Zemiglo: Side Effects & Dosing

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 Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Gemigliptin

Indications/Uses

Adjunct to diet & exercise to improve glycemic control in adults w/ type 2 DM. Monotherapy or in combination w/ metformin as initial therapy in treatment-naive patients w/ inadequate glycemic control by diet & exercise; in patients w/ inadequate glycemic control w/ max tolerated metformin dose alone. In combination w/ metformin & sulfonylurea in patients w/ inadequate glycemic control w/ max tolerated metformin dose & sulfonylurea dual therapy; w/ insulin (w/ or w/o metformin) in patients w/ inadequate glycemic control w/ insulin alone or insulin & metformin dual therapy; w/ dapagliflozin & metformin in patients w/ inadequate glycemic control w/ dapagliflozin & metformin dual therapy.

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Dosage/Direction for Use

Adult Max recommended dose: 50 mg once daily.

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Overdosage

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Administration

May be taken with or without food.

Contraindications

History of serious hypersensitivity reactions ie, angioedema or anaphylaxis to another dipeptidyl peptidase-4 (DPP-4) inhibitor. Type 1 diabetes or diabetic ketoacidosis.

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Special Precautions

Discontinue use if severe hypersensitivity reaction occurs; pancreatitis, bullous pemphigoid are suspected. Not recommended in patients w/ NYHA class II-IV cardiac status. History of pancreatitis; severe & disabling arthralgia; NYHA class I cardiac status. May cause allergic reactions due to sunset yellow FCF. Hypoglycemia w/ sulfonylurea or insulin. May affect ability to drive & use machines. Severe hepatic impairment. Not recommended during pregnancy. Not to be used during lactation. Childn & adolescents <18 yr. Elderly.

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Use In Pregnancy & Lactation

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Adverse Reactions

Hypoglycemia.

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Drug Interactions

Decreased C_max of metformin. Decreased C_max & AUC of pioglitazone. Increased AUC w/ ketoconazole. Decreased C_max & AUC w/ rifampicin. Not recommended w/ other strong CYP3A4 inducers eg, dexamethasone, phenytoin, carbamazepine, rifabutin, phenobarb.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Zemiglo detailed prescribing information

Storage

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Description

View Zemiglo description for details of the chemical structure and excipients (inactive components).

Action

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MIMS Class

Antidiabetic Agents

ATC Classification

A10BH06 - gemigliptin ; Belongs to the class of dipeptidyl peptidase 4 (DPP-4) inhibitors. Used in the treatment of diabetes.

Regulatory Classification

Presentation/Packing

Form

Zemiglo FC tab 50 mg

Packing/Price

28's

Zemiglo

Manufacturer:

Pharmaniaga Marketing

Distributor:

Pharmaniaga Logistics