Generic Flomax .04mg 20 Caps, Tamsulosin Hydrochloride

Generic Flomax .04mg 20 Caps, Tamsulosin Hydrochloride

FLOMAX 0.4
(tamsulosin
hydrochloride)

Presentation
Capsule 0.4mg:
a capsule (elongated #2) with an orange body, olive green cap and imprinted with
the Yamanouchi logo , followed by the product code number (701) on the body, and
with the indication of the strength (0.4) on the cap.

Each capsule contains 0.4mg tamsulosin
hydrochloride equivalent to 0.367mg tamsulosin, which can be identified as pale
yellowish white, modified release granules.

Uses Actions
Tamsulosin binds selectively and
competitively to postsynaptic á1-adrenoceptors, in particular to subtypes
alpha1A and alpha1D. It brings about relaxation of prostatic and urethral smooth
muscle.

FLOMAX 0.4 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 FLOMAX 0.4.

Pharmacokinetics Absorption
Tamsulosin is
rapidly absorbed from the intestine and is almost completely bioavailable.
Absorption of tamsulosin is reduced by a recent meal.

Uniformity of absorption can be promoted by the
patient always taking FLOMAX 0.4 after the same meal.

Tamsulosin shows linear kinetics.

After a single dose of FLOMAX 0.4 in the fed state,
plasma levels of tamsulosin peak at around 6 hours and in the steady state,
which is reached by day 5 of multiple dosing, Cmax in patients is about
two-thirds higher than that reached after a single dose. Although this was seen
in elderly patients, the same finding would also be expected in young
ones.

There is a considerable inter-patient variation in
plasma levels both after single and multiple dosing.

Distribution
In humans
tamsulosin is about 99% bound to plasma proteins and the volume of distribution
is small (about 0.2L/kg).

Biotransformation
Tamsulosin
has a low first pass effect, being metabolized slowly. Most tamsulosin is
present in plasma in the form of unchanged medicine. It is metabolized in the
liver.

In rats, hardly any induction of microsomal liver
enzymes was seen to be caused by tamsulosin.

No dose adjustment is warranted in hepatic
insufficiency.

None of the metabolites are more active than
tamsulosin itself.

Excretion
Tamsulosin and its
metabolites are mainly excreted in the urine with about 9% of a dose being
present in the form of unchanged medicine.

After a single dose of FLOMAX 0.4 in the fed state,
and in the steady state in patients, elimination half-lives of about 10 and 13
hours respectively have been measured.

The presence of renal impairment does not warrant
lowering the dose.

Indications
Treatment of
functional symptoms of benign prostatic hyperplasia (BPH).

Dosage and
Administration
One capsule daily, to be taken after
breakfast, or the first meal of the day.

The capsule should be swallowed whole and should
not be crushed or chewed as this will interfere with the modified release of the
active ingredient.

Contraindications
Hypersensitivity to tamsulosin
hydrochloride or any other component of the product.

A history of orthostatic hypotension.

Severe hepatic insufficiency.

Warnings and
Precautions
As with other alpha1-blockers, reduction in blood
pressure can occur in individual cases during treatment with FLOMAX 0.4, as a
result of which, very rarely, syncope can occur. At the first signs of
orthostatic hypotension (dizziness, weakness), the patient should sit or lie
down until the symptoms have disappeared.

Before therapy with FLOMAX 0.4 is initiated, the
patient should be examined in order to exclude the presence of other conditions
which can cause the same symptoms as benign prostatic hyperplasia. Digital
rectal examination and, when necessary, determination of prostate specific
antigen (PSA) should be performed before treatment and at regular intervals
afterwards.

The treatment of severely renally impaired patients
(creatinine clearance of < 10ml/min) should be approached with caution as
these patients have not been studied.

Pregnancy And Lactation
Not
applicable as FLOMAX 0.4 is intended for male patients only.

Effects On Ability To Drive And Use Machines
No data is available on whether FLOMAX 0.4 adversely
affects the ability to drive or operate machines. However, in this respect
patients should be aware of the fact that dizziness can occur.

Adverse Effects
The following adverse reactions have been reported
during the use of FLOMAX 0.4: dizziness, abnormal ejaculation and, less
frequently (1-2%), headache, asthenia, postural hypotension and
palpitations.

Interactions
No interactions
have been seen when FLOMAX 0.4 was given concomitantly with either atenolol,
enalapril, or nifedipine. Concomitant cimetidine brings about a rise in plasma
levels of tamsulosin, and furosemide a fall, but as levels remain within the
normal range posology need not be changed.

In vitro, neither diazepam nor propranolol,
trichlormethiazide, chlormadinon, amitriptyline, diclofenac, glibenclamide,
simvastatin nor warfarin change the free fraction of tamsulosin in human plasma.
Neither does tamsulosin 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 á1-adrenoceptor
antagonists could lead to hypotensive effects.

Overdosage
No cases of acute overdosage have been
reported. However, acute hypotension could theoretically occur after overdosage
in which case cardiovascular support should be given. Blood pressure can be
restored and heart rate brought back to normal by lying the patient down. If
this does not help then volume expanders and, when necessary, vasopressors could
be employed. Renal function should be monitored and general supportive measures
applied. Dialysis is unlikely to be of help as tamsulosin is very highly bound
to plasma proteins.

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.

Pharmaceutical Precautions
None.

Incompatibilities
None
known.

Special Precautions For Storage
Store below 30°C.

Shelf-Life
FLOMAX 0.4mg
modified release capsules can be used up to four years after manufacture. The
expiry date is printed on the package.

Medicine Classification
Prescription Medicine.

Package Quantities
Strips
containing 10 capsules per strip; three strips in a cardboard box.

Please consult your medical doctor for more information and usage.