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Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/doseOzempic Pre Filled Pen 0.25 mg, 0.5 mg/dose is a glucagon-like peptide 1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular ... Read moreOzempic Pre Filled Pen 0.25 mg, 0.5 mg/dose is a glucagon-like peptide 1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.An adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of: 30 kg/m2 or greater (Obesity) or 27 kg/m2 or greater (Overweight) in the presence of at least one weight-related comorbid condition (e g. hypertension, type 2 diabetes mellitus or dyslipidemia). Composition0.25 mg infection: Each pre-filled syringe contains Semoglutldo INN 0.25 mg in 0.5 ml solution for injection0.50 mg injection: Each pre-filled syringe contains Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose INN 0 50 mg in 0.5 ml solution for injection1 mg Injection: Each pre-filled syringe contains Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose INN 1 mg in 0.5 ml solution for injection1.7 mg injection: Each pre-filled syringe contains Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose INN 1.7 mg in 0.75 ml solution for injection2.4 mg injection: Each pre-filled syringe contains Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose INN 2.4 mg in 0.75 ml solution for InjectionDosage of Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/doseSubcutaneous injection:The starting dose: 0.25 mg Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose once weekly for 4 weeks subcutaneously. Then in 4 weeks intervals, the dose should be increased until a dose of 2.4 mg is reached. The patient should follow the dose escalation schedule given below.Dose Escalation- Week 1 through 4: 0.25 mg Week 5 through 8: 0.5 mg Week 9 through 12: 1 mg Week 13 through 16: 1.7 mg Maintenance dose- Week 17 and onwards: 2.4 mg If patients do not tolerate a dose during dose escalation, consider delaying dose escalation for 4 weeks. If patients do not tolerate the maintenance dose 2.4 mg, the dose can be temporarily decreased to 1.7 mg once weekly for maximum 4 weeks. After 4 weeks increase the dose to 2.4 mg. Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose is to be administered once weekly at any time of the day with or without meals. Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose is to be injected subcutaneously in the abdomen, thigh or in the upper arm. Missed dose: If one dose is missed and the next scheduled dose is more than 2 days away (48 hours), administer Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose as soon as possible. It one dose is missed and the next scheduled dose is less than 2 days away (48 hours), do not administer the dose. Resume dosing on the regular scheduled day of the week.Tablet: Instruct patients to take Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose at least 30 minutes before the first food, beverage, or other oral medications of the day with no more than 4 ounces of plain water only. Waiting less than 30 minutes, or taking with food, beverages (other than plain water) or other oral medications will lessen the effect of Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose. Waiting more than 30 minutes to eat may increase the absorption of Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose.Swallow tablets whole. Do not cut, crush, or chew tablets. Start Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose with 3 mg once daily for 30 days. After 30 days on the 3 mg dose, increase the dose to 7 mg once daily. Dose may be increased to 14 mg once daily if additional glycemic control is needed after at least 30 days on the 7 mg dose.Interaction of Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/doseInitiating Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose concomitant with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin, consider reducing the dose of concomitantly administered insulin secretagogue (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia. In clinical pharmacology trials, Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose did not affect the absorption of orally administered medications to any clinically relevant degree. Nonetheless, caution should be exercised when oral medications are concomitantly administered with Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose.ContraindicationsOzempic Pre Filled Pen 0.25 mg, 0.5 mg/dose is contraindicated in patients with personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) and hypersensitivity to Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose.Side Effects of Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/doseIt is not known if Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose will cause thyroid tumors or medullary thyroid carcinoma (MTC) in people. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath.Precautions & WarningsRisk of Thyroid C-Cell Tumors: It is unknown whether Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans.Pancreatitis: After initiation of Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose should be discontinued and appropriate management initiated; if confirmed, Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose should not be restarted.Diabetic Retinopathy Complications: The effect of long-term glycemic control with Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose on diabetic retinopathy complications has not been studied. Patients with a history of diabetic retinopathy should be monitored for the progression of diabetic retinopathy.Never Share Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose Pen Between Patients: Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose pens must never be shared between patients, even if the needle is changed. Pen-sharing poses a risk for the transmission of blood-borne pathogens.Hypoglycemia with Concomitant Use of Insulin: Secretagogues or Insulin Patients receiving Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or another concomitantly administered insulin secretagogue) or insulin.Acute Kidney Injury: There have been post-marketing reports of acute kidney injury and worsening of chronic renal failure, which may sometimes require hemodialysis, in patients treated with GLP-1 receptoragonists.Hypersensitivity: Do not use in patients with previous hypersensitivity to Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose. If hypersensitivity reactions occur, discontinue the use of Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose; treat promptly per standard of care, and monitor until signs and symptoms resolve.Overdose Effects of Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/doseIn the event of overdose, appropriate supportive treatment should be initiated according to the patient?s clinical signs and symptoms.Storage Conditions Store your Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose in the refrigerator at 2?C to 8?C. After the first use of the Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose, the pen can be stored for 56 days in a refrigerator (2?C to 8?C). Do not freeze Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose. Do not use Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose if it has been frozen. Unused Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose cartridges may be used until the expiration date printed on the label, if kept in the refrigerator (2?C to 8?C). Keep Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose away from heat and out of the light. Keep the pen cap on when not in use. Drug ClassesGLP-1 receptor agonistsMode Of ActionOzempic Pre Filled Pen 0.25 mg, 0.5 mg/dose is a GLP-1 analogue with 94% sequence homology to human GLP-1. Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1. GLP-1 is a physiological hormone that has multiple actions on glucose, mediated by the GLP-1 receptors. The principal mechanism of protraction resulting in the long half-life of Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose is albumin binding, which results in decreased renal clearance and protection from metabolic degradation. Furthermore, Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose is stabilized against degradation by the DPP-4 enzyme. Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose reduces blood glucose through a mechanism where it stimulates insulin secretion and lowers glucagon secretion, both in a glucose-dependent manner. Thus, when blood glucose is high, insulin secretion is stimulated and glucagon secretion is inhibited. The mechanism of blood glucose lowering also involves a minor delay in gastric emptying in the early postprandial phase.PregnancyThere are limited data with Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose use in pregnant women. Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose?should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no data on the presence of Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose in human milk, the effects on the breastfed infant, or the effects on milk production. Discontinue Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose in women at least 2 months before a planned pregnancy due to the long washout period for Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose.Pediatric UsesPediatric Use: The safety and efficacy of Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose have not been established in pediatric patients (younger than 18 years).Geriatric Use: No overall differences in safety or efficacy were detected between geriatric patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.Renal Impairment: No dose adjustment of Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose is recommended for patients with renal impairment.Hepatic Impairment: No dose adjustment of Ozempic Pre Filled Pen 0.25 mg, 0.5 mg/dose is recommended for patients with hepatic impairment.