norethindrone (Camila, Errin, Heather, Jencycla, Jolivette, Lyza, Nor QD, Nora-BE, norethisterone, Norhisterone, Ortho, Ortho Micronor)

Dosing and uses of Camila, Errin (norethindrone)

• Adult
• Pediatric

 

Adult dosage forms and strengths

tablet

• 0.35mg

 

Contraception

Progestin only oral contraceptive

1 tablet (0.35mg) PO qDay

Take at same time each day; use additional contraception x48 hours if dose >3 hours late

Administration is continuous; no interruption between pill packs

Initiate first pill pack on 1st day of menses or day after miscarriage or abortion

 

Pediatric dosage forms and strengths

Pre-menarche: Not recommended

 

Camila, Errin (norethindrone) adverse (side) effects

Frequency not defined

Edema

Weakness

Anorexia

Amenorrhea

Breakthrough bleeding

Change in menstrual flowSpotting

Deep vein thrombosis

Thrombophlebitis

Depression

Dizziness

Headache

Nervousness

Somnolence

Breast tenderness

Galactorrhea

Abdominal pain

Nausea

Vomiting

Weight change

Cholestatic jaundice

 

Postmarketing Reports

Gastrointestinal disorders: Vomiting, abdominal pain

General disorders and administration site conditions: Fatigue, edema

Psychiatric disorders: Depression, nervousness

Musculoskeletal and connective tissue disorders: Pain in extremity

Reproductive system and breast disorders: Genital discharge; breast pain, menstruation delayed, suppressed lactation, vaginal hemorrhage, menorrhagia, withdrawal bleed when product is stopped

Immune system disorders: Anaphylactic/anaphylactoid reaction, hypersensitivity

Hepatobiliary disorders: Hepatitis, cholestatic jaundice

Skin and subcutaneous tissue disorders: Alopecia, rash, pruritic rash

 

Warnings

Contraindications

Documented hypersensitivity

Arterial thromboembolic disease (stroke, MI), thrombophlebitis, DVT/PE, thrombogenic valvular disease

Estrogen-dependent neoplasia

Liver disease, liver tumors

Undiagnosed abnormal vaginal bleeding

Jaundice with prior oral contraceptive use

Pregnancy

Malignancy of breast or genital organs

Liver impairment

Missed abortion or as diagnostic test for pregnancy

 

Cautions

Family history of breast cancer and or DVT/PE, current/history of depression, endometriosis, DM, HTN, bone mineral density changes, renal/hepatic impairment, bone metabolic disease, SLE; conditions exacerbated by fluid retention (eg, migraine, asthma, epilepsy).

Discontinue if the following develop jaundice, visual problems associated with retinal vascular lesions (may cause contact lens intolerance), any signs of VTE, migraine with unusual severity, significang blood pressure increase, severe depression, increased risk of thromboembolic complications after surgery.

Rare hepatic adenomas and focal modular hyperplasia, resulting in fatal intra-abdominal hemorrhage reported with therapy

Irregular menstrual bleeding is common with progestin only contraceptives; rule out nonpharmacologic causes of abnormal bleeding

Discontinue 4 week before major surgery or prolonged immobilization.

Patients on warfarin, oral anticoagulants (increase in anticoagulant dose may be warranted).

Not for use prior to menarche

Some studies link OCP use with increased risk of breast cancer, whereas other studies have not shown a change in risk. Woman's risk depends on conditions where naturally high hormone levels persist for long periods of time including early onset menstruation before age 12, late onset menopause, after age 55, first child after age 30, nulliparity.

Increased risk of cervical cancer with OCP use, however HPV remains as main risk factor for this cancer. Evidence suggests long-term use of OCPs, 5 or more years, may be associated with increased risk. Increased risk of liver cancer with OCP use; risk increases with longer duration of OCP use.

 

Pregnancy and lactation

Pregnancy category: X

Lactation: Excreted in breast milk; use caution

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Camila, Errin (norethindrone)

Mechanism of action

Progestin; inhibits secretion of gonadotropins from pituitary gland; prevents follicular maturation & ovulation, stimulates growth of mammary tissues

 

Absorption

Bioavailability: 64%

Peak Plasma Time: 1-2 hr

 

Distribution

Vd: 4 L/kg

Protein Bound: 61%

 

Metabolism

Liver

Metabolites: Sulfate and glucuronide metabolites (inactive)

 

Elimination

Half-Life: 4-13 hr

Excretion: Urine 33-81%; feces 35-43%