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D-TAM TABS 30S

Product code: 1125452

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D-TAM combines an alpha-blocker with a 5-alpha reductase inhibitor to treat benign prostatic hyperplasia (BPH) by relaxing prostate/bladder muscles while shrinking the enlarged prostate over time. It offers a dual-mechanism approach for men with moderate to severe BPH symptoms.

Ksh 90

D-TAM is a fixed-dose combination of Tamsulosin (an alpha-1 adrenoceptor blocker) and Dutasteride (a dual 5-alpha-reductase inhibitor) for the management of Benign Prostatic Hyperplasia (BPH) in adult men. Tamsulosin relaxes the smooth muscle of the prostate and bladder neck, providing rapid relief of urinary symptoms. Dutasteride inhibits the conversion of testosterone to dihydrotestosterone (DHT), which drives prostate growth, causing gradual prostate volume reduction over months.

Together, the combination provides both immediate symptom relief (Tamsulosin) and long-term disease modification (Dutasteride), making D-TAM suitable for men with moderate-to-severe LUTS due to BPH, particularly those with larger prostates who are at higher risk of acute urinary retention and progression requiring surgery. It is prescribed only for men; women must not handle crushed or broken capsules, as Dutasteride is absorbed through the skin and is teratogenic.

 

4. How to Take This Medicine

Usual Adult Dose

1 capsule/tablet once daily, approximately 30 minutes after the same meal each day.

Consistency

Take at the same time every day for consistent drug levels. Do not skip doses.

Swallow Whole

Swallow whole; do not crush or open the capsule. Dutasteride is a teratogen, and skin absorption by women is a risk.

Duration

Long-term treatment. Dutasteride takes 3–6 months to produce maximum prostate volume reduction. Continue even if rapid symptom relief is felt from Tamsulosin.

Missed Dose

Take as soon as remembered. If a full day has been missed, skip it and continue the next day. Never double dose.

 

5. Side Effects

Common Side Effects

·       Dizziness or orthostatic hypotension (Tamsulosin, especially on standing up suddenly)

·       Ejaculatory dysfunction, retrograde ejaculation or reduced ejaculate volume (Tamsulosin)

·       Decreased libido (Dutasteride)

·       Erectile dysfunction (Dutasteride)

·       Breast tenderness or enlargement (gynaecomastia, Dutasteride)

Uncommon Side Effects

·       Rhinitis (runny nose, Tamsulosin)

·       Headache

·       Rash or urticaria

·       Testicular pain

Serious Side Effects, Seek Immediate Medical Attention

·       Severe allergic reactions including angioedema (rare)

·       Intraoperative Floppy Iris Syndrome (IFIS) during cataract surgery; always inform the ophthalmologist before any eye surgery

·       Prostate cancer: Dutasteride lowers PSA levels by ~50%, adjust PSA interpretation accordingly; a new or rising PSA may indicate prostate cancer

 

6. Contraindications

 

The following patients should NOT use this medication:

• Women and children, for use in adult men ONLY

• Hypersensitivity to tamsulosin, dutasteride, other alpha-blockers, or 5-ARIs

• Severe hepatic impairment

• Orthostatic hypotension, history of significant postural hypotension

• Concurrent use with strong CYP3A4 inhibitors (e.g., ketoconazole) significantly increases dutasteride levels

 

 

 

7. Safety Warnings and Special Precautions

·       PSA MONITORING: Dutasteride reduces PSA by approximately 50% after 3–6 months. Establish a new baseline PSA after 3–6 months of therapy. Any increase in PSA even within the normal range warrants investigation for prostate cancer.

·       INTRAOPERATIVE FLOPPY IRIS SYNDROME: Tamsulosin causes IFIS during cataract surgery even years after stopping; always inform the ophthalmologist before any eye procedure.

·       POSTURAL HYPOTENSION: Counsel patients to rise slowly from sitting or lying position, especially at the start of therapy or after a missed dose.

·       TERATOGENICITY: Dutasteride is teratogenic. Women of childbearing age must not handle broken/crushed capsules. Blood donation prohibited for 6 months after stopping; dutasteride remains in blood.

·       BLOOD DONATION: Patients on dutasteride must not donate blood for at least 6 months after stopping treatment.

·       PROSTATE CANCER: D-TAM does not treat prostate cancer. Prostate cancer must be excluded before starting and monitored during therapy.

 

8. Drug Interactions

Strong CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir): Significantly increase dutasteride levels; avoid combination or use with caution.

Other alpha-blockers (doxazosin, prazosin): Additive hypotension, avoid concurrent use.

Antihypertensives / PDE5 inhibitors (sildenafil, tadalafil): Additive hypotensive effect, caution in combination; start sildenafil at lowest dose.

Warfarin: Dutasteride may slightly affect warfarin metabolism; monitor INR.

Verapamil/diltiazem: Moderate CYP3A4 inhibition, increased dutasteride exposure; monitor.

 

9. Storage Instructions

·       Store below 30°C in a cool, dry place.

·       Keep in original packaging, protect from moisture and light.

·       Keep away from children and women of childbearing age.

·       Do not use after expiry date.

 

10. Prescription Status in Kenya

D-TAM is a prescription-only medicine (POM) in Kenya, prescribed exclusively for adult men with BPH. Available at Pharmily with a valid prescription from a urologist, general practitioner, or physician.

 

11. Patient Guidance

 

💊 Key Points for Patients:

Take D-TAM once daily, 30 minutes after the same meal every day.

Swallow the capsule whole; do not crush or open it.

Women must not handle broken capsules; the medicine can be absorbed through the skin and is harmful in pregnancy.

It may take 3–6 months before you notice the full benefit on prostate size; continue taking the medicine even if you feel better sooner.

Rise slowly from a seated or lying position to avoid dizziness, especially in the first few weeks.

Inform any eye surgeon or ophthalmologist that you are taking D-TAM before any eye operation.

You cannot donate blood while on this medication and for 6 months after stopping.

 

 

 

12. Pharmacist / Prescriber Notes

D-TAM combines the immediate symptomatic benefit of Tamsulosin with the long-term disease-modifying effect of Dutasteride, equivalent to the originator combination product Duodart (GSK). Confirm diagnosis of BPH (with prostate cancer ruled out) before dispensing. Counsel on the dual timeline of benefit: rapid urinary flow improvement from Tamsulosin (days to weeks) versus slow prostate shrinkage from Dutasteride (3–6 months). Critical PSA counselling: Dutasteride halves PSA; establish a new baseline at 3–6 months; any PSA rise thereafter must be investigated urgently.

The IFIS risk with Tamsulosin persists indefinitely; patients must proactively disclose D-TAM use to any ophthalmologist planning cataract or other eye surgery. The teratogenicity of Dutasteride and 6-month blood donation restriction are absolute; document counselling. Flag CYP3A4 inhibitor interactions, particularly antifungal azoles commonly prescribed in Kenya.

 

13. Frequently Asked Questions (FAQs)

What is D-TAM used for?

A: D-TAM is used to treat Benign Prostatic Hyperplasia (BPH), an enlarged prostate gland, in adult men. It relieves urinary symptoms like weak stream, frequent urination, and difficulty starting urination.

How long before D-TAM works?

A: Tamsulosin improves urinary symptoms within days to weeks. Dutasteride takes 3–6 months to significantly reduce prostate size. Continue taking the full combination for maximum benefit.

Can women take D-TAM?

A: No. D-TAM is strictly for adult men only. Women, especially pregnant women, must not even handle crushed or open capsules, as dutasteride can be absorbed through the skin and cause serious harm to a male fetus.

Will D-TAM affect my PSA test results?

A: Yes. Dutasteride reduces PSA levels by about 50%. Your doctor must account for this when interpreting PSA test results. Always inform any doctor ordering a PSA test that you are on D-TAM.

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