Femodette

Uses

Gestodene & Ehinylestradiol is indicatd for prevention of pregnancy.

Femodette is also used to associated treatment for these conditions: Menopausal Osteoporosis, Mild to Moderate Acne, Premenstrual Dysphoric Disorder ( PMDD), Moderate Acne vulgaris, Moderate, severe, Vasomotor Symptoms caused by Menopause, Contraception, Folate supplementation therapyOral Contraceptives

How Femodette works

Ethinylestradiol is a synthetic estrogenic compound. Use of estrogens have a number of effects on the body including reduced bone density. Combined oral contraceptives suppress ovulation by suppressing gonadotrophic hormone, thickening cervical mucus to prevent the travel of sperm, and preventing changes in the endometrium required for implantation of a fertilized egg. Ethinylestradiol decreases luteinizing hormone, decreasing vascularity in the endometrium. It also increases sex hormone binding globulin.

Dosage

Femodette dosage

How to Take Gestodene & Ehinylestradiol-

To achieve maximum contraceptive effectiveness, Gestodene & Ehinylestradiol must be taken in the order directed on the package and at intervals not exceeding 24 hours. Women should be instructed to take the tablets at about the same time every day, preferably after the evening meal or at bedtime. One tablet is to be taken daily for 28 consecutive days. Each subsequent pack is started on the day after the current pack is completed.

1. If you have decided to take Gestodene & Ehinylestradiol for contraception, wait for your next menstruation begins.
2. From the first day of your menstruation, start taking the first white tablet from the left corner of the top row (with arrow mark indicating begin) of your Gestodene & Ehinylestradiol tablet pack.
3. Continue taking one white tablet each day along the arrow mark.
4. After taking 21 white tablets for 21 days, then continue taking the light red placebo tablet every day from the last row in the pack for next 7 days.
5. It is most likely that your menstruation will start while taking the light red inactive tablets. Do not discontinue taking the light red inactive tablets. Taking of the light red tablets for 7 days will help you keep your tablet taking routine. If your menstruation does not start during this time, check with your doctor to make sure you are not pregnant.
6. After completing the seven light red inactive tablets, start taking white active tablets from another Gestodene & Ehinylestradiol pack and continue taking the tablet as long as you don't want to be pregnant.

Management of Missed Tablets-

If you forgot to take a tablet one day, take the missed tablet as soon as you remember. This may mean taking two tablets the very next day. Additionally you should use some other method of contraception while you are taking the tablets & until your next menstruation.If you forget to take the tablets for two continuous days, then it is likely that you will no longer be protected against pregnancy. You should therefore discontinue taking the tablet and adopt some other temporary methods (condom/foam tablet) till your next menstruation. Discard the unfinished pack of tablets and start taking tablets from the very first white tablet of the top row from a fresh pack from the first day of next menstruation.

How to Delay a Period-

To delay a period you should continue with another new pack of Gestodene & Ehinylestradiol just after finishing the white active tablet of the present pack (that is no need to take light redplacebo tablet of present pack). The extension can be carried on for as long as wished until the end of the second pack. When you wish your period to begin, just stop tablet taking. While using the second pack woman may have some breakthrough bleeding or spotting. Start with your next pack after the usual 7 day light red inactive tablet interval.

Advice in Case of Vomiting-

If vomiting occurs within 3-4 hours after white active tablet taking, absorption may not be complete. In such an event, the advice concerning Management of Missed Tablets is applicable. The woman must take the extra active tablet(s) needed from a back up pack after vomiting.

May be taken with or without food.

Side Effects

At the initial stage some women may experience side-effects like dizziness, headache, nausea, diarrhea, abdominal pain, weight gain, fluid retension, depression, mood changes, breast pain, breast tenderness, rash, vaginal discharge, erythema etc. If taken regularly, such types of side-effects normally lessen with time. If she continues to have the side effects beyond 2-3 months, she could consult with a doctor.

Toxicity

Female patients experiencing and overdose may present with withdrawal bleeding, nausea, vomiting, breast tenderness, abdominal pain, drowsiness, and fatigue. Overdose should be treated with symptomatic and supportive care including monitoring for potassium concentrations, sodium concentrations, and signs of metabolic acidosis.

Precaution

Some medications may interfere with the efficacy of the tablet. Contact your doctor if you are taking any drugs, such as antibiotics, rifampicin or medicines for seizures. You may have to use another method of contraception during this time.

Interaction

Interactions between ethinyloestradiol and other drugs may lead to decreased or increased ethinyloestradiol concentrations, respectively. Decreased ethinyloestradiol serum concentrations may cause an increased incidence of breakthrough bleeding and menstrual irregularities and may possibly reduce efficacy of the oral contraceptive. Example of substances that may decrease serum ethinyloestradiol concentrations include rifampicin, phenytoin, primidone, rifabutin, dexamethasone, griseofulvin, topiramate, some protease inhibitors, modafinil, ritonavir and barbiturates. Certain antibiotics including ampicillin, other penicillins and tetracyclines may reduce the efficacy of oral contraceptives. During concomitant use of Gestodene & Ehinylestradiol & other drugs that may lead to decreased ethinyloestradiol serum concentrations, it is recommended that a non hormonal back-up method of contraception to be used in addition to the regular intake of Gestodene & Ehinylestradiol.

Volume of Distribution

A 30µg oral dose has an apparent volume of distribution of 625.3±228.7L and a 1.2mg topical dose has an apparent volume of distribution of 11745.3±15934.8L.

Elimination Route

A 30µg oral dose of ethinylestradiol reaches a C_max of 74.1±35.6pg/mL, with a T_max of 1.5±0.5h, and an AUC of 487.4±166.6pg*h/mL. A 1.2mg dose delivered via a patch reaches a C_max of 28.8±10.3pg/mL, with a T_max of 86±31h, and an AUC of3895±1423pg*h/mL.

in vitro 99% using 3H=R5020 / in vivo similar to progesterone

Half Life

A 30µg oral dose has a half life of 8.4±4.8h and a 1.2mg topical dose has a half life of 27.7±34.2h.

16 to 18 hrs.

Clearance

Ethinylestradiol has an intravenous clearance of 16.47L/h, and an estimated renal clearance of approximately 2.1L/h. A 30µg oral dose has a clearance of 58.0±19.8L/h and a 1.2mg topical dose has a clearance of 303.5±100.5L/h.

Elimination Route

Ethinylestradiol is 59.2% eliminated in the urine and bile, while 2-3% is eliminated in the feces. Over 90% of ethinylestradiol is eliminated as the unchanged parent drug.

Pregnancy & Breastfeeding use

Use during pregnancy: The administration of Gestodene & Ehinylestradiol is contraindicated during pregnancy.

Use during lactation: The use of Gestodene & Ehinylestradiol during breast-feeding is not recommended.

Contraindication

Gestodene & Ehinylestradiol should not be used:

• If you are pregnant or think to become pregnant
• If you had stroke or thrombosis in blood vessels of heart, legs, lungs or other parts of body
• If you are a heavy smoker
• If you suffer from liver disease or jaundice
• If you are suffer from high blood pressure, migraine, feel something hard in your breast, diabetes with vascular involvement, experience excessive bleeding for which no reason has yet been ascertained
• If you have or had a benign or malignant liver tumor
• Hypersensitivity to any of the components of Gestodene & Ehinylestradiol.

Acute Overdose

Symptoms of oral contraceptive overdosage in adults and children may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness, fatigue; withdrawal bleeding may occur in females. There is no specific antidote and further treatment of overdose, if necessary, is directed to the symptoms.

Storage Condition

Store in a cool, dry place. Keep away from light & out of reach of children.

Innovators Monograph

You find simplified version here Femodette