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. Adult. with normal renal funct. (GFR ≥ 90 mL/min): The recomm. dose of Competact is 30 mg/day pioglitazone plus 1,700 mg/day of metformin HCl (this dose is achievable with 1 tab. of 15 mg/850 mg, taken ×2/d.
Dose titration with pioglitazone (added to the optimal dose of metformin) should be consid. before the pt. is switched to this medication. See lit.
Second line tmt. of type 2 diabet. mell. adult pts., particularly overweight pts., who are unable to achieve suffic. glycaem. control at their maxim. tolerated dose of oral metformin alone.
After initiat. of the. with pioglitazone, pts. should be reviewed after 3-6 mnths. to assess adequacy of response to tmt. (e.g. reduct. in HbA1c). In pts. who fail to show an adequate response, pioglitazone should be discont. In light of potent. risks with prolong. ther., prescribers should confirm at subseq. routine reviews that the benefit of pioglitazone is maintain.
C/I: Hypersens. Cardiac fail./ history of card. fail. (NYHA stages I- IV). Current bladder cancer or a hist. of bladder cancer. Uninvestigated macroscop. haematuria. Acute/chron. dis. which may cause tissue hypoxia such as cardiac or respirat. fail., recent MF, shock. Hepat. impair. Acute alcohol intoxicat., alcoholism. Any type of acute metabol. acidos. (e.g. lactic acidosis, diabet. ketoacidosis). Diabet. pre-coma. Severe renal fail. (GFR < 30 mL/min). Acute conditions: Dehydrat., Sev. infec., Shock, Intravasc. administ. of iodinated contrast agents., Breast-feed.