Hydrocodone Bitatrate and Acetaminophen

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Overview

What is Hydrocodone Bitatrate and Acetaminophen?

NORCO (Hydrocodone bitartrate and acetaminophen) is supplied in tablet form for oral administration.

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:

NORCO, for oral administration is available in the following strengths:

NORCO5/325 5 mg 325 mg NORCO 7.5/325 7.5 mg 325 mg NORCO 10/325 10 mg 325 mg

In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Meets USP Dissolution Test 1.

What does Hydrocodone Bitatrate and Acetaminophen look like?

What are the available doses of Hydrocodone Bitatrate and Acetaminophen?

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What should I talk to my health care provider before I take Hydrocodone Bitatrate and Acetaminophen?

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How should I use Hydrocodone Bitatrate and Acetaminophen?

NORCOis indicated for the management of moderate to moderately severe pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see ], reserve NORCOfor use in patients for whom alternative treatment options [e.g., non-opioid analgesics]

Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see ].

Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with NORCOand adjust the dosage accordingly [see ].

What interacts with Hydrocodone Bitatrate and Acetaminophen?

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What are the warnings of Hydrocodone Bitatrate and Acetaminophen?

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What are the precautions of Hydrocodone Bitatrate and Acetaminophen?

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What are the side effects of Hydrocodone Bitatrate and Acetaminophen?

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What should I look out for while using Hydrocodone Bitatrate and Acetaminophen?

NORCOis contraindicated in patients with:

What might happen if I take too much Hydrocodone Bitatrate and Acetaminophen?

Clinical Presentation

Acetaminophen:

Treatment of Overdose

The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to NORCO overdose, administer an opioid antagonist. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to NORCO overdose.

Because the duration of opioid reversal is expected to be less than the duration of action of NORCO in NORCO tablets, carefully monitor the patient until spontaneous respiration is reliably re-established. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product’s prescribing information.

In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be begun with care and by titration with smaller than usual doses of the antagonist.

How should I store and handle Hydrocodone Bitatrate and Acetaminophen?

Storage ConditionsNORCO5/325 is available as capsule-shaped, white tablets bisected on one side and debossed with “NORCO 071” on the other side. Each tablet contains 5 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in bottles of 100.NORCO 7.5/325 is available as capsule-shaped, white tablets bisected on one side and debossed with “NORCO 729” on the other side. Each tablet contains 7.5 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in bottles of 100 and 500.NORCO 10/325 is available as capsule-shaped, white tablets bisected on one side and debossed with “NORCO 539” on the other side. Each tablet contains 10 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in bottles of 100 and 500.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closure.Manufactured by:Warner Chilcott Company, LLCManati, Puerto Rico 00674 Distributed by:Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: April 2016 NORCO5/325 is available as capsule-shaped, white tablets bisected on one side and debossed with “NORCO 071” on the other side. Each tablet contains 5 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in bottles of 100.NORCO 7.5/325 is available as capsule-shaped, white tablets bisected on one side and debossed with “NORCO 729” on the other side. Each tablet contains 7.5 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in bottles of 100 and 500.NORCO 10/325 is available as capsule-shaped, white tablets bisected on one side and debossed with “NORCO 539” on the other side. Each tablet contains 10 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in bottles of 100 and 500.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closure.Manufactured by:Warner Chilcott Company, LLCManati, Puerto Rico 00674 Distributed by:Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: April 2016 NORCO5/325 is available as capsule-shaped, white tablets bisected on one side and debossed with “NORCO 071” on the other side. Each tablet contains 5 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in bottles of 100.NORCO 7.5/325 is available as capsule-shaped, white tablets bisected on one side and debossed with “NORCO 729” on the other side. Each tablet contains 7.5 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in bottles of 100 and 500.NORCO 10/325 is available as capsule-shaped, white tablets bisected on one side and debossed with “NORCO 539” on the other side. Each tablet contains 10 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in bottles of 100 and 500.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closure.Manufactured by:Warner Chilcott Company, LLCManati, Puerto Rico 00674 Distributed by:Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: April 2016 NORCO5/325 is available as capsule-shaped, white tablets bisected on one side and debossed with “NORCO 071” on the other side. Each tablet contains 5 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in bottles of 100.NORCO 7.5/325 is available as capsule-shaped, white tablets bisected on one side and debossed with “NORCO 729” on the other side. Each tablet contains 7.5 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in bottles of 100 and 500.NORCO 10/325 is available as capsule-shaped, white tablets bisected on one side and debossed with “NORCO 539” on the other side. Each tablet contains 10 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in bottles of 100 and 500.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closure.Manufactured by:Warner Chilcott Company, LLCManati, Puerto Rico 00674 Distributed by:Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: April 2016 NORCO5/325 is available as capsule-shaped, white tablets bisected on one side and debossed with “NORCO 071” on the other side. Each tablet contains 5 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in bottles of 100.NORCO 7.5/325 is available as capsule-shaped, white tablets bisected on one side and debossed with “NORCO 729” on the other side. Each tablet contains 7.5 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in bottles of 100 and 500.NORCO 10/325 is available as capsule-shaped, white tablets bisected on one side and debossed with “NORCO 539” on the other side. Each tablet contains 10 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in bottles of 100 and 500.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closure.Manufactured by:Warner Chilcott Company, LLCManati, Puerto Rico 00674 Distributed by:Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: April 2016 NORCO5/325 is available as capsule-shaped, white tablets bisected on one side and debossed with “NORCO 071” on the other side. Each tablet contains 5 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in bottles of 100.NORCO 7.5/325 is available as capsule-shaped, white tablets bisected on one side and debossed with “NORCO 729” on the other side. Each tablet contains 7.5 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in bottles of 100 and 500.NORCO 10/325 is available as capsule-shaped, white tablets bisected on one side and debossed with “NORCO 539” on the other side. Each tablet contains 10 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in bottles of 100 and 500.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closure.Manufactured by:Warner Chilcott Company, LLCManati, Puerto Rico 00674 Distributed by:Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: April 2016 NORCO5/325 is available as capsule-shaped, white tablets bisected on one side and debossed with “NORCO 071” on the other side. Each tablet contains 5 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in bottles of 100.NORCO 7.5/325 is available as capsule-shaped, white tablets bisected on one side and debossed with “NORCO 729” on the other side. Each tablet contains 7.5 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in bottles of 100 and 500.NORCO 10/325 is available as capsule-shaped, white tablets bisected on one side and debossed with “NORCO 539” on the other side. Each tablet contains 10 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in bottles of 100 and 500.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closure.Manufactured by:Warner Chilcott Company, LLCManati, Puerto Rico 00674 Distributed by:Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: April 2016 NORCO5/325 is available as capsule-shaped, white tablets bisected on one side and debossed with “NORCO 071” on the other side. Each tablet contains 5 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in bottles of 100.NORCO 7.5/325 is available as capsule-shaped, white tablets bisected on one side and debossed with “NORCO 729” on the other side. Each tablet contains 7.5 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in bottles of 100 and 500.NORCO 10/325 is available as capsule-shaped, white tablets bisected on one side and debossed with “NORCO 539” on the other side. Each tablet contains 10 mg hydrocodone bitartrate and 325 mg acetaminophen. They are supplied in bottles of 100 and 500.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container with a child-resistant closure.Manufactured by:Warner Chilcott Company, LLCManati, Puerto Rico 00674 Distributed by:Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: April 2016

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Clinical Information

Chemical Structure

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Clinical 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

NORCOis contraindicated in patients with:

Drug Interactions:

The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.

CYP3A4

Inhibitor

The concomitant use of NORCO and CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), and protease inhibitors (e.g., ritonavir), can increase the plasma concentration of NORCO, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of NORCO and CYP3A4 inhibitors, particularly when an inhibitor is added after a stable dose of NORCOis achieved [see ].

After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the NORCO plasma concentration will decrease [see ], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to NORCO.

If concomitant use is necessary, consider dosage reduction of NORCOuntil stable drug effects are achieved. Monitor patients for respiratory depression and sedation at frequent intervals. If a CYP3A4 inhibitor is discontinued, consider increasing the NORCOdosage until stable drug effects are achieved [see ]. Monitor for signs of opioid withdrawal.

Inducer

The concomitant use of NORCO and CYP3A4 inducers, such as rifampin, carbamazepine, and phenytoin, can decrease the plasma concentration of NORCO [see ], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to NORCO [see ].

After stopping a CYP3A4 inducer, as the effects of the inducer decline, the NORCO plasma concentration will increase [see ], which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression.

If concomitant use is necessary, consider increasing the NORCOdosage until stable drug effects are achieved [see ]. Monitor for signs of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider NORCO dosage reduction and monitor for signs of respiratory depression.

Central Nervous System Depressants

Due to additive pharmacologic effect, the concomitant use of CNS depressants such as alcohol, benzodiazepines and other sedative hypnotics, anxiolytics, and tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and other opioids, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.

Consider dose reduction of one or both drugs. Monitor patients for signs of respiratory depression, sedation, and hypotension [see ].

Serotonergic Drugs

The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue), has resulted in serotonin syndrome. [see ].

If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue NORCOif serotonin syndrome is suspected.

Special Risk Patients

Cough Reflex

The most frequently reported adverse reactions are lightheadedness, dizziness, sedation, nausea and vomiting. These effects seem to be more prominent in ambulatory than in nonambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down.

Other adverse reactions include:

Central Nervous System:

Gastrointestinal System:

Genitourinary System:

Respiratory Depression:

Special Senses:

Dermatological:

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.

Postmarketing Experience

Androgen deficiency

Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as symptoms of hypogonadism, such as impotence, erectile dysfunction, or amenorrhea. The causal role of opioids in the syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date. Patients presenting with symptoms of androgen deficiency should undergo laboratory evaluation.

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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. 315.72

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Interactions

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