How to Use / Administration Methods
Subcutaneous Injection (Standard Route): Epithalon is administered via subcutaneous injection into the abdominal region, thigh, or upper arm. Rotate injection sites systematically to prevent lipohypertrophy. Use an insulin syringe for accurate dosing.
Sublingual Administration: Some research protocols have used sublingual Epithalon delivery, including the melatonin study involving 75 women. Bioavailability via sublingual route compared to injection has not been rigorously characterized.
Intranasal Administration: Nasal spray formulations have been explored in limited research settings. Absorption and efficacy data for intranasal delivery are insufficient to make dosing recommendations.
Reconstitution: Epithalon is supplied as a lyophilized (freeze-dried) white powder requiring reconstitution before injection.
- Allow the vial to reach room temperature
- Draw bacteriostatic water (0.9% benzyl alcohol) into a sterile syringe
- Inject the water slowly along the interior vial wall, do not jet directly onto the powder
- Gently swirl until fully dissolved; do not shake
- Inspect the solution for clarity. It should be clear and colorless
Common Reconstitution Ratio:
- 10 mg Epithalon + 1 mL bacteriostatic water = 10 mg/mL (1:1 ratio)
- Each 0.1 mL (10 units on an insulin syringe) = 1 mg
Storage:
- Lyophilized powder: Stable for up to 3 years at -20°C, up to 2 years at 2 to 8°C
- Reconstituted solution: Refrigerate at 2 to 8°C, use within 6 weeks, protect from light
- Discard if solution becomes cloudy, discolored, or contains particulate matter
Reconstitution, Storage & Prep
Epithalon is supplied as a lyophilized white powder requiring reconstitution before subcutaneous injection.
Reconstitution Process:
- Allow the vial to reach room temperature before opening
- Use bacteriostatic water (0.9% benzyl alcohol) as the reconstitution vehicle
- Draw the appropriate volume of bacteriostatic water into an insulin syringe
- Insert the needle through the stopper and inject water slowly along the interior vial wall
- Gently swirl until powder is fully dissolved, do not shake
- Inspect the solution; it should be clear and colorless
Reconstitution Ratio (1:1):
- 10 mg Epithalon + 1 mL bacteriostatic water = 10 mg/mL
- For a 5 mg dose: draw 0.5 mL (50 units on an insulin syringe)
- For a 10 mg dose: draw 1.0 mL (100 units on an insulin syringe)
Storage Guidelines:
- Lyophilized (unreconstituted): Up to 3 years at -20°C; up to 2 years at 2 to 8°C
- Reconstituted solution: Store at 2 to 8°C (refrigerator); use within 6 weeks
- Protect from light at all times
- Do not freeze reconstituted solution
- Discard if the solution becomes cloudy, discolored, or contains particulate matter