Ortho-novum (other name Aygestin)

Product Description

INDICATIONS
Aygestin (norethindrone) is indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer.

INSTRUCTIONS

Use Aygestin as directed by your doctor. Check the label on the medicine for exact dosing instructions. An extra patient leaflet is available with Aygestin. Talk to your pharmacist if you have questions about this information.
Take Aygestin by mouth with or without food.
Take Aygestin at the same time every day, with doses not more than 24 hours apart.
If you miss a dose of Aygestin, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Aygestin.

DOSAGE

Therapy with Aygestin must be adapted to the specific indications and therapeutic response of the individual patient. This dosage schedule assumes the interval between menses to be 28 days. Secondary amenorrhea, abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology: 2.5 to 10 mg Aygestin (norethindrone) may be given daily for 5 to 10 days during the second half of the theoretical menstrual cycle to produce an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen.

Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing Aygestin (norethindrone) therapy. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with Aygestin (norethindrone) .

Endometriosis: Initial daily dosage of 5 mg Aygestin (norethindrone) for two weeks. Dosage should be increased by 2.5 mg per day every two weeks until 15 mg per day of Aygestin (norethindrone) is reached. Therapy may be held at this level for six to nine months or until annoying breakthrough bleeding demands temporary termination.

STORAGE

Store Aygestin in a tightly closed container at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Aygestin out of the reach of children and away from pets.

MORE INFO:
Aygestin is a progestin hormone. It works by altering the lining of the uterus.

SAFETY INFORMATION

Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:
if you are planning to become pregnant or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have seizures (eg, epilepsy), migraines, heart problems, kidney problems, or a history of depression
if you have a history of high blood pressure, diabetes, high blood cholesterol, lupus, or blood clots, or if a member of your family has had these problems
if you smoke or are very overweight

Some MEDICINES MAY INTERACT with Aygestin. Tell your health care provider if you are taking any of the following medicines:
Aprepitant, carbamazepine, felbamate, griseofulvin, HIV protease inhibitors (eg, ritonavir), hydantoins (eg, phenytoin), modafinil, nevirapine, rifampin, St. John's wort, or tetracyclines because they may decrease Aygestin's effectiveness
Corticosteroids (eg, prednisone), theophylline, or troleandomycin because the risk of their side effects may be increased by Aygestin
Beta-adrenergic blockers (eg, propranolol), lamotrigine, or thyroid medicines because their effectiveness may be decreased by Aygestin
This may not be a complete list of all interactions that may occur. Ask your health care provider if Aygestin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

SIDE EFFECTS

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; changes in menstrual flow, including breakthrough bleeding, spotting, or missed periods; dizziness; drowsiness; fever; headache; hot flashes; nausea; nervousness; pain; rash; stomach pain; trouble sleeping; weakness; weight gain or loss.
Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; depression; lumps in the breast or under the armpits; migraine headache; partial or complete loss of vision or changes in vision; shortness of breath; slurred speech; sudden loss of coordination; sudden or severe headache; sudden severe headache, dizziness, vomiting, or fainting; swelling of fingers or ankles; tenderness, pain, or swelling of the calf; weakness, numbness, or pain in the arms or legs; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects.