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Colchicine Wockhardt

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Colchicine Wockhardt

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Method of action: Antigout, Anti-Inflammatory

Treatment option: Gout, Fits, Behcet Syndrome

Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

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Overview of Colchicine Wockhardt

Quick Facts

Property Description
Active ingredient Colchicine (INN)
Form Oral Tablet
Pharmacological class Anti-gout agent, Microtubule inhibitor
General purpose Rapidly disrupts acute inflammatory episodes
Origin Plant-derived alkaloid (from Colchicum autumnale)

What is Colchicine Wockhardt and Its Pharmacological Class?

Colchicine Wockhardt is a prescription-only medicine containing the active compound Colchicine. It is marketed by the global manufacturer Wockhardt Ltd and is a solid oral dosage form, specifically a tablet.

Scientifically, Colchicine is classified as a specialized Microtubule inhibitor and an alkaloid. It is formally recognized as an Anti-gout agent that acts on the body's inflammatory processes. This classification is clinically recognized for defining its highly targeted mechanism against cellular function.


Composition, Origin, and General Purpose

This preparation is a single active ingredient product, relying solely on the therapeutic effects of the Colchicine molecule. The compound itself is historically plant-derived, originating from the Colchicum autumnale plant. While sourced from nature, the commercial medicine utilizes a highly purified form, combined with standard excipients necessary to create the stable tablet form.

Colchicine’s general purpose is to quickly interrupt severe, acute inflammatory attacks. Its primary mechanism is to disrupt the motility and function of key inflammatory cells (neutrophils), which effectively suppresses acute inflammation. This targeted approach allows the medicine to rapidly alleviate the intense pain, swelling, and redness associated with such episodes.

Regulatory References

  1. National Library of Medicine
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What side effects are possible with Colchicine Wockhardt?

Colchicine's safety profile is defined by officially documented adverse reactions classified by frequency and by affected organ system, based on government regulatory standards (FDA, SmPC).

Adverse Reaction Classifications

The most frequently reported adverse effects involve the gastrointestinal system. These symptoms are generally the first signs of toxicity and are classified as common (occurring in 1 to 10 out of 100 people) in official documents.

Classification Common Adverse Reactions (Official List)
Gastrointestinal Nausea, Vomiting, Diarrhea, Abdominal pain/cramping

Adverse effects classified as Not Known (frequency cannot be estimated from available data) include severe reactions like bone marrow depression (agranulocytosis, aplastic anemia, thrombocytopenia), rhabdomyolysis, peripheral neuropathy, hepatotoxicity, and renal damage. These belong to the Blood and Lymphatic System, Musculoskeletal, and Nervous System disorders.


Serious Safety Considerations

Official labeling warns of the potential for fatal overdose and life-threatening systemic toxicity. Serious adverse reactions include severe blood dyscrasias (Myelosuppression) and severe neuromuscular toxicity (Myopathy and Rhabdomyolysis), which are reported with chronic treatment (long-term use).

Safety notes for specific groups are explicitly stated in regulatory texts. The medicine is contraindicated in individuals with severe renal or hepatic impairment and those with pre-existing blood dyscrasias. Older adults are officially noted to be at an increased risk of neuromuscular toxicity, even with seemingly normal kidney and liver function. Furthermore, the use of colchicine with strong CYP3A4 or P-gp inhibitors is contraindicated in patients with organ impairment due to the risk of life-threatening toxicity, reflecting the drug's officially noted narrow therapeutic window.

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Overdose and Emergency Response

The official regulatory profile for Colchicine emphasizes that the margin between a therapeutic dose and a potentially toxic dose is narrow, resulting in a high mortality rate in severe overdose cases. Due to the high risk, all patients with a known or suspected overdose must be referred for immediate medical assessment and emergency services should be contacted immediately.

Symptoms of acute toxicity are often delayed by two to twelve hours. The initial signs involve severe gastrointestinal manifestations, including persistent nausea, vomiting, abdominal pain, and severe bloody diarrhoea. These symptoms can rapidly lead to significant volume depletion and shock.

Following this initial phase, the toxicity can progress to life-threatening delayed complications. These severe outcomes, which often require intensive care monitoring, include acute renal failure, hepatic damage, and cardiovascular collapse. A critical, delayed feature is the onset of bone marrow depression (myelosuppression), which may manifest several days later. Prolonged hospital observation is necessary due to the potential for these delayed, severe complications.

Regulators state that no specific antidote is known for Colchicine toxicity, meaning management is strictly symptomatic and supportive. Patients at increased risk for severe outcomes include the elderly, children, and those with pre-existing renal or hepatic impairment.

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Therapeutic Uses of Colchicine Wockhardt

What Colchicine Wockhardt Treats: Main Uses and Benefits

Colchicine is generally considered relevant across domains involving inflammatory or irritative states, where it may be part of symptomatic management. The medication is applied across three main therapeutic contexts for supportive relief, and is relevant for addressing acute gout flares, managing Familial Mediterranean Fever (FMF), and assisting with secondary reduction of cardiovascular risk.

This medication addresses symptoms related to inflammatory states that may appear suddenly, such as the acute episodes of gout. It is commonly used when symptoms cluster into patterns requiring supportive management to help reduce the frequency of attacks and ease distress.

This application supports general well-being during symptomatic phases and assists with maintaining functional stability.

Quick Fact: Relief for Inflammatory Distress

Property Description
Primary Relief Goal Supports the easing of acute joint discomfort and swelling
Long-Term Benefit Supports stability in recurrent episodic conditions
Cardiovascular Role Applied to manage systemic inflammatory risk

The medication is relevant in conditions involving episodic or fluctuating manifestations, contributing to easing the overall symptom load and helps maintain a sense of stability when symptoms are more noticeable. For established heart disease, it may assist with managing the long-term risk of major acute or disruptive episodes.

Regulatory References

  1. NIH MedlinePlus Drug Information
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Eligibility and Restrictions for Use

Colchicine Wockhardt is subject to strict eligibility rules documented in official government regulatory information, defining which populations can safely use the medicine and which are prohibited.

Contraindications (Must Not Use)

Contraindicated Group Restriction Reason (Official Labeling)
Severe Renal or Hepatic Impairment Risk of fatal toxicity due to drug accumulation
Concurrent Organ Impairment If taking certain strong CYP3A4 or P-gp inhibitors and patient has renal or hepatic impairment
Pre-existing Blood Dyscrasias Conditions like bone marrow depression, aplastic anemia, or other severe blood disorders
Hypersensitivity Documented allergy to colchicine or any component of the tablet
Pregnancy/Lactation Generally not recommended or contraindicated (depending on region) and may be prohibited in women of childbearing potential not using contraception

Age-Related and Conditional Eligibility

  • Adults are the primary approved population for all labeled uses, including gout and Familial Mediterranean Fever (FMF).
  • Pediatric Use: Use is established only for children 4 years of age and older to treat FMF. Use for gout flares is not recommended or not established in children.
  • Geriatric and Debilitated Patients: Use requires caution and close monitoring due to an increased risk of toxicity, often necessitating dose adjustments based on renal function.
  • Mild to Moderate Organ Impairment: Patients with mild or moderate kidney or liver impairment may be deemed conditionally eligible, but require caution and careful monitoring to manage potential drug accumulation.
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What should I know about interactions with other medicines?

Interactions with other medicines and products

This medicine's clearance is significantly affected by co-administration with other substances that interact with its primary elimination pathways. Official regulatory documents define the interaction profile based on two key domains:

1. Pharmacokinetic (PK) Interactions (CYP3A4 and P-gp)

Colchicine is a substrate for the CYP3A4 enzyme and the P-glycoprotein (P-gp) transporter. Inhibition of either pathway reduces colchicine clearance, leading to a significant increase in systemic exposure.

Classification Interacting Agents Contextual Restriction
Contraindicated Strong CYP3A4 Inhibitors and P-gp Inhibitors (e.g., Clarithromycin, Ketoconazole, Cyclosporine, Ranolazine) Prohibited for co-administration in patients with pre-existing renal impairment or hepatic impairment due to the risk of life-threatening toxicity.

2. Pharmacodynamic and Food Interactions

  • Myotoxicity Risk: Concomitant use with HMG-CoA Reductase Inhibitors (Statins) and Fibrates is documented to increase the risk of myopathy and rhabdomyolysis (muscle damage).
  • Food Restriction: Consumption of Grapefruit or Grapefruit Juice is explicitly advised for avoidance because it inhibits the CYP3A4 enzyme, increasing plasma levels of colchicine.
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Mechanism of Action

How Colchicine Wockhardt Works

Colchicine Wockhardt's action is defined by a highly specific engagement with fundamental cellular machinery, primarily targeting two critical areas that modulate acute inflammatory signaling pathways.


Inhibition of Microtubule Assembly in Leukocytes

The primary mechanism involves the drug's high-affinity binding to tubulin heterodimers, the soluble protein subunits required to build the cellular microtubules. This molecular interaction arrests the polymerization (assembly) of microtubules, severely disrupting the structural framework, or cytoskeleton, of key inflammatory cells such as neutrophils. The resulting physiological effect is a pronounced reduction in the functional capabilities of these cells.


️ Functional Blockade of Inflammatory Cascades

The disruption of the cytoskeleton directly impairs two essential pathways involved in the propagation of acute inflammation. First, it impedes leukocyte chemotaxis, the necessary directed movement of inflammatory cells toward a signaling area. Second, the mechanism inhibits the activation of the NLRP3 inflammasome, thereby limiting the processing and secretion of potent chemical messengers, particularly Interleukin-1beta ( IL-1beta). This combined action restricts both the physical accumulation of inflammatory cells and the release of key inflammatory mediators.


⏱️ Mechanistic Kinetics and Constraints

The full physiological effect of pathway modulation is dependent on its prolonged accumulation inside leukocytes, a kinetic requirement that means the maximal physiological effect is not instantaneous. Furthermore, because the molecular target is a fundamental structure (tubulin) present in all cells, the mechanism inherently lacks specificity to inflammatory cells, which defines the intrinsic boundary of the drug's mechanistic effect.

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Dosage and Administration Information

Colchicine is administered orally, and the use of intravenous forms is generally discouraged. The drug is available as an oral tablet, most commonly in 0.6 mg or 0.5 mg strengths. The timing of administration is structured differently depending on the therapeutic objective.

For acute gout flares, the use pattern is short-term and intensive. The initial approach involves taking 1.2 mg (two tablets) followed by 0.6 mg one hour later, resulting in a maximum 1.8 mg dose over a one-hour period. Conversely, use for prophylaxis (prevention) or Familial Mediterranean Fever (FMF) is a long-term, chronic application, typically requiring 0.6 mg to 1.2 mg daily for prophylaxis or up to 2.4 mg daily for FMF. These daily doses may be taken in one or two divided administrations. The tablets should be swallowed whole and can be taken without regard to meals.

Specific use rules apply to different populations. Guidelines specify reduced starting doses for patients with severe renal impairment receiving chronic therapy. For pediatric patients (starting from 4 years old) with FMF, the required daily dose is determined by age and ranges from 0.3 mg to 2.4 mg. After an acute gout regimen, there is a procedural constraint: the regular daily prophylactic schedule must not be resumed for 12 hours. For patients with severe hepatic or renal impairment, a new acute treatment course should not be repeated more than once every two weeks.

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Recent Clinical Evidence

Evidence for Use in Gout Flares and Prophylaxis

Research into this medication has primarily explored short-term Randomized Controlled Trials (RCTs) evaluating acute, active gout flares, and studies examining the prevention of new flares. Research focuses on measuring outcomes such as the intensity of joint pain and tracking the frequency of new gout attacks over defined time intervals. The overall body of evidence for acute treatment is considered heterogeneous, meaning certainty remains low in some areas due to the variety of findings and modest participant numbers.


Evidence for Use in Familial Mediterranean Fever (FMF)

For this condition, the evidence relies on long-term clinical trials and observational cohort studies tracking pediatric and adult populations. Studies were designed to monitor outcomes related to inflammatory attacks and the progression of secondary complications like amyloidosis over many years. Findings indicate patterns related to reduced inflammatory attack frequency. These long-term studies contributed to the medication's role in the broader evidence landscape for managing FMF, though research continues for patients who demonstrate non-response.


Evidence for Secondary Cardiovascular Risk Reduction

Research for this indication involved large-scale, international Randomized Controlled Trials (RCTs) tracking adults with established heart disease over several years. The trials monitored the rate of the composite Major Adverse Cardiovascular Events (MACE). Research highlights the outcomes measured, including specific measurements in the MACE rate compared to the placebo groups. Follow-up durations were typically two to three years, meaning data for very long-term outcomes beyond this timeframe remain insufficient.


What is Still Uncertain About Colchicine Research

Key research gaps include limited information for long-term outcomes regarding the repeated use for recurring acute gout flares and the durability of response in cardiovascular patients. Results apply only to the populations studied. Data for specific groups, such as those who are pregnant or breastfeeding, remain insufficient.

Key Studies & References

  1. Recommendation on Colchicine Dosing and Definition of Colchicine Resistance/Intolerance in the Management of Familial Mediterranean Fever (Referenced for FMF non-response context)
  2. The pharmacologic basis of treatment with colchicine in children with familial Mediterranean fever (Referenced for pediatric use and amyloidosis data)
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Frequently Asked Questions (FAQ)

Common questions about Colchicine Wockhardt (FAQ)

Q: How quickly can a person expect Colchicine Wockhardt to start working for a gout flare?

A: Official information indicates that the full physiological effect of the medicine is not instantaneous because it relies on accumulating inside inflammatory cells. Some public health sources suggest action may begin within 30 minutes to 2 hours. A noticeable reduction in pain for a gout flare is often described as taking up to a day or two to become apparent.

Q: Does Colchicine Wockhardt treat the underlying cause of the condition or just the symptoms?

A: According to regulatory classification, this medicine works as an anti-gout agent that primarily functions by suppressing acute inflammation. It is approved for both treating active inflammatory episodes and for prophylaxis, which is the long-term prevention of future flares.

Q: Is Colchicine Wockhardt the same exact medication as other colchicine brands?

A: Colchicine Wockhardt contains the active compound Colchicine. While all medications with this compound share the same main drug, the official product information notes that the inactive ingredients, known as excipients, may be different between various manufacturers and brands.

Q: Can Colchicine Wockhardt interact with common over-the-counter medications?

A: Official regulatory documents contain guidance that patients should report all current medications, including any non-prescription medications or herbal products. This is because some over-the-counter products can interact with the drug’s elimination pathways, potentially leading to increased risk of toxicity.

Q: Is it safe to drink alcohol while using Colchicine Wockhardt?

A: Regulatory information notes that alcohol use does not directly change how the medicine works in the body. However, official regulatory information includes warnings for individuals with pre-existing alcohol abuse. Furthermore, public health guidance points out that consuming alcohol can raise uric acid levels, which is known to worsen gout.

Q: What happens if a scheduled dose of Colchicine Wockhardt is missed?

A: Official patient labeling describes the procedure for a missed dose as taking it as soon as possible, followed by a return to the normal schedule. It is specifically advised not to take a double dose to compensate for the one that was missed.

Q: Is it normal to feel tired or weak after starting Colchicine Wockhardt?

A: Tiredness or weakness is not listed as a common side effect. However, official labeling contains a warning stating that symptoms of toxicity, which can include muscle weakness, fatigue, and general weakness, require medical evaluation.

Q: Does Colchicine Wockhardt have any potential for dependency or addiction?

A: According to official regulatory labeling, there is no reported potential for tolerance, abuse, or dependence associated with the use of colchicine.

Q: How long does Colchicine Wockhardt stay in your system after stopping the medication?

A: Pharmacokinetic data from official sources indicates that the plasma elimination half-life in healthy adults is about 26.6 hours after chronic dosing. The half-life refers to the time it takes for the concentration of the medicine in the bloodstream to decrease by half.

Q: Can Colchicine Wockhardt cause hair loss?

A: Based on post-marketing surveillance data, hair loss, known as alopecia, has been reported as a rare side effect. This effect is primarily noted with higher or prolonged doses. Official information indicates this side effect is generally considered reversible after the medicine is discontinued.

Q: Why is the active ingredient in Colchicine Wockhardt described as a mitotic inhibitor?

A: Official regulatory descriptions classify the active ingredient as a microtubule inhibitor. This classification relates to its ability to bind to cellular tubulin, which disrupts the structure of microtubules. Since microtubules are essential for cell division (mitosis), the action is known as mitotic inhibition.

Q: Does Colchicine Wockhardt interact with supplements containing Vitamin B12?

A: Regulatory texts indicate that prolonged use of this medicine can sometimes lead to the malabsorption of Vitamin B12. This effect is notable because it can potentially interfere with the accuracy of certain diagnostic blood assays for B12 and folic acid.

Q: What clinical trials or studies are available regarding Colchicine Wockhardt?

A: Official regulatory labeling includes a section on Clinical Studies that cites trials to support the approved uses. These studies include Randomized Controlled Trials (RCTs) examining the treatment of gout flares and the long-term prophylaxis of gout and Familial Mediterranean Fever (FMF).

Q: Why do some people refer to Colchicine Wockhardt as 'Colgout' or 'Colcrys'?

A: The active ingredient in this medication is Colchicine, which is marketed globally under various proprietary names by different manufacturers. Regulatory documents, such as those from the FDA, reference other approved trade names, such as Colcrys, which also contain the same active compound.

Q: Is it required to have routine blood tests while taking Colchicine Wockhardt?

A: Due to the risks of severe adverse reactions like blood dyscrasias and potential organ impairment, public health resources indicate that regular blood and urine tests may be required for monitoring. This is considered important, especially for individuals with pre-existing kidney or liver conditions.

Q: Is there any information about Colchicine Wockhardt affecting fertility in men or women?

A: Regulatory information indicates that the medicine may rarely and transiently impair fertility in males. Nonclinical studies, which are not conducted in humans, have also indicated that the mechanism of action has the potential to interfere with reproductive processes in females.

Q: What is the role of Colchicine Wockhardt in treating FMF (Familial Mediterranean Fever)?

A: Official labeling indicates that Colchicine is approved for the treatment of Familial Mediterranean Fever (FMF) in adults and children four years of age and older. This application is typically a long-term use for the prevention of inflammatory attacks associated with the condition.

Q: What is the general safety profile for long-term use of Colchicine Wockhardt?

A: Official labeling notes that serious adverse reactions are reported with chronic treatment, which is the term for long-term use. These serious reactions include severe blood dyscrasias (such as myelosuppression) and severe neuromuscular toxicity (including rhabdomyolysis).

Q: Does Colchicine Wockhardt affect blood test results?

A: Official regulatory text notes a possible effect on certain blood test results. The medicine is documented to potentially cause the malabsorption of vitamin B12, an effect which can interfere with the accuracy of diagnostic blood assays used to measure levels of B12 and folic acid.

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How should Colchicine Wockhardt be stored and disposed of?

How to Store and Dispose of Colchicine Wockhardt

The storage and disposal of Colchicine Wockhardt tablets must strictly adhere to regulatory requirements to ensure product stability and safety. The medicine must be kept out of the sight and reach of children due to toxicity concerns.


Storage Requirements

Tablets must be stored below 25°C and require protection from light. To maintain these conditions, the product must be kept in the original container. Do not use the tablets past the expiry date or if signs of deterioration, such as discoloration, are visible.


Disposal Instructions

Expired or unused Colchicine tablets must not be disposed of via wastewater or household waste. Consult a pharmacist for instructions on proper disposal, as this procedure is mandated to help protect the environment.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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