β-CALMED PRESCRIBING INFORMATION

A pharmacist is handing a written prescription to a patient for a bottle of β-Calmed, which is on the counter next to them.

 

PRESCRIBING INFORMATION for β-CALMED

These highlights do not include all the information needed to use β-CALMED safely and effectively. See full prescribing information for β-CALMED.

β-CALMED Softgels each serving contains 30mg Broad Spectrum Cannabidiol (CBD), 200mg L-Theanine (Suntheanine®), 120mg Ashwagandha 35% Glycowithanolides (Shoden®), Terpene Complex. Each softgel of β-Calmed contains the following inactive ingredients: MCT Oil, Gelatin. 


----------------------------INDICATIONS AND USAGE ----------------------------

β-CALMED is an herbal anxiolytic indicated for the reduction of symptoms associated with worry, fear, racing thoughts, emotional unease, panic, and distress. β-CALMED has been shown to reduce the rate of emotive unease and worry. (1.1)

----------------------- DOSAGE AND ADMINISTRATION -----------------------

  • Two softgels of β-CALMED taken orally twice daily. (2.1)

  • WARNING: SELECTIVE CYTOCHROME P450 CYP INHIBITION.

1 INDICATIONS AND USAGE

1.1 Any patients experiencing stress associated with feelings of worry, anxiety, and fear.  

2  DOSAGE AND ADMINISTRATION

    • 2.1  General Dosing Information
    • Two softgels twice daily with food.
    • 2.2  Avoid coadministration with Other Anxiolytics (SSRIs) 
    • 2.3 Avoid coadministration with MAOIs

3  DOSAGE FORMS AND STRENGTHS

  • β-CALMED Softgels each serving contains 30 mg Broad Spectrum Cannabidiol (CBD), 200mg L-Theanine (Suntheanine®), 120mg Ashwagandha 35% Glycowithanolides (Shoden®)

4  CONTRAINDICATIONS

    • 4.1  A History Of Suicidal Ideations 

5  WARNINGS AND PRECAUTIONS

    • 5.1  Competitive Inhibition of CYP2C and CYP3A

6  ADVERSE REACTIONS

             6.1 CLINICAL TRIALS 

 7 DRUG INTERACTIONS

Unknown. Avoid coadministration with MAOIs and SSRIs. 

To report SUSPECTED ADVERSE REACTIONS, contact Synergy BioNaturals., at (480)-744-5300, EMAIL drspero@synergybionaturals.com  

8 PREGNANCY

  •   8.1  Nursing Mothers

9  OVERDOSAGE

10  DESCRIPTION

10.1 COMPOUND SUMMARY

11  CLINICAL PHARMACOLOGY

         11.1  Mechanism of Action

12 CLINICAL STUDIES

13  HOW SUPPLIED/STORAGE AND HANDLING

14  PATIENT COUNSELING INFORMATION

15  BENEFITS AND RISKS

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

1.1 β-CALMED is an herbal anxiolytic indicated for the reduction of symptoms associated with worry, fear, racing thoughts, emotional unease, panic, and distress. β-CALMED has been shown to reduce the rate of emotive unease and worry.

2 DOSAGE AND ADMINISTRATION

  • 2.1  General Dosing Information
    Two softgels of β-CALMED orally twice daily.

β-CALMED has been studied only as an addition to a healthy lifestyle. There is limited clinical experience with other prescription drugs.

3 DOSAGE FORMS AND STRENGTHS

β-CALMED softgels, each serving contains 30 mg Broad Spectrum Cannabidiol (CBD), 200mg L-Theanine (Suntheanine®), 120mg Ashwagandha 35% Glycowithanolides (Shoden®), (per serving), are translucent, dark, ambered colored, oval-shaped, no distinct markings viscous oil.

4 CONTRAINDICATIONS

4.1 History of Suicidal Ideations

β-CALMED is contraindicated in patients with a history of suicidal ideations.

Discontinue β-CALMED in patients who experience nausea, dizziness, or GI cramps.

5 WARNINGS AND PRECAUTIONS

5.1 AVOID TAKING WITH ANXIOLYTICS 

MAOI drugs, and SSRIs, β-CALMED together increase the risk of Adverse Reactions.

5.2 STRONG CYP3A INHIBITION

Competitive Inhibition of CYP2C and CYP3A inhibitors can increase the effectiveness of other prescription drugs. 

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

More studies are needed to understand the pharmacodynamics of the ingredients in β-CALMED with other prescription medications. 

7 DRUG INTERACTIONS

7.1 β-CALMED contains CBD, which has been shown to inhibit CYP2C and CYP3A drug-metabolizing enzymes.  

7.2 Ashwagandha has immune-stimulating effects and should be avoided by anyone taking immunosuppressants. Ashwagandha may increase the effectiveness of pharmaceutical sedatives.

8 Pregnancy

There are no clinical studies of β-CALMED to determine its use during pregnancy. Ashwagandha should be avoided by pregnant and nursing mothers due to its rubefacient properties which can possibly elevate maternal core temperature. 

8.1 Nursing Mothers

It is unknown whether the ingredients in β-CALMED are excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants, it's not recommended to prescribe β-CALMED to nursing mothers.

9 OVERDOSAGE

More clinical studies are needed to determine overdose risk. 

10 DESCRIPTION

β-CALMED Softgels each serving contains 30 mg Broad Spectrum Cannabidiol (CBD), 200mg L-Theanine (Suntheanine®), 120mg Ashwagandha 35% Glycowithanolides (Shoden®).

10.1 COMPOUND SUMMARY


CBD

cannabidiol

(-)-Cannabidiol

(-)-trans-Cannabidiol

CBD

314.5 g/mol

C21H30O2

Ashwagandha

Withaferine A

470.6 g/mol

C28H38O6

L-Theanine

L-Theanine

N-Ethyl-L-glutamine

174.2 g/mol

C7H14N2O3

LIMONENE

Dipentene

Cinene

136.23 g/mol

C10H16

MYRCENE

beta-Myrcene

136.23 g/mol

C10H16

Linalool

Linalol

154.25 g/mol

C10H18O

11 CLINICAL PHARMACOLOGY

11.1 Mechanism of Action

β-CALMED 

CBD Broad Spectrum elevates the endogenous cannabinoid Anandamide which increases connections between different areas of the brain such as the limbic system (seat of emotions & memory) and the prefrontal cortex (logic, planning) allowing better emotional processing of anxiety based memories. CBD supports the endocannabinoid system which plays a key role in preventing the formation of emotionally aversive memories. The Endocannabinoid System prevents the consolidation and retrieval of traumatic memories. Our systems learn from stressors. When we encounter the same stressors, are endocannabinoids increase to balance the stress response. In fact, the endocannabinoid system helps support healthy emotional memory.    

Shoden® Ashwagandha provides the bioactive polyphenolic compounds glycowithanolides, which protect the brain from oxidative stress by increasing the activity of endogenous antioxidant enzymes. Shoden® Ashwagandha is a powerful adaptogen, which means it can help the body adapt to stress. The glycowithanolides in Ashwagandha have shown in animal models to increase the cerebral and striatal (movement, reward) concentrations of the antioxidant enzymes, superoxide dismutase (SOD), catalase (CAT) and glutathione (GPX).  

Suntheanine® blocks the activity of the excitatory neurotransmitter Glutamate, promoting Alpha wave activity in higher brain regions. Suntheanine® promotes a healthy stress response in the Hypothalamic Pituitary Adrenal Axis (HPA) by increasing the production of the anxiolytic neurotransmitter GABA. Suntheanine is the most bioavailable form of the naturally occurring amino acid L-Theanine, delivering the pharmacologically active (L) isomer which is well-keyed in neurochemical structures.  

Myrcene has been shown in animal models to act as a muscle relaxant. In human anecdotal reports, Myrcene induces the “couch-lock” sedative effect. Myrcene synergizes with other terpenes to calm the body.  

Linalool has been shown is animal models to suppress the central and peripheral nervous systems by modulating the bidirectional neurotransmitters glutamate (excitatory) and GABA (inhibitory). 

Limonene has been shown in animals to activate 5-HT1A serotonin receptors.  

12 CLINICAL STUDIES

Visit: www.synergybionaturals.com, or request a copy of clinical studies at drspero@synergybionaturals.com

13 HOW SUPPLIED/STORAGE AND HANDLING

β-CALMED softgels, Broad Spectrum Cannabidiol (CBD), L-Theanine (Suntheanine®) 200mg, Ashwagandha 35% Glycowithanolides (Shoden®) 120mg, are translucent, dark, ambered colored, oval-shaped, no distinct markings viscous oil.

They are supplied as follows:

746507778935 UPC 120 softgels
Storage of β-CALMED softgels
Store at 20-25°C (68-77°F), transfer of β-CALMED is permitted 15-30°C (between 59-86°F). Store softgels in the original package with the bottle tightly closed. Keep the cotton in the bottle to protect from moisture.

14 PATIENT COUNSELING INFORMATION

Advise the patient to read the Suggested Use on the back of the bottle or visit www.SynergyBioNaturals.com for more information.

15 BENEFITS AND RISKS

Adumbrate the uses and potential side effects of β-CALMED. Tell patients to take β-CALMED exactly as suggested on the bottle.
Instruct patients to: Inform physicians that taking β-CALMED with other mood-stabilizing medication might increase side effects and/or adverse reactions. 


Tell patients to list all medications, over-the-counter medications, or dietary supplements they are taking or plan to take so that the physician understands possible side effects or interactions.

Manufactured by: Synergy BioNaturals 4742 N. 24th St. Suite 300 Phoenix, AZ 85016. Their respective companies own the trademarks depicted herein.

Copyright © 2020 Synergy BioNaturals LLC., All rights reserved.