Dora

Dora Tab: Each tablet contains 5.0 mg of Dora.

Dora Syr: Each mL of Dora syrup contains 500 mcg of Dora.

Excipients/Inactive Ingredients: Dora Tab: Dibasic calcium phosphate dihydrate, microcrystalline cellulose, maize starch, talc, blue color film-coat material, clear film coat material, white wax and carnauba wax.

1.1 Seasonal Allergic Rhinitis

Dora 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

Dora 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

Dora 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.

Dora 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.

Dora 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.

Dora may also be used for purposes not listed in this medication guide.

Dora Tablets or

Oral Solution may be taken without regard to meals.

The age-appropriate dose of Dora

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 Dora Tablets is one 5-mg tablet once daily. The recommended dose of Dora

Oral Solution is 2 teaspoonfuls (5 mg in 10 mL) once daily.

Children 6 To 11 Years Of Age

The recommended dose of Dora

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 Dora

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 Dora

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

Dora Tablets are light blue, film-coated tablets embossed with “C5” containing 5 mg Dora.

Dora

Oral Solution is a clear orange-colored liquid containing 0.5 mg Dora/1 mL.

Storage And Handling

Dora 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).

Dora

Oral Solution:

Storage

• Dora 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).
• Dora

  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

See also:
What is the most important information I should know about Dora?

You should not take this medication if you are allergic to Dora or to loratadine (Claritin).

Before taking Dora, 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.

Dora disintegrating tablets (Dora) may contain phenylalanine. Talk to your doctor before using this form of Dora if you have phenylketonuria (PKU).

Use Dora 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 Dora orally disintegrating tablets. Talk to your pharmacist if you have questions about this information.
• Take Dora orally disintegrating tablets by mouth with or without food.
• Do not remove the blister from the outer pouch until you are ready to take Dora 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. Dora 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 Dora 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 Dora orally disintegrating tablets.

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 Dora 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 Dora in this setting.

See also:
What other drugs will affect Dora?

Inhibitors Of Cytochrome P450 3A4

In controlled clinical studies co-administration of Dora with ketoconazole, erythromycin, or azithromycin resulted in increased plasma concentrations of Dora and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of Dora.

Fluoxetine

In controlled clinical studies co-administration of Dora with fluoxetine, a selective serotonin reuptake inhibitor (SSRI), resulted in increased plasma concentrations of Dora and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of Dora.

Cimetidine

In controlled clinical studies co-administration of Dora with cimetidine, a histamine H2-receptor antagonist, resulted in increased plasma concentrations of Dora and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of Dora.

Drug Abuse And Dependence

There is no information to indicate that abuse or dependency occurs with Dora Tablets.

See also:
What are the possible side effects of Dora?

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 Dora 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 Dora and placebo-treated patients. The percent of patients who withdrew prematurely due to adverse events was 2.4% in the Dora group and 2.6% in the placebo group. There were no serious adverse events in these trials in patients receiving Dora. All adverse events that were reported by greater than or equal to 2% of patients who received the recommended daily dose of Dora tablets (5 mg once daily), and that were more common with Dora tablets than placebo, are listed in Table 1.

The frequency and magnitude of laboratory and electrocardiographic abnormalities were similar in Dora 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 Dora tablets and 205 received placebo. Adverse events that were reported by greater than or equal to 2% of patients who received Dora tablets and that were more common with Dora than placebo were (rates for Dora 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 Dora

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 Dora and placebo in at least 2 percent of subjects receiving Dora

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 Dora product and placebo in at least 2 percent of subjects receiving Dora

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 Dora and placebo in at least 2 percent of subjects receiving Dora

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 Dora

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 Dora: 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.