Clemastine 2.68mg Tablets

Manufacturer GENUS LIFESCIENCES Active Ingredient Clemastine Tablets(KLEM as teen) Pronunciation KLEM-as-teen
It is used to ease allergy signs.
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Drug Class
Antihistamine
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Pharmacologic Class
H1-receptor antagonist, first-generation
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Pregnancy Category
Category B
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FDA Approved
Sep 1973
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Clemastine is an antihistamine used to relieve symptoms of allergies like sneezing, runny nose, itchy eyes, and skin rash (hives). It can cause drowsiness, so it's important to be careful when driving or doing tasks that require alertness.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. If it causes stomach upset, taking it with food may help.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a safe place, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on the best disposal method. You may also have access to local drug take-back programs.

Missing a Dose

If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
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Lifestyle & Tips

  • Avoid alcohol and other CNS depressants (e.g., sedatives, tranquilizers) as they can increase drowsiness.
  • Avoid driving or operating heavy machinery until you know how this medication affects you.
  • May cause dry mouth; sugarless candy or gum, or ice chips may help.
  • If you experience blurred vision or difficulty urinating, contact your healthcare provider.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 2.68 mg (1 tablet) orally every 8 to 12 hours
Dose Range: 1.34 - 8.04 mg

Condition-Specific Dosing:

Maximum daily dose: Not to exceed 8.04 mg (3 tablets) in 24 hours
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (generally not recommended for infants)
Child: 6 to 12 years: 0.67 mg to 1.34 mg orally twice daily, not to exceed 4.02 mg in 24 hours
Adolescent: 12 years and older: Same as adult dosing
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; consider lower dose
Moderate: Use with caution; consider lower dose
Severe: Use with caution; consider lower dose
Dialysis: Not specifically studied; use with caution, monitor for increased side effects

Hepatic Impairment:

Mild: Use with caution; consider lower dose
Moderate: Use with caution; consider lower dose
Severe: Use with caution; consider lower dose
Confidence: Medium

Pharmacology

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Mechanism of Action

Clemastine is a first-generation antihistamine that competitively blocks histamine H1 receptors, thereby preventing the effects of histamine on capillaries, bronchi, and gastrointestinal smooth muscle. It also possesses significant anticholinergic and sedative properties.
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Pharmacokinetics

Absorption:

Bioavailability: Well absorbed
Tmax: 2-4 hours
FoodEffect: Food may delay absorption but does not significantly affect the extent of absorption.

Distribution:

Vd: Not readily available
ProteinBinding: Approximately 95%
CnssPenetration: Yes

Elimination:

HalfLife: 10-25 hours
Clearance: Not readily available
ExcretionRoute: Primarily via urine as metabolites
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: 15-30 minutes
PeakEffect: 2-4 hours
DurationOfAction: 10-12 hours

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Change in balance

Other Possible Side Effects

Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor for advice:

Feeling dizzy or sleepy
Stomach pain
* Thickening of mucus in the nose or throat

Note: This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe drowsiness or dizziness
  • Confusion or disorientation
  • Difficulty urinating or inability to urinate
  • Rapid or irregular heartbeat
  • Seizures
  • Hallucinations
  • Severe dry mouth or blurred vision
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions and situations to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reactions you have experienced.
If you have asthma.
If you have taken certain medications for depression or Parkinson's disease within the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to very high blood pressure.
If you are taking linezolid or methylene blue, as these medications can interact with this drug.
If you are breastfeeding, as you should not breastfeed while taking this medication.

Special Considerations for Children:

If your child is a premature baby or a newborn, do not administer this medication, as it is not suitable for these age groups.

Additional Important Information:

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This will help ensure that it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere strictly to the dosage instructions provided by your doctor, as taking more than prescribed may increase your risk of experiencing severe side effects. Additionally, do not take this medication for a longer duration than recommended by your doctor.

Until you are aware of how this medication affects you, it is crucial to avoid driving and engaging in other activities that require alertness. It is also recommended to avoid consuming alcohol while taking this drug. Before using marijuana, other forms of cannabis, or any prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor.

If you are scheduled to undergo allergy skin tests, inform your doctor and laboratory personnel that you are taking this medication, as it may impact the test results. Individuals aged 60 or older should exercise caution when using this medication, as they may be more susceptible to side effects. Similarly, when administering this medication to children, use it with caution, as they may have a higher risk of experiencing excitability.

If you are pregnant or planning to become pregnant, it is vital to discuss the benefits and risks of using this medication during pregnancy with your doctor.
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Overdose Information

Overdose Symptoms:

  • Severe drowsiness or sedation
  • Confusion, disorientation, ataxia
  • Hallucinations
  • Seizures
  • Coma
  • Respiratory depression
  • Anticholinergic crisis (e.g., dilated pupils, flushed skin, fever, dry mucous membranes, urinary retention, bowel paralysis)
  • Cardiovascular collapse

What to Do:

Seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222). Treatment is supportive and symptomatic. Activated charcoal may be administered if ingestion is recent. Physostigmine may be considered for severe anticholinergic symptoms.

Drug Interactions

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Contraindicated Interactions

  • Not typically contraindicated with specific drugs, but caution with conditions exacerbated by anticholinergic effects (e.g., narrow-angle glaucoma, prostatic hypertrophy).
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Major Interactions

  • CNS depressants (e.g., alcohol, sedatives, hypnotics, anxiolytics, opioids, other antihistamines): Potentiation of sedative effects.
  • Monoamine Oxidase Inhibitors (MAOIs): Prolong and intensify the anticholinergic effects of clemastine.
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Moderate Interactions

  • Other anticholinergic drugs (e.g., tricyclic antidepressants, atropine, some antipsychotics): Additive anticholinergic effects (e.g., dry mouth, urinary retention, blurred vision, constipation).
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Baseline CNS status (e.g., alertness, cognitive function)

Rationale: To assess potential for sedation and cognitive impairment, especially in elderly patients or those on other CNS depressants.

Timing: Prior to initiation of therapy

History of conditions exacerbated by anticholinergic effects (e.g., glaucoma, urinary retention, prostatic hypertrophy)

Rationale: To identify contraindications or need for caution.

Timing: Prior to initiation of therapy

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Routine Monitoring

Symptom relief (e.g., allergy symptoms)

Frequency: Periodically, as needed

Target: Reduction or resolution of symptoms

Action Threshold: Lack of efficacy may require dose adjustment or alternative therapy

Adverse effects (e.g., sedation, dry mouth, blurred vision, urinary retention, constipation)

Frequency: Regularly, especially during initial therapy or dose changes

Target: Absence or minimal tolerable side effects

Action Threshold: Significant or intolerable side effects may require dose reduction or discontinuation

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Symptom Monitoring

  • Drowsiness
  • Dizziness
  • Dry mouth
  • Blurred vision
  • Urinary retention
  • Constipation
  • Nervousness (paradoxical excitation, especially in children)

Special Patient Groups

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Pregnancy

Category B. Animal studies have not shown fetal harm, but there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed and potential benefits outweigh potential risks.

Trimester-Specific Risks:

First Trimester: Generally considered low risk based on animal data, but human data are limited.
Second Trimester: Generally considered low risk.
Third Trimester: Use with caution near term due to potential for neonatal effects (e.g., irritability, tremors) from antihistamine exposure.
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Lactation

Use with caution. Clemastine is excreted into breast milk and may cause sedation, irritability, or apnea in the nursing infant. It may also decrease milk supply due to its anticholinergic effects.

Infant Risk: L3 (Moderately Safe) - Monitor infant for sedation, irritability, poor feeding, or respiratory depression. Consider alternative agents, especially in preterm or jaundiced infants.
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Pediatric Use

Children, especially those under 6 years, may experience paradoxical excitation (restlessness, insomnia, nervousness) rather than sedation. Not recommended for infants. Use with caution and appropriate dosing in children 6-12 years.

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Geriatric Use

Elderly patients are more susceptible to the sedative, hypotensive, and anticholinergic effects (e.g., confusion, urinary retention, constipation, dry mouth, blurred vision) of clemastine. Use lower doses and monitor closely.

Clinical Information

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Clinical Pearls

  • Clemastine is a first-generation antihistamine known for its significant sedative and anticholinergic side effects.
  • Due to its long half-life, once or twice daily dosing is often sufficient, but patients should be warned about prolonged drowsiness.
  • It is generally less preferred than second-generation antihistamines for chronic allergy management due to its side effect profile, but can be useful for acute, severe symptoms or when sedation is desired (e.g., nighttime use).
  • Patients should be advised to avoid activities requiring mental alertness, such as driving or operating machinery, until they know how the drug affects them.
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Alternative Therapies

  • Second-generation antihistamines (e.g., loratadine, cetirizine, fexofenadine, desloratadine, levocetirizine) for less sedating options.
  • Other first-generation antihistamines (e.g., diphenhydramine, chlorpheniramine, brompheniramine).
  • Nasal corticosteroids (e.g., fluticasone, mometasone) for allergic rhinitis.
  • Mast cell stabilizers (e.g., cromolyn sodium).
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Cost & Coverage

Average Cost: Typically inexpensive per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (preferred generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for clarification. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount, and the time it occurred.