Apri

Apri is an oral preparation which is often used to prevent pregnancy. Desogestrel is a progestogen that is structurally related to levonorgestrel while ethinyl estradiol is a synthetic estrogen.

When used together, they inhibit ovulation by a negative feedback mechanism on the hypothalamus, which alters the normal FSH and LH secretion pattern by the anterior pituitary.

It inhibits the follicular phase FSH and a midcycle surge of gonadotropins. It also causes changes in the cervical mucus, making it unsuitable for sperm penetration. It may also alter the tubal transport of the ova through the fallopian tubes.

This medicine is available only with your doctor's prescription. This product is available in the following dosage forms:

• Tablet

Before using Apri, you must know all about the risks and complications associated with it. The suitable drug therapy is usually chosen by a doctor with the active participation of the patient.

There are some important factors such as drug interactions, the presence of any metabolic impairment, history of hypersensitivity reaction, pregnancy, lactation etc. which may alter the desired therapeutic effects of a medicine.

Sometimes the presence of other health disorders affects the beneficial effects of this medicine and even may cause serious toxic effects. If you have had any allergic reactions to any medicine then you must tell your doctor about that.

The use of this oral contraceptive preparation is contraindicated in those who are hypersensitive to this drug or any of the ingredients of the formulation.

Make sure you inform your doctor if you have any other medical problems, especially:

Absolute contraindications:

• Thromboembolic, coronary, and cerebrovascular disease or a history of it.
• Moderate-to-severe hypertension; hyperlipidemia.
• Active liver disease, hepatoma or history of jaundice during past pregnancy.
• Suspected or overt malignancy of genitals or breast.
• Porphyria.
• Impending major surgery –to avoid excess risk of postoperative thromboembolism.

Relative contraindications (requiring avoidance or cautious use under supervision):

• Diabetes –control may be vitiated.
• Obesity
• Smoking
• Undiagnosed vaginal bleeding
• Uterine leiomyoma –may enlarge with estrogenic preparations; progestin-only pills can be used.
• Mentally ill
• Age above 35 years
• Mild hypertension
• Migraine
• Gallbladder disease

Because of drug-drug interactions, certain medicines should not be used along with this medicine. It is always recommended to consult with your doctor if you are in need of some other medications or even any over-the-counter medicine for another health problem in order to avoid unwanted toxic effects.

The following drug interactions should be kept in mind:

• Contraceptive failure may occur if the following drugs are used concurrently: enzyme inducers –phenytoin, phenobarbitone, primidone, carbamazepine, rifampicin, ritonavir, etc.
• This combined oral pill may reduce the clearance of alprazolam, chlordiazepoxide, and diazepam.
• May increase the clearance of lorazepam, oxazepam, temazepam, clofibric acid, morphine, and salicylic acid.
• Serum level of this drug may be increased when used with paracetamol, ascorbic acid, and atorvastatin.
• Serum level may be reduced by aprepitant, griseofulvin, modafinil, troglitazone, rifampicin, topiramate, nevirapine, amprenavir, lopinavir, nelfinavir, and ritonavir.

Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience.

Thus, this drug should not be used during pregnancy because the risk clearly outweighs any possible benefit. Besides, caution should be exercised when used in lactating women because there are no adequate studies in women for determining infant risk when using this medication during breastfeeding.

To use Apri properly, you must follow all instructions given by your doctor. The dosage schedule and the duration of drug therapy should be individualized and determined based on the physician’s advice. The therapeutic dose may also vary with the patient’s condition or requirement and the strength of the medicine as well.

To make using oral contraceptives as safe and reliable as possible, you should understand how and when to take them and what effects may be expected. This medicine comes with patient instructions. You should read and follow the instructions carefully. Ask your doctor or pharmacist if you have any questions.

For oral dosage form (tablets):

• For contraception (to prevent pregnancy):
  • Adults and teenagers—One light orange tablet is taken at the same time each day for 21 consecutive days followed by one green (inert) tablet daily for 7 days per menstrual cycle.

This medicine is available in blister packs with a tablet dispenser. Each blister pack contains 28 tablets with different colors that need to be taken in the same order as directed on the blister pack.

Your doctor may ask you to begin your dose on the first day of your menstrual period (called Day 1 start) or on the first Sunday after your menstrual period starts (called Sunday start).

When you begin using this medicine, your body will require at least 7 days for adjusting before a pregnancy will be prevented. Use the second form of contraception, such as a condom, spermicide, or diaphragm, for the first 7 days of your first cycle of pills.

If you miss taking a tablet, you should take two tablets the next day and continue as usual. If more than 2 tablets are missed, then the course should be interrupted. Here, an alternative method of contraception should be used and the next course should be started on the 5th day of bleeding.

Do not use this drug in larger amounts, more often, or for a longer time than your doctor ordered. Further, it is advised to store the medicine in a closed container at room temperature away from heat, moisture, and direct light. All kinds of medicines should be kept out of the reach of children. However, outdated medicines should be disposed of by an appropriate way.

Before using Apri, there are some precautions you must take. Firstly, regular visits to your doctor are recommended to check that this medicine is working properly or not.

These visits will usually be every 6 to 12 months, but some doctors require them more often. Your doctor may also want to check your blood pressure while taking this medicine.

Additionally, the following guidelines should be followed to prevent unwanted complications as well as for the better prognosis of the patients:

Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm the unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away. Make sure your doctor knows if you have had a baby within 4 weeks before you start using this medicine.

This medicine does not prevent HIV infection or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.

Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough bleeding when heavier. If the bleeding continues after you have been taking hormonal contraceptives on schedule and for more than 3 months, check with your doctor.

Check with your doctor right away if you miss a menstrual period. Missed periods may occur if you skip one or more tablets and have not taken your pills exactly as directed. If you miss two periods in a row, talk to your doctor. You might need a pregnancy test.

If you suspect that you may be pregnant, stop taking this medicine immediately and check with your doctor.

Using this medicine may increase your risk of having blood clotting problems. This usually occurs when you first start taking this medicine, or after starting birth control pills after not using them for a month or more.

Check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, difficulty with breathing, a sudden, severe headache, slurred speech, a sudden, unexplained shortness of breath, a sudden unexplained shortness of breath, a sudden loss of coordination, or vision changes while using this medicine.

Using this medicine may increase your risk of breast cancer or cervical cancer. Talk with your doctor about this risk. Check with your doctor immediately if your experience abnormal vaginal bleeding.

Check with your doctor immediately if you wear contact lenses or if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want an eye doctor to check your eyes.

Check with your doctor right away if you have pain or tenderness in the upper stomach, dark urine or pale stools, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Using this medicine may increase your risk for gallbladder surgery. Talk with your doctor about this risk.

However, no contraceptive method is 100% effective. Birth control methods such as having surgery to become sterile or not having sex are more effective than birth control pills. Discuss your options for birth control with your doctor.

Make sure you meet with your doctor in using Apri to avoid unwanted potential side effects. Along with the beneficial effects, this medicine may cause some unwanted effects that may not need any medical attention.

These side effects usually go away during the treatment episode as your body adjusts to the medicine. Your healthcare professional may advise you about the ways how to prevent or reduce those unwanted side effects.

Sometimes you may need to consult with the doctor if you notice any of the following toxic effects:

Common non-serious side effects:

• Nausea and vomiting –similar to morning sickness of pregnancy.
• A headache is generally mild; a migraine may be precipitated or worsened.
• Breakthrough bleeding.
• Breast discomfort.

Side effects that appear later:

• Weight gain, acne, and increased body hair.
• Chloasma –pigmentation of cheeks, nose, and forehead, similar to that occurring in pregnancy.
• Pruritus vulvae are infrequent.
• Carbohydrate intolerance and precipitation of diabetes in few subjects.
• Mood swings, abdominal distention are occasional.

Serious complications:

• Leg vein thrombosis and pulmonary embolism.
• Coronary and cerebral thrombosis resulting in myocardial infarction or stroke.
• The rise in blood pressure.
• Gallstone formation is slightly higher.
• Benign hepatoma –may rupture or turn malignant.
• Genital carcinoma –an increased incidence of vaginal, cervical and breast cancer has been reported based on animal data.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.