Citodon (Acetaminophen,Codeine)

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Citodon (Acetaminophen,Codeine)

Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Citodon (Acetaminophen,Codeine)

Quick Facts

Property Description
Active ingredient Acetaminophen (Paracetamol) and Codeine (Codeine phosphate)
Form Tablet (Oral dosage form)
Pharmacological class Combination Analgesic (Opioid and Non-opioid)
Common use Relief of moderate to severe pain
Origin Synthetic compound

What Type of Medicine is Citodon (Acetaminophen, Codeine)?

Citodon is a proprietary brand name for a fixed-dose combination product classified as a combination analgesic, administered via the oral route in tablet form. This medicine combines a non-opioid analgesic with an opioid agonist. Such formulations are intended for their effect compared to using either active ingredient alone, positioning the product for use when non-opioid options have proven insufficient for effective pain relief.


Composition: Acetaminophen, Codeine, and Dual Action

Citodon contains two principal active ingredients: Acetaminophen (Paracetamol) and Codeine. The formulation is designed to provide synergistic analgesia, meaning the pain-relieving effects are mutually enhancing. The Acetaminophen component is a non-opioid analgesic that helps to elevate the pain threshold, while the Codeine component is an opioid that directly alters the perception of pain by binding to specific receptors in the central nervous system. This dual action allows the medicine to target pain through two separate pathways.


General Purpose of Citodon: Targeting Moderate to Severe Pain

The general therapeutic purpose of this combination analgesic is to provide enhanced relief for moderate to severe pain. The product's utility is aligned with the medical need for a multi-modal approach when managing pain that is persistent or more intense than what can be controlled by simple analgesics. By combining the two distinct agents, Citodon serves as a pharmacological option that acts on multiple points in the pain pathway, confirming its role in advanced pain management protocols.

Regulatory References

  1. WHO Analgesic Ladder

What side effects are possible with Citodon (Acetaminophen,Codeine)?

Possible Side Effects and Safety Information

Official regulatory documents classify the safety profile of Acetaminophen/Codeine by the incidence and type of adverse reactions observed during clinical use. Side effects are organized into categories using the System-Organ-Class (SOC) framework.

Frequency-Classified Adverse Reactions

Adverse reactions classified as Common in regulatory labels include effects on the Gastrointestinal Disorders system, such as constipation, nausea, and vomiting. Effects on the Nervous System Disorders are also common and include dizziness and somnolence (sedation). Less common effects may involve skin and subcutaneous tissue disorders, such as pruritus (itching) and urticaria.

Serious Adverse Reactions and Safety Constraints

The label explicitly documents critical safety concerns. The primary serious risk associated with the acetaminophen component is Hepatotoxicity (severe liver damage or acute liver failure). The critical risk associated with the codeine component is Respiratory Depression (severe breathing difficulty). Furthermore, the risk of developing tolerance and physical dependence is associated with prolonged use.

Specific regulatory constraints exist for certain populations. The medicine is contraindicated in severe hepatic insufficiency due to the risk of hepatotoxicity. Official documents also restrict the use of codeine for pain relief in certain pediatric patients who have undergone tonsillectomy and/or adenoidectomy, due to specific risks related to drug metabolism. Older adults and patients with renal or hepatic impairment may exhibit increased susceptibility to certain adverse effects, as noted in the official prescribing information.

Overdose and Emergency Response

The regulatory information for Citodon (Acetaminophen/Codeine) defines overdose risk through dual toxicity: the time-delayed hepatic injury from Acetaminophen and acute respiratory depression from Codeine.

Overdose Risk & Manifestations Official Regulatory Statements
Life-Threatening Outcomes The official label documents the potential for fatal hepatic necrosis (acute liver failure) and life-threatening respiratory depression leading to coma.
Documented Signs Manifestations of opioid overdose include profound sedation, pinpoint pupils (miosis), and shallow, slowed breathing. Early signs of Acetaminophen overdose can include nausea, vomiting, sweating, and abdominal pain.
Population Risk Accidental ingestion of even one dose, particularly by a child, is documented as a risk for fatal overdose. Elderly and debilitated patients require close monitoring due to increased risk of respiratory depression.

Required Emergency Actions:

Regulators mandate that any suspected overdose requires immediate medical attention. This action is required even if the patient feels well initially, due to the potential for delayed onset of severe liver toxicity, which may not be clinically apparent for 48 to 72 hours post-ingestion. Immediate hospitalization and monitoring of vital signs are required. The official overdose management involves the specific antidote N-acetylcysteine (NAC) for Acetaminophen and the opioid antagonist Naloxone for Codeine.

Therapeutic Uses of Citodon (Acetaminophen,Codeine)

The combination is used to provide supportive symptomatic relief for pain. It is utilized to help with symptoms related to significant physical discomfort and the accompanying strain in acute and chronic scenarios, particularly when short-term symptomatic assistance is needed.


Enhanced Support for Moderate to Severe Pain

This medication is utilized when supportive symptom management is appropriate for pain that has become intense or persistent, and is applied in scenarios where additional management of discomfort is required. It is commonly used to help address pain associated with conditions such as postoperative procedures, acute injuries, and flares of osteoarthritis. The combination helps ease the overall symptom burden in situations where patients experience significant discomfort.

Multi-Symptom Relief and Complex Pain Management

The combination can also help address systemic symptoms, such as fever, and it is relevant for easing symptoms related to an irritating, non-productive cough. It is used in supportive care, such as managing certain types of cancer pain or providing specialized relief in palliative care, assisting with maintaining functional stability during difficult episodes.


Quick Fact: Relief for Significant Discomfort and Systemic Symptoms

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Who Can and Cannot Use Citodon (Acetaminophen,Codeine)?

Regulatory labeling strictly defines patient eligibility for products containing acetaminophen and codeine, primarily through absolute contraindications and restrictions based on age, genetics, and health status.

Absolute Contraindications (Must Not Use)

Population or Condition Reason for Exclusion
Children under 12 years of age Due to the risk of life-threatening respiratory depression.
CYP2D6 Ultra-Rapid Metabolizers Genetic risk of codeine being converted too quickly to morphine, leading to toxicity.
Breastfeeding Mothers Risk of serious adverse effects in the infant, especially if the mother is an ultra-rapid metabolizer.
Severe Respiratory Depression Due to the opioid component's effect on breathing.
Post-Operative Pain in Children/Adolescents Contraindicated following tonsillectomy and/or adenoidectomy.
Known Hypersensitivity Allergy to acetaminophen, codeine, or any components.

Restricted Use and Special Caution

Use of the medication is restricted and requires careful monitoring in patients with severe hepatic impairment or severe renal impairment, often necessitating dose adjustments. Adolescents aged 12 to 18 with risk factors for respiratory issues, such as severe lung disease or obesity, should generally avoid use. Extended use during pregnancy may result in Neonatal Opioid Withdrawal Syndrome (NOWS) in the newborn.

What should I know about interactions with other medicines?

Interaction Map: Interactions with other medicines and products — official regulatory information for Citodon (Acetaminophen,Codeine)

Interaction scope

The official profile highlights drug–drug and drug–substance interactions primarily through pharmacokinetic and pharmacodynamic mechanisms, as stated in regulatory documents.

Element Description
Medicinal product categories with documented interactions CNS Depressants (e.g., Anxiolytics, Opioid Agonists); Serotonergic Agents; CYP2D6 and CYP3A4 Inhibitors/Inducers; Oral Anticoagulants; Probenecid; Cholestyramine.
Mechanistic basis of interactions Pharmacokinetic: Alteration of Codeine metabolism via CYP2D6 (conversion) and CYP3A4 (clearance). Pharmacodynamic: Additive effects on the central nervous system (CNS) and hemostasis.

Interaction classifications (high-level)

Regulatory classification mandates strict constraints based on specific patient groups and concomitant substance use.

Element Regulatory Classification / Basis
Interaction severity classification Contraindicated Combinations (e.g., CYP2D6 ultra-rapid metabolizers, MAOIs); Clinically Significant Interactions (e.g., CNS depressants, CYP modulators).
Population-specific interaction notes Contraindicated in children under 12 years of age and in ultra-rapid metabolizers. Caution is advised for patients with hepatic or severe renal impairment, as stated in labeling.

Resulting interaction structure

Official interaction statements detail the documented clinical outcomes of co-administration:

  • The co-administration of CYP2D6 inhibitors (e.g., Quinidine) may reduce the plasma exposure of the active metabolite, potentially resulting in officially documented reduced analgesic effect.
  • The combination with alcohol or other CNS depressants leads to a pharmacodynamic additive effect, which increases the risk of profound sedation and respiratory depression, as noted in regulatory warnings.
  • Chronic use of the Acetaminophen component with Oral Anticoagulants (e.g., Warfarin) is documented to increase the INR, heightening the formal risk of bleeding.

This interaction profile is officially defined by the dual nature of its components, establishing pharmacokinetic constraints via CYP enzymes and pharmacodynamic reinforcement with other CNS-acting agents. Regulatory documents classify combinations as contraindicated or requiring caution to manage resulting changes in exposure or additive effects.

Mechanism of Action

Citodon combines two agents that work through distinct, yet complementary, mechanisms to modulate activity within systems associated with nociception and afferent signal processing.


Central Opioid Receptor Modulation

Codeine, a prodrug, is metabolized into morphine, which acts as an agonist at specific opioid receptors (primarily mu-opioid receptors) in the central nervous system (CNS). This engagement within the receptor-mediated signaling domain modulates key pathways associated with sensory transmission. The resulting effect involves a signaling cascade that decreases afferent signal transmission and modifies pathway activity in CNS regions associated with nociception.


Cyclooxygenase Enzyme Inhibition

Acetaminophen's primary mechanism involves the inhibition of cyclooxygenase (COX) enzymes, particularly in the CNS. This action modifies early molecular steps that shape systemic physiological outcomes by reducing the synthesis of prostaglandins—lipid mediators involved in fever and sensory signal amplification. This pathway modulation results in altered systemic signaling, affecting processes related to central thermoregulation and the excitability of sensory neurons.

Dosage and Administration Information

How Citodon (Acetaminophen, Codeine) is Used: Administration Guidelines

Administration of the combination analgesic Citodon is based on specifications that define dosing, frequency, and duration patterns. The administration route for this product is oral (by mouth), available in tablet, capsule, and liquid forms.

Standard Dosing and Frequency Constraints

Doses are typically administered every 4 hours as needed for acute pain relief, with a minimum interval of 6 hours between doses utilized in some clinical contexts.

Component Maximum 24-Hour Dose (from all sources)
Acetaminophen 4,000 mg (4 g)
Codeine Phosphate 240 mg to 360 mg

Proper use involves adherence to these limits, particularly ensuring the total acetaminophen intake from all sources does not exceed the 4,000 mg maximum.


Duration and Population-Specific Rules

This medication is intended for short-term use. The duration of treatment is limited to a maximum of three days in certain clinical protocols. If the medicine has been used over a prolonged period, the dose is typically tapered gradually upon discontinuation to manage withdrawal.

Age-Group Restrictions: The combination product is contraindicated for use in children under 12 years of age and for adolescents (12–18 years) following tonsillectomy and/or adenoidectomy. Furthermore, patients with renal or hepatic impairment require a prolonged dosing interval or dose reduction to manage drug clearance.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Citodon (Acetaminophen, Codeine)

Evidence Overview for Short-Term, Acute Pain Management

Research exploring the combination of Acetaminophen and Codeine has primarily focused on its application in acute, short-term pain. The most definitive research is structured around Randomized Controlled Trials (RCTs). These studies were used in research exploring how symptoms change over short time intervals, typically measuring outcomes related to physical discomfort and was studied for pain intensity reduction immediately following a single dose. Research highlights that findings describe group patterns, not personal outcomes.

Studies on Chronic and Persistent Pain Conditions

Research investigating the combination for chronic pain and conditions characterized by functional limitations, such as osteoarthritis, has involved limited multiple-dose RCTs alongside a body of Observational Studies. The findings for these studies were mixed. The evidence quality varies across studies, and consistency is lower than what has been observed in the acute pain research structure. The research is ongoing, and the long-term effects are not fully established in the context of chronic pain management.

Follow-up Duration and Understanding Long-Term Effects

The core research supporting this medicine largely comprises short-term studies, meaning follow-up durations were limited. Consequently, there is limited information for long-term outcomes and the durability of any observed response over extended periods (months or years) of consistent use. The evidence designated as 'High' for acute settings is derived from a limited observation time—often a few hours—following a single dose. This limits the application of research findings to use involving repeated administration or extended observation periods.

Limitations, Evidence Gaps, and Regulatory Uncertainty

A significant research gap is the variability in response across individuals. Due to genetic differences, the body's ability to process Codeine into its resulting metabolite may differ considerably. Data for special populations remain insufficient. For example, evidence for very older adults with multiple comorbidities or for children is either limited or subject to significant regulatory warnings that restrict its applicability. Comparative evidence is lacking to definitively frame the role of the combination product relative to all other available pain management strategies.

Key Studies & References Acetaminophen and Codeine: MedlinePlus Drug Information (NIH)

How should Citodon (Acetaminophen,Codeine) be stored and disposed of?

Storage and Disposal Requirements

Storage of acetaminophen and codeine tablets is strictly defined by regulatory requirements to ensure product quality and prevent accidental exposure. The medication must be stored securely at controlled room temperature, typically between 20 C and 25 C, with protection from excessive moisture. Store the product in its original, tightly closed container.

Due to the opioid component, it is mandatory to keep the tablets out of sight and reach of children and store them in a secure, inaccessible location (such as a locked cabinet) to prevent misuse and accidental ingestion.

Proper disposal of unused or expired tablets is essential. The preferred method is using a medicine take-back program or a DEA-registered collector. If these are unavailable, official household instructions must be followed, which include mixing the product with an unpalatable substance (do not crush) and placing it in a sealed container for trash disposal. Disposal must follow local guidelines.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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