Quick Facts

• Relieves signs and symptoms of Rheumatoid Arthritis in adults.
• Addresses pain and swelling related to Osteoarthritis.
• Provides relief for mild to moderate pain.
• Manages symptoms of primary dysmenorrhea (menstrual cramps).

Cataflam-V is indicated for the temporary management of symptoms associated with specific conditions. It provides relief from the signs and symptoms of osteoarthritis and rheumatoid arthritis in adult patients. The therapeutic goal is to help reduce discomfort and address the swelling associated with these conditions.

This medication is also utilized for the relief of mild to moderate acute pain from various sources. A further indicated use is to help manage symptoms of primary dysmenorrhea, which refers to pain experienced during menstruation. Cataflam-V is intended for short-term use and works to address the discomfort and inflammation related to these conditions, aligning with the therapeutic management goals for these patient populations.

Eligibility for Cataflam-V: Official Regulatory Status

Official regulatory documents define specific populations permitted to use Cataflam-V (diclofenac potassium) and those for whom its use is strictly contraindicated.

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Populations For Whom Use is Contraindicated

• Allergy and Hypersensitivity: Patients with known hypersensitivity to diclofenac or any components, and those who have experienced asthma, urticaria, or allergic reactions after taking aspirin or other NSAIDs.
• Organ Failure: Patients with established severe hepatic failure, severe renal failure, or severe heart failure (NYHA Class III-IV).
• GI Disease: Patients with active gastrointestinal ulceration, bleeding, or perforation.
• Surgery: Patients in the setting of coronary artery bypass graft (CABG) surgery.
• Pregnancy: Women in the third trimester of pregnancy (from about 30 weeks gestation).

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Age and Condition Restrictions

• Pediatric Use: The medicine is not recommended for use in children and adolescents under 14 years of age.
• Cardiovascular Risk: Patients with established cardiovascular disease or significant risk factors should be treated only after careful consideration, utilizing the lowest effective dose for the shortest duration possible.
• Mild Impairment: Caution is advised for use in patients with mild-to-moderate renal or hepatic impairment.
• Lactation: Use is not recommended for women who are breastfeeding.

Interactions with other medicines and products

This section outlines the officially documented interaction information for Diclofenac potassium, based on authoritative government regulatory sources.

Interaction Scope and Restrictions

Category	Documented Interacting Substances or Mechanisms
Exposure-Altering Agents	Diclofenac exposure is significantly increased by Voriconazole (a CYP2C9 inhibitor). Diclofenac can raise the plasma concentrations of Lithium and Digoxin by reducing their clearance.
Risk-Augmenting Agents	Concomitant use with Anticoagulants (e.g., Warfarin), Corticosteroids, SSRIs, and Anti-platelet Agents increases the risk of serious bleeding events.
Function-Interfering Agents	Diclofenac may diminish the antihypertensive and diuretic effects of ACE Inhibitors, ARBs, and Diuretics.
Substance/Food	Food causes a reduction in peak plasma concentration (Cmax) of approximately 30%. Alcohol use increases the risk of gastrointestinal bleeding.

Interaction Classifications

Interaction classifications are defined by regulatory authorities to guide prescribing practices:

• Formal Contraindication: Use is contraindicated in the setting of peri-operative pain for Coronary Artery Bypass Graft (CABG) surgery.
• Strong Avoidance: Co-administration with other systemic Nonsteroidal Anti-inflammatory Drugs (NSAIDs) should be avoided due to the potential for additive adverse effects.
• Timing Rule: Caution is recommended when NSAIDs are administered less than 24 hours before treatment with Methotrexate.

The regulatory documents establish the interaction structure by defining two main domains: pharmacokinetic interactions that modify drug levels and pharmacodynamic interactions that augment systemic risks. These official statements define combination restrictions and necessary monitoring for clinically significant drug-drug and drug-substance combinations.

Core Action: Inhibiting Prostaglandin Synthesis

The active molecule, diclofenac, acts as a reversible inhibitor of the Cyclooxygenase (COX) enzymes (both COX-1 and COX-2). This inhibition halts the conversion of arachidonic acid into prostaglandins and other eicosanoids, which are powerful chemical mediators.

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Modulation of Nociceptor and Vascular Pathways

By drastically reducing the production of prostaglandins, the drug limits the chemical signals that normally sensitize peripheral sensory nerve endings (nociceptors), thereby reducing the excitability of these peripheral sensory nerve endings. This reduction also lessens prostaglandin-mediated vascular permeability at the site of irritation, which helps to limit local fluid efflux.

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Influence on Systemic Regulation

The potassium-salt formulation facilitates rapid absorption and systemic distribution of the molecule, allowing for prompt engagement with physiological targets. In addition to local effects, the drug modifies prostaglandin signaling within the central nervous system, which contributes to suppressing prostaglandin signaling within the central thermoregulatory pathways by influencing the body's internal thermal set point.

Official Administration Guidelines for Cataflam-V (Diclofenac Potassium)

The use of Cataflam-V tablets must strictly adhere to the established dosing and procedural instructions.

Administration Scope	Official Guideline
Route of Administration	Oral. Tablets must be swallowed whole with liquid and must not be divided or chewed.
Timing in Relation to Meals	Preferably taken before meals. Food may affect the rate of absorption.
Dosing Schedule (Adults)	Generally, the total daily dose is divided into 2 or 3 separate doses. The recommended initial daily dose is 100 to 150 mg; for milder conditions, 75 to 100 mg daily is usually sufficient.
Dosing for Acute Pain/Dysmenorrhea	The recommended dosage is 50 mg three times a day. An initial dose of 100 mg may be used, followed by 50 mg doses.
Dosing for Migraine	An initial dose of 50 mg should be taken at the first sign of an attack. Subsequent 50 mg doses may be taken at 4- to 6-hour intervals, not exceeding a total of 200 mg per day.
Age-Group Rules	Not recommended for children and adolescents below 14 years of age. No starting dose adjustment is generally required for the elderly, but caution is advised.
Missed Dose	Take the missed dose as soon as remembered. If it is almost time for the next scheduled dose, skip the missed dose. Do not double the dose.

Special Procedural Conditions

To minimize potential risks, the drug should be used at the lowest effective dose for the shortest duration possible consistent with treatment goals. Treatment is recommended only for short-term use.

Cataflam-V: Recent Clinical Evidence

Evidence for Use in Acute Pain

Research exploring the effects of Diclofenac potassium, the active substance in Cataflam-V, for sudden, short-term discomfort has primarily used randomized, double-blind, placebo-controlled trials in adult populations. Studies was evaluated in settings involving specific pain models, such as pain following minor surgical procedures, focusing on what outcomes related to changes in perceived discomfort and effect duration were measured. The research goal was to measure endpoints like the time until a measured change in outcomes related to physical discomfort was first reported and the magnitude of measured outcomes observed over a few hours.

Findings from these trials describe patterns observed in the studies where initial patient-reported outcomes describing perceived discomfort were recorded at specific early time points. These studies contribute to the broader evidence landscape by providing insight into the drug’s performance during episodes where symptoms become more noticeable and disruptive. However, the follow-up durations were limited in most of the core efficacy studies, as they focused on immediate, short-term relief.

Evidence for Use in Chronic Conditions: Osteoarthritis and Rheumatoid Arthritis

For chronic conditions like Osteoarthritis and Rheumatoid Arthritis, the evidence was studied for symptomatic relief in conditions marked by functional limitations. Research included intermediate-term randomized controlled trials as well as longer-term observational settings evaluating daily-life functioning in adult populations. Studies monitored patient-reported outcomes describing perceived discomfort and objective outcomes reflecting daily functioning or activity level. Findings describe patterns observed in the studies where measures of pain and functional capacity were tracked over a period of weeks to months. The controlled efficacy trials typically had follow-up durations that were limited to a few months.

What Remains Uncertain About the Research Base

While research provides context but not individual predictions, the broader scientific literature highlights several areas where data remain insufficient. Long-term effects are not fully established regarding the sustained, multi-year symptomatic management of chronic diseases. Furthermore, comparative evidence is lacking in some areas, and subgroup findings are uncertain for specific populations, particularly those with complex medical histories or the pediatric population. The available evidence highlights what is known—and what is still uncertain—about this medicine. Study results reflect the specific conditions under which they were conducted.

Key Studies & References DailyMed Labeling: DICLOFENAC POTASSIUM (immediate-release oral tablet) - National Institutes of Health (NIH)

Common questions about Cataflam-V (FAQ)

Q: Is Cataflam-V a strong painkiller?

According to official documentation, the active ingredient in Cataflam-V belongs to a class of medicines known as Nonsteroidal Anti-inflammatory Drugs (NSAIDs). Within this class, the substance is generally recognized for its potent anti-inflammatory and pain-relieving properties, according to its official classification.

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Q: Is Cataflam-V addictive or habit-forming?

Official drug labeling confirms that diclofenac potassium, the active substance in Cataflam-V, is not classified as a controlled substance by regulatory agencies. It belongs to the NSAID class of drugs and does not have abuse or dependence warnings in its product information.

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Q: Does Cataflam-V make you sleepy or drowsy?

The full official prescribing information lists drowsiness or sleepiness as a documented adverse reaction, although it is reported as an uncommon or less common effect. Awareness of this possibility is generally included in the patient information, given that the medicine may affect the central nervous system.

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Q: Can I take Cataflam-V with my blood pressure medicine?

Regulatory documents advise caution when taking this medicine with certain types of blood pressure medications, such as ACE inhibitors, ARBs, and diuretics. This is because Cataflam-V may reduce the intended blood pressure-lowering effects of those drugs. Regulatory documents state that monitoring of blood pressure may be necessary when these medicines are used together.

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Q: What is the difference between Cataflam-V and ibuprofen?

Both Cataflam-V and ibuprofen are classified as Nonsteroidal Anti-inflammatory Drugs (NSAIDs), meaning they share a similar mechanism of action against pain and inflammation. However, Diclofenac (the active ingredient in Cataflam-V) is a benzeneacetic acid derivative, which is a distinct chemical subclass from ibuprofen. This difference relates to their core chemical structure.

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Q: Is there a generic version of Cataflam-V?

The active substance in Cataflam-V is diclofenac potassium. This ingredient is available as a generic product in various dosage forms (e.g., immediate-release tablets or capsules) from various manufacturers.

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Q: Can Cataflam-V cause changes in mood?

Changes in mood, including reports of depression, anxiety, or nervousness, are listed in the full prescribing information. These types of nervous system effects are documented as rare or less common adverse reactions associated with diclofenac formulations.

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Q: Does Cataflam-V interact with herbal supplements?

The official regulatory label does not list specific herbal supplements as formal contraindications. However, because Cataflam-V has the potential to affect bleeding risk, official documents mention that caution and monitoring may be necessary when it is taken alongside concurrent agents or supplements known to affect bleeding, such as ginkgo biloba, ginseng, or Vitamin E.

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Q: Why do doctors prescribe Cataflam-V instead of other pain relievers?

Cataflam-V utilizes the potassium salt formulation of diclofenac, which is specifically designed for rapid absorption. This formulation characteristic is intended to provide fast symptomatic relief, which is a key distinguishing feature noted in its official composition.

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Q: How long does Cataflam-V stay in your system?

Pharmacokinetic data available in official documents show that the unchanged active substance, diclofenac, has a reported terminal half-life of approximately 2 hours. This figure refers to the time it takes for the amount of drug in the body to be reduced by half.

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Q: What are the signs of a serious reaction to Cataflam-V?

Official patient information describes key signs of serious adverse events associated with the use of the medicine. These may include the onset of symptoms such as chest pain, shortness of breath, sudden weakness or slurring of speech, black or tarry stools, vomiting blood, or swelling of the face or throat.

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Q: Can Cataflam-V interact with birth control pills?

Official prescribing information notes that diclofenac has the potential to increase the concentration of potassium in the blood. This effect may be of concern for certain birth control pills containing the diuretic ingredient drospirenone, which also affects potassium levels.

Storage and Disposal of Cataflam-V (Diclofenac Potassium)

Official regulatory guidelines define specific conditions for storing and discarding Cataflam-V tablets to maintain stability and ensure safety.

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Storage Requirements

Cataflam-V must be stored at a temperature not exceeding 30°C (86°F). The tablets are required to be kept in the original container and must be protected from both light and moisture. It is a mandatory public safety requirement that the medication be stored out of the sight and reach of children to prevent accidental ingestion.

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Disposal Instructions

Unused or expired Cataflam-V must be disposed of according to local requirements for the collection of medicines. The regulatory guidance explicitly states that the medicine must not be discarded in household trash or flushed down the toilet (wastewater).