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HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ORAL SOLUTION 7.5 mg/500 mg per 15 mL
CIII
Rx only
DESCRIPTION
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 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:
HYDROCODONE BITARTRATE AND ACETAMINOPHEN oral solution contains:
| Per 5 mL | Per 15 mL | |
| Hydrocodone Bitartrate, USP . . . . . . . . . . . . . . | 2.5 mg | 7.5 mg |
| Acetaminophen, USP . . . . . . . . . . . . . . . . . . . | 167 mg | 500 mg |
In addition, the liquid contains the following inactive ingredients: Citric Acid Anhydrous USP, Glycerin USP, Methylparaben NF, Polyethylene Glycol NF, Propylene Glycol USP, Propylparaben NF, Purified Water USP, Saccharin Sodium USP, Sodium Citrate Dihydrate USP, Sorbitol Solution NF, Sucrose NF, with D&C Yellow #10 as coloring and natural flavoring.
CLINICAL PHARMACOLOGY
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
Hydrocodone Bitartrate and Acetaminophen Oral Solution is indicated for the relief of moderate to moderately severe pain.
CONTRAINDICATIONS
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.
WARNINGS
PRECAUTIONS
Pregnancy:
ADVERSE REACTIONS
Potential effects of high dosage are also uled in the OVERDOSAGE section.
DRUG ABUSE AND DEPENDENCE
OVERDOSAGE
Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen.
Signs and Symptoms:
Toxicity from hydrocodone poisoning includes the opioid triad of loss of consciousness, pinpoint pupils, and respiratory depression (Cheyne-Stokes respiration, cyanosis, decrease in respiratory rate and/or tidal volume). Convulsions may occur.
The toxic dose of acetaminophen for adults is 10 grams. In adults hepatic toxicity has rarely been reported with acute overdoses of less than 10 grams, or fatalities with less than 15 grams.
Early symptoms following a potentially hepatotoxic overdose of acetaminophen may include: diaphoresis, general malaise, nausea, and vomiting. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.
Other signs and symptoms of overdose of this product include bradycardia, cold and clammy skin, extreme somnolence progressing to stupor or coma, hypoglycemic coma, hypotension, renal tubular necrosis, skeletal muscle flaccidity, thrombocytopenia.
In severe overdosage, apnea; circulatory collapse; cardiac arrest; dose-dependent, potentially fatal hepatic necrosis; and death may occur.
DOSAGE AND ADMINISTRATION
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 tablespoonful 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 care givers obtain and use a calibrated measuring device. Health care providers should recommend a dropper than can measure and deliver the prescribed dose accurately, and instruct care givers to use extreme caution in measuring the dosage.
HOW SUPPLIED
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ORAL SOLUTION is a yellow-colored tropical fruit punch flavored liquid containing hydrocodone bitartrate 7.5 mg and acetaminophen 500 mg per 15 mL.
Bottles of 1 pint (473 mL). . . . . . . . . . . . . . . . . . NDC No. 0406-0375-16
Patient Information Leaflet
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ORAL SOLUTION 7.5 mg/500 mg per 15 mL
CIII
Rx only
Summary
| Hydrocodone Bitartrate and Acetaminophen Oral Solution is used to relieve moderate to moderately severe pain. You should not take Hydrocodone Bitartrate and Acetaminophen Oral Solution if you are allergic to hydrocodone or acetaminophen. The most common side effects of Hydrocodone Bitartrate and Acetaminophen Oral Solution are abdominal pain, dizziness, drowsiness, light-headedness, nausea, shortness of breath, unusual tiredness, and vomiting. Take this medicine as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. |
Uses
Hydrocodone Bitartrate and Acetaminophen Oral Solution is an analgesic used to relieve moderate to moderately severe pain. Hydrocodone Bitartrate and Acetaminophen Oral Solution is a combination product containing hydrocodone (hye-droe-KO-done) bitartrate and acetaminophen (a-seat-a-MIN-oh-fen). Hydrocodone is a narcotic pain reliever and a cough suppressant. Acetaminophen is a non-narcotic pain reliever and fever reducer. A narcotic analgesic and acetaminophen used together may provide better pain relief than either product used alone. If you have any questions, please call your doctor or pharmacist.
General Cautions
- Do not take this drug if you have allergies or unusual reactions to narcotic pain relievers or acetaminophen because it is likely that you may also be allergic to Hydrocodone Bitartrate and Acetaminophen Oral Solution.
- This product may inhibit your mental and physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while you are taking this product.
- This medicine may not be right for you. Check with your doctor or pharmacist, if you:
- are pregnant.
- are nursing.
- are taking other medications: narcotic pain relievers; allergy medicines; antidepressant medicines; acetaminophen-containing medicines or other medicines that cause central nervous system depression, including alcohol.
- have other medical problems: a history of drug or alcohol abuse; recent head injury; emphysema, asthma, or other chronic lung disease; liver disease, kidney disease; underactive thyroid, Addison's disease, enlarged prostate or difficulty urinating.
Proper Use
Take this medicine as directed by your doctor. Do not share it with anyone else. This medicine can cause drug dependence and has the potential for abuse. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If you think that this medicine is not working properly after taking it for some time, do not increase the dose. Check with your doctor or pharmacist.
Dosing
The dose of this medication will be different for different patients. Follow the directions provided by your doctor. The following information includes only the average doses of this medication. If your dose is different, do not change doses unless your doctor tells you to do so.
| 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 |
It is very important that Hydrocodone Bitartrate and Acetaminophen Oral Solution be dosed accurately. A household teaspoon or tablespoon is not an accurate measuring device, especially when one-half or three-fourths of a teaspoonful is to be measured.
Since a household teaspoon is not accurate and can be mixed-up with a tablespoon (which can cause overdosage), it is strongly recommended that you obtain and use a proper measuring device. Ask your doctor or pharmacist for help to find a dropper that can measure the needed dose properly and ask for help if you do not understand how to use the dropper.
Missed Dose
- To avoid a possible overdose, it is important that you do not take more than a single dosage at one time, or that you don't take doses at intervals less than 4 hours apart.
- If you miss taking a dose of Hydrocodone Bitartrate and Acetaminophen Oral Solution, take it as soon as you remember. However, make sure to wait at least 4 hours before taking your next dose.
- If you missed taking a dose, and it is almost time for your next dose, skip the missed dose and take your medicine as scheduled.
- Do not double the prescribed dose.
Possible Side Effects
Side effects you may experience include abdominal pain, constipation, difficulty urinating, dizziness, drowsiness, fear, fuzzy thinking, general feeling of discomfort or illness, light-headedness, mood changes, nausea, nervousness, rash, shortness of breath, slower reactions, unusual tiredness, and vomiting.
Call your doctor if these effects continue or are bothersome.
Side effects not uled above may sometimes occur. If you notice any other effects, check with your doctor.
Storage
- Keep out of reach of children.
- Store at room temperature (protect from heat, do not refrigerate).
- Keep in original labeled bottle.
- Discard medicines that are old or no longer needed.
- Even a single overdose of this medicine may be a life-threatening situation. If you suspect that you or someone else may have taken more than the prescribed dose of this medicine, contact your local poison control center or emergency room immediately. This medicine was prescribed for your particular condition. Do not use it for another condition or give the drug to others.
- This leaflet provides a summary of information about Hydrocodone Bitartrate and Acetaminophen Oral Solution. If you have any questions or concerns, or want more information about Hydrocodone Bitartrate and Acetaminophen Oral Solution, contact your doctor or pharmacist. Your pharmacist also has a longer leaflet about Hydrocodone Bitartrate and Acetaminophen Oral Solution that is written for health professionals that you can ask to read.
Prepared by Mallinckrodt Inc.
tyco
Healthcare
Mallinckrodt
Rev. 060103