TMP/SMZ

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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 TMP/SMZ

Property Description
Active Ingredients Trimethoprim (TMP) and Sulfamethoxazole (SMZ)
Type Fixed-dose combination product
Pharmacological Class Antibacterial agent / Antimicrobial drug
Routes Oral (Tablet, Suspension) and Intravenous (IV)
Origin Synthetic drug

Dual-Component Antimicrobial Identity and Key Forms

TMP/SMZ, commonly known as Co-trimoxazole, is a synthetic antibacterial agent and a fixed-dose combination product used to effectively fight a wide variety of bacterial infections. This medicine is broadly categorized as an Antimicrobial drug, a type of agent designed to kill or inhibit the growth of microbes. As a chemically manufactured, synthetic drug, it has been globally recognized for decades and is recognized as an essential medicine. The combination is typically administered via the oral route in common dosage forms, including a tablet and oral suspension, and is also available as an intravenous solution for use in clinical settings.


Composition: The Synergistic Role of Two Active Ingredients

The active composition of this medicine is a fixed combination of two distinct antimicrobial components: Sulfamethoxazole and Trimethoprim. Sulfamethoxazole is a sulfonamide antibiotic while Trimethoprim is classified as a diaminopyrimidine antibiotic. The primary objective of combining these two substances, which are delivered together in a fixed ratio, is to achieve a potent synergistic action against bacteria. This dual-component approach allows the medicine to target and block two distinct, consecutive steps in the bacterial process of creating folic acid, which is an essential nutrient required for bacterial growth and survival. The effectiveness of this sequential blockade is clinically recognized for delivering a stronger effect than either component used alone.


Why is TMP/SMZ Considered an Essential Antimicrobial?

The fundamental value of TMP/SMZ is rooted in its unique dual mechanism, which generates a stronger, often bactericidal effect against a broad spectrum of susceptible bacterial pathogens. This coordinated, two-pronged attack is a key differentiator, making the combination a highly effective and reliable broad-spectrum antimicrobial. Clinical data indicates the necessity of this combination to achieve its strong antibacterial effect. This robust, documented action is why TMP/SMZ is frequently utilized in medicine, making it a foundational agent in fighting various bacterial infections worldwide.

Regulatory References

  1. World Health Organization Model List of Essential Medicines
  2. World Health Organization
  3. Co-trimoxazole: MedlinePlus Drug Information

What side effects are possible with TMP/SMZ?

Possible Side Effects and Safety Information

This section outlines the adverse reactions and safety characteristics of the fixed-dose combination of Sulfamethoxazole and Trimethoprim (TMP/SMZ), as documented in official government regulatory documents.

Adverse effects are classified by frequency and grouped according to the physiological system affected.

Frequency-Classified Adverse Reactions

The safety profile includes reactions spanning multiple system-organ classes, with frequency defined by regulatory standards:

Classification Example Adverse Reactions (as listed in official documents)
Very Common Nausea, Vomiting, Skin rashes
Common Headache, Diarrhea, Hyperkalemia (elevated potassium levels), Leukopenia (reduced white blood cells)
Rare / Very Rare Severe cutaneous reactions (e.g., Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis), Aplastic Anemia, Aseptic Meningitis

Serious Reactions and Safety Constraints

Official labeling identifies several events as Serious Adverse Reactions (SARs), including severe hematological disorders, acute liver injury, and life-threatening dermatological conditions (SCARs). The risk of developing severe hypersensitivity reactions is explicitly noted to be highest during the initial weeks of treatment.

Safety notes for specific populations are also documented: the medicine is contraindicated in patients with severe hepatic impairment and is associated with an increased risk of adverse effects, particularly severe blood disorders and hyperkalemia, in older adults and those with renal impairment. These constraints define the limits of the drug's use as determined by regulatory authorities.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdosing on trimethoprim/sulfamethoxazole (TMP/SMZ) can present with symptoms affecting the gastrointestinal tract and central nervous system. In the case of an acute overdose, manifestations may include loss of appetite (anorexia), nausea, vomiting, fever, blood in the urine (hematuria), yellowing of the skin or eyes (jaundice), confusion, and potentially loss of consciousness.

Long-term overexposure to the medication, which may be sustained overdosage, carries the risk of bone marrow depression. This condition is related to the drug's effect on folate metabolism and can be seen as low blood counts, such as megaloblastic anemia, leukopenia, or thrombocytopenia.

Urgent medical attention is immediately required if any overdose is suspected or if serious symptoms occur. You should seek emergency medical attention or call the Poison Help line right away. Furthermore, immediately call emergency services if the individual has collapsed, is experiencing a seizure, has trouble breathing, or cannot be awakened. These actions are necessary to ensure proper assessment and supportive care, which may include specific treatments like gastric lavage or the administration of leucovorin (folinic acid) for folate-related issues.

Therapeutic Uses of TMP/SMZ

The medication is commonly used in situations involving certain distressing symptoms across several therapeutic domains where short-term symptomatic assistance is needed. It may assist with managing symptoms that create noticeable physiological strain and interfere with daily functioning.

The medication is relevant for easing the symptom load of acute infections and is commonly used to address conditions such as painful Urinary Tract Infections (UTIs), acute otitis media (middle ear infections), acute infective exacerbation of chronic bronchitis, and specific Skin and Soft Tissue Infections (SSTIs), in addition to treating severe opportunistic infections like Pneumocystis jirovecii pneumonia (PJP) and acute gastrointestinal distress like traveler's diarrhea.

The drug supports the patient during difficult episodes by easing distress and helps address symptom clusters that may become intense or disruptive. The medication is used in infectious disease management and assists by being applied in addressing conditions involving bacterial or protozoal manifestations across these varied clinical contexts.

“The primary goal is to provide supportive relief when symptoms interfere with routine activities, contributing to improved day-to-day comfort.”

Quick Fact: Support for Acute Symptomatic Episodes
Applied across domains involving acute or disruptive episodes of the urinary, respiratory, and gastrointestinal tracts.
Contributes to improved comfort and assists with maintaining functional stability during symptomatic periods.
Relevant for easing symptoms that cluster into patterns requiring short-term supportive management, especially in acute episodes.

Regulatory References

  1. NIH DailyMed FDA Label for Sulfamethoxazole and Trimethoprim

Eligibility and Restrictions for Use

This medicine is an antibiotic combination generally approved for use in adults and children 2 months of age. However, official regulatory documents strictly prohibit its use in several specific populations, classifying use as contraindicated.

Contraindicated Populations

  • Patients with a known allergy or hypersensitivity to trimethoprim or sulfonamide medications.
  • Individuals with a history of drug-induced immune thrombocytopenia (low platelet count) caused by trimethoprim or sulfonamides.
  • Patients with documented megaloblastic anemia due to a severe folate deficiency.
  • Individuals with marked hepatic damage (severe liver disease).
  • Patients with severe renal insufficiency when their kidney function status cannot be monitored (use is generally not recommended if creatinine clearance is <15 mL/min).
  • Infants less than 2 months of age.
  • Pregnant patients and nursing mothers.

These restrictions are mandatory to prevent serious adverse reactions and are based on the risk of toxicity in vulnerable groups, such as those with blood disorders or significant organ impairment. Use in all other patients is based on a healthcare provider's assessment of need and potential risks.

What should I know about interactions with other medicines?

Trimethoprim/Sulfamethoxazole (TMP/SMZ) may interact with many other medicines, increasing the risk of serious side effects. It is essential to provide your healthcare provider with a complete list of all medications, vitamins, supplements, and herbal products you are currently taking.

Significant Drug Interactions

Do Not Combine: Co-administration with dofetilide (a medication for irregular heart rhythm) is generally avoided due to the significant risk of life-threatening cardiac problems.

Increased Risk of Bleeding: TMP/SMZ can increase the blood-thinning effect of warfarin and other similar anticoagulants. Close and frequent blood monitoring may be necessary to prevent excessive bleeding.

Increased Drug Levels and Toxicity: TMP/SMZ can increase the levels of several drugs in the body, raising the risk of toxicity. This includes:

  • Phenytoin (an anti-seizure medicine).
  • Digoxin (a heart medicine), particularly in older patients.
  • Methotrexate (an anti-folate medicine), which increases the risk of bone marrow suppression and low blood cell counts.

Risk of High Potassium (Hyperkalemia): TMP/SMZ, especially its trimethoprim component, can raise blood potassium levels. This risk is greater when taken with other agents that also increase potassium, such as ACE inhibitors, Angiotensin Receptor Blockers (ARBs), and potassium-sparing diuretics.

Hypoglycemia Risk: TMP/SMZ can enhance the effect of certain diabetes medications (like sulfonylureas), potentially causing blood sugar to drop too low.

Mechanism of Action

The Synergistic Sequential Blockade of Bacterial Folate Metabolism

The core action of Trimethoprim/Sulfamethoxazole is defined by the complementary inhibition of the bacterial metabolic pathway for synthesizing essential folic acid. The mechanism leverages the fact that susceptible bacteria must build their own folate, whereas human cells obtain it from diet. The Sulfamethoxazole component competitively inhibits the enzyme dihydropteroate synthase (DHPS), while Trimethoprim simultaneously targets the next enzyme in the sequence, dihydrofolate reductase (DHFR). This sequential blockade causes a magnified deficit of active folate within the microorganism.


Irreversible Shutdown of DNA and RNA Synthesis

The resulting profound folate deficiency prevents the synthesis of crucial nucleic acid precursors, specifically purines and thymidine. This metabolic cascade results in the halting of the bacteria’s ability to create and repair its DNA and RNA. This mechanism of metabolic deprivation prevents cellular replication and leads to the bactericidal effect, characterized by the cessation of all essential genetic functions.

Dosage and Administration Information

Trimethoprim/Sulfamethoxazole (TMP/SMZ) is utilized through two principal methods: the oral route as tablets or suspension for general use, and the intravenous (IV) infusion for more severe clinical situations. The standard regimen for most acute uses is administered as a Double Strength (DS) tablet—a fixed combination of 160 mg Trimethoprim and 800 mg Sulfamethoxazole—taken in divided doses every 12 hours. Doses for severe opportunistic infections are calculated based on the patient’s body weight using the Trimethoprim component, which defines the required high-dose administration pattern.

The duration of use varies substantially according to the condition, ranging from short courses of 3 to 5 days for certain acute gastrointestinal issues, to standard 10 to 14 day courses for urinary tract infections, and up to 21 days for serious pulmonary infections. For proper administration, oral forms may be taken with or without food, but patients must maintain adequate fluid intake throughout the treatment course.

When administered via the IV route, the concentrate must be diluted in 5% Dextrose in Water (D5W) solution prior to use. The resulting solution is then delivered via slow intravenous infusion over a specific period of 60 to 90 minutes to meet the procedural requirements. Furthermore, clinical guidelines indicate dose adjustment for patients with impaired kidney function when creatinine clearance is 30 mL/min or less, and pediatric dosing is consistently calculated using the child’s weight.

Recent Clinical Evidence

Trimethoprim/sulfamethoxazole (TMP/SMZ) remains a cornerstone antibiotic with new clinical data continuously informing its use, particularly in the face of rising antimicrobial resistance. Clinical guidelines still recommend TMP/SMZ as a first-line empirical therapy for uncomplicated urinary tract infections (UTIs) in regions where local E. coli resistance rates are documented to be low (typically below 10–20%). However, increasing resistance rates in many geographical areas necessitate careful local surveillance and may prompt the use of alternative agents.


Evolving Indications and Prophylaxis

Recent clinical trials and reviews reinforce the role of TMP/SMZ in specific patient populations and infections. Its efficacy against Methicillin-Resistant Staphylococcus aureus (MRSA) skin and soft-tissue infections is well-established, and new studies are exploring its effectiveness and optimal dosing for more severe, invasive MRSA infections in children. Additionally, the drug continues to be the agent of choice for the treatment and prophylaxis of Pneumocystis jirovecii pneumonia (PJP) in immunocompromised individuals. Current research is actively investigating if lower-dose regimens for PJP treatment could significantly reduce adverse events while maintaining therapeutic effectiveness.


Safety and Risk Profile

New data have also contributed to a deeper understanding of TMP/SMZ's safety profile. Large population-based studies have suggested a potential, though rare, association between TMP/SMZ use and an increased risk of acute respiratory failure in otherwise healthy adolescents and young adults, reinforcing existing regulatory warnings. In high-risk patients, such as those in intensive care or those with underlying conditions, research highlights the importance of monitoring for common adverse effects, including hyperkalemia (high potassium levels), elevated creatinine (a marker of kidney function), and blood disorders like thrombocytopenia (low platelet count). These risks are notably higher in patients with pre-existing kidney or liver impairment or those with other concomitant medications.

Frequently Asked Questions (FAQ)

Common questions about TMP/SMZ (FAQ)


Q: Is TMP/SMZ the same thing as Bactrim or Septra?

Yes. Official documentation confirms that Bactrim, Septra, and Co-trimoxazole are common trade names for the fixed-dose combination medication known generically as trimethoprim and sulfamethoxazole.


Q: Why do some people need to drink a lot of water while taking TMP/SMZ?

Regulatory patient information highlights the importance of adequate fluid intake while taking this medicine. This measure is recommended to help prevent a rare complication known as crystalluria, which involves the formation of crystals in the urine and can potentially lead to kidney stones.


Q: Is there a liquid form of TMP/SMZ available for those who can't swallow pills?

Yes, regulatory documents indicate that the medication is available as an oral suspension (liquid) form in addition to tablets. Official documentation notes that this form is available for pediatric use and for individuals who may have difficulty swallowing tablets.


Q: Are there specific foods or juices that should be avoided when taking TMP/SMZ?

Official patient information generally states the drug may be taken with or without food. However, information regarding any specific foods, juices, or dietary supplements consumed should be reviewed with a healthcare provider, as some items could potentially interact with the medication.


Q: What kind of infections is TMP/SMZ actually used to treat?

The medication is approved to treat a variety of susceptible bacterial infections. These typically include infections of the urinary tract, middle ear infections (otitis media), bronchitis, and certain types of skin infections.


Q: Why is TMP/SMZ sometimes prescribed for skin infections?

Official indications note that the medication is used to treat skin and skin structure infections caused by susceptible organisms. This use includes certain types of community-acquired infections, such as those caused by methicillin-resistant Staphylococcus aureus (MRSA).


Q: How long does it usually take for TMP/SMZ to start helping with an infection?

The drug is quickly absorbed into the body, typically reaching peak levels within a few hours after administration. Patient information suggests that subjective symptomatic relief may begin within a few days of starting treatment for common infections.


Q: If I feel better, is it still necessary to finish the entire course of TMP/SMZ?

Regulatory information emphasizes that the full prescribed course should be completed, even if symptoms improve quickly. This practice is considered essential to ensure the infection is fully eradicated and to help reduce the risk of bacterial resistance.


Q: What happens if I miss a dose of TMP/SMZ?

The medication is intended to be taken at evenly spaced times to maintain a consistent level in the body for effectiveness. Management of a missed dose is detailed in the specific product instructions.


Q: Does TMP/SMZ cause sun sensitivity or a stronger sunburn risk?

Official safety information indicates that this medication can increase the skin's sensitivity to sunlight, a condition known as photosensitivity. Regulatory documents suggest that protective measures may be appropriate when exposed to the sun.


Q: Is it common to feel nauseous or have an upset stomach when taking TMP/SMZ?

Yes, nausea, vomiting, and a loss of appetite are listed among the more commonly reported side effects in the official safety information for this medication.


Q: Can TMP/SMZ affect my sleep?

Official drug documentation lists insomnia (trouble sleeping) as a potential adverse effect of the medication.


Q: Why do official documents warn about severe skin reactions like Stevens-Johnson Syndrome?

Severe skin reactions, including Stevens-Johnson Syndrome (SJS), are listed as rare but potentially serious adverse effects in regulatory documentation. The warning is included due to the seriousness of these reactions, which may require immediate evaluation by a healthcare professional if symptoms appear.


Q: Can taking TMP/SMZ make my urine a different color?

Changes in urine color, as well as changes in skin color, are among the potential side effects listed in regulatory documents.


Q: Is it safe to drink alcohol while I am taking TMP/SMZ?

Official patient information indicates that discussion with a healthcare provider is recommended before using alcohol during treatment. This caution is due to the potential risk of experiencing unpleasant side effects such as fast heartbeats or nausea.


Q: Are there any herbal supplements that should not be taken with TMP/SMZ?

Regulatory information highlights the importance of reviewing all substances used, including vitamins and herbal products, with a healthcare provider due to potential interaction risks.


Q: Why is TMP/SMZ listed as a sulfonamide antibiotic?

TMP/SMZ is a combination antibiotic where one component, sulfamethoxazole, is chemically classified as a sulfonamide antibiotic. This classification is based on the chemical structure of that specific ingredient.


Q: Can TMP/SMZ be used by children?

The drug is indicated for use in pediatric patients older than two months of age for various susceptible infections. However, official safety documentation notes that use is contraindicated in infants younger than two months.


Q: Are there specific age groups that cannot use TMP/SMZ?

Yes, official safety information states that the medication is contraindicated (should not be used) in children who are less than two months of age.


Q: Why is TMP/SMZ usually avoided in late pregnancy?

Official regulatory documentation advises avoiding the drug in the first and third trimesters of pregnancy. This advice is due to safety risks, including the potential for adverse effects on the unborn baby.


Q: Is it okay to take TMP/SMZ if I have known kidney problems?

Severe kidney disease that is unmanaged is a contraindication. The official label notes that the level of renal impairment affects the appropriate use and management of the drug.


Q: What is the connection between TMP/SMZ and potassium levels?

Official safety information notes that this medication is associated with a risk of elevated potassium levels in the blood, a condition called hyperkalemia. This risk is particularly noted in individuals with existing kidney impairment.


Q: Does TMP/SMZ lose its effectiveness over time, or is there resistance?

The regulatory principle of completing the full prescribed course is emphasized because failure to do so can lead to the development of bacterial resistance, which would reduce the drug's effectiveness.


Q: Is it true that TMP/SMZ can cause kidney stones?

Official patient information includes a warning that kidney stone formation is a potential risk associated with the medication, specifically linked to the condition known as crystalluria.


Q: How quickly does TMP/SMZ get eliminated from the body?

According to official pharmacokinetics data, the half-life (the time required for half the drug to be eliminated) is approximately 8 to 10 hours for both the sulfamethoxazole component and the trimethoprim component.


Q: What does the term 'combination antibiotic' mean for TMP/SMZ?

It means TMP/SMZ is a fixed-dose combination medication composed of two distinct active antimicrobial components: trimethoprim and sulfamethoxazole. These components are combined to provide a stronger, synergistic effect against bacteria.


Q: Is it normal to feel dizzy or tired after starting TMP/SMZ?

Dizziness, fatigue, and unusual weakness are listed as potential adverse effects in the official drug information.


Q: Are there any known long-term effects of taking TMP/SMZ multiple times?

Official documentation notes that prolonged use, such as in certain preventive regimens, is associated with an increased risk of severe adverse reactions. Monitoring for blood disorders is often recommended during prolonged use.


Q: Can taking TMP/SMZ trigger an allergic reaction later on, even if I've taken it before?

Allergic reactions and severe skin reactions are a listed potential risk of the medication. Official documentation does not contain a statement that rules out the possibility of a reaction occurring after a period of previously well-tolerated use.


Q: Does TMP/SMZ interact with blood thinners like warfarin?

Yes, official information indicates a major interaction with blood thinners such as warfarin. This interaction significantly increases the risk of bleeding, and the interaction may necessitate close monitoring of blood coagulation markers.


Q: Is TMP/SMZ effective against viruses?

Official drug information explicitly states that this medication is an antibiotic intended only to treat bacterial infections. It will not work for viruses, such as the common cold or the flu.


Q: Can TMP/SMZ be taken by people with G6PD deficiency?

Official safety information lists glucose-6-phosphate dehydrogenase (G6PD) deficiency as a condition that requires caution or may be a contraindication for use. This is due to the potential risk of hemolytic anemia (destruction of red blood cells).


Q: Can TMP/SMZ cause a yeast infection?

Use of this medication for prolonged or repeated periods may potentially result in a secondary infection. This includes conditions such as oral thrush or a new yeast infection.


Q: What are the eligibility restrictions related to taking TMP/SMZ if I have HIV/AIDS?

Official information notes that patients with HIV/AIDS may be more sensitive to the drug's side effects. These patients may experience a higher incidence of reactions such as skin rashes, fever, and blood disorders.


Q: Why is folate (folic acid) sometimes discussed in relation to TMP/SMZ?

The drug's mechanism of action involves blocking the ability of bacteria to make and use folate (a B vitamin). The drug is also officially contraindicated in patients who have megaloblastic anemia due to a folic acid deficiency.


Q: Does TMP/SMZ have any known effects on mental clarity or mood?

Potential side effects listed in official safety documentation include central nervous system effects such as confusion, anxiety, and difficulty concentrating.


Q: Are there different brand names for TMP/SMZ available worldwide?

Yes, official documentation confirms that the fixed combination drug is marketed under many different trade names globally. Examples of these brand names include Bactrim, Septra, and Co-trimoxazole.


Q: Can TMP/SMZ cause changes in blood sugar levels?

Low blood sugar (hypoglycemia) is listed as a potential, though rare, serious side effect in official safety documentation.


Q: Why are people with pre-existing blood disorders typically advised against using TMP/SMZ?

The drug is contraindicated in patients with a history of certain blood disorders, such as megaloblastic anemia. This is due to the risk of the drug potentially causing myelosuppression (suppression of bone marrow activity).


Q: What does official data say about TMP/SMZ safety for breastfeeding mothers?

Official data advises caution or avoidance during breastfeeding, particularly if the infant is younger than one month old or has conditions like G6PD deficiency. This advice is due to the potential risk of hyperbilirubinemia/kernicterus.


Q: Is it possible to develop an allergy to TMP/SMZ after taking it for years?

Allergic reactions and severe skin reactions are a listed potential risk of the medication. Official documentation does not contain a statement that rules out the possibility of a reaction occurring after a period of previously well-tolerated use.


Q: What is the difference between sulfamethoxazole and trimethoprim?

They are the two distinct active components in the combination drug. Sulfamethoxazole is categorized as a sulfonamide antibiotic, while trimethoprim is classified as a dihydrofolate reductase inhibitor. They work together by blocking sequential steps in the bacterial life cycle.


Q: Why is TMP/SMZ often used to prevent certain infections in specific patient groups?

The medication is indicated for the prophylaxis (prevention) of certain serious opportunistic infections in specific patient populations. A common example is the prevention of Pneumocystis jirovecii pneumonia (PCP).


Q: Can TMP/SMZ make a person's tongue appear coated or fuzzy?

Official safety information lists potential adverse effects on the tongue. These include a painful or swollen tongue, or redness and soreness of the tongue.


Q: What is the risk of antibiotic-associated diarrhea with TMP/SMZ?

Severe diarrhea, including diarrhea associated with Clostridium difficile (C. diff.)-associated diarrhea, is listed as a serious adverse effect in official documentation for the medication.


Q: Does taking TMP/SMZ affect the results of any common lab tests?

Due to the drug's risk of causing hyperkalemia (high potassium levels) and its interactions with certain other medications, the drug may affect the results of certain blood tests, such as electrolyte levels, which may be monitored during treatment.


Q: Is it true that TMP/SMZ is sometimes used for ear infections?

Yes, official product information includes the treatment of acute otitis media (middle ear infections). This indication is specifically for pediatric patients when the infection is caused by susceptible bacteria.

How should TMP/SMZ be stored and disposed of?

Storage and Disposal of Sulfamethoxazole/Trimethoprim (TMP/SMZ)

The medicine's storage and handling instructions are strictly defined in regulatory documents to maintain product integrity and ensure safety.


Official Storage Requirements

Condition Requirement
Temperature Store at controlled room temperature (20 C to 25 C / 68 F to 77 F). Tablets must be stored below 30 C.
Protection Keep the container tightly closed and protect the product, especially the suspension, from light and excess moisture.
Prohibitions The oral suspension and injection concentrate must be kept from freezing. The prepared intravenous solution must not be refrigerated.
Safety The medication must always be stored out of the reach of children.

Disposal and Stability

Expiration or lack of need requires proper disposal. Disposal of unused or expired product must be done according to local, regional, and national regulations, ensuring the product is not released to the environment (e.g., sewers). The prepared intravenous solution has specific stability limits, often requiring use within 24 hours or less.

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

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