When to take xyzal?

What is levocetirizine used for?

  • Relieving symptoms of hay fever (seasonal allergic rhinitis).
  • Relieving symptoms of nasal allergies such as pet allergies or dust mite allergies that occur throughout the year (perennial allergic rhinitis).
  • Treating itchy, nettle-type, allergic skin rashes (urticaria or hives).

Levocetirizine tablets are suitable for adults and children aged six years and over, while levocetirizine liquid (brand name Xyzal) can be given to children from two years of age and adults.

How does levocetirizine work?

Levocetirizine dihydrochloride is a type of medicine called a non-sedating antihistamine. It works by preventing the actions of histamine – a substance produced by the body when it reacts to a foreign substance such as pollen or pet fur (an allergen). Histamine acts on histamine receptors, causing a chain reaction that results in allergic symptoms.

In allergic reactions like hay fever, histamine causes inflammation of the nose, eyes or airways, resulting in itchy, watery eyes, a runny, blocked or itchy nose and sneezing. In allergic skin reactions histamine causes skin inflammation, rashes and itching.

Levocetirizine blocks histamine receptors and so stops the chain reaction that causes the symptoms of the allergy. It usually starts to work within an hour after taking a dose.

How do I take levocetirizine?

  • Adults and children aged six years and over should take one 5mg tablet OR two 5ml spoonfuls (10ml) liquid once a day, when needed to relieve symptoms of the allergy.
  • Children aged 2 to 6 years should be given 2.5ml of Xyzal liquid twice a day, measured using the oral syringe provided in the pack, when needed to relieve symptoms of the allergy.
  • Levocetirizine tablets and liquid can be taken either with or without food.
  • If you forget to take a dose, take it as soon as you remember. However, do not take a double dose to make up for a missed dose.
  • You can continue to use this medicine daily to relieve symptoms for as long as you are exposed to the allergen, for example throughout the pollen season. Follow the instructions given by your doctor.
  • If symptoms persist despite treatment, seek medical advice from your doctor or pharmacist.
  • Do not exceed the recommended dose.

What should I know before taking levocetirizine?

  • Levocetirizine is called a non-sedating or non-drowsy antihistamine because it doesn’t enter the brain in significant amounts, so it’s unlikely to cause drowsiness. However, some people do find that it makes them feel slightly drowsy. Make sure you know how you or your child react to it before doing potentially hazardous activities like driving, cycling or operating machinery.
  • If you do find levocetirizine makes you sleepy you should avoid drinking alcohol with it, as this could make any sleepiness or reduced alertness worse.
  • If you’re due to have any skin prick or patch tests to diagnose allergies you should stop taking this antihistamine at least three days before the tests. This is because antihistamines can prevent or lessen the skin reactions that indicate an allergy, and so can make the test results unreliable.

Who shouldn’t take levocetirizine?

  • People with severe kidney failure.
  • People who are allergic to piperazine derivatives, such as the related antihistamine cetirizine.
  • People with rare inherited blood disorders called porphyrias.
  • Levocetirizine tablets should not be given to children under six years old.
  • Xyzal liquid should not be given to children under two years old.
  • The medicine should not be used if you are allergic or intolerant to any of its ingredients. Check the ingredients listed in the leaflet that comes with the medicine if you know you or your child have specific allergies or intolerances.

Who might need a lower levocetirizine dose or extra monitoring?

  • People with kidney problems.
  • People who have difficulty passing urine, for example men with an enlarged prostate gland.
  • People with epilepsy.

Can I take levocetirizine while pregnant or breastfeeding?

  • The safety of levocetirizine for use during pregnancy has not been fully established. It should only be used during pregnancy if the benefits to the mother outweigh any potential risks to the developing baby. However, certain other antihistamines, or locally acting medicines like nasal sprays are usually preferred for treating pregnant women who cannot tolerate their hay fever symptoms. Ask your doctor for further advice.
  • Levocetirizine may pass into breast milk. Although the effects of this on a nursing infant are not known, it could potentially make the baby drowsy or irritable. It should only be used by women who are breastfeeding if the benefits to the mother outweigh any potential risks to the nursing infant. Certain other antihistamines, or locally acting medicines like nasal sprays are usually preferred for treating breastfeeding women who cannot tolerate their hay fever symptoms. Ask your doctor for further advice.

What are the possible side effects of levocetirizine?

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects known to be associated with levocetirizine. Just because a side effect is stated here doesn’t mean that all people taking this antihistamine will experience that or any side effect. Children and elderly people tend to be more susceptible to the side effects of antihistamines.

Common (affect between 1 in 10 and 1 in 100 people)

  • Headache.
  • Dry mouth.
  • Mild sleepiness or feeling tired. Don’t drive or drink alcohol if affected.
  • Diarrhoea or constipation in children.

Uncommon (affect between 1 in 100 and 1 in 1000 people)

  • Feeling weak and lacking energy or strength.
  • Abdominal pain.

Frequency unknown

  • Nausea and vomiting.
  • Visual disturbances such as blurred vision.
  • Skin reactions such as itching, rash, hives.
  • Awareness of your heartbeat (palpitations).
  • Fast heart beat (tachycardia).
  • Shortness of breath.
  • Dizziness.
  • Pins and needles sensations.
  • Convulsions (fits).
  • Tremor.
  • Difficulty passing urine.
  • Difficulty sleeping (insomnia).
  • Agitation or aggression.
  • Depression or hallucinations.
  • Weight gain.
  • Liver problems such as inflammation of the liver or abnormal liver function.

Read the leaflet that comes with the medicine or talk to your doctor or pharmacist if you want any more information about the possible side effects of levocetirizine. If you think you or your child have experienced a side effect, did you know you can report this using the yellow card website?

Can I take levocetirizine with other medicines?

Antihistamines may oppose the effect of histamine (used to treat leukaemia) and are not recommended for people having this treatment. Antihistamines may also oppose the effect of betahistine (used to treat Ménière’s disease) so levocetirizine is probably best avoided if you’re taking betahistine.

Other than these, levocetirizine is not known to affect other medicines. However, if you’re already taking any other medicines, including those bought without a prescription and herbal medicines, make sure you tell your doctor or pharmacist before taking levocetirizine as well, to make sure the combination is safe and appropriate.

It’s fine to take levocetirizine in combination with other types of medicine for hay fever, for example nasal sprays or eye drops.

What other medicines contain levocetirizine?

Levocetirizine is a generic medicine; it’s also available under the brand name Xyzal.

Last updated 13.07.2017

About levocetirizine

Type of medicine An antihistamine (non-drowsy)
Used for Allergies such as hay fever and some allergic skin reactions
Also called Xyzal®
Available as Tablets and oral liquid medicine

Levocetirizine is an anti-allergy medicine. It stops the effects of a substance called histamine and this helps to relieve the 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 in 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 an itchy skin rash develops. The rash can be triggered by an allergy to a substance such as a soap or a detergent.

Before taking levocetirizine

Some medicines are not suitable for people with certain conditions, and sometimes a medicine can only be used if extra care is taken. For these reasons, before you start taking levocetirizine it is important that your doctor knows:

  • If you are pregnant or breastfeeding.
  • If you have any problems with the way your kidneys work.
  • If you have epilepsy.
  • If you have a rare inherited blood disorder called porphyria.
  • If you are taking or using any other medicines. This includes any medicines you are taking which are available to buy without a prescription, as well as herbal and complementary medicines.
  • If you have ever had an allergic reaction to another antihistamine, or to any other medicine.

How to take levocetirizine

  • Before you start the treatment, read the manufacturer’s printed information leaflet from inside the pack. It will give you more information about levocetirizine, and will also provide you with a full list of side-effects which you could experience from taking it.
  • The usual dose for adults and older children is one (5 mg) tablet daily. If it is for a younger child (aged 2-6 years), they are likely to be prescribed liquid medicine, so check the label on the bottle carefully to make sure you give the correct dose for the age of your child.
  • Most people take levocetirizine in the morning, but you can take it at whatever time of day you find easiest to remember. Try to take your doses at the same time of day, each day, as this will help you to remember to take them regularly. You can take levocetirizine either before or after a meal. The tablets are best swallowed with a drink of water.
  • If you have been given the liquid medicine, an oral dose syringe will be included in the pack. This is to measure out the dose. Put the tip of the syringe into the medicine and draw the plunger up to the mark which corresponds to the dose prescribed. Remove the syringe from the bottle and empty its contents on to a spoon or into a small glassful of water. The medicine can be swallowed either undiluted, or diluted with water. Remember to rinse the syringe with water after using it.
  • If you forget to take a dose at your usual time, take it as soon as you remember. If you do not remember until the following day then leave out the forgotten dose from the previous day and take the dose that is due that day. Do not take two doses at the same time to make up for a missed dose.

Getting the most from your treatment

  • Many people only need to take an antihistamine when they have symptoms. Unless you are told otherwise, you should stop taking levocetirizine once your symptoms have eased.
  • Although levocetirizine is classed as a non-drowsy antihistamine, it can still cause drowsiness in a few people. If this happens to you, do not drive and do not use tools or machines.
  • If you drink alcohol while you are on levocetirizine, be aware of its effects on you and do not drink more than moderate amounts. Alcohol can increase the risk of side-effects from antihistamines.
  • If you are having an operation, or any treatment or tests (particularly if it is to test for an allergy), make sure you say that you are taking an antihistamine.
  • If you buy any medicines ‘over the counter’, check with a pharmacist that they are suitable to take with an antihistamine. This is because a number of other medicines can increase the risk of side-effects.

Can levocetirizine cause problems?

Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains the most common ones associated with levocetirizine. You will find a full list in the manufacturer’s information leaflet supplied with your medicine. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any continue or become troublesome.

Common levocetirizine side-effects (these affect less than 1 in 10 people) What can I do if I experience this?
Feeling tired, dizzy or sleepy If this happens, do not drive and do not use tools or machines
Dry mouth Try chewing sugar-free gum or sucking sugar-free sweets
Headache Drink plenty of water and ask your pharmacist to recommend a suitable painkiller. If the headaches continue, let your doctor know
Feeling sick (nausea), tummy ache (abdominal pain) Stick to simple meals – avoid rich or spicy foods

If you experience any other symptoms which you think may be due to the medicine, speak with your doctor or pharmacist for further advice.

How to store levocetirizine

  • Keep all medicines out of the reach and sight of children.
  • Store in a cool, dry place, away from direct heat and light.
  • The liquid medicine only keeps for three months once the bottle has been opened. Do not store it or use it for longer than this.

Important information about all medicines

Never take more than the prescribed dose. If you suspect that you or someone else might have taken an overdose of this medicine, go to the accident and emergency department of your local hospital. Take the container with you, even if it is empty.

This medicine is for you. Never give it to other people even if their condition appears to be the same as yours.

Do not keep out-of-date or unwanted medicines. Take them to your local pharmacy which will dispose of them for you.

If you have any questions about this medicine ask your pharmacist.

Xyzal

SIDE EFFECTS

Use of XYZAL has been associated with somnolence, fatigue, asthenia, and urinary retention .

Clinical Trials Experience

The 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 months duration.

The short-term (exposure up to 6 weeks) safety data for adults and adolescents are based upon eight clinical trials in which 1896 patients (825 males and 1071 females aged 12 years and older) were treated with XYZAL 2.5, 5, or 10 mg once daily in the evening.

The short-term safety data from pediatric patients are based upon two clinical trials in which 243 children with allergic rhinitis (162 males and 81 females 6 to 12 years of age) were treated with XYZAL 5 mg once daily for 4 to 6 weeks, one clinical trial in which 114 children (65 males and 49 females 1 to 5 years of age) 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 (28 males and 17 females 6 to 11 months of age) with symptoms of allergic rhinitis or chronic urticaria were treated with XYZAL 1.25 mg once daily for 2 weeks.

The long-term (exposure of 4 or 6 months) safety data in adults and adolescents are based upon two clinical trials in which 428 patients (190 males and 238 females) with allergic rhinitis were exposed to treatment with XYZAL 5 mg once daily. Long term safety data are 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 the clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice.

Adults And Adolescents 12 Years Of Age And Older

In studies up to 6 weeks in duration, the mean age of the adult and adolescent patients was 32 years, 44% of the patients were men and 56% were women, and the large majority (more than 90%) was Caucasian.

In these trials 43% and 42% of the subjects in the XYZAL 2.5 mg and 5 mg groups, respectively, had at least one adverse event compared to 43% in the placebo group.

In placebo-controlled trials of 1-6 weeks in duration, the most common adverse reactions were somnolence, nasopharyngitis, fatigue, dry mouth, and pharyngitis, and most were mild to moderate in intensity. Somnolence with XYZAL showed dose ordering between tested doses of 2.5, 5 and 10 mg and was the most common adverse reaction leading to discontinuation (0.5%).

Table 1 lists adverse reactions that were reported in greater than or equal to 2% of subjects aged 12 years and older exposed to XYZAL 2.5 mg or 5 mg in eight placebo-controlled clinical trials and that were more common with XYZAL than placebo.

Table 1: Adverse Reactions Reported in ≥2%* of Subjects Aged 12 Years and Older Exposed to XYZAL 2.5 mg or 5 mg Once Daily in Placebo-Controlled Clinical Trials 1-6 Weeks in Duration

Additional adverse reactions of medical significance observed at a higher incidence than in placebo in adults and adolescents aged 12 years and older exposed to XYZAL are syncope (0.2%) and weight increased (0.5%).

Pediatric Patients 6 To 12 Years Of Age

A total of 243 pediatric patients 6 to 12 years of age received XYZAL 5 mg once daily in two short-term placebo controlled double-blind trials. The mean age of the patients was 9.8 years, 79 (32%) were 6 to 8 years of age, and 50% were Caucasian. Table 2 lists adverse reactions that were reported in greater than or equal to 2% of subjects aged 6 to 12 years exposed to XYZAL 5 mg in placebo-controlled clinical trials and that were more common with XYZAL than placebo.

Table 2: Adverse Reactions Reported in ≥2%* of Subjects Aged 6-12 Years Exposed to XYZAL 5 mg Once Daily in Placebo-Controlled Clinical Trials 4 and 6 Weeks in Duration

Pediatric Patients 1 To 5 Years Of Age

A total of 114 pediatric patients 1 to 5 years of age received XYZAL 1.25 mg twice daily in a two week placebo-controlled double-blind safety trial. The mean age of the patients was 3.8 years, 32% were 1 to 2 years of age, 71% were Caucasian and 18% were Black. Table 3 lists adverse reactions that were reported in greater than or equal to 2% of subjects aged 1 to 5 years exposed to XYZAL 1.25 mg twice daily in the placebo-controlled safety trial and that were more common with XYZAL than placebo.

Table 3: Adverse Reactions Reported in ≥2%* of Subjects Aged 1-5 Years Exposed to XYZAL 1.25 mg Twice Daily in a 2-Week Placebo-Controlled Clinical Trial

Pediatric Patients 6 To 11 Months Of Age

A total of 45 pediatric patients 6 to 11 months of age received XYZAL 1.25 mg once daily in a two week placebo-controlled double-blind safety trial. The mean age of the patients was 9 months, 51% were Caucasian and 31% were Black. Adverse reactions that were reported in more than 1 subject (i.e. greater than or equal to 3% of subjects) aged 6 to 11 months exposed to XYZAL 1.25 mg once daily in the placebo-controlled safety trial and that were more common with XYZAL than placebo included diarrhea and constipation which were reported in 6 (13%) and 1 (4%) and 3 (7%) and 1 (4%) children in the XYZAL and placebo-treated groups, respectively.

Long-Term Clinical Trials Experience

In two controlled clinical trials, 428 patients (190 males and 238 females) aged 12 years and older were treated with XYZAL 5 mg once daily for 4 or 6 months. The patient characteristics and the safety profile were similar to that seen in the short-term studies. Ten (2.3%) patients treated with XYZAL discontinued because of somnolence, fatigue or asthenia compared to 2 (<1%) in the placebo group.

There are no long term clinical trials in children below 12 years of age with allergic rhinitis or chronic idiopathic urticaria.

Laboratory Test Abnormalities

Elevations of blood bilirubin and transaminases were reported in <1% of patients in the clinical trials. The elevations were transient and did not lead to discontinuation in any patient.

Postmarketing Experience

In addition to the adverse reactions reported during clinical trials and listed above, the following adverse reactions have also been identified during postapproval use of XYZAL. Because these reactions 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.

  • Cardiac disorders: palpitations, tachycardia
  • Ear and labyrinth disorders: vertigo
  • Eye disorders: blurred vision, visual disturbances
  • Gastrointestinal disorders: nausea, vomiting
  • General disorders and administration site conditions: edema
  • Hepatobiliary disorders: hepatitis
  • Immune system disorders: anaphylaxis and hypersensitivity
  • Metabolism and nutrition disorders: increased appetite
  • Musculoskeletal, connective tissues, and bone disorders: arthralgia, myalgia
  • Nervous system disorders: dizziness, dysgeusia, febrile seizure, movement disorders (including dystonia and oculogyric crisis), paresthesia, seizure (reported in subjects with and without a known seizure disorder), tremor
  • Psychiatric disorders: aggression and agitation, depression, hallucinations, insomnia, nightmare, suicidal ideation
  • Renal and urinary disorders: dysuria, urinary retention
  • Respiratory, thoracic, and mediastinal disorders: dyspnea
  • Skin and subcutaneous tissue disorders: angioedema, fixed drug eruption, pruritus, rash and urticaria

Besides these reactions reported under treatment with XYZAL, other potentially severe adverse events have been reported from the postmarketing experience with cetirizine. Since levocetirizine is the principal pharmacologically active component of cetirizine, one should take into account the fact that the following adverse events could also potentially occur under treatment with XYZAL.

  • Cardiac disorders: severe hypotension
  • Gastrointestinal disorders: cholestasis
  • Nervous system disorders: extrapyramidal symptoms, myoclonus, orofacial dyskinesia, tic
  • Pregnancy, puerperium and perinatal conditions: stillbirth
  • Renal and urinary disorders: glomerulonephritis
  • Skin and subcutaneous tissue disorders: acute generalized exanthematous pustulosis (AGEP); rebound pruritus -pruritus within a few days after discontinuation of cetirizine, usually after long-term use (e.g. months to years) of cetirizine.

Read the entire FDA prescribing information for Xyzal (Levocetirizine Dihydrochloride)

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