Zalastin Side effects

How long did you take this medication to work?
sponsored

What are the possible side effects of Zalastin?

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Copyright 2016 Truven Health Analytics, Inc. All Rights Reserved.

Side effects of Zalastin in details

A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
sponsored

Use of Zalastin 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

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

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

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

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

Postmarketing Experience

During the post approval use of Zalastin 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.

What is the most important information I should know about Zalastin?

Zalastin contraindications

Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
sponsored

Hypersensitivity.

References

  1. European Chemicals Agency - ECHA. "4-(p-chlorobenzyl)-2-(hexahydro-1-methyl-1h-azepin-4-yl)-1-(2h)-phthalazinon: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
  2. HSDB. "Azelastine". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).
  3. NIST. "Azelastine". http://www.nist.gov/srd/nist1a.cfm (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Zalastin 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 Zalastin. 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.

User reports

Consumer reported side effects

No survey data has been collected yet


Consumer reviews


There are no reviews yet. Be the first to write one!


Your name: 
Email: 
Spam protection:  < Type 6 here

Information checked by Dr. Sachin Kumar, MD Pharmacology

| Privacy Policy
This site does not supply any medicines. It contains prices for information purposes only.
© 2003 - 2022 ndrugs.com All Rights Reserved