NAVELA 1.5 MG TABLET 1'S (EMERGENCY ORAL CONTRACEPTIVE PILL)

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Navela is a progestin or a synthetic form of the naturally occurring female sex hormone, progesterone. In a woman's normal menstrual cycle, an egg matures and is released from the ovaries (ovulation). The ovary then produces progesterone, preventing the release of further eggs and priming the lining of the womb for a possible pregnancy. If pregnancy occurs, progesterone levels in the body remain high, maintaining the womb lining. If pregnancy does not occur, progesterone levels in the body fall, resulting in a menstrual period. navela tricks the body processes into thinking that ovulation has already occurred, by maintaining high levels of the synthetic progesterone. This prevents the release of eggs from the ovaries.

navela prevents pregnancy by interfering with ovulation, fertilization, and implantation. The levonorgestrel-only containing emergency contraceptive tablet is 89% effective if it is used according to prescribing information within 72 hours after intercourse. The intrauterine and implantable devices releasing levonorgestrel are more than 99% in preventing pregnancy. navela utilized as a component of hormonal therapy helps to prevent endometrial carcinoma associated with unopposed estrogen administration.


Uses

navela is an emergency contraceptive pill for women. navela should be used within 72 hours of unprotected intercourse. It should not be taken as regular birth control pill. This medicine is also known as morning after pill. navela belongs to a group of medicines called progestogen.

This contraception is used as soon as possible, preferably within 12 hours and no later than 72 hours (3 days) after the unprotected sexual intercourse, particularly. If you have had a sexual intercourse whereas either yourself or your partner did not use a contraceptive method

  • If you have forgotten to take consecutive 3 regular contraceptive pills
  • If your partner’s condom has broken, slipped or been improperly removed or if he has forgotten to use it
  • If you fear that your intrauterine device has been expelled
  • If your vaginal diaphragm or your contraceptive cap has moved or if have removed it too easily
  • If you are afraid that the method of coitus interruptus has failed or if you have had sexual intercourse during the period when you are supposed to be fertile while using the rhythm method
  • In the event of rape

navela is also used to associated treatment for these conditions: Endometrial Hyperplasia, Endometriosis, Hypermenorrhea, Postmenopausal Osteoporosis, Pregnant State, Moderate Menopausal Vasomotor Symptoms, Severe Vasomotor Symptoms Associated With Menopause, Emergency Contraception

How navela works

Mechanism of action on ovulation

Oral contraceptives containing levonorgestrel suppress gonadotropins, inhibiting ovulation. Specifically, levonorgestrel binds to progesterone and androgen receptors and slows the release of gonadotropin-releasing hormone (GnRH) from the hypothalamus. This process results in the suppression of the normal physiological luteinizing hormone (LH) surge that precedes ovulation. It inhibits the rupture of follicles and viable egg release from the ovaries. navela has been proven to be more effective when administered before ovulation.

Mechanism of action in cervical mucus changes

Similar to other levonorgestrel-containing contraceptives, the intrauterine (IUD) forms of levonorgestrel likely prevent pregnancy by increasing the thickness of cervical mucus, interfering with the movement and survival of sperm, and inducing changes in the endometrium, where a fertilized ovum is usually implanted. navela is reported to alter the consistency of mucus in the cervix, which interferes with sperm migration into the uterus for fertilization. navela is not effective after implantation has occurred. Interestingly, recent evidence has refuted the commonly believed notion that levonorgestrel changes the consistency of cervical mucus when it is taken over a short-term period, as in emergency contraception. Over a long-term period, however, levonorgestrel has been proven to thicken cervical mucus. The exact mechanism of action of levonorgestrel is not completely understood and remains a topic of controversy and ongoing investigation.

Effects on implantation*

The effects of levonorgestrel on endometrial receptivity are unclear, and the relevance of this mechanism to the therapeutic efficacy of levonorgestrel is contentious. Prescribing information for levonorgestrel IUDs state that they exert local morphological changes to the endometrium (e.g. stromal pseudodecidualization, glandular atrophy) that may play a role in their contraceptive activity.

Mechanism of action in hormone therapy

When combined with estrogens for the treatment of menopausal symptoms and prevention of osteoporosis, levonorgestrel serves to lower the carcinogenic risk of unopposed estrogen therapy via the inhibition of endometrial proliferation. Unregulated endometrial proliferation sometimes leads to endometrial cancer after estrogen use.

Dosage

navela dosage

levonorgestrel 0.75 mg Tablets should be taken at the same time, orally, as soon as possible but within 72 hours after unprotected intercourse. The total dosage for one complete regimen of levonorgestrel consists in a single dose of 1.50 mg levonorgestrel.

navela 1.5 mg Tablets should be taken as soon as possible, preferably within 12 hours, and no later than 72 hours (3 days) after having unprotected sex. navela 1.5 mg tablets can be taken at any time in the menstrual cycle assuming the person is not already pregnant. The tablet should not be chewed but should be swallowed whole with water. If a regular method of contraception, such as the contraceptive pill, is already being used, this can be continued at the regular times. If unprotected intercourse takes place again after the use of navela 1.5 mg tablets (also if this is during the same menstrual cycle), the tablet will not exert its contraceptive effect and there is again the risk of pregnancy.

navela can be taken at any moment during the menstrual cycle. After using an emergency contraception, it is recommended to use a local contraceptive mean (condom, spermicide, cervical cap) until the next menstrual period resume.

The use of navela does not contraindicate the continuation of regular hormonalcontraception. If you have used this medicine while you were using an oral contraception (contraceptive pill), you should carry on taking the usual tablets until the end of the treatment. In case no menstrual period occurs in the next pill free period following the use of navela, a pregnancy test should be performed to rule out a pregnancy.

One tablet should be taken orally with a glass of water.

Side Effects

Undesirable effects which have been observed are:

  • Nausea and vomiting
  • Dizziness, fatigue, headache
  • Abdominal pain
  • A feeling of breast tenderness
  • Bleeding can occur after taking this medicine

Inform doctor of any unwanted effect which is not mentioned here

Toxicity

The oral LD50 in rats is greater than 5000 mg/kg.

An overdose of this drug, like other contraceptives, may cause nausea and withdrawal bleeding. Provide symptomatic treatment in the case of a levonorgestrel overdose and contact the local poison control center. There is no specific antidote for a levonorgestrel overdose.


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