General Instructions/warnings:
Crisanta Tablet drug contains 3 mg of the progestin drospirenone that has anti mineralocorticoid activity, including the potential for hyperkalemia in the high-risk sufferer, comparable to a 25 mg dose of spironolactone. Fixed dose combination of drospirenone and ethinyl estradiol should not be used in patients with conditions that predispose to hyperkalemia.
Ladies getting day by day, long-haul treatment for constant conditions or sicknesses with meds that may expand serum potassium, ought to have their serum potassium level checked amid the main treatment cycle. Medications that may expand serum potassium incorporate ACE inhibitors, angiotensin || receptor rivals, potassium-saving diuretics, heparin, aldosterone adversaries, and NSAIDs.
The utilization of oral contraceptives is related with expanded dangers of a few dangerous conditions including dead myocardial tissue, thromboembolism, stroke, hepatic neoplasia, gallbladder ailment, and hypertension, even though the danger of severe bleakness or mortality is little in sound ladies without essential hazard factors.
Oral contraceptives may exacerbate the impacts of surely understood hazard factors, for example, hypertension, diabetes, hyperlipidemias, age, and weight and fundamentally increment the danger of horribleness and mortality within sight of these essential hazard factors.
Ladies with a past filled with melancholy ought to be precisely watched and the medication suspended if despondency repeats to an extreme degree.
When Not to Use
In the nonlactating mother, Crisanta Tablet medicine may be initiated four weeks postpartum, for contraception. When the pills are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered.
Pediatric use:
Safety and efficacy of this medication have been established in women of reproductive age. Safety and efficacy are expended to be the same for postpubertal adolescents under the age of 16 and users 16 yrs and older. Utilized of this product before menarche is not indicated.
Hepatic impairment:
this medicine is contraindicated in patients with hepatic dysfunction.
Renal impairment:
this drug is contraindicated in patients with renal insufficiency.
Warnings for special population
Pregnancy & Lactation
The fixed dose combination of drospirenone and ethinyl estradiol is not indicated during pregnancy.
During clinical studies out of the fourteen pregnancies that occurred with FDC of drospirenone and ethinyl estradiol exposure in utero, one infant was born with esophageal atresia. A causal association with FDC of drospirenone and ethinyl estradiol is unknown.
Epidemiological studies have revealed no increased possibility of birth defects in ladies who have used oral contraceptives before pregnancy. It is suggested that for any patient who has missed two consecutive periods, pregnancy should be ruled out.
The organization of oral contraceptives to incite withdrawal draining ought not to be utilized as a test for pregnancy. Oral contraceptive should not be used during pregnancy to treat threatened or habitual abortion.
The little amount of oral preventative steroids have been recognized in the drain of nursing moms, and a couple of antagonistic consequences for the tyke have been accounted for, including jaundice and bosom development. Also, oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk.
After oral administration of FDC of drospirenone and ethinyl estradiol, about 0.02% of the drospirenone dose was excreted into the mother milk of postpartum ladies within 24 hrs. This results in a daily dose of about three mcg drospirenone in an infant.
Contradiction
- Hypersensitivity to the active substances or any of the excipients of the formulation.
- Severe renal insufficiency or acute renal failure.
- Hepatic dysfunction
- Adrenal insufficiency
- Thrombophlebitis or thromboembolic disorders.
- A history of deep vein thrombophlebitis, pulmonary embolism or thromboembolic disorders.
- Cerebral vascular or coronary artery disease.
- Valvular heart disease with thrombogenic complications
- Severe hypertension
- Diabetes with vascular involvement
- Headaches with focal neurological symptoms or a migraine.
- Known or suspected carcinoma of the breast.
- Carcinoma of the endometrium/other known or suspected estrogen-dependent neoplasia.
- Undiagnosed abnormal genital bleeding.
- Liver tumor or active liver disease.
- Cholestatic jaundice of pregnancy/jaundice with prior pill use.
- Known or suspected pregnancy.
- Heavy smoking and over age 35.
- Hereditary/ acquired predisposition for venous or arterial thrombosis, such as APC -resistance, antithrombin-||| deficiency, protein S deficiency, hyperhomocysteinemia, and antiphospholipid antibodies.
- Arterial thrombosis presence or in history or prodromal conditions.
The presence of severe or multiple risk factor for arterial thrombosis.
- Severe dyslipoproteinemia.
