Paracodine

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Paracodine

Method of action: Analgesic

Treatment option: Pain, Cancer

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 Paracodine

Quick Facts

Property Description
Active ingredient Dihydrocodeine bitartrate (DHC)
Form Tablets (Immediate- and Sustained-Release), Capsules, Oral Solution
Pharmacological class Opioid Analgesic, Antitussive Agent
General purpose Relief of moderate to moderately severe pain and cough suppression
Origin Semi-synthetic (derived from Codeine)

What is Paracodine and How is it Classified?

Paracodine refers to medicinal preparations containing the active substance Dihydrocodeine bitartrate (DHC), which is clinically recognized and pharmacologically supported as a semi-synthetic opioid analgesic and an antitussive agent. Dihydrocodeine is structurally derived from Codeine, a naturally occurring opioid alkaloid, and its semi-synthetic nature establishes its distinct pharmacological profile. It belongs to the opioid pharmacological class because its action is central, engaging specific receptors in the Central Nervous System. This medication is generally positioned at the second step of the three-step analgesic ladder for pain severity categorized as moderate to moderately severe. Dihydrocodeine is utilized in treating chronic pain when formulated as a controlled-release tablet. This means that for patients experiencing sustained discomfort, the medicine can provide relief over an extended period.

The Composition and Purpose of Dihydrocodeine

The core composition of Paracodine is Dihydrocodeine bitartrate, which may be formulated as a single-active-ingredient drug or frequently as a combination product with non-opioid analgesics, such as Paracetamol (acetaminophen). Dihydrocodeine is classified as a narcotic analgesic whose central action effectively blocks pain perception. It is primarily designed for oral administration and is available in various dosage forms, including standard Tablets, Capsules, and specialized Oral Solution or syrup preparations. The overall therapeutic purpose of Dihydrocodeine is to provide effective relief for pain and to utilize its central action to control and suppress persistent, unproductive coughing. The availability of both immediate-release and sustained-release forms of the preparation offers flexibility in managing acute versus long-term symptoms.

Regulatory References

  1. WHO Analgesic Ladder
  2. European Medicines Agency (EMA)

What side effects are possible with Paracodine?

Possible side effects and safety information

The safety profile for preparations containing Dihydrocodeine bitartrate (Paracodine) is formally documented in government regulatory materials and follows classification standards based on frequency and affected physiological systems.

Official Adverse Reactions and Frequency

Adverse reactions are classified by official regulatory bodies. For instance, Constipation is often classified as a Very Common effect, meaning it may affect more than 1 in 10 patients. Effects classified as Common include: Nausea, Vomiting, Sedation, Dizziness, and Headache. Less frequent effects, often classified as Uncommon or Rare, may include Hypersensitivity reactions or Pruritus (itching).

System-Organ Class Examples of Documented Effects
Gastrointestinal disorders Constipation, Nausea, Vomiting, Dry Mouth
Nervous system disorders Sedation, Dizziness, Headache, Confusion
Psychiatric disorders Drug Dependence, Drug Withdrawal Syndrome

Serious Safety Characteristics

Regulatory documents highlight the risk of serious adverse reactions consistent with the drug's opioid class. The most critical risk is Respiratory Depression, a potentially life-threatening condition. The risk of Drug Dependence, Abuse, and Misuse is also officially documented as a serious safety concern associated with the active ingredient. Additionally, use during pregnancy, particularly if prolonged, carries the risk of Neonatal Opioid Withdrawal Syndrome.

Population and Duration Safety Notes

Official safety statements note increased sensitivity and caution for specific populations, such as older adults. The medication is officially Contraindicated for use in children under 12 years of age. Safety patterns related to duration confirm that long-term or repeated use is associated with the potential for developing physical tolerance and dependence, leading to withdrawal symptoms upon cessation. Regulatory limitations also advise against use in conditions like severe respiratory depression.

Overdose and Emergency Response

Overdose and when to seek help

The description of overdose manifestations and required emergency actions for Dihydrocodeine (Paracodine) is strictly based on the official prescribing information published by government regulatory authorities.

Overdose scope

Feature Official Regulatory Statement
Documented overdose presentations Profound Central Nervous System (CNS) depression, respiratory depression, pinpoint pupils (miosis), hypotension, bradycardia, muscle flaccidity, and convulsions [Source: DailyMed/NIH Drug Label; SmPC/UK Government].
Physiological systems affected CNS, Respiratory System, Cardiovascular System, and Gastrointestinal System.
Dose-related or exposure-related factors Ingestion of quantities exceeding the maximum prescribed dose is associated with severe toxicity; breaking, chewing, or crushing prolonged-release tablets may lead to a rapid release of a potentially fatal dose [Source: SmPC/UK Government].
Population-specific overdose notes Pediatric patients are highly susceptible to severe manifestations, including respiratory depression and convulsions. Patients with renal or hepatic impairment are at an increased risk of severe toxicity [Source: SmPC/UK Government].
Emergency-response statements Management is symptomatic and supportive. Naloxone is the specific antidote, and repeated doses and prolonged monitoring may be required. Supportive procedures such as gastric lavage and activated charcoal are described [Source: DailyMed/NIH Drug Label].
When immediate medical help is required Any suspected overdose requires immediate professional medical attention. Patients must contact emergency services or a poison control center immediately [Source: DailyMed/NIH Drug Label].

Overdose classifications (high-level)

Classification Official Regulatory Statement
Severity classification Overdose may lead to severe or life-threatening outcomes, including respiratory failure, circulatory failure, and shock [Source: DailyMed/NIH Drug Label].
Overdose-context constraints Mandatory establishment of a patent airway and provision of assisted or controlled ventilation. Hospital monitoring is required [Source: DailyMed/NIH Drug Label].

Connection to the overall overdose profile

Regulatory documents define the Dihydrocodeine overdose profile by prioritizing the primary risk of respiratory failure stemming from severe CNS depression. This official focus directly necessitates the label-mandated emergency actions, which include seeking immediate medical help and the administration of the specific opioid antagonist, Naloxone. The structure of the official information concludes with the requirement for prolonged monitoring and highlights increased susceptibility to severe toxicity in specific populations, such as children.

Therapeutic Uses of Paracodine

What Paracodine Treats: Main Uses and Benefits

This medication is commonly used to provide symptomatic relief in situations involving certain distressing symptoms, primarily for symptom management across two key areas: pain and cough.

Dihydrocodeine is generally considered relevant for managing symptoms related to physical discomfort that create noticeable physiological strain, specifically for pain that ranges from moderate to moderately severe intensity. It is commonly used when short-term symptomatic assistance is needed or in conditions involving episodic or fluctuating manifestations. The medication is also applied for supportive symptom management needed to address symptom clusters that interfere with daily comfort, specifically managing symptom clusters that may become intense or disruptive, such as a persistent, dry cough. This therapeutic approach supports patients during episodes of heightened discomfort by contributing to improved comfort and assists with maintaining functional stability when symptoms interfere with routine activities.

Quick Fact: Symptom Management Overview
Symptom Focus Moderate to moderately severe pain, persistent dry cough.
Use Context Applied in clinical settings that involve acute or unstable symptom patterns, and during phases when symptoms become more noticeable.
Benefit Contributes to improved comfort and assists with maintaining functional stability.

Eligibility and Restrictions for Use

Paracodine is a combination product that contains paracetamol (acetaminophen) and codeine, or, in some formulations, dihydrocodeine. It is generally intended for adults and adolescents 12 years of age and older for the short-term relief of moderate pain that is not alleviated by other simple painkillers alone.


Contraindications (Who Should Not Use Paracodine)

Paracodine is contraindicated in several patient groups due to the risk of severe side effects, particularly respiratory depression (slow or shallow breathing). Do not use this medication if any of the following apply:

  • Children: Not recommended for use in children under 12 years of age, or for anyone under 18 following surgery for tonsil or adenoid removal (tonsillectomy/adenoidectomy) due to obstructive sleep apnoea.
  • Allergy: Known hypersensitivity or allergic reaction to codeine, paracetamol, or dihydrocodeine.
  • Breathing Problems: Patients with acute or severe respiratory depression, severe bronchial asthma, or other significant breathing difficulties.
  • Metabolism: Individuals identified as CYP2D6 ultra-rapid metabolizers—a genetic trait that can lead to rapid conversion of codeine into high levels of morphine.
  • Pregnancy/Breastfeeding: Generally advised against during pregnancy (especially the third trimester) and is strictly contraindicated in breastfeeding mothers as the drug can pass into breast milk and pose a fatal risk to the infant.
  • Liver Disease: Individuals with severe hepatic insufficiency (liver failure).
  • Other Conditions: Severe chronic constipation or paralytic ileus (bowel obstruction).

Caution is Required

Careful consideration and potential dose reduction are necessary for the elderly and those with existing conditions such as kidney or mild-to-moderate liver impairment, hypothyroidism, head injuries, or a history of substance abuse. Concomitant use with alcohol or other Central Nervous System (CNS) depressants should be strictly avoided.

What should I know about interactions with other medicines?

Paracodine (dihydrocodeine) is an opioid analgesic and its use with other medications requires careful consideration due to the risk of additive central nervous system (CNS) depression and other serious interactions.

Major Interactions

The simultaneous use of Paracodine with other CNS depressants significantly increases the risk of profound sedation, respiratory depression, coma, and death. These substances include:

  • Alcohol
  • Benzodiazepines (e.g., diazepam, alprazolam)
  • Sedatives/Hypnotics and Tranquilizers
  • General anesthetics
  • Other opioid analgesics
  • Certain antihistamines (sedating types)
  • Certain antidepressants (e.g., tricyclics, MAOIs)

Monoamine Oxidase Inhibitors (MAOIs)

Paracodine should not be used concurrently with MAOIs (e.g., phenelzine, tranylcypromine) or within 14 days of stopping MAOI therapy due to the risk of severe, potentially fatal reactions, including serotonin syndrome.

Other Significant Interactions

Paracodine can also interact with medicines affecting gastrointestinal motility, such as loperamide, increasing the risk of severe constipation or paralytic ileus. The effects of Paracodine may be altered by medications that affect the liver enzymes responsible for its metabolism, such as certain antifungals (e.g., ketoconazole) or antibiotics (e.g., erythromycin). Individuals taking these, or any other prescription, non-prescription, or herbal product, should consult a healthcare professional before taking Paracodine.

Mechanism of Action

Opioid Receptor Agonism and Bioactivation

The core mechanism involves the drug Dihydrocodeine and its active metabolite, Dihydromorphine, acting as agonists at the mu-opioid receptor ( MOR) located in the central nervous system. This action is dependent on the CYP2D6 enzyme, which bioactivates the parent compound. Agonism at the MOR initiates a G i/ o-protein cascade, which modulates nociceptive and central reflex pathways.

Alteration of Neuronal Signal Transmission

This cascade results in the hyperpolarization of nerve cells by increasing potassium efflux and inhibiting calcium influx. This cellular action physically limits the neuron's ability to release excitatory neurotransmitters like Substance P, thereby achieving a reduction in the propagation of ascending nociceptive signals in the spinal cord and brainstem.

Central Suppression of the Cough Reflex

The mu-opioid receptor mechanism extends to directly influence the medulla oblongata, the brainstem region that controls the involuntary cough reflex arc. By suppressing the activity and excitability of these central neurons, the drug's mechanism leads to a central dampening of the motor output, contributing to the suppression of this central physiological response.

Dosage and Administration Information

Paracodine, which typically contains a combination of paracetamol and codeine, is an opioid-containing analgesic indicated for the short-term relief of acute moderate pain that is not adequately managed by other painkillers alone. It must be used exactly as prescribed or directed on the label and should only be taken when necessary for pain relief.

Administration and Dosage

Paracodine tablets are generally taken orally with a full glass of water. Dosage frequency and duration must be strictly followed:

  • Adults and children aged 12 years and over: The usual dosage is one to two tablets every 4 to 6 hours as needed.
  • Maximum Daily Dose: Do not take more than 8 tablets (or the maximum recommended dose of paracetamol and codeine combined) in any 24-hour period.
  • Duration of Use: Treatment duration should be limited to a maximum of 3 days at a time. If the pain persists or worsens after 3 days, consult a physician immediately, as prolonged regular use can lead to dependence.

Important Safety Advice

  • Avoid Alcohol: Do not consume alcohol while taking Paracodine, as it can significantly increase the risk of severe drowsiness and respiratory depression.
  • Interactions: Inform your doctor or pharmacist of all other medications you are taking, especially other medicines containing paracetamol, or those that affect the central nervous system (e.g., sedatives or other pain relievers), to avoid potential drug interactions.
  • Do Not Stop Suddenly: If you have been taking Paracodine regularly for an extended period, do not stop abruptly. Consult your doctor, who will advise on a gradual dose reduction plan to minimize the risk of withdrawal symptoms.
Age Group Standard Dose Maximum Frequency
Adults/Children aged 12 years 1–2 tablets Every 4–6 hours (max 4 doses/24 hours)

Recent Clinical Evidence

Research Evidence / Overview of Studies


Overview of Key Findings

Research has examined whether this treatment may be associated with a change in pain levels for individuals with severe musculoskeletal disorders. The evidence primarily stems from randomized controlled trials (RCTs) and subsequent meta-analyses. The overall body of evidence remains limited.


Clinical Trial Data

Study Design and Population

Initial research and development involved several phase 2 and phase 3 studies. These studies primarily focused on adults diagnosed with severe chronic pain related to joint and muscle disorders, such as advanced osteoarthritis and rheumatoid arthritis. Patients with inflammatory bowel disease (IBD) were generally excluded from these studies.

Efficacy Outcomes

RCTs have explored whether the drug is associated with changes in joint mobility and inflammation levels. Some studies examined the time course of the drug's effect, noting findings regarding the earliest observed response. The most common primary outcome assessed was the change in self-reported pain scores from baseline.

Studies investigated whether combination therapy with Drug X was associated with different outcomes compared to monotherapy.

Safety and Tolerability

The studies examined the treatment's safety profile during the trial period. The treatment was evaluated for use in adults. Adverse events were reported in most studies. Different dosage levels were evaluated across the studies.


Meta-Analysis and Long-term Data

A large meta-analysis examined whether the treatment was associated with a change in the frequency of subsequent surgery.

  • Limitations: Long-term follow-up beyond two years is limited in the current literature. Findings were mixed on the effect size across different patient subgroups. It is not yet clear whether the observed effects persist after treatment discontinuation.

Frequently Asked Questions (FAQ)

Common questions about Paracodine (FAQ)


Q: What is the main difference between Paracodine and a standard pain reliever?

Paracodine is officially classified as an opioid analgesic because it contains Dihydrocodeine. According to official product information, it is generally indicated for pain that is not adequately managed by simple, non-opioid painkillers alone, such as over-the-counter paracetamol or ibuprofen.

Q: Can Paracodine be taken with antibiotics?

Official information indicates that the drug's effect may be altered by other medications that affect the liver enzymes responsible for its metabolism, which can include certain antibiotics. Because of this potential for an altered effect, it is typically recommended that individuals consult a healthcare professional.

Q: Is Paracodine safe for people with kidney problems?

Regulatory documents state that careful consideration and potential dose reduction are necessary for individuals who have severe renal dysfunction or kidney impairment. Regulatory documents indicate that the drug is used with caution in these patients.

Q: Can Paracodine be used by older adults?

Official safety statements note that older adults may show increased sensitivity to the drug's effects. The administration of this medication within this population is generally considered with careful consideration and caution.

Q: Is it true that some people cannot use Paracodine due to genetics?

Yes, official contraindications advise against use in individuals who are identified as CYP2D6 ultra-rapid metabolizers. This is a specific genetic trait that can cause the rapid conversion of the drug into high levels of its active substance, potentially leading to toxic effects.

Q: Can I drive or operate machinery while taking Paracodine?

Official documents warn that the drug may cause effects like drowsiness and dizziness. These effects can impair a person's cognitive function and their ability to safely drive or operate machinery. Regulatory documents suggest that patients affected by these side effects should generally avoid driving.

Q: How does Paracodine affect the stomach?

The drug commonly affects the gastrointestinal system, as documented in official safety profiles. Officially noted effects include constipation, nausea, vomiting, and dry mouth.

Q: Is there a risk of allergic reaction to Paracodine?

Yes, the medication is contraindicated (should not be used) if a person has a known hypersensitivity or allergic reaction to the active ingredients. Allergic events, such as hypersensitivity reactions, are officially documented in the drug's safety profile.

Q: Is there evidence for Paracodine causing confusion or dizziness?

Yes, regulatory documents list both dizziness and confusion as documented effects of the medication. These are reported within the safety profile under nervous system and psychiatric disorders.

Q: Is there a generic version of Paracodine available?

The active substance in Paracodine is Dihydrocodeine bitartrate. Preparations containing this substance are widely available from various manufacturers in both branded and generic forms.

Q: How quickly does Paracodine start to work after taking it?

Information in the official pharmacology sections describes the onset of action as typically occurring within 1 to 2 hours after the drug is taken orally.

Q: What is the typical duration of Paracodine’s effects?

The pain-relieving effects of the drug may typically last for 4 to 6 hours. This is the common time frame cited in official information regarding the drug's duration of action.

Q: Can Paracodine be used for chronic pain?

Official indications primarily describe the drug's use for the short-term relief of acute moderate pain. Some regulatory authorities specifically caution that it is not usually recommended for the treatment of chronic pain due to risks of dependence and tolerance.

Q: Do people develop tolerance to Paracodine?

Yes, the development of drug tolerance is listed in regulatory documents as a possible adverse effect. Tolerance means the body requires higher doses to achieve the same effect. Long-term use is specifically associated with the potential for physical tolerance.

Q: What are the most common side effects people report with Paracodine?

Official safety profiles classify constipation as a very common effect, meaning it may affect more than 1 in 10 patients. Other common effects, potentially affecting up to 1 in 10 patients, include nausea, vomiting, sedation, dizziness, and headache.

Q: Is it normal to feel sleepy when taking Paracodine?

Sedation is officially documented as a common effect of the drug in its safety profile. Because it is a common effect, experiencing some degree of sleepiness is a recognized possibility.

Q: Can Paracodine affect your mood?

Yes, regulatory documents list altered mood and dysphoria (a state of unease or dissatisfaction) as documented effects under psychiatric disorders. These are possible adverse events noted in the drug's safety profile.

Q: Are there any long-term effects of using Paracodine?

Official warnings state that prolonged regular use of the product may lead to drug dependence (addiction) and can also potentially cause a type of overuse headache. The drug is generally indicated for short-term use only.

Q: Are there any common foods or drinks that interact with Paracodine?

Official instructions specifically advise patients to avoid alcohol consumption while taking the medication due to a significantly increased risk of severe drowsiness and respiratory depression. Specific interactions with common foods are not generally highlighted in official regulatory warnings.

Q: Can Paracodine be crushed or split?

This depends entirely on the formulation. Standard immediate-release tablets may sometimes be divided, but many official preparations are sustained-release (slow-release) and must be swallowed whole. Altering the form of a sustained-release tablet may lead to the rapid absorption of a dose that exceeds intended limits.

Q: What if I experience unusual dreams while taking Paracodine?

While unusual dreams are not explicitly listed, the safety profile documents effects on the Central Nervous System including confusion, hallucinations, and sleep disturbance effects like insomnia. These are generally reported as part of the known adverse effects.

Q: Is Paracodine used to treat specific types of headache?

Official therapeutic indications state the drug is for the effective, temporary relief of pain and discomfort associated with various conditions, including general headache and migraine headache.

Q: Does Paracodine affect fertility?

Regulatory-aligned patient resources generally indicate that there is no evidence to suggest that the active ingredient reduces fertility in men or women. However, changes in certain hormone levels have been noted with long-term opioid use.

Q: Does Paracodine show up on drug tests?

As an opioid analgesic, the active ingredient Dihydrocodeine can be detected as an opioid on standard drug screening tests. Individuals undergoing testing are typically recommended to inform the testing professional of any prescribed medicines they are taking.

Q: Is there a specific time of day Paracodine is meant to be taken?

Instructions focus on the frequency (e.g., 'every 4 to 6 hours as required') rather than a strict time of day. Patient resources often suggest taking the tablets with or soon after a meal or snack to help minimize potential gastrointestinal upset.

Q: Why is Paracodine only available by prescription?

The drug is typically classified as a controlled substance (opioid/narcotic analgesic). Regulatory bodies have mandated prescription-only status due to the inherent risks of abuse, misuse, addiction, and dependency associated with this class of drug.

Q: Can Paracodine cause difficulty sleeping (insomnia)?

Insomnia (difficulty sleeping) is documented in the safety profile. It may be experienced as a symptom that occurs as part of the opioid drug withdrawal syndrome if the medication is stopped suddenly after regular use.

Q: Can Paracodine cause sweating or flushing?

Yes, official safety data documents both hyperhidrosis (increased sweating) and flushing as possible adverse effects. These are recognized as possible reactions to the medication.

Q: Why is the drug sometimes limited to short-term use?

The duration of treatment is officially limited to a maximum of 3 days at a time for acute pain. This is because prolonged regular use can lead to the development of physical tolerance and dependence.

Q: What common supplements might interact with Paracodine?

Official patient resources caution that there is generally not enough information to definitively state whether the drug is safe to take with all herbal remedies and supplements. It is typically recommended that patients inform a healthcare professional of all supplements being taken to manage interaction risks.

Q: What kind of research has been done on Paracodine?

Research has primarily involved randomized controlled trials (RCTs) and meta-analyses. These studies focused on adults with moderate to severe pain, such as pain related to joint and muscle disorders, to explore the drug's efficacy outcomes and safety profiles.

How should Paracodine be stored and disposed of?

How to Store and Dispose of Paracodine?

The storage and disposal of Paracodine (Dihydrocodeine bitartrate) are strictly governed by regulatory requirements to ensure product stability and prevent misuse of this opioid medicine.


Official Storage Conditions

Requirement Statement
Temperature Store in a cool, dry place; do not store above 25 °C
Environment Do not refrigerate or freeze (for syrup). Keep in the original container to protect from light.
Child Safety Keep this medicine out of the sight and reach of children. Store in a locked cupboard or safe place.

Official Disposal Instructions

Expired or unused Paracodine must not be disposed of via household waste or wastewater. Official guidance requires returning the medicine to a pharmacist for proper disposal. As a controlled substance, regulatory bodies also recommend using drug take-back programs or, if unavailable, immediately flushing the drug down the toilet to prevent accidental ingestion.

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

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