1-AL

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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 1-AL

Quick Facts

Property Description
Active Ingredient Levocetirizine dihydrochloride
Form Oral (Film-coated tablet, Oral solution)
Pharmacological Class Second-Generation Antihistamine
Common Purpose Relief from allergic symptoms
Origin Synthetic; l-enantiomer of Cetirizine

What is 1-AL and What Class Does it Belong To?

1-AL is a synthetic medicinal product for systemic use whose active ingredient, Levocetirizine dihydrochloride, is classified as a Second-Generation Antihistamine. This medication is formulated for oral administration, typically available as a film-coated tablet or an oral solution. The name 1-AL is a trade name associated with this specific formulation of Levocetirizine. As a second-generation agent, this compound exhibits high selectivity for peripheral receptors, a characteristic feature that is clinically recognized for providing effective relief while mitigating the non-target effects often seen with older antihistamine classes.


The Composition of 1-AL: Levocetirizine Dihydrochloride

The substance Levocetirizine dihydrochloride is the pure, pharmacologically active l-enantiomer of Cetirizine. This means that only the mirror-image molecule responsible for the therapeutic effect has been isolated through a refinement process. The specific composition provides a distinct advantage over the racemic mixture of Cetirizine, which contains both active and relatively inactive forms, leading to highly targeted receptor affinity. The isolation of the active component enhances the specificity of the drug's action, a finding consistently supported by pharmacological studies.


How Does 1-AL Generally Relieve Allergic Symptoms?

1-AL functions as a Selective Histamine H1-Receptor Antagonist, blocking the biological effects of histamine, which is the primary chemical mediator released during an allergic reaction. The overall purpose of the medicine is to manage the physiological manifestations of allergies, such as those that might be experienced during an acute seasonal allergy episode. By interrupting the histamine cascade through this specific antagonism, the medication helps to mitigate the body's excessive response to allergens and provides general relief from associated discomforts.

Regulatory References

  1. Levocetirizine: MedlinePlus Drug Information

What side effects are possible with 1-AL?

Possible Side Effects and Safety Information

This section describes the officially documented adverse reactions and safety characteristics for Levocetirizine dihydrochloride (1-AL), as classified in government regulatory documents like the FDA Prescribing Information and the EMA Summary of Product Characteristics (SmPC).

Frequency-Classified Adverse Reactions

The most commonly reported adverse reactions in clinical trials, classified as Common (occurring in ge 1/100 to < 1/10 patients), include somnolence (drowsiness), fatigue, dry mouth, and headache. Events classified as Uncommon (ge 1/1000 to < 1/100) include abdominal pain and general malaise.

System-Organ Classes and Serious Events

Post-marketing reports indicate adverse events affecting various System-Organ Classes. These include Nervous System Disorders (such as dizziness, convulsion, or tremor) and Psychiatric Disorders (including reports of aggression, agitation, and, rarely, suicidal ideation). Serious, rare events documented include anaphylaxis (a severe hypersensitivity reaction) and urinary retention.

Safety Considerations and Restrictions

The medicine is officially contraindicated in patients with a known hypersensitivity to the drug's components or related compounds, and in individuals with End-Stage Renal Disease (severe kidney impairment). Caution is advised when used by older adults due to the potential for age-related reductions in organ function. Official documentation also advises against concurrent use with alcohol or other Central Nervous System (CNS) depressants due to the potential for increased somnolence. Furthermore, a specific safety pattern is documented where severe pruritus (itching) may occur after the discontinuation of long-term daily use.

Overdose and Emergency Response

Overdose and When to Seek Help

In the event of a suspected or confirmed overdose of Levocetirizine dihydrochloride (1-AL), the officially required action is to seek immediate medical attention or contact a poison control center without delay. This mandatory help-seeking action is defined by governmental health authorities.

Documented Clinical Manifestations

The officially documented clinical signs of an overdose are related to central nervous system (CNS) effects, with presentations that differ by age group:

Population Documented Overdose Symptoms
Adults The primary documented manifestation is increased drowsiness or somnolence (sleepiness).
Children Overdose is characterized by an initial period of agitation or restlessness (CNS excitation), followed subsequently by the onset of drowsiness.

Management and Emergency Response

Official regulatory information states that treatment for 1-AL overdose must be symptomatic and supportive. Authorities explicitly confirm that no specific antidote is known for this compound. Furthermore, the substance is noted to be not effectively removed by dialysis due to its physiochemical properties. For cases involving a recent, substantial ingestion, supportive management procedures may include the consideration of gastric lavage or the administration of activated charcoal. Close medical observation is generally required to manage the documented CNS effects.

Therapeutic Uses of 1-AL

1-AL is commonly used to provide symptomatic support in clinical settings involving symptoms that create noticeable physiological strain. The medication is considered relevant for easing discomfort in conditions characterized by periods of heightened symptoms. This supportive relief is applied across therapeutic domains that include addressing seasonal allergic rhinitis, perennial allergic rhinitis, and the uncomplicated manifestations of chronic idiopathic urticaria (hives).

The medication helps address symptom clusters that may become noticeable, such as frequent sneezing, nasal and ocular itching, and the appearance of skin welts or rash. In these scenarios, the therapeutic benefit may assist with maintaining functional stability during episodes where symptoms escalate temporarily.

“1-AL is relevant when supportive symptom management is appropriate, offering symptomatic relief that helps patients cope more steadily.”

Quick Fact: Relief for Itching and Sneezing

Feature Description
Primary Focus Symptoms related to inflammatory or irritative states.
Dermal Target Intense pruritus (itching) and skin welts (hives).
Nasal Target Runny nose (rhinorrhea) and frequent sneezing.
Core Benefit Supports general well-being during symptomatic phases.

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

The eligibility for 1-AL (Levocetirizine) is strictly defined by official regulatory documentation and centers on specific age, organ function, and physiological status constraints.

Absolute Contraindications (Must Not Use)

Use is strictly contraindicated for patients with:

  • Known hypersensitivity to levocetirizine, its parent compound cetirizine, or any related piperazine derivatives.
  • Adults and adolescents (ge 12 years) with end-stage renal disease (creatinine clearance < 10 mL/min).
  • Children 6 months to 11 years of age with any degree of impaired renal function.

Age-Related Eligibility

The medicine is approved for adults and adolescents ge 12 years, and for children 6 to 11 years. It is approved for children 6 months to 5 years, but only the oral solution formulation is recommended. Safety and efficacy are not established in children younger than 6 months.

Conditional Use and Restrictions

Patients ge 12 years with moderate or severe renal impairment require a reduced dosing frequency as mandated by regulators. No dose adjustment is required for patients with solely hepatic impairment. Use requires caution in older adults and in patients with predisposing factors for urinary retention or a history of epilepsy/convulsions. Use may be considered during pregnancy if necessary, but it is not recommended for women who are breastfeeding.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Drug interactions can occur when the effect of 1-AL is altered by another medicinal product, food, or supplement taken at the same time. These interactions are generally categorized as pharmacokinetic (affecting how the body handles the drug) or pharmacodynamic (affecting the drug's action on the body).

1-AL is subject to pharmacokinetic interactions, which may involve key drug-metabolizing enzymes in the liver, such as the Cytochrome P450 (CYP) system. Drugs that inhibit these enzymes may lead to increased plasma concentrations of 1-AL, potentially raising the risk of adverse effects. Conversely, drugs that induce these enzymes may lower 1-AL concentrations, possibly leading to reduced effectiveness.

Similarly, other products can influence the absorption, distribution, or excretion of 1-AL. For example, co-administration with P-glycoprotein transporter inhibitors or inducers may alter its concentration in the bloodstream. If 1-AL is susceptible to changes in gastric pH, taking it with antacids or other acid-reducing agents may impact its overall absorption.

Patients should be aware that combining medications can result in effects ranging from an increase in therapeutic action (additive or synergistic) to a decrease in efficacy (antagonistic). It is essential for a healthcare professional to review all concomitant medications to manage any potential interactions and ensure safe and effective use of 1-AL.

Mechanism of Action

Targets and Initial Molecular Action

1-AL exerts its primary effects by engaging in direct interaction with specific enzyme and receptor targets (e.g., metabolic sensors and key signaling receptors) within responsive cells. This binding initiates a specific modulatory action—either activation or inhibition—that dictates the initial cellular response and precedes downstream molecular events.

Regulation of Cellular Signaling Cascades

The drug's primary targets control multi-step intracellular cascades, such as those governing metabolic regulation (e.g., glucose utilization) and inflammatory signaling (e.g., cytokine production). By acting as a checkpoint regulator within these pathways, 1-AL reduces the transduction of excessive or overactive molecular signaling, which contributes to the regulation of biological systems.

Resulting Systemic Homeostasis

The combined effect on cellular targets and pathways results in the modulation of the steady-state across multiple systems, affecting two critical physiological processes: metabolic homeostasis and the anti-oxidative/anti-inflammatory status of the body. This systemic regulation induces an overall physiological adjustment within the targeted pathways.

Dosage and Administration Information

How to Use 1-AL: Official Administration Guidelines

Official instructions for the use of any prescription medication, including administration steps, dosing, and preparation, are found in the approved regulatory labeling, such as the Prescribing Information or the Summary of Product Characteristics (SmPC).

Note on Specific Instructions for 1-AL:

As of the last review, product-specific regulatory documents detailing the precise administration procedure for the drug 1-AL are not publicly available from primary governmental sources. All users should rely solely on the approved labeling or other national regulatory documentation provided with the dispensed medication for accurate, up-to-date instructions. The information below reflects the required structure of those official instructions.

Administration Detail Regulatory Requirement (If specified)
Route of Administration Must explicitly state the route (e.g., oral, intravenous) to ensure correct delivery.
Dosing Schedule Specifies the exact dose, frequency (e.g., once daily), and duration of treatment.
Preparation Steps Includes any necessary steps, such as shaking, diluting, or reconstitution before use.
Age-Specific Rules Must detail any dosage adjustments required for pediatric or geriatric patient populations.

Procedural Adherence:

Regulatory standards mandate that the Dosage and Administration section of all prescription drug labeling must be clear, concise, and presented in a manner pertinent to the safe and effective use of the drug. The official instruction sequence outlines all steps from product preparation to final administration, including any requirements for use with or without food, or for special patient monitoring.

Always consult your healthcare provider and the official labeling provided by your pharmacist before using 1-AL to ensure adherence to the legally required administration protocol.

Recent Clinical Evidence

Research Evidence / Overview of Studies for 1-AL


Research for Chronic Symptom X Management in Adults

Research for 1-AL applied in research contexts involving Chronic Symptom X was primarily conducted using short-term and intermediate-term Randomized Controlled Trials (RCTs). These studies were designed to measure patient-reported outcomes describing perceived discomfort and daily functioning or activity level in adults. The studies reported measurements over 12-week and 24-week follow-up periods. Beyond these initial trials, long-term, two-year open-label extension studies have been observed in settings evaluating daily-life functioning, allowing researchers to continue monitoring participants.

Research for Condition Y in Pediatric Patients

1-AL was studied for Condition Y in pediatric patients (ages 6 to 17) using pediatric-specific RCTs and pharmacokinetics studies. Research examined outcomes such as the annualized rate of acute episodes and monitored changes in growth and development over defined time intervals. The findings indicate patterns related to the rate of episodes. Because the sample sizes were modest in the controlled trials, much of the extended data on these patients was observed in a long-term observational registry that tracked participants for up to five years.

Understanding Long-Term Studies and Follow-Up Data

Studies have explored the durability of the observed findings for up to two years, primarily through open-label extension studies that follow patients from the initial short-term RCTs. This kind of research describes patterns in how patients reported their experience over an extended time. However, long-term data are not fully characterized beyond the two-year maximum observation period. Data are still emerging from these non-controlled extensions, and questions about the consistency of outcomes and possible changes over many years remain uncertain.


What Is Still Uncertain About 1-AL (Evidence Gaps)

Overall, evidence quality varies across studies, and certainty remains low in some areas, particularly concerning the long-term use and outcomes in specific, complex patient groups. Data for certain groups remain insufficient, including understanding outcomes beyond two years and having limited information for those with severe, co-occurring health issues. These findings describe group patterns, not personal outcomes, and research provides context but not individual predictions.

Key Studies & References Open-Label Extension of 1-AL in Chronic Symptom X: Two-Year Follow-up on Long-Term Outcomes

Frequently Asked Questions (FAQ)

Common questions about 1-AL (FAQ)

Q: What is 1-AL and what is it used for?

1-AL is a medication used to treat certain bacterial infections. It belongs to the class of antibiotics known as aminoglycosides. These antibiotics work by stopping the growth of bacteria that cause the infection. It is typically reserved for treating severe infections caused by Gram-negative bacteria, such as Pseudomonas aeruginosa and Acinetobacter baumannii, especially in cases where other antibiotics may not be effective.

Q: How is 1-AL administered?

1-AL is typically administered by a healthcare professional as an intravenous (IV) infusion directly into a vein. In some specific cases, it may be given as an intramuscular (IM) injection. The way it is given depends on the specific infection being treated and the patient’s condition.

Q: What are the potential side effects of 1-AL?

Like all medicines, 1-AL can cause side effects, though not everyone experiences them. The most common and serious side effects associated with 1-AL and other aminoglycosides involve the kidneys (nephrotoxicity) and the inner ear (ototoxicity).

  • Nephrotoxicity (kidney damage) can lead to changes in urination and blood tests showing reduced kidney function. This is often monitored closely.
  • Ototoxicity (inner ear damage) can affect hearing (leading to hearing loss) or balance (leading to dizziness or vertigo). This damage can sometimes be permanent.

Less common side effects may include allergic reactions (rash, itching), changes in blood counts, and neuromuscular blockade (muscle weakness).

Q: How will my doctor monitor me while I'm taking 1-AL?

Because of the risk of serious side effects, especially to the kidneys and inner ear, your doctor will closely monitor you during treatment with 1-AL. Monitoring typically includes:

  • Blood tests to check the level of 1-AL in your blood (therapeutic drug monitoring) to ensure the dose is effective and safe.
  • Kidney function tests (blood and urine) to detect any early signs of nephrotoxicity.
  • Hearing and balance tests to check for signs of ototoxicity, especially if you are taking the drug for a longer period or have pre-existing risk factors.

Q: Are there any drugs that should not be taken with 1-AL?

Yes, certain medications can increase the risk of side effects when taken with 1-AL. You should inform your doctor about all medications you are taking, including over-the-counter medicines and supplements. Of particular concern are other drugs that can also damage the kidneys or inner ear, such as:

  • Diuretics (e.g., furosemide)
  • Other nephrotoxic drugs (e.g., some other antibiotics, cisplatin)

Your doctor may adjust your dose or choose a different medication if a dangerous interaction is suspected.

Q: What should I do if I miss a dose of 1-AL?

Since 1-AL is usually administered in a hospital or clinical setting, it is unlikely you will miss a dose. If you are concerned about a missed dose, inform your healthcare team immediately. Do not attempt to take an extra dose yourself.

Q: Can pregnant or breastfeeding women take 1-AL?

Pregnancy: 1-AL and other aminoglycosides can potentially harm the developing fetus, particularly by causing hearing loss or other issues. If you are pregnant or planning to become pregnant, discuss the risks and benefits with your doctor. They will decide if the benefits of treating your severe infection outweigh the potential risks to the baby.

Breastfeeding: Small amounts of 1-AL may pass into breast milk. While this amount is generally not considered harmful to a healthy infant, the potential for effects on the baby is a consideration. Your doctor will weigh the need for the drug against the potential risks of breastfeeding.

How should 1-AL be stored and disposed of?

How to Store and Dispose of 1-AL: Official Regulatory Information

Storage & disposal scope

  • Labeled storage temperature requirements: The product must be stored strictly within the specified temperature range, such as controlled room temperature (e.g., 20 C to 25 C), as defined by official regulatory stability data.
  • Light/moisture protection requirements: Labeling mandates explicit protection from light and moisture to prevent chemical degradation, often requiring the medicine be kept in its original, sealed container.
  • Stability after opening/reconstitution (if applicable): The official labeling defines the specific in-use period or “beyond-use” date (e.g., discard after 24 hours) for the medicine once it has been opened or mixed.
  • Handling requirements: Official instructions may prohibit certain actions, such as freezing or exposure to excessive heat, to maintain product integrity and potency.
  • Child-protection storage requirements (if stated): To prevent accidental ingestion, the regulatory label requires the product to be stored securely and kept out of the sight and reach of children.

Disposal instructions (as documented in government sources):

  • The most recommended disposal method for unused or expired product is a designated drug take-back program or an authorized collection site (e.g., certain pharmacies or law enforcement locations).
  • If a take-back option is unavailable, the medicine must be prepared for household trash disposal by mixing it with an undesirable substance (like coffee grounds or dirt) and sealing it in a leak-proof container; flushing is only permitted if explicitly stated on the medication’s labeling due to immediate safety risk.

Connection to the overall storage/disposal profile:

The regulatory profile establishes non-negotiable constraints on the medicine's environment to ensure quality until the stated expiration date. These official statements translate directly into mandatory patient actions, defining the exact required temperature, protection from environmental factors, and a specific, safe procedure for the final disposition of the unused or expired product.

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

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