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What is the cough syrup that has hydrocodone in it? Understanding Prescriptions and Risks

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6 min read

In 2018, the FDA restricted the use of prescription opioid cough and cold medications, including those with hydrocodone, for minors due to risks like fatal breathing problems. This potent class of cough suppressant is heavily regulated and now primarily reserved for adult patients with a severe, intractable cough when other options have failed.

Quick Summary

Hydrocodone-based cough syrup is a powerful, prescription-only opioid reserved for adults with severe cough, due to significant risks like respiratory depression, abuse, and addiction. Regulatory restrictions have banned its use for pediatric patients. Common brand names often combine hydrocodone with other medications like antihistamines or expectorants, but safer alternatives are widely available.

Key Points

  • Hydrocodone Cough Syrup Brands: Common brand names include Tussionex Pennkinetic, Rezira, and Hycofenix, which often combine hydrocodone with antihistamines, decongestants, or expectorants.

  • FDA Restrictions for Minors: The FDA has banned all hydrocodone-containing cough syrups for anyone under 18 due to severe risks, including fatal respiratory depression.

  • Adult Prescription Only: These medications are potent controlled substances (Schedule II or III) reserved for adults with severe cough when the benefits outweigh significant risks of abuse and addiction.

  • Serious Side Effects: Potential side effects are severe and include respiratory depression, profound sedation, dependence, constipation, nausea, and dizziness.

  • Dangerous Interactions: Hydrocodone should not be taken with alcohol, benzodiazepines, or other CNS depressants, as this can dramatically increase the risk of serious breathing problems.

  • Safer Alternatives Available: Effective and safer alternatives exist for most types of cough, including over-the-counter dextromethorphan and guaifenesin, and prescription benzonatate.

In This Article

What is a Hydrocodone Cough Syrup?

Hydrocodone is a potent, semi-synthetic opioid that acts as an effective antitussive, or cough suppressant. Unlike over-the-counter cough medicines, it is a federally controlled substance due to its high potential for abuse, dependence, and addiction. When used in a cough syrup, hydrocodone works by directly suppressing the cough center located in the brain's medulla, calming the reflex that causes coughing.

Prescription cough syrups containing hydrocodone are combination products, meaning they contain other ingredients to address various cold or allergy symptoms. These additional active ingredients can include:

  • Antihistamines like chlorpheniramine to help with allergy symptoms.
  • Decongestants such as pseudoephedrine to clear up nasal congestion.
  • Expectorants like guaifenesin to help loosen mucus in the chest.

Common Brand Names and Formulations

Because hydrocodone is almost always paired with another active ingredient in cough syrups, you won't find products with just hydrocodone. These combinations have historically been sold under specific brand names, though many have now been discontinued or face strict regulation. Some well-known examples include:

  • Tussionex Pennkinetic: An extended-release suspension containing hydrocodone and the antihistamine chlorpheniramine.
  • Hycodan: A combination of hydrocodone and homatropine, which was a historical brand name now available primarily as a generic.
  • Hycofenix / Rezira: Syrups containing a combination of hydrocodone and guaifenesin.
  • Zutripro: Contains a combination of hydrocodone, chlorpheniramine, and pseudoephedrine.

It is vital to understand that the status of these medications is dynamic due to ongoing FDA oversight. The FDA continues to monitor and regulate unapproved hydrocodone products, emphasizing that patient safety comes first.

Regulatory Landscape and Serious Safety Concerns

The use of hydrocodone cough syrups has been subject to increasing scrutiny and regulation, largely due to safety risks associated with opioids, especially in vulnerable populations. The FDA's 2018 action placed a black box warning on these medications and made their use contraindicated for children and adolescents under 18. This was in response to reported cases of fatal respiratory depression in young children. The risks are not limited to children, and several serious side effects and warnings apply to all users:

  • Respiratory Depression: The most severe risk, hydrocodone can slow or stop breathing, especially when taken in high doses or with other central nervous system (CNS) depressants like alcohol or benzodiazepines.
  • Abuse and Addiction: As a Schedule II or Schedule III controlled substance, hydrocodone carries a high potential for psychological and physical dependence.
  • Withdrawal Symptoms: Patients who use hydrocodone regularly can experience withdrawal symptoms like anxiety, insomnia, and muscle aches if they stop taking the medication abruptly.
  • Drug Interactions: Hydrocodone can have dangerous interactions with many other medications. It is essential to inform your doctor and pharmacist of all drugs, supplements, and vitamins you are taking.

Comparison of Cough Suppressants

To better understand the place of hydrocodone cough syrup in modern medicine, it is helpful to compare it with other, more commonly prescribed and over-the-counter (OTC) alternatives.

Feature Hydrocodone Dextromethorphan (OTC) Benzonatate (Tessalon Perles)
Classification Opioid antitussive Non-opioid antitussive Non-narcotic antitussive
Mechanism Acts on the cough center in the brain to suppress the reflex. Works on the cough center in the brain, but without opioid effects. Acts on the respiratory tract to numb cough receptors.
Controlled Status Yes, Schedule II or III. No, available OTC. No, but is prescription-only.
Prescription Required Yes, for adults only. No. Yes.
Safety Risks High risk of respiratory depression, abuse, and addiction. Generally safe, but misuse can cause adverse effects. Can be toxic if chewed or ingested improperly; not approved for children.
Common Side Effects Drowsiness, dizziness, constipation, nausea. Dizziness, drowsiness, nausea. Dizziness, drowsiness, nausea, constipation.
Pediatric Use No, contraindicated under 18. Yes, but formulations are specific to age. No, contraindicated under 10.

Safer Alternatives to Hydrocodone

Given the significant risks associated with hydrocodone, healthcare providers are more likely to recommend or prescribe safer alternatives for managing cough. The best option depends on the cause of the cough and the patient's overall health, but common alternatives include:

  • Dextromethorphan (DM): A widely available OTC cough suppressant found in products like Robitussin and Mucinex DM. It is effective for suppressing dry coughs.
  • Guaifenesin: An expectorant that thins mucus, making coughs more productive. It is available alone (e.g., Mucinex) or in combination with DM.
  • Antihistamines: If the cough is caused by post-nasal drip from allergies, an antihistamine can help dry up secretions.
  • Benzonatate (Tessalon Perles): A non-narcotic prescription cough medicine that numbs the cough reflex receptors in the lungs and airways.
  • Honey: For adults, a spoonful of honey can soothe a sore throat and reduce coughing, and it is a natural, safe remedy.

Conclusion: Navigating Prescriptions and Safety

So, what is the cough syrup that has hydrocodone in it? It is a powerful, opioid-based prescription medication used to treat severe cough in adults, typically when other less risky options have been ineffective. Brand names like Tussionex Pennkinetic and Hycofenix contain this ingredient, often combined with other medications like antihistamines or expectorants. Due to significant safety concerns, including a high risk of respiratory depression, dependence, and addiction, the FDA has severely restricted its use, particularly for minors. Understanding these risks and discussing safer alternatives, like dextromethorphan or benzonatate, with a healthcare provider is essential for making an informed decision about cough treatment. Patients should never take more than prescribed and should always store this medication securely away from children due to the high risk of fatal overdose. For more detailed information on FDA regulations regarding opioid cough suppressants, refer to the official FDA website.

References

Frequently Asked Questions

Common brand names for cough syrup containing hydrocodone include Tussionex Pennkinetic, Rezira, Hycofenix, and Vituz. These are typically combination products, meaning they contain additional ingredients like antihistamines, decongestants, or expectorants to address multiple symptoms.

No, hydrocodone is a federally controlled substance with a high potential for abuse and addiction. Due to these risks and an FDA-mandated contraindication for minors, it is only available with a prescription for adult patients when medically necessary.

In 2018, the FDA contraindicated hydrocodone cough medicines for children under 18 because of the risk of life-threatening breathing problems. Children are more susceptible to respiratory depression, which can be fatal.

Common side effects include drowsiness, dizziness, constipation, nausea, and dry mouth. More serious side effects, such as slowed breathing and confusion, can also occur and require immediate medical attention.

Yes, many safer and effective alternatives are available, both over-the-counter and by prescription. Common options include dextromethorphan (DM), guaifenesin, and prescription benzonatate.

A hydrocodone overdose is a medical emergency. If you suspect an overdose, characterized by slow or shallow breathing, extreme sleepiness, or unconsciousness, you must call 911 immediately.

Combining hydrocodone with alcohol or other central nervous system (CNS) depressants can significantly increase the risk of serious side effects, including profound sedation, dangerous respiratory depression, coma, and death.

References

  1. 1
    FDA requires labeling changes for prescription opioid cough and cold medicines; recommends against use in children and adolescents
  2. 2
    Tussionex Pennkinetic (hydrocodone polistirex and chlorpheniramine polistirex) Extended-Release Suspension CII
  3. 3
    Hydrocodone and homatropine (oral route)
  4. 4
    Hydrocodone, pseudoephedrine, and guaifenesin (oral route)
  5. 5
    Questions and Answers About FDA's Enforcement Action Regarding Unapproved Hydrocodone Drug Products
  6. 6
    HYDROCODONE (Trade Names: Vicodin®, Lortab®, Lorcet®, Norco®) Drug and Chemical Information
  7. 7
    Prescriptions for Codeine or Hydrocodone Cough and Cold Medications Among Youth and Adults
  8. 8
    Codeine vs. Hydrocodone: 6 Important Differences
  9. 9
    Hydrocodone Withdrawal Symptoms, Timeline, and Detox
  10. 10
    Hydrocodone. National Institutes of Health

Related Topics:

#controlled substance #opioid #Drug Safety #FDA #prescription medication #Hydrocodone #antitussive #cough syrup

Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.