Litace

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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 Litace

What is Litace? Defining the 5-Alpha-Reductase Inhibitor

Property Description
Active ingredient Finasteride
Form Film-coated tablet
Pharmacological class 5-Alpha-Reductase Inhibitor (5-ARI)
General purpose Modulating hormone-driven tissue processes
Origin Synthetic 4-azasteroid compound

Core Identity: What Kind of Medicine is Litace?

Litace is a synthetic prescription medicine whose active component is the generic substance Finasteride. This compound is classified chemically as a 4-azasteroid compound. As a pharmaceutical product, Litace is supplied as a film-coated tablet intended for oral administration, positioning it as an orally active systemic agent.

The medication contains solely Finasteride, confirming its status as a monotherapy. This composition places it firmly within the 5-Alpha-Reductase Inhibitor (5-ARI) pharmacological class. This classification identifies the drug as one that specifically works to modify androgen-related processes in the body.

Pharmacological Class and General Purpose

Litace's classification as a 5-ARI describes its unique physiological action of selectively targeting and blocking the enzyme Type II 5α-reductase. This enzyme plays a crucial role in converting the hormone Testosterone into the significantly more potent androgen, dihydrotestosterone (DHT), which is a key driver of specific tissue growth.

The resulting effect dictates the drug's general therapeutic purpose: to modulate and counteract processes in tissues that are sensitive to the stimulatory effects of DHT. Finasteride acts by impeding this conversion pathway, leading to a controlled and sustained reduction of DHT production, which helps ease the physiological processes driven by this potent androgen. The overall benefit is derived from mitigating the underlying hormonal factors associated with androgen-dependent disorders.

Regulatory References

  1. U.S. National Library of Medicine (MedlinePlus)
  2. NIH

What side effects are possible with Litace?

Possible Side Effects and Safety Information

The safety profile for Litace, whose active ingredient is Finasteride, is primarily characterized by effects linked to the hormonal system, as documented in official regulatory sources. These effects are classified according to frequency observed in clinical data.


Frequency-Classified Adverse Reactions

The most frequently reported adverse reactions are related to the Reproductive System and Breast Disorders system-organ class. Reactions classified as Common in regulatory documents include decreased libido and erectile dysfunction, which were observed in a greater percentage of patients compared to placebo. Decreased volume of ejaculate is also listed as a common effect. Reactions classified as Uncommon include breast enlargement (gynecomastia), breast tenderness, and rash.

Serious Safety Signals and Constraints

Official labeling documents several safety considerations. A clinically significant finding noted in studies of the 5 mg dose is an increased incidence of high-grade prostate cancer (Gleason score 8–10). Additionally, the label notes reports of male breast cancer and psychiatric symptoms, including depression, anxiety, and suicidal ideation, documented in post-marketing experience.

Litace use causes a predictable decrease in serum Prostate Specific Antigen (PSA) levels, a safety note requiring adjustment for the interpretation of prostate cancer screening tests. The label also documents that some sexual adverse effects, such as decreased libido and erectile dysfunction, may persist after discontinuation of the medicine.


Population-Specific Safety

Pregnant or potentially pregnant females should not handle crushed or broken tablets due to the potential risk of absorption and subsequent harm to a developing male fetus. The medicine is not indicated for use in children.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for Litace (Finasteride) overdose is defined by the observations made during clinical studies and the resultant guidance on emergency action.


Documented Overdose Findings

Element Official Regulatory Statement
Acute Manifestations Clinical studies involving single doses up to 400 mg and multiple doses up to 80 mg/day for three months demonstrated no dose-related adverse effects.
Specific Treatment Official labeling states that no specific treatment or antidote is currently recommended for an overdose.

Emergency Action Required

Due to the lack of a specific antidote, management of a suspected overdose is generally understood to be symptomatic and supportive. Individuals who have taken more than the prescribed amount are officially advised to seek immediate medical attention and contact a regional poison control centre.

The regulatory profile, structured around the absence of acute toxicity at high doses, emphasizes that urgent medical help is nevertheless required immediately if the affected person exhibits critical signs of a severe event. This includes, but is not limited to, collapse, having a seizure, experiencing trouble breathing, or being unable to be awakened. The need to contact emergency services (such as 911) for these critical signs is mandated, independent of the drug’s acute toxicity profile.

Therapeutic Uses of Litace

What Litace Treats: Main Uses and Benefits

Litace is commonly used to help with conditions characterized by periods of heightened symptoms related to an enlarged prostate (Benign Prostatic Hyperplasia, or BPH). It is indicated for managing the symptoms associated with this condition, which include frequent or urgent urination and nocturia (waking up at night to urinate). This provides support that helps ease the overall burden of symptoms that interfere with daily comfort.

The medication is applied across therapeutic domains where additional symptomatic support is needed, assisting with maintaining functional stability during episodes of heightened discomfort. In this context, it is considered relevant for managing both BPH manifestations and in certain clinical contexts, male pattern hair loss (androgenetic alopecia).

The medication is applied with the intent of providing symptomatic relief and supporting general well-being. A patient-oriented benefit of this approach is captured by the idea that:

“It supports the patient during difficult episodes by easing distress.”

Quick Fact: Supportive Relief for Urinary Symptoms

This medicine assists with maintaining stability when symptoms become more noticeable and plays a role in managing symptoms that become intense or disruptive.

Eligibility and Restrictions for Use

Litace (Finasteride) is strictly designated for use by adult men and is contraindicated for all other populations according to regulatory documents from authorities like the FDA and EMA.

Populations for Whom Use is Contraindicated

Classification Population or Condition
Absolute Exclusion Women (The medicine is not indicated for female use) [2.8, 3.1]
Absolute Exclusion Pregnant or Potentially Pregnant Women (Risk of external genitalia abnormalities in a male fetus) [2.3, 2.8]
Absolute Exclusion Children and Adolescents (Safety and efficacy not established in patients under 18 years) [2.4, 2.8]
Absolute Exclusion Known Hypersensitivity to Finasteride or any excipient in the formulation [2.4, 2.7]

Conditional Eligibility and Special Considerations

  • Organ Function: No dosage adjustment is necessary for patients with varying degrees of renal impairment (kidney function) [3.2, 3.7]. However, caution should be used when administering Litace to patients with liver function abnormalities because the medicine is extensively metabolized in the liver [3.3, 3.7].
  • Geriatric Use: The elimination rate of Finasteride may be slightly slower in men over 70 years old, but official labeling states that no dosage adjustment is necessary in the elderly [3.4].
  • Handling Restriction: Pregnant women or women who may potentially be pregnant must not handle crushed or broken tablets due to the possibility of absorption through the skin and subsequent risk to a male fetus [2.4, 2.6].

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation for Litace (Finasteride) indicates that no drug interactions of clinical importance have been identified in human studies. This regulatory finding dictates the overall structure of the drug's interaction profile.


Interaction Scope

Category Official Regulatory Statement
Medicinal product categories with documented interactions: None classified as clinically significant. Compounds tested in man included antipyrine, digoxin, propranolol, theophylline, and warfarin.
Mechanistic basis of interactions: Litace does not appear to affect the cytochrome P450-linked drug-metabolizing enzyme system.
Timing-based interaction rules: None documented. The medicine may be administered with or without meals.

Interaction Classifications (High-Level)

Category Official Regulatory Statement
Interaction severity classification: No drug interactions of clinical importance have been identified.
Food, Alcohol, Herbal Product Interactions: Food intake does not affect the bioavailability of Litace.

Resulting Interaction Structure

Official regulatory statements confirm that Litace does not appear to affect the CYP450 enzyme system, which is a common source of metabolic interactions. Furthermore, there are no mandatory restrictions on co-administration timing with food or other specified medicinal products.

Population-Specific Interaction Notes:

  • A caution is advised in the administration of Litace to patients with liver function abnormalities (hepatic impairment), as the medicine is extensively metabolized in the liver. The effect of hepatic insufficiency on pharmacokinetics has not been formally studied.

Mechanism of Action

Litace's mechanism is defined by the highly specific inhibition of a key enzyme in the androgen metabolism pathway. The active component acts as a competitive inhibitor of the Type II 5alpha-reductase enzyme (5alpha-R2), which is concentrated in peripheral, hormone-sensitive tissues.

This inhibition blocks the conversion of the hormone Testosterone into the higher-affinity androgen, Dihydrotestosterone (DHT). By forming a stable enzyme-inhibitor complex, Litace achieves a sustained suppression of DHT production both locally within tissues and systemically.

The resulting reduction in DHT concentration establishes the biochemical environment for subsequent cellular change. Since DHT is the primary trophic signal for certain cells, its suppressed levels result in a lower degree of Androgen Receptor activation. This diminished signaling subsequently induces involution (atrophy) of the affected tissue, which represents the drug's fundamental structural consequence.

Dosage and Administration Information

Official Administration Guidelines and Dosage Regimens

Litace is a film-coated tablet approved for oral administration only. Official usage instructions are strictly defined by two distinct dosage strengths, each corresponding to a standard adult regimen. The medication must be taken once daily, and its intake is stated to be independent of meals.

Clinical Use Context Official Daily Dose Administration Note
Prostate Use (BPH) 5 mg once daily This strength may be used as monotherapy or in combination with an alpha-blocker.
Hair Loss Use 1 mg once daily Continued daily use is necessary to sustain the administered effect.

Procedural Instructions and Use Patterns

For proper administration, the tablet should be swallowed whole; it must not be crushed, broken, or chewed. If a dose is missed, patients are instructed to skip the missed dose and resume the regular once-daily schedule with the next planned dose, avoiding the intake of extra tablets.

Treatment with Litace is defined as a long-term commitment. For certain uses, initial effects may not be observed until three months or more of continuous use has elapsed. Dosage adjustment is not required for adult patients with renal impairment. The medicine is not indicated for use in pediatric patients.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Litace

Evidence for Use in Benign Prostatic Hyperplasia (BPH)

Research examining the use of Litace was studied for managing symptoms associated with an enlarged prostate, a condition characterized by fluctuating urinary symptoms. This research primarily involves Randomized Controlled Trials (RCTs), followed by long-term observation, which were used in research exploring how symptoms evolve in the observed populations compared to a placebo or other therapies. Researchers focused on adult men diagnosed with moderate to severe BPH symptoms, particularly those with an objectively enlarged prostate volume (typically 30 mL or more).

In these studies, research examined patterns related to both urinary symptom scores and the measured functional measures, such as the maximum urinary flow rate (Qmax). Trials monitored and documented the incidence of acute urinary retention and the rate of surgical procedures related to BPH across the groups studied. Studies documented patterns of change in measured prostate volume across the follow-up periods.

Evidence for Use in Male Pattern Hair Loss (Androgenetic Alopecia)

For male pattern hair loss, the evidence base relies mainly on short- to intermediate-term, placebo-controlled Randomized Controlled Trials (RCTs). This research was studied for its application in conditions involving periods of heightened symptoms related to hair thinning. Studies explored outcomes related to physical discomfort regarding appearance, focusing on younger adult men (typically under 41) experiencing hair loss primarily on the vertex (top) or mid-scalp areas.

Research evaluated changes measured during the study period by assessing the difference in terminal hair count within a target scalp area. Photographic assessments documented how hair appearance evolved for study participants over the defined time intervals. Studies report that the measured outcomes were observed only during the period of administration.

What the Clinical Research Still Needs to Explore

While follow-up data exists, the most rigorous placebo-controlled research for BPH largely stops after about four years, and for hair loss, after two years, meaning research results were not sustained under controlled conditions for longer durations. Data for certain groups remain insufficient, particularly for men with smaller prostate volumes in the BPH context, and for men over 41 or those with isolated frontal hair recession in the hair loss context. This highlights that certain outcomes related to physiological strain over very long time horizons were not the focus of controlled research.

Frequently Asked Questions (FAQ)

Common questions about Litace (FAQ)


Q: How quickly should I expect Litace to start working?

Studies and official information indicate that the medicine's effects may take time to become noticeable. For prostate use, it may take up to six months to see the full therapeutic effect. If it is being used for hair loss, effects may not be observed for at least three months, and the benefit continues only with continued daily use.


Q: What is the difference between Litace and other medications in the same class?

Litace's active ingredient, Finasteride, works by specifically inhibiting the Type II 5α-reductase enzyme, which converts testosterone to the more potent androgen, DHT. The official product label does not contain information directly comparing the effectiveness or safety profile of Litace to other medications in the same class (5-Alpha-Reductase Inhibitors).


Q: Why do some people experience a dry cough on Litace?

A dry cough is not typically listed as a common or uncommon side effect in the official product information. However, clinical trials have reported less common respiratory effects such as rhinitis (inflammation in the nose) and dyspnea (shortness of breath). If you experience any new or persistent respiratory symptoms, it is appropriate to consult with your healthcare provider.


Q: What are some natural supplements that should be avoided with Litace?

The official label states that no drug interactions of clinical importance have been identified with many tested compounds. However, co-administration of Litace with other 5-alpha-reductase inhibitors is generally advised against due to the risk of additive effects. Consultation with a healthcare professional regarding all supplements, including herbal products, is recommended.


Q: Will Litace affect my ability to drive or operate machinery?

Some patients have reported experiencing dizziness as a common side effect when taking Litace. If dizziness occurs, this could affect your ability to drive or use heavy machinery. It is important to understand how Litace affects you before driving or operating machinery.


Q: What does the clinical research say about the effectiveness of Litace?

Clinical studies have shown that for prostate use, Litace helps improve urinary symptoms and can reduce the risk of acute urinary retention. For hair loss, research documented an increase in scalp hair count when compared to a placebo over the course of the study period.


Q: Does taking Litace affect cholesterol levels?

The official product labeling, which details adverse reactions from clinical trials and post-marketing experience, does not mention any known effects on cholesterol or lipid levels.


Q: Can Litace affect kidney function over time?

Studies in patients with long-term kidney impairment found that the way the body handles Litace is similar to that of healthy individuals. Official regulatory documents indicate that no dosage adjustment is necessary for patients with renal impairment.


Q: Are there any long-term side effects associated with Litace?

Long-term data from the PCPT trial showed an increased risk of a high-grade prostate cancer (Gleason score 8-10) in men taking the 5 mg dose. Additionally, regulatory reports note that some sexual adverse effects and psychiatric symptoms, such as depression, may persist after discontinuation of the medicine.


Q: Does Litace increase sensitivity to the sun?

Official labeling does not specifically list photosensitivity (sun sensitivity) as a side effect. Reported skin-related adverse reactions in the post-marketing period have included rash, itching, and hives (urticaria).


Q: What is Litace typically prescribed for besides its primary use?

Litace is approved only for the treatment of symptomatic benign prostatic hyperplasia (BPH) and male pattern hair loss (androgenetic alopecia). Official regulatory documents do not list any other approved uses.


Q: Is it common to feel dizzy when first starting Litace?

Official regulatory documents list dizziness as a common adverse reaction, meaning it was observed in a small percentage of patients in clinical trials. This indicates that dizziness is an adverse reaction observed in clinical trials, which may occur particularly when treatment is initiated.


Q: Can Litace interact with herbal teas or supplements?

The official label states that food intake does not affect bioavailability and that no drug interactions of clinical importance have been identified with many of the compounds tested. Specific information on all herbal teas or supplements is not provided, so it is recommended to inform your healthcare provider about all herbal teas and supplements being taken.


Q: How long does Litace stay in your system after stopping it?

The medicine is quickly eliminated from the body. The mean elimination half-life (the time it takes for half the drug to be removed) is approximately 6 hours in younger men. The drug's metabolites are ultimately excreted in both the urine and the feces.


Q: Is Litace appropriate for older adults?

Official regulatory documents indicate that the use of Litace in men over the age of 70 is similar to that in younger men. While the elimination rate may be slightly slower in the elderly, no dosage adjustment is necessary based on age alone.


Q: Is Litace appropriate for people with liver function abnormalities?

Litace is extensively processed by the liver. Official product information advises that caution should be exercised when administering the medicine to patients with liver function abnormalities, as the effect of liver impairment has not been fully studied.


Q: Are there specific symptoms that mean I should contact my doctor about Litace?

Official safety documents advise promptly reporting any changes in the breasts, such as lumps, pain, or nipple discharge, as these may be signs of male breast cancer. Additionally, symptoms potentially indicating an allergic reaction, such as swelling of the lips, face, or throat, warrant immediate medical consultation.


Q: What is the expected duration of treatment with Litace for [condition]?

Treatment with Litace is generally defined as a long-term commitment. For example, it may take six months or more before BPH symptoms are observed to improve. The specific duration of treatment for your condition is determined by your healthcare provider.


Q: Is there a generic version of Litace available?

Yes, Litace is the brand name for the active ingredient Finasteride. This compound is commonly available as a generic medication, which is chemically the same as the brand name drug.


Q: Does Litace affect blood sugar levels?

The official product labeling, which details adverse reactions reported in clinical trials, does not mention any known effects on blood sugar or glucose levels.


Q: What is the half-life of Litace?

The mean elimination half-life of Litace (Finasteride) in the blood plasma is approximately 6 hours in younger adult men. This measures how quickly the drug is cleared from the body.


Q: How is Litace eliminated from the body?

After an oral dose, the body processes Litace into metabolites, which are eliminated primarily through two routes. Official data shows that approximately 39% is excreted in the urine and 57% is excreted in the feces.


Q: Are there specific lab tests required while on Litace?

Litace causes a significant and predictable decrease in serum Prostate Specific Antigen (PSA) levels. Due to this, official regulatory documents indicate that an adjustment is required for the interpretation of prostate cancer screening results, and a new PSA baseline should be established after six months of therapy.


Q: How does Litace affect the heart rate?

Litace is not primarily a heart medication, but common adverse reactions reported in clinical trials have included postural hypotension (low blood pressure when changing position) and hypotension (low blood pressure). The drug is not labeled as having a direct effect on heart rate.


Q: Has Litace been recently approved for a new use?

The FDA-approved indications for Litace (Finasteride) remain the treatment of Benign Prostatic Hyperplasia (BPH) and Male Pattern Hair Loss (Androgenetic Alopecia). Official regulatory documents have not reported any recent new approvals for different conditions.

How should Litace be stored and disposed of?

How to Store and Dispose of Litace

Litace (finasteride) tablets must be stored at Controlled Room Temperature, officially defined as 20 C to 25 C (68 F to 77 F), with permitted excursions up to 30 C (86 F). The medication must be kept dry and protected from excessive heat and moisture. To ensure this, store the product in its original container and keep the container tightly closed.

Handling and Safety

The tablets must be kept out of the reach of children. A critical handling requirement is that women who are or may potentially be pregnant must not handle crushed or broken tablets, due to the risk associated with skin absorption of the active ingredient. Unused or expired Litace must be discarded in accordance with local regulatory requirements for medicinal waste.

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

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