Acetaminophen/codeine phosphate Uses

• Acetaminophen/codeine phosphate indications
• Uses of Acetaminophen/codeine phosphate in details
• Acetaminophen/codeine phosphate dosage
• Acetaminophen/codeine phosphate interactions
• Acetaminophen/codeine phosphate side effects
• Acetaminophen/codeine phosphate contraindications

What is Acetaminophen/codeine phosphate?

Codeine is an opioid pain medication. An opioid is sometimes called a narcotic. Acetaminophen is a less potent pain reliever that increases the effects of codeine.

Acetaminophen/codeine phosphate is a combination medicine used to relieve moderate to severe pain.

Acetaminophen/codeine phosphate may also be used for other purposes not listed in this medication guide.

Acetaminophen/codeine phosphate indications

Acetaminophen/codeine phosphate phosphate tablets are indicated for the relief of mild to moderately severe pain, severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses, reserve Acetaminophen/codeine phosphate phosphate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]

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Have not been tolerated, or are not expected to be tolerated,

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Have not provided adequate analgesia, or are not expected to provide adequate analgesia

How should I use Acetaminophen/codeine phosphate?

Use Acetaminophen/codeine phosphate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Acetaminophen/codeine phosphate by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• If you have been taking Acetaminophen/codeine phosphate regularly or for longer than a few weeks, do not suddenly stop taking it without checking with your doctor. Your doctor may need to gradually lower your dose.
• If you miss a dose of Acetaminophen/codeine phosphate and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Acetaminophen/codeine phosphate.

Uses of Acetaminophen/codeine phosphate in details

Use: Labeled Indications

Pain management: Management of mild to moderate pain where treatment with an opioid is appropriate and for which alternative treatments are inadequate.

Limitations of use: Reserve for use in patients for whom alternative treatment options (eg, nonopioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate.

Acetaminophen/codeine phosphate dosage

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.

Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following dosage increases with Acetaminophen/codeine phosphate phosphate tablets and adjust the dosage accordingly.

Initiating Treatment with Acetaminophen/codeine phosphate Phosphate Tablets

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

The usual adult dosage is:

The usual dose of codeine phosphate in children is 0.5 mg/kg.

Doses may be repeated up to every 4 hours.

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.

Conversion from Other Opioids to Acetaminophen/codeine phosphate 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/codeine phosphate phosphate tablets. It is safer to underestimate a patient’s 24 hour Acetaminophen/codeine phosphate phosphate tablet dosage than to overestimate the 24 hour Acetaminophen/codeine phosphate phosphate tablet dosage and manage an adverse reaction due to overdose.

Titration and Maintenance of Therapy

Individually titrate Acetaminophen/codeine phosphate phosphate tablets to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving Acetaminophen/codeine phosphate 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. 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/codeine phosphate phosphate tablet 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/codeine phosphate Phosphate Tablets

When a patient who has been taking Acetaminophen/codeine phosphate phosphate tablets regularly and may be physically dependent no longer requires therapy with Acetaminophen/codeine phosphate phosphate tablets, use a gradual downward titration of the dosage to prevent signs and symptoms of withdrawal. Do not stop Acetaminophen/codeine phosphate phosphate tablets abruptly.

Acetaminophen/codeine phosphate interactions

See also:
What other drugs will affect Acetaminophen/codeine phosphate?

Acetaminophen/codeine phosphate must be taken carefully with the following medicaments:

- CNS depressants ( including alcohol ) like sleeping medicine, tranquilizers, antihistamines.

- anticholinergic

Acetaminophen/codeine phosphate side effects

See also:
What are the possible side effects of Acetaminophen/codeine phosphate?

The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea and vomiting. These effects seem to be more prominent in ambulatory than in nonambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down.

Other adverse reactions include allergic reactions, euphoria, dysphoria, constipation, abdominal pain, pruritus, rash, thrombocytopenia, agranulocytosis, adrenal insufficiency, serotonin syndrome.

At higher doses codeine has most of the disadvantages of morphine including respiratory depression.

Androgen deficiency

Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as symptoms of hypogonadism, such as impotence, erectile dysfunction, or amenorrhea. The causal role of opioids in the syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date. Patients presenting with symptoms of androgen deficiency should undergo laboratory evaluation.

To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America at 1-800-556-1937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Acetaminophen/codeine phosphate contraindications

See also:
What is the most important information I should know about Acetaminophen/codeine phosphate?

Acetaminophen/codeine phosphate phosphate tablets are contraindicated in patients with:

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Significant respiratory depression

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Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment

Codeine-containing products are contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy.

This product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen.

Active ingredient matches for Acetaminophen/codeine phosphate:

Acetaminophen/codeine phosphate

References

1. DailyMed. "CODEINE SULFATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. DailyMed. "ACETAMINOPHEN; ASPIRIN; CAFFEINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
3. PubChem. "codeine". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology