Sapofen 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. Sapofen does not cure arthritis and will help you only as long as you continue to take it.
In addition, Sapofen can be used to treat fever, menstrual cramps, and other conditions as determined by your doctor.
Sapofen is available both over-the-counter (OTC) and with your doctor's prescription.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
Carefully consider the potential benefits and risks of Sapofen
Oral Suspension and other treatment options before deciding to use Sapofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
In Pediatric Patients, Sapofen
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, Sapofen
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 Sapofen in conjunction with aspirin, the combination cannot be recommended.
How should I use Sapofen?
Use Sapofen capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Sapofen capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Sapofen capsules refilled.
Take Sapofen 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 Sapofen capsules whole. Do not break, crush, or chew before swallowing.
Take Sapofen capsules with a full glass of water (8 oz/240 mL) as directed by your doctor.
If you miss a dose of Sapofen 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 Sapofen capsules.
Uses of Sapofen in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
Sapofen is used to relieve pain from various conditions such as headache, dental pain, menstrual cramps, muscle aches, or arthritis. It is also used to reduce fever and to relieve minor aches and pain due to the common cold or flu. Sapofen is a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. This effect helps to decrease swelling, pain, or fever.
If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.
This form of Sapofen is intended for use by children. Do not give this medication to a child younger than 6 months unless directed by the doctor.
Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.
How to use Sapofen
Read and follow all directions on the product package before using this medication. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth as directed by your doctor or the package label, usually every 6 to 8 hours as needed. Shake the bottle well before each dose. Carefully measure the dose using the provided dropper/syringe. Do not use a household spoon because you may not get the correct dose. If you have stomach upset while taking this medication, take it with food or milk.
The dosage is based on your medical condition and response to treatment. To reduce your risk of stomach bleeding and other side effects, take this medication at the lowest effective dose for the shortest possible time. Do not increase your dose or take this drug more often than directed by your doctor or the package label.
When Sapofen is used by children, the dose is based on the child's weight. Read the package directions to find the proper dose for your child's weight. Consult the pharmacist or doctor if you have questions or if you need help choosing a nonprescription product.
If you are using this drug "as needed" (not on a regular schedule), remember that pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.
If your condition persists or worsens, or if you think you may have a serious medical problem, get medical help right away. If you are using the nonprescription product to treat yourself or a child for fever or pain, consult the doctor right away if fever worsens or lasts more than 3 days, or if pain worsens or lasts more than 10 days.
Sapofen 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 Sapofen is (±)-2-(4-isobutylphenyl) propionic acid. It has a molecular weight of 206.28 and a molecular formula of C13H18O2.
Sapofen 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. Sapofen has a pKa of 4.43±0.03 and an n-octanol/water partition coefficient of 11.7 at pH 7.4.
Sapofen has shown analgesic, anti-inflammatory and antipyretic activity in both animal and human studies. These properties provide symptomatic relief of inflammation and pain.
Generic name: Sapofen
Dosage form: suspension
Sapofen IB tablet, coated
Sapofen Tablets tablet, film coated
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Carefully consider the potential benefits and risks of Sapofen Suspension and other treatment options before deciding to use Sapofen Suspension. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
After observing the response to initial therapy with Sapofen Suspension, the dose and frequency should be adjusted to suit an individual patient's needs.
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. The recommended dose is 5 mg/kg if the baseline temperature is less than 102.5ºF, or 10 mg/kg if the baseline temperature is 102.5ºF 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 child's sleep pattern.
Juvenile Arthritis: The recommended dose is 30 to 40 mg/kg/day divided into three to four doses. 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 Sapofen 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.
Primary Dysmenorrhea: For the treatment of primary dysmenorrhea, beginning with the earliest onset of such pain, Sapofen 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: 1200-3200 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.
Dosage: The dose of Sapofen 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 Sapofen Suspension, subsequent doses may be lowered and still provide adequate fever control.
In a situation when low fever would require the Sapofen 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 Sapofen Suspension 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 patient's 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 Sapofen Suspension that yields acceptable control should be employed.
Sapofen Suspension may be used in combination with gold salts and/or corticosteroids.
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Coumarin-Type Anticoagulants: Several short-term controlled studies failed to wshow that Sapofen 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 Sapofen and other nonsteroidal anti-inflammatory agents have been administered to patients on coumarin-type anticoagulants, the physician should be cautious when administering Sapofen to patients on anticoagulants.
Aspirin: Animal studies wshow that aspirin given with nonsteroidal anti-inflammatory agents, including Sapofen, 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 Sapofen blood levels. Correlative clinical studies have not been performed.
Methotrexate: Apo-Sapofen, 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 Sapofen could enhance the toxicity of methotrexate. Caution should be used if Sapofen is administered concomitantly with methotrexate.
H-2 Antagonists: In studies with human volunteers, co-administration of cimetidine or ranitidine with Sapofen had no substantive effect on Sapofen serum concentrations.
Furosemide: Clinical studies, as well as random observations, have shown that Sapofen 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 Sapofen, the patient should be observed closely for signs of renal failure, as well as to assure diuretic efficacy.
Lithium: Apo-Sapofen 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 Sapofen. Thus, when Sapofen 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).
The pattern of adverse events reported for Sapofen is similar to that for other nonsteroidal anti-inflammatory drugs (NSAIDs).
Gastrointestinal Disorders: The most commonly observed adverse events are gastrointestinal in nature. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, gastrointestinal hemorrhage and exacerbation of colitis and Crohn's disease have been reported following Sapofen administration. Less frequently, gastritis, duodenal and gastric ulcer, and gastrointestinal perforation have been observed.
A transient sensation of burning in the mouth or throat may occur with Sapofen syrup or Sapofen granules.
Immune System Disorders: Hypersensitivity reactions have been reported following treatment with Sapofen. These may consist of nonspecific allergic reaction and anaphylaxis; respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea; or assorted skin disorders including rashes of various types, pruritus, urticaria, purpura, angioedema and very rarely, erythema multiforme, bullous dermatoses (including Stevens-Johnson syndrome and toxic epidermal necrolysis).
Infections and Infestations: Exacerbation of infection-related inflammations (eg, development of necrotising fasciitis) coinciding with the use of NSAIDs has been described. If signs of an infection occur or get worse during use of Sapofen, the patient is therefore, recommended to go to a physician without delay.
Skin and Subcutaneous Tissue Disorders: In exceptional cases, severe skin infections and soft-tissue complications may occur during a varicella infection.
Cardiac and Vascular Disorders: Clinical trial and epidemiological data suggest that use of Sapofen (particularly at high doses of 2,400 mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (eg, myocardial infarction or stroke).
The following adverse reactions possibly related to Sapofen ad displayed by MedDRA frequency convention and system organ classification. Frequency groupings are classified according to the subsequent conventions: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Infections and Infestations: Uncommon: Rhinitis. Rare: Meningitis Aseptic.
Blood and Lymphatic System Disorders: Rare: Leukopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic and hemolytic anemia.
Immune System Disorders: Rare: Anaphylactic reaction.
Skin and Subcutaneous Tissue Disorders: Common: Rash. Uncommon: Urticaria, pruritus, purpura, angioedema, photosensitivity reaction. Very Rare: Severe forms of skin reactions (eg, erythema multiforme, bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis).
Renal and Urinary Disorders: Uncommon: Nephrotoxicity in various forms eg, tubulointerstitial nephritis, nephrotic syndrome and renal failure.
General Disorders and Administration Site Conditions: Common: Fatigue. Rare: Oedema.
Cardiac Disorders: Very Rare: Cardiac failure, myocardial infarction.
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 Sapofen 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 Sapofen, 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 Sapofen can cause damage to your stomach or intestines. Use only the smallest amount of Sapofen needed to get relief from your pain, swelling, or fever.
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).
The results of a survey conducted on ndrugs.com for Sapofen 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 Sapofen. 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.
1 consumer reported useful
Was the Sapofen drug useful in terms of decreasing the symptom or the disease? According to the reports released by ndrugs.com website users, the below mentioned percentages of users say the drug is useful / not useful to them in decreasing their symptoms/disease. The usefulness of the drug depends on many factors, like severity of the disease, perception of symptom, or disease by the patient, brand name used [matters only to a certain extent], other associated conditions of the patient. If the drug is not effective or useful in your case, you need to meet the doctor to get re-evaluated about your symptoms/disease, and he will prescribe an alternative drug.
2 consumers reported price estimates
Was the price you paid to purchase the drug reasonable? Did you feel it was expensive? The below mentioned numbers have been reported by ndrugs.com website users about whether the Sapofen drug is expensive or inexpensive. There is a mixed opinion among users. The rating about the cost of the drug depends on factors like which brand drug the patient purchased, how effective it was for the price paid, the country or place the drug is marketed, and the economic condition of the patient. The users who feel the drug is expensive can look for an alternative brand drug or a generic drug to save the cost.
5 consumers reported time for results
To what extent do I have to use Sapofen before I begin to see changes in my health conditions? As part of the reports released by ndrugs.com website users, it takes 2 days and a few days before you notice an improvement in your health conditions. Please note, it doesn't mean you will start to notice such health improvement in the same time frame as other users. There are many factors to consider, and we implore you to visit your doctor to know how long before you can see improvements in your health while taking Sapofen. To get the time effectiveness of using Sapofen drug by other patients, please click here.
> 3 month
22 consumers reported age
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