Oxykom Plus

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Oxykom Plus

Treatment option: Pain

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Oxykom Plus

Quick Facts

Property Description
Active ingredients Acetaminophen, Oxycodone Hydrochloride
Form Oral Tablet
Pharmacological class Combination Opioid and Non-Opioid Analgesic
General purpose Management of Moderate to Severe Pain
Origin Synthetic (Semi-synthetic opioid derivative)

What Type of Medicine is Oxykom Plus?

Oxykom Plus is defined as a synthetic, fixed-dose combination analgesic administered as an oral Tablet. This medicine is a single pharmaceutical entity that unites two distinct active components for the purpose of comprehensive pain relief. The product's identity as a combination distinguishes it from single-ingredient preparations, ensuring a precise and simultaneous delivery of both agents. The need for the opioid component means it is exclusively a prescription-only medicine (Rx status), a differentiating factor from numerous over-the-counter pain relievers.

It is specifically classified as a narcotic analgesic combination. These combination products are used to relieve pain by acting on the central nervous system. This mechanism means that the medicine works by influencing the brain and nervous system to change how pain is felt.


Composition and Dual Action

The medicine is composed of the International Nonproprietary Name (INN) drugs Acetaminophen (a non-opioid analgesic) and Oxycodone Hydrochloride (an opioid analgesic). This dual composition is designed to address pain through two complementary mechanisms, a strategy clinically recognized for its superior efficacy in targeted patient populations.

The Acetaminophen component works by inhibiting chemical pain messengers in the body, while the Oxycodone component acts centrally on mu-opioid receptors to alter the perception of pain. The critical value of this combination is in providing effective relief for acute pain by utilizing both drugs together.


General Purpose of the Combination Analgesic

The general purpose of Oxykom Plus is to provide effective management for moderate to severe pain. It is intended for discomfort that requires treatment with an opioid and for which alternative, single-mechanism treatments have proven insufficient. This includes scenarios such as acute pain following a minor surgical procedure or short-term treatment for traumatic injury pain. The synergistic effect achieved by combining these two agents allows the medication to modulate and interrupt pain signals through two separate pathways simultaneously.

What side effects are possible with Oxykom Plus?

Possible Side Effects and Safety Information

The safety profile of this medicine is classified by regulatory authorities based on the expected occurrence and severity of adverse reactions associated with its combination of opioid (Oxycodone) and non-opioid (Acetaminophen) components.

Adverse Reaction Classification

Side effects are classified into categories according to frequency and the affected System Organ Class (SOC) as documented in official prescribing information.

Classification Examples of Reactions
Common Reactions Nausea, Vomiting, Constipation, Dizziness, Sedation, Headache, Pruritus.
System Organ Classes Gastrointestinal, Nervous System, Skin, and Psychiatric disorders.

Serious Adverse Reactions

The official labeling documents certain serious adverse reactions and risks inherent to the components.

  • Life-Threatening Respiratory Depression is a serious risk, particularly during treatment initiation or following a dosage increase, as documented by regulatory bodies.
  • Hepatotoxicity and Acute Liver Failure are associated with the Acetaminophen component. Official limitations warn against exceeding a maximum daily dose of 4,000 milligrams to mitigate this risk.
  • Risks related to the opioid component include the potential for Misuse, Abuse, and Addiction, and the possible occurrence of Adrenal Insufficiency or Serotonin Syndrome.

Contextual Safety Notes

The safety profile includes specific considerations for certain populations and duration of use. The risk of adverse effects is officially documented as being higher in Older Adults, who require cautious use. Furthermore, physical dependence and tolerance are recognized risks associated with repeated and long-term administration. The use of the medicine during pregnancy carries a documented risk of Neonatal Opioid Withdrawal Syndrome (NOWS).

Overdose and Emergency Response

Overdose and when to seek help

Overdose involving Oxykom Plus, a combination of Oxycodone and Acetaminophen, presents a dual-toxicity risk that requires immediate emergency action based on regulatory guidance.


Documented Manifestations

Component Toxicity Severe Outcomes Documented
Opioid (Oxycodone) Fatal respiratory depression, extreme somnolence, stupor, circulatory shock, and skeletal muscle flaccidity.
Non-Opioid (Acetaminophen) Potentially fatal hepatic necrosis and acute liver failure, often with initial symptoms like nausea, vomiting, or sweating, followed by delayed signs of jaundice.

When to Seek Urgent Help

Immediate medical attention must be sought for any known or suspected overdose, regardless of initial symptoms, due to the delayed onset of severe liver injury. Regulatory guidance advises contacting Poison Control and emergency services. Naloxone is the specific antagonist available for the opioid component, and N-acetylcysteine is the designated antidote for Acetaminophen toxicity. Monitoring and supportive measures, including maintaining a clear airway and continuous observation of vital signs, are required in a hospital setting. Elderly and debilitated patients, as well as children who ingest even one accidental dose, are considered at particular risk.

Therapeutic Uses of Oxykom Plus

What Oxykom Plus Treats: Main Uses and Benefits

Oxykom Plus is commonly used to help with pronounced symptoms in situations where patients experience symptoms related to physical discomfort that are difficult to tolerate. As such, this medication is applied across therapeutic domains where additional symptomatic support is needed.

The therapeutic benefit is relevant for easing challenging symptoms in conditions presenting with a significant symptomatic burden, such as managing acute pain after traumatic injuries or postoperative recovery, and offering supportive care for chronic, severe pain in settings like palliative care. It is applied in scenarios where additional management of discomfort is required. This medication is used in clinical settings that involve acute or unstable symptom patterns, contributing to improved comfort during episodes of heightened symptoms and assisting with maintaining a sense of stability.

Quick Fact: Symptomatic Support
Symptom Level Targeted Moderate to Severe Pain
Typical Contexts Postoperative, Post-Trauma, Palliative Care
Key Benefit Supports easing the overall symptom load

Regulatory References

  1. NIH MedlinePlus overview of Oxycodone Combination Products

Eligibility and Restrictions for Use

Who Can and Cannot Use Oxykom Plus?

Regulatory agencies define the eligibility for Oxykom Plus (Oxycodone and Acetaminophen combination) based on specific patient populations and pre-existing health conditions. This information strictly details who is allowed, restricted, or prohibited from using the medicine according to official governmental labeling.


Absolute Contraindications

Oxykom Plus is contraindicated (must not be used) in patients with a known hypersensitivity to oxycodone, acetaminophen, or any component of the formulation. It is also contraindicated for individuals experiencing significant respiratory depression, acute or severe bronchial asthma, or a known or suspected paralytic ileus.


Population Eligibility Rules

Population Group Regulatory Status
Adults (18+ ) Approved use for moderate to moderately severe pain.
Pediatric Patients Not recommended; safety and efficacy have not been established.
Older Adults Use requires caution due to increased risk of respiratory depression and organ impairment.
Pregnancy/Lactation Use is restricted to when benefits outweigh hazards (Pregnancy Category C); caution is advised during lactation.

Conditional Use Restrictions

Use requires caution in patients with severe hepatic function impairment (liver disease) or severe renal function impairment (kidney disease). Additionally, patients with head injury, hypothyroidism, Addison's disease, or prostatic hypertrophy are identified as 'Special Risk Patients' and must use the medicine under restricted conditions.

What should I know about interactions with other medicines?

Oxykom Plus, containing an opioid and acetaminophen, carries significant risks when taken with numerous other medicines or products, primarily due to the action of the opioid component.

Major Interaction Risks

Category Risk & Examples Mechanism
CNS Depressants Severe sedation, respiratory depression, coma, and death. Includes alcohol, benzodiazepines, other opioids, muscle relaxants, and general anesthetics. Additive central nervous system depressant effects.
MAO Inhibitors (MAOIs) Serotonin Syndrome and potential for respiratory compromise. Includes Isocarboxazid, Linezolid, Phenelzine. Potentiation of opioid effects; increased serotonin levels.
CYP3A4 Modifiers Increased oxycodone concentration (with inhibitors like Grapefruit Juice) or reduced concentration (with inducers like Rifampin). Altered metabolism via the Cytochrome P450 3A4 enzyme pathway.

Other Documented Interactions

  • Serotonergic Drugs: Use with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), and triptans may lead to Serotonin Syndrome.
  • Mixed Opioid Agonists/Antagonists: Products like Butorphanol or Nalbuphine may diminish the pain relief provided by Oxykom Plus or trigger withdrawal symptoms in physically dependent patients.
  • Other Acetaminophen-containing Products: Taking this product with any other medicine containing acetaminophen increases the risk of serious liver damage.

Mechanism of Action

Receptor-Mediated Signaling Modulation

Oxykom Plus functions primarily as an opioid receptor agonist, selectively engaging the mu (mu) opioid receptors located in the central nervous system (CNS). This molecular interaction activates the G-protein coupled receptor complex, initiating an intracellular signaling cascade that results in the inhibition of the enzyme adenylate cyclase. This early molecular step modifies the subsequent electrochemical properties of the targeted neurons.

Neurotransmitter Release Inhibition

Downstream of receptor engagement, the altered intracellular signaling modulates neuronal excitability by affecting voltage-gated ion channels. Specifically, this cascade promotes the increased efflux of potassium ions and the inhibition of calcium ion influx into the presynaptic terminal. This change in membrane potential and ion availability subsequently reduces the presynaptic release of excitatory neurotransmitters, notably Substance P, thereby modulating afferent neuronal pathway activity.

Dosage and Administration Information

How to Use Oxykom Plus

Oxykom Plus (a combination of oxycodone and acetaminophen) is administered strictly via the oral route as an immediate-release tablet. Its usage is governed by precise, high-level instructions defining dose frequency, maximum limits, and administration conditions, as outlined in official prescribing information.


Official Administration and Dosing

The standard adult regimen involves taking one tablet of the prescribed strength (e.g., 5 mg/325 mg or 10 mg/325 mg) every six hours as needed for pain, or one to two tablets of the lower strengths.

Usage Feature Official Guideline
Route Oral (Tablet)
Frequency Every six hours, as needed
Administration Timing May be taken with or without food
Maximum Dose Constraint The total daily dose of acetaminophen from all sources must not exceed 4,000 mg

Procedural Constraints and Course Duration

Official instructions require the tablet to be swallowed whole and explicitly prohibit crushing, chewing, or splitting. The guiding principle for use is to maintain the lowest effective dose for the shortest duration consistent with treatment goals. Furthermore, the dose must be gradually tapered upon discontinuation in physically dependent patients to mitigate withdrawal effects. In specific populations, such as older adults or those with hepatic impairment, a conservative approach to dose initiation and titration is required.

Recent Clinical Evidence

Research evidence / Overview of Studies for Oxykom Plus


Evidence for Use in Acute Postoperative Pain

This combination medicine was studied for conditions associated with acute or disruptive episodes, specifically outcomes related to physical discomfort. The core evidence comes from short-term, randomized controlled trials (RCTs) and systematic reviews that pooled data. These studies relevant in trials assessing short-term or episodic symptom patterns, such as discomfort following surgical procedures. Studies reported patterns where measurements of the time until participants requested additional pain medication were numerically lower, and patient-reported outcomes describing perceived discomfort showed changes measured during the study period compared to those who received a placebo.

Evidence for Other Acute Situations

The combination was evaluated in studies focusing on episodes where symptoms become more noticeable in emergency settings related to musculoskeletal injuries. In these research scenarios, data show patterns related to pain scores being numerically lower after treatment in the observed groups. However, findings were mixed when the combination was directly compared against certain non-opioid strategies in the same setting, and comparative evidence is lacking for many potential situations.

Evidence for Use in Certain Chronic Pain Situations

The combination was evaluated in studies examining conditions where symptoms may vary in intensity, such as chronic low back pain or pain in a palliative care setting. These trials often involved preliminary or open-label study designs without a placebo comparison. Studies report how symptoms evolved in the observed populations over periods of several weeks, but certainty remains low for long-term use across all chronic non-cancer pain, given these limitations.

Research Gaps and Limitations

The majority of high-quality research concentrates on short-term or episodic symptom patterns, meaning follow-up durations were limited in the most reliable efficacy trials. Long-term effects are not fully established for the combination, and data for certain groups remain insufficient. For instance, the available research provides context but not individual predictions, and subgroup findings are uncertain for older adults or pediatric populations.

Key Studies & References

  1. Oxycodone Combination Products (MedlinePlus Drug Information Overview)

Frequently Asked Questions (FAQ)

Common questions about Oxykom Plus (FAQ)

Q: What is Oxykom Plus and what is it used for?

A: Oxykom Plus is a combination medicine containing two active ingredients: Oxycodone hydrochloride and Naloxone hydrochloride.

  • Oxycodone is an opioid analgesic, which is used to relieve moderate to severe pain.
  • Naloxone is included in the tablet to counteract the effect of oxycodone on bowel function (constipation), a common side effect of opioid medications. When taken orally, the naloxone component has limited absorption into the bloodstream and acts mainly within the gastrointestinal tract. If the tablets are improperly crushed and injected, the naloxone would block the oxycodone’s effects, preventing abuse.

Oxykom Plus is prescribed for the treatment of severe chronic pain that is adequately managed only with opioid analgesics.


Q: How should I take Oxykom Plus?

A: You should always take Oxykom Plus exactly as your doctor or pharmacist has told you. The tablets are for oral use only.

  • Swallow the tablets whole with a sufficient amount of liquid.
  • Do not break, chew, crush, or dissolve the tablets, as this can lead to a rapid release and absorption of the full dose of oxycodone, which may be harmful and potentially fatal.
  • The tablets can be taken with or without food.
  • The usual starting dose is one tablet containing 5 mg of oxycodone hydrochloride and 2.5 mg of naloxone hydrochloride every 12 hours. Your doctor will adjust the dose as needed to achieve effective pain control.
  • Never stop taking this medicine suddenly without consulting your doctor.

Q: What are the possible side effects of Oxykom Plus?

A: Like all medicines, this medicine can cause side effects, although not everybody gets them. Common side effects (may affect more than 1 in 10 people) include:

  • Constipation (which the naloxone component is intended to reduce)
  • Nausea, vomiting
  • Dizziness, headache, drowsiness
  • Fatigue, feeling weak (asthenia)

Uncommon side effects (may affect up to 1 in 100 people) include:

  • Loss of appetite
  • Sleep disturbances, anxiety, nervousness
  • Dry mouth, abdominal pain, diarrhea, flatulence
  • Hot flushes

Serious side effects include difficulty breathing (respiratory depression). If you experience severe breathing difficulties, seek immediate medical attention. Due to the oxycodone component, there is a risk of developing physical dependence and addiction with long-term use. Talk to your doctor about managing the risks.


Q: Can I drink alcohol or take other medicines while on Oxykom Plus?

A: Do not drink alcohol while you are taking Oxykom Plus. Alcohol can increase the sedative effects of oxycodone, making you feel very sleepy or increasing the risk of serious side effects, such as breathing problems, which can be fatal.

Before starting treatment, tell your doctor or pharmacist if you are taking any other medications, especially:

  • Other strong pain killers (opioid medications)
  • Sedatives (like benzodiazepines or hypnotics)
  • Medicines for depression (e.g., MAO inhibitors or certain tricyclic antidepressants)
  • General anesthetics

Taking Oxykom Plus with these types of medicines may increase the risk of serious side effects and may cause severe drowsiness, decreased awareness, respiratory distress, and coma. Your doctor may need to adjust the dose of either medication.


Q: What should I do if I miss a dose of Oxykom Plus?

A: If you forget to take a dose, you should follow this guidance:

  • If your next regular dose is due in 8 hours or more, take the missed dose straight away and continue with your normal dosing schedule.
  • If your next regular dose is due in less than 8 hours, skip the missed dose and take the next dose at the scheduled time.

Do not take a double dose to make up for a forgotten tablet. If you are unsure, always consult your doctor or pharmacist.

How should Oxykom Plus be stored and disposed of?

How to Store and Dispose of Oxykom Plus?

The storage and disposal of this opioid-containing medicine are subject to specific regulatory requirements to ensure product stability and prevent accidental exposure or misuse.


Official Storage Requirements

  • Environment: The tablets must be kept at a Controlled Room Temperature (typically 20 C to 25 C) and protected from both excess heat and moisture.
  • Packaging: Store the medication only in its original container, ensuring the lid is tightly closed.
  • Security: Due to the risk of fatal accidental ingestion, the medication must be stored securely, completely out of the sight and reach of children and visitors, often in a locked cabinet.

Official Disposal Protocol

Regulatory agencies mandate the prompt disposal of any unused or expired tablets. The preferred disposal method is a drug take-back program or a medication collection site. If these options are not readily available, the medicine is explicitly designated for immediate flushing down the toilet to prevent accessibility, as it is classified as one of the few medications posing a high risk for accidental poisoning.

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

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