ribavirin

Contraindicated in:

Hypersensitivity
Patients receiving mechanically assisted ventilation
CCr <50 mL/min
Significant/unstable cardiovascular disease
Hemoglobinopathies
Autoimmune hepatitis or hepatic decompensation before/during treatment
Concurrent use of didanosine, stavudine, or zidovudine
OB: Pregnancy (may cause fetal harm)
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
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

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

Derm: pruritus (↓ in children).

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

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

GU: ↓fertility (males).

Hemat: hemolytic anemia.

MS: arthralgia (↓ in children).

Neuro: dizziness, faintness.

Resp: dyspnea (↓ in children).
Misc: fever (↑ in children).

Interactions ⬆ ⬇

Drug-Drug:

Oral: May ↓ the antiretroviral action of stavudine and zidovudine.
May ↑ hematologic toxicity of zidovudine.
May ↑ risk of pancytopenia when used with azathioprine.
May ↑ blood levels and risk of toxicity of didanosine.

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. Enters breast milk.

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 ⬆ ⬇

(blood levels)

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

Patient/Family Teaching ⬆ ⬇

RSV: Explain the purpose and route of treatment to the patient and parents.
Inform patient and 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 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; or conjunctivitis occurs and to notify health care professional if 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.
- Inform patient about teratogenic effects of ribavirin. Instruct women of reproductive potential, and men with female partners of reproductive potential, to use 2 forms of effective contraception during and for at least 6 mo following conclusion of therapy. Men must use a condom. Avoid breast feeding during therapy.
- Emphasize the importance of routine lab test to monitor for side effects.

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Indications ⬇

Contraind./Precautions ⬆ ⬇