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Guna-Beta-Estradiol

Pronunciation

Generic Name: estradiol
Dosage Form: oral solution, drops

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

GUNA®-Beta-ESTRADIOL

1. INDICATIONS AND USAGE

1.1.    Regenerative Metabolic Support (use with GUNA-MATRIX, GUNA LYMPHO and GUNA-CELL)
1.2.    Female menstrual cycle disorders (use with GUNA-FEM)
1.3.    Infertility (use with GUNA-FEM)
1.4.    Aging and sagging skin
1.5.    Moderate hot flashes (use with GUNA-FEM)

Administration may vary according to individual needs.
GUNA®-BETA-ESTRADIOL may be used together with other homeopathic medications.


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2. DOSAGE AND ADMINISTRATION

The usual initial dose of GUNA®-Beta-ESTRADIOL is:

Adults and children 14 years and older    20 drops in a little water, 2 times per day

for an average of two months. If response is not satisfactory, adjust treatment protocol as recommended by your health care professional.

3. DOSAGE FORMS AND STRENGTHS

3.1.    30 ml Bottle dropper.
3.2.    The ingredient is attenuated according to the procedures stated in the Homeopathic Pharmacopeia of the United States.
Beta-ESTRADIOL 6X.
Inactive Ingredient: Ethylic Alcohol 30%.


4. CONTRAINDICATIONS

4.1.    There is no history of hypersensitivity to GUNA®-Beta-ESTRADIOL. However Estradiol should not be taken by people with a hypersensitivity/allergy.

5. WARNINGS AND PRECAUTIONS

5.1.    Estradiol should not be  administered in cases where undiagnosed vaginal bleeding is present; in cases with known, actual or suspected history of breast cancer; during current treatment for metastatic disease;  with known or suspected estrogen-dependent neoplasia;  with deep vein thrombosis, pulmonary embolism or any history of these conditions; active or recent arterial thromboembolic disease such as stroke or myocardial infarction; or with liver dysfunction or disease.
5.2    Use with caution in patients taking estrogen and/or progesterone therapy.


6. ADVERSE REACTIONS

6.1. None known. (see CONTRAINDICATIONS for hypersensitivity information).

7. DRUG INTERACTIONS

7.1.    None Known.

8. USE IN SPECIFIC POPULATIONS

8.1.    Gender: Guna-Beta-Estradiol is indicated for use in women only.
8.2.    Pregnancy:  Estradiol should not be taken by people who are pregnant or suspected pregnancy. 
8.3.    Nursing mothers:    Since many drugs are secreted in human milk, caution should be exercised when GUNA®-Beta-ESTRADIOL is administered to a nursing woman.
8.4.    Pediatric use: Safety and effectiveness in pediatric patients have not been established. Estrogen treatment of prepubertal girls may induce premature breast development,  vaginal keratinization, and may induce vaginal bleeding. In boys, estrogen treatment may modify the normal pubertal process and induce gynecomastia.
8.5.    Geriatric use: No restrictions. (see USE IN SPECIFIC POPULATIONS, Gender).

9. DRUG ABUSE AND DEPENDENCE

9.1.    No Known.

10. OVERDOSAGE

10.1.    No Known.

11. DESCRIPTION

Guna-Beta-Estradiol is a biochemical homeopathic medication indicated for Regenerative Metabolic Support, Female menstrual cycle disorders, infertility, aging, sagging skin, and moderate hot flashes.

12. CLINICAL PHARMACOLOGY

12.1.    Mechanism of Action
The active ingredient in GUNA®-Beta-ESTRADIOL is a simple biochemical compound. The exact mechanism of action is unknown; however, due to the homeopathic nature of the active ingredient, receptors may be activated by feedback regulation. 
12.2.    Pharmacodynamics
In Homeopathy there is no direct relationship between dose and effect, but rather there is a relationship between attenuation and balancing effect on biochemical pathways.
The attenuation of the physiological ingredients promotes membrane receptor feedback in order to normalize altered biological pathways. In Addition, the attenuation technique activates the low dilutions and stabilizes clinical activity of the compound.
12.3.    Pharmacokinetics
Homeopathic attenuation provides complete bioavailability of the active ingredients.

13. NONCLINICAL TOXICOLOGY

13.1.    GUNA®-Beta-ESTRADIOL has no level of toxicity due to the attenuation of the ingredients.

14. CLINICAL STUDIES

14.1.    The GUNA®-Beta-ESTRADIOL formulation is based on Homeopathic principles.

15. HOW SUPPLIED/STORAGE AND HANDLING

15.1.    NDC  17089-359-18   Oral  Solution/Drops 30 mL
15.2.    Store at room temperature, 20-25°C (68-77° F). Avoid  freezing  and excessive  heat.

16. PATIENT COUNSELING INFORMATION

16.1.    Patients should be informed about Homeopathy and the main differences with conventional clinical approaches.

PACKAGE LABEL

Guna-Beta-Estradiol  
estradiol solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:17089-359
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL (ESTRADIOL) ESTRADIOL 6 [hp_X]  in 30 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL 9 mL  in 30 mL
Packaging
# Item Code Package Description
1 NDC:17089-359-18 1 BOTTLE, DROPPER (BOTTLE) in 1 BOX
1 30 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 12/16/2008
Labeler - Guna spa (430538264)
Establishment
Name Address ID/FEI Operations
Guna spa 430538264 manufacture
Revised: 07/2010
 
Guna spa



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