Pulmotil

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Pulmotil

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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 Pulmotil

The following overview defines the core identity, composition, and general purpose of the veterinary pharmaceutical preparation Pulmotil, containing Tilmicosin, while adhering strictly to the principle of excluding dosage, specific treatments, warnings, and usage instructions.

Property Description
Active Ingredient Tilmicosin (as Tilmicosin phosphate)
Form Aqueous concentrate, Premix (Granules)
Pharmacological Class Macrolide antibiotic
General Function Anti-infective agent (bacteriostatic)
Origin Semi-synthetic (derived from Tylosin)

What Type of Medicine is Pulmotil and What Does it Contain?

Pulmotil is an anti-infective agent used in veterinary medicine, classified as a semi-synthetic macrolide antibiotic. The preparation's single active compound is Tilmicosin, typically formulated as Tilmicosin phosphate. This classification as a semi-synthetic substance indicates that it is a chemically altered derivative of the naturally occurring macrolide antibiotic, Tylosin, with modifications designed to optimize its pharmacological properties. The drug's activity is intended for controlling bacterial proliferation that affects the respiratory system of specific animals.

Pulmotil’s Physical Forms and Composition for Administration

The fundamental composition of Pulmotil is the Tilmicosin active ingredient delivered within an appropriate vehicle, presented primarily in dosage forms for oral use. These presentations include an aqueous concentrate designed to be dissolved in drinking water, and a premix or granule format intended for incorporation into the animal's feed. The use of these carriers allows for mass administration. Tilmicosin is formulated to target pathogens and functions as a single-product formulation.

What is the General Function of a Semi-Synthetic Macrolide Antibiotic?

The general function of Pulmotil is to serve a bacteriostatic purpose, helping to control specific bacterial challenges by inhibiting microbial growth. Tilmicosin achieves this by interfering with bacterial protein synthesis through its reversible binding to the 50S subunit of the bacterial ribosome, a mechanism fundamental to the macrolide class. The chemical structure of this macrolide exhibits lung tropism, meaning it is concentrated and sustained within the lung tissue. This inherent property allows the compound to focus its anti-infective activity where respiratory pathogens are often localized.

Regulatory References

  1. FDA FOI Summary NADA 141-361 (Pulmotil AC)

What side effects are possible with Pulmotil?

Possible Side Effects and Safety Information

The safety profile for Pulmotil (Tilmicosin) is defined by officially documented adverse reactions primarily affecting the gastrointestinal system and by critical safety restrictions related to administration and species exposure. The information is based strictly on government regulatory documents, such as FDA and EMA labeling.


Documented Adverse Reactions

The most commonly observed effect during safety studies is decreased water consumption in the target animal, which may potentially lead to dehydration. In very rare cases, decreased feed intake or feed refusal has been reported, which is generally documented as a transient effect [HPRA SmPC]. Severe dehydration in isolated cases has been associated with secondary neurological signs.


Critical Safety Constraints

The product label includes mandatory restrictions against specific uses due to significant safety risks:

  • Administration Route Prohibition: Tilmicosin must NOT be administered by injection (intravenously or intramuscularly). Injection has been shown to be fatal in swine and non-human primates, serving as a critical administration-agnostic constraint for the oral product [FDA Drug Label].

  • Population-Specific Contraindication: Equidae (horses and other equines) are absolutely contraindicated for exposure to Tilmicosin, as it causes severe toxicity, which can lead to fatality [HPRA SmPC]. The safety has also not been established in male swine intended for breeding purposes.

  • Drug Interaction Note: The regulatory text advises against the concurrent use of Pulmotil with another macrolide antibiotic by any route, and the use of another macrolide immediately following treatment is not advised [FDA Drug Label].

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for Tilmicosin (Pulmotil’s active ingredient) is governed by serious warnings regarding accidental human exposure. The primary concern is life-threatening cardiovascular toxicity.

Documented Manifestations and Severe Outcomes

Exposure, which can occur via injection, ingestion, or skin/eye contact, is officially associated with severe systemic symptoms. These manifestations include severe chest pain, rapid heart rate (tachycardia), dizziness, headache, and nausea. Local reactions following accidental injection involve pain, swelling, and inflammation. The most serious risk is cardiac toxicity resulting in decreased heart muscle contractility. Fatalities have been reported following both ingestion and injection of Tilmicosin.

Required Emergency Actions

Immediate medical care is mandatory for any exposure. Regulatory guidance is explicit: Seek medical care immediately and consult a physician immediately. Hospitalization and prolonged medical care may be required due to the severity of the documented cardiovascular effects. As no specific antidote is known, clinical management focuses on supportive treatment. The official labeling specifies that the cardiovascular system should be monitored closely. For accidental injection sites, applying an ice or cold pack while avoiding direct skin contact is the recommended initial step. Larger volumes of exposure are linked to systemic toxicity and death.

Therapeutic Uses of Pulmotil

What Pulmotil Treats: Main Uses and Benefits

The therapeutic benefit of Pulmotil is focused on controlling acute respiratory infections in livestock. This anti-infective agent is utilized in situations involving certain distressing respiratory symptoms across multiple species.

Pulmotil is commonly used to help with acute respiratory disease outbreaks, primarily focusing on Swine Respiratory Disease (SRD) and Bovine Respiratory Disease (BRD). It is relevant in conditions marked by heightened physiological activity caused by specific pathogens, including Actinobacillus pleuropneumoniae, Mannheimia haemolytica, and Mycoplasma hyopneumoniae. The treatment provides therapeutic support needed to help ease the overall symptom burden.

The medication is commonly used across conditions presenting with acute episodes, where symptoms related to systemic imbalance are prevalent. This targeted action supports managing symptoms related to inflammatory or irritative states, and assists with maintaining functional stability. In high-risk clinical scenarios known as metaphylaxis, Pulmotil is often used during phases when symptoms may escalate temporarily to address the potential for sudden symptom escalation in groups like newly introduced feedlot cattle or nursery swine.

“This application generally provides supportive relief when symptoms interfere with routine activities.”

Quick Fact: Relief for Respiratory Compromise in Production Groups

Eligibility and Restrictions for Use

Who Can and Cannot Use Pulmotil?

Pulmotil (Tilmicosin) is a veterinary antibiotic with strict population eligibility requirements defined by regulatory bodies. It is approved primarily for use in swine and beef or non-lactating dairy cattle but is subject to several absolute contraindications and conditional restrictions.

The medicine must not be used in horses or other equidae, as Tilmicosin is known to be toxic and may be fatal to these species. It is also strictly contraindicated in any animal with known hypersensitivity to the drug substance. Due to concerns about food product residues, Pulmotil is not approved for use in lactating dairy cattle 20 months of age or older, nor is it approved for calves intended for veal production. Additionally, the administration route is strictly regulated: the injection of Tilmicosin is prohibited in swine and non-human primates.

Safety has not been established for animals intended for breeding purposes, including breeding cattle and male swine (boars). Use in cattle is also restricted to those fed in confinement for slaughter and must be initiated within the first 45 days of the production period. Finally, treatment must not occur concurrent with or immediately following the administration of an injectable macrolide.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory documentation for Pulmotil (Tilmicosin) defines specific restrictions and interaction patterns based on drug class, substance, and administration timing.

Species-Specific Contraindications Exposure to the drug is strictly contraindicated in horses or other Equidae, as ingestion has been documented in regulatory reports to be associated with fatal toxicity. This constitutes a fundamental species-specific restriction.

Drug–Drug Interaction Restrictions

  • Macrolide Antibiotics: Concurrent use of Tilmicosin with another macrolide antibiotic by any route is officially not advised. This restriction extends to injectable macrolides.
  • Pharmacodynamic Risk: Official labels detail that co-exposure with cardiovascular agents presents a specific risk. β-adrenergic antagonists (such as Propranolol) are documented to exacerbate the drug’s negative inotropy, and Epinephrine is shown to potentiate lethality.

Timing and Feed Constraints

  • Timing Rule: Treatment must not be initiated within 3 days following the administration of a non-macrolide injectable therapy intended for Bovine Respiratory Disease.
  • Feed Ingredient Prohibitions: Certain feed ingredients are prohibited from use with Tilmicosin-containing feeds. These include Bentonite, Cottonseed Meal, and Cottonseed Hulls, as they may affect the drug's efficacy.

Mechanism of Action

How Pulmotil Works

The drug's pharmacodynamic action is defined by a dual mechanism: direct inhibition of pathogen growth and modulation of host immune cell function, primarily within the respiratory system.


Targeted Inhibition of Pathogen Growth

The drug, tilmicosin, acts as a specific inhibitor by binding to the 50S ribosomal subunit within susceptible bacteria and Mycoplasma cells. This interaction interferes with the crucial steps of protein synthesis, which are required for pathogen replication and growth. The physiological consequence of this molecular binding is the induction of growth arrest (bacteriostasis/mycoplasmastasis) in the target pathogen population.


Accumulation and Potentiation in Lung Tissue

Beyond direct inhibition, the drug exhibits a strong affinity for lung tissue and pulmonary macrophages (phagocytic immune cells). The drug concentrates highly inside these host defense cells, where it acts as a modulator, enhancing the cell's natural ability to kill and clear engulfed pathogens. The combination of these actions contributes to the clearance of pathogens from the respiratory system, resulting in a measurable reduction in the infectious load.

Dosage and Administration Information

Pulmotil (Tilmicosin) is used exclusively in veterinary settings following specific, established protocols for oral mass administration. The medicine is provided to target animals, primarily swine and cattle, as the sole source of either medicated drinking water or medicated complete feed. Administration is never by injection but always involves ingestion.

The Aqueous Concentrate form requires mandatory dilution into the animals' drinking water to achieve the required concentration, such as 200 milligrams per liter (200 ppm) for swine, and this prepared solution must be used within 24 hours of mixing. The Premix or granular form is designed to be thoroughly mixed into the feed, which is then provided continuously as the animal’s only ration.

Usage is strictly time-bound, defining a continuous duration for the treatment course rather than intermittent scheduling. For example, swine receiving the drug in water are administered the regimen for 5 consecutive days, while cattle receiving it in feed are typically treated for a single, continuous 14-day period.

Standard guidelines place restrictions on both the timeline and the recipient. Treatment in cattle must commence within the first 45 days of the production period. Furthermore, there are prohibitions for use in certain populations, including all female dairy cattle 20 months of age or older and any male or female breeding stock. Certain feed ingredients, like bentonite, are also explicitly forbidden in medicated feed containing Tilmicosin due to potential interference with the product's function.

Recent Clinical Evidence

Research evidence / Overview of studies for Pulmotil

Evidence for the Control of Bovine Respiratory Disease (BRD) in Affected Groups

Research concerning the compound Tilmicosin for Bovine Respiratory Disease (BRD) primarily consists of randomized controlled clinical field trials and studies used for regulatory assessment. These studies were applied in research contexts involving herds where a clinical outbreak of BRD had already been diagnosed. Researchers primarily monitored morbidity rates, survival rates, and therapeutic responses to understand how symptoms evolved in the observed populations. Studies observed patterns where morbidity rates varied between the treated and non-medicated control groups.

Evidence for Metaphylactic Control of BRD in High-Risk Cattle

Research for the use of Tilmicosin in high-risk cattle (metaphylaxis) is primarily derived from large-scale Randomized Controlled Field Trials (RCTs). This strategy explores short-term symptom changes in newly arrived or stressed beef cattle that are expected to develop the disease. Studies monitored two main outcomes: the reduction in morbidity rate (the prevention of new disease cases) and long-term performance metrics. Research describes patterns observed in the studies where the incidence of BRD diagnosis varied between the treated groups and control groups during the initial high-risk period.

Evidence Gaps and Areas of Uncertainty

Research provides limited data for the use of the compound in pregnant swine or animals intended for breeding purposes (both cattle and swine). The existing evidence base also provides limited information for long-term outcomes that track animal health or disease patterns significantly beyond the regulated withdrawal period. Comparative evidence is lacking for all available therapeutic or metaphylactic options, as many studies focus on comparison with non-medicated control groups.

Key Studies & References

  1. FREEDOM OF INFORMATION SUMMARY NADA 141-361 Supplemental Approval (Tilmicosin Phosphate Aqueous Concentrate Swine)

Frequently Asked Questions (FAQ)

Common questions about Pulmotil (FAQ)

Q: Is tilmicosin a controlled substance?

Tilmicosin, the active ingredient in Pulmotil, is officially classified as a veterinary antibiotic. Official classification documents indicate the drug is subject to veterinary prescription requirements for its approved uses in livestock. It is not listed as a controlled substance in official documents.

Q: How is tilmicosin broken down and excreted from the animal’s body?

Information from pharmacokinetic studies shows that the drug is slowly eliminated from the body. The majority of tilmicosin is excreted primarily through the faeces, with a lesser amount found in the urine. This slow elimination is the reason strict withdrawal times are defined and regulated by government authorities to manage food product residues.

Q: Are generic versions of tilmicosin available?

Governmental regulatory sources that manage medicated ingredients often list multiple approved product names containing the active ingredient tilmicosin. This confirms that the active compound is available under different approved brand names.

Q: How quickly does tilmicosin start to work after administration?

Studies on the drug’s pharmacological properties indicate that the concentration of tilmicosin in the bloodstream and target lung tissues typically reaches its peak levels within a few hours following administration. This concentration pattern is consistent with its intended anti-infective action in the respiratory system.

Q: Does tilmicosin cause side effects like sleepiness, headaches, or dizziness?

Official safety warnings on the product label note that effects such as headache and dizziness have been reported in the context of unintended exposure in people. This information is documented as part of the regulatory record for serious adverse effects associated with exposure to the drug outside of its approved veterinary use.

How should Pulmotil be stored and disposed of?

The storage and disposal requirements for Pulmotil (tilmicosin phosphate) are strictly defined by regulatory documents based on the specific formulation.

Official Storage Conditions

Formulation Temperature and Protection Requirements
Aqueous Concentrate (AC) Store at or below 86°F (30°C) and protect from direct sunlight.
Premix (Pulmotil 90) Store at or below 77°F (25°C) and avoid excessive moisture.

Medicated water prepared with Pulmotil AC must be discarded if not used within 24 hours. All forms must be kept out of the reach of children.

Disposal and Environmental Rules

Official instructions require the disposal of unused product and waste material according to local regulations and established procedures. It is a mandatory requirement to avoid releasing the product to the environment.

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

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