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Fitaro 0.25
Generics: Semaglutide
Incepta Pharmaceuticals Ltd.
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Medical overview
Indication
Type 2 Diabetes Mellitus
Administration
SC Administration
Administer SC to abdomen, thigh, or upper arm
Administer once weekly, on the same day each week, at any time of the day, with or without meals
Day of weekly administration can be changed if necessary as long as the time betwe ... Show more
Adult Dose
Type 2 Diabetes Mellitus
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
0.25 mg SC qWeek for 4 weeks initially; THEN increase the dosage to 0.5 mg qWeek
If glycemic control not ... Show more
Child Dose
<18 years: Safety and efficacy not established
Renal Dose
Renal impairment
No dosage adjustment required
Contraindication
Personal or family history of MTC or in patients with multiple endocrine neoplasia syndrome type 2 (MEN 2)
Known hypersensitivity to semaglutide or to any of the product components
Mode of Action
Glucagon-like peptide-1 (GLP-1) agonist
Incretins, such as GLP-1, enhance glucose-dependent insulin secretion by pancreatic beta-cells, suppresses inappropriately elevated glucagon secretion, and slows gastric emptying
Precaution
Based on findings in rats and mice, semaglutide may cause thyroid C-cell tumors including MTC, in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined (see Black Box Warnings)
In control trials, acu ... Show more
Side Effect
>10%
Nausea (15.8-20.3%)
Documented symptomatic hypoglycemia, adjunctive therapy [≤70 mg/dL glucose threshold] (16.7-29.8%)
Severe or symptomatic hypoglycemia, adjunctive therapy [≤56 mg/dL glucose threshold] ( 8.3-10.7%)
1-10%
Vomiting (5 ... Show more
Pregnancy Category Note
Pregnancy
Data are limited regarding use in pregnant women
Based on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy; should be used during pregnancy only if the potential benefi ... Show more
Interaction
Coadministration with insulin secretagogues (eg, sulfonylureas) or insulin may increase the risk of hypoglycemia; consider a lower dose of the secretagogue or insulin to reduce risk of hypoglycemia in this setting
Exercise caution when semaglutide i ... Show more
Disclaimer
The information provided herein is accurate, updated and complete as per the best practices of the Company. Please note that this information should not be treated as a replacement for physical medical consultation or advice. We do not guarantee the accuracy and the completeness of the information so provided. The absence of any information and/or warning to any drug shall not be considered and assumed as an implied assurance of the Company. We do not take any responsibility for the consequences arising out of the aforementioned information and strongly recommend you for a physical consultation in case of any queries or doubts.
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