Dydrotone Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Dydrogesterone

Indications/Uses

Management of conditions associated w/ progesterone insufficiency eg, dysmenorrhoea, endometriosis, infertility, irregular menstrual cycles, & pre-menstrual syndrome. May be used w/ estrogen in management of dysfunctional bleeding or secondary amenorrhoea, or in association w/ estrogen in HRT.

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Dosage/Direction for Use

Dysfunctional uterine bleeding 10 mg bid for 5-7 days. Continuous treatment: 10 mg bid from day 11-25 of the cycle. Secondary amenorrhoea 10 mg bid from day 11-25 of the cycle. Pre-menstrual syndrome 10 mg bid from day 12-26 of the cycle, may be increased if necessary. Endometriosis 10 mg bid from day 5-25 of the cycle, or continuously. Dysmenorrhoea 10 mg bid from day 5-25 of the cycle. Irregular cycle 10 mg bid from day 11-25 of the cycle. Infertility due to luteal insufficiency 10 mg bid from day 11-25 of the cycle. Maintain treatment for at least 3 consecutive cycles. HRT 10 mg daily for 14 days of each 28-day estrogen treatment cycle, may be increased to 10 mg bid if either early w/drawal bleeding occurs, or if endometrial biopsy reveals inadequate progestational response.

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Contraindications

Hypersensitivity. Vag bleeding where the cause has not been established. Known or suspected sex hormone dependent malignancies. Combination w/ oestrogens. Presence of serious liver disorders or serious liver disorders in the medical history until the liver function values have returned to normal.

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Special Precautions

Breakthrough bleeding & spotting may occur during 1st mth of treatment. May affect rarely occurring conditions (cholestatic icterus, herpes gestationis, severe pruritus, otosclerosis & porphyria) which may arise or get worse during pregnancy or use of sex hormones. Exclude organic cause prior to treatment for dysfunctional uterine bleeding. Consider discontinuation in the occurrence of disorders eg, exceptionally severe headache, migraine or symptoms that may indicate cerebral ischemia; marked increase in BP; VTE. Carefully monitor patients w/ history of depression & discontinue use if severe depression recurs. Not to be used by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. No data on effect on fertility. May be administered during pregnancy if there is clear indication. Not to be used while breastfeeding.

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Use In Pregnancy & Lactation

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Adverse Reactions

Migraine/headache; nausea; disturbed menstruation (including metrorrhagia, menorrhagia, oligo/amenorrhoea, dysmenorrhoea & irregular menstruation), painful/sensitive breasts.

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Drug Interactions

Metabolism may be increased w/ CYP3A4 & CYP2C19 inducers eg, anticonvulsants (eg, phenobarb, phenytoin, carbamazepine), anti-infectives (eg, rifampicin, rifabutin, nevirapine, efavirenz) & herbal prep containing eg, St. John's wort, valerian root, sage or Ginkgo biloba; ritonavir & nelfinavir.

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Storage

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Description

View Dydrotone description for details of the chemical structure and excipients (inactive components).

Action

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MIMS Class

Oestrogens, Progesterones & Related Synthetic Drugs

ATC Classification

G03DB01 - dydrogesterone ; Belongs to the class of pregnadien derivative progestogens used in progestogenic hormone preparations.

Regulatory Classification

Presentation/Packing

Form

Dydrotone FC tab 10 mg

Packing/Price

10's;20's

Dydrotone

dydrogesterone

Manufacturer:

Par Lab

Distributor:

Corbridge