Acetaminophen/Codeine

What is Acetaminophen/Codeine?

• Acetaminophen/Codeine is a combination of Acetaminophen, an analgesic (pain relievers) and Codeine, an antipyretic (fever reducers) used to treat mild to moderately severe pain.

Codeine and paracetamol

What are the uses of this medicine?

• Acetaminophen/Codeine is a 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.

How does this medicine work?

Codeine:

• Codeine is an opioid agonist relatively selective for the mu-opioid receptor, but with a much weaker affinity than morphine.
• The analgesic properties of codeine have been speculated to come from its conversion to morphine, although the exact mechanism of analgesic action remains unknown.

Acetaminophen:

• Acetaminophen (a seet" a min' oh fen), which is known as paracetamol in Europe, is an aminophenol that is believed to act centrally as an analgesic and antipyretic agent.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• 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.
• child younger than 18 years of age after surgery to remove the tonsils and/or adenoids.
• child younger than 12 years of age.
• 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.

What drug interactions can this medicine cause?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Be sure to mention if you are taking any of the following:

• amiodarone (Nexterone, Pacerone)
• antihistamines (found in cold and allergy medications)
• buprenorphine (Belbuca, Butrans, Probuphine)
• bupropion (Aplenzin, Wellbutrin, Zyban)
• butorphanol
• diuretics ('water pills')
• medications for migraine headaches such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex, in Treximet), and zolmitriptan (Zomig)
• mirtazapine (Remeron)
• nalbuphine
• pentazocine (Talwin)
• selective serotonin-reuptake inhibitors such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Prozac, Pexeva), and sertraline (Zoloft)
• serotonin and norepinephrine reuptake inhibitors such as duloxetine (Cymbalta), desvenlafaxine (Khedezla, Pristiq), milnacipran (Savella), and venlafaxine (Effexor)
• tramadol (Conzip), trazodone (Oleptro)
• or tricyclic antidepressants ('mood elevators') such as amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil).

Tell your doctor or pharmacist if you are taking or receiving the following monoamine oxidase (MAO) inhibitors or if you have stopped taking them within the past two weeks:

• isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate)

Is this medicine FDA approved?

• In 2019, it was the 173rd most commonly prescribed medication in the United States, with more than 3 million prescriptions.

How should this medicine be used?

Recommended dosage:

The usual adult dosage is:

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

Administration:

• The combination of acetaminophen and codeine comes as a tablet, capsule, and liquid to take by mouth.
• It usually is taken every 4 hours as needed.
• If you have taken acetaminophen and codeine for several weeks or longer, do not stop taking the medication without talking to your doctor.
• Your doctor may decrease your dose gradually.
• If you suddenly stop taking acetaminophen and codeine, you may experience withdrawal symptoms.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Acetaminophen and Codeine Phosphate Tablet USP 300 mg/15 mg tablet contains acetaminophen 300 mg and codeine phosphate 15 mg.
• Acetaminophen and Codeine Phosphate Tablet USP 300 mg/30 mg tablet contains acetaminophen 300 mg and codeine phosphate 30 mg.
• Acetaminophen and Codeine Phosphate Tablet USP 300 mg/60 mg tablet contains acetaminophen 300 mg and codeine phosphate 60 mg.
• The combination of acetaminophen and codeine also comes as a capsule and liquid.

This medicine is available in fallowing brand namesː

• Capital & Codeine
• Codrix
• Empracet
• Papa-deine
• Phenaphen® with Codeine
• Proval
• Tylenol with Codeine

What side effects can this medication cause?

The most common side effects of this medicine include:

• constipation
• nausea
• sleepiness
• vomiting
• tiredness
• headache
• dizziness
• abdominal pain

What special precautions should I follow?

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.

• Acetaminophen and codeine phosphate tablets expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Monitor all patients regularly for the development of these behaviors and conditions.
• Serious, life-threatening, or fatal respiratory depression may occur with use of acetaminophen and codeine phosphate tablets. Monitor for respiratory depression, especially during initiation of acetaminophen and codeine phosphate tablets or following a dose increase.
• Accidental ingestion of acetaminophen and codeine phosphate tablets, especially by children, can result in a fatal overdose of acetaminophen and codeine phosphate tablets.
• Life-threatening respiratory depression and death have occurred in children who received codeine. Acetaminophen and codeine phosphate tablets are contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy.
• Prolonged use of acetaminophen and codeine phosphate tablets during pregnancy can result in neonatal opioid withdrawal syndrome. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
• Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death.
• Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
• Advise women that breastfeeding is not recommended during treatment with acetaminophen and codeine phosphate tablets.

What to do in case of emergency/overdose?

Symptoms of overdose may include: Codeine overdose:

• respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death.

Management of overdosage:

• 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.
• Opioid antagonists, such as naloxone, are specific antidotes to respiratory depression resulting from opioid overdose.

Acetaminophen overdose:

• anorexia
• nausea
• vomiting
• diaphoresis
• pallor
• general malaise
• fatal hepatic necrosis is the most serious adverse effect of acetaminophen overdose
• Renal tubular necrosis
• hypoglycemic coma
• coagulation defects

Management of overdosage:

• Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen.
• Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity.
• To obtain the best possible outcome, (NAC) should be administered as soon as possible where impending or evolving liver injury is suspected.
• Vigorous supportive therapy is required in severe intoxication.

Can this medicine be used in pregnancy?

• Prolonged use of acetaminophen and codeine phosphate tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated.
• Inform female patients of reproductive potential that acetaminophen and codeine phosphate tablets can cause fetal harm.

Can this medicine be used in children?

• The safety and effectiveness of acetaminophen and codeine phosphate tablets in pediatric patients below the age of 18 have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• ACETAMINOPHEN
• CODEINE PHOSPHATE

Inactive ingredients:

• CROSPOVIDONE
• MAGNESIUM STEARATE
• MICROCRYSTALLINE CELLULOSE
• POVIDONE, UNSPECIFIED
• STARCH, CORN
• STEARIC ACID

Who manufactures and distributes this medicine?

Manufactured by:

• SpecGx LLC, Webster Groves, MO USA

What should I know about storage and disposal of this medication?

• Store acetaminophen and codeine phosphate tablets at 20° to 25°C (68° to 77°F).
• Dispense in tight, light-resistant container as defined in the USP.
• Store acetaminophen and codeine phosphate tablets securely and dispose of properly.

• Dailymed label info on Acetaminophen/Codeine
• FDA Acetaminophen/Codeine

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