HORMONAL CONTRACEPTIVES


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Khushbu    on Jul 27, 2012 Says :

thank you for sharing such valuable information regarding hormonal contraceptives.
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1 : HORMONAL CONTRACEPTIVES DR RAJEEV SOOD ASTT PROF OBG IGMC SHIMLA
2 : HORMONAL CONTRACEPTIVES Oral Non oral -COC’s -Injectables contraceptives -POP’s -Hormone releasing IUDs -Emergency -Transdermal patches -Contraceptive implants -Contraceptive vaginal rings
3 : HISTORY First orally active synthetic steroidal estrogen was synthesized in 1938 by Hans Herloff & Walter Hohlweg Ethinyl estradiol & Mestranol
4 : HISTORY cont. In 1939, Marker devised the method to convert a sapogenin molecule into progestin. In 1956, with Celso-Ramon Garcia & Edris Rice Wray, the first human trial was performed with norethynodrel; it was also found that by combining norethynodrel with mestranol efficacy can be improved & breakthrough bleeding reduced. In 1960, Enovid(150ug mestranol & 9.85 mg norethynodrel) was approved for contraception. Norethindrone appeared in 1962. Wyeth labs introduced norgestrel in 1968. In 1980s, low dose oral contraceptives were developed.
5 : Mechanism of action Action of estrogen: Decreased FSH release Prevent emergence & selection of dominant follicle Provide stability to endometrium Potentiates the action of progestational agents Prevent irregular shedding Action of progestogens: Prevent LH surge Cervical mucus becomes thick & impervious to sperm transport Produces endometrium not receptive to implantation Influence secretion &peristalsis of fallopian tube Counteracts side effects of estrogen
6 : ORAL HORMONAL CONTRACEPTION Generations of oral contraception Ist generation- products containing 50ug or more of EE 2nd generation- products containing levonorgestrel, norgestimate and 20,30, or 35ug EE 3rd generation- products containing desogestrel or gestodene with 20, 25, or 30ug EE
7 : Categories of COC’s Monophasic pills: OC’s that have the same amount of estrogen & progestin in each active pill in a pack
8 : Biphasic pills: pills alters the level of hormones during menstural cycle.OC’s deliver the same amount of estrogen each day but level of progestin is increased about halfway through cycle Triphasic pills: OC’s contain 3 different doses of hormones in 3 weeks of active pills. Triquilar: 30ug EE + 50ug LNG 40ug EE+ 75ug LNG 30ug EE+ 125ug LNG
9 : Medical Eligibility Criteria (WHO) Category 1: (no restriction of use) Menarche to <40yrs Nulliparous/ parous Postpartum >21 days Postabortion Past ectopic pregnancy h/o hypertension, varicose veins, minor surgery Family h/o breast cancer Endometriosis, fibroid Unexplained vaginal bleeding after evaluation Hypo/hyperthyroidism HIV, malaria, T.B,shistosomiasis, hepatitis(non active) Iron deficiency anemia, thalassemia History of gestational diabetes Depressive disorders PID, STDs Endometrial, ovarian Ca
10 : Category 2 (benefits outweigh risks) Age over40 Obesity BMI 30 or more Family h/o DVT/PE Superficial thrombophlebitis Cigarette smoking <35years Migraine headache without localizing signs or aura <35years Undiagnosed breast mass Surgery without immobilization Unexplained amenorrhea Valvular heart disease uncomplicated Diabetes with no vascular disease Hyperlipidaemias with no risk factors Sickle cell disease Symptomatic gall blader disease treated surgically
11 : Category 3 (risks outweigh benefits) Cigarettes smoking <15/ day in>35 years Postpartum <21 days or <6 months in lactating women History of OC induced cholestatic jaundice or symptomatic gall bladder disease treated medically Mild compensated cirrhosis History of hypertension including PIH -cannot be monitored -SBP=140-159 & DBP=90-99 Hypertriglyceridemia Migraine without aura over 35years Previous breast cancer with no evidence for 5yrs Antibiotics & anticonvulsants
12 : Category 4 (not to be used) Valvular heart disease with thrombogenic complications Stroke & CAD Diabetes with vascular disease & for >20 years Hypertension( SBP>160 & DBP> !00) Cigarette smoking in women with >35years High risk & personal history of thrombosis Suspected pregnancy Multiple risk factors for atherosclerosis Migraine headaches with localizing neurological signs Acute or chronic liver disease Major surgery with prolonged immobilization Breast cancer Hypersensitivity to any component of pill
13 : Commonly available COC’s
14 : How to initiate Effective contraception is present during first cycle of pill use , provided pills are started no later than fifth day of cycle, taken same time every day & no pills are missed First day start Sunday start : use 7 days back-up method Quick start-at any time,pregnancy to be excluded
15 : Timing of initiation of COC’s Post-abortion: immediately Post-ectopic: immediately Postpartum: -initiate 3-4 weeks postpartum if not breastfeeding -6 months postpartum if breastfeeding
16 : 21/7 regimen: pills should be taken daily for 21 days, stopped & restarted after a gap of 7 days irrespective of onset or stoppage of menstruation 24/4 regimen Extended cycle regimen: seasonale ,given continously for 84 days with a break of 7 days Continous regimen:lybrel=0.09mgLNG+20ugEE taken daily for 365 days Continous regimen: Lybrel= 0.09mg LNG+ 20ug EE taken 365 days
17 : Switching from IUD: start immediately, consider barrier for 1 week Switching from implants: start immediately after removal Switching from injectable: start on day of next injection due date or on first Sunday before Switching from patch or ring: start new pack on first day of next cycle Switching from barrier: stop barrier method on initiation of first pill if using 1st day start or after 1st week of OC use if Sunday start method
18 : ADVANTAGES OF HORMONAL CONTRACEPTIVES Contraceptive Non contraceptive
19 : Advantages cont. Prevention of pregnancy Cycle stabilization Cure of menstrual disorders Protection against cancer: Endometrial cancer: reduces risk by 50% Epithelial ovarian cancer: reduces risk by 40% Colon & rectal cancer: reduces risk by 37% Indirectly prevents choriocarcinoma by preventing pregnancy.
20 : Advantages ctd. 5. Protection against benign tumors: Benign breast diseases decreases by 50-70% Ovarian functional cysts- the risk of follicular cyst reduces by 50% & that of corpus luteum cysts by 80% Fibromyoma of uterus, the risk is reduced by 30%
21 : Advantages ctd. Protection against diseases: Ectopic pregnancy Pelvic inflammatory disease Anaemia & malnutrition Endometriosis Acne & hirsutism Dysfunctional uterine bleeding Premenstural syndrome Rheumatoid arthritis
22 : Side effects Estrogen excess Breast tenderness Nausea, vomiting Chloasma Lactation suppression Vascular headaches Irritability Decreased libido Hypertension Arterial & venous thrombosis Glucose intolerance Progestin excess Amennorrhoea Acne, oily skin, hirsutism Increased appetite,weight gain Cholestatic jaundice Mood swings Increase LDL & decrease HDL
23 : Risk of cancer- Breast cancer- 20% increased risk of early & pre menopausal breast cancer in current & recent users but disease is usually localized. Risk completely disappear 10 years after use No effect of higher dose, past & duration of use No further increase in risk in women with positive family history
24 : 2. Cervical cancer- risk of dysplasia & carcinoma in situ increases but conclusions are not definitive women should have pap smears every 6 months for 5 or more years. 3. Liver cancer- WHO find no increased risk of liver cancer from short term use of OC’s The risk of adenomas is related to dose & duration of use.
25 : Medications interfering with action of oral contraceptives Anti-convulsants: barbiturates, carbamazepine,felbamate, phenobarbital, phenytoin, primidone,topiramate, vigabatrin Anti-fungal: Greisofulvin Anti-TB: Rifampicin Antibiotics: ampicillin, amoxycillin, neomycin, nitrofurantoin, metronidazole, penicillin, chloramphenicol, tetracycline, sulfonamide, quinolones.
26 : FOLLOW UP WOMEN WITH NO RISK FACTORS- Examined every 12 mths for exclusion of problems by history,measurement of BP,weight,breast exam.,abdominal and pelvic exam. With pap smear. WOMEN WITH RISK FACTORS- Examined every 6 months and investigated as required
27 : Missed pills- If 1 pill is missed,take the pill as soon as rembers and continue rest as schedule. 2 pills missed in first week-take 2 pills on each of next 2 days,continue rest as schedule,back up for 7 days 2 pills missed in second/ third week,take 2 pills as soon as remembers& 2 more the following day,use back up till next cycle More than 2 pills missed-discard current pack,begin a new pack & back up for 7 days into new cycle If any inactive pills are missed,leave them.remaining pills can be taken,next pack started on schedule..
28 : Warning signs No withdrawal bleeding for 2 months- rule out pregnancy Severe leg pain- rule out blood clot Abdominal pain- rule out pregnancy, ectopic pregnancy, upper tract infection, blood clot Chest pain & shortness of breath- rule out pulmonary embolism, myocardial infarction Speech or visual problem- rule out stroke, blood clot, hypertension Severe or increased frequency of headache- rule out hypertension, stroke Weakness, numbness, pain in extremity- rule out blood clot, stroke
29 : Managing problems with COC’s Breakthrough bleeding: common in smokers cervical infection can be another cause Management: Encouragement & reassurance If bleeding occurs before the end of the pill cycle then stops the pill wait for 7 days & start new cycle If bleeding is prolonged, regardless of point in pill cycle conjugated estrogen 1.25mg or estradiol 2mg administered daily for 7 days &continuing pill taking.
30 : 2. Amenorrhea: -Reassurance If amenorrhea of 1 mth,can start a new pack. If of 2 mths, after a negative pregnancy test- -addition of conjugated estrogen 1.25mg or estradiol 2mg for 21 days while taking pills -Switch to COC’s with higher EE/progestin ratio or OC’s with low progestin ( norgestimate, drosperinone, desogestrel)
31 : 3. Acne: switch to COC’s with norgestimate, drosperinone, desogestrel Ortho Tri-Cyclen is FDA approved to treat acne vulgaris 4.Headaches: Check BP If BP is normal, no localizing signs switch to 20ug EE or progestin only method If there are localizing signs then immediately stop COC’s
32 : . 5. Nausea or vomiting: switch to COC’s with 20ug EE or consider taking with dinner. 6. Breast tenderness: switch to COC’s with 20ug EE. 7. Melasma: switch to COC’s with 20ug EE or progestin only method 8. Mood swings: switch to COC’s with norgestimate, drosperinone, desogestrel or continous COC’s 9.Weight gain:switch to 20-25ugEE COC/DRSP 10.Decreased libido:switch to 20ugEE/POP .
33 : Reproduction after discontinuing COC’s Return of ovulation- 3-6 months No risk of congenital anomaly who conceives on oral contraception. No increase in risk of spontaneous abortions. Dizygous twinning 2 fold increased who conceive immediately after stopping OC’s
34 : COC’s containing Drosperinone Analogue of spironolactone Good cycle control Progestogenic activity suppress LH Anti mineralocorticoid activity- less wt. gain, fluid retention, PMS, mastalgia & hypertension Anti-androgenic activity- beneficial in acne, seborrhoea & hirsutism Little propensity to interact with cytochrome P450 enzymes There is potential for increase in serum K levels
35 : COC’s containing Cyproterone Acetate Progestin with antiandrogenic property & weak glucocorticoid effect Useful in PCOS & Acne
36 : PROGESTIN ONLY MINIPILL
37 : Good candidates for POP’s Women for whom estrogen is contraindicated Women over 35 or 45 yrs -smoker -multiple cardiovascular risk factors( obesity, migraine, sickle cell diease) Breastfeeding women Women who experience problems with COC’s( headache, decreased libido, mastalgia, nausea) Women on valproate & benzodiazepines.
38 : Poor candidates Women on enzyme inducing drugs Adolescents or adults who are unwilling to be rigidly complaint Obese(160lb)-pills may be less effective
39 : Commonly available POP’s
40 : Not to be used Pregnancy or suspected pregnancy Current or history of breast cancer Undiagnosed genital bleeding Acute liver disease Hypersensitivity Hepatic adenoma /carcinoma Relative CI-current coronary art or cerebrovascular ds.
41 : Counseling tips POP’s must be taken at the same time every day, ideally with in 1 hour, but 3 hours is acceptable Desogestrel only pill can be taken 12 hrs late without reducing its efficacy Should be started on first day of normal menses with no pill free interval If a pill is missed it should be taken as soon as possible & a back up method should be used for 7 days of uninterrupted POP use has been completed If pill is taken more than 3 hrs late, back method should be used for 2 days If 2 pills are missed, back up contraception should be used for one cycle No protection from STD or HIV
42 : Advantages over COC’s No effect on milk volume No increase of venous thromboembolism Can be used in diabetes with vascular disease, cardiovascular disease, hypertension, focal migraine, severe SLE
43 : Problems with POP’s Irregular menstrual bleeding Amenorrhoea Functional ovarian follicular cysts Levonorgestrel minipill may be associated with acne May have adverse effect on BMD
44 : NON ORAL HORMONAL CONTRACEPTIVES
45 : Injectable contraceptives In 1992, FDA approved the marketing of DMPA as a contraceptive
46 : Good candidates for long acting progestin injectables Women with iron deficiency anemia from heavy menstrual bleeding Who need short term contraception Breastfeeding after 6 weeks postpartum Heavy cigarette smoking In whom estrogen free contraception is required Sickle cell disease, epilepsy, endometriosis, obesity
47 : Advantages Good compliance- no daily dose required Independent of coitus Safe & effective Free from estrogen related problems Decreased risk of sickle cell crises & frequencies of grand mal seizures Non contraceptive benefits
48 : Instructions to use The initial injection should be given within first 5 days of menses DMPA is given 150mg i/m (gluteal or deltoid) once every 3 months NET EN is given 200mg i/m every 2 months Contraceptive level is maintained for at least for 14 weeks If dose of MPA is missed or delayed , another method should be used to ensure protection
49 : Counseling tips Accept change in menstrual bleeding and a 5-10 mth delay in return of fertility Get adequate Ca intake Limit their calorie intake Get regular exercise
50 : Problems with progestin injectables Irregular bleeding: can be treated with -1.25mg conjugated estrogen or 2mg estradiol -NSAIDS for 1 week -oral contraceptive x 1-3 months Amenorrhea Weight gain 1-3 kg Delay in future fertility- delay to conception is about 9 months after the last injection Bone density changes: appears to be reversible after stopping use
51 : Combined injectable contraceptive Lunelle: 25mg DMPA + 5mg estradiol cypionate every 28-30 days Mesigyna: 50mg norethindrone enanthate + 5mg estradiol valerate given monthly
52 : Best time to start-5-7 days of cycle. Can be started at any time if sure not pregnant.back up method for 7 days. In breast feeding delay of 6 mths. Is advised. In non breast feeding-3 weeks postpartum.
53 : First bleeding occurs after 10-15 days,then every 30 days lasting for about 5 days Injectables undergoing trial- DMPA-Sc-new low dose s/c DMPA,contains 104mg progesterone LNG butanoate inj.-5-10mg 3 mthly inj..
54 : ADVANTAGES Easy to use mothly dose Reversible Not intercourse dependent Contains natural oestrogens which are more lipid friendly
55 : Side effects Irregular,frequent,prolonged bleeding Amenorrhoea Return of fertility 60-90 days
56 : Intrauterine devices Progestasert Mirena Fibroplant
57 : Progestasert- T shaped device containing 38mg progesterone in silicon oil in vertical stem. Releases 65ug/day Forms a thick mucus plug 40% reduction in menstrual flow Life span 1 year Not manufactured now 6-9 fold increase in ectopic pregnancy
58 : Mirena Contains 52 mg of LNG dispersed in polydimethylsiloxane released at rate of 20ug per day Should be inserted in first 7 days of menstrual cycle,life span of 5 yrs
59 : Good candidates for LNG-IUS Women with menorrhagia, dysmenorrhea, endometriosis Women with bleeding disorders or on anticoagulation therapy Breastfeeding women after 4-6 weeks postpartum
60 : Not to be used Suspected pregnancy Immediately following septic abortion Anomalies of uterus Current pelvic inflammatory disease Pelvic tuberculosis Suspected genital bleeding Abnormal pap smear Cervicitis or vaginitis Liver disease Breast cancer
61 : Side effects Expulsion Perforation Irregular bleeding Pelvic infection Ectopic pregnancy
62 : Fibroplant- Smaller version of mirena Contains LNG released@14ug/day Suitable in perimenopausal in whom uterus shrinks Effective for 3 years.
63 : CONTRACEPTIVE PATCH Transdermal contraceptive patch ‘Ortho-Evra ‘ was approved by US FDA in 1992 & is available in developed countries
64 : PRODUCT three layered with area of 20 cm2 Contains 750ug of EE & 6mg of norelgestromin Release 20ug of EE & 150ug of norelgestromin in 24 hrs Therapeutic levels are maintained for7 days of routine patch wear Exercise, bathing, swimming,use of sauna & hot tub do not cause detachment
65 : Instructions to use Patch is applied to dry, healthy skin in one of four areas- buttocks, abdomen, upper torso excluding breasts, outside upper arm Make sure that all edges are sticking & patch remains smooth after application Apply with in first 24hrs of start of period If no applied with in 24hrs or choosing Sunday start , use back up method for 7 days Used for 3wks on & 1wk off
66 : If patch detatches <24 hrs. Reapply to same place or Reapply with new patch No back up reqd. Patch change day remains same >24 hrs. Start a new cycle New patch change day Back up reqd for first week of cycle
67 : If women forgets to change patch In week 1 Apply as soon as remembers New patch change day Back up reqd In week 2 or 3 Upto 48 hrs-apply immediately,next patch on original patch day,no back up reqd >48hrs-start a new cycle New patch change day Back up reqd
68 : In week 4 Take it off as soon as she remembers Next cycle as per schedule No back up reqd.
69 : Advantages & Disadvantages Once a week dosing- good compliance Avoid first pass liver effect Progestin with minimal androgenicity Patch is noticeable Cost may be concern Minor skin reaction Room temperature storage is necessary
70 : CONTRACEPTIVE RINGS The first vaginal contraceptive ring ‘NuvaRing’ was approved by FDA in 2001 & marketed in 2002
71 : Product Flexible, soft, transparent ring made of ethylene vinyl acetate copolymer within silicone tubing Each ring contains 2.7mgEE and 11.7mg ENG Releases 15ug EE & 120ug etonogestrel over 24hrs
72 : Advantages & Disadvantages Once a month dosing Lowest estrogen dose Simple to insert & remove No package to store One week reserve Can be removed up to 3 hrs/day Volume of normal vaginal secretions increased May slip or dislodge with straining or coitus Can not be used with severe vaginal prolapse
73 : Other disadvantages- No protection against STD or HIV Device related problems like- Ring expulsion Foreign body sensation Coital problems
74 : Instructions to use New users may choose to place the ring within 5 days of the onset of menses without back up contraception New ring is used for 3 weeks with 1 week ring free Not necessary to place the ring in a specific position, it need not surround the cervix Cervical cytology & vaginal flora is not affected
75 : Switching fromCOC-start at any time during 28 day cycle,wear for 21 days and remove Switching from IUCD-remove IUGD during menses ,start ring within 5 days of menses Post abortion-immediately Post partum-non breast feeding-3 weeks Breast feeding 6 moths
76 : Forgets to remove ring If users forget to remove ring on correct day, the user should remove as soon as she remembers. If it is with in 28 days of insertion-discard ring & place new one 7 days later. If it was worn >28 days of insertion- start new ring immediately If it was worn for >35 days , use back up for 7 days If vaginal ring is removed & not replaced with 3 hrs, use back up contraception for 7 days
77 : Rings under trial Combined estrogen & progestin vaginal rings Progering Nestorone vaginal ring
78 : CONTRACEPTIVE IMPLANTS NORPLANT I; Consists of 6 silastic capsules with diameter of 2.4 mm & length of 3.4 cm, each containing 36mg of LNG Release rate is 50-80ug in 1st year & 30-35 ug over next 5 years Becomes effective in 24 hrs & remains effective for 5 years
79 : IMPLANON: Single flexible rod 4 cm long, contains 68mg of etonogestrel dispersed in a core of ethylene vinyl acetate Hormone is released at initial rate of 67ug/day decreasing to 30ug/day after 2 years Inhibit ovulation within 8 hrs of insertion & provide contraception for 3 years
80 : LNG rod: Each rod measures 2.5 mm in diameter & 4.3 cm in length containing 75 mg of LNG Uniplant: contains 55 mg nomegestrel acetate in a 4cm silicone capsule with 100ug release per day
81 : Insertion & removal Insertion can be done any time during menstrual cycle Site of placement do not affect circulating progestin level Under aseptic conditions with or without LA, the implant is inserted subdermally on the inner aspect of the non dominant arm Removal requires making 2 mm incision at distal tip of implant
82 : Advantges Safe, highly effective, long acting Can be used by women for whom estrogen is contraindicated Excellent choice for breastfeeding Return of fertility after removal is prompt
83 : Disadvantages Disruption of bleeding patterns Needs surgical procedure performed by trained personnel Visible under skin No protection against STDs Mastalgia, acne, ovarian cyst
84 : Failure rates of various Hormonal Contraceptives
85 : Choice of hormonal contraceptives
86 :
87 : THANK YOU

 

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