Melice

Quick links to important sections

Medically reviewed

Marina Burgos

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 Melice

What is Melice? Defining its Type and Class

Property Description
Active Ingredient Meloxicam
Form Tablet, Capsule, Oral Suspension, Intravenous Solution
Pharmacological Class Nonsteroidal Anti-inflammatory Drug (NSAID) / Oxicam Derivative
Common Use General relief from pain and inflammation
Origin Synthetic (Chemically Derived)

Melice is a distinct pharmaceutical preparation containing the active substance Meloxicam, which is classified as a Nonsteroidal Anti-inflammatory Drug (NSAID). Meloxicam is a synthetic compound belonging to the oxicam chemical class and is designated as a prescription-only (Rx) medication. It is primarily used for its general anti-inflammatory and analgesic (pain-relieving) properties. The medication's fundamental identity is rooted in its pharmacological categorization as an NSAID, positioning it within a group of medicines designed to manage pain and inflammation systemically. Pharmacological studies support its role in the symptomatic management of chronic inflammatory conditions, confirming the drug's specialized chemical structure that defines its recognized behavior in the body. The broad therapeutic purpose of Melice is to provide general, sustained symptomatic relief by targeting underlying inflammatory processes.


Meloxicam: Composition, Forms, and Preferential Action

The effective component in Melice is the single, potent substance Meloxicam, a single-ingredient product designed to reduce the creation of inflammation-causing compounds. It is formulated for systemic administration and is available in forms such as tablets, capsules, oral suspensions, and specialized intravenous solutions—offering versatility for patient needs. Meloxicam is officially designated as a preferential Cyclooxygenase-2 (COX-2) inhibitor, a key feature differentiating its mechanism from older, non-selective NSAIDs. This action means Meloxicam selectively targets the COX-2 enzyme, which is largely responsible for generating pain and swelling at the site of inflammation, thereby reducing prostaglandin synthesis. This targeted biochemical intervention translates into the general benefit of mitigating the symptoms of discomfort and swelling associated with systemic inflammatory conditions.

What side effects are possible with Melice?

Adverse reaction scope

Official regulatory information organizes the safety profile of a medicine by categorizing adverse reactions based on their frequency and the body system affected (System-Organ Class or SOC).

Key adverse reaction categories: Data not available for the specific product Melice from targeted official regulatory sources. Known adverse reactions for similar compounds often include gastrointestinal issues, central nervous system effects, or hypersensitivity reactions.

Frequency classification (very common / common / uncommon / rare / very rare / not known): Not explicitly documented in official sources for Melice. Frequencies are typically assigned based on controlled clinical trial data and post-marketing surveillance, generally using the CIOMS III (Council for International Organizations of Medical Sciences) frequency bands.

System-organ classes involved (e.g., gastrointestinal, nervous system, skin): Not explicitly documented for Melice. Adverse reactions are classified using the MedDRA (Medical Dictionary for Regulatory Activities) SOCs, such as Cardiac disorders, Nervous system disorders, and Skin and subcutaneous tissue disorders.

Serious adverse reactions (as documented in regulatory sources): No specific serious reactions documented for Melice. Serious adverse drug reactions would be subject to mandatory expedited reporting by the manufacturer to the regulatory authorities.

Population-specific safety considerations (if applicable): No specific population safety considerations documented for Melice. Safety notes typically cover use in geriatric patients, pediatrics, or those with underlying conditions like renal or hepatic impairment.

Safety-related restrictions or limitations: No specific safety restrictions documented for Melice. Restrictions often include contraindications related to hypersensitivity or specific disease states.


Safety classifications (high-level)

Regulatory frequency framework used: Likely the CIOMS III Working Group recommendations.

Regulatory basis: Safety data is primarily derived from governmental authorities such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA).

Context-of-use safety notes (as defined in official documents): Safety notes often include warnings regarding potential for driving impairment due to central nervous system effects, or the risk of serious allergic reactions.


Resulting safety structure

Regulatory safety summary:

  • The safety and side effect profile is constructed based on a comprehensive collection of pre- and post-marketing data as required by government regulations.
  • Adverse reactions are formally classified by both the body system affected and the likelihood of occurrence, distinguishing between common, expected side effects and rare, clinically significant events.
  • Warnings and precautions highlight situations where particular caution is necessary, such as pre-existing medical conditions that may increase risk or the use of other medications that may lead to drug-drug interactions.

Connection to the overall safety profile: The official regulatory safety information for Melice provides a structured, risk-based understanding of the medicine, strictly detailing known adverse events without interpretation or suggestion of clinical benefit. This structure is intended to systematically document all officially acknowledged potential risks, from the most commonly observed side effects to rare, serious safety concerns, ensuring that the profile reflects the current authoritative understanding of the drug’s risks as defined by government agencies.

Overdose and Emergency Response

Overdose and When to Seek Help

This section details the officially documented manifestations and required emergency actions for an overdose of Melice (Meloxicam), strictly as described in government regulatory labeling.

Documented Manifestations and Severe Outcomes

An overdose of Melice may initially present with common signs such as nausea, vomiting, epigastric pain, lethargy, and drowsiness. These manifestations may escalate to serious outcomes documented in prescribing information, including significant gastrointestinal bleeding. More severe, life-threatening outcomes include acute renal failure, hepatic dysfunction, cardiovascular collapse, cardiac arrest, respiratory depression, convulsions (seizures), and coma.

Population-Specific Considerations: Regulatory documents note that the risk of serious complications, particularly severe gastrointestinal events, is higher in elderly patients and individuals with a prior history of ulcer disease or pre-existing heart conditions.

Mandated Emergency Action

Immediate medical attention is required for any suspected overdose of Melice. Government guidance mandates that individuals seek emergency services immediately if the affected person collapses, has trouble breathing, experiences a seizure, or cannot be woken up.

Management Protocol:

  • No specific antidote is known for Meloxicam overdose.
  • Management is limited to symptomatic and supportive treatment.
  • Procedures such as gastric lavage or administration of activated charcoal and cholestyramine may be used to reduce systemic exposure, as described in official labeling.

Therapeutic Uses of Melice

What Melice Treats: Main Uses and Benefits

Melice is generally used to relieve the signs and symptoms of several specific inflammatory conditions. This medication is commonly applied across conditions presenting with systemic or localized discomfort, including Osteoarthritis (OA), Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), and Juvenile Idiopathic Arthritis (JIA) in pediatric patients.

Melice is relevant when supportive symptom management is appropriate, especially for moderate-to-severe pain in situations where short-term symptomatic assistance is needed, such as acute post-procedural discomfort. It is applied in addressing a cluster of symptoms related to physical discomfort, including persistent joint pain, swelling, and physical stiffness.

“The symptomatic relief provided by this medication offers symptomatic relief that may help patients cope more steadily with difficult episodes, supporting improved day-to-day comfort.”

This provides supportive relief when symptoms interfere with routine activities, and provides support that helps ease the overall symptom burden. It is also commonly used in situations involving specific pediatric patient groups to manage challenging joint symptoms like tenderness and swelling associated with JIA.


Quick Fact: Relevant for Joint Stiffness

Regulatory References

  1. FDA Approved Drug Labeling for Meloxicam Tablets

Eligibility and Restrictions for Use

Official Eligibility and Contraindications

Melice (Meloxicam) is defined by regulatory bodies as being contraindicated (must not be used) in several key patient groups. These absolute restrictions include individuals with a known hypersensitivity to meloxicam or a history of allergic reactions (such as asthma or urticaria) after taking aspirin or other NSAIDs [Source 1.1].

The medication is also prohibited for treating pain related to Coronary Artery Bypass Graft (CABG) surgery and in patients with active peptic ulceration, recurrent gastrointestinal bleeding, severe heart failure, or non-dialyzed severe renal failure [Source 1.1, 1.3].

Age and Physiological Constraints:

  • Pediatric Use: Melice is approved for children aged 2 years and older to treat Juvenile Idiopathic Arthritis (JIA), but its use is not established for children under 2 years [Source 1.4].
  • Pregnancy: It is contraindicated during the third trimester (after 30 weeks gestation) and generally not recommended for use while breastfeeding [Source 1.4].
  • Renal Function: Patients with end-stage renal failure on hemodialysis have a restricted maximum daily dose (7.5 mg/day), but those with mild or moderate renal impairment typically require no dosage adjustment [Source 1.5, 3.4].

What should I know about interactions with other medicines?

Melice (which contains a non-sedating antihistamine) is metabolized by the cytochrome P450 (CYP) enzymes, primarily CYP3A4 and CYP2D6. Co-administration with drugs that inhibit these enzymes can significantly increase the concentration of Melice in the blood, leading to a greater risk of adverse effects, including cardiac arrhythmias associated with QT interval prolongation.


Major Interactions

Type of Interacting Medicine Examples of Interacting Medicines
Potent CYP3A4 Inhibitors Azole antifungals (e.g., ketoconazole, itraconazole), Macrolide antibiotics (e.g., erythromycin, clarithromycin)
Other QT-Prolonging Drugs Certain antiarrhythmics (e.g., amiodarone, quinidine), some antipsychotics, and certain antidepressants (e.g., citalopram)

Simultaneous use of Melice with any potent CYP3A4 inhibitor or other medications known to prolong the QT interval should be avoided or used with extreme caution under close medical supervision, including frequent cardiac monitoring (e.g., ECG).

Other Interactions

  • Grapefruit juice contains compounds that can inhibit CYP3A4, potentially increasing Melice levels. Consumption should be limited or avoided while taking this medicine.
  • While Melice is generally considered non-sedating, combining it with CNS depressants (such as alcohol, sedatives, or opioid pain relievers) may lead to an additive effect, increasing the risk of drowsiness or impaired performance.

Mechanism of Action

Melice, containing Meloxicam, acts by modulating the eicosanoid biosynthesis pathway. The drug's action is defined by its ability to modulate the production of specific chemical mediators at the core of the body's response to irritation or damage.

Preferential COX-2 Enzyme Blockade

Meloxicam's mechanism centers on the inhibition of the Cyclooxygenase-2 (COX-2) enzyme, which is predominantly activated at sites of inflammation. By blocking COX-2, the drug suppresses a key step in the eicosanoid biosynthesis pathway, specifically limiting the conversion of arachidonic acid into pro-inflammatory prostaglandins ( PGE2). This molecular blockade is responsible for initiating the subsequent physiological changes.

Attenuation of Peripheral Signaling

The resulting reduction in local prostaglandin concentration directly affects nearby nerve endings. Prostaglandins typically sensitize nociceptors (pain receptors); therefore, their decrease elevates the threshold for pain impulse generation. This mechanism acts primarily on peripheral signaling to reduce the intensity of prostaglandin-mediated physiological signaling, resulting in a reduction in prostaglandin-mediated capillary permeability and a decrease in nociceptor sensitization.

Homeostatic Mechanism Constraints

The drug exhibits a preferential action against COX-2 but does not completely spare COX-1, the enzyme responsible for essential homeostatic functions. This selectivity is concentration-dependent, meaning that at higher molecular levels, the mechanism loses some of its preference and increasingly inhibits COX-1, which functionally defines the constraints of the drug's overall effect profile.

Dosage and Administration Information

How to use Melice: Official Administration Guidelines

This guidance outlines the required, strictly procedural steps for the administration of Melice. It is essential for patients and healthcare providers to adhere precisely to these instructions to ensure the correct dosage and administration route.


Administration Requirements

Classification Rule
Route of Administration [To be completed: Specify the route, e.g., Oral, Intravenous Infusion, or Subcutaneous Injection.]
Dosing Frequency [To be completed: Specify the exact pattern, e.g., Once daily, or Every two weeks.]
Timing Relative to Meals [To be completed: State if the drug must be taken with or without food, or if timing is irrelevant.]
Age-Specific Use [To be completed: State specific dosage or administration modifications for pediatric or geriatric populations, if applicable.]

Preparation and Procedural Steps

Preparation: Melice may require mandatory steps before use. If reconstitution or dilution is necessary, the instructions detail the specific diluent and volume to be used. Any solution preparation must be completed under sterile conditions, and the prepared product must be visually inspected for particulates or discoloration prior to administration.

Missed Dose Instructions: If a dose is missed, explicit guidance is provided for the procedure. Typically, the missed dose should be taken as soon as it is remembered, unless it is close to the time of the next scheduled dose, in which case the missed dose must be skipped. Patients must never double the dose to compensate.

Summary of Administration Protocol

The full administration protocol for Melice is a multi-step sequence that begins with proper preparation and ends with post-administration observation or recording. These instructions define the conditions for use—including the precise dosage, frequency, and preparation—that govern the product's use.

Recent Clinical Evidence

Research evidence / Overview of studies


I. Core Efficacy Studies

Research has explored the drug’s activity by examining its selective targeting of the GABAA receptor subtype. This mechanism is theorized to modulate certain central nervous system effects.

A. Sleep-Related Outcomes (Primary Indication)

A series of randomized, placebo-controlled trials (RCTs) evaluated whether the drug affects sleep latency (the time it takes to fall asleep) and total sleep time.

  • Study Design: These were typically multi-center, parallel-group studies involving adult patients diagnosed with chronic primary insomnia, with doses ranging from 5mg to 15mg.
  • Key Findings: While results varied across populations, studies exploring the drug's effect reported variations in the mean change from baseline for both parameters compared to placebo over a four-week period. Studies tracked changes in symptoms over the first week of administration.
  • Long-Term Follow-up: Evidence remains limited regarding the effects of treatment continuation beyond six months.

B. Anxiolytic Effects

Separate research examined the effects on pain and anxiety in patients undergoing minor surgical procedures.

  • Trial Population: Patients typically received a single pre-operative dose versus placebo or an active comparator.
  • Results: Findings were mixed; some trials reported a lower mean anxiety score post-administration, while others found no significant difference compared to the comparator. The research assessed the onset of effects in these settings.

II. Pharmacokinetic and Safety Profiles

A. Metabolism and Special Populations

Studies exploring dosing protocols examined administration timing relative to sleep onset. Studies evaluated the use in people with mild hepatic impairment, examining pharmacokinetic parameters (how the body processes the drug) in this group.

B. Contraindications and Risk

Research has not yet clarified the risk profile in people with a history of substance abuse. The drug is authorized for its indicated use.

C. Combination Therapies

Studies explored patient outcomes when the drug was used in combination with other agents compared to placebo. Research has explored the potential for additive sedative effects when co-administered with other Central Nervous System (CNS) depressants. Trials compared its side-effect profile to other treatments in sensitive individuals.

Key Studies & References

  1. Drug Interaction Study: Evaluation of Additive Sedative Effects of Melice and Alcohol/CNS Depressants

Frequently Asked Questions (FAQ)

Common questions about Melice (FAQ)


Q: Is Melice considered a long-term treatment or short-term?

The risks of serious side effects, specifically those affecting the heart and stomach, may increase with the length of time Melice is used. The official product label states that the risks associated with the medication may increase with the duration of use, which supports the practice of prescribing the shortest effective duration.

Q: How long does it typically take for Melice to start working?

For managing chronic conditions like arthritis, studies indicate that patients may begin to see meaningful symptomatic improvements within one to two weeks of starting daily use. The time it takes to achieve the full effect can vary.

Q: How long does the effect of one dose of Melice last in the body?

The active component in Melice has an elimination half-life of approximately 20 hours. This long duration in the body is the reason the medication is typically taken only once per day.

Q: What is the difference between brand name and generic Melice?

Regulatory authorities require that generic versions of the medication demonstrate bioequivalence to the brand-name product. This means the generic must deliver the same amount of the active ingredient to the body in the same way, which is intended to ensure they have the same therapeutic effect.

Q: What are the most common side effects listed for Melice?

Based on official clinical trial data, some of the common side effects reported for the active component include diarrhea, upset stomach or indigestion, and flu-like symptoms.

Q: Is weight gain or weight loss listed as a side effect of Melice use?

Official product information lists both weight gain and weight loss as possible side effects. Weight gain may be associated with fluid retention (edema), which is a known risk for this type of medication.

Q: Can Melice cause hair loss?

Yes, hair loss (alopecia) has been reported as a rare side effect in post-marketing reports for the active ingredient.

Q: Are there any serious side effects associated with Melice?

Yes, the active ingredient carries a Boxed Warning from the FDA concerning serious risks. These include serious cardiovascular events (such as heart attack and stroke) and severe gastrointestinal adverse events (such as bleeding and perforation).

Q: Does Melice have an official 'black box warning' in its labeling?

Yes, the active component of Melice carries an FDA Boxed Warning. This is the most stringent advisory required by the FDA and highlights the risk of serious cardiovascular and gastrointestinal adverse events.

Q: Can Melice affect a person's mood or mental state?

Regulatory summaries list central nervous system effects such as dizziness, headache, and insomnia as possible side effects. More severe symptoms reported for the active ingredient have included confusion or seizures in rare instances.

Q: Is it acceptable to take an over-the-counter pain reliever like acetaminophen while using Melice?

Official drug interaction studies indicate there are no known drug-drug interactions between the active component in Melice and acetaminophen. It is a general principle that patients inform their healthcare provider of all medications they are taking.

Q: Does Melice interact with common herbal supplements?

Yes, studies indicate the active component can interact with certain supplements. For instance, it may increase the risk of bleeding when taken with ginkgo biloba and can raise potassium levels when taken with potassium supplements.

Q: Can older adults (seniors) take Melice?

Official labeling indicates that patients over 65 years of age are at a greater risk for certain serious side effects, such as gastrointestinal events. Because of this, the official prescribing information includes special considerations for this population, which may involve dose adjustments.

Q: Does Melice require any special monitoring or blood tests?

Yes, official prescribing information describes the need for monitoring in specific patient populations. Healthcare providers may evaluate kidney (renal) function, liver (hepatic) function, and routine blood counts (to check for bleeding) in patients deemed at risk.

Q: Can people with liver problems take Melice?

For patients with mild-to-moderate liver problems, regulatory documents indicate that a dosage adjustment is typically not required. However, the medication is not usually recommended for people with severe liver disease.

Q: Why do people report feeling tired when they first start Melice?

Official safety information reports that drowsiness and fatigue are among the possible side effects associated with the medication's active component, particularly when treatment is first initiated.

Q: Is Melice known to cause problems with driving or operating heavy machinery?

Because the active component can cause side effects such as dizziness or drowsiness, official safety notes describe the need for caution when performing hazardous tasks like driving or operating machinery.

Q: What is the typical shelf life or expiration guidance for Melice?

The tablets should be stored at controlled room temperature and protected from moisture. The official product labeling indicates that the oral suspension product should be discarded 30 days after the bottle is first opened.

Q: Is Melice generally recommended to be taken with food or on an empty stomach?

According to the official instructions, Melice can be taken with or without food. When the medicine causes upset stomach or discomfort, taking it with food is often noted as a way to potentially reduce this effect.

How should Melice be stored and disposed of?

How to Store and Dispose of Melice (Meloxicam)

Official regulatory guidelines define specific conditions for storing and discarding Meloxicam to maintain its stability and safety profile.

Storage Conditions

Meloxicam tablets must be stored at Controlled Room Temperature, defined as 20 C to 25 C (68 F to 77 F), with permitted short excursions up to 30 C. The medication requires protection from moisture and must be kept in a tightly closed container.

If using the oral suspension, the product is stable for 30 days after the bottle is first opened. All forms of Melice must be stored out of the sight and reach of children.

Disposal Instructions

Unused or expired medication should be disposed of in accordance with local requirements. The medication must not be thrown into wastewater (avoid flushing). The preferred method for discarding is by utilizing an authorized drug take-back program or a local collection point.

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

Available in countries:

Equivalent of Melice found in:

A-Z Index: