Semazic 0.5mg/0.375ml Pre-Filled SC Injection

✔️ Dosage and Administration

For Diabetes:

Semaglutide Tablets:

• Before First Meal: Take semaglutide 30 minutes before the first food, beverage, or other oral medications of the day, with no more than 4 ounces (118 ml) of plain water.
• Starter Dose: Begin with 3 mg once daily for 30 days.
• Maintenance Dose: After 30 days, increase the dose to 7 mg once daily.
• For Additional Glycemic Control: After at least 30 days on the 7 mg dose, the dose can be increased to 14 mg once daily.

Semaglutide Injection:

• Starting Dose: 0.25 mg once weekly.
• After 4 weeks, increase to 0.5 mg once weekly.
• If additional control is needed, increase to 1 mg once weekly.
• Maximum Recommended Dose: 1 mg per week.
• Inject subcutaneously (under the skin) in the abdomen, thigh, or upper arm.
• Flexible timing: Can be taken at any time of day, with or without meals. The injection site can be alternated, and the dosing day can be changed as long as it’s at least 3 days (72 hours) apart.

Switching Between Tablets and Injections:

• Patients on the 0.5 mg weekly injection can transition to Semaglutide 7 mg or 14 mg tablets.
• Patients on 14 mg tablets can switch to 0.5 mg injection once weekly, starting the injection the day after their last tablet dose.

For Obesity:

• Semaglutide Injection:
  • Starter Dose: 0.25 mg once weekly for 4 weeks.
  • Escalating the Dose: If necessary, adjust the dose to 2.4 mg after 4 weeks, but doses higher than 2.4 mg are not recommended.
  • Flexible dosing: Can be injected at any time of day, with or without meals. Change the injection site as needed.
  • If the patient doesn't tolerate a higher dose, consider reducing to 1.7 mg once weekly for a maximum of 4 weeks.

✔️ Overdose Effects

• Overdose: Overdoses of up to 4 mg have been reported, usually causing nausea. There is no specific antidote. Treatment should be supportive, depending on the patient's symptoms.

✔️ Use in Special Populations

• Pediatric Use: The safety and effectiveness of Semazic in children and adolescents under 18 years old has not been established.
• Elderly: No dose adjustment is needed for older adults.
• Renal Impairment: Semazic can be used in patients with mild to severe renal impairment, but it is not recommended for those with end-stage renal disease.
• Hepatic Impairment: No dose adjustments are required for patients with liver conditions, but caution is needed.

✔️ Side Effects

Common Side Effects:

• Vomiting, stomach upset, indigestion, acid reflux (heartburn), stomach bloating, constipation, taste changes, tiredness, reduced appetite, gas, and increased pancreatic enzymes (such as lipase and amylase).

Rare Side Effects:

• Serious allergic reactions like anaphylaxis, symptoms of which include difficulty breathing, swelling of the face and throat, wheezing, fast heartbeat, dizziness, or cold, pale skin.

✔️ Interactions

With Medications:
Semazic delays gastric emptying, which can affect the absorption of other oral medications. It is important to account for this when taking other oral medicines.

With Food and Other Substances:
The presence of food reduces the exposure to Semazic, so it’s recommended to take it on an empty stomach, at least 30 minutes before eating.

✔️ Contraindications

• Hypersensitivity: Avoid use in patients with known allergy or sensitivity to semaglutide or any of its ingredients.
• Medullary Thyroid Carcinoma (MTC): Semazic is contraindicated in patients with a personal or family history of MTC or Multiple Endocrine Neoplasia Syndrome Type 2 (MEN 2).
• Pregnancy and Breastfeeding: Semazic should not be used during pregnancy or while breastfeeding.

✔️ Pregnancy and Lactation

Pregnancy: Semazic should not be used during pregnancy as it hasn’t been studied in pregnant women, and there are no controlled trials. If pregnancy occurs, discontinue Semazic immediately and avoid its use for at least 2 months before planning to conceive.

Lactation: There is no data on whether Semazic passes into human milk. As a precaution, it’s advised to discontinue breastfeeding while using Semazic, as it may pose risks to the infant.

✔️ Precautions & Warnings

• Not for Type 1 Diabetes: Semazic should not be used in patients with type 1 diabetes or those experiencing diabetic ketoacidosis.
• Hypoglycemia Risk: Caution is advised for patients who are taking insulin or sulfonylureas in combination with Semazic, as it may increase the risk of low blood sugar (hypoglycemia).
  The dose of insulin or sulfonylureas may need to be reduced when starting Semazic.
• Cardiac Risks: Semazic increases heart rate, so caution should be used in patients with heart conditions like tachyarrhythmias (abnormally fast heart rate).

✔️ Storage Conditions

• Injection: Store in a refrigerator at 2°C to 8°C. Do not freeze. Keep away from light.