Moncet

Perennial Allergic Rhinitis : Moncet

Oral Solution, USP is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing.

Chronic Urticaria: Moncet

Oral Solution, USP is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.

Moncet is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Moncet is used to treat cold or allergy symptoms such as sneezing, itching, watery eyes, or runny nose.

Moncet is also used to treat itching and swelling caused by chronic urticaria (hives).

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

Moncet

Oral Solution, USP can be taken without regard to food consumption.

Children 2 to 5 Years for Chronic Urticaria: The recommended initial dose of Moncet

Oral Solution, USP in children aged 2 to 5 years is 2.5 mg (½ teaspoonful) syrup once daily. The dosage in this age group can be increased to a maximum dose of 5 mg per day given as 1 teaspoonful syrup once a day, or one ½ teaspoonful syrup given every 12 hours.

Children 6 months to < 2 years for Perennial Allergic Rhinitis and Chronic Urticaria: The recommended dose of Moncet

Oral Solution, USP in children 6 months to 23 months of age is 2.5 mg (½ teaspoonful) once daily. The dose in children 12 to 23 months of age can be increased to a maximum dose of 5 mg per day, given as ½ teaspoonful (2.5 mg) every 12 hours.

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What is the most important information I should know about Moncet?

The use of QUZYTTIR is contraindicated in patients with a known hypersensitivity to Moncet or any of its ingredients, levocetirizine, or hydroxyzine.

Use Moncet as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Do not remove the blister unit from the carton until you are ready to take Moncet. Make sure that your hands are dry when you open the blister unit. Do not push the tablet through the foil. Peel back the foil on the blister unit and place the tablet on your tongue. The tablet dissolves quickly and can be swallowed with saliva. Moncet may be taken with or without water. Take the tablet immediately after opening the blister unit. Do not store the removed tablet for future use.
• If you miss a dose of Moncet 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 Moncet.

This combination medication is used to treat tension headaches. Acetaminophen helps to decrease the pain from the headache. Caffeine helps increase the effects of acetaminophen. Butalbital is a sedative that helps to decrease anxiety and cause sleepiness and relaxation.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to treat migraine headaches.

How to use Moncet

Take this medication by mouth with or without food as directed by your doctor, usually every 4 hours as needed.

If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

The dosage is based on your medical condition, age, and response to treatment. This medication works best if it is used as the first signs of a headache occur. If you wait until the headache has worsened, the medication may not work as well.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as nausea/vomiting, mental/mood changes, seizures) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Report any withdrawal reactions right away.

Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.

Tell your doctor if you notice increased use of this medication, a worsening of headaches, an increase in the number of headaches, the medication not working as well, or use of this medication for more than 2 headache episodes a week. Do not take more than recommended. Your doctor may need to change your medication and/or add a separate medication to prevent the headaches.

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What other drugs will affect Moncet?

Theophylline decreases the clearance of Moncet although the disposition of theophylline is not affected.

In common with other antihistamines it is recommended that excessive alcohol consumption be avoided. Concurrent use of Moncet with other CNS depressants should also be avoided as reduction in alertness and impairment of performance may occur.

No evidence of interactions with antipyrine, azithromycin, cimetidine, diazepam, erythromycin, ketoconazole and pseudoephedrine has been reported.

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What are the possible side effects of Moncet?

The following clinically significant adverse reaction is described elsewhere in the labeling:

• Somnolence/Sedation

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 practice.

Oral Moncet

The following adverse reactions associated with the use of oral Moncet were identified in clinical trials.

In clinical trials in patients 12 years and older the most common adverse reactions to oral Moncet occurring with a 2% or greater incidence and greater than placebo were somnolence (14%), fatigue (6%), dry mouth (5%), pharyngitis (2%), and dizziness (2%). In clinical trials in children 6 to 11 years of age with oral Moncet the most common adverse reactions occurring with a 2% or greater incidence and greater than placebo were headache, pharyngitis, abdominal pain, coughing, somnolence, diarrhea, epistaxis, bronchospasm, nausea, and vomiting. Somnolence appeared to be dose related. Adverse reactions reported in placebo-controlled trials with oral Moncet in pediatric patients 2 to 5 years were qualitatively similar in nature and generally similar in frequency to those reported in trials with children 6 to 11 years of age. In placebo-controlled trials of pediatric patients 6 to 24 months of age, the incidences of adverse experiences were similar in the oral Moncet and placebo treatment groups in each trial. In a trial of 1 week duration in children 6 to 11 months of age patients who received oral Moncet exhibited greater irritability/fussiness than patients on placebo. In a trial of 18 months duration in patients 12 months and older, insomnia occurred more frequently in patients who received oral Moncet compared to patients who received placebo.

QUZYTTIR

The safety data of QUZYTTIR was evaluated in a randomized, double-blind, single-dose, non-inferiority study comparing QUZYTTIR to intravenous diphenhydramine in 262 adults with acute urticaria.

The adverse reactions with QUZYTTIR occurred at an incidence of less than 1% and include: dyspepsia, feeling hot, dysgeusia, headache, paresthesia, presyncope, and hyperhidrosis.

An additional randomized, double-blind, single dose study was conducted in 33 adults which showed similar safety results.

Sedation

Subject-rated sedation scores were assessed at baseline, 1 hr, and/or 2 hrs, and/or "Readiness for Discharge”. Sedation was rated on a 0 to 3 scale (0 = none, to 3 = severe) with lower sedation scores indicating less sedation. Subjects in the QUZYTTIR treatment group reported less sedation at all time points compared to subjects treated with diphenhydramine.

Moncet HCl is a piperazine derivative and a metabolite of hydroxyzine. It competes reversibly with histamine to block the histamine (H₁) receptor sites. Moncet HCl is considered a long-acting nonsedating antihistamine and has some mast-cell stabilizing activity.