Rimifon

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Rimifon

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 Rimifon

Property Description
Active ingredient Isoniazid (INH)
Form Oral Tablet, Sterile Solution for Injection
Pharmacological class Antimycobacterial Agent, Antitubercular Drug
Common use First-line treatment and prophylaxis for Tuberculosis
Origin Synthetic compound

Rimifon is a specialized, synthetic medication whose active component is the single ingredient Isoniazid (INH), chemically identified as isonicotinic acid hydrazide. It is precisely classified as an Antimycobacterial Agent and is recognized as a primary Antitubercular Drug. This single-ingredient composition and specific classification distinguish it from multi-drug formulations used in later treatment regimens. Its highly specific role is designed to address infections caused by Mycobacterium species, particularly Mycobacterium tuberculosis.

Composition and Essential Role

The medication is a single-ingredient product whose composition centers entirely on Isoniazid. It is typically available in two principal dosage forms: the Oral Tablet and the Sterile Solution for Injection. This dual presentation facilitates two key routes of administration: the standard oral route and the parenteral route (intravenous or intramuscular) for severely ill patients or those with absorption issues. This wide availability across forms is clinically recognized for ensuring consistent drug delivery to the target patient group, which includes individuals undergoing active treatment as well as children and adults requiring preventative measures.

The general purpose of Rimifon is to serve as a foundational, first-line agent against tuberculosis. Its functional importance is internationally recognized, as Isoniazid has been continuously included on the World Health Organization’s (WHO) Model List of Essential Medicines since 1977. This highlights its established and indispensable role in managing the infection worldwide.

Regulatory References

  1. Isoniazid (INH) entry on the eEML

What side effects are possible with Rimifon?

Possible Side Effects and Safety Information

The officially documented safety profile for Rimifon (Isoniazid) focuses primarily on hepatotoxicity and neurotoxicity, which are its most significant adverse reaction domains. The most common toxic effect documented in regulatory sources is Peripheral Neuropathy, classified as common (1% to 10%), especially in slow acetylators or patients with co-existing conditions like diabetes.


Serious Adverse Reactions and Frequency

The highest priority safety concern is severe and sometimes fatal hepatitis, which is classified as uncommon (up to 1 in 100 people) but carries a high degree of regulatory warning. Other serious reactions documented in official labels include Severe Cutaneous Adverse Reactions (SCARs), such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis, and rare haematological disorders like Agranulocytosis.


Organ System Involvement

Adverse reactions are formally grouped by System-Organ Classes (SOCs), with the most frequently noted being:

  • Hepatobiliary disorders: Hepatitis, acute hepatic failure, and elevated liver enzymes.
  • Nervous system disorders: Peripheral neuropathy, seizures, and optic neuritis.
  • Skin and subcutaneous tissue disorders: Severe skin reactions (SCARs).

Safety Considerations for Specific Populations

Risk factors for developing hepatitis are explicitly linked to patient characteristics. The risk increases with age (especially over 35/50 years) and is also heightened in daily alcohol users and patients with pre-existing hepatic impairment. The majority of clinically apparent hepatitis cases are noted to occur within the first three months of therapy. The drug is strictly contraindicated in patients with acute liver disease or previous drug-induced hepatic injury.

Overdose and Emergency Response

Overdose and When to Seek Help

Acute overdose of Rimifon (Isoniazid) is classified as a severe and potentially life-threatening event requiring immediate intervention. Manifestations of acute toxicity typically emerge within 30 minutes to three hours following ingestion.

Documented Overdose Manifestations

The most critical documented signs involve the Central Nervous System (CNS) and metabolic systems. Overdose may present with recurrent seizures (often generalized tonic-clonic) and stupor rapidly progressing to profound coma. Gastrointestinal symptoms such as nausea and vomiting, as well as pyrexia and tachycardia, may also occur. A key laboratory finding is severe metabolic acidosis, often classified as lactic acidosis, alongside hyperglycemia. Ingestion of doses above mathbf80 mg/kg is documented as rapidly fatal without treatment.

Required Emergency Actions

Immediate medical attention must be sought for any suspected overdose. The official regulatory profile identifies Pyridoxine (Vitamin mathbfB6) as the specific, effective antidote for acute Isoniazid toxicity. Management procedures focus on controlling convulsions and correcting the severe metabolic acidosis. This often requires admission to an intensive monitoring unit (HDU or ICU). Supportive measures, including the use of activated charcoal or gastric lavage, may be considered if administered within the first hour post-ingestion.

Therapeutic Uses of Rimifon

Rimifon is an older brand name for the generic drug Isoniazid, an established medication used exclusively for the management and prevention of tuberculosis (TB).

Main Uses and Patient Benefits

This medication is applied across two key therapeutic domains: management of active TB disease and preventing the progression of latent TB infection. For active disease, the drug is used as a component of a multi-drug regimen to address the bacterial cause, which is applied in addressing symptom clusters related to physical discomfort and systemic imbalance, such as persistent cough, night sweats, chest discomfort, and unexplained weight loss. Isoniazid is in a class of medications called antituberculosis agents and is used to help address the bacterial cause of the infection.

The goal of treatment is to support the management of symptoms and address the long-term risks associated with the condition. The therapy is applied in addressing symptom clusters that create noticeable physiological strain, providing support that helps ease the overall symptom burden, and contributes to improved comfort during periods of heightened symptoms.

Quick Fact: Relief for Respiratory Strain

The medication may assist with easing the respiratory symptoms that create noticeable physiological strain.

In its preventive use for latent infection, the medication is considered relevant for preventing the silent infection from progressing to active disease. By addressing the dormant bacteria, it may offer a benefit that helps maintain a sense of stability and provides supportive relief when symptoms might interfere with routine activities.

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Absolute Contraindications

Rimifon (Isoniazid) is contraindicated and must not be used in individuals with a history of Isoniazid-associated hepatic injury or any active liver disease. Use is also prohibited for patients who have experienced severe adverse reactions or hypersensitivity to the drug, as defined in official regulatory labeling.

Restricted and Conditional Use

Use is permitted for patients with susceptible active or latent tuberculosis, but it is restricted for several populations. Caution is required for patients with impaired liver function, pre-existing seizure disorders, or a history of psychosis. Patients with diabetes mellitus and those with chronic alcoholism require close monitoring due to an elevated risk of hepatitis or other adverse effects, as specified in regulatory documents.

Age and Physiological Restrictions

Isoniazid is not recommended for infants aged 0 to 3 months due to a lack of specific data. Older adults are listed as having an increased risk of hepatitis. For pregnancy and lactation, use is permitted only when the potential benefit outweighs the potential risk, and pyridoxine supplementation is advised in both scenarios.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Rimifon (Isoniazid) interacts with a defined scope of medicinal products and substances, primarily due to its documented effects on metabolic enzymes and specific nutrient pathways.

The core of the interaction profile involves pharmacokinetic changes driven by the drug’s inhibitory effect on certain hepatic enzymes, including CYP2C19 and CYP3A4. This inhibition increases the systemic exposure and plasma concentrations of co-administered drugs, such as Phenytoin, Carbamazepine, certain Benzodiazepines, and Coumarin-derived anticoagulants (like Warfarin). In contrast, Isoniazid's induction of the CYP2E1 enzyme pathway is documented to increase the risk of toxicity from Acetaminophen via toxic metabolite formation.

Specific combinations are listed as contraindicated in regulatory documents, including certain HIV Antivirals and lipid-regulating agents (e.g., Lurasidone and Lovastatin). The combination with Praziquantel is also subject to significant restriction.

Interaction-related restrictions extend to diet and administration timing. Aluminum-containing antacids must be separated from Isoniazid administration by at least one hour to prevent reduced absorption. Due to the drug’s MAO-inhibiting activity, consumption of Histamine- or Tyramine-containing foods may lead to adverse pharmacodynamic reactions. Furthermore, daily consumption of alcohol is linked to an increased risk of Isoniazid-related hepatotoxicity. The drug's interference with Pyridoxine (Vitamin B6) metabolism necessitates supplementation in certain patient groups, and the overall interaction risk is noted as being greater for individuals identified as Slow Acetylators.

Mechanism of Action

Enzymatic Activation: The Prodrug Mechanism

Rimifon acts as a prodrug, meaning it is initially inert and requires activation by a specific bacterial enzyme called KatG (catalase-peroxidase). This process occurs only inside the target bacteria and is essential because the activation converts Isoniazid into a highly reactive molecule (an isonicotinoyl-NAD adduct) that can then proceed to disable key targets.

Molecular Target and Cell Wall Destruction

The activated Isoniazid molecule locks onto and forms a stable, covalent bond with the bacterial enzyme InhA (enoyl-acyl carrier protein reductase). InhA is essential for the production of mycolic acids, the unique, protective lipid components of the mycobacterial cell wall. By disrupting this necessary synthesis pathway, the drug prevents the bacteria from maintaining their structural integrity and causes them to lose their protective barrier.

Physiological Consequence: Cell Lysis

The ultimate physiological result of blocking mycolic acid synthesis is the structural failure and death ( lysis) of the rapidly dividing bacterial cell. This mechanism is the basis for the drug's activity against M. tuberculosis. The mechanism is constrained in non-replicating or dormant bacteria, as the pathway required for activation and synthesis is less active.

Dosage and Administration Information

How to Use Rimifon (Isoniazid) — General Administration Guidelines

Rimifon (Isoniazid) is used in specific dosage forms and regimens. Adherence to the prescribed method, timing, and duration is fundamental to the medication's intended role in treatment.

Administration Details

Instruction Guideline
Route of Administration Oral (tablet, syrup, or dispersible tablet) or Parenteral (Intramuscular/Intravenous injection).
Dosing Schedule Dosing is typically calculated based on body weight (mg/kg) and may be administered once daily (e.g., maximum 300 mg daily for adults) or on an intermittent schedule (e.g., 2 to 3 times per week, max 900 mg) as part of a monitored regimen.
Timing in Relation to Meals Oral doses are generally taken on an empty stomach (e.g., 1 hour before or 2 hours after a meal) to facilitate absorption. In cases of gastrointestinal upset, the medicine may be taken with food.
Age-Group Rules Children typically receive a higher mg/kg dose than adults, up to 300 mg daily. For severe renal impairment, a dose adjustment may be considered, particularly for individuals identified as slow acetylators.
Missed-Dose Rule Standard procedure involves taking a missed dose as soon as it is remembered, unless it is almost time for the next scheduled dose, in which case the missed dose is skipped to maintain the regular schedule. Doses are not doubled.
Special Condition Co-administration of Pyridoxine (Vitamin B6) is a standard recommendation with Isoniazid therapy to help prevent neurological complications.

Procedural Summary

Administration involves taking the dose at the same time each scheduled day, ideally on an empty stomach to enhance drug uptake. The total duration of therapy is typically divided into an initial phase and a continuation phase, spanning several months (e.g., a total of 6 to 9 months) as part of a multi-drug regimen protocol. The concurrent administration of Vitamin B6 is a standard component of this treatment process.

Recent Clinical Evidence

Research evidence / Overview of studies for Rimifon (Isoniazid)

Isoniazid (Rimifon) was evaluated in numerous clinical research settings, including large-scale randomized controlled trials (RCTs), systematic reviews, and long-term observational studies. This extensive research base, which spans several decades, is observed in its role as a key agent for addressing tuberculosis (TB) infection. The findings describe group patterns observed in these studies and provide context, but research does not determine whether an individual will respond similarly.

Evidence for Use in Managing Active Tuberculosis Disease

The research supporting the use of Isoniazid for active TB disease was studied for its application as a key agent within multi-drug combination regimens. Studies monitored outcomes such as treatment success, which included clinical resolution and microbiological clearance, and the rate of relapse following the completion of treatment. Findings describe patterns observed in the studies where individuals receiving a full course of the Isoniazid-containing multi-drug regimen achieved microbiological clearance. What remains uncertain is what types of regimens are necessary when bacterial strains exhibit resistance to Isoniazid alone (Isoniazid mono-resistance).

Evidence for Preventing Progression of Latent TB Infection

Isoniazid for preventive treatment was studied for individuals carrying a latent, or silent, TB infection. The main outcome studied was the incidence of active TB disease developing in the observed populations over time. Research highlights changes measured during the study period where cohorts receiving Isoniazid preventive therapy were observed to have a lower measured incidence of active TB during the follow-up period, compared to control groups. However, long-term effects are not fully established, as some data show patterns related to the protective difference diminishing several years after treatment ends, particularly in areas where re-exposure to TB is common.

What Is Still Uncertain about Rimifon Research

Official regulatory reports and systematic reviews identify areas where research is ongoing or where evidence is limited. The emergence of bacterial strains resistant to Isoniazid is a major research limitation, and new studies are needed to define optimal treatment for resistant strains. Research indicates that follow-up durations were limited in characterizing treatment completion in real-world settings for the 6-to-9 month preventive course, noting that the results apply only to the populations studied and may not reflect varying levels of compliance.

Key Studies & References

  1. Tuberculosis (NG33) - National Institute for Health and Care Excellence (NICE) Guideline

Frequently Asked Questions (FAQ)

Common questions about Rimifon (FAQ)

Q: What is the maximum daily dose of Isoniazid for children?

Official information indicates that the dose for children is based on their body weight ( mg/kg). Regulatory labeling typically cites a maximum daily amount of 300 mg for the dose, regardless of the weight-based calculation.

Q: Is Rimifon a generic drug?

Rimifon is a brand name used for the active ingredient, Isoniazid. Isoniazid is the generic name for the medication. According to regulatory sources and drug availability records, both the brand-name and generic forms are widely available.

Q: How long do I have to take Isoniazid for latent TB?

The duration of treatment for latent tuberculosis infection, also known as preventive therapy, is determined by the specific regimen used. Guidelines reference regimens lasting several months, such as six or nine months, or a shorter duration when Isoniazid is used in combination with other antitubercular drugs.

Q: How is Isoniazid available?

According to the official product information, Isoniazid is primarily available in several forms to suit different administration needs. These include oral tablets, an oral solution or syrup, and a sterile solution intended for injection.

How should Rimifon be stored and disposed of?

How to Store and Dispose of Rimifon (Isoniazid)

Rimifon (Isoniazid) must be stored under specific conditions to maintain its effectiveness, as defined by regulatory labeling.

Storage Requirements

Condition Requirement
Temperature Controlled Room Temperature: 20 C to 25 C (68 F to 77 F). Avoid temperatures above 30 C.
Protection Keep protected from light and moisture. Avoid freezing, as this may cause crystallization in the injection solution.
Container Keep the medicine in its original container and ensure it is tightly closed.
Child Safety Store the medication out of the sight and reach of children and pets.

Disposal Instructions

Expired or unused Isoniazid should be disposed of through a medicine take-back program when available. If a take-back program is unavailable, follow the official procedure for mixing the drug with an unappealing substance (like dirt or coffee grounds), sealing it in a bag, and discarding it in the household trash. Do not flush Isoniazid down the toilet unless directed by regulatory instructions.

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

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