Navela Tablets
Levonorgestrel
1.5mg
EXELTIS GERMANY GmbH
| Pack size | 1's Blister |
|---|---|
| Dispensing mode | PhOM |
| Source | GERMANY |
| Agent | CITY MEDICAL STORE |
| Retail Price | 49.50 AED |
Indications
Navela Tablets is used for:
Contraception, Emergency contraception, Menopausal hormone replacement therapy, Menorrhagia,
Adult Dose
Oral
Emergency contraception
Adult: 1.5 mg as soon as possible or within 72 hr of coitus.
Alternatively, 750 mcg as soon as possible or within 72 hr of coitus followed by a 2nd dose 12 hr later.
Most effective if taken as soon as possible after unprotected intercourse
Menopausal hormone replacement therapy
Adult: As progestogenic component: 75-250 mcg for 10-12 days of a 28-day cycle.
Contraception
Adult: Monotherapy: 30 or 37.5 mcg daily.
Child Dose
Renal Dose
Administration
May be taken with or without food.
Contra Indications
Pregnancy, undiagnosed vaginal bleeding, severe arterial disease; liver adenoma, porphyria; after recent evacuation of hydatidiform mole; history of breast cancer; hepatic impairment.
Precautions
Sex-steroid dependent cancer, past ectopic pregnancy, malabsorption syndromes, functional ovarian cysts, active liver disease, recurrent cholestatic jaundice, history of jaundice in pregnancy, CV or renal impairment, DM, asthma, epilepsy, migraine, conditions aggravated by fluid retention, depression and thromboembolism (high doses); lactation.
Pregnancy-Lactation
Pregnancy
Use of is contraindicated in pregnancy or with a suspected pregnancy because there is no need for pregnancy prevention in a woman who is already pregnant and therapy may cause adverse pregnancy outcomes; if a woman becomes pregnant likelihood of ectopic pregnancy is increased and there is increased risk of miscarriage, sepsis, premature labor, and premature delivery; remove product if possible, if pregnancy occurs in a woman; if product cannot be removed, follow pregnancy closely
Studies report no adverse effects on fetal and infant development associated with long-term use of contraceptive doses of oral progestins in a pregnant woman; however, there have been reported cases of masculinization of external genitalia of female fetus following exposure to progestins at doses greater than those currently used for oral contraception; animal reproduction studies not conducted
Lactation
Published studies report presence of LNG in human milk; small amounts of progestins (approximately 0.1% of total maternal doses) were detected in breast milk of nursing mothers who used other LNG-releasing IUSs, resulting in exposure of LNG to the breastfed infants; there are no reports of adverse effects in breastfed infants with maternal use of progestin-only contraceptives; isolated cases of decreased milk production reported with a LNG-releasing IUS; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child therapy or from underlying maternal condition
Interactions
Reduced efficacy with enzyme-inducing drugs; aminoglutethimide. May inhibit ciclosporin metabolism.
Adverse Effects
Side effects of Levonorgestrel :
>10%
Headache (12%), Acne (15%), Ovarian cysts (13%), Enlarged follicles (12%), Amenorrhea (1-12%), Abdominal pain (12%), Uterine/vaginal bleeding alterations (52%), Intermenstrual bleeding/spotting (23%), Vulvovaginitis (20%), Ectopic pregnancy (≤50%)
1-10%
Depression (4%), Migraine (2%), Alopecia (1%), Dysmenorrhea (9%), Menorrhagia (6%), Breast tenderness (3-9%), Pelvic pain (6%), Leukorrhea (5%), Vaginal discharge (4%), Pelvic infection (1%)
<1%
Angioedema, Cervical perforation, Failed insertion, Sepsis, Uterine bleeding, Device breakage
Potentially Fatal: Thrombocytopenia, stroke.
Mechanism of Action
Levonorgestrel, a nortestosterone derivative, is an active isomer of norgestrel. It is a potent inhibitor of ovulation and has androgenic activity.
Note
Navela 1.5mg Tablets manufactured by EXELTIS GERMANY GmbH. Its generic name is Levonorgestrel. Navela is availble in United Arab Emirates.
Farmaco UAE drug index information on Navela Tablets is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.