Renatrel

Uses of Renatrel

• Contraception
• Menorrhagia
• Menopausal HRT

How does Renatrel work?

Norgestrel is a progestin (female hormones). It works to prevent pregnancy by temporarily stopping the release of an egg from the ovary, or preventing fertilization (union) of the egg by sperm. It may also alter the lining of the uterus (womb) to stop a fertilized egg from attaching to the uterus.

Side Effects of Renatrel

Edema, Weakness, Anorexia, Amenorrhea, Breakthrough bleeding, Change in menstrual flow, Spotting

Quick Tips:

• It's advised to keep your weight within a healthy range (BMI 19.5-24.9) through proper diet and regular exercise. Opt for a diet rich in whole grains, fruits, vegetables, and low-fat dairy products. Avoid smoking and limit alcohol consumption to reduce the risk of complications.
• Regular exercise is recommended to help maintain weight and overall health, especially considering potential weight fluctuations caused by Renatrel.
• It's essential to monitor blood pressure regularly, particularly if there are fluctuations. Any significant changes should be reported to your doctor promptly.
• Including heart-healthy omega-3 fatty acids in your diet and using low-fat cooking oils like olive oil, soybean oil, canola oil, and coconut oil may help lower elevated blood pressure. However, it's advised to consult with a healthcare professional for personalized dietary recommendations.

Indication of Renatrel

Renatrel, when combined with ethinyl estradiol, is primarily utilized for preventing pregnancy in women who choose this method of contraception. Additionally, Renatrel is employed in the treatment of various conditions, including:

1. Abnormal Uterine Bleeding
2. Endometriosis
3. Hypermenorrhea
4. Menstrual Distress (Dysmenorrhea)
5. Polycystic Ovarian Syndrome
6. Emergency Contraception
7. Oral Contraceptives

Pharmacology

Progestin-only oral contraceptives, like Norgestrel tablets, work by several mechanisms to prevent conception:

Suppression of ovulation: Progestins inhibit the release of gonadotropin-releasing hormone (GnRH) from the hypothalamus, which in turn decreases the secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) from the pituitary gland. This suppression of LH and FSH prevents the maturation and release of an egg from the ovary, thus inhibiting ovulation.

Thickening of cervical mucus: Progestins thicken the cervical mucus, making it more difficult for sperm to penetrate into the uterus and reach the egg for fertilization.

Alteration of the endometrium: Progestins alter the lining of the uterus (endometrium), making it less favorable for implantation of a fertilized egg.

Lowering midcycle LH and FSH peaks: By reducing the levels of LH and FSH, progestins help to maintain a state of hormonal suppression, further inhibiting ovulation and pregnancy.

Slowing movement of the ovum: Progestins slow down the movement of the egg through the fallopian tubes, reducing the likelihood of fertilization by sperm.

After oral administration, serum levels of progestins peak about two hours later, followed by rapid distribution and elimination from the body. Within 24 hours after ingestion, serum levels return to near baseline, highlighting the importance of strict adherence to the dosing schedule for efficacy.

Dosage & Administration of Renatrel

Contraception Monotherapy:

• Adult: 30 or 37.5 mcg/day.

Monophasic Combined Oral Contraceptive (COC):

• Adult: 150-250 mcg/day.

Triphasic COC:

• Adult: 50-125 mcg/day.

Emergency Contraception:

• 1.5 mg within 72 hours of coitus, or
• 750 mcg immediately or within 72 hours of coitus, followed by a second dose of 750 mcg 12 hours later.

Menopausal Hormone Replacement Therapy (HRT) as a progestogenic component:

• Adult: 75-250 mcg/day for 10-12 days of a 28-day cycle.

Interaction

Food Interaction:

• Avoid grapefruit products and St. John's Wort
• Take Renatrel at the same time every day
• Grapefruit juice may increase plasma concentrations of drugs metabolized by CYP450 3A4

Alcohol Interaction:

• Ethanol levels and central nervous system effects may be increased, although data are lacking

Cholesterol Interaction:

• Some progestogenic agents may elevate plasma LDL levels, requiring closer monitoring in patients with preexisting hyperlipidemia

Hypertension Interaction:

• Estrogens and progestogens may cause fluid retention, requiring cautious use in patients with preexisting fluid-related conditions

Unknown Drug Interactions:

• Aripiprazole, chlorpheniramine, amoxicillin/clavulanate, citalopram, ciprofloxacin, venlafaxine, etc.

Disease Interactions:

• Major: Hepatic neoplasms, breast malignancy, thromboembolism
• Moderate: Depression, fluid retention, glucose intolerance, hyperlipidemia
• Minor: Weight gain

Contraindications

• Documented hypersensitivity
• Active or history of breast cancer
• Arterial thromboembolic disease, thrombophlebitis, deep vein thrombosis/pulmonary embolism, thrombogenic valvular disease
• Estrogen-dependent neoplasia
• Liver disease, liver tumors
• Undiagnosed abnormal vaginal bleeding
• Uncontrolled hypertension
• Diabetes mellitus with vascular involvement
• Jaundice with prior oral contraceptive use
• Pregnancy or use as a diagnostic test for pregnancy

Pregnancy & Lactation

Contraindicated in pregnancy (Category X) and considered unsafe during lactation

Precautions & Warnings

• Documented hypersensitivity
• History of breast cancer
• Thrombophlebitis, deep vein thrombosis/pulmonary embolism, thrombogenic valvular disease
• Estrogen-dependent neoplasia
• Liver disease, liver tumors
• Undiagnosed abnormal vaginal bleeding
• Uncontrolled hypertension
• Diabetes mellitus with vascular involvement
• History of migraine with aura
• Pregnancy, smoking more than 15 cigarettes per day, and over 35 years of age
• Serum levels should be near baseline 24 hours after ingestion, so adherence to the dosing schedule is crucial
• Conditions such as diabetes mellitus, asthma, cardiac dysfunction, irregular menstrual bleeding patterns, bone mineral density changes, depression, epilepsy, migraine, and renal dysfunction may require monitoring

Storage Conditions:

Store in a cool and dry place.