Bio-Luton - General Information:

The major progestational steroid that is secreted primarily by the corpus luteum and the placenta. Bio-Luton acts on the uterus, the mammary glands and the brain. It is required in embryo implantation; pregnancy maintenance, and the development of mammary tissue for milk production. Bio-Luton, converted from pregnenolone, also serves as an intermediate in the biosynthesis of gonadal steroid hormones and adrenal corticosteroids. [PubChem]

Pharmacology:

Bio-Luton is a progestin or a synthetic form of the naturally occurring female sex hormone, progesterone. In a woman's normal menstrual cycle, an egg matures and is released from the ovaries (ovulation). The ovary then produces progesterone, preventing the release of further eggs and priming the lining of the womb for a possible pregnancy. If pregnancy occurs, progesterone levels in the body remain high, maintaining the womb lining. If pregnancy does not occur, progesterone levels in the body fall, resulting in a menstrual period. Bio-Luton tricks the body processes into thinking that ovulation has already occurred, by maintaining high levels of the synthetic progesterone. This prevents the release of eggs from the ovaries.

Bio-Luton for patients

PATIENT INSERT

PROMETRIUM
(progesterone, USP)
Capsules 100 mg
Capsules 200 mg

Read this PATIENT INFORMATION before you start taking PROMETRIUM® Capsules and read what you get each time you refill PROMETRIUM Capsules, because there may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT PROMETRIUM CAPSULES (A Progesterone Hormone)?

  • Progesterone with or without estrogens should not be used to prevent heart attacks or heart disease.
  • Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens with progestins may increase your risk of dementia. You and your healthcare provider should talk regularly about whether you still need treatment with PROMETRIUM Capsules.

THIS PRODUCT CONTAINS PEANUT OIL AND SHOULD NOT BE USED IF YOU ARE ALLERGIC TO PEANUTS.

WHAT IS PROMETRIUM CAPSULES?

PROMETRIUM Capsules contain the female hormone called progesterone.

What is PROMETRIUM Capsules used for?

Treatment of Menstrual Irregularities
PROMETRIUM Capsules are used for the treatment of secondary amenorrhea (absence of menstrual periods in women who have previously had a menstrual period) due to a decrease in progesterone. When you do not produce enough progesterone, menstrual irregularities can occur. If your healthcare provider has determined your body does not produce enough progesterone on its own, PROMETRIUM Capsules may be prescribed to provide the progesterone you need.

Protection of the Endometrium (Lining of the Uterus)
PROMETRIUM Capsules are used in combination with estrogen-containing medications in postmenopausal women with a uterus. Taking estrogens alone increases the chance of developing a condition called endometrial hyperplasia, that may lead to cancer of the lining of the uterus. In general, the addition of a progestin is recommended for women with a uterus to reduce the chance of getting cancer of the uterus.

Who should not take PROMETRIUM Capsules?

Do not start taking PROMETRIUM Capsules if you:

  • are allergic to peanuts.
  • are allergic to progesterone, progesterone-like drugs, or any of the inactive ingredients in the capsules.
    See the end of this leaflet for a list of ingredients in PROMETRIUM Capsules.
  • are pregnant or suspect that you are pregnant.
  • have or have had blood clots in the legs, lungs, eyes, brain, or elsewhere.
  • have liver disease.
  • have known or suspected cancer of the breast or reproductive organs.
  • have unusual bleeding from the vagina which has not been evaluated by your healthcare provider.
  • have a miscarriage and your healthcare provider suspects some tissue is still in the uterus.
  • are nursing.

Tell your healthcare provider:

  • if you are breastfeeding. The hormones in PROMETRIUM Capsules can pass into your milk.
  • about all of your medical problems. Your healthcare provider may need to check you more carefully if you have certain conditions, such as diabetes, asthma (wheezing), epilepsy (seizures), migraine, endometriosis, lupus, problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
  • about all the medicines you take. This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how PROMETRIUM Capsules works. PROMETRIUM Capsules may also affect how your other medicines work.

How should I take PROMETRIUM Capsules?

  1. Prevention of Endometrial Hyperplasia: Postmenopausal women with a uterus who are taking estrogens should take a single daily dose of 200 mg PROMETRIUM Capsules at bedtime for 12 continuous days per 28-day cycle.
  2. Secondary Amenorrhea: PROMETRIUM Capsules may be given as a single daily dose of 400 mg at bedtime for 10 days.
  3. PROMETRIUM Capsules are to be taken at bedtime as some women become very drowsy* and/or dizzy* after taking PROMETRIUM Capsules. In a small percentage of these women, these effects may be increased including blurred vision, difficulty speaking, difficulty walking, and feeling abnormal. If you experience these symptoms, discuss them with your healthcare provider immediately. Taking PROMETRIUM Capsules at bedtime may minimize the impact of these symptoms.

    * Use caution when driving a motor vehicle or operating machinery as dizziness or drowsiness may occur.

If you experience difficulty in swallowing PROMETRIUM Capsules, it is recommended that you take your daily dose at bedtime with a glass of water while in the standing position.

What are the risks associated with PROMETRIUM Capsules?

  • Risk to the Fetus: Rare cases of cleft palate, cleft lip, and congenital heart defects have been reported in the infants of women using PROMETRIUM Capsules during early pregnancy. Although it is not clear that these events were drug related, you should check with your healthcare provider about the risks to your unborn child of any medication taken during pregnancy.
  • Abnormal Blood Clotting: Use of progestational drugs has been associated with changes in the blood-clotting system. These changes allow the blood to clot more easily, possibly allowing clots to form in the bloodstream. If blood clots do form in your bloodstream, they can cut off the blood supply to vital organs, causing serious problems. These problems may include a stroke (by cutting off blood to part of the brain), a heart attack (by cutting off blood to part of the heart), a pulmonary embolus (by cutting off blood to part of the lungs), visual loss or blindness (by cutting off blood vessels in the eye), or other problems. Any of these conditions may cause death or serious longterm disability. Call your healthcare provider immediately if you suspect you have any of these conditions. He or she may advise you to stop using this drug.
  • Eye Abnormalities: Discontinue medication and call your healthcare provider immediately if you experience sudden partial or complete loss of vision, blurred vision, or sudden onset of bulging eyes, double vision, or migraine.

What are the possible side effects of PROMETRIUM Capsules?

Consult your healthcare provider if you experience any of the side effects mentioned below or other side effects.

SIDE EFFECTS REPORTED IN STUDIES OF PATIENTS AT DOSES OF 100 MG/DAY to 400 MG/DAY:
Blood and Lymphatic System: swelling of the lymph nodes
Cardiovascular System: high blood pressure, hot flashes, pounding or racing of the heart
Digestive System: bloating, constipation, diarrhea, dry mouth, heartburn, indigestion, nausea/vomiting
General Disorders: abdominal pain (cramping), back pain, chest pain, fatigue, fever, fluid retention, headache, intestinal pain, stomach pain, swelling, swelling of the legs and arms
Infections: bronchitis, fungal vaginal infection, infections, inflammation of the vagina, upper respiratory tract infection, urinary tract infection, viral infection
Musculoskeletal System: arthritis, joint pain, muscle or bone pain, leg cramps, muscle cramps
Nervous/Psychiatric System: anxiety, confusion, decreased concentration, depression, dizziness*, drowsiness*, irritability, mood swings, personality disorder, sleep disorder, worry
Respiratory System: coughing, fluid in sinus cavities, nasal congestion, sore throat, fluid in the lungs
Reproductive System: breast pain, breast tenderness, vaginal discharge, vaginal dryness, uterine fibroid
Skin: acne, night sweats
Eyes: blurred vision
Kidney and Urinary System: urinary problems

* Use caution when driving a motor vehicle or operating machinery as dizziness or drowsiness may occur.

During the marketing of PROMETRIUM Capsules, other adverse events have been reported, including reversible cases of liver problems, particularly in patients taking high doses. Additionally, rare occurrences of fainting and/or low blood pressure have also been reported.

These are some of the warning signs of serious side effects:

Be alert for unusual signs and symptoms. If any of these warning signals (or any other unusual symptoms) happen while you are using PROMETRIUM Capsules, call your healthcare provider immediately:

  • Breast lumps (Ask your healthcare provider to show you how to examine your breasts monthly.)
  • Pain, swelling, or tenderness in the abdomen
  • Tremors or seizures, migraine headaches, shortness of breath or asthma, heart problems, or kidney problems
  • Abnormal bleeding from the vagina
  • Feelings of depression
  • Pains in the calves or chest; a sudden shortness of breath; or coughing blood, indicating possible clots in the legs, heart or lungs
  • Severe headache, vomiting, dizziness, faintness, or changes in vision or speech; weakness or numbness in an arm or leg, indicating possible clots in the brain or eye

General information about safe and effective use of PROMETRIUM Capsules

  • Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not take PROMETRIUM Capsules for conditions for which it was not prescribed.
  • Your healthcare provider has prescribed this drug for you and you alone. Do not give PROMETRIUM Capsules to other people, even if they have the same symptoms you have. It may harm them.
  • PROMETRIUM Capsules should be taken as a single daily dose at bedtime. Some women may experience extreme dizziness and/or drowsiness during initial therapy. In a small percentage of women, these effects may be increased including blurred vision, difficulty speaking, difficulty walking, and feeling abnormal. If you experience these symptoms, discuss them with your healthcare provider immediately. A single bedtime dose may reduce the impact of these symptoms.
  • Use caution when driving a motor vehicle or operating machinery as dizziness or drowsiness may occur.

Keep PROMETRIUM Capsules out of the reach of children.

This leaflet provides a summary of the most important information about PROMETRIUM Capsules. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about PROMETRIUM Capsules that is written for health professionals. You can get more information by calling the toll free number 1-800-241-1643.

What are the ingredients in PROMETRIUM Capsules?

Active ingredient: 100 mg or 200 mg micronized progesterone

The inactive ingredients for PROMETRIUM Capsules 100 mg include: peanut oil NF, gelatin NF, glycerin USP, lecithin NF, titanium dioxide USP, D&C Yellow No. 10, and FD&C Red No. 40.

The inactive ingredients for PROMETRIUM Capsules 200 mg include: peanut oil NF, gelatin NF, glycerin USP, lecithin NF, titanium dioxide USP, D&C Yellow No. 10, and FD&C Yellow No.

Bio-Luton Interactions

Drug/Laboratory Test Interactions

The following laboratory results may be altered by the use of estrogen-progestin combination drugs:

  • Increased sulfobromophthalein retention and other hepatic function tests.
  • Coagulation tests: increase in prothrombin factors VII, VIII, IX and X.
  • Metyrapone test.
  • Pregnanediol determination.
  • Thyroid function: increase in PBI, and butanol extractable protein bound iodine and decrease in T3 uptake values.

Fasting and 2-hour plasma insulin and glucose levels following an oral glucose tolerance test (OGTT) and figrinogen levels were measured in patients receiving PROMETRIUM® Capsules at a dose of 200 mg/day for 12 days per 28 day cycle in combination with conjugated estrogens 0.625 mg/day (n-120). Table 6 summarizes this data. Plasma insulin levels 2 hours post-OGTT were decreased from baseline. The fasting plasma glucose and fasting plasma insulin levels were also decreased from baseline. Glucose levels 2 hours post-OGTT were increased slightly. There was no effect on fibrinogen levels.

For information on changes in lipid profile, see the CLINICAL PHARMACOLOGY, Clinical Studies subsection, Table 5.

Table 6

Mean Changes from Baseline in Insulin and Glucose Levels After 36 Months of Treatment

Parameter
Treatment Group Mean
(Mean % Change)

Conjugated Estrogens 0.625 mg + PROMETRIUM 200mg (cyclical)a

Conjugated Estrogens 0. 625 mg (only)

Placebo

N= 173 to 176b N=170 to 172b N=171

mean

mean % change

mean

mean % change

mean

mean % change

OGTT Insulin
(pmol/L)
Fasting
2 hour
-2.2
-45.2
-6.2
 -14.5
-1.1
 -23.9
-3.2
 -7.9
5.1
 -29.7
14.2
 -9.1
Glucose(mg/dL)
 Fasting
2 hour
-3.0
 3.6
-2.9
 5.2
-2.7
5.0
-2.7
7.8
-1.0
2.1
-0.9
3.9

a There are no significant changes (p<0.05) from conjugated estrogens values
b Number of subjects (N) varies by parameter

Also see CLINICAL PHARMACOLOGY.

Bio-Luton Contraindications

PROMETRIUM Capsules should not be used in women with any of the following conditions:

1. PROMETRIUM Capsules should not be used in patients with known hypersensitivity to its ingredients. PROMETRIUM Capsules contain peanut oil and should never be used by patients allergic to peanuts.
2. Undiagnosed abnormal genital bleeding.
3. Known, suspected, or history of cancer of the breast.
4. Active deep vein thrombosis, pulmonary embolism or history of these conditions.
5. Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction).
6. Liver dysfunction or disease.
7. Known or suspected pregnancy. There is no indication for PROMETRIUM Capsules in
pregnancy. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy.

Bio-Luton more info

Indication, Mechanism Of Action, Drug Interactions, Food Interactions, etc..