Description

LEVOFEM

LEVOFEM X 3 X 28 TAB PACK

OVERVIEW

Levofem is used to prevent pregnancy. It contains 2 hormones: levonorgestrel (a progestin) and ethinyl estradiol (an estrogen). Besides preventing pregnancy, birth control pills may make your periods more regular, decrease blood loss and painful periods, decrease your risk of ovarian cysts, and also treat acne.

COMPOSITION

Each blister contains 28 sugar coated tablets, comprising:

1. 21 yellow (active) tablets, each containing :

           0.15mg of Levonorgestrel and 0.03 mg of Ethinylestradiol.

1. And 7 white (inactive) tablets, each containing:

           75mg of ferrous fumarate.

PHARMACOLOGY

Levofem contains two female sex hormones, a type of oestrogen (ethinylestradiol) and a progestogen (levonorgestrel). 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. Levonorgestrel has been proven to be more effective when administered before ovulation.

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.21,22 Levonorgestrel is reported to alter the consistency of mucus in the cervix, which interferes with sperm migration into the uterus for fertilization. Levonorgestrel is not effective after implantation has occurred.

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. 

Estradiol acts on the estrogen receptors to relieve vasomotor systems (such as hot flashes) and urogenital symptoms (such as vaginal dryness and dyspareunia). 

Estradiol has also been shown to exert favorable effects on bone density by inhibiting bone resorption. Estrogen appears to inhibit bone resorption and may have beneficial effects on the plasma lipid profile. Estrogens cause an increase in hepatic synthesis of various proteins, which include sex hormone binding globulin (SHBG) and thyroid-binding globulin (TBG). Estrogens are known to suppress the formation of follicle-stimulating hormone (FSH) in the anterior pituitary gland.

Ferrous fumurate in levofem is not a type of oral contraceptive but works as a blood forming or repairing ingredient by stimulating the formation of red blood cells(erythropoesis).

INDICATION

Levofem is used.

• For prevention of pregnancy and birth spacing
• For treating menstrual disorders such as dysmenorrhea (painful menstruation), menorrhagia (heavy menstrual bleeding), endometriosis, ovulation pain and premenstrual syndrome.

DOSAGE

Starting on the first day of your menstrual period, take 1 tablet starting from the lower righthand corner of the pack, i.e., the first yellow tablet. When you finish the yellow tablets, start the white ones. You should take 1 tablet daily at about the same time for 28 consecutive days. If there is a delay of more than 24 hours, contraceptive protection may be lost. Withdrawal bleeding occurs while the white tablets are being taken.

Whether your bleeding has stopped or not, begin a new pack of Levofem the day after you take the last white tablet in this pack. Be sure to take all of the tablets from one pack before starting a new pack and follow these instructions again.

 CONTRAINDICATIONS

Levofem should not be taken if you have any of the following conditions;

• Pregnancy
• Allergy to any of the ingredients in levofem
• Breastfeeding
• Sickle cell disease
• Personal health history or family history of thromboembolism
• Heart disease
• Obesity
• Migraine
• Personal history of breast or cervical cancer
• Severe depression
• Hyperprolactinaemia
• Dubin-johnson syndrome

WARNING AND PRECAUTIONS

Before starting levofem, tell your doctor, pharmacist, or family planning provider if you have any problems or illnesses.

Oral contraceptives should be immediately discontinued.

• If the symptoms of thromboembolism(blood clots) occur (such as sudden loss of hearing, sense of smell, taste, vision, or touch; stabbing pain when you breathe, pain and tightness in the chest, sudden weakness or numbness on one side of the body)
• If you develop jaundice (yellow skin or eyes)
• If you notice any abnormal changes in your breast (lumps, changes in your nipple)

SIDE EFFECTS

Some women may experience side effects such as

• Headaches
• Gastric upsets
• Nausea
• Vomiting
• Impaired appetite
• Breast tenderness
• Breast enlargement
• Slight changes in body weight or libido
• Depressive moods
• Spotting between periods
• Interference with liver function

Most side effects should disappear after the first few packs of Levofem.

DRUG INTERACTIONS

Some drugs can stop the effect of levofem when co-administered. Drugs such as;

• Barbiturates
• Griseofulvin
• Phenytoin
• St. John’s Wort
• Carbamazepine
• Tranexamic acid
• Lopinavir
• Ritonavir
• Nevirapine
• Oxcarbazepine

Overdosage may cause nausea and early withdrawal bleeding.

What you should do when you miss a tablet

A missed tablet is a dose of active (yellow) tablet that has not been taken for 24 hours or more.

If you forget to take 1 yellow tablet, it should be taken as soon as you remember, and the next one taken at the normal time.