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Ortho Tri-Cyclen

Ethinyl estradiol + Norgestimate

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Description | Uses & Side Effects | Warnings

Ortho Tri-Cyclen is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol.

Each white tablet contains progestational compound, norgestimate, oxime, and estrogenic compound, and ethinyl estradiol. Inactive ingredients include lactose, magnesium stearate, and pregelatinized corn starch.

Each light blue tablet contains progestational compound norgestimate, estrogenic compound, and ethinyl estradiol. Inactive ingredients include FD & C Blue No. 2 Aluminum Lake, lactose, magnesium stearate, and pregelatinized corn starch.

Each blue tablet contains progestational compound norgestimate, estrogenic compound, and ethinyl estradiol. Inactive ingredients include FD & C Blue No. 2 Aluminum Lake, lactose, magnesium stearate, and pregelatinized corn starch.

Each green tablet contains only inert ingredients, as follows: D & C Yellow No. 10 Aluminum Lake, FD & C Blue No. 2 Aluminum Lake, lactose, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch.

Common Uses:

Ortho Tri-Cyclen tablets are used for prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

Ortho Tri-Cyclen is also used in the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. This medication should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.

Off Label Uses:

At this time, off-label Ortho Tri-Cyclen Lo uses include treatment for the following conditions:

Acne
Heavy menstrual bleeding
Painful menstrual periods
Irregular menstrual periods
Premenstrual dysphoric disorder (PMDD)
Various other problems, such as polycystic ovary syndrome

Side Effects:
Some of these common bothersome (but not usually dangerous) side effects include:

Headaches (although birth control pills can improve headaches in some women)
Breakthrough bleeding and spotting between periods (especially for the first few cycles)
Nausea and vomiting
Changes in your eyes that make it more difficult to wear contact lenses
Bloating
Breast tenderness or other breast changes, such as swelling
Changes in sex drive (often a decrease, rather than an increase).

Women are often concerned about weight gain due to birth control pills, but recent research suggests that birth control pills probably do not cause weight gain for most women.

Some side effects with Ortho Tri-Cyclen, while occurring infrequently, are potentially serious and should be reported immediately to your healthcare provider. These include but are not limited to:

Signs of a stroke, such as:

Vision or speech changes
Weakness or numbness in an arm or leg
Severe headache

Signs of liver damage, such as:

Yellow eyes or skin (jaundice)
Dark urine
Upper-right abdominal (stomach) pain

Depression or other emotional changes
Migraines (or changes in your migraines, if you have had them before)
Breast lumps
Signs of a blood clot in the leg, such as:

Pain in the calf
Leg cramps
Leg or foot swelling

Signs of a blood clot in the lung, such as:

Shortness of breath
Sharp chest pain
Coughing up blood

Chest pain or heaviness, which may be signs of a heart attack
Sudden loss of vision or vision changes, which can be a sign of a blood clot in the eye
Heavy vaginal bleeding between periods (light bleeding or spotting is normal)
High blood pressure (hypertension)
High cholesterol
Signs of an allergic reaction, such as:

Unexplained rash
Hives
Itching
Unexplained swelling
Wheezing
Difficulty breathing or swallowing.

Cautions / Warnings:

Warnings and precautions to be aware of prior to using Ortho Tri-Cyclen Lo include the following:

Combined oral contraceptives, including Ortho Tri-Cyclen Lo, increase the risk of blood clots, strokes, and heart attacks. These risks are quite small for healthy, young nonsmokers. However, make sure to tell your healthcare provider if you have ever had a blood clot, stroke, heart attack, or chest pain. Smoking cigarettes greatly increases the risk of serious Ortho Tri-Cyclen Lo side effects. This risk is particularly high for smokers over the age of 35.

Hormonal contraceptives, including Ortho Tri-Cyclen Lo, can increase your blood pressure. This can be a problem if you already have high blood pressure.

Ortho Tri-Cyclen Lo does not protect against HIV, AIDS, or other sexually transmitted diseases (STDs). In many cases, it is advisable to use condoms in addition to Ortho Tri-Cyclen Lo.

Ortho Tri-Cyclen Lo can interact with a number of different medications.

Combined oral contraceptives may slightly increase the risk of breast cancer or cervical cancer, although this is an unresolved and controversial issue. However, combined oral contraceptives seem to help protect women against ovarian and uterine cancer.

Oral contraceptives increase the risk of benign (noncancerous) liver tumors. In rare cases, these tumors can rupture and cause serious problems.

Hormonal contraceptives such as Ortho Tri-Cyclen Lo may make gallbladder disease worse. If you have had a problem with your gallbladder, Ortho Tri-Cyclen Lo may not be the best contraceptive method for you.

Ortho Tri-Cyclen Lo may increase blood sugar, particularly in women with diabetes. Your healthcare provider may need to monitor you more closely. Let your healthcare provider know if you have any sudden vision changes while taking the drug, as this may be a sign of a blood clot in the eyes (a possible side effect of Ortho Tri-Cyclen Lo and other hormonal contraceptives).

Ortho Tri-Cyclen Lo can change your menstrual bleeding patterns. Some women have breakthrough bleeding (bleeding between periods), while others may not have a period at all. It is normal to have shorter and lighter periods while using the drug. However, if you notice any unusual changes in your bleeding patterns, let your healthcare provider know. If you miss a period, you should make sure you are not pregnant.

Ortho Tri-Cyclen Lo can affect your cholesterol. Your healthcare provider may need to check your cholesterol levels after you start the drug, especially if you already have high cholesterol.

Sometimes, hormonal contraceptives may make depression worse. Let your healthcare provider know if you develop new or worsening depression symptoms while taking Ortho Tri-Cyclen Lo.

Occasionally, Ortho Tri-Cyclen Lo (as well as any other hormonal contraceptive) can cause eye changes that make it more difficult to wear contact lenses.

Ortho Tri-Cyclen Lo is considered a pregnancy Category X medication. This means that it should not be used during pregnancy.

Contraceptive hormones, such as the ones in Ortho Tri-Cyclen Lo, pass through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Ortho Tri-Cyclen Lo and Breastfeeding). Combined hormonal contraceptives are usually not recommended for breastfeeding women.

Drug Interactions:
Ortho Tri-Cyclen(norgestimate/ethinyl estradiol) can potentially interact with numerous other medicines. Many of these interactions can be severe enough to cause accidental pregnancy, and a backup method of birth control may be recommended.

If you are ever unsure what to do about an Ortho Tri-Cyclen drug interaction, be sure to use backup birth control until you can speak with your healthcare provider. Some of the medicines that may lead to Ortho Tri-Cyclen drug interactions include:

Aminoglutethimide (Cytadren®)
Antibiotics
Aprepitant (Emend®)
Atorvastatin (Lipitor®)
Barbiturate medications, such as:

Amobarbital (Amytal®)
Butalbital (Fioricet®, Fiorinal®)
Pentobarbital (Nembutal®)
Phenobarbital (Luminal®)
Secobarbital (Seconal®)

Cyclosporine (Gengraf®, Neoral®, Sandimmune®)
Many seizure medications, such as:

Carbamazepine (Carbatrol®, Epitol®, Equetro™, Tegretol®)
Felbamate (Felbatol®)
Lamotrigine (Lamictal®)
Oxcarbazepine (Trileptal®)
Phenytoin (Dilantin®, Phenytek®)
Topiramate (Topamax®)

Modafinil (Provigil®)
Protease inhibitors, such as:

Amprenavir (Agenerase®)
Atazanavir (Reyataz®)
Fosamprenavir (Lexiva®)
Indinavir (Crixivan®)
Nelfinavir (Viracept®)
Ritonavir (Norvir®)

Selegiline (Eldepryl®, Emsam®, Zelapar®)
St. John's wort (Hypericum perforatum)
Theophylline (Uniphyl®, Theocron®, TheoCap®, Theo-24®, Elixophyllin®)

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