Moldamin

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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 Moldamin

Quick Facts

Property Description
Active Ingredient Benzathine Benzylpenicillin
Form Powder for Suspension for Injection
Pharmacological Class Beta-Lactam Antibiotic (Natural Penicillin)
Common Use Anti-infective for systemic use
Origin Derived from the natural penicillin molecule

What Type of Medicine is Moldamin? Defining the Class and Origin

Moldamin is a specific, prescription-only medicine categorized as an anti-infective for systemic use. Its active component, Benzathine Benzylpenicillin, is a specific salt form of Penicillin G, placing it within the Beta-Lactam Antibiotic class. This class is distinguished by its structure, which is clinically recognized for its potent bactericidal activity against a targeted spectrum of susceptible organisms. The molecule itself is derived from the original natural penicillin and is still regarded as an essential medicine by global health authorities, reflecting its therapeutic importance.


Composition and Form: The Benzathine Benzylpenicillin Depot

The core feature of Moldamin is its formulation as a sterile powder for suspension for injection, designed exclusively for deep intramuscular (IM) injection. This choice of delivery is dictated by the chemical properties of Benzathine Benzylpenicillin; its extremely low solubility ensures the formation of a localized depot in the muscle tissue. This low solubility is a key factor in creating the sustained-release effect, which supports the medicine's capability to maintain drug levels over an extended period after a single administration.


High-Level Purpose: Why the Long-Acting Formulation is Necessary

The primary purpose of Moldamin is to ensure a reliable and sustained therapeutic effect necessary for managing systemic infections where continuous exposure to the antibiotic is crucial. The drug functions as a direct bactericidal agent, working by interfering with the synthesis of bacterial cell walls. This long-acting formulation is utilized for conditions requiring prophylaxis or for managing specific infections, ensuring that a constant concentration of the natural penicillin is maintained in the patient's system over many days to facilitate the elimination of targeted pathogens.

Regulatory References

  1. Benzathine Benzylpenicillin on WHO Essential Medicines List

What side effects are possible with Moldamin?

The official safety profile of Moldamin (Benzathine Benzylpenicillin) is structured around categories of adverse reactions and explicit constraints detailed in regulatory documents (EMA, FDA). This information is descriptive and not intended as medical advice.


Adverse Reaction Scope

Category Description
Key Adverse Reaction Categories Hypersensitivity (allergic reactions), Gastrointestinal Disorders, Blood Dyscrasias, Injection Site Reactions, and Neurotoxicity (especially in high concentrations).
Frequency Classification Common (e.g., Diarrhea, Nausea), Uncommon (e.g., Stomatitis, Urticaria), Rare (e.g., Anaphylactic Shock), and Not Known (e.g., Pseudomembranous Colitis, SJS/TEN).
System-Organ Classes Involved Immune System Disorders, Skin and Subcutaneous Tissue Disorders, Gastrointestinal Disorders, Nervous System Disorders, and Renal and Urinary Disorders.
Serious Adverse Reactions Anaphylactic shock, Severe Cutaneous Adverse Reactions (SCARs), and Clostridioides difficile-Associated Diarrhea (Pseudomembranous Colitis) are listed as rare but serious events.

Safety Classifications (High-Level)

Population-Specific Safety Considerations: The medicine is contraindicated in patients with a history of penicillin or excipient hypersensitivity. Caution is advised for patients with a history of significant allergies or asthma. The label notes that renal impairment may increase the risk of systemic adverse reactions, including neurotoxicity, due to delayed excretion.

Safety-Related Restrictions or Limitations: Regulatory documents strictly prohibit intravenous (IV) or intra-arterial administration due to the risk of severe neurovascular damage, which can lead to permanent neurological damage or tissue necrosis. The injection is intended for deep intramuscular (IM) use only.


Resulting Safety Structure

The regulatory structure of the safety profile is defined by two primary concerns: the high risk of hypersensitivity reactions and the strict requirement for deep intramuscular injection only to avoid severe neurovascular damage. Adverse events are grouped by frequency and body system to provide a complete, label-based inventory of all known risks and limitations associated with the medicine. This framework serves as the official safety description.

Overdose and Emergency Response

Overdosage of Benzathine Benzylpenicillin (Moldamin) primarily results in Central Nervous System (CNS) neurotoxicity, which is officially documented to occur when systemic levels of the drug are excessive.

Documented Overdose Manifestations

  • CNS Effects: Manifestations include convulsive seizures, twitching, and neuromuscular hyperirritability. These effects are directly linked to elevated concentrations of the active substance.
  • Severe Outcomes: Outcomes are classified as severe, with the potential for life-threatening events such as collapse and generalized seizures.
  • Population Note: Regulatory documents note that the risk of this dose-related toxicity is acknowledged to be higher in patients with severe renal impairment.

Regulatory Mandates for Emergency Response

Immediate Action Conditions Requiring Action
Seek Emergency Medical Attention Always required if an overdosage is suspected. The poison control helpline should also be contacted.
Call Emergency Services (911) Required immediately if the individual has experienced collapse, a seizure, has trouble breathing, or cannot be awakened.

Supportive Management

It is officially documented that no specific antidote is known for Moldamin overdose. Treatment is therefore strictly focused on providing symptomatic and supportive measures necessary to manage the clinical signs, particularly the CNS effects, until the concentration of the medicine decreases and systemic exposure subsides.

Therapeutic Uses of Moldamin

What Moldamin Treats: Main Uses and Benefits

This medicine is commonly used across conditions presenting with acute episodes. It is considered relevant for easing symptoms associated with acute or episodic changes, supporting patients during difficult episodes by easing distress and contributing to improved day-to-day comfort during symptomatic periods. It is applied across domains where additional symptomatic support is needed. The medicine remains relevant for symptomatic management in specific conditions.

The medication is relevant in contexts involving heightened systemic burden. It is applied in addressing symptoms related to heightened physiological activity, often used across conditions presenting with systemic or localized discomfort, supporting the patient during difficult episodes by easing distress. Moldamin is commonly used to help with symptom clusters that may become intense or disruptive and is applied across conditions involving episodic or fluctuating manifestations.

Quick Fact: Support for Physiological Strain

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Eligibility for Moldamin (Benzathine Benzylpenicillin)

Populations for whom use is Contraindicated

Use is absolutely prohibited for patients with a documented history of hypersensitivity to any penicillin or a severe immediate reaction to any other beta-lactam agent. The medicine is also contraindicated for intravenous (IV), intra-arterial (IA), or near-nerve injection; it must be administered exclusively via deep intramuscular injection.

Populations Requiring Conditional or Restricted Use

Eligibility is restricted for patients with impaired renal function due to the risk of delayed elimination and increased toxicity. Caution is recommended for patients with allergic diathesis or bronchial asthma due to an increased risk of hypersensitivity. The long-acting formulation is not recommended for infections requiring high central nervous system (CNS) penetration, such as neurosyphilis.

Age-Related and Physiological Eligibility

Use is allowed for adults, adolescents, children, and neonates for labeled conditions. Caution is advised for older adults due to the increased frequency of age-related organ impairment. The drug may be used during pregnancy when appropriately indicated, but caution is required during breastfeeding due to the potential for infant sensitization.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information for Benzathine Benzylpenicillin (Moldamin) documents specific interactions that alter drug exposure or affect coagulation, strictly based on label-approved pharmacokinetics and pharmacodynamics.


Documented Pharmacokinetic Interactions

Co-administration with Probenecid results in a pharmacokinetic interaction where the drug's clearance is reduced. Probenecid competitively inhibits the renal tubular secretion of Benzylpenicillin, which officially increases the penicillin's serum concentrations and prolongs its elimination. Similarly, certain Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including Acetylsalicylic Acid, may decrease Benzylpenicillin excretion, potentially leading to higher systemic levels.

Penicillins also reduce the renal excretion of Methotrexate, thereby increasing the systemic exposure of Methotrexate and carrying a heightened risk of toxicity for that co-administered medicine.


Documented Pharmacodynamic Interactions

The co-administration of Benzylpenicillin with Oral Anticoagulants (such as Warfarin) is officially noted to involve a pharmacodynamic interaction. This may lead to the potentiation of the anticoagulant effect, which increases the documented risk of haemorrhages. Regulatory documents specify that frequent monitoring of the International Normalized Ratio (INR) is required for patients receiving this combination.


Note: No specific food, alcohol, or herbal product interactions are officially documented in the regulatory text for this injectable formulation.

Mechanism of Action

The mechanism of Moldamin is a time-dependent action focused on disrupting the structure of the bacterial cell wall. Its action is derived from Penicillin G (Benzylpenicillin), the sole active component.


Irreversible Blockade of Bacterial Cell Wall Assembly

The core mechanism involves the drug's active component irreversibly binding to and inhibiting specific bacterial enzymes, such as Penicillin-Binding Proteins (PBPs) . These enzymes are crucial for the final cross-linking of the peptidoglycan polymer, a process necessary for maintaining the structural integrity of the bacterial cell wall. By forming a stable, covalent bond with the PBP active site, the drug halts this synthesis process, which ultimately leads to the rupture and death (lysis) of the microbial cell due to osmotic instability.


Constraints on Mechanism Functionality

The mechanism’s functionality is limited by bacterial defense systems. It only applies to bacteria that are actively multiplying and synthesizing new cell wall material; it is ineffective against dormant pathogens. Furthermore, the functionality is restricted by the production of beta-lactamase enzymes (which inactivate the drug) or mutations in the PBP target structure, which together restrict the range of susceptible biological targets.

Dosage and Administration Information

Moldamin (Benzathine Benzylpenicillin) is a long-acting formulation administered solely via deep intramuscular (IM) injection as a reconstituted suspension. The administration route is restricted, and the medicine is not for use intravenously (IV), intra-arterially, or subcutaneously, due to its specific chemical and physical properties.

The administration procedure involves several key steps: the powder must be reconstituted with a specified diluent immediately before use, and the injection is performed slowly at the designated site (e.g., the upper, outer quadrant of the buttock in adults), preceded by an aspiration step. For high-volume doses, such as the 2,400,000 IU regimen, the total volume is commonly divided and administered at two separate IM sites.

Dosing is dependent on the clinical context. Regimens range from a single, one-time dose (e.g., 1,200,000 IU for tonsillitis or early syphilis) to a course of weekly injections (e.g., for late latent syphilis). For long-term prophylaxis against conditions like rheumatic fever, the medicine is used in extended cycles administered every 3 to 4 weeks. A dose reduction is required for patients with confirmed renal impairment.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Moldamin


Evidence for Use in Group A Streptococcal (GAS) Pharyngitis Treatment

Moldamin (Benzathine Benzylpenicillin) was evaluated in studies focusing on patients, including children and adults, diagnosed with an infection caused by Group A Streptococcus (GAS), commonly known as strep throat. The research primarily consists of short-term Randomized Controlled Trials (RCTs) and comparative studies. These studies monitored outcomes related to the rates of bacteriological eradication and measured the incidence of treatment failure within a few weeks after administration. Reports generally describe the data gathered. However, evidence remains limited regarding research focusing on long-term outcomes, including potential sequelae that may follow a GAS infection.


Evidence for Preventing Rheumatic Fever Recurrence (Secondary Prophylaxis)

The prophylactic use of Moldamin to prevent the recurrence of Acute Rheumatic Fever (ARF) was evaluated in long-term cohort studies and foundational randomized trials. These studies explored the scheduled, multi-year use of the treatment in patients who had already experienced an ARF episode. Studies report how symptoms evolved in the observed populations over many years. Patterns of lower reported recurrence rates were observed during the monitoring duration among compliant individuals. A major limitation is that the evidence base consists largely of foundational long-term data, which predate many modern placebo-controlled trial methodologies. Data for certain groups remain insufficient regarding the optimal duration of prophylaxis for different stages of RHD severity.


What is Still Uncertain About Moldamin Research

The evidence highlights what is known — and what is still uncertain — about Moldamin. Evidence quality varies across studies, and much of the foundational research for long-term outcomes is still emerging from older data sets. Comparative evidence is lacking for many modern antibiotic options, and subgroup findings are uncertain because the sample sizes were modest in many analyses that focused on special patient groups. Long-term effects are not fully established for all indications, and research is ongoing to better understand the appropriate study design and follow-up necessary for different conditions. Findings describe group patterns, not personal outcomes, and study results reflect the specific conditions under which they were conducted.

Key Studies & References

  1. Study Details | NCT02857959 | One Dose Versus Three Weekly Doses of Benzathine Penicillin G for Patients With Early Syphilis

Frequently Asked Questions (FAQ)

Common questions about Moldamin (FAQ)


Q: Is Moldamin the same as other types of penicillin?

Moldamin is a specific, long-acting type of antibiotic that belongs to the penicillin class. Its active ingredient is Benzathine Benzylpenicillin (Penicillin G). While it treats infections similarly to other penicillins, its chemical formulation is distinct from oral options, which contributes to its long duration of action described in regulatory documents.

Q: What are the most common reasons a doctor might prescribe Moldamin?

According to official product information, Moldamin is indicated for treating specific bacterial infections, such as certain stages of syphilis. It is also commonly used for the long-term prevention, or prophylaxis, of conditions like rheumatic fever recurrence.

Q: Are there different brand names for the medicine in Moldamin?

Yes, the active ingredient in Moldamin is Benzathine Benzylpenicillin, which is its generic name. This active ingredient is sold around the world under various trade names, such as Bicillin L-A and Extencilline, depending on the manufacturer and region.

Q: Can children or teenagers be treated with Moldamin?

Yes, regulatory documents state that Benzathine Benzylpenicillin is indicated for use across a wide range of age groups, including adults, adolescents, children, and neonates (newborns). Official information confirms that dosing regimens are specific and vary based on the patient's age and weight.

Q: Are there any specific concerns about Moldamin use in older adults?

Official product information advises caution for all patients who have any level of confirmed kidney impairment. Since reduced kidney function may be more common in older adults, monitoring is required. Official documents state that dose adjustments are necessary in cases where renal impairment is confirmed.

Q: Is it normal to feel tired after receiving a Moldamin injection?

Unusual tiredness, weakness, or fatigue are listed among the possible adverse reactions reported for Benzathine Benzylpenicillin. While these reactions are documented, official safety data indicates that the frequency of these particular reactions is often classified as uncommon or unknown.

Q: Can Moldamin affect the results of any common lab tests?

Yes, official documents indicate that the presence of penicillins can potentially affect certain laboratory test results. For instance, the medicine may cause false-positive readings when testing for sugar in the urine using some methods. It may also affect the results of specific non-glucose-based lab tests.

Q: Does using Moldamin make someone more sensitive to sunlight?

The official safety profile for Benzathine Benzylpenicillin does not generally list photosensitivity (increased sensitivity to sunlight) as a common or frequent adverse effect. However, patients should be aware of rare or uncommon skin reactions documented in the official regulatory labels.

Q: Can someone who is allergic to penicillin also take Moldamin?

No. Regulatory documents strictly state that the use of this medicine is contraindicated for anyone who has a confirmed history of allergy. This includes hypersensitivity or allergic reactions to any form of penicillin, cephalosporin antibiotics, or any non-active ingredient in the product.

Q: How long after the last injection can side effects from Moldamin appear?

While most immediate adverse reactions occur quickly, official safety documents describe delayed effects. Some severe gastrointestinal adverse reactions, such as Clostridioides difficile-associated diarrhea, may be reported up to two months or more after the final dose has been administered.

Q: Is it necessary to avoid alcohol completely while on Moldamin treatment?

Official regulatory documents for this specific injectable formulation do not list any warnings or known interactions requiring the complete avoidance of alcohol or requiring special dietary changes.

Q: Are there specific foods or drinks that should be avoided when using Moldamin?

Official regulatory documents for this specific injectable formulation do not provide warnings or known interactions that require the avoidance of specific foods or non-alcoholic drinks.

Q: How does Moldamin interact with birth control pills?

Official product information indicates that this medication may interact with estrogen or progestin hormones. This interaction can potentially reduce the effectiveness of hormonal birth control, including oral contraceptives or implants. A temporary change in contraceptive strategy, such as using an additional barrier method, is often considered when this interaction is present.

Q: What if I forget when I was supposed to receive the next Moldamin injection?

Official patient information sheets do not provide specific directions for self-managing a missed dose. Official patient information states that a healthcare professional, such as a doctor or pharmacist, must be contacted immediately if there is suspicion of a missed injection.

Q: Is Moldamin a drug that can be habit-forming or lead to dependence?

No. The active ingredient in Moldamin, Benzathine Benzylpenicillin, is an antibiotic. It is not classified as a controlled substance and official regulatory bodies do not report it as being habit-forming or leading to physical dependence.

Q: Can Moldamin be used during pregnancy, and what is its safety classification?

Regulatory information states that the medicine does cross the placenta. Its use during pregnancy is described in official documents as appropriate when medically indicated and after the clinical benefits and potential risks have been evaluated.

Q: Is Moldamin usage compatible with breastfeeding?

Small amounts pass into breast milk. While serious side effects are not widely reported in breastfed infants, sensitization or interference with the infant's gut flora should be considered. Official guidance indicates that if an infant being breastfed develops concerning symptoms, such as a rash or diarrhea, a healthcare provider should be informed.

Q: Do studies suggest any long-term effects from using Moldamin?

Official regulatory warnings indicate that the prolonged use of any penicillin may occasionally lead to superinfections. This means there is a risk of an overgrowth of non-susceptible organisms, such as certain bacteria or yeast. Regulatory documents state that careful observation is warranted during extended use to identify any potential signs of a new or superinfection.

Q: How is Moldamin different from Amoxicillin?

Moldamin is a specific, long-acting formulation of Penicillin G (Benzylpenicillin) that is only administered via injection. Amoxicillin, by contrast, is a semi-synthetic type of penicillin antibiotic that is typically manufactured and prescribed in an oral form (like a capsule or liquid).

Q: Can Moldamin interact with supplements like iron or vitamins?

Official regulatory documents for this specific injectable formulation do not list any documented interactions with commonly used supplements, including iron or vitamins. The focus of documented interactions is primarily on other prescription medicines.

Q: Does Moldamin have a known effect on mental clarity or driving ability?

Regulatory warnings state that this medicine may impair reaction time and affect a person's ability to drive vehicles or use heavy machinery. This possibility is linked to the risk of rare but severe undesirable effects, such as allergic reactions or nervous system effects.

Q: Why is Moldamin not typically used for simple, common infections?

The medicine is not typically used for simple infections because of its long-acting nature and specific regulatory indications. Its use is generally reserved for treating certain serious infections or for the essential purpose of long-term infection prevention (prophylaxis).

Q: Is Moldamin a generic or a trade-name drug?

Moldamin is a trade name (or brand name) given to the medicine by its manufacturer. The active ingredient itself is known by its generic name, which is Benzathine Benzylpenicillin.

Q: Has there been research comparing Moldamin use to no treatment in specific conditions?

Official documents describing the clinical trials of Moldamin confirm that the evidence base includes randomized controlled trials. These trials have compared the use of the medicine to various treatments, including contexts where participants received no active medicine.

Q: What is the official chemical name for the active ingredient in Moldamin?

The active ingredient is Benzathine Benzylpenicillin. Its full, formal chemical name (IUPAC name) is a long, complex technical description used by chemists and pharmacists: N,N'-dibenzylethane-1,2-diamine; bis((2S,5R,6R)-3,3-dimethyl-7-oxo-6-[(2-phenylacetyl)amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid) (anhydrous).

How should Moldamin be stored and disposed of?

Storage Conditions for Moldamin

Official regulatory labeling dictates specific storage for Moldamin (benzathine benzylpenicillin) to maintain its stability and effectiveness.

Storage Requirement Official Status
Temperature Must be refrigerated at 2 C to 8 C (36 F to 46 F).
Freezing The suspension must not be frozen.
Protection Store in the original container and protect from light.
Safety Keep out of the sight and reach of children.

Disposal Instructions

Unused or expired Moldamin must be safely disposed of according to official guidelines.

  • Do not throw away via household waste or wastewater.
  • Discard all unused product and waste material following local requirements for pharmaceutical waste.

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

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