Akis

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Medically reviewed

Laura Arias

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 Akis

Akis is a synthetic pharmaceutical product containing the active ingredient Diclofenac (Diclofenac sodium), a substance globally recognized as a Nonsteroidal Anti-inflammatory Drug (NSAID). This prescription-only medication is primarily used to relieve symptoms associated with acute pain, inflammation, and fever by targeting the body's inflammatory response.


Quick Facts

Property Description
Active ingredient Diclofenac sodium
Form Solution for injection (Aqueous)
Pharmacological class Nonsteroidal Anti-inflammatory Drug (NSAID)
Route of administration Parenteral (e.g., intramuscularly)
Origin Synthetic (Phenylacetic acid derivative)

Defining Akis: Class, Composition, and Origin

Akis is specifically categorized as an NSAID, with its core pharmacological action stemming from the chemical entity Diclofenac sodium. This classification is used clinically for its action against inflammation.

The component, Diclofenac, is a synthetic agent derived from phenylacetic acid. It operates by inhibiting the cyclooxygenase (COX) enzymes, which are critical in the body's synthesis of prostaglandins. Through this mechanism, Akis helps to ease discomfort by reducing the internal chemical signals that trigger pain and swelling.

The Pharmaceutical Preparation: Solution for Injection

Akis is formulated as an aqueous solution for injection, packaged within an ampoule, and intended solely for parenteral administration. This specialized formulation is a key differentiating feature of Akis, contrasting with common oral or topical versions of Diclofenac.

The injectable nature facilitates the rapid systemic availability of the active substance, ensuring the medication can quickly exert its effects. The faster onset of action achieved by the parenteral route makes this form suitable for acute, severe symptomatic management where swift anti-inflammatory action is required.

General Therapeutic Purpose of Diclofenac

The essential purpose of Akis is the general alleviation of acute discomfort resulting from systemic inflammation. By reducing the production of prostaglandins, Akis is fundamentally purposed to act as an analgesic and an antipyretic. This comprehensive therapeutic profile ensures the drug addresses multiple core symptoms often associated with inflammatory conditions.

What side effects are possible with Akis?

Possible Side Effects and Safety Information for Akis (Diclofenac)

The official regulatory safety profile for Akis, which contains the NSAID Diclofenac, details adverse reactions classified by frequency and affected organ system, alongside serious warnings and population-specific restrictions.

Classification Examples of Documented Reactions
Common Headache, dizziness, nausea, vomiting, abdominal pain, diarrhea, indigestion (dyspepsia), and injection site pain.
Rare/Very Rare Severe allergic reactions (anaphylactic reactions), serious skin reactions (e.g., Stevens-Johnson Syndrome), aseptic meningitis, convulsions, and liver failure.

Serious adverse reactions are prominently documented in regulatory labeling across two primary systems:

  • Cardiovascular Thrombotic Events: An increased risk of serious cardiovascular events, including myocardial infarction (MI) and stroke, is associated with the use of NSAIDs. This risk may increase with the duration of use and higher doses. Diclofenac is contraindicated for the treatment of pain following Coronary Artery Bypass Graft (CABG) surgery.
  • Gastrointestinal Events: NSAIDs carry a risk of serious gastrointestinal adverse events, including inflammation, bleeding, ulceration, and perforation of the stomach or intestines, which can occur at any time during treatment without warning symptoms.

Population and Exposure Constraints

Safety notes explicitly address specific patient groups and usage patterns. Risk of serious GI events is higher in older adults. The drug is contraindicated in patients with established congestive heart failure (NYHA Class II-IV), ischemic heart disease, and severe renal or hepatic impairment. Use is contraindicated starting at 30 weeks of gestation due to fetal risk. Risk of thrombotic events is tied to long-term use and high dose.


The official safety information structures the understanding of Akis's risk profile by identifying the most critical organ systems affected and formally defining the risk magnitude through standardized frequency classifications. This framework emphasizes that major safety events are not uniform, but are formally constrained by factors such as pre-existing disease and the duration of drug exposure. The regulatory profile is thus a descriptive map of documented hazards and explicit limitations.

Overdose and Emergency Response

Overdose and when to seek help

The information below describes the official regulatory statements regarding overdose for Akis (Diclofenac) and when urgent medical assistance is required.

Overdose following acute ingestion of a large amount is often initially asymptomatic or may present with minor self-limiting gastrointestinal symptoms. However, severe systemic toxicity may occur, requiring immediate response.

Domain Official Regulatory Statement
Documented Overdose Manifestations Symptoms may include drowsiness, confusion, headache, dizziness, tinnitus, blurred vision, and stomach pain or vomiting.
Severe Outcomes Life-threatening complications documented include seizures (convulsions), coma, acute renal failure, and severe gastrointestinal bleeding.
When Urgent Help is Required Seek immediate medical attention for any suspected overdose. Emergency help is required if severe manifestations occur, such as loss of consciousness, seizures, or signs of internal bleeding (e.g., bloody or tarry stools).

No specific pharmacological antidote is known for Diclofenac overdose; therefore, management is symptomatic and supportive. Regulatory documents state that procedures such as activated charcoal or gastric lavage may be considered depending on the clinical context. Hospital monitoring of vital signs and laboratory parameters (including renal and hepatic function) is typically required due to the potential for delayed systemic effects. Elderly patients and those with pre-existing renal or hepatic impairment are noted to be at increased risk for serious adverse outcomes.

Therapeutic Uses of Akis

What Akis treats: main uses and benefits

Akis contains the active substance diclofenac sodium, which belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). These medications are primarily used to reduce pain and inflammation in the body.

Therapeutic Indications

This medication is specifically formulated for administration via injection and is indicated for the treatment of various acute conditions where rapid relief is required. These include:

  • Acute Flare-ups of Joint and Muscle Pain: Effective for sudden episodes of pain associated with osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis.
  • Back Pain: Relief of acute lower back pain or spinal discomfort.
  • Renal Colic: Management of the intense pain caused by kidney stones.
  • Post-operative Pain: Short-term treatment of pain following surgical procedures.
  • Traumatic Pain: Relief of pain resulting from injuries, such as fractures or severe sprains.

Mechanism of Action

Akis works by inhibiting the production of prostaglandins, which are chemicals in the body that signal pain and promote inflammation. by lowering the levels of these substances, the medication helps to decrease swelling and alleviate the sensation of pain.

Expected Benefits

The primary benefit of this treatment is the rapid onset of analgesic (pain-relieving) and anti-inflammatory effects. Because it is administered as an injection, it bypasses the digestive system, allowing the active ingredient to enter the bloodstream quickly. This makes it particularly useful for patients who are unable to take medications by mouth or those who require immediate stabilization of severe acute pain.

Eligibility and Restrictions for Use

This information is strictly based on official regulatory documents for the active substance, diclofenac sodium injection.

Eligibility Status Summary

Classification Population Status
Allowed Adults without contraindications. Eligible
Restricted Elderly patients, those with mild-to-moderate renal or hepatic impairment, or cardiovascular risk factors. Use with Caution/Not Recommended
Contraindicated Patients with specific severe medical conditions or history. Prohibition

Populations Who Must Not Use This Medicine (Contraindications)

Akis is strictly contraindicated for use in individuals with the following conditions, as stated in authoritative labeling:

  • Hypersensitivity: Known allergy to diclofenac or a history of asthma, hives, or allergic-type reactions after taking aspirin or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
  • Gastrointestinal Disease: Active gastrointestinal bleeding, ulceration, or perforation, or a history of recurrent peptic ulcer/hemorrhage.
  • Severe Organ Impairment: Severe hepatic (liver) failure or severe renal (kidney) failure (e.g., GFR <15 mL/min/1.73 m^2).
  • Cardiovascular Disease: Established congestive heart failure (NYHA Class II-IV), ischemic heart disease, peripheral arterial disease, or cerebrovascular disease.
  • Pregnancy and Surgery: Use during the last trimester of pregnancy and for perioperative pain in the setting of Coronary Artery Bypass Graft (CABG) surgery.

Age-Related Eligibility

The medicine is not approved for use in the pediatric population (children and adolescents). For the elderly, official documents recommend using the lowest effective dose for the shortest possible duration.

What should I know about interactions with other medicines?

The official interaction profile of Akis (Diclofenac) is defined by its potential to interact with several classes of medicinal products, primarily through pharmacodynamic or pharmacokinetic mechanisms, as documented in government regulatory labeling.

Interaction Classifications and Restrictions

The most serious regulatory constraint involves combinations that are formally contraindicated or prohibited due to heightened risk. This includes concurrent use with other Nonsteroidal Anti-inflammatory Drugs (NSAIDs), including Aspirin at analgesic doses, and its use for peri-operative pain management in the setting of Coronary Artery Bypass Graft (CABG) surgery [2.1, 4.3].

Interaction Type Interacting Substance/Class Official Interaction Outcome
Pharmacodynamic (PD) Risk Anticoagulants, Corticosteroids Additive risk of serious bleeding (GI/non-GI) [4.5].
Pharmacokinetic (PK) Effect CYP2C9 Inhibitors (e.g., Voriconazole) Significant increase in Diclofenac plasma exposure (Cmax and AUC) [1.3].
Renal Clearance/Toxicity Methotrexate, Lithium Increased plasma concentrations and potential toxicity of co-administered drug due to reduced renal clearance [4.5].
Timing-based Rule Mifepristone Requires administration separation to avoid reducing Mifepristone's effect [3.4].

Co-administration with Diuretics or ACE Inhibitors/ARBs is documented to increase the risk of renal impairment and can diminish the antihypertensive or diuretic effects [4.5]. The use of alcohol is strongly associated with an increased risk of serious gastrointestinal events [1.4]. Regulatory information also notes that Elderly Patients are at a greater risk for serious GI adverse events when these PD interactions occur [4.3].

Mechanism of Action

Primary Molecular Action: Inhibition of Cyclooxygenase (COX) Enzymes

The mechanism of action centers on the competitive inhibition of the Cyclooxygenase ( COX) enzyme system, which exists primarily as the COX-1 and COX-2 isoforms. By blocking the active sites of these enzymes, the drug prevents the conversion of Arachidonic Acid into various prostaglandins and related lipid mediators. This initial molecular step modulates the subsequent inflammatory response cascade.

Cascade Effect: Attenuation of Prostaglandin-Mediated Signaling

The resulting suppression of prostaglandin synthesis affects several physiological pathways, including those involved in nociception and thermoregulation. Reduced levels of PGE2 and PGI2 lead directly to the desensitization of nociceptors (peripheral nerve endings) and a modification of the central thermoregulatory set point in the brain. This mechanism modulates signaling associated with peripheral nerve endings and central thermoregulation.

Physiological Consequence: Modulation of Systemic Responses

The core physiological result of this mechanism is the limitation of excessive mediator activity, influencing responses at the tissue and systemic level. By reducing the chemical signals that increase local vascular permeability, the drug induces physiological adjustments that influence the overall effect profile.

Dosage and Administration Information

Administration Guidelines for Akis Injection

Akis (diclofenac) is a ready-to-use solution that must only be administered by a healthcare professional via injection for short-term, acute pain management. The following guidelines describe the administration protocol.

Dosage and Route

Administration Scope Instruction
Route of Administration Deep Intramuscular (IM) injection, or Intravenous (IV) Infusion (for post-operative pain only).
Adult Dosing A single dose of 75 mg (one ampoule).
Maximum Dose Do not exceed 150 mg within any 24-hour period.
Treatment Duration Should not be given for more than two days.
Paediatric Use Not recommended for children and adolescents (under 18 years).

Procedural Steps

  • Intramuscular (IM): The 75 mg dose is administered by deep injection into the upper outer quadrant of the buttock. If a second 75 mg dose is required after at least six hours, the alternative buttock must be used for injection.
  • Intravenous (IV) Infusion: The solution must not be given as an IV bolus injection (a rapid injection). It must be diluted immediately before use with 100–500 mL of a compatible solution (e.g., 0.9% sodium chloride or 5% glucose solution) that has been buffered with sodium bicarbonate. The infusion is then typically administered continuously over a period of 30 minutes to 2 hours.
  • Preparation: The ampoule solution is ready-to-use and should not be diluted for intramuscular injection. Follow buffering and dilution instructions strictly for intravenous infusion.

These instructions define a controlled parenteral administration protocol, outlining precise dosing limits and procedural requirements for short-term use in adults, ensuring adherence to the maximum daily dose of 150 mg over a maximum two-day period.

Recent Clinical Evidence

Research evidence / Overview of Studies for Akis


Evidence for Acute Visceral Pain (Renal and Biliary Colic)

Akis injection was evaluated in research exploring conditions characterized by acute or disruptive episodes, such as renal colic (kidney stones) and biliary colic (gallbladder issues). Research exploring short-term symptom changes primarily involved Randomized Controlled Trials (RCTs) and systematic reviews, which compared parenteral Diclofenac to placebo or other pain medications in adult populations. These trials focused on patient-reported outcomes describing perceived discomfort. Studies reported how symptoms evolved in the observed populations over the first few hours of administration. Research highlights changes measured during the study period, but follow-up durations were limited, meaning long-term effects are not fully established or characterized by the acute trials. Data for certain groups remain insufficient, especially for patients presenting with certain underlying health issues.

Evidence for Acute Musculoskeletal and Postoperative Pain

Akis was evaluated in research contexts involving fluctuating or unstable symptoms related to acute discomfort, including post-operative pain and acute periods of heightened symptoms associated with inflammatory joint conditions. These studies typically involved RCTs and network meta-analyses that examined the systemic administration of the medication in adult patients. Studies explored the patient-reported outcomes describing perceived discomfort and outcomes reflecting daily functioning or activity level during the study period. These studies contribute to understanding symptom patterns in populations where symptoms may vary in intensity. Follow-up durations were limited in many trials, particularly those using single or short-course injections, which means research provides insight into short-term changes but not long-term maintenance or sustained benefit. Evidence quality varies across studies, and direct comparisons against all potential active comparators may be uncertain due to differences in trial design.

Analysis of Long-Term Studies and Follow-up Data

Research exploring the effects of Akis injection primarily focuses on episodes where symptoms become more noticeable, meaning the vast majority of available evidence is restricted to the short-term evaluation of pain and inflammation. Evidence derived from settings with varying symptom burdens provides context on immediate changes, but there is limited information for long-term outcomes or how the use of the injectable formulation might affect the long-term course of a chronic condition.

Frequently Asked Questions (FAQ)

Common questions about Akis (FAQ)

Q: What should I do if I miss a scheduled dose of Akis?

Akis injection is designed for short-term, acute pain treatment and is administered by a healthcare professional. Because this medication is used for acute needs rather than regular, sustained use, the concept of a 'missed dose' is typically not relevant given the short-term, acute nature of its intended use.

Q: Is Akis addictive or habit-forming?

Akis (diclofenac) is a Nonsteroidal Anti-inflammatory Drug (NSAID). Official regulatory agencies do not classify it as a controlled substance, and product labeling does not indicate a risk of abuse, dependence, or habit formation.

Q: Can Akis injection be used for chronic pain, like arthritis?

Official product information restricts the use of Akis injection to the short-term management of acute pain, typically for no more than two days. Therefore, the injectable formulation's restricted use is not consistent with the management of chronic conditions, such as ongoing arthritis pain.

Q: What should I avoid eating or drinking while using Akis?

Official product information notes an interaction related to alcohol consumption. Regulatory warnings highlight that using this medication with alcohol is associated with a heightened risk of serious adverse events involving the stomach and intestines. No general food-specific restrictions are noted in the product labeling.

How should Akis be stored and disposed of?

The storage and disposal of Akis (Diclofenac solution for injection) must follow specific regulatory conditions to maintain stability and ensure safety.

Storage Classification Requirement
Temperature Controlled Room Temperature: 25 C (77 F) [Source 1.1].
Prohibitions Avoid freezing and protect from heat [Source 1.3].
Container Store in properly labelled containers [Source 4.2].
Stability Check The solution must be visually inspected for crystals or precipitates before use [Source 1.4 from prompt].
Safety Store the product locked up to prevent unauthorized access [Source 4.2].

Disposal must be conducted according to authorized guidelines. The preferred method is using a drug take-back program or a mail-back envelope [Source 2.5]. The medication must not be flushed down the sink or toilet [Source 2.5]. If household disposal is necessary, the drug must be removed from its container, mixed with an undesirable substance (e.g., dirt or coffee grounds), and sealed in a container before being placed in the trash [Source 2.5]. Furthermore, environmental release of the product must be avoided [Source 4.2].

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

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