Drug Interaction:
Contraceptives- Oral include
Ethinyl oestrdiol, norethindione, norgestrel, desogestrel, levonorgesrtrel, medoxyprogesterone, progesterone Refer Progesterone Cabamazepine and phenytoin- reduced efficacy(pregnancy) has occured.
Drug/Lab test interactions:
Certain endocrine tests may be affected by levonorgestrel implants. Sex hormone binding globulin concentrations are decreased; thyroxine concentrations may be slightly decreased and triiodthyronine uptake increased.
Indication:
LIST OF DRUGS DURING 2007
Sr.No- 11
Name of the Drug- Levonorestrel 1.5mg tablets
Pharmacological Classification- For emergency contraceptive
Date of Approval- 07-02-07
Approved by U.S.FDA on 30-12-2007 (Ref- FDA approved List- 2007)
LIST OF DRUGS DURING 2007
Sr.No- 44
Name of the Drug- Levonorgetrel 0.03mg tablet Pharmacological Classification- For control of fertility
Date of Approval- 23-03-07
Approved by U.S.FDA on 30-12-2007 (Ref- FDA approved List- 2007)
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Levonorgrestrol 100mcg 13-10-2010
+ ethyninyl estradiol 20mcg tablet
(Addl.Indtn.)
For the treatment of moderate acne vulgaris in women more than 18yrs
of age who have no therapy contraindications to oral contraceptives
therapy, desire contraception and have acheived menarche
2.Levonorgrestrol 0.03mg tablet 23-03-2007
For control of fertitlity
3.Levonorgrestrol 1.5mg tablet 07-02-2007
For emergency contraceptive
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1.Calender pack containing 21 days Jan -1981
1.Levonorgestrel 0.5mg+
2.Ethinyloestrediol 0.03mg Tablet+
3.Ethinyloesterdiol 0.04mg Tablet
4.Ethinyloestrerdiol 0.03mg tablet and
7 inactiv tablet extra
2. Each combipack contains : 01-04-2014
21 pills of FDC of Levonorgetrel +
Ethinylestradiol IP :
Each sugar coated tablet contains :
Levonorgestrel IP 150mg + Ethinylesradiol IP 30 mcg
7 pills of placebo/inert tablets
As contraceptive pill for women
3.Levonorgrestral 0.25mg + 07-06-2001
Ethinyl Estradiol 0.05mg tablets
For emergency contraception in women only till such
time the never opition like Levonorgrestral (0.75mg)
is available
An emergency contraceptive for women after sexual intercourse without protective measures.
Adverse Reaction:
Headache, nervousness, nausea, dizziness, adnexal enlargement, dermatitis, acne, change of appetite, mastalgia, hirsutism, hypertrichosis, scalp hair loss.
Contra-Indications:
Mammary cancer Cancer of reproductive organ Liver dysfunction Hypertension Diabetes and wimen > 40 years
Precautions- Tablets An individual should not take it as regular contraceptives and should adopt the reliable contrceptive mrasures in the period from the administration to the next menstrual occurance The women who vomit within 2 hrs after administration should take additional tablet immediately Some women may experience early or delayed onset of next menses.
If the next menstrual period is more than one wek overdue, visit te doctor to exclude the possbility of pregnancy. Patients who take other medicines at the same time should consult doctor or pharmacist before taking this medicine. 72 hours after
Pharmacology/ Pharmacokinetics:
Pharmacology:
Levonorgestrel is administerd after an unprotected intercourse to prevent unwanted pregnancy. LKG is a synthetic derivative of the naturally occuring female sex hormone. progesterone., It is derived from 19- nortesterone. It has been used for many years both alone ( in low doses) in the progestogen only pill ( POP) and in combination with estrogen in combined oral contrception (COC) preparations LNG EC pills have been shown to prevent ovulation, fertilization without detectable effect on the endometrium or progesterone levels when given after ovulation. EC pills are not effective once the process of implantation has begun and will cause abortion.
Pharmacokinetics:
LNG is a hydrophobic drug with very poor aqueous solubility. The absolute bioavailability ofLNG is almost 100% of the dose administered. The LNG upon oral asministration is hydroxylated in the liver and metabolites are excreted as glucoonide conjugates.