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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Hydrocodone Bitartrate
Brand Name
Hysingla Er
Generic Name
Hydrocodone Bitartrate
Active Ingredient
Hydrocodone BitartrateCategory
Nonsteroidal Anti-inflammatory Drug [EPC]
Variants
6
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Hysingla Er, you must consult a qualified healthcare professional.
| 40 mg/1 | TABLET, EXTENDED RELEASE | ORAL | 59011-273 |
| 20 mg/1 | TABLET, EXTENDED RELEASE | ORAL | 59011-271 |
| 30 mg/1 | TABLET, EXTENDED RELEASE | ORAL | 59011-272 |
Detailed information about Hysingla Er
Hydrocodone Bitartrate is a potent opioid agonist and Schedule II controlled substance primarily indicated for the management of severe pain. It works by altering the perception of pain through central nervous system mu-opioid receptors.
Dosage of Hydrocodone Bitartrate must be highly individualized. For patients who are not 'opioid-tolerant' (those not currently taking opioid medication), the typical starting dose for immediate-release combination products is 2.5 mg to 5 mg every 4 to 6 hours as needed for pain. The maximum daily dose of hydrocodone is often limited by the accompanying non-opioid component (e.g., the 4,000 mg daily limit for acetaminophen).
For extended-release (ER) formulations, the starting dose for opioid-naive patients is typically 20 mg once daily (for products like Hysingla ER) or 10 mg every 12 hours (for products like Zohydro ER). Healthcare providers will gradually 'titrate' or adjust the dose every 3 to 7 days based on the patient's response and tolerability. The goal is to find the lowest dose that provides adequate pain control with manageable side effects.
Hydrocodone Bitartrate is generally not recommended for use in pediatric patients. Most single-entity ER formulations are strictly contraindicated in children due to the risk of fatal respiratory depression. Some combination cough syrups may be used in adolescents over the age of 18, but the FDA has issued strong warnings against the use of opioid-containing cough medications in children under 18. Always consult a pediatric specialist for pain management in minors.
Patients with impaired kidney function may experience decreased clearance of hydrocodone and its metabolites. For patients with severe renal impairment (CrCl < 30 mL/min), healthcare providers typically start with 50% to 75% of the standard dose and monitor closely for signs of CNS or respiratory depression.
Since the liver is the primary site of hydrocodone metabolism, patients with hepatic insufficiency (cirrhosis or hepatitis) are at high risk for drug accumulation. In cases of moderate to severe hepatic impairment, a reduced starting dose and extended dosing intervals are usually required. Frequent monitoring of liver function tests (LFTs) is essential.
Geriatric patients (ages 65 and older) are more sensitive to the effects of opioids. They are at an increased risk for falls, confusion, and respiratory depression. Healthcare providers usually follow the 'start low and go slow' principle, beginning with the lowest possible dose and monitoring for cognitive impairment or sedation.
To ensure safety and efficacy, follow these specific instructions:
If you miss a dose of Hydrocodone Bitartrate, take it as soon as you remember, unless it is almost time for your next scheduled dose. If it is nearly time for the next dose, skip the missed one and return to your regular schedule. Never double the dose to catch up, as this significantly increases the risk of overdose.
An overdose of Hydrocodone Bitartrate is a medical emergency. Signs include extreme somnolence (sleepiness), pinpoint pupils, cold and clammy skin, skeletal muscle flaccidity, and dangerously slow breathing (bradycardia or bradypnea). If an overdose is suspected, call 911 immediately. The opioid antagonist naloxone (Narcan) should be administered if available, but professional medical intervention is still required as the effects of hydrocodone may outlast the effects of naloxone.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose without medical guidance. Misuse of this medication can lead to addiction and death.
Side effects are common with Hydrocodone Bitartrate use, particularly during the initiation of therapy or after a dose increase. The most frequently reported adverse reactions include:
Hydrocodone Bitartrate is a high-risk medication that requires strict adherence to safety protocols. It should only be used by the person for whom it was prescribed. Sharing this medication with others is illegal and dangerous. Patients must be screened for a personal or family history of substance abuse before starting treatment, as this increases the risk of developing an opioid use disorder.
As detailed in the side effects section, the FDA Boxed Warnings emphasize that Hydrocodone Bitartrate is associated with a high potential for Addiction, Abuse, and Misuse. Furthermore, the risk of Life-Threatening Respiratory Depression is highest during the initiation of therapy or following a dose increase. The FDA also warns that Accidental Ingestion by children is a leading cause of fatal opioid poisoning in the home. Finally, the Interaction with Benzodiazepines (like Xanax or Valium) is a critical warning, as the combination significantly increases the risk of fatal overdose.
Certain medications should never be combined with Hydrocodone Bitartrate due to the risk of fatal outcomes:
Hydrocodone Bitartrate must NEVER be used in the following circumstances:
Hydrocodone Bitartrate is generally categorized as Pregnancy Category C (under the old FDA system). There are no adequate and well-controlled studies in pregnant women. However, prolonged use of opioids during pregnancy can lead to Neonatal Opioid Withdrawal Syndrome (NOWS). This is a life-threatening condition where the newborn experiences withdrawal symptoms such as irritability, hyperactivity, abnormal sleep patterns, high-pitched cry, tremor, vomiting, and failure to gain weight. If opioid use is required for a prolonged period in a pregnant woman, the patient should be advised of the risk and the infant must be monitored by neonatologists at birth. Use during labor and delivery is not recommended as it can cause respiratory depression in the newborn.
Hydrocodone is excreted into human breast milk. While small, occasional doses may not cause immediate harm, repeated doses can lead to accumulation in the infant. Symptoms of opioid toxicity in a nursing infant include excessive sleepiness, difficulty breastfeeding, or limpness. In severe cases, fatal respiratory depression can occur. If a breastfeeding mother must take Hydrocodone Bitartrate, the infant should be closely monitored for these signs. Most healthcare providers recommend alternative pain management strategies for nursing mothers.
Hydrocodone Bitartrate is a semi-synthetic pure opioid agonist. Its primary therapeutic action is analgesia, which is mediated by its high affinity for the mu-opioid receptors in the central nervous system. These receptors are G-protein coupled receptors. When hydrocodone binds, it inhibits adenylate cyclase, reduces calcium channel opening, and increases potassium channel opening. This results in hyperpolarization of the neuron and reduced neuronal excitability, effectively 'blunting' the transmission of pain signals. It also acts on the descending inhibitory pathways in the brainstem to further modulate pain perception.
The dose-response relationship of hydrocodone is linear; as the dose increases, so does the level of analgesia and the risk of respiratory depression. Onset of action for immediate-release forms is typically 10-30 minutes, with a duration of 4-6 hours. For extended-release forms, the onset is slower, but the duration of effect lasts 12-24 hours. Tolerance to the analgesic effects can develop with chronic use, requiring higher doses to maintain the same effect, though tolerance to respiratory depression and constipation develops much more slowly or not at all.
Common questions about Hysingla Er
Hydrocodone Bitartrate is a powerful opioid pain medication used to treat severe pain that cannot be managed by other non-opioid treatments. It is most commonly prescribed for acute pain following major surgery or for chronic, long-term pain management in patients who require around-the-clock treatment. Because of its potency and risk for addiction, it is strictly regulated as a Schedule II controlled substance. It works by changing the way your brain and nervous system respond to pain. Healthcare providers only prescribe it when other options like NSAIDs or physical therapy have failed to provide adequate relief.
The most common side effects include constipation, nausea, sleepiness, and dizziness. Constipation is a particularly frequent issue because opioids slow down the digestive system; many doctors recommend a stool softener alongside the medication. Nausea and vomiting are also common, especially when first starting the drug or after a dose increase. Dizziness and a feeling of being 'drugged' or sedated can occur, which makes driving dangerous. Most of these side effects, except for constipation, tend to improve as your body becomes accustomed to the medication over several days.
No, you must never drink alcohol while taking Hydrocodone Bitartrate. Combining alcohol with opioids significantly increases the risk of life-threatening respiratory depression, which can lead to coma or death. Alcohol enhances the sedative effects of the drug, making you more likely to stop breathing. Furthermore, in some extended-release versions of hydrocodone, alcohol can cause the medication to release into your system all at once, known as 'dose dumping.' This creates a massive, potentially fatal spike in drug levels in your bloodstream. Always check with your doctor before consuming any substance that might cause drowsiness.
Hydrocodone Bitartrate is generally not considered safe during pregnancy unless the benefits clearly outweigh the significant risks. Prolonged use of this medication during pregnancy can lead to Neonatal Opioid Withdrawal Syndrome (NOWS), a condition where the baby is born addicted to the drug and goes through painful, dangerous withdrawal. Symptoms in the newborn can include high-pitched crying, tremors, and difficulty feeding. If you are pregnant or planning to become pregnant, you must discuss alternative pain management options with your obstetrician. Opioids should only be used in pregnancy under the most stringent medical supervision.
The time it takes for Hydrocodone Bitartrate to work depends on the formulation your doctor has prescribed. Immediate-release combination products usually begin to provide pain relief within 20 to 30 minutes, with peak effects occurring around 1 to 2 hours after the dose. Extended-release (ER) versions are designed to release the medication slowly over a longer period, so they may take several hours to reach their full effect. ER versions are intended for steady, long-term pain control rather than 'as needed' relief for sudden pain. It is important not to take extra doses if you don't feel immediate relief, as this can lead to an overdose.
You should never stop taking Hydrocodone Bitartrate suddenly if you have been using it for more than a few days. Doing so can trigger a severe withdrawal syndrome because your body has likely developed a physical dependence on the drug. Withdrawal symptoms can include intense anxiety, muscle aches, sweating, diarrhea, and insomnia. While these symptoms are rarely life-threatening for adults, they can be extremely distressing and painful. Your healthcare provider will help you safely 'taper' or slowly lower your dose over several weeks to minimize these effects. Always follow a medically supervised discontinuation plan.
If you miss a dose of Hydrocodone Bitartrate, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. You should never take two doses at the same time to make up for a missed one, as this significantly increases the risk of a dangerous overdose. For extended-release versions, it is especially important to maintain a consistent schedule. If you are unsure what to do after missing multiple doses, contact your doctor or pharmacist for specific instructions tailored to your prescription.
Weight gain is not a common direct side effect of Hydrocodone Bitartrate, but it can occur indirectly. Opioids often cause significant sedation and fatigue, which may lead to a more sedentary lifestyle and reduced physical activity. Additionally, some patients experience changes in appetite or increased cravings for sugary foods while on opioid therapy. Conversely, some patients may actually lose weight due to persistent nausea or a decreased interest in food. If you notice significant changes in your weight while taking this medication, it is important to discuss them with your healthcare provider to rule out other underlying issues like hormonal changes.
Hydrocodone Bitartrate has many serious drug interactions and should be used with caution alongside other medications. It is particularly dangerous to take with benzodiazepines, sleep aids, or other CNS depressants, as these combinations can stop your breathing. Certain antibiotics, antifungals, and heart medications can also change how your body processes hydrocodone, leading to toxic levels in your blood. Even herbal supplements like St. John's Wort can interfere with its effectiveness. Always provide your doctor and pharmacist with a complete list of all medications, vitamins, and supplements you are taking to prevent dangerous interactions.
Yes, Hydrocodone Bitartrate is available as a generic medication, particularly in its immediate-release combination forms (such as Hydrocodone/Acetaminophen). Generic versions are typically much more affordable than brand-name products like Vicodin or Norco. Some of the newer, single-entity extended-release formulations may only be available as expensive brand-name drugs, though generic versions of some ER products have entered the market in recent years. Generic medications are required by the FDA to have the same active ingredient, strength, and effectiveness as the brand-name versions. Your pharmacist can tell you if a generic version of your specific prescription is available.
Other drugs with the same active ingredient (Hydrocodone Bitartrate)
> Warning: Stop taking Hydrocodone Bitartrate and call your doctor immediately if you experience any of these serious reactions:
Prolonged use of Hydrocodone Bitartrate can lead to several physiological changes. Tolerance occurs when the body requires higher doses to achieve the same level of pain relief. Physical dependence means the body has adapted to the drug, and stopping it suddenly will cause withdrawal symptoms (e.g., tremors, sweating, diarrhea). Additionally, long-term use is associated with Opioid-Induced Hyperalgesia (OIH), a paradoxical condition where the patient becomes more sensitive to pain over time despite increasing the dose.
The FDA has issued several Boxed Warnings for Hydrocodone Bitartrate, which are the most serious warnings available. These include:
Report any unusual symptoms or persistent side effects to your healthcare provider immediately.
Healthcare providers will typically require the following monitoring for patients on long-term Hydrocodone Bitartrate therapy:
Hydrocodone Bitartrate may severely impair the mental and physical abilities required for driving or operating heavy machinery. Patients should not engage in these activities until they know how the medication affects them. Sedation and 'nodding off' can occur without warning.
Do not consume alcohol while taking Hydrocodone Bitartrate. Alcohol can dangerously increase the sedative effects of the opioid and may lead to 'dose dumping' in certain extended-release formulations, where the entire dose is released at once, leading to a fatal overdose.
Do not stop taking Hydrocodone Bitartrate suddenly if you have been taking it for more than a few days. Sudden discontinuation can trigger a severe withdrawal syndrome characterized by restlessness, lacrimation (tearing), rhinorrhea (runny nose), yawning, perspiration, chills, myalgia (muscle pain), and mydriasis (dilated pupils). Your doctor will provide a gradual tapering schedule to safely reduce the dose.
> Important: Discuss all your medical conditions, including any history of depression or lung disease, with your healthcare provider before starting Hydrocodone Bitartrate.
Hydrocodone Bitartrate may interfere with certain laboratory tests:
For each major interaction, the management strategy usually involves dose reduction, increased frequency of monitoring, or choosing an alternative non-interacting medication. Always inform your pharmacist of all products you use.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking before starting Hydrocodone Bitartrate.
In these conditions, the risks of Hydrocodone Bitartrate often outweigh the benefits, requiring a careful risk-benefit analysis by a specialist:
Patients who have had an allergic reaction to codeine may also react to hydrocodone, as they are chemically related (both are phenanthrene derivatives). Symptoms of cross-sensitivity can range from mild itching and hives to severe swelling of the airways. If you have ever had a reaction to an 'opiate' or 'opioid' medication, ensure your doctor is aware before taking Hydrocodone Bitartrate.
> Important: Your healthcare provider will evaluate your complete medical history, including your respiratory health and history of allergies, before prescribing Hydrocodone Bitartrate.
As previously noted, the safety and efficacy of Hydrocodone Bitartrate in pediatric patients have not been established. The risk of fatal respiratory depression is significantly higher in children. Extended-release formulations are strictly prohibited for use in children. For acute pain, pediatricians almost always utilize non-opioid alternatives or much weaker, weight-based doses of other medications under strict hospital supervision.
Elderly patients (over 65) are at a high risk for adverse effects from Hydrocodone Bitartrate. Age-related declines in renal and hepatic function can lead to higher plasma concentrations. Furthermore, the sedative effects of opioids increase the risk of falls and hip fractures in this population. Cognitive impairment or 'sundowning' may also be exacerbated. Healthcare providers typically start elderly patients on doses that are 25% to 50% lower than the standard adult dose.
In patients with renal impairment, the clearance of hydrocodone is reduced. For those with a Glomerular Filtration Rate (GFR) below 30 mL/min, the drug can accumulate rapidly. While hydrocodone itself is not efficiently removed by hemodialysis, its metabolites may be. Dosing should be cautious, with frequent monitoring for signs of toxicity like miosis (pinpoint pupils) or lethargy.
Because the liver is the primary site of metabolism via the CYP3A4 and CYP2D6 pathways, hepatic impairment significantly alters the drug's profile. Patients with Child-Pugh Class B or C (moderate to severe impairment) should receive significantly reduced doses. In some cases, the use of extended-release hydrocodone may be contraindicated entirely in patients with severe hepatic failure.
> Important: Special populations require individualized medical assessment and frequent follow-up to ensure the medication is being used safely and effectively.
| Parameter | Value |
|---|---|
| Bioavailability | High (approx. 80% after first-pass) |
| Protein Binding | 19% - 33% |
| Half-life | 4 hours (IR); 7-9 hours (ER) |
| Tmax | 1.3 hours (IR); 6-30 hours (ER) |
| Metabolism | Hepatic (CYP3A4 to norhydrocodone; CYP2D6 to hydromorphone) |
| Excretion | Renal (primarily as metabolites) |
Hydrocodone Bitartrate has the molecular formula C18H21NO3 · C4H6O6 · 2.5H2O. It has a molecular weight of approximately 494.49 g/mol (for the hydrate). It is a fine, white crystal or crystalline powder that is soluble in water and slightly soluble in alcohol. Structurally, it is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5).
Hydrocodone Bitartrate is classified as an Opioid Agonist and is a Schedule II controlled substance. It is chemically related to codeine and morphine. Other medications in this class include oxycodone, morphine, and hydromorphone. Unlike NSAIDs, it does not have anti-inflammatory or anti-pyretic (fever-reducing) properties; its action is purely neurological.