Pisapem

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Pisapem

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Medically reviewed

Rosario Oropesa

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 Pisapem

Property Description
Active ingredient Meropenem, Sodium Bicarbonate
Form Powder for solution for injection/infusion
Pharmacological class Carbapenem Antibiotic
General purpose Treating severe systemic bacterial infections
Origin Synthetic

Pisapem is a powerful, prescription-only broad-spectrum antibiotic belonging to the Carbapenem class. It is engineered as a systemic antibacterial agent specifically intended to combat serious and persistent bacterial infections throughout the body, such as complicated skin or abdominal infections. The core active component, Meropenem, is a synthetic compound derived from thienamycin. Pharmacological studies confirm Meropenem is clinically recognized for its reliable efficacy against a wide range of bacteria, including strains that exhibit resistance to older antibiotic generations.


Composition and Form Differentiation

Pisapem is defined by its two-component composition, supplied as a sterile powder for solution for injection or infusion. This specific combination product includes the therapeutic agent, Meropenem, and Sodium Bicarbonate, which serves as a crucial pharmaceutical buffer. This buffer is a key differentiating feature for this intravenous (IV) formulation, addressing the chemical stability challenges inherent to Meropenem, thereby ensuring the medicine remains fully potent upon reconstitution.

Meropenem's mechanism is bactericidal—it actively kills target bacteria by disrupting their cell wall synthesis, a principle of established medical guidelines. This rapid, definitive action makes Pisapem a valuable tool for controlling the proliferation of pathogenic organisms in critical infection scenarios.

Regulatory References

  1. Meropenem - LiverTox - NCBI Bookshelf

What side effects are possible with Pisapem ?

Possible Side Effects and Safety Information

The safety profile for Pisapem (Meropenem) is defined by officially recognized frequency classifications and system-organ-class groupings established in regulatory documents such as the FDA Prescribing Information and the European SmPC. Adverse reactions are grouped based on how often they occur.

Frequency-Classified Adverse Reactions

Classification Examples of Documented Effects
Common Diarrhea, Nausea, Vomiting, Headache, Thrombocythaemia, injection site inflammation or pain, phlebitis, pruritus, and rash.
Uncommon Thrombocytopenia, Leukopenia, Hypokalaemia, Paraesthesia, Antibiotic-associated colitis, and increases in blood urea or creatinine.
Rare Convulsions (Seizures), Agranulocytosis, and Angioedema.

These effects are categorized by System-Organ Classes, including Gastrointestinal Disorders, Nervous System Disorders, Blood and Lymphatic System Disorders, and Skin and Subcutaneous Tissue Disorders.

Serious Adverse Reactions and Safety Constraints

Regulatory documents highlight Serious Adverse Reactions that include potentially fatal hypersensitivity (anaphylactic) reactions and severe skin conditions known as SCARs (e.g., Stevens-Johnson syndrome). The risk of seizures is increased in patients with pre-existing Central Nervous System (CNS) disorders or renal impairment, a condition where dose adjustment may be necessary in accordance with official guidance for specific populations. Furthermore, Clostridioides difficile-associated diarrhea (CDAD) is a serious gastrointestinal complication documented to occur during or subsequent to antibiotic administration. The medicine is contraindicated in individuals with a known history of hypersensitivity to carbapenems or other beta-lactam antibiotics, and co-administration with Valproic Acid is associated with an increased risk of breakthrough seizures.

Overdose and Emergency Response

The official regulatory profile for Pisapem overdose is primarily defined by the risk of high systemic drug concentration, with documented effects mainly concerning the Central Nervous System (CNS) and the renal system. Documented clinical manifestations include acute neurological signs such as seizures, tremors, and severe headache, along with gastrointestinal effects like nausea, vomiting, and diarrhea. Laboratory findings may show elevated hepatic transaminases and increased serum creatinine, indicating potential systemic involvement.

A key risk noted in official documentation is the potential for severe escalation, including status epilepticus and other reversible neurological disorders. Patients with pre-existing renal impairment are documented to be at a heightened risk for severe CNS toxicity due to impaired drug clearance.

Since no specific antidote is known for this overdose, the required emergency action is the immediate discontinuation of Pisapem and the institution of strictly symptomatic and supportive treatment. For severe overexposure, hemodialysis is documented as a procedural measure that can effectively remove the drug from circulation.

When to Seek Immediate Medical Help: Any suspected overdose, or the observation of signs such as seizures or other severe CNS symptoms, requires immediate medical attention or contact with emergency services, as mandated by regulatory authorities.

Therapeutic Uses of Pisapem

Pisapem: Main Uses and Therapeutic Domains

Pisapem is a prescription medication utilized in hospital settings to address a range of serious infections caused by susceptible bacteria. The therapeutic purpose of this drug is to assist in the management and resolution of bacterial infections within key body systems.

Quick Facts: Therapeutic Uses

  • Skin and Soft Tissue: Employed for complex infections affecting the skin and underlying soft tissues.
  • Intra-abdominal Infections: Appropriate for addressing complex bacterial infections located within the abdominal cavity, such as complicated appendicitis and peritonitis.
  • Meningitis: Used to provide therapeutic support for bacterial meningitis, an infection of the membranes surrounding the brain and spinal cord, in both adults and pediatric patients over three months of age.

This medication is a component of a supportive care plan designed to manage the symptoms and contribute to the resolution of these conditions, helping the body to return to a normal state of health. It is not intended for use against viral infections, such as the common cold or flu.

Eligibility and Restrictions for Use

Who Can and Cannot Use Pisapem?

The eligibility profile for Pisapem (Meropenem) is defined by official regulatory criteria that specify the patient populations allowed, restricted, or prohibited from using the medicine.

Absolute Contraindications

Pisapem is strictly contraindicated in patients with a known hypersensitivity to Meropenem or to any excipient within the formulation. Use is also prohibited for patients with a known history of severe hypersensitivity reactions (such as anaphylaxis) to any other antibiotic in the carbapenem class or to any other beta-lactam antibacterial agent, including penicillins or cephalosporins.

Age and Conditional Use Restrictions

Pisapem is generally approved for use in adults and for pediatric patients who are three months of age or older for established indications. Use in infants under three months of age is generally not recommended because safety and efficacy data are not fully established for all infections.

For adults with severe renal impairment, defined as a creatinine clearance of le 50 mL/ min, use is conditional and requires a mandatory dosage adjustment. Use in patients with pre-existing Central Nervous System disorders or a history of seizures requires caution and monitoring.

Pregnancy and Lactation

Use during pregnancy and lactation is generally restricted and not recommended unless the regulatory-defined benefit is deemed to outweigh the potential risk, due to limited human data.

What should I know about interactions with other medicines?

Pisapem (Meropenem) has a distinct interaction profile defined by specific pharmacokinetic and pharmacodynamic patterns, as documented in official government regulatory sources.


Interactions Affecting Drug Exposure

The official regulatory documents identify a significant pharmacokinetic interaction involving Probenecid, a medicinal product used to inhibit active renal tubular secretion. Co-administration of Probenecid competes with Meropenem for this elimination pathway in the kidney. This interaction formally increases the elimination half-life and plasma concentration of Meropenem, an effect tied to transporter-mediated competition.


Interactions Affecting Anticonvulsant Levels

A second major interaction involves the anticonvulsant agents Valproic Acid and Divalproex Sodium. Co-administration with Pisapem results in a confirmed reduction in the serum concentration of the anticonvulsant. Due to the pharmacodynamic risk of losing seizure control, this combination is generally not recommended in official labeling. This caution is explicitly highlighted for patients whose seizures are otherwise well-controlled by these agents.


Other Interaction Constraints

Official prescribing information does not document specific interactions requiring restrictions with common substances such as alcohol, food, or herbal products and supplements. Furthermore, the regulatory labels do not note any mandatory timing separation rules for the known interacting substances, nor are there any documented interactions mediated by cytochrome P450 (CYP) metabolic enzymes.

Mechanism of Action

Targeted Blockade of Bacterial Cell Wall Synthesis

Pisapem's primary function is to act as a covalent inhibitor of Penicillin-Binding Proteins (PBPs), which are bacterial enzymes required for the final structural assembly of the protective cell wall. This specific, high-affinity interaction permanently disrupts the peptidoglycan synthesis pathway, leading directly to the rapid lysis (rupture and death) of the bacterial cell.


️ Mechanistic Support via Biochemical Stabilization

The second component, Sodium Bicarbonate, plays a crucial role by providing essential mechanistic support as a pH buffer. This stabilization prevents the active Meropenem molecule from undergoing chemical breakdown before it can bind to the PBPs, ensuring that the maximum potential concentration of the drug is available to engage the bactericidal cascade, resulting in reduction of the viable bacterial population.


Constraints on Mechanistic Efficacy

The functional capacity of the mechanism is constrained by resistance mechanisms such as the bacterial development of modified PBPs with reduced binding affinity or the use of efflux pumps to actively expel the drug. These factors interfere directly with the core mechanism, functionally reducing the amount of drug that successfully reaches and inhibits the required enzymatic target.

Dosage and Administration Information

How to use Pisapem

Pisapem is administered strictly within a clinical setting due to its intravenous (IV) route and specialized preparation requirements. The official instructions for its use are structured around the method of delivery, a fixed frequency, and mandatory adjustments for specific populations.

Administration Scope

Field Instruction
Route of administration Intravenous (IV) Infusion (standard method) or Intravenous (IV) Bolus Injection (for doses up to 1 g).
Dosing schedule (Adults) Standard doses range from 500 mg to 2 grams of Meropenem, depending on the infection.
Preparation requirements The medicine is a sterile powder that requires reconstitution and dilution with a compatible intravenous fluid, such as 0.9% Sodium Chloride, immediately prior to administration.
Age-group rules Pediatric Patients (ge 3 months): Dosing is weight-based (10 mg/kg to 40 mg/kg) every 8 hours. Adults with Renal Impairment: Dose and/or interval must be adjusted when creatinine clearance is le 50 mL/min.
Special conditions The IV infusion must be administered over 15 to 30 minutes. The IV bolus (for le 1 g) is given over 3 to 5 minutes. The solution must be visually inspected before administration.

Procedural Structure

The standard frequency is every 8 hours (T.I.D.) for patients with normal kidney function, forming a core part of the use protocol. The official procedure requires first determining the route and dose, then properly preparing the solution, visually inspecting it, and finally administering it over the specified time duration. The treatment course is typically 7 to 14 days.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Pisapem

Evidence for Complicated Skin and Soft Tissue Infections (cSSTI)

The clinical evaluation of Pisapem's active component has included Randomized Controlled Trials (RCTs) and systematic reviews. These studies involved comparisons to other established intravenous antibacterial agents. Researchers examined key outcomes related to clinical response, such as patient improvement or resolution of acute symptoms at a follow-up visit, and the Microbiological eradication rate, which checks if the disease-causing bacteria were eliminated. The studies focused on hospitalized adults and pediatric patients over three months of age with complex infections.

Findings describe patterns observed in the trials where the measured outcomes for this treatment were compared against predefined criteria used for established standard treatments. The reported results apply only to the populations studied and generally describe short-term outcomes measured up to 28 days post-treatment.

What remains uncertain is the durability of the response. Long-term effects are not fully established regarding potential infection recurrence or extended symptom patterns beyond the short observation windows of the main trials.


Evidence for Complicated Intra-abdominal Infections (cIAI)

The evidence base for intra-abdominal infections relies on prospective, randomized, comparator-controlled clinical trials. These studies explored short-term symptom changes in patients with conditions like complicated appendicitis and peritonitis, which are conditions characterized by fluctuating or episodic manifestations. The trials typically monitored both the clinical cure rate and the microbiological eradication rate at specific follow-up appointments.

Research describes clinical and microbiological findings that were observed in relation to other intravenous therapies used to manage these infections. Findings describe patterns observed in the studies, suggesting the treatment has been evaluated in settings with varying symptom burdens.

Subgroup findings are uncertain for patients facing the most severe and complex anatomical complications of intra-abdominal infection. Limited information for long-term outcomes in these critically ill subgroups means evidence is limited regarding the full spectrum of recovery trajectories.


Evidence for Bacterial Meningitis in Children

Dedicated research examined this treatment in children, relying on Randomized Controlled Trials and specialized pharmacokinetic studies to investigate drug levels in the central nervous system. These studies explored how the condition evolved in pediatric patients (infants and children over three months of age). Outcomes related to systemic or functional imbalance were monitored, including the rate of bacteriological outcomes from the cerebrospinal fluid (CSF), and the measurement of long-term neurologic outcomes.

Studies reported how symptoms evolved in the observed populations, with results describing patterns of bacteriological outcomes and clinical response in this severe condition. Follow-up extended beyond the hospital stay to measure long-term effects.

However, data for certain groups remain insufficient. The evidence is limited for use in infants younger than three months of age. Additionally, due to the rare nature of the disease, sample sizes were modest in comparison to trials for more common infections, which limits the ability to draw very broad conclusions.

Key Studies & References

  1. Continuous vs. intermittent meropenem infusion in critically ill patients with sepsis: a systematic review and meta-analysis of randomized controlled trials with trial sequential analysis
  2. Mortality of continuous infusion versus intermittent bolus of meropenem: a systematic review and meta-analysis of randomized controlled trials
  3. Meropenem Injection IP MERONEM (Prescribing Information / Drug Label)

Frequently Asked Questions (FAQ)

Common questions about Pisapem (FAQ)

Q: What is Pisapem generally prescribed for?

A: Official regulatory documents indicate that Pisapem is prescribed to treat serious bacterial infections, including complicated skin and soft tissue infections and complicated infections within the abdomen. It is also indicated for treating bacterial meningitis in children who are three months of age or older.

Q: Is Pisapem the same type of medicine as [similar common drug name]?

A: Pisapem belongs to the carbapenem class of antibiotics, a group reserved for treating severe systemic bacterial infections. While it shares some characteristics with other medicines in this class, such as imipenem, its specific chemical and activity profiles differ.

Q: How quickly does Pisapem start working?

A: Pisapem's active component begins working quickly as a bactericidal agent, meaning it starts killing the target bacteria soon after administration by disrupting their cell walls. Official documents note that the drug's elimination half-life is approximately 1 hour in adults with normal kidney function, which relates to how long it stays in the body.

Q: How long do the effects of Pisapem last?

A: The elimination half-life of the active component is approximately 1 hour for adults with normal renal function. The standard dosing schedule is often structured as every 8 hours to help maintain a consistent therapeutic concentration in the body. This schedule is intended to keep drug levels effective for treating the infection.

Q: Does Pisapem have a 'wearing off' period?

A: The drug is generally scheduled every 8 hours to maintain continuous efficacy. Regulatory guidance states that the treatment's success depends on keeping the drug's concentration above the minimum inhibitory level for the bacteria throughout the entire dosing period.

Q: What are the main findings from the pivotal trials for Pisapem?

A: Studies and official information indicate that the main findings from pivotal trials focused on achieving a satisfactory clinical response and a high microbiological eradication rate in patients. The trials compared the treatment's outcomes against predefined criteria used for other established standard treatments.

Q: Why do some people stop taking Pisapem?

A: A severe allergic or hypersensitivity reaction is a strict contraindication and requires immediate action. Reasons for discontinuation often include documented adverse reactions, such as severe diarrhea, or rare, serious events like seizures.

Q: Can older adults use Pisapem?

A: According to official product information, no dose adjustment is required for elderly patients who have normal kidney function. However, if any adult, including an older adult, has impaired renal function, the dosage is typically adjusted according to mandatory guidelines.

Q: Why do people say they feel 'spacey' or 'foggy' on Pisapem?

A: The experience described as 'spacey' or 'foggy' may be related to reported central nervous system (CNS) adverse effects. These effects include documented symptoms such as confusion, dizziness, or an abnormal tingling/prickling sensation (paraesthesia).

Q: Is it normal to feel tired after taking Pisapem?

A: Unusual tiredness or weakness is listed in the official documents as a potential adverse effect that may be serious. Official safety information advises that such effects warrant being brought to the attention of a healthcare provider.

Q: Will Pisapem cause weight gain?

A: The official safety profile notes that unusual weight gain or rapid weight gain is a rare potential adverse effect reported from post-marketing experience. Official safety documents indicate that unexpected or significant changes in body weight should be monitored during treatment.

Q: Does Pisapem interact with common pain relievers like ibuprofen or acetaminophen?

A: Official regulatory labels do not list an interaction with the common pain reliever acetaminophen. The most significant interaction warning is for anticonvulsants like Valproic Acid, as co-administration can reduce the anticonvulsant's level.

Q: Does Pisapem need to be taken at the same time every day?

A: The prescribed dosing schedule is typically set as every 8 hours. Adherence to this strict dosing interval is important to help maintain the drug concentration at an effective therapeutic level to combat the infection.

Q: Is Pisapem considered a controlled substance?

A: Pisapem (Meropenem) is an antibiotic that is not classified as a controlled substance under the federal Controlled Substances Act. It is a powerful medicine that requires a prescription.

Q: Can Pisapem affect my sleep patterns?

A: Official safety documents list potential side effects that can affect sleep patterns. These include both difficulty falling asleep or staying asleep (insomnia) and, conversely, unusual drowsiness or sleepiness.

Q: Is it true that Pisapem can affect my vision?

A: The official safety information notes that blurred vision is a potential adverse effect that has been reported. This effect is considered rare and was noted during post-marketing experience.

Q: Can I drive or operate machinery while taking Pisapem?

A: Official warnings state that Meropenem may affect your mental alertness and cause motor impairment. Due to the potential for the medicine to affect mental alertness and cause motor impairment, official warnings advise caution regarding activities such as operating machinery or driving motorized vehicles.

Q: Does Pisapem affect mood or anxiety?

A: Rare central nervous system side effects related to mood and behavior have been reported from post-marketing experience. These have included symptoms such as agitation, hostility, and depression.

Q: How is Pisapem different from placebo in clinical trials?

A: Clinical trials established the effectiveness of Pisapem as a single agent therapy for the specified infections. The medicine was primarily evaluated by comparing its outcomes to those of other established intravenous antibacterial agents, rather than to a placebo (an inactive treatment).

Q: Is there a generic version of Pisapem available?

A: The core active ingredient in Pisapem, meropenem, is available generically and is also marketed under various brand names, such as Merrem. Pisapem is the specific name given to this formulation, which includes meropenem combined with a pharmaceutical buffer.

Q: Are there any requirements for monitoring while taking Pisapem?

A: Regulatory guidance recommends that patients receive periodic monitoring of their condition during treatment. This typically includes blood work such as full blood counts and liver function tests, as well as continuous monitoring of renal (kidney) function.

Q: What is the purpose of the black box warning on Pisapem (if applicable)?

A: The FDA label for Meropenem does not feature a Black Box Warning (the highest level of warning). However, it does include a prominent Warning regarding the potential for seizures and the risk of breakthrough seizures when used with the anticonvulsant drug Valproic Acid.

How should Pisapem be stored and disposed of?

How to Store and Dispose of Pisapem

Pisapem (Meropenem and Sodium Bicarbonate, powder for injection) requires specific temperature control to maintain its integrity, as mandated by official labeling.


Storage Conditions

Product Form Temperature Requirement
Unreconstituted Powder Store at Controlled Room Temperature (not exceeding 30 C).
Reconstituted Solution Must not be frozen. Stability is time- and temperature-dependent.

Solution Stability and Disposal

The stability of the prepared solution is limited, ranging from 1 to 15 hours depending on the concentration, diluent, and whether it is refrigerated or stored at room temperature. The product is for single use only. All unused product, including the container, must be disposed of in accordance with local and national regulations for medical waste. Keep this medicine out of the sight and reach of children.

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

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