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Acetaminophen, 4 -hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a nonopiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

Acetaminophen - Structural Formula Illustration
Each VICODIN (Hydrocodone Bitartate and Acetaminophen Tablets, USP 5 mg/300 mg) contains:

Hydrocodone Bitartrate5 mg
Acetaminophen.300 mg

Each VICODIN ES (Hydrocodone Bitartate and Acetaminophen Tablets, USP 7.5 mg/300 mg) contains:

Hydrocodone Bitartrate7.5 mg
Acetaminophen. 300 mg

Each VICODIN HP (Hydrocodone Bitartate and Acetaminophen Tablets, USP 10 mg/300 mg) contains:

Hydrocodone Bitartrate 10 mg
Acetaminophen. 300 mg

In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid.

This product complies with USP dissolution test 2.


Indications
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.

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
DOSAGE AND ADMINISTRATION
Important Dosage And Administration Instructions
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS].

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

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 [see WARNINGS].

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 patients 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.

Titration And Maintenance Of Therapy
Individually titrate hydrocodone bitartrate and acetaminophen tablets to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving hydrocodone bitartrate and acetaminophen tablets to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see WARNINGS]. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.
The opinions expressed here are those of the individual and not those of StreetAdvisor.
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