Hydrocodone Bit/apap
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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. 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.
Hypersensitivity/anaphylaxis – 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 Tablets USP immediately and seek medical care if they experience these symptoms. Do not prescribe Hydrocodone Bitartrate and Acetaminophen Tablets USP for patients with acetaminophen allergy.
Respiratory Depression – 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.
Head Injury and Increased Intracranial Pressure – 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.
Acute Abdominal Conditions – The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
Misuse, Abuse, and Diversion of Opioids – Hydrocodone bitartrate and acetaminophen tablets 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 tablets 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 tablets 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 tablets are 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 Tablets are supplied in tablet form for oral administration.
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:
Each Hydrocodone Bitartrate and Acetaminophen Tablet USP contains:
| Tablet | Hydrocodone Bitartrate USP | Acetaminophen USP |
| 5 mg/325 mg | 5 mg | 325 mg |
| 5 mg/500 mg | 5 mg | 500 mg |
| 7.5 mg/325 mg | 7.5 mg | 325 mg |
| 7.5 mg/500 mg | 7.5 mg | 500 mg |
| 7.5 mg/650 mg | 7.5 mg | 650 mg |
| 7.5 mg/750 mg | 7.5 mg | 750 mg |
| 10 mg/325 mg | 10 mg | 325 mg |
| 10 mg/500 mg | 10 mg | 500 mg |
| 10 mg/650 mg | 10 mg | 650 mg |
| 10 mg/660 mg | 10 mg | 660 mg |
| 10 mg/750 mg | 10 mg | 750 mg |
In addition each tablet contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide, and stearic acid.
The 10 mg/650 mg tablet also contains FD & C Blue No. 1 Aluminum Lake 12%.
Meets USP Dissolution Test 1.
Sources
Hydrocodone Bit/apap Manufacturers
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Medsource Pharmaceuticals
![Hydrocodone Bit/apap (Hydrocodone Bitartrate And Acetaminophen) Tablet [Medsource Pharmaceuticals]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Hydrocodone Bit/apap | Wg Critical Care, Llc
This insert is for the Pharmacy Bulk Package and is intended for preparing IV admixtures only. Dosage recommendations for intramuscular or direct intravenous injection are for informational purposes only.
Infections of the respiratory tract and soft tissues.Patients weighing 40 kg (88 lbs) or more: 250 to 500 mg every 6 hours.
Patients weighing less than 40 kg (88 lbs): 25 to 50 mg/kg/day in equally divided doses at 6- to 8-hour intervals.
Infections of the gastrointestinal and genitourinary tracts (including those caused by Neisseria gonorrhoeae in females).Patients weighing 40 kg (88 lbs) or more: 500 mg every 6 hours.
Patients weighing less than 40 kg (88 lbs): 50 mg/kg/day in equally divided doses at 6-to 8-hour intervals.
In the treatment of chronic urinary tract and intestinal infections, frequent bacteriological and clinical appraisal is necessary. Smaller doses than those recommended above should not be used. Higher doses should be used for stubborn or severe infections. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.
Urethritis in males due to N. gonorrhoeae:Adults: Two doses of 500 mg each at an interval of 8 to 12 hours.
Treatment may be repeated if necessary or extended if required.
In the treatment of complications of gonorrheal urethritis, such as prostatitis and epididymitis, prolonged and intensive therapy is recommended. Cases of gonorrhea with a suspected primary lesion of syphilis should have darkfield examinations before receiving treatment. In all other cases where concomitant syphilis is suspected, monthly serological tests should be made for a minimum of four months.
The doses for the preceding infections may be given by either the intramuscular or intravenous route. A change to oral ampicillin may be made when appropriate.
Bacterial Meningitis.Adults and children: 150 to 200 mg/kg/day in equally divided doses every 3 to 4 hours. (Treatment may be initiated with intravenous drip therapy and continued with intramuscular injections.) The doses for other infections may be given by either the intravenous or intramuscular route.
Septicemia.Adults and children: 150 to 200 mg/kg/day. Start with intravenous administration for at least three days and continue with the intramuscular route every 3 to 4 hours.
Treatment of all infections should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. A minimum of 10-days treatment is recommended for any infection caused by Group A beta-hemolytic streptococci to help prevent the occurrence of acute rheumatic fever or acute glomerulonephritis.
For Administration by Intravenous InfusionReconstitute as directed below (Directions for Proper Use of Pharmacy Bulk Package) prior to diluting with an intravenous solution.
IMPORTANT: This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time. Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible. Stability studies on ampicillin sodium at several concentrations in various intravenous solutions indicate the drug will lose less than 10% activity at the temperatures noted for the time periods stated.
Room Temperature (25°C)
Diluent
Concentrations
Stability Periods
Sterile Water for Injection
up to 30 mg/mL
8 hours
Sodium Chloride Injection, USP 0.9%
up to 30 mg/mL
8 hours
5% Dextrose in Water
10 to 20 mg/mL
1 hour
5% Dextrose in Water
up to 2 mg/mL
2 hours
5% Dextrose in 0.45% NaCl Inj.
up to 2 mg/mL
2 hours
Lactated Ringer’s Solution
up to 30 mg/mL
8 hours
Refrigerated (4°C)
Sterile Water for Injection
30 mg/mL
48 hours
Sterile Water for Injection
up to 20 mg/mL
72 hours
Sodium Chloride Injection, USP, 0.9%
30 mg/mL
24 hours
Sodium Chloride Injection, USP, 0.9%
up to 20 mg/mL
48 hours
Lactated Ringer’s Solution
up to 30 mg/mL
24 hours
5% Dextrose in Water
up to 20 mg/mL
1 hour
5% Dextrose in 0.45% NaCl Inj.
up to 10 mg/mL
1 hour
Only those solutions listed above should be used for the intravenous infusion of Ampicillin for Injection, USP. The concentrations should fall within the range specified. The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of Ampicillin for Injection, USP is administered before the drug loses its stability in the solution in use.
Directions for Proper Use of Pharmacy Bulk PackageThis glass Pharmacy Bulk Package bottle contains 10 grams Ampicillin and is designed for use in the pharmacy in preparing IV admixtures.
a) Add 94 mL Sterile Water for Injection, USP. The resulting soluton will contain 100 milligrams ampicillin activity per mL, and is stable up to one hour at room temperature.
b) Dilute further within ONE HOUR to a concentration of 5 mg to 10 mg per mL. See TABLE for suitable fluid. Use promptly. This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time. Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.
c) Using aseptic technique under a laminar flow hood, the closure should be penetrated only one time after reconstitution using a suitable sterile dispensing set which allows measured dispensing of the contents. Use of a syringe and needle is not recommended as it may cause leakage.
d) After entry, use entire contents of Pharmacy Bulk Package bottle promptly. The entire contents of the Pharmacy Bulk Package bottle must be dispensed within ONE HOUR of reconstitution. This time limit should begin with the introduction of solvent in the Pharmacy Bulk Package Bottle.
e) The hanger label on the Pharmacy Bulk Package provides a suitable hanging device while dispensing contents. If the Pharmacy Bulk Package does not have a hanger label, a plastic bail band will provide a suitable hanging device.
Use of this product is restricted to a suitable work area, such as a laminar flow hood. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
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