Dihydrocodeine Wockhardt

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Dihydrocodeine Wockhardt

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 Dihydrocodeine Wockhardt

Quick Facts: Dihydrocodeine

Property Description
Active ingredient Dihydrocodeine hydrogen tartrate
Form Oral solution (syrup), standard and prolonged-release tablets
Pharmacological class Opioid analgesic / Narcotic analgesic
General purpose Relief of pain and suppression of persistent cough
Origin Semi-synthetic (derived from codeine)

What Type of Medicine is Dihydrocodeine Wockhardt?

Dihydrocodeine Wockhardt is a medication containing the active compound Dihydrocodeine hydrogen tartrate, which is formally classified as a semi-synthetic opioid analgesic. This designation confirms the substance is structurally related to the naturally occurring opioid codeine, developed to optimize its therapeutic effects and potency. This compound is utilized for its analgesic capabilities. Dihydrocodeine is utilized in pain management. It is formally listed as a narcotic analgesic, a high-level classification of drugs that primarily act on the central nervous system.

Forms and Core Composition

The medicinal entity Dihydrocodeine is manufactured in several core dosage forms, including a liquid oral solution and solid tablets, which may be formulated for standard or prolonged release. This variety of forms, particularly the quick-absorbing oral solution, provides adaptability in managing the onset and duration of the medication's effects. The composition involves the active ingredient Dihydrocodeine hydrogen tartrate combined with inert pharmaceutical excipients for the solid forms, or an aqueous base for the liquid forms.

General Therapeutic Purpose of Dihydrocodeine

The primary therapeutic purpose of the drug is derived from its function as a μ-opioid receptor agonist, which modifies pain signals in the spinal cord and brain. Dihydrocodeine is recognized for its dual action: providing general relief by reducing the perception of pain, and acting as an effective antitussive agent. Therefore, its general utility lies in managing moderate to severe discomfort and controlling severe, non-productive coughing that requires intervention within the central nervous system.

Regulatory References

  1. Mechanism and Use Review

What side effects are possible with Dihydrocodeine Wockhardt?

Possible Side Effects and Safety Information

The officially documented adverse reactions for Dihydrocodeine Wockhardt are organized into frequency categories and physiological system classes, reflecting established regulatory reporting standards. The safety profile is characterized by effects primarily related to the central nervous system and the gastrointestinal system.

Frequency-Classified Adverse Reactions

Adverse reactions are classified according to frequency, based on reports in official documents:

Classification Adverse Reactions System-Organ Class Example
Very Common (ge 1/10) Constipation, Nausea, Vomiting, Dizziness, Sedation (Drowsiness) Gastrointestinal/Nervous System
Common (ge 1/100 to <1/10) Headache, Sweating, Pruritus, Dry mouth, Abdominal pain Nervous System/Skin/Gastrointestinal

Serious Regulatory Safety Risks

Official labeling highlights the potential for serious adverse reactions. The most significant concern is the risk of Respiratory Depression, which is a potentially life-threatening event, particularly when dosage is high or in susceptible individuals. There is also a documented risk of developing physical and psychological drug dependence and tolerance with regular, long-term exposure, which can lead to a withdrawal syndrome upon cessation.

Safety Patterns and Restrictions

Side effects affecting the nervous system, such as sedation and dizziness, are often more pronounced when treatment is initiated or following a dose increase. Regulatory limitations state the medicine is contraindicated in individuals with acute respiratory depression, severe obstructive airways disease, known or suspected paralytic ileus, or severe hepatic impairment. Caution is also advised in older adults and those with renal impairment, due to an increased risk of prolonged effects.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documents define the Dihydrocodeine overdose profile by its core manifestation of severe Central Nervous System (CNS) and respiratory depression, which can be life-threatening. Documented clinical presentations include profound sedation, stupor, loss of consciousness (coma), and eventual death. Severe, life-threatening respiratory depression, accompanied by signs such as pinpoint pupils (miosis), low blood pressure (hypotension), and muscle weakness, are key physiological findings listed in labeling.

Mandated Emergency Actions

Regulatory guidance explicitly states that immediate medical attention must be sought upon observing these severe manifestations, particularly slowed, shallow breathing or unconsciousness. Caregivers are instructed to stop giving the medicine and seek medical help immediately if signs like severe sleepiness or confusion are noted. The established supportive measures include the use of the specific opioid antagonist naloxone hydrochloride to reverse the depressant effects, along with other official interventions like administering activated charcoal and providing mechanical breathing support (ventilation) as needed. Continuous monitoring of vital signs is required in overdose situations.

Population-Specific Risk

The official labeling notes that accidental ingestion by children represents an explicit overdose risk due to the potential for fatal respiratory depression. Furthermore, elderly, frail, or debilitated patients are noted as having an increased susceptibility to life-threatening respiratory depression.

Therapeutic Uses of Dihydrocodeine Wockhardt

What Dihydrocodeine Wockhardt treats: Main Uses and Benefits

This medication is used in situations involving certain distressing symptoms across two key therapeutic domains.

It is primarily applied in addressing symptom clusters associated with moderate to severe symptomatic pain and for the management of a persistent and severely disruptive non-productive cough. This makes it relevant for conditions characterized by periods of heightened symptoms, such as post-operative discomfort, pain following trauma, and acute episodes of debilitating cough.

“The medication is applied when symptomatic support is needed because the discomfort or cough has become difficult to tolerate.”

Relief from Moderate to Severe Symptomatic Pain

Dihydrocodeine is used in clinical settings that involve acute or unstable symptom patterns, such as pain following an operation or a serious injury. This application is relevant when supportive symptom management is appropriate because the symptoms of physical discomfort exceed the efficacy of weaker over-the-counter options. Its application provides support that helps ease the overall symptom burden of intense pain, assisting with maintaining functional stability and contributing to improved day-to-day comfort.


Quick Fact: Relief for Pain Symptom Type Intensity Context
Physical Discomfort Moderate to Severe Acute, Post-operative, Chronic Episodes

Management of Persistent and Disruptive Cough

It is also relevant for easing symptom clusters associated with a persistent and severely disruptive cough. This supportive therapeutic benefit is applied in addressing instances where the severe cough symptom creates noticeable physiological strain and interferes with daily functioning. Dihydrocodeine is used to manage the symptom load of the severe, dry cough, helping patients cope with difficult episodes and supporting rest.

Eligibility and Restrictions for Use

Eligibility and Non-Eligibility for Dihydrocodeine Wockhardt

Official regulatory information strictly defines which patient populations are eligible to use dihydrocodeine. Eligibility is primarily restricted by age, specific health conditions, and physiological status.

Absolute Contraindications (Must Not Use)

The medicine is contraindicated and must not be used by individuals with the following conditions or characteristics:

  • Children under 12 years of age for all uses.
  • Adolescents (12 to 18 years) following tonsillectomy and/or adenoidectomy.
  • Known hypersensitivity to dihydrocodeine, codeine, or any excipients.
  • Acute respiratory depression or severe respiratory problems, such as severe bronchial asthma in an unmonitored setting.
  • Known or suspected gastrointestinal obstruction, including paralytic ileus.
  • Individuals known to be ultra-rapid metabolizers of CYP2D6 substrates.

Populations with Restricted or Non-Recommended Use

Use is not recommended in breastfeeding women due to the risk of exposing the infant to the medication. It is also not recommended for use in pregnant women, especially during and immediately before labor and delivery. Special consideration is required for patients with hepatic or renal impairment, which may necessitate dose limitation or avoidance to manage eligibility safely.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Dihydrocodeine is officially defined by specific pharmacokinetic effects involving metabolic enzymes and high-risk additive pharmacodynamic effects, as outlined in government regulatory documentation.

Interaction Scope

Category Official Regulatory Documentation Details
Medicinal product categories with documented interactions Monoamine Oxidase Inhibitors (MAOIs); Central Nervous System (CNS) Depressants; Serotonergic Drugs (e.g., SSRIs); Mixed Agonist/Antagonist Opioid Analgesics; Strong/Moderate CYP2D6 and CYP3A4 Enzyme Inhibitors and Inducers.
Mechanistic basis of interactions Pharmacokinetic: Inhibition or induction of the cytochrome P450 enzymes CYP2D6 and CYP3A4 alters plasma concentration. Pharmacodynamic: Additive depressant effects on the CNS.
Timing-based interaction rules Contraindicated for use within 14 days of receiving a Monoamine Oxidase Inhibitor (MAOI).
Population-specific interaction notes The risks of pharmacodynamic interactions, specifically respiratory depression from CNS depressants, are documented to occur more frequently in elderly, frail, or debilitated patients.
Interaction-related restrictions Co-administration with MAOIs is prohibited. Co-administration with alcohol (ethanol) is prohibited in specific formulations due to the potential for dose dumping and pronounced additive CNS depression.

Official Interaction Statements

  • Co-administration with CYP2D6 inhibitors is documented to result in increased dihydrocodeine plasma concentration and decreased dihydromorphine plasma concentration.
  • The combined use with other CNS depressants is associated with additive pharmacodynamic effects, officially described as resulting in the potential for profound sedation and severe respiratory depression.
  • CYP3A4 inhibitors are officially documented to increase the plasma concentration of dihydrocodeine.
  • Co-administration with Serotonergic Drugs is officially noted as carrying an increased risk of Serotonin Syndrome.

Connection to the overall interaction profile:

The regulatory documents establish that the drug's metabolism via CYP2D6 and CYP3A4 enzymes dictates its pharmacokinetic interaction structure, where modulation alters drug exposure. Concurrently, the profile mandates prohibitions, such as the co-administration ban with MAOIs and alcohol, due to the risk of additive pharmacodynamic effects that can lead to severe adverse outcomes.

Mechanism of Action

Dihydrocodeine functions primarily as an agonist at central mu-opioid receptors (mu-OR), which are G-protein coupled receptors (GPCRs) predominantly localized in the brain and spinal cord. Binding to the mu-OR initiates the molecular pathway by coupling to the inhibitory G-protein Gi/o. This protein coupling leads to the inhibition of the enzyme adenylate cyclase, which results in a reduction of intracellular levels of cyclic adenosine monophosphate (cAMP).

The decreased cAMP concentration constitutes a key intracellular consequence that subsequently modulates ion channel activity. Specifically, this cascade promotes the opening of G-protein coupled inwardly-rectifying potassium channels (GIRK) and inhibits the opening of voltage-gated calcium channels.

These combined actions result in the hyperpolarization of the postsynaptic neuron membrane, decreasing neuronal excitability and suppressing the release of various nociceptive neurotransmitters from the presynaptic terminal. System-level physiological consequences involve the modulated transmission of signals within the ascending pathways and descending modulatory systems of the central nervous system.

Dosage and Administration Information

Dihydrocodeine is administered exclusively via the oral route, available in standard-release (SR) tablets, prolonged-release (PR) tablets, and an oral solution. The administration pattern is governed by the specific formulation used and the labeled dosing schedule.

Official Dosing Regimens and Frequency

The standard-release 30 mg tablets are typically taken every 4 to 6 hours, with the maximum daily dose for this strength not exceeding 180 mg in 24 hours. Conversely, prolonged-release formulations, available in strengths up to 120 mg, are designed for a 12-hourly dosing interval, with a maximum daily limit of 240 mg. For the liquid oral solution, dosage must be measured precisely using a calibrated medical device, as common household spoons do not provide an accurate amount.

Administration Conditions and Adjustments

All forms of Dihydrocodeine are generally instructed to be taken with or soon after a meal or food. A key procedural constraint for the prolonged-release tablets is that they must be swallowed whole; they must not be crushed, broken, or chewed, as this compromises the 12-hour mechanism.

Dosing adjustments are indicated for specific patient groups: a reduced dose is advised for older adults and for patients with hepatic or renal impairment. Use in children is restricted, with a body-weight-based dose calculated for ages 4 to 12 years, and use is not recommended below 4 years of age. If a dose is missed, patients are instructed never to double the next dose to compensate.

Duration and Long-Term Use

For short-term treatment, the medicine is used for limited periods. When regular use extends over a long duration, protocols require the implementation of a pre-established plan for gradual dose reduction to discontinue the medicine, rather than an abrupt cessation.

Recent Clinical Evidence

Dihydrocodeine Wockhardt: Recent Clinical Evidence

Dihydrocodeine has been studied for its application in two main areas: outcomes related to physical discomfort and outcomes related to persistent cough. The available evidence comes from a mix of study types, including controlled clinical trials, but evidence quality varies across studies and between the two intended areas of study.

Evidence Base for Moderate to Severe Symptomatic Pain

Research examining Dihydrocodeine's use for pain relief typically includes Randomized Controlled Trials (RCTs) and systematic reviews. These studies have primarily research examined how symptoms change over time; researchers monitored patient-reported outcomes describing perceived discomfort, such as changes in pain intensity scores, over defined periods.

For acute pain, such as conditions associated with acute or disruptive episodes, the research explores short-term symptom changes over defined time intervals. Findings describe patterns observed in the studies regarding the drug's measured effect, particularly in single-dose comparisons against placebo or other active control agents.

For chronic pain, Dihydrocodeine was examined in studies observing responses over defined time intervals, sometimes lasting several weeks to months. These trials focused on outcomes reflecting daily functioning or activity level and patient-reported outcomes like sleep quality. Long-term effects are not fully established, and follow-up durations were limited in many of the studies that tracked use for chronic conditions.

Evidence Base for Persistent and Disruptive Cough

The research supporting Dihydrocodeine as a cough suppressant is generally based on a more limited number of high-quality clinical trials, although it was studied for conditions where symptoms may vary in intensity and require central nervous system intervention. Studies explored how the drug affects outcomes related to systemic or functional imbalance, such as measures of cough frequency and severity.

Research in this area often involves small clinical trials or comparisons using cough challenge models to assess effects on the cough reflex. Evidence for certain groups remains insufficient or is often extrapolated from studies involving its related compound, codeine. Findings were mixed regarding its use for common, acute non-specific cough, and the evidence base contributes to understanding symptom patterns, but certainty remains low in certain study contexts. The outcomes describing the measured cough severity were typically based on short-term study periods.

Research Gaps and What Remains Uncertain

The overall evidence landscape for Dihydrocodeine highlights several areas where research is ongoing or still needed. One key gap is the limited number of high-quality clinical trials for its antitussive use, especially when compared directly to placebo for common, non-specific cough.

Furthermore, long-term effects are not fully established regarding functional outcomes for individuals managing chronic pain. Subgroup findings are uncertain, as many trials had sample sizes were modest, meaning that the evidence contributes to understanding symptom patterns in the overall group but provides less definitive information for specific patient characteristics or chronic conditions.

Key Studies & References

  1. Dihydrocodeine - Mechanism and Use Review

Frequently Asked Questions (FAQ)

Common questions about Dihydrocodeine Wockhardt (FAQ)


Q: Are there known interactions between this drug and supplements like St. John's Wort?

Official interaction reviews note that St. John’s Wort can affect certain enzymes that process this medicine in the body. Because of this, combining the supplement with Dihydrocodeine may potentially decrease the medicine's effectiveness by altering its concentration in the blood. Official documentation advises caution and monitoring for this potential interaction.


Q: Is it safe to take Dihydrocodeine Wockhardt with other medications that cause drowsiness?

According to the official product information, combining this drug with other central nervous system (CNS) depressants, including those that cause drowsiness, is associated with significant risk. These additive pharmacodynamic effects are officially described as carrying the potential for profound sedation, severe respiratory depression (serious difficulty breathing), and potentially severe outcomes.


Q: Is Dihydrocodeine Wockhardt described as being suitable for use during pregnancy?

Official documents state that its use during pregnancy is generally restricted, and is only indicated when a healthcare provider considers the benefits to outweigh the risks. This is due to limited data available and the established risk of neonatal drug dependence and withdrawal symptoms in the infant if the medicine is used regularly before birth.


Q: What is the risk of overdose described in official safety documents?

Official safety documents describe the symptoms of an overdose, noting the potential for life-threatening outcomes. Symptoms described include severe respiratory depression (difficulty breathing), extreme drowsiness that may progress to stupor or coma, muscle weakness, and pinpoint pupils.


Q: Does Dihydrocodeine Wockhardt have a known risk of tolerance development?

Official safety information acknowledges that regular use of this medication, especially over a long time, may lead to the development of tolerance. Tolerance is a physical effect where the body adapts to the medicine, meaning a higher amount may be required over time to achieve the original effect.


Q: Why is this drug sometimes used for long-term pain?

The medicine is indicated in regulatory documents for the relief of moderate to severe pain. When it is used over extended periods for long-term pain management, official protocols require that a pre-established plan for gradual dose reduction must be implemented when discontinuing the medicine.


Q: Does Dihydrocodeine Wockhardt contain any other active ingredients?

According to official composition documents, the only active ingredient in Dihydrocodeine Wockhardt tablets is Dihydrocodeine hydrogen tartrate. The medicine also contains various inactive pharmaceutical excipients.


Q: Do people take Dihydrocodeine Wockhardt for things other than pain?

The general therapeutic purpose of this medication, as described in regulatory documents, is based on its dual action: the relief of moderate to severe pain and its use as a cough suppressant.


Q: What is the typical time frame for the expected effects to begin?

Authoritative pharmacological documents indicate that for standard-release formulations, the onset of action, or when the expected effects begin, is generally described as occurring within 1 to 2 hours after administration.


Q: How long does the effect of Dihydrocodeine Wockhardt typically last?

The duration of the expected effect for standard-release formulations is generally described in authoritative documents as lasting approximately 4 to 6 hours. Prolonged-release forms are specifically designed to release the active ingredient over a 12-hour period.


Q: Are there any known side effects on mood or mental state?

As a medicine that acts on the central nervous system, Dihydrocodeine may result in changes to mental state, such as a feeling of being relaxed or calm. Common side effects listed in official documents are nervous system-related, including dizziness and sedation.


Q: Are there different strengths of Dihydrocodeine Wockhardt available?

Yes, official prescribing information defines that this medication is available in several strengths for both standard-release (e.g., 30 mg) and prolonged-release tablets. Prolonged-release options can include strengths such as 60 mg, 90 mg, and 120 mg.


Q: Is there a maximum length of time this medication is usually prescribed for?

The medication is typically indicated for use over short periods of time for acute pain. Regulatory patient information advises against taking the medicine for longer than directed, as prolonged use may increase the risk of developing tolerance and dependence.


Q: Is it necessary to avoid grapefruit or grapefruit juice while taking this medication?

This medicine is processed by an enzyme (CYP3A4) that can be affected by grapefruit juice. Official interaction reviews suggest that consuming grapefruit juice may lead to an increase in the medicine's concentration in the blood.


Q: What is the difference between physical dependence and addiction for this medicine?

Regulatory documents note the risk of physical and psychological drug dependence, which refers to a physical adaptation where the body experiences withdrawal when the medicine is stopped. The term addiction (Substance Use Disorder) is defined in broader medical literature as a condition involving a lack of control over use and continued use despite harm.


Q: Is it possible to have an allergic reaction to Dihydrocodeine Wockhardt?

Yes, official documents list known hypersensitivity to dihydrocodeine or any of its ingredients as an absolute contraindication. Hypersensitivity is the regulatory term used to describe a potentially severe allergic reaction to a substance.


Q: Can Dihydrocodeine Wockhardt affect fertility?

Regulatory documentation notes that opioids, including this medicine, may influence the hypothalamic-pituitary-adrenal or –gonadal axes. This potential influence can cause hormonal changes, such as increases in serum prolactin and decreases in testosterone.


Q: Does the official research evidence support the drug's use for severe pain?

The clinical research evidence officially published for this medication examines its application in managing moderate to severe symptomatic pain, according to the official regulatory documents.


Q: Are there any limitations or caveats mentioned in the research about Dihydrocodeine Wockhardt?

Official research documents note several limitations and gaps. These include the limited number of high-quality clinical trials for certain uses, the fact that long-term effects on functional outcomes are not fully established, and that definitive findings for specific patient subgroups remain uncertain.

How should Dihydrocodeine Wockhardt be stored and disposed of?

Official Storage Requirements

Dihydrocodeine must be stored according to regulatory specifications to ensure stability and safety. The medicine should be kept in its original container at a temperature not exceeding 25°C.

As with all opioid medication, it is a mandatory safety requirement to store the product out of the sight and reach of children to prevent accidental ingestion.

Official Disposal Instructions

Expired or unused Dihydrocodeine must not be disposed of in household waste or flushed down wastewater. The official regulatory instruction is to discard the product according to local requirements for pharmaceutical waste. This typically involves returning the unused medicine to a pharmacist or local designated collection point.

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

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