ibuprofen (Caldolor)

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Trade Name: Caldolor

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Cumberland Pharmaceuticals Inc.

Presentation: INJECTION, HUMAN PRESCRIPTION DRUG

Strength: 800 mg/8mL

Storage and handling

IBUPROFEN Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]

Disclaimer:

These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
Trademark shown are property of their respective owners and GNH India does not lay any claim on them.

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Cardiovascular Thrombotic Events
Gastrointestinal Bleeding, Ulceration and Perforation
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
See full prescribing information for complete boxed warning

Non-steroidal 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. ()
CALDOLOR is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. (, )
NSAIDs cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events. ()

CALDOLOR is indicated in adults and pediatric patients six months and older for the:n
CALDOLOR is a nonsteroidal anti-inflammatory drug indicated in adults and pediatric patients six months and older for the:n

Management of mild to moderate pain and the management of moderate to severe pain as an adjunct to opioid analgesics ()n
Reduction of fever ()n

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Use the lowest effective dosage for shortest duration consistent with individual patient treatment goalsnn
CALDOLOR Injection vials must be diluted before administration. ()n
CALDOLOR Injection bags are ready to use. ()n
Adult Pain: 400 mg to 800 mg intravenously over 30 minutes every 6 hours as necessary. ()n
Adult Fever: 400 mg intravenously over 30 minutes, followed by 400 mg every 4 to 6 hours or 100-200 mg every 4 hours as necessary. ()n
Pediatric (pain and fever) ages 12 to 17 years of age: 400 mg intravenously over 10 minutes every 4 to 6 hours as necessary ()n
Pediatric (pain and fever) ages 6 months to 12 years of age: 10 mg/kg intravenously over 10 minutes up to a maximum single dose of 400 mg every 4 to 6 hours as necessary ()n
CALDOLOR must be diluted before administration. ()n

CALDOLOR (ibuprofen) Injection is a clear, colorless, non-pyrogenic, aqueous solution intended for intravenous use available as either an:n
Injection for intravenous use are available in the following presentations:n
800 mg/8 mL (100 mg/mL) single dose vial ()n
800 mg/200 mL (4 mg/mL) single dose, ready-to-use, polypropylene flexible bag ()n

CALDOLOR is contraindicated in the following patients:n

Known hypersensitivity to ibuprofen or any component of the drug product ()n
History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs ()n
In the setting of CABG surgery ()n

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Hepatotoxicityn- and
Hypertension
Heart Failure and Edema
Renal Toxicity
Anaphylactic Reactions
Exacerbation of Asthma Related to Aspirin Sensitivity
Serious Skin Reactions
Premature Closure of Fetal Ductus Arteriosus
Hematologic Toxicity

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:n
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be compared directly to rates in the clinical trials of another drug and may not reflect the rates observed in practice.n
The most common adverse reactions are nausea, flatulence, vomiting, headache, hemorrhage and dizziness (>5%).n
The most common adverse reactions in pediatric patients are infusion site pain, vomiting, nausea, anemia and headache (u22652%). ()n

See for clinically significant drug interactions with ibuprofen.n

Drugs that Interfere with Hemostasis (e.g. warfarin, aspirin, SSRIs/SNRIs):
ACE Inhibitors, Angiotensin Receptor Blockers (ARB), or Beta-Blockers:
ACE Inhibitors and ARBs:
Diuretics:
Digoxin:

Pregnancy
Infertility

Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare [].n
Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes. Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.n
For additional information about overdosage treatment contact a poison control center at 1-800-222-1222.n

CALDOLOR (ibuprofen) Injection is a nonsteroidal anti-inflammatory drug, available as an 800 mg/8 mL single dose vial (100 mg/mL) and 800 mg/200 mL (4 mg/mL) polypropylene, single dose, ready-to-use, flexible bag for intravenous administration. The chemical name is ibuprofen, which is (u00b1)-2-(-isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74u00b0C to 77u00b0C. It has a molecular weight of 206.28. It is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula of ibuprofen is represented below:n
800 mg/8 mL vial: Each 1 mL of solution contains 100 mg of ibuprofen in Water for Injection, USP. The inactive ingredients in CALDOLOR include: 78 mg/mL arginine at a molar ratio of 0.92:1 arginine:ibuprofen. The solution pH is about 7.4.n
800 mg/200 mL polypropylene flexible bag: Each 1 mL of solution contains 4 mg of ibuprofen in Water for Injection, USP. The inactive ingredients in CALDOLOR include: sodium phosphate, sodium hydroxide, and sodium chloride. The solution is iso-osmotic with an approximate pH of 7.4.n
CALDOLOR is sterile and is intended for intravenous administration only.n

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CALDOLOR (ibuprofen) Injection is a clear, colorless, non-pyrogenic, aqueous solution supplied as follows:n
Storage
Store at controlled room temperature 20 u00b0C to 25 u00b0C (68 u00b0F to 77 u00b0F); excursions permitted between 15 u00b0C to 30 u00b0C (59 u00b0F to 86 u00b0F) [see USP Controlled Room Temperature]. Discard the unused portion.n
The stopper in the CALDOLOR vial does not contain natural rubber latex, dry natural rubber, or blends of natural rubber.n

Advise the patient to read the FDA-approved patient labeling (Medication Guide) that accompanies each prescription dispensed. Patients, families, or their caregivers should be informed of the following information before initiating therapy with CALDOLOR and periodically during the course of ongoing therapy.n

Principal Display Panel - 8 mL Vial Label
NDC 66220-287-08 n
Caldolorn (ibuprofen) Injection
800 mg/8 mL
(100 mg/mL)n
FOR INTRAVENOUS USE. MUST DILUTE BEFORE USE.
Store at controlled room temperature,20u00b0C - 25u00b0C (68u00b0 - 77u00b0F).
Single dose vial, discard unused portion.n
DOSAGE:

Principal Display Panel - 8 mL Carton Label
NDC 66220-287-08n
25 x 8 mL Vialsn
800 mg/8 mL
For Intravenous Use
Must Dilute Before Use
Caldolorn (ibuprofen) Injection
800 mg/8 mL
(100 mg/mL)n

Principal Panel Display u2013 Bag Label
200 mL NDC 66220-284-11n
CALDOLORn- Array
(ibuprofen) Injectionn
800 mg/200 mL (4 mg/mL)n
Dosage:n
For intravenous use.n
See package insert for dosage information.n
Use only if solution is clear.n
Single dose container. Discard unused portion.n
Store at controlled room temperature, 20u00b0C-25u00b0C (68u00b0F-77u00b0F)n
Rx Only
Manufactured For:n
CUMBERLAND
PHARMACEUTICALSn
Nashville, TN, USA, 37203n

Principal Panel Display u2013 Case Label
CALDOLORn- Array
(ibuprofen) Injection 800 mg/200 mLn
(4 mg/mL)n
Rx Only Contains 20 bagsn
Each bag contains 800 mg/200 mL ibuprofen inan isosmotic pH 7.4 phosphate buffered sterileinjection solution.n
See package insert for dosage information.n
Single dose container. Discard unused portion.n
LOT: EXP:n
NDC 66220-284-22
Manufactured For:n
CUMBERLAND
PHARMACEUTICALSn
Nashville, TN, USA, 37203
Made in Spainn
Store at controlled room temperaturen
20u00b0C - 25u00b0C (68u00b0F - 77u00b0F)n

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of ibuprofen (Caldolor) which is also known as Caldolor and Manufactured by Cumberland Pharmaceuticals Inc.. It is available in strength of 800 mg/8mL.

ibuprofen (Caldolor) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.