β-Relieved Prescribing Information

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

 

PRESCRIBING INFORMATION for β-RELIEVED

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

β-RELIEVED Softgels each serving contains 30mg Broad Spectrum Cannabidiol (CBD), 600mg Turmeric (BCM-95®), 200mg Boswellia (5-Lox® 30% AKBA), 100mg Ginger (5mg Shogoals), Terpene Complex. Each softgel of β-RELIEVED contains the following inactive ingredients: MCT Oil, Gelatin. 


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

β-RELIEVED is an herbal based analgesic indicated for reducing the symptoms associated with chronic pain and inflammation. (1.1)

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

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

  • WARNING: SELECTIVE CYTOCHROME P450 CYP INHIBITION.

1 INDICATIONS AND USAGE

1.1 Any patients experiencing pain as a result of chronic inflammation in soft-tissue areas. 

2  DOSAGE AND ADMINISTRATION

    • 2.1  General Dosing Information
    • Two softgels twice daily with food.
    • 2.2  Avoid coadministration with Anticoagulants, Diabetic Medication. 
    • 2.3 Avoid coadministration with Metformin

3  DOSAGE FORMS AND STRENGTHS

  • β-RELIEVED Softgels each serving contains 30mg Broad Spectrum Cannabidiol (CBD), 600mg Turmeric (BCM-95®), 200mg Boswellia (5-Lox® 30% AKBA), 100mg Ginger (5mg Shogoals), Terpene Complex

4  CONTRAINDICATIONS

    • 4.1  A History Of Gallstones

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 Anticoagulants and Diabetic Medication. 

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-RELIEVED is an herbal based analgesic indicated for reducing the symptoms associated with chronic pain and inflammation.

2 DOSAGE AND ADMINISTRATION

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

β-RELIEVED 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-RELIEVED softgels, 30mg Broad Spectrum Cannabidiol (CBD), 600mg Turmeric (BCM-95®), 200mg Boswellia (5-Lox® 30% AKBA), 100mg Ginger (5mg Shogoals), Terpene Complex. Each softgel of β-RELIEVED contains the following inactive ingredients: MCT Oil, Gelatin (per serving), are translucent, dark, ambered colored, oval-shaped, no distinct markings viscous oil.

4 CONTRAINDICATIONS

4.1 β-RELIEVED is contraindicated in patients with a history of gallstones.

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

5 WARNINGS AND PRECAUTIONS

5.1 AVOID TAKING WITH ANTICOAGULANTS AND DIABETIC MEDICATION. 

β-RELIEVED with 5.1 together increase the risk of Adverse Reactions.

5.2 STRONG CYP 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-RELIEVED with other prescription medications. 

7 DRUG INTERACTIONS

7.1 β-RELIEVED contains CBD and Turmeric, which have been shown to inhibit CYP2C and CYP3A drug-metabolizing enzymes.  

7.2 Turmeric extract may also inhibit certain isozymes in phase 2 enzymes UDP-glucuronosyltransferases (UGTs) and sulfotransferases (SULTs).

8 Pregnancy

There are no clinical studies of β-CALMED to determine its use during pregnancy. BLEEDING: Turmeric increases the chances of bleeding and bruising by interacting with medications that slow blood clotting.  Anyone undergoing surgery should avoid Turmeric until cleared by their doctor. 

8.1 Nursing Mothers

It is unknown whether the ingredients in β-RELIEVED are excreted in human milk. Since 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-RELIEVED to nursing mothers.

9 OVERDOSAGE

There is little risk of overdose. But more clinical studies are needed to determine overdose risk. 

10 DESCRIPTION

β-RELIEVED contains 30mg Broad Spectrum Cannabidiol (CBD), 600mg Turmeric (BCM-95®), 200mg Boswellia (5-Lox® 30% AKBA), 100mg Ginger (5mg Shogoals)

10.1 COMPOUND SUMMARY


CBD

cannabidiol

(-)-Cannabidiol

(-)-trans-Cannabidiol

CBD

314.5 g/mol

C21H30O2

Turmeric

Curcumin

368.380 g/mol

IC21H20O6

Boswellia

Acetyl-11-keto-beta-Boswellic Acid

512.7 g/mol

C32H48O5

Ginger

Ginger extract, Z. officinale

568.8 g/mol

C35H52O6

MYRCENE

beta-Myrcene

136.23 g/mol

C10H16


Limonene

Dipentene

136.23 g/mol

C10H16

α-Pinene

ALPHA-PINENE

136.23 g/mol

C10H16

11 CLINICAL PHARMACOLOGY

11.1 Mechanism of Action

β-RELIEVED

CBD Broad Spectrum Cannabidiol inhibits the degradation of anandamide, an endogenous cannabinoid involved in the regulation of pain, mood, and cognition. CBD prevents the breakdown of the endocannabinoid Anandamide by binding with fatty acid-binding protein FABP, which solubilizes and transports endocannabinoids such as Anandamide into the cell where it’s broken down by the enzyme fatty acid amide hydrolase FAAH. CBD activates TRPV1 Vanilloid receptors, which play an essential role in pain perception, body temperature, and inflammation. Activation of TRPV1 desensitizes/fatigues pain processing neurons resulting in these brain cells no longer responding to noxious stimuli.  

Turmeric as BCM95® modulates NF-κB signaling, proinflammatory cytokines such as interleukin production and phospholipase A2, COX-2, and 5-LOX activities. NF-κB activation during inflammation leads to increased gene expression of cytokines (TNF-α, IL-1β), chemokines (MCP-1) and other inflammatory proteins (COX-2) that are critical mediators of joint inflammation in rheumatoid arthritis. Inhibition of NFkB turns off the inflammatory cascade. Turmeric blocks the signal that leads to the activation of IKK which is an enzyme that liberates the inflammatory transcription factor NFkB. The IκB kinase (IKK) is an enzyme complex that is involved in propagating the cellular response to inflammation. When released, NF-κB migrates into the nucleus and activates the expression of at least 150 genes involved in inflammation.  

Boswellia as 5-LOXIN® Boswellic acids inhibit 5-lipoxygenase, a key inflammatory mediator. Among boswellic acids, 3-O-acetyl-11-keto-b-boswellic acid (AKBA) is the most potent anti-inflammatory agent. Studies showed that AKBA snugly fits on the active site of 5-LOX. AKBA is also a natural inhibitor of NF-kB. Downstream inflammatory mediators such as TNF-a are lowered as a consequence of NF-kB inhibition.  

Ginger Gingerol, shogaol, and other structurally-related substances in ginger inhibit prostaglandin and leukotriene biosynthesis through suppression of 5-lipoxygenase or prostaglandin synthetase. Ginger synergizes with other herbs by stimulating the absorptive surface of the intestinal mucosal membrane. Ginger suppresses the activity of inflammatory mediating enzymes such as 5-lipoxygenase and cyclooxygenase-2, both of which play a fundamental role in chronic inflammatory diseases. Two major cytokines involved in the initiation of inflammation are TNF-a and IL-1. These proteins have multiple sites of action. Responses can include induction of other cytokines, activation of arachidonic acid metabolism, and priming of polymorphonuclear leukocytes (PMN). In a clinical study, Ginger extract inhibited the expression of TNF-a in synoviocytes (specialized cell type located inside joints) activated by either IL-1 or TNF-a at the transcript and protein levels. 

Myrcene is a natural muscle relaxant that induces the “couch-lock” sedative effect when synergized with other terpenes such as Limonene. Myrcene exerts its anti-inflammatory benefits by inhibiting the activity of the eicosanoid PGE2.  

Limonene synergizes with the terpene myrcene increasing its anti-inflammatory, anti-oxidative, and anti-proliferative benefits


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-RELIEVED softgels, 30mg Broad Spectrum Cannabidiol (CBD), 600mg Turmeric (BCM-95®), 200mg Boswellia (5-Lox® 30% AKBA), 100mg Ginger (5mg Shogoals), are translucent, dark, ambered colored, oval-shaped, no distinct markings viscous oil.

They are supplied as follows:

746507778928 UPC 120 softgels
Storage of β-RELIEVED softgels
Store at 20-25°C (68-77°F), transfer of β-RELIEVED 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-RELIEVED. Tell patients to take β-RELIEVED exactly as suggested on the bottle. Instruct patients to inform physicians that taking β-RELIEVED with anticoagulants and diabetic medication is not advised. 


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.