Hydrocodone and Guaifenesin (Flowtuss) is a combination of two drugs. It is used for the symptomatic treatment of productive cough. It reduces the viscosity of the phlegm that can be easily expectorated.
Hydrocodone and guaifenesin Uses:
-
Cough:
- Symptomatic relief of cough and to release mucus linked with the normal cold in adults
- Use restrictions: Save use for adult patients whose benefits from cough control outweigh the dangers of addiction and misuse and who have had a thorough review of the causes of their cough.
Hydrocodone and Guaifenesin (Flowtuss) Dose in Adults
Hydrocodone and Guaifenesin (Flowtuss) Dose in the treatment of Cough:
- Oral: Hydrocodone 5 mg/guaifenesin 400 mg (10 mL) every 4 to 6 hours as required (maximum: hydrocodone 30 mg/guaifenesin 2,400 mg [60 mL] per 24 hours)
- Discontinuation of therapy:
- Reduce the dose steadily for patients receiving long-term opioid therapy by 25% to 50% every 2 to 4 days.
- Increase the dose to the previous level if the patient exhibits withdrawal symptoms, and then reduce the dose more gradually by lengthening the time between dose reductions, reducing the daily dose reduction, or both.
Use in Children:
Not indicated.
Pregnancy Risk Category: C
- [US Boxed Warning]Pregnancy is not a time for using.
- If opioids are used for long periods of time during pregnancy, it can lead to newborn withdrawal syndrome.
- This condition can be fatal if it is not treated as per the rules of neonatology specialists.
- If opioids are required for prolonged periods in pregnant women, notify them of the danger of neonatal opioid withdrawal syndrome.
- Refer to the individual monographs.
Use during breastfeeding:
- Breast milk contains hydrocodone; however, it is unknown if breast milk contains guaifenesin.
- The manufacturer does not recommend breastfeeding due to the risk of adverse reactions in breastfeeding infants.
- Refer to the individual monographs.
Dose in Kidney Disease:
There are no dosage adjustments provided in the manufacturer’s labeling; use with restrain in acute renal impairment.
Dose in Liver disease:
There are no dosage modifications given in the manufacturer’s labeling; use with caution in severe liver impairment
Also, see individual agents (hydrocodone and Guaifenesin)
Side effects of Hydrocodone and Guaifenesin (Flowtuss):
-
Cardiovascular:
- Decreased blood pressure
-
Central nervous system:
- Dizziness
- Drowsiness
- Headache
-
Endocrine & metabolic:
- Hot flash
-
Gastrointestinal:
- Diarrhea
- Nausea
Contraindications to Hydrocodone and Guaifenesin (Flowtuss):
- Any ingredient in the composition, including Guaifenesin and hydrocodone, could make someone sensitive.
- Severe bronchial asthma can develop without resuscitation tools or in an unmonitored environment.
- GI problems that are recognised or suspected, such as paralytic ileus.
- Major respiratory depression
- Children under 6 years old
- There is not much evidence of cross-reactivity between opioids and allergenic opioids.
- However, cross-sensitivity is possible due to similarities in chemical structure and/or drug pharmacologic effects.
Warnings and precautions
-
CNS depression:
- CNS depression can cause mental or physical impairments.
- Patients must be aware of activities that require mental alertness, such as driving, operating machinery, and other tasks.
-
Hypotension
- Acute hypotension can occur (including orthostasis or syncope).
- Patients with low blood volumes and/or taking concurrent CNS depressions (eg, phenothiazines) are at greater risk.
- Patients with circulatory shock should be avoided
-
Phenanthrene hypersensitivity:
- Patients with allergies to other phenanthrene-derived opioid agonists (codeine and hydromorphone, levorphanol morphine, codeine, oxycodone or oxymorphone) should be restrained.
-
Respiratory depression [US Boxed Warning]
- The use of hydrocodone has been associated with severe, deadly, or life-threatening respiratory depression.
- Monitor for signs and symptoms of respiratory depression during drug initiation, or in patients at greater risk (patients with lung disease, reduced respiratory reserve, or patients who are taking concurrent drugs that could cause respiratory depression).
- The tranquilizing effects of opioids can be exacerbated by carbon dioxide retention caused by opioid-induced respiratory depression.
-
Conditions abdominales:
- Patients with severe abdominal diseases may be misdiagnosed or have their clinical course distorted.
- Patients with underlying intestinal motility disorders should not be restrained; it may lead to constipation and obtrusive stool disease.
- It is not recommended for use in the presence of a known or alleged GI obstruction.
-
Adrenocortical Insufficiency
- Patients with Addison disease or adrenal deficiency should be monitored closely.
- Extended opioid use can lead to secondary hypogonadism. This could cause infertility, sexual dysfunction, mood swings, osteoporosis, and infertility.
-
Insufficiency of the biliary tract:
- Patients with severe biliary dysfunction or severe pancreatitis should not take opioids without caution.
- Opioids can cause constriction of Oddi's sphincter and raise biliary pressure.
-
Delirium tremens:
- Patients with delirium-tremens should be restrained from using the restroom.
-
Diabetes:
- Patients with diabetes should be restrained from using the restroom.
-
Head trauma
- Patients with intracranial abrasions or head trauma should be avoided. Exaggerated intracranial pressure (ICP) might also be a problem.
-
Hepatic impairment
- With caution, patients with severe hepatic impairment may use this drug.
-
Obesity:
- Patients who are very overweight should be cautious.
-
Prostatic hyperplasia, urinary obstruction
- Patients with prostatic hyperplasia or urinary stricture may be restrained.
-
Psychosis:
- Patients with toxic psychosis should be restrained.
-
Renal impairment
- Patients with severe renal impairment should be cautious.
-
Respiratory disease
- Patients with a notable long-lasting obstructive lung disease or corpulmonale should be monitored for respiratory depression.
- It is important to take care of patients who have a reduced respiratory reserve, hypoxia or hypercarbia and are starting therapy. Serious respiratory depression can occur even with therapeutic doses.
- Patients with severe, productive cough or a chronic, life-threatening respiratory condition should not use this product.
- It is not advisable for patients with severe bronchial asthma to take this medicine in unsupervised settings or without access to resuscitative equipment.
-
Seizure disorder:
- Patients with seizure disorders should be cautious. It may lead to or exacerbate existing seizures.
-
Thyroid dysfunction:
- Patients with thyroid dysfunction should be cautious.
Hydrocodone and guaifenesin: Drug Interaction
|
Risk Factor C (Monitor therapy) |
|
|
Alizapride |
May enhance the CNS depressant effect of CNS Depressants. |
|
Amphetamines |
Opioid agonists' analgesic effects might be improved. |
|
Anticholinergic Agents |
Opioid agonists' negative or toxic effects might be heightened. In particular, this combination may raise the risk for constipation and bladder retention. |
|
Aprepitant |
May elevate CYP3A4 substrates' serum concentration (High risk with Inhibitors). |
|
Bosentan |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). |
|
Brimonidine (Topical) |
May enhance the CNS depressant effect of CNS Depressants. |
|
Bromopride |
May enhance the CNS depressant effect of CNS Depressants. |
|
Cannabidiol |
May enhance the CNS depressant effect of CNS Depressants. |
|
Cannabis |
May enhance the CNS depressant effect of CNS Depressants. |
|
Chlorphenesin Carbamate |
May enhance the adverse/toxic effect of CNS Depressants. |
|
Clofazimine |
May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). |
|
CYP2D6 Inhibitors (Strong) |
May decrease serum concentrations of the active metabolite(s) of HYDROcodone. Specifically, concentrations of hydromorphone may be decreased. |
|
CYP3A4 Inducers (Moderate) |
May decrease the serum concentration of HYDROcodone. |
|
CYP3A4 Inducers (Strong) |
May decrease the serum concentration of HYDROcodone. |
|
CYP3A4 Inhibitors (Moderate) |
May increase the serum concentration of HYDROcodone. |
|
CYP3A4 Inhibitors (Strong) |
May increase the serum concentration of HYDROcodone. |
|
Deferasirox |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). |
|
Desmopressin |
Opioid Agonists may enhance the adverse/toxic effect of Desmopressin. |
|
Dimethindene (Topical) |
May enhance the CNS depressant effect of CNS Depressants. |
|
Diuretics |
Opioid Agonists may enhance the adverse/toxic effect of Diuretics. Opioid Agonists may diminish the therapeutic effect of Diuretics. |
|
Dronabinol |
May enhance the CNS depressant effect of CNS Depressants. |
|
Duvelisib |
May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). |
|
Erdafitinib |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). |
|
Erdafitinib |
May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). |
|
Fosaprepitant |
May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). |
|
Fosnetupitant |
May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). |
|
Gastrointestinal Agents (Prokinetic) |
Opioid Agonists may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). |
|
Ivosidenib |
May lower the serum level of CYP3A4 substrates (High risk with Inducers). |
|
Kava Kava |
CNS depressants' harmful or toxic effects could be increased. |
|
Larotrectinib |
May elevate CYP3A4 substrates' serum concentration (High risk with Inhibitors). |
|
Lofexidine |
CNS depressants may have an enhanced CNS depressant impact. Management: Separate drug interaction monographs go into further detail about the medications indicated as exceptions to this book. |
|
Magnesium Sulfate |
May enhance the CNS depressant effect of CNS Depressants. |
|
MetyroSINE |
CNS Depressants may enhance the sedative effect of MetyroSINE. |
|
Minocycline |
May enhance the CNS depressant effect of CNS Depressants. |
|
Nabilone |
May enhance the CNS depressant effect of CNS Depressants. |
|
Netupitant |
May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). |
|
Palbociclib |
May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). |
|
Pegvisomant |
Opioid antagonists may lessen Pegvisomant's therapeutic efficacy. |
|
Piribedil |
CNS Depressants may enhance the CNS depressant effect of Piribedil. |
|
Pramipexole |
CNS Depressants may enhance the sedative effect of Pramipexole. |
|
Ramosetron |
Opioid Agonists may enhance the constipating effect of Ramosetron. |
|
ROPINIRole |
CNS Depressants may enhance the sedative effect of ROPINIRole. |
|
Rotigotine |
CNS Depressants may enhance the sedative effect of Rotigotine. |
|
Rufinamide |
May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. |
|
Sarilumab |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). |
|
Selective Serotonin Reuptake Inhibitors |
CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. |
|
Serotonin Modulators |
Opioid Agonists may enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Exceptions: Nicergoline. |
|
Siltuximab |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). |
|
Simeprevir |
May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). |
|
Succinylcholine |
May enhance the bradycardic effect of Opioid Agonists. |
|
Tetrahydrocannabinol |
May enhance the CNS depressant effect of CNS Depressants. |
|
Tetrahydrocannabinol and Cannabidiol |
May enhance the CNS depressant effect of CNS Depressants. |
|
Tocilizumab |
May lower the serum level of CYP3A4 substrates (High risk with Inducers). Risk C: Follow-up treatment |
|
Risk Factor D (Consider therapy modification) |
|
|
Alvimopan |
Opioid Agonists may enhance the adverse/toxic effect of Alvimopan. This is most notable for patients receiving long-term (i.e., more than 7 days) opiates prior to alvimopan initiation. Management: Alvimopan is contraindicated in patients receiving therapeutic doses of opioids for more than 7 consecutive days immediately prior to alvimopan initiation. |
|
Blonanserin |
CNS Depressants may enhance the CNS depressant effect of Blonanserin. |
|
Chlormethiazole |
CNS depressants may have an enhanced CNS depressant impact. Management: Keep a close eye out for signs of severe CNS depression. If such a combination is required, it should be taken at a dose that has been suitably lowered, according to the instructions for chlormethiazole. |
|
CNS Depressants |
May intensify HYDROcodone's CNS depressive effects. Management: Whenever feasible, refrain from using hydrocodone and benzodiazepines or other CNS depressants concurrently. Only in the event that other treatment choices are insufficient should these medications be combined. Limit the duration and dosage of each medicine when used together. |
|
Dabrafenib |
May lower the serum level of CYP3A4 substrates (High risk with Inducers). Management: When possible, look for substitutes for the CYP3A4 substrate. If concurrent therapy cannot be avoided, pay special attention to the substrate's clinical consequences (particularly therapeutic effects). |
|
Droperidol |
CNS depressants may have an enhanced CNS depressant impact. Consider lowering the dosage of droperidol or other CNS drugs (such as opioids or barbiturates) when they are used concurrently. In separate drug interaction monographs, exceptions to this monograph are covered in more detail. |
|
Enzalutamide |
May lower the serum level of CYP3A4 substrates (High risk with Inducers). Treatment: Enzalutamide should not be used concurrently with CYP3A4 substrates that have a limited therapeutic index. Enzalutamide use, like with the use of any other CYP3A4 substrate, should be done cautiously and under close observation. |
|
Flunitrazepam |
Flunitrazepam's CNS depressing effects may be enhanced by other CNS depressants. |
|
Lorlatinib |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Avoid concurrent use of lorlatinib with any CYP3A4 substrates for which a minimal decrease in serum concentrations of the CYP3A4 substrate could lead to therapeutic failure and serious clinical consequences. |
|
Methotrimeprazine |
CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce adult dose of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established. |
|
MiFEPRIStone |
May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Minimize doses of CYP3A4 substrates, and monitor for increased concentrations/toxicity, during and 2 weeks following treatment with mifepristone. Avoid cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus. |
|
Mitotane |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Doses of CYP3A4 substrates may need to be adjusted substantially when used in patients being treated with mitotane. |
|
Monoamine Oxidase Inhibitors |
May enhance the adverse/toxic effect of HYDROcodone. Management: Consider alternatives to this combination when possible. |
|
Nalmefene |
May diminish the therapeutic effect of Opioid Agonists. Management: Avoid the concomitant use of nalmefene and opioid agonists. Discontinue nalmefene 1 week prior to any anticipated use of opioid agonistss. If combined, larger doses of opioid agonists will likely be required. |
|
Naltrexone |
May diminish the therapeutic effect of Opioid Agonists. Management: Seek therapeutic alternatives to opioids. See full drug interaction monograph for detailed recommendations. |
|
Ombitasvir, Paritaprevir, and Ritonavir |
May increase the serum concentration of HYDROcodone. Management: Reduce the hydrocodone dose by 50% during concurrent use of ombitasvir, paritaprevir, and ritonavir; monitor closely for both analgesic effectiveness and for signs of toxicity or withdrawal. |
|
Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir |
May increase the serum concentration of HYDROcodone. Management: Reduce the hydrocodone dose by 50% during concurrent use of ombitasvir, paritaprevir, ritonavir, and dasabuvir; monitor closely for both analgesic effectiveness and for signs of toxicity or withdrawal. |
|
OxyCODONE |
CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. |
|
Perampanel |
May enhance the CNS depressant effect of CNS Depressants. Management: Patients taking perampanel with any other drug that has CNS depressant activities should avoid complex and high-risk activities, particularly those such as driving that require alertness and coordination, until they have experience using the combination. |
|
PHENobarbital |
May enhance the CNS depressant effect of HYDROcodone. PHENobarbital may decrease the serum concentration of HYDROcodone. Management: Avoid use of hydrocodone and phenobarbital when possible. Monitor for respiratory depression/sedation. Because phenobarbital is also a strong CYP3A4 inducer, monitor for decreased hydrocodone efficacy and withdrawal if combined. |
|
Pitolisant |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Combined use of pitolisant with a CYP3A4 substrate that has a narrow therapeutic index should be avoided. Other CYP3A4 substrates should be monitored more closely when used with pitolisant. |
|
Primidone |
May intensify HYDROcodone's CNS depressive effects. The serum concentration of HYDROcodone may drop while taking primidone. Management: When feasible, refrain from using primidone and hydrocodone. Check for sedation or respiratory depression. In cases where primidone is taken with hydrocodone, keep an eye out for withdrawal symptoms as primidone is a potent CYP3A4 inducer. |
|
Sincalide |
Drugs that Affect Gallbladder Function may diminish the therapeutic effect of Sincalide. Management: Consider discontinuing drugs that may affect gallbladder motility prior to the use of sincalide to stimulate gallbladder contraction. |
|
Sodium Oxybate |
May enhance the CNS depressant effect of CNS Depressants. Management: Consider alternatives to combined use. When combined use is needed, consider minimizing doses of one or more drugs. Use of sodium oxybate with alcohol or sedative hypnotics is contraindicated. |
|
St John's Wort |
May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. |
|
Stiripentol |
May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with stiripentol requires closer monitoring. |
|
Suvorexant |
CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. |
|
Tapentadol |
May enhance the CNS depressant effect of CNS Depressants. Management: Avoid concomitant use of tapentadol and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. |
|
Zolpidem |
CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. |
|
Risk Factor X (Avoid combination) |
|
|
Alcohol (Ethyl) |
May intensify HYDROcodone's CNS depressive effects. Alcohol (Ethyl) may make HYDROcodone more concentrated in the blood. Treatment: Due to potentially lethal consequences, patients using the Zohydro ER brand of extended-release hydrocodone must abstain from drinking alcohol or using products that contain alcohol. It is also anticipated that other hydrocodone drugs will interact, albeit in a less substantial way. |
|
Azelastine (Nasal) |
CNS Depressants may enhance the CNS depressant effect of Azelastine (Nasal). |
|
Bromperidol |
May enhance the CNS depressant effect of CNS Depressants. |
|
Conivaptan |
May elevate CYP3A4 substrates' serum concentration (High risk with Inhibitors). |
|
Eluxadoline |
Eluxadoline's tendency to cause constipation may be increased by opioid agonists. |
|
Fusidic Acid (Systemic) |
May elevate CYP3A4 substrates' serum concentration (High risk with Inhibitors). |
|
Idelalisib |
May elevate CYP3A4 substrates' serum concentration (High risk with Inhibitors). |
|
Opioids (Mixed Agonist / Antagonist) |
May lessen opioid agonists' analgesic effects. Management: If patients are given mixed agonist/antagonist opioids instead of pure opioid agonists, look for alternatives and keep an eye out for withdrawal symptoms in patients who are opioid-dependent or signs of therapeutic failure/high dose requirements. |
|
Orphenadrine |
The CNS depressing action of orphenadrine may be enhanced by CNS depressants. |
|
Oxomemazine |
May enhance the CNS depressant effect of CNS Depressants. |
|
Paraldehyde |
CNS Depressants may enhance the CNS depressant effect of Paraldehyde. |
|
Thalidomide |
CNS Depressants may enhance the CNS depressant effect of Thalidomide. |
Monitoring parameters:
- Relief of symptoms;
- signs and symptoms of addiction, abuse or misuse;
- respiratory status and blood pressure (if clinically indicated);
- signs or symptoms of hypogonadism or hypoadrenalism.
How to administer Hydrocodone and Guaifenesin (Flowtuss)?
Oral: Use an accurate milliliter measuring device; a teaspoon is not an accurate measuring device and could lead to overdose.
Mechanism of action of Hydrocodone and guaifenesin:
Hydrocodone
- It is an analgesic that acts on opioid receptors and modulates pain perception.
- It suppresses the symptoms of cough by acting on the medulla.
Guaifenesin
- It stimulates the production and dilutes respiratory tract secretions.
- This increases respiratory fluid volumes and decreases phlegm viscosity. Talk to individual agents.
International Brand Names of Hydrocodone and guaifenesin:
- Flowtuss
- Obredon
Hydrocodone and guaifenesin Brand Names in Pakistan:
No Brands Available in Pakistan.
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