Medicinal Products

AERODIOL 150 μg / dose

Generic drug of the therapeutic class: Gynecology
active ingredients: Estradiol
laboratory: Servier

Nasal spray solution
Box of 1 bottle of 4.2 ml
All forms

Indication

Hormone Replacement Therapy (HRT) symptoms of estrogen deficiency in postmenopausal women.
The experience of this treatment in women over 65 is limited.

Dosage AERODIOL 150 μg / dose Solution for nasal spray Box of 1 bottle of 4.2 ml

NASAL PATH.
- The recommended dose to start treatment is 150 μg (1 spray) in one nostril.
- After 2 or 3 cycles, the dosage may be adapted depending on the clinical symptomatology:
The usual maintenance dose is 300 μg (2 sprays) per 24 h, ie one spray in each nostril once a day.
. If symptoms of estrogen deficiency persist, it is possible to increase the number of sprays to 3 or 4 per day (450 μg or 600 μg), distributing them morning and evening.
. In the event of signs of hyperestrogenicity such as breast tenderness, abdominal-pelvic swelling, anxiety, nervousness or aggression, the dosage should be decreased to one spray (150 μg) per day.
- To start or continue treatment for the indication of postmenopausal symptoms, the minimum effective dose should be used for the shortest possible duration (see section on warnings and precautions for use).
- AERODIOL can be administered in cyclic or continuous treatment:
. in cyclic treatment (discontinuous): AERODIOL is administered cyclically for 21 to 28 days, followed by a free interval of any treatment of 2 to 7 days;
. in continuous treatment: AERODIOL is administered daily without any period of discontinuation of treatment. Continuous (noncyclic) treatment may be indicated in hysterectomized women or in cases where symptoms of estrogen deficiency occur during the free interval.
- In non-hysterectomized women, it is recommended to associate a progestin with AERODIOL for at least 12 days per cycle to prevent the development of estrogen-induced endometrial hyperplasia (see Warnings and Precautions section). ).
- Sequential treatment with progestins should be as follows:
. If AERODIOL is administered cyclically, a progestin will be administered for at least the last 12 days of estradiol therapy.
Thus there will be no hormonal administration during the free interval of each cycle.
. If AERODIOL is administered continuously, it is recommended to take a progestin at least 12 days a month.
- In both cases, withdrawal bleeding may occur after discontinuation of progestin therapy.
- In hysterectomized women, it is not recommended to combine a progestin unless there is a history of endometriosis.
- Patients previously under discontinuous or continuous sequential cyclic treatment must complete the current cycle and then switch to AERODIOL without stopping the treatment.
Patients previously on continuous combined therapy may begin treatment at any time.
- Priming : before the first use, the bottle must be primed by 3 firm pressures.
The bottle is held vertically during administration; the head is slightly bent forward, the tip is introduced successively into each nostril and pressure is exerted on the pump. The patient should not inhale during spraying, or blow her nose immediately afterwards.
- In case of severe obstruction of the nasal passages, AERODIOL can be administered transiently by the endobuccal route, at the level of the superior gingival sulcus, doubling the usual dosage.
- In case of nasal discharge, patients should blow their nose before administering AERODIOL.
- Administrations will preferably be carried out at the same time every day.
If a dose is missed, it may be given at any time until the next dose, but this dose should not be doubled. An oversight may promote the occurrence of spottings and intercurrent bleeding.
The benefit / risk ratio should be reassessed regularly to adjust the treatment if necessary:
. during the entire duration of treatment with AERODIOL,
. when switching from another hormonal treatment to AERODIOL.

Against indications

- Known hypersensitivity to the active substance or to any of the excipients;
- known or suspected breast cancer or history of breast cancer;
- known or suspected estrogen-dependent malignant neoplasms (eg, endometrial cancer);
- undiagnosed genital haemorrhage;
- untreated endometrial hyperplasia;
- History of idiopathic venous thrombo-embolic accident or evolving venous thrombo-embolic event (deep vein thrombosis, pulmonary embolism);
- Recent or evolving arterial thromboembolic stroke (eg angina, myocardial infarction);
- Acute liver disease or history of liver disease, until hepatic tests are normalized;
- Porphyria.
- Pregnancy: AERODIOL has no indication during pregnancy. The discovery of a pregnancy during treatment with AERODIOL, requires the immediate cessation of treatment. To date, most epidemiological studies have shown no teratogenic or foetotoxic effect in pregnant women inadvertently exposed to therapeutic doses of estrogen.
- Breast-feeding: AERODIOL has no indication during breastfeeding.

Aerodiol side effects

The most commonly reported side effects (> 10%) with AERODIOL are application site reactions: tingling sensation, sneezing, and rhinorrhea.
Other adverse reactions reported in patients receiving AERODIOL or other non-oral administration of estradiol are listed below:
- General system:
. frequent (> 1/100 and <1/10) : Headache.
. infrequent (> 1/1000 and <1/100) : Fluid retention / edema, weight gain or loss, dizziness, asthenia, cramps of the lower limbs, migraine.
- Gastrointestinal system:
. frequent (> 1/100 and <1/10) : Nausea.
. infrequent (> 1/1000 and <1/100) : Bloating, abdominal cramps.
. rare (> 1/10000 and <1/1000) : Cholelithiasis, cholestatic jaundice.
- Uterus, breast:
. frequent (> 1/100 and <1/10) : Intercurrent bleeding, spotting, mastodynia.
. infrequent (> 1/1000 and <1/100) : Dysmenorrhea, endometrial hyperplasia, benign breast tumors.
. rare (> 1/10000 and <1/1000) : Increased size of uterine fibroids.
- Respiratory system :
frequent (> 1/100 and <1/10) : Epistaxis.
- Skin and appendices:
. infrequent (> 1/1000 and <1/100) : Acne, pruritus.
. rare (> 1/10000 and <1/1000) : Urticaria.
- Cardiovascular system :
infrequent (> 1/1000 and <1/100) : Hypertension.
- Psychiatry:
. Frequent (> 1/100 and <1/10) : Increased / decreased libido.
. rare (> 1/10000 and <1/1000) : Depression.
- Breast cancer :
The results of a large number of epidemiological studies and a randomized placebo-controlled study, the WHI study, show that the overall risk of breast cancer increases with the duration of HRT use in women taking or having recently took a HRT.
For estrogens alone, the relative risks (RRs) estimated from a new analysis of 51 epidemiological studies (of which more than 80% used estrogen alone) and MWS are similar, ie 1, (95% CI: 1.21-1.49) and 1.30 (95% CI: 1.21-1.40).
For combined hormonal combinations, several epidemiological studies have shown that the overall risk of breast cancer is higher than for estrogen alone.
The MWS shows that, compared to women who have never used HRT, the use of different estrogen / progestin combinations is at risk for breast cancer (RR = 2.00, 95% CI: 1.88-2, 12) higher than estrogen alone (RR = 1.30, 95% CI: 1.21-1.40) or tibolone (RR = 1.45, 95% CI: 1.25-1.68 ).
In the WHI study, this relative risk is estimated at 1.24 (95% CI: 1.01-1.54) for all women treated for 5.6 years with an estrogen / progestin combination (EEC + MPA). ) compared to placebo.
The absolute risks calculated from the results of the MWS and WHI studies are presented below:
The MWS, taking into account the average incidence of breast cancer in developed countries, estimates that:
. out of 1000 non-users of HRT, about 32 will develop breast cancer between the ages of 50 and 64;
. out of 1000 women taking or having recently taken HRT, the number of additional cases would be:
For users of estrogen alone:
. Between 0 and 3 cases (best estimate = 1.5) for 5 years of use.
. Between 3 and 7 cases (best estimate = 5) for 10 years of use.
For users of estrogen / progestin combinations:
. Between 5 and 7 cases (best estimate = 6) for 5 years of use.
. Between 18 and 20 cases (best estimate = 19) for 10 years of use.
The WHI study estimates that at the end of 5.6 years of follow-up of women aged 50 to 79, the number of additional cases of invasive breast cancer attributable to the use of an estrogen / progestin combination (CEE + MPA) is 8 cases per 10, 000 women-years.
Calculations based on the study data suggest that:
. For 1000 women in the placebo group:
Approximately 16 cases of invasive breast cancer will be diagnosed in 5 years of follow-up.
. For 1000 women using an estrogen / progestin combination (EEC + MPA), the number of additional cases would be:
Between 0 and 9 (best estimate = 4) for 5 years of use.
The number of additional cases of breast cancer is almost identical among users regardless of the age at which treatment is started (between 45 and 65 years of age) (see section on warnings and precautions for use).
- Endometrial cancer :
In non-hysterectomized women treated with estrogen alone, the risk of hyperplasia or endometrial cancer increases with duration of treatment.
According to data from epidemiological studies, the best estimate of risk between ages 50 and 65 is about 5 endometrial cancer diagnoses in 1000 women not using HRT.
Under estrogen alone, the risk of endometrial cancer is multiplied by 2 to 12 compared to non-users, depending on the duration of use and the dose of estrogen used. The combined use of a progestin with estrogen lowers the risk significantly.
- The following undesirable effects are reported during the administration of estrogen / progestogen treatment (class effects):
. benign or malignant estrogen-dependent tumors: endometrial cancer;
. venous thromboembolic disease (deep vein thrombosis of the pelvis or lower extremities, pulmonary embolism), more common in women on HRT than non-users. For further information, see sections contraindications and warnings and precautions for use;
. myocardial infarction and stroke;
. biliary diseases;
. cutaneous and subcutaneous disorders: chloasma, erythema multiforme, erythema nodosum; vascular purpura;
. likely dementia (see Warnings and Precautions section).

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