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INDICATIONS
Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Order vicodin online overnight
Limitations Of Use
Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):
have not been tolerated, or are not expected to be tolerated,
have not provided adequate analgesia, or are not expected to provide adequate analgesia
Dosage
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DOSAGE AND ADMINISTRATION
Important Dosage And Administration Instructions
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
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
Follow patients closely for respiratory depression, especially within the first 24–72 hours of initiating therapy and following dosage increases with hydrocodone bitartrate and acetaminophen tablets and adjust the dosage accordingly.
Initial Dosage
Initiating Treatment With Hydrocodone Bitartrate And Acetaminophen Tablets
VICODIN®
5 mg/300 mg The usual adult dosage is one or two tablets every four to six hours as needed for
pain. The total daily dosage should not exceed 8 tablets.
VICODIN ES®
7.5 mg/300 mg The usual adult dosage is one tablet every four to six hours as needed for pain.
The total daily dosage should not exceed 6 tablets.
VICODIN HP®
10 mg/300 mg The usual adult dosage is one tablet every four to six hours as needed for pain.
The total daily dosage should not exceed 6 tablets.
Conversion From Other Opioids To Hydrocodone Bitartrate And Acetaminophen Tablets
There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dosage of hydrocodone bitartrate and acetaminophen tablets. It is safer to underestimate a patient’s 24-hour hydrocodone bitartrate and acetaminophen tablets dosage than to overestimate the 24-hour hydrocodone bitartrate and acetaminophen tablets dosage and manage an adverse reaction due to overdose.
Conversion From Hydrocodone Bitartrate And Acetaminophen Tablets To Extended-Release Hydrocodone
The relative bioavailability of hydrocodone from hydrocodone bitartrate and acetaminophen tablets compared to extended-release hydrocodone products is unknown, so conversion to extended-release products must be accompanied by close observation for signs of excessive sedation and respiratory depression not guaranteed to be successful and increases the chance of setbacks occurring.
If someone chooses to treat their addiction, working with medical professionals will give them the chance to analyze the patient’s specific situation to determine the best way to wean them off the drug. This method is known as tapering. During this process, doctors will decrease the amount of Vicodin taken weekly to ease the body off of the drug. Tapering is typically the safest method used to detox from drugs.
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Addiction, Abuse, and Misuse
Hydrocodonebitartrate and acetaminophen tablets expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing hydrocodonebitartrate and acetaminophen tablets , and monitor all patients regularly for the development of these behaviors and conditions.
Life-Threatening Respiratory Depression
Serious , life-threatening, or fatal respiratory depression may occur with use of hydrocodonebitartrate and acetaminophen tablets . Monitor for respiratory depression especially during initiation of hydrocodonebitartrate and acetaminophen tablets or following a dose increase.
Accidental Ingestion
Accidental ingestion of hydrocodonebitartrate and acetaminophen tablets , especially by children, can result in a fatal overdose of hydrocodonebitartrate and acetaminophen tablets.
Neonatal Opioid Withdrawal Syndrome
Prolonged use of hydrocodonebitartrate and acetaminophen tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts . If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
Cytochrome P450 3A4 Interaction
The concomitant use of hydrocodonebitartrate and acetaminophen tablets with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations , which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentrations . Monitor patients receiving hydrocodonebitartrate and acetaminophen tablets and any cytochrome P450 3A4 inhibitor or inducer for signs of respiratory depression or sedation.
Hepatotoxicity
Acetaminophen has been as s ociated with cas es of acute liver failure, at times res ulting in liver trans plant and death. Mos t of the cas es of liver injury are as s ociated with the us e of acetaminophen at dos es that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product.
Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants , including alcohol, may result in profound sedation, respiratory depression, coma, and death.
Reserve concomitant prescribing of hydrocodonebitartrate and acetaminophen tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
Limit dosages and durations to the minimum required.
Follow patients for signs and symptoms of respiratory depression and sedation
Hydrocodone bitartrate and acetaminophen are available in tablet form for oral administration.
Hydrocodone bitartrate is an opioid analgesic 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:
Hydrocodone bitartrate — Structural Formula Illustration
Acetaminophen, 4’ -hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a nonopiate, non-salicylate analgesic and antipyretic. It has the following structural formula:
In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid
Signs
Hydrocodone bitartrate and acetaminophen tablets are shown for the administration of torment sufficiently serious to require a narcotic pain relieving and for which elective medicines are lacking.
Restrictions Of Use
As a result of the dangers of enslavement, misuse, and abuse, with narcotics, even at suggested dosages [see WARNINGS], save hydrocodone bitartrate and acetaminophen tablets for use in patients for whom elective treatment alternatives (e.g., non-narcotic analgesics):
have not been endured, or are not expected to be endured,
have not given sufficient absense of pain, or are not expected to give satisfactory absense of pain
Measurement
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Measurement AND ADMINISTRATION
Significant Dosage And Administration Instructions
Utilize the most minimal powerful dose for the briefest length predictable with individual patient treatment objectives
Start the dosing routine for every patient exclusively, considering the patient’s seriousness of agony, persistent reaction, earlier pain relieving treatment experience, and hazard factors for enslavement, misuse, and abuse
Pursue patients intently for respiratory melancholy, particularly inside the initial 24–72 hours of starting treatment and following dose increments with hydrocodone bitartrate and acetaminophen tablets and alter the dose in like manner.
Beginning Dosage
Starting Treatment With Hydrocodone Bitartrate And Acetaminophen Tablets
VICODIN®
5 mg/300 mg The regular grown-up measurements is a couple of tablets each four to six hours as required for
torment. The all out every day dose ought not surpass 8 tablets.
VICODIN ES®
7.5 mg/300 mg The normal grown-up measurement is one tablet each four to six hours as required for agony.
The complete day by day measurements ought not surpass 6 tablets.
VICODIN HP®
10 mg/300 mg The common grown-up dose is one tablet each four to six hours as required for torment.
The complete day by day measurements ought not surpass 6 tablets.
Change From Other Opioids To Hydrocodone Bitartrate And Acetaminophen Tablets
There is between patient fluctuation in the power of narcotic medications and narcotic details. In this manner, a preservationist approach is exhorted when deciding the all out day by day dose of hydrocodone bitartrate and acetaminophen tablets. It is more secure to think little of a patient’s 24-hour hydrocodone bitartrate and acetaminophen tablets measurements than to overestimate the 24-hour hydrocodone bitartrate and acetaminophen tablets dose and deal with an unfriendly response due to overdose.
Change From Hydrocodone Bitartrate And Acetaminophen Tablets To Extended-Release Hydrocodone
The general bioavailability of hydrocodone from hydrocodone bitartrate and acetaminophen tablets contrasted with expanded discharge hydrocodone items is obscure, so change to broadened discharge items must be joined by close perception for indications of over the top sedation and respiratory melancholy not destined to be effective and builds the opportunity of mishaps happening.
On the off chance that somebody treats their fixation, working with restorative experts will allow them to break down the patient’s particular circumstance to decide the most ideal approach to wean them off the medication. This strategy is known as decreasing. Amid this procedure, specialists will diminish the measure of Vicodin taken week by week to dial the body down of the medication. Decreasing is normally the most secure technique used to detox from medications.
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VICODIN®
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Caution
Habit, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; HEPATOTOXICITY; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Habit, Abuse, and Misuse
Hydrocodonebitartrate and acetaminophen tablets uncover patients and different clients to the dangers of narcotic habit, misuse, and abuse, which can prompt overdose and passing. Survey every patient’s hazard preceding endorsing hydrocodonebitartrate and acetaminophen tablets , and screen all patients normally for the improvement of these practices and conditions.
Hazardous Respiratory Depression
Genuine , hazardous, or lethal respiratory wretchedness may happen with utilization of hydrocodonebitartrate and acetaminophen tablets . Screen for respiratory sorrow particularly amid commencement of hydrocodonebitartrate and acetaminophen tablets or following a portion increment.
Unplanned Ingestion
Unplanned ingestion of hydrocodonebitartrate and acetaminophen tablets , particularly by youngsters, can result in a lethal overdose of hydrocodonebitartrate and acetaminophen tablets.
Neonatal Opioid Withdrawal Syndrome
Drawn out utilization of hydrocodonebitartrate and acetaminophen tablets amid pregnancy can result in neonatal narcotic withdrawal disorder, which might be perilous if not perceived and treated, and requires the board as indicated by conventions created by neonatology specialists . In the event that narcotic use is required for a delayed period in a pregnant lady, inform the patient regarding the danger of neonatal narcotic withdrawal disorder and guarantee that proper treatment will be accessible.
Cytochrome P450 3A4 Interaction
The attendant utilization of hydrocodonebitartrate and acetaminophen tablets with all cytochrome P450 3A4 inhibitors may result in an expansion in hydrocodone plasma focuses , which could increment or drag out antagonistic responses and may cause possibly lethal respiratory misery. Moreover, suspension of an associatively utilized cytochrome P450 3A4 inducer may result in an expansion in hydrocodone plasma fixations . Screen patients getting hydrocodonebitartrate and acetaminophen tablets and any cytochrome P450 3A4 inhibitor or inducer for indications of respiratory sorrow or sedation.
Hepatotoxicity
Acetaminophen has been as s ociated with cas es of intense liver disappointment, on occasion res ulting in liver trans plant and passing. Mos t of the cas es of liver damage are as s ociated with the us e of acetaminophen at dos es that surpass 4,000 milligrams for every day, and frequently include more than one acetaminophen-containing item.
Dangers from Concomitant Use with Benzodiazepines or Other CNS Depressants
Accompanying utilization of narcotics with benzodiazepines or other focal sensory system (CNS) depressants , including liquor, may result in significant sedation, respiratory sorrow, extreme lethargies, and passing.
Hold associative endorsing of hydrocodonebitartrate and acetaminophen tablets and benzodiazepines or different CNS depressants for use in patients for whom elective treatment alternatives are deficient.
Cutoff measurements and spans to the base required.
Pursue patients for signs and manifestations of respiratory melancholy and sedation
Depiction
Hydrocodone bitartrate and acetaminophen are accessible in tablet structure for oral organization.
Hydrocodone bitartrate is a narcotic pain relieving and happens as fine, white precious stones or as a crystalline powder. It is influenced by light. The compound name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the accompanying auxiliary recipe:
Hydrocodone bitartrate — Structural Formula Illustration
Acetaminophen, 4' — hydroxyacetanilide, a marginally severe, white, unscented, crystalline powder, is a nonopiate, non-salicylate pain relieving and antipyretic. It has the accompanying basic equation:
Moreover, every tablet contains the accompanying idle fixings: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic corrosive.
This item consents to USP disintegration test 2.
Confinements Of Use
In view of the dangers of dependence, misuse, and abuse, with narcotics, even at prescribed dosages [see WARNINGS], save hydrocodone bitartrate and acetaminophen tablets for use in patients for whom elective treatment alternatives (e.g., non-narcotic analgesics):
Significant Dosage And Administration Instructions
Utilize the most reduced viable measurement for the briefest length reliable with individual patient treatment objectives.
Start the dosing routine for every patient exclusively, considering the patient’s seriousness of torment, understanding reaction, earlier pain relieving treatment experience, and hazard factors for enslavement, misuse, and abuse.