Generic Celecoxib Capsules (Celeheal) – Product Information
Generic Celecoxib (Celeheal capsules ) is a NonSteroidal Anti-Inflammatory Drug (NSAID), which relieves pain and swelling (inflammation). It is used to treat Osteoarthritis (OA), Rheumatoid Arthritis (RA), Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older, Ankylosing Spondylitis (AS), Acute Pain (AP) and Primary Dysmenorrhea (PD). The pain and swelling relief provided by this medication helps you perform more of your normal daily activities.
We also stock Ibuprofen Tablets (Brufen) which is used for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
Name of Drug
Celeheal capsules
When Will Celecoxib Go Generic?
The generic version of Celecoxib is available. We supply Celeheal capsules, a generic version of this medicine.
Manufacturer of Celeheal Capsules – Where Is Celecoxib Manufactured?
Healing Pharma Ltd., India
Website: www.healingpharma.in
Active Pharmaceutical Ingredient
The active pharmaceutical ingredients contained in Celeheal capsules is Celecoxib. Each Celeheal capsule contains 100 mg of Celecoxib.
Mechanism of Action
Celecoxib is a nonsteroidal anti-inflammatory drug that displays anti-inflammatory, analgesic, and antipyretic activities in animal models.
The mechanism of action of Celecoxib is thought to be due to inhibition of prostaglandin synthesis, primarily via inhibition of cyclooxygenase-2 (COX-2), and at therapeutic concentrations in humans, Celecoxib does not inhibit the cyclooxygenase-1 (COX-1) isoenzyme. In animal colon tumor models, Celecoxib reduced the incidence and multiplicity of tumors.
Uses of Generic Celecoxib Capsules (Celeheal)
Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body.
Celecoxib is used to treat pain, fever, swelling, and tenderness or inflammation caused by many conditions such as osteoarthritis, juvenile arthritis, rheumatoid arthritis, ankylosing spondylitis, and menstrual pain. Celecoxib does not prevent the progression of either type of arthritis. It reduces only the symptoms and signs of arthritis.
Can Generic Celecoxib Be Used For Toothache?
Anti-inflammatory analgesics such as Ibuprofen are the best for toothache as the pain is usually caused by swelling. If you can’t take them – if you are allergic to aspirin, for example – then Paracetamol is the next best thing.
However patients could be administered a dose of Celecoxib Capsules On the evening before and 1 hour before oral surgery for tooth extraction instead of the standard anti-inflammatory drug Ibuprofen.
Generic Celecoxib Capsules (Celeheal) – Dosage
Take this medication by mouth as directed by your doctor, usually once or twice daily. To decrease the chance of stomach upset, this drug is best taken with food. The dosage is based on your medical condition and response to treatment. Use lowest effective dose of this medication for the shortest duration consistent with treatment goals for the individual patient.Take this medication with a full glass of water (8 ounces or 240 milliliters) unless your doctor directs you otherwise. Do not lie down for 10 minutes after taking this medication.
Osteoarthritis (OA):
200 mg once daily or 100 mg twice daily
Rheumatoid Arthritis (RA):
100 to 200 mg twice daily
Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older:
50 mg twice daily in patients 10 to 25 kg. 100 mg twice daily in patients more than 25 kg.
Ankylosing Spondylitis (AS):
200 mg once daily single dose or 100 mg twice daily. If no effect is observed after 6 weeks, a trial of 400 mg (single or divided doses) may be of benefit.
Acute Pain (AP) and Primary Dysmenorrhea (PD):
400 mg initially, followed by 200 mg dose if needed on first day. On subsequent days, 200 mg twice daily as needed.
Familial Adenomatous Polyposis (FAP)-adjunct to usual care):
400 mg twice daily with food, as an adjunct to usual care.
Reduce daily dose by 50% in patients with moderate hepatic impairment (Child-Pugh Class B). Consider a dose reduction by 50% (or alternative management for JRA) in patients who are known or suspected to be CYP2C9 poor metabolizers.
Can Celecoxib Be Taken Without Food?
To reduce the chance of stomach upset, Generic Celecoxib (Celeheal Capsules) is best taken with food.
Missed Dosage Instructions for Celecoxib Capsules
In case you miss a dose of Celeheal (Celecoxib Capsules), take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses to make up for the missed dose.
Celeheal Contraindications
Celeheal Capsules are contraindicated in persons with a hypersensitivity (allergy) to Celecoxib or any of the other ingredients of this medicine. Celeheal is also contraindicated in the following patients:
- History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs, have been reported in such patients.
- Celecoxib is contraindicated for the peri-operative treatment of pain in patients undergoing coronary artery bypass graft (CABG) surgery
- In patients who have demonstrated allergic-type reactions to sulfonamides.
- This medicine should not be used with other NSAIDs because of the absence of any evidence demonstrating synergistic benefits and the potential for additive adverse reactions.
- Celecoxib is contraindicated in Patients with unstable ischaemic heart disease of thrombus aetiology, documented myocardial infarction (MI) or stroke within 3 months.
- Patients with active peptic ulceration or gastrointestinal (GI) bleeding
- Patients with estimated creatinine clearance less than 30 mL/min
- Patients with congestive heart failure (NYHA II-IV)
- Patients with severe hepatic impairment (Child-Pugh# score =10)
Storage Instructions for Celeheal Capsules
Store Celeheal (Generic Celecoxib Capsules) at 20°C to 25°C (68°F to 77°F) excursions permitted to 15°C to 30°C (59°F to 86°F)
Can Celecoxib And Ibuprofen Be Taken Together?
NO. The use of Celecoxib and Ibuprofen together is contraindicated due to the potential for increased risk of adverse reactions. Due to the same reason, concomitant use of Celecoxib with any dose of a non-aspirin NSAID should be avoided.
Warnings and Precautions to be taken when using Celecoxib Capsules (Celeheal)
Before using Celecoxib Capsules (Celeheal) please inform your doctor about all the medicines that you take including no prescription medications, over the counter medicines and herbal remedies. The other warnings and precautions to be taken when using this medicine are given below:
- Chronic use of Celecoxib may cause an increased risk of serious adverse cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. Patients with known CV disease/risk factors may be at greater risk.
- Serious gastrointestinal (GI) adverse events, which can be fatal. The risk is greater in patients with a prior history of ulcer disease or GI bleeding, and in patients at high risk for GI events, especially the elderly. Celeheal (Celecoxib Capsules) should be used with caution in these patients.
- Elevated liver enzymes and, rarely, severe hepatic reactions. Discontinue use of Celecoxib Capsules immediately if abnormal liver enzymes persist or worsen.
- As with all NSAIDs, Celecoxib can lead to the onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. New onset or worsening of hypertension. Blood pressure should be monitored closely during treatment with Celeheal (Celecoxib Capsules).
- Fluid retention and edema. Celecoxib should be used with caution in patients with fluid retention or heart failure.
- Renal papillary necrosis and other renal injury with long term use
- Use Celeheal Capsules with caution in the elderly, those with impaired renal function, heart failure, liver dysfunction, and those taking diuretics, ACE-inhibitors, or angiotensin II antagonists
- Anaphylactoid reactions. Do not use Celecoxib in patients with the aspirin triad
- Serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal and can occur without warning even without known prior sulfa allergy. Discontinue Celeheal at first appearance of rash or skin reactions.
- Borderline elevations of one or more liver-associated enzymes may occur in up to 15% of patients taking NSAIDs, and notable elevations of ALT or AST (approximately 3 or more times the upper limit of normal) have been reported in approximately 1% of patients in clinical trials with NSAIDs.
- Celecoxib Capsules cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to exacerbation of corticosteroid-responsive illness
- Anemia is sometimes seen in patients receiving celecoxib. In controlled clinical trials the incidence of anemia was 0.6% with Celecoxib (Celeheal capsules) and 0.4% with placebo.
- Generic Celecoxib should be used only with caution in pediatric patients with systemic onset JRA due to the risk of disseminated intravascular coagulation.
- Patients with asthma may have aspirin-sensitive asthma. The use of Aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm, which can be fatal. Celecoxib should not be administered to patients with this form of aspirin sensitivity and should be used with caution in patients with preexisting asthma, since cross reactivity, including bronchospasm, between aspirin and other nonsteroidal antiinflammatory drugs has been reported in such aspirin-sensitive patients.
- Because serious GI tract ulcerations and bleeding can occur without warning symptoms, physicians should monitor for signs or symptoms of GI bleeding.
- The pharmacological activity of Celecoxib in reducing inflammation, and possibly fever, may diminish the utility of these diagnostic signs in detecting infectious complications of presumed noninfectious, painful conditions.
- The concomitant use of celecoxib with any dose of a non-aspirin NSAID should be avoided due to the potential for increased risk of adverse reactions.
Celecoxib Capsules And Alcohol
Alcohol should be avoided if taking Celecoxib capsules (Celeheal), in particular, because the medication already causes a higher risk of cardiovascular side effects, such as heart attacks and strokes, and alcohol increases that risk. The potential reactions with alcohol include ulcers, stomach bleeding, liver damage.
Side Effects of Celecoxib Capsules
The most common possible Celecoxib Side Effects that occurred during arthritis trials with an occurrence rate of 2% or more and greater than placebo were abdominal pain, diarrhea, dyspepsia, flatulence, peripheral edema, accidental injury, dizziness, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, rash.
The following adverse reactions occurred in 0.1 to 1.9% of patients treated with Celecoxib Capsules (100 mg to 200 mg twice daily or 200 mg once daily):
- Gastrointestinal: Constipation, diverticulitis, dysphagia, eructation, esophagitis, gastritis, gastroenteritis, gastroesophageal reflux, hemorrhoids, hiatal hernia, melena, dry mouth, stomatitis, tenesmus, vomiting
- Cardiovascular: Aggravated hypertension, angina pectoris, coronary artery disorder, myocardial infarction
- General: Hypersensitivity, allergic reaction, chest pain, cyst NOS, edema generalized, face edema, fatigue, fever, hot flushes, influenza-like symptoms, pain, peripheral pain
- Central, peripheral Nervous system: Leg cramps, hypertonia, hypoesthesia, migraine, paresthesia, vertigo
- Hearing and vestibular: Deafness, tinnitus
- Heart rate and rhythm: Palpitation, tachycardia
- Liver and biliary: Hepatic enzyme increased (including SGOT increased, SGPT increased)
- Metabolic and nutritional: BUN increased, CPK increased, hypercholesterolemia, hyperglycemia, hypokalemia, NPN increased, creatinine increased, alkaline phosphatase increased, weight increased
- Musculoskeletal: Arthralgia, arthrosis, myalgia, synovitis, tendinitis
- Platelets (bleeding or clotting): Ecchymosis, epistaxis, thrombocythemia,
- Psychiatric: Anorexia, anxiety, appetite increased, depression, nervousness, somnolence
- Hemic: Anemia
- Respiratory: Bronchitis, bronchospasm, bronchospasm aggravated, cough, dyspnea, laryngitis, pneumonia
- Skin and appendages: Alopecia, dermatitis, photosensitivity reaction, pruritus, rash erythematous, rash maculopapular, skin disorder, skin dry, sweating increased, urticaria
- Application site disorders: Cellulitis, dermatitis contact
- Urinary: Albuminuria, cystitis, dysuria, hematuria, micturition frequency, renal calculus
The following serious side effects (causality not evaluated) occurred in less than 0.1% of patients treated with this medicine:
- Cardiovascular: Syncope, congestive heart failure, ventricular fibrillation, pulmonary embolism, cerebrovascular accident, peripheral gangrene, thrombophlebitis
- Gastrointestinal: Intestinal obstruction, intestinal perforation, gastrointestinal bleeding, colitis with bleeding, esophageal perforation, pancreatitis, ileus
- General: Sepsis, sudden death
- Liver and biliary: Cholelithiasis
- Hemic and lymphatic: Thrombocytopenia
- Nervous: Ataxia, suicide
- Renal: Acute renal failure
Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms: nausea, more tired or weaker than usual, diarrhea, itching,your skin or eyes look yellow, indigestion or stomach pain, flu-like symptoms, vomit blood, there is blood in your bowel movement or it is black and sticky like tar, unusual weight gain, skin rash or blisters with fever or swelling of the arms and legs, hands and feet.
Effects on Ability to Drive and Use Machinery
The effect of Celecoxib capsules on ability to drive or use machinery has not been studied, but based on its pharmacodynamic properties and overall safety profile it is not likely to have an effect.
You should be aware of how you react to Celecoxib capsules before you drive or operate machinery. In case you feel dizzy or drowsy after taking Celecoxib capsules do not drive or operate machinery until these effects wear off.
Can Celecoxib Cause Constipation?
Yes. Constipation is listed among the more common side effects that can occur with Celecoxib oral capsule.
Can Celecoxib Cause Depression?
Depression has been reported in 0.1% to 1.9% of patients taking Celecoxib Capsules (Celeheal). Depression is more common in patients with Ankylosing Spondylitis, especially when it is actively causing pain and stiffness from chronic inflammation.
Can Celecoxib Cause High Blood Pressure?
The Cyclooxygenase 2 (COX-2) inhibitor Celecoxib (Celeheal Capsules) appears to slightly increase blood pressure, but the effect is not as large as that associated with the use of nonselective nonsteroidal anti-inflammatory drugs (NSAIDs) such as Ibuprofen or Naproxen
Can Celecoxib Cause Diarrhea?
Yes. Diarrhea is listed as a common side effect of this medication. Patients undergoing therapy with Celecoxib have complained of upset stomachs, indigestion, or diarrhea.
Celecoxib Capsules (Celeheal) – Drug Interactions
The drug Interactions of Celecoxib Capsules are given below:
- Concomitant use of Celeheal and Warfarin may result in increased risk of bleeding complications.
- Concomitant use of Celecoxib Capsules increases lithium plasma levels.
- Concomitant use of Celecoxib Capsules may reduce the antihypertensive effect of ACE Inhibitors and angiotensin II antaonists
- Use caution with drugs known to inhibit P450 2C9 or metabolized by 2D6 due to the potential for increased plasma levels
Celecoxib Capsules (Celeheal) Overdosage
No overdoses of Celecoxib Capsules (Celeheal) were reported during clinical trials. Doses up to 2400 mg/day for up to 10 days in 12 patients did not result in serious toxicity. Symptoms following acute NSAID overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression and coma could occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.
Patients should be managed by symptomatic and supportive care following an NSAID overdose. There are no specific antidotes for Celeheal overdose. No information is available regarding the removal of Celecoxib by hemodialysis, but based on its high degree of plasma protein binding (greater than 97%) dialysis is unlikely to be useful in overdose. Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose. Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.
Celecoxib Capsules During Pregnancy
Celecoxib (Celeheal Capsules) is classified by the US FDA as Pregnancy Category C (Pregnancy category D from 30 weeks of gestation onward). Use of NSAIDs, including Celecoxib Capsules, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including Celecoxib, in pregnant women starting at 30 weeks of gestation.
No studies have been done to evaluate the effect of celecoxib on the closure of the ductus arteriosus in humans. In animal studies, both COX-1 and COX-2 have been shown to be present in the ductus arteriosus of fetal lambs and to contribute to maintenance of patency. In animal studies, administration of prostaglandin synthesis inhibitors such as Celecoxib, resulted in increased pre- and post-implantation loss. Therefore, use of Celecoxib capsules during the third trimester of pregnancy should be avoided and Celecoxib should not be used during the first and second trimesters of pregnancy unless the potential benefit to the mother justifies the potential risk to the fetus. The effects of Celecoxib (Celeheal Capsules) on labour and delivery in pregnant women are not known.
Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed.
Celecoxib Capsules During Lactation and Breastfeeding
Limited data from 3 published reports that included a total of 12 breastfeeding women showed low levels of Celecoxib in breast milk. The calculated average daily infant dose was 10 mcg to 40 mcg/kg/day, less than 1% of the weight-based therapeutic dose for a two-year old-child. A report of two breastfed infants 17 and 22 months of age did not show any adverse events. Caution should be exercised when Celecoxib (Celeheal Capsules) is administered to a nursing woman.
Buy Generic Celecoxib Capsules Online at a Cheap Price
You can buy Generic Celecoxib Capsules (Celeheal) online at a cheap price from the Swiss Pharmacy. Celeheal 100mg capsules, manufactured by Healing Pharma, India are priced at only $0.40 per unit if you place an order for 360 Capsules.
