What is Normodol?
Normodol is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain, and helps to relieve symptoms of arthritis (osteoarthritis, rheumatoid arthritis, or juvenile arthritis), such as inflammation, swelling, stiffness, and joint pain. Normodol does not cure arthritis and will help you only as long as you continue to take it.
In addition, Normodol can be used to treat fever, menstrual cramps, and other conditions as determined by your doctor.
Normodol is available both over-the-counter (OTC) and with your doctor's prescription.
Normodol indications
Carefully consider the potential benefits and risks of Normodol
Oral Suspension and other treatment options before deciding to use Normodol. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
In Pediatric Patients, Normodol
Oral Suspension is indicated:
- For reduction of fever in patients aged 6 months up to 2 years of age.
- For relief of mild to moderate pain in patients aged 6 months up to 2 years of age.
- For relief of signs and symptoms of juvenile arthritis.
In Adults, Normodol
Oral Suspension is indicated:
- For treatment of primary dysmenorrhea.
- For relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
Since there have been no controlled trials to demonstrate whether there is any beneficial effect or harmful interaction with the use of Normodol in conjunction with aspirin, the combination cannot be recommended.
How should I use Normodol?
Use Normodol capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Normodol capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Normodol capsules refilled.
- Take Normodol capsules by mouth with or without food. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.
- Swallow Normodol capsules whole. Do not break, crush, or chew before swallowing.
- Take Normodol capsules with a full glass of water (8 oz/240 mL) as directed by your doctor.
- If you miss a dose of Normodol capsules and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about the proper use of Normodol capsules.
Uses of Normodol in details
Use: Labeled Indications
Oral: Inflammatory diseases and rheumatoid disorders, mild to moderate pain, fever, dysmenorrhea, osteoarthritis
Normodol injection (Caldolor): Management of mild to moderate pain and management of moderate to severe pain as an adjunct to opioid analgesics in adults and children 6 months and older; reduction of fever in adults and children 6 months and older.
Normodol lysine injection (NeoProfen): Patent ductus arteriosus (PDA): To close a clinically significant PDA in premature infants weighing between 500-1500 g who are no more than 32 weeks of gestational age when usual medical management (eg, diuretics, fluid restriction, respiratory support) is ineffective.
OTC labeling: Reduction of fever; management of pain due to headache, migraine, sore throat, arthritis, physical or athletic overexertion (eg, sprains/strains), menstrual pain, dental pain, minor muscle/bone/joint pain, backache, pain due to the common cold and flu
Off Label Uses
Gout, acute flares
Clinical experience suggests the utility of Normodol as an alternative option for acute gout flares.
Based on the 2012 American College of Rheumatology guidelines for management of gout, NSAIDs are effective and recommended agents in the treatment of acute gout flares.
Pericarditis
Data from double-blind, placebo-controlled, multicenter trials indicate that colchicine in combination with aspirin or Normodol significantly reduces the incidence of symptoms at 72 hours and the risk of recurrence in acute and recurrent pericarditis. Based on Brazilian Society of Cardiology guidelines for the management of myocarditis and pericarditis and European Society of Cardiology (ESC) guidelines for the management of pericardial diseases, nonsteroidal anti-inflammatory drugs (NSAIDs) (typically, aspirin or Normodol) in combination with colchicine are recommended as first-line treatment to manage pain and resolve inflammation in idiopathic and viral acute and recurrent pericarditis.
Normodol description
Normodol is a member of the propionic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). It is a racemic mixture of [+]S- and [-]R-enantiomers.
The chemical name for Normodol is (±)-2-(4-isobutylphenyl) propionic acid. It has a molecular weight of 206.28 and a molecular formula of C13H18O2.
Normodol is a colorless, crystalline stable solid, with a melting point of 75-77°C. It is relatively insoluble in water but readily soluble in most organic solvents. Normodol has a pKa of 4.43±0.03 and an n-octanol/water partition coefficient of 11.7 at pH 7.4.
Normodol has shown analgesic, anti-inflammatory and antipyretic activity in both animal and human studies. These properties provide symptomatic relief of inflammation and pain.
Normodol dosage
2.1 Recommended Dose
A course of therapy is three doses of Normodol Lysine administered intravenously (administration via an umbilical arterial line has not been evaluated). An initial dose of 10 mg per kilogram is followed by two doses of 5 mg per kilogram each, after 24 and 48 hours. All doses should be based on birth weight. If anuria or marked oliguria (urinary output <0.6 mL/kg/hr) is evident at the scheduled time of the second or third dose of Normodol Lysine, no additional dosage should be given until laboratory studies indicate that renal function has returned to normal. If the ductus arteriosus closes or is significantly reduced in size after completion of the first course of Normodol Lysine, no further doses are necessary. If during continued medical management the ductus arteriosus fails to close or reopens, then a second course of Normodol Lysine, alternative pharmacological therapy, or surgery may be necessary.
2.2 Directions for Use
For intravenous administration only.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use Normodol Lysine if particulate matter is observed.
After the first withdrawal from the vial, any solution remaining must be discarded because Normodol Lysine contains no preservative.
For administration, Normodol Lysine should be diluted to an appropriate volume with dextrose or saline. Normodol Lysine should be prepared for infusion and administered within 30 minutes of preparation and infused continuously over a period of 15 minutes. The drug should be administered via the IV port that is nearest the insertion site. After the first withdrawal from the vial, any solution remaining must be discarded because Normodol Lysine contains no preservative.
Since Normodol Lysine is potentially irritating to tissues, it should be administered carefully to avoid extravasation.
Normodol Lysine should not be simultaneously administered in the same intravenous line with Total
Parenteral Nutrition (TPN). If necessary, TPN should be interrupted for a 15-minute period prior to and after drug administration. Line patency should be maintained by using dextrose or saline.
Normodol interactions
See also:
What other drugs will affect Normodol?
Coumarin-Type Anticoagulants: Several short-term controlled studies failed to wshow that Normodol significantly affected prothrombin times or a variety of other clotting factors when administered to individuals on coumarin-type anticoagulants. However, because bleeding has been reported when Normodol and other nonsteroidal anti-inflammatory agents have been administered to patients on coumarin-type anticoagulants, the physician should be cautious when administering Normodol to patients on anticoagulants.
Aspirin: Animal studies wshow that aspirin given with nonsteroidal anti-inflammatory agents, including Normodol, yields a net decrease in anti-inflammatory activity with lowered blood levels of the non-aspirin drug. Single dose bioavailability studies in normal volunteers have failed to wshow an effect of aspirin on Normodol blood levels. Correlative clinical studies have not been performed.
Methotrexate: Apo-Normodol, as well as other nonsteroidal anti-inflammatory drugs, probably reduces the tubular secretion of methotrexate based on in vitro studies in rabbit kidney slices. This may indicate that Normodol could enhance the toxicity of methotrexate. Caution should be used if Normodol is administered concomitantly with methotrexate.
H-2 Antagonists: In studies with human volunteers, co-administration of cimetidine or ranitidine with Normodol had no substantive effect on Normodol serum concentrations.
Furosemide: Clinical studies, as well as random observations, have shown that Normodol can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with Normodol, the patient should be observed closely for signs of renal failure, as well as to assure diuretic efficacy.
Lithium: Apo-Normodol produced an elevation of plasma lithium levels and a reduction in renal lithium clearance in a study of eleven normal volunteers. The mean minimum lithium concentration increased 15% and the renal clearance of lithium was decreased by 19% during this period of concomitant drug administration.
This effect has been attributed to inhibition of renal prostaglandin synthesis by Normodol. Thus, when Normodol and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity. (Read circulars for lithium preparation before use of such concurrent therapy).
Normodol side effects
See also:
What are the possible side effects of Normodol?
6.1 Clinical Trials Experience
The most frequently reported adverse events with Normodol Lysine were as shown in Table 1.
6.2 Renal Function
Compared to placebo, there was a small decrease in urinary output in the Normodol group on days 2-6 of life, with a compensatory increase in urine output on day 9. In other studies, adverse events classified as renal insufficiency including oliguria, elevated BUN, elevated creatinine, or renal failure were reported in Normodol treated infants.
6.3 Additional Adverse Events
The adverse events reported in the multicenter study and of unknown association include tachycardia, cardiac failure, abdominal distension, gastroesophageal reflux, gastritis, ileus, inguinal hernia, injection site reactions, cholestasis, various infections, feeding problems, convulsions, jaundice, hypotension, and various laboratory abnormalities including neutropenia, thrombocytopenia, and hyperglycemia.
6.4 Post-marketing Experience
The following adverse reactions have been identified from spontaneous post-marketing reports or published literature: gastrointestinal perforation, necrotizing enterocolitis, and pulmonary hypertension. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency, or establish a causal relationship to drug exposure.
Normodol contraindications
See also:
What is the most important information I should know about Normodol?
This medicine may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term. Do not use Normodol just before or after heart bypass surgery (coronary artery bypass graft, or CABG).
Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.
This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking Normodol, especially in older adults.
Call your doctor at once if you have symptoms of stomach bleeding such as black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.
Do not take more of this medication than is recommended. An overdose of Normodol can cause damage to your stomach or intestines. Use only the smallest amount of Normodol needed to get relief from your pain, swelling, or fever.
Active ingredient matches for Normodol:
Ibuprofen in Spain.
List of Normodol substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| Norflam T (South Africa) | |
| NORSWEL (India) | |
| 400 mg x 10's (Cadila Healthcare (Zydus Cadila Healthcare Ltd)) | $ 0.08 |
| Norswel 400 mg Tablet (Cadila Healthcare (Zydus Cadila Healthcare Ltd)) | $ 0.01 |
| NORSWEL tab 400 mg x 10's (Cadila Healthcare (Zydus Cadila Healthcare Ltd)) | $ 0.08 |
| Norswel 400mg Tablet (Cadila Healthcare (Zydus Cadila Healthcare Ltd)) | $ 0.01 |
| Norswell | |
| Norswell 400mg TAB / 10 | $ 0.08 |
| Norvectan (Portugal, Spain) | |
| Norvectan Pediatrico (Spain) | |
| Noubid (United Kingdom) | |
| Nova profen (Egypt) | |
| NOVAFEN (Tunisia) | |
| Novalgidol (Italy) | |
| Novartril (Mexico) | |
| Novex Ibuprofen (Georgia) | |
| Novidol (Spain) | |
| Novidol 500 mg x 2 Blister x 10 Tablet (Synpharma) | |
| Novo Dioxadol | |
| Novo Geniol (Paraguay) | |
| Novo-Profen (Canada) | |
| Tablet; Oral; Ibuprofen 200 mg (Novopharm) | |
| Tablet; Oral; Ibuprofen 300 mg (Novopharm) | |
| Tablet; Oral; Ibuprofen 400 mg (Novopharm) | |
| Tablet; Oral; Ibuprofen 600 mg (Novopharm) | |
| Tablets; Oral; Ibuprofen 200 mg (Novopharm) | |
| Tablets; Oral; Ibuprofen 300 mg (Novopharm) | |
| Tablets; Oral; Ibuprofen 400 mg (Novopharm) | |
| Tablets; Oral; Ibuprofen 600 mg (Novopharm) | |
| Novo-profen tablet 600 mg (Novopharm) | |
| Novo-profen tablet 400 mg (Novopharm) | |
| Novo-profen tablet 200 mg (Novopharm) | |
| Novo-profen tablet 300 mg (Novopharm) | |
| Novogeniol (Argentina) | |
| Novogent (Germany) | |
| Capsule, Retard; Oral; Ibuprofen (Temmler) | |
| Capsules, Retard; Oral; Ibuprofen (Temmler) | |
| Novogent N | |
| Novoprofen | |
| Tablet; Oral; Ibuprofen 200 mg | |
| Tablet; Oral; Ibuprofen 300 mg | |
| Tablet; Oral; Ibuprofen 400 mg | |
| Tablet; Oral; Ibuprofen 600 mg | |
| Tablets; Oral; Ibuprofen 200 mg | |
| Tablets; Oral; Ibuprofen 300 mg | |
| Tablets; Oral; Ibuprofen 400 mg | |
| Tablets; Oral; Ibuprofen 600 mg | |
| Nu-Ibuprofen | |
| Tablet; Oral; Ibuprofen 300 mg | |
See 4785 substitutes for Normodol | |
References
- DailyMed. "IBUPROFEN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubChem. "ibuprofen". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "ibuprofen". http://www.drugbank.ca/drugs/DB01050 (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Normodol are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Normodol. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported useful
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Information checked by Dr. Sachin Kumar, MD Pharmacology
