Trade Name: Ibuprofen

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

Manufacturer: VistaPharm, Inc.

Presentation: SUSPENSION, HUMAN PRESCRIPTION DRUG

Strength: 100 mg/5mL

Storage and handling

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

Disclaimer:
  1. 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.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
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  • No data
  • Cardiovascular Thrombotic Events
  • Gastrointestinal Risk
  • 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 74u00b0 to 77u00b0C. 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 u00b1 0.03 and an n octanol/water partition coefficient of 11.7 at pH 7.4. The chemical name for ibuprofen is (u00b1)-2-(-Isobutylphenyl) propionic acid. The molecular weight of ibuprofen is 206.28. Its molecular formula is CHO and it has the following structural formula:
  • Ibuprofen Oral Suspension, USP is a sucrose-sweetened, orange-colored, berry-flavored suspension containing 100 mg of ibuprofen in 5 mL (20 mg/mL). Inactive ingredients include: acesulfame potassium, citric acid anhydrous, D&C yellow #10, FD&C red #40, glycerin, polysorbate 80, pregelatinized corn strach, purified water, sodium benzoate, strawberry flavor, sucrose and xanthan gum.
  • Ibuprofen is a racemic mixture of [-]R- and [+]S-isomers. and studies indicate that the [+]S-isomer is responsible for clinical activity. The [-]R-form, while thought to be pharmacologically inactive, is slowly and incompletely (~ 60%) interconverted into the active [+]S species in adults. The degree of interconversion in children is unknown, but is thought to be similar. The [-]R-isomer serves as a circulating reservoir to maintain levels of active drug. Ibuprofen is well absorbed orally, with less than 1% being excreted in the urine unchanged. It has a biphasic elimination time curve with a plasma half-life of approximately 2 hours. Studies in febrile children have established the dose-proportionality of 5 and 10 mg/kg doses of ibuprofen. Studies in adults have established the dose-proportionality of ibuprofen as a single oral dose from 50 to 600 mg for total drug and up to 1200 mg for free drug.
  • Absorption - studies indicate that ibuprofen is well absorbed orally from the suspension formulation, with peak plasma levels usually occurring within 1 to 2 hours (see Table 1).
  • Antacids - A bioavailability study in adults has shown that there was no interference with the absorption of ibuprofen when given in conjunction with an antacid containing both aluminum hydroxide and magnesium hydroxide.
  • H-2 Antagonists - In studies with human volunteers, coadministration of cimetidine or ranitidine with ibuprofen had no substantive effect on ibuprofen serum concentrations.
  • Food Effects - Absorption is most rapid when ibuprofen is given under fasting conditions. Administration of ibuprofen with food affects the rate but not the extent of absorption. When taken with food, T is delayed by approximately 30 to 60 minutes, and peak levels are reduced by approximately 30 to 50%
  • Distribution - Ibuprofen, like most drugs of its class, is highly protein bound (>99% bound at 20 mcg/mL). Protein binding is saturable and at concentrations >20 mcg/mL binding is non-linear. Based on oral dosing data there is an age- or fever- related change in volume of distribution for ibuprofen. Febrile children <11 years old have a volume of approximately 0.2 L/kg while adults have a volume of approximately 0.12 L/kg. The clinical significance of these findings is unknown.
  • Metabolism - Following oral administration, the majority of the dose was recovered in the urine within 24 hours as the hydroxy-(25%) and carboxypropyl-(37%) phenylpropionic acid metabolites. The percentages of free and conjugated ibuprofen found in the urine were approximately 1% and 14%, respectively. The remainder of the drug was found in the stool as both metabolites and unabsorbed drug.
  • Elimination - Ibuprofen is rapidly metabolized and eliminated in the urine. The excretion of ibuprofen is virtually complete 24 hours after the last dose. It has a biphasic plasma elimination time curve with a half-life of approximately 2.0 hours. There is no difference in the observed terminal elimination rate or half-life between children and adults, however, there is an age- or fever-related change in total clearance. This suggests that the observed change in clearance is due to changes in the volume of distribution of ibuprofen (see Table 1 for CI/F values).
  • Clinical Studies - Controlled clinical trials comparing doses of 5 and 10 mg/kg ibuprofen suspension and 10 to 15 mg/kg of acetaminophen elixir have been conducted in children 6 months to 12 years of age with fever primarily due to viral illnesses. In these studies there were no differences between treatments in fever reduction for the first hour and maximum fever reduction occurred between 2 and 4 hours. Response after 1 hour was dependent on both the level of temperature elevation as well as the treatment. In children with baseline temperatures at or below 102.5u00b0F both ibuprofen doses and acetaminophen were equally effective in their maximum effect. In children with temperatures above 102.5u00b0F, the ibuprofen 10 mg/kg dose was more effective. By 6 hours, children treated with ibuprofen 5 mg/kg tended to have recurrence of fever, whereas children treated with ibuprofen 10 mg/kg still had significant fever reduction at 8 hours. In control groups treated with 10 mg/kg acetaminophen, fever reduction resembled that seen in children treated with 5 mg/kg of ibuprofen, with the exception that temperature elevation tended to return 1 to 2 hours earlier.
  • In patients with primary dysmenorrhea, ibuprofen has been shown to reduce elevated levels of prostaglandin activity in the menstrual fluid and to reduce testing and active intrauterine pressure, as well as the frequency of uterine contractions. The probable mechanism of action is to inhibit prostaglandin synthesis rather than simply to provide analgesia.
  • Pharmacodynamics
  • When a similarly designed study was conducted with enteric-coated aspirin, where healthy subjects were administered enteric-coated aspirin 81 mg once daily for 6 days and ibuprofen 400 mg three times daily (2,u00a0 7u00a0 and 12 h post-aspirin dose) for 6 days, there was an interaction with the antiplatelet activity at 24 hours following the day-6 aspirin dose [67%] (see ).n
  • 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 ).
  • In Pediatric Patients, Ibuprofen Oral Suspension isu00a0 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 ).
  • Ibuprofen 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 , and ).
  • Ibuprofen is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see ).
  • No data
  • No data
  • In patients taking ibuprofen or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1 to 10% of patients are: Abnormal renal function, anemia, dizziness, edema, elevated liver enzymes,u00a0fluid retention, gastrointestinal experiences (including abdominal pain, bloating, constipation, diarrhea, dyspepsia,u00a0 epigastric pain, flatulence, heartburn, nausea, vomiting), headaches, increased bleeding time, nervousness, pruritus, rashes (including maculopapular) and tinnitus.
  • Additional adverse experiences reported occasionally include:
  • Body as a whole
  • Cardiovascular system
  • Digestive system
  • Hemic and lymphatic system
  • Metabolic and nutritional
  • Nervous system
  • Respiratory system
  • Skin and appendages
  • Special senses
  • Urogenital system
  • Other adverse reactions, which occur rarely are:
  • Body as a whole
  • Cardiovascular system
  • Digestive system
  • Hemic and lymphatic system
  • Metabolicu00a0 andu00a0 nutritional
  • Nervous system
  • Respiratory
  • Skin and appendages
  • Special senses
  • Urogenital
  • To report SUSPECTED ADVERSE EVENTS, contact VistaPharm, Inc. at 1-888-655-1505, or FDA at 1-800-FDA-1088 or for voluntary reporting of adverseu00a0 reactions.
  • The toxicity of ibuprofen overdose is dependent upon the amount of drug ingested and the time elapsed since ingestion, though individual response may vary, which makes it necessary to evaluate each case individually. Although uncommon, serious toxicity and death have been reported in the medical literature with ibuprofen overdosage. The most frequently reported symptoms of ibuprofen overdose include abdominal pain, nausea, vomiting, lethargy and drowsiness. Other central nervous system symptoms include headache, tinnitus, CNS depression and seizures. Metabolic acidosis, coma, acute renal failure and apnea (primarily in very young children) may rarely occur. Cardiovascular toxicity, including hypotension, bradycardia, tachycardia and atrial fibrillation also have been reported.
  • The treatment of acute ibuprofen overdose is primarily supportive. Management of hypotension, acidosis and gastrointestinal bleeding may be necessary.
  • In cases of acute overdose, the stomach should be emptied through ipecac-induced emesis or lavage. Emesis is most effective if initiated within 30 minutes of ingestion. Orally administered activated charcoal may help in reducing the absorption and reabsorption of ibuprofen.
  • In children, the estimated amount of ibuprofen ingested per body weight may be helpful to predict the potential for development of toxicity although each case must be evaluated. Ingestion of less than 100 mg/kg is unlikely to produce toxicity. Children ingesting 100 to 200 mg/kg may be managed with induced emesis and a minimal observation time of four hours. Children ingesting 200 to 400 mg/kg of ibuprofen should have immediate gastric emptying and at least four hours observation in a health care facility. Children ingesting greater than 400 mg/kg require immediate medical referral, careful observation and appropriate supportive therapy. Ipecac-induced emesis is not recommended in overdoses greater than 400 mg/kg because of the risk for convulsions and the potential for aspiration of gastric contents.
  • In adult patients the history of the dose reportedly ingested does not appear to be predictive of toxicity. The need for referral and follow-up must be judged by the circumstances at the time of the overdose ingestion. Symptomatic adults should be carefully evaluated, observed and supported.
  • Carefully consider the potential benefits and risks of ibuprofen oral suspension and other treatment options before deciding to use ibuprofen oral suspension. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see ).
  • After observing the response to initial therapy with ibuprofen oral suspension, the dose and frequency should be adjusted to suit an individual patientu2019s needs.
  • Pediatric Patients
  • Fever Reduction: For reduction of fever in children, 6 months up to 2 years of age, the dosage should be adjusted on the basis of the initial temperature level (see ). The recommended dose is 5 mg/kg if the baseline temperature is less than 102.5u00baF, or 10 mg/kg if the baseline temperature is 102.5u00baF or greater. The duration of fever reduction is generally 6 to 8 hours.The recommended maximum daily dose is 40 mg/kg.
  • Analgesia: For relief of mild to moderate pain in children 6 months up to 2 years of age, the recommended dosage is 10 mg/kg, every 6 to 8 hours. The recommended maximum daily dose is 40 mg/kg. Doses should be given so as not to disturb the childu2019s sleep pattern.
  • Juvenile Arthritis: The recommended dose is 30 to 40 mg/kg/day divided into three to four doses (see Individualization of Dosage). Patients with milder disease may be adequately treated with 20 mg/kg/day.
  • In patients with juvenile arthritis, doses above 50 mg/kg/day are not recommended because they have not been studied and doses exceeding the upper recommended dose of 40 mg/kg/day may increase the risk of causing serious adverse events. The therapeutic response may require from a few days to several weeks to be achieved. Once a clinical effect is obtained, the dosage should be lowered to the smallest dose of ibuprofen oral suspension needed to maintain adequate control of symptoms.
  • Pediatric patients receiving doses above 30 mg/kg/day or if abnormal liver function tests have occurred with previous NSAID treatments should be carefully followed for signs and symptoms of early liver dysfunction.
  • Adults
  • Primary Dysmenorrhea: For the treatment of primary dysmenorrhea, beginning with the earliest onset of such pain, ibuprofen oral suspension should be given in a dose of 400 mg every 4 hours, as necessary, for the relief of pain.
  • Rheumatoid Arthritis And Osteoarthritis: Suggested dosage: 1200 to 3200 mg daily (300 mg q.i.d. or 400 mg, 600 mg or 800 mg t.i.d. or q.i.d.). 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.
  • Individualization of Dosage: The dose of ibuprofen oral suspension should be tailored to each patient, and may be lowered or raised from the suggested doses depending on the severity of symptoms either at time of initiating drug therapy or as the patient responds or fails to respond.
  • One fever study showed that, after the initial dose of ibuprofen oral suspension, subsequent doses may be lowered and still provide adequate fever control.
  • In a situation when low fever would require the ibuprofen oral suspension 5 mg/kg dose in a child with pain, the dose that will effectively treat the predominant symptom should be chosen.
  • In chronic conditions, a therapeutic response to ibuprofen therapy 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 patientu2019s dose should be reviewed and adjusted as required.
  • Patients with rheumatoid arthritis seem to require higher doses than do patients with osteoarthritis. The smallest dose of ibuprofen oral suspension that yields acceptable control should be employed.
  • Ibuprofen oral suspension may be used in combination with gold salts and/or corticosteroids.n
  • Ibuprofen Oral Suspension, USP, 100 mg/5 mL
  • Orange-colored, berry-flavored suspension is available as follows:
  • NDC 66689-339-50: Case contains 50 unit-dose cups of 5 mL (NDC 66689-339-01), packaged in 5 trays of 10 unit-dose cups each.
  • Shake well before using. Store at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F) [See USP Controlled Room Temperature].
  • Dispense in a well-closed container as defined in the USP.
  • Manufactured by:
  • Largo, FL 33771
  • VP2272R1
  • 12/19
  • What is the most important information I should know about medicines called n- Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?
  • NSAIDs can cause serious side effects, including:
  • Do not take NSAIDs right before or after a heart surgery called a u201ccoronary artery n- bypass graft (CABG).u201d
  • u00a0n- Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to.
  • u00a0n- Youu00a0n- may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.
  • The risk of getting an ulcer or bleeding increases with:
  • NSAIDs should only be used:
  • 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 n- conditions, including if you:
  • Tellu00a0n- your healthcare provider about all of the medicines you take, including n- prescription or over-the-counter medicines, vitamins or herbal supplements. n- 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 u201cWhat is the most n- important information I should know about medicines called Nonsteroidal Anti-n- 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 n- of the following symptoms:
  • If you take too much of your NSAID, call your healthcare provider or get medical n- help right away.
  • 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. For more information, call VistaPharm, Inc. at 1-888-655-1505.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Manufactured by:
  • Largo, FL 33771
  • VP2273R1
  • 12/19
  • Ibuprofen Oral Suspension, USP
  • 100 mg/ 5 mL
  • Shake Well
  • Delivers 5 mL
  • Store at 20u00b0 - 25u00b0 (68u00b0 - 77u00b0F); (see USP CRT conditions).
  • XACTDOSE
  • Distributed by:
  • VistaPharm, Inc.
  • Largo, FL 33771, USA
  • Rx Only
  • VP2274
  • 11/18
  • NDC 66689-339-01

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Ibuprofen (Ibuprofen) which is also known as Ibuprofen and Manufactured by VistaPharm, Inc.. It is available in strength of 100 mg/5mL.

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