Acetaminophen and Codeine (Page 10 of 11)

Safe Reduction or Discontinuation of Acetaminophen and Codeine Phosphate Tablets

Do not abruptly discontinue acetaminophen and codeine phosphate tablets in patients who may be physically dependent on opioids. Rapid discontinuation of opioid analgesics in patients who are physically dependent on opioids has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide. Rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse. Patients may also attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin, and other substances.

When a decision has been made to decrease the dose or discontinue therapy in an opioid-dependent patient taking acetaminophen and codeine phosphate tablets, there are a variety of factors that should be considered, including the dose of acetaminophen and codeine phosphate tablets the patient has been taking, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient. It is important to ensure ongoing care of the patient and to agree on an appropriate tapering schedule and follow-up plan so that patient and provider goals and expectations are clear and realistic. When opioid analgesics are being discontinued due to a suspected substance use disorder, evaluate and treat the patient, or refer for evaluation and treatment of the substance use disorder. Treatment should include evidence-based approaches, such as medication assisted treatment of opioid use disorder. Complex patients with co-morbid pain and substance use disorders may benefit from referral to a specialist.

There are no standard opioid tapering schedules that are suitable for all patients. Good clinical practice dictates a patient-specific plan to taper the dose of the opioid gradually. For patients on acetaminophen and codeine phosphate tablets who are physically opioid-dependent, initiate the taper by a small enough increment (e.g., no greater than 10% to 25% of the total daily dose) to avoid withdrawal symptoms, and proceed with dose-lowering at an interval of every 2 to 4 weeks. Patients who have been taking opioids for briefer periods of time may tolerate a more rapid taper.

It may be necessary to provide the patient with lower dosage strengths to accomplish a successful taper. Reassess the patient frequently to manage pain and withdrawal symptoms, should they emerge. Common withdrawal symptoms include restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. If withdrawal symptoms arise, it may be necessary to pause the taper for a period of time or raise the dose of the opioid analgesic to the previous dose, and then proceed with a slower taper. In addition, monitor patients for any changes in mood, emergence of suicidal thoughts, or use of other substances.

When managing patients taking opioid analgesics, particularly those who have been treated for a long duration and/or with high doses for chronic pain, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper. A multimodal approach to pain management may optimize the treatment of chronic pain, as well as assist with the successful tapering of the opioid analgesic (see WARNINGS; Withdrawal, DRUG ABUSE AND DEPENDENCE).

HOW SUPPLIED

Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg are white, round, flat, beveled edged tablets debossed “IP 33” on obverse and “3” on reverse.

They are available as follows:

Bottles of 100: NDC 65162-033-10
Bottles of 500: NDC 65162-033-50
Bottles of 1000: NDC 65162-033-11

Store Acetaminophen and Codeine Phosphate Tablets, USP 300 mg/30 mg between 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense in tight, light-resistant container as defined in the USP.

Store acetaminophen and codeine phosphate tablets securely and dispose of properly (see PRECAUTIONS; Information for Patients/Caregivers).

Manufactured by:
Amneal Pharmaceuticals of NY, LLC
Brookhaven, NY 11719

Rev. 07-2020-11

Medication Guide

Acetaminophen and Codeine Phosphate (a seet’ a min’ oh fen and koe’ deen fos’ fate) Tablets CIII

Acetaminophen and Codeine Phosphate Tablets 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 Codeine Phosphate Tablets:

  • Get emergency help or call 911 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. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose.
  • Taking acetaminophen and codeine phosphate tablets 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 tablets. They could die from taking it. Selling or giving away acetaminophen and codeine phosphate tablets is against the law.
  • Store acetaminophen and codeine phosphate tablets securely, out of sight and reach of children and in a location not accessible by others, including visitors to the home.

Important Information Guiding Use in Pediatric Patients:

  • Do not give acetaminophen and codeine phosphate tablets to a child younger than 12 years of age.
  • Do not give acetaminophen and codeine phosphate tablets to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids.
  • Avoid giving acetaminophen and codeine phosphate tablets 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 Tablets if you 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 Phosphate Tablets, tell your healthcare provider if 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, opioid overdose, 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 tablets 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.
  • living in a household where there are small children or someone who has abused street or prescription drugs
  • taking prescription or over-the-counter medicines, vitamins, or herbal supplements. 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.
    • Dispose of expired, unwanted, or unused acetaminophen and codeine phosphate tablets by taking your drug to an authorized DEA-registered collector or drug take-back program. If one is not available, you can dispose of acetaminophen and codeine phosphate tablets by mixing the product with dirt, cat litter, or coffee grounds; placing the mixture in a sealed plastic bag, and throwing the bag in your trash.

While taking Acetaminophen and Codeine Phosphate Tablets DO NOT:

  • Drive or operate heavy machinery, until you know how acetaminophen and codeine phosphate tablets affect 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 Phosphate Tablets:

  • 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 or call 911 right away 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 all the possible side effects of acetaminophen and codeine phosphate tablets. 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 by:
Amneal Pharmaceuticals of NY, LLC
Brookhaven, NY 11719

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

Rev. 07-2020-09

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