Valsartan

WARNING: FETAL TOXICITY

BOXED WARNING SECTION

When pregnancy is detected, discontinue Valsartan as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 )

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

40 mg are deep yellow colored oval shaped coated tablet, engraved "S026" on one side and break line on other side. 80 mg are pink colored almond shaped coated tablet, engraved "S023" on one side and other side is plain. 160 mg are yellow colored almond shaped coated tablet, engraved "S024" on one side and other side is plain. 320 mg are brown colored almond shaped coated tablet, engraved "S025" on one side and other side is plain.

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Do not use in patients with known hypersensitivity to any component. Do not coadminister aliskiren with Valsartan in patients with diabetes [ See Drug Interactions (7.3) ].

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

Limited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. Depressed level of consciousness, circulatory collapse and shock have been reported. If symptomatic hypotension should occur, institute supportive treatment. Valsartan is not removed from the plasma by hemodialysis. Valsartan was without grossly observable adverse effects at single oral doses up to 2000 mg/kg in rats and up to 1000 mg/kg in marmosets, except for salivation and diarrhea in the rat and vomiting in the marmoset at the highest dose (60 and 31 times, respectively, the MRHD on a mg/m 2 basis). (Calculations assume an oral dose of 320 mg/day and a 60-kg patient.)

11 DESCRIPTION

DESCRIPTION SECTION

Valsartan tablets, USP are a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT 1 receptor subtype. Valsartan is chemically described as N -(1-oxopentyl)- N -[[2′-(1 H -tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C 24 H 29 N 5 O 3 , its molecular weight is 435.5, and its structural formula is Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan tablets are available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are colloidal anhydrous silica, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, hydroxypropyl methylcellulose, titanium dioxide and iron oxides (yellow, black and/or red).

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

Valsartan tablets are available as tablets containing valsartan 40 mg, 80 mg, 160 mg, or 320 mg. All strengths are packaged in bottles as described below. The 40 mg tablets are scored on one side and oval shaped. The 80 mg, 160 mg, and 320 mg tablets are unscored and almond-shaped.

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Valsartan tablets, USP are available in four strengths: 40 mg, deep yellow, debossed "S026" on one side, and break line on the other side. NDC 10135-0768-30 Bottle of 30’s 80 mg, pink, debossed "S023" on one side, and plain on the other side. NDC 10135-0769-90 Bottle of 90’s 160 mg, yellow, debossed "S024" on one side, and plain on the other side. NDC 10135-0770-90 Bottle of 90’s 320 mg, brown, debossed "S025" on one side, and plain on the other side. NDC 10135-0771-90 Bottle of 90’s

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Store at 25°C (77°F); excursions permitted to 15°C -30°C (59°F - 86°F) [ see USP Controlled Room Temperature ]. Protect from moisture. Dispense in tight container (USP).

17 PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

SPL PATIENT PACKAGE INSERT SECTION

SPL PATIENT PACKAGE INSERT SECTION

PATIENT INFORMATION Valsartan (val-​SAR-tan) Tablets What is the most important information I should know about Valsartan Tablets? Valsartan Tablets can cause harm or death to an unborn baby. Talk to your healthcare provider about other ways to lower your blood pressure if you plan to become pregnant. If you become pregnant during treatment with Valsartan Tablets, stop taking Valsartan Tablets and tell your healthcare provider right away. What is Valsartan Tablets? Valsartan Tablets is a prescription medicine used in: adults and children 6 years of age and older to lower high blood pressure (hypertension). Valsartan Tablets may be used alone or in combination with other blood pressure medicines. adults to treat heart failure. Valsartan Tablets may help decrease your need for hospitalization that happens with heart failure. adults with certain types of heart failure, to increase the chance of living longer after a heart attack (myocardial infarction). Valsartan Tablets should not be used to treat high blood pressure in children less than 1 year of age. It is not known if Valsartan Tablets are safe and effective in children with certain kidney problems. Do not take VALSARTAN TABLETS if you: are allergic to any of the ingredients in Valsartan Tablets. See the end of this leaflet for a complete list of ingredients in Valsartan Tablets. have diabetes and are also taking aliskiren. Talk to your healthcare provider if you are not sure. Before taking Valsartan Tablets, tell your healthcare provider about all of your medical conditions including, if you: have heart problems have kidney problems are pregnant or plan to become pregnant. See " What is the most important information I should know about VALSARTAN TABLETS? are breastfeeding or plan to breastfeed. It is not known if Valsartan Tablets passes into your breast milk. You should not breastfeed during treatment with Valsartan Tablets. Talk with your healthcare provider about the best way to feed your baby during your treatment with Valsartan Tablets. Tell your healthcare provider about all the medicines you take including prescription and over- the-counter medicines, vitamins and herbal supplements. Valsartan Tablets may affect the way other medicines work. Especially tell your healthcare provider if you take: other medicines for high blood pressure or a heart problem water pills (also called "diuretics") potassium-containing medicines, potassium supplements or salt substitutes containing potassium. Your healthcare provider may check the amount of potassium in your blood regularly. nonsteroidal anti-inflammatory drugs (NSAIDs) Lithium. Your healthcare provider will check the amount of lithium in your blood regularly. Know the medicines you take. Keep a list of your medicines with you to show to your healthcare provider and pharmacist when a new medicine is prescribed. Talk to your healthcare provider or pharmacist before you start taking any new medicine. How should I take Valsartan Tablets? Take Valsartan Tablets exactly as prescribed by your healthcare provider. For treatment of high blood pressure, take Valsartan Tablets 1 time each day For children: Your pharmacist will mix Valsartan Tablets as a liquid suspension for your child, if: o your child is ≥ 6 years of age and cannot swallow tablets, or o if tablets are not available in the prescribed strength needed for your child If your child switches between taking the tablet and the suspension, your healthcare provider will adjust the dose as needed. o Shake the bottle of suspension well for at least 10 seconds before pouring the dose of medicine to give to your child For adults with heart failure or who have had a heart attack, take Valsartan Tablets 2 times each day. Your healthcare provider may start you on a low dose of Valsartan Tablets and may increase the dose during your treatment. Valsartan Tablets can be taken with or without food. If you miss a dose, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Take the next dose at your regular time. If you take too much Valsartan Tablets, call your healthcare provider, or go to the nearest hospital emergency room. What are the possible side effects of Valsartan Tablets? Valsartan Tablets can cause serious side effects, including: See "What is the most important information I should know about Valsartan Tablets?" Low blood pressure (hypotension). Low blood pressure can happen with Valsartan Tablets, especially when you first start taking it and can cause you to feel lightheaded. Feeling lightheaded is most likely to happen if you: take water pills are on a low-salt diet get dialysis treatments do not drink enough liquids are dehydrated (decreased body fluids) due to vomiting and diarrhea you sweat excessively have heart problems Lie down, if you feel lightheaded, dizzy or faint. Call your healthcare provider right away. Kidney problems. Kidney problems may get worse in people that already have kidney disease or heart problems. Your doctor may do blood tests to check for this. Increased potassium in your blood. Some people may develop increased potassium in the blood during treatment with Valsartan Tablets. Your doctor may do a blood test to check your potassium levels as needed. The most common side effects of Valsartan Tablets when used to treat people with high blood pressure include: headache dizziness flu symptoms tiredness stomach (abdominal) pain The most common side effects of Valsartan Tablets when used to treat people with heart failure include: dizziness low blood pressure diarrhea joint and back pain tiredness high blood potassium The most common side effects of Valsartan Tablets when used to treat people after a heart attack that cause them to stop taking Valsartan Tablets include: low blood pressure cough high blood creatinine (decreased kidney function) You should not stop taking Valsartan Tablets without talking to your healthcare provider. These are not all of the possible side effects of Valsartan Tablets. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to Marlex Pharmaceuticals at 1-888-582-1953 or Drugsafety@marlexpharm.com or FDA at 1-800-FDA-1088. How should I store Valsartan Tablets? Store Valsartan tablets at room temperature between 59ºF -86ºF (15ºC -30ºC). Keep Valsartan tablets container tightly closed and in a dry place to protect from moisture. Valsartan suspension is provided in a glass bottle with a child-resistant screw-cap closure. Store bottles of Valsartan suspension at room temperature less than 86ºF (30ºC) for up to 30 days, or refrigerate between 35ºF to 46ºF (2ºC to 8ºC) for up to 75 days. Keep Valsartan Tablets and all medicines out of the reach of children. General information about the safe and effective use of Valsartan Tablets. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use Valsartan Tablets for a condition for which it was not prescribed. Do not give Valsartan Tablets to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about Valsartan Tablets that is written for health professionals. What are the ingredients in Valsartan Tablets? Active ingredient: valsartan Inactive ingredients: colloidal anhydrous silica, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, hydroxypropyl methylcellulose, titanium dioxide and iron oxides (yellow, black and/or red). Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE 19720 Rev. 12/22 SP Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation's Diovan (valsartan) tablets. However, due to Novartis Pharmaceuticals Corporation's marketing exclusivity rights, this drug product is not labeled with that information. This Patient Info...

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label – 40 mg Rx Only NDC 10135-0768-30 Valsartan Tablets, USP 40 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label – 80 mg Rx Only NDC 10135-0769-90 Valsartan Tablets, USP 80 mg 90 Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label – 160 mg Rx Only NDC 10135-0770-90 Valsartan Tablets, USP 160 mg 90 Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label – 320 mg Rx Only NDC 10135-0771-90 Valsartan Tablets, USP 320 mg 90 Tablets