HYDROCODONE BITARTRATE AND ACETAMINOPHEN
CAPSULES
5 mg/500 mg

CIII

Rx only

Hydrocodone Bitartrate and Acetaminophen Capsules are supplied in capsule 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:

Each HYDROCODONE BITARTRATE AND ACETAMINOPHEN 5 mg/500 mg capsule contains:

•  Hydrocodone Bitartrate, USP. . . . . . . . . . . . 5 mg
•  Acetaminophen, USP. . . . . . . . . . . . . . . . 500 mg

In addition each capsule contains the following inactive ingredients: Benzyl Alcohol, Butylparaben, Edetate Calcium Disodium, FD&C Blue 1, FD&C Red 3, Gelatin, Methylparaben, Propylparaben, Sodium Lauryl Sulfate, Sodium Propionate, Titanium Dioxide.

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.

Hydrocodone bitartrate and acetaminophen capsules are indicated for the relief of moderate to moderately severe pain.

This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen.

Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to 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 hydrocodone bitartrate and acetaminophen capsules 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 (seeOVERDOSAGE).

Special Senses– Cases of hearing impairment or permanent loss have been reported predominately 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 uled in the OVERDOSAGE section.

Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen.

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.

The usual adult dosage is one or two capsules every four to six hours as needed for pain. The total daily dosage should not exceed 8 capsules.

Each HYDROCODONE BITARTRATE AND ACETAMINOPHEN 5 mg/500 mg capsule contains Hydrocodone Bitartrate 5 mg and Acetaminophen 500 mg. It is available as an opaque maroon capsule imprinted in white 4357.

•  Bottles of 100......................NDC No. 0406-4357-01

Dispense in a tight, light-resistant container as defined in the USP.