Safyron Tablet 10 mg

Safyron Tablet 10 mg Uses, Dosage, Side Effects, Food Interaction and all others data.

Safyron Tablet 10 mg is a progestogen structurally related to progesterone. However, unlike progesterone, it does not induce an increase in temp nor inhibit ovulation and may be preferred over other progestational agents when contraceptive effect is not required. It does not have oestrogenic or androgenic properties.

Safyron Tablet 10 mg is an orally active progestogen which acts directly on the uterus, producing a complete secretory endometrium in an estrogen-primed uterus. At therapeutic levels, dydrogesterone has no contraceptive effect as it does not inhibit or interfere with ovulation or the corpus luteum. Furthermore, dydrogesterone is non-androgenic, non-estrogenic, non-corticoid, non-anabolic and is not excreted as pregnanediol. Safyron Tablet 10 mg helps to regulate the healthy growth and normal shedding of the uterus lining. Therefore, it may be useful in the treatment of menstrual disorders such as absent, irregular or painful menstrual periods, infertility, premenstrual syndrome and endometriosis.

Safyron Tablet 10 mg
Uses
Dosage
Side Effect
Precautions
Interactions
Uses during Pregnancy
Uses during Breastfeeding
Accute Overdose
Food Interaction
Half Life
Volume of Distribution
Clearance
Interaction With other Medicine
Contradiction
Storage

Trade Name	Safyron Tablet 10 mg
Generic	Dydrogesterone
Dydrogesterone Other Names	Didrogesterona, Didrogesterone, Dydrogesterona, Dydrogestérone, Dydrogesterone, Dydrogesteronum, Gestatron, Hydrogesterone, Hydrogestrone, Isopregnenone
Weight	10 mg
Type	Tablet
Formula	C₂₁H₂₈O₂
Weight	Average: 312.4458 Monoisotopic: 312.20893014
Groups	Approved, Investigational, Withdrawn
Therapeutic Class	Female Sex hormones
Manufacturer	Square Pharmaceuticals Ltd.
Available Country	Bangladesh
Last Updated:	October 19, 2023 at 6:27 am

Uses

Treatment of progesterone deficiencies such as:

Treatment of dysmenorrhoea
Treatment of endometriosis
Treatment of secondary amenorrhoea
Treatment of irregular cycles
Treatment of dysfunctional uterine bleeding
Treatment of pre-menstrual syndrom
Treatment of threatened and habitual abortion, associated with proven progesterone deficiency
Treatment of infertility due to luteal insufficiency

Safyron Tablet 10 mg is also used to associated treatment for these conditions: Abortions spontaneous, Infertility, Menstrual Distress (Dysmenorrhea), Premenstrual Syndrome, Recurrent Miscarriages, Assisted Reproductive Techniques (ART), Menstrual Regulation

How Safyron Tablet 10 mg works

Safyron Tablet 10 mg is a progestogen that works by regulating the healthy growth and normal shedding of the womb lining by acting on progesterone receptors in the uterus.

Dosage

Safyron Tablet 10 mg dosage

Recurrent miscarriage: 10 mg bid given cyclically until conception, then continuously until wk 20 of pregnancy, after which dose may be gradually reduced.

Infertility: 10 mg bid.

Menstrual disorders: 10 mg bid in a cyclical regimen.

Endometriosis: 10 mg bid-tid cyclically or continuously.

Threatened miscarriage: Initially, 40 mg followed by 10 mg or more every 8 hr, continued for a wk after symptoms are relieved. Reduce dose gradually after that unless symptoms return.

Endometrial protection during menopausal hormonal replacement therapy: 10 mg 1-2 times daily in a cyclical regimen or 5 mg daily.

Side Effects

Dizziness, nausea, headache, fatigue, emotional lability, irritability; abdominal pain and distention; muskuloskeletal pain.

Toxicity

No serious or unexpected toxicity has been observed with dydrogesterone. In acute toxicity studies, the LD50 doses in rats exceeded 4,640mg/kg for the oral route.

Precaution

Monitor closely for loss of vision, proptosis, diplopia, migraine, signs and symptoms of embolic disorders. CVD or renal impairment, epilepsy, asthma, other conditions which may be aggravated by fluid retention. Lactation.

Interaction

Carbamazepine, griseofulvin, phenobarbital, rifampicin enhances the clearance of progestogens.

Elimination Route

Rapidly absorbed in the gastrointestinal tract with a bioavailability of 28%.

Half Life

Safyron Tablet 10 mg: 5-7 hours, 20-dihydrodydrogesterone (DHD) metabolite: 14-17 hours

Pregnancy & Breastfeeding use

From spontaneous surveillance systems to date, there is no evidence that dydrogesterone can not be used during pregnancy.

Safyron Tablet 10 mg is excreted in the milk of nursing mothers. A risk to the suckling child cannot be excluded. Safyron Tablet 10 mg should not be used during breast-feeding.

There is no evidence that dydrogesterone decreases fertility at therapeutic dose.

Contraindication

Hypersensitivity to the active substance or to any of the excipients. Known or suspected progestogen dependent neoplasms. Undiagnosed vaginal bleeding

Acute Overdose

Limited data are available with regard to overdose in humans. Safyron Tablet 10 mg was well tolerated after oral dosing (maximum daily dose taken to date in humans 360 mg). No reports of ill-effects from overdose have been recorded. If a large overdose is discovered within two or three hours and treatment seems desirable, gastric lavage is recommended. There are no specific antidotes and treatment should be symptomatic. Aforementioned information is also applicable for overdosing in children.