CYCLOFEMINA (MEDROXI-PROGESTERONA / ESTRADIOL) PRELOAD INJECTION

SKU: 7501124103323

In stock: 959 units

THERAPEUTIC INDICATIONS: CYCLOFEMINA ® is a hormonal contraceptive monthly parenteral application, indicated for the prevention of pregnancy.

CYCLOFEMINA ® in addition to providing protection against pregnancy is associated with the following positive effects: reducing the frequency of benign mastopathy, reducing the risk of endometrial carcinoma, reduction in the frequency of ovarian cysts, and possible reduction in the frequency of ovarian carcinoma . The estrogen-progestogen components CYCLOFEMINA ®, estradiol cypionate (Cip-E2) and medroxyprogesterone acetate (DMPA), offer a special profile, and give an effective contraceptive action, with different characteristics compared to other oral contraceptives and Parenteral: CYCLOFEMINA ® has no significant androgenic activity therefore is devoid, or their impact is minimal androgenic side effects like weight gain, acne and hirsutism, allows a reduced risk for the cardiovascular system, not negatively alter the metabolism lipid. With regard to pretreatment levels, no adverse effects on carbohydrate metabolism, produces no change in systolic or diastolic blood pressure or interfere with the mechanisms of blood clotting, does not cause abnormal atrophic changes in the endometrium and there is a very low frequency of amenorrhea and of bleeding or spotting.

CYCLOFEMINA ® has proven effective as a contraceptive, since with a single injection inhibits ovulation month, has a favorable effect of contraception on cervical mucus to increase viscosity and reduce the amount of mucus produced, and has a pregnancy rate virtually 0%.

Changes in hormone levels of women in treatment, even for prolonged periods, are reversible upon discontinuation of CYCLOFEMINA ® application, no significant change on the values of prolactin and the return to fertility after discontinuing CYCLOFEMINA ® is almost immediate ( within 2 or 3 months).

CYCLOFEMINA ® meets the need of women to have available an anovulatory effective, well tolerated and convenient, yet dispelled the concern of the physician to prescribe a combination hormone to be highly effective to reduce cardiovascular risk by offering a monthly contraceptive perspective parenteral convenience and long-term security. For optimal efficacy profile in a thousand months / woman accumulated (> 20.000) and safety (low incidence of adverse events mild to moderate and decreasing with time and disappear immediately after stopping treatment), CYCLOFEMINA ® is the ideal contraceptive for adoption in family planning programs and the couple helps your decision making by providing a safe and effective means for spacing as desired and allow no more children after you conceived the number.

Pharmacokinetics in Humans: medroxyprogesterone acetate (DMPA) is an efficient and highly selective progestin. It has pharmacological characteristics similar to natural progesterone, being about 10 times more powerful than this. It has some affinity with androgen receptors and is transported by the SHBG (sex hormone binding globulin), joining with low affinity to albumin.

Exerts a potent antigonadotropic anovulatory and, hence contraceptive efficacy with a single injection per month.

Absorption: Following intravenous administration, DMPA muscle is gradually absorbed and peak concentrations are reached within 3-6 days. In this way, the bioavailability of DMPA is greater than 80% of the administered dose.

Metabolism and Excretion: DMPA is metabolized in the liver by hydroxylation of the molecule, conjugation and elimination in the urine and feces. These parameters are not altered when administered together estradiol cypionate, ie called CYCLOFEMINA ® formulation.

The estradiol cypionate (Cip-E2) is an effective estrogen. The main pharmacological activity of estradiol cypionate (Cip-E2) comes from the hydrolytic biotransformation to 17-beta estradiol.

Absorption: Following parenteral administration, the Cip-E2 gradually absorbed and maximum concentrations of E2 in serum are reached after 2-3 days. These parameters are not altered when administered together DMPA, ie the combination called CYCLOFEMINA ®.

Metabolism and Excretion Estradiol is metabolized in the liver to form metabolites estrone and estriol to a lesser extent, which are conjugated to be excreted in urine, secreted into the bile and excreted in the feces. A portion enters the enterohepatic cycle.

Absolute Contraindications: A history of deep vein thrombophlebitis or thromboembolic disorders, cerebrovascular or coronary artery disease, moderate or severe hypertension; existence of more than one of the recognized risk factors for arterial disease, liver disease, past or present history of jaundice during a previous pregnancy or due to steroid use, porphyria, choledocholithiasis, liver, breast carcinoma; estrogenodependientes neoplasms, endometrial hyperplasia or undiagnosed vaginal bleeding, pregnancy confirmed or presumptive, hyperlipoproteinemia, galactorrhea, nipple discharge or other, Papanicolaou grade III or higher.

Relative Contraindications: Epilepsy, migraine, depression, diabetes mellitus. If any of the above conditions are severe or if liver function tests become abnormal, should be discontinued immediately CYCLOFEMINA ® application.

PRECAUTIONS: Do not use if pregnancy is suspected or confirmed pregnancy, if you notice any discoloration in the suspension. If you place or there is any risk of vascular disease, it requires full assessment of the patient.

The first time you use CYCLOFEMINA ® should be administered between 1 and 5 days after the onset of the menstrual cycle. Menstruation may be advanced or delayed the expected date, which is considered as normal, after a period of 2-3 months of individual adaptation, periods and return to normal frequency characteristics. Some patients may present amendments are considered mild to moderate, consisting of amenorrhea, spotting, spotting, change in the quantity and / or duration of bleeding, these effects are temporary and are an adaptation period, which does not imply or interruption or changing contraceptive therapy. Do not use other hormones to regulate menstruation. The injections should be administered promptly.

Are advised to consult doctor in case of disturbances in menstruation, before stopping treatment.

Use in Pregnancy and Lactation CYCLOFEMINA ® like any other steroid should not be administered during pregnancy or if pregnancy is suspected. The estrogen component of combination hormonal contraceptives may induce a decrease in the amount of breast milk. Although not stated whether it can cause adverse effects in infants is not recommended for use during lactation.

ADVERSE REACTIONS: We observed a low incidence of side effects reported more frequently in the initial cycles of hormonal contraceptive therapy, such as bleeding or spotting, abnormal bleeding pattern normal and rarely leads to amenorrhea, nausea , vomiting, headache and slight alteration of body weight.

Adverse effects such as acne, hirsutism, breast pain, breast pain, metabolic changes, liver, irritability, have been reported in connection with the implementation of CYCLOFEMINA ®.

DRUG INTERACTIONS AND OTHER GENDER: CYCLOFEMINA ®, like any other oral or parenteral hormonal contraceptives may decrease the antidepressant response to tricyclics and increase the frequency of adverse effects from the simultaneous use of estrogen compounds.

Anticonvulsants such as phenobarbital, primidone, carbamazepine and phenytoin, induce liver enzymes can reduce the contraceptive effect.

The use of tuberculosis such as rifampicin or certain antibiotics such as ampicillin can also decrease the contraceptive effect, so it is suggested as a precautionary measure also use non-hormonal contraceptive method (barrier) when administered concomitantly CYCLOFEMINA ® with these drugs.

CHANGES IN RESULTS OF LABORATORY TESTS: There are no reports of changes in the results obtained after up to 24 cycles of treatment with CYCLOFEMINA ®, none of the parameters evaluated in laboratory tests designed to assess blood clotting mechanisms, the profile thyroid, lipid profile and glucose metabolism.

PRECAUTIONS IN RELATION TO EFFECTS OF CARCINOGENESIS, MUTAGENESIS, Impairment of Fertility: Preclinical studies of acute, subacute and chronic CYCLOFEMINA ®, dosing schedules using simple and multiple, have shown no effects that are relevant to humans. The LD50 is greater than 1.000 mg / kg in all species studied, and no reported toxic potential medium and long term. In vitro or in vivo has not been observed teratogenicity, embryotoxicity or mutagenic with even prolonged administration CYCLOFEMINA ®.

DOSAGE AND ADMINISTRATION: Each injection should be intramuscular, preferably applied as deep in the gluteal region.

Dosage: 1 month injection (see Instructions).

The first time you use it, CYCLOFEMINA ® should be administered between 1. and 5. days after the onset of the menstrual cycle, counting the first day of menstruation as the first day of the cycle.

The second shot should be between 27 and 33 days after the first application (30 days ± 3 days), regardless of the date of this menstruation, which after the first injection can be advanced up to 10 days after the date normal.

The following injections should be applied in the same range between 27 and 33 days after the previous injection, the periods should return to its normal rate.

In case you missed the days indicated to apply CYCLOFEMINA ®, is recommended to wait to present the next period before restarting treatment (initiation or resumption of treatment with CYCLOFEMINA ® always between 1. And 5. Day of the cycle) and During the timeout, use non-hormonal birth control.

REPRESENTATIONS AND MANAGEMENT Overdosage: No reports of overdosage with CYCLOFEMINA ®.

The steroid overdose would cause nausea / vomiting, headache.

Vial with 0.5 ml: Box of 1 vial with 0.5 ml in blister pack with Cyclo-calendar ® and informative annex.

Uniject ® injection device prefilled with 0.5 ml: Box containing 1 Uniject ® injection device for low-density polyethylene with 0.5 ml pre-filled and informative annexes.

Prefilled syringe with 0.5 ml: Box with a syringe prefilled with 0.5 ml sterile disposable needle and bubble packaging with printed instructions and Cyclo-calendar ® and instructive appendices.

Name of medicine: Cyclofemina

Comparable patent medicine: Cyclofemina

Active ingredient: Medroxyprogesterone / Estradiol

Presentation: Suspension for injection

Concentration: 25mg/5mg

Laboratory: Carnot

0.5ml prefilled syringe and needle

Made in: Mexico

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