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Medically reviewed by Oliinyk Elizabeth Ivanovna, PharmD. Last updated on 15.06.2022
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1.1 Seasonal Allergic Rhinitis
Aria-des 2,5 mg/5 ml Tablets are indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 12 years of age and older.
1.2 Perennial Allergic Rhinitis
Aria-des 2,5 mg/5 ml Tablets are indicated for the relief of the nasal and non-nasal symptoms of perennial allergic rhinitis in patients 12 years of age and older.
1.3 Chronic Idiopathic Urticaria
Aria-des 2,5 mg/5 ml Tablets are indicated for the symptomatic relief of pruritus, reduction in the number of hives, and size of hives, in patients with chronic idiopathic urticaria 12 years of age and older.
Aria-des 2,5 mg/5 ml is an antihistamine that reduces the effects of the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.
Aria-des 2,5 mg/5 ml is used to treat the symptoms of allergies, such as sneezing, watery eyes, and runny nose. It is also used to treat skin hives and itching in people with chronic skin reactions.
Aria-des 2,5 mg/5 ml may also be used for purposes not listed in this medication guide.
Aria-des 2,5 mg/5 ml Tablets or
Oral Solution may be taken without regard to meals.
The age-appropriate dose of Aria-des 2,5 mg/5 ml
Oral Solution should be administered with a commercially available measuring dropper or syringe that is calibrated to deliver 2 mL and 2.5 mL (½ teaspoon).
Adults And Adolescents 12 Years Of Age And Over
The recommended dose of Aria-des 2,5 mg/5 ml Tablets is one 5-mg tablet once daily. The recommended dose of Aria-des 2,5 mg/5 ml
Oral Solution is 2 teaspoonfuls (5 mg in 10 mL) once daily.
Children 6 To 11 Years Of Age
The recommended dose of Aria-des 2,5 mg/5 ml
Oral Solution is 1 teaspoonful (2.5 mg in 5 mL) once daily.
Children 12 Months To 5 Years Of Age
The recommended dose of Aria-des 2,5 mg/5 ml
Oral Solution is ½ teaspoonful (1.25 mg in 2.5 mL) once daily.
Children 6 To 11 Months Of Age
The recommended dose of Aria-des 2,5 mg/5 ml
Oral Solution is 2 mL (1 mg) once daily.
Adults With Hepatic Or Renal Impairment
In adult patients with liver or renal impairment, a starting dose of one 5-mg tablet every other day is recommended based on pharmacokinetic data. Dosing recommendation for children with liver or renal impairment cannot be made due to lack of data.
How supplied
Dosage Forms And Strengths
Aria-des 2,5 mg/5 ml Tablets are light blue, film-coated tablets embossed with “C5” containing 5 mg Aria-des 2,5 mg/5 ml.
Aria-des 2,5 mg/5 ml
Oral Solution is a clear orange-colored liquid containing 0.5 mg Aria-des 2,5 mg/5 ml/1 mL.
Storage And Handling
Aria-des 2,5 mg/5 ml Tablets: Embossed “C5”, light blue, film-coated tablets that are packaged in high-density polyethylene plastic bottles of 100 (NDC 0085-1264-01) and 500 (NDC 0085-1264-02).
Aria-des 2,5 mg/5 ml
Oral Solution:
NDCNDCStorage
- Aria-des 2,5 mg/5 ml Tablets: Protect Unit-of-Use packaging and Unit-Dose Hospital Pack from excessive moisture. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Heat Sensitive. Avoid exposure at or above 30°C (86°F).
- Aria-des 2,5 mg/5 ml
Oral Solution:
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from light.
Manufactured by: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Manufactured by: Schering-Plough Canada, Inc., Pointe Claire, Quebec, Canada. Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Revised: Nov 2013
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What is the most important information I should know about Aria-des 2,5 mg/5 ml?
You should not take this medication if you are allergic to Aria-des 2,5 mg/5 ml or to loratadine (Claritin).
Before taking Aria-des 2,5 mg/5 ml, tell your doctor if you are allergic to any drugs, or if you have liver or kidney disease.
Do not give this medication to a child younger than 2 years old without the advice of a doctor.
Aria-des 2,5 mg/5 ml disintegrating tablets (Aria-des 2,5 mg/5 ml) may contain phenylalanine. Talk to your doctor before using this form of Aria-des 2,5 mg/5 ml if you have phenylketonuria (PKU).
Use Aria-des 2,5 mg/5 ml orally disintegrating tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Aria-des 2,5 mg/5 ml orally disintegrating tablets. Talk to your pharmacist if you have questions about this information.
- Take Aria-des 2,5 mg/5 ml orally disintegrating tablets by mouth with or without food.
- Do not remove the blister from the outer pouch until you are ready to take Aria-des 2,5 mg/5 ml orally disintegrating tablets. Make sure that your hands are dry when you open the blister pack. Do not push the tablet through the foil. Peel back the foil on the blister pack and place the tablet on your tongue. The tablet dissolves quickly and can be swallowed with saliva. Aria-des 2,5 mg/5 ml orally disintegrating tablets may be taken with or without water. Take the tablet immediately after opening the blister pack. Do not store the removed tablet for future use.
- If you miss a dose of Aria-des 2,5 mg/5 ml orally disintegrating tablets and you are taking it regularly, take 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 take 2 doses at once.
Ask your health care provider any questions you may have about how to use Aria-des 2,5 mg/5 ml orally disintegrating tablets.
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.Use: Labeled Indications
Allergic rhinitis: Relief of nasal and non-nasal symptoms of seasonal (SAR) and perennial (PAR) allergic rhinitis
Urticaria: Symptomatic relief of pruritus, reduction in number of hives, and reduction in size of hives associated with chronic idiopathic urticaria (CIU)
Off Label Uses
NSAID-associated urticaria (prophylaxis)
Data from a retrospective study with a limited number of patients suggest that Aria-des 2,5 mg/5 ml may be beneficial for prophylactic therapy in patients with NSAID-associated urticaria prior to receiving a strong COX-1 inhibitor. Additional trials may be needed to further define the role of Aria-des 2,5 mg/5 ml in this setting.
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What other drugs will affect Aria-des 2,5 mg/5 ml?
Inhibitors Of Cytochrome P450 3A4
In controlled clinical studies co-administration of Aria-des 2,5 mg/5 ml with ketoconazole, erythromycin, or azithromycin resulted in increased plasma concentrations of Aria-des 2,5 mg/5 ml and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of Aria-des 2,5 mg/5 ml.
Fluoxetine
In controlled clinical studies co-administration of Aria-des 2,5 mg/5 ml with fluoxetine, a selective serotonin reuptake inhibitor (SSRI), resulted in increased plasma concentrations of Aria-des 2,5 mg/5 ml and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of Aria-des 2,5 mg/5 ml.
Cimetidine
In controlled clinical studies co-administration of Aria-des 2,5 mg/5 ml with cimetidine, a histamine H2-receptor antagonist, resulted in increased plasma concentrations of Aria-des 2,5 mg/5 ml and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of Aria-des 2,5 mg/5 ml.
Drug Abuse And Dependence
There is no information to indicate that abuse or dependency occurs with Aria-des 2,5 mg/5 ml Tablets.
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What are the possible side effects of Aria-des 2,5 mg/5 ml?
The following adverse reactions are discussed in greater detail in other sections of the label:
- Hypersensitivity reactions.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the 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 clinical practice.
Adults and Adolescents
Allergic Rhinitis: In multiple-dose placebo-controlled trials, 2834 patients ages 12 years or older received Aria-des 2,5 mg/5 ml tablets at doses of 2.5 mg to 20 mg daily, of whom 1655 patients received the recommended daily dose of 5 mg. In patients receiving 5 mg daily, the rate of adverse events was similar between Aria-des 2,5 mg/5 ml and placebo-treated patients. The percent of patients who withdrew prematurely due to adverse events was 2.4% in the Aria-des 2,5 mg/5 ml group and 2.6% in the placebo group. There were no serious adverse events in these trials in patients receiving Aria-des 2,5 mg/5 ml. All adverse events that were reported by greater than or equal to 2% of patients who received the recommended daily dose of Aria-des 2,5 mg/5 ml tablets (5 mg once daily), and that were more common with Aria-des 2,5 mg/5 ml tablets than placebo, are listed in Table 1.
The frequency and magnitude of laboratory and electrocardiographic abnormalities were similar in Aria-des 2,5 mg/5 ml and placebo-treated patients.
There were no differences in adverse events for subgroups of patients as defined by gender, age, or race.
Chronic Idiopathic Urticaria: In multiple-dose, placebo-controlled trials of chronic idiopathic urticaria, 211 patients ages 12 years or older received Aria-des 2,5 mg/5 ml tablets and 205 received placebo. Adverse events that were reported by greater than or equal to 2% of patients who received Aria-des 2,5 mg/5 ml tablets and that were more common with Aria-des 2,5 mg/5 ml than placebo were (rates for Aria-des 2,5 mg/5 ml and placebo, respectively): headache (14%, 13%), nausea (5%, 2%), fatigue (5%, 1%), dizziness (4%, 3%), pharyngitis (3%, 2%), dyspepsia (3%, 1%), and myalgia (3%, 1%).
Pediatrics
Two hundred and forty-six pediatric subjects 6 months to 11 years of age received Aria-des 2,5 mg/5 ml
Oral Solution for 15 days in three placebo-controlled clinical trials. Pediatric subjects aged 6 to 11 years received 2.5 mg once a day, subjects aged 1 to 5 years received 1.25 mg once a day, and subjects 6 to 11 months of age received 1.0 mg once a day.
In subjects 6 to 11 years of age, no individual adverse event was reported by 2 percent or more of the subjects.
In subjects 2 to 5 years of age, adverse events reported for Aria-des 2,5 mg/5 ml and placebo in at least 2 percent of subjects receiving Aria-des 2,5 mg/5 ml
Oral Solution and at a frequency greater than placebo were fever (5.5%, 5.4%), urinary tract infection (3.6%, 0%) and varicella (3.6%, 0%).
In subjects 12 months to 23 months of age, adverse events reported for the Aria-des 2,5 mg/5 ml product and placebo in at least 2 percent of subjects receiving Aria-des 2,5 mg/5 ml
Oral Solution and at a frequency greater than placebo were fever (16.9%, 12.9%), diarrhea (15.4%, 11.3%), upper respiratory tract infections (10.8%, 9.7%), coughing (10.8%, 6.5%), appetite increased (3.1%, 1.6%), emotional lability (3.1%, 0%), epistaxis (3.1%, 0%), parasitic infection (3.1%, 0%), pharyngitis (3.1%, 0%), rash maculopapular (3.1%, 0%).
In subjects 6 months to 11 months of age, adverse events reported for Aria-des 2,5 mg/5 ml and placebo in at least 2 percent of subjects receiving Aria-des 2,5 mg/5 ml
Oral Solution and at a frequency greater than placebo were upper respiratory tract infections (21.2%, 12.9%), diarrhea (19.7%, 8.1%), fever (12.1%, 1.6%), irritability (12.1%, 11.3%), coughing (10.6%, 9.7%), somnolence (9.1%, 8.1%), bronchitis (6.1%, 0%), otitis media (6.1%, 1.6%), vomiting (6.1%, 3.2%), anorexia (4.5%, 1.6%), pharyngitis (4.5%, 1.6%), insomnia (4.5%, 0%), rhinorrhea (4.5%, 3.2%), erythema (3.0%, 1.6%), and nausea (3.0%, 0%).
There were no clinically meaningful changes in any electrocardiographic parameter, including the QTc interval. Only one of the 246 pediatric subjects receiving Aria-des 2,5 mg/5 ml
Oral Solution in the clinical trials discontinued treatment because of an adverse event.
Post-Marketing Experience
Because adverse events 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. The following spontaneous adverse events have been reported during the marketing of Aria-des 2,5 mg/5 ml: tachycardia, palpitations, rare cases of hypersensitivity reactions (such as rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis), psychomotor hyperactivity, movement disorders (including dystonia, tics, and extrapyramidal symptoms), seizures, and elevated liver enzymes including bilirubin, and very rarely, hepatitis.
Aria-des 2,5 mg/5 ml Tab: Each tablet contains 5.0 mg of Aria-des 2,5 mg/5 ml.
Aria-des 2,5 mg/5 ml Syr: Each mL of Aria-des 2,5 mg/5 ml syrup contains 500 mcg of Aria-des 2,5 mg/5 ml.
Excipients/Inactive Ingredients: Aria-des 2,5 mg/5 ml Tab: Dibasic calcium phosphate dihydrate, microcrystalline cellulose, maize starch, talc, blue color film-coat material, clear film coat material, white wax and carnauba wax.
However, we will provide data for each active ingredient