Levocetirizine

Before taking levocetirizine,

• tell your doctor and pharmacist if you are allergic to levocetirizine, cetirizine (Zyrtec), or any other medications.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antidepressants; medications for anxiety, mental illness, or seizures; ritonavir (Norvir, in Kaletra); sedatives; sleeping pills; theophylline (Theochron, Theolair); and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or ever have had kidney disease.
• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking levocetirizine, call your doctor. Do not breast-feed while you are taking levocetirizine.
• you should know that levocetirizine may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
• ask your doctor about the safe use of alcoholic beverages while you are taking levocetirizine. Alcohol can add to the drowsiness caused by this medication.

Xyzal is the brand name of the drug levocetirizine, which is used to treat year-round or seasonal allergies.

The medicine can treat allergy symptoms, such as runny nose; sneezing; or red, itchy, and watery eyes. The drug may also be used to treat the itching and swelling that occur with hives.

Xyzal is in a class of medicines called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergy symptoms.

This drug is used to treat symptoms of year-round allergies and hives in adults and children who are at least 6 months old. It's used to treat seasonal allergies in adults and children who are at least 2 years old.

The medicine was approved by the Food and Drug Administration (FDA) in 2007 and is manufactured by Sanofi.

Xyzal Warnings

It's important not to give a child more of this medication than is the doctor prescribes. A child's body absorbs twice as much of the same dose of Xyzal as an adult's body does.

You shouldn't give this medication to an infant who is younger than 6 months old.

Don't use Xyzal if you are allergic to levocetirizine or cetirizine (Zyrtec).

Before taking Xyzal, you should tell your doctor if you have or have ever had:

• Liver disease
• Kidney disease
• An enlarged prostate
• Problems with urination
• Gallbladder problems

You shouldn't take this drug if you have end-stage kidney disease or are on dialysis. Children younger than age 12 with kidney disease shouldn't take Xyzal.

Call your doctor if your symptoms don't improve or worsen or you also have a fever.

Tell your doctor you are taking Xyzal before having any laboratory exams, as the medication can interfere with the results of certain tests.

Pregnancy and Xyzal

Xyzal is a Pregnancy Category B drug, which means it's not expected to harm an unborn baby. You should tell your doctor if you are pregnant or plan to become pregnant while taking this medicine.

The drug can pass into breast milk and may harm a breastfeeding baby. You shouldn't breastfeed while taking Xyzal.

Serious side effects have been reported with levocetirizine. See the "Levocetirizine Precautions" section.

Common side effects of levocetirizine include:

• drowsiness
• tiredness
• weakness
• sore throat
• dry mouth
• fever
• cough
• nosebleed

This is not a complete list of levocetirizine side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Follow the directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

It is very important not to give a child more than the prescribed dose of this medication. A child's body absorbs twice as much of the same dose size of levocetirizine as an adult's body.

Taking more of this medication will not make it more effective, and may cause severe drowsiness.

Levocetirizine is usually taken in the evening. You may take this medication with or without food.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Call your doctor if your symptoms do not improve, if they get worse, or if you also have a fever.

Store at room temperature away from moisture and heat.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can increase certain side effects of levocetirizine.

Get emergency medical help if you have signs of an 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:

• painful or difficult urination;

• little or no urinating;

• signs of an ear infection (fever, ear pain or full feeling, trouble hearing, drainage from the ear, fussiness in a child);

• a light-headed feeling, like you might pass out;

• fever; or

• worsening allergy or urticaria symptoms.

Common side effects may include:

• drowsiness, weakness;

• feeling tired;

• fever;

• stuffy nose, sinus pain, sore throat, cough;

• nosebleed;

• ear infection;

• 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.

1.2 Perennial Allergic Rhinitis
Levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in adults and children 6 months of age and older.

The use of Levocetirizine dihydrochloride tablet is contraindicated in:
4.1 Patients with known hypersensitivity
Patients with known hypersensitivity to Levocetirizine or any of the ingredients of Levocetirizine dihydrochloride tablets, or to cetirizine. Observed reactions range from urticaria to anaphylaxis [see Adverse Reactions (6.2)].
4.2 Patients with end-stage renal disease
Patients with end-stage renal disease (CLCR < 10 mL/min) and patients undergoing hemodialysis

4.3 Pediatric patients with impaired renal function
Children 6 months to 11 years of age with impaired renal function

8.1 Pregnancy
Pregnancy Category B
There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Levocetirizine dihydrochloride should be used during pregnancy only if clearly needed.
Teratogenic Effects
In rats and rabbits, Levocetirizine was not teratogenic at oral doses approximately 320 and 390, respectively, times the maximum recommended daily oral dose in adults on a mg/m 2 basis.
8.3 Nursing Mothers
No peri- and post-natal animal studies have been conducted with Levocetirizine. In mice, cetirizine caused retarded pup weight gain during lactation at an 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 indicated 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 recommended.
8.4 Pediatric Use
The recommended dose of Levocetirizine dihydrochloride for the treatment of the 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 [see Clinical Studies (14)].

The recommended dose of Levocetirizine dihydrochloride in patients 6 months to 2 years of age for the treatment of the symptoms of perennial allergic rhinitis and 6 months to 11 years of age with chronic idiopathic urticaria is based on cross-study comparisons of the systemic exposure of Levocetirizine dihydrochloride in both adult and pediatric patients at doses equal to or higher than the recommended 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-controlled clinical trials lasting 4 and 6 weeks. The 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 [see Adverse Reactions (6.1)].

The effectiveness of Levocetirizine dihydrochloride 1.25 mg once daily (6 months to 5 years of age) and 2.5 mg once daily (6 to 11 years of age) for the treatment of the symptoms of perennial allergic rhinitis and chronic idiopathic urticaria is supported by the extrapolation of demonstrated efficacy of Levocetirizine dihydrochloride 5 mg once daily in patients 12 years of age and older based on the pharmacokinetic comparison between adults and children.

Cross-study comparisons indicate that administration of a 5 mg dose of Levocetirizine dihydrochloride to 6 to 12 year old pediatric patients resulted in about 2-fold the systemic exposure (AUC) observed when 5 mg of Levocetirizine dihydrochloride was administered to healthy adults. Therefore, in children 6 to 11 years of age the recommended dose of 2.5 mg once daily should not be exceeded. In a population pharmacokinetics study the administration of 1.25 mg once daily in children 6 months to 5 years of age resulted in systemic exposure comparable to 5 mg once daily in adults. [see Dosage and Administration (2.2); Clinical Studies (14); and Clinical Pharmacology (12.3)].
8.5 Geriatric Use
Clinical studies of Levocetirizine dihydrochloride for each approved indication did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.
8.6 Renal Impairment
Levocetirizine dihydrochloride is known to be substantially excreted by the kidneys and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function [see Dosage and Administration (2) and Clinical Pharmacology (12.3)].
8.7 Hepatic Impairment
As Levocetirizine is mainly excreted unchanged by the kidneys, it is unlikely that the clearance of Levocetirizine is significantly decreased in patients with solely hepatic impairment [see Clinical Pharmacology (12.3)].

Levocetirizine dihydrochloride tablets, USP 5 mg are white, oval, biconvex, film-coated functional scored tablets debossed with “S” on the left side of bisect and “G” on the right side of bisect and other side “1” on the left side and “36” on the right side of the bisect. They are supplied in unit of use HDPE bottles.

90 Tablets (NDC 69117-1000-1)

Storage:
Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].

Somnolence
Caution patients 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 tablets.
Concomitant Use of Alcohol and other Central Nervous System Depressants
Instruct patients to avoid concurrent use of Levocetirizine dihydrochloride tablets with alcohol or other central nervous system depressants because additional reduction in mental alertness may occur.
Dosing of Levocetirizine Dihydrochloride Tablets
Do not exceed the recommended daily dose in adults and adolescents 12 years of age and older of 5 mg once daily in the evening. In children 6 to 11 years of age the recommended dose is 2.5 mg once daily in the evening. Advise patients to not ingest more than the recommended dose of Levocetirizine dihydrochloride tablets because of the increased risk of somnolence at higher doses.

Manufactured for:
ScieGen Pharmaceuticals, Inc.
Hauppauge, NY 11788 USA

Distributed by:

Yiling Pharmaceutical, Inc.
5348 Vegas DR, Las Vegas, NV 89108

Rev. 02/17

1 hour (Devillier 2008)

Time to Peak

Children 1 to 2 years: Oral solution: Median: 1 hour (range: 1 to 6 hours) (Cranswick 2005); Children 6 to 11 years: Oral tablet: 1.2 ± 0.2 hours (Simons 2005); Adults: Oral solution: 0.5 hours; Tablet: 0.9 hours

Total body Cl was approximately 33% lower in 9 elderly subjects, compared with younger adults.

Refer to adult dosing; dosing should begin at the lower end of the dosing range.

Chronic idiopathic urticaria: Oral:

Children 6 months to 5 years: 1.25 mg once daily (in the evening); maximum dose: 1.25 mg/day

Children 6 to 11 years: 2.5 mg once daily (in the evening); maximum dose: 2.5 mg/day

Children ≥12 years and Adolescents: Oral: 5 mg once daily (in the evening); some patients may experience relief of symptoms with 2.5 mg once daily.

Perennial allergic rhinitis: Oral: Children 6 months to 2 years: 1.25 mg once daily (in the evening); maximum dose: 1.25 mg/day

Allergic rhinitis (OTC only): Oral:

Children 2 to 5 years: 1.25 mg once daily (in the evening); maximum dose: 1.25 mg/day

Children 6 to 11 years: 2.5 mg once daily (in the evening); maximum dose: 2.5 mg/day

Children ≥12 years and Adolescents: Refer to adult dosing.

AbobotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of AbobotulinumtoxinA. Monitor therapy

Acetylcholinesterase Inhibitors: Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Acetylcholinesterase Inhibitors may diminish the therapeutic effect of Anticholinergic Agents. Monitor therapy

Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Monitor therapy

Amantadine: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy

Amifampridine: May diminish the anticholinergic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Amifampridine. Monitor therapy

Amphetamines: May diminish the sedative effect of Antihistamines. Monitor therapy

Analgesics (Opioid): CNS Depressants may enhance the CNS depressant effect of Analgesics (Opioid). Management: Avoid concomitant use of opioid analgesics and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification

Anticholinergic Agents: May enhance the adverse/toxic effect of other Anticholinergic Agents. Monitor therapy

Azelastine (Nasal): CNS Depressants may enhance the CNS depressant effect of Azelastine (Nasal). Avoid combination

Benzylpenicilloyl Polylysine: Antihistamines may diminish the diagnostic effect of Benzylpenicilloyl Polylysine. Management: Suspend systemic H1 antagonists for benzylpenicilloyl-polylysine skin testing and delay testing until systemic antihistaminic effects have dissipated. A histamine skin test may be used to assess persistent antihistaminic effects. Consider therapy modification

Betahistine: Antihistamines may diminish the therapeutic effect of Betahistine. Monitor therapy

Blonanserin: CNS Depressants may enhance the CNS depressant effect of Blonanserin. Consider therapy modification

Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Buprenorphine: CNS Depressants may enhance the CNS depressant effect of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine patches (Butrans brand) at 5 mcg/hr in adults when used with other CNS depressants. Consider therapy modification

Cannabis: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Chloral Betaine: May enhance the adverse/toxic effect of Anticholinergic Agents. Monitor therapy

Chlormethiazole: May enhance the CNS depressant effect of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. Consider therapy modification

Chlorphenesin Carbamate: May enhance the adverse/toxic effect of CNS Depressants. Monitor therapy

Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Avoid combination

CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Monitor therapy

Dimethindene (Topical): May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Doxylamine: May enhance the CNS depressant effect of CNS Depressants. Management: The manufacturer of Diclegis (doxylamine/pyridoxine), intended for use in pregnancy, specifically states that use with other CNS depressants is not recommended. Monitor therapy

Dronabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Droperidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (e.g., opioids, barbiturates) with concomitant use. Consider therapy modification

Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Avoid combination

Flunitrazepam: CNS Depressants may enhance the CNS depressant effect of Flunitrazepam. Consider therapy modification

Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Monitor therapy

Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Avoid combination

Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Avoid combination

Hyaluronidase: Antihistamines may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving antihistamines (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Consider therapy modification

HYDROcodone: CNS Depressants may enhance the CNS depressant effect of HYDROcodone. Management: Avoid concomitant use of hydrocodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification

HydrOXYzine: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Monitor therapy

Kava Kava: May enhance the adverse/toxic effect of CNS Depressants. Monitor therapy

Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Avoid combination

Lofexidine: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Methotrimeprazine: May enhance the CNS depressant effect of CNS Depressants. CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Management: Reduce adult dose of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established. Consider therapy modification

MetyroSINE: CNS Depressants may enhance the sedative effect of MetyroSINE. Monitor therapy

Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy

Minocycline: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. Monitor therapy

Mirtazapine: CNS Depressants may enhance the CNS depressant effect of Mirtazapine. Monitor therapy

Nabilone: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Nitroglycerin: Anticholinergic Agents may decrease the absorption of Nitroglycerin. Specifically, anticholinergic agents may decrease the dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin absorption. Monitor therapy

OnabotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of OnabotulinumtoxinA. Monitor therapy

Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Avoid combination

Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Oxomemazine: May enhance the CNS depressant effect of CNS Depressants. Avoid combination

OxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification

Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Avoid combination

Perampanel: May enhance the CNS depressant effect of CNS Depressants. Management: Patients taking perampanel with any other drug that has CNS depressant activities should avoid complex and high-risk activities, particularly those such as driving that require alertness and coordination, until they have experience using the combination. Consider therapy modification

Piribedil: CNS Depressants may enhance the CNS depressant effect of Piribedil. Monitor therapy

Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Avoid combination

Potassium Citrate: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Citrate. Avoid combination

Pramipexole: CNS Depressants may enhance the sedative effect of Pramipexole. Monitor therapy

Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Consider therapy modification

Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Monitor therapy

RimabotulinumtoxinB: Anticholinergic Agents may enhance the anticholinergic effect of RimabotulinumtoxinB. Monitor therapy

ROPINIRole: CNS Depressants may enhance the sedative effect of ROPINIRole. Monitor therapy

Rotigotine: CNS Depressants may enhance the sedative effect of Rotigotine. Monitor therapy

Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Monitor therapy

Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid concomitant use of anticholinergic agents and secretin. Discontinue anticholinergic agents at least 5 half-lives prior to administration of secretin. Consider therapy modification

Selective Serotonin Reuptake Inhibitors: CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. Monitor therapy

Sodium Oxybate: May enhance the CNS depressant effect of CNS Depressants. Management: Consider alternatives to combined use. When combined use is needed, consider minimizing doses of one or more drugs. Use of sodium oxybate with alcohol or sedative hypnotics is contraindicated. Consider therapy modification

Suvorexant: CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Consider therapy modification

Tapentadol: May enhance the CNS depressant effect of CNS Depressants. Management: Avoid concomitant use of tapentadol and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification

Tetrahydrocannabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Thalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide. Avoid combination

Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Monitor therapy

Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Avoid combination

Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Monitor therapy

Trimeprazine: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Consider therapy modification

Adverse events have not been observed in animal reproduction studies; therefore, the manufacturer classifies levocetirizine as pregnancy category B. The use of antihistamines for the treatment of rhinitis during pregnancy is generally considered to be safe at recommended doses. Information related to the use of levocetirizine during pregnancy is limited; therefore, other agents are preferred. Levocetirizine is the active enantiomer of cetirizine; refer to the Cetirizine monograph for additional information.

5 mg orally once a day in the evening

Comments:
-Some patients may be adequately controlled on 2.5 mg orally once a day in the evening.

Uses: For the relief of symptoms associated with seasonal allergic rhinitis; for the relief of symptoms of perennial allergic rhinitis; and for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria