Leuprolide and Norethindrone (Intramuscular, Oral)

Overview

Norethindrone tablets and leuprolide injection are used in combination to treat pain caused by endometriosis. This drug combination can also be used to prevent the symptoms of endometriosis from reoccurring. This medication shouldn't be used for longer than a 12-month period.

Leuprolide injection is a man-made hormone similar to a natural hormone produced by the brain. It works by decreasing the amount of estrogen in the body and therefore helps in the treatment of endometriosis.

Norethindrone is a man-made progestin hormone that is used to prevent the thinning of the bones that are caused by leuprolide.

You cannot obtain this medication on your own, it's only available via a prescription from your doctor. It's available in the following dosage forms: 3-month powder for suspensions, 1-month powder for suspensions and tablet for oral consumption.

Condition(s) treated

  • Endometriosis

Type of medicine

  • Solution

Side effects

Alongside the intended effects of treating pain from endometriosis, this drug can produce some unwanted side effects. You may not suffer from all of these side effects, but if any do occur, you may need medical attention.

Consult with your doctor right away if you suffer from any of the following side effects while taking this drug combination.

More common

Incidence not known

  • Redness, pain or swelling in the leg or arm

Some of the side effects that may occur with this drug combination, don't typically require medical attention. You usually find these side effects go away as your body started adjusting to the medication. However, you can seek advice from your local healthcare professional for ways to reduce or prevent the intensity of these side effects. You should check with a doctor if any of the following side effects listed below linger or become bothersome.

More common

  • Changes in appetite

Less common

  • Stopping of menstrual bleeding

You may suffer from other side effects that are not listed above. You should seek advice from a healthcare professional if you notice any other effects. You can report all side effects to the FDA on 1-800-FDA-1088.

Dosage

The final dose of any medication will depend upon different factors. Your doctor will consider your weight, age, and height, what other medical conditions you are suffering from and any corresponding treatment you take for them. Your doctor will also take into account the strength of the medication, the duration you will be taking the medication and your reaction to the first dose. Do not change your dose without speaking with a doctor first. If you take too much of this medication you could increase your risk of unwanted side effects, but if you take too little you could reduce your treatment. Do not share this medication with anyone else.

For oral dosage form (tablets) for the treatment of pain due to endometriosis:

Adults:

Should be given five mg once daily for up to six months.

Children:

The use of this drug is not recommended for children.

Missed Dose

If you miss a dose of Leuprolide and Norethindrone, you should take it as soon as you have remembered. However, if it's almost time for your next dose, you should then skip the dose you have missed and return to the regular dosing schedule as set by your doctor. Don't double your doses.

Proper Use

This medication typically comes alongside a patient information leaflet. You should read the information in this leaflet carefully and ensure you understand them before you take this medication. Ask your doctor if you have any questions.

Lupaneta Pack® is a kit that contains two medications: norethindrone tablets and leuprolide injection.

Leuprolide injection is given as an injection into a muscle by a trained health professional in a clinic or hospital. It's a long-acting form of the medication that can be given once every month or once every three months for up to a period of six months of treatment.

Norethindrone tablets are only to be taken via the mouth each day for up to a period of six months after you have received the above injection.

Interactions

This drug can interact with a number of other medications. These interactions could reduce the effectiveness of either drug in its treatment or even produce severe reactions. To help limit the risk of these interactions, you need to make your doctor or healthcare team aware of any other medications you are currently taking to treat any other medical conditions. This list should include all vitamin supplements, herbal remedies and prescription and nonprescription drugs. In most cases, your doctor will avoid treating you with this drug combination to avoid interactions, but in rare cases, it may still be necessary.

The use of this mediation alongside any of the following medications is not typically recommended. Your doctor may avoid treating you with this drug combination or change some of the other medications you are taking.

  • Piperaquine

The use of this medication alongside any of the following medicines is not typically recommended. However, in some cases, it may be necessary. If you are given both medications at the same time, your doctor may alter your dose or the frequency in which you use either medication.

  • Dolasetron

The use of this medication alongside any of the following drugs could increase your risk of certain side effects. But, in some both medications may still be the best medication for you. If you are given both medications together, your doctor may change the dose or frequency in which you use either medication.

  • Cyclosporine

Let your doctor know if you are taking any of the following drugs:

  • Penbutolol

Other interactions

Some medications cannot be used at or around the time of eating food as it could increase the risk of interactions occurring. The use of tobacco or alcohol can also increase interactions with some medication.

The use of this medication alongside any of the following could increase your risk of certain side effects, but in some cases, it may be unavoidable. If you use both together, your doctor may change the dose or frequency in which you use this medication or give you specific instructions about the use of tobacco or alcohol or food.

  • Caffeine

Other Medical Conditions

The presence of other medical conditions could reduce the effect nature of this drug or even increase your risk of interactions. It's important to let your doctor know about any other medical conditions you may suffer from including:

Warnings

There are a number of things to consider before you decide to take this medication. Some of these considerations are listed below.

Allergies

Let your doctor know if you have ever suffered an unusual or allergic reaction to this drug combination before, or any other medications. It's also smart to let your doctor know about any other allergies you may suffer from including animals, dyes, preservatives or foods.

Pediatric population

Appropriate studies have not been conducted on the relationship of age to the effects of Lupaneta Pack® in the younger population. Therefore efficacy and safety have not been established.

Geriatric population

Lupaneta Pack® use has not been studied in women aged sixty-five and older or those postmenopausal women.

Use in pregnancy and breastfeeding

This drug is under FDA pregnancy category X. The use of leuprolide can cause birth defects or harm an unborn child. Don't use if you are currently pregnant. You should stop taking norethindrone tablets right away and let your doctor know if you fall pregnant whilst being treated.

Leuprolide is likely to cause you not to have menstrual periods during the six-month treatment, or cause you not to ovulate. You may still be able to get pregnant.

Us a barrier form of birth control (diaphragm, condom with spermicide) or an intrauterine device. Hormonal contraception (injections, birth control pills, implants, vaginal rings, skin patches) may not be effective enough to prevent you from falling pregnant during treatment.

It's unknown whether this drug combination could pass into breast milk or could harm a nursing baby. You shouldn't breastfeed while using this medication.

It's important that you return to your doctor's office at the correct for your leuprolide injections. Ensure to keep all your appointments.

This medication can cause a serious allergic reaction called including anaphylaxis. This can be life-threatening and requires urgent medical attention. Contact your healthcare professional immediately if you have a itching, rash, hoarseness, trouble swallowing, trouble to breathe, or any swelling of your face, hands or mouth while you are using this medication.

This medication can cause a decrease in your bone mineral density, which could lead to weakened bones or osteoporosis. You should discuss with your doctor or healthcare team about how this could affect you.

Inform your doctor immediately if you have a sudden loss of vision, bulging eyes, double vision, or a migraine headache.

Let your doctor know if you drink alcohol on a regular basis or you use tobacco products or smoke.

Storage

Leuprolide and Norethindrone should be stored in a closed container and kept at room temperature. you should ensure it's kept away from moisture, heat and direct light. Prevent this medication from freezing. You should keep this medication out of the reach of children. Dispose of all medication you no longer need or has passed its expiry date. Your local pharmacist can give you assistance on the best method of disposal for medicines you no longer require.

Summary

When used as directed, this drug combination is successful in the treatment of symptoms of endometriosis. Due to a large number of interactions possible with this drug, it's important that you give your doctor or healthcare team a full list of all the medications you are currently taking. The safety and efficacy have not been established for the use of this drug in children under the age of eighteen. This drug cannot be used in women older than 65 years of age. You should only take this medication as directed, don't take more or less of it. Try to take this medication at a similar time each day. Ensure you turn up at the right times for the injection part of this medication combination. You should not use this medication if you are pregnant as it could cause serious harm or birth defects to the unborn child. Let your doctor know right away if you fall pregnant whilst using this medication. Take measures to prevent pregnancy whilst taking this drug combination. You should also avoid breastfeeding whilst taking Leuprolide and Norethindrone. Do not share this drug with anyone else. If you require any further information about the practical uses of this drug combination, or if you have any more questions or queries, you should contact your local healthcare professional or doctor for more advice.