ESTRACOMB TTS Patches / Transdermal
Norethisterone + Estradiol
"4mg (Estraderm), 10mg, 30mg (Estragest) "
CIBA GEIGY
| Pack size | 4 Sachets (Estraderm) + 4 Sachets (Estragest) |
|---|---|
| Dispensing mode | POM |
| Source | SWITZERLAND |
| Agent | CITY MEDICAL STORE |
| Retail Price | 89.50 AED |
Indications
ESTRACOMB TTS Patches / Transdermal is used for:
Hormonal contraception
Adult Dose
Contraception, by deep slow IM injection (preferably intragluteal, alternatively into the upper arm), 1 mL on 1st day of a cycle; repeat doses are given regardless of the cycle pattern at intervals of 30 ± 3 days (i.e. minimum 27, maximum 33 days)
NOTE:
Administer the IM injection slowly to avoid short lasting reactions (urge to cough, coughing fits, respiratory distress) which may occur during or immediately after the injection of oily solutions.
Place a plaster over the injection site after the injection to prevent any reflux of the solution.
If the injection is extended beyond the maximum of 33 days, no adequate contraceptive cover will be available from that time onwards.
If no withdrawal bleeding occurs within 30 days after an injection, pregnancy must be ruled out by means of a suitable test.
A vaginal bleeding episode will occur 1-2 weeks after the first injection. This is normal and if the treatment is continued, bleeding episodes will usually occur at 30-day intervals.
The time of the monthly injection will normally be during the bleeding free interval.
Ability to conceive is usually resumed within 60 days after the last injection, otherwise appropriate treatment is indicated in women who wish to become pregnant
Child Dose
Renal Dose
Administration
For Intramuscular injection.
Administer the IM injection slowly to avoid short lasting reactions (urge to cough, coughing fits, respiratory distress) which may occur during or immediately after the injection of oily solutions.
Place a plaster over the injection site after the injection to prevent any reflux of the solution
Contra Indications
Pregnancy.
Severe disturbances of liver function.
Jaundice or persistent itching during a previous pregnancy.
Dubin-Johnson syndrome; Rotor syndrome.
Past or present liver tumours.
Past or present thromboembolic processes in arteries or veins and conditions which predispose to such diseases (e.g., disturbances of the clotting system with a tendency towards thrombosis, certain heart diseases),
Sickle-cell anaemia.
Present or treated cancer of the breast or the endometrium.
Severe diabetes with vascular changes.
Disturbances of lipometabolism.
History of herpes of pregnancy.
Otosclerosis with deterioration during pregnancy
See under Pregnancy & Lactation
Precautions
Regular general medical and gynaecological examination (including the breasts and a cytological smear of the cervix) before starting treatment and at 6-monthly intervals; rule out disturbances of the clotting system; exclude pregnancy.
Risk of venous and arterial thromboembolic diseases (e.g., stroke, myocardial infarction) appears to increase further when heavy smoking, increasing age and the use of combined hormonal contraceptives coincide.
Rarely, malignant liver tumours leading to threatening intraabdominal haemorrhage may occur; patient should report any unusual upper abdominal complaints.
Monitor patient closely for diabetes mellitus, hypertension, varicose veins, a history of phlebitis, otosclerosis, multiple sclerosis, epilepsy, porphyria, tetany, chorea minor.
Breastfeeding must be stopped if the newborn is suffering from severe or persistent jaundice.
Discontinue medication if:
- Risk factors for thrombolism are present namely first time migrainous headache or frequent and unusually severe headache; sudden perceptual disorders (e.g., disturbances of vision or hearing)
- First signs of thrombophlebitis or thromboembolic symptoms (e.g., unusual pain in or swelling of the legs, stabbing pain on breathing or coughing for no apparent reason)
- Pain and tightness in the chest
- Impending operations (six weeks before hand)
- Immobilization (for instance, after accidents)
- Onset of jaundice
- Hepatitis
- Itching over the whole body
- Increase in frequency of epileptic seizures
- Significant rise in blood pressure
- Pregnancy
See under Pregnancy & Lactation
Pregnancy-Lactation
Recommendations on the use of Norethisterone in Pregnancy & Lactation:
Norethisterone should be avoided during pregnancy because of associated risk of virilization of the genitalia of the female infant. When used during lactation, it has little or no effect on the volume of breast milk but can alter the composition of the milk. It is often combined with ethinyl estradiol for combined hormonal contraception and is recommended as MEC 3/4 for contraceptive use during the first 6 months postpartum (Faculty of Sexual and Reproductive Healthcare, 2017; Schaefer et al., 2015; World Health Organization, 2015).
NOTE:
Medical Eligibility Criteria (MEC) 3: Use of Norethisterone as progestogen-only pill (POP) during the first 6 weeks postpartum is not usually recommended unless other more appropriate methods are not available or acceptable.
Medical Eligibility Criteria (MEC) 4: Use of Norethisterone as combined pill (COC) during the first 6 weeks postpartum is NOT recommended.
References:
1. Faculty of Sexual and Reproductive Healthcare. (2017). Contraception after pregnancy. Faculty of Sexual and Reproductive Healthcare. the faculty of Sexual and Reproductive Healthcare
2. Schaefer, C., Peters, P., & Miller, R. K. (2015). Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment (Third Edition). Academic Press.
3. World Health Organization. (2015). Medical eligibility criteria for contraceptive use (5th edition). World Health Organization
Interactions
Adverse Effects
Side effects of Norethisterone + Estradiol :
Mechanism of Action
Note
ESTRACOMB TTS "4mg (Estraderm), 10mg, 30mg (Estragest) " Patches / Transdermal manufactured by CIBA GEIGY. Its generic name is Norethisterone + Estradiol. ESTRACOMB TTS is availble in United Arab Emirates.
Farmaco UAE drug index information on ESTRACOMB TTS Patches / Transdermal is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.