Даларгин

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Даларгин

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.

Overview of Даларгин

Quick Facts

Property Description
Active ingredient Tyrosine-D-alanyl-glycyl-phenylalanyl-leucyl-arginine Diacetate
Form Lyophilisate (Powder for injection solution)
Pharmacological class Synthetic Hexapeptide, Delta-Opioid Receptor Agonist
General purpose Cell protection and tissue regeneration
Origin Synthetic

What is Даларгин and What Type of Medicine is It?

Даларгин (Dalargin) is a highly specific, chemically synthetic hexapeptide medication. It is classified pharmacologically as a Delta-Opioid Receptor Agonist, meaning it acts on specific receptors in the body to modify physiological responses. This action places it within the class of drugs that function as analogues of the body’s natural opioid peptide, leucine-enkephalin.

The drug's core active substance is Tyrosine-D-alanyl-glycyl-phenylalanyl-leucyl-arginine Diacetate. Its synthetic origin is a differentiating factor: the molecule is specifically engineered with a D-alanine substitution to provide resistance to enzymatic breakdown by peptidases. This stability is essential for its therapeutic action, setting it apart from the short-lived natural peptide.


Composition and Form: The Active Ingredient and Its Preparation

The medicine is supplied as a sterile, white, amorphous powder known as a lyophilisate, a form necessary due to the delicate peptide nature of the active compound. The lyophilisate contains the single-ingredient peptide and must be mixed with a solvent just prior to use.

The resulting aqueous solution is intended exclusively for parenteral administration, specifically via intravenous or intramuscular injection. This injection route is clinically recognized as necessary because the active ingredient would be rapidly destroyed by stomach acids if taken orally, making direct delivery to the bloodstream essential.


What is the General Purpose of Даларгин?

The general purpose of Даларгин is to act as a potent cytoprotective and regenerative agent for internal tissues. It provides high-level structural support and facilitates the natural rebuilding of damaged cells and tissue linings. A typical scenario for its use involves supporting the regeneration of the mucous membranes of the digestive tract.

The drug achieves this overall benefit by influencing cellular processes to favor recovery. It helps stabilize cell membranes against damaging factors and suppresses destructive biological actions, such as the excessive release of tissue-degrading enzymes and corrosive digestive fluids. This general action promotes the fundamental restoration of tissue integrity in affected organs.

Regulatory References

  1. NIH ClinicalTrials.gov Search Result
  2. PubMed search for Dalargin cytoprotection

What side effects are possible with Даларгин?

Possible side effects and safety information

The official safety documentation for Dalargin outlines the adverse reactions and constraints that define the medicine's risk profile, emphasizing that the potential for certain effects is related to the dose administered.

Adverse reaction scope

Element Regulatory Statement (Based on Official Sources)
Key adverse reaction categories Reduction in arterial blood pressure (Hypotension), Dizziness, Visual perception impairment, and Allergic reactions.
Frequency classification Not categorized using standard frequency terms (e.g., 'common', 'rare'). Occurrence is noted to be dose-dependent.
System-organ classes involved Vascular Disorders (e.g., blood pressure changes); Nervous System Disorders (e.g., dizziness); Eye Disorders (e.g., visual perception); Immune System/Skin Disorders (e.g., allergic reactions).
Serious adverse reactions The potential for significant reduction in arterial blood pressure and severe allergic reactions is documented.
Dose- or exposure-related patterns Documented adverse reactions are associated with the administration of higher doses of the medication.
Safety-related restrictions or limitations Officially contra-indicated in patients with pre-existing arterial hypotension, acute infectious processes, and known hypersensitivity to components.

Safety classifications (high-level)

The regulatory documentation focuses on specific constraints and dose-dependent risk rather than a formal frequency framework.

Element Regulatory Statement (Based on Official Sources)
Regulatory basis Governed by national regulatory instructions, such as the Russian State Register of Medicines (GRLS).
Context-of-use safety notes Includes high-level notes regarding potential altered effects when used concomitantly with narcotic analgesic agents and Naloxone.

Resulting safety structure

  • The official safety profile outlines specific adverse reactions, including a drop in blood pressure, dizziness, and visual disturbances, which are explicitly linked to the use of higher doses.
  • The profile defines clear regulatory constraints, prohibiting the use of the drug in individuals diagnosed with pre-existing low blood pressure or those experiencing acute infectious processes.
  • Adverse effects map primarily to the vascular, nervous, and immune systems, providing a systemic view of potential regulatory-documented risks.

Connection to the overall safety profile

The official safety information strictly structures the understanding of Dalargin's risks by establishing that the documented adverse reactions are associated with dose levels and not a generalized risk frequency. This framework emphasizes specific safety constraints, defining absolute regulatory limits on the medication's use by formally contraindicating it in patients with certain pre-existing conditions like arterial hypotension or acute infections.

Overdose and Emergency Response

The official regulatory documents define the overdose profile of Dalargin (Даларгин) based on potential physiological manifestations and mandated emergency protocols. The available data is constrained by the official statement that clinical reports of human overdose are extremely limited.

Documented Manifestations of Overdose

Excessive administration of the drug is formally documented to carry the potential for specific dose-dependent manifestations. These reported signs include a reduction in arterial pressure (hypotension), dizziness, and impaired visual perception. The regulatory information also notes a potential for increased risk of allergic reactions with higher doses.

System Affected Potential Overdose Sign
Cardiovascular Reduced Arterial Pressure
Central Nervous / Sensory Dizziness, Impaired Visual Perception

When to Seek Immediate Medical Help

The regulator-mandated action for any suspected overdose or administration exceeding the prescribed amount is to seek immediate medical consultation. This required action must be taken without delay. Upon consulting the doctor or emergency services, official instructions stipulate that the patient or caregiver show the drug packaging to assist the medical professional with identification.

Regulatory Context

The official prescribing information states that, to date, no cases of overdose have been formally reported to the authority. Additionally, a population-specific note is included: information regarding the safety and effectiveness of the drug in children is absent, leading to a recommendation against prescribing the drug to this patient group.

Therapeutic Uses of Даларгин

What Даларгин Treats: Main Uses and Benefits

Даларгин is generally used to provide supportive symptomatic relief in clinical settings characterized by heightened patient distress and fluctuating symptoms. It is considered relevant across domains where short-term symptomatic assistance is appropriate for managing intense discomfort. It is primarily applied across conditions presenting with episodic or fluctuating symptom patterns within the upper digestive tract, including conditions involving inflammatory or irritative processes, and also in clinical settings associated with organ-specific functional stress.

Symptom and Condition Focus

This medication plays a role in managing symptoms that may become intense or disruptive, such as those arising in conditions associated with acute or disruptive episodes and those involving systemic or localized discomfort. It is relevant for managing symptom clusters that create noticeable physiological strain and become temporarily overwhelming.

“It supports the patient during difficult episodes by easing distress and offers symptomatic relief that helps patients cope more steadily with difficult episodes.”

By focusing on managing these intense manifestations, it provides supportive relief when symptoms interfere with routine activities, which helps improve day-to-day comfort during symptomatic periods.


Quick Fact: Symptom Support Context The medication is commonly used during phases of increased distress or discomfort when symptoms associated with inflammatory or irritative states intensify and supportive relief is needed.

Eligibility and Restrictions for Use

Eligibility Map: Who can and Cannot Use Даларгин

Official regulatory documentation primarily defines the population for Даларгин (Tyrosine-D-alanyl-glycyl-phenylalanyl-leucyl-arginine Diacetate) by strict Absolute Contraindications, with use generally permitted only for adults who do not meet any of the exclusion criteria.

Scope Regulatory Status
Populations for whom use is allowed Adults (18 years of age and older).
Age-related exclusion Contraindicated in children and adolescents under 18 years of age.

Absolute Prohibitions

The medicine is officially contraindicated and must not be used in the presence of the following conditions or population characteristics:

  • Hypersensitivity to the active substance or any excipients.
  • Malignancy or oncological diseases.
  • Acute infectious processes, including conditions such as severe sepsis or acute purulent inflammation.
  • Acute circulatory shock, including cardiogenic shock.
  • Severe arterial hypotension (pathologically low blood pressure).
  • Pregnancy or Lactation (breastfeeding).

Conditional Use

Official labeling specifies that the medicine should be used with caution in patients with documented severe renal impairment or severe hepatic impairment, although these are not listed as absolute contraindications.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation on the interaction profile of Даларгин is primarily focused on pharmacodynamic effects resulting from its action as a Delta-Opioid Receptor Agonist. The official government regulatory summary documents specific interactions with agents that also influence the opioid system.


Documented Pharmacodynamic Interactions

The product's regulatory profile highlights two key interaction patterns:

  • Opioid Analgesics (Narcotic Pain Relievers): Co-administration is officially documented to enhance the pharmacological action of narcotic analgesic agents.
  • Naloxone: The presence of the opioid antagonist Naloxone is officially stated to block the anti-ulcer therapeutic effect of Даларгин.

Officially Undocumented Interaction Categories

Based on regulatory summaries, the following interaction patterns have not been specifically detailed in the official government documentation:

Interaction Category Regulatory Status
Formal Contraindicated Combinations Not explicitly documented
Pharmacokinetic Interactions (CYP/Transporter) Not specifically documented
Food, Alcohol, or Herbal Products Not specifically documented
Timing or Separation Requirements Not specifically documented
Exposure Modification (AUC/Cmax) Not specifically documented

The drug's official interaction structure is thus limited to the functional reinforcement and functional antagonism observed with other opioid-system agents, as stated in the government-mandated prescribing information.

Mechanism of Action

Даларгин (Dalargin) is a synthetic peptide that acts as an enkephalin analog. Its primary mechanism involves binding as an agonist to the delta-opioid receptors (mathrmDOR) located on cell membranes of gastric and duodenal tissues. Activation of these mathrmDORs, which are G-protein coupled receptors (mathrmGPCRs), inhibits adenylyl cyclase activity, thereby reducing intracellular cyclic adenosine monophosphate (mathrmcAMP) levels. This binding and subsequent mathrmG-protein signaling initiates a cascade leading to the stabilization of mast cell membranes, thereby attenuating the release of inflammatory mediators, specifically histamine and serotonin. By this selective interaction and resultant cascade, Даларгин modulates inflammatory pathways and facilitates localized tissue repair, contributing to the preservation of mucosal integrity.

Dosage and Administration Information

The use of Даларгин is defined by a strict parenteral protocol. The medicine is supplied as a lyophilisate (a 1 mg powder for injection) and is administered exclusively via Intravenous (IV) or Intramuscular (IM) injection.


Administration Scope

Feature Details
Route of administration Intravenous (IV) injection or Intramuscular (IM) injection.
Dosing schedule (Adults) The typical single dose is 5 mg per administration. The maximum prescribed daily dose is up to 20 mg, depending on the specific regimen.
Frequency and Timing Administration frequency varies, often ranging from 3 to 4 times per day for acute regimens, necessitating 6 to 8-hour intervals between doses.
Preparation requirements The lyophilisate powder must be dissolved with 1 mL of 0.9% sodium chloride solution immediately prior to injection. The prepared solution must be used immediately.
Course Duration Use is time-bound and short-term, typically ranging from 2 to 6 days for acute supportive applications or up to 3–4 weeks for certain other supportive courses.

Procedural Structure

The protocol requires specific preparation steps to ensure the drug's integrity prior to administration. Dosage and frequency are set to ensure the correct total amount is delivered over the prescribed short-term duration, establishing a fixed, multiple-times-daily use pattern. Available technical descriptions for the medication do not provide explicit instructions for specific dose adjustments in older adults or for managing a missed dose.

Recent Clinical Evidence

Даларгин: Research Evidence Overview

Evidence for Gastrointestinal Conditions

Research involving Даларгин has explored its use in conditions associated with tissue damage and fluctuating symptoms, such as duodenal ulcer disease. Comparative clinical trials evaluated outcomes related to the physical integrity of the digestive lining, including the rate and time to ulcer scarring. Findings describe patterns observed in the evolution of scarring during the short-term treatment period.

Similarly, research has explored the agent’s role as an adjuvant treatment for chronic pancreatitis. These studies were designed to evaluate changes in patient-reported discomfort and systemic functional imbalance, monitored through levels of pancreatic enzymes and hormones. In both the ulcer and pancreatitis studies, the agent was frequently studied as part of a combination therapy, making it challenging to understand its specific effect independent of other treatments.

Studies in Acute and Specialized Settings

The agent was also evaluated in specialized clinical trials for supportive use in high-stress medical environments, such as during and immediately following major surgery. These studies focused on outcomes monitoring physiological strain and organ stability, including tracking narcotic analgesic consumption during the short-term recovery phase. The results from these trials apply only to the specific, acute populations studied.

Research Gaps and Uncertainty

Follow-up durations were limited across many core studies. Consequently, evidence concerning the long-term durability of effects, recurrence prevention, or outcomes related to years of use is not well characterized. Additionally, data for certain patient groups remain insufficient; for instance, there is limited evidence exploring its use in pediatric or pregnant populations. A key area of scientific uncertainty relates to its extensive use in combination therapy, as the evidence quality varies across studies and certainty remains low regarding the generalizability of some findings.

Frequently Asked Questions (FAQ)

Common questions about Даларгин (FAQ)

Q: Does Даларгин cause extreme fatigue or drowsiness?

A: Official regulatory documents list potential adverse reactions affecting the central nervous system and general state, including dizziness, visual perception impairment, and general weakness. Because of these potential effects, instructions recommend caution when engaging in activities that require high concentration or quick reactions.

Q: Can I use Даларгин if I have a history of low blood pressure (arterial hypotension)?

A: Official regulatory documents indicate that the medicine is contraindicated (must not be used) in patients diagnosed with Arterial Hypotension (pathologically low blood pressure).

Q: Does Даларгин interact with common anti-depressant medications?

A: Official regulatory documents detail specific interactions only with narcotic analgesic agents (opioid pain relievers) and the drug Naloxone. Interactions with other common drug classes, including anti-depressant medications, are not specifically documented in the official prescribing information.

Q: How is Даларгин generally described in official medical texts—as a primary or supplementary treatment?

A: The drug’s official role is defined as a potent cytoprotective (cell-protecting) and regenerative agent. Official studies and product information often describe its use as part of a combination (adjuvant) therapy to support tissue repair in acute conditions.

Q: What should I do if I accidentally miss a scheduled dose of Даларгин?

A: The regulatory documents outlining the administration protocol provide rigid dosing and timing instructions but do not provide specific guidance on how to manage or compensate for a missed dose.

Q: Are there any specific lifestyle changes mentioned in regulatory guidance that support Даларгин treatment?

A: Official regulatory documents do not specify any required lifestyle changes, diet modifications, or general restrictions in relation to common food products or supplements.

Q: Does Даларгин have a black box warning or similar serious regulatory alert?

A: While official Russian regulatory documents (GRLS) do not use the US term 'black box warning,' the official instructions include a specific, high-level recommendation to avoid driving or operating machinery due to the potential risk of low blood pressure and visual disturbances.

Q: Can Даларгин be used if a patient is simultaneously receiving chemotherapy?

A: The official product information lists Malignancy (oncological diseases) as an absolute contraindication. Its use is therefore prohibited in patients with this condition, including those who are currently undergoing treatment for it.

Q: Is Даларгин used for any other conditions besides stomach ulcers and pancreatitis?

A: The only conditions officially listed as indications for the use of the drug are peptic ulcer disease (stomach and duodenum) and acute pancreatitis/pancreonecrosis.

Q: Can Даларгин be taken at the same time as pain relievers like Ibuprofen or Paracetamol?

A: The official regulatory documents only detail specific interactions with narcotic analgesic agents (opioid drugs) and Naloxone. No specific interaction is documented for common non-narcotic pain relievers like Ibuprofen or Paracetamol.

Q: What does it mean that Даларгин is a peptide drug?

A: The drug is a synthetic peptide (a small protein-like fragment). Its chemical nature makes it easily broken down by stomach acids. This is why it is supplied as a powder for injection and must be administered exclusively via intramuscular or intravenous injection.

Q: Is it safe to drink coffee or tea while using Даларгин?

A: Official regulatory documents do not specify any interaction with or required restriction regarding coffee or tea.

Q: Is there any information on how Даларгин affects the immune system?

A: The official mechanism of action describes how the drug works to stabilize mast cell membranes. This action is known to attenuate the release of inflammatory mediators like histamine and serotonin, which are part of the body's inflammatory and immune response.

Q: Do official sources describe any specific blood pressure changes associated with Даларгин?

A: Official regulatory documents state that a key dose-dependent adverse reaction is a reduction in arterial blood pressure (hypotension).

Q: Are there any specific warnings about driving or operating machinery while receiving Даларгин?

A: Yes, due to the potential for low blood pressure, dizziness, and visual impairment listed as side effects, official instructions recommend avoiding driving and engaging in potentially hazardous activities that require high concentration.

Q: What happens in the body when Даларгин is administered?

A: The drug acts as an agonist on delta-opioid receptors (mathrmDOR) found on cell membranes, particularly in digestive tissues. This initiates a process that helps manage inflammatory responses and facilitates localized tissue repair by preserving mucosal integrity.

Q: Do official documents mention any connection between Даларгин and digestive function improvement?

A: The drug's primary function is described as a cytoprotective and regenerative agent for internal tissues. This action promotes the fundamental restoration of tissue integrity in the digestive tract, which is supportive of overall healing.

Q: Is it normal to feel a stinging or burning sensation at the injection site?

A: Official documents list local reactions at the injection site as potential adverse effects. These documented reactions include localized redness, soreness, and itching.

Q: What is the shelf life of Даларгин injections before being prepared?

A: Official instructions require the lyophilisate powder to be dissolved with the solvent immediately prior to injection. Furthermore, the resulting solution must be used immediately after preparation to ensure effectiveness.

Q: Is there regulatory information about using Даларгин for pain management related to its primary uses?

A: Official regulatory information notes that the drug enhances the pharmacological action of narcotic analgesic agents (opioids). This is a functional interaction documented in the product summary.

Q: Does Даларгин have any known interactions with alcoholic beverages?

A: Official regulatory documents do not specifically detail any interaction with or restriction regarding alcoholic beverages.

Q: Can Даларгин interact with common supplements like vitamins or herbal remedies?

A: Official regulatory documents do not specifically detail any interaction with or restriction regarding vitamins or herbal remedies.

Q: Do regulatory documents mention any specific organs that Даларгин targets?

A: The official mechanism of action specifies that the delta-opioid receptors (mathrmDOR) that the drug targets are primarily located on the cell membranes of gastric and duodenal tissues.

How should Даларгин be stored and disposed of?

Storage and Handling Requirements

Даларгин (Dalargin), supplied as a lyophilized powder, must be stored under specific environmental constraints to maintain stability. The official regulatory requirement mandates storage at a temperature not higher than 25°C. The medicine must be kept in a dry place and protected from light by being stored in a dark place.

To ensure proper light protection, the ampoules must remain within their original secondary packaging (cardboard box) until use. As a critical safety requirement, the product must always be stored out of the reach of children.

Disposal Instructions

Expired or unused Даларгин must be disposed of in compliance with local legal requirements for pharmaceutical waste. Patients should consult a pharmacist or healthcare provider for specific guidance on proper disposal procedures.

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

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