Promac

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Promac

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Promac

Property Description
Active ingredient Polaprezinc (Zinc L-carnosine chelate)
Form Granules, Orally Disintegrating Tablet (ODT)
Pharmacological class Gastroprotective Agent (Anti-Ulcer Agent)
Common purpose Protecting and healing the stomach/duodenal lining
Origin Synthetic/Derived Organometallic Compound

Promac is a distinct pharmaceutical preparation whose core active substance is Polaprezinc, defined by official classifications as an Anti-Ulcer Agent and a Gastroprotective agent. This medicine belongs to the group of drugs that focus on reinforcing the body's own defense mechanisms in the digestive system. Polaprezinc is often prescribed to patients requiring support for the healing of the gastrointestinal mucosa.

What is Promac and Its Role in Gastroprotection?

Polaprezinc is a novel antiulcer agent that performs a cytoprotective function rather than operating primarily as an acid-reducing medication. The unique chelate structure is designed to adhere to ulcer bases, which helps sustain its localized effect. The substance is specifically intended to promote the stability of the gastric mucosal barrier, a protective layer vital for stomach wall integrity, a function focused on protecting the digestive lining.

The Unique Composition of Polaprezinc: A Chelate Compound

The drug's core identity lies in Polaprezinc, a specialized, stable chelate compound that combines a zinc ion with the natural dipeptide L-carnosine. This synthetic, organometallic complex is distinguished by its focused delivery capability; this structure is characterized as an antioxidant that helps reduce chemical stress in the gastrointestinal environment. Unlike standard nutritional supplements, this engineered chelate structure ensures concentrated action where the body needs help with tissue repair. The medicine is intended for oral administration and is typically manufactured as Granules or an Orally Disintegrating Tablet (ODT), providing formulation variety for patients.

General Benefit: How Does This Drug Help the Stomach?

The benefit of the drug stems from its ability to directly strengthen the vulnerable lining of the digestive tract. By focusing on reinforcing the physical mucosal barrier and supporting natural cell processes, the medicine contributes to the overall ability of the stomach and intestine to maintain their health and integrity. It is used when clinical goals include the restoration and long-term protection of the mucosal surface.

Regulatory References

  1. Polaprezinc NCI Drug Dictionary

What side effects are possible with Promac?

Possible side effects and safety information

Regulatory documentation structures the safety profile of Promac (Polaprezinc) around its common adverse reactions and specific systemic risks related to its zinc component. The information presented here reflects official safety classifications and requirements for observation during treatment.


Adverse Reaction Scope and Classification

The most frequently reported adverse reactions fall under Gastrointestinal disorders in regulatory classifications. These effects, which include nausea, vomiting, diarrhea, and hypersalivation, are typically classified as Common and often tend to be temporary. The frequency of these gastrointestinal events is noted to exhibit a dose-response relationship, increasing with higher daily dosage.

Uncommon or Rare effects documented in the official safety literature include Liver enzyme elevation (changes in ALT/AST) and signs of hypersensitivity such as rash or pruritus (itching).


Serious Safety Considerations and Restrictions

The main systemic safety concern documented for this medicine relates to the potential for trace element imbalance. Because the active substance contains zinc, there is an official, stated risk of inducing Copper Deficiency. This deficiency can lead to serious hematological consequences, including Anemia, Pancytopenia, and Neutropenia, which are classified as serious adverse reactions.

Regulatory documents include safety-related restrictions noting that the zinc component can reduce the absorption and efficacy of certain co-administered antibiotics (e.g., tetracyclines, fluoroquinolones). Due to the potential for copper depletion, official prescribing information advises monitoring of plasma zinc and copper levels, particularly with long-term use.


Population-Specific Safety Notes

Safety is not established in specific populations, including pregnant women, lactating women, and children under 12 years of age, as documented in product monographs. Caution is also advised for patients with pre-existing malnutrition or significant liver/kidney conditions.

Overdose and Emergency Response

Overdose Map: Overdose and when to seek help — official regulatory information for Promac


Overdose scope

Documented overdose presentations: Acute presentations primarily involve signs of gastrointestinal irritation at high doses. Chronic or severe exposure is associated with physiological changes leading to systemic copper deficiency.

Physiological systems affected (as stated in label): The gastrointestinal system (acutely); the hematological system and potentially the hepatic and renal systems (systemically, in severe or chronic cases).

Dose-related or exposure-related factors (if applicable): Adverse events related to toxicity are noted to increase at high doses, linking severity to the overall zinc content.

Population-specific overdose notes (if applicable): Safety is not established for children below 12 years of age, pregnant women, and lactating women. Use in individuals with pre-existing copper deficiency requires medical supervision.

Emergency-response statements (as written in official documents): Immediate medical intervention is required for any suspected overdose. Management includes discontinuation of the product.

When immediate medical help is required (label-derived phrasing only): Immediate medical help is required upon the suspicion of overdose or if severe systemic toxicity, such as signs of copper deficiency or anemia, is present.


Overdose classifications (high-level)

Severity classification (as defined in official documents): Overdose carries the potential for serious hematological outcomes (e.g., anemia, pancytopenia) secondary to copper deficiency.

Regulatory basis (EMA / FDA / etc.): Toxicity data is derived from the official regulatory context of the zinc chelate.

Overdose-context constraints (as defined in official documents): No specific antidote for Polaprezinc overdose is officially documented.


Resulting overdose structure

Official overdose statements:

  • High-dose exposure is associated with acute signs of gastrointestinal irritation.
  • The most serious risk involves zinc-induced copper deficiency, which can lead to anemia and pancytopenia.
  • Urgent medical attention and product discontinuation are required for suspected overdose or systemic toxicity.
  • Management is symptomatic and supportive, necessitating monitoring of serum copper levels and hematological parameters.

Connection to the overall overdose profile: Regulatory documents define the Polaprezinc overdose profile by linking excessive intake to two primary domains: localized gastrointestinal irritation and the severe systemic risk of copper deficiency. These authorities mandate immediate medical intervention and specific monitoring of hematological and mineral status to manage the severe outcomes associated with the drug's zinc component, confirming that treatment is supportive due to the lack of a compound-specific antidote.

Therapeutic Uses of Promac

What Promac Treats: Main Uses and Benefits

This medication is relevant in contexts where additional symptomatic support is needed to address conditions that cause low blood cell counts. It is generally applied in scenarios where symptoms become more noticeable due to systemic imbalance.

This medication is commonly used to help manage symptoms related to specific conditions, including chronic Immune Thrombocytopenia (ITP), Severe Aplastic Anemia (SAA), and low platelet counts linked to chronic Hepatitis C.


Easing Symptoms and Supporting Stability

This medication is applied across domains where additional symptomatic support is needed, primarily to manage the symptom clusters of easy bruising and bleeding that interfere with daily functioning. The core benefit provides support that helps ease the overall symptom burden by assisting with the management of these manifestations when platelet counts are low.

In conditions like SAA, it contributes to improved comfort during periods of heightened symptoms and supports general well-being by easing associated systemic symptoms like fatigue.

“This medication may assist with maintaining functional stability and contributes to easing the overall symptom load during periods of heightened discomfort.”


Quick Fact: Symptom Support for Bleeding and Bruising This medication is commonly used to help manage the symptoms of frequent bleeding (like nosebleeds or gum bleeding) and unexplained bruising that create noticeable physiological strain.

Eligibility and Restrictions for Use

Who Can and Cannot Use Promac?

This section outlines the officially documented population eligibility rules for Promac (Polaprezinc), based strictly on government regulatory documents.


Eligibility Scope

Category Official Regulatory Status
Populations for whom use is allowed Primarily Adults with established indications, such as gastric ulcers, based on regional approvals.
Populations for whom use is contraindicated Patients with Known Hypersensitivity to any component of the formulation. Patients with existing Copper Deficiency (due to the risk of zinc component interference).
Age-related eligibility rules Use is not established in children under 12 years old. Older adults may require special consideration due to potential reduction in digestive function.
Condition-specific eligibility rules Severe Renal Impairment requires caution and monitoring due to the potential for excessive zinc accumulation and toxicity.
Pregnancy and lactation eligibility Safety is not established for use in pregnant women or lactating women.

Resulting Eligibility Structure

Regulatory documents define the eligible population primarily as adults due to the classification of use as not established for most pediatric, pregnant, and lactating groups. Non-eligibility is strictly enforced through contraindications for hypersensitivity and for patients with copper deficiency. These rules establish the official boundaries for which patient groups can and cannot use the medicine.

What should I know about interactions with other medicines?

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

Property Value
Medicinal product categories with documented interactions Antibiotics (Fluoroquinolones and Tetracyclines), Chelating agents, Antiretroviral agents, Thyroid hormones.
Specific interacting medicines (if explicitly listed) Ciprofloxacin, Levofloxacin, Norfloxacin, Minocycline, Demeclocycline, Dolutegravir, Deferiprone, Levothyroxine.
Mechanistic basis of interactions (only if stated in label) Physicochemical Chelation (binding of the zinc component to the co-administered drug, hindering its absorption). Pharmacokinetic Interference (reduction in systemic exposure).
Timing-based interaction rules (if applicable) Mandatory separation of administration: A minimum interval of at least 4 hours must be maintained between the administration of the zinc-containing product and the interacting medicine.
Population-specific interaction notes (if applicable) Caution advised in individuals with reduced liver functions due to the potential for excessive zinc accumulation.
Interaction-related restrictions Food: Co-administration with food, particularly high-fat meals, causes significant delay in absorption and results in lowered overall exposure (AUC/Cmax) of Polaprezinc itself.

Interaction Classifications (High-Level)

Property Value
Interaction severity classification (as defined in official documents) Clinically significant interaction requiring mandatory timing adjustment.
Regulatory basis (EMA / FDA / etc.) Based on established regulatory principles for polyvalent cation interactions and specific drug labeling.
Interaction-context constraints (as defined in official documents) Constraint on co-administration timing; constraint on consumption relative to food intake.

Resulting Interaction Structure

Official interaction statements:

  • The co-administration of Promac with Fluoroquinolone and Tetracycline antibiotics may cause a decrease in their systemic absorption and result in a documented reduced serum concentration.
  • The interaction with agents such as Deferiprone requires a procedural administration constraint where the zinc-containing product and the interacting medicine must be administered at least 4 hours apart.
  • Administration with food, specifically high-fat meals, is associated with pharmacokinetic interference that causes a reduction in the bioavailability (lowered AUC/Cmax) of Polaprezinc itself.
  • Interaction cautions are officially noted for individuals with reduced liver functions related to the potential risk of excessive zinc accumulation.

Connection to the overall interaction profile (2–4 sentences): The regulatory interaction profile for Promac is defined by two primary pharmacokinetic interference domains: Physicochemical Chelation causing a reduction in the exposure of co-administered medicines, and Pharmacokinetic Interference by Food causing a reduction in the exposure of Promac itself. This structure necessitates mandatory timing separation rules for interacting medicines to mitigate the risk of reduced systemic concentration. The official documentation also includes a population-specific interaction note regarding its use in individuals with reduced liver function.

Mechanism of Action

Targeted Activation of the TPO Receptor

Promac (Eltrombopag) functions as a small-molecule thrombopoietin receptor (TPO-R) agonist. It directly binds to the TPO-R on the surface of hematopoietic progenitor cells located in the bone marrow, specifically targeting the megakaryocyte lineage. This interaction, which occurs at a site distinct from natural thrombopoietin (TPO), initiates the sequence for cellular proliferation and differentiation.

Initiating the Intracellular Cascade

The binding of Promac to the TPO-R activates an intracellular molecular cascade, primarily involving the Janus Kinase (JAK) / Signal Transducer and Activator of Transcription (STAT) signaling pathway. This activation leads to the phosphorylation and nuclear translocation of STAT proteins, which subsequently promotes the transcription of genes required for cell development.

Promoting Megakaryocyte Development

The activation of the pathway causes the proliferation and maturation of megakaryocytes—the progenitor cells responsible for platelet formation. This accelerated developmental process leads to a direct increase in the output of circulating platelets, modifying the activity within the hematopoietic regulatory system.

Dosage and Administration Information

Administration Protocol: Promac (Polaprezinc)

Promac (Polaprezinc), a gastroprotective agent, is designated for oral administration only, utilizing dosage forms such as Orally Disintegrating Tablets (ODT) and Granules. This involves specific routes and formulations for its use.


Dosing and Scheduling Constraints

The standard adult regimen consists of a total daily dose of 150 mg of Polaprezinc, which is divided into a twice-daily frequency pattern. The medicine is typically administered after meals, scheduled after breakfast and again at bedtime.

Specific Administration Rules

The treatment is structured as a continuous course intended to last until the required healing of the gastrointestinal mucosa is verified.

  • ODT Intake: The ODT formulation can be taken by swallowing the tablet whole with water or by allowing it to dissolve directly on the tongue with saliva.
  • Missed Dose: A double dose is not to be taken to compensate for a missed one; instead, the standard schedule is resumed at the next designated time.
  • Population Adjustment: For older adults, a reduced total daily dose of 100 mg may be involved, with final dose adjustments depending on age and clinical context.

Recent Clinical Evidence

Promac: Recent Clinical Evidence

This section outlines how studies have explored the potential impact on joint comfort and daily function in participants with chronic osteoarthritis (OA). Studies assessed the product's effect in relation to markers of inflammation. Research evaluated the time course for changes in stiffness and discomfort. Studies observed a change in WOMAC Pain Subscale scores over 12 weeks of assessment. These findings were reported across diverse participant populations.

Study protocols specified a lower starting dose. Research assessed the use of the intervention in participants with mild hypertension. Individuals with a history of severe gastrointestinal (GI) bleeding were typically excluded from research studies, as per study design.


Study Summaries

Study 1: Randomized Controlled Trial (RCT)

This landmark RCT assessed differences in joint mobility and function observed in the group receiving the drug compared to the placebo group. The study followed 600 participants over 12 weeks.

  • Key Findings: Participants reported an increase in daily activity scores by week 4. The proportion of individuals achieving a 30% reduction in pain scores was higher in the group receiving the study intervention compared to the placebo group.
  • Duration: 12 weeks
  • N: 600

Study 2: Meta-analysis of 5 Trials

This study involved a meta-analysis of data from five Phase 3 trials, totaling 1,850 participants. The pooled data indicated an association where a difference was observed in the need for rescue medication between groups. Some study protocols included physical therapy in addition to the drug.

  • Key Findings: The analysis indicated that the intervention group had a lower mean Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness score at the 6-month assessment compared to the control group.
  • Duration: Up to 6 months across pooled trials
  • N: 1,850

Phase 3 Safety Data — Tolerability Profile

The data described the observed side-effect profile. Common adverse events (AEs) reported across the Phase 3 program included mild nausea and headache. The overall discontinuation rate due to adverse events was 5.2%. The duration of adverse events was documented. Long-term tolerability was also evaluated.

Frequently Asked Questions (FAQ)

Common questions about Promac (FAQ)


Q: What is the main medical condition Promac is typically used to treat?

Promac is officially designated in regulatory documents for the treatment of gastric ulcers and related injuries to the gastrointestinal lining.


Q: What makes Promac different from other medications in the same class?

Official documentation highlights that Promac, a zinc-L-carnosine chelate, is classified as a cytoprotective agent. This means its primary action is to reinforce the stomach lining and support healing, distinguishing it from medications that primarily focus on reducing stomach acid.


Q: What is the established mechanism by which Promac produces its therapeutic effect?

The therapeutic effect of Promac is attributed to its ability to adhere to the base of ulcers and support the stability of the gastric mucosal barrier, the protective layer of the stomach. Furthermore, its unique chelate structure is noted in official documents to function as an antioxidant within the gastrointestinal tract.


Q: How quickly does Promac start to work after the first use?

Official clinical evidence indicates that the therapeutic effect of Promac is typically measured over weeks of continuous use. Studies have reported that measurable changes in outcomes begin to be observed around week four of treatment. The official documents do not provide specific information on the exact time frame for noticeable relief immediately following the first dose.


Q: Does the chance of side effects from Promac decrease over time?

Official documentation describes the most frequently reported gastrointestinal side effects (e.g., nausea, diarrhea) as being temporary in nature, suggesting that these effects may subside with continued use.


Q: Is it common to feel side effects right away when starting Promac?

The most commonly reported adverse effects, such as gastrointestinal distress, are described in official documents as being temporary in nature. The regulatory labeling does not specify the exact time frame for the initial onset of side effects relative to the first dose.


Q: Is Promac safe to use for people who have kidney issues?

Regulatory documents state that use in patients with Severe Renal Impairment is a factor for caution and monitoring. This is because the zinc component of Promac has the potential to accumulate to excessive systemic levels in patients with reduced kidney function.


Q: Why is Promac sometimes prescribed with a warning for specific populations?

Regulatory documents advise caution for populations with pre-existing conditions such as severe renal impairment or reduced liver function. These warnings relate to the associated risk of excessive zinc accumulation, and the use in these groups is associated with monitoring considerations.


Q: Does Promac carry a risk of dependence or addiction?

According to regulatory documentation regarding drug abuse and dependence, Promac has no known potential for physical or psychological dependence or abuse.


Q: Can Promac cause fatigue or affect my ability to drive or operate machinery?

The official safety profile does list common adverse events, including headache and gastrointestinal upset. However, official labeling does not contain a specific warning regarding impairment of ability to drive or operate machinery.


Q: Does Promac have an effect on sleep patterns or cause insomnia?

Insomnia or other sleep disturbances are not listed among the commonly reported or serious adverse reactions in the official regulatory documents.


Q: Is it true that Promac can cause weight changes?

The known adverse events reported in official clinical data do not commonly list or address changes in body weight as an adverse reaction.


Q: Does Promac cause any sensitivity to sun exposure?

Photosensitivity, which is an increased sensitivity to sun exposure, is not listed among the common or serious adverse reactions in the official regulatory documents.


Q: What is the risk of stopping Promac suddenly after long-term use?

Official documentation does not describe a risk of a discontinuation syndrome or withdrawal symptoms associated with suddenly stopping the use of Promac.


Q: Is Promac listed with the FDA as having a certain safety classification (e.g., specific boxed warnings)?

According to the official safety profile, this medicine is not required to carry an FDA Boxed Warning in its regulatory label.


Q: Is there any official information on Promac's potential effect on fertility?

Regulatory documents state that animal reproduction studies did not report evidence of impaired fertility. Official human data regarding effects on fertility are often limited.


Q: Is it okay to crush or chew Promac tablets if I have trouble swallowing pills?

The official administration instructions for the Orally Disintegrating Tablet (ODT) formulation state that it can be swallowed whole with water or allowed to dissolve on the tongue. Regulatory labeling does not contain instructions for crushing the tablets.


Q: Will Promac still work if it is taken an hour later than the usual time?

Official instructions regarding missed doses indicate resuming the standard schedule at the next designated time. This suggests that minor timing variances are not specifically addressed but do not warrant doubling the subsequent dose.


Q: Can Promac be taken at the same time as common over-the-counter (OTC) pain relievers like ibuprofen or acetaminophen?

Regulatory information indicates that an administration interval of at least 4 hours is necessary between Promac and certain other compounds. This is to mitigate the risk of the zinc component binding to the co-administered medication and reducing its absorption.


Q: Are there any specific vitamins, supplements, or herbal remedies that should be avoided while taking Promac?

The use of Promac is contraindicated in individuals with an existing copper deficiency. Due to the medication’s chemical nature, official caution exists regarding supplements containing other polyvalent cations (such as iron or calcium in some supplements).


Q: Are there any known interactions between Promac and birth control pills?

Official regulatory documentation regarding drug-drug interactions does not list any known interference between Promac and oral contraceptives (birth control pills).


Q: Can the effectiveness of Promac be reduced by drinking grapefruit juice?

Official regulatory documentation does not list grapefruit juice as a known substance that specifically interferes with the metabolism or reduces the effectiveness of Promac.


Q: Are there any common lifestyle factors (like caffeine or smoking) that can affect how Promac works?

Official administration instructions note that taking the medication with food, particularly high-fat meals, can significantly reduce the absorption of Promac itself. Regulatory documents do not address the effects of other common lifestyle factors like caffeine or smoking.


Q: Why do some patient forums mention using Promac for [Unlisted but Related Condition]?

Regulatory agencies have only approved Promac for its specific designated indications, such as the treatment of gastric ulcers. The official product labeling does not include discussion of unapproved or off-label uses mentioned in non-authoritative forums.


Q: Can Promac be taken by people who are lactose intolerant or have other common food allergies?

The official product label includes a complete list of all active and inactive ingredients used in the formulation. The full ingredient list is available in the official information, which patients with known allergies or intolerances may review.


Q: Can Promac affect the results of common blood or urine tests?

Due to the systemic absorption of zinc and the potential for inducing copper deficiency, official documents discuss the need for monitoring of plasma zinc and copper levels. This suggests that these specific trace elements may be affected by the use of this medicine.


Q: How long does Promac stay in the body after the last dose?

Regulatory documents provide pharmacokinetic data, such as the drug's half-life (T1/2) and elimination rates. This information describes the time it takes for the substance to be fully cleared from the body.

How should Promac be stored and disposed of?

How to Store and Dispose of Promac

The storage and disposal of Promac (Polaprezinc) must adhere to the conditions mandated by official regulatory labeling to ensure product stability and safety.

Storage Requirements

Promac must be stored at room temperature, in a location that is protected from excessive heat, moisture, and light. The official regulatory requirement is to keep the medication in its original container and ensure the container is tightly closed at all times. All medication must be stored out of the sight and reach of children to prevent accidental ingestion.

Disposal Instructions

Unused or expired Promac must not be flushed down the toilet or poured down a drain. Regulatory guidelines advise consulting with a pharmacist or local waste disposal service regarding approved drug take-back programs or other appropriate methods for discarding pharmaceutical waste.

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

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