Sprintec

Name: Sprintec

Description

Sprintec® (norgestimate and ethinyl estradiol tablets USP) is a combination oral contraceptive containing the progestational compound norgestimate, USP and the estrogenic compound ethinyl estradiol, USP.

Each blue tablet contains 0.250 mg of the progestational compound norgestimate (18, 19-Dinor-17- pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna, 1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive ingredients include anhydrous lactose, FD&C blue no. 2 aluminum lake, lactose monohydrate, magnesium stearate, and pregelatinized corn starch.

Each white tablet contains only inert ingredients as follows: anhydrous lactose, hydroxypropyl methylcellulose 2208, magnesium stearate, and microcrystalline cellulose.

The structural formula is as follows:


C23H31NO3     M.W. 369.50


C20H24O2      M.W. 296.40

Overdose

There have been no reports of serious ill effects from overdosage of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Sprintec Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known
  • Abdominal or stomach pain
  • absent, missed, or irregular menstrual periods
  • anxiety
  • change in vision
  • changes in skin color
  • chest pain or discomfort
  • chills
  • clay-colored stools
  • constipation
  • cough
  • dark urine
  • diarrhea
  • dizziness or lightheadedness
  • fainting
  • fever
  • headache
  • hives or welts
  • itching skin
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • medium to heavy, irregular vaginal bleeding between regular monthly periods, which may require the use of a pad or a tampon
  • nausea and vomiting
  • pain or discomfort in the arms, jaw, back, or neck
  • pain, tenderness, or swelling of the foot or leg
  • pains in the chest, groin, or legs, especially in the calves of the legs
  • pounding in the ears
  • rash
  • redness of the skin
  • severe headaches of sudden onset
  • slow or fast heartbeat
  • sudden loss of coordination or slurred speech
  • sudden onset of shortness of breath for no apparent reason
  • sudden shortness of breath or troubled breathing
  • sweating
  • unusual tiredness or weakness
  • vomiting of blood

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known
  • Abdominal or stomach cramps
  • bloating
  • blotchy spots on the exposed skin
  • breast enlargement or tenderness
  • discouragement
  • feeling sad or empty
  • irritability
  • itching of the vagina or outside the genitals
  • loss of interest or pleasure
  • pain during sexual intercourse
  • thick, white curd-like vaginal discharge without odor or with mild odor
  • tiredness
  • trouble concentrating
  • trouble sleeping
  • trouble wearing contact lenses

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How is this medicine (Sprintec) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Follow how to use as you have been told by the doctor or read the package insert.
  • Take Sprintec at the same time of day.
  • Take with or without food. Take with food if it causes an upset stomach.
  • If you also take colesevelam, take it at least 4 hours after you take this medicine.
  • Do not skip doses, even if you do not have sex very often.
  • If you throw up or have diarrhea, Sprintec may not work as well to prevent pregnancy. If this happens within 3 to 4 hours after you take an active tablet, take another tablet. If it goes on for more than 1 day, use an extra form of birth control and call your doctor. Call your doctor if you throw up or have diarrhea and are not sure what to do.
  • If you miss 2 periods in a row, take a pregnancy test before starting a new cycle.

What do I do if I miss a dose?

  • If a dose is missed, check the package insert or call the doctor to find out what to do. If using this medicine to prevent pregnancy, another form of birth control may need to be used for some time to prevent pregnancy.

What are some other side effects of Sprintec?

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.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Sprintec (ethinyl estradiol and norgestimate), please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Sprintec. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Sprintec.

Review Date: October 4, 2017

Contraindications

Do not prescribe Sprintec to women who are known to have the following conditions:

• A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: o Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)] o Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)] o Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)] o Have cerebrovascular disease [see Warnings and Precautions (5.1)] o Have coronary artery disease [see Warnings and Precautions (5.1)] o Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1)] o Have uncontrolled hypertension [see Warnings and Precautions (5.3)] o Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.5)] o Have headaches with focal neurological symptoms or migraine headaches with aura [see Warnings and Precautions (5.6)] ▪ Women over age 35 with any migraine headaches [see Warnings and Precautions (5.6)] • Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.2)] • Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.7)] • Pregnancy, because there is no reason to use COCs during pregnancy [see Warnings and Precautions (5.8) and Use in Specific Populations (8.1)] • Breast cancer or other estrogen-or progestin-sensitive cancer, now or in the past [see Warnings and Precautions (5.10)]

Package/Label Display Panel, Part 2 of 2

Sprintec 0.25 mg/0.035 mg, 6 Blister Cards, 28 Tablets Each Carton Text

NDC 0555-9016-58

6 Blister Cards, 28 Tablets Each

28
DAY
REGIMEN

Sprintec®

(norgestimate and ethinyl
estradiol tablets USP)

0.25 mg/0/035 mg

Usual Dosage: One tablet daily for 28 consecutive days per menstrual
cycle in the following order: 21 blue tablets followed by 7 white tablets
as prescribed.

See enclosed package information.

To the Dispenser: This carton contains one combination labeling
piece of information intended for the patient. Informational pieces are
to be provided to the patient with each prescription.

Rx only

SHAPING
WOMEN’S HEALTH®

TEVA

Sprintec 
norgestimate and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0555-9016
Packaging
# Item Code Package Description
1 NDC:0555-9016-58 6 POUCH in 1 CARTON
1 1 BLISTER PACK in 1 POUCH
1 1 KIT in 1 BLISTER PACK
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21 
Part 2
Part 1 of 2
Sprintec 
norgestimate and ethinyl estradiol tablet
Product Information
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NORGESTIMATE (NORGESTIMATE) NORGESTIMATE 0.25 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.035 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE  
FD&C BLUE NO. 2  
INDIGOTINDISULFONATE SODIUM  
AMMONIUM SULFATE  
SODIUM CARBONATE  
SODIUM BICARBONATE  
ALUMINUM CHLORIDE  
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
STARCH, CORN  
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code b;987
Contains     
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075804 09/26/2002
Part 2 of 2
INERT 
inert tablet
Product Information
Route of Administration ORAL DEA Schedule     
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE  
HYPROMELLOSE 2208 (3 MPA.S)  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code b;143
Contains     
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075804 09/26/2002
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075804 09/26/2002
Labeler - Teva Pharmaceuticals USA, Inc. (001627975)
Revised: 08/2016   Teva Pharmaceuticals USA, Inc.

For the Consumer

Applies to ethinyl estradiol / norgestimate: oral tablet

Along with its needed effects, ethinyl estradiol / norgestimate may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ethinyl estradiol / norgestimate:

Incidence not known
  • Abdominal or stomach pain
  • absent, missed, or irregular menstrual periods
  • anxiety
  • change in vision
  • changes in skin color
  • chest pain or discomfort
  • chills
  • clay-colored stools
  • constipation
  • cough
  • dark urine
  • diarrhea
  • dizziness or lightheadedness
  • fainting
  • fever
  • headache
  • hives or welts
  • itching skin
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • medium to heavy, irregular vaginal bleeding between regular monthly periods, which may require the use of a pad or a tampon
  • nausea and vomiting
  • pain or discomfort in the arms, jaw, back, or neck
  • pain, tenderness, or swelling of the foot or leg
  • pains in the chest, groin, or legs, especially in the calves of the legs
  • pounding in the ears
  • rash
  • redness of the skin
  • severe headaches of sudden onset
  • slow or fast heartbeat
  • sudden loss of coordination or slurred speech
  • sudden onset of shortness of breath for no apparent reason
  • sudden shortness of breath or troubled breathing
  • sweating
  • unusual tiredness or weakness
  • vomiting of blood

Some side effects of ethinyl estradiol / norgestimate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known
  • Abdominal or stomach cramps
  • bloating
  • blotchy spots on the exposed skin
  • breast enlargement or tenderness
  • discouragement
  • feeling sad or empty
  • irritability
  • itching of the vagina or outside the genitals
  • loss of interest or pleasure
  • pain during sexual intercourse
  • thick, white curd-like vaginal discharge without odor or with mild odor
  • tiredness
  • trouble concentrating
  • trouble sleeping
  • trouble wearing contact lenses

(web3)