Indication:
As per US FDA guidelines as per USPDA 1997
It is the intention to bring out the salient features. Hence relevent details as prescribed by US FDA guidelines as per USPDA 1997 are brought out clearly in the following chapters.
Descriptons are detailed only to the Group Head and the indiviual items can be seen by visiting the Web Site
HORMONES-
OESTROGENS-
Includes- Dieoestriol, ethinyl estradiol,oestradiol, oestrone, stilbesterol
Oestrogens are used for treatment of post monopausal defeciency sttes.They are particularly helpful when active ovaries have been removed surgically and abrupt hormone withdrawal causes severe menopausal symptoms. Creams are often preferable for local treatment of atrophic vulvitis
PROGESTOGENS-
Includes- Agents with pronounced progestational activity and little other activity: Allyloestrenol, slight oes?rogenic activity:Dydrogesterone,hydro-xyprogesterone, medr?oxyprogesterone, progesterone.
Agents with minor androgenic activity at approximate pharmacological( not necsesarily therapeutic ) doses: ethynodiol, lynoestrenol, norethisterone, norges?rel , norethynodrel
Danazol is a synthetic steroid which surpresses pitutary gonodotrophin output
GnRH analouges (Buserelin, Goserelin, Leuprorelin, Nafarelin and Triptorelin) are substantiall more active than the endogenous peptide and initially give rise to supraphysilogical plasma levels of LH, FAH,and oestrogen
Refer- Progesterone- Bleeding disorders
1. Refer to patient package insert
2.To acheive maximum contraceptive effectiveness, take OCs exactly as directed at intervals not exceeding 24 hours. preferably at the same time each day.
3 Take tablets regularly with a meal or at bed time. Efficacy depends on strict adherence to the dosage schedule.
4. For missed doses- While there is likelihood of ovulation ocuring if only 1 tablet is missed, the possibility of spotting or bleeding is increased.
5. The possibility of ovulation ocuring increase with each successive day that scheduled tablets are missed. This is particularly likely to occur if > 2 consecutive tablets are missed
6. Anytime >1 active tablet have been missed,use another method of contraception for the balance of the cycle until tablets have been taken for 7 consecutive days
7. May cause spotting or breakthrough bleeding during the first few months of the therapy- if bleeding occurs in > 1 cycle or lasts more than a few days, notify physician
8. Use an additional method of birth control until the first week of administration in the initial cycle, or for the entire cycle if vomiting or diarrhea occurs.
9. Allergies- tell your doctor if you have ever had any unusual or allergic reaction to progestins. Also tell your doctor if you are allergic to any other substances, such as foods, presevatives or dyes.
10.Pregnancy - low doses og progestins such as those dose for contraception have not caused major problems when used accidentally during pregnancy,but small (low birth weight ) babies have occured in some cases.
11.Breast feeding- be sure that you have discussed the risks and benefits of the medicine with your doctor.
12. Children - no specific information available. However, this medicine is not expected to cause different side effects or problems than it does in adults.
13.Elderly- not expected to cause different side effects or problems in older people than in younger adults.
14. Other medicines -
Aminoglutethimides or
Carbamazepines or
Phenobarbital or
Phenytoin or
Rifabutin or
Rifampicin - these medicines may decrease the efects of progestins and increase the chance of
pregnancy, so use of a second form of birth control is recommended
15. Other medical problems -
Tell your doctor if you have any other medical problems especially -
Asthma - possible allergic reaction
Epilepsy or
Heart or circulation problems or
Kidney disease or
Migraine headaches - progstins may cause fluid build up and may cause these conditions to
become worse
Bleeding problems - may make diagnosis of these problems difficult
Blood clots or
Stroke or
Varicose veins - may have greater chance of causing blood clots if these conditions are already
present when high doses of progestin are taken
Breast disease - may make the conditions worse
CNS disorders- or
High blood cholesterol - effects of progestins may make these conditions worse
Dibetes mellitus - may cause an increase in blood sugar and a change in the amount of medicine required
Liver disease- may make the condition worse
Other conditions that increase the chances of osteoporosis- since it is possible that certain doses of progestins may cause temporary thinning of the bones by changing the hormone balance. It is important that your doctor know that you have an increased risk to osteoporosis. Progestins can help protect against osteoporosis in post menopausal women.
16. Missed dose -
If you miss a dose of this medicine, take it as soon as possible. however, if it is almost time for the next dose, skip the missed dose. Do not double doses.
17. Storage -
Keep out of reach of children. Store away from heat or direct sunlight. Do not store
the capsule in bathroom, near the kitchen sink, or in other damp places.
18. Outdated medicines -
Do not keep outdated medicine or medicine no longer needed. Be sure that any
discarded medicine is out of reach of children.
