Disclaimer:
Medidex is not a provider of medical services and all information is provided for the convenience of the user. No medical decisions should be made based on the information provided on this website without first consulting a licensed healthcare provider.This website is intended for persons 18 years or older. No person under 18 should consult this website without the permission of a parent or guardian.
Zamicet
Overview
What is Zamicet?
Zamicet (hydrocodone bitartrate and acetaminophen oral solution) is supplied in liquid form for oral administration.
What does Zamicet look like?
What are the available doses of Zamicet?
Sorry No records found.
What should I talk to my health care provider before I take Zamicet?
Sorry No records found
How should I use Zamicet?
Zamicet (hydrocodone bitartrate and acetaminophen oral solution) is indicated for the relief of moderate to moderately severe pain.
Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.
The usual adult dosage is one tablespoonful (15 mL) every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablespoonfuls.
The usual dosages for children are given by the table below, and are to be given every 4 to 6 hours as needed for pain. These dosages correspond to an average individual dose of 0.20 mL/kg of Zamicet (providing 0.135 mg/kg of hydrocodone bitartrate and 4.38 mg/kg of acetaminophen). Dosing should be based on weight whenever possible.
The total daily dosage for children should not exceed 6 doses per day. It is of utmost importance that the dose of Zamicet be administered accurately. A household teaspoon or tablespoon is not an adequate measuring device, especially when one-half or three-fourths of a teaspoonful is to be measured. Given the inexactitude of the household spoon measure and the possibility of using a tablespoon instead of a teaspoon, which could lead to overdosage, it is strongly recommended that caregivers obtain and use a calibrated measuring device. Health care providers should recommend a dropper that can measure and deliver the prescribed dose accurately, and instruct caregivers to use extreme caution in measuring the dosage.
What interacts with Zamicet?
This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone, acetaminophen, or any other component of this product.
Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone.
What are the warnings of Zamicet?
Hepatotoxicity
Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.
The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.
Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.
Serious Skin Reactions
Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
Hypersensitivity/Anaphylaxis
There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue Zamicet immediately and seek medical care if they experience these symptoms. Do not prescribe Zamicet for patients with acetaminophen allergy.
Respiratory Depression
At high doses or in sensitive patients, hydrocodone may produce dose-related respiratory depression by acting directly on the brain stem respiratory center. Hydrocodone also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing.
Infants may have increased sensitivity to the respiratory depressant effects of opioids (see ). If use of hydrocodone bitartrate and acetaminophen oral solution in such patients is contemplated, it should be administered cautiously, in substantially reduced initial doses, by personnel experienced in administering opioids to infants, and with intensive monitoring.
Head Injury and Increased Intracranial Pressure
The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries.
Acute Abdominal Conditions
The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
Misuse, Abuse and Diversion of Opioids
Zamicet contains hydrocodone, an opioid agonist, and is a Schedule II controlled substance. Opioid agonists have the potential for being abused and are sought by abusers and people with addiction disorders, and are subject to diversion.
Zamicet can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Zamicet in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion (see ).
What are the precautions of Zamicet?
General
Special Risk Patients
As with any narcotic analgesic agent, Zamicet should be used with caution in elderly or debilitated patients, and those with severe impairment of hepatic or renal function, hypothyroidism, Addison's disease, prostatic hypertrophy or urethral stricture. The usual precautions should be observed and the possibility of respiratory depression should be kept in mind.
Cough Reflex
Hydrocodone suppresses the cough reflex; as with all narcotics, caution should be exercised when Zamicet is used postoperatively and in patients with pulmonary disease.
Information for Patients/Caregivers
- Do not take Zamicet if you are allergic to any of its ingredients.
- If you develop signs of allergy such as a rash or difficulty breathing stop taking Zamicet and contact your healthcare provider immediately.
- Do not take more than 4000 milligrams of acetaminophen per day. Call your doctor if you took more than the recommended dose.
Hydrocodone, like all narcotics, may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking this product.
Alcohol and other CNS depressants may produce an additive CNS depression, when taken with this combination product, and should be avoided.
Hydrocodone may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.
Physicians should instruct patients and caregivers to read the patient information leaflet, which appears as the last section of the labeling.
Laboratory Tests
In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.
Drug Interactions
Patients receiving narcotics, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with Zamicet may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced.
The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.
Drug/Laboratory Test Interactions
Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No adequate studies have been conducted in animals to determine whether hydrocodone has a potential for carcinogenesis, mutagenesis, or impairment of fertility.
Hydrocodone has not demonstrated mutagenic potential using the Ames Salmonella-Microsomal Activation test, the Basc test on Drosophila germ cells, and the Micronucleus test on mouse bone marrow.
No adequate studies have been conducted in animals to determine whether acetaminophen has a potential for carcinogenesis, mutagenesis, or impairment of fertility.
Acetaminophen has not demonstrated mutagenic potential using the Ames Salmonella-Microsomal Activation test, the Basc test on Drosophila germ cells, and the Micronucleus test on mouse bone marrow.
Pregnancy
Teratogenic Effects
Nonteratogenic Effects
Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever. These signs usually appear during the first few days of life. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. There is no consensus on the best method of managing withdrawal.
Labor and Delivery
Narcotic analgesics cross the placental barrier. The closer to delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn. Narcotic analgesics should be avoided during labor if delivery of a premature infant is anticipated. If the mother has received narcotic analgesics during labor, newborn infants should be observed closely for signs of respiratory depression. Resuscitation may be required (see ). The effect of hydrocodone, if any, on the later growth, development, and functional maturation of the child is unknown.
Nursing Mothers
Acetaminophen is excreted in breast milk in small amounts, but the significance of its effects on nursing infants is not known. It is not known whether hydrocodone is excreted in human milk. 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.
Pediatric Use
Safety and effectiveness in the pediatric population below the age of two years have not been established. Use of hydrocodone bitartrate and acetaminophen in the pediatric population is supported by the evidence from adequate and well controlled studies of hydrocodone and acetaminophen combination products in adults with additional data which support the development of metabolic pathways in children two years of age and over (see for pediatric dosage information).
Geriatric Use
Clinical studies of hydrocodone bitartrate and acetaminophen oral solution 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 concomitant disease or other drug therapy.
Hydrocodone and the major metabolites of acetaminophen are known to be substantially excreted 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 acetaminophen oral solution and observed closely.
What are the side effects of Zamicet?
Potential effects of high dosage are also listed in the OVERDOSAGE section.
Cardio-renal:
Central Nervous System/Psychiatric:
Endocrine:
Gastrointestinal System:
Genitourinary System:
Hematologic:
Hypersensitivity:
Musculoskeletal:
Respiratory Depression:
Special Senses:
Skin:
What should I look out for while using Zamicet?
This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone, acetaminophen, or any other component of this product.
Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone.
What might happen if I take too much Zamicet?
Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen.
How should I store and handle Zamicet?
Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Zamicet is a yellow-colored, fruit flavored liquid containing 10 mg hydrocodone bitartrate and 325 mg acetaminophen per 15 mL, with 6.7% alcohol. It is supplied in the following oral dosage forms:NDC 0121-1542-07: 7.5 mL unit dose cupNDC 0121-1542-40: Case contains 40 unit dose cups of 7.5 mL (0121-1542-07) packaged in 4 trays of 10 unit dose cups each.NDC 0121-2313-15: 15 mL unit dose cupNDC 0121-2313-40: Case contains 40 unit dose cups of 15 mL (0121-2313-15) packaged in 4 trays of 10 unit dose cups each. Zamicet is a yellow-colored, fruit flavored liquid containing 10 mg hydrocodone bitartrate and 325 mg acetaminophen per 15 mL, with 6.7% alcohol. It is supplied in the following oral dosage forms:NDC 0121-1542-07: 7.5 mL unit dose cupNDC 0121-1542-40: Case contains 40 unit dose cups of 7.5 mL (0121-1542-07) packaged in 4 trays of 10 unit dose cups each.NDC 0121-2313-15: 15 mL unit dose cupNDC 0121-2313-40: Case contains 40 unit dose cups of 15 mL (0121-2313-15) packaged in 4 trays of 10 unit dose cups each. Zamicet is a yellow-colored, fruit flavored liquid containing 10 mg hydrocodone bitartrate and 325 mg acetaminophen per 15 mL, with 6.7% alcohol. It is supplied in the following oral dosage forms:NDC 0121-1542-07: 7.5 mL unit dose cupNDC 0121-1542-40: Case contains 40 unit dose cups of 7.5 mL (0121-1542-07) packaged in 4 trays of 10 unit dose cups each.NDC 0121-2313-15: 15 mL unit dose cupNDC 0121-2313-40: Case contains 40 unit dose cups of 15 mL (0121-2313-15) packaged in 4 trays of 10 unit dose cups each. Zamicet is a yellow-colored, fruit flavored liquid containing 10 mg hydrocodone bitartrate and 325 mg acetaminophen per 15 mL, with 6.7% alcohol. It is supplied in the following oral dosage forms:NDC 0121-1542-07: 7.5 mL unit dose cupNDC 0121-1542-40: Case contains 40 unit dose cups of 7.5 mL (0121-1542-07) packaged in 4 trays of 10 unit dose cups each.NDC 0121-2313-15: 15 mL unit dose cupNDC 0121-2313-40: Case contains 40 unit dose cups of 15 mL (0121-2313-15) packaged in 4 trays of 10 unit dose cups each. Zamicet is a yellow-colored, fruit flavored liquid containing 10 mg hydrocodone bitartrate and 325 mg acetaminophen per 15 mL, with 6.7% alcohol. It is supplied in the following oral dosage forms:NDC 0121-1542-07: 7.5 mL unit dose cupNDC 0121-1542-40: Case contains 40 unit dose cups of 7.5 mL (0121-1542-07) packaged in 4 trays of 10 unit dose cups each.NDC 0121-2313-15: 15 mL unit dose cupNDC 0121-2313-40: Case contains 40 unit dose cups of 15 mL (0121-2313-15) packaged in 4 trays of 10 unit dose cups each.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Hydrocodone is a semisynthetic narcotic analgesic and antitussive with multiple actions qualitatively similar to those of codeine. Most of these involve the central nervous system and smooth muscle. The precise mechanism of action of hydrocodone and other opiates is not known, although it is believed to relate to the existence of opiate receptors in the central nervous system. In addition to analgesia, narcotics may produce drowsiness, changes in mood and mental clouding.
The analgesic action of acetaminophen involves peripheral influences, but the specific mechanism is as yet undetermined. Antipyretic activity is mediated through hypothalamic heat regulating centers. Acetaminophen inhibits prostaglandin synthetase. Therapeutic doses of acetaminophen have negligible effects on the cardiovascular or respiratory systems; however, toxic doses may cause circulatory failure and rapid, shallow breathing.
Non-Clinical Toxicology
This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone, acetaminophen, or any other component of this product.Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone.
Patients receiving narcotics, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with Zamicet may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced.
The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.
Potential effects of high dosage are also listed in the OVERDOSAGE section.
Cardio-renal:
Central Nervous System/Psychiatric:
Endocrine:
Gastrointestinal System:
Genitourinary System:
Hematologic:
Hypersensitivity:
Musculoskeletal:
Respiratory Depression:
Special Senses:
Skin:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
Review
Read user comments about the side effects, benefits, and effectiveness of losartan oral.
Overall User Ratings
516Total User Reviews
User Reviews
Learn about
User Reviews
Professional
Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
Tips
Interactions
Interactions
A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).