What is spironolactone?

Spironolactone is a potassium-sparing diuretic (water pill) that prevents your body from absorbing too much salt and keeps your potassium levels from getting too low.

Spironolactone is used to treat heart failure, high blood pressure (hypertension), or hypokalemia (low potassium levels in the blood).

Spironolactone also treats fluid retention (edema) in people with congestive heart failure, cirrhosis of the liver, or a kidney disorder called nephrotic syndrome.

Spironolactone is also used to diagnose or treat a condition in which you have too much aldosterone in your body. Aldosterone is a hormone produced by your adrenal glands to help regulate the salt and water balance in your body.

Warnings

You should use spironolactone with caution if you have kidney problems, high levels of potassium in your blood, Addison’s disease, if you are unable to urinate, or if you are also taking eplerenone.

Spironolactone has caused tumors in animals but it is not known whether this could occur in people. Do not use this medicine for any condition that has not been checked by your doctor.

Before taking this medicine

You should not use spironolactone if you are allergic to it, or if you have:

• Addison’s disease (an adrenal gland disorder);
• high levels of potassium in your blood (hyperkalemia);
• if you are unable to urinate; or
• if you are also taking eplerenone.

To make sure spironolactone is safe for you, tell your doctor if you have:

• an electrolyte imbalance (such as low levels of calcium, magnesium, or sodium in your blood);
• kidney disease;
• liver disease; or
• heart disease.

Tell your doctor if you are pregnant or plan to become pregnant. Having congestive heart failure, cirrhosis, or uncontrolled high blood pressure during pregnancy may lead to medical problems in the mother or the baby. Your doctor should decide whether you take spironolactone if you are pregnant.

It may not be safe to breastfeed while using spironolactone. Ask your doctor about any risk.

How should I take spironolactone?

Take spironolactone exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Do not share this medicine with another person, even if they have the same symptoms you have.

You may take spironolactone with or without food, but take it the same way each time.

You will need frequent medical tests.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using spironolactone.

If you need surgery, tell your surgeon you currently use this medicine. You may need to stop for a short time.

If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store at room temperature away from heat, light, and moisture.

Dosing information

Usual Adult Dose for Edema:

25 to 200 mg orally per day in single or divided doses

Duration of therapy: When given as the sole diuretic, continue the initial dose for at least 5 days, after which the initial dose may be adjusted to an optimal maintenance dose.

Comments:

-A second diuretic that acts more proximally at the renal tubule may be added if adequate diuresis has not been achieved after 5 days. The dose of this drug should remain unchanged if a second diuretic is added.

Uses:

-Treatment of edematous conditions in patients with congestive heart failure who are only partially responsive to or intolerant of other therapeutic measures or who are taking digitalis when other therapies are considered inappropriate.

-Treatment of edematous conditions in patients with liver cirrhosis accompanied by edema and/or ascites.

-Treatment of edematous conditions in patients with nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics do not provide an adequate response.

Usual Adult Dose for Hypertension:

Initial dose: 50 to 100 mg orally per day in single or divided doses

Duration of therapy: Treatment should be continued for at least 2 weeks to achieve a maximum response. Subsequently, the dose may be adjusted according to patient response.

Usual Adult Dose for Congestive Heart Failure:

Initial dose: 25 mg orally once a day assuming serum potassium is less than or equal to 5 mEq/L and serum creatinine is less than or equal to 2.5 mg/dL

Maintenance dose:

-Patients tolerant of initial dose: May increase to 50 mg orally once a day as clinically indicated

-Patients intolerant of initial dose: May decrease to 25 mg orally every other day

Use: To increase survival and reduce the need for hospitalization of severe heart failure patients (New York Heart Association [NYHA] class III to IV) when used in addition to standard therapy.

Usual Adult Dose for Primary Hyperaldosteronism:

Diagnostic dose:

-Long test: 400 mg orally per day for 3 to 4 weeks

-Short test: 400 mg orally per day for 4 days

Maintenance dose: 100 to 400 mg orally per day until surgery; may be used long-term at the lowest effective dose in patients deemed unsuitable for surgery.

Comments:

-For the long test, correction of hypokalemia and hypertension provides presumptive evidence of primary hyperaldosteronism.

-For the short test, increased serum potassium with this drug and a decrease upon discontinuation provide presumptive evidence of primary hyperaldosteronism.

Uses:

-Initial diagnostic measure to provide presumptive evidence of primary hyperaldosteronism while patients are on normal diets.

-Short-term preoperative treatment of patients with primary hyperaldosteronism.

-Long-term maintenance therapy for patients deemed unsuitable for surgery or those with idiopathic hyperaldosteronism.

Usual Adult Dose for Hypokalemia:

25 to 100 mg orally per day

Uses:

-Treatment of patients with hypokalemia when other measures are considered inappropriate or inadequate.

-Prophylaxis of hypokalemia in patients taking digitalis when other measures are considered inadequate or inappropriate.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What to avoid

Drinking alcohol can increase certain side effects.

Do not use potassium supplements or salt substitutes, unless your doctor has told you to.

Avoid a diet high in salt. Too much salt will cause your body to retain water and can make this medication less effective.

Avoid driving or hazardous activity until you know how spironolactone will affect you. Your reactions could be impaired. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Spironolactone side effects

Get emergency medical help if you have signs of an allergic reaction to spironolactone: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• little or no urination;
• high potassium level – nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement; o
• signs of other electrolyte imbalances – increased thirst or urination, confusion, vomiting, muscle pain, slurred speech, severe weakness, numbness, loss of coordination, feeling unsteady.

Common spironolactone side effects may include:

• breast swelling or tenderness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect spironolactone?

Using spironolactone with other drugs that make you dizzy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all your other medicines, especially:

• colchicine;
• digoxin;
• lithium;
• loperamide;
• trimethoprim;
• heart or blood pressure medicine (especially another diuretic);
• medicine to prevent a blood clot; or
• NSAIDs (nonsteroidal anti-inflammatory drugs) – aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may interact with spironolactone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

What is Sabril?

Sabril is an anticonvulsant used for refractory complex partial seizures in specific patients 2 years and older and to treat infantile spasms 1 month to 2 years old. It can cause serious side effects, including vision loss, and should only be used if the potential benefits outweigh the potential risks.

Sabril (vigabatrin) is thought to work by stabilizing the electrical activity in your brain and calming it. It does this by increasing the amount of an inhibitory neurotransmitter (chemical messenger) called GABA (gamma aminobutyric acid).

What is Sabril used for?

Sabril is FDA-approved to treat refractory complex partial seizures in patients 2 years and older who have not responded to other medicines. It is used together with another anticonvulsant, and only if the potential benefits outweigh the risk of any loss of vision. It is not used as a first-line treatment for complex partial seizures.

Sabril is also FDA-approved to treat infantile spasms in babies and children between the ages of 1 month and 2 years. It should be used if the potential benefits outweigh the potential risk of vision loss. It can be used as a single therapy for infantile spasms.

Warnings

Taking Sabril can cause permanent vision loss, even after you stop using this medicine. Tell your doctor if you have any vision problems, such as retinitis or glaucoma and advise your doctor right away about any changes in your vision. You must have frequent eye exams before, during, and shortly after taking this medicine.

To be sure Sabril is not causing harmful effects on your vision, you will need a thorough eye exam before you start taking the medication and then every 3 months during treatment, even if your vision seems normal. If you ever stop taking this medicine, you may still need to have eye exams every 3 to 6 months after your treatment ends. Do not miss any follow-up visits to your doctor.

Some babies treated with vigabatrin have had abnormal brain changes seen on magnetic resonance imaging (MRI). Tell any doctor who treats your baby that the child is taking this medicine.

Some people have thoughts about suicide while taking seizure medication. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Before taking this medicine

Some people taking Sabril have developed vision problems within weeks to years after starting treatment. Vision loss caused by vigabatrin may be permanent, and you may notice only mild symptoms at first.Talk to your doctor about this possibility.

Sabril is available only from a certified pharmacy under a special program. You must be registered in the program and agree to have vision exams before, during, and shortly after taking vigabatrin. Be sure you understand the risks and benefits of taking this medicine.

You should not use Sabril if you are allergic to vigabatrin.

To make sure Sabril is safe for you, tell your doctor if you (or the child taking this medicine) have ever had:

• vision problems;
• kidney disease;
• anemia (low red blood cells); or
• depression, a mood disorder, mental illness, or suicidal thoughts or actions.

Some people have thoughts about suicide while taking Sabril. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Do not start or stop taking seizure medication during pregnancy without your doctor’s advice.Having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of vigabatrin on the baby.

You should not breastfeed while you are using Sabril.

Do not give this medicine to a child without medical advice.

Sabril pregnancy and breastfeeding warnings

How should I take Sabril?

Take Sabril exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

You may take Sabril with or without food.

Sabril powder must be mixed only with water, and can be given to the child with a meal. Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Anyone taking Sabril can develop vision problems that could get worse, even after you stop using this medicine. The more you take this medicine, the more likely you are to develop severe vision problems.

You will need a thorough eye exam before you start taking this medicine and then every 3 months during treatment, even if your vision seems normal. Eye exams may not fully prevent vision damage, but they will help your doctor decide whether to change your treatment plan. Stay alert to any changes in your vision and report them to your doctor right away.

If you stop taking Sabril, you should have another eye exam about 3 to 6 months after your last dose.

It may be more difficult to test vision in a baby or young child. However, your doctor may still prescribe vigabatrin for the child if the benefit of preventing seizures outweighs any risk. Tell the doctor right away if you think your child’s vision may be changing.

Call your doctor if your complex partial seizures do not improve after 3 months of treatment, or if your baby’s infantile spasms do not improve after 2 to 4 weeks of treatment.

Do not stop using Sabril suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Follow your doctor’s instructions about tapering your dose.

Store in the original container at room temperature away from moisture and heat.

Dosing information

Usual Sabril Adult Dose for Refractory Complex Partial Seizures (17 years of age and older)

Initial dose: 1 g orally daily (administered as one 500 mg orally 2 times daily) with or without food. The total daily dose may be increased in 500 mg increments at weekly intervals depending on response.

Recommended dose: 3 g orally daily (1.5 g orally 2 times daily)

A 6 g daily dose has not been shown to confer additional benefit compared to the 3 g daily dose and is associated with an increased incidence of adverse events.

Approved indication: For adults and children 2 years of age and older as adjunctive therapy for refractory complex partial seizures (CPS) who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss. Sabril is not indicated as a first line agent for complex partial seizures.

Usual Sabril Pediatric Dose for Refractory Complex Partial Seizures (2 to 16 years of age)

The recommended dosage is based on body weight and administered as two divided doses. The dosage may be increased in weekly intervals, depending on response. Dose patients weighing more than 60 kg according to adult recommendations.

Usual Pediatric Dose for Infantile Spasms (1 month to 2 years of age)

Initial dose: 50 mg/kg (25 mg/kg twice daily); increase total daily dose every 3 days, in increments of 25 mg/kg/day to 50 mg/kg/day, up to a maximum daily dose of 150 mg/kg (75 mg/kg twice daily).
Each individual dose should be prepared immediately before use and administered cold or at room temperature.

Approved indication: As monotherapy for pediatric patients who are 1 month to 2 years of age with infantile spasms (IS) and for whom the potential benefits outweigh the potential risk of vision loss.

Comments

• Renal Impairment: Dose adjustment is recommended.
• Sabril is available as tablets (500 mg), for oral solution 500 mg per packet
• What happens if I miss a dose?

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Call your doctor for instructions if your baby is taking Sabril and misses a dose, takes only part of a dose, or spits up or vomits after taking the medicine.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe drowsiness or dizziness, confusion, trouble speaking, feeling agitated or irritable, unusual thoughts or behavior, increased seizures, slow heart rate, weak or shallow breathing, or fainting.

What to avoid

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Sabril side effects

Get emergency medical help if you have signs of an allergic reaction to Sabril (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Taking vigabatrin can cause permanent vision loss. Tell your doctor right away about any changes in your vision. If a child is taking Sabril: Tell the doctor right away if the child shows signs of vision changes, such as bumping into things or being easily startled or surprised.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• increased or worsening seizures;
• any change in your vision, no matter how mild;
• unusual or involuntary eye movements;
• severe drowsiness, fussiness, or feeding problems (in a baby taking vigabatrin);
• numbness, tingling, or burning pain in your hands or feet;
• weight gain with or without swelling;
• signs of an ear infection – fever, ear pain or full feeling, trouble hearing, drainage from the ear, fussiness in a child; or
• low red blood cells (anemia) – pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Some babies treated with Sabril have had abnormal brain changes seen on magnetic resonance imaging (MRI). It is not known if these changes are caused by vigabatrin or if they are harmful. Tell any doctor who treats your baby that the child is taking this medicine.

Common Sabril side effects may include:

• blurred vision or other eye problems;
• drowsiness, dizziness, feeling tired;
• problems with walking or coordination;
• tremors or shaking;
• aggressive behavior;
• confusion, problems with thinking or memory;
• weight gain;
• joint pain;
• cold symptoms such as stuffy nose, sneezing, sore throat; or
• (in babies) fussiness, ear infection, cough, breathing problems.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Sabril?

Other drugs may interact with vigabatrin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

What is sacubitril and valsartan?

Sacubitril and valsartan is a combination medicine that is used in adults with chronic heart failure. sacubitril and valsartan lowers the risk of being hospitalized when symptoms get worse and reduces the risk of death from heart failure.

Sacubitril and valsartan is also used to treat symptomatic heart failure in children who are at least 1 year old.

Sacubitril and valsartan may also be used for purposes not listed in this medication guide.

Sacubitril and valsartan side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Sacubitril and valsartan may cause serious side effects. Call your doctor at once if you have:

• feeling like you might pass out;
• high blood potassium–nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement; or
• kidney problems–swelling, urinating less, feeling tired or short of breath.

Common side effects of sacubitril and valsartan may include:

• kidney problems;
• high potassium levels in your blood;
• dizziness, feeling like you might pass out; or
• cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. 

Warnings

Do not use if you are pregnant. Stop using sacubitril and valsartan and tell your doctor right away if you become pregnant.

If you have diabetes, do not take sacubitril and valsartan with any medication that contains aliskiren (a blood pressure medicine).

Tell your doctor about all your other medicines. Some drugs should not be used with sacubitril and valsartan.

Before taking this medicine

You should not use this medicine if you are allergic to sacubitril or valsartan or if you have or have ever had a severe allergic reaction to similar medicines such as:

• an ACE inhibitor–benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, trandolapril; or
• an ARB–azilsartan, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, valsartan.

You should not take sacubitril and valsartan within 36 hours before or after you have taken any ACE inhibitor medication.

If you have diabetes, do not take sacubitril and valsartan with any medication that contains aliskiren (a blood pressure medicine).

You may also need to avoid taking sacubitril and valsartan with aliskiren if you have kidney disease.

Tell your doctor if you have or have ever had:

• diabetes;
• low blood pressure;
• low levels of aldosterone (hypoaldosteronism);
• hereditary angioedema;
• if you are dehydrated;
• if you are on a low-salt-diet;
• if you are on a high-potassium diet; or
• severe liver or kidney disease.

Stop using this medicine and tell your doctor right away if you become pregnant. Sacubitril and valsartan can cause injury or death to the unborn baby if you use the medicine during your second or third trimester.

Ask a doctor if it is safe to breastfeed while using this medicine.

How should I take sacubitril and valsartan?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Your dose needs may change if you switch to a different strength or form of sacubitril and valsartan. Avoid medication errors by using exactly as directed on the label or as prescribed by your doctor.

Sacubitril and valsartan is usually taken twice per day with or without food. You may need to take more than one capsule or tablet to receive a full dose. Follow your doctor’s instructions.

Doses are based on weight in children and teenagers. Your child’s dose may change if the child gains or loses weight.

Read and carefully follow the Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don’t understand these instructions.

If you are unable to swallow a tablet whole, a pharmacist can make an oral suspension (liquid). Tell the doctor if the person taking this medicine has trouble swallowing the tablet.

Shake the oral suspension (liquid). Measure a dose with the supplied measuring device (not a kitchen spoon).

The oral pellets are inside the capsule. Do not swallow the capsule whole, and do not chew and crush the oral pellets inside the capsule. The capsule must be opened before taking the oral pellets. Do not swallow the empty capsule shell after opening.

To take the oral pellets, open the capsule and sprinkle the contents with 1 to 2 teaspoons of a soft food, such as applesauce, yogurt, or pudding. Swallow the mixture right away after adding the pellets.

Do not give the oral pellets through a feeding tube. The pellets may clog the tube.

Your doctor will need to check your progress on a regular basis. Your blood and kidney function may need to be tested often.

Store at room temperature away from moisture and heat. Throw away any oral suspension not used within 15 days after it was mixed. Do not keep the oral suspension in a refrigerator.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking sacubitril and valsartan?

Do not take potassium supplements or use salt substitutes, unless your doctor has told you to.

What is Sabril?

Sabril is an anticonvulsant used for refractory complex partial seizures in specific patients 2 years and older and to treat infantile spasms 1 month to 2 years old. It can cause serious side effects, including vision loss, and should only be used if the potential benefits outweigh the potential risks.

Sabril (vigabatrin) is thought to work by stabilizing the electrical activity in your brain and calming it. It does this by increasing the amount of an inhibitory neurotransmitter (chemical messenger) called GABA (gamma aminobutyric acid).

What is Sabril used for?

Sabril is FDA-approved to treat refractory complex partial seizures in patients 2 years and older who have not responded to other medicines. It is used together with another anticonvulsant, and only if the potential benefits outweigh the risk of any loss of vision. It is not used as a first-line treatment for complex partial seizures.

Sabril is also FDA-approved to treat infantile spasms in babies and children between the ages of 1 month and 2 years. It should be used if the potential benefits outweigh the potential risk of vision loss. It can be used as a single therapy for infantile spasms.

Warnings

Taking Sabril can cause permanent vision loss, even after you stop using this medicine. Tell your doctor if you have any vision problems, such as retinitis or glaucoma and advise your doctor right away about any changes in your vision. You must have frequent eye exams before, during, and shortly after taking this medicine.

To be sure Sabril is not causing harmful effects on your vision, you will need a thorough eye exam before you start taking the medication and then every 3 months during treatment, even if your vision seems normal. If you ever stop taking this medicine, you may still need to have eye exams every 3 to 6 months after your treatment ends. Do not miss any follow-up visits to your doctor.

Some babies treated with vigabatrin have had abnormal brain changes seen on magnetic resonance imaging (MRI). Tell any doctor who treats your baby that the child is taking this medicine.

Some people have thoughts about suicide while taking seizure medication. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Before taking this medicine

Some people taking Sabril have developed vision problems within weeks to years after starting treatment. Vision loss caused by vigabatrin may be permanent, and you may notice only mild symptoms at first. Talk to your doctor about this possibility.

Sabril is available only from a certified pharmacy under a special program. You must be registered in the program and agree to have vision exams before, during, and shortly after taking vigabatrin. Be sure you understand the risks and benefits of taking this medicine.

You should not use Sabril if you are allergic to vigabatrin.

To make sure Sabril is safe for you, tell your doctor if you (or the child taking this medicine) have ever had:

• vision problems;
• kidney disease;
• anemia (low red blood cells); or
• depression, a mood disorder, mental illness, or suicidal thoughts or actions.

Some people have thoughts about suicide while taking Sabril. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Do not start or stop taking seizure medication during pregnancy without your doctor’s advice. Having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of vigabatrin on the baby.

You should not breastfeed while you are using Sabril.

Do not give this medicine to a child without medical advice.

How should I take Sabril?

Take Sabril exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

You may take Sabril with or without food.

Sabril powder must be mixed only with water, and can be given to the child with a meal. Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Anyone taking Sabril can develop vision problems that could get worse, even after you stop using this medicine. The more you take this medicine, the more likely you are to develop severe vision problems.

You will need a thorough eye exam before you start taking this medicine and then every 3 months during treatment, even if your vision seems normal. Eye exams may not fully prevent vision damage, but they will help your doctor decide whether to change your treatment plan. Stay alert to any changes in your vision and report them to your doctor right away.

If you stop taking Sabril, you should have another eye exam about 3 to 6 months after your last dose.

It may be more difficult to test vision in a baby or young child. However, your doctor may still prescribe vigabatrin for the child if the benefit of preventing seizures outweighs any risk. Tell the doctor right away if you think your child’s vision may be changing.

Call your doctor if your complex partial seizures do not improve after 3 months of treatment, or if your baby’s infantile spasms do not improve after 2 to 4 weeks of treatment.

Do not stop using Sabril suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Follow your doctor’s instructions about tapering your dose.

Store in the original container at room temperature away from moisture and heat.

Dosing information

Usual Sabril Adult Dose for Refractory Complex Partial Seizures (17 years of age and older)

Initial dose: 1 g orally daily (administered as one 500 mg orally 2 times daily) with or without food. The total daily dose may be increased in 500 mg increments at weekly intervals depending on response.

Recommended dose: 3 g orally daily (1.5 g orally 2 times daily)

A 6 g daily dose has not been shown to confer additional benefit compared to the 3 g daily dose and is associated with an increased incidence of adverse events.

Approved indication: For adults and children 2 years of age and older as adjunctive therapy for refractory complex partial seizures (CPS) who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss. Sabril is not indicated as a first line agent for complex partial seizures.

Usual Sabril Pediatric Dose for Refractory Complex Partial Seizures (2 to 16 years of age)

The recommended dosage is based on body weight and administered as two divided doses. The dosage may be increased in weekly intervals, depending on response. Dose patients weighing more than 60 kg according to adult recommendations.

Usual Pediatric Dose for Infantile Spasms (1 month to 2 years of age)

Initial dose: 50 mg/kg (25 mg/kg twice daily); increase total daily dose every 3 days, in increments of 25 mg/kg/day to 50 mg/kg/day, up to a maximum daily dose of 150 mg/kg (75 mg/kg twice daily).
Each individual dose should be prepared immediately before use and administered cold or at room temperature.

Approved indication: As monotherapy for pediatric patients who are 1 month to 2 years of age with infantile spasms (IS) and for whom the potential benefits outweigh the potential risk of vision loss.

Comments

• Renal Impairment: Dose adjustment is recommended.
• Sabril is available as tablets (500 mg), for oral solution 500 mg per packet
• What happens if I miss a dose?

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Call your doctor for instructions if your baby is taking Sabril and misses a dose, takes only part of a dose, or spits up or vomits after taking the medicine.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include severe drowsiness or dizziness, confusion, trouble speaking, feeling agitated or irritable, unusual thoughts or behavior, increased seizures, slow heart rate, weak or shallow breathing, or fainting.

What to avoid

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Sabril side effects

Get emergency medical help if you have signs of an allergic reaction to Sabril (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Taking vigabatrin can cause permanent vision loss. Tell your doctor right away about any changes in your vision. If a child is taking Sabril: Tell the doctor right away if the child shows signs of vision changes, such as bumping into things or being easily startled or surprised.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• increased or worsening seizures;
• any change in your vision, no matter how mild;
• unusual or involuntary eye movements;
• severe drowsiness, fussiness, or feeding problems (in a baby taking vigabatrin);
• numbness, tingling, or burning pain in your hands or feet;
• weight gain with or without swelling;
• signs of an ear infection – fever, ear pain or full feeling, trouble hearing, drainage from the ear, fussiness in a child; or
• low red blood cells (anemia) – pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Some babies treated with Sabril have had abnormal brain changes seen on magnetic resonance imaging (MRI). It is not known if these changes are caused by vigabatrin or if they are harmful. Tell any doctor who treats your baby that the child is taking this medicine.

Common Sabril side effects may include:

• blurred vision or other eye problems;
• drowsiness, dizziness, feeling tired;
• problems with walking or coordination;
• tremors or shaking;
• aggressive behavior;
• confusion, problems with thinking or memory;
• weight gain;
• joint pain;
• cold symptoms such as stuffy nose, sneezing, sore throat; or
• (in babies) fussiness, ear infection, cough, breathing problems.

What is salbutamol?
Salbutamol (albuterol) is a medication used to relax and open up your airways. It is used to relieve wheezing, coughing, chest tightness and breathlessness in people with asthma and chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
Salbutamol is a fast-acting bronchodilator and reliever medication. It belongs to a class of medications known as short-acting beta-2 adrenergic agonist. Salbutamol works by stimulating the beta-2 adrenoceptors in your bronchial muscles, which are the smooth muscles lining the two large tubes (bronchi) that carry air from your windpipe (trachea) to your lungs. This causes your bronchi to relax and dilate, widening your airway for a short period of about 4 to 6 hours and making it easier for you to breathe. It can also act on beta-2 adrenoceptors in your uterus (womb).
Branded and generic formulations of salbutamol are available worldwide. In many countries this medication is known by the generic name salbutamol, which is the generic name assigned using the International Nonproprietary Name (INN) system. In the US, however, salbutamol is known by the name albuterol (ProAir, Ventolin), which is the generic name assigned using the United States Adopted Names (USAN) system. Usually the INN and USAN names for a drug are the same.
Salbutamol became available in the UK in the late 1960s and in the US in the 1980s. Salbutamol and albuterol are both marketed under the brand name Ventolin.
What is salbutamol used for?
Salbutamol is used to relieve the symptoms of asthma or bronchospasm. Salbutamol is used to relieve symptoms such as chest tightness, wheezing, shortness of breath and coughing in some other chest diseases too, such as COPD.
Salbutamol can also be used to prevent asthma symptoms which occur with exercise or on exposure to an allergen, such as cat or dog fur, pollen or house dust.
Salbutamol injection is also used for the management of uncomplicated premature labour between 22 and 37 weeks of pregnancy.
Important information
If your breathing suddenly becomes more difficult after using salbutamol, contact your healthcare provider immediately.
If you need to use this medication more frequently than usual, this can be a sign that your breathing condition is getting worse. Follow your treatment action plan or contact your healthcare provider for advice.
Who should not use salbutamol?
Do not use salbutamol if you are:
allergic to it or any of the ingredients in it
you are pregnant, think you may be pregnant or intend to become pregnant (unless agreed by your doctor)
you are breast-feeding (unless agreed by your doctor)
What should I tell my doctor before using salbutamol?
Before you take salbutamol, tell your healthcare provider about all of your medical conditions, including if you:
are being treated for an overactive thyroid (thyrotoxicosis)
are being treated for high blood pressure
have a history of heart disease, irregular heart rhythm or angina
have liver problems
have kidney problems
have a tumor near your kidney (a phaeochromocytoma)
have low potassium levels in your blood
have diabetes
have you been told you have an aneurysm (a swelling or dilation of a blood vessel)
are you about to have an operation requiring a general anaesthetic
have had to stop taking an asthma medication in the past
are taking any other medicines
How should I use salbutamol?
Always take this medication exactly as your doctor or pharmacist tells you to. You should check with them if you are not sure.
Read the instructions for use that come with your medication about the right way to take it.
Salbutamol aerosol inhalers are usually used in the following way:1 to 2 puffs are usually taken as needed to relieve symptoms
1 to 2 puffs may be taken about 15 minutes before exercise or exposure to a trigger substance to prevent symptoms
Do not used more than 2 puffs every 4 hours up to a maximum of 4 times (up to 8 puffs) in 24 hours
If your inhaler does not relieve your symptoms for at least 3 hours then contact your healthcare provider
Aerosol salbutamol inhalers can by used with a spacer device if required
Regularly wash and dry your inhaler as instructed
Salbutamol dry powder inhalers (accuhalers) are usually used in the following way:1 inhalation taken up to 4 times per day is usually taken as needed to relieve symptoms
1 inhalation may be taken 10 to 15 minutes before exercise or exposure to a trigger substance to prevent symptoms
Do not take more than 1 dose up to 4 times in 24 hours
Wipe the mouthpiece of the dry powder inhaler with a dry tissue to clean it
Salbutamol oral syrup is usually used in the following way:Shake the bottle before use
Use the oral syringe or measuring device that comes with your medication to measure out your prescribed dose
Can be swallowed with or without food
Is usually taken 3 to 4 times per day
Salbutamol tablets are usually used in the following way:Swallow tablets whole with water
Is usually taken 3 or 4 times per day
Salbutamol respirator solution 5 mg/ml – for use with nebulizer:Salbutamol respirator solution must only be used with a nebulizer. A nebulizer produces a fine mist which you breathe in through a face mask or a mouthpiece. Make sure that you know how to use it properly. If you have problems ask your doctor, nurse or pharmacist.
Take care not to let the mist from the nebulizer get in your eyes.
Use your nebulizer in a well ventilated room as some of the mist will be released into the air and may be breathed in by others.
To use salbutamol nebulizer solution:Prepare the nebulizer for filling
Measure out the prescribed amount of respirator solution and put it in the nebulizer bowl
Add the right amount of sterile normal saline solution (make sure your doctor has told you how much to use)
Put the top on the nebulizer bowl and shake it gently to mix the contents
Assemble the nebulizer and use it as directed
After use throw away any solution remaining in the nebulizer bowl. Clean your nebulizer in the recommended way
Salbutamol injections are usually:Administered by a healthcare professional
Given by injection into the fat layer just under the skin (subcutaneous), into a muscle (intramuscular), or slowly into a vein (intravenous)
The length of treatment and the number of doses you receive will depend on your symptoms and the condition you are being treated for, for example whether you’re being treated for severe bronchospasm, status asthmaticus or preterm labor. Your healthcare provider will determine the correct dose and schedule for you.
What happens if I miss a dose?
If you forget a dose of salbutamol, take it as soon as you remember. If it is time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
What happens if I overdose?
If you take too much salbutamol, seek emergency medical attention or call the Poison Help line at 1-800-222-1222 straight away even if you do not feel unwell or have symptoms of an overdose. An overdose of salbutamol can be fatal.
Overdose symptoms may include dry mouth, tremors or feeling shaky, chest pain, fast or irregular heartbeat, nausea, general ill feeling, seizure (convulsions), feeling light-headed or fainting.
Dosing information
The recommended dose of salbutamol depends on the age of the patient, condition being treated and the formulation being used.
A general guide to the recommended dosage is given below.
Asthma symptoms and bronchospasm
Salbutamol inhaler 100 micrograms (mcg) per dose:Adults: 1-2 puffs every 4 hours up to 4 times (8 puffs) in 24 hours to relieve symptoms. To prevent symptoms caused by exercise or other triggers, the recommended dose is 2 puffs 15 minutes before exposure.
Children: 1 puff (increased to 2 puffs if required) every 4 hours up to 4 times (8 puffs) in 24 hours to relieve symptoms. To prevent symptoms caused by exercise or other triggers, the recommended dose is 1 puff (increased to 2 puffs if required) 15 minutes before exposure.
Salbutamol dry powder inhaler 200 mcg per dose:Adults, adolescents aged 12 years and over and children 4 to 11 years of age: 1 inhalation up to 4 times per day to relieve symptoms. To prevent symptoms caused by exercise or other triggers, the recommended dose is 1 inhalation 10 to 15 minutes before exposure.
Salbutamol oral syrup 2 mg/5 ml:Adults (over 18 years old): The usual dose is 5 ml to 20 ml, up to 4 times a day.
Children over 12 years old: The usual dose is 5 ml to 10 ml, 3 or 4 times a day.
Children aged between 6 and 12 years: The usual dose is 5 ml, 3 or 4 times a day.
Children aged between 2 and 6 years: The usual dose is 2.5 ml to 5 ml, 3 or 4 times a day.
Elderly (over 65 years old): The usual dose is 5 ml, up to 3 times a day.
Salbutamol tablets 2mg and 4mg:Adults: The recommended dose is 4mg 3 or 4 times a day. Your doctor may increase this gradually up to a maximum of 8mg three or four times a day. Some patients may be treated successfully with 2mg three or four times a day.
Children over 12 years old: The recommended dose is 2 mg to 4 mg 3 or 4 times a day.
Children aged between 6 and 12 years: The recommended dose is 2 mg 3 or 4 times a day
Children aged between 2 and 6 years: The recommended dose is 1 to 2 mg 3 or 4 times a day.
Elderly or patients known to be sensitive to this product or other similar drugs: The recommended dose is initially 2 mg 3 or 4 times a day.
Salbutamol respirator solution 5 mg/ml – for use with nebulizer:Intermittent treatment – Adults and adolescents aged 12 years and over: The usual dose is 0.5 ml to 1 ml of respirator solution (2.5 to 5 mg salbutamol). Some patients may require up to 2 ml (10 mg salbutamol).
Intermittent treatment – Children aged 18 months to 12 years: The usual dose is 0.5 ml to 1 ml (2.5 to 5 mg salbutamol) of Ventolin Respirator Solution.
Intermittent treatment may be given up to 4 times per day.
Continuous treatment: The usual dose is 1 to 2 mg of salbutamol per hour. This dose can be obtained by diluting 1 or 2 ml of respirator solution to 100 ml with sterile normal saline solution to produce a solution containing 50 or 100 micrograms/ml of salbutamol, and inhaling the mist from a suitable nebulizer.
Severe bronchospasm and status asthmaticus
Salbutamol injection 500 micrograms/ml:Adults: The recommended dose for subcutaneous or intramuscular injection is 500 micrograms (8 micrograms/kg bodyweight) and repeated every 4 hours as required.
Salbutamol solution for infusion 5mg/5ml:Adults: The recommended dose is 250 micrograms (4 micrograms/kg bodyweight) injected slowly. If necessary the dose may be repeated. 250 micrograms in 5 mL (50 micrograms/mL) is a suitably dilute preparation for slow intravenous injection.

In status asthmaticus, infusion rates of 3 to 20 micrograms per minute are generally adequate but in patients with respiratory failure, higher dosage has been used with success. A starting dose of 5 micrograms per minute is recommended with appropriate adjustment in dosage according to patient response.
Preterm labor
Salbutamol solution for infusion 5mg/5ml:Infusion rates of 10-45 micrograms per minute are generally adequate to control uterine contractions but greater or lesser infusion rates may be required according to the strength and frequency of contractions.
See the full prescribing details for more information about salbutamol dosing.
What are the side effects of salbutamol?
Serious side effects of salbutamol include:
Allergic reactions. If you have an allergic reaction, stop taking this medication and see a doctor straight away. Signs of an allergic reaction include swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, itchy rash, feeling faint and light headed (due to low blood pressure), and collapse.

Talk to your doctor as soon as possible if:you feel your heart is beating faster or stronger than usual (palpitations). This is usually harmless, and usually stops after you have used the medicine for a while
you may feel your heartbeat is uneven or it gives an extra beat
Do not stop using this medicine unless told to do so.
Tell your doctor if you have any of the following side effects which may also happen with this medicine:
Common side effects of salbutamol include:feeling shaky
headache
muscle cramps
Rare and very rare side effects of salbutamol include:Your heart beats too fast, too slow or irregularly (cardiac arrhythmia)
A low level of potassium in your blood (hypokalemia)
Increased blood flow to your extremities (peripheral dilatation)
Changes in sleep patterns and changes in behavior, such as restlessness and excitability
Muscle tension
The following side effects can also happen but the frequency of these are not known:Chest pain, due to heart problems such as angina. Tell your doctor, nurse or pharmacist if this occurs. Do not stop using this medicine unless told to do so.
Lactic acidosis has also been reported very rarely in patients receiving intravenous and nebulized salbutamol therapy for the treatment of acute asthma exacerbation.
Salbutamol injections and infusions have also uncommonly been associated with pulmonary edema.
These are not all of the possible side effects of salbutamol.
Call your doctor for medical advice about side effects. 
Interactions
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you are taking any of the medicines listed below:
Corticosteroids, such as beclometasone dipropionate for your asthma
Diuretics or water tablets, such as furosemide
Medicine to reduce blood pressure, such as atenolol or propranolol
Medicines to control an irregular heart beat/rhythm (digoxin), or very fast pulse
Tablets prescribed for your asthma to help your breathing, including xanthine derivatives (theophylline, aminophylline)
Certain medications for depression including moclobemide, phenelzine, amitriptyline, clomipramide or imipramine
Some general anaesthetics may interact with salbutamol to cause heart problems and decrease blood pressure. If you are having an operation, advise hospital staff that you are taking salbutamol.

Pregnancy and breastfeeding
Tell your doctor if you are pregnant or are planning to get pregnant. Your doctor will tell you whether or not you should take salbutamol during pregnancy.

Tell your doctor if you are breastfeeding of planning to breastfeed. Salbutamol’s use in people who are breastfeeding is not recommended unless the expected benefits outweigh any potential risk. It is not known whether salbutamol in breast milk has a harmful effect on the neonate.
Storage
Store below 77-86°F (25-30°C) or as recommended.
Protect inhalers from light, frost, heat and moisture.
Do not freeze or refrigerate.
The metal canister in aerosol inhalers is pressurized. Do not burn it or puncture it, even when it is empty. Do not expose it to temperatures higher than 122°F (50°C).
Keep out of sight and reach of children.
What are the ingredients in salbutamol?
Active ingredient: salbutamol sulfate
Inactive ingredients:
Ventolin CFC-Free inhaler: non- CFC propellant HFA134a also known as norflurane or 1,1,1,2- tetrafluoroethane.
Ventolin Accuhaler (dry powder inhaler): lactose (contains milk protein).
Ventolin oral syrup: sodium citrate, citric acid monohydrate, hypromellose, sodium benzoate, saccharin sodium, sodium chloride, orange flavoring and water.
Ventolin tablets 2 mg and 4 mg: maize starch, lactose monohydrate, dispersed pink (erythrosine (E127), carmoisine (E122), titanium dioxide (E171)), sodium starch glycollate, talc, magnesium stearate.
Ventolin respirator solution: water, benzalkonium chloride and sulfuric acid.
Ventolin injection and solution for IV infusion: sodium chloride, sodium hydroxide, dilute sulphuric acid, water for injection.
Inactive ingredients may vary depending on the brand or generic version and formulation of salbutamol you take. Check the product label for the version you take for a full list of ingredients.