Overview
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).
Mechanism of Action
CLINICAL PHARMACOLOGY Mechanism of Action Combined oral contraceptives (COCs) prevent pregnancy primarily by suppressing ovulation.
Indications
- 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.
Common Doses
- Refer to label
Dosage
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.
Black Box Warning
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs are contraindicated in women who are over 35 years of age and smoke [see Contraindications ] .
Contraindications
- 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...
Side Effects
- 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...
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.