Pioglitazone Hydrochloride Tablets (P-Glitz) are used along with diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

1. Pioglitazone Hydrochloride Tablets
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Pioglitazone Hydrochloride Tablets (P-Glitz) are
used along with diet and exercise to improve
glycemic control in adults with type 2 diabetes
mellitus.

2. P-Glitz Tablets
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P-Glitz Tablets are manufactured by
Cipla Limited, India.
(Website: www.cipla.com)

3. Pioglitazone Hydrochloride Tablets – Brand Names
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Pioglitazone Hydrochloride tablets are
available as Actos, P-Glitz, Pioglit ,
Diavista, Bioglita, Dibizone, Elith, G-
Tase, Glizone, Glito, Oglo, Opam,
Path, Pepar, Piogem, Pioglar, Piokap,
Piolem, Piolet, Piomed, Piomeri,
Pionorm,Piorest, Piosafe, Piosys,
Piostar, Piotop, Piozit, Piozone,
Pizorad, Pozitiv and Zipio.

4. Active Ingredient
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The active ingredient contained in P-Glitz
tablets is Pioglitazone Hydrochloride.
Each P-Glitz tablet contains 30 mg of
Pioglitazone Hydrochloride.

5. Chemical Structure
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The structure of Pioglitazone Hydrochloride
is given below:

6. Uses of P-Glitz Tablets
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P-Glitz (Generic Pioglitazone Tablets) is an
oral diabetes medicine that is used along
with diet and exercise to control blood sugar
levels. P-Glitz tablets are indicated for
people with type 2 diabetes.
P-Glitz is sometimes used in combination
with insulin or other medications, but it is not
for treating type 1 diabetes.

7. Pioglitazone HCl Tablets Dosage
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➢P-Glitz (Generic Pioglitazone tablets) should be
taken once daily and can be taken without regard to
meals.
➢The recommended starting dose for patients
without congestive heart failure is 15 mg or 30 mg
once daily.
➢The recommended starting dose for patients with
congestive heart failure (NYHA Class I or II) is 15 mg
once daily.
➢The dose can be titrated in increments of 15 mg up
to a maximum of 45 mg once daily based on
glycemic response as determined by HbA1c.
The dosage of P-Glitz tablets (Pioglitazone
Hydrochloride) is given below:

8. Storage Instructions
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P-Glitz (Generic Pioglitazone
Hydrochloride tablets) have to be stored
at controlled room temperature i.e. from
20°C to 25°C (68°F to 77°F) with
excursions permitted between 15° to
30°C (59° to 86°F).
Protect from moisture. Dispense in a
tight, light-resistant container.
Keep this as well as all other medicines
away from children and pets.

9. Warnings
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Pioglitazone Hydrochloride , like other thiazolidinediones,
can cause dose-related fluid retention when used alone
or in combination with other antidiabetic medicines and is
most common when Pioglitazone Hydrochloride is used
in combination with insulin.
In controlled clinical trials, edema was reported more
frequently in patients treated with Pioglitazone
Hydrochloride than in placebo-treated patients and is
dose-related.
There have been postmarketing reports of fatal and non-
fatal hepatic failure in patients taking Pioglitazone
Hydrochloride, although the reports contain insufficient
information necessary to establish the probable cause.
There has been no evidence of drug-induced
hepatotoxicity in the Pioglitazone Hydrochloride
controlled clinical trial database to date.

10. Warnings
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During clinical trials patients were force-titrated up to 45 mg
daily or placebo. During a mean follow-up of 34.5 months, the
incidence of bone fracture in females was 5.1% for
Pioglitazone Hydrochloride versus 2.5% for placebo.No
increase in the incidence of fracture was observed in men
treated with Pioglitazone Hydrochloride (1.7%) versus placebo
(2.1%). The risk of fracture should be considered in the care of
patients, especially female patients, treated with Pioglitazone
Hydrochloride.
Tumors were observed in the urinary bladder of male rats in the
two-year carcinogenicity study. In two 3-year trials in which
Pioglitazone Hydrochloride was compared to placebo or
glyburide,after excluding patients in whom exposure to study
drug was less than one year at the time of diagnosis of bladder
cancer, there were six (0.16%) cases on Pioglitazone
Hydrochloride and two (0.05%) cases on placebo.

11. Warnings
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Patients receiving Pioglitazone Hydrochloride
in combination with insulin or other anti-
diabetic medications (particularly insulin
secretagogues such as sulfonylureas) may be
at risk for hypoglycemia.
Macular edema has been reported in
postmarketing experience in diabetic patients
who were taking Pioglitazone Hydrochloride
or another thiazolidinedione. Some patients
presented with blurred vision or decreased
visual acuity, but others were diagnosed on
routine ophthalmologic examination.

12. Warnings
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Therapy with Pioglitazone Hydrochloride , like
other thiazolidinediones, may result in
ovulation in some premenopausal anovulatory
women. As a result, these patients may be at
an increased risk for pregnancy while taking
Pioglitazone Hydrochloride.
There have been no clinical studies
establishing conclusive evidence of
macrovascular risk reduction with
Pioglitazone Hydrochloride or any other anti-
diabetic drug.

13. P-Glitz Tablets
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Contraindications
P-Glitz is contraindicated in patients with a
hypersensitivity to Pioglitazone Hydrochloride
or any other component of this medication.
Do not administer this medicine in patients with
NYHA Class III or IV heart failure.

14. Generic Pioglitazone HCl Side Effects
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➢Most common Generic Pioglitazone Hydrochloride side
effects with an incidence rate of 5% or more and at a
rate higher than with placebo include upper respiratory
tract infection, headache, sinusitis, myalgia, and
pharyngitis.
➢Stop using Generic Pioglitazone (P-Glitz) and call your
doctor immediately in case you have any of these serious
side effects: stomach pain, blood in your urine; painful
urination; feeling short of breath, even with mild exertion;
swelling or rapid weight gain; chest pain, general ill
feeling; nausea, upper stomach pain, itching, loss of
appetite, dark urine, clay-colored stools, jaundice
(yellowing of the skin or eyes); blurred vision;
increased thirst or hunger, urinating more than usual; or
pale skin, easy bruising or bleeding, weakness.

15. Pioglitazone Hydrochloride Overdose
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During controlled clinical trials with this
medicine, one case of overdose with
Pioglitazone Hydrochloride tablets (P-
Glitz) was reported. A male patient took
120 mg per day for four days, and
subsequently 180 mg per day for seven
days. The patient denied any clinical
symptoms during this period.

16. P-Glitz Overdose
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In the case of overdosage of P-Glitz
tablets, appropriate supportive treatment
must be started according to patient’s
clinical signs and symptoms.

17. Pioglitazone During Pregnancy
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Pioglitazone Hydrochloride Tablets (P-Glitz)
has been classified by the US FDA as
Pregnancy Category C.
Controlled animal studies using Pioglitazone
at 10 to 40 times the maximum recommended
human dose have shown increased rates of
postimplantation loss, delayed development,
reduced fetal weights, and delayed
parturition. There are no adequate and well-
controlled studies in pregnant women.

18. P-Glitz Tablets
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P-Glitz Tablets click here
© Clearsky Pharmacy
P-Glitz (Pioglitazone Hydrochloride
tablets) by Cipla Limited, India.