Optihist AZ (ENTOD) nasal spray is used to help relieve symptoms (eg, stuffy or runny nose, itching, sneezing) of seasonal (short-term) or perennial (year-round) allergic rhinitis (hay fever), and vasomotor rhinitis.
Optihist AZ (ENTOD) is an antihistamine. It works by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes.
Optihist AZ (ENTOD) is available only with your doctor's prescription.
Optihist AZ (ENTOD) indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Optihist AZ (ENTOD) 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.
How should I use Optihist AZ (ENTOD)?
Use Optihist AZ (ENTOD) spray as directed by your doctor. Check the label on the medicine for exact dosing instructions.
An extra patient leaflet is available with Optihist AZ (ENTOD) spray. Talk to your pharmacist if you have questions about this information.
Optihist AZ (ENTOD) spray is for the nose only. Do not get it in your eyes or mouth. If you get Optihist AZ (ENTOD) 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 Optihist AZ (ENTOD) spray. This will help you to avoid the bitter taste that may be caused by Optihist AZ (ENTOD) spray.
After using Optihist AZ (ENTOD) 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 Optihist AZ (ENTOD) 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 Optihist AZ (ENTOD) spray.
Uses of Optihist AZ (ENTOD) in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Optihist AZ (ENTOD) 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).
Optihist AZ (ENTOD) description
Optihist AZ (ENTOD), 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. Optihist AZ (ENTOD) is also available as a combination product of Optihist AZ (ENTOD) hydrochloride and fluticasone propionate called Dymista™. Dymista™ is indicated in patient over 12 years old for symptomatic relief of seasonal allergic rhinitis.
Optihist AZ (ENTOD) dosage
Seasonal Allergic Rhinitis
The recommended dosage of Optihist AZ (ENTOD) hydrochloride nasal solution (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 Optihist AZ (ENTOD) hydrochloride nasal solution (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 Optihist AZ (ENTOD) hydrochloride nasal solution (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 Optihist AZ (ENTOD) hydrochloride nasal solution (nasal spray) by the intranasal route only.
Priming: Prime Optihist AZ (ENTOD) hydrochloride nasal solution (nasal spray) before initial use by releasing 4 sprays or until a fine mist appears. When Optihist AZ (ENTOD) hydrochloride nasal solution (nasal spray) has not been used for 3 or more days, reprime with 2 sprays or until a fine mist appears. Avoid spraying Optihist AZ (ENTOD) hydrochloride nasal solution (nasal spray) into the eyes.
Optihist AZ (ENTOD) interactions
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Additive effects with CNS depressants and ethanol.
Use of Optihist AZ (ENTOD) hydrochloride nasal solution (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
Optihist AZ (ENTOD) Hydrochloride Nasal Solution (Nasal Spray) Two Sprays Per Nostril Twice Daily
Adverse experience information for Optihist AZ (ENTOD) hydrochloride nasal solution (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 Optihist AZ (ENTOD) hydrochloride nasal solution (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 Optihist AZ (ENTOD) hydrochloride nasal solution (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 Optihist AZ (ENTOD) hydrochloride nasal solution (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 (%)]
Optihist AZ (ENTOD) Hydrochloride Nasal Solution (Nasal Spray)
N = 391
Vehicle Placebo
N = 353
Bitter Taste
77 (19.7%)
2 (0.6%)
Headache
58 (14.8%)
45 (12.7%)
Somnolence
45 (11.5%)
19 (5.4%)
Nasal Burning
16 (4.1%)
6 (1.7%)
Pharyngitis
15 (3.8%)
10 (2.8%)
Paroxysmal Sneezing
12 (3.1%)
4 (1.1%)
Dry Mouth
11 (2.8%)
6 (1.7%)
Nausea
11 (2.8%)
4 (1.1%)
Rhinitis
9 (2.3%)
5 (1.4%)
Fatigue
9 (2.3%)
5 (1.4%)
Dizziness
8 (2.0%)
5 (1.4%)
Epistaxis
8 (2.0%)
5 (1.4%)
Weight Increase
8 (2.0%)
0 (0.0%)
Optihist AZ (ENTOD) Hydrochloride Nasal Solution (Nasal Spray) One Spray Per Nostril Twice Daily
Adverse experience information for Optihist AZ (ENTOD) hydrochloride nasal solution (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 Optihist AZ (ENTOD) hydrochloride nasal solution (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 Optihist AZ (ENTOD) hydrochloride nasal solution (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 Optihist AZ (ENTOD) hydrochloride nasal solution (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 Optihist AZ (ENTOD) Hydrochloride Nasal Solution (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 Optihist AZ (ENTOD) hydrochloride nasal solution (nasal spray) dosed at 1 or 2 sprays per nostril twice daily in U.S. clinical trials.
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 Optihist AZ (ENTOD) hydrochloride nasal solution (nasal spray) is derived from two placebo-controlled clinical studies which included 216 patients 12 years and older with vasomotor rhinitis who received Optihist AZ (ENTOD) hydrochloride nasal solution (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 Optihist AZ (ENTOD) hydrochloride nasal solution (nasal spray) and vehicle placebo was 2.8% and 2.9%, respectively.
The following adverse reactions were reported with frequencies ≥ 2% in the Optihist AZ (ENTOD) hydrochloride nasal solution (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 (%)]
Optihist AZ (ENTOD) Hydrochloride Nasal Solution (Nasal Spray)
N = 216
Vehicle Placebo
N = 210
Bitter Taste
42 (19.4%)
5 (2.4%)
Headache
17 (7.9%)
16 (7.6%)
Dysesthesia
17 (7.9%)
7 (3.3%)
Rhinitis
12 (5.6%)
5 (2.4%)
Epistaxis
7 (3.2%)
5 (2.4%)
Sinusitis
7 (3.2%)
4 (1.9%)
Somnolence
7 (3.2%)
2 (1.0%)
Reactions observed infrequently (<2% and exceeding placebo incidence) in patients who received Optihist AZ (ENTOD) hydrochloride nasal solution (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 Optihist AZ (ENTOD) hydrochloride formulations, there were infrequent occurrences of hepatic transaminase elevations.
Postmarketing Experience
During the post approval use of Optihist AZ (ENTOD) hydrochloride nasal solution (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.
The results of a survey conducted on ndrugs.com for Optihist AZ (ENTOD) are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Optihist AZ (ENTOD). We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
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