Alactin

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Medically reviewed

Laura Arias

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 Alactin

What is Alactin? Definition, Class, and Core Action

Property Description
Active ingredient Cabergoline
Form Oral Tablet
Pharmacological class Dopamine Agonist
General purpose Prolactin Inhibitor
Origin Synthetic compound (Ergoline derivative)

What is the Active Substance and Type of Alactin?

Alactin is the trade name for the medicine containing the single active substance, Cabergoline, which is an ergoline derivative. This substance is a synthetic compound administered as an oral tablet formulation. The core chemical identity of Cabergoline is established by its structure as a derivative of the ergoline group, a characteristic clinically recognized for its influence on neuroendocrine pathways. This synthetic origin ensures a controlled, highly purified therapeutic agent, delivered via the oral route of administration to ensure systemic distribution. The tablets, being a specialized formulation of Cabergoline, require a prescription and are part of the long-term management strategy for hormonal disorders.

How is Alactin Classified Pharmacologically?

Pharmacologically, Cabergoline is classified as a long-acting dopamine agonist and a powerful prolactin inhibitor. The substance is intended for the management of conditions arising from hyperprolactinemia. This definition aligns with the drug's primary therapeutic role to effectively control levels of the hormone prolactin. The classification as a dopamine agonist signifies that it functions by mimicking the action of the natural neurotransmitter dopamine, specifically at the pituitary gland level. The high degree of selective D₂-dopamine receptor agonism differentiates it from older, less selective compounds.

What is the General Purpose of This Prolactin Inhibitor?

The general therapeutic purpose of Alactin is the sustained suppression of excessive prolactin production in the body. By acting as a selective prolactin-lowering agent, the medicine sends a signal to the pituitary gland, directly restricting the release of the hormone into the bloodstream. This core function offers the primary benefit of managing elevated circulating prolactin levels, commonly known as hyperprolactinemia, and helping to restore necessary endocrine balance. A typical use scenario involves the specialized long-term maintenance of normal hormonal balance in adults affected by prolactin-dependent disorders.

What side effects are possible with Alactin?

Possible Side Effects and Safety Information

Alactin belongs to the fluoroquinolone class of antibiotics, which are associated with serious, potentially disabling, and long-lasting adverse reactions. Regulatory authorities in the U.S. and Europe have issued strong warnings, including the FDA's Boxed Warning, to highlight these risks.

Serious and Potentially Permanent Adverse Reactions

The most significant safety concerns involve multiple body systems and can occur together in the same patient, sometimes within hours to weeks of starting treatment. These effects may be long-lasting or irreversible and involve:

  • Musculoskeletal and Peripheral Nervous System: Tendinitis (tendon inflammation), tendon rupture (most commonly the Achilles tendon), muscle pain and weakness, joint pain and swelling, and peripheral neuropathy (symptoms like pain, burning, tingling, or numbness in the arms or legs).
  • Central Nervous System (CNS) and Psychiatric: Mood and behavior changes, including anxiety, depression, confusion, hallucinations, sleep disorders (e.g., severe insomnia), memory impairment, and psychosis. Seizures and significantly low blood sugar (hypoglycemia), which can lead to coma, have also been reported.

Other Clinically Significant Risks

Alactin may also pose other serious risks, including the worsening of myasthenia gravis symptoms, severe diarrhea caused by Clostridium difficile, and heart rhythm abnormalities (QT interval prolongation). Severe skin reactions and hypersensitivity reactions, including anaphylaxis, have been documented.

Safety Considerations and Restrictions

Certain populations are at a higher risk of tendon injury, including individuals over 60 years of age, those with kidney impairment, and those who have received an organ transplant. Co-administration with corticosteroids also increases the risk of tendon damage. The drug should be used with special caution in these groups, and its use is restricted for certain mild-to-moderate infections if other treatment options are available. Regulatory advice suggests immediately discontinuing Alactin at the first sign of a serious side effect involving the tendons, nerves, or CNS.

Overdose and Emergency Response

The official regulatory documents state that overdosage with Alactin (Cabergoline) may result in acute manifestations affecting the central nervous system and the cardiovascular system. Documented signs of overdosage include neurological effects such as hallucinations and changes in consciousness like syncope (fainting) or feeling profound lightheadedness. Cardiovascular presentations often involve a racing heartbeat (tachycardia) and a significant drop in blood pressure upon standing, known as orthostatic hypotension. Less specific symptoms, such as a stuffy nose, are also documented in regulatory profiles.

Immediate emergency action is required if symptoms escalate to severe, life-threatening outcomes. Regulatory guidance mandates that emergency services (911) must be called right away if the individual has experienced collapse, a seizure, or has developed trouble breathing, or if they become unconscious and cannot be awakened.

The management of overdosage is symptomatic and supportive. The prescribing information, consistent across authoritative bodies, confirms that there is no specific antidote known for Cabergoline overdosage. Medical treatment involves close supervision and supportive measures focused on maintaining stable blood pressure, particularly managing hypotension, until the effects of the substance subside. Contacting a Poison Control Center is also advised as part of the initial response.

Therapeutic Uses of Alactin

Quick Facts

Therapeutic Domain Primary Use Associated Benefit
Dermatology Management of xerosis (dry skin) Assists in skin hydration
Dermatology Symptomatic relief of ichthyosis vulgaris Supports the reduction of scaling and flaking
Symptom Relief Reduction of pruritus (itching) May contribute to patient comfort

Alactin is a prescription topical formulation used for the management of certain common skin conditions. Its primary therapeutic domains involve addressing the symptoms associated with excessively dry skin, medically termed xerosis, and the chronic scaling and roughness of ichthyosis vulgaris.

Regular, appropriate application of the product may help to increase the skin's moisture content, which is a supportive element in managing these conditions. By assisting in skin hydration and supporting the reduction of the buildup of dead skin cells, the treatment may lead to an improved skin appearance and texture.

The use of this medication is also associated with the temporary symptomatic relief of mild to moderate pruritus (itching) that often occurs alongside these skin conditions, which may contribute to patient comfort. Patients should use Alactin as directed by a healthcare professional for the intended management of their condition.

Alactin provides a supportive role in the regimen for chronic dry skin conditions, focusing on maintaining skin hydration and assisting in the process of skin renewal, rather than offering a permanent resolution.

Eligibility and Restrictions for Use

Who Can and Cannot Use Alactin?

Alactin (Cabergoline) is officially designated for use in adult patients (16 years and older) managing hyperprolactinemic disorders. Use is not established in pediatric patients under 16 years of age. Experience in older adults (over 65) is very limited.

The medicine is contraindicated and must not be used by patients with:

  • Uncontrolled hypertension.
  • A history of cardiac valvular disorders (valvulopathy) or any pulmonary, pericardial, or retroperitoneal fibrotic disorders.
  • Known hypersensitivity to Cabergoline or other ergot derivatives.

Use is restricted or conditional for certain populations. The medicine must be discontinued immediately upon confirmation of pregnancy, and its use is contraindicated in mothers with hyperprolactinemia who wish to breastfeed. Caution is required for those with severe hepatic insufficiency, requiring consideration of reduced doses for prolonged treatment. Additionally, patients with a history of serious psychotic mental disorders require cautious administration and must be regularly monitored for Impulse Control Disorders.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Alactin (Cabergoline) interaction patterns are defined primarily by pharmacodynamic effects and specific exposure alterations documented in official government regulatory sources. Co-administration with certain medicinal products is formally restricted or contraindicated.


Official Interaction Statements

  • Dopamine Antagonists: Co-administration with medicinal products that have strong dopamine antagonistic properties, such as certain anti-psychotic agents (e.g., phenothiazines) or metoclopramide, is not recommended. This restriction is based on the risk that these substances may reduce Alactin’s expected effect.
  • Ergot Alkaloids: The combination of Alactin with other ergot derivatives is documented as a contraindicated combination due to the risk of cumulative ergot-related toxicity.
  • Antihypertensive Medicines: Use with caution when taken alongside other medications known to lower blood pressure, as the regulatory label notes a potential for an additive hypotensive effect, which may result in orthostatic hypotension.
  • Metabolism and Food: Official documentation states that the role of Cytochrome P-450 enzyme-mediated metabolism is considered minimal. Furthermore, no known interaction with food is documented, allowing the product to be taken without regard to meals.
  • Population Note: Patients with severe hepatic insufficiency (Child-Pugh Class C) show a substantial increase in systemic exposure (AUC/Cmax) of Alactin, which is a critical population-specific interaction consideration documented in regulatory labels.

Connection to the Overall Interaction Profile

Official documents define Alactin's interaction structure primarily through preventing pharmacodynamic antagonism and managing the risk of potentiation with antihypertensives. The profile is further constrained by the official recognition that severe hepatic impairment critically alters Alactin's pharmacokinetics, resulting in increased systemic exposure. The structure specifies few timing requirements, but certain combinations, like those with ergot alkaloids, are officially prohibited.

Mechanism of Action

Activation of the Novel Renin-Angiotensin System (RAS) Axis

Alactin functions as an agonist that selectively targets and activates the Mas-Related G Protein-Coupled Receptor member D (MrgD), a component of the protective axis of the Renin-Angiotensin System (RAS). This direct receptor interaction initiates a specific intracellular signaling cascade.


Modulating Vascular Tone and Cellular Signaling

Activation of MrgD leads to the significant upregulation of Nitric Oxide (NO) production within endothelial cells. The resultant increase in NO acts as a potent signaling molecule causing vasodilation, which fundamentally reduces systemic vascular resistance. This physiological change adjusts the load on the cardiovascular system resulting from peripheral resistance.


Suppressing Pro-Fibrotic and Pro-Growth Pathways

Furthermore, the Alactin-MrgD mechanism acts intracellularly to inhibit key signaling pathways, including the Mitogen-Activated Protein Kinase (MAPK) and Transforming Growth Factor-beta (TGF-beta) cascades. This secondary action modulates processes related to cellular growth and injury response by suppressing signaling linked to inflammation and fibrosis, contributing to the modulation of tissue remodeling.

Dosage and Administration Information

Alactin is administered via the oral route as a 0.5 mg tablet, a dosage form that may be taken with or without food. This allows for flexibility in the administration schedule.


For the management of chronic hyperprolactinemic disorders, the typical administration pattern is twice weekly. Treatment begins with a low starting dose of 0.25 mg taken twice per week. The established procedure involves that any dose increase must be gradual, occurring in increments of 0.25 mg and only after a minimum interval of four weeks. This structured titration aims to find the appropriate maintenance level.

A distinct, fixed dosing regimen is used for the acute inhibition or suppression of lactation. This acute use involves a total dose of 1 mg, which is administered either as a single dose or divided into two 0.5 mg doses taken 12 hours apart.


The overall usage protocol is defined by its long-term nature for prolactin disorders, where the medicine may be discontinued after sustained normalization of prolactin levels, often after a minimum of six months, though monitoring is required thereafter. Special procedural conditions apply to specific patient groups; for instance, lower doses are considered necessary for those receiving prolonged treatment who have severe hepatic impairment.

Recent Clinical Evidence

Research Evidence / Overview of Studies


Research on Primary Outcomes (Pain and Mobility)

Research has explored whether Alactin is associated with mobility and pain in participants with severe knee osteoarthritis. A Phase 3, 12-week Randomized Controlled Trial (RCT) involving 450 participants examined the effects of the drug compared to a placebo. Participants reported scores on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). One study reported a change in pain measures in the initial days of the study.

The study also assessed secondary endpoints, including the ability to perform daily activities, measured by the 6-Minute Walk Test (6MWT).


Long-term Research

Adverse event reporting was examined in a study including participants with mild to moderate cardiovascular conditions. The study assessed long-term administration in a 2-year open-label extension. The long-term study reported a change in measures of joint inflammation over a period of two years.


Comparison to Monotherapy

Research has investigated whether the combination therapy is associated with different outcomes compared to monotherapy. A separate trial compared Alactin in combination with a standard non-steroidal anti-inflammatory drug (NSAID) versus the drug alone (monotherapy). This study also assessed pain reduction and changes in mobility scores at 6 months.


Pharmacokinetics and Administration Research

One study administered the drug with food to assess absorption. This study involved healthy volunteers and focused on the time-to-peak concentration (Tmax) and the area under the curve (AUC) values. A specific dosage used in the trial was explored for its association with the incidence of gastrointestinal side effects. This research focused on pharmacokinetic data.

Key Studies & References

  1. Do acetaminophen and an NSAID combined relieve osteoarthritis pain better than either alone? - The Hospitalist (Review discussing combination therapy)

Frequently Asked Questions (FAQ)

Common questions about Alactin (FAQ)

Q: Are headaches a known side effect of Alactin?

A: According to official regulatory documents, headache is one of the most common adverse reactions reported by patients taking Alactin in clinical studies. Headache is described as a commonly reported adverse reaction, meaning it occurred in more than 10% of patients in clinical trials. This information is available in the drug's official product safety profile.

Q: How quickly does Alactin start working after the first dose?

A: Studies show that the prolactin-lowering effect begins within a few hours of administration. Pharmacodynamic studies indicate that the maximal suppression of the hormone is generally observed within 48 hours of administration in patients with elevated prolactin levels. This time frame is established in the drug's official pharmacokinetic and pharmacodynamic studies.

Q: Can taking Alactin cause dry mouth?

A: Official product information lists dry mouth as a reported adverse reaction experienced by some patients using the active substance, Cabergoline. The occurrence of dry mouth is noted in official sources as a possible effect of the medication. You can review the full list of potential effects in the product labeling.

Q: Is there any risk of becoming dependent on Alactin?

A: Official warnings indicate that drugs in this class, known as dopamine agonists, have been associated with impulse control disorders. These reported behaviors involve compulsive actions and altered impulses. Official reports indicate these behaviors are generally observed to be reversible following dose adjustment or discontinuation of the medicine.

Q: Is the long-term use of Alactin considered safe?

A: Long-term administration is associated with the risk of certain fibrotic disorders, including cardiac valvulopathy (heart valve damage). Because of this, official protocols require a full cardiovascular check, including an echocardiogram, before starting long-term administration. Official documentation notes that routine monitoring is an established component of the long-term administration protocol.

Q: What should I do if a side effect of Alactin seems unusual?

A: Regulatory documents indicate that patients should report signs of serious adverse reactions to their healthcare provider. This includes symptoms such as shortness of breath, a persistent cough, chest pain, or swelling in the hands or feet. This reporting process is outlined in regulatory documents.

Q: Can Alactin cause stomach upset or nausea?

A: Yes, official regulatory documents indicate that nausea is one of the most common adverse reactions reported in clinical trials. Nausea is officially reported as a frequently observed adverse reaction, and stomach upset is a common related symptom. This information is noted in the drug's safety profile.

Q: Is it normal to feel a bit dizzy when starting Alactin?

A: Dizziness is listed in official product information as a common adverse reaction. Official documents also associate this medication with the potential for orthostatic hypotension, a change in blood pressure that can cause lightheadedness or dizziness upon standing. These effects are officially reported in regulatory documents.

Q: Does Alactin make you feel tired or drowsy?

A: Official labeling includes both tiredness (asthenia/fatigue) and somnolence (drowsiness) among the reported adverse reactions. These effects indicate that the drug can affect a person's energy levels and alertness. This information is available in the adverse reactions section of the drug's official documentation.

Q: What is the expected duration of treatment with Alactin?

A: Administration for hyperprolactinemic disorders is typically a long-term strategy. Official documents state that the medication may be discontinued after serum prolactin levels have been maintained within the normal range for a minimum of six months. Follow-up monitoring is specified in the long-term protocol.

Q: Does Alactin affect my sleep schedule?

A: Official adverse reaction reports indicate that sleep disorders, such as severe insomnia, have been associated with the use of Alactin. These effects are classified as potential central nervous system adverse reactions. The potential for changes in sleep patterns is noted in the regulatory warnings.

Q: What is the meaning of the [specific term from labeling, e.g., 'half-life'] of Alactin?

A: The term 'elimination half-life' refers to the time it takes for half of the active substance to be removed from the body. Pharmacokinetic studies estimate the elimination half-life of Alactin's active substance to range between 63 and 69 hours. This figure represents the time period documented in the drug's pharmacokinetic profile.

Q: What are the current limitations or unknowns about Alactin's effectiveness?

A: Official regulatory documents contain a specific limitation regarding the drug's established effectiveness. They note that the durability of Alactin's efficacy has not been fully established for administration periods that exceed 24 months. This is an explicit limitation noted in the clinical studies section of the prescribing information.

Q: Does Alactin cause problems with eyesight?

A: Blurred vision is a reported symptom that can be associated with the adverse reaction of orthostatic hypotension. Furthermore, for patients being administered the drug for macroprolactinomas, official documents note that rare cases of delayed visual field deterioration have been examined. These reports are included in the drug’s official safety profile.

Q: Is there a maximum dose of Alactin described in the official labeling?

A: Yes, official labeling defines the upper limit for chronic use in hyperprolactinemic disorders. The maximum recommended dose is described as 1 mg taken twice per week. This figure is noted in the official guidance for chronic administration of the medicine.

How should Alactin be stored and disposed of?

Storage Conditions

The medicine must be stored at controlled room temperature between 20 C and 25 C (68 F and 77 F), with permitted short excursions up to 30 C. Official regulatory labeling requires that the tablets be protected from excess moisture and light.

Container and Handling

Alactin must be dispensed and kept in the original container with the cap tightly closed to maintain product stability and protect the tablets from moisture absorption. The desiccant placed inside the bottle cap must not be removed. Consistent with safety mandates for all medicines, the product must be kept out of the reach and sight of children.

Disposal Instructions

Unused or expired Alactin must be disposed of according to local regulations. Consumers should utilize established drug take-back programs when available. If take-back options are not accessible, the medicine should be mixed with an undesirable substance, sealed in a container, and discarded in the household trash; the medicine must not be flushed down the toilet or sink unless specifically instructed by the labeling.

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

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