All the Active Ingredient Drugs
Thiazolidinediones. Pioglitazone 15, 30, 45 mg. TABS.: 15 mg, 30 mg, 45
mg x 28.
Once dly with or w/o food. Initial treat.:
15 mg or 30 mg once dly; may be
increased up to 45 mg once dly. May
be used in combination with insulin.
See lit. Elderly: No dose adjustment is
necessary. Renal impair.ent: No dose
adjustment is necessary in pts. with
impaired renal func. (CLcr > 4 ml/min) Not to be used in dialysed pts. Hepatic
impair.ent: should not be used in pts.
With hepatic impair.ent Paediatric: Not
to be used in children and adolescents
under 18 yrs of age.
As second or third line treatment of type 2
diabetes mellitus: as monotherapy: in
adult patients (particularly overweight
patients) inadequately controlled by diet
and exercise for whom metformin is
inappropriate because of
contraindications or intolerance as dual
oral therapy in combination with
metformin, in adult patients (particularly
overweight patients) with insufficient
glycaemic control despite maximal
tolerated dose of monotherapy with
metformin; with a sulphonylurea, only in
adult patients who show intolerance to
metformin or for whom metformin is
contraindicated, with insufficient
glycaemic control despite maximal
tolerated dose of monotherapy with a
sulphonylurea. As triple oral therapy in
combination with: metformin and a
sulphonylurea, in adult patients
(particularly overweight patients) with
insufficient glycaemic control despite dual
oral therapy.Pioglitazone is also indicated
for combination with insulin in type 2
diabetes mellitus adult patients with
insufficient glycaemic control on insulin
for whom metformin is inappropriate
because of contraindications or
intolerance.After initiation of therapy with
pioglitazone, patients should be reviewed
after 3 to 6 months to assess adequacy of
response to treatment (e.g. reduction in
HbA1c). In patients who fail to show an
adequate response, pioglitazone should
be discontinued. In light of potential risks
with prolonged therapy, prescribers should
confirm at subsequent routine reviews
that the benefit of pioglitazone is
C/I: Hypersens. to product; cardiac
failure or history of cardiac failure (NYHA
stages I to IV); hepatic impair.ent;
diabetic ketoacidosis; current bladder
cancer or a history of bladder cancer;
uninvestigated macroscopic haematuria.
Biguanide, Thiazolidinediones. Pioglitazone (as HCl) 15 mg, Metformin Hydrochloride 850 mg. F.C. TABS. 56. 1 tab twice dly. Dose titrat. with pioglitazone should be consid. Not
recommend. for pts. under 18 yrs. old.
2nd line tmt. of type 2 diab. mell. adult
pts., particul. overweight pts., who are
unable to achieve suffic. glyc. control at
their maxim. tolerated dose of oral
metformin alone. After initiat. of ther. w/
pioglitazone, review. pts after 3- 6 mnths
to assess adeq. response to tmt. (e.g.
reduct. in HbA1c). In pts. who fail adeq.
response, pioglitazone should be discount.
In light of potent. risks w/prolong. ther.,
confirm at subseq. routine reviews that the
benefit of pioglitazone is maintained.
C/I: Hypersens. ,Card. fail., hist. of card. fail.
(NYHA stages I to IV). Current/ hist blad.
cancer, Uninvestigated macroscop.
haematur., Acute or chron. dis. which may
cause tissue hypox. (E.G. card. or resp. fail.,
recent MI, shock), hep. impair., acute
alcohol intox., alcoholism, diab.
ketoacidosis or diabetic precoma, ren. fail.,
ren. dysfunc. (CrCl <60 ml/min),Acute
cond. with the potent. to alter ren. func.
(such as: dehydr., severe infec., shock,
intravasc. administ. of iod. contrast ag.),