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.
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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.
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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
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6. Contraindications |
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⚠ 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
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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.
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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.
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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.
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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.
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11. Patient Guidance |
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💊 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.
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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.
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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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