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Levocetirizine Dihydrochloride 5 Mg

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Last Updated: 24 September 2020

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General | Latest Info

The daily recommended dose is 5 mg. Adjustment of Dose is recommended in elderly Patients with Moderate to Severe Renal Impairment. Dosing intervals must be individualise according to Renal function. Refer to the following table and adjust dose as indicated. To use this dosing table, estimate of patient's creatinine clearance in mL / min is needed. CLCR may be estimated from serum creatinine determination using the following formula: in paediatric patients suffering from Renal Impairment, dose will have to be adjusted on an individual basis taking into account renal clearance of patient and his body weight. There is no specific data for Children with Renal Impairment. No dose adjustment is needed in Patients with solely Hepatic Impairment. In Patients with Hepatic Impairment and Renal Impairment, adjustment of dose is recommend. The daily recommended dose is 5 mg. For children aged 2 to 6 years, no adjusted dosage is possible with film - coat tablet formulation. It is recommended to use paediatric formulation of Levocetirizine. Film - coated tablets must be taken orally, swallowed whole with liquid and may be taken with or without food. It is recommended to take Daily Dose in one single intake. Intermittent Allergic Rhinitis has to be treated according to the disease and its history; it can be stopped once symptoms have disappeared and can be restart again when symptoms reappear. In the case of persistent Allergic Rhinitis, continuous therapy can be proposed to patients during period of exposure to allergens. There is Clinical Experience with Use of Levocetirizine For treatment periods of at least 6 Months. In Chronic Urticaria and Chronic Allergic Rhinitis, There is Clinical Experience of Use of cetirizine for up to one year. Precaution is recommended with concurrent intake of alcohol. Caution should be taken in patients with predisposing factors of Urinary Retention As Levocetirizine may increase the risk of Urinary Retention. Caution should be taken in patients with epilepsy and patients at risk of convulsion as Levocetirizine may cause seizure aggravation. Response to allergy Skin tests are inhibited by antihistamines and a wash - out period is required before performing them. Patients with rare hereditary problems of galactose intolerance, Total lactase deficiency or glucose - galactose malabsorption should not take this medicine. Pruritus may occur when Levocetirizine is stopped even if those symptoms were not present before treatment initiation. Symptoms may resolve spontaneously. In some cases, symptoms may be intense and may require treatment to be restart. Symptoms should resolve when treatment is restart. Use of film - coat tablet formulation is not recommended in children aged less than 6 years since this formulation does not allow for appropriate dose adaptation. It is recommended to use paediatric formulation of Levocetirizine. No Interaction Studies have been performed with Levocetirizine; Studies with racemate compound cetirizine demonstrate that there were no clinically relevant ADVERSE interactions.

* 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

Acetaminophen; Butalbital: concurrent use of cetirizine / levocetirizine with barbiturates should generally be avoid. Coadministration may increase the risk of CNS depressant - related side effects. If concurrent use is necessary, monitor for excessive sedation and somnolence. Acetaminophen; Butalbital; Caffeine: concurrent use of cetirizine / levocetirizine with barbiturates should generally be avoid. Coadministration may increase the risk of CNS depressant - related side effects. If concurrent use is necessary, monitor for excessive sedation and somnolence. Acetaminophen; Butalbital; Caffeine; Codeine: concomitant use of opioid agonists with cetirizine / levocetirizine may cause excessive sedation and somnolence. Limit use of opioid pain medications with cetirizine to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, lowest effective doses and minimum treatment durations are needed to achieve desired clinical effect. Educate patients about risks and symptoms of excessive CNS depression. Concurrent use of cetirizine / levocetirizine with barbiturates should generally be avoid. Coadministration may increase the risk of CNS depressant - related side effects. If concurrent use is necessary, monitor for excessive sedation and somnolence. Acetaminophen; Caffeine; Dihydrocodeine: concomitant use of opioid agonists with cetirizine / levocetirizine may cause excessive sedation and somnolence. Limit use of opioid pain medications with cetirizine to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, lowest effective doses and minimum treatment durations are needed to achieve desired clinical effect. Educate patients about risks and symptoms of excessive CNS depression. Acetaminophen; Codeine: concomitant use of opioid agonists with cetirizine / levocetirizine may cause excessive sedation and somnolence. Limit use of opioid pain medications with cetirizine to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, lowest effective doses and minimum treatment durations are needed to achieve desired clinical effect. Educate patients about risks and symptoms of excessive CNS depression. Acetaminophen; Hydrocodone: concomitant use of opioid agonists with cetirizine / levocetirizine may cause excessive sedation and somnolence. Limit use of opioid pain medications with cetirizine to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, lowest effective doses and minimum treatment durations are needed to achieve desired clinical effect. Educate patients about risks and symptoms of excessive CNS depression. Acetaminophen; Oxycodone: concomitant use of opioid agonists with cetirizine / levocetirizine may cause excessive sedation and somnolence. Limit use of opioid pain medications with cetirizine to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, lowest effective doses and minimum treatment durations are needed to achieve desired clinical effect. Educate patients about risks and symptoms of excessive CNS depression. Acetaminophen; Pentazocine: concurrent use of cetirizine / levocetirizine with Pentazocine should generally be avoid. Coadministration may increase the risk of CNS depressant - related side effects. If concurrent use is necessary, monitor for excessive sedation and somnolence. Acetaminophen; Propoxyphene: concomitant use of opioid agonists with cetirizine / levocetirizine may cause excessive sedation and somnolence. Limit use of opioid pain medications with cetirizine to only patients for whom alternative treatment options are inadequate.

* 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

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


Table 2

* Clinically relevant drug - drug interactions are unlikely with most second - generation H 1 antihistamines. * Onset / duration of action is based on wheal and flare studies. Five or 6 decades ago, when many of first - generation H 1 antihistamines were introduce, pharmacokinetic and pharmacodynamic studies were not required by regulatory agencies. They have subsequently been perform for some of these drugs. Empirical dosage regimens persist; for example, manufacturers recommend diphenhydramine dose for allergic rhinitis is 25 to 50 mg every 4 to 6 hours, and diphenhydramine dose for insomnia is 25 to 50 mg at bedtime. Use of sustained - action formulations persists, despite long terminal elimination half - life values identified for medications such as chlorpheniramine. Intranasal and ophthalmic H 1 antihistamines: t max, t1 / 2, and drug - drug interactions were determined after oral administration. | Intranasal and ophthalmic H 1 antihistamine formulations: onset and duration of action is based on the usual adult dose of 1 to 2 sprays in each nostril or 1 drop in each eye.

* 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

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

Side Effects

Relief of symptoms associated with seasonal and perennial allergic rhinitis treatment of uncomplicated skin manifestations of chronic idiopathic urticaria use of XYZAL has been associated with somnolence, fatigue, asthenia, and urinary retention. The most common Adverse Reactions were somnolence, nasopharyngitis, fatigue, dry mouth, and pharyngitis in subjects 12 years of age and older, and pyrexia, somnolence, cough, and epistaxis in children 6 to 12 years of age. In subjects 1 to 5 years of age, most common Adverse Reactions were pyrexia, diarrhea, vomiting, and otitis media. In subjects 6 to 11 months of age, most common Adverse Reactions were diarrhea and constipation. In addition to Adverse Reactions reported during Clinical trials and list above, adverse events have also been identified during post - approval use of XYZAL. Because these events are reported voluntarily from population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse events of hypersensitivity and anaphylaxis, increased appetite, angioedema, fix Drug eruption, pruritus, rash and urticaria, convulsion, paraesthesia, dizziness, tremor, dysgeusia, vertigo, movement disorders, aggression and agitation, hallucinations, depression, insomnia, suicidal ideation, visual disturbances, blur vision, palpitations, tachycardia, dyspnea, nausea, vomiting, hepatitis, dysuria, urinary retention, myalgia, and edema have been report. Besides these events reported under treatment with XYZAL, other potentially severe adverse events have been reported from post - marketing experience with cetirizine. Since levocetirizine is the principal pharmacologically active component of cetirizine, one should take into account the fact that following adverse events could also potentially occur under treatment with XYZAL: orofacial dyskinesia, severe hypotension, cholestasis, glomerulonephritis, still birth, tic, myoclonus, and extrapyramidal symptoms. Xyzal is available as 2. 5 mg / 5 mL oral solution and as 5 mg breakable tablets, allowing for administration of 2. 5 mg, if needed XYZAL can be taken without regard to food consumption. In vitro data indicate that levocetirizine is unlikely to produce pharmacokinetic interactions through inhibition or induction of liver Drug - metabolizing enzymes. No in vivo Drug - Drug interaction studies have been performed with levocetirizine. Drug interaction studies have been performed with racemic cetirizine. Pharmacokinetic interaction studies performed with racemic cetirizine demonstrate that cetirizine does not interact with antipyrine, pseudoephedrine, erythromycin, azithromycin, ketoconazole, and cimetidine. There was a small decrease in clearance of cetirizine caused by 400 mg dose of theophylline. It is possible that higher theophylline doses could have a greater effect. Ritonavir increases the plasma AUC of cetirizine by about 42%, accompanied by an increase in half - life and decrease in clearance of cetirizine. Disposition of ritonavir was not altered by concomitant cetirizine administration. There are no adequate and well - controlled studies on pregnant women. Because animal reproduction studies are not always predictive of human response, XYZAL should be used during pregnancy only if clearly needed. No peri - and post - natal animal studies have been conducted with levocetirizine. Cetirizine has been reported to be excreted in human breast milk. Because levocetirizine is also expected to be excreted in human milk, use of XYZAL in nursing mothers is not recommend.


Clinical Trials Experience

Safety data described below reflect exposure to XYZAL 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 are based upon eight clinical trials in which 1896 patients were treated with XYZAL 2. 5 5, or 10 mg once daily in the evening. Short - term safety data from pediatric patients are based upon two clinical trials in which 243 children with allergic rhinitis were treated with XYZAL 5 mg once daily for 4 to 6 weeks, one clinical trial in which 114 children with allergic rhinitis or chronic idiopathic urticaria were treated with XYZAL 1. 25 mg twice daily for 2 weeks, and one clinical trial in which 45 children with symptoms of allergic rhinitis or chronic urticaria were treated with XYZAL 1. 25 mg once daily for 2 weeks. Long - term safety data in adults and adolescents are based upon two clinical trials in which 428 patients with allergic rhinitis were exposed to treatment with XYZAL 5 mg once daily. Long term safety data is also available from an 18 - month trial in 255 XYZAL - treated subjects 12 - 24 months of age. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of drug cannot be directly compared to rates in clinical trial of another drug and may not reflect rates observed in practice.

* 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

Overview TOP

The dose of this medicine will be different for different patients. Follow your doctor's orders or directions on the label. The following information includes only average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of medicine. Also, number of doses you take each day, time allowed between doses, and length of time you take medicine depend on the medical problem for which you are using medicine. For oral dosage forms: for hay fever or hives: Adults and children 12 years of age and older5 milligrams or 10 milliliters once day in evening. Your doctor may adjust your dose as needed for children 6 to 11 years of age2. 5 mg or 5 mL once a day in the evening. Children 6 months to 5 years of age1. 25 mg or 2. 5 mL once a day in the evening. Infants up to 6 months of ageUse and dose must be determined by your doctor.

* 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

HOW SUPPLIED

In deciding to use medicine, risks of taking medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, following should be consider: tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non - prescription products, read the label or package ingredients carefully. Appropriate studies performed to date have not demonstrated pediatric - specific problems that would limit the usefulness of levocetirizine in children. Safety and efficacy have not been established in infants younger than 6 months of age for levocetirizine oral solution, children younger than 2 years of age for Children's Xyzal Allergy 24HR oral solution, and children younger than 6 years of age for tablet.S Use is not recommended in children 6 months to 11 years of age with kidney disease. Appropriate studies performed to date have not demonstrated geriatric - specific problems that would limit the usefulness of levocetirizine in the elderly. However, elderly patients are more likely to have age - related liver, kidney, or heart problems, which may require caution and adjustment in dose for patients receiving levocetirizine. There are no adequate studies in women to determine infant risk when using this medication during breastfeeding. Weigh potential benefits against potential risks before taking this medication while breastfeeding. Although certain medicines should not be used together at all, in other cases, two different medicines may be used together even if interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. Following interactions have been selected on the basis of their potential significance and are not necessarily all - inclusive. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines. Pitolisant certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional about use of your medicine with food, alcohol, or tobacco. The presence of other medical problems may affect use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially: enlarged prostate or lesions in the spinal cordUse. With caution. May increase the risk of urinary retention. Kidney disease, severe or patients undergoing hemodialysisShould not be used in patients with these conditions. Urinary retention use with caution. May make this condition worse.

* 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

OVERDOSE

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. The recommended dose of Levocetirizine dihydrochloride tablets is 5 mg once daily in the evening. Some patients may be adequately controlled by 2. 5 mg once daily in the evening. The recommended dose of Levocetirizine dihydrochloride tablets 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. 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.

* 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?

The typical dosage is one 5 - mg tablet once per day in the evening. The typical dosage is one 5 - mg tablet once per day in the evening. The typical dosage is one half - tablet once per day in the evening. Dosage for levocetirizine oral tablet hasnt been established for children younger than 6 years of age. Kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more drugs stay in your body for longer time. This raises your risk of side effects. Your doctor may start you on a lower dose or different dosing schedule. This can help keep levels of this drug from building up too much in your body.

* 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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