Registered Rwanda · Rwanda FDA

VIRALEX

INOSINE PRANOBEX

Rwanda FDA-HMP-MA-2019 TABLETS 500MG dermatologicals INN generic

What it does

Inosine is a substance that helps support the immune system and improve energy levels.

Commonly used for: viral infections, gout, multiple sclerosis

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
Rwanda FDA-HMP-MA-2019
Registration date
17/08/2024
Expiry date
16/08/2029
Status
Registered
Active ingredient
INOSINE PRANOBEX
Dosage form
TABLETS
Strength
500MG
Pack size
6x10 Tablets, 10 Tablets
Therapeutic class
-
ATC class (WHO)
D06BB - Antivirals
Drug group
DERMATOLOGICALS
RxNorm RxCUI
1483575
Manufacturer / MAH
Themis Medicare
Applicant / LTR
THEMIS MEDICARE LIMITED
Country of origin
INDIA
Manufacturer location
11/12, Udyog Nagar Industrial Estate, SV Road, Goregaon West, Udyog Nagar, Goregaon West, Mumbai, Maharashtra 400104, India

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:04 · updated 2026-09-17 02:30:43

Disclaimer: This information is sourced from Rwanda Food and Drugs Authority (Rwanda). Always consult a qualified healthcare professional before using any medication.

About inosine

Inosine is a substance that helps support the immune system and improve energy levels.

What it treats

  • viral infections
  • gout
  • multiple sclerosis

How it works

Inosine helps boost the body's immune response and may aid in the production of energy at the cellular level.

Who it's for

Inosine is generally used for individuals dealing with certain viral infections, gout, or conditions like multiple sclerosis.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About pranobex

Pranobex is a medication that helps boost the body's immune system to fight off certain infections.

What it treats

  • viral infections
  • herpes simplex virus infections
  • human papillomavirus infections

How it works

It enhances the immune response, helping the body to better fight off viruses.

Who it's for

It is for individuals who need help in managing certain viral infections.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: inosine

BNF-referenced

Inosine is a purine nucleoside that plays a significant role in cellular metabolism and energy transfer. It is involved in various biological processes, including neuroprotection, cardioprotection, and immunomodulation. Inosine's effects have been studied in various models, showing potential benefits in nerve regeneration and inflammation reduction.

Indications

  • Neuroprotection
  • Cardioprotection
  • Anti-inflammatory conditions
  • Immunomodulation

Dosage

Children: Refer to the BNF for Children for specific dosing recommendations.

Adults: Refer to the BNF for specific dosing recommendations.

Mechanism of action

Inosine has been found to promote axon growth in vivo, potentially acting as an agonist for nerve growth factor-activated protein kinase (N-Kinase). It may also convert to cyclic nucleotides that help nerve endings overcome myelin inhibitory effects. Additionally, inosine has exhibited positive inotropic effects on cardiac muscle, mild coronary vasodilation, and enhanced myocardial carbohydrate uptake, while also inhibiting production of proinflammatory cytokines in immune cells.

Pharmacodynamics

Inosine may possess neuroprotective, cardioprotective, anti-inflammatory, and immunomodulatory properties. These activities suggest its potential therapeutic applications in conditions involving nerve damage and inflammation.

Pharmacokinetics

The pharmacokinetics of inosine, including absorption, distribution, metabolism, and excretion, are not extensively detailed in the provided sources. Further studies would be necessary to clarify these aspects.

Pregnancy

There are no adequate and well-controlled studies in pregnant women. Inosine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

It is not known whether inosine is excreted in human milk. Caution should be exercised when inosine is administered to a nursing woman.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: pranobex

Pranobex is an antiviral and immunomodulating agent, primarily used in the treatment of viral infections such as herpes simplex and human papillomavirus. It is a combination of 2-amino-5-(phosphonomethoxy)benzoic acid and other components that enhance its antiviral activity. Pranobex has been shown to stimulate immune responses and modulate the activity of certain immune cells, making it beneficial in treating conditions linked to viral pathogens.

Indications

  • Herpes simplex virus infections
  • Human papillomavirus infections
  • Other viral infections

Dosage

Children: Refer to the BNF for Children for appropriate dosing information.

Adults: Refer to specific guidelines or the BNF for appropriate dosing information.

Mechanism of action

Pranobex exerts its effects by enhancing the immune response to viral infections. It increases the synthesis of interferon and other cytokines, which are crucial for the antiviral immune response. Additionally, it may inhibit viral replication by interfering with nucleic acid synthesis in infected cells.

Pharmacodynamics

Pranobex's pharmacodynamic properties include its ability to enhance both humoral and cell-mediated immune responses. It activates lymphocytes and promotes the production of antibodies, which contribute to the body's defense against viral infections. The drug also exhibits direct antiviral activity against certain viruses by inhibiting their replication.

Pharmacokinetics

Pranobex is well absorbed after oral administration, with peak plasma concentrations achieved within a few hours. It is metabolized in the liver, and its metabolites are excreted primarily via the kidneys. The elimination half-life is typically a few hours, necessitating multiple doses to maintain effective therapeutic levels in the body.

Contra-indications

  • Hypersensitivity to pranobex or any of its components
  • Severe liver dysfunction
  • Active autoimmune diseases

Adverse effects

  • Gastrointestinal disturbances
  • Rash or other allergic reactions
  • Headache
  • Dizziness
  • Fatigue
  • Liver enzyme elevation

Interactions

  • May enhance the effects of immunosuppressive drugs
  • Potential interaction with anticoagulants leading to increased bleeding risk
  • May affect the metabolism of certain drugs processed by the liver

Precautions

  • Use cautiously in patients with liver impairment
  • Monitor liver function periodically
  • Assess for signs of hypersensitivity reactions
  • Evaluate the risk of bleeding in patients taking anticoagulants

Pregnancy

Limited data on the safety of pranobex in pregnancy; use only if potential benefits justify the potential risks to the fetus.

Breast-feeding

Limited information available; consider the benefits of breastfeeding alongside the potential risks of drug exposure.

Storage

Store at room temperature, away from light and moisture. Keep out of reach of children.

Formulations

  • Oral tablet
  • Oral suspension

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: inosine

PubChem CID 135398641

Molecular formula: C10H12N4O5

Mechanism of action

Inosine has been found to have potent axon-promoting effects in vivo following unilateral transection of the corticospinal tract of rats. The mechanism of this action is unclear. Possibilities include serving as an agonist of a nerve growth factor-activated protein kinase (N-Kinase), conversion to cyclic nucleotides that enable advancing nerve endings to overcome the inhibitory effects of myelin, stimulation of differentiation in rat sympathetic neurons, augmentation of nerve growth factor-induced neuritogenesis and promotion of the survival of astrocytes, among others. The mechanism of inosine's possible cardioprotective effect is similarly unclear. Inosine has been reported to have a positive inotropic effect and also to have mild coronary vasodilation activity. Exogenous inosine may contribute to the high-energy phosphate pool of cardiac muscle cells and favorably affect bioenergetics generally. Inosine has also been reported to enhance the myocardial uptake of carbohydrates relative to free fatty acids as well as glycolysis. In cell culture studies, inosine has been found to inhibit the production, in immunostimulated macrophages and spleen cells, of the proinflammatory cytokines, tumor necrosis factor (TNF)-alpha, interleukin (IL)-1, interleukin (IL)-12, macrophage-inflammatory protein-1 alpha and interferon (IFN)-gamma. It also suppressed proinflammatory cytokine production and mortality in a mouse endotoxemic model. These actions might account for the possible immunomodulatory, anti-inflammatory and anti-ischemic actions of inosine.

Pharmacodynamics

Inosine may have neuroprotective, cardioprotective, anti-inflammatory and immunomodulatory activities.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.