Malu

A semisynthetic alkylated estradiol with a 17-alpha-ethinyl substitution. It has high estrogenic potency when administered orally, and is often used as the estrogenic component in oral contraceptives.

Desogestrel (Malu) and Ethinyl Estradiol (Malu) Tablets, USP and Ethinyl Estradiol (Malu) Tablets, USP are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.

Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates.

Preventing pregnancy. It may also be used for other conditions as determined by your doctor.

Desogestrel (Malu)/Ethinyl Estradiol (Malu) is a combination progesterone and estrogen birth control pill. It works by preventing ovulation. It may also change the cervical mucus to prevent the sperm from reaching the egg and change the lining of the uterus to prevent a fertilized egg from implanting in the uterus.

To achieve maximum contraceptive effectiveness, Desogestrel (Malu) and Ethinyl Estradiol (Malu) Tablets, USP and Ethinyl Estradiol (Malu) Tablets, USP must be taken exactly as directed and at intervals not exceeding 24 hours. Desogestrel (Malu) and Ethinyl Estradiol (Malu) Tablets, USP and Ethinyl Estradiol (Malu) Tablets, USP may be initiated using either a Sunday start or a Day 1 start.

NOTE: Each blister is preprinted with the days of the week, starting with Sunday, to facilitate a Sunday start regimen. Six different "day label strips" are provided with each blister in order to accommodate a Day 1 start regimen. In this case, the patient should place the self-adhesive "day label strip" that corresponds to her starting day over the preprinted days.

IMPORTANT: The possibility of ovulation and conception prior to initiation of use of Desogestrel (Malu) and Ethinyl Estradiol (Malu) Tablets, USP and Ethinyl Estradiol (Malu) Tablets, USP should be considered.

The use of Desogestrel (Malu) and Ethinyl Estradiol (Malu) Tablets, USP and Ethinyl Estradiol (Malu) Tablets, USP for contraception may be initiated 4 weeks postpartum in women who elect not to breast-feed. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered.

If the patient starts on Desogestrel (Malu) and Ethinyl Estradiol (Malu) Tablets, USP and Ethinyl Estradiol (Malu) Tablets, USP postpartum, and has not yet had a period, she should be instructed to use another method of contraception until a white tablet has been taken daily for 7 days.

SUNDAY START

When initiating a Sunday start regimen, another method of contraception should be used until after the first 7 consecutive days of administration.

Using a Sunday start, tablets are taken daily without interruption as follows: The first white tablet should be taken on the first Sunday after menstruation begins (if menstruation begins on Sunday, the first white tablet is taken on that day). One white tablet is taken daily for 21 days, followed by 1 green (inert) tablet daily for 2 days and 1 light peach (active) tablet daily for 5 days. For all subsequent cycles, the patient then begins a new 28-tablet regimen on the next day (Sunday) after taking the last light peach tablet. [If switching from a Sunday Start oral contraceptive, the first Desogestrel (Malu) and Ethinyl Estradiol (Malu) Tablets, USP and Ethinyl Estradiol (Malu) Tablets, USP should be taken on the second Sunday after the last tablet of a 21 day regimen or should be taken on the first Sunday after the last inactive tablet of a 28 day regimen.]

If a patient misses 1 white tablet, she should take the missed tablet as soon as she remembers. If the patient misses 2 consecutive white tablets in Week 1 or Week 2, the patient should take 2 tablets the day she remembers and 2 tablets the next day; thereafter, the patient should resume taking 1 tablet daily until she finishes the cycle pack. The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after missing pills. If the patient misses 2 consecutive white tablets in the third week or misses 3 or more white tablets in a row at any time during the cycle, the patient should keep taking 1 white tablet daily until the next Sunday. On Sunday the patient should throw out the rest of that cycle pack and start a new cycle pack that same day. The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after missing pills.

DAY 1 START

Counting the first day of menstruation as "Day 1", tablets are taken without interruption as follows: One white tablet daily for 21 days, one green (inert) tablet daily for 2 days followed by 1 light peach (Ethinyl Estradiol (Malu)) tablet daily for 5 days. For all subsequent cycles, the patient then begins a new 28-tablet regimen on the next day after taking the last light peach tablet. [If switching directly from another oral contraceptive, the first white tablet should be taken on the first day of menstruation which begins after the last ACTIVE tablet of the previous product.]

If a patient misses 1 white tablet, she should take the missed tablet as soon as she remembers. If the patient misses 2 consecutive white tablets in Week 1 or Week 2, the patient should take 2 tablets the day she remembers and 2 tablets the next day; thereafter, the patient should resume taking 1 tablet daily until she finishes the cycle pack. The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after missing pills. If the patient misses 2 consecutive white tablets in the third week or if the patient misses 3 or more white tablets in a row at any time during the cycle, the patient should throw out the rest of that cycle pack and start a new cycle pack that same day. The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after missing pills.

ALL ORAL CONTRACEPTIVES

Breakthrough bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing oral contraceptives. In breakthrough bleeding, as in all cases of irregular bleeding from the vagina, non-functional causes should be borne in mind. In undiagnosed persistent or recurrent abnormal bleeding from the vagina, adequate diagnostic measures are indicated to rule out pregnancy or malignancy. If both pregnancy and pathology have been excluded, time or a change to another preparation may solve the problem. Changing to an oral contraceptive with a higher estrogen content, while potentially useful in minimizing menstrual irregularity, should be done only if necessary since this may increase the risk of thromboembolic disease.

Use of oral contraceptives in the event of a missed menstrual period:

1. If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period and oral contraceptive use should be discontinued until pregnancy is ruled out.
2. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing oral contraceptive use.

See also:
What is the most important information I should know about Malu?

Estrogens should not be used in women (or men) with any of the following conditions:

1. Known or suspected cancer of the breast except in appropriately selected patients being treated for metastatic disease.

2. Known or suspected estrogen-dependent neoplasia.

3. Known or suspected pregnancy.

4. Undiagnosed abnormal genital bleeding.

5. Active thrombophlebitis or thromboembolic disorders.

6. A past history of thrombophlebitis, thrombosis, or thromboembolic disorders associated with previous estrogen use (except when used in treatment of breast or prostatic malignancy).

Use Desogestrel (Malu)/Ethinyl Estradiol (Malu) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Desogestrel (Malu)/Ethinyl Estradiol (Malu). Talk to your pharmacist if you have questions about this information.
• Take Desogestrel (Malu)/Ethinyl Estradiol (Malu) by mouth with or without food.
• If you are also taking colesevelam, take it at least 4 hours before or after taking Desogestrel (Malu)/Ethinyl Estradiol (Malu).
• Eating grapefruit or drinking grapefruit juice while you are taking Desogestrel (Malu)/Ethinyl Estradiol (Malu) may increase the amount of Desogestrel (Malu)/Ethinyl Estradiol (Malu) in your blood, which may increase your risk for side effects. Talk with your doctor before including grapefruit or grapefruit juice in your diet.
• Talk with your doctor about how you should start to take your first pack of Desogestrel (Malu)/Ethinyl Estradiol (Malu). If you begin to take Desogestrel (Malu)/Ethinyl Estradiol (Malu) during the first 24 hours of your period, you do not need to use an extra form of birth control. If you begin to take Desogestrel (Malu)/Ethinyl Estradiol (Malu) on the Sunday after your period starts, you will need to use an extra form of birth control (eg, condoms) for 7 days after you start taking Desogestrel (Malu)/Ethinyl Estradiol (Malu).
• To achieve maximum effectiveness of Desogestrel (Malu)/Ethinyl Estradiol (Malu), it must be taken every day (every 24 hours) and at the same time each day.
• For Desogestrel (Malu)/Ethinyl Estradiol (Malu) to be effective, it must be taken every day. Do not skip doses even if you do not have sex very often. Do not skip pills if you are spotting, bleeding, or nauseated. If you have these side effects and they do not go away, check with your doctor.
• Be sure to have an extra full pack of this medication available at all times.
• If you miss 1 dose of Desogestrel (Malu)/Ethinyl Estradiol (Malu), take it as soon as you remember. Take your next dose at the regular time. This means you may take 2 doses on the same day. You do not need to use a backup method of birth control if you only miss 1 pill. If you miss more than 1 active dose of Desogestrel (Malu)/Ethinyl Estradiol (Malu), read the extra patient information leaflet that comes with Desogestrel (Malu)/Ethinyl Estradiol (Malu) or contact you doctor for instructions. You must use a backup method of birth control if you miss more than 1 active dose of Desogestrel (Malu)/Ethinyl Estradiol (Malu). If you are not sure about how to handle missed doses, use an extra form of birth control (eg, condoms) and talk with your doctor.

Ask your health care provider any questions you may have about how to use Desogestrel (Malu)/Ethinyl Estradiol (Malu).

Serum levels may be increased when used with paracetamol, ascorbic acid, atorvastatin. Serum levels may be reduced by aprepitant, griseofulvin, modafinil, troglitazone, rifampicin, topiramate, nevirapine, amprenavir, lopinavir, nelfinavir and ritonavir. May affect the efficacy of coumarin derivatives. Concurrent use with aminoglutethimide, carbamazepine, felbamate, phenobarbital, phenytoin or topiramate may lead to decrease in contraceptive effectiveness. May reduce the clearance of alprazolam, chlordiazepoxide and diazepam. May increase the clearance of lorazepam, oxazepam, temazepam, clofibric acid, morphine, salicylic acid. May inhibit the metabolism of theophylline, ciclosporin and prednisolone. May decrease the serum levels of lamotrigine. May increase serum levels of selegiline and TCAs e.g. amitriptyline, imipramine.

Food Interaction:

CNS effects of caffeine may be increased if used with caffeine.

See also:
What are the possible side effects of Malu?

Applies to Desogestrel (Malu) / Ethinyl Estradiol (Malu): oral tablet

In addition to its needed effects, some unwanted effects may be caused by Desogestrel (Malu) / Ethinyl Estradiol (Malu). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking Desogestrel (Malu) / Ethinyl Estradiol (Malu):

Incidence not known:

• Abdominal or stomach pain
• absent, missed, or irregular menstrual periods
• anxiety
• change in vision
• changes in skin color
• chest pain or discomfort
• chills
• clay-colored stools
• constipation
• cough
• dark urine
• diarrhea
• dizziness, lightheadedness, fainting
• fever
• hives or welts
• itching skin or rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• nausea and vomiting
• pain or discomfort in the arms, jaw, back, or neck
• pain, tenderness, or swelling of the foot or leg
• pains in the chest, groin, or legs, especially in the calves of the legs
• severe headaches of sudden onset
• slow or fast heartbeat
• sudden loss of coordination or slurred speech
• sudden onset of shortness of breath for no apparent reason
• sudden shortness of breath or troubled breathing
• sweating
• unusual tiredness or weakness
• vomiting of blood

Minor Side Effects

Some of the side effects that can occur with Desogestrel (Malu) / Ethinyl Estradiol (Malu) may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Incidence not known:

• Bloating
• blotchy spots on the exposed skin
• breast enlargement or tenderness
• feeling sad or empty
• irritability
• itching of the vagina or outside the genitals
• loss of interest or pleasure
• pain during sexual intercourse
• thick, white curd-like vaginal discharge without odor or with mild odor
• trouble wearing contact lenses