Duranzo

Quick links to important sections

Duranzo

Treatment option:

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 Duranzo

Quick Facts

Property Description
Active ingredients Codeine Phosphate, Diclofenac Sodium
Form Oral Tablet (Fixed-Dose Combination)
Pharmacological class Combined Analgesic (Opioid and NSAID)
General purpose Relief of moderate to severe pain
Origin Semi-synthetic (Codeine) and Synthetic (Diclofenac)

What Type of Medicine is Duranzo?

Duranzo is formally classified as a Combined Analgesic delivered as an Oral Tablet. It is a Fixed-Dose Combination (FDC) medicine, meaning it combines two distinct active substances into a single unit to ensure simultaneous therapeutic action. This formulation is composed of an Opioid Analgesic and a Nonsteroidal Anti-inflammatory Drug (NSAID). Its use is generally reserved for managing pain that cannot be adequately controlled by non-opioid, single-ingredient treatments alone.

Composition and Dual-Action Components

The active ingredients in Duranzo are Diclofenac Sodium and Codeine Phosphate. Diclofenac is a synthetic compound recognized for its anti-inflammatory properties, acting by inhibiting the production of mediators responsible for swelling and pain. Codeine is an alkaloid derivative, making it a semi-synthetic opioid derivative, which provides a central effect by modulating pain signals within the central nervous system. The combination ensures that the medicine addresses pain via both peripheral anti-inflammatory pathways and central nervous system modulation.

Why is a Combined Analgesic Used?

The general purpose of Duranzo is to provide relief for moderate to severe pain, which often benefits from two complementary mechanisms. This dual-action strategy allows the Diclofenac component to address underlying inflammation, while the Codeine component simultaneously increases the patient’s pain tolerance centrally. This approach is used in scenarios where pain is associated with both significant inflammation and the necessity of higher-level pain control.

Regulatory References

  1. Codeine: NIH/NCBI Study
  2. MedlinePlus Drug Information

What side effects are possible with Duranzo?

Possible Side Effects and Safety Information

Serious and Clinically Significant Adverse Reactions

The official labeling for Duranzo includes a BOXED WARNING regarding several life-threatening risks. These risks include Addiction, Abuse, and Misuse, as well as Life-Threatening Respiratory Depression, which is the most significant danger. The warning also covers Accidental Exposure (which can be fatal), Neonatal Opioid Withdrawal Syndrome in newborns, and the risks from drug interactions with Cytochrome P450 3A4 inhibitors/inducers or Benzodiazepines/CNS depressants, which can lead to profound sedation, coma, and death.

Other serious documented adverse reactions include Serotonin Syndrome, Adrenal Insufficiency, Severe Hypotension, and rare but severe Immune-Mediated Reactions (e.g., hepatitis, colitis).

Common Adverse Reactions

Adverse reactions reported in ge5% of patients include nausea, vomiting, dizziness, somnolence, insomnia, constipation, hyperhidrosis (excessive sweating), fatigue, feeling cold, anorexia, headache, and diarrhea.

Safety Considerations and Restrictions

  • Contraindications: Duranzo is contraindicated in patients who are opioid-naïve, those with significant respiratory depression, acute or severe asthma, or known/suspected gastrointestinal obstruction.
  • Population-Specific Risks: Increased risk of life-threatening respiratory depression exists for the elderly, debilitated patients, and those with chronic pulmonary disease; these patients require close monitoring.
  • Exposure Warning: The application site must not be exposed to direct external heat (e.g., heating pads, hot baths), as this increases drug absorption and can lead to a potentially fatal overdose. Severe hepatic or renal impairment generally necessitates avoiding the use of this medication.

Overdose and Emergency Response

The official regulatory profile for Duranzo overdose is defined by the toxicological effects of both the opioid (Codeine) and the Nonsteroidal Anti-inflammatory Drug (Diclofenac) components, as documented in authoritative government sources.

Documented Overdose Presentations

Overdose manifestations include signs of Central Nervous System (CNS) depression, such as profound somnolence and miosis (pinpoint pupils), and potentially life-threatening respiratory depression. Other documented signs may include hypotension, epigastric pain, and tinnitus.

Severe Outcomes and Emergency Action

Severe or life-threatening outcomes documented in regulatory labeling include respiratory arrest, coma, acute renal failure, and signs of hepatic damage. Emergency medical attention is required immediately upon suspicion of overdose or if any associated manifestations, particularly difficulty breathing or loss of consciousness, occur. Regulatory authorities mandate that emergency services be contacted immediately.

Management and Monitoring

Management involves symptomatic and supportive treatment. A specific opioid antagonist is described for use to counteract the respiratory effects of the Codeine component; however, no specific antidote is known for the Diclofenac component. Monitoring of cardiorespiratory function as well as renal and hepatic function is required. The labeling notes that the risk of severe toxicity may be increased in the elderly and in patients with pre-existing hepatic or renal impairment.

Therapeutic Uses of Duranzo

Duranzo is commonly used to help manage symptoms related to physical discomfort and inflammatory or irritative states. It is applied in contexts where additional symptomatic support is needed. This medication is used in clinical settings that involve acute or unstable symptom patterns.

This combination is considered relevant in conditions characterized by periods of heightened symptoms, such as Rheumatoid Arthritis and severe Osteoarthritis. It is also applicable within clinical settings that involve acute or disruptive symptom patterns like post-operative pain and localized episodes. The medication is commonly used to help with clusters of pronounced pain, swelling, and tenderness. It provides support that helps manage the symptom load and may assist with maintaining functional stability. The medication is relevant for managing symptoms that interfere with daily comfort and create noticeable functional strain. It contributes to easing distress and supporting general well-being during symptomatic periods.


Quick Fact: Therapeutic Scope: Management of Moderate to Severe Symptoms

Clinical Context Target Symptoms Therapeutic Role
Inflammatory Conditions Pronounced pain, swelling, tenderness Relevant for easing symptoms in chronic contexts
Acute Pain Episodes Symptoms that become disruptive during flare-ups Relevant when short-term symptomatic assistance is needed
Functional Strain Symptoms that interfere with daily comfort Helps manage the symptom load

Regulatory References

  1. ClinicalTrials.gov overview on Diclofenac and Codeine

Eligibility and Restrictions for Use

Official Eligibility and Contraindication Profile

Duranzo (Drospirenone Chewable Tablets) is approved for use by females of reproductive potential. The official regulatory profile establishes a clear set of absolute exclusions based on specific health conditions, primarily due to the drug's anti-mineralocorticoid activity and hormonal properties.

Populations Who Must Not Use Duranzo (Contraindications)

Contraindicated Group Reason for Exclusion (Regulatory Basis)
Organ Function Renal impairment, adrenal insufficiency, or hepatic impairment (including liver tumors, benign or malignant) due to risk of hyperkalemia.
Cancer History Presence or history of progestin-sensitive cancers (e.g., breast cancer).
Physiological Status Undiagnosed abnormal uterine bleeding or known pregnancy (must discontinue if pregnancy occurs).

Age and Conditional Use Rules

Use is not established for the indicated purpose in geriatric patients (age 65 and older). The medicine is contraindicated in any patient with a pre-existing condition that predisposes to hyperkalemia. Additionally, individuals on long-term treatment with medications that may increase serum potassium concentration require serum potassium monitoring before starting and during the first cycle.

What should I know about interactions with other medicines?

The regulatory profile for Duranzo, combining an Opioid (Codeine) and an NSAID (Diclofenac), details several categories of clinically significant interactions as documented by government health authorities.

Formal Contraindications and Restrictions

Duranzo is formally restricted from co-administration with other systemic nonsteroidal anti-inflammatory drugs (NSAIDs) due to the risk of additive gastrointestinal and renal adverse effects. Use is also contraindicated for perioperative pain in the setting of Coronary Artery Bypass Graft (CABG) surgery. Additionally, co-administration with Monoamine Oxidase Inhibitors (MAOIs) is prohibited; a mandatory 14-day separation period is required after stopping the MAOI.

Pharmacokinetic and Exposure Effects

Interactions related to drug metabolism are documented. CYP2D6 inhibitors can reduce the conversion of codeine to its active metabolite, potentially resulting in reduced analgesic effect. Conversely, CYP3A4 inhibitors may increase codeine plasma concentration, raising the risk of opioid toxicity. Separately, the Diclofenac component’s exposure can be significantly increased by certain inhibitors like Voriconazole, and it may also increase the serum concentration of Digoxin.

Pharmacodynamic Risk Reinforcement

The combination carries a documented risk of additive effects. Co-administration with Central Nervous System (CNS) depressants, including alcohol, can result in profound sedation, respiratory depression, and related severe outcomes. Furthermore, combining Duranzo with anticoagulants (such as Warfarin) or anti-platelet agents increases the risk of serious gastrointestinal bleeding. Diclofenac may also diminish the therapeutic effects of Antihypertensives and Diuretics.

Mechanism of Action

How Duranzo Works

Duranzo exerts its effects through two independent, non-overlapping mechanistic domains targeting distinct physiological processes.

Interaction with Signaling Pathways

The first component operates through the inhibition of cyclooxygenase (COX) enzymes, specifically COX-1 and COX-2. COX enzymes catalyze the conversion of arachidonic acid into prostanoids, including prostaglandins. Inhibition of this enzymatic step modifies early molecular events that govern local tissue responses, reducing the formation of these downstream lipid mediators.

Modulation of Neurotransmitter Dynamics

The second component acts within the central nervous system (CNS) by engaging specific neurotransmitter receptors and simultaneously inhibiting the reuptake of key monoamines, namely serotonin and norepinephrine, from the synaptic cleft. This dual interaction alters the signaling sequences involved in afferent nociceptive transmission. The resulting increase in synaptic monoamine concentrations modulates descending inhibitory pathways, leading to an alteration in overall systemic physiological output.

Dosage and Administration Information

Administration Guidelines

Duranzo is formulated as an oral tablet and is intended to be administered by swallowing the unit whole. If the tablet incorporates a controlled-release component, such as an enteric-coated Diclofenac, it must not be crushed, split, or chewed. The medicine is utilized in an as-needed fashion to manage symptoms, with doses typically repeated every 4 to 6 hours.

Guidelines limit the total daily intake of both active components. The Diclofenac portion must not exceed 150 mg per day, and the Codeine component's daily limit is generally set between 240 mg and 300 mg. Administration can occur with or without food as practical usage instructions permit.

Usage follows the principle of employing the lowest effective dose for the shortest possible duration. For the management of acute pain, treatment should not normally exceed 3 days. Furthermore, specific rules apply to certain populations: older adults and patients with diagnosed hepatic or renal impairment are administered a reduced dose to accommodate physiological changes in drug metabolism and clearance. These parameters describe the approach to using the medicine.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Duranzo

Overview of Research on Moderate to Severe Pain

Research into this combination was studied for use in populations whose pain was described as not adequately controlled by single, non-opioid medications. Much of the evidence supporting this general indication comes from pharmacological studies that examine the drug's metabolism, as well as regulatory and clinical setting overviews that define its place in research. The outcomes that research examined primarily relate to measurements of pain intensity and overall symptom change scores. Pharmacological research indicates that findings show patterns related to differing individual responses to the codeine component, which may influence the patterns measured in studies.

Evidence for Use in Acute Pain Episodes and Post-operative Settings

The research structure for this combination was observed in short-term, controlled clinical trials (such as randomized controlled trials (RCTs)). For example, the drug was studied for pain management following procedures like third molar (wisdom tooth) extraction, a procedure often used in research to evaluate acute pain. Research examined outcomes related to physical discomfort, specifically by monitoring pain intensity scores and recording how quickly and how often patients needed to take any rescue pain medication. Findings indicate patterns of symptom change measured over a short period.

Evidence Gaps and Areas of Uncertainty

Follow-up durations were limited for the combination overall. The available evidence provides context into immediate responses, but data for long-term outcomes and the study of repeated exposure remain insufficient. One significant gap relates to the variability in individual responses observed in studies, and research is still exploring this aspect. Furthermore, comparative evidence is lacking for the fixed-dose combination against all other available combination pain medications used for moderate to severe pain. Data for certain subgroups, such as children or older adults, remain insufficient, meaning subgroup findings are uncertain.

Key Studies & References

  1. COMPARISON OF EFFICACY OF DIFFERENT DRUG COMBINATIONS IN ACUTE SCIATICA (ClinicalTrials.gov Identifier: NCT05626140)

Frequently Asked Questions (FAQ)

Common questions about Duranzo (FAQ)


Q: How long does it typically take for Duranzo to start working?

The absorption of the Diclofenac component may have an onset delay of approximately 1 to 4.5 hours after the oral tablet is administered. The medicine is intended for short-term relief, with doses repeated every 4 to 6 hours in a manner consistent with its recommended duration of action.


Q: Is it possible to become dependent on Duranzo?

Official product information regarding the opioid component (Codeine) states that physical dependence is an expected physiological adaptation that can occur during treatment. This physiological state is distinct from addiction, which is characterized by a loss of control over drug use. Regulatory guidance indicates that discontinuation of the medication requires management by a healthcare provider.


Q: Are there any specific foods or drinks I should avoid while taking Duranzo?

The combination of Duranzo and alcohol is subject to a formal warning and should be avoided due to the risk of severe outcomes, including profound sedation and respiratory depression. While administration can occur with or without food, this specific interaction with alcohol is noted in the regulatory documents.


Q: Is Duranzo safe to take long-term?

Official prescribing information for acute pain typically defines the treatment period as not normally exceeding three days. Furthermore, research evidence is insufficient to assess long-term outcomes or the effects of repeated exposure to the drug.


Q: Why do some people say Duranzo didn't work for them?

Studies and official information indicate that there are patterns related to differing individual responses to the codeine component of the medication. This variability in how the body processes Codeine may influence the level of effectiveness experienced by individual patients.


Q: Is there a risk of withdrawal symptoms when stopping Duranzo?

If physical dependence develops with use, withdrawal symptoms may occur if the medication is abruptly discontinued. Regulatory guidance indicates that the process of discontinuing this medication requires management by a healthcare provider.


Q: What is the difference between Duranzo and a placebo in clinical trials?

Research into this combination medicine was conducted in short-term, controlled clinical trials to assess the drug's effect. The outcomes examined primarily related to measurements of pain intensity and overall symptom change scores when compared to control groups.


Q: What kind of monitoring is typically involved when taking Duranzo?

Regulatory labeling describes the necessity of close monitoring for patients with certain risk factors, such as the elderly or those who are debilitated, due to the increased risk of life-threatening respiratory depression. Official guidelines outline that patients with diagnosed kidney or liver impairment may require a reduced dose to account for physiological changes in drug clearance.


Q: Is the feeling of [Common side effect, e.g., mild dizziness] normal when starting Duranzo?

Adverse reactions such as dizziness, somnolence (drowsiness), nausea, and headache are listed among the common adverse reactions reported in clinical trials (in ge5% of patients). The presence of these effects is documented in the official safety information for the product.


Q: What if Duranzo stops seeming to work after a while?

The potential for tolerance, where a patient may require an increased dose to achieve the same effect, is associated with the opioid component. This development is part of the serious risks addressed in the BOXED WARNING for Addiction, Abuse, and Misuse.


Q: What are the common signs of an overdose with Duranzo?

The most significant danger associated with overdose is life-threatening respiratory depression. Signs may include shallow or slow breathing, profound sedation, extreme sleepiness, or unresponsiveness. These symptoms are listed in the regulatory documents as serious adverse events.


Q: Can Duranzo cause weight gain or weight loss?

Official drug labeling for the Diclofenac component lists weight changes among the possible metabolic and nutritional adverse experiences documented in regulatory reporting.


Q: Can people with [Common chronic condition, e.g., high blood pressure] use Duranzo?

The Diclofenac component can cause new or worsening hypertension (high blood pressure) and may reduce the effectiveness of blood pressure medications. Official prescribing information notes that monitoring is necessary for patients with hypertension.


Q: Does Duranzo cause any common allergic reactions?

The medication is strictly contraindicated in patients who have a history of asthma, hives, or other allergic-type reactions after taking aspirin or other NSAIDs. Rare but severe immune-mediated reactions are also documented in official sources.


Q: Can Duranzo be prescribed to individuals under 18?

Regulatory documents state that the product is strictly contraindicated in children younger than 12 years of age. Regulatory documents recommend avoiding use in adolescents aged 12 to 18 who have specific risk factors that increase sensitivity to the opioid component.


Q: Can people with severe allergies take Duranzo?

The medicine is contraindicated in patients with known hypersensitivity, which includes severe allergies, to diclofenac or any components of the drug product. This is based on the risk of allergic-type reactions following the use of aspirin or other NSAIDs.


Q: Are there specific lifestyle changes mentioned alongside Duranzo use?

Official safety warnings include a restriction on co-administration with alcohol due to the risk of severe respiratory depression and profound sedation. There are also warnings against exposing the application site to direct external heat, such as heating pads or hot baths.


Q: Does Duranzo cause sun sensitivity?

Photosensitivity, which is an increased sensitivity of the skin to sunlight, is listed as an adverse reaction for the Diclofenac component in the official drug labeling. The official drug labeling lists this potential adverse reaction.

How should Duranzo be stored and disposed of?

Storage and Disposal Requirements

Duranzo tablets must be stored at Controlled Room Temperature, specifically between 20 C and 25 C (68 F to 77 F), with limited allowances for temperature excursions. The medicine must be kept in its original container, tightly closed, and protected from both light and moisture. It is prohibited to refrigerate or freeze the tablets.

Due to the Codeine component, the product must be stored in a secure, locked location and kept strictly out of the sight and reach of children to prevent fatal accidental ingestion.

Disposal must follow local, national, and international regulations. The preferred method is using an authorized Drug Take-Back Program. If this is not available, regulatory guidance for high-risk opioid products instructs that the tablets be flushed down the toilet to immediately remove the risk of accidental exposure.

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

Equivalent of Duranzo found in:

A-Z Index: