Ortho-Novum 10/11 (ethinyl estradiol and norethindrone) is a progestin/estrogen combined oral contraceptive used by women to prevent unwanted pregnancy.
Contents:
Indications for use
Oral contraception.
Mechanism of action
It works mainly by preventing the release of an egg during your menstrual cycle. It also makes vaginal fluid thicker, which makes it impossible for sperm to reach an egg and changes the lining of the uterus to prevent attachment of a fertilized egg. As a result, it just passes out of the body.
Besides, this medicine may make your periods more regular, light and less painful, decrease the risk of ovarian cysts. It can also treat acne.
Dosage and mode of application
1 tablet orally once a day at about the same time of the day, with water, with or without food. Take pills in the order indicated in the blister. Start taking pills on the first day of your period or on the first Sunday following the onset of your period. Do not skip doses. Do not take more pills than indicated. Do not make interruption between packs. You period should begin on Week 4 (when you are taking inert pills).
Side effects
Common side effects that do not require medical attention:
- bloating;
- tiredness;
- trouble sleeping;
- itching of the vagina or outside genitals;
- loss of interest or pleasure;
- discouragement;
- feeling sad or empty;
- irritability;
- blotchy spots on the exposed skin;
- breast enlargement or tenderness;
- pain during sexual intercourse;
- trouble concentrating;
- stomach cramps;
- trouble wearing contact lenses;
- thick, white curd-like vaginal discharge without odor or with mild odor.
Contact your doctor right away or seek urgent medical attention if you have any of the following side effects:
- absent, missed, or irregular menstrual periods;
- anxiety;
- constipation;
- change in vision;
- chills;
- clay-colored stools;
- cough;
- medium to heavy, irregular vaginal bleedingbetween regular monthly periods;
- nausea;
- changes in skin color;
- chest pain or discomfort;
- redness of the skin;
- pain or discomfort in the arms, jaw, back, or neck;
- pounding in the ears;
- rash;
- pain, tenderness, or swelling of the foot or leg;
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs;
- severe headaches of sudden onset;
- slow or fast heartbeat;
- pains in the chest, groin, or legs, especially in the calves of the legs;
- troubled breathing;
- fainting;
- unusual tiredness or weakness;
- vomiting;
- sudden loss of coordination or slurred speech;
- sweating;
- stomach pain;
- dark urine;
- diarrhea;
- vomiting of blood;
- fast heartbeat;
- fever;
- headache;
- itching skin;
- dizziness or lightheadedness;
- loss of appetite;
- hives or welts.
Contraindications
Absolute contraindications for Ortho-Novum 10/11:
- breast malignancy;
- carcinomas (estrogenic);
- hypertension;
- thromboembolism;
- abnormal genital bleeding;
- abnormal vaginal bleeding;
- hypercalcemia in breast cancer;
- liver disease;
- thromboembolism/cardiovascular;
- hepatic neoplasms.
Relative contraindications:
- liver disease;
- fluid retention;
- melasma;
- hyperlipidemia;
- depression;
- hyperlipidemia;
- weight gain;
- glucose intolerance;
- retinal thrombosis;
- hypercalcemia;
- thyroid function tests;
- angioedema;
- gallbladder disease.
Interactions
Avoid taking Ortho-Novum 10/11 with any of the following medicines and foods:
- Amifampridine;
- Anagrelide;
- Apalutamide;
- Aprepitant;
- Armodafinil;
- Boceprevir;
- Bosentan;
- Brigatinib;
- Bupropion;
- Carbamazepine;
- Cenobamate;
- Ceritinib;
- Colesevelam;
- Dabrafenib;
- Dasabuvir;
- Darunavir;
- Dexamethasone;
- Donepezil;
- Efavirenz;
- Elagolix;
- Encorafenib;
- Enzalutamide;
- Eslicarbazepine Acetate;
- Etravirine;
- Fosaprepitant;
- Fosphenytoin;
- Glecaprevir;
- Griseofulvin;
- Isotretinoin;
- Ivosidenib;
- Lesinurad;
- Lixisenatide;
- Lorlatinib;
- Lumacaftor;
- Mitotane;
- Modafinil;
- Nafcillin;
- Nevirapine;
- Oxcarbazepine;
- Ombitasvir;
- Paclitaxel;
- Paclitaxel Protein-Bound;
- Paritaprevir;
- Phenobarbital;
- Phenytoin;
- Pibrentasvir;
- Piperaquine;
- Pitolisant;
- Prednisone;
- Primidone;
- Rifabutin;
- Rifampin;
- Rifapentine;
- Ritonavir;
- Rufinamide;
- Ritonavir;
- St John’s Wort;
- Sugammadex;
- Tazemetostat;
- Theophylline;
- Tizanidine;
- Tranexamic Acid;
- Topiramate;
- Ulipristal;
- Valproic Acid;
- Caffeine;
- Grapefruit products.
Pregnancy and breastfeeding
Use is contraindicated. Exclude pregnancy prior to using pills. Discontinue using this product if pregnancy is confirmed. The hormones can get into breast milk so you should not take these pills if you are breast-feeding a baby. Non-hormonal methods of birth control should be preferred during breast-feeding.
What if I miss a pill?
Try not to skip doses. Missing an active pill of Ortho-Novum 10/11 increases your risk of becoming pregnant.
- If you miss 1 active pill, take it as soon as you remember and take the next pill at your usual time (this means you may need to take 2 pills in 1 day); an additional contraception method is not required;
- If you miss 2 active pills in a row on week 1 or week 2, take 2 pills on the day you remember and 2 pills the next day, then take 1 pill every day until you finish the pack; an additional contraception method is required for the next 7 days if you have sex;
- If you miss 2 active pills in a row on Week 3, or 3 or you miss more pills in a row, throw out the rest of the pack and start a new pack the same day for Day 1 starters; for Sunday starters, continue to take 1 pill each day until Sunday, on Sunday, discard the rest of the pack and start a new pack the same day; an additional contraception method is required for the next 7 days if you have sex;
- If you miss any of the inert pills, discard the missed pills and continue to take 1 pill per day until the pack is empty.
Precautions
You should undergo a complete physical examination prior to using these birth control pills.
Severe vomiting or diarrhea may reduce the absorption of the product and you may need to use additional birth control measures; if vomiting or diarrhea occurs within 3 to 4 hours after taking an active pill, consider this a missed pill.
Women using this contraceptive should visit a doctor regularly for check-ups.
Regularly monitor blood pressure throughout hormonal contraception.
The efficacy of Ortho-Novum 10/11 has not been studied in women with a body mass index of greater than 35 kg/m2.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if you think you have an overdose. The symptoms may include vaginal bleeding, nausea, or vomiting.
Avoid smoking when on the pills. Smoking cigarettes can greatly increase the risk of blood clots, stroke, and other cardiovascular events.
This product does not protect you and your partner against HIV infection, AIDS, and other sexually transmitted diseases.