Genac Plus(75 mg+20 mg)/2 ml

This intramuscular injection combines the NSAID diclofenac sodium with a small amount of the local anaesthetic lidocaine, which is added specifically to reduce discomfort at the injection site rather than to provide independent pain relief. It is used for short-term treatment of acute pain and inflammation, including:

• Acute exacerbations of rheumatic disease, such as rheumatoid arthritis and osteoarthritis
• Acute low back pain and sciatica
• Renal colic
• Postoperative pain
• Severe migraine attacks
• Other acute musculoskeletal pain conditions

Marketed formulations of this combination commonly contain diclofenac sodium 75 mg together with a small amount of lidocaine hydrochloride (for example, 20 mg) per 3 mL ampoule, with the lidocaine included specifically to reduce pain on intramuscular injection rather than for its own therapeutic anaesthetic effect. Exact strengths may vary between products; confirm the specific product's composition on its own label.

Diclofenac sodium with lidocaine is an intramuscular injection that combines a nonsteroidal anti-inflammatory drug (diclofenac) with a small dose of a local anaesthetic (lidocaine). The lidocaine is included to make the injection more comfortable, while diclofenac provides the pain-relieving and anti-inflammatory effect. It is used for short courses of treatment for acute, moderate-to-severe pain and inflammation, typically for no more than a couple of days before switching to oral or other formulations if further treatment is needed.

Therapeutic Class: Nonsteroidal Anti-inflammatory Drug (Injectable) with Local Anaesthetic Additive

Diclofenac sodium is rapidly absorbed after intramuscular injection and is highly protein-bound in plasma; it is metabolized in the liver and excreted mainly in the urine and bile. Lidocaine, included at a low dose in this combination, acts locally at the injection site to reduce the discomfort associated with intramuscular diclofenac administration, with limited systemic absorption at the dose used for this purpose.

• Given only by deep intramuscular injection into the upper outer quadrant of the buttock, by a healthcare professional
• Must not be given as an intravenous injection
• Injection sites should be alternated if more than one dose is required
• Not intended for prolonged or repeated daily use beyond the short course recommended by the prescriber

The following should be assessed by a healthcare professional before combining with this injection:

• Other NSAIDs or aspirin, which increases the risk of gastrointestinal bleeding and ulceration
• Anticoagulants such as warfarin, and antiplatelet agents, which increase bleeding risk
• Lithium and digoxin, whose blood levels may be raised by diclofenac, requiring monitoring
• ACE inhibitors, angiotensin receptor blockers, and diuretics, which may have reduced effectiveness and increased risk of kidney impairment when combined with NSAIDs
• Other local anaesthetics or antiarrhythmic drugs affecting cardiac conduction, due to the lidocaine component

Common side effects

• Pain, redness, or induration at the injection site
• Headache or dizziness
• Nausea or stomach discomfort

Serious side effects (seek urgent medical attention)

• Signs of gastrointestinal bleeding: black or bloody stools, vomiting blood, severe stomach pain
• Signs of a heart attack or stroke: chest pain, shortness of breath, weakness on one side of the body
• Signs of a serious allergic reaction: swelling of the face or throat, difficulty breathing, severe rash
• Signs of kidney problems: reduced urination, swelling of the legs or ankles
• Injection-site abscess or tissue damage (rare)

Pregnancy

NSAIDs including diclofenac should be avoided from around 20 weeks of pregnancy onward, as they may cause fetal kidney problems, and are contraindicated in the third trimester due to risk of premature closure of the ductus arteriosus in the fetus. Use earlier in pregnancy should only occur if a doctor considers it necessary.

Breastfeeding

Diclofenac passes into breast milk in small amounts; use during breastfeeding should be guided by a healthcare professional, weighing the mother's need for treatment against potential infant exposure.

• NSAIDs, including diclofenac, are associated with an increased risk of serious cardiovascular thrombotic events, including heart attack and stroke.
• NSAIDs increase the risk of serious gastrointestinal adverse events, including bleeding, ulceration, and perforation, which can occur without warning symptoms.
• This injection must be given by deep intramuscular injection only, never intravenously, due to the local anaesthetic component and risk of systemic toxicity if injected into a blood vessel.
• Use with caution in patients with a history of cardiac conduction abnormalities, given the lidocaine component.
• Use with caution in patients with renal, hepatic, or cardiovascular impairment.
• Not recommended for use for more than a couple of days by this injectable route; longer courses should switch to oral or rectal diclofenac.

Overdose may cause symptoms related to the NSAID component, such as nausea, vomiting, abdominal pain, drowsiness, gastrointestinal bleeding, or effects on kidney function and blood pressure, and, from the lidocaine component at high systemic exposure, symptoms such as dizziness, numbness around the mouth, or, in severe cases, cardiac or neurological effects. Suspected overdose requires prompt medical evaluation and treatment in a healthcare facility.

Store ampoules at room temperature, protected from light, as directed on the product label. Do not use if the solution appears discolored or contains particulate matter, or after the labeled expiry date.

• Elderly: Increased risk of NSAID-related gastrointestinal and cardiovascular complications; use with caution and at the lowest effective dose.
• Renal impairment: Contraindicated in severe impairment; use with caution and appropriate monitoring in mild to moderate impairment.
• Hepatic impairment: Contraindicated in severe impairment; use with caution in milder impairment.

This injectable form is intended for short-term treatment of acute pain, generally limited to about 1-2 days; if pain relief needs to continue beyond this, treatment is typically switched to oral diclofenac tablets or rectal suppositories, as directed by the prescribing doctor.

Drug Class: Phenylacetic acid derivative NSAID (diclofenac) combined with an amide-type local anaesthetic (lidocaine)

Diclofenac works by inhibiting cyclooxygenase enzymes, reducing the production of prostaglandins that mediate pain, inflammation, and fever, which provides analgesic and anti-inflammatory effects. Lidocaine works by blocking sodium channels in local nerve endings at the injection site, which reduces the sensation of pain caused by the injection itself.

This intramuscular diclofenac and lidocaine combination is not recommended for use in children, as safety and effectiveness have not been established in this age group for the injectable form.