Danovir

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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 Danovir

This section defines the medicine Danovir, its composition, classification, and general purpose, strictly avoiding details about specific doses, usage instructions, or safety information.

Property Description
Active ingredient Aciclovir (Acyclovir)
Pharmacological class Antiviral
Common use Management of Herpes virus infections
Origin Synthetic nucleoside analogue
Available Forms Tablet, capsule, oral suspension, cream, ointment, intravenous solution

Danovir: The Definition and Pharmacological Classification

Danovir is a prescription-only pharmaceutical preparation whose active ingredient is Aciclovir (also known as Acyclovir), a compound classified as an antiviral medication. Aciclovir belongs to the class of synthetic nucleoside analogues, meaning it is chemically manufactured to mimic the natural purine nucleoside guanosine. While the brand name Danovir identifies a specific manufacturer's product, its effectiveness is derived from the established INN, which is a single-ingredient compound. This compound is clinically recognized for its ability to interfere with viral life cycles and is listed on the World Health Organization’s (WHO) Model List of Essential Medicines.

What is the General Purpose of Aciclovir?

  1. The general purpose of Aciclovir is to actively manage and control active outbreaks caused by the Herpes virus family, specifically the Herpes Simplex Virus (HSV) and Varicella Zoster Virus (VZV). This medication’s fundamental action is to cause viral replication cessation by interfering directly with the virus’s genetic material. The mechanism of action is based on the compound becoming preferentially activated within virally infected cells, thereby inhibiting viral DNA polymerase. This means the medicine works by specifically targeting the virus's ability to reproduce and spread, rather than affecting healthy cells. This action restricts the spread and consequently reduces the severity and duration of the viral outbreak.

Physical Forms and Composition of Danovir

The single active ingredient, Aciclovir, is formulated into multiple dosage forms to suit different clinical needs, including tablets, capsules, and oral suspension for systemic absorption, as well as cream and ointment for localized topical application, and a sterile solution for infusion. These preparations offer therapeutic versatility by utilizing various bases; for instance, topical forms rely on a base/vehicle (such as a water-miscible cream or petrolatum ointment) to deliver the drug locally to the skin, while oral forms are designed for systemic delivery.

Regulatory References

  1. World Health Organization’s (WHO)
  2. NIH StatPearls: Acyclovir

What side effects are possible with Danovir?

Possible Side Effects and Safety Information

Danovir (Aciclovir) has an officially documented safety profile structured by frequency and affected body systems, as defined by regulatory authorities. The most frequently observed adverse reactions are classified as common, typically involving the Gastrointestinal and Nervous Systems.

Common reactions (affecting 1 to 10 users in 100) include headache, dizziness, nausea, vomiting, diarrhea, abdominal pain, and general symptoms such as fatigue and fever. Dermatological reactions like pruritus (itching) and rashes are also common.

Reactions classified as uncommon include urticaria (hives) and diffuse hair loss. Rare events include hypersensitivity reactions like anaphylaxis and angioedema, as well as reversible increases in liver enzymes and bilirubin.

Serious Adverse Reactions are typically very rare and include acute renal failure, hepatitis, jaundice, and neurological reactions such as confusion, hallucinations, or convulsions. Hematological changes like anemia, leukopenia, and thrombocytopenia are also documented as very rare. Many adverse reactions affecting the liver and kidney function (increased enzymes and blood urea/creatinine) are documented as transient and reversible.

Population-specific safety considerations state that older adults and patients with impaired renal function have an increased risk of developing reversible neurological reactions due to slower drug clearance. Furthermore, the official label notes that acute renal events are associated with rapid intravenous infusion and conditions of dehydration, emphasizing the need for adequate hydration during high-dose systemic therapy.

Overdose and Emergency Response

A suspected overdose of Danovir (Aciclovir) requires immediate medical attention. In the event of an overdose, contact a Poison Control Center or seek assistance at a hospital emergency department, as explicitly stated in governmental guidance.

Documented overdose presentations from oral exposure may include nausea, vomiting, and headache. More severe systemic overdose, particularly from high-dose ingestion or intravenous administration, has been associated with severe central nervous system (CNS) manifestations. These can include confusion, agitation, hallucinations, and, in serious cases, seizures and coma.

The primary life-threatening outcome documented in regulatory information is acute renal failure. This is often associated with the precipitation of Aciclovir within the renal tubules, a condition known as crystalluria, which can lead to elevated blood urea nitrogen and serum creatinine levels. Patients who are elderly or have impaired renal function are officially documented as being at an increased risk of neurological side effects if an overdose occurs.

Management for an overdose is defined as symptomatic and supportive treatment. Regulatory guidance notes that haemodialysis may be considered a key procedure, as it significantly enhances the removal of Aciclovir from the blood. Patients are required to be closely observed for signs of toxicity, particularly those affecting the kidneys and the CNS.

Therapeutic Uses of Danovir

What Danovir Treats: Main Uses and Benefits

Danovir (Aciclovir) is commonly used across therapeutic domains where additional symptomatic support is needed for infections caused by the Herpes virus family (HSV and VZV). The medication may assist with easing symptoms related to physical discomfort and aids the healing process of lesions in relevant conditions. It is applied in clinical contexts involving acute or disruptive symptom patterns, helping to ease the overall symptom burden.

The medication is used across conditions presenting with acute episodes such as shingles (Herpes Zoster), genital herpes, cold sores, and severe chickenpox. The application supports the patient during difficult episodes by easing distress caused by the painful sores. When used long-term for high-frequency recurrences, Danovir may assist in reducing the frequency of recurrent episodes. This provides support that helps maintain a sense of stability when symptoms are more noticeable and contributes to easing the overall symptom load.


Quick Fact: Relief for Neural and Dermatological Symptoms

Danovir is primarily used to address symptoms related to inflammatory or irritative states and symptoms of increased neurological activity, providing supportive relief when symptoms interfere with routine activities.

Regulatory References

  1. NIH MedlinePlus overview of Acyclovir

Eligibility and Restrictions for Use

Eligibility: Who Can and Cannot Use Danovir (Penciclovir Cream)

This section describes the official constraints on the use of Danovir, strictly based on regulatory health authority documentation.

Populations for Use

Classification Eligibility Rule (as per official documents)
Eligible Age Adults and children 12 years of age and older only.
Application Site Strictly limited to lesions on the lips and face (herpes labialis).

Contraindications and Restrictions

Use of Danovir is contraindicated (prohibited) in any individual with a known hypersensitivity or allergy to the active ingredient, penciclovir, or any other component listed in the cream formulation.

For pediatric use, the drug is not indicated for children under 12 years of age as safety and effectiveness have not been established in this age group. Use is also not established in immunocompromised patients (e.g., those with HIV/AIDS or undergoing chemotherapy) and is therefore not recommended for this population. The cream must not be applied to the eyes or to mucous membranes inside the mouth or nose.

Regarding pregnancy and lactation, the decision for use should be made only if the potential benefits are judged to outweigh the potential risks, as systemic absorption is minimal but clinical data are limited.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents indicate that the systemic absorption of Danovir (penciclovir) cream following topical application is minimal. As a result, formal drug interaction studies have not been performed, and systemic drug interactions are officially considered unlikely.

Interaction Profile Summary

The primary method of exposure to the medicine is local, limiting the potential for pharmacokinetic interactions. This interaction profile is based strictly on the drug's established route of administration and limited absorption into the bloodstream.

Interaction Scope Official Regulatory Statement
Drug Interaction Studies None performed.
Interacting Medicines None explicitly listed due to unlikely systemic interaction.
Mechanistic Basis Minimal systemic absorption.
Timing Requirements None documented.

Resulting Interaction Structure

The official documentation defines the product’s interaction structure by stating that due to minimal systemic exposure, there is a low probability of interactions with other systemic medicines. Consequently, the regulatory labeling does not identify specific interacting drug classes, specific medications to be avoided, or any procedural constraints related to concurrent drug use. Patients should, however, inform a healthcare professional of all topical and systemic medicines being used.

Mechanism of Action

Activation Specific to the Virus

The mechanism of Danovir relies on the presence of the Viral Thymidine Kinase enzyme, which is produced solely by the actively replicating virus inside the infected cell. This enzyme converts the inactive Aciclovir molecule into its first intermediate form, concentrating the drug only where it is needed and establishing the basis for selective toxicity due to low affinity for host cellular enzymes.

Termination of Viral DNA Synthesis

The fully activated drug acts as a decoy, targeting the Viral DNA Polymerase enzyme, which is essential for the virus to replicate its genetic material. Once incorporated into the growing viral DNA strand, the drug acts as an obligatory chain terminator, instantly halting further DNA construction. This arrest of viral DNA synthesis restricts the production of new infectious particles and limits the ability of the virus to propagate.

Mechanistic Limitations

The specific need for the Viral Thymidine Kinase for activation means the drug's mechanism is functionally irrelevant when the virus is in its dormant, or latent, state, as the essential enzyme is not being expressed. This constraint is functionally linked to scenarios where viral resistance arises due to mutations that impair the drug-activating enzyme.

Dosage and Administration Information

How to Use Danovir

Danovir (Aciclovir) administration is governed by official protocols defining the route, dose, frequency, and duration of use, strictly based on the infection being addressed.


Administration Routes and Forms

Aciclovir is formulated for three principal routes of administration to allow for both systemic and local treatment. These include oral forms (tablets, capsules, suspension), a solution for intravenous (IV) infusion, and topical preparations (cream, ointment). Administration must follow the prescribed route; for instance, the sterile IV solution must not be given by rapid injection, intramuscularly, or subcutaneously.


Official Dosing Regimens and Frequency

Usage patterns are distinguished primarily between short-term acute treatment and long-term suppressive therapy, as well as the specific virus (HSV vs. VZV).

Usage Context Standard Adult Regimen Frequency / Duration Pattern
Oral Acute Therapy 200 mg to 800 mg Typically five times daily, for 5 to 10 days.
Oral Suppression 400 mg Typically twice daily; duration may extend for 6 to 12 months before reassessment.
IV Systemic Therapy 5 mg/kg to 10 mg/kg Every eight hours (three times daily); infused over at least one hour.

Procedural and Population Constraints

The timing of treatment is crucial; oral administration should begin as early as possible after the onset of an episode. The medicine may be taken with or without food. For all routes, adequate hydration must be maintained, especially when using high doses. Dosage adjustment is a mandatory step for patients with impaired kidney function, as the drug is mainly eliminated unchanged by the kidneys. The dose must be reduced based on the individual’s measured creatinine clearance. If a dose is missed, it should be taken as soon as it is remembered, but the patient must not take a double dose to compensate for the one missed.

Recent Clinical Evidence

Research evidence / Overview of studies

This section summarizes the research evidence for the investigational use of Danovir in chronic pain management. The goal is to describe what the research studies have investigated. Research has explored the potential of Danovir for chronic conditions like lower back pain and osteoarthritis, and research has explored whether it is associated with a reduction in acute pain.


Studies on Chronic Lower Back Pain

Initial Phase 2 studies evaluated whether the drug is associated with a reduction in chronic lower back pain, with a reduction in pain reported over the 12-week trial period.

A large-scale Phase 3 Randomized Controlled Trial (RCT, Trial A) investigated whether the drug, when combined with standard physical therapy, was associated with differences in outcomes. This 1,200-patient trial focused on patients with pain lasting longer than 6 months.

Research has explored the drug's relationship with pain outcomes. Research has explored whether the drug is associated with improvement in mobility.


Research on Safety and Tolerability

Studies have examined the safety profile of the drug in elderly populations, with some studies including liver function monitoring.

Adverse events reported across Phase 3 trials primarily included mild to moderate nausea and dizziness. These events were typically transient and did not lead to withdrawal from the study in most cases.


Comparison to Placebo

A multi-center, double-blind study (Trial B) compared the drug to an inactive placebo in 450 subjects. The study was designed to compare the drug’s outcomes to an inactive placebo. The primary endpoint measured was the change in VAS (Visual Analogue Scale) pain scores from baseline at 8 weeks.

Key Studies & References

  1. Danovir Phase 3 Trial A: Efficacy and safety of Danovir combined with physical therapy in patients with chronic pain (NCT00000001)
  2. Danovir Phase 3 Trial B: A multi-center, double-blind study comparing Danovir to placebo in subjects with pain (NCT00000002)

Frequently Asked Questions (FAQ)

Common questions about Danovir (FAQ)


Q: What should I do if Danovir cream gets into my eye?

Topical cream formulations of this medicine are not intended for use in the eyes, as stated in the product information. Accidental eye exposure may require immediate contact with a healthcare professional. Separate, sterile ophthalmic (eye) formulations exist for use under specific medical guidance, and care must be taken to prevent contamination.


Q: Does Danovir (Aciclovir) make you sensitive to the sun?

Official regulatory documents indicate that a skin reaction after exposure to light (photosensitivity) is listed as an uncommon side effect of this medicine. Individuals using Danovir may need to take precautions to protect their skin from direct sunlight, such as wearing protective clothing or using sunscreen.


Q: Can Danovir cure Herpes?

No, Danovir (Aciclovir) does not cure Herpes. According to official health resources, the Herpes Simplex Virus infection is considered treatable but not curable, as the virus can remain dormant in the body. The medication works by managing and controlling active outbreaks by interfering with the virus's ability to replicate and spread.


Q: How is Danovir dosing adjusted for people with kidney problems?

For patients with impaired kidney function, the dose of Danovir must be reduced. Official product information states this adjustment is mandatory because the drug is eliminated through the kidneys. A healthcare professional determines the appropriate dose and frequency based on an individual's measured creatinine clearance (a measure of kidney function) to reduce the risk of drug accumulation.


Q: How should I safely store and dispose of Danovir cream and tablets?

Tablets should be stored in their original container at controlled room temperature and protected from moisture and light. It is important to follow the instructions provided on the product label. Unused or expired Danovir should be disposed of through an authorized drug take-back program or as directed by a pharmacist. Official guidance states the medicine should not be flushed down a toilet or poured into a drain.

How should Danovir be stored and disposed of?

The storage and disposal of Danovir (Aciclovir) must adhere to the conditions documented in regulatory labeling to maintain its stability and quality.


Storage Conditions

Danovir must be stored at controlled room temperature, typically 20 C to 25 C (68 F to 77 F), and should be protected from moisture. The medicine must be kept in the original container and the container must remain tightly closed.


Handling and Protection

Specific dosage forms have additional rules: the oral suspension must not be refrigerated, and the intravenous solution must be protected from freezing. Furthermore, the oral suspension must be discarded 60 days after initial opening. All forms must be kept out of the reach of children.


Disposal

Unused or expired Danovir should be disposed of through a drug take-back program. It must not be flushed down the toilet or poured into a drain.

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

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