DIVIGEL

Divigel is a brand name for a generic hormonal medication: Estradiol Gel. It is a prescription drug that got FDA approval in 1975 for the prevention or treatment of moderate to severe vasomotor symptoms- hot flashes and night sweats, associated with menopause in women.

Divigel contains 0.1% of Estradiol Gel as its active ingredient. By applying Divigel, which contains Estradiol Gel, to the skin, the Estradiol is absorbed into the bloodstream. Once in the bloodstream, Estradiol helps alleviate menopausal symptoms by replenishing the levels of estrogen in the body. It helps to restore hormonal balance and reduce the severity of symptoms experienced during menopause.

The following pharmacologically inactive components present in this medicine are triethanolamine, carbomer, propylene glycol, ethanol, and purified water. It is a colorless, clear gel that turns odorless upon drying. Estradiol is chemically designated as estra-1,3,5(10)-triene-3,17ß-diol.

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Divigel belongs to the pharmacological class: Estrogen derivatives.

Estrogen derivatives are the class of medications whose FDA-approved use is in hormone replacement therapy. These types of drugs can prevent and treat symptoms of menopause and various other conditions associated with menopause such as bone loss, cardiovascular disease, and vaginal dryness. They are even useful in the treatment of breast cancers (in women) and prostate cancers (in men).

Divigel is an Estradiol which is one of the most common naturally occurring forms of estrogen. Estrogen is a hormone produced by ovaries, adrenal glands, and fat tissues. It is naturally present in abundance in women and less in men. Its main role is sexual and reproductive development in females.

Divigel sachets come in 5 dosage strengths:

• 0.25mg
• 0.5mg
• 0.75mg
• 1mg
• 1.25mg

Starting with the lowest effective dose and regularly reevaluating the treatment plan is a common approach to HRT, aiming to provide symptom relief while minimizing potential risks. Also, these different strengths allow individualized treatment, as the appropriate dosage of the gel can vary depending on the severity of menopausal symptoms and the specific needs of each patient.

It's important to note that the choice of dosage strength should be made in consultation with your healthcare provider, as they will assess your specific needs and adjust the dosage accordingly.

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Divigel is the medication for the treatment of menopause symptoms, Hot flashes and Night Sweats.

• Menopause is that time of life of a woman when she no longer has menstrual periods and it’s been a year for this change of life to happen. It marks the end of women’s childbearing years or fertility. It occurs because of a halt in the production of estrogen and progesterone hormones by the ovaries. However, menopause can also happen if a woman undergoes surgical removal of her ovaries.     
• Hot flashes are sudden, brief waves of mild or extreme body heat that are caused by a rush of hormonal fluctuation- the drop in estrogen level. These are episodes of warm feelings, sometimes leading to flushing all over the body or perspiration.
• Night sweats are severe hot flashes that occur only at night and cause a drenching sweat.

There is no specific prescribed dose of Divigel for all women suffering from hot flashes and night sweats due to menopause. The healthcare provider can choose among the five FDA-approved dosing options that are appropriate for the patient.

Generally, every user should start using 0.25mg Divigel sachet once a day and then gradually increase their dose as per their severity of hot flashes and night sweats as well as their response to the medication. The doctor should evaluate the patient periodically and adjust her dose.

The suggested maximum dose of Divigel is 1.25 mg daily.

Divigel is available as a soothing, clear gel for transdermal application to the left or right upper thigh. Transdermal application of Divigel offers several advantages. It bypasses the digestive system, reducing the likelihood of gastrointestinal side effects that can occur with oral hormone therapy. It also provides a steady and controlled release of Estradiol into the bloodstream, maintaining more consistent hormone levels.

To apply Divigel:

1. Select a clean, dry area on the left or right upper thigh.
2. Open the sachet by tearing it along the perforation.
3. Squeeze the gel onto your palm and apply it in a thin layer to the thigh.
4. Gently massage the gel into the skin until fully absorbed, avoiding broken or irritated skin.
5. Wash the hands thoroughly with soap and water after application.
6. Allow the application site to dry before dressing to prevent transfer onto clothing or surfaces.

The most common side effects may include:

• Breast tenderness or swollen breasts.
• Vaginal spotting or irregular vaginal bleeding.
• Nausea, Vomiting.
• Loss of appetite
• Skin color changes, Acne.
• Depression
• Dizziness
• Migraine headaches
• Reduced sex drive, trouble in having an orgasm.
• Vaginal itching, unusual vaginal discharge.
• Cold
• Infections of the pharynx, larynx, nose, and sinuses.

Some of the serious, rarely occurring side effects are:

• Blood clotting, strokes, heart attacks.
• Uterine lining cancer, breast cancer, ovarian cancer.
• Dementia
• Gallbladder disease
• Uterine fibroids
• Liver problems
• Hypo and Hypercalcemia (low and high blood calcium).
• High triglycerides.
• Low levels of thyroid hormones in the blood.
• Allergic reactions.
• Diabetes or high blood sugar.
• Fluid retention, worsening of angioedema (face and tongue swelling).

Divigel may interact with the following drugs and supplements:

• Blood thinners
• St. John’s wort
• Carbamazepine
• Ritonavir
• Antimicrobial agents (antibiotics/antifungals).
• Phenobarbital.

Any of the drugs that induce or inhibit CYP3A4 may affect the metabolism of Estradiol in Divigel and reduce or increase the plasma concentration of estrogen hormone. Thus, users of Divigel sachets must tell doctors about their current use of medications and supplements before they start using Divigel.

Divigel sachets are not safe for use by:

• Women who have known allergy or angioedema to Divigel formulation.
• Women who have known liver impairment/disease or thrombophilic disorders such as deficiency of protein C, protein S, and antithrombin.
• Women who have been diagnosed, suspected, or history of breast cancer.
• Patients who suffer from arterial thromboembolic disease like stroke and MI or have records of such medical conditions.
• Patients who have active PE, DVT, or a history of these conditions.
• Women who are diagnosed with estrogen-dependent neoplasia or suspected of this condition.  
• Women who have undiagnosed unusual genital bleeding.
• Pregnant women
• Children and men.

Following are the precautions:

• Avoid smoking and use of tobacco products.
• Limit alcohol intake and avoid eating grapefruit or drinking grapefruit juice.
• Use Divigel with extra care for those aged above 65 years.
• Tell the doctor beforehand if pregnant, nursing a child, or planning of pregnancy.
• Limit or avoid sun and wear sunblocks as Divigel may cause blotchy, dark skin in areas of gel application.

• Store Divigel Sachets at controlled room temperature, preferably 20-25℃ and not beyond the range of 15-30℃.
• Avoid freezing the sachets.
• Keep them protected from heat and moisture and small children.

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