Norelgestromin/ Ethinylestradiol

Registered South African indications:

• Contraception

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Current or previous arterial or venous thrombotic or embolic processes (e.g., deep vein thrombosis, retinal thrombosis, pulmonary embolism, cerebrovascular accident, myocardial infarction, thrombophlebitis) or significantly predisposing conditions such as arterial fibrillation and significant cases of structural heart disease
• Known thrombophilic conditions predisposed to arterial or venous thrombosis (thrombophilia)
• Migraine
• Porphyria
• Previous pemphigus gestation
• Uncontrolled hypertension (persistent values of ≥160+/100+ mm Hg)
• Diabetes with vascular involvement
• Benign intracranial hypertension (pseudotumour cerebri)
• Known or suspected carcinoma of the breast
• Carcinoma of the endometrium or other known or suspected oestrogen-dependent neoplasia
• Steroid-dependent jaundice, cholestatic jaundice, history of jaundice of pregnancy
• Abnormal liver function related to acute or chronic hepatocellular disease
• Hepatic adenomas or carcinomas
• Known or suspected pregnancy
• Undiagnosed abnormal genital bleeding

Cautions

• Breastfeeding
• Renal impairment
• Obesity
• Cardiovascular disease
• Family history of venous thromboembolism
• Older than 35 years
• Smoking
• Hyperhomocysteinaemia
• Vulvular heart disease 
• Atrial fibrillation
• Hypertriglyceridaemia, or a family history thereof
• Cholecystitis 
• Cholelithiasis
• Systemic lupus erythematosus
• Haemolytic ureamic syndrome
• Sydenham's chorea
• Herpes gestationis
• Otosclerosis-related hearing loss
• Diabetes mellitus
• Depression
• Epilepsy
• Inflammatory bowel disease
• History of chloasma gravidarum

Forms avail. in SA and covered in this monograph: pat

Contraception

Norelgestromin/ Ethinyloestradiol
6mg/600μg

• Transdermal (pat): 1 pat, weekly

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See additional prescribing points

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If Cycle 1 therapy starts after Day 1 of the menstrual cycle, a non-hormonal contraceptive should be used concurrently for the first 7 consecutive days of the first treatment cycle only

If there are more than 7 patch-free days non-
hormonal contraceptive must then be used concurrently for 7 days

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Patches should not be reapplied if no longer sticky. Do not use supplemental adhesives or wraps to hold patch in place

Not established for use in children younger than 18 years

Pregnancy

• Contraindicated

Breastfeeding

• Caution; not recommended
• Breastfeeding may be influenced by combined hormonal contraceptives as they may reduce the quantity and change the composition of breast milk. Therefore, the use of norelgestromin/ oestrogen is not to be recommended until the breastfeeding mother has completely weaned her child

Fertility

• Women may experience a delay in conception following discontinuation of Norelgestromin/Oestrogen patch

Renal Impairment

• Caution; no dose adjustment recommended

Hepatic Impairment

• Contraindicated

Elderly

• Not indicated for use in geriatric patients

Porphyria Information

• Contraindicated

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache
• Migraine
• Dizziness
• Stroke
• Cerebral haemorrhage
• Fatigue
• Mood disorders
• Affect disorders
• Anxiety disorders
• Insomnia
• Decreased libido 
• Increased libido 
• Anger
• Frustration

Cardiovascular Disorders

• Arterial thromboembolism
• Myocardial infarction
• Hypertension
• Hypertensive crisis
• Arterial thrombosis
• Venous thrombosis

Respiratory Disorders

• Pulmonary  thrombosis
• Pulmonary embolism

Gastrointestinal Disorders

• Nausea and vomiting
• Abdominal pain
• Diarrhoea
• Abdominal distension
• Colitis

Hepatobiliary Disorders

• Hepatic neoplasm
• Cholecystitis
• Cholelithiasis
• Hepatic lesion
• Cholestasis
• Hepatic adenoma

Genitourinary Disorders

• Breast tenderness
• Dysmenorrhoea
• Vaginal bleeding 
• Menstrual disorders
• Uterine spasm
• Vulvovaginal dryness
• Cervical dysplasia
• Genital discharge
• Vaginal fungal infection
• Vaginal candidiasis
• Breast cancer
• Cervix carcinoma
• Uterine leiomyoma
• Fibroadenoma of breast

Endocrine and Metabolic Disorders

• Hypercholesterolaemia
• Fluid retention
• Increased appetite
• Hyperglycaemia
• Insulin resistance
• Increased weight 
• Lipid disorders
• Abnormal blood glucose 
• Breast disorders
• Galactorrhoea
• Premenstrual syndrome
• Suppressed lactation

Musculoskeletal Disorders

• Muscle spasm

Skin and Subcutaneous Tissue Disorders

• Acne
• Rash
• Pruritus
• Skin irritation
• Alopecia
• Allergic dermatitis 
• Eczema
• Photosensitivity reaction
• Contact dermatitis 
• Urticaria
• Erythema
• Angioedema
• Chloasma
• Exfoliative rash
• Pruritus 
• Seborrhoeic dermatitis
• Generalised oedema
• Peripheral oedema 
• Swelling
• Rash pustular
• Application site pustules

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions
• Neoplasms

Sensory Disorders

• Contact lens intolerance
• Abnormal taste

• CYP450 inducers
• Protease inhibitors 
• Non-nucleoside reverse transcriptase inhibitors
• Etoricoxib 
• Ciclosporin
• Lamotrigine

• Pregnancy test
• Blood pressure
• Pelvic examination
• Breast examination
• Cervical cytology

Specific cases may require

• Lipid profile
• Blood glucose
• Hepatic function

Administration directions

• Apply to clean, dry, hairless, intact healthy skin on the buttock, abdomen, upper outer arm or upper torso, in a place where it will not be rubbed by tight clothing
• Do not place on the breasts or on skin that is red irritated or cut. Each consecutive patch should be applied to a different place on the skin to help avoid potential irritation
• Contraception begins on the first day of menses. A single transdermal patch is applied and worn for one full week (7 days). The day the first transdermal patch is applied (Day 1/Start Day) determines the subsequent Change Days. The transdermal patch Change Day will be on this day every week (cycle Days 8, 15, 22 and Day 1 of the next cycle). The fourth week is transdermal patch-free starting on Day 22

Treatment interruption

• Patch partly detached < 24 hours: Reapply or replace immediately, no additional contraception required
• Patch partly detached > 24 hours: Stop cycle, start a new cycle immediately; use additional barrier contraception for 7 days
• Patch change day delayed in week 1: Apply patch immediately and non-hormonal contraceptive to be used for 7 days
• Patch change day delayed in week 2-3, <48 hours: Apply new patch immediately, the next patch should be applied on the usual change day. No additional contraception is required
• Patch change day delayed in week 2-3, >48 hours: Stop current cycle. Start new 4 week cycle, with new change day. Non-hormonal contraception must be used for first 7 days of the new cycle
• Patch change day adjustment: To postpone a menstrual cycle, the woman must omit the patch free interval. A patch free week is needed within 6 weeks 

Changing from different contraceptive methods

• Oral combined contraceptive: Treatment should begin on the first day of withdrawal bleeding. If therapy starts after the first day of withdrawal bleeding, a non-hormonal contraceptive must be used concurrently for 7 days. If intercourse has occurred during such an extended pill-free interval, the possibility of pregnancy should be considered
• Progestogen-only contraceptive: The woman may switch any day from the progestogen-only pill (from an implant on the day of its removal, from an injectable when the next injection would be due), but a back-up barrier method of birth control must be used during the first 7 days

Initiating in special circumstances

• Abortion/miscarriage < 20 weeks gestation: Patch may be applied immediately. An additional method of contraception is not needed if started immediately
• Abortion/miscarriage > 20 weeks gestation: Patch may be started either on Day 21 post-abortion or on the first day of the first spontaneous menstruation, whichever comes first
• Postpartum non-breastfeeding: The patch can be started no sooner than 4 weeks after childbirth. If > 4 weeks use a barrier method for the first 7 days. However, if intercourse has already occurred, pregnancy should be excluded

Norelgestromin/estrogen acts through the mechanism of gonadotropin suppression by the estrogenic and progestational actions of ethinyl estradiol and norelgestromin. The primary mechanism of action is inhibition of the ovulation, but the alterations of the cervical mucus, and to the endometrium may also contribute to the efficacy of the product.

COMBINATION PREPARATIONS

Ethinylestradiol/ Norelgestromin

Patch 0.6mg/6mg

• Evra (Janssen) originator