Acetaminophen and Codeine Phosphate (Page 10 of 11)

Acetaminophen

Dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect of acetaminophen. Renal tubular necrosis, hypoglycemic coma, and coagulation defects may also occur.

Early symptoms following a potentially hepatotoxic overdose may include; anorexia, nausea, vomiting, diaphoresis, pallor and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.

Treatment of Overdose

Codeine

In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or serious arrhythmias will require advanced life-support measures.

The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to acetaminophen and codeine phosphate oral solution overdose, administer an opioid antagonist. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to codeine overdose.

Because the duration of opioid reversal is expected to be less than the duration of action of acetaminophen and codeine phosphate oral solution, carefully monitor the patient until spontaneous respiration is reliably reestablished. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product’s prescribing information.

In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be begun with care and by titration with smaller than usual doses of the antagonist.

Acetaminophen

Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation.

Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration.

Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose- dependent and occurs early in the course of intoxication.

DOSAGE AND ADMINISTRATION

Important Dosage and Administration Instructions

Ensure accuracy when prescribing, dispensing, and administering acetaminophen and codeine phosphate oral solution to avoid dosing errors due to confusion between mg and mL, and with other acetaminophen and codeine phosphate oral solution of different concentrations, which could result in accidental overdose and death. Ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total dose in volume.

Ensure that the dose is communicated clearly and dispensed accurately. A household teaspoon or tablespoon is not an adequate measuring device. Given the inexactitude of the household spoon measure and the risk 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 calibrated device that can measure and deliver the prescribed dose accurately, and instruct caregivers to use extreme caution in measuring the dosage [see WARNINGS].

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS].

Initiate the dosing regimen for each patient individually, taking into account the patient’s severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see WARNINGS].

Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with acetaminophen and codeine phosphate oral solution and adjust the dosage accordingly [see WARNINGS].

Initial Dosage

Initiating Treatment with Acetaminophen and Codeine Phosphate Oral Solution

Dosage should be adjusted according to severity of pain and response of the patient.

However, it should be kept in mind that tolerance to codeine can develop with continued use and that the incidence of untoward effects is dose related. Adult doses of codeine higher than 60 mg are associated with an increased incidence of adverse reactions and are not associated with greater efficacy.

Acetaminophen and codeine phosphate oral solution contains 120 mg of acetaminophen and 12 mg of codeine phosphate per 5 mL (teaspoonful) and is given orally.

Adults

15 mL (1 tablespoonful) every 4 hours as needed.

Conversion from Other Opioids to Acetaminophen and Codeine Phosphate Oral Solution

There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dosage of acetaminophen and codeine phosphate oral solution. It is safer to underestimate a patient’s 24-hour acetaminophen and codeine phosphate oral solution dosage than to overestimate the 24-hour acetaminophen and codeine phosphate oral solution dosage and manage an adverse reaction due to overdose.

Titration and Maintenance of Therapy

Individually titrate acetaminophen and codeine phosphate oral solution to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving acetaminophen and codeine phosphate oral solution to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see WARNINGS]. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.

If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the acetaminophen and codeine phosphate oral solution dosage. If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

Discontinuation of Acetaminophen and Codeine Phosphate Oral Solution

When a patient who has been taking acetaminophen and codeine phosphate oral solution regularly and may be physically dependent no longer requires therapy with acetaminophen and codeine phosphate oral solution, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Do not abruptly discontinue acetaminophen and codeine phosphate oral solution in a physically-dependent patient [see WARNINGS, DRUG ABUSE AND DEPENDENCE].

HOW SUPPLIED

Product: 53002-3410

NDC: 53002-3410-1 118 mL in a BOTTLE

MANUFACTURED BY

Pharmaceutical Associates, Inc.
Greenville, SC 29605
www.paipharma.com

R06/18 I05040618

MEDICATION GUIDE
See attached.

Medication Guide Acetaminophen and Codeine Phosphate (a seet’ a min’ oh fen and koe’ deen fos’fate) Oral Solution, CV
Acetaminophen and Codeine Phosphate Oral Solution is:
  • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage mild to moderate pain when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
  • An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
Important information about Acetaminophen and Codeine Phosphate Oral Solution:
  • Get emergency help right away if you take too much acetaminophen and codeine phosphate oral solution (overdose). When you first start taking acetaminophen and codeine phosphate oral solution, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
  • Taking acetaminophen and codeine phosphate oral solution with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
  • Never give anyone else your acetaminophen and codeine phosphate oral solution. They could die from taking it. Store acetaminophen and codeine phosphate oral solution away from children and in a safe place to prevent stealing or abuse. Selling or giving away acetaminophen and codeine phosphate oral solution is against the law.
Important Information Guiding Use in Pediatric Patients:
  • Do not give acetaminophen and codeine phosphate oral solution to a child younger than 12 years of age.
  • Do not give acetaminophen and codeine phosphate oral solution to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids.
  • Avoid giving acetaminophen and codeine phosphate oral solution to children between 12 to 18 years of age who have risk factors for breathing problems such as obstructive sleep apnea, obesity, or underlying lung problems.
Do not take Acetaminophen and Codeine Phosphate Oral Solution if you have:
  • severe asthma, trouble breathing, or other lung problems.
  • a bowel blockage or have narrowing of the stomach or intestines.
  • previously had an allergic reaction to codeine or acetaminophen .
Before taking Acetaminophen and Codeine Phosphate Oral Solution, tell your healthcare provider if you have a history of:
  • head injury, seizures
  • problems urinating
  • liver, kidney, thyroid problems
  • pancreas or gallbladder problems
  • abuse of street or prescription drugs, alcohol addiction, or mental health problems.
  • Have been told by your healthcare provider that you are a “rapid metabolizer” of certain medicines.
Tell your healthcare provider if you are:
  • pregnant or planning to become pregnant. Prolonged use of acetaminophen and codeine phosphate oral solution during pregnancy can cause withdrawal symptoms in your newborn baby that could be life- threatening if not recognized and treated.
  • breastfeeding. Not recommended; may harm your baby.
  • taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking acetaminophen and codeine phosphate oral solution with certain other medicines can cause serious side effects that could lead to death.
When taking Acetaminophen and Codeine Phosphate Oral Solution:
  • Do not change your dose. Take acetaminophen and codeine phosphate oral solution exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
  • Always use a calibrated measuring device acetaminophen and codeine phosphate oral solution to correctly measure your dose. A household teaspoon or tablespoon is not an adequate measuring device. 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.
  • Take your prescribed dose at the same time every day. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
  • Call your healthcare provider if the dose you are taking does not control your pain.
  • If you have been taking acetaminophen and codeine phosphate oral solution regularly, do not stop taking acetaminophen and codeine phosphate oral solution without talking to your healthcare provider.
  • After you stop taking acetaminophen and codeine phosphate oral solution to properly dispose of the acetaminophen and codeine phosphate oral solution flush it down the toilet or dispose of in accordance with local state guidelines and/or regulations.
While taking Acetaminophen and Codeine Phosphate Oral Solution DO NOT:
  • Drive or operate heavy machinery, until you know how acetaminophen and codeine phosphate oral solution affects you. Acetaminophen and codeine phosphate oral solution can make you sleepy, dizzy, or lightheaded.
  • Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with acetaminophen and codeine phosphate oral solution may cause you to overdose and die.
The possible side effects of Acetaminophen and Codeine Phosphate Oral Solution:
  • constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.
Get emergency medical help if you have:
  • trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, throat, or hands, hives, itching, rash, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.
These are not all the possible side effects of acetaminophen and codeine phosphate oral solution. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov. Manufactured and Distributed By: Pharmaceutical Associates, Inc., Greenville, SC 29605, www.paipharma.com.
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: February 2018

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.