Cyclafem

Last updated on RxList: 7/22/2020
Cyclafem Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Cyclafem 7/7/7?

Cyclafem 7/7/7 (norethindrone and ethinyl estradiol kit) is a combined oral contraceptive (COC) indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.

What Are Side Effects of Cyclafem 7/7/7?

Side effects of Cyclafem 7/7/7 include:

Dosage for Cyclafem 7/7/7

The dosage of Cyclafem 7/7/7 tablets, for the initial cycle of therapy, is one “active” tablet administered daily from the 1st through the 21st day of the menstrual cycle, counting the first day of menstrual flow as “Day 1” followed by one light-green "reminder" tablet daily for 7 days. Tablets are taken without interruption for 28 days. After 28 tablets have been taken, a new course is started the next day.

Cyclafem 7/7/7 In Children

Safety and efficacy of Cyclafem 7/7/7 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.

What Drugs, Substances, or Supplements Interact with Cyclafem 7/7/7?

Cyclafem 7/7/7 may interact with other medicines such as:

  • phenytoin,
  • barbiturates,
  • carbamazepine,
  • bosentan,
  • felbamate,
  • griseofulvin,
  • oxcarbazepine,
  • rifampicin,
  • topiramate,
  • rifabutin,
  • rufinamide,
  • aprepitant,
  • St. John's wort,
  • atorvastatin,
  • rosuvastatin,
  • ascorbic acid,
  • acetaminophen,
  • itraconazole,
  • voriconazole,
  • fluconazole,
  • grapefruit juice,
  • ketoconazole,
  • HIV/HCV protease inhibitors,
  • non-nucleoside reverse transcriptase inhibitors (NNRTIs),
  • HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir,
  • colesevelam,
  • cyclosporine,
  • prednisolone,
  • theophylline,
  • tizanidine,
  • lamotrigine, and
  • thyroid hormone replacement therapy

Tell your doctor all medications and supplements you use.

Cyclafem 7/7/7 During Pregnancy and Breastfeeding

Cyclafem 7/7/7 is not recommended for use during pregnancy as it is intended to prevent pregnancy. Small amounts of oral contraceptive steroids have been identified in the milk of nursing mothers and a few adverse effects on the child have been reported, including jaundice and breast enlargement. In addition, oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. A breastfeeding woman is advised to use other forms of contraception until she has completely weaned her child.

Additional Information

Our Cyclafem 7/7/7 (norethindrone and ethinyl estradiol kit) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Which of the following are methods for contraception? See Answer
Cyclafem Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
  • signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • liver problems--loss of appetite, upper stomach pain, tiredness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • increased blood pressure--severe headache, blurred vision, pounding in your neck or ears;
  • swelling in your hands, ankles, or feet;
  • a change in the pattern or severity of migraine headaches;
  • a breast lump; or
  • symptoms of depression--sleep problems, weakness, tired feeling, mood changes.

Common side effects may include:

  • nausea, vomiting;
  • breast tenderness;
  • breakthrough bleeding;
  • headache; or
  • problems with contact lenses.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Cyclafem (Norethindrone and Ethinyl Estradiol Kit)

SLIDESHOW

Choosing Your Birth Control Method See Slideshow
Cyclafem Professional Information

SIDE EFFECTS

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

  • Thrombophlebitis and venous thrombosis with or without embolism
  • 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 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
  • Allergic reaction, including rash, urticaria, angioedema
  • Mental depression
  • Reduced tolerance to carbohydrates
  • Vaginal candidiasis
  • Change in corneal curvature (steepening)
  • Intolerance 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:

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

The following adverse reactions were also reported in clinical trials or during post-marketing experience:

Gastrointestinal Disorders: diarrhea, pancreatitis;
Musculoskeletal and Connective Tissue Disorders: muscle spasms, back pain;
Reproductive System and Breast Disorders: vulvovaginal pruritus, pelvic pain, dysmenorrhea, vulvovaginal dryness;
Psychiatric Disorders: anxiety, mood swings, mood altered;
Skin and Subcutaneous Tissue Disorders: pruritus, photosensitivity reaction;
General Disorders and Administration Site Conditions: edema peripheral, fatigue, irritability, asthenia, malaise;
Neoplasms Benign, Malignant, and Unspecified (Including Cysts and Polyps): breast cancer, breast mass, breast neoplasm, cervix carcinoma;
Immune System Disorders: anaphylactic/anaphylactoid reaction;
Hepatobiliary Disorders: hepatitis, cholelithiasis.

Read the entire FDA prescribing information for Cyclafem (Norethindrone and Ethinyl Estradiol Kit)

© Cyclafem Patient Information is supplied by Cerner Multum, Inc. and Cyclafem Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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