ribavirin

Contraindicated in:

Hypersensitivity;
Receiving mechanically assisted ventilation;
CCr <50 mL/min;
Significant/unstable cardiovascular disease;
Hemoglobinopathies;
Autoimmune hepatitis or hepatic decompensation before/during treatment;
Concurrent use of zidovudine;
OB: Pregnancy;
OB: Male partners of pregnant patients.

Use Cautiously in:

Sarcoidosis (may exacerbate condition);
Anemia (dose reduction/discontinuation may be required);
Any pre-existing cardiac disease;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Rep: Women of reproductive potential and men with female partners of reproductive potential;
Pedi: May result in ↓ growth in children.

Adv. Reactions/Side Effects ⬆ ⬇

Inhalation

CV: CARDIAC ARREST, hypotension

Derm: rash

EENT: blurred vision, conjunctivitis, erythema of the eyelids, ocular irritation, photosensitivity

Hemat: hemolytic anemia, reticulocytosis

Oral

Derm: pruritus (↓ in children)

EENT: optic neuritis, papilledema, retinal artery/vein thrombosis, retinal detachment, retinal hemorrhage, retinopathy (with macular edema), visual abnormalities

GI: anorexia (↑ in children), dry mouth, dyspepsia (↓ in children), vomiting (↑ in children)

GU: ↓fertility (males)

Hemat: hemolytic anemia

MS: arthralgia (↓ in children)

Neuro: depression, aggressive behavior, dizziness, emotional lability (↑ in children), faintness, fatigue (↓ in children), HOMICIDAL IDEATION, impaired concentration (↓ in children), insomnia (↓ in children), irritability (↓ in children), SUICIDAL IDEATION/ATTEMPTS

Resp: dyspnea (↓ in children)

Misc: fever (↑ in children)

Interactions ⬆ ⬇

Drug-drug:

Oral: May ↓ the antiretroviral action of zidovudine.
May ↑ hematologic toxicity of zidovudine.
May ↑ risk of pancytopenia when used with azathioprine.

Availability ⬆ ⬇

(Generic available)

Capsules: 200 mg
Powder for reconstitution for aerosol use (Virazole): 6 g/vial
Tablets: 200 mg; 400 mg; 600 mg

Route/Dosage ⬆ ⬇

RSV Infection

Inhaln (Infants and Young Children): 300 mL of 20 mg/mL solution delivered via mist for 12–18 hr/day.

Chronic Hepatitis C

Viral Genotype 1 or 4
PO (Adults ≥75 kg): 600 mg twice daily for 48 wk.
PO (Adults <75 kg): 500 mg twice daily for 48 wk.
PO (Children ≥5 yr and ≥75 kg): 600 mg in the morning, then 600 mg in the evening for 48 wk.
PO (Children ≥5 yr and 60–74 kg): 400 mg in the morning, then 600 mg in the evening for 48 wk.
PO (Children ≥5 yr and 47–59 kg): 400 mg in the morning, then 400 mg in the evening for 48 wk.
PO (Children ≥5 yr and 34–46 kg): 200 mg in the morning, then 400 mg in the evening for 48 wk.
PO (Children ≥5 yr and 23–33 kg): 200 mg in the morning, then 200 mg in the evening for 48 wk.

Renal Impairment

PO (Adults ): CCr 30–50 mL/min: 200 mg/day alternating with 400 mg/day every other day for 48 wk; CCr <30 mL/min or Hemodialysis: 200 mg once daily for 48 wk.
Viral Genotype 2 or 3
PO (Adults ): 400 mg twice daily for 24 wk.
PO (Children ≥5 yr and ≥75 kg): 600 mg in the morning, then 600 mg in the evening for 24 wk.
PO (Children ≥5 yr and 60–74 kg): 400 mg in the morning, then 600 mg in the evening for 24 wk.
PO (Children ≥5 yr and 47–59 kg): 400 mg in the morning, then 400 mg in the evening for 24 wk.
PO (Children ≥5 yr and 34–46 kg): 200 mg in the morning, then 400 mg in the evening for 24 wk.
PO (Children ≥5 yr and 23–33 kg): 200 mg in the morning, then 200 mg in the evening for 24 wk.

Renal Impairment

PO (Adults ): CCr 30–50 mL/min: 200 mg/day alternating with 400 mg/day every other day for 24 wk; CCr <30 mL/min or Hemodialysis: 200 mg once daily for 24 wk.

US Brand Names ⬆ ⬇

~~Copegus,~~ ~~Rebetol,~~ Virazole

Action ⬆ ⬇

Inhibits viral DNA and RNA synthesis and subsequent replication.
Must be phosphorylated intracellularly to be active.

Therapeutic effects:

Inhaln: Virustatic action.
PO: Decreased progression and sequelae of chronic hepatitis C.

Classifications ⬆ ⬇

Therapeutic Classification: antivirals

Pharmacologic Classification: nucleoside analogues

Pharmacokinetics ⬆ ⬇

Absorption: Systemic absorption occurs following nasal and oral inhalation. Rapidly and extensively absorbed following oral administration, but undergoes first-pass hepatic metabolism (64% bioavailability).

Distribution: 70% of inhaled drug is deposited in the respiratory tract. Appears to concentrate in the respiratory tract and red blood cells.

Metabolism/Excretion: Eliminated from the respiratory tract by distribution across membranes, macrophages, and ciliary motion. Metabolized primarily by the liver; metabolites are renally excreted.

Half-Life: Inhaln: 9.5 hr (40 days in RBCs); oral: 43.6 hr (single dose); 12 days (multiple dose).

Canadian Brand Names ⬆ ⬇

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
Inhaln	unknown	end of inhaln	unknown
PO	unknown	1.7–3 hr	12 hr

Patient/Family Teaching ⬆ ⬇

RSV: Explain purpose and side effects of medication. Advise parents to read Patient Information before starting therapy.
Inform parents that ribavirin may cause blurred vision and photosensitivity.
Chronic Hepatitis C: Instruct patient to take ribavirin at the same time each day for the full course of therapy. Take missed doses as soon as remembered. If total day dose is missed, notify health care professional; do not double doses. Advise patient to read Medication Guide before starting therapy and with each Rx refill in case of changes.
- Advise patient to brush teeth twice daily, have regular dental examinations, and rinse mouth thoroughly after vomiting to prevent dental and periodontal disorders.
- May cause dizziness, confusion, fatigue, and drowsiness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
- Inform patient that ribavirin may not reduce the risk of transmission of the hepatitis C virus (HCV) to others or prevent cirrhosis, liver failure, or liver cancer.
- Discuss with patient the possibility of hair loss. Explore methods of coping.
- Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
- Advise patient to stop taking ribavirin and notify health care professional immediately if rash with fever; blisters or sores in mouth, nose, or eyes; conjunctivitis; trouble breathing; hives or swelling; chest pain; severe stomach pain or low back pain; bloody diarrhea or bloody or black stools; bruising or unusual bleeding; change in vision; fever >100.5°F; worsening psoriasis; worsening depression; or suicidal thoughts occur.
- May cause fetal harm. Instruct women of reproductive potential and men with female partners of reproductive potential to use two forms of effective contraception during therapy and for at least 6 mo (females) and 9 mo (males) following conclusion of therapy. Men must use a condom. Avoid breastfeeding during therapy.
- Emphasize the importance of routine lab test to monitor for side effects.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

0187- Bausch Health US, LLC
- 0187-0007- Virazole
  - 0187-0007-01- 1 VIAL, GLASS in 1 CARTON (0187-0007-01) / 1 POWDER, FOR SOLUTION in 1 VIAL, GLASS

42494- Cameron Pharmaceuticals
- 42494-423- Ribavirin
  - 42494-423-01- 1 VIAL, GLASS in 1 CARTON (42494-423-01) / 1 POWDER, FOR SOLUTION in 1 VIAL, GLASS

44657- Curia Italy S.r.l.
- 44657-0076-
  - 44657-0076-1- 25 kg in 1 DRUM (44657-0076-1)

63629- Bryant Ranch Prepack
- 63629-2149- Ribavirin
  - 63629-2149-1- 1 VIAL, GLASS in 1 CARTON (63629-2149-1) / 1 POWDER, FOR SOLUTION in 1 VIAL, GLASS

65862- Aurobindo Pharma Limited
- 65862-207- Ribavirin
  - 65862-207-05- 500 TABLET, FILM COATED in 1 BOTTLE (65862-207-05)

65862- Aurobindo Pharma Limited
- 65862-207-
  - 65862-207-39- 3000 TABLET, FILM COATED in 1 BAG (65862-207-39)

65862- Aurobindo Pharma Limited
- 65862-207- Ribavirin
  - 65862-207-68- 168 TABLET, FILM COATED in 1 BOTTLE (65862-207-68)

65862- Aurobindo Pharma Limited
- 65862-290- Ribavirin
  - 65862-290-05- 500 CAPSULE in 1 BOTTLE (65862-290-05)

65862- Aurobindo Pharma Limited
- 65862-290- Ribavirin
  - 65862-290-18- 180 CAPSULE in 1 BOTTLE (65862-290-18)

65862- Aurobindo Pharma Limited
- 65862-290-
  - 65862-290-39- 3000 CAPSULE in 1 BAG (65862-290-39)

65862- Aurobindo Pharma Limited
- 65862-290- Ribavirin
  65862-290-42- 42 CAPSULE in 1 BOTTLE (65862-290-42)

65862- Aurobindo Pharma Limited
- 65862-290- Ribavirin
  - 65862-290-56- 56 CAPSULE in 1 BOTTLE (65862-290-56)

65862- Aurobindo Pharma Limited
- 65862-290- Ribavirin
  - 65862-290-70- 70 CAPSULE in 1 BOTTLE (65862-290-70)

65862- Aurobindo Pharma Limited
- 65862-290- Ribavirin
  - 65862-290-84- 84 CAPSULE in 1 BOTTLE (65862-290-84)

65862- Aurobindo Pharma Limited
- 65862-409-
  - 65862-409-37- 50 kg in 1 DRUM (65862-409-37)

66122- Zhejiang Cheng Yi Pharmaceutical Co., Ltd.
- 66122-0002-
  66122-0002-1- 51 kg in 1 DRUM (66122-0002-1)

68382- Zydus Pharmaceuticals USA Inc.
- 68382-395- RIBAVIRIN
  68382-395-04- 4 VIAL in 1 CARTON (68382-395-04) / 1 POWDER, FOR SOLUTION in 1 VIAL

68475- Navinta LLC
- 68475-003- RIBAVIRIN
  - 68475-003-04- 4 VIAL in 1 CARTON (68475-003-04) / 1 POWDER, FOR SOLUTION in 1 VIAL

68682- Oceanside Pharmaceuticals
- 68682-019- Ribavirin
  - 68682-019-01- 1 VIAL, GLASS in 1 CARTON (68682-019-01) / 1 POWDER, FOR SOLUTION in 1 VIAL, GLASS

68682- Oceanside Pharmaceuticals
- 68682-019- Ribavirin
  - 68682-019-06- 4 VIAL, GLASS in 1 CARTON (68682-019-06) / 1 POWDER, FOR SOLUTION in 1 VIAL, GLASS

72162- Bryant Ranch Prepack
- 72162-1331- Ribavirin
  - 72162-1331-2- 1 VIAL, GLASS in 1 CARTON (72162-1331-2) / 1 POWDER, FOR SOLUTION in 1 VIAL, GLASS

73301- LSNE, Inc
- 73301-006-
  - 73301-006-01- 100 mL in 1 VIAL (73301-006-01)

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Indications ⬇

Contraind./Precautions ⬆ ⬇