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CONJUGASE

COMPOSITION

Each tablet of CONJUGASE contains:

Conjugated Estrogens USP - 0.625 mg

DESCRIPTION

CONJUGASE consists of conjugated estrogens, which is a combination of

sodium salt of the sulfate esters of estrogenic substances, principally estrone

and equilin. The pharmacological effects of conjugated estrogens are similar

to those of endogenous estrogen.

HIGHLIGHTS (USPs)

§ Economical

§ Meets USP drug release test

CLINICAL PHARMACOLOGY

Conjugated estrogens is a mixture of estrogens obtained exclusively from

natural sources, occurring as the sodium salts of water-soluble estrogen

sulfates blended to represent the average composition of material derived

from pregnant mares' urine. It contains estrone, equilin, and 17 dihydroequilin, together with smaller amounts of

17 a-estradiol, equilenin, and

17 a-dihydroequilenin as salts of their sulfate esters.

INDICATIONS AND USAGE

§ Moderate to severe vasomotor symptoms associated with menopause

§ Atrophic vaginitis and atrophic urethritis

§ Hypoestrogenism due to hypogonadism, ovariectomy or primary ovarian

failure.

CONTRAINDICATIONS

Conjugated estrogens tablets should not be used in patients hypersensitive to

its ingredients.

§ Known / suspected breast cancer

§ Known / suspected estrogen-dependent neoplasia

§ Known / suspected pregnancy

§ Undiagnosed abnormal genital bleeding

§ Active thrombophlebitis / thromboembolic disorders

PRECAUTIONS

§ Patients on prolonged treatment should be periodically assessed for any

form of cancerous growth.

§ Periodic monitoring of blood pressure and blood glucose should be carried

out.

ADVERSE REACTIONS

Generally,CONJUGASE is well tolerated. However, some mild side effects

such as headache, nausea & vomiting, painful / tender breasts, weight gain,

fluid retention, depression may be seen. There is an increase risk of

endometrial cancer.

The following additional adverse reactions have been reported with estrogen

therapy.

Genitourinary system: Changes in vaginal bleeding pattern and abnormal

withdrawal bleeding or flow. Breakthrough bleeding, spotting, increase in size

of uterine fibromyomata, vaginal candidiasis, change in amount of cervical

secretion.

Breasts: Tenderness, enlargement.

Gastrointestinal: Nausea, vomiting; abdominal cramps, bloating; cholestatic

jaundice.

Skin: Chloasma or melasma that may persist even when drug is

discontinued; erythema multiforme; erythema nodosum; hemorrhagic

eruption; loss of scalp hair; hirsutism.

Eyes: Changes in corneal curvature; intolerance of contact lenses.

CNS: Headache, migraine, dizziness; mental depression; chorea.

Miscellaneous: Increase or decrease in weight; reduced carbohydrate

tolerance; aggravation of porphyria; edema; changes in libido.

OVERDOSAGE

Overdosage of estrogen may cause nausea and vomiting. None other serious

side effects have been observed.

DOSAGE AND ADMINISTRATION

§ Administration may be continuous e.g. without a break in therapy, or cyclic

i.e.. 3 weeks on and one week off.

§ The lowest dose that will control symptoms should be used.

§ Continuous therapy may be started arbitrarily if the patient has

menstruated within the last two months or more. If the patient is

menstruating, cyclic administration on day 5 of bleeding.

§ Cyclic administration is started arbitrarily, if the patient has not

menstruated within the last 2 months or more. It the patient is

menstruating, cyclic administration is started on the 5th day of bleeding.

§ Vasomotor symptoms : 0.625 – 1.25 mg daily

§ Atrophic vaginitis & Atrophic urethritis : ≤ 0.3 – 1.25 mg daily

§ If the bleeding occurs before the end of the 10-day period, begin a 20 day

estrogen – progesterone cyclic regimen with CONJUGASE 2.5 – 7.5 daily

in divided doses for 20 days. During the last five days of Estrogen therapy,

oral progesterone is to be given. If bleeding occurs before the conclusion

of this regimen, the therapy is to be discontinued and should be resumed

on the 5th day of bleeding.

PRESENTATION

CONJUGASE is available in a strip of 28 tablets.

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
© DR. PRAVEEN RAMACHANDRA
womenhormone@gmail.com, womenhormone@rediffmail.com