Crisanta Tablets (Generic Drospirenone and Ethinyl Estradiol Tablets)

Crisanta Tablets (Generic Drospirenone and Ethinyl Estradiol Tablets)
© All Contraceptives

Crisanta Tablets (Generic Drospirenone and Ethinyl Estradiol
Tablets) are used as an oral contraceptive, to prevent
pregnancy. This medicine is also used to treat Premenstrual
Dysphoric Disorder (PMDD) or moderate acne in patients who
prefer to use birth control pills as the method of pregnancy
prevention.
Besides preventing pregnancy, Crisanta could make the patient's
periods more regular, decrease blood loss and painful periods,
and also decrease the risk of ovarian cysts. Using this medication
does not protect you or your partner against sexually transmitted
diseases (such as HIV, gonorrhea, chlamydia).

The active ingredients present in Crisanta tablets are Drospirenone
and Ethinyl Estradiol. Each film-coated Crisanta tablet contains 3.0 mg
of Drospirenone and 0.03 mg of Ethinylestradiol (Ethinyloestradiol or
Ethinyl Estradiol).
Active Ingredients

Chemical Structure - Drospirenone

Chemical Structure - Ethinyl Estradiol

Crisanta Tablets
Crisanta tablets are manufactured by Cipla Limited, India
and are available as tablets in the strengths of 3 mg of
Drospirenone and 0.03 mg (300 mcg) of Ethinylestradiol.
( Website: https://www.cipla.com/ )
URL: https://www.allcontraceptives.com/crisanta-tablets.html

Uses of Crisanta Tablets
Drospirenone and Ethinyl Estradiol combination (Crisanta tablets) is used
to prevent pregnancy. It is a birth control pill that contains two types of
hormones, Ethinyl Estradiol and Drospirenone, and when taken properly,
prevents pregnancy. It works by stopping a woman's egg from fully
developing each month. The egg can no longer accept a sperm and
fertilization (pregnancy) is prevented.
This medicine is also used to treat premenstrual dysphoric disorder
(PMDD) in women at least 16 years of age. PMDD is a severe form of
premenstrual syndrome (PMS). Patients with PMDD may have severe
emotional and physical symptoms 10 to 14 days before their menstrual
flow starts.

Uses of Crisanta Tablets
This medicine is also used to treat moderate acne vulgaris in women 16
years of age or greater who have no known contraindications to oral
contraceptive therapy, desire contraception, and have achieved menarche.
Crisanta tablets should be used for the treatment of acne only if the
patient desires an oral contraceptive for birth control.
This medicine does not prevent AIDS or other sexually transmitted
diseases. It will not help as emergency contraception, such as after
unprotected sexual contact.

Recommended Dosage
The dosage of Crisanta tablets (Generic Drospirenone and Ethinyl
Estradiol Tablets) is given below:
The recommended dosage is orally once a day, with or without meals as
described below. Inorder to achieve maximum contraceptive
effectiveness, Crisanta pills must be taken exactly as directed in the order
on the blister pack. A patient must begin to take Crisanta on the first day
(Day 1) of her menstrual period.
During the first cycle of Crisanta use, the patient should be instructed to
take one tablet daily, beginning on day 1 of her menstrual cycle (the first
day of menstruation is day one). She should take one tablet daily for 21
consecutive days, followed by 7 pill-free days.

Recommended Dosage
The dosage of Crisanta tablets (Generic Drospirenone and Ethinyl
Estradiol Tablets) is given below:
It is recommended that Crisanta be taken at the same time each day,
preferably after the evening meal or at bedtime.
If Crisanta is first administered later than the first day of the menstrual
cycle, it must not be considered effective as a contraceptive until after the
first 7 consecutive days of product administration. The patient should use
a non-hormonal contraceptive as back-up during the first 7 days. The
possibility of ovulation and conception prior to initiation of this medicine
must also be considered.

Recommended Dosage
The dosage of Crisanta tablets (Generic Drospirenone and Ethinyl Estradiol Tablets) is
given below:
The patient must begin her next and all subsequent 28-day regimens of Crisanta
contraceptive pill on the same day of the week that she began her first regimen,
following the same schedule. She should begin taking her pills on the next day after the
7 pill-free days, regardless of whether or not a menstrual period has occurred or is still in
progress. Any time a subsequent cycle of Crisanta tablets is started later than the day
following 7 pill-free days, the patient should use another method of contraception until
she has taken a tablet daily for 7 consecutive days.
When Switching from a Different Birth Control Pill: When switching from another birth
control pill, Crisanta should be started on the same day that a new pack of the previous
oral contraceptive would have been started.

Recommended Dosage
The dosage of Crisanta tablets (Generic Drospirenone and Ethinyl Estradiol Tablets) is
given below:
When Switching from a Method other than a Birth Control Pill: When switching from
a transdermal patch or a vaginal ring, Crisanta must be started when the next application
would have been due. When switching from an injection, Crisanta should be started when
the next dose would have been due. When switching from an intrauterine contraceptive
or an implant, Crisanta therapy must be started on the day of removal.
Withdrawal bleeding usually occurs within 3 days following the last tablet. If spotting or
breakthrough bleeding occurs while taking Crisanta pills, the patient should be instructed
to continue taking Crisanta as instructed and as per the regimen described above. She
should be instructed that this type of bleeding is usually transient and without
significance. However, in case the bleeding is persistent or prolonged, the patient must be
advised to consult the doctor as soon as possible.

Contraindications
Crisanta tablets are contraindicated in persons with a hypersensitivity (allergy)
to Drospirenone, Ethinyl Estradiol or any of the other ingredients of this
medicine. The other contraindications are: Women over 35 years old who smoke
should not use Crisanta tablets. Cigarette smoking increases the risk of serious
cardiovascular events from combination oral contraceptive (COC) use.
Presence or a history of venous or arterial thrombotic/thromboembolic events
(e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a
cerebrovascular accident.
Presence or history of prodromi of a thrombosis (e.g. transient ischaemic attack,
angina pectoris)
Presence of a severe or multiple risk factor(s) for venous or arterial thrombosis
may also constitute a contraindication.

Contraindications
History of migraine with focal neurological symptoms
Diabetes mellitus with vascular involvement
Pancreatitis or a history thereof if associated with severe hypertriglyceridemia
Use of direct-acting antiviral (DAA) medicinal products containing Ombitasvir,
Paritaprevir, or Dasabuvir, and combinations of these.
Presence or history of severe hepatic disease as long as liver function values have not
returned to normal
Presence or history of liver tumours (benign or malignant)
Severe renal insufficiency or acute renal failure
Known or suspected sex-steroid influenced malignancies (e.g. of the genital organs or
the breasts).
Undiagnosed vaginal bleeding
Known or suspected pregnancy

Storage Instructions
Crisanta Tablets (Generic Drospirenone and
Ethinyl Estradiol Tablets) have to be stored at
controlled room temperature i.e. from 20°C to
25°C (68°F to 77°F) with excursions
permitted between 15° to 30°C (59° to 86°F).
Keep this as well as all other medicines away
from children and pets.

Warnings
Women over 35 years old who smoke should not use Crisanta pills. Cigarette smoking
increases the risk of serious cardiovascular events from combination oral contraceptive
(COC) use. Stop Crisanta in case an arterial or venous thrombotic (VTE) event occurs.
Based on presently available information on DRSP-containing COCs with 0.03 mg Ethinyl
Estradiol (that is, Crisanta), DRSP-containing COCs may be associated with a higher risk of
Venous Thromboembolism (VTE) than COCs containing the progestin levonorgestrel or
some other progestins. Epidemiologic studies that compared the risk of VTE reported that
the risk ranged from no increase to a three-fold increase. Before starting use of Crisanta in
a new COC user or a woman who is switching from a contraceptive that does not contain
Drospirenone, consider the risks and benefits of a DRSP-containing COC in light of her risk
of a VTE. Known risk factors for VTE include smoking, obesity, and family history of VTE,
in addition to other factors that contraindicate use of COCs.
Crisanta contains 3 mg of the progestin Drospirenone which has anti-mineralocorticoid
activity, including the potential for hyperkalemia in high-risk patients, comparable to a 25
mg dose of spironolactone.

Warnings
Crisanta is contraindicated in patients with conditions that predispose to hyperkalemia
(that is, renal impairment, hepatic impairment, and adrenal insufficiency). Women
receiving daily, long-term treatment for chronic conditions or diseases with medications
that may increase serum potassium concentration should have their serum potassium
concentration checked during the first treatment cycle.
Women who currently have or have had breast cancer should not use Crisanta because
breast cancer is a hormonally-sensitive tumor.
Discontinue Crisanta if jaundice develops. Steroid hormones may be poorly metabolized in
patients with impaired liver function. Acute or chronic disturbances of liver function may
necessitate the discontinuation of COC use until markers of liver function return to normal
and COC causation has been excluded.
For women with well-controlled hypertension, monitor blood pressure and stop Crisanta
in case blood pressure rises significantly. Women with uncontrolled hypertension or
hypertension with vascular disease should not use COCs.

Warnings
Studies suggest a small increased relative risk of developing gallbladder disease
among COC users.
Carefully monitor prediabetic and diabetic women who are taking Crisanta.
COCs may decrease glucose intolerance in a dose-related fashion.
Consider alternative contraception for women with uncontrolled dyslipidemias. A
small proportion of women will have adverse lipid changes while on COC’s.
Women with hypertriglyceridemia, or a family history thereof, may be at an
increased risk of pancreatitis when using COCs.
If a woman taking Crisanta develops new headaches that are recurrent,
persistent, or severe, evaluate the cause and discontinue Yaz if indicated.
An increase in frequency or severity of migraine during COC use (which may be
prodromal of a cerebrovascular event) may be a reason for immediate
discontinuation of the COC.

Warnings
Unscheduled (breakthrough or intracyclic) bleeding and spotting
sometimes occur in patients on COCs, especially during the first
three 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, bleeding irregularities may
resolve over time or with a change to a different Combined oral
contraceptive.

Side Effects
The most frequent Drospirenone and Ethinyl Estradiol Tablets
(Crisanta) side effects with an incidence rate of 2% and greater in
contraception and acne clinical trials were: headache/migraine
(6.7%), menstrual irregularities (4.7%), nausea/vomiting (4.2%),
breast pain/tenderness (4.0%) and mood changes (2.2%).
The most frequent Drospirenone and Ethinyl Estradiol Tablets
(Crisanta) side effects with an incidence rate of 2% and greater in
PMDD clinical trials were: menstrual irregularities (24.9%), nausea
(15.8%), headache (13.0%), breast tenderness (10.5%), fatigue
(4.2%), irritability (2.8%), decreased libido (2.8%), increased
weight (2.5%), and affect lability (2.1%).

Overdose
There have been no reports of serious ill effects from overdose,
including ingestion by children. Overdosage may cause withdrawal
bleeding in females and nausea.
Drospirenone is a Spironolactone analogue which has
antimineralocorticoid properties. Serum concentration of potassium
and sodium, and evidence of metabolic acidosis, should be monitored
in cases of overdose.

Crisanta Tablets During Pregnancy
Drospirenone and Ethinyl Estradiol tablets (Crisanta tablets) are
classified by the US FDA as Pregnancy Category X.
If pregnancy occurs during use of Drospirenone and Ethinyl Estradiol, the
medicine should be withdrawn immediately. There is little or no increased risk
of birth defects in women who inadvertently use COCs during early pregnancy.
Extensive epidemiological studies have revealed neither an increased risk of
birth defects in children born to women who used COCs prior to pregnancy, nor
a teratogenic effect when COCs were taken inadvertently during pregnancy.
Epidemiologic studies and meta-analyses have not found an increased risk of
genital or non-genital birth defects (including cardiac anomalies and limb-
reduction defects) following exposure to low dose COCs prior to conception or
during early pregnancy.

For more details on
Crisanta tablets click here
by Cipla Limited, India.

Crisanta Tablets (Generic Drospirenone and Ethinyl Estradiol Tablets)

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