Epifenac Amp

Epifenac 75 mg/3ml 3 im/iv amp

Description:

Epifenac 75 mg/3 ml im/iv amp is a prescription-only injectable non-steroidal anti-inflammatory drug (NSAID) containing diclofenac sodium, manufactured by EIPICO. It is formulated for intramuscular (im) or intravenous (iv) administration and is used for rapid relief of moderate to severe pain and inflammation in various acute and chronic musculoskeletal and rheumatic conditions. As a systemic analgesic, antipyretic, and anti-inflammatory medication, Epifenac is commonly used in hospital, emergency, and perioperative settings when oral therapy is not suitable or when fast onset of action is required.

Indications:

• Acute and chronic treatment of signs and symptoms of osteoarthritis and rheumatoid arthritis.
• Management of acute musculoskeletal pain (e.g., back pain, sprains, strains, trauma-related pain) where parenteral NSAID therapy is indicated.
• Short-term treatment of acute gouty arthritis pain and inflammation (as directed by a physician).
• Postoperative pain and inflammation (orthopedic, gynecological, dental, and other surgeries) when oral intake is not possible or not yet resumed.
• Renal colic and biliary colic pain relief as part of hospital-based management.
• Adjunctive treatment for painful inflammatory conditions such as ankylosing spondylitis and other rheumatic disorders.

Active Ingredients / Key Components:

• Diclofenac sodium – 75 mg per 3 ml ampoule (25 mg/ml).
• Excipients: The full list of inactive ingredients (e.g., solvents, stabilizers, preservatives) is not available in the provided information; please refer to the official package insert for complete details.

Dosage & Administration / How to Use:

• Route of administration: Intramuscular (im) deep injection into the gluteal muscle or intravenous (iv) administration as directed by a healthcare professional.
• Typical adult dose (im): 75 mg (1 ampoule) once daily; in severe cases, the dose may be increased up to 150 mg/day (2 ampoules) in divided doses as prescribed by the physician. Maximum daily dose must not be exceeded. Exact dosing regimen must follow the doctor’s instructions and local prescribing information.
• Intravenous use: Usually administered as a slow iv injection or infusion after dilution, under strict medical supervision in a hospital or clinical setting. The method, dilution, and rate of infusion must follow the official product guidelines and physician’s orders.
• Duration of treatment: Intended for short-term use at the lowest effective dose for the shortest possible duration. Once symptoms are controlled and the patient can take oral medication, switching to oral diclofenac or another suitable form is usually recommended.
• Special populations: Dose adjustments and careful monitoring may be required in elderly patients, those with renal or hepatic impairment, or patients at higher risk of gastrointestinal or cardiovascular events. Use only under medical supervision.
• Do not self-inject: Epifenac ampoules must be administered only by qualified healthcare professionals using aseptic technique.

Clinical Benefits:

• Provides strong analgesic action for rapid relief of moderate to severe pain associated with rheumatic and musculoskeletal conditions.
• Reduces inflammation by inhibiting cyclooxygenase (cox-1 and cox-2) and decreasing peripheral prostaglandin synthesis, improving joint mobility and function.
• Exerts antipyretic effects by acting on the hypothalamus, helping to lower elevated body temperature in inflammatory conditions.
• Parenteral formulation (im/iv) offers fast onset of action, making it suitable for acute pain crises, postoperative pain, and situations where oral administration is not feasible.

Warnings & Contraindications:

• Contraindicated in patients with known hypersensitivity to diclofenac, other NSAIDs, or any component of the formulation.
• Contraindicated in patients with a history of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs (risk of severe bronchospasm and anaphylactoid reactions).
• Contraindicated in active peptic ulcer, gastrointestinal bleeding, or perforation, or a history of recurrent peptic ulcer/gi bleeding.
• Contraindicated in severe heart failure, severe hepatic impairment, or severe renal impairment unless specifically directed and closely monitored by a specialist.
• Use with extreme caution in patients with cardiovascular disease or risk factors (e.g., hypertension, hyperlipidemia, diabetes, smoking) due to potential increased risk of thrombotic events (myocardial infarction, stroke) with NSAIDs.
• Use with caution in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease), bleeding disorders, or those taking anticoagulants or antiplatelet agents.
• May cause fluid retention and edema; caution in patients with hypertension, heart failure, or kidney disease.
• Pregnancy and breastfeeding: Use is generally not recommended, especially in the third trimester of pregnancy, due to risk of fetal and maternal complications. Use only if clearly needed and prescribed by a physician.
• May cause dizziness, drowsiness, or visual disturbances; patients should avoid driving or operating machinery if affected.
• Avoid concomitant use with other NSAIDs (including selective cox-2 inhibitors) to reduce risk of additive side effects.
• Regular monitoring of liver function, renal function, and blood counts may be required during prolonged use.
• Consult your doctor before use if pregnant, nursing, taking medications, or have medical conditions such as liver disease, kidney disease, heart disease, hypertension, gastrointestinal disorders, asthma, or bleeding disorders.
• Not intended to diagnose, treat, cure, or prevent any disease without appropriate medical supervision.
• Keep out of reach of children.

Side Effects:

• Common side effects: Nausea, vomiting, abdominal pain, dyspepsia, diarrhea, flatulence, headache, dizziness, injection site pain or irritation.
• Less common but serious side effects: Gastrointestinal bleeding, ulceration or perforation; severe allergic reactions (rash, itching, swelling, bronchospasm, anaphylaxis); liver function abnormalities or hepatitis; kidney impairment; edema; increased blood pressure; cardiovascular events (myocardial infarction, stroke) in at-risk patients.
• Stop treatment and seek immediate medical attention if you experience severe abdominal pain, black or bloody stools, vomiting blood, chest pain, sudden shortness of breath, weakness on one side of the body, severe skin reactions, facial or throat swelling, or difficulty breathing.
• Report any unusual or persistent side effects to your doctor or pharmacist promptly.

Storage Instructions:

Store in a cool, dry place away from direct sunlight. Keep in the original packaging to protect from light. Do not freeze. Keep container tightly closed and ampoules intact until use. Keep out of reach of children.

Specifications:

• Form: Injectable solution in ampoules for intramuscular or intravenous use.
• Strength: 75 mg diclofenac sodium per 3 ml ampoule (25 mg/ml).
• Pack size: 3 im/iv ampoules per pack.
• Intended use: Prescription medicine for pain, inflammation, and fever control under medical supervision.

Disclaimer:
All pharmacy products are intended for general use only and do not replace professional medical advice, diagnosis, or treatment. Always consult a healthcare provider before use. Results may vary, and no specific outcomes are guaranteed. Products are not intended to diagnose, treat, cure, or prevent any disease unless stated. Follow label instructions carefully, as misuse may cause adverse effects. Compliance with local laws is the customer’s responsibility.