Ortho Tri-Cyclen Lo

Ortho Tri-Cyclen Lo is a prescription birth control medication used:

• to prevent pregnancy
• to treat acne in females at least 15 years of age who have started having menstrual periods

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• antibiotics such as rifampin
• antifungals such as griseofulvin, itraconazole, and ketoconazole
• barbiturates such as phenobarbital
• seizure medications such as phenytoin (Dilantin), carbamazepine (Tegretol), oxcarbazepine (Trileptal), topiramate (Topamax), and lamotrigine (Lamictal)
• certain anti-HIV medications called protease inhibitors
• St. John's Wort
• atorvastatin (Lipitor)

This is not a complete list of Ortho Tri-Cyclen Lo interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Ortho Tri-Cyclen Lo including:

• Blood clots, heart attack and stroke - Tell your healthcare provider right away if you have some or all of the following:
  • shortness of breath
  • sharp or crushing chest pain
  • weakness or numbness in an arm or leg
  • slurring of speech
  • coughing of blood
  • pain in the calf
  • sudden severe headache or vomiting
  • dizziness or fainting
• Hypertension - Have your blood pressure monitored by your doctor closely if taking Ortho Tri-Cyclen Lo, especially if you have a history of hypertension or are taking medications to treat hypertension
• Lipid disorders - Women who are being treated for hyperlipidemia (high blood fat/cholesterol) should be monitored closely, as steroids can elevate lipid levels.
• Breast, ovarian, or uterine cancer - Tell your healthcare provider right away if you detect a lump in the breast.  
• Liver problems - Tell your healthcare provider right away if you have some or all of the following:
  • severe pain or tenderness in the stomach area
  • yellowing of the skin or eyeballs
• Severe depression - Tell your healthcare provider right away if you have some or all of the following:
  • difficulty sleeping
  • weakness, lack of energy, fatigue
  • change in mood
• Eye conditions - Tell your healthcare provider right away if you have some or all of the following:
  • unexplained partial or complete loss of vision
  • double vision
  • bulging of the eyes
• Severe migraine headaches - Tell your healthcare provider right away if you experience recurrent or persistent headaches.

• have a history of heart attack or stroke
• have blood clots in the legs, lungs, or eyes
• have a history of blood clots in the deep veins of your legs
• have chest pain (angina pectoris)
• have or have had cerebral vascular or coronary artery disease
• have disease of the heart valves with complications
• have severe hypertension (very high blood pressure)
• have diabetes with blood vessel involvement
• have headaches with focal neurological symptoms (movement disorders affecting a specific region of the body, such as the left arm or right leg)
• have had a major surgery requiring a long period of inactivity
• have, may have, or have had cancer of the breast
• have cancer of the lining of the uterus or other estrogen-dependent cancer
• have undiagnosed abnormal genital bleeding
• have jaundice (yellowing of the skin or eyes)
• have liver disease with abnormal liver function
• have tumors of the liver
• are or may be pregnant
• are allergic to any component of Ortho Tri-Cyclen Lo

Tell your doctor if you are breastfeeding or plan to breastfeed.  

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies on the relationship of age to the effects of ethinyl estradiol and norgestimate combination have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in teenagers are not expected. This medicine may be used for birth control in teenage females but should not be used before the start of menstruation.

Geriatric

Appropriate studies on the relationship of age to the effects of ethinyl estradiol and norgestimate combination have not been performed in the geriatric population. This medicine should not be used in elderly women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Dasabuvir
• Ombitasvir
• Paritaprevir
• Ritonavir
• Tranexamic Acid

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Anagrelide
• Aprepitant
• Boceprevir
• Bosentan
• Bupropion
• Carbamazepine
• Ceritinib
• Dabrafenib
• Darunavir
• Dexamethasone
• Donepezil
• Eliglustat
• Enzalutamide
• Fosphenytoin
• Griseofulvin
• Idelalisib
• Isotretinoin
• Lesinurad
• Lixisenatide
• Lumacaftor
• Mitotane
• Modafinil
• Oxcarbazepine
• Paclitaxel
• Paclitaxel Protein-Bound
• Phenytoin
• Piperaquine
• Pitolisant
• Prednisone
• Rifabutin
• Rifampin
• St John's Wort
• Sugammadex
• Theophylline
• Tizanidine
• Topiramate
• Ulipristal
• Valproic Acid

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alprazolam
• Amprenavir
• Atazanavir
• Bacampicillin
• Betamethasone
• Bexarotene
• Clarithromycin
• Colesevelam
• Cyclosporine
• Delavirdine
• Efavirenz
• Eslicarbazepine Acetate
• Etoricoxib
• Fosamprenavir
• Fosaprepitant
• Ginseng
• Lamotrigine
• Licorice
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nelfinavir
• Parecoxib
• Prednisolone
• Rifapentine
• Ritonavir
• Roflumilast
• Rosuvastatin
• Rufinamide
• Selegiline
• Telaprevir
• Tipranavir
• Troglitazone
• Troleandomycin
• Valdecoxib
• Voriconazole
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Caffeine
• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal or unusual vaginal bleeding or
• Blood clots (eg, deep vein thrombosis, pulmonary embolism), or history of or
• Breast cancer, known or suspected or
• Diabetes with kidney, eye, nerve, or blood vessel damage or
• Endometrial cancer or
• Heart attack, history of or
• Heart or blood vessel disease (eg, coronary artery disease, heart valve problems), or history of or
• Hypertension (high blood pressure) that is not under good control or
• Jaundice during pregnancy or from using hormonal therapy in the past or
• Liver disease, including tumors or cancer or
• Major surgery with prolonged periods of immobilization or
• Migraine headache or
• Stroke, history of or
• Tumors (estrogen-dependent), known or suspected—Should not be used in patients with these conditions.

• Breast cancer, family history of or
• Cervical cancer or
• Chloasma (skin discoloration of the face during pregnancy), history of or
• Depression, history of or
• Edema (fluid retention or body swelling) or
• Epilepsy (seizures) or
• Gallbladder disease or
• Hereditary angioedema or
• Hypertension (high blood pressure)—Use with caution. May make these conditions worse.

• Diabetes or
• Hyperlipidemia (high cholesterol or fats in the blood) or
• Kidney disease or
• Obesity, or history of—Use with caution. These conditions may increase risk for more serious side effects.

• It is used to prevent pregnancy.
• It is used to treat pimples (acne).
• It may be given to you for other reasons. Talk with the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Weight gain.
• Headache.
• Upset stomach or throwing up.
• Gas.
• Feeling nervous and excitable.
• Belly pain.
• Enlarged breasts.
• Tender breasts.
• Period (menstrual) changes. These include spotting or bleeding between cycles.
• This medicine may cause dark patches of skin on your face. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

How to Start Ortho Tri-Cyclen Lo

Ortho Tri-Cyclen Lo is dispensed in either a DIALPAK Tablet dispenser or a VERIDATE Tablet Dispenser [see How Supplied/Storage and Handling (16)]. Ortho Tri-Cyclen Lo may be started using either a Day 1 start or a Sunday start (see Table 1). For the first cycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration.

How to Take Ortho Tri-Cyclen Lo

Starting Ortho Tri-Cyclen Lo after Abortion or Miscarriage

First-trimester

• After a first-trimester abortion or miscarriage, Ortho Tri-Cyclen Lo may be started immediately. An additional method of contraception is not needed if Ortho Tri-Cyclen Lo is started immediately.
• If Ortho Tri-Cyclen Lo is not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of her first cycle pack of Ortho Tri-Cyclen Lo.

Second-trimester

• Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Ortho Tri-Cyclen Lo, following the instructions in Table 1 for Day 1 or Sunday start, as desired. If using Sunday start, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient's first cycle pack of Ortho Tri-Cyclen Lo. [see Contraindications (4), Warnings and Precautions (5.1), and FDA-Approved Patient Labeling.]

Starting Ortho Tri-Cyclen Lo after Childbirth

• Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Ortho Tri-Cyclen Lo following the instructions in Table 1 for women not currently using hormonal contraception.
• Ortho Tri-Cyclen Lo is not recommended for use in lactating women [see Use in Specific Populations (8.3)].
• If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of Ortho Tri-Cyclen Lo [see Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1 and 8.3), and FDA-Approved Patient Labeling].

DIALPAK® Tablet Dispenser:

VERIDATE® Tablet Dispenser

• Place the refill in the VERIDATE Tablet Dispenser so that the V notch in the refill is at the top of the dispenser. Press the refill down so that it fits firmly under all the nibs (see illustration below).
• If the patient starts pill-taking on Sunday, the first active pill should be taken on the first Sunday after the patient's menstrual period begins. Remove the first active pill at the top of the dispenser (Sunday) by pressing the pill through the hole in the bottom of the dispenser.
  
• If the patient will start pill-taking on a day other than Sunday, a calendar label has been provided and should be placed over the calendar in the center of the VERIDATE. To place the label correctly, identify the correct starting day, locate that day printed in blue on the label, and line that day up with the first white pill directly under the V notch at the top of the dispenser. Remove the label from the backing. Press the center of the label down onto the center of the printed calendar. Remove that white pill by pressing the pill through the hole in the bottom of the dispenser.
• After all the dark green pills have been taken, insert a new refill into the VERIDATE. The patient should take the first pill on the next day, even if the patient's period is not over yet.

To Insert New Refill:

• Lift the empty refill out of the VERIDATE Tablet Dispenser.
• Insert the new refill so that the V notch in the refill is at the top of the dispenser. Press the refill down so that it fits firmly under the nibs.

Missed Tablets

Advice in Case of Gastrointestinal Disturbances

In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting or diarrhea occurs within 3 to 4 hours after taking an active tablet, handle this as a missed tablet [see FDA-Approved Patient Labeling].

Carcinogenesis, Mutagenesis, Impairment of Fertility

[See Warnings and Precautions (5.2, 5.11) and Use in Specific Populations (8.1).]

How Supplied

Ortho Tri-Cyclen Lo Tablets are available in a single pouch containing a VERIDATE blister card (refill) of 28 tablets: NDC 50458-251-28. Ortho Tri-Cyclen Lo Tablets are packaged in a carton containing 6 pouches and 6 unfilled VERIDATE Tablet Dispensers: NDC 50458-251-06

Each blister card (28 tablets) contains in the following order:

• 7 white, round, biconvex, coated tablets (active) imprinted "O-M" on one side and "180" on the other side contains 0.180 mg, norgestimate and 0.025 mg ethinyl estradiol
• 7 light blue, round, biconvex, coated tablets (active) imprinted "O-M" on one side and "215" on the other side contains 0.215 mg norgestimate and 0.025 mg ethinyl estradiol
• 7 dark blue, round, biconvex, coated tablets (active) imprinted "O-M" on one side and "250" on the other side contains 0.250 mg norgestimate and 0.025 mg ethinyl estradiol
• 7 dark green, round, biconvex, coated tablets (non-hormonal placebo) imprinted "O-M" on one side and "P" on the other side contains inert ingredients

Ortho Tri-Cyclen Lo Tablets are also available for clinic usage in a VERIDATE Tablet Dispenser (unfilled) and VERIDATE refills: NDC 50458-251-20 and NDC 50458-251-12

Ortho Tri-Cyclen Lo Tablets are available in a DIALPAK Tablet Dispenser (unfilled) and DIALPAK refills: NDC 50458-251-00 and NDC 50458-251-15

Storage Conditions

• Store at 20–25°C (68–77°F); excursions permitted to 15° to 30°C (59° to 86°F).
• Protect from light.
• Keep out of the reach of children.

28
day

NDC 50458-251-15

ORTHO
TRI~CYCLEN® LO
(norgestimate/ethinyl estradiol)
TABLETS

Each white tablet contains 0.180 mg norgestimate and 0.025 mg ethinyl
estradiol. Each light blue tablet contains 0.215 mg norgestimate and 0.025 mg
ethinyl estradiol. Each dark blue tablet contains 0.250 mg norgestimate and
0.025 mg ethinyl estradiol. Each green tablet contains inert ingredients.

Rx only.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).
Protect from light.

Contains: 6 Dialpak®
Tablet Dispensers
and 6 Refills

Janssen

Manufactured by:
Janssen Ortho, LLC
Manati, Puerto Rico 00674

Manufactured for:
Janssen Pharmaceuticals, Inc.
Titusville, New Jersey 08560