Desloratadina Zydus Nikkho 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.
Desloratadina Zydus Nikkho 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.
Desloratadina Zydus Nikkho may also be used for purposes not listed in this medication guide.
Desloratadina Zydus Nikkho indications
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.
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1.1 Seasonal Allergic Rhinitis
Desloratadina Zydus Nikkho 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
Desloratadina Zydus Nikkho 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
Desloratadina Zydus Nikkho 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 Desloratadina Zydus Nikkho?
Use Desloratadina Zydus Nikkho 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 Desloratadina Zydus Nikkho orally disintegrating tablets. Talk to your pharmacist if you have questions about this information.
Take Desloratadina Zydus Nikkho orally disintegrating tablets by mouth with or without food.
Do not remove the blister from the outer pouch until you are ready to take Desloratadina Zydus Nikkho 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. Desloratadina Zydus Nikkho 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 Desloratadina Zydus Nikkho 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 Desloratadina Zydus Nikkho orally disintegrating tablets.
Uses of Desloratadina Zydus Nikkho 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.
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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 Desloratadina Zydus Nikkho 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 Desloratadina Zydus Nikkho in this setting.
Desloratadina Zydus Nikkho description
Desloratadina Zydus Nikkho Tab: Each tablet contains 5.0 mg of Desloratadina Zydus Nikkho.
Desloratadina Zydus Nikkho Syr: Each mL of Desloratadina Zydus Nikkho syrup contains 500 mcg of Desloratadina Zydus Nikkho.
Excipients/Inactive Ingredients:Desloratadina Zydus Nikkho Tab: Dibasic calcium phosphate dihydrate, microcrystalline cellulose, maize starch, talc, blue color film-coat material, clear film coat material, white wax and carnauba wax.
Desloratadina Zydus Nikkho dosage
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Desloratadina Zydus Nikkho Dosage
Generic name: Desloratadina Zydus Nikkho 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 Desloratadina Zydus Nikkho may be available in the marketplace, Desloratadina Zydus Nikkho® RediTabs® Tablets are no longer marketed.
Desloratadina Zydus Nikkho Tablets,
Oral Solution, or RediTabs Tablets may be taken without regard to meals. Place Desloratadina Zydus Nikkho (Desloratadina Zydus Nikkho) 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 Desloratadina Zydus Nikkho
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 Desloratadina Zydus Nikkho Tablets or Desloratadina Zydus Nikkho Tablets is one 5-mg tablet once daily. The recommended dose of Desloratadina Zydus Nikkho
Oral Solution is 2 teaspoonfuls (5 mg in 10 mL) once daily.
Children 6 to 11 Years of Age
The recommended dose of Desloratadina Zydus Nikkho
Oral Solution is 1 teaspoonful (2.5 mg in 5 mL) once daily. The recommended dose of Desloratadina Zydus Nikkho Tablets is one 2.5-mg tablet once daily.
Children 12 Months to 5 Years of Age
The recommended dose of Desloratadina Zydus Nikkho
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 Desloratadina Zydus Nikkho
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.
More about Desloratadina Zydus Nikkho (Desloratadina Zydus Nikkho)
In controlled clinical studies co-administration of Desloratadina Zydus Nikkho with ketoconazole, erythromycin, or azithromycin resulted in increased plasma concentrations of Desloratadina Zydus Nikkho and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of Desloratadina Zydus Nikkho.
Fluoxetine
In controlled clinical studies co-administration of Desloratadina Zydus Nikkho with fluoxetine, a selective serotonin reuptake inhibitor (SSRI), resulted in increased plasma concentrations of Desloratadina Zydus Nikkho and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of Desloratadina Zydus Nikkho.
Cimetidine
In controlled clinical studies co-administration of Desloratadina Zydus Nikkho with cimetidine, a histamine H2-receptor antagonist, resulted in increased plasma concentrations of Desloratadina Zydus Nikkho and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of Desloratadina Zydus Nikkho.
Drug Abuse And Dependence
There is no information to indicate that abuse or dependency occurs with Desloratadina Zydus Nikkho Tablets.
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 Desloratadina Zydus Nikkho 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 Desloratadina Zydus Nikkho and placebo-treated patients. The percent of patients who withdrew prematurely due to adverse events was 2.4% in the Desloratadina Zydus Nikkho group and 2.6% in the placebo group. There were no serious adverse events in these trials in patients receiving Desloratadina Zydus Nikkho. All adverse events that were reported by greater than or equal to 2% of patients who received the recommended daily dose of Desloratadina Zydus Nikkho tablets (5 mg once daily), and that were more common with Desloratadina Zydus Nikkho tablets than placebo, are listed in Table 1.
The frequency and magnitude of laboratory and electrocardiographic abnormalities were similar in Desloratadina Zydus Nikkho 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 Desloratadina Zydus Nikkho tablets and 205 received placebo. Adverse events that were reported by greater than or equal to 2% of patients who received Desloratadina Zydus Nikkho tablets and that were more common with Desloratadina Zydus Nikkho than placebo were (rates for Desloratadina Zydus Nikkho 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 Desloratadina Zydus Nikkho
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 Desloratadina Zydus Nikkho and placebo in at least 2 percent of subjects receiving Desloratadina Zydus Nikkho
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 Desloratadina Zydus Nikkho product and placebo in at least 2 percent of subjects receiving Desloratadina Zydus Nikkho
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 Desloratadina Zydus Nikkho and placebo in at least 2 percent of subjects receiving Desloratadina Zydus Nikkho
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 Desloratadina Zydus Nikkho
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 Desloratadina Zydus Nikkho: 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.
You should not take this medication if you are allergic to Desloratadina Zydus Nikkho or to loratadine (Claritin).
Before taking Desloratadina Zydus Nikkho, 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.
Desloratadina Zydus Nikkho disintegrating tablets (Desloratadina Zydus Nikkho) may contain phenylalanine. Talk to your doctor before using this form of Desloratadina Zydus Nikkho if you have phenylketonuria (PKU).
Active ingredient matches for Desloratadina Zydus Nikkho:
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).
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