Generic Alesse – Combined Oral Birth Control for Women Aged 18-45

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Alesse is a combined hormonal contraceptive for oral application. The contraceptive effect is achieved through two mechanisms. Under the influence of levonorgestrel, there is a blockade of the hypothalamus releasing factors (LH and FSH), inhibition of the secretion of gonadotropic hormones by the pituitary gland, which contributes to inhibition of maturation and the egg release. This egg is ready for fertilization (ovulation). Ethinylestradiol helps to keep a high viscosity of cervical mucus. As a result, it makes it difficult for sperm to enter the uterine cavity.

Along with the contraceptive effect, the regular use of drugs containing this combination normalizes the menstrual cycle due to the endogenous hormones level replenishment.

When are this drug taken?

This drug is taken in the following cases:

• oral contraception;
• functional disorders of the menstrual cycle (including dysmenorrhea without an organic cause, dysfunctional metrorrhagia);
• premenstrual tension syndrome.

What side effects are caused by Alesse?

• The reproductive system: tenderness of the mammary glands, decreased libido, intermenstrual bleeding; rarely – increased vaginal secretion, vaginal candidiasis.
• The digestive system: nausea, vomiting; jaundice, hepatitis, liver adenoma, gallbladder disease (eg, cholelithiasis, cholecystitis), diarrhea.
• The nervous system: headache, depressed mood; with long-term use – an increase in the frequency of epileptic seizures.
• The organs of senses: eyelid edema, conjunctivitis, visual impairment, discomfort when wearing contact lenses (these phenomena are temporary and disappear after withdrawal without prescribing any therapy); with prolonged use – hearing loss.
• The side of metabolism: an increase in body weight; an increase in the concentration of triglycerides, glucose in the blood, a decrease in glucose tolerance.
• The skin and subcutaneous tissues: chloasma; skin rash, hair loss; long-term use – generalized itching.
• Others: increased fatigue, increased blood pressure, thrombosis and venous thromboembolism; long-term use – cramps of the calf muscles, voice hoarsening.

What are the contraindications for this combined drug?

• Thrombosis (venous and arterial) and thromboembolism at present or in history;
• States preceding thrombosis (including transient ischemic attacks, angina pectoris) at present or in anamnesis;
• Multiple or severe risk factors for venous or arterial thrombosis;
• Hereditary or acquired predisposition to venous or arterial thrombosis:
• Resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, the presence of antibodies to phospholipids (antibodies to cardiolipin, lupus anticoagulant);
• Migraine with focal neurological symptoms at present or in history;
• Uncontrolled arterial hypertension;
• Diabetes mellitus accompained by diabetic angiopathy;
• Pancreatitis with severe hypertriglyceridemia at present or in anamnesis;
• Liver failure and severe liver disease;
• Liver tumors (benign or malignant), currently or in the anamnesis;
• Severe dyslipoproteinemia;
• Identified hormone-dependent malignant diseases (including genitals or mammary glands);
• Vaginal bleeding of unknown origin;
• Pregnancy;
• Lactation period (breastfeeding);
• Postmenopausal period;
• Age up to 18 years;
• Hypersensitivity to the birth control pills’ components.

Who should take the drug with caution?

The potential risk and expected benefit of using combined oral contraceptive drugs (COCs) in each individual case should be carefully weighed in the presence of the following diseases/conditions or risk factors:

• risk factors for the development of thrombosis and thromboembolism: smoking, hereditary predisposition to thrombosis (thrombosis, myocardial infarction, or cerebrovascular accident at a young age in one of the immediate family), overweight, dyslipoproteinemia, controlled arterial hypertension, migraine without focal neurological symptoms, uncomplicated heart valve disease;
• other diseases in which peripheral circulation disorders may occur: diabetes mellitus without diabetic angiopathy, hemolytic uremic syndrome, Crohn’s disease and ulcerative colitis, sickle cell anemia, phlebitis of superficial veins;
• hypertriglyceridemia;
• liver disease of mild and moderate severity with normal liver function tests;
• diseases that first appeared or worsened during a previous pregnancy or on the background of previous use of sex hormones (for example, jaundice, cholestasis, gallbladder disease, otosclerosis with impaired hearing, porphyria, herpes during pregnancy, Sydenham’s chorea);
• women with hereditary angioedema, chloasma, depression, epilepsy.

Application during pregnancy and lactation

Alesse is contraindicated in pregnancy and lactation.

Birth control in children and teenagers

The efficacy and safety of Alesse as a contraceptive have been studied in women of reproductive age. It is assumed that in the post-pubertal period up to 18 years old, the efficacy and safety of the drug are similar to those in women over 18 years old. The use of the drug before the onset of menarche is not indicated.

Birth control in elderly patients

Not applicable. Generic Alesse is not indicated after menopause.

Patients with liver disorders

The drug is contraindicated in women with severe liver disease until the liver function tests return to normal.

Patients with renal impairment

This combined birth control has not been specifically studied in patients with renal impairment. The available data do not suggest a dosage adjustment in these patients.

Decreased efficiency of levonorgestrel/ethinylestraiol

The effectiveness of this combined oral contraceptive drug can be reduced in the following cases: when pills are missed, with vomiting and diarrhea, or as a result of drug interactions.

What are possible interactions?

The interaction of oral contraceptives with other drugs can result in breakthrough bleeding and/or a decrease in contraceptive effectiveness. Women taking these drugs should temporarily use barrier methods of contraception in addition to this birth control, or choose another method of contraception. The following types of interactions have been reported:

• the effect on hepatic metabolism: the use of drugs that induce liver microsomal enzymes can lead to an increase in the clearance of sex hormones. These drugs include: phenytoin, barbiturates, primidone, carbamazepine, rifampicin; there are also suggestions for oxcarbazepine, topiramate, felbamate, griseofulvin and preparations containing St. John’s wort.
• HIV proteases (eg, ritonavir) and non-nucleoside reverse transcriptase inhibitors (eg, nevirapine) and combinations thereof can also potentially affect hepatic metabolism.
• the effect on intestinal-hepatic circulation: according to some studies, some antibiotics (for example, penicillins and tetracyclines) can reduce intestinal-hepatic recirculation of estrogens, thereby reducing the concentration of ethinylestradiol.
• when taking drugs that affect microsomal enzymes. Within 28 days after their withdrawal, you should additionally use a barrier method of contraception.
• while taking antibiotics (such as penicillins and tetracyclines) and within 7 days after their withdrawal, you should additionally use a barrier birth control. If the period of using the barrier method of contraception ends later than the tablets in the package, you need to move on to the next package without the regular break.

Alesse and antibiotics

Women have been warned for decades to use additional contraception when taking oral contraceptives like levonorgestrel ad ethynilestradiol and antibiotics together. It all started back in the 70s, when several women taking oral contraceptives took rifampicin and then became pregnant. Additional individual reports have begun suggesting that other antibiotics may be associated with the problem of unwanted pregnancies in women taking oral contraceptives.

One theory is that antibiotics have killed gut bacteria that are involved in the estrogen absorption. Researchers later found that rifampicin and griseofulvin actually increased the metabolism of oral contraceptives, making them less effective.

But the effect for other antibiotics is questionable. In fact, oral contraceptive levels are not decreased by most antibiotics such as tetracycline, doxycycline, ampicillin, quinolones, and metronidazole.

There is also growing evidence that most women who take antibiotics and oral contraceptives do not have an increased risk of getting pregnant.

The doctor should tell women to continue using additional contraception for the entire course of antibiotics and for 7 days after their withdrawal. Explain to them that diseases or antibiotic side effects such as diarrhea or vomiting can increase oral contraceptive failure.

Alesse and alcohol

Many women are interested in the question: is it possible to drink alcoholic beverages if you are taking oral birth control? As with any drugs, oral contraceptives have their own indications and contraindications. In the instructions for use, the need to refuse alcohol is not described, however, many experts do not recommend drinking alcohol when prescribing contraceptives.

The researchers have good news for women taking oral contraceptives: alcohol does not influence the birth control effectiveness. However, alcohol can have an indirect effect, as it changes the behavior.

First, if you drink a lot, there is a chance that you will forget to take your birth control pill on time. In the case of birth control pills, only taking the medication at about the same time will guarantee effective contraception: skipping or taking the pill late can contribute to ovulation.

Secondly, alcohol consumption, as well as taking birth control pills, is associated with an increased load on the liver, so these substances are extremely undesirable for patients with a history of liver disease. Hormones reduce the liver’s ability to metabolize alcohol, so you can get drunk faster.

One study also discusses the effect of concomitant use of alcohol and birth control pills on blood lipids and lipoproteins. The study suggests that women who take oral contraceptives and alcohol may have increased triglyceride and apolipoprotein A1 levels. High triglyceride levels and low levels of apolipoprotein A1 are thought to be risk factors for cardiovascular disease. The increased level of apolipoprotein A1 may not have clinical significance, but its causes may be just alcohol consumption, heredity, pregnancy. Thus, the effect of alcohol consumption on the risk of cardiovascular disease remains uncertain.