Hydrocodone Bitartrate and, Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL

/Hydrocodone Bitartrate and, Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL
Hydrocodone Bitartrate and, Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL2018-09-06T09:12:40+00:00

Prescription Drug Name:

Hydrocodone Bitartrate and, Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL

ID:

3322107f-096e-40f9-96be-bcd71578c47f

Code:

34391-3

Hepatotoxicity


id: b895b85d-b9ca-4a95-9d28-ad6345d5bfaf
displayName: BOXED WARNING SECTION
FDA Article Code: 34066-1

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product.

DESCRIPTION


id: ce412564-ee76-4fc5-9428-598ef0baccfb
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, 5 α-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 5 mL Per 10 mL Per 15 mL
 Hydrocodone Bitartrate  2.5 mg  5 mg  7.5 mg
 Acetaminophen  167 mg  334 mg  500 mg
 Alcohol  7%  7%  7%
In addition hydrocodone bitartrate and acetaminophen oral solution contains the following inactive ingredients: citric acid, glycerin, methylparaben, propylene glycol, purified water, saccharin sodium, sorbitol solution, sucrose, with D&C Yellow No. 10 as coloring and natural and artificial flavoring.

CLINICAL PHARMACOLOGY


id: 3af499cb-4e49-42a3-b7f4-5a7123e75b73
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

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.

INDICATIONS AND USAGE


id: 17ce1eb2-f03b-4c9e-8f61-42578b482f06
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: c450e6e5-8e06-4bec-a88a-be60af984d47
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: b86500d4-a4d6-4ac5-bf65-98589503fc40
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: 0337c352-7966-440d-89e1-ee453d3c55b8
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

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

DOSAGE AND ADMINISTRATION


id: 8809597d-9bac-4d7a-96ab-731f05336ca6
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 0.27 mL/kg of hydrocodone bitartrate and acetaminophen oral solution (providing 0.135 mg/kg of hydrocodone bitartrate and 9 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  ¾ teaspoonful = 3.75 mL  4½ teaspoonfuls = 22.5 mL
 16 to 22 kg
35 to 50 lbs.
 4 to 6 years  1 teaspoonful = 5 mL  6 teaspoonfuls = 30 mL
 23 to 31 kg
51 to 69 lbs.
 7 to 9 years  1½ teaspoonfuls = 7.5 mL  9 teaspoonfuls = 45 mL
 32 to 45 kg
70 to 100 lbs.
 10 to 13 years  2 teaspoonfuls = 10 mL  12 teaspoonfuls = 60 mL
 46 kg and up
101 lbs. and up
 14 years to adult  1 Tablespoonful = 15 mL  6 Tablespoonfuls = 90 mL
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: 2d148c25-5186-4b14-9ea6-7d939333931b
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Hydrocodone bitartrate and acetaminophen oral solution is a yellow-colored, fruit flavored liquid containing 7.5 mg hydrocodone bitartrate and 500 mg acetaminophen per 15 mL, with 7% alcohol. It is supplied in the following oral dosage forms: Bottles of 16 fl oz (473 mL) – NDC 53217-0020-01

Patient Information Leaflet


id: 0e840d6e-32d3-424f-a881-ad55eef2316d
displayName: SPL PATIENT PACKAGE INSERT SECTION
FDA Article Code: 42230-3

Hydrocodone Bitartrate and
Acetaminophen Oral Solution
7.5 mg/500 mg per 15 mL
CIII Rx ONLY Summary

PRINCIPAL DISPLAY PANEL – 15 mL Bottle Label


id: 8f045a63-a631-4ec4-aa12-21fa8d779936
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

NDC 53217-0020-01 Hydrocodone Bitartrate and
Acetaminophen Oral Solution
CIII
7.5 mg/500 mg per 15 mL

Per   Per
 Contains:    5 mL      15 mL
          
 Hydrocodone
Bitartrate
   2.5 mg      7.5 mg
 Acetaminophen    167 mg    500 mg 
 Alcohol 7%        
Rx ONLY 16 fl oz (473 mL)