Hydrocodone 539

Hydrocodone 539

$280.00$630.00

Norco®
(hydrocodone acetaminophen and bitartrate) 10mg/325 mg, Tablets for Oral Administration

DESCRIPTION

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:

 

Hydrocodone bitartrate - Structural Formula Illustration

Acetaminophen, 4´-hydroxy acetani lide, 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

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

Hydrocodone

Bitartrate Acetaminophen

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; the 7.5 mg/325 mg tablets include FD&C Yellow #6 Aluminum Lake, the 10 mg/325 mg tablets include D&C Yellow #10 Aluminum Lake. Meets USP Dissolution Test 1.

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Description

INDICATIONS

NORCO® is indicated for the relief of moderate to moderately severe pain.

DOSAGE AND ADMINISTRATION

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 tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets.

HOW SUPPLIED

NORCO® 7.5/325 is available as capsule-shaped, light orange 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 as follows:

Bottles of 30
Bottles of 100
Bottles of 500

NORCO 10/325 is available as capsule-shaped, yellow 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 as follows:

Bottles of 100
Bottles of 500

 

SIDE EFFECTS

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: Drowsi ness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, psychic dependence, mood changes.

Gastrointestinal System: Prolonged administration of NORCO® 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 centers

Special Senses : Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose.

Dermatological: Skin rash, pruritus.

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