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Menopur
Overview
What is Menopur?
MENOPUR is a preparation of gonadotropins (FSH and LH activity), extracted from the urine of postmenopausal women, which has undergone additional steps for purification.
MENOPUR is a sterile, lyophilized powder intended for subcutaneous (SC) injection after reconstitution with sterile 0.9% Sodium Chloride Injection, USP. Each vial of MENOPUR contains 75 International Units of follicle-stimulating hormone (FSH) activity and 75 International Units of luteinizing hormone (LH) activity, plus 21 mg lactose monohydrate and 0.005 mg Polysorbate 20 and Sodium Phosphate Buffer (Sodium Phosphate Dibasic, Heptahydrate and Phosphoric Acid).
The biological activity of MENOPUR is determined using the bioassays for FSH (ovarian weight gain assay in female rats) and LH (seminal vesicle weight gain assay in male rats), modified to increase the accuracy and reproducibility of these assays. The FSH and LH activity assays are standardized using the Fourth International Standard for Urinary FSH and Urinary LH, November 2000, by the Expert Committee on Biological Standardization of the World Health Organization (WHO ECBS). Both FSH and LH are glycoproteins that are acidic and water-soluble. Human Chorionic Gonadotropin (hCG) is detected in MENOPUR.
MENOPUR has been mixed with BRAVELLE with no evidence of aggregation.
Therapeutic class: Infertility
What does Menopur look like?
What are the available doses of Menopur?
Lyophilized powder for injection: containing 75 IU FSH and 75 IU of LH activity, supplied as lyophilized powder or pellet in sterile vials with diluent vials and Q•Cap vial adapters. ()
What should I talk to my health care provider before I take Menopur?
How should I use Menopur?
MENOPUR (menotropins for injection) is a gonadotropin indicated for:
Initial starting dose of the first cycle - 225 International Units per day, administered subcutaneously ()
Dosage adjustments after 5 days and by no more than 150 International Units at each adjustment ()
Do not administer doses greater than 450 International Units per day ()
MENOPUR may be administered together with BRAVELLE (urofollitropin for injection, purified). Only the total starting dose of 225 International Units (150 International Units of MENOPUR and 75 International Units of BRAVELLE or 75 International Units of MENOPUR and 150 International Units of BRAVELLE) was studied in a clinical trial. ()
What interacts with Menopur?
Sorry No Records found
What are the warnings of Menopur?
Sorry No Records found
What are the precautions of Menopur?
Sorry No Records found
What are the side effects of Menopur?
Sorry No records found
What should I look out for while using Menopur?
MENOPUR is contraindicated in women who exhibit:
What might happen if I take too much Menopur?
Aside from possible OHSS and multiple gestations , there is no additional information on the consequences of acute overdosage with MENOPUR.
How should I store and handle Menopur?
Lyophilized powder may be stored refrigerated or at room temperature (3° to 25° C/37° to 77°F) until dispensed. Protect from light. Use immediately after reconstitution. Discard unused material.ALREX® (loteprednol etabonate ophthalmic suspension, 0.2%) is supplied in a plastic bottle with a controlled drop tip in the following sizes:5 mL (NDC 24208-353-05) 10 mL (NDC 24208-353-10) DO NOT USE IF NECKBAND IMPRINTED WITH "Protective Seal" AND YELLOW IS NOT INTACT.ALREX® (loteprednol etabonate ophthalmic suspension, 0.2%) is supplied in a plastic bottle with a controlled drop tip in the following sizes:5 mL (NDC 24208-353-05) 10 mL (NDC 24208-353-10) DO NOT USE IF NECKBAND IMPRINTED WITH "Protective Seal" AND YELLOW IS NOT INTACT.ALREX® (loteprednol etabonate ophthalmic suspension, 0.2%) is supplied in a plastic bottle with a controlled drop tip in the following sizes:5 mL (NDC 24208-353-05) 10 mL (NDC 24208-353-10) DO NOT USE IF NECKBAND IMPRINTED WITH "Protective Seal" AND YELLOW IS NOT INTACT.ALREX® (loteprednol etabonate ophthalmic suspension, 0.2%) is supplied in a plastic bottle with a controlled drop tip in the following sizes:5 mL (NDC 24208-353-05) 10 mL (NDC 24208-353-10) DO NOT USE IF NECKBAND IMPRINTED WITH "Protective Seal" AND YELLOW IS NOT INTACT.ALREX® (loteprednol etabonate ophthalmic suspension, 0.2%) is supplied in a plastic bottle with a controlled drop tip in the following sizes:5 mL (NDC 24208-353-05) 10 mL (NDC 24208-353-10) DO NOT USE IF NECKBAND IMPRINTED WITH "Protective Seal" AND YELLOW IS NOT INTACT.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
MENOPUR, administered for 7 to 20 days, produces ovarian follicular growth and maturation in women who do not have primary ovarian failure. Treatment with MENOPUR in most instances results only in follicular growth and maturation. When sufficient follicular maturation has occurred, hCG must be given to induce ovulation.
Non-Clinical Toxicology
MENOPUR is contraindicated in women who exhibit:Amphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., ), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.
Antibiotics Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (See Hepatic Enzyme Inducers, Inhibitors and Substrates).
Anticholinesterases Concomitant use of anticholinesterase agents (e.g., ) and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. If concomitant therapy must occur, it should take place under close supervision and the need for respiratory support should be anticipated.
Anticoagulants, Oral Co-administration of corticosteroids and usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect.
Antidiabetics Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.
Antitubercular Drugs Serum concentrations of may be decreased.
Bupropion Since systemic steroids, as well as bupropion, can lower the seizure threshold, concurrent administration should be undertaken only with extreme caution; low initial dosing and small gradual increases should be employed.
Cholestyramine Cholestyramine may increase the clearance of corticosteroids.
Cyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use.
Digitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.
Estrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.
Fluoroquinolones Post-marketing surveillance reports indicate that the risk of tendon rupture may be increased in patients receiving concomitant fluoroquinolones (e.g., ) and corticosteroids, especially in the elderly. Tendon rupture can occur during or after treatment with quinolones.
Hepatic Enzyme Inducers, Inhibitors and Substrates Drugs which cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., ) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Drugs which CYP 3A4 (e.g., ) have the potential to result in increased plasma concentrations of corticosteroids. Glucocorticoids are moderate inducers of CYP 3A4. Co-administration with other drugs that are metabolized by CYP 3A4 (e.g., ) may increase their clearance, resulting in decreased plasma concentration.
Ketoconazole Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. In addition, ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal.
Nonsteroidal Anti-Inflammatory Agents (NSAIDS) Concomitant use of (or other ) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids; this could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn.
Phenytoin In post-marketing experience, there have been reports of both increases and decreases in phenytoin levels with dexamethasone co-administration, leading to alterations in seizure control. Phenytoin has been demonstrated to increase the hepatic metabolism of corticosteroids, resulting in a decreased therapeutic effect of the corticosteroid.
Quetiapine Increased doses of quetiapine may be required to maintain control of symptoms of schizophrenia in patients receiving a glucocorticoid, a hepatic enzyme inducer.
Skin Tests Corticosteroids may suppress reactions to skin tests.
Thalidomide Co-administration with thalidomide should be employed cautiously, as toxic epidermal necrolysis has been reported with concomitant use.
Vaccines Patients on corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (See Vaccination).
MENOPUR should only be used by physicians who are experienced in infertility treatment. MENOPUR contains gonadotropic substances capable of causing in women, Ovarian Hyperstimulation Syndrome (OHSS) with or without pulmonary or vascular complications and multiple births . Gonadotropin therapy requires the availability of appropriate monitoring facilities . Use the lowest effective dose.
The following serious adverse reactions are discussed elsewhere in the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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