Remogliflozin Etabonate

Remogliflozin Etabonate is an Anti-diabetic Agent belonging to the pharmacological class of Sodium-glucose transport protein 2 (SGLT2) Inhibitors.

Remogliflozin etabonate is approved for treating type 2 diabetes mellitus and is generally used alone or in conjunction with other antidiabetic drugs to achieve glycemic control.

After being taken orally, remogliflozin etabonate is well absorbed and reaches peak plasma concentrations in one to two hours. It is primarily excreted as unaltered medication in urine after minimal metabolism, usually in a few days.

The most common side effects of remogliflozin etabonate in humans include nausea, headache, frequent urge to urinate, increased thirst, urinary tract infections, and hypoglycemia (low blood sugar levels).

Remogliflozin Etabonate is available in the form of oral tablets.

The molecule is available in the United States, Canada, India, South Korea, United Kingdom, France, Japan, Germany and Australia.

Remogliflozin Etabonate is an Anti-diabetic Agent belonging to the pharmacological class of Sodium-glucose transport protein 2 (SGLT2) Inhibitors.

Remogliflozin etabonate inhibits glucose reabsorption in the kidneys by inhibiting SGLT2. As a result, blood glucose levels are lowered due to increased glucose excretion in urine. It lowers blood sugar levels independently of insulin action by blocking the body from reabsorbing glucose and encouraging the excretion of excess glucose. Using the kidneys to eliminate excess glucose helps control hyperglycemia and provides a different approach from other antidiabetic drugs, concentrating on insulin synthesis or sensitivity. In people with type 2 diabetes, the inhibition of SGLT2 helps with urine excretion of glucose, which improves glycemic control.

Remogliflozin Etabonate duration of action typically occurs approximately, ranging up to 24 hours.

The onset of action for Remogliflozin etabonate typically begins within hours after oral administration.

The Data of Tmax of Remogliflozin Etabonate is approximately 1 to 2 hours after oral administration.

The Cmax of Remogliflozin Etabonate typically ranges between 100 to 200 ng/mL when a single dose is taken.

Remogliflozin Etabonate is available in oral tablets.

Tablets: To be swallowed whole with water/liquid. Do not chew, crush or break it.

As the physician recommends, take the medication orally once daily, generally with a meal.

Remogliflozin Etabonate can be used in the following health conditions:

To regulate elevated amounts of blood sugar or glucose. It facilitates the removal of excess glucose from the body through urination and a key component of diabetes management is lowering blood glucose levels.

To effectively manage diabetes, the blood glucose levels must be reduced. Controlling blood sugar levels will lower the likelihood of any of the severe complications of diabetes, including kidney damage, eye damage, nerve problems, and amputation of limbs. The risk of cardiac disease and stroke can be decreased with proper diabetes management. Individuals can live longer if they take this medication consistently and follow a healthy diet and exercise routine.

Remogliflozin etabonate is indicated for the management of adult type 2 diabetes. To help lower blood sugar levels by boosting glucose excretion in the urine, it is administered in conjunction with diet and exercise, frequently in addition to other antidiabetic drugs.

Orally: Remogliflozin Etabonate is a tablet that can be taken orally. It should be taken once daily in the morning with or without food, and it is best to take it regularly at a fixed time each day following the physician's prescribed schedule for regular and evenly spaced intervals because the dose and duration of therapy are individualized per specific conditions to achieve the most effective and successful treatment outcome.

The dosage and duration of treatment should be as per the treating physician's clinical judgment.

Remogliflozin Etabonate is available in the form of oral tablets.

Dose: The recommended starting dose for remogliflozin etabonate is usually 100 mg t PO once daily, commonly administered in the morning, with or without food.

Remogliflozin Etabonate should be used in treating Diabetes Mellitus, along with appropriate nutritional limits.

While taking Remogliflozin Etabonate, maintain regular meal schedules with balanced macronutrient content to help stabilize blood sugar levels.

Include foods high in vitamin B1, such as meats, beans, dairy, eggs, nuts, and seeds, as well as enriched cereals, in your diet. Maintain steady blood sugar levels by eating a diet high in fibre and including good carbohydrates from whole grains, fruits, and vegetables. Reduce alcohol consumption to avoid blood sugar management problems. Be cautious when it comes to the risk of low blood sugar, mainly if one is on diabetes medication that might cause hypoglycemia. If needed, keep fast-acting glucose sources readily, such as tablets, to quickly raise blood sugar levels.

The dietary restriction should be individualized as per patient requirements.

Remogliflozin Etabonate may be contraindicated in the following conditions: -

Patients with a history of recurrent genital mycotic infections should be cautious while using this medication, as it may exacerbate such conditions.

Because remogliflozin etabonate carries a higher risk of ketoacidosis, hypotension, and dehydration, it is recommended to be used with caution. Patients should drink enough water to stay adequately hydrated and Patients with moderate to severe hepatic impairment should use caution. Dosage adjustment may be necessary.

A hypoglycemic reaction may occur if remogliflozin etabonate is taken with insulin or insulin secretagogues. Particularly when combined with other anti-diabetic drugs, careful monitoring of blood glucose levels is advised.

The clinically relevant drug interactions of Remogliflozin Etabonate are briefly summarized here.

Drug-Drug Interaction: Remogliflozin Etabonate may interact with selenium (Glimepiride), fluconazole (antibiotic), sildenafil (impotence medication), and pregabalin (anticonvulsant).

Drug-Food Interaction: Refrain from drinking alcohol as it raises the possibility of low blood sugar.

Interaction between Drug and Disease: Before using Remogliflozin Etabonate, let the physician know if patients have any heart, kidney, or liver ailments, breathing issues, blood disorders, dehydration, alcohol use, low blood pressure, or genital yeast infection.

The most common side effects of Insulin Isophane in humans are:

Nausea

Diarrhea

Constipation

Fungal infection in the genital area

Increased thirst

Hypoglycemia (low blood glucose level)

Dyslipidemia

Hypotension (low blood pressure)

Urinary tract infection

Fever

Cough

Headache

The presence of remogliflozin etabonate or remogliflozin (active moiety) in human breast milk is unknown, and no clinical trials with pregnant or nursing women have been carried out with this medication. It is not advisable to take remogliflozin etabonate whilst pregnant or nursing. Women who are or may become pregnant should not become pregnant before remogliflozin etabonate is administered, and they should use recommended contraceptives. ORAL hormonal contraceptives may not be an effective method of contraception due to the probable absorption-affecting impact of remogliflozin etabonate; instead, a suitable alternate means of preventing pregnancy should be employed.

Remogliflozin etabonate did not affect the fertility of male rats (200, 600, and 1200 mg/kg/day; oral) or female rats (200, 600, and 1000 mg/kg/day; oral). The NOAEL was 1200 mg/kg/day (approximately 58 times the maximum recommended human daily dose (MRHDD) of 100 mg twice daily (200 mg/day) on a body surface area [mg/m2] basis. The NOAEL was 1000 mg/kg/day (approximately 49 times the MRHDD of 200 mg/day on a mg/m2 basis), respectively. Oral dosages of 1000 and 500 mg/kg/day (or around 49 times the MRHDD of 200 mg/day on a mg/m2 basis) of remogliflozin etabonate did not cause teratogenic effects in rats (200, 600, and 1000 mg/kg/day) or rabbits (125, 250, and 500 mg/kg/day). No treatment-related effects were observed in pregnant or lactating females or on the development of the conceptus and the offspring following exposure up to 1000 mg/kg/day (approximately 49 times the MRHDD of 200 mg/day on mg/m2 basis) in a pre-and post-natal developmental study conducted in rats (200, 600, and 1000 mg/kg/day; oral).

As per FDA, safety and effectiveness in the pediatric population have yet to be established.

In clinical trials, geriatric patients (65 years of age and older) have demonstrated the safety and efficacy of Remogliflozin etabonate, similar to adult populations. However, due to age-related factors influencing response and tolerance, close monitoring for renal function, fluid balance, and individualized dosing is recommended.

Patients with renal impairment (mild to moderate) may need more frequent adjustments to the dosage of Remogliflozin Etabonate whereas patients with severe impairment (eGFR <30 mL/min/1.73m²) is not recommended.

Patients with hepatic impairment may need more frequent adjustments to the dosage of Remogliflozin Etabonate.

The physician should be vigilant about the knowledge pertaining to identifying and treating overdosage of Remogliflozin Etabonate in humans.

Overconsumption of Remogliflozin Etabonate in humans may cause increased urinary frequency, genital mycotic infections (such as yeast infections), urinary tract infections, and a potential risk of dehydration or hypotension.

There is no specific antidote or treatment for excessive intake of Remogliflozin Etabonate in humans. However, immediate medical attention is essential. Remogliflozin Etabonate should be terminated immediately when an overdose is suspected or if any unusual symptoms occur after intake. Immediate gastric lavage or induced vomiting might be considered if the overdose has happened within a short time. Activated charcoal can be administered to reduce absorption if the ingestion is recent.

Treatment may involve supportive care to maintain adequate hydration and electrolyte balance. Appropriate measures to restore fluid volume should be undertaken in severe hypotension or dehydration cases.

Intramuscular/subcutaneous glucagon or concentrated intravenous glucose may treat more severe episodes accompanied by coma, seizure, or neurologic impairment.

Maintain a healthy lifestyle through proper nutritional diet, regular physical activity, and stress management. These factors can help improve blood sugar control and reduce the risk of hypoglycemia.

Remogliflozin etabonate is quickly absorbed and transforms into remogliflozin in its active state. Food consumption slightly postpones the peak concentration without changing the overall exposure, giving administrators more choices. Mean Cmax and AUC0-tau values are observed at steady state levels at 100 mg and 250 mg dosages in Indian individuals with type 2 diabetes. In one investigation, absorption of over 93% was noted. Given their nearly complete absorption, remogliflozin etabonate and remogliflozin function as P-gp substrates rather than inhibitors, suggesting that P-gp inhibitors have no apparent effect on their pharmacokinetics.

Remogliflozin etabonate is swiftly absorbed and converted to active forms like remogliflozin. Remogliflozin etabonate is absorbed quickly and converted to active forms like remogliflozin. Absorption exceeds 93%, acting as a P-gp substrate, not an inhibitor. Therefore, P-gp inhibitors aren't expected to affect its pharmacokinetics.

Approximately 65% of remogliflozin is bound to plasma proteins. The distribution of remogliflozin etabonate or remogliflozin was not preferential to blood cells, nor did remogliflozin or its metabolites selectively associate with tissues that contained melanin.

Numerous metabolic processes occur throughout the extended metabolism of remogliflozin etabonate, including oxidation, glucose loss, glucuronidation, N-dealkylation, O-dealkylation, and loss of ethyl hydrogen carbonate.

Human hepatic microsomes metabolize remogliflozin primarily through the CYP3A4 enzyme, with CYP2C19 playing an insignificant role, according to in vitro research. Remogliflozin exposure increased 1.8-fold in a clinical investigation with the powerful CYP3A4 inhibitor ketoconazole, indicating that the various elimination pathways reduce the risk of medication interactions with CYP inhibitors.

Within the identical investigation, the prodrug's average plasma half-life ranged from 0.4 to 0.7 hours. A little over 11% of the dose was recovered as remogliflozin in the urine of the radiolabeled AME trial, which expelled about 93% of the drug; most drug-related material is removed in the urine as inactive glucuronide metabolites.