Important Safety Information: Oxytocin Solution | Compounded Formulation
What is this?
This Important Safety Information summarizes key warnings and precautions for Oxytocin Solution, a compounded formulation containing oxytocin as the active ingredient. Oxytocin is a hormone naturally produced in the body that plays a role in social bonding, emotional regulation, and certain reproductive functions.
This compounded formulation has not been reviewed or approved by the U.S. Food and Drug Administration (FDA) for safety or efficacy. It should only be used exactly as directed by a licensed healthcare provider. This summary does not include all available information. Always read your medication label and follow your provider’s instructions.
Most Serious Warnings
Product can cause:
Severe allergic reactions, including swelling of the face, lips, or tongue
Difficulty breathing or throat tightness
Significant changes in blood pressure
Neurological symptoms such as severe headache or confusion
Nausea or vomiting that does not resolve
Seek immediate medical attention if you experience signs of a serious allergic reaction or any severe or unusual symptoms.
Compounded oxytocin formulations may carry sterility or formulation risks due to limited FDA oversight.
Who Should NOT Take Oxytocin
Do not use this medication if you:
Have a known allergy to oxytocin or any component of the formulation
Have been advised by your provider to avoid oxytocin therapy
Have a medical condition where oxytocin use would be contraindicated by your healthcare provider
Before Taking Oxytocin, Tell Your Healthcare Provider if You:
Have any known allergies to medications, foods, or substances
Take prescription medications
Take nonprescription medications
Use supplements or herbal products
Smoke, drink alcohol, or use recreational substances
Have any chronic medical conditions
Are pregnant, planning pregnancy, or breastfeeding
Provide a complete list of everything you take, as certain substances may interact with your compounded formulation.
Possible Side Effects
All medications may cause side effects. Some individuals may have no side effects or only mild symptoms.
Common (mild to moderate):
Upset stomach
Nausea or vomiting
Serious (seek medical care immediately):
Swelling of the face, lips, tongue, or throat
Difficulty breathing
Severe or unusual reactions
These are not all possible side effects. Contact your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA MedWatch program at www.fda.gov/medwatch or by calling 1-800-FDA-1088.
While Taking Oxytocin
Tell your healthcare provider if:
Your symptoms do not improve in a timely manner
You develop new or worsening symptoms
You experience unusual or severe side effects
It may take some time for this medication to begin working and for your body to adjust.
What May Interact with This Medication
Check with your healthcare provider before adding any new medications, supplements, or herbal products to your routine. Certain substances may interact with oxytocin.
Missed Dosage
If you miss a scheduled dose:
Take the missed dose when you remember, unless it is close to your next scheduled dose
If it is near the time of your next dose, skip the missed dose
Do not double up on doses
Contact your healthcare provider if you are unsure how to resume your dosing schedule.
Overdose
Symptoms of overdose may include:
Severe nausea or vomiting
Severe headache
Significant changes in blood pressure
Difficulty breathing
If overdose is suspected, seek emergency medical attention or contact Poison Control immediately.
Storage
Keep out of reach of children and pets
Store according to the instructions on your prescription label
Speak with your healthcare provider if you are unsure about proper storage
Medication Disposal
Dispose of unused or expired medication according to local medication disposal guidelines. Do not flush medication or dispose of it in household drains unless instructed. Consult your healthcare provider for proper disposal recommendations.
Provider Oversight and Order Review
This compounded medication requires review and oversight by licensed Superior Health & Wellness providers. Dosing and therapy schedules must be discussed directly with your provider to ensure safety and clinical appropriateness.
Telemedicine Disclosure
This prescription may have been issued via telemedicine. If you experience concerning or severe symptoms, contact your prescribing clinician immediately or seek emergency medical care.
Disclaimer
This summary does not include all information about oxytocin and should not replace medical guidance. Always consult your healthcare provider for complete safety information, potential interactions, and individualized treatment recommendations. This compounded medication has not been evaluated or approved by the FDA for safety or efficacy.
