Norgestrel - Oral contraceptive- ( FDC- List )- (Aug 1968)
Drug Name:
Norgestrel - Oral contraceptive- ( FDC- List )- (Aug 1968)
List Of Brands:
Indication Type Description:
Drug Interaction:
Contraceptives- Oral include - Ethinyl oestrdiol, norethindione, norgestrel, desogestrel, levonorgesrtrel, medoxyprogesterone, progesterone
Refer Progesterone
Rifampicin, griseofluvin, phenobarbitone and phenytoin and antibiotics like tetracycline, ampicillin, antihistamines, analgesics, and tranquillisers reduce efficacy causing breakthrough bleeding or failure of contraception.
Efficacy potentiated by Vitamin C.
Reduced efficacy of anticoagulants, antihypertensives, oral antidiabetic drugs and antidepressant drugs.
Indication:
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Each combipack of 21 tablets 29-07-2011
contains-
i.FDC of Norgestrel &
Ethinyl estradiol tablets IP
Each sugar coated whit tablet
contains-
Norgestrel 0.03mg &
Ethinyl estradiol 0.03mg
ii. 7 tablets of Ferrous Fumarate
Each sugar coated tablet contains
Ferrous Fumarate 75mg
eqv. 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.DL-Norgestrel 0.25mg+ Sept -1971
Ethinyl estradiol 0.05mg tablet
2.DL - Norgestrel 0.5mg + Aug 1974
Ethinyl estradiol 0.03mg tablet
3. DL- Norgestrel 300mcg + Oct- 1976
Ethinyl estradiol 30mcg tablet
As contraceptive pill for women
4.Each Combipack of 21 tablet contains: 27.07-2011
A. FDC of Norgestrel & Ethinyl estradiol tablets IP
Each sugar coated contains :
Norgestrel 0.03mg & Ethinylestradiol 0.03mg
B. 7 tablets of Ferrous Fumarate :
Each sugar coated tablet contains :
Ferrous Fumarate 75mg eq.to 24.375mg of ferrous iron
As contraceptive for women
5.Norgestrel + Aug 1968
Ethinylestradiol tablet
Endometriosis Dysfunctional uterine bleeding Dysmenorrheoa Menstrual irregularities
Adverse Reaction:
Thromboembolism: Pulmonary embolism, coronary thrombosis, cerebral thrombosis and haemorrhage, hypertension, liver functions and congenital anamolies
Mental depression, retinal thrombosis, optic neuritis, hyperglycaemia, cataract, alopecia, cholestatic jaundice, porphyria, exacerbration of epilepsy/migraine, breast discomfort, dizziness, nausea, vomiting, dysmenorrhoea, oedema, changes in libido and appetite.
Contra-Indications:
Severe renal function disturbances, iodopathic jaundice of pregnancy, history of severe pruritus or herpes of pregnancy Dubin-Johnson syndrome. Rotors syndrome, pregnancy, undiagnosd vaginal bleeding.
Special precautions:
Hypertension, CVS disease, hepatic impairment, epilepsy.
Dosages/ Overdosage Etc:
Indication-
Endometriosis Dysfunctional uterine bleeding Dysmenorrheoa Menstrual irregularities Endometrosis-
Dosage-
1 tab daily for 6 -12 months
Dysfunctional uterine bleeding 2 - 4 tabs till acute bleeding stops subsequently
daily dose reduced to 1- 2 tabs till a total of 21 days