Ibuprofen (Page 4 of 4)

OVERDOSAGE

Approximately 1½ hours after the reported ingestion of from 7 to 10 ibuprofen tablets (400 mg), a 19-month old child weighing 12 kg was seen in the hospital emergency room, apneic and cyanotic, responding only to painful stimuli. This type of stimulus, however, was sufficient to induce respiration. Oxygen and parenteral fluids were given; a greenish-yellow fluid was aspirated from the stomach with no evidence to indicate the presence of ibuprofen. Two hours after ingestion the child’s condition seemed stable; she still responded only to painful stimuli and continued to have periods of apnea lasting from 5 to 10 seconds. She was admitted to intensive care and sodium bicarbonate was administered as well as infusions of dextrose and normal saline. By four hours post-ingestion she could be aroused easily, sit by herself and respond to spoken commands. Blood level of ibuprofen was 102.9 µg/mL approximately 8½ hours after accidental ingestion. At 12 hours she appeared to be completely recovered.

In two other reported cases where children (each weighing approximately 10 kg) accidentally, acutely ingested approximately 120 mg/kg, there were no signs of acute intoxication or late sequelae. Blood level in one child 90 minutes after ingestion was 700 µg/mL — about 10 times the peak levels seen in absorption-excretion studies.

A 19-year old male who had taken 8,000 mg of ibuprofen over a period of a few hours complained of dizziness, and nystagmus was noted. After hospitalization, parenteral hydration and three days bed rest, he recovered with no reported sequelae.

In cases of acute overdosage, the stomach should be emptied by vomiting or lavage, though little drug will likely be recovered if more than an hour has elapsed since ingestion. Because the drug is acidic and is excreted in the urine, it is theoretically beneficial to administer alkali and induce diuresis. In addition to supportive measures, the use of oral activated charcoal may help to reduce the absorption and reabsorption of ibuprofen tablets.

DOSAGE AND ADMINISTRATION

Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

After observing the response to initial therapy with ibuprofen tablets, the dose and frequency should be adjusted to suit an individual patient’s needs.

Do not exceed 3200 mg total daily dose. If gastrointestinal complaints occur, administer ibuprofen tablets with meals or milk.

Rheumatoid arthritis and osteoarthritis, including flare-ups of chronic disease

Suggested Dosage: 1200 mg-3200 mg daily (300 mg qid; 400 mg, 600 mg or 800 mg tid or qid). Individual patients may show a better response to 3200 mg daily, as compared with 2400 mg, although in well-controlled clinical trials patients on 3200 mg did not show a better mean response in terms of efficacy. Therefore, when treating patients with 3200 mg/day, the physician should observe sufficient increased clinical benefits to offset potential increased risk.

The dose should be tailored to each patient, and may be lowered or raised depending on the severity of symptoms either at time of initiating drug therapy or as the patient responds or fails to respond.

In general, patients with rheumatoid arthritis seem to require higher doses of ibuprofen tablets than do patients with osteoarthritis.

The smallest dose of ibuprofen tablets that yields acceptable control should be employed. A linear blood level dose-response relationship exists with single doses up to 800 mg (See CLINICAL PHARMACOLOGY for effects of food on rate of absorption).

The availability of four tablet strengths facilitates dosage adjustment.

In chronic conditions , a therapeutic response to therapy with ibuprofen tablets is sometimes seen in a few days to a week but most often is observed by two weeks. After a satisfactory response has been achieved, the patient’s dose should be reviewed and adjusted as required.

Mild to moderate pain: 400 mg every 4 to 6 hours as necessary for relief of pain.

In controlled analgesic clinical trials, doses of ibuprofen tablets greater than 400 mg were no more effective than the 400 mg dose.

Dysmenorrhea

For the treatment of dysmenorrhea, beginning with the earliest onset of such pain, ibuprofen tablets should be given in a dose of 400 mg every 4 hours as necessary for the relief of pain.

HOW SUPPLIED

Ibuprofen tablets are available in the following strengths:

400 mg (white to off white, round, biconvex, film coated tablets debossed with ‘121’ on one side and plain on other side)

Bottles of 100 (NDC 42582-111-10)

Bottles of 500 (NDC 42582-111-18)

600 mg (white to off white, capsule shaped, biconvex, film coated tablets debossed with ‘122’ on one side and plain on other side)

Bottles of 100 (NDC 42582-112-10)

Bottles of 500 (NDC 42582-112-18)

800 mg (white to off white, capsule shaped, biconvex, film coated tablets debossed with ‘123’ on one side and plain on other side)

Bottles of 100 (NDC 42582-132-10)

Bottles of 500 (NDC 42582-113-18)


Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]

Rx only

Manufactured for:
Bi-Coastal Pharma International LLC
1161 Broad Street
Shrewbury, NJ 07702

Manufactured by:
Marksans Pharma Ltd.
Plot No. L-82, L-83 Verna Indl. Estate
Verna, Goa-403 722, India

SPL Medguide

Medication Guide for Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

What is the most important information I should know about medicines called Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)?

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 NSAIDs
    • with longer use of NSAIDs

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

Avoid taking NSAIDs after 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:
    • anytime during use
    • without warning symptoms
    • 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

NSAIDs should only be used:

  • exactly as prescribed
  • at the lowest dose possible for your treatment
  • for the shortest time needed

What are NSAIDs?

NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps and other types of short-term pain.

Who should not take NSAIDs?

Do not take NSAIDs:

  • if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs
  • right before or after heart bypass surgery.

Before taking NSAIDs tell your healthcare provider about all of your medical conditions, including if you:

  • have liver or kidney problems
  • if you have high blood pressure
  • have asthma
  • are pregnant or plan to become pregnant. Talk to your healthcare provider if you are considering taking NSAIDs during pregnancy. You should not take NSAIDs after 29 weeks of pregnancy.
  • are breast feeding or plan to breast feed.

Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact witheach other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.

What are the possible side effects of NSAIDs?

NSAIDs can cause serious side effects, including:

See “What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?

  • new or worse high blood pressure
  • heart failure
  • liver problems including liver failure
  • kidney problems including kidney failure
  • low red blood cells (anemia)
  • life-threatening skin reactions
  • life-threatening allergic reactions
  • Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

Get emergency help right away if you get any of the following symptoms:

  • shortness of breath or trouble breathing
  • chest pain
  • weakness in one part or side of your body
  • slurred speech
  • swelling of the face or throat

Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms:

  • nausea
  • more tired or weaker than usual
  • diarrhea
  • itching
  • your skin or eyes look yellow
  • indigestion or stomach pain
  • flu-like symptoms
  • vomit blood
  • there is blood in your bowel movement or it is black and sticky like tar
  • unusual weight gain
  • skin rash or blisters with fever
  • swelling of the arms, legs, hands and feet

If you take too much of your NSAID, Call your healthcare provider or get medical help right away.

These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs.

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

Other information about NSAIDs

  • Aspirin is an NSAID 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.
  • Some NSAIDs are sold in lower doses without a prescription (over-the counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.

General information about the safe and effective use of NSAIDs

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NSAIDs for a condition for which it was not prescribed. Do not give NSAIDs to other people, even if they have the same symptoms that you have. It may harm them.

If you would like more information about NSAIDs, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for health professionals.

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

Manufactured for:
Bi-Coastal Pharma International LLC
1161 Broad Street
Shrewbury, NJ 07702


Manufactured by:
Marksans Pharma Ltd.
Plot No. L-82, L-83, Verna Indl. Estate,
Verna, Goa-403 722, India

NDC 42582-111-10
Bi-Coastal Pharma Inertnational, LLC
IBUPROFEN
TABLETS, UPS
400 mg
Parmacist: Dispence the Medicatlone Guide provided separatelu to each patientRx ONLY 100 Tablets

ibu400mg
(click image for full-size original)

NDC 42582-112-10
Bi-Coastal Pharma Inertnational, LLC
IBUPROFEN
TABLETS, UPS
400 mg
Parmacist: Dispence the Medicatlone Guide provided separatelu to each patientRx ONLY 100 Tablets

ibu600mg
(click image for full-size original)

NDC 42582-113-10
Bi-Coastal Pharma Inertnational, LLC
IBUPROFEN
TABLETS, UPS
400 mg
Parmacist: Dispence the Medicatlone Guide provided separatelu to each patientRx ONLY 100 Tablets

image description
(click image for full-size original)
IBUPROFEN ibuprofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42582-111
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 400 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
POLYVINYL ALCOHOL, UNSPECIFIED
STARCH, PREGELATINIZED CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND (round, biconvex, film coated tablets) Size 13mm
Flavor Imprint Code 121
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42582-111-10 100 TABLET in 1 BOTTLE None
2 NDC:42582-111-18 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090796 04/14/2016
IBUPROFEN ibuprofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42582-112
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 600 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
POLYVINYL ALCOHOL, UNSPECIFIED
STARCH, PREGELATINIZED CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape CAPSULE (capsule shaped, biconvex, film coated tablets) Size 18mm
Flavor Imprint Code 122
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42582-112-10 100 TABLET in 1 BOTTLE None
2 NDC:42582-112-18 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090796 04/14/2016
IBUPROFEN ibuprofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42582-113
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 800 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
POLYVINYL ALCOHOL, UNSPECIFIED
STARCH, PREGELATINIZED CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape CAPSULE (capsule shaped, biconvex, film coated tablets) Size 19mm
Flavor Imprint Code 123
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42582-113-10 100 TABLET in 1 BOTTLE None
2 NDC:42582-113-18 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090796 04/14/2016
Labeler — Bi-Coastal Pharma International LLC (078397428)

Revised: 04/2016 Bi-Coastal Pharma International LLC

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