OCELLA (Page 7 of 9)

13. PEDIATRIC USAGE

Safety and efficacy of OCELLA have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use of this product before menarche is not indicated.

INFORMATION FOR THE PATIENT

See Patient Labeling printed below.

ADVERSE REACTIONS

An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS).

  • Thrombophlebitis
  • Arterial thromboembolism
  • Pulmonary embolism
  • Myocardial infarction
  • Cerebral hemorrhage
  • Cerebral thrombosis
  • Hypertension
  • Gallbladder disease
  • Hepatic adenomas or benign liver tumors

There is evidence of an association between the following conditions and the use of oral contraceptives, although additional confirmatory studies are needed:

  • Mesenteric thrombosis
  • Retinal thrombosis

The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:

  • Nausea
  • Vomiting
  • Gastrointestinal symptoms (such as abdominal cramps and bloating)
  • Breakthrough bleeding
  • Spotting
  • Change in menstrual flow
  • Amenorrhea
  • Temporary infertility after discontinuation of treatment
  • Edema
  • Melasma which may persist
  • Breast changes: tenderness, enlargement, secretion
  • Change in weight (increase or decrease)
  • Change in cervical erosion and secretion
  • Diminution in lactation when given immediately postpartum
  • Cholestatic jaundice
  • Migraine
  • Rash (allergic)
  • Mental depression
  • Reduced tolerance to carbohydrates
  • Vaginal candidiasis
  • Change in corneal curvature (steepening)
  • lntolerance to contact lenses

The following adverse reactions have been reported in users of oral contraceptives and a causal association has been neither confirmed nor refuted:

  • Acne
  • Budd-Chiari syndrome
  • Cataracts
  • Changes in appetite
  • Changes in libido
  • Colitis
  • Cystitis-like syndrome
  • Dizziness
  • Erythema multiforme
  • Erythema nodosum
  • Headache
  • Hemolytic uremic syndrome
  • Hemorrhagic eruption
  • Hirsutism
  • Impaired renal function
  • Loss of scalp hair
  • Nervousness
  • Porphyria
  • Pre-menstrual syndrome
  • Vaginitis

The following are the most common adverse events reported with use of OCELLA during the clinical trials, occurring in > 1% of subjects and which may or may not be drug related: Headache, Menstrual Disorder, Breast Pain, Abdominal Pain, Nausea, Leukorrhea, Flu Syndrome, Acne, Vaginal Moniliasis, Depression, Diarrhea, Asthenia, Dysmenorrhea, Back Pain, Infection, Pharyngitis, Intermenstrual Bleeding, Migraine, Vomiting, Dizziness, Nervousness, Vaginitis, Sinusitis, Cystitis, Bronchitis, Gastroenteritis, Allergic Reaction, Urinary Tract Infection, Pruritus, Emotional Lability, Surgery, Rash, Upper Respiratory Infection.

OVERDOSAGE

Serious ill effects have not been reported following acute ingestion of large doses of other oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in females. Drospirenone, however, is a spironolactone analogue which has antimineralocorticoid properties. Serum concentration of potassium and sodium, and evidence of metabolic acidosis, should be monitored in cases of overdose.

NON-CONTRACEPTIVE HEALTH BENEFITS

The following non-contraceptive health benefits related to the use of oral contraceptives are supported by epidemiological studies which largely utilized oral contraceptive formulations containing doses exceeding 0.035 mg of ethinyl estradiol or 0.05 mg mestranol.

Effects on menses

  • increased menstrual cycle regularity
  • decreased blood loss and decreased incidence of iron-deficiency anemia
  • decreased incidence of dysmenorrhea

Effects related to inhibition of ovulation

  • decreased incidence of functional ovarian cysts
  • decreased incidence of ectopic pregnancies

Effects from long-term use

  • decreased incidence of fibroadenomas and fibrocystic disease of the breast
  • decreased incidence of acute pelvic inflammatory disease
  • decreased incidence of endometrial cancer
  • decreased incidence of ovarian cancer

DOSAGE AND ADMINISTRATION

OCELLA

To achieve maximum contraceptive effectiveness, OCELLA (drospirenone and ethinyl estradiol) must be taken exactly as directed at intervals not exceeding 24 hours.

OCELLA consists of 21 tablets of a monophasic combined hormonal preparation plus 7 inert tablets. The dosage of OCELLA is one yellow tablet daily for 21 consecutive days followed by 7 white inert tablets per menstrual cycle. A patient should begin to take OCELLA either on the first day of her menstrual period (Day 1 Start) or on the first Sunday after the onset of her menstrual period (Sunday Start).

Day 1 Start. During the first cycle of OCELLA use, the patient should be instructed to take one yellow OCELLA daily, beginning on day one (1) of her menstrual cycle. (The first day of menstruation is day one.) She should take one yellow OCELLA daily for 21 consecutive days, followed by one white inert tablet daily on menstrual cycle days 22 through 28. It is recommended that OCELLA be taken at the same time each day, preferably after the evening meal or at bedtime. If OCELLA is first taken later than the first day of the menstrual cycle, OCELLA should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. The possibility of ovulation and conception prior to initiation of medication should be considered.

Sunday Start. During the first cycle of OCELLA use, the patient should be instructed to take one yellow OCELLA daily, beginning on the first Sunday after the onset of her menstrual period. She should take one yellow OCELLA daily for 21 consecutive days, followed by one white inert tablet daily on menstrual cycle days 22 through 28. It is recommended that OCELLA be taken at the same time each day, preferably after the evening meal or at bedtime. OCELLA should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. The possibility of ovulation and conception prior to initiation of medication should be considered.

The patient should begin her next and all subsequent 28-day regimens of OCELLA on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her yellow tablets on the next day after ingestion of the last white tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Anytime a subsequent cycle of OCELLA is started later than the day following administration of the last white tablet, the patient should use another method of contraception until she has taken a yellow OCELLA daily for seven consecutive days.

When switching from another oral contraceptive, OCELLA should be started on the same day that a new pack of the previous oral contraceptive would have been started.

Withdrawal bleeding usually occurs within 3 days following the last yellow tablet. If spotting or breakthrough bleeding occurs while taking OCELLA , the patient should be instructed to continue taking her OCELLA as instructed and by the regimen described above. She should be instructed that this type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient should be advised to consult her physician.

Although the occurrence of pregnancy is unlikely if OCELLA is taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed dosing schedule (missed one or more active tablets or started taking them on a day later than she should have), the possibility of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out. Hormonal contraception should be discontinued if pregnancy is confirmed.

The risk of pregnancy increases with each active yellow tablet missed. For additional patient instructions regarding missed pills, see the “WHAT TO DO IF YOU MISS PILLS” section in the DETAILED PATIENT LABELING which follows. If breakthrough bleeding occurs following missed tablets, it will usually be transient and of no consequence. If the patient misses one or more white tablets, she should still be protected against pregnancy provided she begins taking yellow tablets again on the proper day.

In the nonlactating mother, OCELLA may be initiated 4 weeks postpartum, for contraception. When the tablets are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered. (See CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS concerning thromboembolic disease.)

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