Balance Blend Rx (Fluoxetine, L-Theanine, Vitamin B6)

Balance Blend Rx is compounded by licensed pharmacists using active pharmaceutical ingredients: Fluoxetine (generic for Prozac®), L-theanine, and vitamin B6. Unless otherwise indicated, the safety information below is based on the known safety profiles of these active ingredients as used in the compounded medication. Like all compounded medications, Balance Blend Rx is not FDA approved. This means that the safety, effectiveness, and quality of this medication has not been verified by the FDA, as the FDA does not verify the safety, effectiveness, and quality of any compounded drugs.

The following provides a medication overview of Balance Blend Rx, how the active ingredients work, and how to effectively and safely use it to support the treatment of symptoms of anxiety and depression, like panic attacks, low mood, irritability, and lack of energy. It does not contain all possible information. You will also receive a physical document called a medication guide or patient drug information in the package with your medication when it arrives from the pharmacy which contains full information about Balance Blend Rx. Please read all of the information, specific to the medication(s) you were prescribed, before taking your medication and at each refill. It’s important to take your medication as directed by your provider and to always read your prescription label and follow your healthcare provider's instructions. If you’re not sure which medication you were prescribed, please reference the label on your prescription bottle or contact a member of your Care Team.

In this treatment plan

Usage

Take as prescribed

Balance Blend Rx is a holistic approach to anxiety and depression treatment, which compounds an FDA-approved SSRI medication with nutritional supplements to support your overall health. The Balance Blend Rx your provider prescribed for you contains the following ingredients: fluoxetine, L-theanine, and vitamin B6.  

Fluoxetine (generic for Prozac®) is a medication for treating symptoms of anxiety and depression, like panic attacks, low mood, irritability, and lack of energy. Fluoxetine is also used to treat obsessive compulsive disorder (OCD), bulimia nervosa, premenstrual dysphoric disorder (PMDD) and may also be helpful when prescribed “off-label” for body dysmorphic disorder, dysthymia, or posttraumatic stress disorder (PTSD).  

L-theanine has been shown to enhance sleep quality—and may assist in the reduction of stress or depression symptoms when taken with an SSRI. Vitamin B6 is an established vitamin to support your overall health. Vitamin B6 helps in the production of neurotransmitters in the brain.L-theanine has been shown to enhance sleep quality—and may assist in the reduction of stress or depression symptoms when taken with an SSRI. 

Vitamin B6 is a vitamin to support your overall health and helps in the production of neurotransmitters in the brain.

What to expect during treatment

When you first start taking Balance Blend Rx, sleep, energy, or appetite may show some improvement within the first 1-2 weeks. Improvement in these physical symptoms can be an important early signal that the medication is working. Depressed mood and lack of interest in activities may need up to 4-8 weeks to fully improve.

Take as prescribed

It’s important to take your medication as directed by your provider and to review the directions on your prescription label. 

Do not abruptly stop taking Balance Blend Rx without first informing your healthcare provider, even when you feel better. Abruptly stopping a higher dose can cause discontinuation symptoms, including nausea, irritability, dizziness, headaches, sensation of tingling skin, or nightmares. Studies have shown that a taper can reduce possible discontinuation symptoms. Your healthcare provider can provide individualized guidance on tapering your medication. If you choose to discontinue Balance Blend Rx without consulting your provider, the following are general tapering guidelines for Balance Blend Rx:

• If you are taking Balance Blend Rx with 44 mg of fluoxetine, take 1/2 pill (20 mg) daily for 1 week, then you may stop your medication.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is closer to the time of your next dose. Do not double your next dose or take more than what is prescribed.

Can I continue taking this medication if I become pregnant?

The safety of this medication during pregnancy has not been evaluated. If you become pregnant or decide to try to conceive, please alert your provider who will direct you to follow up with your primary care provider or OBGYN for continued management.

Can I drink alcohol while taking this medication?

Drinking alcohol while taking mental health medication is not advised.  Research shows that over time alcohol worsens anxiety and depression. It can also increase the side effects of some medications, such as drowsiness, dizziness and coordination problems. It is recommended to avoid drinking alcohol while taking your medication, especially if you will be driving, operating dangerous machinery, or participating in dangerous activities.  If you find that you are binge drinking (drinking 4 or more drinks within 2 hours) on a daily or almost daily basis, we recommend informing your healthcare provider and try to cut back on alcohol use to a healthier level.

Can I take cannabis while taking this medication?

Using cannabis products can worsen depression and increase the side effects of some medications, such as drowsiness, dizziness and coordination problems.  It is recommended to avoid cannabis use while taking your medication, especially if you will be driving, operating dangerous machinery, or participating in dangerous activities. 

Is it safe to stop taking Xanax now that I’m going to start my daily mental health medication?   

If you are taking a benzodiazepine (Ativan, Xanax, Klonopin, Valium, etc) and you start feeling better, you should talk to your prescriber about tapering down from the benzodiazepine. Abruptly stopping the daily use of a benzodiazepine can lead to dangerous side effects such as seizures, so careful monitoring by your primary care provider is recommended.

Should I stop taking hydroxyzine for anxiety now that I’m going to start my daily mental health medication?

You should inform your hydroxyzine prescriber about the addition of Balance Blend Rx (Fluoxetine, L-Theanine, Vitamin B6) to your mental health treatment plan.  Hydroxyzine is frequently taken alongside mental health medication for treatment of anxiety and is generally well tolerated.  Your prescriber can help you decide if continuing hydroxyzine is the right choice for you and will help monitor your symptoms if you choose to continue or stop hydroxyzine. 

Is this medication safe to take with my medication for ADHD?

Medication for anxiety and depression can increase the blood level of medications used to treat ADHD (Adderall, Vyvanse, Concerta, or other stimulants). Please monitor closely for side effects such as anxiety and insomnia and make sure the provider prescribing your ADHD medication is aware of all medications you are taking.

Before you take Balance Blend Rx, tell your healthcare provider if you:

• Have thoughts of suicide or harming yourself

• Have a history of psychiatric or medical problems, including bipolar disorder

• Have taken any medication in the past for your condition, whether effective or not

• Have suffered adverse or side effects from previous medication therapies

• Drink alcohol or use/abuse recreational or prescription drugs

• Are pregnant, plan to become pregnant, or are breast-feeding

Tell your healthcare provider about all the medicines you are taking, including prescription and over-the-counter medicines, vitamins, herbal supplements, and recreational drugs.

Warnings

SUICIDALITY AND ANTIDEPRESSANT DRUGS

Fluoxetine (the active ingredient and other antidepressant medicines may increase suicidal thoughts or actions within the first few months of treatment or when the dose is changed, especially in people 24 years of age and younger. If you are experiencing a mental health crisis, please call or text 988 to be connected with help, or go to your nearest hospital emergency department. Pay particular attention to such changes when starting treatment with Balance Blend Rx is started or when the dose is changed.

Patients, their families, and caregivers should be alert to the emergence of anxiety, restlessness, irritability, aggressiveness, and insomnia. If these symptoms emerge, they should be reported to the patient’s prescriber or healthcare professional. All patients being treated with antidepressants for any indication should watch for and notify their healthcare provider for worsening symptoms, suicidality, and unusual changes in behavior, especially during the first few months of treatment.

IMPORTANT SAFETY INFORMATION

Do not take Balance Blend Rx if you:

• are allergic to fluoxetine, or any of the ingredients in Balance Blend Rx

• take any medication for Parkinson’s Disease or depression called monoamine oxidase inhibitors (MAOI), or if you have stopped taking an MAOI in the last 14 days as they may cause a dangerous increase in blood pressure. MAOIs include, but are not limited to:  isocarboxazid, phenelzine, rasagiline, selegiline, tranylcypromine

• take other medication that may cause an increase in serotonin levels such as linezolid, methylene blue, tryptophan

• take St John’s Wort or 5-Hydroxytryptophan (5-HTP)

• taking tamoxifen

• are drinking large amounts of alcohol

• are abusing recreational drugs or prescription medications

If you are already taking an L-theanine supplement, you will need to stop taking it before you start taking Balance Blend Rx. 

• Please use caution when taking additional over-the-counter vitamins or supplements and ensure that your total daily intake does not exceed recommended limits

Balance Blend Rx may affect the way other medicines work, and other medicines may affect the way Balance Blend Rx works, causing side effects. Especially tell your healthcare provider if you take any of the following:

• Aspirin or nonsteroidal anti-inflammatory drugs (e.g., ibuprofen, naproxen, celecoxib, diclofenac)

• Warfarin or other anticoagulants

• Any other serotonergic medications including: trazodone, migraine medications (triptans), pain medications (tramadol), antibiotic linezolid, amphetamines 

• Anticonvulsants (phenytoin, carbamazepine)

• Antipsychotics (haloperidol, aripiprazole)

• Atomoxetine

• Tricyclic antidepressants (imipramine, desipramine)

• Beta blockers (metoprolol, propranolol)

• Tamoxifen

The fluoxetine in Balance Blend Rx may increase the risk of bleeding when taking blood thinners or nonsteroidal anti-inflammatory drugs (NSAIDs). If you are currently taking blood thinners or NSAIDs, we strongly recommend that you inform your primary care provider that you have started taking this mental health medication. Be sure to report any signs of abnormal bleeding to your provider, such as bleeding gums, unexplained bruising, or black, tarry stools.

Side effects

During treatment, common side effects of this medication may go away as your body adjusts to the medication. Common side effects of fluoxetine include:

• Headache

• Nausea 

• Diarrhea

• Vomiting

• Constipation

• Upset stomach

• Decreased appetite

• Flu-like symptoms

• Nose or throat irritation

• Dry mouth

• Increased sweating

• Feeling nervous

• Restlessness

• Fatigue

• Unusual dreams

• Sleepiness or having trouble sleeping (insomnia)

• Sexual side effects, such as reduced interest in sex and difficulty reaching climax. Sexual side effects often do not diminish over time as long as the medication is continued, but they go away when the medication is stopped.

Rare but serious side effects of fluoxetine include:

If you notice any of these side effects, stop taking the medication and seek urgent medical care.

• Low sodium blood levels (symptoms may include headache, weakness, difficulty remembering or concentrating, feeling confused, seizures, change in balance, a significant weight gain or loss)

• Angle closure glaucoma (symptoms of angle closure glaucoma may include eye pain, changes in vision, swelling or redness in or around eye)

• Serotonin syndrome (symptoms may include shivering, diarrhea, confusion, severe muscle tightness, fever, seizures, and death)

• Increased bleeding (gums)

• Seizures

• Dizziness

• Slow heartbeat

• Menstrual changes

• Passing urine more often

• Trouble controlling body movements

• Erection that lasts more than 4 hours

• Teeth grinding

• QT prolongation and ventricular arrhythmia including torsades de pointes (changes in the electrical activity of your heart; symptoms may include fast, slow or irregular heartbeat, shortness of breath, and dizziness or fainting)

• Increased risk of bleeding events when combined with use of aspirin, nonsteroidal anti-inflammatory drugs (e.g. ibuprofen, naproxen), warfarin, and other anticoagulants

These are not all the side effects of fluoxetine.  For more information, read the drug information that comes with your compounded medication, ask your healthcare provider, or ask your pharmacist.Tell your healthcare provider if you have any side effect that bothers you or that does not go away. You are encouraged to report all side effects to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

L-theanine and vitamin B6 are generally considered safe

• Although L-theanine can help with sleep, it does not cause sedation or drowsiness.  A slight lowering of blood pressure can happen when taking L-theanine, so if you are taking a blood pressure medication and notice dizziness, please notify your provider.

• Vitamin B6 generally has no side effects and is well tolerated, but when taken in excess (>100 mg), side effects may include extreme sensitivity to sunlight, nausea, heartburn, and painful skin patches. Balance Blend Rx contains 3 mg of Vitamin B6.