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Levocetirizine Dihydrochloride Tablet

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Last Updated: 18 September 2020

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General | Latest Info

Levocetirizine Dihydrochloride Tablets are available as 5 mg breakable Tablets, allowing for administration of 2. 5 mg, if needed Levocetirizine Dihydrochloride Tablets can be taken without regard to food consumption. Recommend Dose of Levocetirizine Dihydrochloride tablet is 5 mg Once Daily in evening. Some patients may be adequately controlled by 2. 5 mg Once Daily in the evening. The recommended dose of Levocetirizine Dihydrochloride tablet is 2. 5 mg Once Daily in the evening. 2. The 5 mg dose should not be exceeded because systemic exposure of 5 mg is approximately twice that of adults. In adults and children 12 years of age and older with: mild Renal Impairment: Dose of 2. 5 mg Once Daily is recommend; Moderate Renal Impairment: Dose of 2. 5 mg Once every other day is recommend; Severe Renal Impairment: Dose of 2. 5 mg Twice weekly is recommend; End - stage Renal disease patients and patients undergoing hemodialysis should not receive Levocetirizine Dihydrochloride Tablets. No dose adjustment is needed in Patients with solely Hepatic Impairment. In Patients with both Hepatic Impairment and Renal Impairment, adjustment of dose is recommend. Use of Levocetirizine Dihydrochloride tablet is contraindicate In: 4. 1 Patients with known hypersensitivity Patients with known hypersensitivity to Levocetirizine or any of ingredients of Levocetirizine Dihydrochloride Tablets, or to cetirizine. Observed REACTIONS range from Urticaria to anaphylaxis. 4. 2 Patients with End - stage Renal disease Patients with End - stage Renal disease and Patients undergoing hemodialysis 4. 3 Pediatric Patients with impaired Renal function Children 6 Months to 11 Years of Age with impaired Renal function 5. 1 Somnolence in Clinical Trials occurrence of somnolence, fatigue, and asthenia has been reported in some patients under therapy with Levocetirizine Dihydrochloride. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness, and motor coordination such as operating machinery or driving a motor vehicle after ingestion of Levocetirizine Dihydrochloride. Concurrent Use of Levocetirizine Dihydrochloride with Alcohol or other Central Nervous System Depressants should be avoided because additional reductions in alertness and additional impairment of Central Nervous System performance may occur. 5. 2 Urinary Retention Urinary Retention has been reported Post - Marketing with Levocetirizine Dihydrochloride. Levocetirizine Dihydrochloride should be used with Caution in Patients with predisposing factors of Urinary Retention As Levocetirizine Dihydrochloride may increase the risk of Urinary Retention. Discontinue Levocetirizine Dihydrochloride if Urinary Retention occurs. Use of Levocetirizine Dihydrochloride has been associated with Somnolence, fatigue, asthenia, and Urinary Retention. 6. 1 Clinical Trials Experience safety Data described below reflect exposure to Levocetirizine Dihydrochloride in 2708 Patients with Allergic Rhinitis or Chronic Idiopathic Urticaria in 14 Controlled Clinical Trials of 1 Week to 6 Month Duration. Short - Term safety Data for adults and adolescents is based upon eight Clinical Trials in which 1896 patients were treated with Levocetirizine Dihydrochloride 2. 5 5, or 10 mg Once daily in the evening.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Uses

It is very important that your doctor check your or your child's progress to make sure this medicine is working properly. Urine tests may be needed to check for unwanted effects. If your symptoms do not improve within a few days or if they become worse, check with your doctor. This medicine may cause incomplete emptying of the bladder. Check with your doctor right away if you have a decrease in the frequency of urination or urine volume, difficulty in passing urine, or painful urination. This medicine may make you tired or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system. Use of alcohol or other medicines that affect CNS with levocetirizine may worsen side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Do not take other medicines unless they have been discussed with your doctor. This includes prescription or non - prescription medicines and herbal or vitamin supplements.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Interactions

Levocetirizine is an over - counter antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes / nose, sneezing, hives, and itching. It works by blocking certain natural substances that your body makes during allergic reaction. Levocetirizine is available under the following different brand names: Xyzal Allergy 24HR Tablets, Xyzal Allergy 24HR Oral Solution, and Xyzal. 5 mg 2. 5 mg / 5 mL indicates for relief of symptoms associated with seasonal and perennial allergic rhinitis. 5 mg orally daily in the evening. Some patients may respond to 2. 5 mg / day indicated for relief of symptoms associated with seasonal and perennial allergic rhinitis. Infants under 6 months: Safety and efficacy are not established Infants over 6 months to children 5 years: 1. 25 mg orally each day in evening children 6 - 12 years: 2. 5 mg orally each day in evening Children over 12 years: 5 mg orally each day in evening; Some patients may respond to 2. 5 mg / day indicates for uncomplicated skin manifestations of chronic idiopathic hives. 5 mg orally daily in the evening indicates uncomplicated skin manifestations of chronic idiopathic hives. Infants under 6 months: Safety and efficacy are not established Infants over 6 months to children 5 years: 1. 25 mg orally each day in evening children 6 - 12 years: 2. 5 mg orally each day in the evening Children over 12 years: 5 mg orally each day in evening Creatinine Clearance 50 - 80 mL / min: 2. 5 mg orally each day Creatinine Clearance 30 - 50 mL / min: 2. 5 mg orally every other day Creatinine Clearance 10 - 30 mL / min: 2. 5 mg orally 2 times / week Creatinine Clearance less than 10 mL / min and or hemodialysis: contraindicate Creatinine Clearance 50 - 80 mL / min: 2. 5 mg orally each day Creatinine Clearance l 30 - 50 mL / min: 2. 5 mg orally every other day Creatinine Clearance 10 - 30 mL / min: 2. 5 mg orally 2 times / week Creatinine Clearance less than 10 mL / min and or hemodialysis: contraindicate any degree of renal impairment: contraindicate adult and Pediatric: No dose adjustment required

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Drug Class: Antihistamines, 2nd Generation

Table

ConditionXyzalAllegra
Allergic rhinitisYesYes
Skin allergiesYesYes
Chronic idiopathic urticariaYesYes

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Precautions

Levocetirizine is an antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes / nose, and sneezing. It is also used to relieve itching and hives. It works by blocking certain natural substances that your body makes during allergic reaction. Levocetirizine does not prevent hives or prevent / treat serious allergic reaction.S If your doctor has prescribed epinephrine to treat Allergic Reactions, always carry your epinephrine injector with you. Do not use levocetirizine in place of your epinephrine. If you are taking over - counter product to self - treat, read and follow all directions on the product package before taking this medication. If you have any questions, consult your pharmacist. If your doctor has prescribed this medication, take it directly. This medication is taken by mouth with or without food, usually Once daily in the evening. If you are using the liquid form of this medication, measure the dose carefully using a special measuring device / spoon. Do not use household spoon because you may not get the correct dose. Dosage is based on your age, medical condition, and response to treatment. Do not increase your dose or take this medication more often than direct. If your condition does not get better or if it gets worse, or if you think you may have a serious medical problem, get medical help right away.


Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use and share it with your doctor and pharmacist. Do not start, stop, or change dosage of any medicines without your doctor's approval. Tell your doctor or pharmacist if you are taking other products that cause drowsiness, such as opioid pain or cough relievers, alcohol, marijuana, drugs for sleep or anxiety, muscle relaxants, or other antihistamines. Check labels on all your medicines because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely. Do not use any other antihistamines applied to the skin because increased side effects may occur. Levocetirizine is very similar to hydroxyzine and cetirizine. Do not use these medications while using levocetirizine. This medication may interfere with certain laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Side Effects

Get emergency medical help if you have signs of allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using levocetirizine and call your doctor at once if you have: worsening allergy or urticaria symptoms; painful or difficult urination; little or no urination; light - head feeling, like you might pass out; fever; or signs of ear infection - ear pain or full feeling, trouble hearing, drainage from your ear, fussiness in child. Drowsiness, tiredness; sinus pain; ear infection; cough; fever; nosebleed; vomiting, diarrhea, constipation; dry mouth; or weight gain. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1 - 800 - FDA - 1088.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

teratorgenic effects:

In rats and rabbits, levocetirizine was not teratogenic at oral doses of approximately 320 and 390, respectively, maximum recommended daily oral dose in adults on a mg / m 2 basis. No peri - and post - natal animal studies have been conducted with levocetirizine. In mice, cetirizine caused retarded pup weight gain during lactation at oral dose in dams that was approximately 40 times the maximum recommended daily oral dose in adults on a mg / m 2 basis. Studies in beagle dogs indicate that approximately 3% of the dose of cetirizine was excreted in milk. Cetirizine has been reported to be excreted in human breast milk. Because levocetirizine is also expected to be excreted in human milk, use of levocetirizine dihydrochloride in nursing mothers is not recommend. Recommended dose of levocetirizine dihydrochloride for treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in patients 6 months to 17 years of age is based on extrapolation of efficacy from adults 18 years of age and older. Recommend dose of levocetirizine dihydrochloride in patients 6 months to 11 years of age for treatment of symptoms of perennial allergic rhinitis and chronic idiopathic urticaria and in patients 2 to 11 years of age for treatment of symptoms of seasonal allergic rhinitis is based on cross - study comparisons of systemic exposure of levocetirizine dihydrochloride in adults and pediatric patients and on safety profile of levocetirizine dihydrochloride in both adult and pediatric patients at doses equal to or higher than recommend dose for patients 6 months to 11 years of age. The Safety of levocetirizine dihydrochloride 5 mg once daily was evaluated in 243 pediatric patients 6 to 12 years of age in two placebo - control clinical trials lasting 4 and 6 weeks. Safety of levocetirizine dihydrochloride 1. 25 mg twice daily was evaluated in one 2 - week clinical trial in 114 pediatric patients 1 to 5 years of age and the safety of levocetirizine dihydrochloride 1. 25 mg once daily was evaluated in one 2 - week clinical trial in 45 pediatric patients 6 to 11 months of age. Effectiveness of levocetirizine dihydrochloride 1. 25 mg once daily and 2. 5 mg once daily for treatment of symptoms of seasonal and perennial allergic rhinitis and chronic idiopathic urticaria is supported by extrapolation of demonstrated efficacy of levocetirizine dihydrochloride 5 mg once daily in patients 12 years of age and older based on pharmacokinetic comparison between adults and children. Cross - study comparisons indicate that administration of 5 mg dose of levocetirizine dihydrochloride to 6 to 12 year old pediatric seasonal allergic rhinitis patients results in about 2 - fold systemic exposure observed when 5 mg of levocetirizine dihydrochloride was administered to healthy adults. Therefore, for children 6 to 11 years of age, recommend a dose of 2. 5 mg once daily should not be exceed. In population pharmacokinetics study administration of 1. 25 mg once daily in children 6 months to 5 years of age results in systemic exposure comparable to 5 mg once daily in adults.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

What is levocetirizine?

Levocetirizine is an anti - allergy medicine. It stops the effects of a substance called histamine and this helps to relieve symptoms of allergies such as hay fever and urticaria. Exposure to substances such as pollen, pet fur, house dust or insect bites can cause your body to produce allergic symptoms. Cells on the lining of your nose and eyes release histamine when they come into contact with these substances. This leads to inflammation in your nose and eyes, which produces symptoms such as sneezing and watery eyes. Urticaria is a condition where itchy skin rash develops. Rash can be triggered by allergy to substances such as soap or detergent.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Take as directed

The Levocetirizine oral tablet is used for short - term treatment of seasonal allergies and long - term treatment of chronic itching. It comes with risks if you do take it as prescribe. If you stop taking drug suddenly or do take it at all: If you take this drug to treat allergy symptoms, these symptoms may not be controlled or may get worse. These symptoms can include sneezing, runny nose, and red, watery, itchy eyes. If youre taking this drug to treat itching caused by hives, this itching may not be controlled or may get worse. If you miss doses or do take drugs on schedule: Your medication may not work as well or may stop working completely. For this drug to work well, certain amount needs to be in your body at all times. If you take too much: you could have dangerous levels of drugs in your body. Symptoms of overdose of this drug can include: increased drowsiness, agitation and restlessness, followed by drowsiness. If you think youve take too much of this drug, call your doctor or local poison control center. If your symptoms are severe, call 911 or go to the nearest emergency room right away. What to do If you miss dose: Take your dose as soon as you remember. But if you remember just a few hours before your next scheduled dose, take only one dose. Never try to catch up by taking two doses at once. This could result in dangerous side effects. How to tell if a drug is working: If you taking this drug to treat allergy symptoms, these symptoms should improve. These can include sneezing, runny nose, and red, watery, itchy eyes. If youre taking this drug to treat itching caused by hives, this itching should improve.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Sources

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

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