HYDROCODONE BITARTRATE AND IBUPROFEN

Main information

  • Trade name:
  • HYDROCODONE BITARTRATE AND IBUPROFEN- hydrocodone bitartrate and ibuprofen tablet, film coated
  • Composition:
  • HYDROCODONE BITARTRATE 7.5 mg
  • Administration route:
  • ORAL
  • Prescription type:
  • PRESCRIPTION DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • HYDROCODONE BITARTRATE AND IBUPROFEN- hydrocodone bitartrate and ibuprofen tablet, film coated
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Hydrocodone bitartrate and ibuprofen tablets are indicated for the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Carefully consider the potential benefits and risks of hydrocodone bitartrate and ibuprofen tablets and other treatment options before deciding to use hydrocodone bitartrate and ibuprofen tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals ( s e e   WARNINGS: Cardiovascular Thrombotic Events , Gastrointestinal Bleeding, Ulceration, and Perforation ) . Do not use hydrocodone bitartrate and ibuprofen tablets for the treatment of conditions such as osteoarthritis or rheumatoid arthritis. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses ( s e e   WARNINGS: Addiction, Abuse, and Misuse ) , reserve hydrocodone bitartrate and ibuprofen tablets for use in patients for whom alternative treatment options (e.g., n
  • Product summary:
  • Hydrocodone bitartrate and ibuprofen tablets are available as: White, film-coated round convex tablets, debossed with "524 " on one side and plain on the other side. Bottles of 100-NDC 62037-524-01 Bottles of 500-NDC 62037-524-05 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. B 7/2018

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • Abbreviated New Drug Application
  • Authorization number:
  • 62037-524-01, 62037-524-05
  • Last update:
  • 16-06-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

coated

Actavis Pharma, Inc.

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MedicationGuide

Hydrocodone Bitartrate (hye” droe koe’ done bye tar’ trate) and Ibuprofen (eye" bue proe'

fen) Tablets), CII

Hydrocodone bitartrate and ibuprofen tablets are:

A strong prescription pain medicine that contains an opioid (narcotic) and a non-steroidal anti-

inflammatory drug (NSAID), that is used to manage short-term (acute) pain, when other pain

treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot

tolerate them.

An opioid pain medicine can put you at risk for overdose and death. Even if you take your dose

correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to

death.

NSAIDs are used to treat pain, redness, swelling, and inflammation.

Important information about hydrocodone bitartrate and ibuprofen tablets:

Get emergency help right away if you take too much hydrocodone bitartrate and ibuprofen

tablets (overdose). When you first start taking hydrocodone bitartrate and ibuprofen

tablets, when your dose is changed, or if you take too much (overdose), serious or life-

threatening breathing problems that can lead to death may occur.

Taking hydrocodone bitartrate and ibuprofen

tablets with other opioid medicines, benzodiazepines, alcohol, or other central

nervous system depressants (including street drugs) can cause severe drowsiness, decreased

awareness, breathing problems, coma, and death.

Never give anyone else your hydrocodone bitartrate and ibuprofen tablets. They could die from

taking it. Store hydrocodone bitartrate and ibuprofen tablets away from children and in a

safe place to prevent stealing or abuse. Selling or giving away hydrocodone bitartrate and

ibuprofen tablets is against the law.

Hydrocodone bitartrate and ibuprofen tablet contains an NSAID. NSAIDs can

cause serious side effects, including:

Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in

treatment and may increase:

○ with increasing doses of medicine containing NSAIDs

○ with longer use of medicine containing NSAIDs

Do not take NSAIDS right before or after a heart surgery called a “coronary artery bypass graft (CABG).”

Avoid taking NSAIDS after a recent heart attack, unless your healthcare provider tells you

to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.

Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading

from the mouth to the stomach), stomach and intestines:

o any time during use

o without warning symptoms

o that may cause death

The risk of getting an ulcer or bleeding increases with:

○ past history of stomach ulcers, or stomach or

intestinal bleeding with use of NSAIDs

○ taking medicines called “corticosteroids,”

“anticoagulants,” “SSRIs,” or “SNRIs”

○ increasing doses of NSAIDS

○ older age

○ longer use of NSAIDS

○ poor health

○ smoking

○ advanced liver disease

○ drinking alcohol

○ bleeding problems

Do not take hydrocodone bitartrate and ibuprofen tablets:

if you have severe asthma, trouble breathing, or other lung problems.

if you have a bowel blockage or have narrowing of the stomach or intestines.

if you have had an asthma attack, hives, or other allergic reaction with aspirin, other NSAIDs, or

opioid medicine.

right before or after heart bypass surgery.

Before taking hydrocodone bitartrate and ibuprofen

tablets, tell your healthcare provider if you have a history of:

head injury or seizures

liver, kidney, or thyroid problems

problems urinating

pancreas or gallbladder problems

high blood pressure

asthma

abuse of street or prescription drugs, alcohol addiction, or mental health problems.

Tell your healthcare provider if you are:

pregnant or planning to become pregnant. Talk to your healthcare provider if you are

considering taking hydrocodone bitartrate and ibuprofen

tablets during pregnancy. Prolonged use of hydrocodone bitartrate and ibuprofen tablets during

pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if

not recognized and treated. You should not take NSAIDs after 29 weeks of pregnancy.

breastfeeding or planning to breastfeed. Hydrocodone bitartrate and ibuprofen

passes into breast milk and may harm your baby.

taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking

hydrocodone bitartrate and ibuprofen

tablets with certain other medicines can cause serious side effects that could lead to death.

When taking hydrocodone bitartrate and ibuprofen tablets:

Do not change your dose. Take hydrocodone bitartrate and ibuprofen

tablets exactly as prescribed by your healthcare provider.

Use the lowest dose possible for the shortest time needed.

Take your prescribed dose every 4 to 6 hours, as needed. Do not take more than your

prescribed dose. If you miss a dose, take your next dose at your usual time.

Call your healthcare provider if the dose you are taking does not control your pain.

If you have been taking hydrocodone bitartrate and ibuprofen tablets regularly, do

not stop taking it without talking to your healthcare provider.

After you stop taking hydrocodone bitartrate and ibuprofen

tablets, flush any unused tablets down the toilet or contact the

Drug Enforcement Agency (DEA) to find the location of an authorized collector (1-800-882-

9539) after you stop taking hydrocodone bitartrate and ibuprofen tablets.

While taking hydrocodone bitartrate and ibuprofen tablets DO NOT:

drive or operate heavy machinery, until you know how it affects you. Hydrocodone bitartrate and

ibuprofen tablets can make you sleepy, dizzy, or lightheaded.

drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using produc

ts containing alcohol during treatment with hydrocodone bitartrate and ibuprofen

tablets may cause you to overdose and die.

The possible side effects of hydrocodone bitartrate and ibuprofen tablets:

constipation, diarrhea, gas, heartburn, nausea, sleepiness, vomiting, tiredness, headache,

dizziness, abdominal pain, heart attack, stroke, new or worse high blood pressure, heart failure,

liver problems including liver failure, kidney problems including kidney failure, bleeding and ulce

rs in the stomach and intestine, low red blood cells (anemia), life-threatening skin reactions, life-

threatening allergic reactions, asthma attacks in people who have asthma. Call your healthcare

provider if you have any of these symptoms and they are severe.

Get emergency medical help if you have:

trouble breathing or shortness of breath

agitation

fast heartbeat

high body temperature

chest pain

trouble walking

swelling of your face, tongue, or throat

stiff muscles

extreme drowsiness

mental changes such as confusion

lightheadedness when changing positions

weakness in one part or side of your body

a fainting spell

slurred speech

Stop hydrocodone bitartrate and ibuprofen

tablets and call your healthcare provider right away if you have any of the following symptoms:

nausea

flu-like symptoms

more tired or weaker than usual

vomit blood

diarrhea

there is blood in your bowel movement or it is

black and sticky like tar

itching

unusual weight gain

your skin or eyes look yellow

skin rash or blisters with fever

indigestion or stomach pain

swelling of the arms and legs, hands and feet

These are not all the possible side effects of hydrocodone bitartrate and ibuprofen tablets. Call your

doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For

more information go to dailymed.nlm.nih.gov.

Other information:

Aspirin is an NSAID medicine, but it does not increase the chance of a heart attack. Aspirin can

cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach

and intestines.

Do not take other NSAID medicines, even those sold in lower doses without a prescription (over-

the-counter) while taking hydrocodone bitartrate and ibuprofen tablets. NSAIDs may be present in

over-the-counter medications for treatment of colds, fever, or insomnia.

Manufactured by:

Actavis Laboratories FL, Inc.

Fort Lauderdale, FL 33314 USA

Distributed by:

Actavis Pharma, Inc.

Parsippany, NJ 07054 USA

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: January 2017

Revised: 1/2017

Document Id: e5666a18-5187-4405-b7c5-a45736cdedde

34391-3

Set id: 9cc32777-1f3b-4309-b2eb-ca165ad56aca

Version: 19

Effective Time: 20170101

Actavis Pharma, Inc.