Amlodipine Besylate - ST. MARY'S MEDICAL PARK PHARMACY

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

7 DRUG INTERACTIONS

DRUG INTERACTIONS SECTION

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

10 OVERDOSAGE

OVERDOSAGE SECTION

Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. In humans, experience with intentional overdosage of amlodipine is limited. Single oral doses of amlodipine maleate equivalent to 40 mg amlodipine/kg and 100 mg amlodipine/kg in mice and rats, respectively, caused deaths. Single oral amlodipine maleate doses equivalent to 4 or more mg amlodipine/kg or higher in dogs (11 or more times the maximum recommended human dose on a mg/m 2 basis) caused a marked peripheral vasodilation and hypotension. If massive overdose should occur, initiate active cardiac and respiratory monitoring. Frequent blood pressure measurements are essential. Should hypotension occur, provide cardiovascular support including elevation of the extremities and the judicious administration of fluids. If hypotension remains unresponsive to these conservative measures, consider administration of vasopressors (such as phenylephrine) with attention to circulating volume and urine output. As amlodipine is highly protein bound, hemodialysis is not likely to be of benefit.

11 DESCRIPTION

DESCRIPTION SECTION

Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl] 4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C 20 H 25 ClN 2 O 5 •C 6 H 6 O 3 S and its structural formula is: Amlodipine besylate, USP is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlohowdipinebesylate Tablets, USP are formulated as yellow tablets equivalent to 2.5 mg or white tablets equivalent to 5 and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP, each tablet contains the following inactive ingredients: colloidal silicon dioxide,magnesium stearate,microcrystalline cellulose and sodium starch glycolate. The 2.5 mg strength additionally contains ferric oxide yellow as coloring agent.

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

14 CLINICAL STUDIES

CLINICAL STUDIES SECTION

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

16.1 How Supplied Amlodipine Besylate Tablets, USP 10mg White to off-white round flat faced beveled edge tablets debossed with 'U' on one side and '10' on the other side BOTTLE OF 30 (60760-445-30) 05/2026 16.2 Storage Store at 20° to 25°C (68° to 77° F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] and dispense in tight, light-resistant containers. Additional Summary of Information About leaflets can be obtained by calling Unichem at 1-866-562-4616.

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SUMMARY OF INFORMATION ABOUT Amlodipine Besylate Tablets, USP Read this information carefully before you start taking amlodipine besylate tablets and each time you refill your prescription. There may be new information. This information does not replace talking with your doctor. If you have any questions about amlodipine besylate tablets , ask your doctor. Your doctor will know if amlodipine besylate tablets are right for you. What are amlodipine besylate tablets? Amlodipine besylate tablets are a type of medicine known as a calcium channel blocker (CCB). It is used to treat high blood pressure (hypertension) and a type of chest pain called angina. It can be used by itself or with other medicines to treat these conditions. High Blood Pressure (hypertension) High blood pressure comes from blood pushing too hard against your blood vessels. Amlodipine besylate tablets relaxes your blood vessels, which lets your blood flow more easily and helps lower your blood pressure. Drugs that lower blood pressure lower your risk of having a stroke or heart attack. Angina Angina is a pain or discomfort that keeps coming back when part of your heart does not get enough blood. Angina feels like a pressing or squeezing pain, usually in your chest under the breastbone. Sometimes you can feel it in your shoulders, arms, neck, jaws, or back. Amlodipine besylate tablets can relieve this pain. Who should not use amlodipine besylate tablets? Do not use amlodipine besylate tablets if you are allergic to amlodipine (the active ingredient in amlodipine besylate tablets ), or to the inactive ingredients. Your doctor or pharmacist can give you a list of these ingredients. What should I tell my doctor before taking amlodipine besylate tablets? Tell your doctor about any prescription and non-prescription medicines you are taking, including natural or herbal remedies. Tell your doctor if you: ever had heart disease ever had liver problems are pregnant, or plan to become pregnant. Your doctor will decide if amlodipine besylate tablets is the best treatment for you. are breast-feeding. Amlodipine passes into your milk. How should I take amlodipine besylate tablets? Take amlodipine besylate tablets once a day, with or without food. It may be easier to take your dose if you do it at the same time every day, such as with breakfast or dinner, or at bedtime. Do not take more than one dose of amlodipine besylate tablets at a time. If you miss a dose, take it as soon as you remember. Do not take amlodipine besylate tablets if it has been more than 12 hours since you missed your last dose. Wait and take the next dose at your regular time. Other medicines: You can use nitroglycerin and amlodipine besylate tablets together. If you take nitroglycerin for angina, don't stop taking it while you are taking amlodipine besylate tablets. While you are taking amlodipine besylate tablets , do not stop taking your other prescription medicines, including any other blood pressure medicines, without talking to your doctor. If you took too much amlodipine besylate tablets , call your doctor or Poison Control Center, or go to the nearest hospital emergency room right away. What should I avoid while taking amlodipine besylate tablets? Do not start any new prescription or non-prescription medicines or supplements, unless you check with your doctor first. What are the possible side effects of amlodipine besylate tablets? Amlodipine besylate tablets may cause the following side effects. Most side effects are mild or moderate: swelling of your legs or ankles tiredness, extreme sleepiness stomach pain, nausea dizziness flushing (hot or warm feeling in your face) arrhythmia (irregular heartbeat) heart palpitations (very fast heartbeat) muscle rigidity, tremor and/or abnormal muscle movement It is rare, but when you first start taking amlodipine besylate tablets or increase your dose, you may have a heart attack or your angina may get worse. If that happens, call your doctor right away or go directly to a hospital emergency room. Tell your doctor if you are concerned about any side effects you experience. These are not all the possible side effects of amlodipine besylate tablets . For a complete list, ask your doctor or pharmacist. How do I store amlodipine besylate tablets? Keep amlodipine besylate tablets away from children. Store at 20º to 25°C (68° to 77º F); excursions permitted between 15° to 30°C (59° to 86°F). Keep amlodipine besylate tablets out of the light. Do not store in the bathroom. Keep amlodipine besylate tablets in a dry place. General advice about amlodipine besylate tablets Sometimes, doctors will prescribe a medicine for a condition that is not written in the patient information leaflets. Only use amlodipine besylate tablets the way your doctor told you to. Do not give amlodipine besylate tablets to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or doctor for information about amlodipine besylate tablets , or you can contact Unichem Pharmaceuticals (USA), Inc., at 1 866-562-4616 Additional Summary of Information About leaflets can be obtained by calling Unichem at 1-866-562-4616. Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India. and UNICHEM LABORATORIES LTD. Ind Area, Meerut Road, Ghaziabad – 201 003, India Manufactured for: East Brunswick, NJ 08816 07-R-08/2022 13014142

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL