Riamilovir Sodium Dihydrate

Registered South African indications:

• Influenza and other acute respiratory viral infections

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of its excipients

South African recommendations

Caution in the following patient groups

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly

Angioedema

• Angioedema has been identified as a potential risk but has not been detected in the current clinical studies available in humans. Data in animal studies indicates that riamilovir exhibits no allergic or toxic immunological properties

Immunocompromised patients

• Safety and efficacy have not been established in immunocompromised patients

Cardiac disease

• Safety and efficacy have not been established in patients with cardiac disease

Influenza vaccination

• Riamilovir is not a substitute for influenza vaccination
• Use of riamilovir must not affect the evaluation of individuals for annual influenza vaccination

Effects on ability to drive and use machines

• The effects of riamilovir on the ability to drive and use machines has not been studied yet. However, on the basis of the spectrum of adverse reactions, no effect on these activities is expected

Forms avail. in SA and covered in this monograph: cap

South African registered indications and dosages

Influenza and other acute respiratory viral infections

• Oral (cap): 250mg, 3 times a day; Treatment duration: 5 consecutive days; Max: 750mg/24hrs

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If necessary, combine with the use of symptomatic medicines

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Method of administration

Oral use. Riamilovir is taken orally, with or without food with sufficient drinking water. The capsule should be swallowed whole, it is not recommended to chew or crush the capsule

Not recommended for use in children below 18 years

Pregnancy

South African recommendations

• Caution; not recommended
• The safety of riamilovir during pregnancy has not been established
• Experimental data has not shown any safety concerns in rats and mice during prenatal development
• Riamilovir is not recommended for use during pregnancy​​

Breastfeeding

South African recommendations

• Caution; not recommended
• The safety of riamilovir during breastfeeding has not been established
• Experimental data has not shown any safety concerns during the nursing period in rats and mice
• Riamilovir is not recommended for use during lactation

Fertility

South African recommendations

• Administration of riamilovir in a dose 12 times higher than the recommended human dose does not affect the reproductive function in male and female rats
• The experiments revealed no adverse effect on fertility of experimental animals and pre-and postnatal development of their offsprings. No studies on fertility have been done in humans

South African recommendations

• Caution; not recommended
  Riamilovir is not recommended for patients with renal impairment as safety and efficacy have not been established

South African recommendations

• Caution; not recommended
  Riamilovir is not recommended for patients with hepatic impairment as safety and efficacy have not been established

South African recommendations

• Caution; not recommended
  Riamilovir is not recommended for elderly patients as safety and efficacy have not been established

Infections and Infestations

Frequency unknown

• Helminthosis
• Respiratory syncytial infection (RS-infection)

Blood and Lymphatic System Disorders

Very rare

• Increased eosinophils

Immune System Disorders

Very rare

• Allergic reactions

Endocrine Disorders

Frequency unknown

• Parotid atheroma

Nervous System Disorders

Frequency unknown

• Headache

Respiratory, Thoracic and Mediastinal Disorders

Frequency unknown

• Catarrhal symptoms

Gastrointestinal Disorders

Very rare

• Dyspeptic phenomena
  • Flatulence
  • Diarrhoea
  • Nausea
  • Vomiting
  • Bloating with pasty stools
  • Heartburn
  • Abdominal pain

Skin and Subcutaneous Tissue Disorders

Frequency unknown

• Skin irritation
• Angioedema

Renal and Urinary Disorders

Very rare

• Increased erythrocytes
• Increased leukocytes
• Increased squamous epithelial cells
• Presence of bacteria in the urine

Investigations

Very rare

• Increased plasma alanine transferase (ALT)
• Increased plasma aspartate transferase (AST)
• Increased plasma bilirubin

• Purine analogues in anticancer therapy
• Pyrimidine bases in anticancer therapy
• Ribavirin

None routine

Riamilovir is a synthetic analogue of purine nucleoside (guanine) bases, with a pronounced antiviral effect. It possesses broad-spectrum antiviral activity against RNA-containing viruses. The main mechanism of action of the molecule is the inhibition of synthesis of viral RNA and replication of viral fragments. The obtained data suggests that the use of riamilovir in etiotropic treatment of influenza helps to reduce the length of the main symptoms: intoxication, fever, catarrhal symptoms and decrease the severity of the disease. Riamilovir reduced the level of post-treatment detection rate of influenza virus type A and B, with significantly reduced duration and amount of concomitant symptomatic treatment. Use of riamilovir reduced the incidence of complications. Administration of riamilovir promotes normalisation of a number of blood counts, reflecting severity of the disease, severity of the process and the immune system status of patients.