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Rosepire drug has the main ingredients including Drospirenone, Ethinylestradiol and other excipients in a sufficient amount. The drug is used to prevent pregnancy, treat acne and increase sebum production on the skin.
1. What is Rosepire birth control pill?
Rosepire birth control pills are available as round, film-coated tablets that are pink for the active ingredient and white for the placebo.
The drug is packaged in a box of 01 blister x 28 tablets (including 21 pills containing active ingredients and 7 placebo pills). Rosepire contains two main ingredients: Drospirenone and Ethinylestradiol.
1.1. The pharmacokinetics of Rosepire The contraceptive effect of the combined oral contraceptive is based on the interactions of many different factors, the most important being inhibition of ovulation and alteration of cervical secretions. bow. With its contraceptive effect, the combined Rosepire oral contraceptive may be the choice for birth control, menstrual cycle regulation, less menstrual bleeding and less pain. At the same time, the drug also works to reduce iron deficiency in the body. Drospirenone has anti-mineralocorticoid effects that limit weight gain and other signs and symptoms caused by water retention. The active ingredient Drospirenone has the effect of neutralizing the sodium retention of estrogen, creating good tolerance and positive effects on premenstrual syndrome (PSM). When combined with Ethinylestradiol, Drospirenone acts as an appropriate lipid source to increase HDL. Drospirenone has an anti-androgen effect that reduces the growth of acne and sebum on the skin's surface. The active ingredient Drospirenone does not counteract the Ethinylestradiol-related increase in SHBG levels, providing an effect on the binding and inactivation of androgens in the body. Drospirenone has similar biochemical and pharmacological properties to the naturally occurring hormone progesterone. In addition, the combination of two active ingredients, Drospirenone and Ethinylestradiol, also reduces the risk of endometrial cancer, ovarian cancer, pelvic inflammatory disease, breast tumors and ectopic pregnancy.
1.2. Pharmacokinetics of the drug Drospirenone For the pharmaceutical substance Drospirenone
Absorption when using the drug Drospirenone orally, the drug is rapidly and almost completely absorbed. Peak serum concentrations of about 38 ng/ml are achieved 1 to 2 hours after a single oral dose. Bioavailability of the drug is about 76-85%. Concomitant administration of the drug with food does not affect the bioavailability of this drug. Distribution: Drospirenone is bound to serum albumin and not to sex hormone-binding globulin (SHBG) and corticoid liver globulin (CBG). The volume of distribution of active substance Drospirenone is 3.7 + 1.2 I/kg. Metabolism: Drospirenone is almost completely metabolised after oral administration. Drospirenone is minimally metabolised by CYP3A4. Elimination: Drospirenone is excreted in very small amounts as unchanged drug. The active metabolite Drospirenone is excreted in the feces and urine with an excretion ratio of 1.2 to 1.4. The half-life of metabolites in human urine and feces is approximately 40 hours. Steady state: During the treatment cycle, the maximum steady-state drug concentration of Drospirenone in serum is about 70 ng/ml, achieved about 7 days after taking the drug. For the pharmaceutical substance Ethinylestradiol
Absorption ability: When using the drug orally, the drug is rapidly and completely absorbed. After administration of the drug at a dose of 30ug, peak serum concentrations of 100pg/ml were achieved 1-2 hours after oral administration. Bioavailability of the active substance is about 45%. Taking the drug with food reduces the bioavailability of the drug. The volume of distribution is 5 L/kg. Metabolism: Ethinylestradiol is metabolised in both the small intestine and the liver. The active substance Ethinylestradiol is metabolized primarily through aromatic hydroxylation and a variety of hydroxylation and methylation metabolites are formed, which are either free or bound to sulfates and glucuronide radicals. Elimination: The drug is not excreted unchanged. The metabolites of the active substance Ethinylestradiol are excreted mainly in urine and bile in a ratio of 4:6. The average elimination time of metabolites is about 24 hours. The half-life of the chemical is about 20 hours on average.
2. Indications of the drug Rosepire
Rosepire contraceptives are indicated for use in the following cases:
Oral contraceptives, which work well for women with a history of hormone-induced water retention. Treatment of acne pathology and excess sebum on the skin.
3. Usage and dosage of the drug Rosepire
3.1. How to use Rosepire Birth control pills Rosepire oral contraceptives are used by mouth. You should take your medicine at the same time every day to avoid forgetting it. For a pack of 28 pills: the medicine must be taken continuously. Take one tablet per day for 28 consecutive days. Because the next pack of pills is taken after the last pill of the previous pack is finished. A woman's menstrual cycle typically begins on days 2-3 after taking the placebo pill (the white pill) and may not end before the next pack.
Note when you have started taking the pill:
Not using hormonal birth control (last month): start taking Rosepire on the first day of your menstrual cycle. Change to another combined oral contraceptive (COC): start taking Rosepire the day after finishing the placebo pill or after stopping the usual pill of the previous pack. Changing from a Progesterone-Only Method (pill, injection, implant): can be started on any day when you are using only progesterone (if you have an implant or are using an IUD, take the pill on the day of removal, if you are injecting the drug, use it on the day of the next dose). With all of the above methods, after changing, it is recommended to use an additional mechanical method of contraception during the first 7 days of taking the drug. After miscarriage in the first 3 months of pregnancy: take Rosepire birth control pill immediately, then no need to use another method of contraception. After delivery or after a miscarriage in the second trimester of pregnancy: Start using Rosepire on the 21st to 28th day after giving birth or after having a miscarriage in the 2nd stage. If starting use Later in pregnancy, an additional mechanical method of contraception should be used for the first 7 days. However, if you have had sex, pregnancy must be ruled out before you use combined oral contraceptives or must wait until your first period. 3.2. Missing/overdose Cases of Rosepire oral contraceptive overdose include: You may experience signs and symptoms such as nausea, vomiting and light bleeding in young women. In case of an emergency, you need to contact or immediately go to the nearest medical facility. Currently, there is no specific antidote, treating symptoms when necessary.
In case of missed dose: If you miss a placebo pill: Does not affect the effectiveness of Rosepire oral contraceptives. You should discard the forgotten placebo pill, not extend the week of taking the placebo pill.
If you forget to take a pill containing the active ingredient: If you miss less than 12 hours after taking your daily pill, the contraceptive effect of Rosepire is not reduced. You should take the pill as soon as you remember and take the next pill at the same time every day. If you miss the pill more than 12 hours after taking it, the contraceptive effect may be reduced.
Note: Rosepire should not be discontinued for longer than 7 days, it must be taken continuously for 7 days to achieve adequate suppression of the hypothalamic-pituitary and ovarian axis.
4. Undesirable effects of the drug Rosepire
Serious undesirable effects have been reported with the use of Rosepire oral contraceptives :
Venous thromboembolism ; Thromboembolic disease; Hypertension ; Tumors in the liver; For most women who are pregnant and using Rosepire oral contraceptives, some symptoms of jaundice and/or pruritus may be present due to cholestasis, gallstones, porphyria, lupus erythematosus (systemic lupus erythematosus), hemolysis, syndrome Sydenham chorea, gestational herpes, hearing loss associated with otosclerosis. Melasma, freckles; Acute or chronic liver failure requires discontinuation of the drug until liver function returns to normal. Inform the treating doctor about the unwanted effects encountered when using the birth control pill Rosepire.
5. Contraindications of the drug Rosepire
Rosepire contraceptives are contraindicated in the following cases:
People with a history or appearance of venous thromboembolism, arterial thromboembolism, cerebrovascular accident, severe liver disease (except in cases where liver function is already impaired). normalized), liver tumor (benign or malignant). There are risk factors for arterial thrombosis, including diabetes, vascular complications, severe hypertension, and lipoprotein metabolism disorders. People with hereditary or predisposing factors for arterial thrombosis, such as anti-APC, clotting factor Ill deficiency, protein C deficiency, protein S deficiency, homozygous anemia, and antiphospholipid antibodies (anticardiolipin antibodies). , lupus anticoagulant). Have a history of pancreatitis or a history of elevated triglycerides. Severe renal failure or acute renal failure. People who have been diagnosed or suspected to have hormone-related malignancies. Vaginal bleeding of unknown cause. History of migraine with CNS signs. Hypersensitivity or local sensitivity to one of the ingredients of the drug. Women who are pregnant or breastfeeding.
6. Rosepire drug interactions
Effects of other drugs on oral contraceptives: interactions between oral contraceptives and other drugs may disrupt the cycle and/or affect the contraceptive effect of the drug. Drug interactions may occur when used with hydantoin, barbiturates, primidone, oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin. Contraceptive efficacy is impaired when used in combination with antibiotics such as ampicillin and tetracycline. Women on Rifampicin treatment should use an additional method of contraception along with oral contraceptives while using Rifampicin and 28 days after using the drug. If you are taking two pills at the same time until you run out of the active pill of the birth control pill pack, then take the next pack without a break or without using the placebo pill. Laboratory tests: Use of steroid contraceptives may affect a number of laboratory tests, including biochemical parameters of the liver, thyroid, adrenal and renal function, serum protein levels, eg. Corticosteroid-binding globulin and lipid/lipoprotein, parameters of carbohydrate metabolism, coagulation and fibrinolysis. Changes are still within the normal range. Drugs that increase the activity of aldosterone in the kidney cause salt retention.
7. Some notes when using Rosepire
Women in pregnancy: Do not use Rosepire birth control pills for pregnant women. If pregnancy is detected while taking the drug, it should be discontinued immediately.
Lactating women: May be affected by birth control pills Rosepire reduce milk quality. Do not use combination birth control pills until you are breastfeeding. Small amounts of steroid contraceptives and/or its metabolites may pass into breast milk while using the drug and may affect your baby.
Effects on ability to drive and use machines: No studies on the effects of Rosepire oral contraceptives on the ability to drive and use machines. However, it should be noted that the side effects of Rosepire oral contraceptives are headaches and otosclerosis, which reduces the ability to hear, which may affect the ability to drive or use machines.
Rosepire drug has the main ingredients including Drospirenone, Ethinylestradiol and other excipients in a sufficient amount. The drug is used to prevent pregnancy, treat acne and increase sebum production on the skin. To ensure effective use, users need to strictly follow the instructions of the doctor, pharmacist.
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