Xyzal 5 mg drug reviews Uses, Dosage, Side Effects & Warnings
what is xyzal ?
- XYZAL 5 mg film-coated tablets are indicated for the treatment of the symptoms of allergic rhinitis (including persistent allergic rhinitis).
- XYZAL film-coated tablets are also indicated for the treatment of urticaria symptoms such as itching and redness.
what is xyzal used for & indication ?
Xyzal, 5 mg film-coated tablets is indicated for the symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and urticaria in adults and children 6 years of age and older.
The tablets will be swallowed with a drink and can be taken during or after meals. It is advisable to take the daily dose in one take.
Adults and children over 12 years old:
- 5 mg per day, ie 1 film-coated tablet.
- A dose adjustment is recommended in elderly patients with moderate to severe renal impairment (see “renal impairment” below).
Children from 6 to 12 years old:
- xyzal 5 mg per day, ie 1 film-coated tablet.
- The film-coated form does not allow dosage adjustment for children aged 2 to 6 years. It is recommended to use a pediatric form of levocetirizine.
- The interval between doses should be adjusted according to renal function as shown in the table below.
To use this table, it is necessary to calculate the creatinine clearance (CL cr ) of the patient in ml / min. The LC cr (ml / min) can be estimated from the value of serum creatinine (in mg / dl) according to the following formula:
[140 – age (years)] x weight (kg)
CL cr = ———————————————– x ( 0.85 for women )
72 x serum creatinine (mg / dl)
Dosage adjustment in patients with renal impairment:
|Group||Creatinine clearance (ml / min)||Dose and frequency of administration|
|Normal kidney function||$ 80||1 tablet once a day|
|Mild renal insufficiency||50-79||1 tablet once a day|
|Moderate renal insufficiency||30-49||1 tablet once every 2 days|
|Severe renal insufficiency||<30||1 tablet once every 3 days|
|End Stage Renal Insufficiency and Dialysis Patients||<10||Against-indicated|
In children with renal impairment, the dose will be adjusted individually based on the patient’s renal clearance and weight. There are no specific data in children with kidney failure.
- No dose adjustment is necessary in patients with isolated hepatic impairment.
Duration of the treatment
- Intermittent allergic rhinitis, defined by the presence of symptoms less than 4 days per week or over a period of less than 4 weeks, will be treated according to the pathology and its history. The treatment can be stopped once the symptoms have disappeared and resumed at the reappearance of symptoms. In case of persistent allergic rhinitis (defined by the occurrence of symptoms more than 4 times per week and over a period of more than 4 weeks), continuous treatment may be offered to the patient during the period of allergen exposure.
- Clinical experience is 6 months of treatment with 1 tablet 5 mg levocetirizine daily.
- With cetirizine (a racemic form), there is clinical experience of up to one year of treatment for chronic urticaria and chronic allergic rhinitis.
- Levocetirizine hypersensitivity
- Cetirizine hypersensitivity
- Hydroxyzine hypersensitivity
- Hypersensitivity derivatives of piperazine
- Severe renal impairment (Clcr <10 ml / min)
- Child under 6
- Galactose intolerance
Hypersensitivity to the active substance, to cetirizine, to hydroxyzine or to piperazine derivatives or to any of the excipients listed in section Composition.
Severe renal impairment with creatinine clearance less than 10 ml / min.
how xyzal works ?
Pharmacotherapeutic group: Antihistamines for systemic use, piperazine derivatives, ATC code: R06AE09 .
- Levocetirizine, the R-enantiomer of cetirizine, is a potent and selective antagonist of peripheral H 1 receptors .
- Receptor binding studies revealed that levocetirizine has a high affinity for human H 1 receptors (Ki = 3.2 nmol / l). Levocetirizine has a 2-fold higher affinity than cetirizine (Ki = 6.3 nmol / l). The dissociation half-life of levocetirizine from H 1 receptors is 115 ± 38 min.
- The receptor occupancy after single administration of levocetirizine has been shown to be 90% after 4 hours and 57% after 24 hours.
- Pharmacodynamic studies in healthy volunteers showed comparable activity between cetirizine and levocetirizine at half-dose, both in the skin and nose.
- The pharmacodynamic properties of levocetirizine have been studied in randomized controlled trials.
- A study compared the effects of levocetirizine 5 mg, 5 mg of desloratadine and a placebo on the reaction erythematous papular induced histamine. Treatment with levocetirizine significantly reduced the formation of papules and erythema with maximum intensity in the first 12 hours and maintained for 24 h ( p <0.001) compared to placebo and desloratadine.
- In a controlled study against placebo in pollen exposure room, the onset time of symptoms was 1 hour after administration of 5 mg of levocetirizine.
- In vitro studies (Boyden’s chamber and cell culture technique) show that levocetirizine inhibits eotaxin-induced transendothelial migration of eosinophils through dermal and bronchial cells. In an in vivo experimental placebo- controlled pharmacodynamic study in 14 adult patients (dermal chamber technique), three main inhibitory effects of levocetirizine 5 mg were detected in the first 6 hours of the exposure-induced reaction. pollen: inhibition of VCAM-1 release, modulation of vascular permeability and decrease in recruitment to eosinophils.
Efficacy and clinical safety
- The efficacy and safety of levocetirizine has been demonstrated in several clinical studies double-blind, controlled versus placebo in adult patients with seasonal allergic rhinitis, perennial or persistent. Levocetirizine significantly improved the symptoms of allergic rhinitis, including nasal obstruction in some studies.
- A 6-month clinical study in 551 adult patients (276 patients treated with levocetirizine) with persistent allergic rhinitis (symptoms present 4 days a week for at least 4 consecutive weeks) and sensitized to dust mites and grass pollen showed that Levocetirizine 5 mg was significantly more clinically and statistically effective than placebo in improving the overall symptom score for allergic rhinitis throughout the study, without tachyphylaxis. Throughout the study, levocetirizine significantly improved the quality of life of patients.
- In a placebo-controlled clinical study in 166 patients with chronic idiopathic urticaria, 85 patients were treated with placebo and 81 patients received levocetirizine 5 mg once daily for 6 weeks. Levocetirizine treatment significantly reduced the severity of pruritus during the first week and throughout the course of treatment compared with placebo. Levocetirizine also improved the quality of life related health outcomes assessed using the Dermatology Life Quality Index compared to placebo.
- Chronic idiopathic urticaria has been studied as a model for urticarial manifestations. Since histamine release is the factor responsible for urticarial manifestations, the efficacy of levocetirizine in the symptomatic treatment of chronic idiopathic urticaria can be extrapolated to other forms of urticaria.
- ECGs did not show any relevant effects of levocetirizine on the QT interval.
- The efficacy and safety of pediatric levocetirizine tablets in pediatric patients was studied in two placebo-controlled clinical studies in children aged 6 to 12 years with seasonal or perennial allergic rhinitis. In both studies, levocetirizine treatment significantly improved symptoms and quality of life related to health status.
- In children under 6, clinical safety has been established on the basis of several short or long-term therapeutic studies:
- A clinical trial in which 29 children aged 2-6 years with allergic rhinitis were treated with levocetirizine 1.25 mg twice daily for 4 weeks;
- A clinical trial in which 114 children aged 1-5 years with allergic rhinitis or chronic idiopathic urticaria were treated with levocetirizine 1.25 mg twice daily for 2 weeks;
- A clinical trial in which 45 children aged 6 to 11 months with allergic rhinitis or chronic idiopathic urticaria were treated with levocetirizine 1.25 mg once daily for 2 weeks;
- A long-term (18-month) clinical trial of 255 atopic patients treated with levocetirizine, 12-24 months of age at baseline.
- The safety profile was similar to that observed in short-term studies in children aged 1 to 5 years.
What are the side effects of Xyzal?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Frequent (may affect up to 1 in 10 people)
- Dry mouth, headache, tiredness and drowsiness / falling asleep
Uncommon (may affect up to 1 in 100 people)
- Exhaustion and stomachaches
Not known (frequency of occurrence can not be estimated from the available data)
- Palpitations, increased heart rate, convulsions, tingling and tingling, dizziness, syncope, tremors, dysgeusia (taste alteration), vertigo (feeling of rotation or movement), visual disturbances, blurred vision, pain or difficulty in passing urine, inability to completely empty the bladder, swelling, pruritus (itching), redness, hives (swelling, redness and itching of the skin), rash, shortness of breath, weight gain, muscle pain, joint pain, aggressive or restless behavior , hallucinations, depression, insomnia, recurrent ideas or suicidal concerns, hepatitis, abnormal liver function, vomiting, increased appetite, nausea and diarrhea. Pruritus (intense itching) after stopping treatment.
At the first sign of an allergic reaction, stop taking XYZAL and contact your doctor. Allergic symptoms may include swelling of the mouth, tongue, face and / or throat, difficulty breathing or swallowing (chest tightness or wheezing), hives, sudden drop in blood pressure which may lead to collapse or a potentially fatal shock.
Xyzal medication interactions
- No interaction studies were performed with levocetirizine (in particular, no study with CYP3A4 inducers); studies with cetirizine (racemic form) revealed no clinically relevant interactions (with antipyrine, azithromycin, cimetidine, diazepam, erythromycin, glipizide, ketoconazole and pseudoephedrine). A slight decrease in the clearance of cetirizine (16%) was observed with theophylline taken repeatedly (400 mg once daily), whereas the bioavailability of theophylline was not affected by concomitant administration of theophylline. cetirizine.
- In a multiple-dose study of ritonavir (600 mg twice daily) and cetirizine (10 mg daily), the extent of cetirizine exposure increased by approximately 40%, while the bioavailability of cetirizine increased by approximately 40%. ritonavir was slightly impaired (-11%) following concomitant administration of cetirizine.
- The absorption rate of levocetirizine is not decreased by diet, although its rate of absorption is reduced.
- Concomitant use of alcohol or other central nervous system (CNS) depressants with cetirizine or levocetirizine may result in increased impairment of alertness or performance in sensitive patients.
Warnings and Precautions
- XYZAL 5 mg , film-coated tablet is not suitable for children under 6 years of age, the tablet form does not allow the adaptation of the dose.
Drive and use machines
- Comparative clinical studies with levocetirizine at the recommended dosage have not revealed any impairment of alertness, reaction time or ability to drive.
- However, some patients may experience somnolence, fatigue, and asthenia during levocetirizine therapy. Therefore, patients who intend to drive a vehicle, engage in potentially hazardous activities, or use machines should consider their response to the medication.
Xyzal and PREGNANCY / BREAST FEEDING / FERTILITY:
xyzal tablet during pregnancy
- No or very little data is available on the use of levocetirizine during pregnancy (less than 300 cases of pregnancy). However, for cetirizine (racemic form of levocetirizine), the available data are numerous (more than 1000 cases of pregnancy) and have not shown evidence of malformative effect or fœto-neonatal toxicity.
- Animal studies have not revealed direct or indirect harmful effects on pregnancy, embryonic and fetal development, parturition and postnatal development ( see Preclinical Safety ).
- The use of levocetirizine may be considered during pregnancy, if necessary.
xyzal tablet during Breastfeeding
- Cetirizine (the racemic form of levocetirizine) has been shown to be excreted in breast milk. Therefore, it is likely that levocetirizine is also. Adverse effects associated with levocetirizine are likely to occur in breastfed infants. Therefore, caution is advised when prescribing levocetirizine in breastfeeding women.
xyzal tablet during Fertility
- No clinical data is available for levocetirizine.
What should I do if I miss a dose?
Do not take a double dose to make up for the dose you forgot to take.
xyzal overdose side effects ?
Overdosage can lead to drowsiness and drowsiness in the adult and to drowsiness and drowsiness.
Contact your doctor if you have taken more tablets than needed.
What is Forms and Composition ?
|FORMS and PRESENTATIONS|
- xyzal 5 mg film-coated tablet (white to off-white, oval, engraved “Y” on one side): Boxes of 14 and 28, in blister packs.
|Levocetirizine dihydrochloride||5 mg|
- Excipients: Core: microcrystalline cellulose, lactose monohydrate, anhydrous colloidal silica, magnesium stearate. Film coating : Opadry ® Y-1-7000 (hypromellose compound (E464), titanium dioxide (E171), macrogol 400).
- Excipient with known effect: lactose monohydrate (63.50 mg / cp).
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- For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.
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