Medication Guide
Bosentan (boe sen' tan) Tablets for Oral Suspension
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Read the Medication Guide that comes with bosentan tablets for oral suspension before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or your treatment.
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What is the most important information I should know about bosentan tablets for oral suspension?
Bosentan tablets for oral suspension can cause serious side effects including:
Liver damage.
- Liver damage may not cause symptoms at first. Only a blood test can show if you have early liver damage. You must have your blood tested to check your liver function before you start bosentan tablets for oral suspension and each month after that. Your healthcare provider will order these tests. Regular blood tests are important because they will help your healthcare provider adjust or stop your treatment before there is permanent damage.
- Tell your healthcare provider if you have had liver problems, including liver problems while taking other medicines. Call your healthcare provider right away if you have any of these symptoms of liver problems while taking bosentan tablets for oral suspension:
- nausea
- vomiting
- fever
- unusual tiredness
- stomach area (abdominal) pain
- yellowing of the skin or the whites of your eyes (jaundice)
Because of the risk for liver damage, bosentan is only available through a restricted program called the Bosentan REMS. Before you begin taking bosentan, you must read and agree to all of the requirements of the Bosentan REMS.
Serious birth defects.
- Bosentan tablets for oral suspension can cause serious birth defects if taken during pregnancy. You should not be pregnant when you start taking bosentan tablets for oral suspension or during bosentan treatment. Serious birth defects from bosentan tablets for oral suspension may happen early in pregnancy. Females who are able to get pregnant should have a negative pregnancy test before starting treatment with bosentan tablets for oral suspension.
- Talk to your healthcare provider about your menstrual cycle. Your healthcare provider will decide when to do a pregnancy test and will order a pregnancy test for you depending on your menstrual cycle.
- Females who are able to get pregnant are females who:
- have entered puberty, even if they have not started their menstrual period and
- have a uterus and
- have not gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed.
- Females who are not able to get pregnant are females who:
- have not yet entered puberty, or
- do not have a uterus, or
- have gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed or
- are infertile for other medical reasons and this infertility is permanent and cannot be reversed.
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Females who are able to get pregnant should use effective birth control prior to starting treatment with bosentan tablets for oral suspension, during treatment with bosentan tablets for oral suspension and for one month after stopping bosentan tablets for oral suspension because the medicine may still be in the body.
- Talk with your healthcare provider or gynecologist (a doctor who specializes in female reproduction) to find out about options for effective birth control that you may use to prevent pregnancy during treatment with bosentan tablets for oral suspension.
- If you decide that you want to change the form of birth control that you use, talk with your healthcare provider or gynecologist to be sure that you choose another acceptable form of birth control.
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Do not have unprotected sex. Talk to your healthcare provider or pharmacist right away if you have unprotected sex or if you think your birth control has failed. Your healthcare provider may talk with you about using emergency birth control.
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Tell your healthcare provider right away if you miss a menstrual period or think you may be pregnant.
If you are the parent or caregiver of a female child who started taking bosentan tablets for oral suspension before reaching puberty, you should check your child regularly to see if she is developing signs of puberty. Tell your healthcare provider right away if you notice that she is developing breast buds or any pubic hair. Your healthcare provider should decide if your child has reached puberty. Your child may reach puberty before having her first menstrual period.
Bosentan tablets for oral suspension 32 mg dispersible tablets contain Aspartame. Phenylketonurics: Contains Phenylalanine 2.08 mg per 32 mg dispersible tablet.
See " What are the possible side effects of bosentan tablets for oral suspension? " for more information about side effects.
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What are bosentan tablets for oral suspension?
Bosentan tablets for oral suspension are a prescription medicine used to treat people with certain types of pulmonary arterial hypertension (PAH), which is high blood pressure in the vessels of the lungs.
Bosentan tablets for oral suspension can improve your ability to exercise and can slow the worsening of your physical condition and symptoms. Bosentan tablets for oral suspension lowers high blood pressure in your lungs and lets your heart pump blood more efficiently.
Bosentan tablets for oral suspension is only:
Prescribed by healthcare providers who are enrolled in the Bosentan REMS.
Available to people who understand the risks and requirements and agree to enroll in the Bosentan REMS.
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Who should not take bosentan tablets for oral suspension?
Do not take bosentan tablets for oral suspension if you:
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are pregnant, plan to become pregnant, or become pregnant during bosentan tablets for oral suspension treatment. Bosentan tablets for oral suspension can cause serious birth defects. All females should read the birth defects section of " What is the most important information I should know about bosentan tablets for oral suspension? "
- take any of these medicines:
- cyclosporine A used to treat psoriasis and rheumatoid arthritis and to prevent rejection of heart, liver and kidney transplants
- glyburide used to treat diabetes
- are allergic to bosentan or any of the ingredients in bosentan tablets for oral suspension. See the end of this Medication Guide for a complete list of the ingredients in bosentan tablets for oral suspension. If you have a rash, hives or your lips swell after taking bosentan tablets for oral suspension, it may be a sign of allergy. You should stop taking your bosentan tablets for oral suspension and talk to your healthcare provider.
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What should I tell my healthcare provider before taking bosentan tablets for oral suspension?
Bosentan tablets for oral suspension may not be right for you. Tell your healthcare provider about all your medical conditions, including if you:
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have liver problems.
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are pregnant or plan to become pregnant. See "What is the most important information I should know about bosentan tablets for oral suspension?"
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are breast-feeding or plan to breast feed. Bosentan passes into your breast milk. It is not known if bosentan in breast milk can harm your baby. You and your healthcare provider should decide if you will take bosentan tablets for oral suspension or breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Bosentan tablets for oral suspension and other medicines may affect how each other works and cause side effects. Especially tell your healthcare provider if you take:
- hormone-based birth control, such as pills, shots, patches and implants. These birth control methods may not work as well when taken with bosentan tablets for oral suspension.
- simvastatin or other "-statin" medicines used to lower cholesterol
- rifampin used for tuberculosis
- ketoconazole, fluconazole, itraconazole, or voriconazole used for fungal infections
- warfarin sodium used to prevent blood clots
- ritonavir used to treat HIV
There may be more than one brand name medicine. Ask your healthcare provider if you are not sure if your medicine is one that is listed above.
Know the medicines you take. Keep a list of them and show it to your healthcare provider or pharmacist when you get a new medicine.
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How should I take bosentan tablets for oral suspension?
Your healthcare provider will give you detailed information about the Bosentan REMS Program.
- Bosentan tablets for oral suspension are only available through certified pharmacies. You will only receive a 30-day supply of bosentan tablets for oral suspension at one time.
- Take bosentan tablets for oral suspension exactly as prescribed.
- Your healthcare provider will tell you how much bosentan tablets for oral suspension to take and when to take it.
- In most cases, you will take 1 tablet in the morning and 1 in the evening.
- You can take bosentan tablets for oral suspension orally with or without food.
- If you take more than the prescribed dose of bosentan tablets for oral suspension, call your healthcare provider right away.
- If you miss a dose of bosentan tablets for oral suspension, take your tablet as soon as you remember. Do not take 2 doses at the same time. If it is almost time for your next dose, skip the missed dose. Just take the next dose at your regular time.
- Do not stop taking bosentan tablets for oral suspension unless your healthcare provider tells you to. Suddenly stopping your treatment may cause your symptoms to get worse. If you need to stop taking bosentan tablets for oral suspension, speak with your healthcare provider about the right way to stop.
- If necessary, the 32 mg dispersible tablet can be divided into halves by breaking along a line cut into the surface. Hold the tablet between the thumb and index finger on either side of the line, with the line facing upwards and break the tablet along the line (see figure below).
- Each 32 mg dispersible tablet, or tablet part, can be dispersed in a minimal amount of water to make a liquid medicine immediately before administration. When the tablet has fully dispersed, the liquid should be administered to the patient.
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What are the possible side effects of bosentan tablets for oral suspension?
Bosentan tablets for oral suspension can cause serious side effects, including:
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See "What is the most important information I should know about bosentan tablets for oral suspension?"
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Fluid retention and swelling of your ankles and legs. Bosentan tablets for oral suspension can cause your body to hold too much water and you may get swelling of your ankles and legs. Tell your healthcare provider if you have swelling of your ankles and legs that happens either with or without weight gain, or if you have more trouble with your breathing than normal. Your healthcare provider will look for the cause of this.
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Lower Sperm Count. Some men who take bosentan tablets for oral suspension may have lower sperm counts. This may affect your ability to father a child. Tell your healthcare provider if fertility is a concern for you.
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Low red blood cell levels (anemia). Your healthcare provider will do blood tests to check your red blood cells during treatment with bosentan tablets for oral suspension.
The most common side effects of bosentan tablets for oral suspension include:
- respiratory tract infection
- headache
- fainting
- flushing
- low blood pressure
- inflamed nose passages (sinusitis)
- joint pain
- irregular heart beats
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of bosentan tablets for oral suspension. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at
1-800-FDA-1088.
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How should I store bosentan tablets for oral suspension?
- Store bosentan tablets for oral suspension at room temperature between 68oF to 77oF (20oC to 25oC).
- Dispersible tablets that have been broken to adjust the dose of medicine can be stored at room temperature, between 68oF to 77oF (20oC to 25oC) and should be used within 7 days of having been broken. Tablet pieces may be returned to the opened blister and stored there out of reach of children for up to 7 days.
- Drug bosentan tablets for oral suspension come in child-resistant unit-dose blister pack of 56 tablets.
Keep bosentan tablets for oral suspension and all medicines out of the reach of children.
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General information about bosentan tablets for oral suspension
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use bosentan tablets for oral suspension for a condition for which it was not prescribed. Do not give bosentan tablets for oral suspension to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about bosentan tablets for oral suspension. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about bosentan tablets for oral suspension that is written for health professionals. For more information, go to MedicalAffairs@zydususa.com or Tel.: 1-877-993-8779.
What are the ingredients in bosentan tablets for oral suspension?
Active ingredient: bosentan
Inactive ingredients: acesulfame potassium, aspartame, basic butylated methacrylate copolymer, colloidal silicon dioxide, corn starch, croscarmellose sodium, magnesium stearate, mannitol, sodium lauryl sulfate, stearic acid, talcum and tutti frutti flavor.
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Manufactured by:
Zydus Lifesciences Ltd.
Ahmedabad-382213, India
Distributed by:
Zydus Pharmaceuticals (USA) Inc.
Pennington, NJ 08534
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Rev.: 11/25
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