What is a Generic Drug?
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
Asacol (5-ASA)
Prescription Required
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Product Details
Description
What kind of drug is Asacol?
Chemical Name MESALAMINE (me-SAL-a-meen)Asacol is used to treat inflammatory bowel disease, such as ulcerative colitis. It works inside the bowel by helping to reduce the inflammation and other symptoms of the disease. Asacol is generally used to treat ulcerative colitis, proctitis, and proctosigmoiditis. It may also be used to prevent the symptoms of ulcerative colitis from recurring.
Fact Table
Formula
C7H7NO3
License
FDA-approved
Bioavailability
Approximately 28% (for delayed-release tablets)
Legal Status
US: Rx-only
EU: Rx-onlyChemical Name
Mesalazine / 5-ASA
Elimination Half-life
Variable, approximately 0.5 to 1.5 hours for the parent drug (mesalazine), but the metabolite (N-acetyl-5-aminosalicylic acid) has a half-life of approximately 5 to 10 hours
Dosage (Strength)
Oral delayed-release tablets: 400 mg, 800 mg (Asacol HD), and other strengths depending on the brand and formulation
Rectal suspension: 4g/60ml
Rectal foam: 1g/applicationPregnancy Advice
Category B (FDA); considered safe but should be used under the advice of a healthcare provider
Brands
Asacol, Lialda, Pentasa, Delzicol, and others depending on the region and formulation
Protein Binding
Approximately 43%
PubChem CID
4075
MedlinePlus
a688021
ChEBI
6775
ATC code
A07EC02
DrugBank
DB00244
KEGG
D00377
Routes of Administration
Oral, rectal
Directions
Take Asacol exactly as prescribed by your doctor or indicated on the prescription label.
Asacol is usually taken with a full glass of water. It can be taken with or without food. Consult your doctor for instructions. It is important not to crush, break, or chew the tablet. Swallow the tablet whole because the enteric-coated tablet has a special coating to protect your stomach. Breaking the pill could damage this coating.
Cautions
Before using Asacol, patients should be aware of essential safety information that may affect them. Tell your doctor if you have any of the conditions listed below as you may need special testing or dose adjustments to safely take Asacol:
- Kidney disease
- Liver disease
- Pyloric stenosis
- Congestive heart failure
- History of allergy to sulfasalazine (Azulfidine)
This medication must not be used during pregnancy because it may cause harm to an unborn baby. If you become pregnant or think you may be pregnant, inform your doctor immediately. It is not known whether this drug passes into breast milk. Breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.Side Effects
Every medication has side effects; however, it is rare that they may occur. Patients can usually find the complete list of side effects with their medication.
Serious side effects may include:
- Allergic reaction including hives, difficulty breathing, swelling of your face, lips, Tongue, or throat
- Severe stomach pain or cramping
- Fever
- Headache
- Bloody diarrhea
Common serious side effects may include:- Mild nausea or vomiting
- Stomach cramps
- Diarrhea
- Gas
- Fever, sore throat, or other flu symptoms
- Constipation
- Headache or dizziness
- Fatigue
- Skin rash
Important: Call your doctor if you find undissolved tablets in your stool.This is not a complete list of side effects and others may occur. Call your doctor for medical advice about additional side effects or any side effect that bothers you or that do not go away.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.
Product Code : 1352
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