Drug Profile
2. Brand(s):
| Brand Name | Manufacturer | Dosage Form | Pack Size | MRP |
| Megafen Megafen IBU-slow IFEN | Platinum Adamjee | Suspension Tablet 200 mg Tablet 400mg Tablet 600mg Tablet 200mg Tablet 400mg | 90 ml bottle 50*10 25*10 20 50*10 25*10 | Rs 22.60 Rs 287 Rs 206 Rs 80.95 Rs 401.49 Rs 387.12 |
3. Pharmacological Group:
4. Formulation:
Brufen tab 200mg,400mg,800mg,
Brufen syrup
5. General Information:
NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk
6. Dosage Form:
Solids
| Tablets ◙ |
| Capsules | ||
| Hard Capsules | Soft Capsules | Modified Released Capsules |
| Uncoated Tablets | Coated Tablets ◙ | Modified Released Tablets | Sublingual Tablets |
| Powders | |
| Powders for suspension | Powders for Inhalers |
| Others |
| Liquids | Syrup ◙ | Oral drops | Nasal Drops | Topical Solutions | Eye Preparations | Ear Preparations | Others |
| Parenterals Preparations | Injections | Infusions | Powders for injection | Others |
| Topical Solids | Ointment | Creams | lotions | Gels | Pastes | Others |
6. Therapeutic Uses:
7. Information for the user:
i. How to take:
Ibuprofen may be taken with food or milk to prevent stomach upset. If you are taking ibuprofen on a regular basis, you should take it at the same time(s) every day
ii. Frequency & Time of Doses:
Taken three or four times a day for arthritis or every 4-6 hours as needed for pain. Do not exceed 3200 mg total daily dose.
iii. Recommended Dosage Range:
| Neonates/ Children | Adult | Geriatric | Dose according to clinical condition |
| 5-8mg/kg after 6 hrs | 800 milligrams per dose or 3200 mg per day (4 maximum doses). | Dose should be reduced due to less functionality of Liver and kidney | |
iv. Onset of effect:
30 min
v. Duration of Action:
6-8 hrs
vi. Diet Advice:
Drinking too much alcohol may increase the amount of uric acid in the blood and lessen the effects of Ibuprofen. Taking too much vitamin C may make the urine more acidic and increase the possibility of kidney stones forming while you are taking Ibuprofen Therefore, check with your doctor before you take vitamin C while taking this medicine.
vii. Storage:
Store Ibuprofen at room temperature away from moisture and heat.
:
viii: Missed Dose:
Since ibuprofen is sometimes taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not take extra medicine to make up the missed dose.
ix. Stopping the drug:
Stopping the Drug at once after the completion of therapy may not produce any harmful symptoms but a low dose regime is required to avoid relapse.
x. Exceeding the dose (overdose):
In cases of acute over dosage, 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.
8. Possible Adverse Effects:
GASTROINTESTINAL
Nausea, epigastric pain, heartburn, diarrhea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or pain, fullness of GI tract (bloatin CENTRAL NERVOUS SYSTEM
Dizziness, headache, nervousness g and flatulence)
Nausea, epigastric pain, heartburn, diarrhea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or pain, fullness of GI tract (bloatin CENTRAL NERVOUS SYSTEM
Dizziness, headache, nervousness g and flatulence)
DERMATOLOGIC
Rash (including maculopapular type), pruritus
Rash (including maculopapular type), pruritus
SPECIAL SENSES
Tinnitus
Tinnitus
HEMATOLOGIC: Neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia
9. Contraindications:
Ibuprofen tablets are contraindicated in patients with known hypersensitivity to Ibuprofen.
Ibuprofen tablets 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.
Ibuprofen tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery
10. Interactions:
| Drug-Drug Interactions | Drug-Food Interactions |
| ACE-Inhibitors, Aspirin Diuretics, Methotrexate Warfarin-type anticoagulants H-2 Antagonists | Using alcohol or tobacco with Ibuprofen may cause interactions to occur. Vit C rich food can leads to Kidney stones. |
11. Prolonged Use:
Prolong use may lead to peptic ulcer
12. Special Precautions:
i. Be sure to tell your doctor if:
If you are allergic to ibuprofen, aspirin or other NSAIDs or if you have:
· a history of heart attack, stroke, or blood clot;
· heart disease, congestive heart failure, high blood pressure;
· a history of stomach ulcers or bleeding;
· asthma;
· polyps in your nose; or
- liver or kidney disease,
· systemic lupus erythematosus (SLE);
· a bleeding or blood clotting disorder; or
· if you smoke.
ii. Pregnancy:
In late pregnancy, as with other NSAIDs, Ibuprofen tablets should be avoided because it may cause premature closure of the ductus arteriosus.
iii. Breast Feeding/Lactation:
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human-milk and because of the potential for serious adverse reactions in nursing infants from Ibuprofen tablets, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
iv. Infants & Children:
Safety and effectiveness of Ibuprofen tablets in pediatric patients have not been established.
v. Over 60:
In the absence of specific data, the lowest dosage which produces satisfactory urate reduction data should be used.
vi. Driving & Hazardous work:
A few patients may experience the dizziness or drowsiness or disturbance of vision. In case of such effect avoid driving and machine work.
vii. Alcohol:
Do not drink alcohol while taking Ibuprofen. Alcohol can increase the risk of stomach bleeding caused by Ibuprofen.
13. Pharmacological Properties:
13.(i). Pharmacodynamic Properties:
Ibuprofen is an NSAID which is believed to work through inhibition of cyclooxygenase (COX), thus inhibiting prostaglandin synthesis. There are at least 2 variants of cyclooxygenase (COX-1 and COX-2). Ibuprofen inhibits both COX-1 and COX-2. It appears that its analgesic, antipyretic, and anti-inflammatory activity are achieved principally through COX-2 inhibition; whereas COX-1 inhibition is responsible for its unwanted effects on platelet aggregation and the GI mucosa.
13.(ii). Pharmacokinetic Properties:
i. Absorption:
Tablets is rapidly absorbed
ii. Distribution:
| Bioavailability | %Protein binding | Half Life | Volume of distribution | Blood Brain Barrier | Placental Barrier |
| 49–73% | 99% | 1.8–2 hours | 0.1-2 L/kg | | crosses |
iii. Metabolism
| Site of Metabolism | Active Metabolites |
| Hepatic | |
iv. Elimination:
| Elimination Half Life | Route of Elimination |
| 1.8 to 2.0 hours | Renal |
15. Preclinical Safety Data:
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16. Instructions for Handling:
Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
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