FEMCON Fe (Page 5 of 8)

9. INTERACTIONS WITH LABORATORY TESTS

Certain endocrine and liver function tests and blood components may be affected by oral contraceptives:

  1. Increased prothrombin and factors VII, VIII, IX, and X; decreased antithrombin 3; increased norepinephrine-induced platelet aggregability.
  2. Increased thyroid-binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 by column or by radioimmunoassay. Free T3 resin uptake is decreased, reflecting the elevated TBG, free T4 concentration is unaltered.
  3. Other binding proteins may be elevated in serum.
  4. Sex hormone binding globulins are increased and result in elevated levels of total circulating sex steroids and corticoids; however, free or biologically active levels remain unchanged.
  5. Triglycerides may be increased and levels of various other lipids and lipoproteins may be affected.
  6. Glucose tolerance may be decreased.
  7. Serum folate levels may be depressed by oral contraceptive therapy. This may be of clinical significance if a woman becomes pregnant shortly after discontinuing oral contraceptives.

10. CARCINOGENESIS

See WARNINGS section.

11. PREGNANCY

Pregnancy Category X. See CONTRAINDICATIONS and WARNINGS sections.

12. NURSING MOTHERS

Small amounts of oral contraceptive steroids and/or metabolites have been identifed in the milk of nursing mothers and a few adverse effects on the child have been reported, including jaundice and breast enlargement. In addition, combination oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. If possible, the nursing mother should be advised not to use combination oral contraceptives but to use other forms of contraception until she has completely weaned her child.

13. PEDIATRIC USE

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

14. GERIATRIC USE

This product has not been studied in women over 65 years of age and is not indicated in this population.

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 section):

  • 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:

  • 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 pain, cramps and bloating)
  • Breakthrough bleeding
  • Spotting
  • Change in menstrual flow
  • Amenorrhea
  • Temporary infertility after discontinuation of treatment
  • Edema/fluid retention
  • Melasma/chloasma which may persist
  • Breast changes: tenderness, pain, enlargement, and secretion
  • Change in weight or appetite (increase or decrease)
  • Change in cervical ectropion and secretion
  • Possible diminution in lactation when given immediately postpartum
  • Cholestatic jaundice
  • Migraine headache
  • Rash (allergic)
  • Mood changes, including depression
  • Vaginitis, including candidiasis
  • Change in corneal curvature (steepening)
  • Intolerance to contact lenses
  • Decrease in serum folate levels
  • Exacerbation of systemic lupus erythematosus
  • Exacerbation of porphyria
  • Exacerbation of chorea
  • Aggravation of varicose veins
  • Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms

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

  • Premenstrual syndrome
  • Cataracts
  • Optic neuritis, which may lead to partial or complete loss of vision
  • Cystitis-like syndrome
  • Headache
  • Nervousness
  • Dizziness
  • Hirsutism
  • Loss of scalp hair
  • Erythema multiforme
  • Erythema nodosum
  • Hemorrhagic eruption
  • Impaired renal function
  • Hemolytic uremic syndrome
  • Budd-Chiari syndrome
  • Acne
  • Changes in libido
  • Colitis
  • Pancreatitis
  • Dysmenorrhea

OVERDOSAGE

Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in females.

NONCONTRACEPTIVE HEALTH BENEFITS

The following noncontraceptive 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 of 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

To achieve maximum contraceptive effectiveness, FEMCON Fe must be taken exactly as directed and at intervals not exceeding 24 hours. The dosage of FEMCON Fe is one white tablet daily for 21 consecutive days, followed by one brown tablet daily for 7 consecutive days. It is recommended that tablets be taken at the same time each day. The pill may be swallowed whole or chewed and swallowed. If the pill is chewed, the patient should drink a full glass (8 ounces) of liquid immediately after swallowing. During the first cycle of use, the patient is instructed to begin taking FEMCON Fe on either Day 1 or the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (white) is taken that day. One white tablet should be taken daily for 21 consecutive days followed by one brown tablet daily for 7 consecutive days. Withdrawal bleeding should usually occur within three days following discontinuation of white tablets and may not have finished before the next pack is started. During the first cycle with a Sunday start, contraceptive reliance should not be placed on FEMCON Fe until a white tablet has been taken daily for 7 consecutive days and a non-hormonal back-up method of birth control (such as condoms or spermicide) should be used during those 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

The patient begins her next and all subsequent 28-day courses of tablets on the same day of the week on which she began her first course, following the same schedule: 21 days on white tablets—7 days on brown tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself against pregnancy by using a non-hormonal back-up method of birth control until she has taken a white tablet daily for 7 consecutive days.

When the patient is switching from a 21-day regimen of tablets, she should wait 7 days after her last tablet before she starts FEMCON Fe. She will probably experience withdrawal bleeding during that week. She should be sure that no more than 7 days pass after her previous 21-day regimen. When the patient is switching from a 28-day regimen of tablets, she should start her first pack of FEMCON Fe on the day after her last tablet. She should not wait any days between packs. The patient may switch any day from a progestin-only pill and should begin FEMCON Fe the next day. If switching from an implant or injection, the patient should start FEMCON Fe on the day of implant removal or, if using an injection, the day the next injection would be due.

If spotting or breakthrough bleeding occurs, the patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her healthcare provider. Although pregnancy is unlikely if FEMCON Fe 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 schedule (missed one or more tablets or started taking them on a day later than she should have), the probability 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 contraceptives should be discontinued if pregnancy is confirmed.

For additional patient instructions regarding missed pills, see the “WHAT TO DO IF YOU MISS PILLS” section in the DETAILED PATIENT LABELING. Any time the patient misses two or more white tablets, she should also use another method of non-hormonal back-up contraception until she has taken a white tablet daily for seven consecutive days. If the patient misses one or more brown tablets, she is still protected against pregnancy provided she begins taking white tablets again on the proper day. If breakthrough bleeding occurs following missed white tablets, it will usually be transient and of no consequence. The possibility of ovulation increases with each successive day that scheduled white tablets are missed. The risk of pregnancy increases with each active (white) tablet missed.

FEMCON Fe may be initiated no earlier than day 28 postpartum in the nonlactating mother due to the increased risk for thromboembolism. 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). The patient should be advised to use a non-hormonal back-up method for the first 7 days of tablet-taking. However, if intercourse has already occurred, the possibility of ovulation and conception prior to initiation of medication should be considered. FEMCON Fe may be initiated after a first-trimester abortion; if the patient starts FEMCON Fe immediately, additional contraceptive measures are not needed.

For additional patient instructions regarding complete dosing instructions, see the “HOW TO TAKE THE PILL” section in the DETAILED PATIENT LABELING.

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