Amabelz Tablet: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Amabelz Tablet contains estradiol (an estrogen) and norethindrone acetate (a progestogen), a sex hormone combination. It is a prescription hormone replacement therapy used by women who still have a uterus to treat moderate to severe hot flashes and vaginal changes caused by menopause, and to help reduce the chance of osteoporosis after menopause. It is taken as one tablet daily, exactly as prescribed, and carries important warnings about heart, stroke, cancer, and blood clot risks.

What is Amabelz Tablet

Amabelz is a prescription medicine that contains two hormones, an estrogen (estradiol) and a progestogen (norethindrone acetate). It is combination hormone replacement therapy used by women who still have a uterus.

Amabelz Tablet uses

• Reduce moderate to severe hot flashes (hot flushes) caused by menopause
• Treat moderate to severe menopausal changes in and around the vagina
• Help reduce the chance of getting osteoporosis (thin, weak bones) after menopause

Benefits of Amabelz Tablet

• Reduces moderate-to-severe hot flashes and night sweats by replacing declining natural estrogen
• Relieves vaginal dryness, irritation, and discomfort during intercourse caused by menopause
• Helps prevent postmenopausal bone loss and reduces fracture risk
• The progestin component protects the uterus lining from overgrowth that estrogen alone could cause

How Amabelz Tablet works

Amabelz works by replacing estrogen that the ovaries stop making after menopause, which eases hot flashes and vaginal changes. The progestin part helps protect the lining of the uterus from the effects of estrogen, lowering the chance of uterine lining overgrowth that could lead to cancer.

Amabelz Tablet dosage

Use Amabelz exactly as your healthcare provider tells you to use it. Take one tablet at the same time each day. Talk with your healthcare provider regularly, about every 3 to 6 months, about whether you still need treatment. Each blister pack is set up so you take one tablet daily, moving across each row, and you wait 24 hours between tablets. When one blister pack is empty, start the next pack the day after the last tablet, always beginning on the same day of the week.

Available forms and strengths

• Tablet
• 0.5 mg estradiol / 0.1 mg norethindrone acetate
• 1 mg estradiol / 0.5 mg norethindrone acetate

Side effects of Amabelz Tablet

Common

• Body aches or pain
• Chills or fever
• Cold or flu-like symptoms
• Difficulty breathing
• Headache
• Itching of the vagina or genital area
• Non-menstrual vaginal bleeding
• Pain during sexual intercourse
• Thick, white vaginal discharge with no odor or with a mild odor
• Unusual tiredness or weakness
• Back pain
• Cramps
• Weight gain
• Trouble sleeping
• Nausea
• Stomach or abdominal cramps, bloating
• Vomiting
• Breast pain
• Diarrhea
• Fluid retention
• Vaginal yeast infection

Serious

• Heart attack
• Stroke
• Blood clots
• Breast cancer
• Cancer of the lining of the uterus (womb)
• Cancer of the ovary
• Dementia
• High or low blood calcium levels
• Gallbladder disease
• Visual abnormalities
• High blood pressure
• High levels of fat (triglycerides) in the blood
• Liver problems
• Changes in thyroid hormone levels
• Worsening swelling of face and tongue (angioedema) in women with a history of angioedema
• Enlargement of benign tumors of the uterus (fibroids)

Warnings and precautions

• Do not use estrogens with or without progestogens to try to prevent heart disease, heart attacks, strokes, or a decline in brain function.
• Taking estrogen with progestogen may raise the chance of heart attacks, strokes, breast cancer, or blood clots.
• Taking estrogen with progestogen may raise the chance of dementia, based on a study in women 65 and older.
• Do not use this medicine if you have had your uterus removed, because you would not need the progestogen component.
• Do not start this medicine if you have unusual vaginal bleeding, a bleeding disorder, current or past certain cancers, a past stroke or heart attack, current or past blood clots, current or past liver problems, or an allergy to the medicine or its ingredients.
• Long-term use may raise the risk of blood clots, strokes, and heart attacks, and this risk can continue even after stopping the medicine. The risk is higher with high blood pressure, high cholesterol, diabetes, being overweight, or smoking.
• Amabelz is not for pregnant women. If you think you have become pregnant while using the medicine, tell your doctor right away.
• The hormones in Amabelz can pass into breast milk, so tell your healthcare provider if you are breastfeeding.
• Significant kidney disease requires clinician assessment, particularly if fluid retention develops.
• Do not start using Amabelz if you currently have or have had liver problems.
• Excessive alcohol may increase some estrogen-related health risks.
• Amabelz usually does not directly impair driving, although dizziness may occur.

Storage

• Store Amabelz at room temperature between 68°F to 77°F (20°C to 25°C).
• Store Amabelz in a dry place protected from light.
• Keep Amabelz and all medicines out of the reach of children.

When to see a doctor

• Call your healthcare provider right away if you notice new breast lumps, unusual vaginal bleeding, changes in vision or speech, sudden severe headaches, or severe chest or leg pain with or without shortness of breath, weakness, and fatigue.
• Contact your doctor immediately if you have chest pain, confusion, difficulty speaking, double vision, headaches, inability to move your arms, legs, or facial muscles, or inability to speak.
• Check with your doctor immediately if you have severe headache, sudden loss of vision, or any other change in vision while using this medicine.
• Check with your doctor if you experience stomach pain, nausea, and vomiting, which could signal gallbladder disease.
• Check with your doctor immediately if you have abnormal vaginal bleeding.

Alternatives

• Activella
• Mimvey
• Lopreeza
• Estradiol plus progesterone