Hydrocodone Bitartrate And Acetaminophen Syrup
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Questions & Answers
Side Effects & Adverse Reactions
HEPATOTOXICITY
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.
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. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.
The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.
Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.
Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue hydrocodone bitartrate and acetaminophen oral solution immediately and seek medical care if they experience these symptoms. Do not prescribe hydrocodone bitartrate and acetaminophen oral solution for patients with acetaminophen allergy.
At high doses or in sensitive patients, hydrocodone may produce dose-related respiratory depression by acting directly on the brain stem respiratory center. Hydrocodone also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing.
Infants may have increased sensitivity to the respiratory depressant effects of opioids (see PRECAUTIONS, Pediatric Use). If use of hydrocodone bitartrate and acetaminophen oral solution in such patients is contemplated, it should be administered cautiously, in substantially reduced initial doses, by personnel experienced in administering opioids to infants, and with intensive monitoring.
The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Furthermore, narcotics produce adverse reactions, which may obscure the clinical course of patients with head injuries.
The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
Hydrocodone bitartrate and acetaminophen oral solution contains hydrocodone, an opioid agonist, and is a Schedule III controlled substance. Opioid agonists have the potential for being abused and are sought by abusers and people with addiction disorders, and are subject to diversion.
Hydrocodone bitartrate and acetaminophen oral solution can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing hydrocodone bitartrate and acetaminophen oral solution in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion (see DRUG ABUSE AND DEPENDENCE).
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Hydrocodone bitartrate and acetaminophen oral solution is indicated for the relief of moderate to moderately severe pain.
History
There is currently no drug history available for this drug.
Other Information
Hydrocodone bitartrate and acetaminophen is supplied in liquid form for oral administration.
WARNING: May be habit-forming (see PRECAUTIONS, Information for Patients/Caregivers, 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:
C18H21NO3 • C4H6O6 • 2½ H2O M.W. 494.490
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:
C8H9NO2 MW = 151.16
Hydrocodone bitartrate and acetaminophen oral solution contains:
| Per 5 mL |
Per 15 mL |
||
| Hydrocodone Bitartrate |
.......................... |
2.5 mg |
7.5 mg |
| Acetaminophen |
.......................... |
108.0 mg |
325.0 mg |
| Alcohol |
.......................... |
7 % |
7 % |
In addition, the liquid contains the following inactive ingredients: citric acid anhydrous, ethyl maltol, glycerin, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sorbitol solution, sucrose, with D&C Red #33 and FD&C Red #40 as coloring and natural and artificial flavoring.
Sources
Hydrocodone Bitartrate And Acetaminophen Syrup Manufacturers
-
Talec Pharma, Llc
![Hydrocodone Bitartrate And Acetaminophen Syrup [Talec Pharma, Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Hydrocodone Bitartrate And Acetaminophen Syrup | Talec Pharma, Llc
Dosage should be adjusted according to 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 every 4 to 6 hours as needed for pain. The total daily dosage for adults 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 5.85 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 that can measure and deliver the prescribed dose accurately, and instruct care givers to use extreme caution in measuring the dosage.
-
Mikart, Inc.
Hydrocodone Bitartrate And Acetaminophen Syrup | Mikart, Inc.
Dosage should be adjusted according to 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 11.25 milliliters every 4 to 6 hours as needed for pain. The total daily dosage for adults should not exceed 67.5 milliliters.
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 4.0 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
16.8 mL
16 to 22 kg
(35 to 50 lbs.)
4 to 6 years
3.75 mL
22.5 mL
23 to 31 kg
(51 to 69 lbs.)
7 to 9 years
5.6 mL
33.6 mL
32 to 45 kg
(70 to 100 lbs.)
10 to 13 years
7.5 mL
45 mL
46 kg and up
(101 lbs. and up)
14 years to adult
11.25 mL
67.5 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. It is strongly recommended that care givers 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 care givers to use extreme caution in measuring the dosage.
-
Mikart, Inc.
Hydrocodone Bitartrate And Acetaminophen Syrup | Mikart, Inc.
Dosage should be adjusted according to 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 every 4 to 6 hours as needed for pain. The total daily dosage for adults 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 5.85 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 that can measure and deliver the prescribed dose accurately, and instruct care givers to use extreme caution in measuring the dosage.
![Hydrocodone Bitartrate And Acetaminophen Syrup [Mikart, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7da90197-5801-4855-956e-a9373b3dec8c&name=7da90197-5801-4855-956e-a9373b3dec8c-03.jpg)
![Hydrocodone Bitartrate And Acetaminophen Syrup [Mikart, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9cdd9d7e-f0b9-4d81-8f20-a16e687b479e&name=41bea822-9428-4695-aea8-841309fda61c-03.jpg)
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