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Bosentan monohydrate information from DrugsUpdate  

See Available Brands of Bosentan monohydrate in India

Bosentan monohydrate is indicated for the treatment of pulmonary arterial hypertension. Bosentan monohydrate is a competitive blocker of endothelin-1 receptors. The drug can improve the ability to do exercise in PAH patients and prevents worsening of symptoms.

Pharmacodynamics

No information available

Pharmacokinetics

No information available

Bosentan monohydrate Indications / Bosentan monohydrate Uses

No information available

Bosentan monohydrate Adverse Reactions / Bosentan monohydrate Side Effects

Bosentan monohydrate cause jaundice-like symptoms with itching, fatigue, headache, dizziness, GI upset, odema in the extremities and flushing.

Precautions

No information available

Special Precautions

No information available

Other Drug Interactions

Drugs such as statins, Amiodarone, diltiazem, rifampicin, erythromycin, warfarin, ketoconazole, itraconazole, fluconazole and tacrolimus may interact with Bosentan monohydrate.

Other Interactions

No information available

Dosage

Adults:
Pulmonary arterial hypertension treatment:
40 kg or over: Start with 62.5 mg, twice daily for four weeks. For maintenance therapy, the drug dosage can be increased to 125 mg, twice daily.
Less than 40 kg: Start with 62.5 mg, twice daily for four weeks. For maintenance therapy, the drug dosage should be maintained until the disappearance of clinical symptoms
 
Pediatric:
Pulmonary arterial hypertension:
Full term newborn: 1 mg/kg/oral dose, twice daily for 2 – 16 days. The dose and duration can be adjusted according to treatment response.
 
One month to twelve years:
>10 kg: Start with 1-2 mg/kg, oral dose, twice daily for 4 weeks. For maintenance, the dosage can be increased to 2-4 mg/kg, oral dose, twice daily.
10 to 20 kg: Start with 31.25 mg, oral dose, twice daily. For maintenance, the dosage can be increased to 31.25 mg, twice daily.
<20 to 40 kg: Start with 31.25 mg, oral dose, twice daily. For maintenance, the dosage can be increased to 62.5, twice daily.
<40 kg: Start with 62.5 mg, oral dose, twice daily. For maintenance, the dosage can be increased to 125 mg, twice daily.
12 years and above:
>40 kg: 62.5 mg, oral dose, twice daily.

40 kg and over: Start with 62.5 mg, oral dose, twice daily. For maintenance, the dosage can be increased to 125 mg, twice daily.

Food(before/after)

May be taken with or without food

List of Contraindications

Bosentan monohydrate and Pregnancy

Contraindicated in pregnancy
USFDA pregnancy category X. Bosentan monohydrate is a teratogenic drug that can harm the unborn fetus. Perform pregnancy tests before using Bosentan monohydrate. Use effective contraceptive modes to prevent unintended pregnancies while taking Bosentan monohydrate. Bosentan monohydrate is contraindicated in pregnant women.

Bosentan monohydrate and Lactation

Nursing mothers should consult the healthcare provider before Bosentan monohydrate treatment.

Bosentan monohydrate and Children

No information available

Bosentan monohydrate and Geriatic

No specific information

Bosentan monohydrate and Other Contraindications

No information available

Storage

Store at 20-25°C

Lab interference

Store at 20-25°C

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