FERTYL Clomifene Citrate 50mg Tablet 1's
RXDRUG-DRP-7035-01-1pc
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
For the treatment of anovulatory infertility.
Dosage/Direction for Use
First Course: 50 mg daily for 5 days. If ovulation appears not to have occurred, a second course of 100 mg daily for 5 days should be given. Maximum dose is 100 mg/day for 5 days.
Administration
May be taken with or without food.
Contraindications
Liver disease; History of liver dysfunction; abnormal bleeding of undetermined origin; pregnancy.
Use In Pregnancy & Lactation
Clomifene is contraindicated during pregnancy.
Adverse Reactions
Abdominal pain, diarrhea, dyspepsia, Flatulence, nausea, dizziness, headache, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, back pain, insomnia, rash.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacology: Pharmacodynamics: Mechanism of Action: Clomifene appears to inhibit estrogen in hypothalamus, thereby inhibiting negative feedback of estrogen on gonadotropin production. It may also result in direct stimulation of the hypothalamic-pituitary axis. Zuclomifene, a more active isomer, stays bound for long period of time.
In normal physiologic female hormonal cycling, at 7 days past ovulation, high levels of estrogen and progesterone produced from the corpus luteum inhibit GnRH, FSH and LH at the hypothalamus and anterior pituitary. If fertilization does not occur in the post-ovulation period the corpus luteum disintegrates due to lack of beta-HCG. This would normally be produced by the embryo in the effort of maintaining progesterone and estrogen levels during pregnancy.
Therapeutically, clomifene is given early in the menstrual cycle. It is typically prescribed beginning on day 1, 3 or 5 and continuing for 5 days. By the time, FSH level is rising steadily, causing development of a few follicles. Follicles in turn produce the estrogen, which circulated in serum. In the presence of clomifene, the body perceives a low level of estrogen, similar to a day 22 in the previous cycle. Since estrogen can no longer effectively exert negative feedback on the hypothalamus, GnRH secretion becomes more rapidly pulsatile, which results in increased pituitary gonadotropin (FSH, LH) release. (It should be noted that more rapid, lower amplitude pulses of GnRH lead to increased LH/FSH secretion, while more irregular, larger amplitude pulses of GnRH leads to a decrease in the production of LH/FSH.) Increased FSH level causes growth of more ovarian follicles, and subsequently rupture of follicles resulting in ovulation.
Pharmacokinetics: Clomifene citrate is absorbed from the gastrointestinal tract. It is metabolized in the liver and slowly excreted via the bile.
Unchanged drug and metabolites are excreted in the feces. The biological half-life is reported to be 5 days although traces are found in the feces for up to 6 weeks. Enterohepatic recirculation takes place.
In normal physiologic female hormonal cycling, at 7 days past ovulation, high levels of estrogen and progesterone produced from the corpus luteum inhibit GnRH, FSH and LH at the hypothalamus and anterior pituitary. If fertilization does not occur in the post-ovulation period the corpus luteum disintegrates due to lack of beta-HCG. This would normally be produced by the embryo in the effort of maintaining progesterone and estrogen levels during pregnancy.
Therapeutically, clomifene is given early in the menstrual cycle. It is typically prescribed beginning on day 1, 3 or 5 and continuing for 5 days. By the time, FSH level is rising steadily, causing development of a few follicles. Follicles in turn produce the estrogen, which circulated in serum. In the presence of clomifene, the body perceives a low level of estrogen, similar to a day 22 in the previous cycle. Since estrogen can no longer effectively exert negative feedback on the hypothalamus, GnRH secretion becomes more rapidly pulsatile, which results in increased pituitary gonadotropin (FSH, LH) release. (It should be noted that more rapid, lower amplitude pulses of GnRH lead to increased LH/FSH secretion, while more irregular, larger amplitude pulses of GnRH leads to a decrease in the production of LH/FSH.) Increased FSH level causes growth of more ovarian follicles, and subsequently rupture of follicles resulting in ovulation.
Pharmacokinetics: Clomifene citrate is absorbed from the gastrointestinal tract. It is metabolized in the liver and slowly excreted via the bile.
Unchanged drug and metabolites are excreted in the feces. The biological half-life is reported to be 5 days although traces are found in the feces for up to 6 weeks. Enterohepatic recirculation takes place.
MedsGo Class
Trophic Hormones & Related Synthetic Drugs
Features
Brand
FERTYL
Full Details
Dosage Strength
50 mg
Drug Ingredients
- Clomifene Citrate
Drug Packaging
Tablet 1's
Generic Name
Clomifene Citrate
Dosage Form
Tablet
Registration Number
DRP-7035-01
Drug Classification
Prescription Drug (RX)
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