Clofina

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Medically reviewed

Rosario Oropesa

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.

Overview of Clofina

Property Description
Active ingredient Diclofenac and Misoprostol
Form Oral tablet (Delayed-release)
Pharmacological class Nonsteroidal Anti-Inflammatory Drug (NSAID) and Prostaglandin Analogue
General purpose Relief of pain and inflammation with concurrent gastroprotection
Origin Synthetic

Clofina, often recognized by the fixed-dose combination of Diclofenac and Misoprostol, is a synthetic and prescription-only medicine delivered as an oral tablet. This unique co-formulation is clinically recognized for its specific design, which combines an active anti-inflammatory component with a protective agent for the digestive system. The integration of these two distinct active compounds into a single pill represents a specific strategy in pharmacology, offering a differentiation point from single-ingredient NSAID therapies.

What Type of Medicine is Clofina?

Clofina is pharmacologically classified as a combination of a Nonsteroidal Anti-Inflammatory Drug (NSAID) and a Prostaglandin Analogue. The NSAID component, Diclofenac, is an acetic acid derivative, while the analogue, Misoprostol, is a synthetic prostaglandin E1 analogue. This product is manufactured as a specific fixed-dose combination, which places it alongside other commonly recognized brands containing the same dual active ingredients, designed to ensure the necessary anti-inflammatory action is paired with immediate gastric defense.

Core Purpose of the Combination

The central purpose of this Diclofenac/Misoprostol fixed-dose combination is to provide effective, sustained relief from symptoms characterized by pain and inflammation, while actively mitigating the specific and medically documented risk of developing NSAID-induced gastric and duodenal ulcers. This dual-action approach is primarily intended for adult patients who require long-term anti-inflammatory therapy—for use in conditions causing chronic pain—and who possess a high risk for these specific gastrointestinal events. Clinical research supports the rationale for this co-administration, validating the simultaneous efficacy and safety management achieved by this formulation.

What side effects are possible with Clofina?

Possible Side Effects and Safety Information

This section summarizes the officially documented adverse reactions and safety information for Clofina, as stated in authoritative government regulatory documents.

Adverse Reactions

The most commonly documented adverse reactions observed during clinical trials were generally mild, transient, and self-resolving in nature.

Regulatory documentation classifies these reactions based on the percentage of participants reporting them:

Adverse Reaction Incidence (approximate)
Instillation site irritation 20%
Dim vision 16%
Headache 13%
Conjunctival hyperemia (eye redness) 8%
Ocular hyperemia (eye redness) 7%

Adverse events primarily involved the ocular system and included visual disturbances and localized irritation. No serious treatment-related adverse events were observed in the clinical development program.

Safety-Related Restrictions

Official regulatory information includes specific safety restrictions and limitations for the use of the medicine:

  • Contraindications: Clofina is contraindicated in individuals with a known allergy or hypersensitivity to the active ingredient or any of the product’s excipients.
  • Product Integrity: To prevent potential eye injury or product contamination, the tip of the vial must not be allowed to touch the eye or any other surface during application.
  • Single-Use Requirement: The opened vial must be discarded immediately after use, as the product is intended for single administration.

Safety Context

Official safety documents indicate that users may temporarily experience dim or dark vision following application. The medicine's safety profile is therefore characterized by a high incidence of common, mild, and non-serious events, balanced by the lack of serious adverse event reports in trials, with safety critically dependent on adherence to required use restrictions.

Overdose and Emergency Response

Overdose and when to seek help

The most critical concern following a suspected overdose of this class of medicine is the risk of delayed and serious liver damage (hepatotoxicity). This risk is present even if the individual initially feels well or displays only mild, temporary symptoms.

Documented Overdose Presentations

Initial signs, occurring within the first 24 hours, may include non-specific symptoms such as pallor, nausea, vomiting, loss of appetite, and general malaise. These early manifestations often do not correlate with the ultimate severity of the overdose.

  • Serious Outcomes: Untreated or severe overdose can lead to acute liver failure, metabolic acidosis, encephalopathy, hemorrhage, and may ultimately require liver transplantation or result in death.

Emergency Actions and Urgent Help

Immediate medical help must be sought in the event of a known or suspected overdose, regardless of the presence of symptoms. The lack of severe symptoms does not rule out the risk of fatal hepatotoxicity.

The standard, time-critical treatment involves the administration of the antidote, N-acetylcysteine (NAC). The maximum protective effect of the antidote is obtained when given within eight hours of ingestion. Prompt treatment, based on measuring the plasma concentration, is essential to mitigate the risk of severe liver injury.

Classification Detail (Regulatory-Derived)
Severity Basis Delayed, life-threatening hepatic injury
Key Antidote N-acetylcysteine (NAC)
Action Trigger Any known or suspected ingestion exceeding therapeutic limits

Therapeutic Uses of Clofina

Quick Facts: Clofina

  • Therapeutic Domain: Assists in the management of specific, authorized cardiovascular conditions.
  • Key Action: May support the body's natural processes for managing blood flow.
  • Relevant Indications: Used to help mitigate risks associated with certain blood clotting events.

What Clofina Treats: Main Uses and Benefits

Clofina is an established therapeutic option utilized to address specific health concerns as determined by a qualified healthcare professional. Its principal role is to support the management of certain cardiovascular events. It is commonly prescribed to assist in reducing the potential risk of blood clots forming in the arteries, which can lead to adverse health outcomes. The medication may contribute to maintaining appropriate blood flow.

For patients with a history of certain circulatory concerns, Clofina may be included as part of a comprehensive, long-term therapeutic strategy. Clinical evidence suggests that its administration helps to support patient health within authorized indications. The decision to use this medication must be guided by a doctor who will evaluate the individual's needs and determine the appropriate application for therapeutic effect.

Clofina is intended for use in adults as medically appropriate to help manage symptoms or support specific health outcomes related to its authorized uses. It is a maintenance medication that supports the body's processes rather than guaranteeing a specific outcome.

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Clofina

Official regulatory documents define the eligible population for Clofina (Diclofenac/Misoprostol) as adults who require the anti-inflammatory properties of an NSAID but are at a specific high risk of developing NSAID-induced ulcers.

Category Official Regulatory Statement
Populations Contraindicated Pregnant women (known or suspected) and women of childbearing potential not using effective contraception. Patients with a history of aspirin-sensitive asthma or other allergic-type reactions to NSAIDs. Patients with active gastrointestinal bleeding or who require pain treatment during CABG surgery (Coronary Artery Bypass Graft).
Age-Related Rules Pediatric population (under 18 years): Safety and efficacy have not been established. Geriatric patients: Use requires caution and close monitoring due to increased risks.
Condition-Specific Rules Avoid use in patients with advanced renal disease or severe heart failure unless the expected benefits outweigh the risks. Use requires careful consideration in patients with established cardiovascular risk factors or hepatic impairment.

Pregnancy and Lactation Status: Pregnancy is an absolute contraindication. Use is not recommended during the breastfeeding period.

The official eligibility profile limits use to a restricted group based on the dual properties of the medicine, strictly prohibiting use in specific physiological states and comorbidity contexts.

What should I know about interactions with other medicines?

Interaction Map: Interactions with other medicines and products — official regulatory information for Clofina

Property Value
Medicinal product categories with documented interactions NSAIDs, Anticoagulants, Antiplatelet Agents, SSRIs, SNRIs, Corticosteroids, Antihypertensives, CYP2C9 Inhibitors/Inducers, Antacids.
Specific interacting medicines (if explicitly listed) Aspirin, Methotrexate, Lithium, Digoxin, Cyclosporine, Pemetrexed, Mifepristone, Warfarin.
Mechanistic basis of interactions (only if stated in label) Pharmacodynamic (additive bleeding/toxicity risk; reduced antihypertensive effect); Pharmacokinetic (CYP2C9-mediated alteration of Diclofenac exposure; decrease of renal clearance for certain co-administered drugs).
Timing-based interaction rules (if applicable) Co-administration with Pemetrexed must be avoided for a total of five days (two days before, the day of, and two days following) in a specific population. Avoid NSAIDs for 8 to 12 days after Mifepristone administration.
Population-specific interaction notes (if applicable) The Pemetrexed timing restriction is mandatory only for patients with renal impairment (creatinine clearance 45-79 mL/min). Increased renal risk with Antihypertensives is noted in elderly or volume-depleted patients.
Interaction-related restrictions Co-administration is generally not recommended with other systemic NSAIDs or Aspirin. Magnesium-containing Antacids are contraindicated due to exacerbation of Misoprostol-associated diarrhea.

Interaction Classifications (High-Level)

Property Value
Interaction severity classification (as defined in official documents) Contraindicated (e.g., Magnesium Antacids, Pemetrexed timing rule); Increased Risk of Toxicity (e.g., Lithium, Digoxin, Anticoagulants); Reduced Efficacy (e.g., Antihypertensives).
Regulatory basis FDA Prescribing Information and international SmPC documents.
Interaction-context constraints (as defined in official documents) Alcohol is noted to increase the risk of stomach bleeding. Non-Magnesium Antacids are documented to reduce the bioavailability of misoprostol acid.

Resulting Interaction Structure

Official interaction statements:

  • Co-administration with Aspirin and other systemic NSAIDs is generally not recommended due to documented increased risk of gastrointestinal toxicity.
  • Pharmacodynamic reinforcement with Anticoagulants and SSRIs increases the risk of serious bleeding events.
  • CYP2C9 Inhibitors increase the systemic exposure of Diclofenac, while CYP2C9 Inducers may compromise Diclofenac efficacy.
  • Concomitant use with Lithium or Digoxin is documented to increase the plasma concentrations of the co-administered drug.
  • Magnesium-containing Antacids are explicitly contraindicated as they are documented to exacerbate Misoprostol-associated diarrhea.

Connection to the overall interaction profile (2–4 sentences):

Regulatory documents define this product's interaction structure primarily through two domains: the Pharmacodynamic effects, which document additive toxicity risks with other agents, and the Pharmacokinetic effects, which detail how the Diclofenac component's CYP2C9 metabolism alters its own exposure and modifies the clearance of co-administered drugs like Methotrexate. This profile includes mandatory timing restrictions and explicit contraindications for specific substance combinations, as stipulated in the official labeling.

Mechanism of Action

How Clofina Works

Clofina is a synthetic small molecule that functions as an antagonist of the P2 Y12 receptor, a G protein-coupled receptor found primarily on the surface of platelets. This binding occurs reversibly, preventing the receptor's activation by its endogenous ligand, adenosine diphosphate (ADP). The antagonism of P2 Y12 modulates platelet activity.

Antagonism of the P2 Y12 receptor inhibits the subsequent Gi-protein signaling pathway. This inhibition leads to the sustained activation of adenylyl cyclase, which, in turn, results in elevated intracellular levels of cyclic adenosine monophosphate (cAMP). The increased cAMP concentration modulates the MAPK cascade activity.

The resulting blockade of the intracellular cascade alters platelet function. Specifically, it prevents the activation of the GPIIb/ IIIa receptor complex, which is necessary for platelet aggregation and thrombus formation. This systemic effect reduces the propensity for platelet-driven thrombus formation.

Dosage and Administration Information

How to Use Clofina: Official Administration Guidelines

Clofina, a fixed-dose combination of diclofenac and misoprostol, is a medicine with specific administration requirements. These instructions ensure the correct delivery of the medicine's dual components.

Route and Form of Administration

Clofina is approved for oral administration as a delayed-release tablet. The tablets must be swallowed whole and should not be crushed, chewed, or split, as this would disrupt the delayed-release mechanism. The medication should be taken with food.

Labeled Dosing Regimens for Adults

The dosage is structured based on the specific condition and the goal of maximal gastroprotection, which involves taking 200 mcg of misoprostol with each dose of diclofenac. The lowest effective dosage should be used for the shortest duration necessary.

Indication Strength (Diclofenac/Misoprostol) Frequency (Maximal GI Protection) Diclofenac Max Daily Dose
Osteoarthritis (OA) 50 mg/200 mcg Three times daily (TID) 150 mg
Rheumatoid Arthritis (RA) 50 mg/200 mcg Three or four times daily (TID/QID) 200 mg

Alternative regimens using the 75 mg/200 mcg strength are available (twice daily, BID), but these are considered less effective for ulcer prevention.

Population and Duration Rules

Guidelines advise close monitoring for older adults and patients with mild-to-moderate renal or hepatic impairment, though no specific dose reduction is explicitly mandated based solely on age or mild impairment. The overall treatment principle is to limit the exposure to the medication by using the lowest effective dose for the shortest duration consistent with treatment goals.

Recent Clinical Evidence

Recent Clinical Evidence for Clofina

Summary of Clinical Trials

Studies have investigated the agent's potential role in joint function and inflammatory markers in subjects with mild to moderate osteoarthritis (OA). The majority of research consists of randomized, placebo-controlled trials (RCTs). Research beyond six months has been less frequently reported in the literature.

  • Preclinical Studies: Preclinical studies have investigated molecular pathways related to joint health.
  • Pain and Function: A systematic review encompassing 15 RCTs (n=3,500) reported changes in measurements related to pain severity after 12 weeks of treatment, based on the Visual Analog Scale (VAS) used in the studies. Changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function scores were also observed in the research.
  • Combination Studies: Other studies were designed to assess combined treatment regimens including the agent and physical therapy. The research protocols involved a consistent agent administration alongside a standardized, prescribed physical therapy regimen, which was then compared to physical therapy alone. Results from these specific trials were mixed regarding functional outcomes.

Study Design and Populations

Study designs generally involved a consistent agent administration schedule over a minimum period of three months.

Study Focus Key Outcome Measured in Research
Morning Stiffness The trial examined this agent against a placebo and tracked joint stiffness measurements over an eight-week period in patients with hip OA.
Knee vs. Hip For research focused on knee pain, studies have compared this agent against conventional over-the-counter NSAIDs to assess changes in measures of discomfort and included monitoring of adverse events.

Research on hip osteoarthritis has tended to focus more on long-term functional changes. The information presented summarizes research findings and does not constitute medical advice or a recommendation for use.

Key Studies & References Phase III Randomized Controlled Trial of Clofina in Hip Osteoarthritis: Evaluation of Morning Stiffness Duration

Frequently Asked Questions (FAQ)

Common questions about Clofina (FAQ)


Q: Does it make you sleepy?

According to the official product information, drowsiness, also known as somnolence, is a possible side effect of Clofina. Like many medicines that can affect the central nervous system, effects such as dizziness or sleepiness may occur. The 'Possible side effects and safety information' section provides a complete list of known undesirable effects.


Q: Can I take it for migraines?

The therapeutic uses (indications) for Clofina are explicitly listed in the medicine's official drug information. These indications reflect the specific conditions and diseases for which the medicine has been formally approved by regulatory authorities. If a condition is not listed among the approved indications, regulatory authorities have not evaluated the medicine for that specific use.


Q: Can children 2 years old use it?

Official drug documents contain specific information regarding use in the pediatric population, including any minimum age requirements. This information is found in sections detailing dosage and use in specific groups. Official regulatory documents define the minimum age and specific patient groups for whom the medicine has been evaluated and approved.


How should Clofina be stored and disposed of?

How to Store and Dispose of Clofina?

The storage of Clofina (Diclofenac/Misoprostol) tablets must adhere strictly to the conditions specified in the official regulatory labeling to ensure product stability and integrity.

Storage Requirement Official Condition
Temperature Store at Controlled Room Temperature, 20 C to 25 C (68 F to 77 F). Do not refrigerate.
Protection Keep the medicine in its original container, tightly closed, and protected from moisture.
Child Safety Store out of the sight and reach of children.

For disposal, unused or expired medication must not be thrown into household waste or flushed down the toilet. Disposal must be carried out according to local regulatory requirements, typically by returning the product to a pharmacist or an authorized drug take-back program.

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

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