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HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Overview
What is ZYDONE?
ZYDONE (hydrocodone bitartrate and acetaminophen tablets), for oral administration, contain hydrocodone bitartrate and acetaminophen in the following strengths:
In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. The 5 mg/400 mg strength contains FD&C Yellow No. 10; 7.5 mg/400 mg contains FD&C Blue No. 2; and 10 mg/400 mg contains FD&C Red No. 40.
ZYDONE Tablets meet USP Dissolution Test 1.
Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula:
Acetaminophen, 4’-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:
What does ZYDONE look like?
What are the available doses of ZYDONE?
Sorry No records found.
What should I talk to my health care provider before I take ZYDONE?
Sorry No records found
How should I use ZYDONE?
ZYDONE (hydrocodone bitartrate and acetaminophen tablets) is indicated for the relief of moderate to moderately severe pain.
Dosage should be adjusted according to severity of pain and 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.
5 mg/400 mg: The usual adult dose is one or two tablets every four to six hours as needed for pain.
The total daily dosage should not exceed eight tablets.
7.5 mg/400 mg: The usual adult dosage is one tablet every four to six hours as needed for pain.
The total daily dosage should not exceed six tablets.
10 mg/400 mg: The usual adult dosage is one tablet every four to six hours as needed for pain.
The total daily dosage should not exceed six tablets.
What interacts with ZYDONE?
ZYDONE tablets 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 ZYDONE?
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.
Head Injury and Increased Intracranial Pressure
The respiratory depressant effects of opioids 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, opioids produce adverse reactions which may obscure the clinical course of patients with head injuries.
Acute Abdominal Conditions
The administration of opioids may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
What are the precautions of ZYDONE?
General
As with any opioid analgesic agent, ZYDONE tablets 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.
Hydrocodone suppresses the cough reflex; as with all opioids, caution should be exercised when ZYDONE tablets are used postoperatively and in patients with pulmonary disease.
Information for Patients
Hydrocodone, like all opioids, may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery; patients should be cautioned accordingly.
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.
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 opioids, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with hydrocodone bitartrate and acetaminophen tablets 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 or acetaminophen have a potential for carcinogenesis, mutagenesis, or impairment of fertility.
Pregnancy
There are no adequate and well-controlled studies in pregnant women. ZYDONE tablets 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. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever. 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
As with all opioids, administration of this product to the mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used.
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 pediatric patients have not been established.
Geriatric Use
Clinical Studies of hydrocodone bitartrate and acetaminophen tablets 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 tablets and observed closely.
What are the side effects of ZYDONE?
The most frequently reported adverse reactions are light-headedness, dizziness, sedation, nausea and vomiting. These effects seem to be more prominent in ambulatory than in non-ambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down.
Other adverse reactions include:
Central Nervous System
Drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, psychic dependence, mood changes.
Gastrointestinal System
Prolonged administration of ZYDONE (hydrocodone bitartrate and acetaminophen tablets) may produce constipation.
Genitourinary System
Ureteral spasm, spasm of vesical sphincters and urinary retention have been reported with opiates.
Respiratory Depression
Hydrocodone bitartrate may produce dose-related respiratory depression by acting directly on brain stem respiratory center (see ).
Special Senses
Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose.
Dermatological
Skin rash, pruritus.
The following adverse drug events may be borne in mind as potential effects of acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis.
Potential effects of high dosage are listed in the section.
What should I look out for while using ZYDONE?
ZYDONE tablets 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 ZYDONE?
Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen.
How should I store and handle ZYDONE?
ZYDONE (hydrocodone bitartrate and acetaminophen tablets) is supplied as follows:5 mg/400 mgYellow, elongated octagonal, convex tablets debossed with “E” on one side and “5” on the other.Bottles of 100 NDC 63481-668-707.5 mg/400 mgBlue, elongated octagonal, convex tablets debossed with “E” on one side and “7.5” on the other.Bottles of 100 NDC 63481-669-7010 mg/400 mgRed, elongated octagonal, convex tablets debossed with “E” on one side and “10” on the other. Bottles of 100 NDC 63481-698-70Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). A Schedule III Opioid. Oral prescription where permitted by state law.Manufactured for: Endo Pharmaceuticals Inc. Chadds Ford, Pennsylvania 19317ZYDONE is a Registered Trademark of Endo Pharmaceuticals Inc.NARCAN is a Registered Trademark of Endo Pharmaceuticals Inc.Copyright © Endo Pharmaceuticals Inc. 2003Printed in U.S.A.413742/June, 2003ZYDONE (hydrocodone bitartrate and acetaminophen tablets) is supplied as follows:5 mg/400 mgYellow, elongated octagonal, convex tablets debossed with “E” on one side and “5” on the other.Bottles of 100 NDC 63481-668-707.5 mg/400 mgBlue, elongated octagonal, convex tablets debossed with “E” on one side and “7.5” on the other.Bottles of 100 NDC 63481-669-7010 mg/400 mgRed, elongated octagonal, convex tablets debossed with “E” on one side and “10” on the other. Bottles of 100 NDC 63481-698-70Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). A Schedule III Opioid. Oral prescription where permitted by state law.Manufactured for: Endo Pharmaceuticals Inc. Chadds Ford, Pennsylvania 19317ZYDONE is a Registered Trademark of Endo Pharmaceuticals Inc.NARCAN is a Registered Trademark of Endo Pharmaceuticals Inc.Copyright © Endo Pharmaceuticals Inc. 2003Printed in U.S.A.413742/June, 2003ZYDONE (hydrocodone bitartrate and acetaminophen tablets) is supplied as follows:5 mg/400 mgYellow, elongated octagonal, convex tablets debossed with “E” on one side and “5” on the other.Bottles of 100 NDC 63481-668-707.5 mg/400 mgBlue, elongated octagonal, convex tablets debossed with “E” on one side and “7.5” on the other.Bottles of 100 NDC 63481-669-7010 mg/400 mgRed, elongated octagonal, convex tablets debossed with “E” on one side and “10” on the other. Bottles of 100 NDC 63481-698-70Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). A Schedule III Opioid. Oral prescription where permitted by state law.Manufactured for: Endo Pharmaceuticals Inc. Chadds Ford, Pennsylvania 19317ZYDONE is a Registered Trademark of Endo Pharmaceuticals Inc.NARCAN is a Registered Trademark of Endo Pharmaceuticals Inc.Copyright © Endo Pharmaceuticals Inc. 2003Printed in U.S.A.413742/June, 2003ZYDONE (hydrocodone bitartrate and acetaminophen tablets) is supplied as follows:5 mg/400 mgYellow, elongated octagonal, convex tablets debossed with “E” on one side and “5” on the other.Bottles of 100 NDC 63481-668-707.5 mg/400 mgBlue, elongated octagonal, convex tablets debossed with “E” on one side and “7.5” on the other.Bottles of 100 NDC 63481-669-7010 mg/400 mgRed, elongated octagonal, convex tablets debossed with “E” on one side and “10” on the other. Bottles of 100 NDC 63481-698-70Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). A Schedule III Opioid. Oral prescription where permitted by state law.Manufactured for: Endo Pharmaceuticals Inc. Chadds Ford, Pennsylvania 19317ZYDONE is a Registered Trademark of Endo Pharmaceuticals Inc.NARCAN is a Registered Trademark of Endo Pharmaceuticals Inc.Copyright © Endo Pharmaceuticals Inc. 2003Printed in U.S.A.413742/June, 2003ZYDONE (hydrocodone bitartrate and acetaminophen tablets) is supplied as follows:5 mg/400 mgYellow, elongated octagonal, convex tablets debossed with “E” on one side and “5” on the other.Bottles of 100 NDC 63481-668-707.5 mg/400 mgBlue, elongated octagonal, convex tablets debossed with “E” on one side and “7.5” on the other.Bottles of 100 NDC 63481-669-7010 mg/400 mgRed, elongated octagonal, convex tablets debossed with “E” on one side and “10” on the other. Bottles of 100 NDC 63481-698-70Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). A Schedule III Opioid. Oral prescription where permitted by state law.Manufactured for: Endo Pharmaceuticals Inc. Chadds Ford, Pennsylvania 19317ZYDONE is a Registered Trademark of Endo Pharmaceuticals Inc.NARCAN is a Registered Trademark of Endo Pharmaceuticals Inc.Copyright © Endo Pharmaceuticals Inc. 2003Printed in U.S.A.413742/June, 2003ZYDONE (hydrocodone bitartrate and acetaminophen tablets) is supplied as follows:5 mg/400 mgYellow, elongated octagonal, convex tablets debossed with “E” on one side and “5” on the other.Bottles of 100 NDC 63481-668-707.5 mg/400 mgBlue, elongated octagonal, convex tablets debossed with “E” on one side and “7.5” on the other.Bottles of 100 NDC 63481-669-7010 mg/400 mgRed, elongated octagonal, convex tablets debossed with “E” on one side and “10” on the other. Bottles of 100 NDC 63481-698-70Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). A Schedule III Opioid. Oral prescription where permitted by state law.Manufactured for: Endo Pharmaceuticals Inc. Chadds Ford, Pennsylvania 19317ZYDONE is a Registered Trademark of Endo Pharmaceuticals Inc.NARCAN is a Registered Trademark of Endo Pharmaceuticals Inc.Copyright © Endo Pharmaceuticals Inc. 2003Printed in U.S.A.413742/June, 2003ZYDONE (hydrocodone bitartrate and acetaminophen tablets) is supplied as follows:5 mg/400 mgYellow, elongated octagonal, convex tablets debossed with “E” on one side and “5” on the other.Bottles of 100 NDC 63481-668-707.5 mg/400 mgBlue, elongated octagonal, convex tablets debossed with “E” on one side and “7.5” on the other.Bottles of 100 NDC 63481-669-7010 mg/400 mgRed, elongated octagonal, convex tablets debossed with “E” on one side and “10” on the other. Bottles of 100 NDC 63481-698-70Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). A Schedule III Opioid. Oral prescription where permitted by state law.Manufactured for: Endo Pharmaceuticals Inc. Chadds Ford, Pennsylvania 19317ZYDONE is a Registered Trademark of Endo Pharmaceuticals Inc.NARCAN is a Registered Trademark of Endo Pharmaceuticals Inc.Copyright © Endo Pharmaceuticals Inc. 2003Printed in U.S.A.413742/June, 2003ZYDONE (hydrocodone bitartrate and acetaminophen tablets) is supplied as follows:5 mg/400 mgYellow, elongated octagonal, convex tablets debossed with “E” on one side and “5” on the other.Bottles of 100 NDC 63481-668-707.5 mg/400 mgBlue, elongated octagonal, convex tablets debossed with “E” on one side and “7.5” on the other.Bottles of 100 NDC 63481-669-7010 mg/400 mgRed, elongated octagonal, convex tablets debossed with “E” on one side and “10” on the other. Bottles of 100 NDC 63481-698-70Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). A Schedule III Opioid. Oral prescription where permitted by state law.Manufactured for: Endo Pharmaceuticals Inc. Chadds Ford, Pennsylvania 19317ZYDONE is a Registered Trademark of Endo Pharmaceuticals Inc.NARCAN is a Registered Trademark of Endo Pharmaceuticals Inc.Copyright © Endo Pharmaceuticals Inc. 2003Printed in U.S.A.413742/June, 2003ZYDONE (hydrocodone bitartrate and acetaminophen tablets) is supplied as follows:5 mg/400 mgYellow, elongated octagonal, convex tablets debossed with “E” on one side and “5” on the other.Bottles of 100 NDC 63481-668-707.5 mg/400 mgBlue, elongated octagonal, convex tablets debossed with “E” on one side and “7.5” on the other.Bottles of 100 NDC 63481-669-7010 mg/400 mgRed, elongated octagonal, convex tablets debossed with “E” on one side and “10” on the other. Bottles of 100 NDC 63481-698-70Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). A Schedule III Opioid. Oral prescription where permitted by state law.Manufactured for: Endo Pharmaceuticals Inc. Chadds Ford, Pennsylvania 19317ZYDONE is a Registered Trademark of Endo Pharmaceuticals Inc.NARCAN is a Registered Trademark of Endo Pharmaceuticals Inc.Copyright © Endo Pharmaceuticals Inc. 2003Printed in U.S.A.413742/June, 2003ZYDONE (hydrocodone bitartrate and acetaminophen tablets) is supplied as follows:5 mg/400 mgYellow, elongated octagonal, convex tablets debossed with “E” on one side and “5” on the other.Bottles of 100 NDC 63481-668-707.5 mg/400 mgBlue, elongated octagonal, convex tablets debossed with “E” on one side and “7.5” on the other.Bottles of 100 NDC 63481-669-7010 mg/400 mgRed, elongated octagonal, convex tablets debossed with “E” on one side and “10” on the other. Bottles of 100 NDC 63481-698-70Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). A Schedule III Opioid. Oral prescription where permitted by state law.Manufactured for: Endo Pharmaceuticals Inc. Chadds Ford, Pennsylvania 19317ZYDONE is a Registered Trademark of Endo Pharmaceuticals Inc.NARCAN is a Registered Trademark of Endo Pharmaceuticals Inc.Copyright © Endo Pharmaceuticals Inc. 2003Printed in U.S.A.413742/June, 2003ZYDONE (hydrocodone bitartrate and acetaminophen tablets) is supplied as follows:5 mg/400 mgYellow, elongated octagonal, convex tablets debossed with “E” on one side and “5” on the other.Bottles of 100 NDC 63481-668-707.5 mg/400 mgBlue, elongated octagonal, convex tablets debossed with “E” on one side and “7.5” on the other.Bottles of 100 NDC 63481-669-7010 mg/400 mgRed, elongated octagonal, convex tablets debossed with “E” on one side and “10” on the other. Bottles of 100 NDC 63481-698-70Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). A Schedule III Opioid. Oral prescription where permitted by state law.Manufactured for: Endo Pharmaceuticals Inc. Chadds Ford, Pennsylvania 19317ZYDONE is a Registered Trademark of Endo Pharmaceuticals Inc.NARCAN is a Registered Trademark of Endo Pharmaceuticals Inc.Copyright © Endo Pharmaceuticals Inc. 2003Printed in U.S.A.413742/June, 2003ZYDONE (hydrocodone bitartrate and acetaminophen tablets) is supplied as follows:5 mg/400 mgYellow, elongated octagonal, convex tablets debossed with “E” on one side and “5” on the other.Bottles of 100 NDC 63481-668-707.5 mg/400 mgBlue, elongated octagonal, convex tablets debossed with “E” on one side and “7.5” on the other.Bottles of 100 NDC 63481-669-7010 mg/400 mgRed, elongated octagonal, convex tablets debossed with “E” on one side and “10” on the other. Bottles of 100 NDC 63481-698-70Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). A Schedule III Opioid. Oral prescription where permitted by state law.Manufactured for: Endo Pharmaceuticals Inc. Chadds Ford, Pennsylvania 19317ZYDONE is a Registered Trademark of Endo Pharmaceuticals Inc.NARCAN is a Registered Trademark of Endo Pharmaceuticals Inc.Copyright © Endo Pharmaceuticals Inc. 2003Printed in U.S.A.413742/June, 2003ZYDONE (hydrocodone bitartrate and acetaminophen tablets) is supplied as follows:5 mg/400 mgYellow, elongated octagonal, convex tablets debossed with “E” on one side and “5” on the other.Bottles of 100 NDC 63481-668-707.5 mg/400 mgBlue, elongated octagonal, convex tablets debossed with “E” on one side and “7.5” on the other.Bottles of 100 NDC 63481-669-7010 mg/400 mgRed, elongated octagonal, convex tablets debossed with “E” on one side and “10” on the other. Bottles of 100 NDC 63481-698-70Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). A Schedule III Opioid. Oral prescription where permitted by state law.Manufactured for: Endo Pharmaceuticals Inc. Chadds Ford, Pennsylvania 19317ZYDONE is a Registered Trademark of Endo Pharmaceuticals Inc.NARCAN is a Registered Trademark of Endo Pharmaceuticals Inc.Copyright © Endo Pharmaceuticals Inc. 2003Printed in U.S.A.413742/June, 2003ZYDONE (hydrocodone bitartrate and acetaminophen tablets) is supplied as follows:5 mg/400 mgYellow, elongated octagonal, convex tablets debossed with “E” on one side and “5” on the other.Bottles of 100 NDC 63481-668-707.5 mg/400 mgBlue, elongated octagonal, convex tablets debossed with “E” on one side and “7.5” on the other.Bottles of 100 NDC 63481-669-7010 mg/400 mgRed, elongated octagonal, convex tablets debossed with “E” on one side and “10” on the other. Bottles of 100 NDC 63481-698-70Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). A Schedule III Opioid. Oral prescription where permitted by state law.Manufactured for: Endo Pharmaceuticals Inc. Chadds Ford, Pennsylvania 19317ZYDONE is a Registered Trademark of Endo Pharmaceuticals Inc.NARCAN is a Registered Trademark of Endo Pharmaceuticals Inc.Copyright © Endo Pharmaceuticals Inc. 2003Printed in U.S.A.413742/June, 2003ZYDONE (hydrocodone bitartrate and acetaminophen tablets) is supplied as follows:5 mg/400 mgYellow, elongated octagonal, convex tablets debossed with “E” on one side and “5” on the other.Bottles of 100 NDC 63481-668-707.5 mg/400 mgBlue, elongated octagonal, convex tablets debossed with “E” on one side and “7.5” on the other.Bottles of 100 NDC 63481-669-7010 mg/400 mgRed, elongated octagonal, convex tablets debossed with “E” on one side and “10” on the other. Bottles of 100 NDC 63481-698-70Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). A Schedule III Opioid. Oral prescription where permitted by state law.Manufactured for: Endo Pharmaceuticals Inc. Chadds Ford, Pennsylvania 19317ZYDONE is a Registered Trademark of Endo Pharmaceuticals Inc.NARCAN is a Registered Trademark of Endo Pharmaceuticals Inc.Copyright © Endo Pharmaceuticals Inc. 2003Printed in U.S.A.413742/June, 2003ZYDONE (hydrocodone bitartrate and acetaminophen tablets) is supplied as follows:5 mg/400 mgYellow, elongated octagonal, convex tablets debossed with “E” on one side and “5” on the other.Bottles of 100 NDC 63481-668-707.5 mg/400 mgBlue, elongated octagonal, convex tablets debossed with “E” on one side and “7.5” on the other.Bottles of 100 NDC 63481-669-7010 mg/400 mgRed, elongated octagonal, convex tablets debossed with “E” on one side and “10” on the other. Bottles of 100 NDC 63481-698-70Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). A Schedule III Opioid. Oral prescription where permitted by state law.Manufactured for: Endo Pharmaceuticals Inc. Chadds Ford, Pennsylvania 19317ZYDONE is a Registered Trademark of Endo Pharmaceuticals Inc.NARCAN is a Registered Trademark of Endo Pharmaceuticals Inc.Copyright © Endo Pharmaceuticals Inc. 2003Printed in U.S.A.413742/June, 2003ZYDONE (hydrocodone bitartrate and acetaminophen tablets) is supplied as follows:5 mg/400 mgYellow, elongated octagonal, convex tablets debossed with “E” on one side and “5” on the other.Bottles of 100 NDC 63481-668-707.5 mg/400 mgBlue, elongated octagonal, convex tablets debossed with “E” on one side and “7.5” on the other.Bottles of 100 NDC 63481-669-7010 mg/400 mgRed, elongated octagonal, convex tablets debossed with “E” on one side and “10” on the other. Bottles of 100 NDC 63481-698-70Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). A Schedule III Opioid. Oral prescription where permitted by state law.Manufactured for: Endo Pharmaceuticals Inc. Chadds Ford, Pennsylvania 19317ZYDONE is a Registered Trademark of Endo Pharmaceuticals Inc.NARCAN is a Registered Trademark of Endo Pharmaceuticals Inc.Copyright © Endo Pharmaceuticals Inc. 2003Printed in U.S.A.413742/June, 2003ZYDONE (hydrocodone bitartrate and acetaminophen tablets) is supplied as follows:5 mg/400 mgYellow, elongated octagonal, convex tablets debossed with “E” on one side and “5” on the other.Bottles of 100 NDC 63481-668-707.5 mg/400 mgBlue, elongated octagonal, convex tablets debossed with “E” on one side and “7.5” on the other.Bottles of 100 NDC 63481-669-7010 mg/400 mgRed, elongated octagonal, convex tablets debossed with “E” on one side and “10” on the other. Bottles of 100 NDC 63481-698-70Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). A Schedule III Opioid. Oral prescription where permitted by state law.Manufactured for: Endo Pharmaceuticals Inc. Chadds Ford, Pennsylvania 19317ZYDONE is a Registered Trademark of Endo Pharmaceuticals Inc.NARCAN is a Registered Trademark of Endo Pharmaceuticals Inc.Copyright © Endo Pharmaceuticals Inc. 2003Printed in U.S.A.413742/June, 2003ZYDONE (hydrocodone bitartrate and acetaminophen tablets) is supplied as follows:5 mg/400 mgYellow, elongated octagonal, convex tablets debossed with “E” on one side and “5” on the other.Bottles of 100 NDC 63481-668-707.5 mg/400 mgBlue, elongated octagonal, convex tablets debossed with “E” on one side and “7.5” on the other.Bottles of 100 NDC 63481-669-7010 mg/400 mgRed, elongated octagonal, convex tablets debossed with “E” on one side and “10” on the other. Bottles of 100 NDC 63481-698-70Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). A Schedule III Opioid. Oral prescription where permitted by state law.Manufactured for: Endo Pharmaceuticals Inc. Chadds Ford, Pennsylvania 19317ZYDONE is a Registered Trademark of Endo Pharmaceuticals Inc.NARCAN is a Registered Trademark of Endo Pharmaceuticals Inc.Copyright © Endo Pharmaceuticals Inc. 2003Printed in U.S.A.413742/June, 2003ZYDONE (hydrocodone bitartrate and acetaminophen tablets) is supplied as follows:5 mg/400 mgYellow, elongated octagonal, convex tablets debossed with “E” on one side and “5” on the other.Bottles of 100 NDC 63481-668-707.5 mg/400 mgBlue, elongated octagonal, convex tablets debossed with “E” on one side and “7.5” on the other.Bottles of 100 NDC 63481-669-7010 mg/400 mgRed, elongated octagonal, convex tablets debossed with “E” on one side and “10” on the other. Bottles of 100 NDC 63481-698-70Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). A Schedule III Opioid. Oral prescription where permitted by state law.Manufactured for: Endo Pharmaceuticals Inc. Chadds Ford, Pennsylvania 19317ZYDONE is a Registered Trademark of Endo Pharmaceuticals Inc.NARCAN is a Registered Trademark of Endo Pharmaceuticals Inc.Copyright © Endo Pharmaceuticals Inc. 2003Printed in U.S.A.413742/June, 2003ZYDONE (hydrocodone bitartrate and acetaminophen tablets) is supplied as follows:5 mg/400 mgYellow, elongated octagonal, convex tablets debossed with “E” on one side and “5” on the other.Bottles of 100 NDC 63481-668-707.5 mg/400 mgBlue, elongated octagonal, convex tablets debossed with “E” on one side and “7.5” on the other.Bottles of 100 NDC 63481-669-7010 mg/400 mgRed, elongated octagonal, convex tablets debossed with “E” on one side and “10” on the other. Bottles of 100 NDC 63481-698-70Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). A Schedule III Opioid. Oral prescription where permitted by state law.Manufactured for: Endo Pharmaceuticals Inc. Chadds Ford, Pennsylvania 19317ZYDONE is a Registered Trademark of Endo Pharmaceuticals Inc.NARCAN is a Registered Trademark of Endo Pharmaceuticals Inc.Copyright © Endo Pharmaceuticals Inc. 2003Printed in U.S.A.413742/June, 2003
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Hydrocodone is a semisynthetic opioid 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, opioids 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
ZYDONE tablets 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 opioids, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with hydrocodone bitartrate and acetaminophen tablets 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.
The most frequently reported adverse reactions are light-headedness, dizziness, sedation, nausea and vomiting. These effects seem to be more prominent in ambulatory than in non-ambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down.
Other adverse reactions include:
Central Nervous System
Drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, psychic dependence, mood changes.
Gastrointestinal System
Prolonged administration of ZYDONE (hydrocodone bitartrate and acetaminophen tablets) may produce constipation.
Genitourinary System
Ureteral spasm, spasm of vesical sphincters and urinary retention have been reported with opiates.
Respiratory Depression
Hydrocodone bitartrate may produce dose-related respiratory depression by acting directly on brain stem respiratory center (see ).
Special Senses
Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose.
Dermatological
Skin rash, pruritus.
The following adverse drug events may be borne in mind as potential effects of acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis.
Potential effects of high dosage are listed in the section.
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.
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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
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