Acetaminophen and Codeine Phosphate (Page 5 of 6)

DOSAGE AND ADMINISTRATION

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS].
Important Dosage and Administration Instructions

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 to 72 hours of initiating therapy and following dosage increases with acetaminophen and codeine phosphate tablets and adjust the dosage accordingly [see WARNINGS].

Initial Dosage
Initiating Treatment with Acetaminophen and Codeine Phosphate Tablets
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.

The usual adult dosage is:

Acetaminophen and Codeine Phosphate Tablets (codeine 15 mg and acetaminophen 300 mg): Take 1 to 2 tablets every 4 hours as needed for pain.

Acetaminophen and Codeine Phosphate Tablets (codeine 30 mg and acetaminophen 300 mg): Take 1 to 2 tablets every 4 hours as needed for pain.

Acetaminophen and Codeine Phosphate Tablets (codeine 60 mg and acetaminophen 300 mg): Take one tablet every 4 hours as needed for pain.

Single Doses (Range) Maximum 24-Hour Dose

Codeine Phosphate

15 mg to 60 mg

360 mg

Acetaminophen

300 mg to 1000 mg

4000 mg

The prescriber must determine the number of tablets per dose, and the maximum number of tablets per 24 hours, based upon the above dosage guidance. This information should be conveyed in the prescription.
The usual dose of codeine phosphate in children is 0.5 mg/kg. Doses may be repeated up to every 4 hours.

Conversion from Other Opioids to Acetaminophen and Codeine Phosphate Tablets
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 Tablets. It is safer to underestimate a patient’s 24-hour Acetaminophen and Codeine Phosphate Tablets dosage than to overestimate the 24-hour Acetaminophen and Codeine Phosphate Tablets dosage and manage an adverse reaction due to overdose.
Initiating Treatment with Acetaminophen and Codeine Phosphate Tablets

The prescriber must determine the number of tablets per dose, and the maximum number of tablets per 24 hours based upon the above dosage guidance. This information should be conveyed in the prescription.

It should be kept in mind, however, 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 fail to give commensurate relief of pain but merely prolong analgesia and are associated with an appreciably increased incidence of undesirable side effects. Equivalently high doses in children would have similar effects.
Titration and Maintenance of Therapy

Individually titrate acetaminophen and codeine phosphate tablets to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving acetaminophen and codeine phosphate tablets 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 tablets 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 tablets

When a patient who has been taking acetaminophen and codeine phosphate tablets regularly and may be physically dependent no longer requires therapy with acetaminophen and codeine phosphate tablets,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 Tablets in a physically-dependent patient [see WARNINGS, DRUG ABUSE AND DEPENDENCE].

HOW SUPPLIED

Acetaminophen and codeine phosphate tablets, USP are supplied as follows:
300 mg/30 mg
White to off-white, round, flat-faced, beveled-edged tablets, debossed with “U36” on one side and plain on the other side.
Bottles of 15 NDC 63187-815-15

Bottles of 20 NDC 63187-815-20
Bottles of 30 NDC 63187-815-30
Bottles of 60 NDC 63187-815-60
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Keep this and all medication out of the reach of children.
Protect from moisture. Dispense in a tight, light-resistant container as described in the USP.
PROTECT FROM LIGHT
Dispense with Medication Guide availableat www.aurobindousa.com/product-medication-guides
Manufactured by:
Aurolife Pharma LLC
Dayton, NJ 08810
Manufactured for:
Aurobindo Pharma USA, Inc.
Dayton, NJ 08810

Repackaged by:
Proficient Rx LP.
Thousand Oaks, CA 91320
Revised: 12/2016
LM 2126

Medication Guide

MEDICATION GUIDE

Acetaminophenand Codeine Phosphate Tablets, USP CIII

ass-cet-ah-MEE-noe-fenwith KOE-deen FOSS-fate

Acetaminophen and Codeine PhosphateTablets are:

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 codeinephosphate tablets:

Get emergency help right away if you take too much acetaminophen and codeine phosphate tablets (overdose). When you first start taking acetaminophen and codeine phosphate tablets, 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.
Acetaminophen and Codeine Phosphate Tablets can cause severe drowsiness, breathing problems (respiratory depression), coma and death when taken with benzodiazepines or other medicines that depress consciousness.
Never give anyone else your acetaminophen and codeine phosphate tablets. They could die from taking it. Store acetaminophen and codeine phosphate tablets away from children and in a safe place to prevent stealing or abuse. Selling or giving away acetaminophen and codeine phosphate tablets are against the law.

Do not take Acetaminophen and Codeine Phosphate Tablets ifyou have:

severe asthma, trouble breathing, or other lung problems.

•a bowel blockage or narrowing of the stomach or intestines.

•previously had an allergic reaction to codeine or acetaminophen.

Before taking acetaminophen and codeine phosphatetablets, tell your healthcare providerif you have a history of:

head injury, seizures
liver, kidney, thyroid problems
problems urinating
pancreas or gallbladder problems
abuse of street or prescription drugs, alcohol addiction, or mental health problems.

Tell your healthcare provider if you are:

pregnant or planning to become pregnant. Prolonged use of acetaminophen and codeine phosphate tablets during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
breastfeeding. acetaminophen and codeine phosphate passes into breast milk and may harm your baby.
taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking acetaminophen and codeine phosphate tablets with certain other medicines can cause serious side effects that could lead to death.

When taking Acetaminophen and Codeine Phosphate Tablets:

Do not change your dose. Take Acetaminophen and Codeine Phosphate Tablets exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.

•Take your prescribed dose every 4 hours as needed. Do not take more than your prescribed dose. If you miss a dose, take your next dose when needed.

•Call your healthcare provider if the dose you are taking does not control your pain.

•If you have been taking Acetaminophen and Codeine Phosphate Tablets regularly, do not stop taking Acetaminophen and Codeine Phosphate Tablets without talking to your healthcare provider.

•After you stop taking Acetaminophen and Codeine Phosphate Tablets, to properly dispose of the Acetaminophen and Codeine Phosphate Tablets flush it down the toilet or dispose of in accordance with local state guidelines and/or regulations.

While taking acetaminophen and codeine phosphate tabletsDO NOT:

Drive or operate heavy machinery, until you know howacetaminophen and codeine phosphate tablets affects you. Acetaminophen and codeine phosphate tablets 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 tablets may cause you to overdose and die.

The possible side effects of acetaminophen and codeine phosphatetablets:

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, or throat, 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 allthe possible side effects of acetaminophen and codeine phosphate tablets. Callyour doctor for medical advice about side effects. You may also request medicalinformation or to report suspected adverse reactions, contact Aurobindo PharmaUSA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088. For more information go todailymed.nlm.nih.gov

What are the ingredients in Acetaminophen and CodeinePhosphate Tablets?

Active Ingredients: acetaminophenand codeine phosphate

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium,crospovidone, magnesium stearate, microcrystalline cellulose, povidone,pregelatinized starch, sodium lauryl sulfate, and stearicacid

This Medication Guide has beenapproved by the U.S. Food and Drug Administration.

Manufacturedby:

Aurolife Pharma LLC

Dayton, NJ 08810

Manufacturedfor:

Aurobindo Pharma USA, Inc.

Dayton, NJ 08810

Repackaged by:
Proficient Rx LP.
Thousand Oaks, CA 91320

Revised: 12/2016

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.