Zelanex Uses

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What is Zelanex?

Zelanex 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.

Zelanex 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.

Zelanex is available only with your doctor's prescription.

Zelanex 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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Zelanex 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 Zelanex?

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

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

Uses of Zelanex 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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Zelanex 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).

Zelanex description

Zelanex, 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. Zelanex is also available as a combination product of Zelanex hydrochloride and fluticasone propionate called Dymista™. Dymista™ is indicated in patient over 12 years old for symptomatic relief of seasonal allergic rhinitis.

Zelanex dosage

Seasonal Allergic Rhinitis

The recommended dosage of Zelanex 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 Zelanex 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 Zelanex 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 Zelanex hydrochloride nasal solution (nasal spray) by the intranasal route only.

Priming: Prime Zelanex hydrochloride nasal solution (nasal spray) before initial use by releasing 4 sprays or until a fine mist appears. When Zelanex 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 Zelanex hydrochloride nasal solution (nasal spray) into the eyes.

Zelanex interactions

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Additive effects with CNS depressants and ethanol.

Zelanex side effects

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

Use of Zelanex 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

Zelanex Hydrochloride Nasal Solution (Nasal Spray) Two Sprays Per Nostril Twice Daily

Adverse experience information for Zelanex 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 Zelanex 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 Zelanex 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 Zelanex 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 (%)]
Zelanex 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%)

Zelanex Hydrochloride Nasal Solution (Nasal Spray) One Spray Per Nostril Twice Daily

Adverse experience information for Zelanex 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 Zelanex 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 Zelanex 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 Zelanex 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 Zelanex 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 Zelanex hydrochloride nasal solution (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 Zelanex 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 Zelanex 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 Zelanex 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 Zelanex 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 (%)]
Zelanex 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 Zelanex 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 Zelanex hydrochloride formulations, there were infrequent occurrences of hepatic transaminase elevations.

Postmarketing Experience

During the post approval use of Zelanex 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.

Zelanex contraindications

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

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Hypersensitivity.

Active ingredient matches for Zelanex:

Azelastine in Bangladesh.


List of Zelanex substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Oculast 0.05% w/v Eye Drops / 5ml (Centaur Pharmaceuticals Pvt.Ltd.)$ 0.80
Oculast Eye 5 ml Drop (Centaur Pharmaceuticals Pvt.Ltd.)$ 0.14
OCULAST 0.05% EYE DROP 1 packet / 5 ML eye drop each (Centaur Pharmaceuticals Pvt.Ltd.)$ 0.94
OCULAST 0.05% EYE DROP 1 packet / 15 ML eye drop each (Centaur Pharmaceuticals Pvt.Ltd.)$ 0.85
OCULAST eye drops 0.05 % w/v x 5ml (Centaur Pharmaceuticals Pvt.Ltd.)$ 0.80
Oculast 0.05% w/v Eye Drops / 5ml (Centaur Pharmaceuticals Pvt.Ltd.)$ 0.80
Drops; Ophthalmic; Azelastine Hydrochloride (Meda)
Optihist AZ Eye 5 ml Drop (Entod Pharmaceuticals Ltd)$ 0.18
OPTIHIST AZ EYE DROP 1 packet / 5 ML eye drop each (Entod Pharmaceuticals Ltd)$ 1.03
Optihist AZ 0.50% Eye Drop (Entod Pharmaceuticals Ltd)$ 1.03
Optihist AZ NA Eye Drop (Entod Pharmaceuticals Ltd)$ 1.03
OPTIHIST AZ / ENTOD 0.50% EYE DROP 1 packet / 5 ML eye drop each (Entod Pharmaceuticals Ltd)$ 1.03
Solution; Ophthalmic; Azelastine Hydrochloride 0.05% (Asta medica)
Spray, Metered-Dose; Nasal; Azelastine Hydrochloride 0.14 mg / dose
Solution; Nasal; Azelastine Hydrochloride 0.1% (Novartis sante)
Spray; Nasal; Azelastine Hydrochloride 0.1% (Viatris)
Sarnase Fluticasone 50 mcg, azelastine140 mcg. N-SPY / 15ml (Ranbaxy)$ 2.88
SARNASE 50 MCG/140 MCG NASAL SPRAY 1 packet / 15 ML nasal spray each (Ranbaxy)$ 2.88
SARNASE nasal spray 15ml (Ranbaxy)$ 2.88
Sarnase 50 mcg/140 mcg Nasal Spray (Ranbaxy)$ 2.88
Solution; Ophthalmic; Azelastine Hydrochloride (Mann)

References

  1. PubChem. "azelastine". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  2. DrugBank. "azelastine". http://www.drugbank.ca/drugs/DB00972 (accessed September 17, 2018).
  3. MeSH. "Anti-Allergic Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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