Diclofenac Sodium Injection

Active Ingredients: Diclofenac Sodium

Diclofenac Sodium Injection is a parenteral nonsteroidal anti-inflammatory drug (NSAID) used in adults for the short-term treatment of acute pain and inflammatory conditions when injectable therapy is clinically appropriate.

Diclofenac is a phenylacetic acid derivative with analgesic, anti-inflammatory and antipyretic properties. Its therapeutic activity is primarily associated with inhibition of cyclooxygenase enzymes (COX-1 and COX-2), which reduces the synthesis of prostaglandins involved in inflammation and pain signaling.

Injectable diclofenac is used in clinical settings where rapid parenteral treatment may be appropriate, including certain acute musculoskeletal conditions, renal colic, acute gout, trauma and postoperative pain. Indications, administration routes and dosing requirements may differ according to the formulation and approved prescribing information in each country.

This page describes Diclofenac Sodium Injection intended for human pharmaceutical use. Human and veterinary diclofenac products may differ in concentration, excipients, packaging, approved indications and administration requirements and should not be considered interchangeable.

AdvaCare Pharma is a GMP-certified manufacturer and exporter of Diclofenac Sodium Injections, Diclofenac Potassium Tablets, and Diclofenac Sodium Tablets. We offer a wide range of high-quality and cost-effective medications that are available for distribution. These medications have been produced in our facilities in China, India, and the USA.

AdvaCare Pharma is a US-owned pharmaceutical company and manufacturer of Diclofenac Sodium Injection for international pharmaceutical distribution. Production is carried out through GMP-compliant manufacturing facilities operating under established quality-management procedures for injectable medicines.

Our pharmaceutical injection portfolio includes more than 120 products across multiple therapeutic classes, enabling distributors and institutional buyers to consolidate sourcing across a broad injectable range.

For importing pharmaceutical distributors, AdvaCare Pharma provides market-oriented support that may include product documentation, registration assistance, packaging adaptation and commercial supply planning according to applicable market and regulatory requirements.

Our products are distributed across more than 65 markets through pharmaceutical distributors, hospitals, pharmacies, government procurement programs and other healthcare channels.

What is Diclofenac Sodium used for?

It is used for the short-term treatment of acute pain and inflammation in adults.

Intravenous infusion formulations may also be used in hospital settings for the treatment or prevention of postoperative pain.

Diclofenac Sodium Injection is intended for short-term treatment rather than routine long-term management of chronic inflammatory disease.

How are Diclofenac Sodium Injections used?

Diclofenac Sodium Injection must be administered by a qualified healthcare professional.

Standard diclofenac sodium ampoules containing 25mg/ml, including the 75mg/3ml presentation, may be administered by deep intramuscular injection. Where intravenous administration is authorized, the medicine is diluted appropriately and administered as an intravenous infusion.

Standard 25mg/ml diclofenac ampoule formulations should not be administered as a direct intravenous bolus unless the specific approved product information expressly authorizes that route.

Correct intramuscular injection technique is important because improper administration has been associated with injection-site injury, including tissue necrosis.

What dose should be given and for how long?

Diclofenac should be used at the lowest effective dose for the shortest duration necessary to control symptoms.

The total daily dose of diclofenac should generally not exceed 150mg.

Parenteral diclofenac treatment is normally limited to a maximum of 2 days. If continued NSAID treatment is necessary, the patient may be switched to an appropriate oral or rectal formulation according to medical judgment.

The 50mg/2ml and 75mg/3ml presentations have the same concentration of 25mg/ml, but dose selection and administration must follow the approved product information for the specific presentation and market.

Refer to a doctor, pharmacist or locally approved prescribing information for specific dosage instructions. Dose selection depends on the indication, formulation, patient characteristics, concomitant medicines and clinical response.

Who can use Diclofenac Sodium?

Diclofenac Sodium Injection is primarily intended for adult patients when a healthcare professional determines that parenteral NSAID treatment is appropriate.

Pregnant NSAID exposure from approximately 20 weeks of pregnancy may cause fetal renal dysfunction and oligohydramnios. If treatment between 20 and 30 weeks is considered clinically necessary, the lowest effective dose should be used for the shortest possible duration.

Diclofenac should be avoided from approximately 30 weeks of pregnancy because NSAIDs may cause premature constriction or closure of the fetal ductus arteriosus. Diclofenac is contraindicated during the third trimester under current European prescribing information.

Treatment during pregnancy must therefore be determined by a qualified healthcare professional.

Diclofenac may also reversibly impair female fertility and is generally not recommended in women attempting to conceive unless treatment is considered necessary.

Nursing Diclofenac passes into breast milk in small amounts. Available lactation data indicate that milk exposure is generally low; however, recommendations may differ between product labels and countries.

The benefits of breastfeeding, the clinical need for diclofenac and potential risks to the infant should therefore be considered by a healthcare professional.

Pediatric The safety, efficacy and appropriate dosing of standard Diclofenac Sodium Injection have not been established for children in many product registrations. Injectable diclofenac should only be used in pediatric patients where specifically authorized by the approved local product information.

Geriatric Older patients are more susceptible to adverse effects associated with NSAIDs, particularly gastrointestinal bleeding, renal impairment and cardiovascular complications.

The lowest effective dose should be used, particularly in frail elderly patients or those with low body weight, and appropriate monitoring should be considered.

Other warnings

In patients with mild hepatic insufficiency, dosage reductions are not necessary. In patients with moderate to severe hepatic insufficiency, Diclofenac Sodium Injection has not been studied and is not recommended for use.

Cases of rare, severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis (with and without jaundice), and liver failure, some of which resulted in fatalities or liver transplantation, have been reported with diclofenac use. These cases have primarily been reported with oral diclofenac; however, the risk should still be considered with Diclofenac Sodium Injection use.

Patients at an increased risk for hepatotoxicity should have their transaminase levels monitored. Diclofenac treatment should be discontinued immediately if elevated transaminases persist or worsen, if signs of liver disease develop, or if symptoms of systemic liver dysfunction occur.

In patients with mild renal insufficiency, dosage adjustments are not necessary. In patients with moderate to severe renal insufficiency, Diclofenac Sodium Injection use is contraindicated. Long-term NSAID use can result in renal papillary necrosis and other renal injury. This risk of renal toxicity may be lower with Diclofenac Sodium Injection, as it is only indicated for short-term therapy.

Clinical studies of various NSAIDs have shown an increased risk of serious CV events, including myocardial infarction and stroke, which can be fatal. It is unclear if the risk of adverse CV events is similar for all NSAIDs. The increased risk of adverse CV events from NSAID use is similar in those with and without CV disease or dysfunction, however, those with CV disease or dysfunction had higher incidences of adverse CV effects. These effects can begin as early as the first weeks of treatment and have mostly been observed at higher doses. There is no evidence that aspirin can mitigate these risks, and aspirin use should be avoided, as it increases the risk of adverse GI events.

Diclofenac Sodium Injection use after coronary artery bypass graft is contraindicated due to the increased incidence of myocardial infarctions and strokes with NSAID use following surgery. Diclofenac use in patients with a recent myocardial infarction should be avoided.

NSAIDs, including diclofenac sodium, can cause serious and potentially fatal GI adverse events, including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, or intestines. Those with a longer duration of NSAID treatment, who are concomitantly using oral corticosteroids, aspirin, anticoagulants, selective serotonin reuptake inhibitors (SSRIs), or serotonin and norepinephrine reuptake inhibitors (SNRIs), and who have a history of liver disease, peptic ulcers, GI bleeding, or bleeding disorders are at an increased risk. These serious adverse events can occur at any time, and only approximately 20% of patients are symptomatic. Most cases involve long-term treatment, but short-term treatment with Diclofenac Sodium Injection is not without risk.

Concomitant use of diclofenac with other NSAIDs is not recommended due to the increased risk of adverse GI events.

Potentially fatal anaphylactic reactions that require immediate medical attention have been reported with NSAID use. Diclofenac hypersensitivity can cause adverse skin events, such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), some of which can be fatal and can occur with or without warning. Diclofenac should be discontinued at the first sign of skin rash or other hypersensitivity reactions.

The antipyretic and anti-inflammatory effects of diclofenac may mask the clinical signs of present infection.

As with all pharmaceuticals, some unwanted effects can occur from the use of Diclofenac Sodium Injection.

Patients should receive urgent medical attention if they develop symptoms such as chest pain, sudden weakness or difficulty speaking, difficulty breathing, vomiting blood, black or bloody stools, severe skin reactions, facial swelling, or yellowing of the skin or eyes.

This is not a complete list of adverse effects. Healthcare professionals should consult the approved prescribing information for the relevant Diclofenac Sodium Injection before administration.

Additional restrictions apply to intravenous diclofenac. Depending on the approved product information, IV administration may be contraindicated in patients with significant dehydration or hypovolemia, bleeding disorders, concurrent anticoagulant treatment, certain renal impairment or procedures associated with a high risk of bleeding.

Before treatment, inform your doctor or pharmacist about all medicines being taken. Clinically important interactions may occur with anticoagulants or antiplatelet medicines, systemic corticosteroids, SSRIs/SNRIs, other NSAIDs, diuretics, ACE inhibitors or angiotensin receptor blockers, lithium, digoxin, methotrexate, ciclosporin, tacrolimus and some other medicines.

Diclofenac should be used at the lowest effective dose for the shortest necessary duration. Patients with gastrointestinal disease, hypertension, cardiovascular risk factors, asthma, kidney or liver impairment, fluid depletion, coagulation disorders, or advanced age may require additional monitoring.

Contraindications, warnings and interactions can differ between formulations and regulatory jurisdictions. Prescribers should always consult the locally approved product information before administration.

Clinical Observation on Therapeutic Effect of Electroacupuncture Combined with Diclofenac Sodium in Treatment of Acute Gouty Arthritis: A Randomized Controlled Study

The main objective of this research was to observe the clinical effect of electroacupuncture (EA) combined with diclofenac sodium (DS) in the treatment of acute gouty arthritis (AGA).

Patients with AGA were randomly divided into three groups: the EA + DS treatment group (i.e., EA + DS group), the low-dose DS treatment group (i.e., low-dose DS group), and the conventional-dose DS treatment group (i. e., conventional DS group).

The conclusion of this study is that EA combined with DS can improve AGA patients’ joint pain and functional status and improve their quality of life. This combined treatment can reduce the levels of inflammatory markers and SUA, leading to fewer adverse reactions in AGA patients.