Claritin pseudoephedrine. Claritin-D: A Comprehensive Guide to Uses, Dosage, and Side Effects
What is Claritin-D and how does it work. What are the common uses of Claritin-D. How should Claritin-D be taken and what are the recommended dosages. What are the potential side effects of Claritin-D. Who should avoid taking Claritin-D. What precautions should be taken when using Claritin-D. How does Claritin-D interact with other medications.
Understanding Claritin-D: Composition and Mechanism of Action
Claritin-D is a combination medication that contains two active ingredients: loratadine and pseudoephedrine. This powerful duo works together to provide relief from various allergy and cold symptoms. But how exactly does each component function?
Loratadine: The Antihistamine Component
Loratadine is an antihistamine that effectively reduces the effects of histamine in the body. Histamine is a natural chemical that can trigger allergy symptoms such as sneezing, itching, watery eyes, and runny nose. By blocking the action of histamine, loratadine helps alleviate these uncomfortable symptoms.
Pseudoephedrine: The Decongestant Element
The second active ingredient, pseudoephedrine, serves as a decongestant. It works by shrinking blood vessels in the nasal passages, which helps reduce nasal congestion or stuffiness. This action provides relief from the uncomfortable sensation of a blocked nose often associated with allergies and colds.
How does the combination of loratadine and pseudoephedrine enhance the effectiveness of Claritin-D? The synergistic effect of these two components allows Claritin-D to target multiple symptoms simultaneously, providing comprehensive relief from both allergies and cold-related discomfort.
Common Uses and Applications of Claritin-D
Claritin-D is primarily used to treat a range of symptoms associated with allergies and the common cold. These symptoms include:
- Sneezing
- Runny or stuffy nose
- Itchy or watery eyes
- Hives
- Skin rash
- Itching
Can Claritin-D be used for other conditions? While its primary use is for allergy and cold symptoms, some healthcare providers may recommend it for other related conditions. However, it’s crucial to consult with a medical professional before using Claritin-D for any off-label purposes.
Proper Usage and Dosage Guidelines for Claritin-D
To ensure maximum effectiveness and safety, it’s essential to use Claritin-D exactly as directed on the label or as prescribed by your healthcare provider. Here are some key points to remember:
General Usage Instructions
- Claritin-D is intended for short-term use until symptoms clear up.
- Always follow the directions on the medicine label, especially when giving it to children.
- Swallow the tablet whole without crushing, chewing, or breaking it.
- If symptoms don’t improve after 7 days of treatment or if you develop a fever, consult your doctor.
Dosage Recommendations
The appropriate dosage of Claritin-D can vary depending on the specific formulation and the patient’s age. Here are the typical dosages for adults and children over 12 years:
- For 12-hour formulation: 1 tablet (5 mg loratadine – 120 mg pseudoephedrine) orally twice a day
- For 24-hour formulation: 1 tablet (10 mg loratadine – 240 mg pseudoephedrine) orally once daily
Is it safe to adjust the dosage of Claritin-D on your own? It’s crucial to stick to the recommended dosage and not alter it without consulting your healthcare provider. Adjusting the dosage independently could lead to ineffective treatment or potential side effects.
Potential Side Effects and Adverse Reactions
While Claritin-D is generally well-tolerated, like all medications, it can cause side effects in some individuals. It’s important to be aware of these potential reactions:
Common Side Effects
- Dry mouth, nose, or throat
- Mild dizziness
- Sleep problems (insomnia)
Serious Side Effects
Although rare, some users may experience more severe side effects. Seek immediate medical attention if you experience:
- Signs of an allergic reaction (hives, difficulty breathing, swelling of face, lips, tongue, or throat)
- Pounding heartbeats or fluttering in your chest
- Severe dizziness, nervousness, or restless feeling
How can you minimize the risk of side effects when taking Claritin-D? To reduce the likelihood of adverse reactions, always follow the recommended dosage, avoid alcohol consumption while on the medication, and inform your healthcare provider about any pre-existing conditions or other medications you’re taking.
Contraindications and Precautions
While Claritin-D can be beneficial for many, certain individuals should exercise caution or avoid using this medication altogether. Here are some important considerations:
Who Should Avoid Claritin-D?
Claritin-D is not suitable for everyone. You should not use this medication if:
- You have used an MAO inhibitor in the past 14 days
- You are pregnant (unless advised by a doctor)
- You are breastfeeding
Medical Conditions Requiring Caution
If you have any of the following conditions, consult your healthcare provider before using Claritin-D:
- Liver or kidney disease
- Heart disease or high blood pressure
- Diabetes
- Thyroid disorder
- Enlarged prostate and urination problems
Why is it crucial to inform your healthcare provider about these conditions? These medical conditions can potentially interact with Claritin-D or increase the risk of side effects. Your doctor can assess whether the benefits of using Claritin-D outweigh the potential risks in your specific case.
Drug Interactions and Compatibility
Understanding how Claritin-D interacts with other medications is crucial for ensuring safe and effective treatment. Here are some key points to consider:
Medications to Avoid
- MAO inhibitors: Do not use Claritin-D if you’ve taken an MAO inhibitor in the past 14 days
- Other cold, allergy, or sleep medicines: These may contain similar ingredients, potentially leading to overdose
Precautions with Other Substances
- Alcohol: Can increase certain side effects of Claritin-D
- Other cough or cold medicines: Check with a doctor or pharmacist before combining with Claritin-D
How can you ensure safe use of Claritin-D alongside other medications? Always inform your healthcare provider about all medications, supplements, and herbal products you’re using. They can advise on potential interactions and help you create a safe treatment plan.
Special Considerations and Lifestyle Adjustments
When using Claritin-D, it’s important to be aware of how it may affect your daily activities and what precautions you should take. Here are some key considerations:
Driving and Operating Machinery
Claritin-D may cause blurred vision or impair your thinking or reactions. Exercise caution when driving or performing tasks that require alertness and clear vision. It’s advisable to understand how the medication affects you before engaging in these activities.
Alcohol Consumption
Drinking alcohol can increase certain side effects of Claritin-D. It’s best to avoid alcohol while taking this medication to prevent potential adverse reactions.
Medical Procedures
If you’re scheduled for surgery or medical tests, inform your healthcare provider about your use of Claritin-D. The medication may interfere with certain procedures or test results.
How can you maintain your regular routine while taking Claritin-D? It’s important to plan your activities around your medication schedule and be mindful of potential side effects. If you notice any significant changes in your ability to perform daily tasks, consult your healthcare provider for guidance.
Remember, while Claritin-D can provide effective relief from allergy and cold symptoms, it’s crucial to use it responsibly and in accordance with medical advice. Always consult your healthcare provider if you have any concerns or questions about using this medication.
Claritin-D: Uses, Dosage, Side Effects
Generic name: loratadine and pseudoephedrine [ lor-AT-a-deen-and-SOO-doe-ee-FED-rin ]
Brand names: Claritin-D 12 Hour, Claritin-D 24 Hour
Drug class: Upper respiratory combinations
Medically reviewed by Philip Thornton, DipPharm. Last updated on Jun 14, 2023.
What is Claritin-D?
Claritin-D contains a combination of loratadine and pseudoephedrine. Loratadine 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.
The pseudoephedrine in Claritin-D is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
Claritin-D is used to treat sneezing, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.
Warnings
Do not use Claritin-D if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.
Ask a doctor or pharmacist before using any other cold, allergy, or sleep medicine. Antihistamines and decongestants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine or decongestant. Claritin-D may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly. Drinking alcohol can increase certain side effects of Claritin-D.
Before taking this medicine
Do not use Claritin-D if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.
Ask a doctor or pharmacist if Claritin-D is safe to use if you have:
liver or kidney disease;
heart disease, high blood pressure;
diabetes;
thyroid disorder; or
an enlarged prostate and urination problems.
Do not use this medicine without a doctor’s advice if you are pregnant.
You should not breast-feed while using this medicine.
How should I take Claritin-D?
Use Claritin-D exactly as directed on the label, or as prescribed by your doctor. Cold or allergy medicine is only for short-term use until your symptoms clear up.
Always follow directions on the medicine label about giving Claritin-D to a child. Do not use the medicine only to make a child sleepy. Death can occur from the misuse of cold or allergy medicines in very young children.
Swallow the tablet whole and do not crush, chew, or break it.
Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever.
If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken a cold or allergy medicine within the past few days.
Store at room temperature away from moisture and heat.
Dosing information
Usual Adult Dose for Allergic Rhinitis:
1 tablet (5 mg-120 mg) orally twice a day
-or-
1 tablet (10 mg-240 mg) orally once daily.
Usual Adult Dose for Nasal Congestion:
1 tablet (5 mg-120 mg) orally twice a day
-or-
1 tablet (10 mg-240 mg) orally once daily.
Usual Pediatric Dose for Allergic Rhinitis:
over 12 years:
1 tablet (5 mg-120 mg) orally twice a day
-or-
1 tablet (10 mg-240 mg) orally once daily.
Usual Pediatric Dose for Nasal Congestion:
over 12 years:
1 tablet (5 mg-120 mg) orally twice a day
-or-
1 tablet (10 mg-240 mg) orally once daily.
What happens if I miss a dose?
Since Claritin-D is used when needed, you may not be on a dosing schedule. Skip any missed dose if it’s almost time for your next dose. Do not use two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
An overdose can cause severe drowsiness.
What to avoid
This medicine may cause blurred vision and may impair your reactions. Avoid driving or hazardous activity until you know how this medicine will affect you.
Drinking alcohol can increase certain side effects of this medication.
Ask a doctor or pharmacist before using other cough or cold medicines that may contain similar ingredients.
Claritin-D side effects
Get emergency medical help if you have signs of an allergic reaction to Claritin-D: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using this medicine and call your doctor at once if you have:
pounding heartbeats or fluttering in your chest; or
severe dizziness, nervousness, or restless feeling.
Common Claritin-D side effects may include:
dry mouth, nose, or throat;
mild dizziness; or
sleep problems (insomnia).
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.
What other drugs will affect Claritin-D?
Using Claritin-D with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.
Other drugs may interact with loratadine and pseudoephedrine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
More about Claritin-D (loratadine / pseudoephedrine)
- Check interactions
- Compare alternatives
- Reviews (71)
- Drug images
- Side effects
- Dosage information
- During pregnancy
- Support group
- Drug class: upper respiratory combinations
Patient resources
Other brands
Alavert D-12 Hour Allergy and Sinus, Allergy & Congestion Relief, Clear-Atadine-D
Other formulations
- Claritin
Related treatment guides
- Allergic Rhinitis
- Nasal Congestion
Further information
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Claritin-D 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: 11.01.
Claritin-D 24 Hour Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing
Uses
How to use Claritin-D 24 Hour
Take this medication by mouth usually once daily; or take as directed by your doctor. Take with a full glass of water. Swallow the tablets whole. Do not crush or chew the tablets. Doing so can release all of the drug at once, increasing the risk of side effects.
Do not increase your dose or take this more often than directed.
Do not take this medication for several days before allergy testing since test results can be affected. Consult your doctor or pharmacist for more information.
Side Effects
Dry mouth, mild stomach upset, trouble sleeping, dizziness, headache, nervousness, loss of appetite, or thirst may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.
If your doctor has directed you to use this medication, remember that your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: fast/irregular heartbeat, uncontrolled shaking or tremor, mental/mood changes (such as confusion), difficulty urinating.
Get medical help right away if you have any very serious side effects, including: seizures.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Precautions
Before taking loratadine with pseudoephedrine, tell your doctor or pharmacist if you are allergic to it; or to desloratadine; or if you have any other allergies. Also, tell your doctor if you have had serious side effects from similar medications (such as other decongestants, including phenylephrine). This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, problems urinating (such as due to enlarged prostate), high blood pressure, diabetes, heart problems (such as coronary artery disease), thyroid problems (hyperthyroidism), glaucoma.
This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.
Older adults may be more sensitive to the side effects of this drug, especially fast/irregular heartbeat, dizziness, problems urinating, trouble sleeping, or confusion. Dizziness, trouble sleeping, and confusion can increase the risk of falling.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
This medication passes into breast milk. Consult your doctor before breast-feeding.
Interactions
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.
Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.
Check the labels on all your medicines (such as cough-and-cold products) because they may contain similar ingredients (decongestants such as phenylephrine). Ask your pharmacist about using those products safely.
Loratadine is very similar to desloratadine. Do not use medications containing desloratadine while using loratadine.
This medication may interfere with certain laboratory tests (including allergy skin testing), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
Does Claritin-D 24 Hour interact with other drugs you are taking?
Enter your medication into the WebMD interaction checker
Overdose
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: irregular or unusually slow or fast heartbeat, unusual nervousness or excitement, and seizures.
Do not share this medication with others.
If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Images
Claritin-D 24 Hour 10 mg-240 mg tablet,extended release
Color: whiteShape: ovalImprint: CLARITIN-D 24 HOUR
This medicine is a white, oval, coated, tablet imprinted with “CLARITIN-D 24 HOUR”.
Claritin-D 24 Hour 10 mg-240 mg tablet,extended release
Color: whiteShape: ovalImprint: CLARITIN-D 24 HOUR
This medicine is a white, oval, coated, tablet imprinted with “CLARITIN-D 24 HOUR”.
Claritin-D 24 Hour 10 mg-240 mg tablet,extended release
Color: whiteShape: ovalImprint: CLARITIN-D 24 HOUR
This medicine is a white, oval, coated, tablet imprinted with “CLARITIN-D 24 HOUR”.
Claritin-D 24 Hour 10 mg-240 mg tablet,extended release
Color: whiteShape: ovalImprint: Andrx 605
This medicine is a white, oval, coated, tablet imprinted with “CLARITIN-D 24 HOUR”.
Claritin-D 24 Hour 10 mg-240 mg tablet,extended release
Color: whiteShape: ovalImprint: CLARITIN-D 24 HOUR
This medicine is a white, oval, coated, tablet imprinted with “CLARITIN-D 24 HOUR”.
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CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.
Claritin D (Loratadine and Pseudoephedrine) Side Effects, Warnings, Uses
- Generic Name: Loratadine and Pseudoephedrine
- Brand Name: Claritin D
- Overview
- Consumer Information 900 04
- Professional information
- Related resources
Claritin D Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
What is Claritin D?
Claritin D (loratadine and pseudoephedrine) is a combination antihistamine and decongestant used to treat allergies, nasal congestion, and sinus pressure. Claritin D is available over-the-counter and in generic form.
What are the side effects of Claritin D?
Side effects of Claritin D may include:
- dizziness;
- drowsiness;dry mouth,
- headache,
- fatigue,
- nausea,
- abdominal pain,
- constipation,
- loss of appetite,
- upset stomach, 900 04
- nervousness,
- sleep problems (insomnia),
- sore throat,
- blurred vision,
- redness (feeling of warmth, redness or tingling under the skin),
- restlessness or excitability (especially in children),
- skin rash or itching,
- problems with memory or concentration, or
- ringing in the ears.
Dosage Claritin D
Claritin D is available in 12-hour and 24-hour dosages.
What drugs, substances or supplements interact with claritin D?
Do not use if you have taken an MAOI or have taken an MAOI within the last 2 weeks. Claritin D should not be used in patients with severe blood pressure (hypertension), glaucoma, or severe coronary heart disease without medical supervision. Claritin D may interact with other medicines that can cause drowsiness (cold or allergy medicines, sedatives, pain relievers, sleeping pills, muscle relaxants, and medicines for seizures, depression, or anxiety), blood pressure medicines, diuretics (water pills), medications. for the treatment of irritable bowel syndrome, bladder or urinary drugs, aspirin or salicylates, beta-blockers or antidepressants. Tell your doctor about all medications and supplements you are taking.
Claritin D during pregnancy and lactation
If you are pregnant or breastfeeding, consult your physician before use. Discontinue use if allergic reaction occurs or symptoms persist within 7 days.
37 weeks pregnant frequent bowel movements
More Information
Our Claritin D Side Effects Center provides a comprehensive overview of available drug information about the potential side effects of this medication.
This is not a complete list of side effects and they may occur. Ask your doctor about side effects. You can report side effects to the FDA at 1-800-FDA-1088.
Consumer Information Claritin D
Get emergency medical help if you have signs of an allergic reaction : hives; labored breathing; swelling of the face, lips, tongue, or throat.
Stop using this medicine and call your doctor at once if you have:
- palpitations or fluttering in the chest; or
- severe dizziness, nervousness or restless feeling.
Common side effects may include:
- dry mouth, nose or throat;
- slight dizziness; or
- sleep problems (insomnia).
This is not a complete list of side effects and they may occur. Ask your doctor about side effects. You can report side effects to the FDA at 1-800-FDA-1088.
Read full detailed patient monograph for Claritin D (loratadine and pseudoephedrine)
Learn more ‘ Claritin D Professional Information
SIDE EFFECTS
Loratadine; Extended-release tablets 12 hours pseudoephedrine sulfate
Experience from controlled and uncontrolled clinical studies involving approximately 10,000 patients treated with a combination of loratadine; pseudoephedrine sulfate for up to 1 month provides information on adverse reactions. The usual dose was one tablet every 12 hours for up to 28 days.
In controlled clinical trials using the recommended dose of one tablet every 12 hours, the incidence of adverse events reported was similar to placebo, except for insomnia (16%) and dry mouth (14%).
hydrocodone / apap 7.5 / 325
TABLE 2 Reported adverse events with frequency & sup3; 2% for loratadine; Pseudoephedrine sulfate extended release tablets 12 hours in placebo controlled clinical trials | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Percentage of patients seeking care | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Loratadine; Pseudoephedrine sulfate, 12 hours | Loratadine | Pseudoephedrine | Placebo | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
n = 1023 | n = 543 | n = 548 | n = 922 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Headache | 19 | 18 | 17 | 19 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Insomnia | 16 | 4 | 19 | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dry mouth | 14 | 4 | 9 | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Drowsiness 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Nervousness | 5 | 3 | 7 | two | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dizziness | 1 | 5 | two | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fatigue | 4 | 6 | 3 | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dyspepsia 9014 4 | 3 | two | 3 | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Anorek sia | two | 1 | two | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Thirst | two | 1 | two 019 Adverse event rates did not appear to differ significantly by age, sex, or race, although the number of non-whites subjects were relatively small. In addition to the above adverse events (> 2%), the following less frequent adverse events were reported in at least one patient treated with loratadine; pseudoephedrine sulfate 12 hours extended release tablets. Autonomic nervous system: Pathological lacrimation, dehydration, hypoesthesia, increased sweating, mydriasis. Body as a whole: Asthenia, back pain, blurred vision, chest pain, conjunctivitis, ear pain, ear infection, eye pain, fever, flu-like symptoms, leg cramps, lymphadenopathy, malaise, photophobia, chills, tinnitus, viral infection, weight gain. Cardiovascular system: Arterial hypertension, arterial hypotension, palpitations, peripheral edema, syncope, tachycardia, ventricular extrasystoles. Central and peripheral nervous system: Dysphonia, hyperkinesia, hypertension, migraine, paresthesia, tremor, dizziness. Gastrointestinal system: Abdominal distention, upset stomach, abdominal pain, taste change, constipation, diarrhea, belching, flatulence, gastritis, gum bleeding, hemorrhoids, increased appetite, stomatitis, loss of taste, discoloration tongue, toothache, vomiting. Liver and biliary system: Impaired liver function. Musculoskeletal system: Arthralgia, myalgia, torticollis. Psychiatric: Aggressive reaction, agitation, anxiety, apathy, confusion, decreased libido, depression, emotional lability, euphoria, impaired concentration, irritability, paronyria. Reproductive system: Dysmenorrhea, impotence, intermenstrual bleeding, vaginitis. Respiratory system: Bronchitis, bronchospasm, chest congestion, cough, dry throat, shortness of breath, epistaxis, halitosis, nasal congestion, nasal irritation, sinusitis, sneezing, increased sputum, upper respiratory infections , wheezing. Skin and appendages: Acne, bacterial infection of the skin, dry skin, eczema, edema, epidermal necrolysis, erythema, hematoma, pruritus, rash, urticaria. Urinary system: Dysuria, frequent urination, nocturia, polyuria, urinary retention. 24 hour extended release tablets Information on adverse reactions was obtained from placebo-controlled studies involving more than 2000 patients, 605 of whom received loratadine; pseudoephedrine sulfate 24 hour extended release tablet once daily for up to 2 weeks. These studies reported the frequency of adverse events with loratadine; Pseudoephedrine sulfate 24-hour extended-release tablets were similar to tablets taken twice a day (every 12 hours) with only sustained-release pseudoephedrine 120 mg.
Adverse events occurring at greater than or equal to 2% loratadine; Pseudoephedrine sulfate treated with 24-hour extended release tablets but more common in the placebo group, including headache. Adverse events did not appear to differ significantly by age, sex, or race, although the number of non-whites was relatively small. In addition to the adverse events mentioned above, the following adverse events were reported in less than 2% of patients treated with loratadine; pseudoephedrine sulfate 24 hour extended-release tablets. Autonomic nervous system: Altered lacrimation, hyperemia, increased sweating, mydriasis, thirst. Whole body: Visual impairment, asthenia, back pain, chest pain, conjunctivitis, ear pain, eye pain, facial swelling, fever, flu-like symptoms, leg cramps, lymphadenopathy, malaise, chills , noise in ears. Cardiovascular system: Hypertension, palpitations, tachycardia. Central and peripheral nervous system: Convulsions, dysphonia, hyperkinesis, hypertonicity, migraine, paresthesia, tremor. Gastrointestinal system: Bloating, taste changes, constipation, diarrhea, dyspepsia, flatulence, gastritis, stomatitis, ulceration of the tongue, toothache, vomiting.
Liver and biliary system: Cholelithiasis. Musculoskeletal system: Arthralgia, musculoskeletal pain, myalgia, tendonitis. Psychiatric: Agitation, depression, emotional lability, irritability. Reproductive system: Vaginitis. Mechanism of resistance: Abscess, viral infection. Respiratory system: Bronchospasm, shortness of breath, epistaxis, hemoptysis, nasal congestion, nasal irritation, pleurisy, pneumonia, sinusitis, increased sputum, wheezing. Skin and appendages: Acne, pruritus. Urinary system: Oliguria, frequent urination, urinary retention, urinary tract infections. Additional side effects reported with the combination of loratadine and pseudoephedrine include liver dysfunction, aggressive reaction, restlessness, apathy, confusion, euphoria, paronyria, postural hypotension, syncope, urticaria, dizziness, weight gain. Post-marketing reports of mechanical upper gastrointestinal obstruction and esophageal perforation in patients treated with the previously marketed formulation of loratadine; pseudoephedrine sulfate 24 hour extended-release tablets. In some, but not all, cases, patients had narrowing of the upper gastrointestinal tract or abnormal esophageal motility. Whether this will be a re-formulation of loratadine is not known; Pseudoephedrine sulfate extended-release 24-hour tablets have the potential to cause this adverse event (see PRECAUTIONS and DOSAGE AND ADMINISTRATION ). 12 and 24 hour extended release tablets The following additional adverse events have been reported with loratadine; Pseudoephedrine sulfate tablets: Alopecia, altered salivation, amnesia, anaphylaxis, angioedema, blepharospasm, breast enlargement, chest pain, dermatitis, dry hair, erythema multiforme, laryngitis, menorrhagia, dry nose, photosensitivity reaction, purpura, seizures reducing gastrointestinal disturbances. Additional side effects for extended-release 24-hour tablets only: Abdominal upset, urination disorders, bronchitis, decreased libido, dry skin, hypoesthesia, impaired concentration, impotence, increased appetite, peripheral edema, rash, and upper respiratory tract infections. Pseudoephedrine may cause mild CNS stimulation in hypersensitive patients. Nervousness, irritability, restlessness, dizziness, weakness, or insomnia may occur. Headache, drowsiness, tachycardia, palpitations, pressor activity and cardiac arrhythmias have been reported. Sympathomimetic drugs are also associated with other unwanted effects such as fear, anxiety, tension, tremors, hallucinations, convulsions, pallor, breathing difficulties, dysuria, and cardiovascular collapse.
DRUG ABUSE AND DEPENDENCENo information available to indicate abuse or dependence on loratadine. Pseudoephedrine, like other central nervous system stimulants, is subject to abuse. When taking high doses, subjects typically experience an elevated mood, a feeling of increased energy and alertness, and a decrease in appetite. Some people become anxious, irritable, and talkative. In addition to the pronounced euphoria, the user experiences a feeling of markedly increased physical strength and mental capacity. With continued use, tolerance develops, the user increases the dose, and toxic signs and symptoms appear. Depression may follow rapid withdrawal. Read all FDA Prescribing Information for Claritin D (Loratadine and Pseudoephedrine) Read More’ Related Resources for Claritin D Health Related
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Claritin D Patient Information is provided by Cerner Multum, Inc. and Claritin D Consumer Information is provided by First Databank, Inc., used under license and subject to their respective copyrights. Erius – description of the drug, composition, indications for useSchering-Plough / USA – one of the largest innovative companies – is the world leader in the development of antiallergic drugs. The company’s scientists were at the origins of the creation of the first antihistamines. So, in 1948, the first generation antihistamine drug, pheniramine maleate, was developed, and in 1949, chlorpheniramine maleate, which is used in clinical practice to this day. At 1988, the most popular anti-allergic drug Claritin was created over the past decade (since 1994) (data from IMS Health). According to the results of sales on the world pharmaceutical market in 2001, Claritin entered the top five most popular drugs (see “APTEKA Weekly” No. 13 (334). It is the No. 1 antihistamine drug in the world, and is also one of the 15 drugs of all anatomical and therapeutic groups in the USA (see “PHARMACY Weekly” No. 12 (333). Due to its high efficiency and safety, Claritin is widely prescribed not only for adults, but also for children. In 2000, the company allocated 1.3 billion US dollars.The latest development of the research centers of Schering-Plough is the innovative drug Erius (desloratadine).Erius has attractive pharmacodynamic and pharmacokinetic properties.Desloratadine selectively binds to H 1 – histamine receptors and does not have a toxic effect on the myocardium. A distinctive feature of Erius is that, in addition to the blockade of H 1 -histamine receptors, it also has anti-allergic and anti-inflammatory effects.
The use of molecular biological, immunological and genetic approaches has allowed scientists to better understand the mechanisms of allergic conditions. It has been established that allergy is a complex systemic pathology, which is based on the change in immune function caused by the allergen. Most often, a chronic inflammatory process develops in the mucous membrane of the upper respiratory tract, which causes the well-known symptoms of allergic rhinitis, such as sneezing, rhinorrhea, and nasal congestion. These and other allergy symptoms, including mucosal (sneezing, rhinorrhea, cough) and skin (pruritus), are caused not only by excessive release of histamine from mast cells, as previously thought, but also by other mediators of systemic allergic inflammation. Thus, allergy is a systemic disease of immune origin with corresponding local manifestations in a particular target organ. In an allergic reaction, mast cells are degranulated with the release of histamine, as well as the activation of T-helpers, basophilic and eosinophilic granulocytes under the influence of cytokines (interleukins – IL-4, IL-5, IL-6, IL-8, IL-13) with the release into the blood of certain leukotrienes and prostaglandins, as well as chemokines (eotaxin and RANTES – Regulated on Activation Normal T-Cell Expressed and Secreted). At the same time, adhesion molecules are expressed, including ICAM-1 (InterCellular Adhesion Molecule-1) and P-selectin. These biochemical and immunological mechanisms are responsible for the development of the inflammatory response cascade in allergy.
There are a number of antihistamines on the pharmaceutical market. A reasonable question may arise – why is another new drug of this group needed? First generation antihistamines have undesirable effects – sedation, anticholinergic and a number of contraindications, which limits their clinical use. Some second-generation antihistamines (terfenadine, astemizole) have a cardiotoxic effect on myocardial function. In addition, none of them has a complex effect on the course of allergic inflammation. Erius systemically affects different parts of the allergic inflammatory process, regardless of the nosological form (DuBuske L.M., 2001). Clinical practice shows that with a particular allergic pathology, doctors prefer a certain antihistamine. So, for example, Claritin is more often used for rhinitis, while cetirizine is used for urticaria (it has a more pronounced antipruritic effect due to the sedative effect) (Negro-Alvarez J.M., Miralles-Lopez J.C., 2001). At the same time, clinicians did not have a drug at their disposal that would allow pathogenetic therapy of systemic allergic inflammation, regardless of the nosological form of the disease, and at the same time provide the patient with an adequate quality of life, as well as avoid the development of side effects. All these problems can be successfully solved with the help of Erius (Agrawal D.K., 2001).
Erius is the first representative of a class of antihistamines that has a complex effect – antihistamine, antiallergic and anti-inflammatory, since it affects a number of mediators of the allergic inflammation cascade (histamine, leukotrienes, prostaglandins), IL-4, IL-5, IL-6, IL-8, IL-13, chemokines (eotaxin and RANTES), effectively inhibiting their formation and release. None of the antihistamines has such a complex effect (Agrawal D.K., 2001; DuBuske L.M., 2001).
The affinity of desloratadine for H 1 -histamine receptors is much higher than other antihistamines, including loratadine. Binding to H 1 -histamine receptors occurs even at subnanomolar concentrations of desloratadine. As a result, the clinical efficacy of Erius exceeds that of loratadine and other antihistamines (see table) (Anthes S.C. et al., 2000). As a result of the metabolism of loratadine, 4 metabolites are formed that compete for binding with H 1 – histamine receptors. However, not all metabolites of loratadine are characterized by an adequate pharmacokinetic and pharmacodynamic profile. Desloratadine has optimal properties in this regard. The clinical efficacy of Erius is 4 times higher than that of Claritin (Henz B. M., 2001; Korostovtsev D.S., 2002). Table Affinity constants for H 1 – histamine receptors
Desloratadine selectively binds to H 1 – histamine receptors. Its affinity for H 1 -histamine receptors is 15–20 times higher than for M-cholinergic receptors, adrenoreceptors and some other receptors (Bonini S., 2001). Anticholinergic activity, to some extent characteristic of all antihistamines (especially the first generation), in desloratadine in vitro is observed only at concentrations that are at least 10 times higher than plasma therapeutic levels, and in vivo – at a dose exceeding 2000 times the clinically significant dose of desloratadine. Therefore, Erius does not cause any undesirable effects inherent in antihistamines of the first generation. It should be noted that Claritin, like other representatives of second-generation antihistamines, was devoid of these undesirable effects (Geha R.S. et al., 2001).
The safety and efficacy of Erius has been studied in a number of large, multicenter, placebo-controlled studies involving more than 10,000 people. According to the results of studies, it was found that Erius effectively eliminates nasal and non-nasal symptoms in allergic rhinitis. Other antihistamines generally do not provide consistent relief from nasal congestion. The results of the studies indicate that Erius (1 time per day at a dose of 5 mg – 1 tablet) causes a statistically significant decrease in swelling and nasal congestion throughout the entire treatment. The degree of reduction in the severity of the above symptoms is similar both in patients with rhinitis and in patients in whom allergic rhinitis is combined with bronchial asthma (Salmun L.M., 2002; Nayak A.S., Schenkel E., 2001). It was also found that with urticaria, including idiopathic, Erius significantly reduces the severity of skin itching, the number and size of urticaria rashes. After taking 1 tablet (5 mg), there is an improvement in the 28th minute. A significant improvement occurs within 1 hour. A persistent therapeutic effect persists evenly throughout the day, due to the strong binding of desloratadine to H 1 receptors and a long half-life of 14-28 hours (Salmun L.M., 2002; Ring J. et al. 2001). It has been noted that the use of Erius in patients in whom allergic rhinitis is combined with bronchial asthma leads not only to the elimination of nasal and non-nasal symptoms, but also has an anti-inflammatory effect on the bronchial mucosa, leading to an improvement in the course of bronchial asthma and a decrease in the need for use b 2 -agonists (Baena-Cagnani C.E., 2001). All patients who took Erius noted an improvement in their general condition and quality of life – improved sleep, increased social, physical and emotional activity. Erius does not develop addiction, with prolonged use its effectiveness does not decrease (Kosoglou T., 2000).
Although Erius is not a nasal decongestant, it effectively relieves this swelling and the associated symptom of nasal congestion in allergic rhinitis. The severity of the decongestive effect of Erius is comparable to that of pseudoephedrine (Tayak A.S., Schenkel E., 2001; Bachert S., 2001).
Why is Claritin the best-selling antihistamine in the world today? Because it is effective and safe. From the above data, we can conclude that desloratadine has a number of advantages over loratadine. Erius is a worthy successor to Claritin. It is widely used in the treatment of both adults and children. In Ukraine, Erius is registered in the form of tablets and is approved for use in children from 12 years of age. For children under 12, Schering-Plow has developed Erius in the form of a syrup, which will be registered in Ukraine. In Europe and the USA, Erius in the form of a syrup is used in children from 2 years of age.
Some second-generation antihistamines have a cardiotoxic effect, which is expressed in the prolongation of the interval Q-T and ventricular arrhythmias (fusiform tachycardia syndrome or torsade de pointes syndrome). Antihistamines with a pronounced cardiotoxic effect (terfenadine, astemizole) were withdrawn from the pharmaceutical markets of a number of countries. This circumstance stimulated research to further improve the pharmacodynamic and pharmacokinetic profile of second generation drugs. At the same time, the advantage was given to the development of derivatives of the classical representatives of effective and safe antihistamines of the second generation, which are formed during their metabolic transformations. Erius became such a drug (Geha R.S. et al., 2001).
It is known that a significant part of xenobiotics undergo redox reactions involving cytochrome P450. Since desloratadine is not metabolized with the participation of this cytochrome, then when it is prescribed in combination with other drugs, one should not be afraid of drug interactions. Therefore, patients who are prescribed Erius can simultaneously take erythromycin or ketoconazole (Kosoglou T. et al., 2000; Barecki M.E. et al., 2001).
Since food and drinks (in particular, grapefruit juice) do not affect the absorption and bioavailability of Erius, this drug can be used on an empty stomach or after meals, at any time convenient for the patient. Erius is taken only once a day, which helps patients adhere to the treatment regimen. Erius can be combined with alcohol intake. It does not cause drowsiness and does not reduce the patient’s attention when driving vehicles, as well as when performing other activities that require increased attention. An important aspect is the safety of Erius for aircraft pilots (Bolder W.E. et al., 1990; Data on file, 2000).
Erius is an over-the-counter drug. Therefore, the pharmacist can independently recommend it to the patient without fear of the risk of developing serious adverse reactions. |