"The U.S. Food and Drug Administration today approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternat"...
Potential effects of high dosage are also listed in the OVERDOSAGE section.
Central Nervous System/Psychiatric: Anxiety, dizziness, drowsiness, dysphoria, euphoria, fear, general malaise, impairment of mental and physical performance, lethargy, light-headedness, mental clouding, mood changes, psychological dependence, sedation, somnolence progressing to stupor or coma.
Endocrine: Hypoglycemic coma.
Genitourinary System: Spasm of vesical sphincters, ureteral spasm, and urinary retention.
Hypersensitivity: Allergic reactions.
Musculoskeletal: Skeletal muscle flaccidity.
Special Senses: Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose.
Skin: Cold and clammy skin, diaphoresis, pruritus, rash.
Drug Abuse And Dependence
Misuse Abuse and Diversion of Opioids
Addiction is a primary, chronic, neurobiologic disease, with genetic psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease utilizing a multidisciplinary approach, but relapse is common.
"Drug seeking" behavior is very common in addicts and drug abusers. Drug seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated "loss" of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). "Doctor shopping" to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.
Abuse and addiction are separate and distinct from physical dependence and tolerance. Physical dependence usually assumes clinically significant dimensions only after several weeks of continued opioid use, although a mild degree of physical dependence may develop after a few days of opioid therapy. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is manifested initially by a shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients. Physicians should be aware that abuse of opioids can occur in the absence of true addiction and is characterized by misuse for nonmedical purposes, often in combination with other psychoactive substances. ZOLVIT™, like other opioids, may be diverted for nonmedical use. Record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.
Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.
Read the Zolvit (hydrocodone bitartrate and acetaminophen oral solution) Side Effects Center for a complete guide to possible side effects
Patients receiving narcotics, antihistamines, antipsy-chotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with ZOLVIT™ may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced.
Drug/Laboratory Test Interactions
Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.
Last reviewed on RxList: 8/15/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Zolvit Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Chronic Pain/Back Pain
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