DRUGS & SUPPLEMENTS
1 INDICATIONS AND USAGE
Omnaris Nasal Aerosol is a corticosteroid indicated for treatment of symptoms associated with seasonal and perennial allergic rhinitis in adults and adolescents 12 years of age and older.
1.1 Treatment of Allergic Rhinitis
Omnaris® (ciclesonide) Nasal Aerosol is indicated for the treatment of symptoms associated with seasonal and perennial allergic rhinitis in adults and adolescents 12 years of age and older.
2 DOSAGE AND ADMINISTRATION
For Intranasal use only
2.1 Administration Information
Administer Omnaris by the intranasal route only. Prior to initial use, Omnaris must be primed by actuating three times. If Omnaris is not used for ten consecutive days, it must be primed by actuating three times. If Omnaris is dropped, the canister and actuator may become separated. If this happens, reassemble Omnaris and test spray once into the air before using. Illustrated patient's instructions for proper use accompany each package of Omnaris.
2.2 Allergic Rhinitis
Adults and Adolescents (12 Years of Age and Older): The recommended dose of Omnaris is 1 actuation per nostril once daily (37 mcg per actuation). The maximum total daily dosage should not exceed 1 actuation in each nostril (74 mcg per day).
3 DOSAGE FORMS AND STRENGTHS
Omnaris Nasal Aerosol is provided at strength of 37 mcg per actuation strength containing 60 actuations per canister.
Omnaris is contraindicated in patients with a known hypersensitivity to Omnaris or any of the ingredients of Omnaris [see Warnings and Precautions (5.3)].
5 WARNINGS AND PRECAUTIONS
5.1 Local Nasal Effects
Epistaxis and Nasal Ulceration: In clinical trials of 2 to 26 weeks in duration, epistaxis was observed more frequently in patients treated with Omnaris than those who received placebo. In the 26-week open-label extension of the perennial allergic rhinitis trial, nasal ulceration was identified in 4 of 824 patients administered Omnaris (148 mcg). [see Adverse Reactions (6)]
The occurrence of local nasal adverse events was further evaluated in a separate, postmarketing 26-week randomized, open-label, active-controlled nasal and ocular safety trial conducted in patients with perennial allergic rhinitis. In this study epistaxis was observed in 6% of patients treated with Omnaris and nasal ulceration was identified in 3 of 367 patients administered Omnaris. [see Adverse Reactions (6)]
Nasal Septal Perforation: Nasal septal perforation has been reported in patients following the intranasal application of Omnaris. Three short-term placebo-controlled trials (2 weeks) and one long-term (26 weeks with placebo control and 26 weeks open-label extension without placebo control) trial were conducted in patients with seasonal and perennial allergic rhinitis. Nasal septal perforations were reported in 2 patients out of 2335 treated with Omnaris compared with none of 892 treated with placebo. No nasal septal perforations were reported in 367 patients treated with Omnaris in a postmarketing 26-week, open-label, active-controlled trial in patients with perennial allergic rhinitis. [see Adverse Reactions (6)]
Before starting Omnaris conduct a nasal examination to ensure that patients are free of nasal disease other than allergic rhinitis. Periodically monitor patients with nasal examinations during treatment for adverse effects in the nasal cavity. If an adverse reaction (e.g. erosion, ulceration, perforation) is noted, discontinue Omnaris. Avoid spraying Omnaris directly onto the nasal septum.
Candida Infection: In clinical trials with another formulation of Omnaris, the development of localized infections of the nose or pharynx with Candida albicans has occurred. If such an infection develops with Omnaris, it may require treatment with appropriate local therapy and discontinuation of Omnaris.
Impaired Wound Healing: Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal septal ulcers, nasal surgery, or nasal trauma should not use Omnaris until healing has occurred.
5.2 Glaucoma and Cataracts
Nasal and inhaled corticosteroids may result in the development of glaucoma and cataracts. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, or cataracts.
Omnaris is contraindicated in patients with a known hypersensitivity to Omnaris or any of the ingredients of Omnaris. Cases of hypersensitivity reactions following administration of Omnaris with manifestations such as angioedema, with swelling of the lips, tongue and pharynx, have been reported.
Patients who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease or prior corticosteroid treatment to the risk is also not known. If a patient is exposed to chicken pox, prophylaxis with varicella zoster immune globulin may be indicated. If a patient is exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated.. If chickenpox develops, treatment with antiviral agents may be considered.
Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; or in patients with untreated local or systemic fungal or bacterial infections; systemic viral or parasitic infections; or ocular herpes simplex because of the potential for worsening of these infections.
5.5 Hypothalamic-Pituitary-Adrenal Axis Suppression
Hypercorticism and adrenal suppression may occur when intranasal corticosteroids, such as Omnaris, are used at higher than recommended dosages or in susceptible individuals at recommended dosages. If such changes occur, the dosage of Omnaris should be discontinued slowly, consistent with accepted procedures for discontinuing oral steroid therapy.
The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency. In addition, some patients may experience symptoms of corticosteroid withdrawal, e.g., joint and muscular pain, lassitude, and depression. Patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids should be carefully monitored for acute adrenal insufficiency in response to stress. In those patients who have asthma or other clinical conditions requiring long-term systemic corticosteroid treatment, rapid decreases in systemic corticosteroid dosages may cause a severe exacerbation of their symptoms.
5.6 Effect on Growth
Corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth routinely (e.g., via stadiometry) in pediatric patients receiving Omnaris. [see Pediatric Use (8.4)]
6 ADVERSE REACTIONS
Systemic and local corticosteroid use may result in the following:
The most common adverse reactions (≥2% incidence) included nasal discomfort, headache and epistaxis. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Sunovion Pharmaceuticals Inc. at 1-877-737-7226 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience
The safety data described below for adults and adolescents 12 years of age and older are based on 4 clinical trials evaluating doses of Omnaris nasal aerosol from 74 to 282 mcg. Three of the clinical trials were 2 to 6 weeks in duration and one trial was 26 weeks in duration with an additional 26-week open-label extension. Data from the first 6 weeks of the 26-week trial were pooled with data from the three 2-week trials. Short-term data (2 to 6 weeks) included 3001 patients with seasonal and perennial allergic rhinitis, of these, 884 received ZETONNA 74 mcg once daily and 892 received placebo. The short-term data included 1098 (36.6%) males, 1903 (63.4%) females, 2587 (86.2%) Caucasians, 320 (10.7%) Blacks, 49 (1.6%) Asians, and 45 (1.5%) patients classified as Other. The 26-week trial was conducted in 1110 patients with perennial allergic rhinitis [394 (35.5%) males and 716 (64.5%) females, ages 12 to 78 years old] treated with Omnaris 74 mcg, 148 mcg or placebo once daily. Of these patients, 298 were treated with 74 mcg Omnaris, 505 with 148 mcg, and 307 with placebo. The racial distribution in this trial included 922 (83.1%) Caucasians, 146 (13.2%) Blacks, 18 (1.6%) Asians, and 24 (2.2%) patients classified as Other. The 26-week open-label extension included 824 patients [295 (35.8%) males and 529 (64.2%) females, ages 12 to 79 years old] given Omnaris 148 mcg once daily. The racial distribution in the open-label extension included 690 (83.7%) Caucasians, 104 (12.6%) Blacks, 15 (1.8%) Asians, and 15 (1.8%) patients classified as Other.
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 the rates observed in practice.
Short-Term (2-6 weeks) Trials:
In three short-term trials and the first 6 weeks of one long-term trial, conducted in the US, 884 patients with a history of seasonal or perennial allergic rhinitis were treated with Omnaris 74 mcg daily. Adverse reactions did not differ appreciably based on age, gender, or race. The table below displays reactions that occurred with an incidence of at least 2.0% and more frequently with Omnaris 74 mcg than with placebo in seasonal or perennial allergic rhinitis clinical trials of 2 to 6 weeks duration.
When considering the data from higher doses evaluated in the short-term trials, epistaxis demonstrated a dose response. In addition, two patients treated with Omnaris 74 mcg experienced nasal septal perforations in the short-term trials compared to no patients treated with placebo.
Approximately 1.2% of patients treated with Omnaris 74 mcg in clinical trials discontinued because of adverse reactions; this rate was similar for patients treated with placebo. Discontinuations due to local adverse reactions were similar in Omnaris 74 mcg treated patients (0.8%) compared to placebo treated patients (0.8%). Local adverse reactions leading to discontinuation that occurred only in Omnaris treated patients included ear infection, nasal discomfort, nasal dryness, nasal mucosal/septum disorders, pharyngitis, streptococcal pharyngitis, sinus headache, and tonsillitis.
Long-Term (26-Week Double-Blind and 26-Week Open-Label) Safety Trial:
In one 26-week double-blind, placebo-controlled safety trial that included 1110 adult and adolescent patients with perennial allergic rhinitis, additional adverse reactions, with an incidence of at least 2%, that occurred more frequently with Omnaris than with placebo were upper respiratory tract infection, urinary tract infection, oropharyngeal pain, nasal mucosal/septum disorders, viral upper respiratory tract infection, cough, influenza, bronchitis, streptococcal pharyngitis, muscle strain, and nausea. Nasal discomfort (5.7%) and epistaxis
(11.4%) were also more frequent in the 26-week safety trial compared to clinical trials 2 to 6 weeks in duration. Nasal mucosal/septum disorders and cough demonstrated a dose response.
Discontinuations due to adverse reactions were higher in Omnaris treated patients compared to placebo treated patients and demonstrated a dose response. Local adverse reactions leading to discontinuation were also higher in Omnaris 74 mcg treated patients (1.7%) compared to placebo treated patients (0.7%). The only local adverse reaction leading to discontinuation that occurred in Omnaris treated patients and was not observed in the 2- to 6-week trials was upper respiratory tract infection.
A total of 824 patients with perennial allergic rhinitis who completed the 26-week double-blind trial enrolled into an open-label extension and received Omnaris 148 mcg for 26 weeks. Additional adverse reactions, observed with an incidence of at least 2% were sinusitis, nasopharyngitis, and back pain.
A total of 4 nasal septal ulcerations were also reported in the 26-week open-label extension.
There were no reports of nasal septal perforations in the long-term safety trial.
Long-Term (6-Month Open-Label) Nasal Safety Trial:
Nasal and ocular safety was evaluated in one 26-week, postmarketing, randomized, open-label, active-controlled trial, in adult and adolescent patients 12-74 years of age with a history of perennial allergic rhinitis. A total of 737 patients were treated with Omnaris 74 mcg or Omnaris nasal spray 200 mcg once daily. The combined incidence of nasal mucosal or septum disorders, including erosions and ulcerations, was 3 (0.8%) for Omnaris 74 mcg and 4 (1.1%) for Omnaris nasal spray 200 mcg treated patients. There were no nasal septal perforations reported with either treatment. Ocular findings, including the development or worsening of lens opacities, increase in intraocular pressure, and worsening visual acuity, were also evaluated over the 26-week treatment period. The occurrence of ocular safety events was similar for the Omnaris 74 mcg and Omnaris nasal spray 200 mcg treatment groups.
6.2 Post-marketing Experience
The following adverse reactions have been identified during post-approval use of other formulations of Omnaris, ALVESCO® Inhalation Aerosol and OMNARIS® Nasal Spray. 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.
ALVESCO® Inhalation Aerosol: immediate or delayed hypersensitivity reactions such as angioedema with swelling of the lips, tongue, and pharynx.
OMNARIS® Nasal Spray: nasal congestion, nasal ulcer, and dizziness. Localized infections of the nose or mouth with Candida albicans have also occurred with OMNARIS® Nasal Spray.
7 DRUG INTERACTIONS
In vitro studies and clinical pharmacology studies suggested that des-ciclesonide has no potential for metabolic drug interactions or protein binding-based drug interactions [see Clinical Pharmacology (12.3)]. In a drug interaction study, co-administration of orally inhaled Omnaris and oral ketoconazole, a potent inhibitor of cytochrome P450 3A4, increased the exposure (AUC) of des-ciclesonide by approximately 3.6-fold at steady state, while levels of Omnaris remained unchanged. Erythromycin, a moderate inhibitor of cytochrome P450 3A4, had no effect on the pharmacokinetics of either des-ciclesonide or erythromycin following oral inhalation of Omnaris [see Clinical Pharmacology (12.3)].
8 USE IN SPECIFIC POPULATIONS
Teratogenic Effects: Pregnancy Category C.
There are no adequate and well-controlled trials in pregnant women. Omnaris should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Experience with oral corticosteroids since their introduction in pharmacologic, as opposed to physiologic, doses suggests that rodents are more prone to teratogenic effects from corticosteroids than humans.
Oral administration of Omnaris in rats at approximately 120 times the maximum recommended human daily intranasal dose in adults (on a mcg/m2 basis at a maternal dose of 900 mcg/kg/day) produced no teratogenicity or other fetal effects. However, subcutaneous administration of Omnaris in rabbits at similar to MRHDID (on a mcg/m2 basis at a maternal dose of 5 mcg/kg/day) produced fetal toxicity. This included fetal loss, reduced fetal weight, cleft palate, skeletal abnormalities including incomplete ossifications, and skin effects. No toxicity was observed at ¼ of the MRHDID in adults (on a mcg/m2 basis at a maternal dose of 1 mcg/kg/day).
Nonteratogenic Effects: Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Such infants should be carefully monitored.
8.3 Nursing Mothers
It is not known if Omnaris is excreted in human milk. However, other corticosteroids are excreted in human milk. In a study with lactating rats, minimal but detectable levels of radiolabeled Omnaris were recovered in milk. Caution should be used when Omnaris is administered to nursing women.
8.4 Pediatric Use
The safety and effectiveness for seasonal and perennial allergic rhinitis in children 12 years of age and older have been established. The safety and efficacy of Omnaris for treatment of the symptoms of seasonal and perennial allergic rhinitis in patients 11 years of age and younger have not been established.
The safety and efficacy of Omnaris in pediatric patients 6-11 years of age were evaluated in two randomized, double blind, parallel placebo-controlled clinical trials in 1693 pediatric patients with allergic rhinitis. Of the two trials, one was 2 weeks in duration and evaluated the efficacy of two doses of Omnaris in 847 patients with seasonal allergic rhinitis. The second clinical trial was 12 weeks in duration and evaluated the efficacy of two doses of Omnaris (37 mcg and 74 mcg once daily) in 846 patients with perennial allergic rhinitis. The trials were similar in design to the trials conducted in adolescents and adults. The primary efficacy endpoint was the difference from placebo in the change from baseline of the average morning and evening reflective total nasal symptom scores (rTNSS) averaged over 2 weeks of treatment in the seasonal allergic rhinitis trial and over the first 6 weeks of treatment in the perennial allergic rhinitis trial. In the 2-week trial in patients with seasonal allergic rhinitis, treatment with Omnaris at either dose failed to demonstrate efficacy. In the 12-week trial in patients with perennial allergic rhinitis, Omnaris 37 mcg and 74 mcg once daily both demonstrated significant improvement in rTNSS compared to placebo with treatment differences of 0.59 (95% CI: 0.23, 0.95) and 0.47 (95% CI: 0.11, 0.83), respectively. The safety profile observed in children 6 to 11 years of age with seasonal or perennial allergic rhinitis was similar to the adverse reactions observed in the clinical trial population of patients 12 year of age and older [see Adverse Reactions (6.1)].
The effect of Omnaris on the HPA axis was evaluated in one placebo-controlled clinical study of 6 weeks in duration in children 6 to11 years of age with perennial allergic rhinitis [see Clinical Pharmacology (12.2)].
Studies in children under 6 years of age have not been conducted.
Controlled clinical trials have shown that intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. This effect has been observed in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA)-axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA-axis function. The long-term effects of this reduction in growth velocity associated with intranasal corticosteroids, including the impact on final adult height, are unknown. The potential for “catch-up” growth following discontinuation of treatment with intranasal corticosteroids has not been adequately studied. The growth of pediatric patients receiving intranasal corticosteroids, including Omnaris, should be monitored routinely (e.g., via stadiometry). A 52-week, multi-center, double-blind, randomized, placebo-controlled parallel-group trial was conducted to assess the effect of orally inhaled Omnaris (ALVESCO® Inhalation Aerosol) on growth rate in 609 pediatric patients with mild persistent asthma, aged 5 to 8.5 years. Treatment groups included orally inhaled Omnaris 40 mcg or 160 mcg or placebo given once daily. Growth was measured by stadiometer height during the baseline, treatment and follow-up periods. The primary comparison was the difference in growth rates between Omnaris 40 and 160 mcg and placebo groups. Conclusions cannot be drawn from this trial because compliance could not be assured. Omnaris blood levels were also not measured during the one-year treatment period. There was no difference in efficacy measures between the placebo and the orally inhaled Omnaris (ALVESCO® Inhalation Aerosol) groups.
The potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of safe and effective noncorticosteroid treatment alternatives. To minimize the systemic effects of intranasal corticosteroids, each patient should be titrated to the lowest dose that effectively controls his/her symptoms.
The potential for Omnaris to cause growth suppression in susceptible patients or when given at higher than recommended dosages cannot be ruled out.
8.5 Geriatric Use
Clinical trials of Omnaris did not include sufficient numbers of patients age 65 and over to determine whether they responded differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Chronic overdosage may result in signs or symptoms of hypercorticism [see Warnings and Precautions (5.5)]. There are no data on the effects of acute or chronic overdosage with Omnaris.
The active component of Omnaris is Omnaris, a non-halogenated glucocorticoid having the chemical name pregna -1,4-diene-3,20-dione, 16,17-[[R-cyclohexylmethylene]bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxopropoxy)-,(11ß,16α)-. Omnaris is delivered as the R-epimer. The empirical formula is C32H44O7 and its molecular weight is 540.7. Its structural formula is as follows:
Priming Your Omnaris Nasal Aerosol For Use
Using Your Omnaris Nasal Aerosol
Step 1. Open the purple plastic dust cap.
Step 2. Hold the nasal actuator upright, with the nose piece pointing upwards, between your thumb and forefinger (and middle finger) (See Figure D ).
Step 3. Tilt your head back slightly and insert the end of the nose piece into 1 nostril, pointing it slightly toward the outside nostril wall away from the nasal septum (the wall between the 2 nostrils), while holding your other nostril closed with 1 finger (See Figure E ). Do not get any spray in your eyes or directly on your nasal septum.
Step 4. Press down on the canister to release 1 spray and at the same time breathe in gently through the nostril. Hold your breath for a few seconds then breathe out slowly through your mouth.
Step 5. Remove the nose piece from your nostril. Make sure the canister has returned to its original position and repeat steps 2-4 for the second spray in your other nostril.
Step 6. Replace the protective purple dust cap on the nasal actuator.
Step 7. Avoid blowing your nose for the next 15 minutes.
Cleaning Your Nasal Actuator
The outside of the nose piece should be cleaned weekly, by wiping with a clean, dry tissue or cloth (see Figure F ).
Do not wash or put any part of the Omnaris Nasal Aerosol canister or actuator in water.
How to Tell if Your Omnaris Nasal Aerosol Is Empty
What to Do if You Drop Your Omnaris Nasal Aerosol
This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.
Sunovion Pharmaceuticals Inc.
Marlborough, MA 01752 USA
Made in the United Kingdom
© 2014 Sunovion Pharmaceuticals Inc. All rights reserved.
For customer service, call 1-888-394-7377
Figure A Figure B Figure C Figure D Figure E Figure F Figure G Figure H
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - carton – 37 mcg 60-count
Net Contents: 6.1 g
(ciclesonide) Nasal Aerosol
37 mcg per actuation
For Intranasal Use Only.
Omnaris Nasal Aerosol Canister
Should Be Used with Omnaris
Nasal Aerosol Actuator Only.
60 Metered Actuations
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL – canister - 37 mcg 60-count
Net Contents: 6.1 g
(ciclesonide) Nasal Aerosol
37 mcg per actuation
For Intranasal Use Only.
Use with Omnaris Nasal Aerosol
60 Metered Actuations
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL – actuator - 37 mcg 60-count
(ciclesonide) Nasal Aerosol
37 mcg per actuation
For Intranasal Use Only.
Use with Omnaris
Nasal Aerosol Canister Only.
60 Metered Actuations
Omnaris pharmaceutical active ingredients containing related brand and generic drugs:
Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.
Omnaris available forms, composition, doses:
Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.
Omnaris destination | category:
Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.
Omnaris Anatomical Therapeutic Chemical codes:
A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.
Omnaris pharmaceutical companies:
Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.
Frequently asked QuestionsCan i drive or operate heavy machine after consuming Omnaris?
Depending on the reaction of the Omnaris after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Omnaris not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Omnaris addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
Reviewsdrugs.com conducted a study on Omnaris, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Omnaris consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.
Visitor reported usefulNo survey data has been collected yet
Visitor reported side effectsNo survey data has been collected yet
One visitor reported price estimatesWhat is your opinion about drug cost? Did you feel the cost is apt, or did you feel it is expensive?
The report given by the sdrugs.com website users shows the following figures about several people who felt the medicine Omnaris is expensive, and the medicine is not expensive. The results are mixed. The perception of the cost of the medicine to be expensive or not depends on the brand name of the medicine, country, and place where it is sold, and the affordability of the patient. You can choose a generic drug in the place of the branded drug to save the cost. The efficiency of the medicine will not vary if it is generic or a branded one.
Visitor reported frequency of useNo survey data has been collected yet
Visitor reported dosesNo survey data has been collected yet
Visitor reported time for resultsNo survey data has been collected yet
Visitor reported administrationNo survey data has been collected yet
Visitor reported ageNo survey data has been collected yet
The information was verified by Dr. Arunabha Ray, MD Pharmacology