Endogen HP Dosage & Drug Information

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

Concise Prescribing Info

Contents

Urofollitropin

Indications/Uses

Ovulation induction & multiple follicular development (controlled ovarian stimulation) during ART cycle in patients w/ previously received pituitary suppression.

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Dosage/Direction for Use

Infertile patient w/ oligo-anovulation Individualized dosage. Patient who have received GnRH agonist or antagonist pituitary suppression Initially 150 IU daily SC or IM for the 1st 5 days of treatment. Adjust dose not more frequently than once every 2 days & should not exceed more than 75-150 IU/adjustment. Followed by hCG 7,500 IU given 1 day following the last dose of urofollitropin or the follicle attains a size >18 mm. Max: 450 IU/day & 12 days. Patient undergoing IVF & donor egg who have received GnRH agonist or antagonist pituitary suppression Initially 225 IU daily SC for the 1st 5 days of treatment. Adjust dose not more frequently than once every 2 days & should not exceed more than 75-50 IU/adjustment. Max: 450 IU & not beyond 12 days. Once adequate follicular development is evident, highly purified hCG 7,500 IU should be administered.

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Overdosage

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Contraindications

Hypersensitivity. Women w/ high FSH level indicating primary ovarian failure; uncontrolled thyroid & adrenal dysfunction; organic intracranial lesions eg, pituitary tumor; presence of any cause on infertility other than anovulation; abnormal bleeding of undetermined origin; ovarian cysts or enlargement not due to polycystic ovary syndrome. Pregnancy.

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Warnings

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Special Precautions

Hypersensitivity/anaphylactic reactions. Mild to moderate uncomplicated ovarian enlargement accompanied by abdominal distension &/or pain. Discontinue if severe ovarian hyperstimulation syndrome (OHSS) occurs. Perform gynecologic & endocrine evaluation before treatment. Cervical dilation & curettage should always be done for diagnosis before starting therapy in patients in late reproductive life who demonstrate abnormal uterine bleeding or other signs of endometrial abnormalities. Carefully exam to rule out early pregnancy. Evaluation of the husband's fertility potential should be included in the workup. Multiple pregnancies. Lactation. Elderly.

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Use In Pregnancy & Lactation

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Adverse Reactions

Nausea, vomiting, abdominal pain; headache, pain, malaise; OHSS.

Storage

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Description

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Action

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MIMS Class

Trophic Hormones & Related Synthetic Drugs

ATC Classification

G03GA04 - urofollitropin ; Belongs to the class of gonadotropins. Used as ovulation stimulants.

Regulatory Classification

Presentation/Packing

Form

Endogen HP powd for inj 75 IU

Packing/Price

(+ 1 mL diluent (amp)) 1's

Endogen HP

urofollitropin

Manufacturer:

MedEthix

Distributor:

MedEthix