Hydrocodone Bitartrate and, Acetaminophen Oral Solution, 10 mg/325 mg per 15 mL, CII

/Hydrocodone Bitartrate and, Acetaminophen Oral Solution, 10 mg/325 mg per 15 mL, CII
Hydrocodone Bitartrate and, Acetaminophen Oral Solution, 10 mg/325 mg per 15 mL, CII2018-09-06T09:12:40+00:00

Prescription Drug Name:

Hydrocodone Bitartrate and, Acetaminophen Oral Solution, 10 mg/325 mg per 15 mL, CII

ID:

bda6a236-c3b9-466e-b38a-335d7ab3591d

Code:

34391-3

DESCRIPTION


id: b313175a-0b08-41d1-9864-4235ba4a6263
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Hydrocodone bitartrate and acetaminophen is supplied in liquid form for oral administration. Warning: May be habit forming (see PRECAUTIONS, Information for Patients, and DRUG ABUSE AND DEPENDENCE). Hydrocodone bitartrate is an opioid analgesic and antitussive which 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: Hydrocodone bitartrate and acetaminophen oral solution contains:

Per 7.5 mL Per 15 mL
Hydrocodone bitartrate 5 mg 10 mg
Acetaminophen 163 mg 325 mg
Alcohol 6.7% 6.7%
In addition hydrocodone bitartrate and acetaminophen oral solution contains the following inactive ingredients: citric acid, edetate disodium, glycerin, methylparaben, propylene glycol, purified water, saccharin sodium, sorbitol solution, sucrose, with D&C Yellow No. 10 as coloring and natural and artificial flavoring.

INDICATIONS AND USAGE


id: 906e9491-97f8-4b1c-a407-2920e46ddf5e
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Hydrocodone bitartrate and acetaminophen oral solution is indicated for the relief of moderate to moderately severe pain.

CONTRAINDICATIONS


id: ad4ab63f-7504-4f89-8402-2721aaa1a966
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone, acetaminophen, or any other component of this product. Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone.

ADVERSE REACTIONS


id: b1c17228-dbb2-4a63-9199-6b636fbff509
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

Potential effects of high dosage are also listed in the OVERDOSAGE section. Cardio-renal: Bradycardia, cardiac arrest, circulatory collapse, renal toxicity, renal tubular necrosis, hypotension. Central Nervous System/Psychiatric: Anxiety, dizziness, drowsiness, dysphoria, euphoria, fear, general malaise, impairment of mental and physical performance, lethargy, light-headedness, mental clouding, mood changes, psychological dependence, sedation, somnolence progressing to stupor or coma. Endocrine: Hypoglycemic coma. Gastrointestinal System: Abdominal pain, constipation, gastric distress, heartburn, hepatic necrosis, hepatitis, occult blood loss, nausea, peptic ulcer, and vomiting. Genitourinary System: Spasm of vesical sphincters, ureteral spasm, and urinary retention. Hematologic: Agranulocytosis, hemolytic anemia, iron deficiency anemia, prolonged bleeding time, thrombocytopenia. Hypersensitivity: Allergic reactions. Musculoskeletal: Skeletal muscle flaccidity. Respiratory Depression: Acute airway obstruction, apnea, dose-related respiratory depression (see OVERDOSAGE), shortness of breath. Special Senses: Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose. Skin: Cold and clammy skin, diaphoresis, pruritus, rash.

OVERDOSAGE


id: 44586182-f9d6-4c01-933d-e48ee518666a
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

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

DOSAGE AND ADMINISTRATION


id: 8797623f-cb3a-40a6-af45-d54c84739651
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

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 tablespoonful (15 mL) every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablespoonfuls. The usual dosages for children are given by the table below, and are to be given every 4 to 6 hours as needed for pain. These dosages correspond to an average individual dose of 0.20 mL/kg of hydrocodone bitartrate and acetaminophen oral solution (providing 0.135 mg/kg of hydrocodone bitartrate and 4.38 mg/kg of acetaminophen). Dosing should be based on weight whenever possible.

BODY WEIGHT APPROXIMATE AGE DOSE
every 4 to 6 hours
MAXIMUM TOTAL DAILY DOSE
(6 doses per day)
12 to 15 kg
(27 to 34 lbs)
2 to 3 years 2.8 mL (approx.
½ teaspoonful)
16.8 mL (approx.
3¼ teaspoonfuls)
16 to 22 kg
(35 to 50 lbs)
4 to 6 years 3.75 mL (approx.
¾ teaspoonful)
22.5 mL (approx.
4½ teaspoonfuls)
23 to 31 kg
(51 to 69 lbs)
7 to 9 years 5.6 mL (approx.
1 teaspoonful)
33.6 mL (approx.
6½ teaspoonfuls)
32 to 45 kg
(70 to 100 lbs)
10 to 13 years 7.5 mL (approx.
1½ teaspoonfuls)
45 mL (approx.
9 teaspoonfuls)
46 kg and up
(101 lbs and up)
14 years to adult 11.25 mL (approx.
2¼ teaspoonfuls)
67.5 mL (approx.
13½ teaspoonfuls)
—- Adult 15 mL
(1 Tablespoonful)
90 mL
(6 Tablespoonfuls)
The total daily dosage for children should not exceed 6 doses per day. It is of utmost importance that the dose of hydrocodone bitartrate and acetaminophen oral solution be administered accurately. A household teaspoon or tablespoon is not an adequate measuring device, especially when one-half or three-fourths of a teaspoonful is to be measured. Given the inexactitude of the household spoon measure and the possibility of using a tablespoon instead of a teaspoon, which could lead to overdosage, it is strongly recommended that caregivers obtain and use a calibrated measuring device. Health care providers should recommend a dropper that can measure and deliver the prescribed dose accurately, and instruct caregivers to use extreme caution in measuring the dosage.

HOW SUPPLIED


id: 22b82d01-916f-47af-bcb4-e37073acdf6d
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Hydrocodone bitartrate and acetaminophen oral solution is a yellow-colored, fruit flavored liquid containing 10 mg hydrocodone bitartrate and 325 mg acetaminophen per 15 mL, with 6.7% alcohol. It is supplied in the following oral dosage forms: Bottles of 4 fl oz (118 mL) – NDC 0121-0771-04 Bottles of 16 fl oz (473 mL) – NDC 0121-0771-16 Unit dose cups of 7.5 mL packaged in trays of 10 – NDC 0121-4771-07 Unit dose cups of 15 mL packaged in trays of 10 – NDC 0121-4771-15

Patient Information Leaflet


id: 6a628b18-1632-47f6-8255-4f8058e318aa
displayName: SPL PATIENT PACKAGE INSERT SECTION
FDA Article Code: 42230-3

Hydrocodone Bitartrate and
Acetaminophen Oral Solution
10 mg/325 mg per 15 mL
CII
Rx ONLY Summary

PRINCIPAL DISPLAY PANEL – 15 mL Cup Label


id: e87bdf3a-2ca5-4ba2-afb9-e7362151c6c9
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Delivers 15 mL

NDC 0121-4771-15 HYDROCODONE BITARTRATE

and ACETAMINOPHEN ORAL SOLUTION

CII 10 mg/325 mg per 15 mL Alcohol 6.7%
FOR INSTITUTIONAL USE ONLY
Usual Dosage: See Package Insert for
Complete Dosage Recommendations.
Rx ONLY PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
A47711501