Clasem

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Clasem

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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 Clasem

Clasem (Cefdinir) Overview: Defining the Drug's Identity and Class

Property Description
Active Ingredient Cefdinir
Form Capsule, Oral Suspension
Pharmacological Class Third-Generation Cephalosporin Antibiotic
General Use Treating Susceptible Bacterial Infections
Origin Semi-synthetic

Clasem is a prescription-only medication containing the active ingredient Cefdinir, a semi-synthetic beta-lactam antibiotic belonging to the third-generation cephalosporins pharmacological class. This formulation is a widely prescribed oral medication that works by stopping the growth of bacteria. This classification as a third-generation agent gives it an advantage, as it is clinically recognized for its reliable activity against a broader spectrum of bacteria, including key respiratory pathogens.


Purpose and Action: How This Antibiotic Works Generally

The essential function of Clasem is to serve as a bactericidal agent, meaning it actively kills susceptible bacteria rather than just inhibiting their growth. Its unique mechanism involves the inhibition of bacterial cell wall synthesis, a structural process crucial for the microbe's survival. The drug specifically binds to Penicillin-Binding Proteins, thereby preventing the final cross-linking of the bacterial cell wall structure. This action allows Clasem to directly eliminate the bacterial population responsible for the infection, representing a decisive therapeutic benefit. The drug's inherent resistance against certain bacterial beta-lactamase enzymes provides a differentiating factor from some older antibiotics.


Available Forms and Oral Administration

Clasem is supplied in two principal dosage forms for oral administration: a solid capsule and a prepared oral suspension (liquid). Both forms are taken by mouth to facilitate the systemic absorption of Cefdinir. The provision of an oral suspension is a key differentiating feature as it addresses the needs of pediatric patients (infants ge 6 months) who may have difficulty swallowing the solid capsule form, ensuring that the medication can be precisely and reliably delivered across the entire target audience.

Regulatory References

  1. Cefdinir: MedlinePlus Drug Information

What side effects are possible with Clasem?

Possible Side Effects and Safety Information

The officially documented safety profile for Clasem (Cefdinir) is structured by classifying adverse reactions based on incidence reported in clinical trials and post-marketing surveillance, consistent with regulatory standards.


Frequency and System Classification

Side effects are primarily classified by the body system affected (System-Organ-Class or SOC). The most frequently reported events involve the gastrointestinal tract.

Classification Common (ge 1% incidence) Uncommon (<1% incidence)
Adverse Reactions Diarrhea, Nausea, Abdominal Pain, Headache, Vaginal Moniliasis, Vaginitis Rash, Dyspepsia, Flatulence, Vomiting, Dizziness, Insomnia, Pruritus, Somnolence

Serious Adverse Reactions and Safety Constraints

Severe adverse reactions, while rare, are documented in regulatory labeling. These include Clostridium difficile-Associated Diarrhea (CDAD), which can occur up to two months after treatment completion, and severe Hypersensitivity Reactions such as anaphylaxis and Stevens-Johnson Syndrome.

Safety limitations include a contraindication for individuals with a known allergy to the cephalosporin class of antibiotics. Due to the high rate of renal elimination, patients with significant renal impairment require dosage adjustment to prevent excessively high plasma concentrations, which increases the potential for adverse effects, including seizures.

Co-administration with iron-containing products results in the formation of a nonabsorbable complex that leads to the documented observation of reddish-colored stools.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory information for Clasem (Cefdinir) overdose is based on documented toxic signs from the beta-lactam antibiotic class and mandates specific emergency actions. Information on overdosage in humans is limited in regulatory literature.


Documented Overdose Manifestations

Symptoms associated with overdosage of Cefdinir's pharmacological class may include:

  • Gastrointestinal Effects: Nausea, vomiting, diarrhea, and epigastric distress.
  • Neurological Effects: The possibility of seizures or convulsions is noted as a severe toxic reaction.

Required Emergency Actions

The immediate actions required by official guidance are contingent upon the severity of the symptoms:

  • Contact the Poison Control Helpline and seek immediate medical attention for suspected overdose.
  • Immediately call emergency services if the affected person has collapsed, is experiencing a seizure, has trouble breathing, or cannot be awakened (unresponsive state).

Management and Considerations

No specific antidote for Cefdinir overdose is formally documented. Management involves symptomatic and supportive treatment. As Cefdinir is primarily eliminated by the kidneys, hemodialysis is documented as a procedure that removes the drug and may be useful, particularly if a serious toxic reaction occurs and renal function is compromised.

Therapeutic Uses of Clasem

What Clasem Treats: Main Uses and Benefits

Clasem (Cefdinir) is generally used to manage and support conditions presenting with systemic or localized discomfort. It is applicable across therapeutic domains where supportive symptom management is appropriate, primarily for infections of the skin, ears, sinuses, throat, tonsils, and the lower respiratory tract.

This medication is commonly used to help with acute symptomatic episodes such as pharyngitis, tonsillitis, acute maxillary sinusitis, acute bacterial otitis media, community-acquired pneumonia, acute exacerbations of chronic bronchitis, and uncomplicated skin structure infections.

This medication is relevant in clinical settings that involve acute or unstable symptom patterns, such as the sudden onset of ear pain, severe sore throat, or breathing difficulty. The medication helps address symptom clusters that may become intense or disruptive, and supports the patient during difficult episodes by easing distress.

“This medicine is commonly used to help patients cope more steadily with symptom fluctuations associated with acute respiratory or skin infections.”

Quick Fact: Focus on Symptomatic Relief

Clasem contributes to easing the overall symptom load. This assists with maintaining functional stability when symptoms are more noticeable, and supports general well-being during symptomatic phases.

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

The eligibility for using Clasem (Cefdinir) is strictly governed by population-specific restrictions and patient physiological status as defined in official regulatory labeling.

Contraindicated Populations

Use is contraindicated in patients with a documented allergy to the active ingredient, Cefdinir, or to the cephalosporin class of antibiotics.

Age-Related Eligibility

Cefdinir is generally approved for use in adults and adolescents (13 years of age and older). Pediatric use is established for children starting from 6 months of age. Safety and effectiveness have not been established in infants younger than 6 months of age.

Condition-Based Restrictions

Use is restricted and requires specific modification in patients with markedly compromised renal function (creatinine clearance < 30 mL/min) and those undergoing hemodialysis, as Cefdinir is primarily eliminated by the kidneys. For patients with hepatic impairment, dosage adjustment is not expected to be required.

Pregnancy and Lactation Status

Official labeling classifies the medicine as Pregnancy Category B. For nursing mothers, Cefdinir is reported to be minimally detected in human breast milk, and use should be considered with caution.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section outlines the officially documented interaction patterns of Clasem (Cefdinir) as described in authoritative government regulatory labels.


Pharmacokinetic Interactions and Restrictions

Interacting Substance Official Interaction Mechanism Regulatory Restriction
Iron Supplements (Elemental Iron) Chelation interaction reducing Cefdinir absorption, resulting in significantly lower plasma concentrations (Cmax and AUC). Must be administered at least 3 hours before or 3 hours after the iron product.
Antacids (Aluminum/Magnesium) Reduced rate and extent of Cefdinir absorption due to increased gastric pH. Must be administered at least 2 hours before or 2 hours after the antacid.
Probenecid Inhibition of renal tubular secretion, which prevents the kidney from fully eliminating Cefdinir. Results in substantially increased and prolonged plasma concentrations of Cefdinir.

Other Documented Interaction Contexts

Context Official Statement
Food Interaction Absorption is generally not significantly affected by food; the oral suspension may be taken without regard to meals.
Renal Function Clearance is substantially reduced in patients with impaired renal function, leading to elevated systemic exposure (increased Cmax and AUC).

The regulatory labels define the product’s interaction structure primarily through exposure-modifying effects that necessitate mandatory timing separation rules for antacids and iron products. The interaction with Probenecid further demonstrates interference with Cefdinir's renal elimination pathway.

Mechanism of Action

How Clasem Works: Pharmacodynamic Mechanism

Clasem (Cefdinir) functions as a bactericidal agent by specifically interfering with the structural integrity of susceptible bacteria, resulting in their death (lysis). The mechanism is highly localized to the pathogen's machinery for cell maintenance and division.

At the molecular level, Clasem targets Penicillin-Binding Proteins (PBPs), a class of bacterial transpeptidase enzymes crucial for cell wall construction. By forming a stable, covalent bond with the PBP's active site, Clasem acts as an irreversible inhibitor, irreversibly halting the enzyme’s capacity to catalyze the cross-linking reaction.

This blockade prevents the cross-linking of peptidoglycan, which provides structural rigidity to the bacterial cell wall. This failure leaves the microbe unable to resist internal osmotic pressure, causing the rupture and death (cell lysis) of the microbial cell. The action can be limited by certain bacterial beta-lactamase enzymes, which hydrolyze and inactivate the drug's active chemical structure before it can engage the PBP target.

Dosage and Administration Information

How to Use Clasem (Cefdinir)

Clasem is strictly an oral medication, provided in either capsule or oral suspension form. The official usage protocol is structured around a total daily dose of 600 mg for adults and adolescents, which is administered according to two primary frequency patterns.


Official Administration Guidelines

Guideline Official Requirement (Label-Based)
Route & Forms Oral administration only (Capsule and Oral Suspension).
Adult Dosing 600 mg total daily dose, given as 300 mg every 12 hours or 600 mg once every 24 hours.
Dosing Timing May be taken without regard to meals.
Pediatric Use Dosing for children (6 months to 12 years) is weight-based (14 mg/kg/day), not to exceed 600 mg per day.
Course Duration Treatment is a short course, typically lasting 5 to 10 days, depending on the specific condition.

Special Procedural Requirements

Proper administration requires attention to the timing of co-administered substances. Clasem must be taken at least two hours before or two hours after consuming aluminum- or magnesium-containing antacids or iron supplements, including iron-fortified foods, to prevent inadequate absorption.

Patients with significant kidney function impairment (creatinine clearance < 30 mL/min) require an official dose reduction to 300 mg once daily. Additionally, the oral suspension formulation requires reconstitution with water and must be shaken well prior to each use to ensure the correct concentration is administered.

Recent Clinical Evidence

Research Evidence: Overview of Studies for Clasem (Cefdinir)

The research evidence for Clasem (Cefdinir) was studied for conditions characterized by fluctuating or episodic manifestations. The evidence comes mainly from short-term, controlled clinical trials where Clasem was studied against other common antibiotics or against non-treatment observation. Findings describe group patterns and contribute to the broader evidence landscape. Study results reflect the specific conditions under which they were conducted.


Evidence for Use in Acute Respiratory and Throat Infections

Research for conditions characterized by acute or disruptive episodes often involves studies conducted during periods of increased symptom activity. For infections of the throat and airways, trials were observed in studies exploring short-term symptom changes.

Research for Pharyngitis/Tonsillitis

Clasem was studied for pharyngitis and tonsillitis caused by the specific bacterium Streptococcus pyogenes in short-term, randomized controlled trials. These studies primarily examined measurements related to bacterial counts in throat cultures and the resolution of symptoms related to physical discomfort. Studies describe patterns related to the bacterial counts where findings were mixed when compared to the standard antibiotic penicillin. The measured outcomes reflecting daily functioning were observed in some studies as comparable to the comparator.

Research for Acute Exacerbations of Chronic Bronchitis (AECB)

For adults experiencing acute exacerbations of chronic bronchitis, randomized trials explored whether a short-course regimen of Clasem was comparable to a longer regimen of another antibiotic. The research monitored outcomes related to systemic or functional imbalance and measurements related to bacterial counts identified at the test-of-cure visit. Studies report how symptoms evolved in the observed populations, where the measurements were observed in some studies as comparable between the studied regimens. The existing studies provide limited insight into patients requiring hospitalization.


Evidence for Ear and Other Community-Acquired Infections

Research for Acute Bacterial Otitis Media (Ear Infection)

The evidence for acute bacterial otitis media (ear infection) was observed in controlled trials focused primarily on pediatric patients (children 6 months to 6 years of age). These studies explored outcomes related to physical discomfort, often comparing Clasem against other antibiotics. Findings were mixed depending on the specific antibiotic and duration studied. Research also highlighted changes measured in patient-reported outcomes describing perceived discomfort related to administration.

Research for Community-Acquired Pneumonia (CAP)

Clasem was evaluated in randomized trials for mild to moderate Community-Acquired Pneumonia (CAP) in adults and adolescents. These studies monitored clinical outcomes and rates of bacterial counts, comparing Clasem against other oral antibiotics. The research describes clinical outcomes that appear to be comparable to those observed with the comparator antibiotics.


The Study Landscape: Follow-up and Long-Term Data

The evidence for Clasem is primarily derived from short-term follow-up durations that research examined over defined time intervals. The majority of studies monitored responses lasting up to two to three weeks post-initiation. Long-term effects are not fully established; there is limited information for long-term outcomes, such as the durability of the observed response beyond the immediate post-treatment period.

How should Clasem be stored and disposed of?

How to Store and Dispose of Clasem

The storage and disposal instructions for Clasem (Cefdinir) are strictly defined in the official regulatory labeling to maintain the medicine's stability.

Storage Conditions

Clasem Capsules and the dry powder for suspension must be stored at Controlled Room Temperature, maintained between 20°C and 25°C (68°F and 77°F). It is mandatory to keep the medicine from freezing and protect it from moisture and direct light.

Stability and Disposal

The reconstituted oral suspension has a strict stability limit and must be discarded after 10 days from the time it was mixed, even if unused. The suspension container should be kept tightly closed and shaken well before each use. All forms of Clasem must be stored out of the reach of children. Unused or expired product should be disposed of according to professional and local pharmaceutical guidelines.

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

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