BOSENTAS
Brand:
BOSENTAS
Manufacturer:
CIPLA
Manufacturer Details
CIPLA
Compositions:
Bosentan monohydrate 62.5mg/ 125mg tabs,
|
Strength
|
Rate
|
Packing Style
|
|
62.5mg
|
897.13
|
10s tablets
|
|
125mg
|
1359.26
|
10s tablets
|
List of Related Indications:
List Of Drugs:
- Bosentan monohydrate - @ -Vasodilators- (June 2009)
Indication Type Description:
Pharmacology/ Pharmacokinetics
Drug Interaction:
Ketoconazole, Itraconazole, Voriconazole, Fluconazole Ritronavir Cyclosporin Rifampicin Nimodipine Glibenclamide Tacrolimus, Sirolimus Sidenafil, Simavastatin Warfarin, Digoxin, O.C.
Indication:
Pulmonary arterial hypertension
New drugs approved For Marketing by Drug Controller General of India(DCGI )
during the period January 1988 to November 2014
(Ref- IDMA Annual Publication 2015)
Name of Drug Indication Date of Approval
Bosentan as monohydrate tablets 62.5mg/125mg 23-06-2009
For the treatment of pulmonary arterial hypertension
(who group in patients with class III or or IV symptoms.
To improve excercise ability and decrease the rate of
clinical worsening
Adverse Reaction:
Headache, flushing, abnormal hepatic function Leg oedema, Anemia URTIs , Nasopharyngitis, pneumonia Palpitation, dypepsia, dry mouth Hypotension,chest pain, pruritus, fatigue Arthalgia, dizzinees Rarely liver failure, anaphylaxis, neutropenia, leucopenia
Contra-Indications:
Moderate to severe hepatic impairment, Hepatic aminotransferase levels > 3 upper limit. Concomittant cyclosporin, glibenclamide Pregnancy Lactation
Special Precautions-
Raised liver enzymes Monitor prior to and at monthly itervals during therapy and two weeks after any increase in dose.
Advice patients to report any signs suggestive of liver damage Monitor for signs of fluid retention, LV, severe systolic dysfunction
Women of child bearing potential should use non-hormonal contraception during treatment Peform monthly pregnancy tests where appropiate . Hypotension.Withdraw gradually.
Dosages/ Overdosage Etc:
Indication-
Pulmonary arterial hypertension
Dosage-
Dosages above Initially 62.5mg twice daily for 4 weeks increasing to maintenance of 125mg twice daily
Maximum dose- dosage above 125mg twice daily did not appear to confer additional benefit to offset the increased risk of liver injury
Children below 12 years- consult doctor
Patient Information:
Discuss with patients the importance of monthly monitoring of serum aminotransferases and urine or serum pregnancy testing and of avoidance of pregnancy.
Discuss options of effective contraception and measures to prevent pregnancy with women. Seek input from a gynaecologist or an expert on adequate contraception as needed.
Pharmacology/ Pharmacokinetics:
Pharmacology-
Bosentan is a specific and competetive antagonist at endothelin receptor types ETa ETb . Bosantan has a slightly higher affinity for ETa receptors than for ETb receptors
Phamacokinetics-
After oral admin of Bosentan Cmx of bosentan are attained within 3 to 5 hours. Steady state is reached within 3 to 5 days
Pregnancy and lactation:
Contraindicated in pregnancy and lactation
