Claritin – Uses, Side Effects, Interactions

How does this medication work? What will it do for me?

Loratadine belongs to the class of medications called second-generation antihistamines, specifically the class known as histamine receptor antagonists. It works by blocking the action of one of the body’s natural chemicals known as histamine. Histamine is responsible for many of the symptoms caused by allergies.

Loratadine is used for the relief of symptoms associated with seasonal allergies, including sneezing, itchy and runny nose, and tearing and redness of the eyes. It is also used for the relief of symptoms associated with allergic skin conditions, including chronic hives and other skin disorders. Loratadine is also used for the relief of symptoms associated with year-round allergies. Loratadine usually starts working within 2 hours and lasts for 24 hours.

This medication may be available under multiple brand names and/or in several different forms.  Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Regular tablets (10 mg)

Each white, oval, shallow, deep-scored tablet contains 10 mg of loratadine. Nonmedicinal ingredients: cornstarch, lactose, and magnesium stearate.

Rapid Dissolve Tablets (10 mg)

Each white, round, tablet-shaped unit with a debossed “C10” contains 10 mg of micronized loratadine. Nonmedicinal ingredients: citric acid, gelatin, mannitol, and mint flavour.

Kids Rapid Dissolve Tablets (5 mg)

Each white, round, tablet-shaped unit with a debossed “C5” contains 5 mg of micronized loratadine. Nonmedicinal ingredients: citric acid, gelatin, mannitol, and mint flavour.

Liquid Capsules (10 mg)

Each oval, transparent, blue gelatin capsule, etched with a “10” logo contains 10 mg of loratadine. Nonmedicinal ingredients: triglycerides, mono- and di-glycerides, gelatin, sorbitol sorbitan solution, povidone, glycerin, polysorbate, purified water, and FD&C blue.

Claritin Kids Syrup – Grape Flavour

Each 1 mL of clear, colorless-to-light-yellow, grape-flavoured syrup contains 1 mg of loratadine. Nonmedicinal ingredients: artificial grape flavour, edetate disodium, glycerin, maltitol, monobasic sodium phosphate monohydrate, phosphoric acid, propylene glycol, purified water, sodium benzoate, sorbitol, and sucralose.

How should I use this medication?

Tablets: For adults and children 12 years of age and older, the recommended dose of loratadine is 10 mg once daily. The regular tablets may be taken with or without food.

Rapid-dissolving tablets: For adults and children over 10 years of age who weigh more than 30 kg, the recommended dose of loratadine is 10 mg once daily. The recommended dose for children 2 to 9 years of age who weigh 30 kg or less, is 5 mg once daily. The rapid-dissolving tablets should be taken on an empty stomach. Water or other liquids are not necessary with the rapid-dissolving tablets, as they will melt instantly on the tongue.

Capsules: For adults and children 12 years of age and older, the recommended dose of loratadine is 10 mg once daily with water.

Syrup: A liquid form of loratadine is available for children 2 years of age and older, as well as adults who are unable to swallow tablets. The recommended dose of loratadine syrup for adults and children over 10 years of age (weighing more than 30 kg) is 10 mL (10 mg) once daily. The recommended dose for children 2 to 9 years of age (weighing 30 kg or less) is 5 mL (5 mg) once daily.

Children between 2 and 12 years of age should not take loratadine for longer than 14 days unless recommended by a doctor. Adults and children over 12 years of age can take loratadine for up to 6 months.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as suggested by your doctor or pharmacist. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take more than one dose in 24 hours. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not use this medication if you are allergic to loratadine or to any of the ingredients of the medication.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication.  If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• cough
• dizziness
• drowsiness
• dry mouth
• fatigue
• headache
• heartburn
• increased appetite
• nausea
• nervousness or restlessness (especially in children)

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

Stop taking the medication and seek immediate medical attention if any of the following occur:

• hair loss
• pounding, fast, or irregular heartbeat
• seizures
• signs of liver problems (e. g., dark urine, diarrhea, loss of appetite, nausea, pale stools, skin itching, vomiting, weight loss, yellowing of the skin or whites of the eyes)
• stomach pain
• symptoms of a severe allergic reaction such as difficulty breathing, hives, or swelling of the face and throat

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take this medication.

Drowsiness: Loratadine usually causes minimal drowsiness when used as directed by your doctor or pharmacist. If you are taking higher-than-recommended doses of loratadine, you may experience drowsiness. Do not drive or operate machinery if you become drowsy while taking this medication.

Liver problems: If you have reduced liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. People with severely reduced liver function should take a lower dose (5 mg once daily or 10 mg every other day) of this medication.

Pregnancy: The safety of using this medication during pregnancy has not been established. Women who are pregnant should not use this medication. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: The safety of loratadine has not been established for women who are breast-feeding. Women who are breast-feeding should not take loratadine.

Children: The safety and effectiveness of using this medication have not been established for children younger than 2 years of age. For children between the ages of 2 and 12, do not give this medication for longer than 14 days, unless recommended by a doctor.

What other drugs could interact with this medication?

There may be an interaction between loratadine and any of the following:

• acetylcholinesterase inhibitors (e.g., donepezil, galantamine, neostigmine, pyridostigmine, rivastigmine)
• aclidinium
• alcohol
• amantadine
• antiarrhythmics (e.g., amiodarone, disopyramide)
• antihistamines (e.g., azelastine, cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine, rupatadine)
• antipsychotics (e.g., cariprazine, chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
• atropine
• barbiturates (e.g., butalbital, phenobarbital)
• benzodiazepines (e. g., alprazolam, diazepam, lorazepam)
• benztropine
• betahistine
• botulinum toxin
• brimonidine
• cannabis
• chloral hydrate
• clidinium
• clonidine
• darifenacin
• dimenhydrinate
• diphenoxylate
• domperidone
• efavirenz
• eluxadoline
• entacapone
• esketamine
• fesoterodine
• flibanserin
• flunarizine
• general anesthetics (medications used to put people to sleep before surgery)
• glucagon
• glycopyrrolate
• guanfacine
• hyaluronidase
• ipratropium
• kava kava
• ketoconazole
• lemborexant
• magnesium sulfate
• methadone
• metoclopramide
• minocycline
• mirabegron
• mirtazapine
• monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, tranylcypromine)
• muscle relaxants (e.g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine)
• nabilone
• narcotic pain relievers (e. g., codeine, fentanyl, morphine, oxycodone, tapentadol, tramadol)
• nitroglycerin
• olopatadine
• oxybutynin
• perampanel
• pitolisant
• pizotifen
• pomalidomide
• potassium chloride
• pramipexole
• pregabalin
• procarbazine
• propiverine
• prucalopride
• ropinirole
• rotigotine
• scopolamine
• seizure medications (e.g., carbamazepine, levetiracetam, phenytoin, primidone, rufinamide, topiramate, valproic acid)
• selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
• sodium oxybate
• solifenacin
• tetrabenazine
• thalidomide
• thiazide diuretics (water pills; e.g., hydrochlorothiazide, indapamide, metolazone)
• tiotropium
• tizanidine
• trazodone
• tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, imipramine)
• trihexyphenidyl
• trospium
• umeclidinium
• valerian
• zolpidem
• zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist.  Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2023. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Claritin

Claritin: Uses, Dosage & Side Effects

Generic name: loratadine [ lor-AT-a-deen ]
Brand names: Claritin, Claritin Reditab
Dosage forms: oral capsule (10 mg), oral syrup (5 mg/5 mL), oral tablet (10 mg), oral tablet, chewable (5 mg; 10 mg), oral tablet, disintegrating (5mg; 10 mg)
Drug class: Antihistamines

Medically reviewed by Sophia Entringer, PharmD. Last updated on Oct 9, 2021.

What is Claritin?

Claritin is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Claritin is used to treat sneezing, runny nose, watery eyes, hives, skin rash, hay fever, itching, and other cold or allergy symptoms.

Claritin is also used to treat skin hives and itching in people with chronic skin reactions

Warnings

You should not take Claritin if you are allergic to loratadine or to desloratadine (Clarinex).

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Some chewable dosage forms of Claritin may contain phenylalanine. Talk to your doctor before using these forms of loratadine if you have phenylketonuria (PKU).

Ask a doctor or pharmacist before taking Claritin if you have liver or kidney disease.

Before taking this medicine

Ask a doctor or pharmacist if Claritin is safe to use if you have ever had:

• kidney disease; or

• liver disease.

The chewable Claritin tablet may contain phenylalanine and could be harmful if you have phenylketonuria (PKU).

Ask a doctor before using this medicine if you are pregnant or breastfeeding.

Do not give this medicine to a child younger than 2 years old without medical advice.

How should I take Claritin?

Use Claritin exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cold or allergy medicine is usually taken only for a short time until your symptoms clear up.

Do not give Claritin to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Claritin is usually taken once per day. Follow your doctor’s instructions.

Do not crush, chew, or break the regular tablet. Swallow the tablet whole.

A child’s dose is based on age and some forms of loratadine are not for use in children younger than 6 years old. Carefully follow the dosing instructions provided with this medicine.

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.

The Claritin chewable tablet must be chewed before you swallow it.

To take the orally disintegrating tablet (Claritin RediTab):

• Keep the tablet in its blister pack until you are ready to take it. Open the package and peel back the foil. Do not push a tablet through the foil or you may damage the tablet.

• Use dry hands to remove the tablet and place it in your mouth.

• Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing. If desired, you may drink liquid to help swallow the dissolved tablet.

Call your doctor if your symptoms do not improve, or if they get worse.

Store at room temperature away from moisture and heat.

Claritin side effects

Get emergency medical help if you have signs of an allergic reaction to Claritin: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

Common Claritin side effects may include:

• headache;

• feeling tired or drowsy;

• stomach pain, vomiting;

• dry mouth; or

• feeling nervous or hyperactive.

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.

Dosing information

Usual Adult Dose for Allergic Rhinitis:

10 mg orally once a day
-Maximum dose: 10 mg/day

Use: Temporary relief of symptoms associated with hay fever or other upper respiratory allergies (e.g., runny nose, itchy, watery eyes, sneezing, itching of the nose/throat)

Usual Adult Dose for Urticaria:

10 mg orally once a day
-Maximum dose: 10 mg/day

Use: Temporary relief of symptoms associated with hay fever or other upper respiratory allergies (e. g., runny nose, itchy, watery eyes, sneezing, itching of the nose/throat)

Usual Pediatric Dose for Allergic Rhinitis:

2 to 5 years: 5 mg orally once a day
-Maximum dose: 5 mg/day

6 years and older: 10 mg orally once a day
-Maximum dose: 10 mg/day

Use: Temporary relief of symptoms associated with hay fever or other upper respiratory allergies (e.g., runny nose, itchy, watery eyes, sneezing, itching of the nose/throat)

Usual Pediatric Dose for Urticaria:

2 to 5 years: 5 mg orally once a day
-Maximum dose: 5 mg/day

6 years and older: 10 mg orally once a day
-Maximum dose: 10 mg/day

Use: Temporary relief of symptoms associated with hay fever or other upper respiratory allergies (e.g., runny nose, itchy, watery eyes, sneezing, itching of the nose/throat)

What other drugs will affect Claritin?

Other drugs may interact with loratadine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

What happens if I miss a dose?

Claritin is used when needed. Do not use Claritin more than once in a 24-hour period. Do not use two doses at one time.

What happens if I overdose?

Overdose symptoms may include headache, drowsiness, and fast or pounding heartbeat.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Claritin?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Popular FAQ

Loratadine does not usually cause drowsiness and is considered a non-sedating antihistamine. However, some people may get sleepy so use caution before driving, operating machinery or performing other hazardous tasks until you know how loratadine affects you.

Loratadine (brand example: Claritin), an over-the-counter (OTC) non-sedating antihistamine, does not usually increase blood pressure when used alone as a single ingredient. Some OTC combination products do contain loratadine plus the decongestant pseudoephedrine (brand example: Claritin-D), which can raise your blood pressure. In the US, Claritin-D and the generic are normally kept behind the pharmacy counter. If you have high blood pressure, are being treated for high blood pressure, or have concerns about your blood pressure, ask your doctor before you use pseudoephedrine in any form.

Loratadine fully works within one hour after you take it and its effect should last for 24 hours. Your symptoms should start to improve in about 20 minutes. You only have to take loratadine once a day. Loratadine is an effective over-the-counter, non-sedating antihistamine used to treat sneezing, runny nose or watery eyes due to a cold or allergy, skin hives and itching.

More FAQ

• Zyrtec vs Claritin: Which is more effective for allergies?
• What are the most common skin conditions? (with photos)
• Allegra vs Claritin: Which is more effective for allergies?

View more FAQ

References

1. Claritin Product Label

More about Claritin (loratadine)

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Professional resources

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• Claritin-D

Related treatment guides

• Allergic Rhinitis
• Urticaria

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Claritin only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Copyright 1996-2023 Cerner Multum, Inc. Version: 10.01.

Claritin is the No. 1 drug in the world against allergies

In the spring and summer period, the peak of allergic diseases is observed, so the question of choosing antihistamines becomes relevant. The variety of drugs in this group makes it difficult to make the right choice. For clarification, we turned to the leading specialist.

O.I. Lasitsa — chief pediatric allergist of the Ministry of Health of Ukraine, professor, head. Department of Pediatrics No. 1 KMAPE named after. P.L. Shupika

– Among the many antiallergic drugs, only a few have proven to be equally effective and safe, which is time-tested and confirmed by clinical practice.

In pediatrics, when choosing a treatment method, we are primarily guided by the principle of safety. And this point of view coincides with the generally accepted in the world, which is reflected in international agreements on the treatment of allergic diseases (allergic rhinitis, bronchial asthma) in children. However, doctors and pharmacists often do not think about the safety of treating each individual patient, including a child.

Pediatricians do not have as wide a choice of antiallergic drugs as allergists treating adults. When prescribing an antiallergic drug, like any other drug, it is necessary to take into account the presence of contraindications, concomitant diseases, the age of the patient, concurrent treatment with other drugs, and much more.

It is well known that traditional antihistamines (1st generation) have side effects that limit their use. Taking antihistamines with a sedative effect by children, especially for a long time, adversely affects the mental and mental development of the child, disrupts the learning and memorization process. This should be taken into account when prescribing antiallergic therapy. Today, there are practically no children who have only one disease, especially when it comes to allergies. As a rule, multiple organ pathologies are noted: diseases of the digestive tract, respiratory, nervous, genitourinary systems, etc., which significantly limits the possibility of using classic antihistamines.

Most of the new antihistamines (acrivastine, ebastine, fexofenadine) in children are age-limited (prescribed only to children over 12 years of age), so they cannot be used to treat the majority of our patients either.

Since some 2nd generation drugs (terfenadine and astemizole) and some of their metabolites may have cardiotoxic effects, when prescribing these drugs at high doses, many factors must be taken into account and a number of precautions must be observed (ECG monitoring during treatment).

Another criterion for choosing an antiallergic drug is its effectiveness. Most antihistamines, as a rule, affect only one link in the allergy – they block H ₁ receptors and do not allow the biological effects of histamine to manifest themselves. But allergy is a complex process that involves many components. Therefore, the more pathogenetic mechanisms we can influence, the higher the effectiveness of treatment. Therefore, with the advent of drugs that act on various parts of allergies, the possibilities of therapy are significantly expanding.

Claritin (loratadine) is one of the few drugs that can solve the problem of allergies in a complex way. All over the world, it has established itself as the most effective and safe anti-allergic agent. According to IMS, since 1994, Claritin has been the most prescribed antiallergic drug in the world [9]. The fact is that, along with N ₁ -blocking effect, Claritin has a number of additional anti-allergic properties [10], which are very important in clinical practice, because, firstly, they expand the therapeutic possibilities of the drug in the treatment of various allergic pathologies, and secondly , allow you to avoid the appointment of a large number of other drugs (Claritin has a decongestant and vasoconstrictor effect on the nasal mucosa, prevents bronchospasm, has a membrane-stabilizing effect, etc. ). Claritin has also proven itself in the complex treatment of combined allergic pathology, such as bronchial asthma and allergic rhinitis, atopic dermatitis and bronchial asthma, etc. [7,10]. Its use allows you to quickly achieve remission and prevent exacerbations of chronic allergic diseases, especially in children.

In pediatrics, an important role in choosing an antihistamine drug is played by the fact that most antiallergic drugs are not recommended for more than 7–10 days, since their effectiveness decreases with longer use [7,10,11], and the risk of side effects increases. The cost of a course of treatment with claritin is comparable to that of treatment with traditional antihistamines (chloropyramine, clemastine, ketotifen), despite the fact that side effects with its use are extremely rare.

Since most of our patients have a chronic pathology that requires long-term treatment and prophylaxis with antiallergic drugs, then, given the above, we choose Claritin, which is a highly effective and safe antiallergic drug that can be prescribed to children from 1 year old as a short course – in acute allergic diseases, and for a long time – from 3 to 12 months in chronic and recurrent allergic diseases, such as atopic dermatitis, allergic rhinitis, atopic bronchial asthma, urticaria, etc. [7,10]. Claritin is taken orally once a day, regardless of food intake. For children aged 1 to 2 years, Claritin is prescribed at a dose of 2.5 mg (2.5 ml of syrup or 1/4 tablet), from 2 to 12 years – 5 mg (5 ml of syrup or 1/2 tablet), from 12 years old and adults – 10 mg (10 ml of syrup or 1 tablet).

Claritin has practically no contraindications for use (with the exception of hypersensitivity to the drug), rarely causes the development of side effects, is compatible with other drugs, does not potentiate the effects of alcohol. The drug can be prescribed to children, adults, elderly patients.

New antihistamines are now available as second-generation metabolites that may be more effective, but it will take time and clinical experience to establish themselves as safe and uphold this reputation. Claritin has a long history of successful clinical use in more than 100 countries around the world.

Prescribing Claritin to children, we are always confident in the success and safety of treatment.

Given the above, we can draw the following conclusions:

Claritin, the world’s most widely used antiallergic drug, has been proven to be effective and safe.

Unlike first generation antihistamines Claritin:

• has the highest affinity for H ₁ receptors (I generation drugs – about 30% on average) [6,11];
• is not displaced by histamine from the connection with H ₁ receptors;
• does not cause dry skin and mucous membranes;
• does not adversely affect the function of the digestive tract;
• blocks H ₁ receptors for 24 hours (the duration of action of the first generation drugs is 2-4 hours) [6,8].

Along with the blockade of H ₁ receptors, Claritin has additional effects by acting on other pathogenetic mechanisms of allergy.

Claritin additionally has a vasoconstrictive and anti-edematous effect on the mucous membrane of the nasal cavity, a moderately pronounced bronchodilator, antitussive effect, reduces bronchial hyperreactivity, which is especially important in case of combined skin and respiratory manifestations of allergy [6, 8, 10, 11];

· Claritin does not cause the development of tachyphylaxis with long-term prophylactic use [6, 10, 11];

· Claritin may be given concomitantly with other drugs, including first-generation antihistamines.

The rapid development of additional anti-allergic effects, including membrane stabilizing, in claritin is observed from the 5th day of the course of administration (in the treatment with ketotifen – from the 4th week of therapy) [8];

The combination of blockade of H ₁ receptors and other anti-allergic effects allows to achieve a rapid development of the clinical effect and replace the use of several drugs with the use of one – claritin.

REFERENCES

The publication was prepared based on materials provided by the representative office of Schering-Plough in Ukraine

Claritin ^® vs. allergy: 20 years of successful fight in Ukraine

Claritin: instruction, price, analogues | Bayer

• Pharmacological properties
• Indications Claritin
• Application of Claritin
• Contraindications
• Side effects
• Special instructions
• Interactions
• Overdose
• Storage conditions
• Diagnosis
• Recommended alternatives
• Trade names

pharmacodynamics. Loratadine (the active ingredient of Claritin) is a tricyclic antihistamine with selective activity for peripheral H ₁ receptors.

In the majority of patients, when used at the recommended dose, loratadine does not have a clinically significant sedative and anticholinergic effect. During long-term treatment, there were no clinically significant changes in vital signs, laboratory tests, physical examination, or ECG. Loratadine has no significant effect on H ₂ – histamine receptors. The drug does not inhibit the absorption of norepinephrine and does not actually affect the function of the cardiovascular system or the activity of the pacemaker of the heart.

Histamine skin testing studies following a single 10 mg dose have shown that antihistamine effect occurs after 1–3 hours, peaks at 8–12 hours, and lasts longer than 24 hours. No development of drug resistance after 28 days use of loratadine.

Clinical efficacy and safety . More than 10,000 people (aged 12 years and over) have been treated with loratadine (10 mg tablets) in controlled clinical trials. Loratadine (tablets) 10 mg once daily was more effective than placebo and as effective as clemastine in improving symptoms (nasal and non-nasal) of allergic rhinitis. In these studies, drowsiness occurred at a lower rate with loratadine than with clemastine and at about the same rate as with terfenadine and placebo.

Among the participants in these studies (aged 12 years and over), 1,000 patients with chronic idiopathic urticaria were also enrolled in placebo-controlled studies. Loratadine 10 mg once daily was superior to placebo in the treatment of chronic idiopathic urticaria, as evidenced by the improvement in pruritus, erythema, and allergic rash. In these studies, the incidence of drowsiness was similar between loratadine and placebo.

Children . Approximately 200 children (aged 6–12 years) with seasonal allergic rhinitis received loratadine (syrup) at doses up to 10 mg once daily in controlled clinical trials. In another study, 60 children (aged 2–5 years) received loratadine (syrup) at a dose of 5 mg once a day. Unforeseen adverse reactions were not noted.

Efficacy in children was similar to that in adults.

Pharmacokinetics

Suction . Loratadine is rapidly and well absorbed. The use of the drug during meals may slightly delay the absorption of loratadine, but this does not affect the clinical effect. The bioavailability of loratadine and its active metabolite is dose proportional.

Distribution . Loratadine binds actively (97-99%) to plasma proteins, and its active metabolite is moderately active (73-76%).

In healthy volunteers, the plasma half-life of loratadine and its active metabolite is approximately 1 and 2 hours, respectively.

Biotransformation . After oral administration, loratadine is rapidly and well absorbed and extensively metabolized during the first pass through the liver, mainly by CYP 3A4 and CYP 2D6. The main metabolite desloratadine is pharmacologically active and is more responsible for the clinical effect. Loratadine and desloratadine reach C _max in blood plasma (T _max ) 1–1.5 and 1.5–3.7 hours, respectively, after drug administration.

Derivation of . About 40% of the dose is excreted in the urine and 42% in the feces within 10 days, mainly in the form of conjugated metabolites. About 27% of the dose is excreted in the urine during the first 24 hours. Less than 1% of the active substance is excreted in the unchanged active form – as loratadine or desloratadine.

In healthy adult volunteers, the mean T _½ loratadine was 8.4 hours (range 3–20 hours), and the main active metabolite was 28 hours (range 8.8–92 hours).

Impaired renal function . In patients with chronic renal impairment, the AUC and C _max plasma levels of loratadine and its active metabolite increased compared to those in patients with normal renal function. The average T _½ of loratadine and its active metabolite did not differ significantly from those in healthy people. In patients with chronic hepatic impairment, hemodialysis does not affect the pharmacokinetics of loratadine and its active metabolite.

Impaired liver function . In patients with chronic alcoholic liver disease, the AUC and C _max values ​​of loratadine were 2 times higher, and their active metabolite did not change significantly when compared with such indicators in patients with normal liver function. T _½ loratadine and its active metabolite is 24 and 37 hours, respectively, and increases depending on the severity of liver disease.

Elderly patients . The pharmacokinetics of loratadine and its active metabolite were similar in healthy adult volunteers and healthy elderly volunteers.

tablets : symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria.

Syrup : symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria in adults and children over 2 years of age.

tablets

How to use . Apply orally. The tablets can be taken with or without food.

Dosage . Adults and children over 12 years of age – take 1 tablet (10 mg loratadine) once a day.

In children aged 2–12 years, the dose depends on body weight. With a body weight> 30 kg: 10 mg (1 tablet) 1 time per day. In children weighing <30 kg, the drug should be used in the form of a syrup.

Elderly patients. Dose adjustment is not required in the elderly.

Patients with impaired liver function. Patients with severe hepatic impairment should be treated at a lower initial dose as they may have decreased clearance of loratadine. For adults and children weighing >30 kg, the recommended starting dose is 10 mg every other day.

Patients with impaired renal function. No dose adjustment is necessary in patients with impaired renal function.

Children . The efficacy and safety of loratadine in children under 2 years of age have not been established.

Claritin tablet, for use in children weighing >30 kg.

Syrup

How to use . Apply orally. The syrup can be taken with or without food.

Dosage . Adults and children over the age of 12 take 10 ml of syrup (10 mg loratadine) once a day.

Doses for children aged 2–12 years are based on body weight.

Children weighing >30 kg – 10 ml syrup (10 mg loratadine) once a day.

Children weighing <30 kg - 5 ml syrup (5 mg loratadine) once a day.

Elderly patients . Dose adjustment is not required in the elderly.

Patients with impaired liver function . Patients with severe hepatic impairment should be given a lower initial dose due to a possible decrease in the clearance of loratadine. For adults and children weighing >30 kg, the recommended starting dose is 10 mg every other day, and for children weighing up to 30 kg, 5 mg every other day.

Patients with impaired renal function . There is no need for dose adjustment in patients with impaired renal function.

Children . The efficacy and safety of the drug in children under the age of 2 years have not been established.

Claritin is contraindicated in patients with hypersensitivity to the active substance or any other component of the drug.

safety profile summary . In clinical studies involving adults and adolescents, when using loratadine at the recommended dose of 10 mg / day for indications including allergic rhinitis and chronic idiopathic urticaria, adverse reactions were reported in 2% of patients (which is higher than in patients who received placebo). The most common adverse reactions reported more frequently than placebo were drowsiness (1.2%), headache (0.6%), increased appetite (0.5%) and insomnia (0.1%). In clinical studies in children aged 2–12 years, adverse events such as headache (2.7%), nervousness (2.3%) or fatigue (1%) were noted.

List of Adverse Reactions Adverse reactions reported during the post-marketing period are listed by organ system class. Frequency was defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to < 1/1000), very rare (<1/10,000) and unknown (cannot be determined from the available data).

In each frequency group, adverse reactions are listed in descending order of severity.

From the immune system: very rarely – hypersensitivity reactions, including anaphylaxis and angioedema.

From the nervous system: very rarely – dizziness, convulsions.

From the side of the heart: very rarely – tachycardia, palpitation.

From the gastrointestinal tract: very rarely – nausea, dry mouth, gastritis.

From the hepatobiliary system: very rarely – pathological changes in liver function.

From the side of the skin and subcutaneous tissue: very rarely – rash, alopecia.

Violations of the general condition and associated with the way the drug is used: very rarely – fatigue.

Studies : frequency unknown – weight gain.

Claritin Tablets should be used with caution in patients with severe hepatic impairment.

The preparation contains lactose. In case of known intolerance to some sugars, patients with rare hereditary problems of galactose intolerance, lactase deficiency and glucose-galactose malabsorption should not use this drug.

Claritin should be discontinued at least 48 hours prior to skin tests as antihistamines may neutralize or otherwise reduce a positive skin reactivity index response.

Claritin Syrup should be used with caution in patients with severe hepatic impairment.

This medicinal product contains 3 g of sucrose per 5 ml; 6 g sucrose in 10 ml. Use with caution in patients with diabetes mellitus. May be harmful to teeth. Claritin syrup should not be administered to patients with rare hereditary disorders of fructose, galactose intolerance, hereditary lactase deficiency, glucose/galactose malabsorption syndrome, or sucrase/isomaltase deficiency. If you have an intolerance to some sugars, you should consult your doctor before taking this medicine.

The drug should be discontinued no later than 48 hours before skin diagnostic allergy tests to prevent false results.

Use during pregnancy or lactation

Pregnancy . A significant amount of data on the use during pregnancy (more than 1000 results) indicates that loratadine does not cause malformations and is non-toxic to the fetus and newborn. Animal studies have shown no direct or indirect adverse effects regarding reproductive toxicity. It is advisable, as a safety measure, to avoid the use of Claritin during pregnancy.

Breastfeeding . Physicochemical data suggest that loratadine/metabolites are excreted in breast milk. Since a risk to the baby cannot be ruled out, Claritin should not be used during breastfeeding.

Fertility . There are no data on the effect of the product on female or male fertility.

The ability to influence the reaction rate when driving vehicles or operating other mechanisms. In clinical studies that studied the ability to drive a car, no changes were found in patients who used loratadine. Claritin has no or negligible effect on the ability to drive or use machines. However, the patient must be informed that very rarely drowsiness may occur, which may affect the ability to drive vehicles or mechanisms.

when used simultaneously with alcohol, the effects of Claritin do not increase, which is confirmed by studies of psychomotor function.

Potential interactions are possible with all known inhibitors of CYP 3A4 or CYP 2D6, which leads to an increase in the level of loratadine, and this, in turn, may be the cause of an increase in the incidence of adverse reactions.

In controlled studies, an increase in the concentration of loratadine in blood plasma after simultaneous use with ketoconazole, erythromycin and cimetidine was reported, which was not accompanied by clinically significant changes (including ECG).

Children. Interaction studies with other drugs have only been performed in adults.

overdose of loratadine increases the incidence of anticholinergic symptoms. In case of overdose, drowsiness, tachycardia and headache have been reported. In case of overdose, symptomatic and supportive treatment is recommended for the required period. It is possible to use activated carbon in the form of an aqueous suspension. You can also do gastric lavage. Loratadine is not excreted from the body during hemodialysis; the effectiveness of peritoneal dialysis in removing the drug is unknown. After emergency care, the patient should remain under medical supervision.

at a temperature not exceeding 25 °C.

Skin abscess, furuncle and carbuncle of other locations	ICD L02.8
Allergic contact dermatitis due to cosmetics	ICD L23.2
Allergic contact dermatitis, cause unspecified	ICD L23. 9
Allergic rhinitis	ICD J30.4
Atopic dermatitis, unspecified	ICD L20.9
Bacterial pneumonia, unspecified	ICD J15.9
Lobar pneumonia, unspecified	ICD J18.1
Other acute nonpurulent otitis media	ICD H65.1
Idiopathic urticaria	ICD L50.1
Acute allergic bronchitis	ICD J20.9
Acute laryngitis	ICD J04.0
Acute serous otitis media	ICD H65.0
Acute pharyngotonsillitis	ICD J03.9
Acute ethmoid sinusitis (ethmoiditis)	ICD J01. Leave a Reply Cancel reply Your email address will not be published. Required fields are marked * Comment * Name * Email * Website