Guna-Beta-Estradiol

Generic Name: estradiol

Dosage Form: oral solution, drops
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.

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 NDC Product Code (Source) 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

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 17089-359-18 1 BOTTLE In 1 BOX contains a BOTTLE, DROPPER 1 30 mL In 1 BOTTLE, DROPPER This package is contained within the BOX (17089-359-18)

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: 07/2010Guna spa

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