Actos: Dosing, Side Effect & Interaction

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Pioglitazone HCl

Indications/Uses

Monotherapy for type 2 DM patients particularly overwt patients, inadequately controlled by diet & exercise for whom metformin is inappropriate because of contraindications or intolerance. In combination w/ metformin or sulphonylurea for type 2 DM patients w/ insufficient glycaemic control.

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Dosage/Direction for Use

Adult Monotherapy Initially 15 or 30 mg once daily, may be increased in increments up to 45 mg once daily. Combination therapy Current metformin or sulphonylurea dose can be continued upon initiation of pioglitazone therapy.

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Overdosage

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Administration

May be taken with or without food.

Contraindications

Hypersensitivity. Cardiac failure (NYHA I-IV); diabetic ketoacidosis, current or history of bladder cancer, uninvestigated macroscopic haematuria. Hepatic impairment.

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Special Precautions

Not to be used in type 1 diabetes or diabetic ketoacidosis. Heart failure, wt gain, oedema, reduced cardiac reserve; hypoglycaemia; new-onset or worsening diabetic macular oedema w/ decreased visual acuity. Increased incidence of bone fractures in women. Assess risk factors for bladder cancer prior to treatment. Monitor liver enzymes prior to & periodically thereafter. Strict calorie-controlled diet. Not to be given to patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Concomitant use w/ CYP450 2C8 inhibitors (eg, gemfibrozil) or inducers (eg, rifampicin). May affect ability to drive & use machines. Not to be used in hepatic impairment & dialysed patients. Resumption of ovulation in patients w/ PCOS. Not to be used during pregnancy & lactation. Not recommended in childn & adolescents <18 yr. Elderly.

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Use In Pregnancy & Lactation

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Adverse Reactions

URTI; hypoaesthesia; bone fracture; increased wt; visual disturbance. W/ metformin: Anaemia; headache; arthralgia; haematuria; erectile dysfunction. W/ sulphonylurea: Dizziness; flatulence.

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Drug Interactions

Increased AUC w/ gemfibrozil. Decreased AUC w/ rifampicin.

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Storage

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Description

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Action

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MIMS Class

Antidiabetic Agents

ATC Classification

A10BG03 - pioglitazone ; Belongs to the class of thiazolidinediones. Used in the treatment of diabetes.

Regulatory Classification

Presentation/Packing

Form

Actos tab 15 mg

Packing/Price

30's

Form

Actos tab 30 mg

Packing/Price

30's

Actos

pioglitazone

Manufacturer:

Bora Pharma

Distributor:

DKSH