Sudogest Cold & Allergy Tablets

Manufacturer MAJOR PHARMACEUTICALS Active Ingredient Chlorpheniramine and Pseudoephedrine Tablets(klor fen IR a meen & soo doe e FED rin) Pronunciation KLOR-fen-IR-uh-meen & SOO-doe-e-FED-rin
It is used to treat nose stuffiness.It is used to ease allergy signs.
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Drug Class
Antihistamine, Decongestant
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Pharmacologic Class
H1-receptor antagonist (Chlorpheniramine), Alpha-adrenergic agonist (Pseudoephedrine)
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Pregnancy Category
Category C
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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?

This medication combines an antihistamine (chlorpheniramine) to relieve sneezing, runny nose, and watery eyes, with a decongestant (pseudoephedrine) to clear up stuffy nose and sinus pressure. It helps reduce common cold and allergy symptoms.
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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 place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them 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 drug take-back programs 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, follow your doctor's instructions and do not take it more frequently than recommended.
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Lifestyle & Tips

  • Avoid alcohol and other sedating medications while taking this product, as it can increase drowsiness.
  • Use caution when driving or operating machinery until you know how this medication affects you.
  • Stay hydrated to help with dry mouth, a common side effect.
  • Do not exceed the recommended dose, as it can lead to serious side effects.

Dosing & Administration

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Adult Dosing

Standard Dose: 1 tablet every 4-6 hours as needed

Condition-Specific Dosing:

Maximum daily dose: Do not exceed 6 tablets in 24 hours
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not recommended for children under 12 years of age without physician consultation. For children 6-11 years, specific pediatric formulations or physician guidance is required.
Adolescent: 1 tablet every 4-6 hours as needed (12 years and older), do not exceed 6 tablets in 24 hours
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; consider lower doses or extended dosing intervals.
Moderate: Use with caution; consider lower doses or extended dosing intervals. Pseudoephedrine excretion is reduced.
Severe: Contraindicated or use with extreme caution; significant dose reduction or avoidance may be necessary. Pseudoephedrine excretion is significantly impaired.
Dialysis: Pseudoephedrine is dialyzable. Chlorpheniramine is not significantly dialyzable. Consult physician.

Hepatic Impairment:

Mild: Use with caution.
Moderate: Use with caution; consider lower doses or extended dosing intervals due to reduced chlorpheniramine metabolism.
Severe: Use with caution; significant dose reduction or avoidance may be necessary due to reduced chlorpheniramine metabolism.

Pharmacology

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Mechanism of Action

Chlorpheniramine is an alkylamine antihistamine that competitively antagonizes H1-receptors, thereby preventing histamine from binding and reducing symptoms like sneezing, rhinorrhea, and watery eyes. Pseudoephedrine is a sympathomimetic amine that acts directly and indirectly on alpha-adrenergic receptors in the nasal mucosa, causing vasoconstriction and reducing swelling and congestion.
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Pharmacokinetics

Absorption:

Bioavailability: Chlorpheniramine: ~25-50% (variable due to first-pass metabolism); Pseudoephedrine: >90%
Tmax: Chlorpheniramine: 2-6 hours; Pseudoephedrine: 0.5-2 hours
FoodEffect: Food may delay absorption but generally does not significantly affect extent of absorption.

Distribution:

Vd: Chlorpheniramine: 3.2 L/kg; Pseudoephedrine: 2.6 L/kg
ProteinBinding: Chlorpheniramine: ~70%; Pseudoephedrine: Low (~10-20%)
CnssPenetration: Chlorpheniramine: Yes (causes sedation); Pseudoephedrine: Limited (less than ephedrine)

Elimination:

HalfLife: Chlorpheniramine: 12-43 hours (highly variable); Pseudoephedrine: 9-16 hours (pH-dependent)
Clearance: Not available
ExcretionRoute: Chlorpheniramine: Renal (primarily metabolites); Pseudoephedrine: Renal (primarily unchanged drug)
Unchanged: Chlorpheniramine: <1%; Pseudoephedrine: 55-90%
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Pharmacodynamics

OnsetOfAction: 30-60 minutes
PeakEffect: 1-3 hours
DurationOfAction: 4-6 hours

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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, or swelling of the mouth, face, lips, tongue, or throat.

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. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
- Dizziness or drowsiness
- Feeling nervous and excitable
- Difficulty sleeping

Additional Information on Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact 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 dizziness or drowsiness
  • Nervousness, restlessness, or difficulty sleeping that is severe or persistent
  • Fast, pounding, or irregular heartbeat (palpitations)
  • Significant increase in blood pressure
  • Difficulty urinating
  • Blurred vision
  • Hallucinations or confusion
  • Allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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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:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have taken certain medications for depression or Parkinson's disease within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of very high blood pressure.
If you are currently taking linezolid or methylene blue, as these medications can interact with this drug.

To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your medical history, including any health problems you have

This information will help your doctor determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first 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 medications that may cause drowsiness, consult with your doctor.

If you are considering giving this medication to a child, it is vital to discuss the appropriate dosage with their doctor, as different brands may have varying dosage recommendations for children. When administering this medication to a child, exercise caution, as they may be at a higher risk of experiencing excitability. Furthermore, this medication should not be used as a means to induce sleep in children; instead, consult with their doctor for guidance.

If you are pregnant, planning to become pregnant, or are breastfeeding, it is essential to discuss the potential benefits and risks of this medication with your doctor, taking into account the well-being of both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe drowsiness or sedation
  • Excitement, restlessness, or hallucinations (especially in children)
  • Seizures
  • Dilated pupils
  • Flushing
  • Dry mouth and skin
  • Fever
  • Unsteady gait
  • Coma
  • Severe hypertension
  • Tachycardia, arrhythmias
  • Respiratory depression

What to Do:

Immediately call 911 or Poison Control (1-800-222-1222). Seek emergency medical attention. Treatment is supportive and symptomatic.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI discontinuation) - risk of hypertensive crisis
  • Other sympathomimetics (e.g., decongestants, appetite suppressants, amphetamines) - increased cardiovascular effects
  • Severe uncontrolled hypertension
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Major Interactions

  • CNS depressants (e.g., alcohol, sedatives, hypnotics, anxiolytics, opioids) - increased sedation and CNS depression
  • Anticholinergic drugs (e.g., tricyclic antidepressants, atropine, some antipsychotics) - increased anticholinergic effects (dry mouth, urinary retention, blurred vision)
  • Beta-blockers - may increase pseudoephedrine's pressor effects
  • Digitalis glycosides - increased risk of ectopic pacemaker activity
  • Ergot alkaloids (e.g., ergotamine, dihydroergotamine) - increased risk of vasoconstriction
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Moderate Interactions

  • Urinary acidifiers (e.g., ammonium chloride) - may increase pseudoephedrine excretion, decreasing its effect
  • Urinary alkalinizers (e.g., sodium bicarbonate) - may decrease pseudoephedrine excretion, increasing its effect
  • Antihypertensives (e.g., methyldopa, reserpine, guanethidine) - pseudoephedrine may reduce their hypotensive effects
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Minor Interactions

  • Certain herbal supplements (e.g., St. John's Wort, ephedra-containing products) - potential for additive effects or interactions

Monitoring

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Symptom Monitoring

  • Effectiveness in relieving cold/allergy symptoms (nasal congestion, sneezing, runny nose, watery eyes)
  • Adverse effects: Drowsiness, dizziness, dry mouth, blurred vision, urinary retention, nervousness, insomnia, palpitations, increased blood pressure
  • Signs of overdose: Severe drowsiness, confusion, hallucinations, seizures, severe hypertension, tachycardia, arrhythmias

Special Patient Groups

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Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Pseudoephedrine use in the first trimester has been associated with a small increased risk of gastroschisis and other vascular disruptions, though data are conflicting. Chlorpheniramine is generally considered safer in later trimesters but should be used cautiously.

Trimester-Specific Risks:

First Trimester: Pseudoephedrine: Potential small increased risk of gastroschisis and other vascular disruptions. Chlorpheniramine: Limited data, generally avoided if possible.
Second Trimester: Generally considered safer than first trimester, but use with caution and only if clearly needed.
Third Trimester: Pseudoephedrine: Avoid close to term due to potential for maternal hypertension and fetal tachycardia. Chlorpheniramine: Avoid close to term due to potential for neonatal irritability or respiratory depression.
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Lactation

L3 (Moderately Safe). Both chlorpheniramine and pseudoephedrine are excreted into breast milk. Pseudoephedrine can reduce milk supply. Chlorpheniramine can cause drowsiness or irritability in the infant. Use with caution, monitor infant for adverse effects, and consider alternative non-pharmacological treatments or single-ingredient products if possible.

Infant Risk: Drowsiness, irritability, decreased milk supply (pseudoephedrine), potential for anticholinergic effects in infant.
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Pediatric Use

Not recommended for children under 12 years of age without physician consultation due to risk of serious side effects, especially with pseudoephedrine. Over-the-counter cough and cold products are generally not recommended for children under 6 years of age. Always use pediatric-specific formulations and dosing for younger children if prescribed.

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Geriatric Use

Increased susceptibility to anticholinergic effects (e.g., sedation, confusion, dry mouth, urinary retention, constipation) and adrenergic effects (e.g., increased blood pressure, tachycardia, insomnia) due to age-related changes in metabolism and sensitivity. Use with caution, start with lower doses, and monitor closely for adverse effects. Avoid in elderly patients with prostatic hypertrophy, glaucoma, or cardiovascular disease.

Clinical Information

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Clinical Pearls

  • Advise patients that this product can cause drowsiness and to avoid activities requiring mental alertness until they know how it affects them.
  • Emphasize the importance of not exceeding the recommended dose due to the risk of serious cardiovascular and CNS side effects from pseudoephedrine.
  • Counsel patients with pre-existing conditions like hypertension, heart disease, thyroid disease, diabetes, or prostate enlargement to consult a doctor before use.
  • Remind patients to check other medications for similar active ingredients to avoid accidental overdose.
  • Pseudoephedrine can be diverted for illicit purposes; advise patients of legal restrictions on purchase limits.
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Alternative Therapies

  • Single-ingredient antihistamines (e.g., loratadine, fexofenadine, cetirizine for non-drowsy relief; diphenhydramine for drowsy relief)
  • Single-ingredient decongestants (e.g., pseudoephedrine, phenylephrine)
  • Nasal saline sprays/washes
  • Nasal corticosteroids (e.g., fluticasone, triamcinolone)
  • Oral cromolyn sodium (for allergy prevention)
  • Non-pharmacological measures (e.g., humidifiers, rest, fluids)
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Cost & Coverage

Average Cost: $5 - $20 per 30 tablets
Generic Available: Yes
Insurance Coverage: Generally not covered by prescription insurance as it is an OTC product, but may be eligible for FSA/HSA.
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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 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.