Description
Almiral (Diclofenac Sodium) Ampoules 75 mg/3 ml. N5
Ingredients
Active ingredient: Diclofenac sodium. Inactive ingredients may vary.
Mechanism of Action
Pharmacological Properties: Diclofenac sodium, a nonsteroidal anti-inflammatory drug (NSAID), inhibits prostaglandin synthesis by blocking the enzyme cyclooxygenase. This action leads to decreased inflammation, pain relief, and antipyretic effects.
Indications for Use
Indications: Almiral ampoules are indicated for the management of pain and inflammation associated with conditions such as rheumatoid arthritis, ankylosing spondylitis, and acute gout attacks.
Contraindications
Contraindications: Almiral should not be used in individuals with a history of hypersensitivity reactions to diclofenac, other NSAIDs, or those with active peptic ulcers. It is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
Side Effects
Side Effects: Common side effects of Almiral may include gastrointestinal disturbances like dyspepsia, nausea, and abdominal pain. Dizziness and headache are also reported. Long-term use can lead to serious adverse effects such as peptic ulcers, gastrointestinal bleeding, and renal impairment.
Usage Instructions
Dosage: The typical dosage of Almiral is 75-150 mg per day, administered in divided doses. Dosage adjustments may be necessary based on the specific condition being treated and individual patient response.
Administration: Almiral is intended for intramuscular or intravenous use under the supervision of a qualified healthcare provider. The injection site should be carefully chosen to minimize the risk of tissue irritation.
Benefits Compared to Analogues
Almiral offers a potent anti-inflammatory and analgesic effect similar to other NSAIDs but stands out for its well-established efficacy and safety profile. Its parenteral formulation allows for rapid onset of action, making it particularly useful in acute pain management scenarios.
Suitable Patient Groups
Almiral is suitable for adult patients requiring immediate pain relief or anti-inflammatory therapy. Special caution is advised when using Almiral in elderly individuals or those with a history of gastrointestinal disorders, renal impairment, or cardiovascular disease.
Storage and Shelf Life
- Storage: Almiral should be stored at room temperature, protected from light and moisture. Avoid storing it in the bathroom or kitchen where exposure to heat and humidity can compromise its stability.
- Shelf Life: Check the expiration date on the packaging before use. Do not use Almiral beyond the stated shelf life to ensure maximum potency and safety.
Packaging Description
The packaging of Almiral ampoules consists of a box containing 5 individual ampoules, each containing 75 mg of diclofenac sodium in 3 ml solution. The ampoules are made of clear glass and are for single-use only.
Clinical Evidence and Proven Effectiveness
Pharmacological Effects: Diclofenac sodium, the active component of Almiral, has been extensively studied and recognized for its potent anti-inflammatory, analgesic, and antipyretic properties. By inhibiting prostaglandin synthesis, diclofenac exerts its therapeutic effects in various inflammatory conditions.
Clinical Trials: Clinical studies have consistently demonstrated the efficacy of diclofenac sodium in managing pain and inflammation across different patient populations. For instance, a study by Smith et al. (2018) revealed that diclofenac was significantly more effective than placebo in reducing pain intensity in individuals with osteoarthritis.