Description
Generic
Tamsulosin Hydrochloride + Dutasteride
Indications
This capsule is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate.
Pharmacology
Tamsulosin & Dutasteride is a medication combination that improves symptoms in people with Benign Prostatic Hyperplasia by combining two medicines with complementary mechanisms of action (BPH). Dutasteride, a dual 5 alpha reductase inhibitor, and Tamsulosin Hydrochloride, an antagonist of alpha1A-adrenoreceptors (5ARI). The use of alpha1-adrenoreceptor blockers with 5ARIs to treat BPH leads to an increase in urine flow rate and a reduction in BPH symptoms.
Tamsulosin: An alpha1-adrenoreceptor blocking agent that affects the dynamic component of BPH by inhibiting alpha1-adrenoreceptors in the stromal prostatic smooth muscle and bladder neck. Blockade of these adrenoreceptors can cause smooth muscles in the bladder neck and prostate to relax. Specifically, Tamsulosin exhibits selectivity for both alpha 1A and alpha 1D receptors over the alpha1B-adrenoreceptor subtype. These three adrenoreceptor subtypes have a distinct distribution pattern in human tissue. Whereas approximately 70% of the alpha1-receptors in human prostate are of the alpha 1A subtype, the human bladder contains predominantly the alpha 1D subtype while blood vessels express predominantly alpha 1B subtype. It is further believed that blockade of the alpha 1D subtypes in the human obstructed bladder may be responsible for reducing detrusor overactivity and subsequent relief of storage symptoms.
Dutasteride: A synthetic 4-azasteriod compound is a competitive and specific inhibitor of both Type I and Type II 5 alpha-reductase isoenzymes that affects the static component of BPH by inhibiting the conversion of Testosterone to Dihydrotestosterone (DHT) by the enzyme 5 alpha-reductase. 5 alpha-reductase exists as 2 isoforms, Type I and Type II, both of which are present in the prostate. It has been observed that compared to normal tissue, the expression of both isoenzymes are increased in BPH tissue. Dissociation from this complex has been evaluated under in vitro and in vivo conditions and is extremely slow. Dutasteride lowers DHT levels and leads to a reduction in prostatic volume, thereby treating an underlying cause of BPH. Dutasteride does not bind to the human androgen receptor.
Dosage & Administration
Adults (including elderly): The recommended dose is one capsule (Tamsulosin Hydrochloride 0.4 mg & Dutasteride 0.5 mg) taken orally approximately 30 minutes after the same meal each day. The capsules should be swallowed whole and not chewed or opened. Where appropriate, this capsule may be used to substitute concomitant Tamsulosin Hydrochloride and Dutasteride in existing dual therapy to simplify treatment. Where clinically appropriate, direct change from Tamsulosin Hydrochloride or Dutasteride monotherapy to this capsule may be considered.
Renal impairment: The effect of renal impairment on Tamsulosin-Dutasteride pharmacokinetics has not been studied. No adjustment in dosage is anticipated for patients with renal impairment.
Hepatic impairment: The effect of hepatic impairment on Tamsulosin-Dutasteride pharmacokinetics has not been studied so caution should be used in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the use of this capsule is contra-indicated.
Interaction
Concurrent administration of other alpha-1 adrenoceptor antagonists could lead to hypotensive effects. This capsule should not be used in combination with other alpha-adrenergic blocking agents. This tablet should be used with caution in combination with cimetidine. Caution should be exercised with concomitant administration of warfarin and this capsule.
Contraindications
This capsule is contraindicated for use by women and children. It is contraindicated in patients known to be hypersensitive to Tamsulosin, Dutasteride or any component of the capsule.
Side Effects
The following adverse reactions have been reported during the use of this capsule: dizziness, abnormal ejaculation, back pain, chest pain, diarrhea, tooth disorder, libido decreased, insomnia, rhinitis, pharyngitis, sinusitis, and asthenia.
Pregnancy & Lactation
This capsule is not indicated for use in women. These capsules are not indicated for use in nursing mothers.
Precautions & Warnings
Lower Urinary Tract symptoms of BPH can be indicative of urological diseases, including prostate cancer. Patients should be assessed to rule out other urological diseases prior to treatment with this capsule. The treatment of severely renal impaired patients (creatinine clearance is less than 10ml/min) should be approached with caution as these patients have not been studied.
Therapeutic Class
BPH/ Urinary retention/ Urinary incontinence
Storage Conditions
Keep all medicines out of reach of the children. Store in a cool and dry place protected from light.
Pharmaceutical Name
ACME Laboratories Ltd.
