Hydrocodone 2.5/500mg

INDICATIONS

Lortab 2.5 (hydrocodone bitartrate and acetaminophen tablets) /500 tablets (Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 2.5 mg/500 mg) are 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 or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 8 tablets.

HOW SUPPLIED

Lortab ® 2.5/500 tablets (Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 2.5 mg/500mg) contain hydrocodone bitartrate 2.5 mg and acetaminophen 500 mg. They are supplied as white with pink specks, capsule-shaped, bisected tablets, debossed “ucb” on one side and “901” on the other side, in containers of 100 tablets NDC 50474-925-01, and 500 tablets NDC 50474-925-50.

STORAGE: Store at controlled room temperature, 15°-30°C (59°-86°F).

Dispense in a tight, light-resistant container with a child-resistant closure.

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 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 Lortab 2.5 (hydrocodone bitartrate and acetaminophen tablets) /500 tablets 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 the brain stem respiratory centers (see OVERDOSAGE).

Special Senses: Cases of hearing impairment or permanent loss have been reported predominantly 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 listed in the OVERDOSAGE section.