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:
shortness of breath
tightness in chest
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:
Bitter taste in mouth
temporary eye burning or stinging
Burning, dry or itching eyes
blurred vision, temporary
eye discharge or excessive tearing
general feeling of discomfort or illness
hoarseness or other voice changes
loss of appetite
muscle aches and pains
redness, pain, swelling of eye, eyelid, or inner lining of eyelid
tender, swollen glands in neck
trouble in swallowing
unusual tiredness or weakness
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.
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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.
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) 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.
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.
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 (%)]
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.
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 drops may cause blurred vision. This effect may be worse if you take it with alcohol or certain medicines. Use Zalastin drops with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Zalastin drops may cause harm if it is swallowed. If you may have taken it by mouth, contact your or emergency room right away.
Do not use Zalastin drops for future eye problems without first checking with your doctor.
Soft contact lenses may absorb a chemical in Zalastin drops; wait 10 minutes after you use Zalastin drops before you put your contacts back in.
Do not wear contact lenses if your eyes are red. Zalastin drops should not be used to treat redness caused by contact lenses.
Zalastin drops should not be used in CHILDREN younger than 3 years old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Zalastin drops while you are pregnant. It is not known if Zalastin drops is found in breast milk. If you are or will be breast-feeding while you use Zalastin drops, check with your doctor. Discuss any possible risks to your baby.
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.
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).
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.
Consumer reported side effects
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