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

Mobifen Plus injection is indicated for the short-term relief of acute pain and inflammation in a variety of musculoskeletal and post-traumatic conditions. Its established and commonly accepted uses include:

Established / Guideline-supported uses

• Acute exacerbations of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis
• Acute musculoskeletal disorders such as periarthritis (frozen shoulder), tendinitis, tenosynovitis, and bursitis
• Acute low back pain and post-traumatic pain and inflammation following sprains, strains, and fractures
• Post-operative pain and inflammation
• Acute gouty arthritis
• Renal and biliary colic (adjunct analgesic use)

Adjunct / symptomatic use

• Primary dysmenorrhea (short-term symptomatic relief of pain)

Mobifen Plus is intended for short-term intramuscular use only; the lidocaine component reduces pain at the injection site but does not extend the duration of analgesia. Long-term management of chronic inflammatory conditions should be continued with an oral or other appropriate formulation of diclofenac as advised by a physician.

Each 2 mL ampoule for intramuscular injection contains Diclofenac Sodium 75 mg and Lidocaine Hydrochloride 20 mg. Diclofenac Sodium + Lidocaine Hydrochloride combines a potent non-steroidal anti-inflammatory drug (diclofenac) with an amide-type local anaesthetic (lidocaine) that is included solely to reduce the discomfort of the intramuscular injection itself.

Mobifen Plus is a sterile injectable combination product supplied as 2 mL ampoules for intramuscular administration. It combines diclofenac sodium, a widely used non-steroidal anti-inflammatory drug (NSAID), with lidocaine hydrochloride, an amide-type local anaesthetic added to reduce pain associated with the injection.

Mobifen Plus is used for the rapid, short-term relief of moderate to severe acute pain and inflammation associated with musculoskeletal, post-traumatic, post-operative, and certain painful colic conditions. It is not intended for long-term or repeated daily use beyond a short course, after which therapy is typically continued with an oral or other suitable formulation.

Mobifen Plus belongs to the class of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), specifically the phenylacetic acid derivative group, combined with an amide-type local anaesthetic (lidocaine) used as an injection-pain-reducing adjuvant.

Diclofenac Sodium + Lidocaine Hydrochloride combines two active substances with distinct mechanisms of action:

Diclofenac Sodium

Diclofenac is a potent non-steroidal anti-inflammatory drug (NSAID) that exerts its analgesic, anti-inflammatory, and antipyretic effects primarily through reversible, non-selective inhibition of cyclo-oxygenase (COX-1 and COX-2) enzymes. This reduces the synthesis of prostaglandins and thromboxanes, mediators responsible for pain, inflammation, and fever at sites of tissue injury.

Lidocaine Hydrochloride

Lidocaine is an amide-type local anaesthetic that stabilises the neuronal membrane by inhibiting the ionic fluxes (mainly sodium influx) required for the initiation and conduction of nerve impulses. In this combination it acts locally at the injection site to reduce the pain of intramuscular administration; onset of local anaesthetic action is rapid, with an effect typically lasting 1–2 hours. It does not add to or prolong the systemic analgesic effect of diclofenac.

Mobifen Plus must be given only by deep intramuscular injection into the upper outer quadrant of the gluteal muscle, by a trained healthcare professional. It must never be administered intravenously. Aspirate before injecting to confirm the needle is not in a blood vessel. Avoid repeated injections at the same site. Do not mix with other injectable solutions in the same syringe.

Mobifen Plus should be used cautiously with the following medicines because of well-established, clinically significant interactions:

• Other NSAIDs or aspirin: Concurrent use increases the risk of gastrointestinal ulceration and bleeding and should generally be avoided.
• Anticoagulants (e.g., warfarin) and antiplatelet agents: Increased risk of bleeding; monitor closely if co-administration is necessary.
• ACE inhibitors, angiotensin receptor blockers, and diuretics: Mobifen Plus may reduce their antihypertensive effect and, particularly when all three are combined, increases the risk of acute renal impairment.
• Lithium and digoxin: The diclofenac component can raise plasma concentrations of lithium and digoxin; monitoring of drug levels is advised.
• Methotrexate: Diclofenac can increase methotrexate plasma levels and toxicity, especially if given within 24 hours of methotrexate dosing.
• Corticosteroids and SSRIs: Increased risk of gastrointestinal bleeding when combined with the diclofenac component.
• Cyclosporine and other nephrotoxic drugs: Increased risk of nephrotoxicity.
• Class I antiarrhythmics and other local anaesthetics or CNS depressants: May have additive effects with the lidocaine component, increasing the risk of systemic toxicity.
• Cimetidine and beta-blockers (e.g., propranolol): May reduce hepatic clearance of lidocaine, increasing the risk of lidocaine toxicity.

Most side effects of Mobifen Plus are mild and transient, but patients should be aware of the following:

Common

• Injection-site pain, induration, or discomfort
• Gastrointestinal discomfort, nausea, dyspepsia, or diarrhoea
• Headache and dizziness

Less common / serious

• Gastrointestinal ulceration or bleeding
• Elevated liver enzymes
• Fluid retention, oedema, or elevated blood pressure
• Rare injection-site reactions including local induration, abscess, or tissue necrosis
• Hypersensitivity reactions (skin rash, itching, rarely anaphylactoid reactions)
• Cardiovascular thrombotic events such as myocardial infarction or stroke (a recognised class effect of NSAIDs, more likely with prolonged use or in patients with cardiovascular risk factors)
• Signs of lidocaine systemic effect if absorbed in excess or inadvertently injected intravascularly — light-headedness, perioral numbness, tinnitus, blurred vision, tremor; rarely seizures or cardiac arrhythmia (see Precautions and Warnings)

Pregnancy: Mobifen Plus is contraindicated during the third trimester of pregnancy because the diclofenac component may cause premature closure of the fetal ductus arteriosus, fetal renal impairment, and reduced amniotic fluid. Use during the first and second trimesters should be avoided unless clearly necessary; if used, the lowest effective dose for the shortest possible duration should be given, only if the potential benefit to the mother justifies the potential risk to the fetus, and under a physician's supervision.

Lactation: Diclofenac passes into breast milk in small amounts. Mobifen Plus should be used during breastfeeding only if clearly needed and after consulting a physician, weighing the benefit to the mother against any potential risk to the nursing infant.

Mobifen Plus should be used with caution and under close medical supervision, particularly regarding the following:

• Cardiovascular risk: NSAIDs, including the diclofenac component, may increase the risk of serious cardiovascular thrombotic events; use the lowest effective dose for the shortest duration, with extra caution in patients with cardiovascular disease or risk factors.
• Gastrointestinal risk: Risk of ulceration, bleeding, or perforation, which can occur without warning; use with caution in patients with a history of GI disease, in the elderly, and avoid combination with other NSAIDs or corticosteroids where possible.
• Renal function: Use with caution in patients with renal impairment, dehydration, heart failure, or those on diuretics or ACE inhibitors/ARBs, as NSAIDs can precipitate acute kidney injury.
• Hepatic function: Use with caution in hepatic impairment; discontinue if abnormal liver function persists or worsens.
• Route of administration: Must be given by deep intramuscular injection only, with aspiration before injection to avoid accidental intravascular administration, which can precipitate acute lidocaine systemic toxicity (dizziness, seizures, cardiac arrhythmia). Do not exceed the recommended dose or frequency.
• Cardiac conduction abnormalities: Caution advised in patients with pre-existing conduction disturbances, due to the lidocaine component's effects on cardiac conduction if absorbed systemically in excess.
• Hypersensitivity/asthma: Use with caution in patients with a history of asthma, nasal polyps, or hypersensitivity reactions to NSAIDs.
• Duration of use: Not intended for prolonged or repeated use; limit to a maximum of 2 consecutive days and switch to an alternative formulation for continued treatment.

Overdose of Mobifen Plus may present with symptoms related to either component. Diclofenac overdose can cause gastrointestinal symptoms (nausea, vomiting, abdominal pain), drowsiness, hypotension, respiratory depression, renal impairment, and rarely seizures. Excessive or inadvertent intravascular exposure to the lidocaine component can cause systemic local anaesthetic toxicity, including perioral numbness, tinnitus, visual disturbances, tremor, seizures, and cardiovascular collapse or arrhythmia.

There is no specific antidote for either component. In case of suspected overdose or an adverse reaction suggestive of systemic toxicity, seek immediate medical attention or contact emergency services/a poison control centre. Treatment is supportive and symptomatic, provided under medical supervision.

Store at room temperature (below 30°C), protected from light. Do not freeze. Keep out of reach of children. Discard any unused portion of an opened ampoule; do not reuse.

Renal impairment

Use Mobifen Plus with caution in patients with renal impairment; use the lowest effective dose and monitor renal function, as NSAIDs can worsen renal function, particularly in dehydrated or volume-depleted patients.

Hepatic impairment

Use with caution in patients with hepatic impairment; the lowest effective dose should be used, and liver function should be monitored during prolonged treatment.

Elderly

Elderly patients are at higher risk of gastrointestinal, renal, and cardiovascular adverse effects; use the lowest effective dose for the shortest duration necessary.

Cardiac disease

Use with caution in patients with cardiac conduction abnormalities, ischaemic heart disease, or heart failure; see Contraindications and Precautions.

Paediatric use

The intramuscular route is generally not recommended for routine use in children; when the diclofenac component is used for juvenile chronic arthritis, oral formulations dosed at 1–3 mg/kg/day in divided doses are typically preferred. Safety and efficacy of the intramuscular combination in children have not been well established; use only under specialist paediatric supervision.

Mobifen Plus injection is intended for short-term use only, generally not exceeding 2 consecutive days. If continued anti-inflammatory or analgesic therapy is required beyond this period, treatment should be switched to an oral, rectal, or other suitable formulation of diclofenac under medical advice.

Non-Steroidal Anti-Inflammatory Drug (NSAID) — phenylacetic acid derivative (diclofenac sodium) combined with an amide-type local anaesthetic (lidocaine hydrochloride).

Diclofenac Sodium + Lidocaine Hydrochloride acts through two complementary mechanisms. Diclofenac sodium non-selectively inhibits cyclo-oxygenase (COX-1 and COX-2), reducing the synthesis of prostaglandins that mediate pain, inflammation, and fever, thereby producing analgesic, anti-inflammatory, and antipyretic effects. Lidocaine hydrochloride, an amide-type local anaesthetic, blocks voltage-gated sodium channels in local nerve fibres at the injection site, reducing the sensation of pain caused by the intramuscular injection itself; it does not enhance or prolong the systemic analgesic effect of diclofenac.

The intramuscular route of Mobifen Plus is generally not recommended for routine use in children, and safety and efficacy of the intramuscular combination have not been well established in paediatric patients. When the diclofenac component is required for juvenile chronic (rheumatoid) arthritis, it is typically dosed orally at 1–3 mg/kg body weight per day in divided doses under specialist paediatric supervision, rather than by the intramuscular route. Use in children should only be undertaken on the advice of a physician after careful assessment of the risks and benefits.