Turqoz

INDICATIONS AND USAGE Turqoz is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15 to 40 years was approximately 1 pregnancy per 100 women-years of use.

DOSAGE AND ADMINISTRATION To achieve maximum contraceptive effectiveness, Turqoz (norgestrel and ethinyl estradiol tablets) must be taken exactly as directed and at intervals not exceeding 24 hours. The dosage of Turqoz is one white to off-white tablet daily for 21 consecutive days, followed by one orange inert tablet daily for 7 consecutive days, according to prescribed schedule. It is recommended that Turqoz tablets be taken by mouth at the same time each day. How to Start Turqoz Consider the possibility of ovulation and conception prior to initiation of medication. Instruct the patient to begin taking Turqoz on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (white to off-white) is taken that day. The patient should take one white to off-white tablet daily for 21 consecutive days followed by one orange inert tablet daily for 7 consecutive days. Withdrawal bleeding will usually occur within 3 days following discontinuation of white to off-white tablets and may not have finished before the next pack is started. During the first cycle, the patient should not rely on Turqoz for contraception until a white to off-white tablet has been taken daily for 7 consecutive days and she should use a non-hormonal back-up method of birth control during those 7 days. After the first cycle of use The patient is to begin her next and all subsequent 28-day courses of tablets on the same day of the week (Sunday) on which she began her first course, following the same schedule: 21 days of white to off-white tablets, followed by 7 days of orange inert tablets. If in any cycle the patient starts tablets later than the proper day, instruct her to protect herself against pregnancy by using a non-hormonal back-up method of birth control until she has taken a white to off-white tablet daily for 7 consecutive days. Switching from another hormonal method of contraception When the patient is switching from a 21-day regimen of tablets, instruct her to wait 7 days after her last tablet before she starts Turqoz. She will probably experience withdrawal bleeding during that week. Instruct her not to let more than 7 days pass after her previous 21-day regimen before she starts Turqoz. When the patient is switching from a 28-day regimen of tablets, instruct her to start her first pack of Turqoz on the day after her last tablet. She should not wait any days between packs. The patient may switch any day from a progestin-only pill and should begin Turqoz the next day. If switching from an implant or injection, instruct the patient to start Turqoz on the day of implant removal or the day the next injection would be due. If switching from a contraceptive vaginal ring or transdermal patch instruct the patient to start Turqoz on the day they would have inserted the next ring or applied the next patch. If switching from an Intrauterine Device (IUD) or Intrauterine System (IUS), instruct the patient to start Turqoz on the day of IUD/IUS removal. If the IUD/IUS is not removed on the first day of the patient's menstrual cycle, instruct her to use a non-hormonal back-up method of birth control for the first 7 days of tablet-taking. Use after pregnancy, abortion, or miscarriage Initiate Turqoz no earlier than day 28 postpartum in the nonlactating mother or after a second-trimester abortion due to the increased risk for thromboembolism (see Contraindications , Warnings , and Precautions concerning thromboembolic disease). Advise the patient to use a non-hormonal back-up method for the first 7 days of tablet-taking. Turqoz may be initiated immediately after a first-trimester abortion or miscarriage. If the patient starts Turqoz immediately, back-up contraception is not needed. If spotting or breakthrough bleeding occurs If spotting or breakthrough bleeding occurs, instruct the patient to continue on the same regimen. This type of bleeding is usually transient and without significance; however, advise the patient to consult …

CONTRAINDICATIONS Turqoz is contraindicated in females who are known to have or develop the following conditions: A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: Smoke, if over age 35 Have deep-vein thrombosis or pulmonary embolism, now or in the past Have inherited or acquired coagulopathies Have cerebrovascular disease Have coronary artery disease Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease or atrial fibrillation) Have uncontrolled hypertension Have diabetes mellitus with vascular disease Headaches with focal neurological symptoms or migraine headaches with aura Women over age 35 with any migraine headaches Liver tumors, benign or malignant, or liver disease Undiagnosed abnormal uterine bleeding Pregnancy, because there is no reason to use COCs during pregnancy Current diagnosis or history of breast cancer, which may be hormone sensitive Hypersensitivity to any of the components of Turqoz Women who are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see Warnings , Risk of liver enzyme elevations with concomitant hepatitis c treatment).

ADVERSE REACTIONS An increased risk of the following serious adverse reactions (see Warnings section for additional information) has been associated with the use of oral contraceptives: Serious cardiovascular events and stroke [see Boxed Warning ] Vascular events Liver disease Adverse reactions commonly reported by COC users are: Irregular uterine bleeding Nausea Breast tenderness Headache Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of Turqoz was evaluated in 1,343 healthy women of child-bearing potential who participated in 9 clinical trials and received at least one dose of Turqoz for contraception. Subjects were exposed for a total of 11,085 cycles, with 429 women completing one year of exposure. Subjects ranged in age from 15 to 40 years. Demographics were 69 % Caucasian, 28 % Black, and 3 % other. Common Adverse Reactions (≥ 2 % of women) Weight increase (11 %) Cervical erosion (9 %) Weight decrease (6 %) Acne (4 %) Dysmenorrhea (4 %) Vaginal discharge (4 %) Abdominal pain, cramps, and bloating (3 %) Appetite increase (3 %) Depression (3 %) Nervousness (3 %) Chloasma/melasma (2 %) Fatigue (2 %) Varicose veins, aggravation of (2 %) A total of 8% of subjects discontinued the trials prematurely due to an adverse reaction, most commonly due to unscheduled bleeding, spotting, headache (including migraine), nausea, acne, changes in menstrual flow, weight increase, nervousness, high blood pressure, and depression. Postmarketing Experience Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 to 1.12 (Figure 1). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 1). One of these studies reported no association between breast cancer risk and COC use. The other two studies found an increased relative risk of 1.19 to 1.33 with current or recent use. Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8 to 10 years of COC use. Figure 1: Relevant Studies of Risk of Breast Cancer with Combined Oral Contraceptives RR = relative risk; OR = odds ratio; HR = hazard ratio. "ever COC" are females with current or past COC use; "never COC use" are females that never used COCs. The following additional adverse drug reactions have been reported from worldwide postmarketing experience with Turqoz. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Arterial Events Arterial thromboembolism, Myocardial infarction, Cerebral hemorrhage Eye Disorder Optic neuritis, which may lead to partial or complete loss of vision, Intolerance to contact lenses, Change (steepening) in corneal curvature Gastrointestinal Disorders Colitis, Nausea, Pancreatitis Hepatobiliary Disorders Gallbladder disease, Cholestatic jaundice, Budd-Chiari syndrome Immune System Disorders Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms Metabolism and Nutrition Disorders Carbohydrate and lipid effects, Porphyria, exacerbation of Porphyria Neoplasms, Benign, Malignant, and Unspecified Carcinoma of the reproductive organs and breasts, Hepatic neoplasia (including hepatic adenomas or benign liver tumors) Psychiatric Disorders Mood changes Reproductive System and Breast Disorders Temp …

DESCRIPTION Turqoz TM is a combination oral contraceptive containing the progestational compound norgestrel and the estrogenic compound ethinyl estradiol. Norgestrel is designated as (17α)-(±)-13-ethyl-17-hydroxy-18, 19-dinorpregn-4-en-20-yn-3-one and ethinyl estradiol is designated as (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Each white to off-white active Turqoz TM tablet contains 0.3 mg norgestrel and 0.03 mg ethinyl estradiol and inert ingredients lactose monohydrate, magnesium stearate and povidone. Each orange placebo tablet contains only inert ingredients: Inert ingredients: croscarmellose sodium, FD&C Yellow No. 6, lactose monohydrate, magnesium stearate and microcrystalline cellulose. Each pill pack contains 21 white to off-white active tablets and 7 orange inert tablets. image-1

OVERDOSAGE 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.

HOW SUPPLIED Turqoz (norgestrel and ethinyl estradiol tablets USP) 0.3 mg/0.03 mg are available in blister containing 28 tablets (NDC 68180-895-11) packed in a pouch (NDC 68180-895-11). The pouch will be further packed in a carton and available as below: One Pouch (NDC 68180-895-11) in a Carton (68180-895-12) Three Pouches (NDC 68180-895-11) in a Carton (68180-895-13) Six Pouches (NDC 68180-895-11) in a Carton (68180-895-14) Each blister (28 tablets) contains in the following order: 21 active, white to off-white, round shaped tablets, debossed with "LU" on one side and "Z41" on the other side. 7 inert, orange, round, bevel edge tablets, debossed with "LU" on one side and "T22" on the other side. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep this and all medications out of reach of children. Turqoz TM is a trademark of Lupin Pharmaceuticals, Inc. Distributed by: Lupin Pharmaceuticals, Inc. Naples, FL 34108 United States. Manufactured by: Lupin Limited Pithampur (M.P.) - 454 775 INDIA Revised: November 2024 trade mark