What is the use of Kliogest (Progesterone) 1mg and 2mg tablets?

Kliogest Tablet: Composition and Clinical Use

Kliogest is a combined hormone replacement therapy (HRT) tablet containing 2mg estradiol (17β-estradiol) and 1mg norethisterone acetate, used primarily for the management of menopausal symptoms and prevention of osteoporosis in postmenopausal women with an intact uterus.

Composition and Classification

Kliogest is a continuous combined HRT preparation containing:

• 2mg of estradiol (17β-estradiol) - a natural estrogen
• 1mg of norethisterone acetate - a synthetic progestin derived from 19-nortestosterone

Primary Indications

• Relief of menopausal symptoms (vasomotor symptoms, vaginal atrophy)
• Prevention of postmenopausal bone loss and osteoporosis
• Protection against endometrial hyperplasia in women with an intact uterus 1, 2, 3

Clinical Benefits

• Increases bone mineral density (spine +6%, hip +2%) 3
• Improves lipid profile by lowering total cholesterol and LDL-C (both -16%) 3
• Relieves menopausal symptoms (though some studies show variable efficacy) 2, 3
• Prevents endometrial hyperplasia by counteracting the effects of estrogen on the uterine lining 1, 4

Risks and Adverse Effects

Continuous combined HRT with estrogen plus progestin increases risk of:

• Stroke (9 more per 10,000 woman-years)
• Deep venous thrombosis (12 more per 10,000 woman-years)
• Pulmonary embolism (9 more per 10,000 woman-years)
• Invasive breast cancer (8 more per 10,000 woman-years)
• Gallbladder disease (20 more per 10,000 woman-years)
• Dementia (22 more per 10,000 woman-years)
• Urinary incontinence (872 more per 10,000 woman-years) 1, 4

Appropriate Candidates

Kliogest is most appropriate for:

• Women under 60 years of age
• Women within 10 years of menopause onset
• Women without elevated risk for cardiovascular disease, stroke, or breast cancer 4

Contraindications

Absolute contraindications include:

• History of hormone-related cancers
• Active liver disease
• History of abnormal vaginal bleeding
• Previous venous thromboembolism or stroke
• Coronary heart disease 4
• Peanut allergy (if formulation contains peanut oil) 5

Administration

• Typically administered as a single daily tablet
• Should be taken at the same time each day
• For postmenopausal women with an intact uterus, the continuous combined regimen helps prevent withdrawal bleeding 4

Clinical Considerations

1. Risk-Benefit Assessment: Benefits typically outweigh risks in women under 60 years and within 10 years of menopause onset 4

2. Route of Administration: While Kliogest is an oral preparation, transdermal estradiol is generally preferred over oral formulations due to its improved safety profile regarding thrombotic risk 4

3. Monitoring: Patients should be evaluated after 3-6 months of treatment, with annual follow-up thereafter, including assessment of:

   • Blood pressure
   • Weight
   • Lipid profile
   • Symptom control
   • Bleeding patterns 4

4. Duration of Use: Should be used at the lowest effective dose for the shortest duration needed to control symptoms 4

Common Pitfalls to Avoid

1. Prescribing for cardiovascular prevention: HRT should not be used for prevention of cardiovascular disease, heart attacks, or strokes 4, 5

2. Ignoring bleeding patterns: Irregular bleeding during the first months of treatment is common but should decrease over time; persistent bleeding requires investigation 3

3. Overlooking metabolic effects: While Kliogest improves some lipid parameters, it may decrease HDL-C (-18%) 3

4. Missing contraindications: Always screen thoroughly for contraindications before prescribing 4