Sular

Dosage Forms & Strengths

tablet, extended-release (generic)

• 8.5mg
• 17mg
• 20mg
• 25.5mg
• 30mg
• 34mg
• 40mg

tablet, extended-release (Sular, new hydrogel ER formulation)

• 8.5mg
• 17mg
• 34mg

Hypertension

Hydrogel ER tablets (Sular's new formulation): 17 mg PO qDay initially; may increase slowly by at least 1-week intervals; not to exceed 34 mg PO qDay

Coat-core ER tablets (generic; old Sular formulation): 20 mg PO qDay initially; may increase slowly by at least 1-week intervals; not to exceed 60 mg/day

Hepatic Impairment

Hydrogel ER tablets (Sular's new formulation): Initial dose should not exceed 8.5 mg PO qDay; may increase slowly by at least 1-week intervals; not to exceed 34 mg PO qDay

Coat-core ER tablets (generic; old Sular formulation): Initial dose should not exceed 10 mg PO qDay; may increase slowly by at least 1-week intervals; not to exceed 30 mg PO qDay

Administration

Take on empty stomach; 1 hr before or 2 hr after meals

Swallow tablet whole; do not crush, divide, or chew

Safety and efficacy not established

Hydrogel ER tablets (Sular's new formulation): 8.5 mg PO qDay initially; may increase slowly by at least 1-week intervals; not to exceed 34 mg PO qDay

Coat-core ER tablets (generic; old Sular formulation): 10 mg PO qDay initially; may increase slowly by at least 1-week or longer intervals to minimum effective dose

Sular

Tablets (Extended Release): 8.5, 17, 20, 25.5, 30, 34, and 40 mg.

Tablets should be stored below 30 C (86 F) and should be protected from light and moisture.

Nisoldipine is in a group of drugs called calcium channel blockers. Nisoldipine relaxes (widens) blood vessels and improves blood flow.

Nisoldipine is used to treat high blood pressure (hypertension).

Nisoldipine may also be used for purposes not listed in this medication guide.

You should not use this medication if you are allergic to nisoldipine, or to similar medications such as amlodipine (Norvasc), felodipine (Plendil), nicardipine (Cardene), nifedipine (Procardia, Adalat), or nimodipine (Nimotop).

Before using nisoldipine, tell your doctor if you are allergic to any drugs, or if you have coronary artery disease, congestive heart failure, or liver disease.

Take nisoldipine on an empty stomach, at least 1 hour before or 2 hours after a meal. Avoid eating grapefruit or drinking grapefruit juice when you take nisoldipine.

Call your doctor at once if you have a serious side effect such as swelling in your legs or ankles, chest pain, fast or pounding heartbeats, or if you feel like you might pass out.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms, so you may not know when your blood pressure is high. You may need to use blood pressure medication for the rest of your life.

There are many other medicines that can interact with nisoldipine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

You should not use this medication if you are allergic to nisoldipine, or to similar medications such as amlodipine (Norvasc), felodipine (Plendil), nicardipine (Cardene), nifedipine (Procardia, Adalat), or nimodipine (Nimotop).

To make sure you can safely take nisoldipine, tell your doctor if you have other medical conditions, especially:

• coronary artery disease;
• congestive heart failure; or
• liver disease.

FDA pregnancy category C. It is not known whether nisoldipine is harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known if nisoldipine passes into breast milk or if it could harm a nursing infant. Do not take nisoldipine without telling your doctor if you are breast-feeding a baby.

Sular is part of the drug class:

• Dihydropyridine derivatives

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that block the enzyme CYP3A4, such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antimycotics (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan, delavirdine, and nefazodone
• medications that increase the enzyme CYP3A4 such as carbamazepine, phenobarbital, phenytoin, rifampin, St John's wort
• cimetidine (Tagamet)

This is not a complete list of Sular drug interactions. Ask your doctor or pharmacist for more information.

You should not use this medicine if you are allergic to nisoldipine, or to similar medications such as amlodipine, felodipine, nicardipine, nifedipine, or nimodipine.

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

• coronary artery disease;

• congestive heart failure;

• liver disease; or

• asthma, or a history of severe allergic reaction (sneezing, runny or stuffy nose, wheezing, shortness of breath) after taking aspirin.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether nisoldipine passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Nisoldipine is not approved for use by anyone younger than 18 years old.

• Inhibits transmembrane influx of extracellular calcium ions across the membranes of myocardial cells and vascular smooth muscle cells.1

• Peripheral arterial vasodilator; acts directly on vascular smooth muscle causing reduction in peripheral vascular resistance (afterload) and BP.1

• Importance of swallowing extended-release tablets whole; do not chew, crush, or break.1

• Importance of avoiding administration with a high-fat meal; administer 1 hour before or 2 hours after a meal.600

• Importance of avoiding grapefruit-containing foods and beverages for at least 1 hour before and after administration of a dose.1 44 46

• Importance of informing patients that some preparations may contain tartrazine.600

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

• Importance of informing patients of other important precautionary information.1 (See Cautions.)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of nisoldipine in the pediatric population. Safety and efficacy have not been established ..

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of nicardipine in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems which may require an adjustment of dose in patients receiving nisoldipine .

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Itraconazole
• Ketoconazole
• Primidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amiodarone
• Ceritinib
• Clarithromycin
• Clopidogrel
• Cobicistat
• Conivaptan
• Dantrolene
• Digoxin
• Fluconazole
• Idelalisib
• Lacosamide
• Mibefradil
• Netupitant

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cimetidine
• Dalfopristin
• Fosphenytoin
• Indinavir
• Phenytoin
• Quinidine
• Quinupristin
• Rifampin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Congestive heart failure or
• Coronary artery disease or
• Low blood pressure—Use with caution. May increase risk of serious side effects .

• Liver disease—Use with caution. The effects of nisoldipine may be increased because of the slower removal of the medicine from the body .

It is important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects .

It is very important that your doctor check your blood regularly while you are taking this medicine. You may also need to monitor your blood pressure at home. If you notice any changes to your recommended blood pressure, call your doctor right away .

Low blood pressure (hypotension) may occur while taking this medicine. Check with your doctor right away if you have the following symptoms: blurred vision; confusion; severe dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly; sweating; or unusual tiredness or weakness .

This medicine may cause dizziness, lightheadedness, or fainting. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you experience these effects.

Nisoldipine should not be taken with a high-fat meal or with grapefruit juice or other grapefruit products because these may increase the levels of nisoldipine in the body .

Sular is contraindicated in patients with known hypersensitivity to dihydropyridine calcium channel blockers.

Bottle Label - 17 mg

NDC 70515-501-10          100 Tablets

Sular®
(nisoldipine)

Extended Release
Tablets

17 mg          Rx only

Keep out of reach of children.

See package insert for full
prescribing information.

Store at 20°-25°C (68°-77°F);
excursions permitted between
15°-30°C (59°-86°F) [See USP
Controlled Room Temperature].

Protect from light and moisture.
Dispense in USP tight,
light-resistant container.

COVIS
Manufactured for:
Covis Pharma
Zug, 6300 Switzerland

Made in Germany

100263          Rev. 12/16

458900

LOT:
EXP:

Bottle Label - 34 mg

NDC 70515-503-10          100 Tablets

Sular®
(nisoldipine)

Extended Release
Tablets

34 mg          Rx only

Keep out of reach of children.

See package insert for full prescribing
information.

Store at 20°-25°C (68°-77°F); excursions
permitted between 15°-30°C (59°-86°F)
[See USP Controlled Room Temperature].

Protect from light and moisture. Dispense
in USP tight, light-resistant container.

COVIS
Manufactured for:
Covis Pharma
Zug, 6300 Switzerland

Made in Germany

100265          Rev. 12/16

458902

LOT:
EXP: