Sudogest 30mg Tablets

Manufacturer MAJOR Active Ingredient Pseudoephedrine Capsules and Tablets(soo doe e FED rin) Pronunciation soo-doe-e-FED-rin
It is used to treat nose stuffiness.
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Drug Class
Decongestant
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Pharmacologic Class
Alpha-adrenergic agonist; Sympathomimetic
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Pregnancy Category
Category C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled (List I Chemical, regulated under Combat Methamphetamine Epidemic Act of 2005)

Overview

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What is this medicine?

Pseudoephedrine is a decongestant that helps relieve stuffy nose and sinus pressure caused by colds, allergies, or hay fever. It works by narrowing the blood vessels in your nasal passages, which reduces swelling and allows you to breathe more easily.
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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. Swallow the medication whole - do not chew, break, or crush it.

Storing and Disposing of Your Medication

Store your medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a safe location, 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, check with your pharmacist for guidance on the best disposal method or explore 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

  • Stay hydrated by drinking plenty of fluids.
  • Get adequate rest.
  • Avoid excessive caffeine intake, as it can worsen side effects like nervousness or insomnia.
  • Do not take pseudoephedrine close to bedtime if you experience insomnia.

Dosing & Administration

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Adult Dosing

Standard Dose: 30 mg every 4-6 hours as needed
Dose Range: 30 - 60 mg

Condition-Specific Dosing:

Maximum daily dose: 240 mg in 24 hours
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (generally not recommended under 2 years)
Child: 2-5 years: 15 mg every 4-6 hours (max 60 mg/24 hours); 6-12 years: 30 mg every 4-6 hours (max 120 mg/24 hours)
Adolescent: 12 years and older: 30-60 mg every 4-6 hours (max 240 mg/24 hours)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed
Moderate: Consider dose reduction or extended dosing interval (e.g., 30 mg every 6-8 hours)
Severe: Use with caution; consider dose reduction or extended dosing interval (e.g., 30 mg every 8-12 hours)
Dialysis: Pseudoephedrine is dialyzable; consider supplemental dose after dialysis, but generally not a primary concern for intermittent use.

Hepatic Impairment:

Mild: No specific adjustment needed
Moderate: No specific adjustment needed
Severe: No specific adjustment needed (primarily renally eliminated)

Pharmacology

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Mechanism of Action

Pseudoephedrine is a sympathomimetic amine that acts directly on alpha-adrenergic receptors in the mucosa of the respiratory tract, producing vasoconstriction. This reduces swelling of nasal mucous membranes, decreases tissue hyperemia, edema, and nasal congestion, and opens obstructed Eustachian ostia. It also has some direct beta-adrenergic activity and indirect activity by releasing norepinephrine from storage sites.
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Pharmacokinetics

Absorption:

Bioavailability: High (nearly complete)
Tmax: 0.5-2 hours (immediate release)
FoodEffect: Minimal effect on absorption rate or extent

Distribution:

Vd: 2.6-3.5 L/kg
ProteinBinding: Low (approximately 13-20%)
CnssPenetration: Yes (readily crosses blood-brain barrier, leading to CNS stimulation)

Elimination:

HalfLife: 4.3-8 hours (highly dependent on urinary pH; shorter in acidic urine, longer in alkaline urine)
Clearance: Not readily available, but primarily renal
ExcretionRoute: Renal (urine)
Unchanged: 55-90% (excreted unchanged in urine)
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Pharmacodynamics

OnsetOfAction: Within 30 minutes
PeakEffect: 1-2 hours
DurationOfAction: 4-6 hours (immediate release)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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 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
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Fainting
+ Changes in eyesight
Chest pain or pressure
Rapid or abnormal heartbeat
Shortness of breath
Shakiness

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 symptoms that bother you or persist, contact your doctor:

Dizziness
Feeling nervous and excitable
* Trouble sleeping

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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 dizziness or lightheadedness
  • Fast or pounding heartbeat (palpitations)
  • Severe headache
  • Nervousness, anxiety, or restlessness that is severe or persistent
  • Difficulty urinating
  • Rash or itching
  • Any signs of an allergic reaction (e.g., swelling of face/tongue/throat, severe dizziness, trouble breathing)
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Before Using This Medicine

Before taking this medication, it is essential to inform your doctor about the following:

Any allergies you have, including allergies to this drug, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
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 increase the risk of very high blood pressure.
* If you are currently taking linezolid or methylene blue, as these medications may interact with this drug.

It is crucial to provide your doctor and pharmacist with a comprehensive list of all your medications, including prescription and over-the-counter drugs, natural products, and vitamins. This will help ensure that it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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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.

To minimize the risk of severe side effects, do not exceed the dosage prescribed by your doctor. Taking more than the recommended amount may increase your chances of experiencing adverse reactions. Additionally, do not take this medication for a longer duration than specified by your doctor.

When taking this drug, it is recommended to limit your consumption of caffeine-containing products, such as tea, coffee, and cola, as well as chocolate. Combining these substances with this medication may cause nervousness, shakiness, and an increased heart rate.

Please note that different formulations of this medication may be suitable for children of various ages. Before administering this drug to a child, consult with their doctor to ensure the appropriate form and dosage are used.

If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to discuss the potential benefits and risks of this medication with your doctor. This conversation will help you understand the implications for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe nervousness, restlessness, or anxiety
  • Tremor
  • Seizures
  • Hallucinations
  • High blood pressure (hypertensive crisis)
  • Rapid or irregular heartbeat (tachycardia, arrhythmias)
  • Nausea, vomiting
  • Difficulty breathing
  • Urinary retention

What to Do:

Seek immediate medical attention or call Poison Control at 1-800-222-1222. 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
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Major Interactions

  • Other sympathomimetics (e.g., decongestants, appetite suppressants, amphetamines) - additive cardiovascular effects
  • Beta-blockers (non-selective) - may increase risk of hypertension and bradycardia due to unopposed alpha-adrenergic activity
  • Tricyclic antidepressants (TCAs) - may potentiate pressor effects
  • Ergot alkaloids (e.g., ergotamine, bromocriptine) - increased risk of vasoconstriction and hypertension
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Moderate Interactions

  • Digitalis glycosides - increased risk of cardiac arrhythmias
  • Antihypertensives (e.g., guanethidine, methyldopa, reserpine) - pseudoephedrine may reduce their hypotensive effects
  • Linezolid - potential for hypertensive crisis (weak MAOI activity)
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Minor Interactions

  • Caffeine - additive CNS stimulation

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline, especially in patients with pre-existing hypertension or cardiovascular disease, due to pseudoephedrine's vasoconstrictive effects.

Timing: Prior to initiation in at-risk patients

Heart Rate (HR)

Rationale: To establish baseline, especially in patients with pre-existing cardiac conditions, due to pseudoephedrine's sympathomimetic effects.

Timing: Prior to initiation in at-risk patients

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Routine Monitoring

Blood Pressure (BP)

Frequency: As needed, if symptoms of elevated BP occur or in patients with pre-existing hypertension

Target: Individualized, generally within patient's target range

Action Threshold: Significant increase from baseline or above clinically acceptable limits (e.g., >140/90 mmHg consistently)

Heart Rate (HR)

Frequency: As needed, if symptoms of palpitations or tachycardia occur

Target: Individualized, generally within patient's target range

Action Threshold: Significant increase from baseline or sustained tachycardia (e.g., >100 bpm at rest)

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Symptom Monitoring

  • Nervousness
  • Restlessness
  • Insomnia
  • Dizziness
  • Headache
  • Palpitations
  • Tremor
  • Anxiety
  • Difficulty urinating (especially in men with prostatic hypertrophy)

Special Patient Groups

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Pregnancy

Pseudoephedrine is generally considered Category C. While some studies suggest a possible association with gastroschisis (a birth defect) when used in the first trimester, data are conflicting and overall risk appears low. Use should be avoided in the first trimester if possible, and used with caution in later trimesters, especially in patients with pre-existing hypertension or preeclampsia.

Trimester-Specific Risks:

First Trimester: Possible, but low, risk of gastroschisis; generally avoided if alternatives are available.
Second Trimester: Generally considered safer than first trimester, but use with caution.
Third Trimester: Use with caution, especially near term, due to potential for maternal vasoconstriction and effects on uterine blood flow; avoid in preeclampsia.
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Lactation

Pseudoephedrine is excreted into breast milk in small amounts. It is rated L2 (Safer). While generally considered compatible with breastfeeding, it can reduce milk supply, especially in the first few weeks postpartum. Monitor infant for irritability or sleep disturbances.

Infant Risk: Low risk of adverse effects; potential for irritability or sleep disturbances. Risk of decreased milk supply.
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Pediatric Use

Not recommended for children under 2 years of age due to potential for serious side effects. Use with caution and appropriate dosing in children 2-12 years. Always use pediatric-specific formulations and dosing guidelines. Risk of CNS stimulation (e.g., hyperactivity, insomnia) may be higher in children.

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Geriatric Use

Use with caution in elderly patients, who may be more susceptible to the adverse effects of sympathomimetics, particularly cardiovascular (e.g., hypertension, tachycardia) and central nervous system (e.g., insomnia, nervousness, confusion) effects. Start with lower doses and titrate carefully. Increased risk of urinary retention in men with prostatic hypertrophy.

Clinical Information

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Clinical Pearls

  • Pseudoephedrine is a controlled substance in many regions due to its use in illicit methamphetamine production. It is typically sold behind the pharmacy counter and requires ID for purchase.
  • Advise patients to avoid taking pseudoephedrine close to bedtime due to its stimulant effects, which can cause insomnia.
  • Counsel patients on the importance of not exceeding the recommended dose to minimize side effects, especially cardiovascular and CNS effects.
  • Patients with pre-existing conditions such as hypertension, heart disease, thyroid disease, diabetes, or enlarged prostate should consult a healthcare professional before using pseudoephedrine.
  • Pseudoephedrine is often combined with antihistamines or pain relievers in multi-symptom cold and allergy products; ensure patients are aware of all active ingredients to avoid accidental overdose.
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Alternative Therapies

  • Phenylephrine (another oral decongestant, less effective than pseudoephedrine)
  • Oxymetazoline (topical nasal decongestant spray)
  • Xylometazoline (topical nasal decongestant spray)
  • Saline nasal sprays/washes
  • Antihistamines (for allergy-related congestion, e.g., loratadine, fexofenadine, cetirizine)
  • Nasal corticosteroids (for chronic allergy-related congestion, e.g., fluticasone, mometasone)
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Cost & Coverage

Average Cost: $5 - $20 per 30 tablets (generic 30mg)
Generic Available: Yes
Insurance Coverage: Often not covered by prescription drug plans as it is an over-the-counter (OTC) medication. May be covered by some FSA/HSA accounts.
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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 your 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 seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.