DYGRO

(Dydrogesterone)

COMPOSITION

Each film coated tablet contains
10mg
Tablets
Dydrogesterone………….. 10mg
(USP Specifications)

DESCRIPTION

Dydrogesterone is a synthetic progesterone for menstrual cycle regulation, infertility treatment, prevention of miscarriage, and other conditions. tiktok live apk in Pakistan Chemically it is designed as (85,9R,105,135,145,175)-17-acetyl-10,13-dimeth- yl-1,2,8,9,11,12,14,15,16,17-decahydrocyclopenta(a)phenanthren-3-one
Empirical formula: C21H2802
Molecular Weight: 312.4g/mol

MECHANISM OF ACTION

Dydrogesterone is orally active progestogen which produces a complete secretory endometrium in an estrogen-primed uterus thereby providing protection against the increased risk for endometrium hyperplasia and/or carcinogenesis induced by estrogens. It is indicated in all cases of progesterone deficiency. Dydrogeserone has no oestrogenic, androgenic, anabolic and corticoid properties.Tiktok live download

Dydrogesterone does not suppress ovulation. As a result, conception remains possible if dydrogesterone is used by women of child-bearing age. In postmenopausal women with a uterus, oestrogen replacement leads to an increase in the risk of endometrial hyperplasia and endometrial carcinoma. The addition of a progestogen prevents this additonal
risk.

PHARMACOKINETICS

ABSORPTION

After oral administration dydrogesterone is rapidly absorbed with a Tmax of between 0.5 and 2.5 hours. The absolute biological availability of dydrogesterone (20 mg oral dose versus 7.8 mg intravenous infusion) is 28%. The following tables gives the pharmacokinetic parameters of dydrogesterone (D) and 20a-dihydrodydrogesterone (DHD) after administration of a single dose of 10 mg dydrogesterone:

DISTRIBUTION

After intravenous administration of dydrogesterone the steady-state distribution volume is around 1400 I. More than 90% of dydrogesterone and DHD are bound to plasma-proteins.

METABOLISM

After oral administration dydrogesterone is quickly metabolised to DHD. The plasma levels of the main active metabolite DHD show a peak around 1.5 hours after administering the dose. The plasma levels of DHD are substantially higher than the related medicinal product. The AUC and Cmax ratios of DHD and dydrogesterone are of the order of magnitude of respectively 40 and 25. The mean terminal half-life of dydrogesterone and DHD varies from respectively 5 to 7 and 14 to 17 hours. A common characteristic of all characterised metabolites is the retention of the 4,6-diene-2-one configuration of the original product and the absence of 17a hydroxylation. This explains the absence of oestrogenic and androgenic effects of dydrogesterone.

EXCRETION

After oral administration of labelled dydrogesterone on average 63% of the dose is excreted in the urine. The total plasma clearance is 6.4 l/minute. Within 72 hours the excretion is complete, DHD is present in the urine mainly as the conjugated glucuronic acid.

INDICATION

It is indicated in progesterone deficiencies.

DOSAGE AND ADMINISTRATION

to the seriousness of the disorder to be treated and the individual patients’ responses to the treatment. The following dosage regimens are recommended for treatment with Dygro. The quantities can be adjusted according

REGULATION OF THE CYCLE

It is possible to achieve a cycle lasting 28 days by giving 1 tablet of Dygro a day from the
11th to the 25th day of the cycle.
of 10 mg several times a day should be spread over the day. It is recommended that treatment should start at the highest ENDOMETRIOSIS: 1 to 3 tablets of Dygro a day from the 5th to the 25th day of the cycle or for the entire cycle. Dosages
dose.

DYSMENORRHOEA

1 to 2 tablets of Dygro a day from the 5th to the 25th day of the cycle. Dosages of 10 mg several times a day should be spread over the day. It is recommended that treatment should start at the highest dose.

INFERTILITY AS A RESULT OF CORPUS LUTEUM INSUFFICIENCY

1 tablet of Dygro a day from the 14th to the 25th day of the cycle. Treatment should be continued for at least 6 consecutive cycles. It is advisable to continue this treatment for the first months of any pregnancy at dosages as indicated for habitual abortion.

THREATENED ABORTION

Starting dose: 4 tablets of Dygro at once followed by 1 tablet of Dygro every 8 hours. Dosages of 10 mg several times a day should be spread over the day. It is recommended that treatment should start at the highest
dose.
If the symptoms persist or recur during the treatment, the dose should be increased by 1 tablet of Dygro every 8 hours. The effective dose should be maintained for one week after symptoms have ceased; it can then be gradually reduced. If the symptoms recur, the treatment should be resumed immediately at the effective dose.

HABITUAL ABORTION

1 tablet of Dygro a day up to the 20th week of pregnancy; the dose can then be gradually reduced. Treatment should preferably be started before conception.
If the symptoms of threatened abortion occur during treatment, treatment should be continued as described for that indication.

DYSFUNCTIONAL UTERINE BLEEDING

Bleeding is stopped by 2 tablets of Dygro a day for 5 to 7 days. The blood loss is reduced considerably within a few days. A few days after the end of this treatment, a heavy withdrawal bleed occurs and the patient should be warned about this.

Subsequent heavy bleeding can be prevented by prescribing a prohylactic dose of 1 tablet of Dygro a day from the 11th to the 25th day of the cycle, if necessary combined with an oestrogen for 2 to 3 cycles. After this the treatment can be discontinued, in order to check that the patient has a normal cycle again.

SECONDARY AMENORRHOEA

1 or 2 tablets of Dygro per day from the 11th to the 25th day of the cycle to give optimum secretion transformation of the endometrium, that is adequately prepared with an endogenous or exogenous oestrogen.

PRE-MENSTRUAL SYNDROME

10 mg twice daily from day 11 to day 26 of the cycle.

DOSING INFORMATION

For oral use.
For administration of higher doses the tablets should be taken in divided doses over the day.

CONTRAINDICATIONS

Vaginal bleeding, where the cause has not been established.
returned to normal.
Presence of serious liver disorders, or serious liver disorders in the medical history until the liver function values have . Contraindications for use of oestrogens in combination with progestogens such as dydrogesterone in combined
therapy

Known hypersensitivity to dydrogesterone or any of the excipients. Known or suspected sex hormone dependent malignancies.
WARNING AND PRECAUTIONS:
Before starting treatment with dydrogesterone because of dysfunctional uterine bleeding an organic cause should be
excluded.
Breakthrough bleeding and spotting may occur during the first months of treatment. If breakthrough bleeeding and spotting continue to occur when treatment has already been underway for some time, or continue when treatment is discontinued, the cause of this should be ascertained, if necessary by taking an endometrial biopsy to exclude malignancy of the endometrium.
If one of the following disorders occurs during use for the first time or gets worse, stopping the treatment should be
considered.

exceptionally severe headache, migraine or symptoms that may indicate cerebral ischemia.
-marked increase in blood pressure.
-occurrence of venous thromboembolism.
In cases of habitual or threatened abortion, the viability of the foetus should be ascertained, and it is necessary to monitor during treatment whether the pregnancy is still progressing and whether the embryo is still alive.

CONDITIONS FOR WHICH MONITORING IS NECESSARY

It is known that the following rarely occurring conditions may be affected by sex hormones and may arise or get worse during pregnancy or during the use of sex hormones: cholestatic icterus, herpes gestationis, severe pruritus, otosclerosis and porphyria.
Patients with a history of depression must be carefully monitored; if severe depression recurs, treatment with dydrogesterone must be stopped.

ADVERSE EFFECTS

Metrorrhagia, painful/ sensitive breasts, migraine/headache, nausea, vomiting.

DRUG INTERACTIONS

The metabolisation of dydrogesterone may therefore be increased by concomitant use of substances known to induce these isoenzymes, such as anticonvulsants (e.g. phenobarbital, phenytoin, carbamazepine), anti-infectives (e.g. rifampicin, rifabutin, nevirapine, efavirenz) and herbal preparations containing e.g. St. John’s Wort (hypericum perforatum), valerian root, sage, or gingko biloba.
Ritonavir and nelfinavir are of course well-known powerful inhibitors of cytochrome enzymes but do in fact have an enzyme-inducing action if they are used concomitantly with steroid hormones.
Clinically an increase in the metabolisation of dydrogesterone may lead to a reduction in effect and changes in the bleeding pattern.
In vitro studies show that dydrogesterone and DHD enzymes that metabolise CYP substances do not inhibit or induce.

USE IN SPECIAL POPULATIONS

PREGNANCY

Dydrogesterone may be administered during pregnancy if there is a clear indication for use.

LACTATION

It is not known whether dydrogesterone is excreted in breast milk. No research has been done into the excretion of dydrogesterone in breast milk. Experiences with other progestogens indicate that progestogens and their metabolites are found in small quantities in breast milk. It is not known whether there is a risk for the child. Dydrogesterone should therefore not be used while breastfeeding.

PEDIATRIC USE

The safety and efficacy of dydrogesterone in adolescents aged below 18 years has not been established.

OVERDOSAGE

SYMPTOMS

Dydrogesterone is a substance with very low toxicity. Nausea, vomiting, lethargy and dizziness are symptoms which may theoretically occur in the event of an overdose. There are no known cases in which an overdose of dydrogesterone led to harmful effects.

TREATMENT

Specific treatment is clearly not necessary. In case of overdose symptomatic treatment may be considered.
I

NSTRUCTIONS

Store in a cool & dry place below 30°C. Protect from heat, sunlight & moisture. Keep out of the reach of children. To be sold on the prescription of a registered medical practitioner only.

PRESENTATION

Dygro (Dydrogesterone) 10mg tablets is available in 20’s