Drug Interaction:
Contraceptives- Oral include - Ethinyl oestrdiol, norethindione, norgestrel, desogestrel, levonorgesrtrel, medoxyprogesterone, progesterone Refer Progesterone
Anticonvulsants, barbiturates, antibiotics, griseofluvin, hepatic enzyme inducers, activated charcoal, Certain laxatives, anti-HIV protease inhibitors, Anticoagulants.TCADs azole antifungals, St johns wort Cyclospor, tacrolimus, modanafinil, Antidiabetics, antihypertensives, Corticosteroids. selegiline, theophyline Herbal products
Indication:
Cranial diabetes insipidus, Primary nocturnal enuresis.
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Desogestrel Oral contraceptive January 1989
( to be combined with
Ethinyl cestradiol)
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
Desogestrel 0.15mg + Nov- 1983
Ethinylestradiol 0.03mg each tablet
Contraceptives- Oral include - Ethinyl oestrdiol, norethindione, norgestrel, desogestrel, levonorgesrtrel, medoxyprogesterone, progesterone Refer Progesterone
Adverse Reaction:
Thromboembolism, myocardial infarction,
Cerebrovascular disease, hepatic tumors, Chloasma, weight gain, fluid retention, Mood changes, reduced glucose tolerance,
GI upset,genito-urinaryb changes and or /cancer Breast enlargement and tendrness, Depression, headahe, loss of libido,
Menstrual changes, break through bleeding Irregular vaginal bleeding,
Skin reactions, Hypetension, cardiovascular effects, Contact lens iritation, hepatic impairment
Disturbance of lipid metabolism, Rarely, photosensitivity
Contra-Indications:
Circulatory disorders including thrombotic disorders, Hypertension, lipod disorders. Multiple cardiovascular risk factors, Arterial disease or cerebrovascular accident, Heart disease associated with pulmonary hypertension or risk of embolus
Trancient cerbral ischaemic attacks without headache Valvular heart disease , atrial fubrilation Severe hepatic disease including cholestatic jaundice, hepatitis ( for history ) Abnormal LFTs ( previous 3 months ) Dubin- Johnson syndrome Hepatic tumors Abnormal vaginal bleeding SLE assoiated with previos steroid ( inl. OCs) or pregnancy
Pregnancy. Lactation ( until weaning or for 6 months after birth
Special precaution:
Single cardiovascular or thromboembolic risk factor. Cardiac failure, renal impairment Epilepsy Oestrogen sensitive gynaecological disorders, obesity ( BMI > 30kgm2 )
Diabetes, inf;ammatory bowel disease, severe depression, Sickle -cell disease Varicose veins, gall bladder disease Angioedema, severediarrhea and vomiting Heavy smoking ( > 15 cigerettes /day ) andover 35 years of age
Dosages/ Overdosage Etc:
Indication-
Oral contraception
Dosage-
1 tablet daily at the same time, starting on 1st or 5th day of cycle, without interruption for 21 days followed by 7 day tablet free period
Patient Information:
Contraceptives- Oral include - Ethinyl oestrdiol, norethindione, norgestrel, desogestrel, levonorgesrtrel, medoxyprogesterone, progesterone Refer Progesterone
Pharmacology/ Pharmacokinetics:
Contraceptives- Oral include - Ethinyl oestrdiol, norethindione, norgestrel, desogestrel, levonorgesrtrel, medoxyprogesterone, progesterone Refer Progesterone
Pregnancy and lactation:
Pregnancy, lactation. Observe caution