Composition:
Pioglitazone (as hydrochloride) 15mg and 30mg.
Presentation: Tablets, white to off-white.
Action: Thiazolidinedione antihyperglycaemic.
Indications: Oral combination treatment of type 2 diabetes mellitus in patients
with insufficient glycaemic control despite maximal tolerated dose of oral monotherapy
with either metformin or a sulphonylurea. In combination with metformin only
in obese patients. In combination with a sulphonylurea only in patients who
show intolerance to metformin or for whom metformin is contraindicated.
Contraindications: Hypersensitivity to active substance or excipients; cardiac
failure or history of cardiac failure; in combination with insulin.
Dosage and administration: Pioglitazone is taken once daily with or without
food and should not be used as monotherapy.
Combination with metformin, pioglitazone may be taken at a dose of 15mg or 30mg
daily. The current metformin dose can be continued upon initiation of pioglitazone.
Combination with sulphonylurea, pioglitazone may be taken at a dose of 15mg
or 30mg daily. The current sulphonylurea dose can be continued upon initiation
of pioglitazone. However, the dose should be decreased if hypoglycaemia is reported.
Elderly, no dosage adjustment required.
Renal impairment (creatinine clearance >4ml/min), no dosage adjustment required.
Pioglitazone should not be used in dialysed patients as no information is available.
Hepatic impairment, should not be used.
Children and adolescents (under 18 years), not recommended as no data available.
Pregnancy and lactation, should not be used. It is not known whether pioglitazone
is secreted in human milk.
Overdosage: One case reported and no symptoms were reported.
Precautions: Pioglitazone can cause fluid retention. Patients should be observed
for signs and symptoms of heart failure, particularly those with reduced cardiac
reserve. Discontinue if deterioration in cardiac status occurs. Liver enzymes
should be checked prior to initiating therapy in all patients. Following initiation,
liver enzymes should be monitored every two months for the first 12 months and
periodically thereafter (see SPC). Check liver enzymes if symptoms suggestive
of hepatic dysfunction develop. Discontinue if jaundice is observed. Weight
should be closely monitored. Use of pioglitazone in patients with polycystic
ovarian syndrome may result in resumption of ovulation and patients should be
aware of the risk of pregnancy (see SPC).
Drug interactions: Concomitant administration with NSAIDs may increase the risk
of oedema. Cases of cardiac failure have been reported with use of pioglitazone
with insulin.
Side effects: Pioglitazone in combination with metformin; common adverse effects
(>1 per cent, <10 per cent) included anaemia, weight increase, headache,
abnormal vision, arthralgia, haematuria, impotence; uncommon (>0.1 per cent,
<1 per cent) flatulence. Pioglitazone in combination with sulphonylurea;
common adverse effects included weight increase, dizziness, flatulence; uncommon
included increase in lactic dehydrogenase, hypoglycaemia, glycosuria, appetite
increase, headache, vertigo, abnormal vision, sweating, proteinuria, fatigue.
Oedema was reported in both treatment groups and was mild to moderate.
Net price: 28 15mg £26.60, 30mg £36.96.
Supplier: Takeda UK, Takeda House, The Mercury Centre, Wycombe Lane, Wooburn
Green, High Wycombe, Buckinghamshire HP10 0HH. Tel 01628 537900, fax 01628 526617.
Legal class: POM.