Oxycodone Kalceks 10 mg/ml
Solution for injection or infusion — strong opioid analgesic for moderate to severe pain
Oxycodone Kalceks 10 mg/ml is a sterile solution for injection or infusion that contains the strong opioid analgesic oxycodone hydrochloride. It is used in hospital and palliative-care settings to treat moderate to severe pain that cannot be adequately controlled with non-opioid analgesics or oral opioids. Because Oxycodone Kalceks is a parenteral formulation, it is administered by a qualified healthcare professional, most commonly by intravenous, subcutaneous or intramuscular injection, or as a continuous infusion through a syringe pump or patient-controlled analgesia (PCA) device. Like all opioids, it must be used under close medical supervision due to the risk of respiratory depression, addiction, and other serious adverse effects.
Quick Facts
Key Takeaways
- Oxycodone Kalceks 10 mg/ml is a parenteral opioid given only by healthcare professionals for moderate to severe pain in supervised clinical settings.
- It can be administered intravenously, subcutaneously, intramuscularly, or as a continuous infusion — including through patient-controlled analgesia (PCA) pumps.
- The intravenous route produces the fastest onset; doses are titrated carefully, particularly in opioid-naive patients, elderly people, and those with impaired lung, kidney, or liver function.
- The most serious risk is respiratory depression, which is potentiated by benzodiazepines, alcohol, and other CNS depressants — monitoring of respiratory rate, oxygen saturation, and sedation level is essential.
- Oxycodone Kalceks is a Schedule II / Schedule 2 controlled substance; when treatment is no longer required, the dose must be tapered gradually to prevent withdrawal.
What Is Oxycodone Kalceks and What Is It Used For?
Quick Answer: Oxycodone Kalceks is a clear, sterile solution containing 10 mg of oxycodone hydrochloride per millilitre, supplied in ampoules or vials for injection or infusion. It is indicated for the treatment of moderate to severe pain in adults and adolescents aged 12 years and over, including post-operative pain, acute pain crises, and cancer-related pain, when an oral opioid is not suitable or a faster onset is required.
Oxycodone is a semi-synthetic opioid analgesic that belongs to the phenanthrene class of alkaloids, chemically related to thebaine. It is a full agonist at mu-opioid receptors in the brain, spinal cord, and peripheral tissues. By activating these receptors, oxycodone inhibits the transmission of pain signals along ascending pathways in the central nervous system and modifies the way pain is perceived and the emotional response it provokes. In parenteral form, the onset of analgesia is substantially faster than with oral preparations: after intravenous injection, clinically meaningful pain relief typically begins within a few minutes.
Oxycodone Kalceks is formulated specifically for parenteral administration. It is used when oral therapy is impossible or undesirable — for example, in patients who are unable to swallow, who have nausea or vomiting, who have compromised gastrointestinal absorption, or who require rapid titration of analgesia under direct medical supervision. Typical clinical situations include immediate post-operative care, trauma, acute myocardial ischaemia, severe cancer pain, breakthrough pain in palliative care, and the initial phase of opioid therapy in hospital before transitioning to an oral or transdermal formulation.
Because the parenteral route bypasses first-pass metabolism in the liver, the bioavailability of intravenous oxycodone is effectively 100 per cent, compared with about 60 to 87 per cent following oral administration. As a result, parenteral doses are lower than equivalent oral doses. A widely used approximation is that 1 mg of intravenous oxycodone is equivalent to approximately 2 mg of oral oxycodone, although individual variability and clinical context must always be considered when making dose conversions.
Oxycodone is classified as a controlled substance in virtually every country because of its potential for abuse, misuse, and dependence. In the United States it is listed as a Schedule II controlled substance under the Controlled Substances Act; in the United Kingdom it is a Schedule 2 controlled drug under the Misuse of Drugs Regulations; and in the European Union it is subject to national narcotic drug laws. These classifications reflect its accepted medical utility alongside its recognised addiction potential, and they impose strict record-keeping, storage, and prescription requirements on the healthcare institutions that use it.
Oxycodone Kalceks is manufactured by AS Kalceks, a Latvia-based pharmaceutical company specialising in sterile injectable medicines, and is marketed in several European countries as a generic hospital analgesic. Its composition and quality standards comply with the European Pharmacopoeia and the applicable product information approved by national medicines regulators. Although the brand name refers to the manufacturer, the active substance and clinical profile are identical to other oxycodone hydrochloride injections.
What Should You Know Before Receiving Oxycodone Kalceks?
Quick Answer: Before Oxycodone Kalceks is administered, your healthcare team will review your medical history and all current medications. It must not be given if you have severe respiratory depression, severe chronic lung disease, paralytic ileus, an acute abdomen, or a known hypersensitivity to opioids. Many other conditions require caution and dose reduction, and any history of substance use disorder must be disclosed.
Contraindications
Oxycodone Kalceks must not be administered in the following situations:
- Hypersensitivity to oxycodone hydrochloride or to any of the excipients of the solution (including citric acid, sodium citrate, sodium chloride and water for injection).
- Severe respiratory depression with hypoxia (low blood oxygen) or hypercapnia (elevated carbon dioxide).
- Severe chronic obstructive pulmonary disease (COPD), cor pulmonale, and other conditions that severely compromise breathing.
- Acute or severe bronchial asthma, particularly in environments without resuscitation equipment or respiratory monitoring.
- Paralytic ileus or any known or suspected mechanical bowel obstruction.
- Acute abdomen or delayed gastric emptying when the diagnosis is not yet established, because opioids can mask symptoms.
- Raised intracranial pressure or head injury where the clinical picture cannot be reliably assessed.
- Moderate to severe hepatic impairment requires particular caution and may contraindicate use in individual cases.
Warnings and Precautions
Before starting Oxycodone Kalceks, your clinician will carry out a full risk assessment. Particular caution, dose adjustment, and close monitoring are required if you have or have had any of the following conditions:
- Advanced age or debility, as elderly patients are more sensitive to the sedative and respiratory-depressant effects of opioids.
- Impaired pulmonary function, including chronic bronchitis, emphysema, and sleep apnoea syndromes.
- Impaired renal or hepatic function, which can prolong the half-life of oxycodone and its metabolites and increase the risk of accumulation.
- Hypothyroidism, adrenal insufficiency (for example Addison's disease), or prostatic hypertrophy with urinary retention.
- Inflammatory or obstructive bowel disease, biliary tract disease, pancreatitis, or Sphincter of Oddi dysfunction.
- Hypotension, hypovolaemia, or cardiovascular instability, as oxycodone may cause peripheral vasodilation and hypotension.
- Seizure disorders or a history of seizures, because opioids may lower the seizure threshold.
- Psychiatric disorders, depression, anxiety, or psychosis, particularly those triggered or exacerbated by substance misuse.
- A personal or family history of alcohol or drug dependence, as the risk of misuse is elevated.
- Concurrent treatment with other CNS depressants, MAO inhibitors, or serotonergic agents (see the drug interactions section below).
Even when used as prescribed under medical supervision, Oxycodone Kalceks carries a serious risk of addiction (opioid use disorder), physical dependence, and tolerance. Risk is elevated in patients with a personal or family history of substance misuse, those who smoke, and those with certain mental health conditions. Parenteral opioids are attractive targets for diversion and must be handled according to controlled-substance protocols in every clinical environment. Discharge planning should always include a structured tapering schedule and a plan for safe disposal of any remaining supply.
Respiratory depression — characterised by a slow respiratory rate, reduced tidal volume, and impaired gas exchange — is the most serious dose-related adverse effect of all opioids, including Oxycodone Kalceks. The risk is greatest at the start of treatment, after any dose increase, when switching from another opioid, and when oxycodone is combined with benzodiazepines, alcohol, sedatives, general anaesthetics, or other opioids. Continuous monitoring of respiratory rate, oxygen saturation, and level of consciousness is essential, particularly during the first 24 hours of therapy, in elderly or debilitated patients, and whenever the route of administration is intravenous.
Pregnancy and Breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, inform your doctor before Oxycodone Kalceks is given. Opioids cross the placental barrier and pass into breast milk.
Pregnancy: Oxycodone Kalceks should only be used during pregnancy if the expected benefit clearly outweighs the potential risks to the fetus. Data on its safety in pregnancy are limited. Chronic opioid exposure during pregnancy can cause neonatal opioid withdrawal syndrome (NOWS), which presents with irritability, hypertonia, tremor, high-pitched cry, feeding difficulties, sweating, sneezing, vomiting, and diarrhoea, and may be life-threatening without recognition and treatment. Use during the last trimester or during labour may cause respiratory depression in the newborn that requires naloxone and supportive measures.
Breastfeeding: Oxycodone and its metabolites are excreted into human milk. Infants of breastfeeding mothers receiving opioids may experience sedation, respiratory depression, and poor feeding. Breastfeeding is generally not recommended during Oxycodone Kalceks therapy. If a single or very short course is unavoidable, the infant should be observed closely for signs of opioid effects.
Driving and Operating Machinery
Oxycodone Kalceks can markedly impair the ability to drive vehicles or operate machinery. Patients who have received parenteral oxycodone must not drive for at least 24 hours after the last dose, and longer if drowsiness, dizziness, or visual disturbances persist. During ongoing therapy, the decision on when driving can safely resume should be made individually with your physician.
Children Under 12 Years
The safety and efficacy of Oxycodone Kalceks in children under 12 years of age have not been established. Its use in this age group is generally restricted to specialist paediatric palliative care or acute post-operative settings, where dosing is strictly individualised and monitoring is continuous.
How Does Oxycodone Kalceks Interact with Other Drugs?
Quick Answer: Oxycodone Kalceks interacts with many medications. The most dangerous interactions are with benzodiazepines, alcohol, and other CNS depressants, which can cause life-threatening respiratory depression. MAO inhibitors, CYP3A4 inhibitors/inducers, and serotonergic drugs (SSRIs, SNRIs, tramadol) also have clinically significant interactions. A full medication review is essential before the first dose.
Oxycodone is metabolised predominantly in the liver by cytochrome P450 enzymes, mainly CYP3A4 (to noroxycodone) and CYP2D6 (to the more potent metabolite oxymorphone). Medications that inhibit or induce these enzymes can significantly alter oxycodone plasma concentrations, either intensifying opioid effects or reducing analgesia. Additionally, any medication that depresses the central nervous system can produce additive or synergistic sedation, respiratory depression, and hypotension when combined with Oxycodone Kalceks.
Co-administration of Oxycodone Kalceks with benzodiazepines (such as diazepam, lorazepam, midazolam, or alprazolam) or other CNS depressants (sedative-hypnotics, gabapentinoids, muscle relaxants, sedating antihistamines, alcohol, or general anaesthetics) dramatically increases the risk of profound sedation, respiratory depression, coma, and death. When such combinations are unavoidable — for example, during anaesthesia — the lowest effective doses and the shortest duration should be used, with continuous monitoring.
Major Interactions
| Drug / Drug Class | Effect | Clinical Significance |
|---|---|---|
| Benzodiazepines (diazepam, lorazepam, midazolam, alprazolam) | Additive CNS and respiratory depression | Life-threatening; avoid unless clearly necessary. Use lowest doses and monitor continuously. |
| MAO Inhibitors (tranylcypromine, phenelzine, moclobemide, linezolid, methylene blue) | Unpredictable severe reactions including serotonin syndrome and CNS excitation or depression | Contraindicated within 14 days of MAO inhibitor use. |
| Alcohol | Enhanced CNS depression | Strictly prohibited. Can cause fatal respiratory depression and loss of consciousness. |
| CYP3A4 Inhibitors (ketoconazole, itraconazole, voriconazole, clarithromycin, ritonavir) | Increased oxycodone plasma concentrations | May increase or prolong opioid effects including respiratory depression. Dose reduction usually required. |
| CYP3A4 Inducers (rifampicin, rifabutin, carbamazepine, phenytoin, St John's wort) | Decreased oxycodone plasma concentrations | May reduce analgesic effect; dose adjustment or alternative opioid may be needed. |
| Serotonergic drugs (SSRIs, SNRIs: fluoxetine, paroxetine, sertraline, venlafaxine, duloxetine; tramadol, linezolid) | Risk of serotonin syndrome | May cause agitation, hyperthermia, tremor, muscle rigidity, hyperreflexia, autonomic instability. |
| Other opioid analgesics (morphine, fentanyl, tramadol, codeine) | Additive CNS and respiratory depression | Avoid duplication. Equianalgesic conversion required if switching. |
| Mixed opioid agonist-antagonists (buprenorphine, nalbuphine, pentazocine) | Reduced analgesic effect of oxycodone and potential precipitation of withdrawal | Avoid concurrent use. |
Other Notable Interactions
| Drug / Drug Class | Effect | Recommendation |
|---|---|---|
| Muscle relaxants | Enhanced sedation and respiratory depression | Monitor closely; dose reduction may be needed. |
| Sedating antihistamines (promethazine, hydroxyzine) | Increased drowsiness and CNS depression | Use non-sedating alternatives where possible. |
| Antipsychotics and neuroleptics | Enhanced sedation and hypotension | Monitor blood pressure and level of sedation. |
| Gabapentin and pregabalin | Increased risk of CNS and respiratory depression | Use lowest effective doses; monitor. |
| Cimetidine | May inhibit oxycodone metabolism | Monitor for increased opioid effects. |
| Coumarin anticoagulants (warfarin) | Potential changes in anticoagulant effect | Monitor INR closely when starting or stopping oxycodone. |
| Grapefruit juice | CYP3A4 inhibition may increase oxycodone plasma levels | Avoid grapefruit juice during treatment. |
| Quinidine | Decreases CYP2D6-mediated metabolism | Clinical significance generally minor; observe for altered response. |
Oxycodone Kalceks 10 mg/ml solution for injection can typically be diluted in 0.9% sodium chloride, 5% glucose, or water for injection for continuous infusion. It should not be mixed in the same syringe with alkaline solutions, thiopental, or phenytoin because of potential precipitation. Always consult the official product information and local hospital guidelines before preparing infusions or mixtures.
What Is the Correct Dosage of Oxycodone Kalceks?
Quick Answer: Dosing of Oxycodone Kalceks is strictly individualised by a physician. Typical adult starting doses are 1 to 10 mg by slow intravenous injection over 1 to 2 minutes, repeated every 4 hours as required. For continuous infusions, a typical starting rate is 2 mg per hour, titrated to effect. Subcutaneous and intramuscular doses are generally 5 mg every 4 hours, adjusted to response. Doses are reduced in elderly patients and in those with hepatic or renal impairment.
Oxycodone Kalceks must be prepared and administered only by healthcare professionals familiar with opioid pharmacology and with the management of opioid-related adverse events, including the availability of naloxone and resuscitation equipment. The dose is determined by the intensity of the pain, the patient's prior opioid exposure, body weight, age, and coexisting conditions. The principle of start low and go slow applies particularly to opioid-naive patients, the elderly, and patients with impaired hepatic or renal function.
Adults and Adolescents (12 Years and Older)
Intravenous (IV) Bolus Injection
- Opioid-naive adults: 1–10 mg given by slow intravenous injection over 1 to 2 minutes. The typical starting dose is 2 mg, repeated at intervals of not less than 4 hours as required.
- Post-operative titration: 1–3 mg incrementally every 5 to 10 minutes until adequate analgesia is achieved, with continuous monitoring.
- Do not administer more often than every 4 hours for routine dosing outside a titration or PCA setting.
Continuous Intravenous Infusion
- Typical starting rate: 2 mg/hour, adjusted according to the patient's response.
- Solutions may be diluted to 1 mg/ml in 0.9% sodium chloride or 5% glucose before infusion.
- Patient-controlled analgesia (PCA) regimens typically use a bolus dose of 0.03 mg/kg with a lock-out interval of 5 to 10 minutes.
Subcutaneous (SC) Administration
- Opioid-naive adults: 5 mg every 4 hours as required, titrated to pain relief.
- Continuous subcutaneous infusion: 7.5 mg/day initially, titrated to effect. Useful in palliative care when IV access is not feasible.
Intramuscular (IM) Administration
- Rarely used in modern practice but may be considered where IV or SC routes are unavailable. Typical dose 5 mg every 4 hours as required.
| Patient Group | Starting Dose | Typical Range | Notes |
|---|---|---|---|
| Opioid-naive adult (IV) | 1–2 mg slow IV, titrated | 1–10 mg every 4 h | Start low; monitor respiratory rate and sedation |
| Opioid-naive adult (SC/IM) | 5 mg every 4 h | 5–10 mg every 4 h | SC route preferred over IM in palliative care |
| Continuous IV infusion | 2 mg/h | Titrate to response | Dilute to 1 mg/ml in 0.9% NaCl or 5% glucose |
| PCA bolus | 0.03 mg/kg | Lock-out 5–10 min | Individualised for post-operative pain |
| Opioid-tolerant adult (cancer pain) | Based on prior opioid dose | Equianalgesic conversion | 1 mg IV approx. 2 mg oral oxycodone |
| Elderly or debilitated | 25–50% dose reduction | Individualised | Increased sensitivity to respiratory depression |
| Mild-moderate hepatic impairment | One-third to one-half of standard dose | Individualised | Reduced metabolism; monitor closely |
| Renal impairment (CrCl < 60 ml/min) | 50% dose reduction | Individualised | Accumulation of metabolites may occur |
| Adolescents 12–17 years | Specialist supervision | Individualised | Use only when alternatives are unsuitable |
Duration of Treatment
Parenteral oxycodone is usually given for the shortest duration necessary to control acute pain, typically a few days in the post-operative setting. Patients requiring longer-term opioid therapy are usually converted to an oral or transdermal formulation once their clinical condition is stable and they can tolerate enteral medication. The total daily parenteral dose is used to calculate the equianalgesic dose of the oral long-acting opioid, with a conservative reduction of approximately 25 to 50 per cent to allow for incomplete cross-tolerance.
Missed Dose
Because Oxycodone Kalceks is administered only by healthcare professionals, missed doses are unusual in clinical practice. If a scheduled dose is omitted, the clinical team will reassess pain control and administer the next dose according to the patient's current analgesic needs. A double dose must never be given to compensate for a missed one.
Overdose
Opioid overdose is a medical emergency. Seek immediate emergency help if an overdose is suspected. Signs and symptoms of Oxycodone Kalceks overdose include:
- Pinpoint pupils (miosis)
- Slow, shallow, or absent breathing (respiratory depression)
- Extreme drowsiness progressing to unresponsiveness
- Reduced muscle tone (skeletal muscle flaccidity)
- Dangerously low blood pressure (hypotension)
- Slow heart rate (bradycardia)
- Cold, clammy skin; cyanosis of lips and fingertips
- In severe cases: circulatory collapse, pulmonary oedema, coma, and death
Immediate treatment involves administration of the opioid antagonist naloxone (typically 0.4–2 mg intravenously, repeated every 2 to 3 minutes as needed) together with supportive measures including airway management, assisted ventilation, oxygen, and circulatory support. Because naloxone has a shorter half-life than oxycodone, repeated doses or continuous infusion may be required. Patients should be observed for a sufficient period to ensure that the effects of the opioid do not outlast the effects of naloxone.
What Are the Side Effects of Oxycodone Kalceks?
Quick Answer: The most frequent side effects of Oxycodone Kalceks include drowsiness, nausea, vomiting, constipation, dizziness, and headache. The most dangerous adverse effect is respiratory depression, which can be fatal. Local injection-site reactions may also occur. Seek emergency help for sudden difficulty breathing, severe allergic reactions, or loss of consciousness.
Like all medicines, Oxycodone Kalceks can cause adverse effects, though not everyone will experience them. The adverse event profile of parenteral oxycodone is similar to that of other strong opioids, with some differences due to the faster onset and higher peak plasma concentrations of intravenous administration. The side effects below are grouped by frequency according to clinical trial data and post-marketing surveillance of oxycodone-containing injections.
- Sudden shortness of breath, swelling of the face, lips or tongue, or widespread hives (signs of severe allergic reaction or anaphylaxis)
- Very slow, shallow, or stopped breathing (respiratory depression)
- Marked confusion, inability to stay awake, or loss of consciousness
- Sudden drop in blood pressure, fainting, or chest pain
- Severe rigidity of the muscles with high fever (signs of serotonin syndrome when combined with certain antidepressants)
Very Common
Affects more than 1 in 10 people
- Drowsiness and sedation (especially at the start of treatment)
- Dizziness and light-headedness
- Headache
- Nausea
- Vomiting
- Constipation (does not usually resolve spontaneously)
- Itching (pruritus), which may be generalised or localised
Common
Affects up to 1 in 10 people
- Dry mouth, indigestion (dyspepsia), abdominal pain, diarrhoea
- Loss of appetite (anorexia)
- Anxiety, confusion, depression, insomnia, nervousness, nightmares, abnormal dreams
- Tremor, hypoaesthesia, paraesthesia, lethargy
- Bronchospasm, dyspnoea, reduced cough reflex
- Rash, increased sweating (hyperhidrosis)
- Urinary frequency, urinary urgency
- Weakness (asthenia), fatigue
- Injection-site reactions (pain, erythema, swelling) — specific to parenteral use
- Hypotension and postural hypotension
Uncommon
Affects up to 1 in 100 people
- Hypersensitivity reactions including urticaria and angioedema
- Syndrome of inappropriate antidiuretic hormone secretion (SIADH) with hyponatraemia
- Agitation, euphoria, mood swings, hallucinations, personality changes
- Decreased libido, drug dependence, drug tolerance
- Seizures (particularly in patients with epilepsy)
- Muscle rigidity, involuntary muscle contractions, myoclonus
- Amnesia, migraine, speech disturbance, fainting
- Visual disturbance, miosis (pinpoint pupils), lacrimation disorder
- Tachycardia, palpitations, vasodilation
- Voice alteration, rhinitis, cough
- Mouth ulcers, gum inflammation, dysphagia, flatulence, eructation, ileus
- Increased hepatic enzymes
- Dry skin
- Ureteral spasm, urinary retention, erectile dysfunction
- Chills, pain (including chest pain), malaise, peripheral oedema, thirst
- Physical dependence with withdrawal symptoms if stopped abruptly
- Accidental injury (particularly related to sedation)
Rare and Very Rare
Affects up to 1 in 1,000 people (or fewer)
- Severe anaphylactic reactions
- Herpes simplex reactivation
- Lymphadenopathy
- Dehydration, increased appetite, weight changes
- Aggression
- Hyperalgesia (paradoxical increase in pain sensitivity, does not improve with dose increase)
- Dark, tarry stools (sign of gastrointestinal bleeding), bleeding gums, tooth discolouration, dental caries
- Exfoliative dermatitis and photosensitivity
- Haematuria
- Sphincter of Oddi dysfunction causing severe upper abdominal pain
- Amenorrhoea
- Withdrawal syndrome in the neonate following maternal use
Hormonal and Endocrine Effects
Chronic use of opioids, including oxycodone, can suppress the hypothalamic-pituitary-gonadal and hypothalamic-pituitary-adrenal axes. This may cause secondary hypogonadism (reduced testosterone or oestrogen levels), menstrual irregularities, decreased libido, erectile dysfunction, infertility, and in rare cases adrenal insufficiency. These effects are most relevant for patients on long-term opioid therapy and should be discussed with your doctor if symptoms appear.
Managing Common Side Effects
Anticipatory management of opioid side effects is a cornerstone of quality parenteral analgesia. Nausea and vomiting are frequent at the start of treatment and are usually managed with antiemetics such as ondansetron, metoclopramide, or haloperidol. Constipation occurs in nearly all patients on opioid therapy of more than a few days' duration and should be prevented proactively with stimulant laxatives (for example, senna) combined with osmotic agents; peripherally acting mu-opioid receptor antagonists (methylnaltrexone, naloxegol) may be used in refractory cases. Drowsiness usually lessens within 2 to 3 days once tolerance develops; persistent excessive sedation may require a dose reduction.
What Happens When Oxycodone Kalceks Treatment Is Stopped?
Quick Answer: Oxycodone Kalceks should never be discontinued abruptly after more than a few days of continuous use. Sudden cessation can cause an uncomfortable and sometimes severe withdrawal syndrome. Your medical team will either convert you to an equivalent oral opioid or taper the parenteral dose gradually over several days to weeks to minimise withdrawal symptoms.
When opioids are used continuously for more than about a week, the body develops physical dependence. This is a predictable, neuroadaptive response and does not imply addiction. However, it does mean that an abrupt reduction in the opioid dose, or the administration of an opioid antagonist, can precipitate a characteristic withdrawal syndrome.
Typical withdrawal symptoms associated with oxycodone include:
- Yawning, sneezing, lacrimation (tearing), and rhinorrhoea (runny nose)
- Dilated pupils (mydriasis)
- Piloerection (goosebumps) and cold flashes
- Sweating, tremor, restlessness, irritability, anxiety
- Insomnia and dysphoria
- Muscle aches, abdominal cramps, nausea, vomiting, diarrhoea
- Increased heart rate and blood pressure
- Craving for opioids
Withdrawal from parenteral opioids such as Oxycodone Kalceks generally begins within 6 to 12 hours of the last dose, peaks at about 36 to 72 hours, and resolves over 5 to 10 days. A carefully supervised tapering schedule — usually a 25 to 50 per cent reduction every 1 to 2 days for short courses, or slower for longer courses — typically prevents significant withdrawal. Adjuvant medications such as clonidine or lofexidine may be used to manage autonomic withdrawal symptoms when necessary. Patients at risk of opioid use disorder should be referred to specialist addiction services for further support.
How Should Oxycodone Kalceks Be Stored?
Quick Answer: Oxycodone Kalceks ampoules and vials should be stored below 25°C, in the original packaging, protected from light. As a controlled substance it must be kept in a locked cabinet within a secure clinical area, with documented entry of each dose drawn and any waste. Do not use after the expiry date, and dispose of unused product according to local regulations for narcotic drugs.
Proper storage preserves both the chemical stability and the security of Oxycodone Kalceks. Because the product is a sterile parenteral solution, any deterioration in appearance (for example, cloudiness, discolouration, visible particles, or precipitate) should prompt disposal of the affected ampoule or vial. The solution should normally be clear and colourless.
- Storage temperature: below 25°C. Do not freeze.
- Light protection: keep in the outer carton to protect from light until immediately before use.
- Security: store in a locked, tamper-resistant cabinet with controlled access; log all additions, withdrawals, and waste in a dedicated controlled-drug register.
- After opening or dilution: use immediately. If dilution is prepared in advance, refer to the product information and local guidelines for chemical and microbiological stability (typically no more than 24 hours at 2–8°C).
- Expiry: do not use after the expiry date printed on the label. The expiry date refers to the last day of the stated month.
- Disposal: return unused ampoules, vials, and any residual solution to the pharmacy for destruction in accordance with local narcotic drug regulations. Never discard controlled substances into household waste or wastewater.
As a Schedule II / Schedule 2 controlled substance, Oxycodone Kalceks is a target for theft and diversion. Institutions must implement appropriate chain-of-custody, stock reconciliation, and waste witnessing procedures. Accidental exposure — particularly in children or opioid-naive adults — can be rapidly fatal; call your local emergency number immediately if exposure is suspected.
What Does Oxycodone Kalceks Contain?
Quick Answer: Each millilitre of Oxycodone Kalceks contains 10 mg of oxycodone hydrochloride as the active substance. The excipients are citric acid monohydrate, trisodium citrate dihydrate, sodium chloride, and water for injection, with hydrochloric acid or sodium hydroxide used for pH adjustment. The solution is clear and colourless.
Active substance: Oxycodone hydrochloride. Each millilitre of solution contains 10 mg of oxycodone hydrochloride, equivalent to approximately 8.96 mg of oxycodone base. Typical pack sizes include 1 ml and 2 ml glass ampoules, providing 10 mg and 20 mg of oxycodone hydrochloride respectively.
Inactive Ingredients (Excipients)
- Citric acid monohydrate — buffering agent
- Trisodium citrate dihydrate — buffering agent
- Sodium chloride — tonicity adjustment
- Water for injection — solvent
- Hydrochloric acid / sodium hydroxide — used for pH adjustment
Each millilitre of Oxycodone Kalceks contains less than 1 mmol (23 mg) of sodium, and is therefore considered essentially sodium-free. However, the final sodium content will depend on the diluent used in infusions — 0.9% sodium chloride contains clinically significant sodium and this should be taken into account in patients on a controlled sodium diet.
Pharmaceutical Form and Appearance
Oxycodone Kalceks is a clear, colourless, or almost colourless solution supplied in sealed, colourless glass ampoules (Type I). The product is manufactured and quality-controlled in accordance with the European Pharmacopoeia and the applicable standards of EU good manufacturing practice (EU GMP). Each pack contains the product information leaflet in the locally approved language(s).
Marketing Authorization Holder and Manufacturer
The marketing authorization holder and manufacturer of Oxycodone Kalceks is AS Kalceks, based in Riga, Latvia. Kalceks is a specialist manufacturer of sterile injectable medicines, with products distributed across the European Union and other international markets. For information about local approval status, detailed prescribing information, and batch-specific technical documentation, refer to the national medicines regulator (for example, the EMA, MHRA, or the relevant EU national agency).
Frequently Asked Questions About Oxycodone Kalceks
Oxycodone Kalceks 10 mg/ml is a solution for injection or infusion used to treat moderate to severe pain in adults and adolescents aged 12 years and over. It is typically administered in hospital for post-operative pain, severe acute pain (for example, following trauma or myocardial infarction), and cancer-related pain when oral therapy is unsuitable or when a rapid onset of analgesia is required. It may also be used in palliative care via continuous subcutaneous infusion.
Oxycodone Kalceks is administered only by qualified healthcare professionals. It can be given as a slow intravenous bolus (typically over 1 to 2 minutes), as a subcutaneous or intramuscular injection, or as a continuous infusion via a syringe driver or a patient-controlled analgesia (PCA) pump. The choice of route depends on the clinical situation, the need for rapid onset, the patient's venous access, and the setting (hospital ward, ICU, or palliative care at home).
After intravenous administration, analgesic effect typically begins within 2 to 5 minutes, with peak effect reached at approximately 5 to 15 minutes. Subcutaneous and intramuscular routes have a slower onset (approximately 15 to 30 minutes). The duration of action after a single dose is around 3 to 4 hours, which is why regular dosing every 4 hours or a continuous infusion is commonly used for ongoing pain.
Yes. Oxycodone, regardless of formulation, carries a significant risk of physical dependence, tolerance, and opioid use disorder. During short-term, supervised hospital use this risk is minimised by careful dose selection, monitoring, and rapid transition to non-opioid analgesia as soon as pain intensity allows. Patients with a history of substance use disorder, mental health conditions, or chronic pain are at higher risk and should be identified before opioid therapy begins.
Slow, shallow, or irregular breathing after an opioid dose is a medical emergency. Call for help immediately, position the patient on their side, ensure the airway is open, and provide oxygen if available. Healthcare professionals will administer naloxone intravenously and support ventilation as required. Because naloxone is shorter-acting than oxycodone, the patient must be monitored closely, and repeated doses or a continuous infusion may be needed.
Some compatibility data exist for mixing oxycodone with other opioids, antiemetics, or local anaesthetics in continuous subcutaneous infusions used in palliative care, but compatibility depends on concentrations and diluents. Do not mix Oxycodone Kalceks with any other medicine unless compatibility has been confirmed by your hospital pharmacy or the official prescribing information. Never mix with strongly alkaline solutions, thiopental, or phenytoin due to the risk of precipitation.
No. After any dose of parenteral oxycodone you must not drive or operate machinery for at least 24 hours, and longer if you still feel drowsy, dizzy, or cognitively impaired. Your driving ability should be reviewed by your doctor before resumption. In many countries, driving while impaired by opioid analgesics is a criminal offence regardless of medical prescription.
References
- World Health Organization (WHO). WHO Guidelines for the Pharmacological and Radiotherapeutic Management of Cancer Pain in Adults and Adolescents. Geneva: WHO; 2018. Available at: who.int
- European Medicines Agency (EMA). Oxycodone Hydrochloride — Summary of Product Characteristics (SmPC). European public assessment reports. Available at: ema.europa.eu
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This article has been written and medically reviewed by the iMedic Medical Editorial Team, a group of licensed specialist physicians, clinical pharmacologists, and healthcare professionals with expertise in pain medicine, anaesthesiology, and opioid pharmacology. All medical information is evidence-based, following international guidelines from the WHO, EMA, FDA, the British National Formulary (BNF), and the EAPC.
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