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Lupaneta Pack

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Overview

What is Lupaneta Pack?

LUPANETA PACK (leuprolide acetate for depot suspension; norethindrone acetate tablets) 1-month contains one dual chamber syringe with leuprolide acetate for depot suspension 3.75 mg and norethindrone acetate tablets USP: 5 mg (bottle of 30 tablets).

Leuprolide Acetate for Depot Suspension

Leuprolide acetate for depot suspension is a synthetic nonapeptide analog of gonadotropin-releasing hormone (GnRH or LH-RH), a GnRH agonist. The chemical name is 5- oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:

Leuprolide acetate for depot suspension 3.75 mg is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection.

The front chamber of leuprolide acetate for depot suspension 3.75 mg prefilled dual-chamber syringe contains leuprolide acetate for depot suspension (3.75 mg), gelatin (0.65 mg), DL-lactic and glycolic acids copolymer (33.1 mg), and D-mannitol (6.6 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH.

During the manufacture of leuprolide acetate for depot suspension, acetic acid is lost, leaving the peptide.

Norethindrone Acetate

Norethindrone acetate tablets USP - 5 mg oral tablets.

Norethindrone acetate USP, (17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one acetate), a synthetic, orally active progestin, is the acetic acid ester of norethindrone. It is a white, or creamy white, crystalline powder.

Norethindrone acetate tablets USP, 5 mg contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and talc.



What does Lupaneta Pack look like?



What are the available doses of Lupaneta Pack?

LUPANETA PACK 1-month copackaged kit contains two separate components:

What should I talk to my health care provider before I take Lupaneta Pack?

Pediatric: Safety and effectiveness of LUPANETA PACK has not been established in pediatric patients.

Geriatric: LUPANETA PACK has not been studied in women over 65 years of age and is not indicated in this population.

How should I use Lupaneta Pack?

LUPANETA PACK (leuprolide acetate for depot suspension and norethindrone acetate tablets) is indicated for initial management of the painful symptoms of endometriosis and for management of recurrence of symptoms.

Limitation of Use: Duration of use is limited due to concerns about adverse impact on bone mineral density . The initial treatment course of LUPANETA PACK is limited to six months. A single retreatment course of not more than six months may be administered after the initial course of treatment if symptoms recur. Use of LUPANETA PACK for longer than a total of 12 months is not recommended.

LUPANETA PACK is a co-packaging of leuprolide acetate for depot suspension for intramuscular use and norethindrone acetate tablets for oral use. Administer as follows:

The initial course of treatment with leuprolide acetate for depot suspension 3.75 mg in combination with norethindrone acetate 5 mg daily is not to exceed six months.

If the symptoms of endometriosis recur after the initial course of therapy, consider retreatment with LUPANETA PACK for up to another six months. It is recommended that bone density be assessed before retreatment begins .

Treatment beyond two six-month courses has not been studied and is not recommended due to concerns about adverse impact on bone mineral density.


What interacts with Lupaneta Pack?

Sorry No Records found


What are the warnings of Lupaneta Pack?

Sorry No Records found


What are the precautions of Lupaneta Pack?

Sorry No Records found


What are the side effects of Lupaneta Pack?

Sorry No records found


What should I look out for while using Lupaneta Pack?

Hypersensitivity to GnRH, GnRH agonist or any of the excipients in leuprolide acetate for depot suspension or norethindrone acetate

Undiagnosed abnormal uterine bleeding

Pregnancy or suspected pregnancy

Women who are breast-feeding

Known, suspected or history of breast or other hormone-sensitive cancer

Thrombotic or thromboembolic disorders

Liver tumors or liver disease


What might happen if I take too much Lupaneta Pack?

Sorry No Records found


How should I store and handle Lupaneta Pack?

Store at 25 °C (77 °F); excursions permitted to 15-30 °C (59-86 °F). LUPANETA PACK for 1-month copackaged kit (NDC 0074-1052-05) is available incartons containing: leuprolide acetate for depot suspension 3.75 mg for 1-month administration Kit (NDC 0074-3641-04)norethindrone acetate 5 mg tablets; 30 count bottle (NDC 0074-1049-02)Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [See USP Controlled Room Temperature]LUPANETA PACK for 1-month copackaged kit (NDC 0074-1052-05) is available incartons containing: leuprolide acetate for depot suspension 3.75 mg for 1-month administration Kit (NDC 0074-3641-04)norethindrone acetate 5 mg tablets; 30 count bottle (NDC 0074-1049-02)Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [See USP Controlled Room Temperature]LUPANETA PACK for 1-month copackaged kit (NDC 0074-1052-05) is available incartons containing: leuprolide acetate for depot suspension 3.75 mg for 1-month administration Kit (NDC 0074-3641-04)norethindrone acetate 5 mg tablets; 30 count bottle (NDC 0074-1049-02)Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [See USP Controlled Room Temperature]LUPANETA PACK for 1-month copackaged kit (NDC 0074-1052-05) is available incartons containing: leuprolide acetate for depot suspension 3.75 mg for 1-month administration Kit (NDC 0074-3641-04)norethindrone acetate 5 mg tablets; 30 count bottle (NDC 0074-1049-02)Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [See USP Controlled Room Temperature]LUPANETA PACK for 1-month copackaged kit (NDC 0074-1052-05) is available incartons containing: leuprolide acetate for depot suspension 3.75 mg for 1-month administration Kit (NDC 0074-3641-04)norethindrone acetate 5 mg tablets; 30 count bottle (NDC 0074-1049-02)Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [See USP Controlled Room Temperature]


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Leuprolide Acetate for Depot Suspension

Leuprolide acetate for depot suspension is a long-acting GnRH analog. A single injection of leuprolide acetate for depot suspension results in an initial elevation followed by a prolonged suppression of pituitary gonadotropins. Repeated dosing at quarterly intervals results in decreased secretion of gonadal steroids; consequently, tissues and functions that depend on gonadal steroids for their maintenance become quiescent. This effect is reversible on discontinuation of drug therapy.

Leuprolide acetate is not active when given orally.

Norethindrone Acetate

Norethindrone acetate induces secretory changes in an estrogen-primed endometrium.

Non-Clinical Toxicology
Hypersensitivity to GnRH, GnRH agonist or any of the excipients in leuprolide acetate for depot suspension or norethindrone acetate

Undiagnosed abnormal uterine bleeding

Pregnancy or suspected pregnancy

Women who are breast-feeding

Known, suspected or history of breast or other hormone-sensitive cancer

Thrombotic or thromboembolic disorders

Liver tumors or liver disease

Antipsychotic drugs such as phenothiazines or haloperidol; tricyclic antidepressants .

Leuprolide acetate for depot suspension induces a hypoestrogenic state that results in loss of bone mineral density (BMD), some of which may not be reversible. Concurrent use of norethindrone acetate is effective in reducing the loss of BMD that occurs with leuprolide acetate . Nonetheless, duration of use of LUPANETA PACK is limited to two six-month courses of treatment due to concerns about the adverse impact on BMD. It is recommended that BMD be assessed before retreatment. Retreatment with leuprolide acetate for depot suspension alone is not recommended.

In women with major risk factors for decreased BMD such as chronic alcohol (> 3 units per day) or tobacco use, strong family history of osteoporosis, or chronic use of drugs that can decrease BMD, such as anticonvulsants or corticosteroids, use of LUPANETA PACK may pose an additional risk, and the risks and benefits should be weighed carefully.

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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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Professional

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Tips

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Interactions

Interactions

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