Important Safety Information: Oxytocin | Compounded Buccal Troche

What is this?

This Important Safety Information summarizes key warnings and precautions for Oxytocin 100U Troche (Mint), a compounded buccal medication intended for absorption through the cheek (troche dosage form). Oxytocin is a naturally occurring hormone produced in the hypothalamus and released from the posterior pituitary. It plays a role in uterine contraction, milk ejection, and has been associated with bonding, social behaviors, and sexual response.

Compounded oxytocin formulations are not reviewed or approved by the U.S. Food and Drug Administration (FDA) for safety or efficacy. This medication 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, tongue, or throat

• Hypersensitive uterine reactions in susceptible individuals

• Cardiovascular effects if used inappropriately

• Worsening of underlying medical conditions without proper medical supervision

Compounded medications may carry sterility, potency, or formulation risks due to limited FDA oversight.

Who Should NOT Take Oxytocin

Do not take this medication if you:

• Have a known allergy to oxytocin or any ingredient in the formulation

• Are pregnant unless specifically directed and monitored by a qualified healthcare provider

• Have been advised to avoid uterine-stimulating medications

• Have medical conditions where uterine stimulation may be unsafe

Before Taking Oxytocin, Tell Your Healthcare Provider if You:

• Have a history of uterine sensitivity or complications

• Have cardiovascular disease or blood pressure concerns

• Are pregnant, planning pregnancy, or breastfeeding

• Take prescription, over the counter, or herbal medications

• Use alcohol, tobacco, or recreational drugs

• Have any known allergies to medications or compounded products

Possible Side Effects

Common (mild to moderate):

• Headache

• Flushing

• Dizziness

• Mild gastrointestinal discomfort

Serious (seek medical care immediately):

• Swelling of the face, lips, tongue, or throat

• Difficulty breathing

• Severe abdominal pain

• Persistent or severe symptoms that are unusual for you

While Taking Oxytocin

Tell your healthcare provider immediately if you:

• Experience unusual uterine cramping or abdominal pain

• Develop symptoms of an allergic reaction

• Notice worsening symptoms or new concerning symptoms

• Do not experience expected improvement within a reasonable timeframe

Dosage and Administration

This medication is a troche dosage form intended for buccal administration. Use exactly as directed by your healthcare provider. If you are unsure how to use this medication, contact your provider before taking it.

Missed Dosage

If you miss a dose:

• Take the missed dose when you remember, unless it is close to your next scheduled dose

• Skip the missed dose if it is near the time of your next dose

• Do not double doses

Overdose

Symptoms of overdose may include:

• Severe headache

• Marked abdominal cramping

• Significant adverse reactions

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

• Protect from excessive heat and moisture

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.

Provider Oversight and Order Review

This compounded medication requires review and oversight by a licensed healthcare provider. Dosing and treatment 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 any 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 or pharmacist 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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.