Amlodipine Besylate (Page 5 of 5)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Amlodipine Besylate Tablets USP 2.5mg

White to off-white round flat faced bevelled edged tablets debossed with ‘U’ on one side and ‘241’ on the other side

NDC 12634-599-00 Bottles of 10

NDC 12634-599-01 Bottles of 100

NDC 12634-599-09 Bottles of 35

NDC 12634-599-12 Bottles of 120

NDC 12634-599-18 Bottles of 180

NDC 12634-599-40 Bottles of 40

NDC 12634-599-42 Bottles of 42

NDC 12634-599-45 Bottles of 45

NDC 12634-599-50 Bottles of 50

NDC 12634-599-52 Blister Pack of 12

NDC 12634-599-54 Blister Pack of 14

NDC 12634-599-57 Blister Pack of 20

NDC 12634-599-59 Blister Pack of 30

NDC 12634-599-60 Bottles of 60

NDC 12634-599-61 Blister Pack of 10

NDC 12634-599-63 Blister Pack of 3

NDC 12634-599-66 Blister Pack of 6

NDC 12634-599-67 Blister Pack of 7

NDC 12634-599-69 Blister Pack of 9

NDC 12634-599-71 Bottles of 30

NDC 12634-599-74 Bottles of 24

NDC 12634-599-78 Bottles of 28

NDC 12634-599-79 Bottles of 25

NDC 12634-599-80 Bottles of 20

NDC 12634-599-81 Bottles of 21

NDC 12634-599-82 Bottles of 12

NDC 12634-599-84 Bottles of 14

NDC 12634-599-85 Bottles of 15

NDC 12634-599-90 Bottles of 90

NDC 12634-599-91 Blister Pack of 1

NDC 12634-599-92 Bottles of 2

NDC 12634-599-93 Bottles of 3

NDC 12634-599-94 Bottles of 4

NDC 12634-599-95 Bottles of 5

NDC 12634-599-96 Bottles of 6

NDC 12634-599-97 Bottles of 7

NDC 12634-599-98 Bottles of 8

NDC 12634-599-99 Bottles of 9

16.2 Storage

Store at 20º to 25°C (68° to 77º 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.

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

Marketed by:

Company Logo

Hasbrouck Heights, NJ 07604

05-R-06/2016

13008422

Repackaged & Distributed by:

Apotheca Inc.

Phoenix, AZ 85006

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. Do not breast-feed while taking amlodipine besylate tablets. You can stop breast-feeding or take a different medicine.

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 breast-feed. It is not known if amlodipine will pass through your milk.
  • 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) [see USP Controlled Room Temperature] and dispense in tight, light-resistant containers. 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

Marketed by:

Company Logo

Hasbrouck Heights, NJ 07604

03-R-06/2016

13008422

label
(click image for full-size original)

AMLODIPINE BESYLATE amlodipine besylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:12634-599(NDC:29300-241)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code U;241
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:12634-599-00 10 TABLET in 1 BOTTLE None
2 NDC:12634-599-01 100 TABLET in 1 BOTTLE None
3 NDC:12634-599-09 35 TABLET in 1 BOTTLE None
4 NDC:12634-599-12 120 TABLET in 1 BOTTLE None
5 NDC:12634-599-18 180 TABLET in 1 BOTTLE None
6 NDC:12634-599-40 40 TABLET in 1 BOTTLE None
7 NDC:12634-599-42 42 TABLET in 1 BOTTLE None
8 NDC:12634-599-45 45 TABLET in 1 BOTTLE None
9 NDC:12634-599-50 50 TABLET in 1 BOTTLE None
10 NDC:12634-599-52 12 TABLET in 1 BLISTER PACK None
11 NDC:12634-599-54 14 TABLET in 1 BLISTER PACK None
12 NDC:12634-599-57 20 TABLET in 1 BLISTER PACK None
13 NDC:12634-599-59 30 TABLET in 1 BLISTER PACK None
14 NDC:12634-599-60 60 TABLET in 1 BOTTLE None
15 NDC:12634-599-61 10 TABLET in 1 BLISTER PACK None
16 NDC:12634-599-63 3 TABLET in 1 BLISTER PACK None
17 NDC:12634-599-66 6 TABLET in 1 BLISTER PACK None
18 NDC:12634-599-67 7 TABLET in 1 BLISTER PACK None
19 NDC:12634-599-69 9 TABLET in 1 BLISTER PACK None
20 NDC:12634-599-71 30 TABLET in 1 BOTTLE None
21 NDC:12634-599-74 24 TABLET in 1 BOTTLE None
22 NDC:12634-599-78 28 TABLET in 1 BOTTLE None
23 NDC:12634-599-79 25 TABLET in 1 BOTTLE None
24 NDC:12634-599-80 20 TABLET in 1 BOTTLE None
25 NDC:12634-599-81 21 TABLET in 1 BOTTLE None
26 NDC:12634-599-82 12 TABLET in 1 BOTTLE None
27 NDC:12634-599-84 14 TABLET in 1 BOTTLE None
28 NDC:12634-599-85 15 TABLET in 1 BOTTLE None
29 NDC:12634-599-90 90 TABLET in 1 BOTTLE None
30 NDC:12634-599-91 1 TABLET in 1 BLISTER PACK None
31 NDC:12634-599-92 2 TABLET in 1 BOTTLE None
32 NDC:12634-599-93 3 TABLET in 1 BOTTLE None
33 NDC:12634-599-94 4 TABLET in 1 BOTTLE None
34 NDC:12634-599-95 5 TABLET in 1 BOTTLE None
35 NDC:12634-599-96 6 TABLET in 1 BOTTLE None
36 NDC:12634-599-97 7 TABLET in 1 BOTTLE None
37 NDC:12634-599-98 8 TABLET in 1 BOTTLE None
38 NDC:12634-599-99 9 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203245 03/03/2014
Labeler — Apotheca Inc. (051457844)
Establishment
Name Address ID/FEI Operations
Apotheca Inc. 051457844 relabel (12634-599), repack (12634-599)

Revised: 01/2017 Apotheca Inc.

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