Zolvit
- Generic Name: hydrocodone bitartrate and acetaminophen oral solution
- Brand Name: Zolvit
Zolvit (Hydrocodone Bitartrate and Acetaminophen Oral Solution) side effects drug center
Zolvit Side Effects Center
Zolvit (hydrocodone bitartrate and acetaminophen) is a combination of an opioid analgesic and antitussive and a non-opiate, non-salicylate analgesic and antipyretic indicated for the relief of moderate to moderately severe pain. Zolvit is available in generic form. Common side effects of Zolvit include:
- anxiety
- dizziness
- drowsiness
- nausea
- vomiting
- upset stomach
- constipation
- headache
- mood changes
- blurred vision
- ringing in your ears, or
- dry mouth
Zolvit comes in liquid form containing hydrocodone bitartrate 10 mg strength and acetaminophen 300 mg strength per 15 ml, with 7% alcohol; it is available in 16 fluid oz. bottles (473.17 ml). Initial dose is based on weight (see Zolvit Side Effects Drug Center chart). Dosage may be adjusted according to severity of the pain and response of the patient; however, tolerance to hydrocodone can develop with continued use and that the incidence of untoward the effects are dose related. Zolvit may interact with other narcotic pain medications, sedatives, tranquilizers, sleeping pills, muscle relaxers, other medicines that can make you sleepy or slow your breathing, antidepressants, MAO inhibitors, atropine, benztropine, dimenhydrinate, glycopyrrolate, mepenzolate, methscopolamine, scopolamine, bladder or urinary medications, bronchodilators, or irritable bowel medications. Tell your doctor all medications and supplements you use. Zolvit should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. Withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from hydrocodone and acetaminophen, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Use in pediatric patients under the age of two years has not been established; children two and older may be given weight-based doses of Zolvit.
Our Zolvit Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Zolvit Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.
In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.
Call your doctor at once if you have:
- noisy breathing, sighing, shallow breathing, breathing that stops;
- a light-headed feeling, like you might pass out;
- liver problems--nausea, upper stomach pain, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- low cortisol levels-- nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; o
- high levels of serotonin in the body--agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.
Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders.
Common side effects include:
- dizziness, drowsiness, feeling tired;
- nausea, vomiting, stomach pain;
- constipation; or
- headache.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Zolvit (Hydrocodone Bitartrate and Acetaminophen Oral Solution)
Zolvit Professional Information
SIDE EFFECTS
Potential effects of high dosage are also listed in the OVERDOSAGE section.
Cardio-renal: Bradycardia, cardiac arrest, circulatory collapse, renal toxicity, renal tubular necrosis, hypotension.
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.
Gastrointestinal System: Abdominal pain, constipation, gastric distress, heartburn, hepatic necrosis, hepatitis, occult blood loss, nausea, peptic ulcer, and vomiting.
Genitourinary System: Spasm of vesical sphincters, ureteral spasm, and urinary retention.
Hematologic: Agranulocytosis, hemolytic anemia, iron deficiency anemia, prolonged bleeding time, thrombocytopenia.
Hypersensitivity: Allergic reactions.
Musculoskeletal: Skeletal muscle flaccidity.
Respiratory Depression: Acute airway obstruction, apnea, dose-related respiratory depression (see OVERDOSAGE), shortness of breath.
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
ZOLVIT™ contains hydrocodone, an opioid agonist, and is a Schedule III controlled substance. ZOLVIT™, and other opioids used in analgesia can be abused and are subject to criminal diversion.
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 entire FDA prescribing information for Zolvit (Hydrocodone Bitartrate and Acetaminophen Oral Solution)
&Copy; Zolvit Patient Information is supplied by Cerner Multum, Inc. and Zolvit Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.