Diclofenac and warfarin may decrease elimination of tamsulosin.

However dosage adjustments are not required but excercise caution with warfarin. No significant interaction with nifedipine, altenolol, enalapril, digoxin, or theophylline was observed Dutasteride pharmacokinetics is not significantly affected by concomittant exposure to alpha 1-adrenoceptor antagonists (eg. tamsulosin) digoxin, or warfarin.

Benign prostatic hyperplasia

US FDA APPROVED LIST- 2006

Combiikit of Tamsulosin Hcl 0.4mg M.R Capsules 10 Nos &

Dutaseride Soft gelatin Capsules 0.5mg 10 nos

For BPH

19/01/2006

Dutastertride was generally well tolerated. Impotence, reduced libido, gynaecomastia and ejaculation disorder occured significantly more often in diasteride than placebo receipients, but incidence was generally low.

The incidence of adverse events with tamsulosin was siimilar to that with placebo in two randomised, double-binded 13 weeks studies.

The common adverse efects are dizziness, abnormal ejaculation, rhinitis, gastrointestinal upset.

Hypersensitivity , severe liver enlargement,

Pregnancy, lactation,
child, adolescent

Special Precautions-

Excreted in semen  therefore use of condom recommended
Women of child bearing potential should avoid handling leaking capsule of dutasteride

Prostrate carcinoma should be ruled out before starting the therapy
Blood  donation to be avoided during and at least 6mths after discontinuation of drug

Indication-

Benign prostatic hyperplasia

Dosage-

To be taken after a meal

Recommended dosage is 0.4 mg taken orally once daily after a meal. Diasteride recommendedcdosage is 0.5mg taken once daily after meals

Pharmacology-

Tamusulosin is a selective alpha 1A and alpha 1D adrenoreceptor antagonist making the probable choice in the management of BPH Dutasteride , 4-azasteroid is a selective inhibitor of type 1 and 2 5-alpha reductase. Duatasteride reduced DHT levels in a majority of patients.

Pharmacokinetics-

Tamsulosin has an oral bioavailability of 90%. The steady state plasma concentration is acheived by day 5, 99% bound to plasma proteins.

Tamsulosin undegoes hepatic metabolism (cytochrome P450) with minimally active metabolites mainly excreted in the urine. Dutasteride is quickly absorbed from the intestine with bioavailability of approximately 60% (range 40-94%) with steady state plasma concentrations demonstrating dose proportionately that are reached after 3- 6 monhs . Mean steady-state dutasteride serum concentration were 40 mg/ml. The protein binding was > 99.5%.

The elimination half-life was 3-5 weeks. Rational for combination therapy- Long term treatment with combination therapy resulted in greater improvement in the AUA symptom score than did either drug alone. Long term therapy is both safe and the most effective therapy for patients with lower urinary tract symptoms LUTS and benign prostatic hyperplasia and its use is appropiate in men with increased risk of progression.

To be taken after a meal