1 What is Gianvi?

Brand: Gianvi, Loryna, Nikki, Ocella, Syeda, Vestura, Yasmin, YAZ, Yaz 28, Zarah

Generic: Drospirenone and Ethinyl Estradiol

Gianvi is used to prevent pregnancy as a birth control pill. It contains two types of hormones, Ethinyl Estradiol and Drospirenone. This drugs when taken, will be able to prevent the pregnancy.

It combination of combination of Drospirenone and Ethinyl Estradiol prevents the woman's egg from fully developing each and every months. The egg will not be able to receive or accept a sperm and fertilization is prevented hence the pregnancy. It is also used to treat premenstrual dysphoric disorders (PMDD) and acne in women when at minimum 14 years of age.

PMDD is a severe form of premenstrual syndrome (PMS). It is known that PMDD may have severe emotional and physical symptoms which may come between 10-14 days before the menstrual flows begin. However, it is known that no contraceptive is 100% effective.

Birth control methods which involve surgical procedures in order to become sterile or not having sex are more effective birth controls compared to the pills. It is important that the options of the birth control pills are discussed with your doctor.

These drugs also do not protect one from AIDs or other STDS. This will also not help in emergency contraception more especially after having unprotected sex. This medicine is available with a doctor’s prescription and in a variety of dosage forms.

2 What to Know Before Using

Before using Gianvi, you must know all about the risks and complications associated with it.

Risks for taking the medicines needs to weight against the potential benefit of the medicine. This is a decision that needs to be weighed by you and your doctor. In addition, allergies to the use of the drugs also need to be checked. This should be checked against the use of medicines or other medicines. Any other allergies against food, dyes or preservatives must also be evaluated. In case of non-prescriptions products, the labels need to be read carefully before using the medicine.

Studies on the effects of the combination of Drospirenone and Ethinyl Estradiol have not been done on the pediatrics. However, it is not expected that the teenagers to use this type of medicine. Similarly, age related studies have also not been performed on the children. The problems that limit the usefulness of these medications in teenagers are also not anticipated.

This medicine may be used for birth control in teenagers but is not supposed to be used for menstruation. Geriatric studies to evaluate the relationship between age to effects of combination of Drospirenone and Ethinyl Estradiol have also not been performed. This medicine may also not be used for elderly women.

The uses of the combination of Drospirenone and Ethinyl Estradiol have demonstrated positive evidence of fetal abnormalities. This drug need not be used for women that are intending to become pregnant and or may become pregnant since the risk for use out-weighs the potential benefits. Finding from women breastfeeding have demonstrated that the drug causes harmful infants effects. It is recommended that an alternative medicine needs to be prescribed or stopped immediately in breastfeeding mothers.

Studies on Ethinyl Estradiol show that this medication may alter milk production or composition. Even with use of an alternative of this medicine, monitoring of side effects to the infants needs to be done and ensure that adequate milk intake is guaranteed.

Drug interactions may also be possible when using this drugs when used together with other drugs. However, this may still be used even with interaction with other forms of medicines. However, the doctor may prescribe other lower doses and precautions be taken as necessary. Always inform your medical doctor on any of the medicines that you are taking. For drugs that cause interactions, they are not recommended for use with combination of Drospirenone and Ethinyl Estradiol.

Other options may be explored or change of other medicines be done. Some of the drugs include:

  • Boceprevir
  • Dasabuvir
  • Ombitasvir
  • Paritaprevir
  • Ritonavir and
  • Tranexamic Acid

These drugs must never be used with this medicines. However, they may be required in some of the cases. Whenever they are prescribed together, you doctor will change the dose and how the drugs are used or both medicines. Some other drugs increase the risk of causing side effects when used with other drugs. This drugs include:

  • Anagrelide
  • Boceprevir
  • Bupropion
  • Carbamazepine
  • Ceritinib
  • Clozapine
  • Crizotinib
  • Dabrafenib
  • Darunavir
  • Donepezil
  • Eliglustat
  • Fentanyl
  • Idelalisib
  • Isotretinoin
  • Lumacaftor
  • Nilotinib
  • Paclitaxel
  • Paclitaxel
  • Protein-Bound
  • Piperaquine
  • Pirfenidone
  • Sugammadex
  • Theophylline
  • Tizanidine
  • Ulipristal

However, using both form of the treatment will the best option for treatment when prescribed together. Your medical doctor may also change the dose or how frequent the drug can be used for both medicines or each of the medicines. Some optional drugs for consideration include:

  • Alprazolam
  • Amprenavir
  • Aprepitant
  • Atazanavir
  • Bacampicillin
  • Betamethasone
  • Bexarotene
  • Bosentan
  • Clarithromycin
  • Colesevelam
  • Cyclosporine
  • Delavirdine
  • Efavirenz
  • Eslicarbazepine Acetate
  • Etoricoxib
  • Etravirine
  • Fosamprenavir
  • Fosaprepitant
  • Fosphenytoin
  • Ginseng
  • Griseofulvin
  • Lamotrigine
  • Licorice
  • Modafinil
  • Mycophenolate
  • Mofetil
  • Mycophenolic Acid
  • Nelfinavir
  • Oxcarbazepine
  • Parecoxib
  • Phenobarbital
  • Phenytoin
  • Prednisolone
  • Primidone
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Ritonavir
  • Roflumilast
  • Rosuvastatin
  • Rufinamide
  • Selegiline
  • St John's Wort
  • Telaprevir
  • Tipranavir
  • Topiramate
  • Troglitazone
  • Troleandomycin
  • Valdecoxib
  • Voriconazole
  • Warfarin

In addition, some drugs may cause other forms of drug interaction when used at the time of eating food or eating certain types of foods since interactions may occur. Using these drugs together with tobacco or alcohol may also cause other forms of interaction. Use of these drugs may lead to increased side effects and may be unavoidable in some cases. If they have to be used together, there may be need to change the dose or how this medicine may be used.

The doctor may also provide special instructions on the use of food, alcohol or tobacco. Grapefruits are also not recommended for use with these medicines. Inform your medical doctor in case of medical problems.

The more serious problems include: Abnormal or unusual vaginal bleeding or adrenal disease or blood disorders e.g hypercoagulopathy or breast cancer, diabetes, kidney, eye or blood vessels damage or history of heart attack, uncontrolled kidney or liver diseases such as tumour, cancers or migraine headache, clots in the blood circulation, problem with heart valves or stroke. Angioedema may also present characterized by the swelling of the face, tongue, or throat, inherited or Chloasma gravidarum which is a form of skin disorder during pregnancy, history of Cholestasis associated with problems with the bile during pregnancy, depression, Diabetes or Dyslipidemia (high cholesterol or fats in the blood), disorders or diseases of gallbladder disease or hyperkalemia or Hypertension and other conditions need to be controlled.

This drugs needs to be used in this condition with caution. This is because they may make this disease worse.

3 Proper Usage

To use Gianvi correctly, you must follow all instructions given by your doctor.

It is important that one understand how and when to take the oral contraceptives so as to make the use of the drugs safe and reliable as much as possible. The side effects of the medicines also need to be understood. The medicines are packaged with patient information which needs to be read and followed strictly. In case of any queries, ask your doctors or pharmacists.

The medicines are also available in blister packs. Every of the blister packs contain 28 tablets with different colors which must be used as instructed in the blister pack. The drug takes about 7 days before the pregnancy can be prevented. One also needs to use another form of contraception such as a condom, spermicide or diaphragm for the first 7 days of the cycle of pills.

The medicine needs to be taken same time every day after every meal or at bedtime. The medicine can be taken with or without food. No skipping or delaying the pill for more than 24 hours. In case of missed dose, chances of getting pregnant are higher. Seeks for ways of reminding yourself of ways of taking your pill or use another method of birth control.

Spotting may occur during the first pill. Sometimes, one may feel sick nauseous in the first few months after using this medicine. In case of persistent nausea, inform your doctor. When vomiting and diarrhea within a span of 3 or 4 hours of using the medicine. Always follow the instructions in the leaflet or call your doctor when in need of proper advice.

When switching from a combination of hormonal method or another form of a pill, patch or vaginal ring to using another drug such as yasmin.

Always use this drug on the first day of your period. If the periods do not occur, check on your doctor for a pregnancy test. If you have been using a vaginal ring or patch, use the pill on the day the ring is removed. A second precautionary methods of birth control must be used such a diaphragm, condom, spermicide for the first 7 days after taking the medicine. When shifting from progestin only such as progestin only pill, implant, injection,intrauterine systems to using yasmin.

It is advisable that you should take the medicine on the day you were to take the next progestin only pill on the day the implant is removed, or when you would have had your next injection.

A second method of birth control can also be used for the first seven days after taking this medicine. The dose for this medicine will vary from patient to patient. Always follow the instruction provided on the dose of the medicine or as instructed by your medical doctor. Information provided here is just an average dose for this medicine as should never be deemed as the right dosage for a medicine. Never change your dosage as administered by your doctor unless your doctor recommends it.

The amount of medicine administered also relies on the strength of the medicine, duration to be taken and how frequent the dose must be administered. You may be asked to start your dose on the first day of your menstrual period which is referred to as Day 1 start or even the first Sunday called Sunday start. Follow the same schedule after starting the medicine even after missing a dose of a medicine. In case the schedule is not convenient, consult your doctor about changing it.

In case of a Sunday start, it will require the use of another form of birth control such as a condom,diaphragm or spermicide for the first 7 days. The all 28 day regime for the drug need also to be followed strictly and follow the same schedule strictly.

As for the oral dosage, for use in contraception, PMDD or acne in adults and teenagers: One yellow tablet should be taken at the same time for 21 days followed by a white tablet for 7 days every menstrual cycle. One pink tablet when taken at the same time each day for 24 consecutive days followed by a white (inert_ tablet daily for four days as per the menstrual cycle. As for children, use a dose that will be determined by the medical doctor.

Store drugs appropriately as instructed at room temperature, heat, moisture and light. Avoid freezing places. Never use outdated medicine and must be dispose off when not needed. Always ask your medical doctor how the medicine can be disposed of and when not in use.

4 Precautions to Take

Before using Gianvi, there are some precautions you must take.

Regular checkups for progress after use of the medicines are important so as to check on whether the medicines are working and affecting the expected effect in the body. This is also to screen for unwanted effects. The screening can take about 6 to 12 months but more time can be used when required. The blood pressure may also be checked while using this medicine.

In addition, this medicine when taken in pregnancy, it is likely to cause harm to the unborn baby though it can be used in the prevention of pregnancy. In case one gets pregnant after using this medicine, inform your medical doctor right away. Always inform your medical doctor if you had a baby within duration of 4 weeks before you can start using the medicine.

Often, vaginal bleeding of various amounts may occur between times when the menstrual periods are to occur in the first three months. This is referred to as spotting when both light of break through heavy spotting occurs. You are advised to continue with your medication on a regular schedule. Often, the bleeding will stop after a period of 1 week. But when the bleeding continuous for more than 1 week, inform your medical doctor immediately. When the bleeding proceeds after using the hormonal contraceptive for more than 3 months, check with your doctor.

If you miss the menstrual period,check on your doctor immediately.Missed periods may occur when one skips one or more tablets and you did not follow the instructions on taking the pill. When two periods in a row is missed, talk to your doctor. It is Important that a pregnancy test be performed. If you suspect pregnancy, the medicine has to be stopped immediately and check with your doctor.

Never use cigarettes when using this medicines and when over 35 years of age. Smoking while using pills containing Drospirenone increases a risk of having blood clots, may lead to heart attack, or stroke. When over the age of 35 years, suffering from diabetes, high blood pressure, high cholesterol or overweight, your risk to blood clots is even higher. Ask for advice on ways to stop smoking. Keep diabetes under control. Use diet and exercise to control for your weight and blood cholesterol levels.

Use of these medicines may increase your risk of blood clot problems more especially in the first 6 months of use. The risk is even higher when using you uses the pill in the first 6 months of use. The risk is increased when using a birth control pill containing Drospirenone and Ethinyl Estradiol. It is advised to stop using this pill and check with your medical doctor immediately.

In case of pain in the chest, legs or calves or difficulty in breathing, sudden headache, slurred speech, shortness of breath, loss of coordinatoon or change in vision while using this medicine. Check immediately with your doctor and stop using the contact lenses, but if the vision is blurred, and experiencing the difficulty in reading, stop using this medicine and check with your doctor.

Sometimes, one may have pain, tenderness in the upper stomach, dark urine, pale stool, yellow eyes, skin. This may be an indication of liver problems. Always check with your doctor before refilling an old prescription after pregnancy.

Physical examination may be needed and you doctor may vary the prescriptions. Other medical practitioners handling your problem may need to know that you if you are using this medicine. One may be expected to stop using this medicine at least 4 weeks before and 2 weeks before one can have a major surgical procedure.

The hormone pills may cause skin discoloration. It is advised to use sun screen when outdoors. Do not use sun lamps and tanning beds. Never take the medicines unless they have been discussed with your medical doctor.

5 Potential Side Effects

If you notice any side effects of Gianvi, immediately make an appointment with your doctor. Inform your medical doctor when common side effects such as:

  • Breast pain
  • Tenderness
  • Headache
  • Severe and throbbing heavy non menstrual vaginal bleeding
  • Irregular menstrual periods
  • Nausea
  • Normal menstrual bleeding starting earlier than required and lasting longer than expected

Less common are:

  • Longer and heavier menstrual periods with unusual tiredness or weakness and vomiting
  • Sometimes, abdominal pain or chills may be involved
  • Chills
  • Clay colored stool
  • Dark urine difficulty in breathing
  • Dizziness
  • Fever
  • Headache
  • Itching
  • Loss of appetite
  • Pain in the chest, groin, or
  • Slurred speech
  • Sudden loss of coordination
  • Severe weakness or numbness in the arm or legs
  • Sudden or unexplained shortness of breath
  • Unpleasant breath odor
  • Unusual tiredness
  • Weakness
  • Changes in vision
  • Vomiting blood
  • Yellow eyes or skin

Some side effects may however not need any form of medical attention since their effects may go away during the treatment as your body adjusts to the medicine. Your medical doctor may also advice you on ways of reducing the side effects.

In addition, check with your medical doctor when the side effect persists and becomes bothersome. In addition, when having medical questions about the use of the pills, seek the attention of your medical doctor.

Less common side effects following the use of a combination of drospirenone and ethinyl estradiol include:

  • Crying
  • Decreased interest in sexual activity
  • Delusions of persecutions
  • Mistrusts
  • Suspiciousness and combativeness
  • False unusual sense of wellbeing
  • Inability to have or keep an erection
  • Irritability
  • Loss of sexual ability, desire, drive or performance
  • Mental depression
  • Quick to react and overreact emotionally with rapidly changing moods
  • Weight gain

Other side effects are not listed here may also occur in patients. In case of any other side effects, ask your healthcare professional for advice. You may also call to report directly to FDA at 1-800-FDA-1088.

6 Related Clinical Trials