Ryclora 2mg/5ml Oral Solution

Manufacturer CARWIN ASSOCIATES Active Ingredient Dexchlorpheniramine(deks klor fen EER a meen) Pronunciation deks-klor-FEN-eer-a-meen
It is used to ease allergy signs.
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Drug Class
Antihistamine
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Pharmacologic Class
First-Generation H1-Receptor Antagonist
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Pregnancy Category
Category B (Some sources list C, but B is more common for this class when considering older antihistamines)
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Ryclora is an antihistamine that helps relieve symptoms like sneezing, runny nose, watery eyes, and itching caused by allergies or the common cold. It works by blocking a natural substance called histamine that your body makes during an allergic reaction. It can also make you feel sleepy.
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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, but if it causes stomach upset, take it with food to help minimize discomfort. When taking the liquid form, measure the dose carefully using the measuring device that comes with the medication. If no device is provided, ask your pharmacist for a suitable measuring tool.

Storing and Disposing of Your Medication

Store this 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. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.

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, do not take it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Avoid driving or operating heavy machinery until you know how this medication affects you, as it can cause drowsiness or dizziness.
  • Avoid alcohol and other sedating medications, as they can increase drowsiness.
  • Drink plenty of fluids to help with dry mouth.
  • If you experience blurred vision, avoid activities requiring clear vision.
  • Do not exceed the recommended dose, especially in children, as overdose can be serious.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: 2 mg (5 mL) every 4 to 6 hours
Dose Range: 2 - 4 mg

Condition-Specific Dosing:

maximumDailyDose: 12 mg (30 mL) in 24 hours
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Pediatric Dosing

Neonatal: Not established (Contraindicated in neonates and premature infants)
Infant: Not established (Use with extreme caution, generally not recommended under 2 years)
Child: Age 2 to 5 years: 0.5 mg (1.25 mL) every 4 to 6 hours, not to exceed 3 mg (7.5 mL) in 24 hours; Age 6 to 11 years: 1 mg (2.5 mL) every 4 to 6 hours, not to exceed 6 mg (15 mL) in 24 hours
Adolescent: Age 12 years and older: 2 mg (5 mL) every 4 to 6 hours, not to exceed 12 mg (30 mL) in 24 hours
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, but monitor for increased side effects.
Moderate: Consider dose reduction (e.g., 50%) or extended dosing interval (e.g., every 8-12 hours).
Severe: Avoid use or significantly reduce dose (e.g., 25% of normal dose) and extend interval (e.g., every 12-24 hours).
Dialysis: Dexchlorpheniramine is not significantly removed by dialysis. Administer after dialysis if used.

Hepatic Impairment:

Mild: No specific adjustment recommended, but monitor for increased side effects.
Moderate: Consider dose reduction (e.g., 50%) or extended dosing interval.
Severe: Avoid use or significantly reduce dose and extend interval due to impaired metabolism.

Pharmacology

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Mechanism of Action

Dexchlorpheniramine is a first-generation antihistamine that competitively antagonizes H1 histamine receptors, thereby preventing the effects of histamine on capillaries, bronchi, and gastrointestinal smooth muscle. It also possesses significant anticholinergic (muscarinic) and sedative properties due to its ability to cross the blood-brain barrier.
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Pharmacokinetics

Absorption:

Bioavailability: Variable, generally good oral absorption (estimated 25-50% due to first-pass metabolism)
Tmax: 2-6 hours
FoodEffect: Food may slightly delay absorption but does not significantly affect the extent of absorption.

Distribution:

Vd: Approximately 3-7 L/kg
ProteinBinding: Approximately 72%
CnssPenetration: Yes (readily crosses the blood-brain barrier, contributing to sedative effects)

Elimination:

HalfLife: Approximately 8-12 hours (can range from 2-43 hours, highly variable)
Clearance: Not precisely quantified, but significant hepatic and renal clearance.
ExcretionRoute: Primarily renal (urine), with some fecal excretion.
Unchanged: Approximately 34% (variable)
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Pharmacodynamics

OnsetOfAction: Within 30-60 minutes
PeakEffect: 2-6 hours
DurationOfAction: 4-6 hours

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Immediately

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

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
Urination problems, such as:
+ Inability to pass urine
+ Changes in the amount of urine passed
Seizures
Shakiness
Severe dizziness or fainting
Changes in vision
Changes in balance
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Confusion
Abnormal burning, numbness, or tingling sensations
Ringing in the ears
Excessive sweating

Other Possible Side Effects

Like all medications, this drug can cause side effects. While 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 unusual symptoms, contact your doctor for advice:

Dizziness, drowsiness, fatigue, or weakness
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Dry mouth, nose, or throat
Feeling nervous or excitable
Irritability
Sleep disturbances
Restlessness
Thickening of mucus in the nose or throat

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 hallucinations
  • Difficulty urinating or inability to urinate
  • Severe dry mouth or throat
  • Blurred vision or eye pain
  • Fast or irregular heartbeat
  • Seizures
  • Paradoxical excitability (especially in children)
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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 before starting this medication:

Any allergies you have, including allergies to this drug, 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 your safety while taking this medication. Never start, stop, or change the dose of any medication without consulting your doctor first.
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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 instructed by your doctor, as taking more than prescribed may increase your risk of experiencing severe side effects. Do not exceed the recommended treatment duration, and only use this medication for the length of time specified by your doctor.

Until you understand how this medication affects you, avoid operating a vehicle or engaging in any activities that require your full attention. Additionally, refrain from consuming alcohol while taking this drug. Before using marijuana, other cannabis products, or any prescription or over-the-counter medications that may cause drowsiness, consult with your doctor to discuss potential interactions.

Be cautious when exposed to sunlight, as this medication may increase your susceptibility to sunburn. If you experience easy sunburning while taking this drug, notify your doctor. If you are 60 years or older, exercise caution when using this medication, as you may be more prone to side effects.

When administering this medication to children, use it with caution, as they may have a higher risk of experiencing excitability. It is crucial to be aware that overdoses have occurred in children taking this medication, which can lead to severe health complications and potentially be fatal. If you have any questions or concerns, consult with your doctor.

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

Overdose Symptoms:

  • Severe drowsiness or deep sleep
  • Dilated pupils
  • Flushed skin
  • Dry mouth and skin
  • Fever
  • Agitation, hallucinations, or delirium (especially in children)
  • Ataxia (loss of coordination)
  • Tremors
  • Seizures
  • Coma
  • Respiratory depression
  • Cardiovascular collapse

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic, including gastric lavage, activated charcoal, and management of vital signs and seizures.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI discontinuation due to intensified and prolonged anticholinergic and CNS depressant effects)
  • Potassium Chloride (oral forms, especially extended-release, due to increased risk of GI lesions from anticholinergic effects)
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Major Interactions

  • CNS Depressants (e.g., alcohol, benzodiazepines, opioids, sedatives, hypnotics, tricyclic antidepressants) - additive CNS depression
  • Anticholinergic Drugs (e.g., atropine, scopolamine, tricyclic antidepressants, some antipsychotics) - additive anticholinergic effects (dry mouth, blurred vision, urinary retention, constipation)
  • Other First-Generation Antihistamines (additive effects)
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Moderate Interactions

  • Beta-2 Agonists (e.g., albuterol) - potential for additive cardiovascular effects (tachycardia)
  • Metoclopramide (antagonism of prokinetic effect)
  • Phenytoin (may alter phenytoin levels)
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Minor Interactions

  • Topical Anesthetics (additive local anesthetic effect)

Monitoring

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Baseline Monitoring

Patient's medical history (especially glaucoma, prostatic hypertrophy, urinary retention, asthma, cardiovascular disease)

Rationale: To identify contraindications or conditions requiring caution due to anticholinergic effects or potential for exacerbation.

Timing: Prior to initiation of therapy

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Routine Monitoring

Sedation/Drowsiness level

Frequency: Regularly, especially during initial therapy or dose adjustments

Target: Minimal to tolerable drowsiness

Action Threshold: Excessive sedation interfering with daily activities or safety; consider dose reduction or alternative.

Anticholinergic side effects (e.g., dry mouth, blurred vision, urinary hesitancy/retention, constipation)

Frequency: Regularly

Target: Minimal to tolerable

Action Threshold: Severe or bothersome symptoms; consider dose reduction or alternative.

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Symptom Monitoring

  • Effectiveness in relieving allergy symptoms (sneezing, runny nose, itching)
  • Drowsiness or sedation
  • Dry mouth
  • Blurred vision
  • Difficulty urinating
  • Constipation
  • Dizziness
  • Nervousness or excitability (paradoxical effect, especially in children)

Special Patient Groups

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Pregnancy

Use with caution during pregnancy. While generally considered Category B, some sources list C. It should only be used if the potential benefit justifies the potential risk to the fetus. Avoid use in the third trimester due to potential for adverse effects in the neonate (e.g., irritability, tremors).

Trimester-Specific Risks:

First Trimester: Limited data, but generally not associated with major congenital malformations.
Second Trimester: Generally considered safer than first or third trimester, but use only if clearly needed.
Third Trimester: Avoid use due to potential for premature infants to develop seizures, and for full-term infants to experience irritability, tremors, or other anticholinergic effects.
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Lactation

Not recommended during breastfeeding. Dexchlorpheniramine is excreted into breast milk and can cause drowsiness, irritability, or other anticholinergic effects in the infant. It may also decrease milk supply due to its anticholinergic effects.

Infant Risk: Moderate to High (L3-L4) - potential for infant sedation, irritability, and theoretical risk of decreased milk supply.
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Pediatric Use

Use with extreme caution, especially in children under 2 years of age, due to increased susceptibility to adverse effects, including respiratory depression and paradoxical excitation. Dosage must be carefully calculated based on age and weight. Contraindicated in neonates and premature infants.

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Geriatric Use

Increased risk of adverse effects, particularly sedation, dizziness, confusion, hypotension, and anticholinergic effects (e.g., dry mouth, urinary retention, constipation). Start with lower doses and titrate carefully. Avoid use in elderly patients with cognitive impairment or prostatic hypertrophy.

Clinical Information

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Clinical Pearls

  • First-generation antihistamines like dexchlorpheniramine are generally more sedating and have more anticholinergic side effects compared to second-generation antihistamines.
  • Advise patients to take the first dose at bedtime to assess the level of sedation.
  • Patients should be warned about the additive sedative effects with alcohol and other CNS depressants.
  • Monitor elderly patients closely for confusion, falls, and urinary retention.
  • Paradoxical excitation (restlessness, insomnia, nervousness) can occur, especially in young children and the elderly.
  • This oral solution formulation is particularly useful for pediatric patients or those who have difficulty swallowing tablets.
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Alternative Therapies

  • Second-generation antihistamines (e.g., loratadine, fexofenadine, cetirizine, levocetirizine, desloratadine) - generally less sedating and fewer anticholinergic effects.
  • Other first-generation antihistamines (e.g., diphenhydramine, chlorpheniramine, brompheniramine)
  • Intranasal corticosteroids (e.g., fluticasone, mometasone) for allergic rhinitis.
  • Nasal saline rinses for symptomatic relief.
  • Decongestants (e.g., pseudoephedrine, phenylephrine) for nasal congestion (often combined with antihistamines).
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Cost & Coverage

Average Cost: Not available (highly variable by pharmacy and insurance) per 120 mL bottle
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (often covered as a generic or preferred brand)
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General Drug Facts

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