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Maxflo-U®
Presentation
Maxflo-U® Capsule: Each capsule contains Tamsulosin Hydrochloride INN 0.4 mg as modifiedrelease pellets.
Description
Maxflo-U® (Tamsulosin Hydrochloride) is a selective antagonist of alpha1A adrenoreceptor in
the prostate. It is also called alpha1A-urospecific antagonist. This selectivity of Tamsulosin may
result in a reduced incidence of cardiovascular side effects. Maxflo-U® (Tamsulosin
Hydrochloride) binds selectively and competitively to postsynaptic Alpha1-adrenoreceptors, in
particular to subtypes alpha1A and alpha1D. It brings about relaxation of Prostatic and urethral
smooth muscle.
Tamsulosin increases the maximum urinary flow rate. It relieves obstruction by relaxing smooth
muscle in prostate and urethra.
It also improves the irritative symptoms in which bladder instability plays an important role.
These effects on storage and voiding symptoms are maintained during long-term therapy. The
need for surgical treatment is significantly delayed.
Alpha1-blockers can reduce blood pressure by lowering peripheral resistance. No reduction in
blood pressure of any clinical significance was observed during studies with Maxflo-U®
(Tamsulosin Hydrochloride).Tamsulosin Hydrochloride is not indicated for the treatment of
hypertension.
Indication and Use
Maxflo-U® (Tamsulosin Hydrochloride) capsules are indicated for the treatment of the signs and
symptoms of Benign Prostatic Hyperplasia (BPH).
Dosage and Administration
Maxflo-U® (Tamsulosin Hydrochloride) 0.4 mg daily is recommended as the dose for the
treatment of the signs and symptoms of Benign Prostatic Hyperplasia (BPH). It should be
administered approximately half an hour following the same meal each day. For those patients
who fail to respond to the 0.4-mg dose after two to four weeks of dosing, the dose of Maxflo-U®
(Tamsulosin Hydrochloride) can be increased to 0.8 mg once daily.
Contraindication
Tamsulosin Hydrochloride is contraindicated in patients known to be hypersensitive to
Tamsulosin Hydrochloride. It is also contraindicated to patients with a history of orthostatic
hypotension and severe hepatic insufficiency.
Use in Pregnancy and Lactation
Tamsulosin Hydrochloride is not recommended for women.
Pediatric Use
Tamsulosin Hydrochloride is not indicated for use in the pediatrics.
Effects on ability to Drive and use Machines
No data is available on whether Tamsulosin adversely affects the ability to drive or operate
machines. However, in this respect, patients should be aware of the fact that dizziness may
occur.
Side Effect
The following adverse reactions have been reported during the use of Tamsulosin Hydrochloride
Capsules: Dizziness, abnormal ejaculation and less frequently (1-2%) headache, asthenia,
postural hypotension and palpitations.
Precaution
Carcinoma of the prostate: Carcinoma of the prostate and Benign Prostatic Hyperplasia (BPH)
causes many of the same symptoms. These two diseases frequently co-exist. Patients should be
evaluated prior to the start of Tamsulosin Hydrochloride therapy to rule out the presence of
carcinoma of the prostate.
The pharmacokinetic and pharmacodynamic interactions between Tamsulosin Hydrochloride and
other alpha-adrenergic blocking agents have not been determined. However, interactions may be
expected and Maxflo-U® should not be used in combination with other alpha-adrenergic
blocking agents.
Warning
The signs and symptoms of orthostasis (postural hypotension, dizziness and vertigo) were
detected more frequently in Tamsulosin Hydrochloride. As with other alpha-1 adrenergic
blocking agents, there is a potential risk of syncope.
Drug Interaction
Treatment with Cimetidine resulted in a significant decrease (26%) in the clearance of
Tamsulosin Hydrochloride that resulted in a moderate increase in Tamsulosin Hydrochloride.
Therefore, Maxflo-U® should be used with caution in combination with Cimetidine, particularly
at doses higher than 0.4 mg.
No interactions have been seen when Tamsulosin Hydrochloride was given concomitantly with
either atenolol, enalapril or nifedipine. In vitro, neither diazepam nor propranolol,
trichlormethiazide, chlormadinon, amitriptyline, diclofenac, glibenclamide, simvastatin, warfarin
changes the free fraction of Tamsulosin in human plasma. Neither does Tamsulosin
Hydrochloride change the free fractions of diazepam, propranolol, trichlormethiazide and
chlormadinon.
No interactions at the level of hepatic metabolism have been seen during in vitro studies with
liver microsomal fractions (representative of the cytochrome P450-linked drug metabolizing
enzyme system), involving amitriptyline, salbutamol, glibenclamide and finasteride. Diclofenac
and warfarin, however, may increase the elimination rate of Tamsulosin.
Concurrent administration of other alpha1-adrenoreceptor antagonists could lead to hypotensive
effects.
Overdose
As overdose of Tamsulosin Hydrochloride capsules lead to hypotension, support the
cardiovascular system is of first importance. Restoration of blood pressure and normalization of
heart rate may be accomplished by keeping the patient in supine position. If this measure is
inadequate, then administration of intravenous fluid should be considered. Measures, such as
emesis, can be taken to impede absorption. When large quantities are involved, gastric lavage
can be applied and activated charcoal and an osmotic laxative, such as sodium sulphate, can be
administered.
Storage Condition
Store in a cool & dry place, protected from light & moister.
Keep Maxflo-U® (Tamsulosin Hydrochloride) out of the reach of children.
Commercial Pack
Maxflo-U® capsule: Box containing 7x4 capsules in Alu-Alu blister pack.