Omnistat
- Each capsule of Omnistat® contains:
Tamsulosin hydrochloride 0,4 mg.
Indecation
- Omnistat® capsules are indicated for the treatment of the signs and symptoms of
benign prostatic hyperplasia (BPH). These signs and symptoms may include
difficulty urinating (Poor stream), dribbling, urgency and having to urinate
frequently at night as well as during the day.
- Omnistat® capsules are not indicated for the treatment of hypertension.
Dosage & Administration
- Omnistat® capsules should not be crushed, chewed or opened.
- 0.4 mg once daily taken approximately one-half hour following the same meal each
day.
- Can be increased to 0.8 mg once daily for patients who fail to respond to the 0.4
mg dose after 2 to 4 weeks of dosing .
- If discontinued or interrupted for several days, therapy should start again with the
0.4 mg once-daily dose .
* Women & Children:
- Omnistat® capsules are not for women and children .
Pharmacodynamic
Mechanism of Action:
- Tamsulosin, an alpha1 adrenoceptor blocking agent, exhibits selectivity for alpha1
receptors in the human prostate. At least three discrete alpha1 - adrenoceptor
subtypes have been identified: alpha1A , alpha1B and alpha1D ; their distribution
differs between human organs and tissue. Approximately 70% of the alpha1-
receptors in human prostate are of the alpha1A subtype.
Pharmacokinetic properties:
- Absorption
Absorption of tamsulosin hydrochloride from Omnistat® capsules 0.4 mg is
essentially complete (>90%) following oral administration under fasting conditions.
Tamsulosin hydrochloride exhibits linear kinetics following single and multiple
dosing, with achievement of steady-state concentrations by the fifth day of
once-a-day dosing.
- Distribution
The mean steady-state apparent volume of distribution of tamsulosin hydrochloride
after intravenous administration to ten healthy male adults was 16 L, which is
suggestive of distribution into extracellular fluids in the body. Tamsulosin
hydrochloride is extensively bound to human plasma proteins (94% to 99%).
- Metabolism
Tamsulosin hydrochloride is extensively metabolized by cytochrome P450 enzymes
in the liver and less than 10% of the dose is excreted in urine unchanged.
- Exceration
On administration of the radiolabeled dose of tamsulosin hydrochloride to four
healthy volunteers, 97% of the administered radioactivity was recovered, with urine
(76%) representing the primary route of excretion compared to feces (21%) over 168
hours. Following intravenous or oral administration of an immediate-release
formulation, the elimination half-life of tamsulosin hydrochloride in plasma range
from five to seven hours. Because of absorption rate-controlled pharmacokinetics
with Omnistat® capsules, the apparent half-life of tamsulosin hydrochloride is
approximately 9 to 13 hours in healthy volunteers and 14 to 15 hours in the target
population.
- Omnistat® capsules are contraindicated in patients known to be hypersensitive to
tamsulosin hydrochloride or any component of Omnistat® capsules.
Cytochrome P450 Inhibition
- Tamsulosin is extensively metabolized, mainly by CYP3A4 and CYP2D6.
The effects of coadministration of both a CYP3A4 and a CYP2D6 inhibitor with
Omnistat® capsules have not been evaluated. However, there is a potential for
significant increase in tamsulosin exposure when Omnistat® 0.4 mg is
coadministered with a combination of both CYP3A4 and CYP2D6 inhibitors.
- Treatment with cimetidine resulted in a significant decrease (26%) in the clearance of
tamsulosin hydrochloride, which resulted in a moderate increase in tamsulosin
hydrochloride AUC (44%).
PDE5 Inhibitors(A phosphodiesterase type 5 inhibitor)
Caution is advised when alpha adrenergic blocking agents including Omnistat® are
coadministered with PDE5 inhibitors. Alpha-adrenergic blockers and PDE5
inhibitors are both vasodilators that can lower blood pressure. Concomitant use of
these two drug classes can potentially cause symptomatic hypotension.
Warfarin
Caution should be exercised with concomitant administration of warfarin and
Omnistat®capsules.
Nifedipine, Atenolol, Enalapril
Dosage adjustments are not necessary when Omnistat® capsules are administered
concomitantly with nifedipine, atenolol, or enalapril.
Digoxin and Theophylline
Dosage adjustments are not necessary when a Omnistat® capsule is administered
concomitantly with digoxin or theophylline .
Furosemide
Omnistat® capsules had no effect on the pharmacodynamics (excretion of
electrolytes) of furosemide. While furosemide produced an 11% to 12% reduction in
tamsulosin hydrochloride C max and AUC, these changes are expected to be
clinically insignificant and do not require adjustment of the Omnistat® capsules dosage
- Omnistat® is not indicated for use in pregnant and lactating women. Tamsulosin
hydrochloride is present in the milk of lactating rats.
Like all medicines, Omnistat® can cause sides effects, although not everybody gets
them.
Common (less than 1 in 10, more than 1 in 100 (1 - 10%)):
- Dizziness, particularly when going to sit or stand up.
- Abnormal ejaculation. The latter means that semen does not leave the body via the
urethra, but instead goes into the bladder. This phenomenon is harmless.
Uncommon (More than 1 in 1000, less than 1 in 100 (0,1 - 1%)):
- Headache, palpitations (the heart beats more rapidly than normal and it is also
noticeable ), reduced blood pressure e.g. when getting up quickly from a seating or
lying position sometimes associated with dizziness; runny or blocked nose
(rhinitis), diarrhoea, feeling sick and vomiting, constipation, weakness
(asthenia), rashes, itching and hives(urticaria).
Rare(More than 1 in 10,000, less than 1 in 1000 (0,01 - 0,1%)):
- Faintness and sudden local swelling of the soft tissues of the body (e.g. the throat or
tongue) difficult breathing and /or itching and rash, often as an allergic reaction
(angioedema).
Vary rare (less than 1 in 10,000 (<0,01%)):
- Priapism (painful prolonged unwanted erection for which immediate medical
treatment is required).
- Rash, inflammation and blistering of the skin and / or mucous membrane of the lips,
eyes, mouth, nasal passages or genitals (Stevens-Johnson syndrome).
- Abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia),
difficult breathing (dyspnoea).
Overdosage:-
- Overdosage with tamsulosin hydrochloride can potentially result in severe hypotensive
effects. Gastric lavage can be applied and activated charcoal and an osmotic laxative.
Laboratory data indicate that tamsulosin is 94% to 99% protein bound; therefore dialysis
is unlikely to be of benefit.
* Orthostasis
Patients beginning treatment with Omnistat® capsules should be cautioned to avoid
situations in which injury could result should syncope occur.
* Screening for Prostate Cancer
Prostate cancer and BPH frequently coexist; therefore, patients should be screened
for the presence of prostate cancer prior to treatment with Omnistat®capsules and at
regular intervals afterwards.
* Intraoperative Floppy Iris Syndrome (IFIS)
IFIS may increase the risk of eye complications during and after the operation.
* Sulfa Allergy
In patients with sulfa allergy, allergic reaction to Omnistat®capsules has been rarely
reported. If a patient reports a serious or life-threatening sulfa allergy, caution is
warranted when administering Omnistat®capsules.
Use in Specific Populations:-
* Renal impairment
Patients with renal impairment do not require an adjustment in Omnistat® capsules
dosing. However, patients with end-stage renal disease have not been studied.
* Hepatic Impairment
Patients with moderate hepatic impairment do not require an adjustment in
Omnistat®capsules dosage. Omnistat® has not been studied in patients with severe
hepatic impairment.
* Geriatric Use
Of the total number of subjects (1783) in clinical studies of tamsulosin, 36% were 65
years of age and over. No overall differences in safety or effectiveness were observed
between these subjects and younger subjects, and the other reported clinical
experience has not identified differences in responses between the elderly and
younger patients.
- Omnistat® ( Blister of 10 capsules, pack of three Blister).
- Store at a temperature not exceeding 25 °C, protect from light.