Dynacirc

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

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

Call your doctor at once if you have any of these serious side effects:

• feeling like you might pass out;
• feeling short of breath, even with mild exertion;
• swelling in your hands and feet;
• fast or pounding heartbeats; or
• chest pain.

Less serious side effects may include:

• dizziness;
• warmth, redness, or tingly feeling under your skin;
• headache;
• weakness, tired feeling;
• nausea, vomiting, diarrhea, upset stomach; or
• skin rash or itching.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. Breaking the pill may cause too much of the drug to be released at one time.

Some tablet forms of isradipine are made with a shell that is not absorbed or melted in the body. Therefore, you may see what looks like part of a tablet in your stool. This is a normal side effect of isradipine and will not make the medication less effective.

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.

To be sure this medication is helping your condition, your blood pressure will need to be checked on a regular basis. Do not miss any scheduled appointments.

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

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include fast heart rate, sluggish feeling, or feeling like you might pass out.

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

DynaCirc® (isradipine) is a calcium antagonist available for oral administration in capsules containing 2.5 mg or 5 mg. The structural formula of isradipine is:

Chemically, isradipine is 3,5-Pyridinedicarboxylic acid, 4-(4-benzofurazanyl)-1,4-dihydro-2,6-dimethyl-, methyl 1-methylethyl ester. Isradipine is a yellow, fine crystalline powder which is odorless or has a faint characteristic odor. Isradipine is practically insoluble in water ( < 10 mg/L at 37°C), but is soluble in ethanol and freely soluble in acetone, chloroform and methylene chloride.

Active Ingredient: isradipine

Inactive Ingredients: colloidal silicon dioxide, D&C Red No. 7 Calcium Lake, FD&C Red No. 40 (5 mg capsule only), FD&C Yellow No. 6 Aluminum Lake, gelatin, lactose, starch (corn), titanium dioxide and other ingredients.

The 2.5 mg and 5 mg capsules may also contain: benzyl alcohol, butylparaben, edetate calcium disodium, methylparaben, propylparaben, sodium propionate.

Before taking Dynacirc, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have liver or kidney problems
• have heart problems
• have a narrowing of the gastrointestinal tract (includes the stomach, intestines, and colon)
• are pregnant or breastfeeding

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

Your pharmacist can provide more information about isradipine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 4.11. Revision date: 12/15/2010.

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You should not take this medication if you are allergic to isradipine.

Before taking isradipine, tell your doctor if you have kidney or liver disease, congestive heart failure, or a narrowing or blockage in your digestive tract.

Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. Breaking the pill may cause too much of the drug to be released at one time.

Isradipine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Some tablet forms of isradipine are made with a shell that is not absorbed or melted in the body. Therefore, you may see what looks like part of a tablet in your stool. This is a normal side effect of isradipine and will not make the medication less effective.

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.

To be sure this medication is helping your condition, your blood pressure will need to be checked on a regular basis. Do not miss any scheduled appointments.

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. Breaking the pill may cause too much of the drug to be released at one time.

Some tablet forms of isradipine are made with a shell that is not absorbed or melted in the body. Therefore, you may see what looks like part of a tablet in your stool. This is a normal side effect of isradipine and will not make the medication less effective.

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.

To be sure this medication is helping your condition, your blood pressure will need to be checked on a regular basis. Do not miss any scheduled appointments.

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

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

Before taking isradipine, tell your doctor if you are using any of the following drugs:

• cimetidine (Tagamet, Tagamet HB);

• fentanyl (Duragesic, Ionsys, Actiq); or

• rifampin (Rifadin, Rimactane, Rifater).

This list is not complete and there may be other drugs that can interact with isradipine. 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.

In multiple dose U.S. studies in hypertension, 1228 patients received DynaCirc® (isradipine) alone or in combination with other agents, principally a thiazide diuretic, 934 of them in controlled comparisons with placebo or active agents. An additional 652 patients (which includes 374 normal volunteers) received DynaCirc® (isradipine) in U.S. studies of conditions other than hypertension, and 1321 patients received DynaCirc® (isradipine) in non-U.S. studies. About 500 patients received DynaCirc® (isradipine) in long-term hypertension studies, 410 of them for at least 6 months. The adverse reaction rates given below are principally based on controlled hypertension studies, but rarer serious events are derived from all exposures to DynaCirc® (isradipine), including foreign marketing experience.

Most adverse reactions were mild and related to the vasodilatory effects of DynaCirc® (dizziness, edema, palpitations, flushing, tachycardia), and many were transient. About 5% of isradipine patients left studies prematurely because of adverse reactions (vs. 3% of placebo patients and 6% of active control patients), principally due to headache, edema, dizziness, palpitations, and gastrointestinal disturbances.

The following table shows the most common adverse reactions, volunteered or elicited, considered by the investigator to be at least possibly drug related. The results for

the DynaCirc® (isradipine) treated patients are presented for all doses pooled together (reported by 1% or greater of patients receiving any dose of isradipine), and also for the two treatment regimens most applicable to the treatment of hypertension with DynaCirc® (isradipine): (1) initial and maintenance dose of 2.5 mg b.i.d., and (2) initial dose of 2.5 mg b.i.d. followed by maintenance dose of 5.0 mg b.i.d.

Except for headache, which is not clearly drug-related (see previous table), the more frequent adverse reactions listed show little change, or increase slightly, in frequency over time, as shown in the following table:

 Edema, palpitations, fatigue, and flushing appear to be dose-related, especially at the higher doses of 15-20 mg/day.

In open-label, long-term studies of up to two years in duration, the adverse events reported were generally the same as those reported in the short-term controlled trials. The overall frequencies of these adverse events were slightly higher in the long-term than in the controlled studies, but as in the controlled trials most adverse reactions were mild and transient.

The following adverse experiences were reported in 0.5%-1.0% of the isradipine-treated patients in hypertension studies, or are rare. More serious events from this and other data sources, including postmarketing exposure, are shown in italics. The relationship of these adverse events to isradipine administration is uncertain.

Skin: pruritus, urticaria

Musculoskeletal: cramps of legs/feet

Respiratory: cough

Cardiovascular: shortness of breath, hypotension, atrial fibrillation, ventricular fibrillation, myocardial infarction, heart failure

Gastrointestinal: abdominal discomfort, constipation, diarrhea

Urogenital: nocturia

Nervous System: drowsiness, insomnia, lethargy, nervousness, impotence, decreased libido, depression, syncope, paresthesia (which includes numbness and tingling), transient ischemicattack, stroke

Autonomic: hyperhidrosis, visual disturbance, dry mouth, numbness

Miscellaneous: throat discomfort, leukopenia, elevated liver function tests

DynaCirc® (isradipine) Capsules

mg

White, imprinted twice with the DynaCirc® logo and “DynaCirc” on one end, and “Reliant” and “2.5” on the other, twice.

Bottles of 100 capsules (NDC 65726-226-25)

Bottles of 60 capsules (NDC 65726-226-15)

5 mg

Light pink, imprinted twice with the DynaCirc® logo and “DynaCirc” on one end, and “Reliant” and “5”on the other, twice.

Bottles of 100 capsules (NDC 65726-227-25)

Bottles of 60 capsules (NDC 65726-227-15)

Store and Dispense

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-89°F) [see USP Controlled Room Temperature] and dispense in a tight, light-resistant container.

Distributed by:

Reliant Pharmaceuticals

Liberty Corner, New Jersey 07938

PRINTED IN USA 222F601

There are no data on the excretion of isradipine into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.