IBUPROFEN suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)

Available from:

Akorn

INN (International Name):

IBUPROFEN

Composition:

IBUPROFEN 100 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of ibuprofen oral suspension and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). In Pediatric Patients, ibuprofen oral suspension is indicated: In Adults, ibuprofen oral suspension is indicated: Since there have been no controlled trials to demonstrate whether there is any beneficial effect or harmful interaction with the use of ibuprofen in conjunction with aspirin, the combination cannot be recommended (see PRECAUTIONS-Drug Interactions ). Ibuprofen oral suspension is contraindicated in patients with known hypersensitivity to ibuprofen. Ibuprofen should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS-Anaphylactoid Reactions , and PREC

Product summary:

Ibuprofen Oral Suspension, USP 100 mg/5 mL Orange-colored, berry-flavored suspension - 5 mL unit dose in trays of ten cups Case of 40, NDC 50383-584-06 Case of 100, NDC 50383-584-07 - 10 mL unit dose in trays of ten cups Case of 40, NDC 50383-584-11 Case of 100, NDC 50383-584-12 - Bottles of 4 fl oz (118 mL) have a calibrated dosage cup included for consumer use. NDC 50383-584-04 - Bottles of 16 fl oz (473 mL), NDC 50383-584-16 Shake well before using. Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Dispense in a well-closed container as defined in the USP. Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701 Rev. 584:01 03/19 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: o with increasing doses of NSAIDs o 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 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. o anytime during use o without warning symptoms o that may cause death The risk of getting an ulcer or bleeding increases with: o past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs o taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs” o increasing doses of NSAIDs o longer use of NSAIDs o smoking o drinking alcohol o older age o poor health o advanced liver disease o bleeding problems NSAIDs should only be used: o exactly as prescribed o at the lowest dose possible for your treatment o 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: Before taking NSAIDs, tell your healthcare provider about all of your medical conditions, including if you: 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 with each 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)? Get emergency help right away if you get any of the following symptoms: Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms: 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 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. Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 For more information, go to Hitechpharm.com or call 1-800-262-9012. This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised June 2016

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IBUPROFEN- IBUPROFEN SUSPENSION
AKORN
----------
IBUPROFEN ORAL SUSPENSION, USP 100 MG/5 ML
RX ONLY
CARDIOVASCULAR THROMBOTIC EVENTS
•
•
GASTROINTESTINAL RISK
DESCRIPTION
The active ingredient in Ibuprofen Oral Suspension, USP is ibuprofen,
which is a member
of the propionic acid group of nonsteroidal anti-inflammatory drugs
(NSAIDs). Ibuprofen
is a racemic mixture of [+]S- and [-]R-enantiomers. It is a white to
off-white crystalline
powder, with a melting point of 74° to 77°C. It is practically
insoluble in water (< 0.1
mg/mL), but readily soluble in organic solvents such as ethanol and
acetone. Ibuprofen
has a pKa of 4.43 ± 0.03 and an n-octanol/water partition coefficient
of 11.7 at pH 7.4.
The chemical name for ibuprofen is (±)-2-(_p_-Isobutylphenyl)
propionic acid. The
molecular weight of ibuprofen is 206.28. Its molecular formula is C
H
O and it has
the following structural formula:
Ibuprofen Oral Suspension, USP is a sucrose-sweetened, orange-colored,
berry-flavored
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk
of
serious cardiovascular thrombotic events, including myocardial
infarction and
stroke, which can be fatal. This risk may occur early in treatment and
may
increase with duration of use [_see WARNINGS and PRECAUTIONS_].
Ibuprofen oral suspension is contraindicated in the setting of
coronary artery
bypass graft (CABG) surgery [_see CONTRAINDICATIONS and WARNINGS_].
• NSAIDs cause an increased risk of serious gastrointestinal adverse
events
including bleeding, ulceration, and perforation of the stomach or
intestines,
which can be fatal. These events can occur at any time during use and
without
warning symptoms. Elderly patients are at greater risk for serious
gastrointestinal events (_ See WARNINGS_ ).
13
18
2
suspension containing 100 mg of ibuprofen in 5 mL (20 mg/mL). Inactive
ingredients
include: carboxymethyl cellulose sodium, citric acid anhydrous,
glycerin, natural and
artificial berry flavor, polysorbate 80, purified water, sodium
benzoate, sodium citrate
dihy