Estradiol Missed Doses 5 Days on 1 Mg How Do I Start Taking Again

What is Sprintec and how is it used?

Sprintec is a prescription medicine used equally contraception to preclude pregnancy. Sprintec may exist used alone or with other medications.

Sprintec belongs to a class of drugs chosen Estrogens/Progestins; Contraceptives, Oral.

It is not known if Sprintec is safe and effective in children.

What are the possible side effects of Sprintec?

Sprintec may cause serious side effects including:

• sudden numbness or weakness (particularly on one side of the body),
• sudden severe headache,
• slurred speech communication,
• problems with vision,
• problems with balance,
• sudden vision loss,
• stabbing chest pain,
• shortness of jiff,
• coughing upwards blood,
• pain or warmth in one or both legs,
• chest hurting or pressure,
• pain spreading to your jaw or shoulder,
• nausea,
• sweating,
• loss of appetite,
• upper stomach pain,
• tiredness,
• fever,
• dark urine,
• clay-colored stools,
• yellowing of the peel or eyes (jaundice),
• pounding in your cervix or ears,
• swelling in your hands, ankles, or feet,
• changes in the pattern or severity of migraine headaches,
• breast lump,
• sleep bug,
• weakness, and
• mood changes

Get medical assistance correct away, if yous have any of the symptoms listed above.

The well-nigh common side effects of Sprintec include:

• breadbasket hurting,
• gas,
• nausea,
• vomiting,
• breast tenderness,
• acne,
• darkening of facial skin,
• headache,
• nervousness,
• mood changes,
• issues with contact lenses,
• changes in weight,
• breakthrough bleeding,
• vaginal itching or belch, and
• rash

Tell the doctor if you have any side effect that bothers y'all or that does not become away.

These are not all the possible side effects of Sprintec. For more than information, ask your doctor or chemist.

Phone call your doc for medical advice about side furnishings. You may report side effects to FDA at one-800-FDA-1088.

WARNING

CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

Cigarette smoking increases the hazard of serious cardiovascular events from combination oral contraceptive (COC) apply. This take a chance increases with historic period, especially in women over 35 years of historic period, and with the number of cigarettes smoked. For this reason, COCs are contraindicated in women who are over 35 years of historic period and smoke [see CONTRAINDICATIONS].

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-iv-en-20-yn-3-1,17-(acetyloxy)-xiii-ethyl-, oxime, (17α)-(+)-) and 0.035 mg of the estrogenic chemical 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 merely inert ingredients as follows: anhydrous lactose, hydroxypropyl methylcellulose 2208, magnesium stearate, and microcrystalline cellulose.

The structural formula is as follows:

C₂₃H₃₁NO_three One thousand.Westward. 369.fifty

C₂₀H₂₄O₂ Grand.W. 296.40

iii pharmacies almost 11430 have coupons for Estarylla (Make Names:Sprintec for 28 Tablets)

INDICATIONS

Oral Contraceptive

Sprintec® (norgestimate and ethinyl estradiol tablets) is indicated for use by females of reproductivepotential to prevent pregnancy [see Clinical Studies].

DOSAGE AND Administration

How To Start Sprintec

Sprintec is dispensed in a blister pack tablet dispenser [come across HOW SUPPLIED/Storage and Handling]. Sprintec may be started using either a Day i start or a Dominicus showtime (see Table ane). For the first bicycle of a Sunday Beginning regimen, an additional method of contraception should exist used until after the showtime 7 consecutive days of administration.

How To Have Sprintec

Table ane: Instructions for Administration of Sprintec

Starting COCs in women not currently using hormonal contraception (Day i Start or Sun Start) Important: Consider the possibility of ovulation and conception prior to initiation of this production. Tablet Color: Sprintec agile tablets are blue (24-hour interval 1 to Day 21). Sprintec has white inactive tablets (Day 22 to Day 28).	Day 1 Start: Take get-go agile tablet without regard to meals on the outset day of menses. Have subsequent active tablets once daily at the same time each twenty-four hour period for a total of 21 days. Take one white inactive tablet daily for 7 days and at the same fourth dimension of twenty-four hour period that active tablets were taken. Begin each subsequent pack on the same day of the calendar week as the first cycle pack (i.due east., on the day afterwards taking the last inactive tablet)
	Sun Kickoff: Take first active tablet without regard to meals on the kickoff Lord's day after the onset of menses. Due to the potential risk of condign significant, use boosted non-hormonal contraception (such as condoms and spermicide) for the commencement 7 days of the patient'south first wheel pack of Sprintec. Take subsequent active tablets in one case daily at the same time each day for a full of 21 days. Have one white inactive tablet daily for the post-obit seven days and at the same time of day that active tablets were taken. Brainstorm each subsequent pack on the aforementioned twenty-four hour period of the week every bit the beginning wheel pack (i.e., on the Sunday subsequently taking the last inactive tablet) and boosted non-hormonal contraceptive is not needed.
Switching to Sprintec from some other oral contraceptive	Outset on the aforementioned day that a new pack of the previous oral contraceptive would have started.
Switching from another contraceptive method to Sprintec	Start Sprintec:
Trans dermal patch	On the day when next application would have been scheduled
Vaginal ring	On the twenty-four hour period when next insertion would have been scheduled
Injection	On the 24-hour interval when side by side injection would have been scheduled
Intrauterine contraceptive	On the day of removal If the IUD is not removed on commencement day of the patient's menstrual wheel, additional non-hormonal contraceptive (such as condoms and spermicide) is needed for the offset seven days of the first cycle pack.
Implant	On the day of removal
Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-Approved Patient Labeling.

Starting Sprintec after Abortion or Miscarriage

First-trimester

• Afterwards a offset-trimester ballgame or miscarriage, Sprintec may exist started immediately. An boosted method of contraception is not needed if Sprintec is started immediately.
• If Sprintec is not started inside five days after termination of the pregnancy, the patient should use boosted non-hormonal contraception (such as condoms and spermicide) for the first vii days of her starting time cycle pack of Sprintec.

2d-trimester

• Do not outset until 4 weeks after a 2d-trimester ballgame or miscarriage, due to the increased risk of thromboembolic disease. Start Sprintec, following the instructions in Table 1 for Solar day one or Dominicus start, as desired. If using Sunday kickoff, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient’s first cycle pack of Sprintec. [Run across CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and FDA Canonical Patient Labeling.]

Starting Sprintec subsequently Childbirth

• Practise not start until 4 weeks after commitment, due to the increased gamble of thromboembolic affliction. Start contraceptive therapy with Sprintec following the instructions in Table 1 for women not currently using hormonal contraception.
• Sprintec is not recommended for utilise in lactating women [see Use in Specific Populations].
• If the woman has not all the same had a period postpartum, consider the possibility of ovulation and formulation occurring prior to apply of Sprintec. [See CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, Use in Specific Populations, and FDA-Canonical Patient Labeling].

There are two ways to start taking birth-control pills, Dominicus First or Mean solar day 1 First. Your healthcare professional will tell yous which to use.

How to Use Cicatrice Cards for the 28 Tablets

1. Pick the Days of the Week Sticker that starts the first day of your period. (This is the day you lot begin bleeding or spotting, fifty-fifty if information technology is midnight when bleeding begins.) When you have picked the right sticker, throw away the others and place the sticker on the blister card over the preprinted days of the calendar week and make sure information technology lines up with the pills.
2. Your blister parcel consists of three parts, the foil pouch, wallet, and a blister pack containing 28 individually sealed pills. Annotation that the pills are arranged in four numbered rows of 7 pills, with the pre-printed days of the week printed above them. All 21 blue pills are "active" nascency-control pills, and 7 white "reminder" pills. Refer to the sample of the cicatrice carte du jour below:



3. After taking the concluding white pill, start a new blister carte the very next day no matter when your period started. You volition be taking a pill every day without interruption. Whatsoever time you commencement the pills subsequently than directed, protect yourself by using another method of birth control until you lot have taken a pill a day for 7 consecutive days. Later on taking the final white pill, start taking the start blue pill from the blister card the very next mean solar day.
4. Take the pills in each new packet as before. Showtime with the blue pill on row #ane and take 1 pill each day, left to right, until the last white pill has been taken.

Three Ways to Remember in What Order to Take the Pills

1. Follow the sticker with the days of the week (placed above the pills).
2. Always go from left to right.
3. Always stop all your blue pills.

Missed Tablets

Tabular array 2: Instructions for Missed Sprintec Tablets

If i active tablet is missed in Weeks i, 2, or 3	Take the tablet every bit soon as possible. Proceed taking one tablet a day until the pack is finished.
If 2 active tablets are missed in Week i or Week two	Have the ii missed tablets as shortly as possible and the side by side 2 active tablets the next day. Continue taking one tablet a twenty-four hours until the pack is finished. Additional non-hormonal contraception (such as condoms and spermicide) should be used every bit redundancy if the patient has sex within vii days subsequently missing tablets.
If 2 active tablets are missed in the third week or three or more agile tablets are missed in a row in Weeks one, 2, or three	Solar day one start: Throw out the remainder of the pack and first a new pack that same mean solar day. Sun showtime: Continue taking one tablet a day until Sunday, then throw out the remainder of the pack and kickoff a new pack that same day. Additional non-hormonal contraception (such every bit condoms and spermicide) should be used equally redundancy if the patient has sex inside 7 days after missing tablets.

Advice in Instance 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 three to 4 hours later on taking an active tablet, handle this as a missed tablet [meet FDA-Approved Patient Labeling].

HOW SUPPLIED

Dosage Forms And Strengths

Sprintec (norgestimate and ethinyl estradiol tablets USP) is available in blister cards. Each blister card contains 28 tablets in the following order:

21 blue, round, flat-faced, askew-edge, unscored tablet debossed with stylized b on one side and 987 on the other side contains 0.250 mg norgestimate and 0.035 mg ethinyl estradiol

seven white, round, flat-faced, beveled-edge, unscored tablet (not-hormonal placebo) debossed with stylized b on one side and 143 on the other side contains inert ingredients

Storage And Treatment

Sprintec® (norgestimate and ethinyl estradiol tablets USP) is packaged in cartons of half-dozen blister cards. Each card contains 21 blue tablets and vii white tablets containing inert ingredients. Each blueish tablet contains 0.250 mg of the progestational compound, norgestimate, together with 0.035 mg of the estrogenic compound, ethinyl estradiol which are round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on ane side and 987 on the other side. Each white tablet contains inert ingredients and are round, flat-faced, askew-edge, unscored tablets, debossed with stylized b on one side and 143 on the other side. NDC: 0555-9016-58

Telephone call your medico for medical advice about side furnishings. You may study side furnishings to FDA at one-800-FDA-1088.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Storage Conditions

• Shop at xx° to 25°C (68° to 77°F) [Run into USP Controlled Room Temperature].
• Protect from calorie-free.

TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454. Revised: Aug 2016

SLIDESHOW

Choosing Your Nascency Command Method Meet Slideshow

SIDE EFFECTS

The following serious adverse reactions with the use of COCs are discussed elsewhere in labeling:

• Serious cardiovascular events and stroke [see BOXED WARNING and WARNINGS AND PRECAUTIONS]
• Vascular events [run across WARNINGS AND PRECAUTIONS]
• Liver affliction [see WARNINGS AND PRECAUTIONS]

Agin reactions commonly reported past COC users are:

• Irregular uterine bleeding
• Nausea
• Breast tenderness
• Headache

Clinical Trial Experience

Considering clinical trials are conducted under widely varying conditions, agin reaction rates observed in the clinical trials of a drug cannot be straight compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical exercise.

The condom of norgestimate and ethinyl estradiol was evaluated in 1,647 healthy women of changeable potential who participated in 3 clinical trials and received at least ane dose of norgestimate and ethinyl estradiol for contraception. Ii trials were randomized active-controlled trials and 1 was an uncontrolled open-label trial. In all 3 trials, subjects were followed for upward to 24 cycles.

Common Adverse Reactions ( ≥ two% of subjects): The most common adverse reactions reported by at to the lowest degree 2% of the 1,647 women were the following in gild of decreasing incidence: headache/migraine (32.9%), abdominal/gastrointestinal pain (seven.viii%), vaginal infection (8.4%), genital discharge (6.8%), breast problems (including breast pain, belch, and enlargement) (six.3%), mood disorders (including depression and mood contradistinct) (5%), flatulence (iii.2%), nervousness (two.9%), and rash (two.6%).

Adverse Reactions Leading to Study Discontinuation: Over the three trials, between 11 to 21% of subjects discontinued the trial due to an agin reaction. The about common adverse reactions ( ≥ i%) leading to discontinuation were: metrorrhagia (6.9%), nausea/vomiting (5%), headache (4.one%), mood disorders (including low and mood contradistinct) (2.4%), premenstrual syndrome (1.7%), hypertension (i.iv%), breast pain (i.4%), nervousness (ane.3%), amenorrhea (ane.1%), dysmenorrhea (1.i%), weight increased (1.i%), and flatulence (1.1%).

Serious Adverse Reactions: breast cancer (1 subject), mood disorders including depression, irritability, and mood swings (1 subject area), myocardial infarction (1 subject), and venous thromboembolic events including pulmonary embolism (i subject) and deep vein thrombosis (DVT) (1 bailiwick).

Postmarketing Feel

The post-obit additional adverse drug reactions have been reported from worldwide postmarketing experience with norgestimate/ethinyl estradiol. Considering these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or institute a causal relationship to drug exposure.

Infections and Infestations: Urinary tract infection;

Neoplasms Benign, Cancerous and Unspecified (Incl. Cysts and Polyps): Breast cancer, benign breast neoplasm, hepatic adenoma, focal nodular hyperplasia, chest cyst;

Immune System Disorders: Hypersensitivity;

Metabolism and Nutrition Disorders: Dyslipidemia;

Psychiatric Disorders: Feet, indisposition;

Nervous Organisation Disorders: Syncope, convulsion, paresthesia, dizziness;

Eye Disorders: Visual impairment, dry eye, contact lens intolerance;

Ear and Labyrinth Disorders: Vertigo;

Cardiac Disorders: Tachycardia, palpitations;

Vascular Events: Deep vein thrombosis, pulmonary embolism, retinal vascular thrombosis, hot flush;

Arterial Events: Arterial thromboembolism, myocardial infarction, cerebrovascular blow;

Respiratory, Thoracic and Mediastinal Disorders: Dyspnea;

Gastrointestinal Disorders: Pancreatitis, abdominal distension, diarrhea, constipation;

Hepatobiliary Disorders: Hepatitis;

Skin and Subcutaneous Tissue Disorders: Angioedema, erythema nodosum, hirsutism, dark sweats, hyperhidrosis, photosensitivity reaction, urticaria, pruritus, acne;

Musculoskeletal, Connective Tissue, and Bone Disorders: Muscle spasms, hurting in extremity, myalgia, dorsum pain;

Reproductive System and Chest Disorders: Ovarian cyst, suppressed lactation, vulvovaginal dryness;

General Disorders and Assistants Site Conditions: Chest pain, asthenic weather.

DRUG INTERACTIONS

Consult the labeling of concurrently used drugs to obtain further data about interactions with hormonal contraceptives or the potential for enzyme alterations.

No drug-drug interaction studies were conducted with Sprintec.

Furnishings Of Other Drugs On Combined Oral Contraceptives

Substances Decreasing The Plasma Concentrations Of COCs

Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of COCs and potentially diminish the effectiveness of COCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John'south wort. Interactions between hormonal contraceptives and other drugs may lead to quantum bleeding and/or contraceptive failure. Counsel women to use an alternative method of contraception or a back-up method when enzyme inducers are used with COCs, and to go on redundancy contraception for 28 days afterwards discontinuing the enzyme inducer to ensure contraceptive reliability.

Colesevelam: Colesevelam, a bile acid sequestrant, given together with a COC, has been shown to significantly subtract the AUC of EE. The drug interaction between the contraceptive and colesevelam was decreased when the two drug products were given 4 hours autonomously.

Substances Increasing The Plasma Concentrations Of COCs

Co-assistants of atorvastatin or rosuvastatin and sure COCs containing ethinyl estradiol (EE) increase AUC values for EE past approximately 20 to 25%. Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation. CYP3A4 inhibitors such equally itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma hormone concentrations.

Human Immunodeficiency Virus (HIV)/Hepatitis C Virus (HCV) Protease Inhibitors And Non-nucleoside Reverse Transcriptase Inhibitors

Significant changes (increment or decrease) in the plasma concentrations of estrogen and/or progestin accept been noted in some cases of co-assistants with HIV protease inhibitors (decrease [e.thou., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir] or increase [e.g., indinavir and atazanavir/ritonavir])/HCV protease inhibitors (decrease [east.g., boceprevir and telaprevir]) or with non-nucleoside contrary transcriptase inhibitors (decrease [e.g., nevirapine] or increment [e.grand., etravirine]).

Effects Of Combined Oral Contraceptives On Other Drugs

• COCs containing EE may inhibit the metabolism of other compounds (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) and increment their plasma concentrations.
• COCs have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, temazepam and lamotrigine. Significant subtract in plasma concentration of lamotrigine has been shown, likely due to induction of lamotrigine glucuronidation. This may reduce seizure command; therefore, dosage adjustments of lamotrigine may be necessary. Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone considering the serum concentration of thyroid-binding globulin increases with employ of COCs.

Interference With Laboratory Tests

The use of contraceptive steroids may influence the results of certain laboratory tests, such equally coagulation factors, lipids, glucose tolerance, and bounden proteins.

WARNINGS

Included as function of the PRECAUTIONS department.

PRECAUTIONS

Thromboembolic Disorders And Other Vascular Problems

• Stop Sprintec if an arterial thrombotic event or venous thromboembolic (VTE) upshot occurs.
• Stop Sprintec if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately [see Adverse REACTIONS].
• If feasible, stop Sprintec at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to accept an elevated risk of VTE as well as during and following prolonged immobilization.
• Commencement Sprintec no before than iv weeks after delivery, in women who are not breastfeeding. The chance of postpartum VTE decreases after the tertiary postpartum week, whereas the risk of ovulation increases subsequently the third postpartum week.
• The employ of COCs increases the take a chance of VTE. However, pregnancy increases the take a chance of VTE every bit much or more than the use of COCs. The chance of VTE in women using COCs is 3 to 9 cases per 10,000 woman-years. The risk of VTE is highest during the first year of utilize of COCs and when restarting hormonal contraception after a break of 4 weeks or longer. The take a chance of thromboembolic illness due to COCs gradually disappears after utilize is discontinued.
• Use of COCs also increases the adventure of arterial thromboses such as strokes and myocardial infarctions, specially in women with other hazard factors for these events. COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes). This risk increases with age, specially in women over 35 years of historic period who smoke.
• Use COCs with caution in women with cardiovascular disease run a risk factors.

Liver Disease

Impaired Liver Function

Do not utilise Sprintec in women with liver disease, such equally acute viral hepatitis or astringent (decompensated) cirrhosis of liver [see CONTRAINDICATIONS]. Acute or chronic disturbances of liver office may necessitate the discontinuation of COC utilize until markers of liver function render to normal and COC causation has been excluded. Discontinue Sprintec if jaundice develops.

Liver Tumors

Sprintec is contraindicated in women with beneficial and malignant liver tumors [see CONTRAINDICATIONS]. Hepatic adenomas are associated with COC employ. An estimate of the owing take chances is iii.3 cases/100,000 COC users. Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage.

Studies accept shown an increased take chances of developing hepatocellular carcinoma in long-term ( > 8 years) COC users. However, the adventure of liver cancers in COC users is less than 1 instance per million users.

High Blood Pressure

Sprintec is contraindicated in women with uncontrolled hypertension or hypertension with vascular disease [meet CONTRAINDICATIONS]. For women with well-controlled hypertension, monitor blood pressure and finish Sprintec if blood force per unit area rises significantly.

An increase in blood force per unit area has been reported in women taking COCs, and this increase is more than likely in older women with extended duration of use. The incidence of hypertension increases with increasing concentrations of progestin.

Gallbladder Disease

Studies advise a pocket-size increased relative risk of developing gallbladder illness among COC users. Use of COCs may worsen existing gallbladder affliction. A past history of COC-related cholestasis predicts an increased risk with subsequent COC use. Women with a history of pregnancy-related cholestasis may be at an increased chance for COC related cholestasis.

Sugar And Lipid Metabolic Effects

Advisedly monitor prediabetic and diabetic women who take Sprintec. COCs may subtract glucose tolerance.

Consider alternative contraception for women with uncontrolled dyslipidemia. A small proportion of women will take adverse lipid changes while on COCs.

Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs.

Headache

If a woman taking Sprintec develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue Sprintec if indicated.

Consider discontinuation of Sprintec in the case of increased frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular upshot).

Haemorrhage Irregularities And Amenorrhea

Unscheduled Haemorrhage And Spotting

Unscheduled (breakthrough or intracyclic) bleeding and spotting sometimes occur in patients on COCs, especially during the first 3 months of use. If bleeding persists or occurs after previously regular cycles, check for causes such as pregnancy or malignancy. If pathology and pregnancy are excluded, haemorrhage irregularities may resolve over time or with a modify to a dissimilar contraceptive product.

In clinical trials of norgestimate and ethinyl estradiol, the frequency and duration of breakthrough bleeding and/or spotting was assessed in 1,647 patients (21,275 evaluable cycles). A total of 100 (7.5%) women discontinued norgestimate and ethinyl estradiol, at to the lowest degree in part, due to bleeding or spotting. Based on data from the clinical trials, 14 to 34% of women using norgestimate and ethinyl estradiol experienced unscheduled bleeding per cycle in the first yr. The per centum of women who experienced breakthrough/unscheduled haemorrhage tended to decrease over time.

Amenorrhea And Oligomenorrhea

Women who utilise Sprintec may experience amenorrhea. Some women may experience amenorrhea or oligomenorrhea afterward discontinuation of COCs, especially when such a condition was pre-real.

If scheduled (withdrawal) bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or more active tablets or started taking them on a day later on than she should take), consider the possibility of pregnancy at the time of the starting time missed menstruation and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses 2 consecutive periods, rule out pregnancy.

COC Apply Earlier Or During Early Pregnancy

Extensive epidemiological studies accept revealed no increased risk of nativity defects in women who have used oral contraceptives prior to pregnancy. Studies also do not suggest a teratogenic issue, especially in so far as cardiac anomalies and limb reduction defects are concerned, when oral contraceptives are taken inadvertently during early pregnancy. Discontinue Sprintec use if pregnancy is confirmed.

Administration of COCs to induce withdrawal haemorrhage should not be used as a test for pregnancy [see Utilise in Specific Populations].

Depression

Carefully discover women with a history of low and discontinue Sprintec if depression recurs to a serious caste.

Carcinoma Of Chest And Cervix

• Sprintec is contraindicated in women who currently have or accept had breast cancer considering breast cancer may be hormonally sensitive [encounter CONTRAINDICATIONS].
  At that place is substantial evidence that COCs practise not increase the incidence of breast cancer. Although some past studies accept suggested that COCs might increase the incidence of chest cancer, more recent studies have not confirmed such findings.
• Some studies advise that COC use has been associated with an increment in the risk of cervical cancer or intraepithelial neoplasia. However, there continues to be controversy most the extent to which such findings may be due to differences in sexual behavior and other factors.

Issue On Binding Globulins

The estrogen component of COCs may raise the serum concentrations of thyroxine-bounden globulin, sex hormone-binding globulin, and cortisol-binding globulin. The dose of replacement thyroid hormone or cortisol therapy may demand to exist increased.

Monitoring

A woman who is taking COCs should have a yearly visit with her healthcare provider for a blood pressure bank check and for other indicated healthcare.

Hereditary Angioedema

In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema.

Chloasma

Chloasma may occasionally occur, peculiarly in women with a history of chloasma gravidarum. Women with a trend to chloasma should avert exposure to the sun or ultraviolet radiation while taking Sprintec.

Patient Counseling Data

See FDA-approved patient labeling (PATIENT Data and Instructions for Use).

Counsel patients about the post-obit information:

• Cigarette smoking increases the risk of serious cardiovascular events from COC employ, and that women who are over 35 years sometime and fume should not apply COCs [meet BOXED WARNING].
• Increased gamble of VTE compared to non-users of COCs is greatest after initially starting a COC or restarting (following a four-week or greater pill-free interval) the same or a different COC [see WARNINGS AND PRECAUTIONS].
• Sprintec does not protect confronting HIV infection (AIDS) and other sexually transmitted infections.
• Sprintec is not to be used during pregnancy; if pregnancy occurs during use of Sprintec instruct the patient to stop further employ [see WARNINGS AND PRECAUTIONS].
• Have 1 tablet daily by oral fissure at the aforementioned time every day. Instruct patients what to practice in the issue tablets are missed [see DOSAGE AND ADMINISTRATION].
• Use a back-upwards or culling method of contraception when enzyme inducers are used with Sprintec [run into DRUG INTERACTIONS].
• COCs may reduce breast milk product; this is less likely to occur if breastfeeding is well established [meet Employ in Specific Populations].
• Women who start COCs postpartum, and who accept non however had a period, should employ an additional method of contraception until they have taken an active tablet for 7 consecutive days [see DOSAGE AND ADMINISTRATION].
• Amenorrhea may occur. Consider pregnancy in the effect of amenorrhea at the time of the first missed flow. Rule out pregnancy in the event of amenorrhea in ii or more than consecutive cycles [come across WARNINGS AND PRECAUTIONS ].

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Damage Of Fertility

[See WARNINGS AND PRECAUTIONS and Use in Specific Populations]

Use In Specific Populations

Pregnancy

There is little or no increased hazard of birth defects in women who inadvertently utilise COCs during early pregnancy. Epidemiologic studies and meta-analyses have non found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb reduction defects) post-obit exposure to low dose COCs prior to formulation or during early pregnancy.

Practise not administrate COCs to induce withdrawal bleeding as a test for pregnancy. Practise not utilise COCs during pregnancy to treat threatened or habitual abortion.

Nursing Mothers

Advise the nursing mother to employ other forms of contraception, when possible, until she has weaned her child. COCs can reduce milk production in breastfeeding mothers. This is less likely to occur in one case breastfeeding is well-established; nevertheless, it can occur at any fourth dimension in some women. Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk.

Pediatric Utilise

Safety and efficacy of Sprintec Tablets take been established in women of reproductive age. Efficacy is expected to be the same for postpubertal adolescents nether the age of xviii and for users 18 years and older. Use of this product earlier menarche is non indicated.

Geriatric Utilize

Sprintec has not been studied in postmenopausal women and are non indicated in this population.

Hepatic Impairment

The pharmacokinetics of Sprintec have not been studied in subjects with hepatic harm. Nonetheless, steroid hormones may be poorly metabolized in patients with hepatic impairment. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC utilise until markers of liver function return to normal and COC causation has been excluded. [See CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS]

Renal Damage

The pharmacokinetics of Sprintec have not been studied in women with renal impairment.

Overdosage & Contraindications

OVERDOSE

At that place have been no reports of serious sick effects from overdosage of oral contraceptives, including ingestion past children. Overdosage may crusade withdrawal bleeding in females and nausea.

CONTRAINDICATIONS

Do not prescribe Sprintec to women who are known to take the post-obit conditions:

• A high chance of arterial or venous thrombotic diseases. Examples include women who are known to:
  • Smoke, if over age 35 [run across BOXED WARNING and WARNINGS AND PRECAUTIONS]
  • Take deep vein thrombosis or pulmonary embolism, now or in the past [see WARNINGS AND PRECAUTIONS]
  • Accept inherited or caused hypercoagulopathies [see WARNINGS AND PRECAUTIONS]
  • Take cerebrovascular disease [see WARNINGS AND PRECAUTIONS]
  • Have coronary artery disease [see WARNINGS AND PRECAUTIONS]
  • Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for case, subacute bacterial endocarditis with valvular affliction, or atrial fibrillation) [see WARNINGS AND PRECAUTIONS]
  • Have uncontrolled hypertension [see WARNINGS AND PRECAUTIONS]
  • Have diabetes mellitus with vascular illness [run across WARNINGS AND PRECAUTIONS]
  • Take headaches with focal neurological symptoms or migraine headaches with aureola [see WARNINGS AND PRECAUTIONS]
    • Women over age 35 with any migraine headaches [come across WARNINGS AND PRECAUTIONS]
• Liver tumors, benign or malignant, or liver disease [see WARNINGS AND PRECAUTIONS]
• Undiagnosed abnormal uterine bleeding [encounter WARNINGS AND PRECAUTIONS]
• Pregnancy, because there is no reason to use COCs during pregnancy [see WARNINGS AND PRECAUTIONS and Utilise in Specific Populations]
• Breast cancer or other estrogen-or progestin-sensitive cancer, now or in the by [come across WARNINGS AND PRECAUTIONS]

CLINICAL PHARMACOLOGY

Machinery Of Action

• Oral Contraception
  COCs lower the hazard of becoming meaning primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.
• Acne
  Acne is a peel condition with a multifactorial etiology, including androgen stimulation of sebum production. While the combination of ethinyl estradiol and norgestimate increases sexual practice hormone-bounden globulin (SHBG) and decreases costless testosterone, the human relationship between these changes and a decrease in the severity of facial acne in otherwise healthy women with this pare condition has not been established.

Pharmacodynamics

No specific pharmacodynamic studies were conducted with Sprintec.

Pharmacokinetics

Absorption

Norgestimate (NGM) and EE are rapidly absorbed following oral administration. NGM is rapidly and completely metabolized by get-go laissez passer (intestinal and/or hepatic) mechanisms to norelgestromin (NGMN) and norgestrel (NG), which are the major active metabolites of norgestimate.

Peak serum concentrations of NGMN and EE are by and large reached by 2 hours afterwards administration of Sprintec. Accumulation following multiple dosing of the 250 mcg NGM / 35 mcg EE dose is approximately 2-fold for NGMN and EE compared with unmarried dose assistants. The pharmacokinetics of NGMN is dose-proportional following NGM doses of 180 mcg to 250 mcg. Steady-state concentration of EE is accomplished by Twenty-four hour period 7 of each dosing bike. Steady-state concentrations of NGMN and NG are achieved past Day 21. Non-linear aggregating (approximately 8 fold) of NG is observed as a result of high-analogousness bounden to SHBG, which limits its biological activity (Table 3).

Table iii: Summary of NGMN, NG and EE pharmacokinetic parameters.

Mean (SD) Pharmacokinetic Parameters of Sprintec During a Three					Cyc le Report
Analyte	Cycle	Day	Cmax	tmax (h)	AUC0-24h	t:½ (h)
NGMN	1	1	1.78 (0.397)	1.19 (0.25)	ix.9 (three.25)	18.four (5.91)
	3	21	2.19 (0.655)	1.43 (0.68)	eighteen.1 (5.53)	24.9 (9.04)
NG	ane	1	0.649 (0.49)	1.42 (0.69)	half dozen.22 (2.46)	37.eight (fourteen)
	3	21	2.65 (i.eleven)	1.67 (1.32)	48.two (20.five)	45 (xx.4)
EE	1	1	92.2 (24.5)	i.2 (0.26)	629 (138)	10.i (1.90)
	3	21	147 (41.5)	1.xiii (0.23)	1210 (294)	15 (two.36)
Cmax = peak serum concentration, tmax = fourth dimension to accomplish peak serum concentration, AUC0-24 = area under serum concentration vs time bend from 0 to 24 hours, t½ = elimination one-half-life, NC = not calculated. NGMN and NG: Cmax = ng/mL, AUC0-24 = h•ng/mL EE: Cmax = pg/mL, AUC0-24 = h•pg/mL

Nutrient Effect

The effect of nutrient on the pharmacokinetics of Sprintec has not been studied.

Distribution

NGMN and NG are highly bound ( > 97%) to serum proteins. NGMN is bound to albumin and non to SHBG, while NG is bound primarily to SHBG. EE is extensively bound ( > 97%) to serum albumin and induces an increase in the serum concentrations of SHBG.

Metabolism

NGM is extensively metabolized past first-pass mechanisms in the gastrointestinal tract and/or liver. NGM'due south master agile metabolite is NGMN. Subsequent hepatic metabolism of NGMN occurs and metabolites include NG, which is also active, and various hydroxylated and conjugated metabolites. Although NGMN and its metabolites inhibit a variety of P450 enzymes in human liver microsomes, under the recommended dosing regimen, the in vivo concentrations of NGMN and its metabolites, even at the summit serum levels, are relatively depression compared to the inhibitory abiding (Grand ). EE is too metabolized to various hydroxylated products and their glucuronide and sulfate conjugates.

Excretion

The metabolites of NGMN and EE are eliminated by renal and fecal pathways. Following assistants of ^xivC-norgestimate, 47% (45 to 49%) and 37% (16 to 49%) of the administered radioactive decay was eliminated in the urine and carrion, respectively. Unchanged NGM was not detected in the urine. In addition to 17-deacetyl norgestimate, a number of metabolites of NGM have been identified in human urine following administration of radiolabeled NGM. These include 18, nineteen-Dinor-17-pregn-iv-en-twenty- yn-3-one,17-hydroxy-thirteen-ethyl,(17α)-(-);18,nineteen-Dinor-5&bata;17-pregnan-20-yn,3α,17&bata;-dihydroxy-xiii- ethyl,(17α), various hydroxylated metabolites and conjugates of these metabolites.

Clinical Studies

Contraception

In iii U.s. clinical trials with norgestimate and ethinyl estradiol, 1,651 women anile eighteen to 38 years were studied for up to 24 cycles, proving a full of 24,272 cycles of exposure. The racial demographic was about 73 to 86% Caucasian, 8 to xiii% African-American, half-dozen to 14% Hispanic with the remainder Asian or Other ( ≤ 1%). At that place were no exclusions on the footing of weight; the weight range for women treated was 82 to 303 lbs, with a mean weight of about 135 lbs. The pregnancy rate was approximately one pregnancy per 100 women-years.

PATIENT INFORMATION

Sprintec®
[sprin-tek]
(norgestimate and ethinyl estradiol tablets )

What is the most important information I should know about Sprintec?

Do not use Sprintec if you lot smoke cigarettes and are over 35 years erstwhile. Smoking increases your run a risk of serious cardiovascular side effects from hormonal birth control pills, including death from heart set on, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.

What is Sprintec?

Sprintec is a birth control pill (oral contraceptive) used by women to prevent pregnancy.

How does Sprintec work for contraception?

Your take chances of getting pregnant depends on how well you follow the directions for taking your birth control pills. The better you follow the directions, the less hazard you take of getting pregnant.

Based on the results of clinical studies, about one out of 100 women may get pregnant during the first year they use Sprintec.

The following chart shows the chance of getting pregnant for women who apply dissimilar methods of nascence control. Each box on the chart contains a list of nativity control methods that are similar in effectiveness. The about effective methods are at the top of the nautical chart. The box on the bottom of the nautical chart shows the chance of getting significant for women who do not use nascence control and are trying to get pregnant.

Who should not accept Sprintec?

Exercise non take Sprintec if you lot:

• smoke and are over 35 years of historic period
• had blood clots in your arms, legs, lungs, or eyes
• had a problem with your blood that makes it jell more than normal
• have sure middle valve bug or irregular heart crush that increases your risk of having claret clots
• had a stroke
• had a center assail
• have loftier blood pressure that cannot be controlled by medicine
• have diabetes with kidney, eye, nervus, or claret vessel damage
• have certain kinds of severe migraine headaches with aureola, numbness, weakness or changes in vision, or any migraine headaches if you are over 35 years of age
• have liver problems, including liver tumors
• take any unexplained vaginal bleeding
• are pregnant
• had breast cancer or whatever cancer that is sensitive to female person hormones

If any of these weather condition happen while you are taking Sprintec, stop taking Sprintec correct away and talk to your healthcare provider. Apply non-hormonal contraception when you stop taking Sprintec.

What should I tell my healthcare provider before taking Sprintec?

Tell your healthcare provider if you:

• are pregnant or think you may be pregnant
• are depressed now or take been depressed in the past
• had yellowing of your skin or eyes (jaundice) caused by pregnancy (cholestasis of pregnancy)
• are breastfeeding or program to breastfeed. Sprintec may decrease the amount of breast milk you lot make. A small amount of the hormones in Sprintec may pass into your chest milk. Talk to your healthcare provider about the best birth control method for you while breastfeeding.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Sprintec may touch the manner other medicines work, and other medicines may affect how well Sprintec works.

Know the medicines y'all take. Continue a list of them to bear witness your healthcare provider and pharmacist when you get a new medicine.

How should I take Sprintec?

Read the Instructions for Use at the end of this Patient Data.

What are the possible serious side effects of Sprintec?

• Like pregnancy, Sprintec may cause serious side effects, including claret clots in your lungs, centre attack, or a stroke that may lead to death. Some other examples of serious blood clots include blood clots in the legs or optics.

Serious blood clots can happen especially if you smoke, are obese, or are older than 35 years of age. Serious claret clots are more than likely to happen when y'all:

• offset start taking birth control pills
• restart the aforementioned or different nativity control pills afterwards non using them for a month or more than

Call your healthcare provider or go to a hospital emergency room right away if yous take:

• leg pain that volition non go away
• a sudden, astringent headache unlike your usual headaches
• sudden astringent shortness of breath
• weakness or numbness in your arm or leg
• sudden alter in vision or blindness
• problem speaking
• chest pain

Other serious side furnishings include:

• liver bug, including:
  • rare liver tumors
  • jaundice (cholestasis), especially if yous previously had cholestasis of pregnancy. Phone call your healthcare provider if y'all have yellowing of your skin or optics.
• high claret pres sure. You lot should run across your healthcare provider for a yearly cheque of your claret force per unit area.
• gallbladder bug
• changes in the carbohydrate and fat (cholesterol and triglycerides ) levels in your blood
• new or worsening headaches including migraine headaches
• irregular or unusual vaginal bleeding and spotting between your menstrual periods, especially during the first 3 months of taking Sprintec.
• low
• possible cancer in your breast and neck
• swelling of your skin peculiarly around your mouth, eyes, and in your throat (angioedema). Call your healthcare provider if you take a bloated confront, lips, mouth tongue or pharynx, which may lead to difficulty swallowing or breathing. Your chance of having angioedema is higher is you have a history of angioedema.
• nighttime patches of skin around your forehead, olfactory organ, cheeks and around your mouth, especially during pregnancy (chloasma). Women who tend to get chloasma should avert spending a long fourth dimension in sunlight, tanning booths, and nether sunday lamps while taking Sprintec. Utilize sunscreen if you accept to be in the sunlight.
  What are the most common side furnishings of Sprintec?
• headache (migraine)
• breast hurting or tenderness, enlargement or discharge
• stomach pain, discomfort, and
• gas
• vaginal infections and discharge
• mood changes, including depression
• nervousness
• changes in weight
• skin rash
  These are not all the possible side effects of Sprintec. For more information, ask your healthcare provider or pharmacist.
  Y'all may study side furnishings to the FDA at one-800-FDA-1088.
  What else should I know nearly taking Sprintec?
  • If y'all are scheduled for whatever lab tests, tell your healthcare provider you are taking Sprintec. Certain claret tests may be affected past Sprintec.
  • Sprintec does not protect against HIV infection (AIDS) and other sexually transmitted infections.

How should I store Sprintec?

• Store at 20° to 25°C (68° to 77°F).
• Proceed Sprintec and all medicines out of the reach of children.
• Shop abroad from calorie-free.

Full general information about the safe and constructive us east of Sprintec.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Sprintec for a condition for which information technology was non prescribed. Do non give Sprintec to other people, fifty-fifty if they have the aforementioned symptoms that you have. This Patient Information summarizes the most important data about Sprintec. You can ask your pharmacist or healthcare provider for information about Sprintec that is written for health professionals.

For more data, call 1-888-838-2872.

Practise birth control pills cause cancer?

Nascence command pills practice non seem to cause breast cancer. Still, if you have breast cancer now, or have had it in the by, do non use birth control pills because some breast cancers are sensitive to hormones.

Women who utilize birth control pills may have a slightly higher gamble of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners.

What if I want to get meaning?

You may finish taking the pill whenever you wish. Consider a visit with your healthcare provider for a pre-pregnancy checkup before y'all stop taking the pill.

What should I know about my flow when taking Sprintec?

Your periods may be lighter and shorter than usual. Some women may miss a period. Irregular vaginal bleeding or spotting may happen while you are taking Sprintec, peculiarly during the get-go few months of apply. This unremarkably is non a serious trouble. Information technology is of import to continue taking your pills on a regular schedule to prevent a pregnancy.

What are the ingredients in Sprintec?

Agile ingredients : Each blue pill contains norgestimate and ethinyl estradiol.

Inactive ingredients :

Blue pills: anhydrous lactose, FD&C blueish no. 2 aluminum lake, lactose monohydrate, magnesium stearate, and pregelatinized corn starch.

White pills: anhydrous lactose, hydroxypropyl methylcellulose 2208, magnesium stearate, and microcrystalline cellulose.

Instructions For Use

Sprintec®
[s prin-tek]
(norgestimate and ethinyl estradiol tablets )

Important Data well-nigh taking Sprintec

• Have 1 pill every day at the same time. Take the pills in the order directed on your tablet dispenser.
• Do non skip your pills, even if you practise not accept sex often. If you miss pills (including starting the pack late) yous could get pregnant. The more than pills yous miss, the more than probable you lot are to get pregnant.
• If you accept trouble remembering to accept Sprintec, talk to your healthcare provider. When you first get-go taking Sprintec, spotting or lite bleeding in betwixt your periods may occur. Contact your healthcare provider if this does not go away after a few months.
• You may feel sick to your stomach (nauseous), particularly during the first few months of taking Sprintec. If you feel sick to your stomach, do not finish taking the pill. The problem will ordinarily go away. If your nausea does not go away, phone call your healthcare provider.
• Missing pills can likewise crusade spotting or light haemorrhage, even when you take the missed pills after. On the days you take 2 pills to make up for missed pills (see What should I practice if I miss any Sprintec pills ? beneath), you could also feel a petty ill to your breadbasket.
• Information technology is not uncommon to miss a catamenia. Nevertheless, if yous miss a catamenia and take not taken Sprintec according to directions, or miss 2 periods in a row, or feel like y'all may be meaning, phone call your healthcare provider. If you accept a positive pregnancy test, y'all should end taking Sprintec.
• If you have vomiting or diarrhea inside iii to 4 hours of taking your pill, take another pill of the same color from your extra tablet dispenser. If you do non have an extra tablet dispenser, take the next pill in your tablet dispenser. Proceed taking all your remaining pills in order. Start the first pill of your next tablet dispenser the day after finishing your current tablet dispenser. This will be one day before than originally scheduled. Continue on your new schedule.
• If you take vomiting or diarrhea for more than 1 day, your birth control pills may not work too. Use an additional nativity command method, like condoms and a spermicide, until you check with your healthcare provider.
• Stop taking Sprintec at least 4 weeks before you have major surgery and do not restart after the surgery without asking your healthcare provider. Be certain to utilize other forms of contraception (like condoms and spermicide) during this fourth dimension period.

Before you start taking Sprintec:

• Determine what fourth dimension of day you desire to accept your pill. Information technology is important to take it at the same time every day and in the order as directed on your tablet dispenser.
• Have backup contraception (condoms and spermicide) available and if possible, an extra full pack of pills as needed.

When should I start taking Sprintec?

If you s tart taking Sprintec and y'all accept not united states of america ed a hormonal nativity control method before:

• There are 2 ways to first taking your birth control pills. Yous tin either start on a Sunday (Sunday Start) or on the commencement day (Twenty-four hours 1) of your natural menstrual menstruum (Day ane Start). Your healthcare provider should tell you lot when to offset taking your birth control pill.
• If yous use the Sunday Start, utilize non-hormonal back-up contraception such equally condoms and spermicide for the first 7 days that you take Sprintec. You exercise not demand dorsum-upward contraception if you use the Day 1 Showtime.

If yous start taking Sprintec and yous are switching from another nascency control pill:

• Start your new Sprintec pack on the same day that you would start the adjacent pack of your previous nascence command method.
• Do not continue taking the pills from your previous birth control pack.

If you first taking Sprintec and previously used a vaginal band or trans dermal patch:

• Start using Sprintec on the twenty-four hours you would have reapplied the next ring or patch.

If y'all first taking Sprintec and you lot are switching from a progestin-simply method such as an implant or injection:

• Starting time taking Sprintec on the 24-hour interval of removal of your implant or on the mean solar day when you lot would have had your side by side injection.

If you commencement taking Sprintec and you are switching from an intrauterine device or system (IUD or IUS):

• First taking Sprintec on the day of removal of your IUD or IUS.
• You lot do not need redundancy contraception if your IUD or IUS is removed on the first day (Day 1) of your menstruum. If your IUD or IUS is removed on any other mean solar day, use not-hormonal back-up contraception such as condoms and spermicide for the outset seven days that yous take Sprintec.

Keep a calendar to rails your flow:

If this is the first time y'all are taking nascency control pills, read, "When should I start taking Sprintec?"above.

Follow these instructions for either a Sunday Start or a Day one Start.

Lord's day Offset:

Y'all will apply a Sunday Start if your healthcare provider told you to take your first pill on a Sunday.

• Accept pill one on the Lord's day after your period starts.
• If your menstruation starts on a Sunday, take pill "1" that twenty-four hour period and refer to Day 1 Offset instructions below.
• Take 1 pill every day in the order on the pill dispenser at the aforementioned time each day for 28 days.
• After taking the last pill on Day 28 from the tablet dispenser, start taking the outset pill from a new pack, on the same day of the calendar week as the beginning pack (Sunday). Take the starting time pill in the new pack whether or not you are having your menses.
• Use non-hormonal redundancy contraception such as condoms and spermicide for the first seven days of the first cycle that you take Sprintec.

Day i First:

You volition use a Day one Showtime if your doc told you lot to take your get-go pill (Twenty-four hour period ane) on the first day of your period.

• Have one pill every twenty-four hour period in the lodge of the cicatrice pack tablet dispenser, at the same fourth dimension each solar day, for 28 days.
• Afterward taking the final pill on Day 28 from the tablet dispenser, outset taking the starting time pill from a new pack, on the same twenty-four hours of the calendar week equally the first pack. Take the first pill in the new pack whether or not you lot are having your period.

Sprintec comes in a blister pack tablet dispenser.

There are ii ways to start taking nascence-command pills, Sun Start or Day 1 Showtime. Your healthcare professional volition tell you which to apply.

How to Apply Blister Cards for the 28 Tablets

1. Pick the Days of the Week Sticker that starts the first twenty-four hours of your flow. (This is the day y'all begin bleeding or spotting, fifty-fifty if it is midnight when haemorrhage begins.) When you have picked the right sticker, throw away the others and place the sticker on the cicatrice bill of fare over the preprinted days of the week and make sure it lines up with the pills.
2. Your blister packet consists of iii parts, the foil pouch, wallet, and a cicatrice pack containing 28 individually sealed pills. Note that the pills are arranged in 4 numbered rows of 7 pills, with the pre-printed days of the week printed above them. All 21 blue pills are "agile" birth-control pills, and vii white "reminder" pills. Refer to the sample of the blister card beneath:



3. Subsequently taking the concluding white pill, first a new blister card the very next twenty-four hour period no matter when your period started. You volition exist taking a pill every twenty-four hour period without break. Any fourth dimension you starting time the pills later on than directed, protect yourself past using another method of birth control until you have taken a pill a day for 7 consecutive days. Later on taking the last white pill, commencement taking the outset blue pill from the blister card the very adjacent 24-hour interval.
4. Have the pills in each new parcel as before. Start with the blue pill on row #one and have one pill each day, left to right, until the concluding white pill has been taken.

Three Ways to Remember in What Society to Take the Pills

1. Follow the sticker with the days of the week (placed above the pills).
2. E'er go from left to right.
3. Always finish all your blue pills

What should I practice if I miss any Sprintec pills ?

If yous miss ane pill in Weeks i, two, or 3, follow these steps:

• Take it equally soon as you remember. Take the side by side pill at your regular fourth dimension. This means you may take two pills in ane twenty-four hours.
• So continue taking 1 pill every day until you lot stop the pack.
• Y'all exercise not need to utilize a back-up nativity command method if you have sex.

If you miss 2 pills in Week 1 or Week two of your pack, follow these steps :

• Have the 2 missed pills as soon as possible and the next 2 pills the next twenty-four hours.
• So go on to take one pill every solar day until y'all finish the pack.
• Employ a not-hormonal birth control method (such as a rubber and spermicide) as a back-upwardly if you have sex during the first 7 days afterward missing your pills.

If you miss 2 pills in a row in Week iii, or you miss 3 or more pills in a row during Weeks 1, two, or three of the pack, follow these steps :

• If you lot are a Day 1 Starter:
  • Throw out the rest of the pill pack and start a new pack that aforementioned day.
  • You may non accept your period this calendar month but this is expected. However, if yous miss your menstruum 2 months in a row, call your healthcare provider because you lot might exist pregnant.
  • You could go pregnant if you accept sexual practice during the offset 7 days after you restart your pills. Yous MUST use a non-hormonal nascence control method (such as a safe and spermicide) as a back-up if y'all have sexual practice during the first 7 days later you restart your pills.
• If you are a Sunday Starter:
  • Keep taking 1 pill every day until Sun. On Sunday, throw out the rest of the pack and start a new pack of pills that aforementioned day.
  • Use a not-hormonal nativity control method (such as a prophylactic and spermicide) as a back-upwards if yous take sex during the first 7 days after you restart your pills.

If you take any questions or are unsure about the information in this leaflet, call your healthcare provider.

From

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Yous are encouraged to written report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call ane-800-FDA-1088.

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