Delarex 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.
Delarex 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.
Delarex may also be used for purposes not listed in this medication guide.
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.
1.1 Seasonal Allergic Rhinitis
Delarex 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
Delarex 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
Delarex 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.
How should I use Delarex?
Use Delarex 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 Delarex orally disintegrating tablets. Talk to your pharmacist if you have questions about this information.
Take Delarex orally disintegrating tablets by mouth with or without food.
Do not remove the blister from the outer pouch until you are ready to take Delarex 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. Delarex 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 Delarex 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 Delarex orally disintegrating tablets.
Uses of Delarex 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.
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 Delarex 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 Delarex in this setting.
Delarex Tab: Each tablet contains 5.0 mg of Delarex.
Delarex Syr: Each mL of Delarex syrup contains 500 mcg of Delarex.
Excipients/Inactive Ingredients:Delarex Tab: Dibasic calcium phosphate dihydrate, microcrystalline cellulose, maize starch, talc, blue color film-coat material, clear film coat material, white wax and carnauba wax.
Generic name: Delarex 5mg
Dosage form: tablet, film coated; oral solution
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Although an orally disintegrating tablet formulation of Delarex may be available in the marketplace, Delarex® RediTabs® Tablets are no longer marketed.
Oral Solution, or RediTabs Tablets may be taken without regard to meals. Place Delarex (Delarex) RediTabs Tablets on the tongue and allow to disintegrate before swallowing. Tablet disintegration occurs rapidly. Administer with or without water. Take tablet immediately after opening the blister.
The age-appropriate dose of Delarex
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 Delarex Tablets or Delarex Tablets is one 5-mg tablet once daily. The recommended dose of Delarex
Oral Solution is 2 teaspoonfuls (5 mg in 10 mL) once daily.
Children 6 to 11 Years of Age
The recommended dose of Delarex
Oral Solution is 1 teaspoonful (2.5 mg in 5 mL) once daily. The recommended dose of Delarex Tablets is one 2.5-mg tablet once daily.
Children 12 Months to 5 Years of Age
The recommended dose of Delarex
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 Delarex
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.
In controlled clinical studies co-administration of Delarex with ketoconazole, erythromycin, or azithromycin resulted in increased plasma concentrations of Delarex and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of Delarex.
In controlled clinical studies co-administration of Delarex with fluoxetine, a selective serotonin reuptake inhibitor (SSRI), resulted in increased plasma concentrations of Delarex and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of Delarex.
In controlled clinical studies co-administration of Delarex with cimetidine, a histamine H2-receptor antagonist, resulted in increased plasma concentrations of Delarex and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of Delarex.
Drug Abuse And Dependence
There is no information to indicate that abuse or dependency occurs with Delarex Tablets.
The following adverse reactions are discussed in greater detail in other sections of the label:
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 Delarex 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 Delarex and placebo-treated patients. The percent of patients who withdrew prematurely due to adverse events was 2.4% in the Delarex group and 2.6% in the placebo group. There were no serious adverse events in these trials in patients receiving Delarex. All adverse events that were reported by greater than or equal to 2% of patients who received the recommended daily dose of Delarex tablets (5 mg once daily), and that were more common with Delarex tablets than placebo, are listed in Table 1.
The frequency and magnitude of laboratory and electrocardiographic abnormalities were similar in Delarex 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 Delarex tablets and 205 received placebo. Adverse events that were reported by greater than or equal to 2% of patients who received Delarex tablets and that were more common with Delarex than placebo were (rates for Delarex 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%).
Two hundred and forty-six pediatric subjects 6 months to 11 years of age received Delarex
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 Delarex and placebo in at least 2 percent of subjects receiving Delarex
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 Delarex product and placebo in at least 2 percent of subjects receiving Delarex
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 Delarex and placebo in at least 2 percent of subjects receiving Delarex
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 Delarex
Oral Solution in the clinical trials discontinued treatment because of an adverse event.
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 Delarex: 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.
DailyMed. "DESLORATADINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
The results of a survey conducted on ndrugs.com for Delarex 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 Delarex. 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 useful
No survey data has been collected yet
1 consumer reported price estimates
Was the price you paid to purchase the drug reasonable? Did you feel it was expensive? The below mentioned numbers have been reported by ndrugs.com website users about whether the Delarex drug is expensive or inexpensive. There is a mixed opinion among users. The rating about the cost of the drug depends on factors like which brand drug the patient purchased, how effective it was for the price paid, the country or place the drug is marketed, and the economic condition of the patient. The users who feel the drug is expensive can look for an alternative brand drug or a generic drug to save the cost.
1 consumer reported time for results
To what extent do I have to use Delarex before I begin to see changes in my health conditions? As part of the reports released by ndrugs.com website users, it takes 1 day and a few days before you notice an improvement in your health conditions. Please note, it doesn't mean you will start to notice such health improvement in the same time frame as other users. There are many factors to consider, and we implore you to visit your doctor to know how long before you can see improvements in your health while taking Delarex. To get the time effectiveness of using Delarex drug by other patients, please click here.
4 consumers reported age
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