Select

Save Up To 85% With This Free Zohydro Er Discount Card!

Click here to request card

Comments (0)

LOG IN WITH
OR PICK A NAME
Your email is safe with us. It is only used for moderation and optional notifications.
Email is incorrect.

Zohydro Er Reviews (0)

Average Rating

Your Star Rating, the more stars the better
LOG IN WITH
OR PICK A NAME
Your email is safe with us. It is only used for moderation and optional notifications.
Email is incorrect.

Zohydro Er Prescribing Information

This information is not for clinical use. These highlights do not include all the information needed to use Zohydro Er safely and effectively. Before taking Zohydro Er please consult with your doctor. See full prescribing information for Zohydro Er.

Warning

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTION WITH ALCOHOL; and CYTOCHROME P450 3A4 INTERACTION Addiction, Abuse, and Misuse ZOHYDRO ER exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing ZOHYDRO ER and monitor all patients regularly for the development of these behaviors or conditions [see Warnings and Precautions (5.1)]. Life-threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of ZOHYDRO ER. Monitor for respiratory depression, especially during initiation of ZOHYDRO ER or following a dose increase. Instruct patients to swallow ZOHYDRO ER capsules whole; crushing, chewing, or dissolving ZOHYDRO ER capsules can cause rapid release and absorption of a potentially fatal dose of hydrocodone [see Warnings and Precautions (5.2)]. Accidental Ingestion Accidental ingestion of even one dose of ZOHYDRO ER, especially by children, can result in a fatal overdose of hydrocodone [see Warnings and Precautions (5.2)]. Neonatal Opioid Withdrawal Syndrome Prolonged use of ZOHYDRO ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions (5.3)]. Interaction with Alcohol Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking ZOHYDRO ER. The co-ingestion of alcohol with ZOHYDRO ER may result in increased plasma levels and a potentially fatal overdose of hydrocodone [see Warnings and Precautions (5.4) and Clinical Pharmacology (12.3)]. Cytochrome P450 3A4 Interaction The concomitant use of ZOHYDRO ER with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentration. Monitor patients receiving ZOHYDRO ER and any CYP3A4 inhibitor or inducer [see Warnings and Precautions (5.13) and Clinical Pharmacology (12.3)]. WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTION WITH ALCOHOL; and CYTOCHROME P450 3A4 INTERACTION See full prescribing information for complete boxed warning. ZOHYDRO ER exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk before prescribing, and monitor regularly for development of these behaviors or conditions . (5.1) Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Instruct patients to swallow ZOHYDRO ER whole to avoid exposure to a potentially fatal dose of hydrocodone. (5.2) Accidental ingestion of ZOHYDRO ER, especially in children, can result in a fatal overdose of hydrocodone. (5.2) Prolonged use of ZOHYDRO ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. (5.3) Instruct patients not to consume alcohol or any products containing alcohol while taking ZOHYDRO ER because co-ingestion can result in fatal plasma hydrocodone levels. (5.4) Initiation of CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of hydrocodone from ZOHYDRO ER. (5.13)

Indications And Usage

ZOHYDRO® ER (hydrocodone bitartrate) is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve ZOHYDRO ER for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. ZOHYDRO ER is not indicated as an as-needed (prn) analgesic. ZOHYDRO ER is an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. (1) Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve ZOHYDRO ER for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. (1) ZOHYDRO ER is not indicated as an as-needed (prn) analgesic. (1)

Does this card cost me anything?

NO - The Pharmacy Savings Card alone does not cost you anything

Dosage And Administration

Table 1. Conversion Factors to ZOHYDRO ER (Not Equianalgesic Doses)
Prior Oral Opioid Oral Dose (mg) Approximate Oral Conversion Factor
Hydrocodone 10 1
Oxycodone 10 1
Methadone 10 1
Oxymorphone 5 2
Hydromorphone 3.75 2.67
Morphine 15 0.67
Codeine 100 0.10
The conversion ratios in this table are only to be used for the conversion from current opioid therapy to ZOHYDRO ER.

Dosage Forms And Strengths

ZOHYDRO ER (hydrocodone) extended-release capsules are available in 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 50 mg hard gelatin capsules for oral administration, containing white to off-white beads, roughly spherical in shape, and uniform in appearance. Extended-release capsules: 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 50 mg (3)

Contraindications

ZOHYDRO ER is contraindicated in patients with: Significant respiratory depression Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment Known or suspected paralytic ileus Hypersensitivity (e.g., anaphylaxis) to hydrocodone bitartrate or any other ingredients in ZOHYDRO ER Significant respiratory depression (4) Acute or severe bronchial asthma (4) Known or suspected paralytic ileus (4) Hypersensitivity to hydrocodone bitartrate (4)

Warning and Cautions

See Boxed WARNINGS Interactions with CNS depressants: Concomitant use may cause profound sedation, respiratory depression, and death. If coadministration is required, consider dose reduction of one or both drugs. (5.4) Elderly, cachectic, debilitated patients, and those with chronic pulmonary disease: Monitor closely because of increased risk for life-threatening respiratory depression. (5.5, 5.6) Hypotensive effects: Monitor during dose initiation and titration. (5.7) Patients with head injury or increased intracranial pressure: Monitor for sedation and respiratory depression. Avoid use of ZOHYDRO ER in patients with impaired consciousness or coma susceptible to intracranial effects of CO2 retention. (5.8) Concomitant use of CYP3A4 inhibitors may increase opioid effects. (5.13) 5.1 Addiction, Abuse, and Misuse ZOHYDRO ER contains hydrocodone, a Schedule II controlled substance. As an opioid, ZOHYDRO ER exposes users to the risks of addiction, abuse, and misuse [see Drug Abuse and Dependence (9)]. As modified-release products such as ZOHYDRO ER deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of hydrocodone present. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed ZOHYDRO ER and in those who obtain the drug illicitly. Addiction can occur at recommended doses and if the drug is misused or abused. Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing ZOHYDRO ER, and monitor all patients receiving ZOHYDRO ER for the development of these behaviors or conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol addiction or abuse) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the prescribing of ZOHYDRO ER for the proper management of pain in any given patient. Patients at increased risk may be prescribed modified-release opioid formulations such as ZOHYDRO ER, but use in such patients necessitates intensive counseling about the risks and proper use of ZOHYDRO ER along with intensive monitoring for signs of addiction, abuse, and misuse. Abuse or misuse of ZOHYDRO ER by crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of the hydrocodone and can result in overdose and death [see Overdosage (10)]. Opioid agonists such as ZOHYDRO ER are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing ZOHYDRO ER. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug [see Patient Counseling Information (17)]. Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product. 5.2 Life- T hreatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression has been reported with the use of modified-release opioids, even when used as recommended. Respiratory depression from opioid use, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status [see Overdosage (10)]. Carbon dioxide (CO2) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of ZOHYDRO ER, the risk is greatest during the initiation of therapy or following a dose increase. Closely monitor patients for respiratory depression when initiating therapy with ZOHYDRO ER and following dose increases. To reduce the risk of respiratory depression, proper dosing and titration of ZOHYDRO ER are essential [see Dosage and Administration (2)]. Overestimating the ZOHYDRO ER dose when converting patients from another opioid product can result in fatal overdose with the first dose. Accidental ingestion of even one dose of ZOHYDRO ER, especially by children, can result in respiratory depression and death due to an overdose of hydrocodone. 5.3 Neonatal Opioid Withdrawal Syndrome Prolonged use of ZOHYDRO ER during pregnancy can result in withdrawal signs in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. 5.4 Interactions with Central Nervous System Depressants Patients must not consume alcoholic beverages, or prescription or non-prescription products containing alcohol, while on ZOHYDRO ER therapy. The co-ingestion of alcohol with ZOHYDRO ER may result in increased plasma levels and a potentially fatal overdose of hydrocodone [see Clinical Pharmacology (12.3)]. Hypotension, profound sedation, coma, respiratory depression, and death may result if ZOHYDRO ER is used concomitantly with alcohol or other central nervous system (CNS) depressants (e.g., sedatives, anxiolytics, hypnotics, neuroleptics, other opioids). When considering the use of ZOHYDRO ER in a patient taking a CNS depressant, assess the duration of use of the CNS depressant and the patient’s response, including the degree of tolerance that has developed to CNS depression. Additionally, evaluate the patient’s use of alcohol or illicit drugs that cause CNS depression. If the decision to begin ZOHYDRO ER is made, start with a lower ZOHYDRO ER dose than usual (i.e., 20%-30% less), monitor patients for signs of sedation and respiratory depression, and consider using a lower dose of the concomitant CNS depressant [see Drug Interactions (7.2)]. 5. 5 Use in Elderly, Cachectic, and Debilitated Patients Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients as they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients. Monitor such patients closely, particularly when initiating and titrating ZOHYDRO ER and when ZOHYDRO ER is given concomitantly with other drugs that depress respiration [see Warnings and Precautions (5.2)]. 5. 6 Use in Patients with Chronic Pulmonary Disease Monitor for respiratory depression in patients with significant chronic obstructive pulmonary disease or cor pulmonale, and patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or preexisting respiratory depression, particularly when initiating therapy and titrating with ZOHYDRO ER, as in these patients, even usual therapeutic doses of ZOHYDRO ER may decrease respiratory drive to the point of apnea [see Warnings and Precautions (5.2)]. Consider the use of alternative non-opioid analgesics in these patients if possible. 5. 7 Hypotensive Effect ZOHYDRO ER may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is an added risk to individuals whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs such as phenothiazines or other agents which compromise vasomotor tone. Monitor these patients for signs of hypotension after initiating or titrating the dose of ZOHYDRO ER. In patients with circulatory shock, ZOHYDRO ER may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid the use of ZOHYDRO ER in patients with circulatory shock. 5. 8 Use in Patients with Head Injury and Increased Intracranial Pressure Monitor patients taking ZOHYDRO ER who may be susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors) for signs of sedation and respiratory depression, particularly when initiating therapy with ZOHYDRO ER. ZOHYDRO ER may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Opioids may also obscure the clinical course in a patient with a head injury. Avoid the use of ZOHYDRO ER in patients with impaired consciousness or coma. 5. 9 Use in Patients with Gastrointestinal Conditions ZOHYDRO ER is contraindicated in patients with known or suspected paralytic ileus. Opioids diminish propulsive peristaltic waves in the gastrointestinal tract and decrease bowel motility. Monitor for decreased bowel motility in post-operative patients receiving opioids. The administration of ZOHYDRO ER may obscure the diagnosis or clinical course in patients with acute abdominal conditions. Hydrocodone may cause spasm of the sphincter of Oddi. Monitor patients with biliary tract disease, including acute pancreatitis. 5. 10 Use in Patients with Convulsive or Seizure Disorders The hydrocodone in ZOHYDRO ER may aggravate convulsions in patients with convulsive disorders, and may induce or aggravate seizures in some clinical settings. Monitor patients with a history of seizure disorders for worsened seizure control during ZOHYDRO ER therapy. 5 .1 1 Avoidance of Withdrawal Avoid the use of mixed agonist/antagonist (i.e., pentazocine, nalbuphine, and butorphanol) or partial agonist (buprenorphine) analgesics in patients who have received, or are receiving, a course of therapy with a full opioid agonist analgesic, including ZOHYDRO ER. In these patients, mixed agonist/antagonist and partial agonist analgesics may reduce the analgesic effect and/or may precipitate withdrawal symptoms [see Drug Interactions (7.4) ] 5. 1 2 Driving and Operating Machinery ZOHYDRO ER may impair the mental and physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of ZOHYDRO ER and know how they will react to the medication. 5.13 Cytochrome P450 CYP3A4 Inhibitors and Inducers Since the CYP3A4 isoenzyme plays a major role in the metabolism of ZOHYDRO ER, drugs that alter CYP3A4 activity may cause changes in clearance of hydrocodone which could lead to changes in hydrocodone plasma concentrations. Inhibition of CYP3A4 activity by its inhibitors such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents, (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), may increase plasma concentrations of hydrocodone and prolong opioid effects. CYP3A4 inducers, such as rifampin, carbamazepine, and phenytoin, may induce the metabolism of hydrocodone and, therefore, may cause increased clearance of the drug which could lead to a decrease in hydrocodone plasma concentrations, lack of efficacy or, possibly, development of an abstinence syndrome in a patient who had developed physical dependence to hydrocodone. If co-administration is necessary, monitor patients closely who are currently taking, or discontinuing, CYP3A4 inhibitors or inducers. Evaluate these patients at frequent intervals and consider dose adjustments until stable drug effects are achieved [see Drug Interactions (7.3) and Clinical Pharmacology (12.3)].

Adverse Reactions

The following serious adverse reactions are discussed elsewhere in the labeling: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1) ] Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2)] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.3)] Interactions with Other CNS Depressants [see Warnings and Precautions (5.4)] Hypotensive Effect [see Warnings and Precautions (5.7) ] Gastrointestinal Conditions [see Warnings and Precautions (5.9)] Seizures [see Warnings and Precautions (5.10) ] Adverse reactions in ≥2% of patients in placebo-controlled trials include constipation, nausea, somnolence, fatigue, headache, dizziness, dry mouth, vomiting, pruritus, abdominal pain, edema peripheral, upper respiratory tract infection, muscle spasms, urinary tract infection, back pain, and tremor. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Zogenix, Inc. at 1-866-ZOGENIX or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of ZOHYDRO ER was evaluated in a total of 1,148 subjects in Phase 3 clinical trials. Table 3 lists the most frequently occurring adverse reactions occurring at a greater frequency than placebo from the placebo-controlled trial in subjects with moderate-to-severe chronic lower back pain. Table 3. Treatment-Emergent Adverse Events in ≥2% of Subjects During the Open-Label Titration Period and/or the Double-Blind Treatment Period, by Preferred Term —Number (%) of Treated Subjects (Placebo-Controlled Study in Opioid-Experienced Subjects with Moderate-to-Severe Chronic Lower Back Pain) Open-Label Titration Period Double-Blind Treatment Period ZOHYDRO ER ZOHYDRO ER Placebo Preferred Term (N = 510) (n = 151) (n = 151) Constipation 56 (11%) 12 (8%) 0 (0%) Nausea 50 (10%) 11 (7%) 5 (3%) Somnolence 24 (5%) 1 (1%) 0 (0%) Fatigue 21 (4%) 1 (1%) 2 (1%) Headache 19 (4%) 0 (0%) 2 (1%) Dizziness 17 (3%) 3 (2%) 1 (1%) Dry mouth 16 (3%) 0 (0%) 0 (0%) Vomiting 14 (3%) 7 (5%) 1 (1%) Pruritus 13 (3%) 0 (0%) 0 (0%) Abdominal pain 8 (2%) 4 (3%) 0 (0%) Edema peripheral 7 (1%) 4 (3%) 0 (0%) Upper respiratory tract infection 7 (1%) 5 (3%) 1 (1%) Muscle spasms 6 (1%) 4 (3%) 2 (1%) Urinary tract infection 4 (1%) 8 (5%) 3 (2%) Back pain 4 (1%) 6 (4%) 5 (3%) Tremor 1 (0%) 4 (3%) 1 (1%) The common (≥1% to <10%) adverse drug reactions reported at least once by subjects treated with ZOHYDRO ER in the Phase 3 clinical trials and not represented in Table 3 were: Gastrointestinal Disorders: abdominal discomfort, abdominal pain, gastroesophageal reflux disease General Disorders and Administration Site Conditions: non-cardiac chest pain, pain, peripheral edema, pyrexia Injury, Poisoning and Procedural Complications: contusion, fall, foot fracture, joint injury, joint sprain, muscle strain, skin laceration Investigations: increased blood cholesterol, increased gamma-glutamyltransferase Metabolism and Nutrition Disorders: dehydration, hypokalemia Musculoskeletal and Connective Tissue Disorders: arthralgia, musculoskeletal pain, myalgia, neck pain, osteoarthritis, pain in extremity Nervous System Disorders: lethargy, migraine, paresthesia Psychiatric Disorders: anxiety, depression, insomnia Respiratory, Thoracic, and Mediastinal Disorders: cough, dyspnea Skin and Subcutaneous Tissue Disorders: hyperhidrosis, night sweats, rash Vascular Disorders: hot flush

Drug Interactions

Mixed agonists/antagonists and partial agonist analgesics: Avoid use with ZOHYDRO ER because they may reduce analgesic effect of ZOHYDRO ER or precipitate withdrawal symptoms. (7.4) The use of MAO inhibitors or tricyclic antidepressants with ZOHYDRO ER may increase the effect of either the antidepressant or ZOHYDRO ER. (7.5) 7.1 Alcohol Concomitant use of alcohol with ZOHYDRO ER can result in an increase of hydrocodone plasma levels and potentially fatal overdose of hydrocodone. Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products containing alcohol while on ZOHYDRO ER therapy [see Clinical Pharmacology (12.3) ]. 7.2 CNS Depressants The concomitant use of ZOHYDRO ER with other CNS depressants including sedatives, hypnotics, tranquilizers, general anesthetics, phenothiazines, other opioids, and alcohol, can increase the risk of respiratory depression, profound sedation, coma, or death. Monitor patients receiving CNS depressants and ZOHYDRO ER for signs of respiratory depression, sedation, and hypotension. When combined therapy with any of the above medications is considered, the dose of one or both agents should be reduced [see Dosage and Administration (2.1) and Warnings and Precautions (5.4) ]. 7.3 Drugs Affecting Cytochrome P450 Isoenzymes Inhibitors of CYP3A4 and 2D6 Because the CYP3A4 isoenzyme plays a major role in the metabolism of hydrocodone, drugs that inhibit CYP3A4 activity may cause decreased clearance of hydrocodone which could lead to an increase in hydrocodone plasma concentrations and result in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of CYP2D6 and 3A4 inhibitors. If co-administration with ZOHYDRO ER is necessary, monitor patients for respiratory depression and sedation at frequent intervals and consider dose adjustments until stable drug effects are achieved [see Clinical Pharmacology (12.3)]. Inducers of CYP3A4 Cytochrome P450 3A4 inducers may induce the metabolism of hydrocodone and, therefore, may cause increased clearance of the drug which could lead to a decrease in hydrocodone plasma concentrations, lack of efficacy or, possibly, development of a withdrawal syndrome in a patient who had developed physical dependence to hydrocodone. If co-administration with ZOHYDRO ER is necessary, monitor for signs of opioid withdrawal and consider dose adjustments until stable drug effects are achieved [see Clinical Pharmacology (12.3)]. After stopping the treatment of a CYP3A4 inducer, as the effects of the inducer decline, the hydrocodone plasma concentration will increase which could increase or prolong both the therapeutic and adverse effects, and may cause serious respiratory depression [see Clinical Pharmacology (12.3)]. 7.4 Interactions with Mixed Agonist/Antagonist Opioid Analgesics Mixed agonist/antagonist (i.e., pentazocine, nalbuphine, butorphanol) and partial agonist (buprenorphine) analgesics may reduce the analgesic effect of hydrocodone or precipitate withdrawal symptoms. Avoid the use of mixed agonist/antagonist and partial agonist analgesics in patients receiving ZOHYDRO ER. 7.5 Monoamine Oxidase Inhibitors The effects of opioid analgesics may be potentiated by monoamine oxidase (MAO) inhibitors. ZOHYDRO ER is not recommended for use in patients who have received MAO inhibitors within 14 days as severe and unpredictable potentiation by MAO inhibitors has been reported with opioid analgesics. No specific interaction between hydrocodone and MAO inhibitors has been observed, but caution in the use of any opioid in patients taking this class of drugs is appropriate. 7.6 Anticholinergics Anticholinergics or other drugs with anticholinergic activity when used concurrently with opioid analgesics may increase the risk of urinary retention or severe constipation, which may lead to paralytic ileus. Monitor patients for signs of urinary retention and constipation in addition to respiratory and central nervous system depression when ZOHYDRO ER is used concurrently with anticholinergic drugs.

Use In Specific Populations

Pregnancy: May cause fetal harm. (8.1) Lactation: Not recommended. (8.2) Hepatic impairment: No adjustment in starting dose with ZOHYDRO ER is required in patients with mild or moderate hepatic impairment; however, in patients with severe hepatic impairment, start with the lowest dose, 10 mg. Monitor these patients closely for adverse events such as respiratory depression. (8.6) Renal impairment: Use a low initial dose of ZOHYDRO ER in patients with renal impairment and monitor closely for adverse events such as respiratory depression. (8.7) 8.1 Pregnancy Risk Summary Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.3)]. There are no studies of ZOHYDRO ER use in pregnant women. The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. Rats administered oral hydrocodone during gestation and lactation showed increases in stillborn pups and decreases in pup survival at doses equivalent to the human dose of 100 mg/day. Reduced nursing behavior and decreased body weights were observed at 2 times the human dose. Reduced fetal weights were observed in rabbits administered hydrocodone during the period of organogenesis at doses equivalent to 5 times the human dose of 100 mg/day. In this study, increases in the number of umbilical hernias, irregularly shaped bones, and delays in fetal skeletal maturation were observed at doses 15 times the human dose of 100 mg/day. No fetal malformations were observed in animal reproduction studies with oral administration of hydrocodone bitartrate during organogenesis in rats and rabbits at doses approximately 2 and 10 times a human dose of 100 mg/day, respectively [see Data]. Based on animal data, advise pregnant women of the potential risks to a fetus. Clinical Considerations Fetal/neonatal adverse reactions Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the newborn and neonatal opioid withdrawal syndrome shortly after birth. Observe newborns for symptoms of neonatal opioid withdrawal syndrome, such as poor feeding, diarrhea, irritability, tremor, rigidity, and seizures, and manage accordingly [see Warnings and Precautions (5.3)]. Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid antagonist such as naloxone must be available for reversal of opioid induced respiratory depression in the neonate. ZOHYDRO ER is not recommended for use in women during and immediately prior to labor, when shorter-acting analgesics or other analgesic techniques are more appropriate. Opioid analgesics, including ZOHYDRO ER, can prolong labor through actions which temporarily reduce the strength, duration and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilatation, which tends to shorten labor. Data Animal Data Oral doses of hydrocodone bitartrate up to 25 mg/kg/day in rats and 50 mg/kg/day in rabbits, equivalent to 2 and 10 times an adult human dose of 100 mg/day, respectively on a mg/m2 basis, did not result in any fetal malformations. Fetuses of rabbits administered oral doses of 75 mg/kg/day hydrocodone bitartrate (15 times an adult human dose of 100 mg/day on a mg/m2 basis) during the period of organogenesis exhibited an increased number of malformations consisting of umbilical hernia, and irregularly shaped bones (ulna, femur, tibia and/or fibula). Maternal toxicity was evident at this dose (decreased body weight). In addition, oral hydrocodone bitartrate reduced fetal weights at doses greater than or equal to 25 mg/kg/day (equivalent to approximately 5 times an adult human dose of 100 mg/day on a mg/m2 basis). Delays in fetal skeletal maturation (reduced ossification of hyoid bodies and xiphoid bones) were seen following dosing with 75 mg/kg/day (a dose equivalent to 15 times an adult human dose of 100 mg/day on a mg/m2 basis). Hydrocodone bitartrate administered orally to female rats at oral doses of 10 and 25 mg/kg/day during gestation and lactation resulted in pups which were noted as cold to touch and caused a reduction in fetal viability (increases in the number of stillborn pups and/or pups dying postpartum). The doses causing these effects were equivalent to approximately 1 and 2.4 times an adult human dose of 100 mg/day, on a mg/m2 basis. Nursing was reduced in pups of mothers administered 25 mg/kg/day which correlated with decreased body weight/body weight gain and food consumption in male pups. Minimal maternal toxicity was evident at 25 mg/kg (decreased body weight). 8.2 Lactation Risk Summary Hydrocodone is present in human milk. A published lactation study reports variable concentrations of hydrocodone and hydromorphone (an active metabolite) in breast milk with administration of immediate-release hydrocodone to nursing mothers in the early post-partum period. This lactation study did not assess breastfed infants for potential adverse drug reactions. Lactation studies have not been conducted with extended-release hydrocodone, including ZOHYDRO ER, and no information is available on the effects of the drug on the breastfed infant or the effects of the drug on milk production. Because of the potential for serious adverse reactions, including excess sedation and respiratory depression in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with ZOHYDRO ER. Clinical Considerations Infants exposed to ZOHYDRO ER through breast milk should be monitored for excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped. 8.3 Females and Males of Reproductive Potential Infertility No effects on male fertility were observed with hydrocodone at doses equivalent to 10 times the human dose of 100 mg/day, however, decreases in the weight of male reproductive organs were observed in all treated groups at doses equivalent to 2.4 times the human dose of 100 mg/day and above. Reductions in female fertility indices were observed at doses of hydrocodone equivalent to 2 times the human dose of 100 mg/day and above. These changes are attributed to a hydrocodone-mediated decrease in prolactin levels in the rat. Unique to rodents, prolactin is required for normal estrous cycling and the effects on fertility observed in this study are most likely rodent-specific and not believed to be clinically relevant [see Nonclinical Toxicology (13.1)]. 8.4 Pediatric Use The safety and effectiveness of ZOHYDRO ER in pediatric patients below the age of 18 years have not been established. 8.5 Geriatric Use Clinical studies of ZOHYDRO ER did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of the concomitant disease or other drug therapy. Hydrocodone is known to be substantially secreted by the kidney. Thus the risk of toxic reactions may be greater in patients with impaired renal function due to the accumulation of the parent compound and/or metabolites in the plasma. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Hydrocodone may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of hydrocodone bitartrate and observed closely for adverse events such as respiratory depression. 8.6 Hepatic Impairment Patients with hepatic impairment may have higher plasma concentrations than those with normal function. No adjustment in starting dose with ZOHYDRO ER is required in patients with mild or moderate hepatic impairment; however, in patients with severe hepatic impairment, start with the lowest dose, 10 mg. Monitor these patients closely for adverse events such as respiratory depression [ s ee Clinical Pharmacology (12.3) ]. 8.7 Renal Impairment Patients with renal impairment have higher plasma concentrations than those with normal function. Use a low initial dose of ZOHYDRO ER in patients with renal impairment and monitor closely for adverse events such as respiratory depression [ s ee Clinical Pharmacology (12.3) ].

Always pay a fair price for your medication!

Our FREE Zohydro Er discount card helps you save money on the exact same Zohydro Er prescription you're already paying for. Print the card in seconds, then take it to your pharmacy the next time you get your Zohydro Er prescription filled. Hand it to them and save between 10% - 85% off this prescription!

7 Great Reasons To Print Your Zohydro Er Coupon Card Today

  • 100% FREE (no fees, ever)
  • Print and use immediately
  • Everyone qualifies
  • Easy To Use
  • No Paperwork
  • Unlimited uses and no expiration date
  • Accepted at over 63,000 pharmacies nationwide!

Save on the cost of your prescription with our free Zohydro Er Discount Card

Be sure to ask your pharmacist not to substitute another card for ours as we are confident we offer the highest savings possible.

image description
SAVINGS OF 70%! "If you have a high deductible medical insurance (like me) or no insurance at all and you want to save money on your prescriptions, print a card. It's free and no personal information required. This card saved me $218.89 today on my prescription! It's unbelievable but it`s true. I am so grateful, for now I can actually afford my medication." Zarah
SAVINGS OF 70%! "Hi! Just want to say thanks to this website for providing a card such as this to the public for free! A few weeks ago I printed out one of your cards and used it on one of my medications because my co-pay went up and to my surprise instead of paying a $45.00 co-pay through my insurance, I ended up paying only $17.00 by just running it through the discount card! Now I will be comparing prices!" Steve
SAVINGS OF 70%! "I went to a chain pharmacy today and wanted to fill a prescription and not run it through my insurance.They quoted me $164.00 for a 90 day generic supply, I asked them to double check and it was the best they could do. I came home, checked your online price, registered and had a card in 15 seconds. Went back, and the prescription was $16.92!"
"FYI the pharmacist asked for the website and wants it to refer customers in store directly. I don’t quite understand how it works, but honestly, I don’t care how it works, it did!!!!"
Ivan S.
SAVINGS OF 70%! "Today I went to get a seizure Rx filled at the pharmacy for my daughter, Erica. The pharmacy told me it would be $230. I used your card and it cost me less than $28. Thank you so much." Melissa
SAVINGS OF 70%! "I needed an prescription eye drop last week. The cost was going to be $129. With your prescription savings card it cost $25! I’m telling everyone I know. Thanks!!" Monday M.
SAVINGS OF 70%! "When I first used my card, both the pharmacist and I were amazed! She took the information from it for herself and then compared the costs to what my prices would have been had I gone through my insurance (I had none at the time I 1st used my card), and I still saved a lot of money!! They entered the new info. into their system and in the meantime I`ve told lots of friends and family members about how to save.....THANK YOU SO VERY MUCH!!!!!" Elizabeth H.
SAVINGS OF 70%! "My beloved Border Collie - named Mickey - was recently diagnosed with a form of plasmacytoma cancer and is on both Melphalan and Prednisone drugs as part of his monthly treatment. I printed out the prescription savings card and took it to my local pharmacist. I was so pleasantly surprised to know that the card indeed will save us money! I was able to buy the Melphalan chemotherapy drug for $34 less than the last 2 months, since we started treatment! Thanks so much!" Mary L.
SAVINGS OF 70%! "Wow! I can`t believe this actually worked. I have no insurance at this time and have to pay
I lost my insurance coverage and went online seeking help and found this CARD! It worked and saved me money $$$$$ very 1st time. There are others out there but with less coverage and a smaller list of drugs or they charge you a monthly fee. I am so happy I take 3 prescriptions a month forever and at times more and I will save over 78% as I figured it out, and that is great tell everybody you know as I am doing."
David B.
SAVINGS OF 70%! "My husband and I lost our insurance. This is the card to use to save money. His blood pressure medicine is $55. I now can get it for $13.44. That is quite a difference!" Candace
SAVINGS OF 70%! "Thank you SO MUCH! My patients have saved so much money using these cards." Danielle <br/>Primary Care Coalition<br/>primarycarecoalition.org
SAVINGS OF 70%! "While I am blessed to be a Medicaid patient, I know plenty of people which could include me if I didn’t have Medicaid who rely heavily on the WalMart and Target $4 lists. After comparing prices on this and other sites I have seen that there is the greatest free drug card savings potential on this site. I have already printed out 3 cards for loved ones." Jacques M.
SAVINGS OF 70%! "I have been using the RX card for almost a year now. In that time, it has saved my family over $4000. We have no insurance, and the RX card has been a God send. My husband and I are both disabled, and my 65-year old mother is almost blind and diabetic, so we would have simply had to do without. The RX card enabled us to have the meds we need. Thank you so very much!" Sharon H.
SAVINGS OF 70%! "Today, on three different prescriptions, I saved over $70!!! Thank you so much." Susan

Talked about in

Accepted at over 63,000 pharmacies nationwide including:

Save up to 85% on your medication:

PRINT FREE CARD NOW