Tusnel C Syrup

Manufacturer LLORENS Active Ingredient Guaifenesin, Pseudoephedrine, and Codeine(gwye FEN e sin, soo doe e FED rin, & KOE deen) Pronunciation Guaifenesin (gwye FEN e sin), Pseudoephedrine (soo doe e FED rin), Codeine (KOE deen)
WARNING: For all patients taking this drug:This drug has an opioid drug in it. Opioid drugs can put you at risk for drug use disorder. Misuse or abuse of this drug can lead to overdose and death. If you have questions, talk with your doctor.This drug has an opioid drug in it. Severe side effects have happened when opioid drugs were used with benzodiazepines, alcohol, marijuana or other forms of cannabis, or prescription or OTC drugs that may cause drowsiness or slowed actions. This includes slow or troubled breathing and death. Benzodiazepines include drugs like alprazolam, diazepam, and lorazepam. Benzodiazepines may be used to treat many health problems like anxiety, trouble sleeping, or seizures. If you have questions, talk with the doctor.Many drugs interact with this drug and can raise the chance of side effects like deadly breathing problems. Talk with your doctor and pharmacist to make sure it is safe to use this drug with all of your drugs.Do not take with alcohol or products that have alcohol. Unsafe and sometimes deadly effects may happen.Get medical help right away if you feel very sleepy, very dizzy, or if you pass out. Caregivers or others need to get medical help right away if the patient does not respond, does not answer or react like normal, or will not wake up.This drug may cause very bad and sometimes deadly breathing problems. Call your doctor right away if you have slow, shallow, or trouble breathing.Children:This drug is not for use in children younger than 18 years of age. The benefits of taking this drug for a cough due to allergies, a cold, or other infection do not outweigh the risks in children. If your child has been given this drug or if you have any questions, talk with your child's doctor. @ COMMON USES: It is used to treat nose stuffiness.It is used to thin mucus so it can be taken from the body by coughing.It is used to relieve coughing.
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Drug Class
Antitussive, Expectorant, Decongestant
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Pharmacologic Class
Opioid agonist (Codeine), Alpha-adrenergic agonist (Pseudoephedrine), Expectorant (Guaifenesin)
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Pregnancy Category
Category D (due to Codeine in 3rd trimester or prolonged use; otherwise C)
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FDA Approved
Jan 1970
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DEA Schedule
Schedule V

Overview

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What is this medicine?

This medicine is a combination of three drugs used to treat cough and cold symptoms. Guaifenesin helps thin and loosen mucus in your lungs, making it easier to cough up. Pseudoephedrine helps clear up stuffy nose by shrinking blood vessels in the nasal passages. Codeine helps stop your cough by affecting the cough center in your brain.
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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. Take your medication with or without food, but if it causes stomach upset, take it with food to help minimize discomfort. It's essential to drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.

When measuring liquid doses, use the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device. Avoid using household teaspoons or tablespoons, as this can lead to inaccurate dosing and potentially harmful effects.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, avoiding bathrooms and areas where children or pets can access it. Keep it in a secure location, such as a locked box or cabinet, to prevent unauthorized use. Dispose of unused or expired medication by throwing it away, but do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on proper disposal methods, including potential 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 scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one. 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

  • Do not drive or operate machinery until you know how this medicine affects you, as it can cause drowsiness or dizziness.
  • Avoid alcohol consumption while taking this medication, as it can increase drowsiness and other side effects.
  • Drink plenty of fluids to help loosen mucus.
  • Do not take more than the recommended dose or for longer than prescribed.
  • Store at room temperature, away from light and moisture, and out of reach of children.

Dosing & Administration

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Adult Dosing

Standard Dose: Typically 10 mL (containing Guaifenesin 200 mg, Pseudoephedrine 30 mg, Codeine 10 mg) orally every 4-6 hours as needed, not to exceed 6 doses in 24 hours.
Dose Range: 10 - 15 mg

Condition-Specific Dosing:

maxDailyDose: 60 mL (Guaifenesin 1200 mg, Pseudoephedrine 180 mg, Codeine 60 mg)
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Pediatric Dosing

Neonatal: Not established (Contraindicated due to Codeine)
Infant: Not established (Contraindicated due to Codeine)
Child: Contraindicated in children younger than 12 years (due to Codeine)
Adolescent: Not recommended in adolescents 12 to 18 years of age (due to Codeine)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, monitor for increased side effects.
Moderate: Use with caution, consider reduced dose or extended interval due to Codeine and Pseudoephedrine accumulation.
Severe: Contraindicated or significantly reduced dose with close monitoring due to risk of accumulation and adverse effects (especially Codeine).
Dialysis: Not well studied for combination; Codeine and its metabolites are dialyzable to some extent. Pseudoephedrine is dialyzable. Use with extreme caution, if at all.

Hepatic Impairment:

Mild: Use with caution, monitor for increased side effects.
Moderate: Reduced dose or extended interval recommended due to impaired Codeine metabolism and increased risk of adverse effects.
Severe: Contraindicated or significantly reduced dose with close monitoring due to risk of accumulation and adverse effects (especially Codeine).

Pharmacology

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Mechanism of Action

Guaifenesin acts as an expectorant by increasing the volume and decreasing the viscosity of respiratory tract secretions, thereby facilitating their removal. Pseudoephedrine is a sympathomimetic amine that acts directly and indirectly on adrenergic receptors, causing vasoconstriction in the nasal mucosa, leading to decongestion. Codeine is an opioid agonist that acts on mu-opioid receptors in the central nervous system to suppress the cough reflex.
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Pharmacokinetics

Absorption:

Bioavailability: Guaifenesin: ~60-90%; Pseudoephedrine: ~90-100%; Codeine: ~40-70%
Tmax: Guaifenesin: ~1 hour; Pseudoephedrine: ~1-2 hours; Codeine: ~0.5-1 hour
FoodEffect: Minimal effect on absorption for all components, but may delay Tmax.

Distribution:

Vd: Guaifenesin: ~0.5 L/kg; Pseudoephedrine: ~2.5 L/kg; Codeine: ~2.6 L/kg
ProteinBinding: Guaifenesin: ~10-20%; Pseudoephedrine: ~10-20%; Codeine: ~7-25%
CnssPenetration: Guaifenesin: Limited; Pseudoephedrine: Yes; Codeine: Yes

Elimination:

HalfLife: Guaifenesin: ~1 hour; Pseudoephedrine: ~9-16 hours (pH dependent); Codeine: ~2.5-4 hours
Clearance: Guaifenesin: Rapid; Pseudoephedrine: Renal; Codeine: Hepatic and Renal
ExcretionRoute: Guaifenesin: Renal (as metabolites); Pseudoephedrine: Renal (primarily unchanged); Codeine: Renal (as metabolites and unchanged drug)
Unchanged: Guaifenesin: <1%; Pseudoephedrine: ~55-90%; Codeine: ~5-10%
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Pharmacodynamics

OnsetOfAction: Guaifenesin: ~30 minutes; Pseudoephedrine: ~30 minutes; Codeine: ~30-60 minutes
PeakEffect: Guaifenesin: ~1 hour; Pseudoephedrine: ~1-2 hours; Codeine: ~1-2 hours
DurationOfAction: Guaifenesin: ~4-6 hours; Pseudoephedrine: ~4-6 hours; Codeine: ~4-6 hours

Safety & Warnings

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BLACK BOX WARNING

Risk of respiratory depression and death in children: Codeine is contraindicated for cough and cold in children younger than 12 years of age. Risk of respiratory depression and death in ultra-rapid metabolizers of codeine: Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to a CYP2D6 polymorphism. Breastfeeding mothers: Codeine is not recommended for breastfeeding mothers.
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Side Effects

Serious Side Effects: Seek Medical Attention 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 help 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
Severe dizziness or fainting
Chest pain or pressure, rapid heartbeat, or irregular heartbeat
Breathing difficulties, slow breathing, or shallow breathing
Noisy breathing
Sleep apnea (breathing problems during sleep)
Confusion
Hallucinations (seeing or hearing things that are not there)
Mood changes
Seizures
Severe headache
Urination difficulties
Shakiness
Changes in vision
Severe constipation or stomach pain, which may indicate a serious bowel problem

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
Nervousness or excitability
Sleep disturbances
Constipation
Upset stomach or vomiting
* Excessive sweating

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. 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:

  • Slow or shallow breathing
  • Extreme drowsiness or difficulty waking up
  • Severe dizziness or lightheadedness
  • Chest pain or fast/irregular heartbeat
  • Severe headache
  • Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
  • Hallucinations or unusual thoughts/behavior
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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 to ensure safe treatment:

Any allergies you have, including allergies to this medication, other medications, foods, or substances. Describe the allergic reaction and its symptoms.
Certain health problems, such as:
+ Lung or breathing issues, including asthma, breathing difficulties, or sleep apnea
+ High levels of carbon dioxide in the blood
+ Stomach or bowel blockage or narrowing
Respiratory conditions, including:
+ A cough producing excessive mucus
+ A long-term cough caused by smoking or exposure to smoke
+ Lung problems, such as asthma or emphysema
Recent use of specific medications for depression or Parkinson's disease within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (as these may cause very high blood pressure)
Current use of certain medications, including:
+ Buprenorphine
+ Butorphanol
+ Linezolid
+ Methylene blue
+ Nalbuphine
+ Pentazocine
If your doctor has informed you that you are a rapid metabolizer of certain medications
* If you are breast-feeding, as you should not breast-feed while taking this medication

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe use. Never start, stop, or change the dose of any medication without consulting your doctor.
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Precautions & Cautions

Important Warnings and 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 chance of experiencing severe side effects. Additionally, do not take this medication for a longer period than specified by your doctor, as it may be habit-forming with long-term use.

If you have been taking this medication regularly and decide to stop, do not do so abruptly without consulting your doctor first. Stopping this medication suddenly may lead to withdrawal symptoms. If you experience any adverse effects, notify your doctor promptly.

Until you understand how this medication affects you, avoid driving and other activities that require alertness. To reduce the risk of dizziness or fainting, rise slowly from a sitting or lying position, and exercise caution when navigating stairs.

Do not take this medication concurrently with other strong pain medications or use a pain patch without first discussing it with your doctor. This medication may interfere with certain laboratory tests, so it is crucial to inform all your healthcare providers and laboratory personnel that you are taking this medication.

Keep this medication out of reach of children, as accidental exposure can be fatal. If a child ingests this medication, seek medical attention immediately.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Children, particularly those with breathing problems, are at a higher risk of experiencing severe side effects, including life-threatening breathing difficulties. Consult your doctor to discuss the potential risks.

Using this medication during pregnancy may harm the unborn baby. If you become pregnant or are already pregnant while taking this medication, contact your doctor immediately. Prolonged use of this medication during pregnancy may lead to withdrawal symptoms in the newborn, which can be life-threatening if left untreated.
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Overdose Information

Overdose Symptoms:

  • Severe drowsiness or unconsciousness
  • Slow, shallow, or stopped breathing
  • Pinpoint pupils
  • Cold, clammy skin
  • Bluish lips or fingernails
  • Extreme weakness or limpness
  • Seizures
  • High blood pressure or rapid heart rate (early pseudoephedrine overdose)
  • Low blood pressure or slow heart rate (late pseudoephedrine/codeine overdose)

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Naloxone may be administered for codeine overdose.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of Pseudoephedrine)
  • Other opioid analgesics (additive CNS depression, respiratory depression)
  • Benzodiazepines and other CNS depressants (additive CNS depression, respiratory depression)
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Major Interactions

  • Alcohol (additive CNS depression)
  • Antihistamines (sedating, additive CNS depression)
  • Tricyclic antidepressants (additive CNS depression, increased pseudoephedrine effects)
  • Beta-blockers (may reduce pseudoephedrine effect, risk of hypertension)
  • Digoxin (increased risk of arrhythmias with pseudoephedrine)
  • CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine, bupropion) (may decrease codeine efficacy by inhibiting conversion to morphine)
  • CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) (may decrease codeine efficacy)
  • CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) (may increase codeine levels and side effects)
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Moderate Interactions

  • Antihypertensives (pseudoephedrine may reduce efficacy)
  • Diuretics (pseudoephedrine may reduce efficacy)
  • St. John's Wort (may induce CYP3A4, reducing codeine efficacy)
  • Dextromethorphan (additive cough suppression, potential for serotonin syndrome)
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Minor Interactions

  • Caffeine (may counteract sedative effects, but also increase pseudoephedrine stimulation)

Monitoring

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Baseline Monitoring

Respiratory rate and depth

Rationale: To assess baseline respiratory function before initiating opioid therapy.

Timing: Prior to first dose

Blood pressure and heart rate

Rationale: To assess baseline cardiovascular status due to pseudoephedrine's vasoconstrictive effects.

Timing: Prior to first dose

Cough severity and characteristics

Rationale: To establish baseline for efficacy assessment.

Timing: Prior to first dose

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Routine Monitoring

Respiratory rate and depth

Frequency: Periodically, especially during initial therapy or dose changes

Target: Normal for age (e.g., 12-20 breaths/min for adults)

Action Threshold: <10 breaths/min or signs of respiratory distress

Blood pressure and heart rate

Frequency: Periodically, especially in patients with hypertension or cardiovascular disease

Target: Within patient's normal range

Action Threshold: Significant increase from baseline or symptomatic changes

Level of consciousness/sedation

Frequency: Daily, or as needed

Target: Alert and oriented

Action Threshold: Excessive drowsiness, confusion, or difficulty arousing

Cough relief and sputum production

Frequency: Daily

Target: Improved symptoms

Action Threshold: No improvement or worsening of symptoms after several days

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Symptom Monitoring

  • Drowsiness
  • Dizziness
  • Nausea/Vomiting
  • Constipation
  • Dry mouth
  • Nervousness
  • Insomnia
  • Hypertension
  • Tachycardia
  • Respiratory depression (slow, shallow breathing)
  • Confusion
  • Itching
  • Rash

Special Patient Groups

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Pregnancy

Generally not recommended during pregnancy, especially in the third trimester or with prolonged use, due to the codeine component. Codeine is associated with neonatal opioid withdrawal syndrome if used chronically during pregnancy. Pseudoephedrine use in the first trimester has been linked to minor birth defects in some studies, though data are conflicting.

Trimester-Specific Risks:

First Trimester: Pseudoephedrine: Potential for minor birth defects (e.g., gastroschisis, limb reduction defects) in some studies, though overall risk is low. Codeine: Limited data, but generally avoided.
Second Trimester: Codeine: Risk of respiratory depression in fetus if used close to delivery. Pseudoephedrine: Generally considered safer than first trimester, but still used with caution.
Third Trimester: Codeine: High risk of neonatal opioid withdrawal syndrome (NOWS) if used chronically. Risk of respiratory depression in neonate if used close to delivery. Pseudoephedrine: Risk of vasoconstriction affecting uterine blood flow, potential for maternal hypertension.
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Lactation

Contraindicated in breastfeeding mothers due to the codeine component. Codeine is metabolized to morphine, which can be excreted into breast milk and cause serious, life-threatening adverse reactions, including respiratory depression and death, in breastfed infants, especially if the mother is an ultra-rapid metabolizer of codeine. Pseudoephedrine is excreted into breast milk and may cause irritability or decreased milk supply.

Infant Risk: High (due to Codeine)
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Pediatric Use

Contraindicated in children younger than 12 years of age due to the risk of respiratory depression and death associated with codeine. Not recommended in adolescents 12 to 18 years of age. Pseudoephedrine is also not recommended for children under 4 years of age for cough/cold symptoms.

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Geriatric Use

Use with caution in elderly patients due to increased sensitivity to the sedative and respiratory depressant effects of codeine, and the cardiovascular effects of pseudoephedrine. Start with lower doses and monitor closely for adverse effects, including confusion, constipation, and urinary retention.

Clinical Information

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Clinical Pearls

  • This combination product carries significant risks due to codeine, especially in pediatric and breastfeeding populations, and should be used with extreme caution and only when clearly indicated.
  • Educate patients on the signs of respiratory depression and the importance of not exceeding the prescribed dose.
  • Advise patients to avoid concurrent use of alcohol or other CNS depressants.
  • Consider alternative, safer options for cough and cold symptoms, especially in vulnerable populations, before resorting to codeine-containing products.
  • Pseudoephedrine can cause insomnia and nervousness; advise patients to avoid taking doses close to bedtime.
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Alternative Therapies

  • Single-ingredient guaifenesin (expectorant)
  • Single-ingredient pseudoephedrine or phenylephrine (decongestant)
  • Dextromethorphan (antitussive)
  • Honey (for cough relief)
  • Saline nasal sprays (for congestion)
  • Non-pharmacological measures (humidifier, rest, fluids)
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Cost & Coverage

Average Cost: Price varies widely per 120 mL or 480 mL bottle
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (often requires prior authorization due to codeine)
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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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.