Drug Interaction:
Contraceptives- Oral include -
Ethinyl oestrdiol, norethindione, norgestrel, desogestrel, levonorgesrtrel, medoxyprogesterone,progesterone
Refer Progesterone
Interacting drugs - summary
Estrogens +
Anticoagulants Oral
estrogen theoritically reduce the hypoprothrombineic effect of
anticoagulants
Antidepressants Tricyclic
pharmacologic effects of these agents altered by estrogens.
An increased incidence of toxic reactions occur
Corticosteroids
estrogen coadministration reduce the clearance and increase the
elimination half-life of corticosteroids
Dantrolene
Observe caution with concomittant use. Hepatoxicity has occured
more often in women.
Hydantoins + estrogen or Estrogen + Hydantoin
breakthrough bleeding and pregnancy have resulted when used
concurrently, Loss of seizure control has also been suggested
Indication:
Female hypogonadism, Breast Cancer
New drugs approved For Marketing by Drug Controller General of India(DCGI )
during the period January 1988 to November 2014
(Ref- IDMA Annual Publication 2015)
Name of Drug Indication Date of Approval
Combipack of 21 tablets of FDC of 13-10-2010
Ethynylestradiol IP 0.03 mg +
Levonorgesterol IP 0.15mg and
7 Tablets of Ferrous Fumerate IP
75mg equiv. to 24.375mg of Ferrous
Iron
As contraceptive pill for women
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1.Combipack of 1 tablet of Gestodene 60mcg+ 17-02-2000
Ethinyl estradiol 15mcg &
24 Tablets +
4 Dummy tablets per pack
Oral contraceptive for women
2.Combipack of 21 tablets of FDC of 13-10-2010
Ethinylestradiol IP 0.03mg+
Levonorgestrel IP 0.15mg and
7 tablets of Ferrous Fumarate IP 75mg
eq.to 24.375mg of Ferrous Iron )
As contraceptive pill for women
3. Combipack of 22 tablets of Lynostrenol 1mg + Jun -1980
Ethylnyloestradiol 50mg &
6 placebo tablets of Ferrous sulphate 60mg
4.Combipack of 28 tablets of Cyproteron acetate 2mg + 20-02-2003
7 tablets of Ethinyl estradiol 0.35mg
Androgen dependent disease in women such as acne, alopecia
and mild hirution
5.Combipack of 7 blue tablets of Desogestrel 0.025mg + 29-05-2000
Ethinyl estrafiol 0.04mg &
15 white tablets of Desogretrel 0.125mg +
Ethyl estradiol 0.03mg
For oral contraception in women only
6.Combipack of Desogestral and Ethinyl Estradiol 29-05-2000
For oral contraception of women only
7. Combipack of Estradiol + Dydrogesterone : 14-11-2006
1. Each pack contains 28 tablets of Estradiol 1mg+
Dydrogesterone 5 mg
2.Each combipack contains 28 tablets ;
each of 14 tablets contain estradiol 1mg &
other each of 14 tablets contain estradiol 1mg+
Dydrogesterone 10mg
For the treatment of Hormone Replacement Therapy (HRT) in
estrogen deficiency in postmenopausal women with a uterus
and prevention of osteoporosis in postmenopausal women
who are intolrent of other products approved to prevention of
osteoporosis
8. Combipack of FDC Gestodene 60mg + 18-07-2000
Ethinyl Estradiol 0.15mg &
4 dummy tablets
Oral contraceptives for women
9.Lynestrenal 0.75mg + April 1979
Ethinyl estradiol 37.5mcg tablet
10.Lynestrenal 1mg + Sep 1973
Ethinyl estradiol 50mcg tablet
11.Lynestenal 2.5mg + Sep 1970
Ethinyl estradiol 50mcg
12. Lynestranal 2.5mg + Apr 1967
Mestranol 0.75mg tablet
Patient Information:
1. Patient information is available with products
2. Diabetic patients- Notify physician if any of the following occur. Pain in the groin or calves of the leg, sharp chest pain,or sudden shortness of breath, abnormal vaginal bleeding, missed menstrual period or suspected pregnancy lumps in the breast, sudden severe headache, dizziness or fainting, vision or speech disturbance,weakness or numbness in the arm or leg, severe abdominal pain, yellowing of the skin or eyes, severe depression
3. May cause photosensitivity (sensitivity to sunlight). Avoid prolonged exposure to the sun and other ultraviolet light.
Use sunscreens and wear protective clothing until tolerance is determined
Manufacturer Details