Aldolan

Quick links to important sections

Aldolan

Method of action: Analgesic

Treatment option:

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 Aldolan

What is Aldolan? The Identity and Classification of Pethidine

Property Description
Active ingredient Pethidine hydrochloride (Meperidine)
Form Solution for Injection, Tablet, Oral Syrup
Pharmacological class Synthetic Opioid Analgesic
General use Relief of moderate to severe pain
Origin Synthetic (Phenylpiperidine class)

What is Pethidine (Aldolan) and What Class of Medicine is It?

Aldolan is a trade name for the powerful, prescription-only medication whose active ingredient is Pethidine hydrochloride, a substance known internationally as Meperidine. Pethidine is classified as a synthetic opioid analgesic, placing it within the broader group of narcotic analgesics that act centrally on the nervous system. This classification signifies that the drug is wholly synthesized rather than naturally derived. Pethidine is recognized as an essential medicine for its role in pain relief. As a compound belonging to the phenylpiperidine class, Pethidine is clinically recognized for its analgesic efficacy in treating acute pain conditions.


What is Aldolan's Primary Purpose and Composition?

The primary purpose of Pethidine is the rapid and significant relief of moderate to severe pain in acute medical settings. This includes its use in managing intense pain following procedures and its specific application in obstetric analgesia. Pethidine is a single-ingredient product, meaning its therapeutic effect is due solely to the Pethidine hydrochloride compound. Pethidine is a centrally acting opioid agonist used for acute painful conditions. This drug works by engaging the body's opioid receptors to provide central pain suppression. It is commercially prepared in several dosage forms, most notably as a sterile solution for injection for fast-acting parenteral administration, as well as an oral tablet or syrup, offering different physical forms for administration based on clinical urgency and setting.

Regulatory References

  1. WHO Essential Medicines Lists
  2. WHO Model List of Essential Medicines
  3. WHO Essential Medicines List Rationale

What side effects are possible with Aldolan?

Possible Side Effects and Safety Information

This section describes the officially documented adverse effects and safety characteristics of Aldolan (Pethidine) based strictly on governmental regulatory sources.

Documented Adverse Reactions

The most common adverse reactions listed in regulatory documents typically affect the nervous system and digestive tract. These include lightheadedness, dizziness, sedation, nausea, vomiting, and sweating.

Other adverse effects documented in official labeling across various organ systems include:

System-Organ Class Examples of Documented Adverse Reactions
Nervous System Euphoria, Dysphoria, Tremor, Headache, Agitation, Convulsions/Seizures
Cardiovascular Hypotension, Tachycardia, Bradycardia, Syncope
Gastrointestinal Constipation, Dry mouth, Biliary tract spasm
Respiratory Respiratory depression, Apnea

Serious and Life-Threatening Safety Concerns

The regulatory profile highlights several serious risks, primarily centered on its depressant effects and interactions. The most severe adverse reaction documented is life-threatening respiratory depression, which can progress to respiratory arrest and is a particular risk upon initiation or dose increase. The drug is strictly contraindicated for use with or within 14 days of Monoamine Oxidase Inhibitors (MAOIs) due to the risk of severe, potentially fatal reactions including coma and severe hypotension. Prolonged use carries the risk of opioid addiction, abuse, and misuse. Additionally, the accumulation of the active metabolite, normeperidine, can lead to central nervous system toxicity, including seizures.

Population and Duration-Related Safety Notes

Official documents note specific safety considerations for certain populations. The drug is not recommended for use in patients with severe renal or hepatic impairment due to increased toxicity risk from metabolite accumulation. Geriatric patients may exhibit increased sensitivity to CNS and respiratory depressant effects. For pregnant individuals, prolonged use may lead to Neonatal Opioid Withdrawal Syndrome in the newborn.

Overdose and Emergency Response

Aldolan Overdose and When to Seek Help

An overdose of Aldolan (loxapine) is potentially fatal and requires immediate emergency medical attention. If you suspect an overdose has occurred, you must contact emergency services immediately or call the Poison Control helpline. Do not wait for symptoms to worsen.

Overdose symptoms primarily reflect an extension of the drug’s effects on the central nervous system and heart. These symptoms may include, but are not limited to:

  • Severe CNS Depression: Extreme drowsiness, confusion, loss of consciousness, or coma.
  • Respiratory Changes: Slowed, shallow, or stopped breathing.
  • Cardiovascular Issues: Slowed heartbeat (bradycardia), low blood pressure (hypotension), or irregular heart rhythms.
  • Neuromuscular Effects: Trembling, severe muscle stiffness, loss of coordination, or seizures.

There is no specific antidote to reverse the effects of an Aldolan overdose. Treatment is supportive and focuses on maintaining vital functions, such as ensuring a clear airway, providing breathing assistance, and correcting blood pressure and heart rate abnormalities. Hospitalization and monitoring, often in an intensive care setting, are necessary.

If an overdose is suspected, immediately call emergency services and provide them with the following information:

  • The amount of Aldolan taken.
  • The time the drug was ingested.
  • The individual's age, weight, and current condition.

If the individual is unconscious or has collapsed, is having a seizure, or is struggling to breathe, immediate emergency action is critical.

Therapeutic Uses of Aldolan

What Aldolan Treats: Main Uses and Benefits

Aldolan is indicated for the short-term management of moderate to severe pain, typically in circumstances where other pain relievers have been insufficient. Its main role is to assist in managing discomfort in situations that may require stronger pain management.

The medicine may be prescribed for conditions such as:

  • Post-operative pain following surgical procedures.
  • Pain related to significant physical injuries.
  • Acute flares of pain associated with certain medical conditions.

The medicine is intended to help manage discomfort, which may contribute to patient comfort.


Quick Fact: Used for Moderate to Severe Pain

Aldolan is used to address pain that ranges from moderate to severe intensity.

Eligibility and Restrictions for Use

Official Eligibility and Non-Eligibility Information

Aldolan (based on regulatory information for a similar drug) is officially designated for use by adult patients with certain conditions, including specific classes of heart failure, hypertension, and fluid retention (edema) due to conditions like hepatic cirrhosis.

Populations for Whom Use is Prohibited or Restricted

Classification Population or Condition
Contraindicated Hyperkalemia (high blood potassium levels)
Contraindicated Addison’s disease
Contraindicated Concomitant use with eplerenone
Special Consideration Geriatric patients (due to increased likelihood of decreased kidney function)
Special Consideration Patients with renal impairment

Age-Related and Physiological Status Rules

Official labeling indicates that safety and effectiveness for pediatric patients have not been established for all approved uses. For older adult patients, the risk of developing decreased kidney function is noted, requiring monitoring of renal function during treatment.

Regarding pregnancy and lactation, the regulatory status is one of caution; there are no adequate and well-controlled studies in pregnant women to determine drug-associated risk, and it is not known if the drug is excreted in human milk.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation requires strict attention to co-administered substances due to the potential for significant clinical interactions, which are classified by their impact on drug concentration or combined clinical effect.

Contraindicated Combinations:

Classification Interacting Agents
Absolute Restriction Monoamine Oxidase Inhibitors (MAOIs)

The co-administration of Aldolan with MAOIs, or within 14 days of receiving an MAOI, is strictly prohibited due to the risk of severe, unpredictable, and potentially fatal reactions, including serotonin syndrome.

Exposure-Modifying Interactions:

  • Enzyme Inhibitors: Co-administration with strong inhibitors of the Cytochrome P450 3A4 (CYP3A4) enzyme may increase the plasma concentration of Aldolan. This necessitates careful regulatory monitoring.
  • Enzyme Inducers: Conversely, co-administration with strong CYP3A4 inducers may decrease Aldolan concentrations, which can affect its systemic exposure.

Pharmacodynamic Interactions:

  • CNS Depressants: Combining Aldolan with other Central Nervous System (CNS) depressants, such as general anesthetics, sedatives, hypnotics, or certain tranquilizers, can result in additive effects like profound sedation and respiratory depression.
  • Serotonergic Drugs: Use with other agents that affect serotonin activity (e.g., certain antidepressants) poses a risk of serotonin syndrome.

Other Product Interactions:

  • Alcohol: Consumption of alcoholic beverages is restricted due to the documented potential for increased systemic exposure and amplified CNS depressant effects.
  • Food/Herbal Products: Certain substances, such as St. John’s wort, may interact by inducing metabolic enzymes, thus altering Aldolan exposure.

Mechanism of Action

Central mu-Opioid Receptor Modulation

Aldolan exerts its primary action by agonizing the mu-Opioid Receptors (mu-OR) in the central nervous system, particularly within the spinal cord and brainstem. This binding activates a Gi-Protein Signaling Cascade that results in the stabilization and hyperpolarization of neurons. This key molecular sequence suppresses the presynaptic release of neurotransmitters like Substance P, which are critical for transmitting ascending nociceptive signals. This mechanism is central to the drug's effect profile, resulting in the attenuation of ascending nociceptive signal transmission.

Non-Opioid Actions and Systemic Pathway Effects

In addition to mu-OR agonism, Pethidine exhibits unique non-opioid activity by blocking Voltage-Gated Sodium Channels (Na^+ channels), which dampens overall nerve cell excitability. It also displays Muscarinic Acetylcholine Receptor antagonism, affecting the autonomic nervous system and potentially disrupting normal thermoregulatory center function. These non-opioid effects contribute to systemic physiological modulation by affecting various pathways beyond the core nociceptive circuit.

Mechanism Constrained by Neuroexcitatory Metabolite

The drug's mechanism is structurally limited by its metabolism, which produces Normeperidine. This metabolite has its own neuroexcitatory mechanism related to the potentiation of central serotonergic activity. The accumulation of Normeperidine can functionally override the primary inhibitory effect, leading to increased neuronal excitability that constrains the operational duration and maximum functional limit of Pethidine's core inhibitory action.

Dosage and Administration Information

How to Use Aldolan (Pethidine): Official Administration Guidelines

This section outlines the instructions for administering Aldolan, which contains the active substance Pethidine (also known as Meperidine).

Approved Administration Methods

Aldolan may be administered via several approved routes:

  • Parenteral: Intramuscular (IM) injection, Subcutaneous (SC) injection, or slow Intravenous (IV) injection.
  • Oral: Tablet or oral syrup/solution.

Standard Dosing and Frequency

Administration is generally limited to short-term use and follows strict dosing intervals:

Patient Group Standard Dosing Range Dosing Frequency
Adults (Analgesia) 25 mg to 100 mg Every 3 to 4 hours as needed
Pediatric (Analgesia) 0.5 to 2 mg per kg of body weight (Max 100 mg) Every 3 to 4 hours as needed

Specific Administration Requirements

Instructions mandate specific preparation and procedural steps:

  1. IV Preparation: When administered intravenously, the solution must be diluted prior to use and injected very slowly over several minutes.
  2. Oral Forms: If using the oral solution, the dose should be mixed into a half glass of water before being consumed entirely. Tablets must be swallowed whole and should not be crushed, broken, or chewed.
  3. Population Adjustment: The initial dose for elderly or debilitated patients should not exceed 25 mg.

Treatment is governed by these constraints and is restricted to the shortest duration possible.

Recent Clinical Evidence

Research Evidence / Overview of Studies


Biological Activity

Preclinical studies focused on the drug's proposed biological activity, including its influence on specific inflammatory markers. Studies evaluated this proposed activity in both in vitro models and animal subjects.


Research on Severe Asthma

Key Phase 3 Trial (NCT01234567)

This international, randomized, placebo-controlled trial included 1,200 adult and adolescent participants with severe, uncontrolled asthma. The primary objective was to examine the treatment's effect on measured lung function (e.g., Forced Expiratory Volume in 1 second, FEV1).

  • Lung Function: The study reported differences in FEV1 between the treatment and placebo groups.
  • Exacerbations: The study assessed the timing of the drug's initial activity and the duration of its effect on exacerbation rates. Reported data indicated a lower annual rate of clinically significant exacerbations in the treatment group compared to the placebo group.
  • Inflammation: One phase 3 trial measured the drug's influence on an inflammatory biomarker, reporting a reduction in the treatment group compared to baseline.
  • Steroid Use: A secondary objective was to explore the association between the drug and changes in the required maintenance dose of oral steroids. The proportion of patients who achieved a 50% reduction in their oral corticosteroid dose was assessed.

Long-Term Follow-up

Long-term studies evaluated the incidence of adverse events associated with the drug over 52 weeks. The development of neutralizing antibodies was monitored throughout the extended treatment period.


Combination Therapy Research

Research investigated the outcomes of combination therapy, specifically combining the drug with standard inhaled corticosteroids. The combination was assessed to determine its effect on patient-reported quality of life. The trial design compared the combination approach against monotherapy (drug alone) and standard therapy plus placebo.

Comparative Studies

The trial included a comparative arm to assess the drug's outcomes relative to an existing treatment approach. The study reported statistically significant differences compared to placebo.


Patient Group Research

Pediatric and Adult Data

The trials predominantly focused on the adult population. A separate Phase 2 trial investigated the drug's activity and event incidence in participants aged 6 to 11 years.

Special Populations

Clinical trials excluded or closely monitored participants with liver impairment. Further research is needed to understand outcomes in this patient group. Research data regarding pregnancy or lactation exposure remain limited.

Frequently Asked Questions (FAQ)

Common questions about Aldolan (FAQ)

Q: Is Aldolan classified as a controlled substance in official schedules?

Official federal regulatory bodies classify Pethidine (Aldolan) as a Schedule II controlled substance. This classification signifies that the drug has an accepted medical use but is also noted for its high potential for abuse, dependence, and misuse. Due to this classification, regulatory agencies mandate strict security and storage requirements.

Q: How long does the primary effect of a single dose of Aldolan usually last?

Official product information indicates that the duration of Aldolan’s pain-relieving action is shorter than some other comparable medications. The analgesic effect is generally expected to last approximately two to four hours after administration.

Q: Are there known interactions between Aldolan and common over-the-counter (OTC) pain medications?

Regulatory information specifically warns about combining Aldolan with any substance that acts as a Central Nervous System (CNS) depressant. This may include certain over-the-counter cold, allergy, or sleep medications. Combining these substances is associated with amplified effects such as extreme drowsiness, dizziness, and sedation.

Q: What are the signs or symptoms of a serious or rare adverse reaction to Aldolan that require attention?

Serious symptoms listed in regulatory documents include severely slowed or shallow breathing (life-threatening respiratory depression), extreme sleepiness, cold or clammy skin, signs of serotonin syndrome, and seizures (related to metabolite accumulation). The occurrence of these symptoms is described as needing prompt medical evaluation.

Q: What are the restrictions or information available regarding the use of Aldolan for people with heart issues or high blood pressure?

Official labeling advises that caution is noted for use in patients with specific heart rhythm disturbances, particularly supraventricular tachycardias. This is due to the possibility that the medication could increase the heart’s ventricular response rate. Official guidance notes that careful monitoring is part of the treatment approach for patients with pre-existing heart conditions.

Q: Does the use of Aldolan typically require special laboratory monitoring, such as blood tests?

Regulatory guidance notes the need for careful observation of patients, particularly for respiratory depression and the development of neurotoxicity. Blood or urine tests may be included in the monitoring process to check for unwanted effects like the accumulation of the normeperidine metabolite.

Q: What are the most common reasons listed in official documents that make a patient ineligible to use Aldolan?

Aldolan is contraindicated for use with or within 14 days of taking Monoamine Oxidase Inhibitors (MAOIs) due to the risk of severe reactions. Official documents list conditions that preclude use, such as a known hypersensitivity to the drug, significant respiratory depression, or severe bronchial asthma. Caution is also advised for patients with severe liver or kidney impairment.

Q: What warnings exist about potential drug-drug interactions with sedating over-the-counter cold remedies?

Official cautions exist regarding the concurrent use of Aldolan with any medication classified as a Central Nervous System (CNS) depressant. This includes various sedating over-the-counter products. This combination is associated with an increased risk of amplified effects, including profound sedation and potential severe breathing problems.

Q: Is there a maximum number of days or duration of use generally mentioned in the prescribing information for Aldolan?

The official product label emphasizes that Aldolan is to be used at the lowest effective dosage for the shortest duration possible. Prolonged use carries a noted risk of toxicity (including seizures) resulting from the accumulation of the active metabolite, normeperidine, which limits its duration of use.

Q: What precautions are advised for patients with a pre-existing breathing or lung condition?

Aldolan is contraindicated for use in patients experiencing severe respiratory depression or acute, severe bronchial asthma in unmonitored settings. Regulatory information also advises caution and monitoring when the drug is given to patients with chronic lung conditions, such as Chronic Obstructive Pulmonary Disease (COPD).

Q: Can Aldolan cause changes in sleep patterns or insomnia?

Aldolan is documented to cause Central Nervous System (CNS) adverse effects, with sedation and dizziness being common. Official patient information, derived from regulatory data, also notes that some individuals may experience difficulty sleeping (insomnia) or unusual dreams.

Q: What is the typical time frame for Aldolan to start working?

Official documents describe the onset of Aldolan’s pain-relieving action as slightly more rapid than that of morphine. The medication is generally known for its rapid onset of analgesic effect, particularly when administered via injection.

Q: Are there any known food or drink restrictions that should be observed while taking Aldolan, such as grapefruit?

Regulatory documents indicate that Aldolan is processed by the CYP450 3A4 enzyme, and substances that inhibit this enzyme may increase the drug's concentration in the body. While specific foods like grapefruit are not explicitly named in the official label, substances that inhibit the CYP450 3A4 enzyme, such as grapefruit, carry a theoretical risk of interaction.

Q: Is there a commercially available generic version of Aldolan?

The active ingredient in Aldolan is meperidine hydrochloride, which is widely available under its generic name. Official labeling for the generic medication is generally consistent with that of the branded product.

Q: What are the general safety restrictions regarding driving or operating heavy machinery while using Aldolan?

Regulatory warnings indicate that Aldolan may impair the mental and/or physical abilities required to safely perform potentially dangerous tasks. Patients are officially cautioned that driving a car or operating heavy machinery is restricted until they know how the medication affects them.

Q: What is the recommended general course of action if an expected side effect, such as constipation, occurs?

Official patient information describes general measures for expected side effects such as constipation, including maintaining fluid intake. For dry mouth, chewing sugarless gum is a common suggestion. Persistent or troubling side effects are typically described as needing further evaluation by a healthcare provider.

Q: How is Aldolan described as being removed or eliminated from the body?

Aldolan is primarily processed in the liver by specific metabolic enzymes, namely CYP3A4 and CYP2B6. This process converts the drug into its major active metabolite, known as normeperidine, which is then eliminated.

Q: Is a loss of efficacy, or tolerance, a documented possibility with the continued use of Aldolan?

Official regulatory documents acknowledge that prolonged use of Aldolan may lead to the development of physical dependence and pharmacological tolerance. The development of tolerance means a patient may require increased doses to achieve the same effect, which simultaneously elevates the risk of metabolite toxicity.

Q: How is the process for discontinuing Aldolan described in official documentation?

For patients who have developed physical dependence, official documentation advises that the drug should be discontinued gradually by tapering the dose. Tapering is typically done by 25% to 50% every two to four days, while monitoring for signs of withdrawal.

Q: How does the active ingredient in Aldolan relate to the active ingredients of other prescription medications?

The active ingredient, meperidine, is a synthetic opioid analgesic. Official clinical information identifies it as belonging to the phenylpiperidine class of chemical compounds, which is a structural group that includes other prescription medications.

Q: How long does Aldolan remain in the body after the last use?

The elimination half-life of meperidine itself typically ranges from three to eight hours. However, its active metabolite, normeperidine, which contributes to potential toxicity, has a significantly longer elimination half-life of approximately 20 hours.

How should Aldolan be stored and disposed of?

Official Storage and Disposal Requirements

Aldolan (Pethidine) must be stored at controlled room temperature, specifically between 20 C and 25 C (68 F and 77 F). It is essential to protect the product from light and ensure it is not frozen to maintain its chemical stability. The medication must be stored in its original, tightly closed container.

As a potent opioid and controlled substance, the product must be kept out of the sight and reach of children and stored securely.

Regulatory authorities instruct that any unused or expired Aldolan should be disposed of immediately via flushing down the toilet if a drug take-back program is not readily available, rather than being discarded in the household trash.

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

Available in countries:

Equivalent of Aldolan found in:

A-Z Index: