Volfenac Retard (Diclofenac)

Active Ingredient: Diclofenac
Dosage: 100 mg
Route of Administration: Oral
Dosage Form: Extended-release tablets (dragee)
Quantity per package: 20

Reasons for Unavailability in the USA

The primary reason Volfenac Retard may not be available in the USA could be due to the regulatory environment, availability of similar formulations, and potential safety concerns specific to diclofenac, which carries a risk of cardiovascular events and gastrointestinal issues.

Equivalent Drugs Sold in the USA

For Rheumatic and Inflammatory Conditions:

What is Volfenac Retard?

Volfenac Retard (diclofenac) is a pharmaceutical formulation containing diclofenac, a non-steroidal anti-inflammatory drug (NSAID) that provides anti-rheumatic, anti-inflammatory, and analgesic (pain relief) properties. It’s particularly effective in treating rheumatic diseases like osteoarthritis and rheumatoid arthritis, as well as other inflammatory conditions with pain, such as ankylosing spondylitis, tendinitis, and bursitis.

Indications

Volfenac Retard is indicated as an anti-rheumatic, anti-inflammatory drug with analgesic action.

It is used to treat:

• inflammatory and degenerative forms of rheumatism;
• rheumatoid arthritis;
• ankylopoietic spondylarthritis;
• osteoarthritis and spondylarthrosis;
• syndromes that hurt from the vertebral column;
• extraarticular rheumatism;
• inflammation and painful post-traumatic and postoperative swelling;
• painful and / or inflammatory conditions in gynecology, for example, primary dysmenorrhea.

Popularity and Usage in Other Countries

• Latin America & Europe: Volfenac Retard is popular in some Latin American and European countries, where it’s available and commonly prescribed for chronic inflammatory and pain conditions due to its effectiveness and sustained release formulation.
• Reason for Usage: In these regions, the sustained-release nature allows for convenient once-a-day dosing, making it easier for patients to adhere to their treatment plans.

Dosage and administration

Administration way: Oral.

Dose: adults: in general, the initial daily dose is 100-150 mg. In mild cases and in prolonged treatment, a daily dragee of Volfenac Retard will be sufficient. If discomfort prevails at night or in the morning, the drug should preferably be taken in the afternoon. Dragees should be swallowed whole together with liquid, preferably during meals. Children: this product is not recommended for children because of a high concentration of the active substance.

Contraindications

• Gastroduodenal ulcer;
• Hypersensitivity to the active substance;
• Patients who have suffered an asthma attack, hives or acute rhinitis after administration of acetylsalicylic acid or other medications that inhibit the activity of prostaglandin synthase;
• Patients experiencing vertigo;
• Severe arterial hypertension;
• Heart, kidney and liver failure;
• Cytopenias.

Side effects

• Gastrointestinal tract: epigastric pain, nausea, vomiting, diarrhea, abdominal cramps, dyspepsia, flatulence, anorexia, gastrointestinal bleeding (hematemesis, mane, bloody diarrhea), gastric or intestinal ulcer with or without bleeding or perforation, aphthous stomatitis, glossitis, esophageal lesions, intestinal stenosis due to “diaphragm” formation, lower intestinal disorders, such as nonspecific hemorrhagic colitis and exacerbation of ulcerative colitis or Crohn’s disease; constipation, pancreatitis;
• Central nervous system: headache, dizziness or vertigo, drowsiness, sensitivity disorders, including paraesthesia, memory disorders, disorientation, insomnia, irritability, seizures, depression, anxiety, nightmares, tremor, psychotic reactions, aseptic meningitis;
• Alterations of the senses: vision disorders (blurred vision, diplopia), hearing loss, tinnitus, taste disturbances;
• Skin: erythema or rashes, hives, vesicular rashes, eczema, erythema multiforme, Stevens-Johnson syndrome, Lyell syndrome (acute toxic epidermolysis), erythroderma (exfoliative dermatitis), hair loss, photosensitivity reaction, purple;
• Kidneys: edema, acute renal failure, urinary disorders such as hematuria and proteinuria, interstitial nephritis, nephrotic syndrome, papillary necrosis;
• Liver: occasionally: increased serum aminotransferases, hepatitis with or without jaundice, fulminant hepatitis;
• Hypersensitivity: hypersensitivity reactions such as asthma, anaphylactic or anaphylactoid systemic reactions including hypotension, vasculitis, pneumonitis;
• Cardiovascular system: palpitation, chest pain, hypertension, congestive heart failure.

Overdose

The treatment of acute poisoning with nonsteroidal anti-inflammatory drugs consists mainly of symptomatic support measures. A typical clinical picture associated with overdosing with diclofenac is unknown. The therapeutic measures to be taken in case of overdose with Volfenac Retard are as follows: absorption will be immediately prevented by washing the stomach and administering activated carbon. Supportive and symptomatic measures will be applied against complications, gastrointestinal irritation and respiratory depression. Specific treatments, such as forced diuresis, dialysis or hemoperfusion, are probably of little use to eliminate non-steroidal anti-inflammatories because of their high protein binding rate and extensive metabolism.

Interaction

Simultaneous use of diclofenac and lithium or digoxin-based preparations may increase their plasma level. It is possible that various nonsteroidal anti-inflammatory drugs inhibit the effect of diuretics. Concomitant treatment with potassium-sparing diuretics is related to hyperkalemia, which requires frequent monitoring of serum potassium levels. Concomitant administration of various non-steroidal systemic anti-inflammatories may cause side effects. Although clinical studies seem to indicate that Volfenac Retard does not influence the effect of anticoagulants, there are isolated reports of an increased risk of bleeding during the combined use of diclofenac and anticoagulants. Therefore, it is recommended to closely monitor these patients. Clinical studies have shown that Volfenac Retard can be administered together with oral antidiabetics without influencing its clinical effect. However, there are isolated reports that both hypoglycemic and hyperglycemic effects can be caused by Volfenac Retard and require changing the dosage of the hypoglycemic agent. Caution is advised when non-steroidal anti-inflammatories are used less than 24 hours before or after treatment with methotrexate, as they can raise the blood concentration of methotrexate and increase its toxicity. The nephrotoxicity of cyclosporine may be greater due to the effects of non-steroidal anti-inflammatory drugs on renal prostaglandins. There are isolated reports of seizures possibly due to the concomitant use of quinolones and non-steroidal anti-inflammatory drugs.