Cricef-AZ

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Cricef-AZ

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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 Cricef-AZ

Quick Facts

Property Description
Active Ingredients Azithromycin, Cefixime
Form Oral tablet or powder for suspension
Pharmacological Class Broad-spectrum Antibiotics (Macrolide + Cephalosporin)
General Purpose To clear bacterial infections
Origin Synthetic

Cricef-AZ is a synthetic broad-spectrum antimicrobial agent classified as an antibiotic that utilizes a dual-component strategy to treat bacterial infections. It is provided as a fixed-dose combination product (FDC), a preparation containing two distinct active substances in a single dosage unit. This architectural design is often chosen to enhance efficacy and broaden coverage against various susceptible bacterial pathogens, providing utility in complex therapeutic environments.


What Type of Medicine is Cricef-AZ?

Cricef-AZ is a combination antibiotic that merges two pharmacologically separate classes of antibiotics to create a comprehensive treatment profile. The design of a fixed-dose combination (FDC) aims to deliver a synergistic effect, meaning the combined therapeutic outcome is greater than the activity of each individual drug administered alone. This strategy is a key approach in managing bacterial illnesses, particularly by working against multiple resistance mechanisms that may limit the effectiveness of monotherapies. The strategic pairing of agents in FDCs is often utilized in settings where drug resistance is a concern.


Composition: Active Ingredients and Dual-Action Strategy

The medication's active core is defined by the International Nonproprietary Names (INN) Azithromycin and Cefixime. Azithromycin is a macrolide antibiotic that achieves a primarily bacteriostatic action by inhibiting bacterial protein synthesis. Cefixime is a third-generation cephalosporin, a type of beta-lactam antibiotic, which primarily exerts a bactericidal action by directly disrupting the synthesis of the bacterial cell wall. The cephalosporin component's reliable action in killing bacteria by interfering with their cell structure supports its foundational role in the combination.


Cricef-AZ Dosage Form and General Benefit

Cricef-AZ is typically prepared for the oral route of administration, most commonly presented as an oral tablet or occasionally as an oral powder for suspension. The general benefit derived from its dual-action composition is the capacity to effectively address a wider spectrum of microbial targets. This makes it a powerful therapeutic tool for managing complex or persistent bacterial infections where comprehensive, two-pronged antimicrobial coverage is required for complex infections.

Regulatory References

  1. Fixed-dose combination (FDC) - WHOCC PPRI
  2. Definition of cefixime - NCI Drug Dictionary - National Cancer Institute

What side effects are possible with Cricef-AZ?

Possible Side Effects and Safety Information

The official safety profile for this combination medicine (Azithromycin and Cefixime) is based on the documented adverse reactions and safety constraints established by government regulatory agencies. The full range of possible effects is formally categorized by frequency and the body system affected.

Adverse Reaction Scope

The most frequently observed adverse reactions are classified as Common and typically involve the Gastrointestinal System. These commonly reported effects include diarrhea, loose stools, abdominal pain, nausea, and vomiting, as documented in official regulatory labeling. Less common effects may involve the nervous system (e.g., headache, dizziness) or skin.

Serious Adverse Reactions and Systemic Constraints

Official regulatory documents explicitly highlight the risk of Serious Adverse Reactions. These include severe hypersensitivity events, such as anaphylaxis, Stevens-Johnson Syndrome (SJS), and Toxic Epidermal Necrolysis (TEN). The macrolide component is associated with a specific risk of QT prolongation, which can lead to serious cardiac arrhythmias, and hepatotoxicity, including the potential for hepatic failure.

Safety restrictions outlined in the labeling include known hypersensitivity to any cephalosporin or macrolide/ketolide drug, and a history of drug-induced cholestatic jaundice or hepatic dysfunction. Time-related safety notes specify that certain serious conditions, such as Clostridioides difficile-associated diarrhea (CDAD), may occur during or after the completion of the antibiotic course.

Population-Specific Notes

The safety profile includes constraints for specific populations. The macrolide component carries a documented risk of Infantile Hypertrophic Pyloric Stenosis (IHPS) when administered to neonates (up to 42 days old). Furthermore, older adults may exhibit increased susceptibility to the cardiac risk of QT prolongation.

Overdose and Emergency Response

Cricef-AZ overdose is associated with documented risks affecting the cardiovascular and central nervous systems. Officially documented overdose presentations include severe gastrointestinal effects such as nausea, vomiting, diarrhea, and abdominal pain. Overdosage of the Azithromycin component can result in prolongation of the QT interval, which carries the documented, life-threatening risk of developing Torsades de pointes, a severe irregular heart rhythm. The Cefixime component increases the potential for neurotoxicity and encephalopathy, which may manifest as seizures or disturbances of consciousness. Patients with renal impairment and elderly patients are noted in regulatory information as having increased susceptibility to these serious neurological and cardiac outcomes, respectively.

In the event of a suspected overdose, immediate medical attention must be sought. Official regulatory statements mandate that emergency services must be called immediately if the person experiences collapse, a seizure, severe trouble breathing, or cannot be awakened. Management is primarily symptomatic and supportive, as no specific antidote is known for either active substance. Procedural guidance confirms that standard measures like hemodialysis are not effective for removing the Cefixime component in significant quantities.

Therapeutic Uses of Cricef-AZ

What Cricef-AZ Treats: Main Uses and Benefits

Cricef-AZ is commonly used across therapeutic domains where additional symptomatic support is needed, focusing on short-term symptom relief and stabilization during acute episodes of discomfort. This medication plays a role in managing symptoms that create noticeable physiological strain and interfere with daily comfort.

The use of such therapies is relevant in clinical settings that involve acute or unstable symptom patterns, which may include conditions presenting with systemic or localized discomfort. The medication is applied across therapeutic domains where additional symptomatic support is needed.


Key Symptomatic Benefits

This supportive therapy is often applied during phases of increased distress or discomfort. It helps maintain a sense of stability when symptoms are more noticeable, assisting with functional stability. This supportive role contributes to improved comfort during periods of heightened symptoms.


Management Contexts

Cricef-AZ is considered relevant for easing symptom clusters that may become intense or disruptive, especially in conditions characterized by periods of heightened symptoms or acute episodes. It provides supportive relief when symptoms interfere with routine activities.

Quick Fact: The medication is relevant for managing symptoms related to physical discomfort and systemic imbalance.

Eligibility and Restrictions for Use

This section outlines the official eligibility rules for Cricef-AZ, based on regulatory documentation, defining which populations are permitted, restricted, or prohibited from using the combination medication.

Contraindicated Populations (Must Not Use)

Classification Rule (Regulatory Basis)
Hypersensitivity Individuals with a known allergy to Azithromycin, Cefixime, any macrolide, or any cephalosporin antibiotic class.
Prior Liver Damage Patients with a history of cholestatic jaundice or hepatic dysfunction associated with previous Azithromycin use.

Age and Physiological Restrictions

  • Infants: Use is not established and generally contraindicated in infants under six months of age due to lack of established safety and efficacy data.
  • Older Adults: Generally permitted, but caution is advised for older adults due to the increased susceptibility to QT interval prolongation (cardiac risk) linked to the Azithromycin component.
  • Pregnancy/Lactation: Use is restricted and permitted only when the potential benefit strictly justifies the documented potential risks to the fetus or infant.

Condition-Based Limitations

Conditional Use is required for patients with pre-existing conditions that affect drug clearance or increase specific risks:

  • Severe Organ Impairment: Patients with severe renal impairment require dose adjustment or restriction due to Cefixime's primary elimination route. Use in severe hepatic impairment is also highly restricted.
  • Cardiac Risk: Caution is required in patients with pre-existing QT prolongation, bradycardia, or uncorrected electrolyte imbalances (e.g., hypokalemia).

What should I know about interactions with other medicines?

Cricef-AZ Interactions with other medicines and products

Cricef-AZ is a combination product whose activity may be affected by several types of other medications, potentially altering the amount of the drug absorbed into the body or its metabolism.

Potential Drug Interactions

Interacting Product Category Potential Effect & Mechanism
Acid-Reducing Agents (Antacids, H2 Blockers, PPIs) Decreased Absorption of Cricef-AZ components due to increased stomach pH. Reduced absorption may lower the medication’s effectiveness. Regulatory Note: Separation of administration time is often necessary.
CYP3A4 Inhibitors/Inducers Altered Drug Levels (increased or decreased) of Cricef-AZ components in the body. This is due to one component being metabolized by the CYP3A4 enzyme system. Co-administration should be approached cautiously.
P-glycoprotein (P-gp) Inhibitors Increased Drug Levels of a component of Cricef-AZ. P-gp is a transporter that removes drugs from cells; its inhibition can lead to higher systemic exposure.
Oral Anticoagulants (e.g., Warfarin) Increased Bleeding Risk. One component of Cricef-AZ may enhance the effect of anticoagulants, requiring close monitoring of blood clotting indices.

Summary

Before taking Cricef-AZ, inform your healthcare provider about all medications, supplements, and herbal products you are taking. The main interaction concerns involve medications that change stomach acid levels, which can reduce Cricef-AZ's absorption, and drugs that interfere with the body's major processing enzymes ( CYP3 A4) or transport proteins ( P-gp). Clinical monitoring may be necessary when combining Cricef-AZ with certain other products, such as anticoagulants, to prevent serious adverse events.

Mechanism of Action

How Cricef-AZ Works

Cricef-AZ operates via a specific pharmacodynamic mechanism centered on the modulation of defined [Receptor/Enzyme/System] activity. The drug engages this primary biological target with high affinity, initiating a cascade of effects at the cellular level. This interaction type, which may be an antagonist or selective inhibitor depending on the specific target, modifies the early molecular steps that govern cellular communication.

This molecular adjustment leads directly to the modulation of [Neural or Humoral] signaling pathways. Cricef-AZ operates within these well-characterized cascades to dampen the transmission of overactive signals and suppress specific signaling sequences. By limiting the propagation of excessive molecular activation, the drug contributes to a shift in physiological dynamics. This mechanism results in a more regulated state within the targeted pathways, defining the overall pattern of systemic physiological change.

Dosage and Administration Information

How to Use Cricef-AZ: Administration Guidelines

Cricef-AZ is a fixed-dose combination product containing Azithromycin and Cefixime, and its use is guided by established administration protocols for its two components.

Administration Scope

Feature Guideline
Route of administration Approved for the oral route as a tablet, capsule, or liquid suspension.
Dosing Schedule (Adults) The Cefixime component is typically 400 mg daily, administered either as a single dose or in two divided doses (200 mg every 12 hours). The Azithromycin component often follows a regimen of 500 mg once daily for 3 days, or a sequential course of 500 mg on day 1 followed by 250 mg daily on days 2–5.
Timing in relation to meals Administration is generally without regard to food for most oral forms, though taking with food may improve tolerability for the Azithromycin component.
Preparation requirements Oral suspension formulations must be shaken well and measured precisely with a calibrated device prior to administration.
Age-group administration Pediatric patients (ge 6 months): Dosing is calculated on a weight-based formula (e.g., 8 mg/kg/day for the Cefixime component). Renal Impairment: Dose adjustments are required for the Cefixime component in cases of severe renal impairment, based on creatinine clearance.

Procedural Structure

Standard procedures define a fixed-duration course for this antimicrobial therapy. Dosage forms such as chewable tablets must be chewed or crushed before swallowing, while film-coated tablets should be swallowed whole. If a dose is missed, it should be taken as soon as remembered, unless it is close to the next scheduled dose, in which case the missed dose must be skipped; double doses should not be taken. Furthermore, certain infections require a course duration of at least 10 days for the Cefixime component to ensure the required duration of exposure.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Cricef-AZ


Evidence for Use in Uncomplicated Typhoid Fever

The research for Cricef-AZ includes large-scale Randomized Controlled Trial (RCT) Protocols that research examined in the context of uncomplicated typhoid fever (enteric fever). This type of research is relevant in trials assessing short-term or episodic symptom patterns, particularly where the bacteria have developed resistance to single-drug treatments. These studies monitored outcomes related to systemic imbalance and episodic or acute changes in a broad group of ambulatory (out-patient) participants, including children (ge 2 years) to adults (le 65 years).

While these studies utilize controlled designs, the trials examined the time it took for the fever to clear, which researchers call the fever clearance time (FCT). Research also explored the time until a participant met the criteria for treatment failure, which was defined by a need to switch to a different antimicrobial therapy or a specific set of clinical metrics. The evidence is often concentrated in multi-site trials targeting specific geographic areas where resistance is common, meaning results apply primarily to the specific populations studied.


Evidence Supporting Strategy Against High-Resistance Pathogens

This part will focus on the Phase I Pharmacokinetic (PK) studies and laboratory (in vitro) research that explore the dual-action strategy of the combination and its theoretical application in settings where standard treatments face high resistance.

Research on the combination was evaluated in studies known as Phase I Pharmacokinetic (PK) studies. These studies research examined how the body handles the two medications when they are given together, specifically looking at how long the drugs stay in the bloodstream and at what concentration. This research also included laboratory (in vitro) synergy studies that tested the combined effect of the two drugs against isolated bacterial strains to see if the combined activity differed from the activity of each drug administered alone.

This body of evidence is considered to have limited information for long-term outcomes because the data is largely preclinical. The research describes patterns related to drug distribution in healthy people or laboratory activity against bacteria. Because these studies are not large-scale, controlled clinical trials for treating specific high-resistance infections, data for certain groups remain insufficient regarding patient recovery.


Key Limitations and Areas of Research Uncertainty

The evidence base, while including rigorous research designs like RCT Protocols, presents several areas of uncertainty. Follow-up durations were limited in many studies, meaning long-term effects are not fully established. Overall, while research describes the activity and observed patterns of the combination, the certainty of the data may vary across studies due to differences in sample size and study populations, and data for other applications appears to remain insufficient.

Key Studies & References

  1. Study Details | NCT02708992 | The Pharmacokinetics of Extended Duration High-Dose Cefixime Co-administered With Azithromycin
  2. Fixed dose combination product (FDC) - WHOCC PPRI Definition

Frequently Asked Questions (FAQ)

Common questions about Cricef-AZ (FAQ)


Q: Can I drink alcohol while taking this medicine?

A: Official information does not typically state a direct contraindication for the concurrent use of alcohol with the medication components. However, both the medication and alcohol can cause side effects involving the gastrointestinal system (like nausea and diarrhea), and concurrent use is described as potentially leading to increased severity of these common effects. Furthermore, the concurrent use of alcohol could potentially mask or complicate the presentation of serious adverse reactions, such as those affecting the liver.


Q: Does this medication affect my ability to drive or operate heavy machinery?

A: The official product labeling for both components of Cricef-AZ lists dizziness and drowsiness as possible side effects. Official labeling states that users should consider how the medication affects them before engaging in activities that require focus, such as driving or operating machinery.


Q: Are there any 'black box' warnings for this drug?

A: The macrolide component (Azithromycin) includes warnings in its official prescribing information regarding serious adverse events. These include the risk of severe allergic reactions, hepatotoxicity (liver damage), and changes in heart rhythm called QT interval prolongation. The cephalosporin component (Cefixime) also carries warnings about serious hypersensitivity reactions and Clostridioides difficile-associated diarrhea (CDAD).


Q: What is the primary or most common type of infection this medicine is used to treat?

A: According to regulatory documents, the components of Cricef-AZ are indicated for treating various bacterial infections. This may include those of the respiratory tract (such as bronchitis and pneumonia), urinary tract infections, middle ear infections (otitis media), and specific sexually transmitted infections like uncomplicated gonorrhea.


Q: How quickly does the medication start to work?

A: Official drug labels describe how the medicine works at a biological level but do not provide a specific timeframe (e.g., hours or days) for a patient to feel better. The therapeutic effect begins as soon as the drug concentration builds up in the body’s tissues. Official administration guidelines define a fixed-duration course to ensure required therapeutic exposure.


Q: Can I take this drug if I am also taking oral birth control pills?

A: General guidelines and official information indicate that broad-spectrum antibiotics like Azithromycin and Cefixime do not typically reduce the effectiveness of combined hormonal contraceptives (such as the Pill, Patch, or Ring). Official regulatory information provides the most current understanding of specific interaction risks.


Q: Does this antibiotic make you feel tired or fatigued?

A: Yes, fatigue or feelings of unusual tiredness/weakness are listed as potential, though generally uncommon, side effects in the official adverse reaction reports for the Azithromycin component. The product labeling states that users should be mindful of potential symptoms that may affect daily activities.


Q: Does it cause changes in vision or a metallic taste in the mouth?

A: Official documents list changes in taste (dysgeusia), which can include a metallic taste, as an uncommon side effect of Azithromycin. Blurred vision and other visual disturbances are noted as rare adverse reactions.


Q: What is the official safety classification for use in pregnancy?

A: Under the previous system, both Azithromycin and Cefixime were designated as Pregnancy Category B. Official documents state that the use of these drug components during pregnancy is restricted and generally permitted only when the potential benefit is determined to strictly justify the documented potential risks.


Q: Does this drug make you more sensitive to the sun (photosensitivity)?

A: The macrolide component (Azithromycin) has been associated with increased sensitivity to sunlight (photosensitivity) and subsequent severe sunburn as a potential adverse reaction. The regulatory information includes a note that avoidance of excessive sun exposure is recommended while using the medication due to this potential reaction.


Q: Can I take this antibiotic with ibuprofen?

A: Official drug interaction checkers for the components of Cricef-AZ do not list a known interaction with Ibuprofen. The use of any combination of medications should consider existing health conditions and the potential risks to organ systems like the heart, kidney, or gastrointestinal tract.


Q: Will this drug interfere with any lab tests?

A: Yes, regulatory documentation states that the Cefixime component has been reported to cause false-positive reactions for ketones in the urine when certain testing methods (using nitroprusside) are used. The medication may also potentially affect the results of certain liver function tests.

How should Cricef-AZ be stored and disposed of?

How to Store and Dispose of Cricef-AZ?

Storage and disposal instructions are dictated by official regulatory product labeling to maintain the efficacy and safety of this antibiotic.


Storage Requirements

Requirement Official Condition
Temperature Store tablets/dry powder at controlled room temperature (e.g., 20°C to 25°C).
Protection Keep in the original, tightly closed container and protect from moisture and excessive heat.
Handling Rules Do not freeze any form of the product. The liquid suspension should not be refrigerated if the label specifies room temperature storage.
Stability The reconstituted liquid suspension has a limited shelf-life (e.g., 10 days) and any unused portion must be discarded after this time.

Disposal and Safety

Mandatory instructions require that Cricef-AZ be kept out of the sight and reach of children. Disposal of unused or expired medicine must not be via wastewater (sinks or toilets) or household trash. Instead, follow official guidelines, often recommending a drug take-back program, to discard the product according to local regulations.

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

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