Valestra 2 mg (Tablet)

Indications

• Hormone replacement therapy for estrogen deficiency symptoms
• Prevention of osteoporosis in postmenopausal women

Pharmacology

• Free entry of estradiol into target cells
• Interactions with target cell receptor
• Regulation of gene transcription
• Increase in hepatic synthesis of sex hormone binding globulin (SHBG)
• Metabolism by cytochrome P450
• Excretion via urine with glucuronide and sulfate conjugates

Dosage & Administration

• 1 mg tablet to be taken daily
• Continuous treatment without a break
• Lowest effective dose for the shortest duration
• Addition of progestogen in women with an intact uterus
• Administration with or without food
• Swallowing whole with water or milk
• Pediatric population not recommended

Contraindications

• Known, past or suspected breast cancer
• Undiagnosed genital bleeding
• Untreated endometrial hyperplasia
• Previous idiopathic or current venous thromboembolism
• Acute liver disease or history of liver disease
• Hypersensitivity to active substances or excipients
• Porphyria

Side Effects

• Increased risk of breast cancer, endometrial hyperplasia/cancer, and ovarian cancer
• Venous thromboembolism, heart disease, stroke, memory loss
• Vaginal bleeding, breast changes, indigestion, skin issues, headache, fluid retention, changes in body weight and sex drive
• Muscle cramps, nose bleeds, visual disturbances

Pregnancy & Lactation

• Not indicated during pregnancy
• Treatment withdrawal if pregnancy occurs
• No teratogenic or foetotoxic effects indicated by epidemiological studies
• Not indicated during breastfeeding

Precautions & Warnings

• HRT initiation for symptoms adversely affecting quality of life
• Annual risk and benefit appraisal
• Limited evidence regarding risks in premature menopause
• Complete personal and family medical history before initiating or reinstituting HRT
• Periodic check-ups advised during treatment
• Appropriate investigations including imaging tools

Overdose Effects

• Nausea and vomiting
• Withdrawal bleeding in some women
• No specific antidotes
• Symptomatic treatment

Therapeutic Class

• Hormone replacement therapy
• Female sex hormones

Storage Conditions

• Store below 30°C
• Store in a dry place
• Keep away from light
• Keep out of the reach of children

Related Brands

• Evadol 2 mg (Tablet) - renata-limited
• Valestra 1 mg (Tablet) - nuvista-pharma-ltd