization, depression, nervousness, sleep disorder, thinking abnormal. Respiratory: bronchospasm, coughing, throat burning, laryngitis, bronchitis, dry throat, nocturnal dyspnea, nasopharyngitis, nasal congestion, pharyngolaryngeal pain, sinusitis, nasal dryness, paranasal sinus hypersecretion, post nasal drip.

Special Senses: conjunctivitis, eye abnormality, eye pain, watery eyes, taste loss.

Urogenital: albuminuria, amenorrhea, breast pain, hematuria, increased urinary frequency.

Whole Body: allergic reaction, back pain, herpes simplex, viral infection, malaise, pain in extremities, abdominal pain, pyrexia.

Vasomotor Rhinitis

Adverse experience information for Azeflo Nasal Spray is derived from two placebo-controlled clinical studies which included 216 patients 12 years and older with vasomotor rhinitis who received Azeflo Nasal Spray at a dose of 2 sprays per nostril twice daily for up to 28 days. The incidence of discontinuation due to adverse reactions in patients receiving Azeflo Nasal Spray and vehicle placebo was 2.8% and 2.9%, respectively.

The following adverse reactions were reported with frequencies ≥ 2% in the Azeflo Nasal Spray treatment group and more frequently than placebo.

Table 2: Adverse Reactions Reported in ≥ 2% Incidence in Placebo-Controlled Trials in Patients with Vasomotor Rhinitis [n (%)]

Reactions observed infrequently ( < 2% and exceeding placebo incidence) in patients who received Azeflo Nasal Spray (2 sprays/nostril twice daily) in U.S. clinical trials in vasomotor rhinitis were similar to those observed in U.S. clinical trials in seasonal allergic rhinitis.

In controlled trials involving nasal and oral Azeflo hydrochloride formulations, there were infrequent occurrences of hepatic transaminase elevations.

Postmarketing Experience

During the post approval use of Azeflo Nasal Spray, the following adverse reactions have been identified. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions reported include: anaphylaxis, application site irritation, atrial fibrillation, chest pain, confusion, dyspnea, facial edema, involuntary muscle contractions, nasal sores, palpitations, paresthesia, parosmia, pruritus, rash, disturbance or loss of sense of smell and/or taste, tolerance, urinary retention, vision abnormal and xerophthalmia.

Azeflo, a phthalazine derivative, is an antihistamine and mast cell stabilizer available as a nasal spray for hay fever and as eye drops for allergic conjunctivitis. Azeflo is also available as a combination product of Azeflo hydrochloride and Azeflo propionate called Dymista™. Dymista™ is indicated in patient over 12 years old for symptomatic relief of seasonal allergic rhinitis.