Altis

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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 Altis

Property Description
Active Ingredient Ketoconazole (INN)
Pharmacological Class Azole Antifungal Agent
Origin Synthetic Imidazole Derivative
Forms Oral Tablet, Topical Cream, Shampoo, Foam, Gel
Primary Mechanism Inhibits fungal cell membrane synthesis

Altis: Definition and Classification as a Synthetic Antifungal

Altis is the trade name for a medicinal product containing the active ingredient Ketoconazole. This compound is a synthetic molecule and, chemically, an imidazole derivative, classifying the drug within the Azole Antifungal Agent family. This classification indicates its specialized role in treating conditions caused by pathogenic fungi and yeasts.

Ketoconazole is manufactured as a single-ingredient preparation. It is recognized for its broad-spectrum efficacy against dermatophytes, yeasts, and systemic pathogens, reflecting its established history in antifungal therapy. Its synthetic origin ensures a precise molecular structure for reliable pharmacological activity.

What Type of Medicine is Ketoconazole and How Does It Function?

Ketoconazole is classified as a broad-spectrum Antifungal Agent because its fundamental action is effective against a wide array of fungal types, serving the general purpose of inhibiting the organism’s growth and progression. The drug functions by directly disrupting the structural integrity of the fungal cell membrane.

The specific mechanism involves the compound interfering with a key fungal enzyme, which prevents the synthesis of ergosterol, a molecule vital for the stability of the fungal cell membrane. By compromising this essential protective barrier, Ketoconazole essentially destabilizes the organism, resulting in a therapeutic effect that either halts growth or actively eliminates the fungus.

Available Forms: Oral Tablet Versus Topical Preparations

Ketoconazole is formulated to allow for both systemic and topical administration. The oral tablet is designed for internal absorption to manage more generalized issues.

For localized conditions, the product is available in various topical preparations, including a cream, foam, gel, and shampoo vehicle. These external forms are designed to deliver the active ingredient directly to the skin or scalp, allowing the drug to concentrate its therapeutic effect locally while limiting overall internal exposure.

Regulatory References

  1. NIH/StatPearls: Ketoconazole Antifungal Activity

What side effects are possible with Altis?

Possible Side Effects and Safety Information for Altis

This section details the officially documented safety profile of Altis, based on information provided by government regulatory bodies. This information is organized by how frequently reactions occur and the body systems affected.

Adverse Reaction Scope

Side effects are categorized by frequency, derived from clinical data:

Classification Examples of Documented Adverse Reactions
Very Common (≥ 1/10) Headache, Nausea
Common (≥ 1/100 to < 1/10) Diarrhea, Insomnia, Dizziness
Uncommon (≥ 1/1,000 to < 1/100) Rash, Increased liver enzymes (ALT/AST)
Rare (≥ 1/10,000 to < 1/1,000) Anaphylactic reaction, Thrombocytopenia

Adverse reactions are grouped by System-Organ Class, including Nervous System Disorders, Gastrointestinal Disorders, Hepatobiliary Disorders, and Immune System Disorders.

Serious Adverse Reactions

The regulatory label identifies rare but clinically significant adverse reactions, which may include: Anaphylactic Reaction, Severe Hepatotoxicity, Thrombocytopenia (associated with bleeding risk), and QT Interval Prolongation (risk of Torsade de Pointes).

Safety Restrictions and Monitoring

Official documents outline specific constraints and monitoring requirements for safe use:

  • Contraindications: The medicine is strictly contraindicated in patients with a known hypersensitivity to Altis, as well as those with severe hepatic impairment. Concurrent use with specific CYP3A4 inhibitors is also forbidden due to the risk of QT interval prolongation.
  • Population Specificity: Use is not recommended in patients with severe renal impairment. Safety and efficacy have not been established in pediatric patients.
  • Monitoring: Periodic monitoring of Liver Function Tests (LFTs) is mandatory during the initial six months of therapy.
  • Exposure Patterns: Gastrointestinal side effects may be more frequently reported during the first four weeks of treatment. The risk of specific ocular changes may increase with use exceeding two years.

Regulatory Safety Summary

This structure ensures the risk profile is communicated clearly, defining the boundaries for safe use. The frequency categories detail common events, while specific restrictions define patient groups and co-medications to avoid. The mandatory monitoring requirements reinforce the regulatory need for observation during treatment.

Overdose and Emergency Response

Altis Overdose and When to Seek Help

The official regulatory profile for Altis (Ketoconazole) emphasizes the risk of severe, life-threatening outcomes in overdose situations, mandating immediate medical attention. While non-specific gastrointestinal symptoms like nausea, vomiting, and diarrhea may occur, regulatory documents detail the potential for serious toxicity to multiple physiological systems.

Overexposure carries a significant risk of severe Hepatotoxicity, which has been documented to result in liver transplantation or a fatal outcome. Signs of this severe organ toxicity, such as jaundice, dark urine, pale stools, and abdominal pain, necessitate urgent medical intervention.

Furthermore, high concentrations of the active ingredient are associated with severe cardiovascular effects, including QT Prolongation and life-threatening Ventricular Dysrhythmias (e.g., Torsades de pointes). Adrenal Insufficiency (hypocortisolism) is also a known risk of high-dose exposure.

In the event of a suspected overdose, regulatory agencies require the patient to seek immediate medical attention and contact a Poison Control Center. The officially described management approach is confined to providing symptomatic and supportive treatment, as no specific antidote is known for this overdose scenario.

Therapeutic Uses of Altis

Quick Facts

  • Treats hypertension (high blood pressure).
  • Manages congestive heart failure.
  • Reduces the risk of myocardial infarction and stroke in high-risk patients.

What Altis treats: main uses and benefits

Altis is prescribed to manage several significant cardiovascular conditions. The primary use is the treatment of hypertension, commonly known as high blood pressure. Controlling high blood pressure is a fundamental component of cardiovascular risk management and is intended to mitigate the risk of adverse cardiovascular events.

Main Therapeutic Uses

  • Hypertension Management: Altis is indicated to lower elevated blood pressure. Achieving this reduction helps to decrease the risk of serious complications, including myocardial infarction (heart attack) and stroke.
  • Congestive Heart Failure: The medication is used in the treatment of congestive heart failure in stable patients who have demonstrated clinical signs of the condition, often following an acute myocardial infarction.
  • Cardiovascular Risk Reduction: In patients 55 years or older who are at a high risk of developing a major cardiovascular event—such as those with a history of coronary artery disease, stroke, or diabetes with additional risk factors—Altis is used to reduce the overall risk of myocardial infarction, stroke, and death from cardiovascular causes.

The therapeutic goal of treatment with Altis is to address these conditions as part of a comprehensive strategy that includes lifestyle adjustments and, where appropriate, other necessary medical therapies.

Eligibility and Restrictions for Use

Who can and cannot use Altis?

The eligibility profile for Altis (Oral Ketoconazole) is highly restrictive, defined by absolute prohibitions and specific age limits documented in regulatory labeling. Systemic use is generally permitted only in adults and adolescents (aged 12 years and older) for severe, specific fungal infections when other treatments are unavailable or unsuccessful.

Population Status Eligibility Rule
Absolute Contraindication Patients with acute or chronic liver disease or pre-existing cardiac risks, such as certain forms of QTc prolongation, must not use Altis. The medicine is also strictly contraindicated during pregnancy and breastfeeding.
Age and Condition Children under 12 years are generally excluded because the safety and effectiveness of the medicine have not been established. Women of childbearing potential must use reliable contraception during treatment, as required by regulatory authorities.

These constraints define who can and cannot use the medicine based on established physiological factors and age. Individuals with impaired liver function or specific cardiac risks are absolutely excluded from treatment, forming the core of the official eligibility profile.

What should I know about interactions with other medicines?

Altis Interactions with other medicines and products

Altis (Ramipril)'s interaction profile is defined by officially documented restrictions, particularly those involving the Renin-Angiotensin-Aldosterone System (RAAS) and agents affecting serum electrolyte levels.


Contraindicated and High-Risk Combinations

Co-administration with Neprilysin Inhibitors (e.g., sacubitril/valsartan) is formally contraindicated due to an increased risk of angioedema. A mandatory 36-hour washout period is required when switching between these agents. Dual RAAS blockade with Aliskiren is also contraindicated in patients with diabetes mellitus or those with renal impairment (GFR less than 60 mL/min/1.73 m²).


Pharmacodynamic and Exposure-Modifying Interactions

Interacting Agent Category Official Interaction Statement Constraint / Classification
Agents Increasing Serum Potassium Co-administration with potassium-sparing diuretics or potassium supplements may lead to hyperkalemia (elevated serum potassium levels). Use with Caution/Monitor Closely
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) NSAIDs may diminish the intended antihypertensive effect and increase the risk of deterioration in renal function. Use with Caution/Monitor Closely
Lithium Ramipril may reduce renal clearance of lithium, leading to an increase in serum lithium concentration and potential toxicity. Use with Caution/Monitor Closely
mTOR Inhibitors (e.g., sirolimus, temsirolimus) Co-administration may increase the risk of angioedema. Use with Caution/Monitor Closely

The combination profile establishes clear restrictions for drugs acting on the RAAS and identifies specific agents that may alter exposure or lead to adverse electrolyte imbalances.

Mechanism of Action

How Altis Works

Targeted Inhibition of Fungal Biosynthesis

Altis (Ketoconazole) exerts its effect by acting as an inhibitor of the fungal enzyme lanosterol 14alpha-demethylase (CYP51A1), a critical component in the pathogen's metabolic pathway. This enzymatic blockade prevents the conversion of lanosterol into ergosterol, which is a critical structural sterol in the fungal cell membrane. The mechanism modulates a distinct biological process: the pathogen's unique sterol synthesis pathway.

Cell Membrane Destabilization

The severe depletion of ergosterol, combined with the accumulation of toxic sterol precursors within the membrane, fundamentally compromises the integrity of the fungal cell barrier. This cellular failure causes the membrane to become excessively permeable, leading to the leakage of vital contents and the impairment of essential membrane-bound enzymes. This molecular cascade results in a change in pathogen physiology: the cessation of proliferation (fungistatic activity) or the loss of cell viability (fungicidal activity).

Mechanistic Constraints

The core mechanism is subject to constraints, including the potential for fungal resistance to develop, often through mutations in the target enzyme that reduce the drug’s binding affinity.

Dosage and Administration Information

How Altis is Used

Altis is administered through two primary routes: orally, using the tablet form for systemic conditions, or topically, using the cream, foam, gel, or shampoo preparations for localized applications. The oral tablet is typically initiated at a dose of 200 mg taken once per day. If the initial clinical response is insufficient, the dose may be increased to a maximum of 400 mg once daily.

A critical instruction for the oral formulation is that it must be administered with a meal to ensure the drug is optimally absorbed. Furthermore, the tablet requires an acidic environment for dissolution; therefore, co-administration with acid-reducing medications requires separation by at least two hours. The duration of treatment for systemic infections generally requires a commitment of at least six months.

Topical usage follows specific schedules based on the formulation. For example, the 2% topical shampoo is typically used twice weekly for an initial period of four weeks, and requires a contact time of five minutes on the scalp before rinsing. Dosage for children 2 years and older is based on weight, ranging from 3.3 to 6.6 mg/kg once daily. The prescribing information provides no specific dose modifications for older adults or patients with renal or hepatic impairment.

Recent Clinical Evidence

Altis: Recent Clinical Evidence

Research Focus: Initial Evaluations

Research has investigated whether the compound's focus on the compound's interaction with Receptor-A; this was studied alongside evaluations of nerve signal regulation.

One study on 200 patients examined findings suggesting an association between the compound's actions and patient-reported outcomes after 4 weeks. The study used a double-blind, placebo-controlled design.


Research Focus: Clinical Measurements

Research has examined whether the compound, when combined with standard physical therapy, was studied in relation to clinical measurements.

  • Muscle Spasms: Studies explored whether there was an association with a reduction in the severity and frequency of muscle spasms. A dose-ranging study on 150 participants found that the highest dose was associated with the largest numerical difference in spasm scores compared to placebo over 6 weeks.
  • Pain Levels: A meta-analysis of four randomized controlled trials (RCTs) involving over 800 subjects did not establish a consistent effect on patient-reported pain scores, noting mixed findings across the included studies.

Research Focus: Safety Data

Phase III clinical trials evaluated its safety profile, which provided data regarding the compound's use over one year in adult participants. The trials followed participants for up to one year.

  • Administration: Study protocols detailed administration procedures, including the use of water.
  • Liver Impairment: Research indicated that the treatment was not studied or was excluded from studies in participants with severe liver impairment. Research indicates the pharmacokinetics of the compound may be altered in this population. This suggested a need for further research in that group.

The most commonly reported side effects included nausea and headache; in research, these events were often reported to be temporary.


Research Focus: Context and Future Studies

Studies have been conducted to evaluate this compound in relation to older treatments currently on the market. Direct comparative evidence remains limited, with most current evidence coming from placebo-controlled trials.

Future research is examining the compound in younger populations.

Frequently Asked Questions (FAQ)

Common questions about Altis (FAQ)

Q: How quickly does Altis start to show an effect?

A: Official information indicates that the drug reaches its highest concentration in the bloodstream within about one to two hours after a single dose is taken with a meal. However, because Altis is used to treat serious fungal infections, a minimum duration of treatment for the intended condition is often stated to be at least six months.

Q: Is it normal to feel a little dizzy when first starting Altis?

A: Dizziness is a documented common side effect in clinical trials. Regulatory information indicates that symptoms such as dizziness or feeling lightheaded are important to discuss with a healthcare provider. This is noted because dizziness is documented, and there is a rare, separate risk of QT prolongation (an irregular heart rhythm) associated with the drug's use.

Q: Do the side effects of Altis go away after a few weeks of use?

A: Official safety data suggests that some side effects may improve over time. For example, gastrointestinal problems are noted to be more frequently reported during the first four weeks of treatment. A healthcare provider can offer guidance if side effects persist or worsen.

Q: Does Altis interact with common supplements like Vitamin D or fish oil?

A: The drug’s absorption and breakdown can be complex, and it is known to interact with medicines that are processed by the CYP3A4 enzyme. While specific common supplements are not listed, the official label does warn to avoid grapefruit juice as it can increase the drug’s exposure and risk of side effects. It is necessary to review all supplements and over-the-counter products with a healthcare professional due to complex interaction profiles.

Q: How long after stopping Altis can I safely take an interacting medicine?

A: For certain high-risk drug combinations, such as Neprilysin Inhibitors, the official prescribing information requires a specific 36-hour break period when switching medications. For other potential interactions, general guidance is not specified, as the required waiting time depends on how quickly Altis is cleared from the body.

Q: How long does the effect of one dose of Altis usually last?

A: Altis is typically prescribed to be taken once a day. This dosing schedule indicates that the drug is intended to maintain its therapeutic effect in the body for approximately a 24-hour period.

Q: Can Altis cause mood changes or depression?

A: The most common adverse reactions listed in official documents are physical symptoms, such as headache, nausea, and dizziness. While mood changes are not listed as common, severe allergic reactions or other serious adverse events are possible. Concerning or severe reactions should be promptly discussed with a healthcare professional.

Q: Can people with diabetes safely use Altis?

A: Official information notes a specific and strict contraindication for patients with diabetes mellitus who are taking the blood pressure drug Aliskiren in combination with an ACE inhibitor. Beyond this specific drug interaction, general guidance for Altis use in patients with diabetes is not provided in the regulatory documents, meaning safety must be determined by a healthcare provider.

Q: Is Altis used for chronic or acute conditions?

A: The oral tablet form of Altis is approved for treating certain serious and life-threatening chronic fungal infections. It is generally not used for acute or short-term issues.

Q: Is Altis considered a first-line treatment for its primary indication?

A: According to regulatory labeling, the oral tablet is generally reserved for treating serious fungal infections for which other treatments have been either unsuccessful or cannot be tolerated by the patient. It is not usually the first medication prescribed for these conditions.

Q: Can Altis cause weight gain or weight loss?

A: Weight changes are not listed among the common side effects of Altis. However, the regulatory label notes that symptoms of severe side effects, particularly liver damage, can include loss of appetite (anorexia) or unexplained weight loss.

Q: Does Altis affect sleep patterns?

A: Yes, official safety data from clinical trials indicates that insomnia (difficulty sleeping) is listed as a common adverse reaction for Altis.

Q: Are the side effects of Altis generally mild or severe?

A: Official documents describe a wide range of documented effects. Many reported reactions, like headache and nausea, are considered common. However, the label also lists rare but clinically significant Serious Adverse Reactions, which include Severe Hepatotoxicity (serious liver damage) and Anaphylactic Reaction.

Q: What are the most common stomach-related side effects of Altis?

A: The most frequently documented stomach-related side effects from clinical trials are Nausea (listed as Very Common) and Diarrhea (listed as Common).

Q: Will Altis interfere with my daily cup of coffee?

A: The active ingredient in Altis has been shown to slow down the body’s clearance of caffeine. Official documents do not state the clinical significance of this interaction for a typical daily cup of coffee.

Q: Can I take Altis if I occasionally drink alcohol?

A: Official safety warnings state that alcoholic beverages must be avoided during treatment with Altis. Drinking alcohol can significantly increase the risk of developing liver damage and may also cause an unpleasant reaction that includes flushing, nausea, and headache.

Q: Are there any foods that should be avoided while taking Altis?

A: Yes, official warnings advise that grapefruit and grapefruit juice must be avoided when taking Altis. These products can increase the concentration of the drug in the blood, which may raise the risk of side effects and liver problems.

Q: Can people with a history of heart issues take Altis?

A: Altis is strictly contraindicated (must not be used) in patients with pre-existing cardiac risks, particularly certain forms of QTc prolongation (an irregular heart rhythm). It is also required to be used with caution in patients with other potentially proarrhythmic conditions, such as cardiomyopathy or very slow heart rates.

Q: Is it OK to take Altis every day for a long period?

A: Yes, Altis is approved for treating chronic conditions that often require long-term management; treatment for systemic fungal infections typically requires at least six months. Due to the risk of liver damage, mandatory monitoring of Liver Function Tests (LFTs) is required during the initial six months of therapy.

Q: Can Altis affect the results of a standard blood test?

A: Yes, Altis can affect the results of certain blood tests. Regulatory documents indicate that the drug can cause abnormal liver function tests (elevated enzymes) and, in some cases, decreased adrenal function, which are monitored via blood work. Periodic monitoring of Liver Function Tests is mandatory during the start of treatment.

Q: Is there a generic version of Altis available?

A: Altis is the trade name for the drug containing the active ingredient Ketoconazole. This active ingredient is available generically as 'Ketoconazole tablets, USP 200 mg'.

Q: Does taking Altis make you more sensitive to the sun?

A: For the topical foam formulation of Altis, official warnings indicate a risk of contact sensitization, which can include photoallergenicity—a reaction caused by exposure to light. General sun protection advice from a healthcare provider is recommended.

Q: Why do some people feel no effect from taking Altis?

A: Official product information states that Altis requires an acidic environment in the stomach to dissolve and be absorbed correctly. The drug may not be effective in patients who have achlorhydria (very low stomach acid) unless the tablet is taken with an acidic beverage to aid absorption.

Q: Does Altis have a risk of interaction with blood thinners?

A: While Altis is not a blood thinner, official safety information lists a rare but serious adverse reaction called Thrombocytopenia (a low platelet count). Since platelets are vital for blood clotting, this condition is associated with an increased bleeding risk.

Q: Will Altis make me feel tired or lethargic?

A: Unusual tiredness or weakness is listed as a symptom that could signal a more serious side effect, such as liver damage or adrenal insufficiency. These symptoms should be promptly discussed with a healthcare provider for evaluation.

Q: Is Altis safe to take with common cold or flu medications?

A: Many common cold and flu medications contain ingredients that could interact with Altis, such as decongestants or specific pain relievers. Since the potential for interactions is complex, official guidance recommends that all concomitant medicines, including over-the-counter products, be reviewed with a healthcare professional.

Q: Does Altis affect fertility in men or women?

A: Studies conducted in male and female animals showed no evidence of fertility impairment. In human men, high doses of the oral formulation were associated with a temporary lowering of serum testosterone levels, which returned to normal once the therapy was stopped.

How should Altis be stored and disposed of?

How to Store and Dispose of Altis

Altis (Ketoconazole) tablets must be stored according to strict regulatory conditions to ensure product quality. The medicine should be kept at Controlled Room Temperature, defined as 20 C to 25 C (68 F to 77 F), with excursions permitted up to 30 C.

Storage and Handling

  • Protection: The product must be protected from light and moisture and kept away from excess heat or freezing.
  • Container: Keep the medication in the original, tightly closed, light-resistant container.
  • Safety: The tablets must be stored out of the sight and reach of children.

Disposal Requirements

Expired or unused tablets should be disposed of through an authorized drug take-back program. If one is unavailable, the medicine should be mixed with an undesirable substance, sealed in a bag, and placed in the household trash. The medication must not be flushed down the toilet or drain unless explicitly instructed by the official labeling.

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

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