Class: 5-alpha reductase inhibitors, alpha blocker

Manufacturer: Saitech Medicare Pvt. Ltd, Village Kheri Trilokpur Road, Kala-Amb 173 030 (H.P.), India.

Dosage Form: Tablet

Similar Brands:

Uses:

D-TAM indicated for the treatment of symptomatic benign hyperplasia in men with enlarged prostrate.

Dosage:

One tablet of D-TAM (Dutasteride 0.5mg and Tamsulosin Hydrochloride 0.4mg) once daily approximately 30 minutes after the same meal each day. Or as directed by the physician.

Side Effects:

The most common adverse reactions, reported in ≥1% of patients, treated with coadministered dutasteride and tamusolin are ejaculation disorders, impotence, decreased libido, dizziness, and breast disorders.

Warnings & Precautions:

Orthostatic hypotension and/or syncope can occur. Adverse patients of symptomatic related to postural hypotension and to avoid situations where injury could result if syncope occurs.

Do not use D-TAM with other alpha adrenergic antagonists, as this may increase the risk of hypotension, D-TAM reduces serum prostate-specific antigen (PSA) concentration by approximately 50%. However, any confirmed increase in PSA while on D-TAM may signal the presence of prostate cancer and should be evaluated, even if those values are still within the normal range of untreated men.

Do not use D-TAM with strong inhibitors of cytochrome P450 (GYP) 3A4 (e.g. ketoconazole). Use caution in combination with moderate CYP3A4 inhibitors (e.g erythromycin) Concomitant use with known inhibitors can cause marked increase in drug exposure.

Exercise caution with concomitant use of phosphodiesterase-5 inhibitors (PDE-5), as this may increase the risk of hypotension.

Drugs that contain dutasteride, including D-TAM, may increase the risk of high-grade prostate cancer.

Prior to initiating treatment with D-TAM, consideration should be given to other urological conditions that may cause similar symptoms.

Women who are pregnant or could become pregnant should not handle D-TAM tablets due to potential risk to a male fetus.

Advise patients about the possibility and seriousness of priapism.

Patients should not donate blood until 6 months after their last dose of D-TAM, intraoperative floppy iris syndrome has been observed during cataract surgery to tell their ophthalmologist that they take or have taken D-TAM tablets. Exercise caution with concomitant use of warfarin

Pregnancy & Lactation:

Category X

D-TAM is contraindicated for use in women.

Dutasteride: as with other 5-alpha reductase inhibitors, dutasteride inhibits the conversion of testosterone to dihydrotestosterone and may, if administered to a woman carrying a male foetus, inhibit the development of the external genitalia of the foetus.

Nursing mothers

D-TAM is contraindicated for use in women. It is not known whether dutasteride or tamsulosin is excreted in breast milk.

Drug Interactions:

Avoid with strong inhibitors of CYP3A4 (e.g. ketoconazole); may increase tamsulosin exposure. Caution with potent, chronic inhibitors of CYP3A4 (e.g ritonavir), moderate inhibitors of CYP3A4 – (e.g erythromycin), strong (e.g. paroxetine) or moderate (e.g. terbinafine) inhibitors of CYP2D6; potential for significant increase in tamsulosin exposure when coadministered with a combination of both CYP3A4 and CYP2D6 inhibitors. Caution with cimetidine and warfarin. Avoid with other alpha-adrenergic antagonists; may cause symptomatic hypotension

Contraindications:

D-TAM is contraindicated for use in pregnancy, women of child bearing potential, pediatric patients. Patients with previously demonstrated, clinically significant hypersensitivity (e.g. serious skin reactions, angioedema) to dutasteride, other 5α-reductase inhibitors, tamsulosin, or any other component of D-TAM.

Price: Ksh 2,185

Notes:

Composition

Each film coated tablet contains:

Tamsulosin Hydrochloride BP 0.4mg, Dutasteride BP 0.5mg, Excipients q.s.

Colour: Titanium Dioxide BP

Mechanism of action

D-TAM (Dutasteride/Tamsulosin) is a combination of two drugs with complementary mechanism of action to improve symptoms in patients with Benign Prostatic Hyperplasia (BPH): dutasteride, a dual 5alpha-reductase inhibitor (SARI) and tamsulosin hydrochloride, an antagonist of alpha 1A-adrenoreceptors.

Dutasteride: Selective type I and II 5α-reductase inhibitor, inhibits conversion of testosterone to dihydrotestosterone, the androgen primarily responsible for the initial development and subsequent enlargement of the prostate gland.

Tamsulosin: α1 A antagonist; selective blockade of α1adrenoceptors in the prostate results in relaxation of the smooth muscles of the bladder neck and prostate, improving urine flow rate and reducing BPH symptoms.

Pediatric use

D-TAM is contraindicated for use in pediatric. Safety and effectiveness of D-TAM in pediatric patients have not been established.

Getriatric use

Of 1,610 male subjects treated with co administered dutasteride and tamsulosin in combAT trial, 58% of enrolled subjects were aged 75 years and older. No overall differences in safety or efficacy wore observed between these subjects and younger subjects but greater sensitivity of some older individuals cannot be ruled out.

Overdose

Dutasteride: in volunteer studies, single doses of dutasteride up to 40mg (80 times the therapeutic dose) for 7 days have been administered without significant safety concerns. In a clinical study, daily doses of 5mg (10 times the therapeutic dose) were administered to 60 subjects of 6 months with no additional adverse effects to those seen at therapeutic doses of 0.5mg. There is no specific antidote for dutasteride. Therefore, in cased of suspected overdosage symptomatic and supportive treatment should be given as appropriate, taking the long half-life of dutasteride into consideration.

Tamsulosin: should over dosage of tamsulosin lead to hypotension, support of the cardiovascular system is of first importance. Restoration of blood pressure and normalization of heart rate may be accomplished by keeping the patient in the supine position. If this measure is inadequate, then administration of intravenous fluids should be considered. If necessary, vasopressors should then be used and renal function should be monitored and supported as needed. Laboratory data indicated that tamsulosin is 94% to 99% protein bound; therefore, dialysis is unlikely to be of benefit.

Manufactured for: Galaxy Pharmaceutical Ltd, P.O Box 39107-00623, Nairobi, Kenya