Celecoxib (Capsules) Instructions for Use

Instructions
Dosage forms

ATC Code

M01AH01 (Celecoxib)

Active Substance

Celecoxib (Rec.INN registered by WHO)

Clinical-Pharmacological Group

NSAID. Highly selective COX-2 inhibitor

Pharmacotherapeutic Group

Anti-inflammatory and antirheumatic drugs; non-steroidal anti-inflammatory and antirheumatic drugs; coxibs

Pharmacological Action

NSAID. It is a selective inhibitor of COX-2, thereby blocking the formation of inflammatory prostanoids.

At therapeutic concentrations in humans, Celecoxib does not inhibit COX-1, and therefore does not affect prostanoids synthesized through the activation of COX-1.

The criteria for determining specificity for COX-2 include the absence of side effects caused by the action of COX-1, especially ulcerative lesions of the stomach and duodenum, serious complications from the upper gastrointestinal tract (bleeding, perforations, pyloric obstruction) and the absence of inhibition of COX-2-dependent platelet aggregation activity.

Indications

Symptomatic treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis; pain syndrome (back pain, musculoskeletal, postoperative, and other types of pain); treatment of primary dysmenorrhea.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
M05	Seropositive rheumatoid arthritis
M15	Polyosteoarthritis
M19.9	Unspecified arthrosis
M25.5	Pain in joint
M45	Ankylosing spondylitis
M47	Spondylosis
M54.1	Radiculopathy
M54.3	Sciatica
M54.4	Lumbago with sciatica
M54.9	Dorsalgia, unspecified
M79.1	Myalgia
N94.4	Primary dysmenorrhea
R52.0	Acute pain
R52.2	Other chronic pain

ICD-11 code	Indication
8B93.Z	Radiculopathy, unspecified
8E4A.1	Paraneoplastic or autoimmune diseases of the peripheral or autonomic nervous system
FA05	Polyosteoarthritis
FA0Z	Osteoarthritis, unspecified
FA20.0	Seropositive rheumatoid arthritis
FA8Z	Degenerative disease of spine, unspecified
FA92.0Z	Ankylosing spondylitis, unspecified
FB56.2	Myalgia
GA34.3	Dysmenorrhea
ME82	Pain in joint
ME84.20	Lumbago with sciatica
ME84.3	Sciatica
ME84.Z	Back pain, unspecified
MG30.Z	Chronic pain syndrome, unspecified
MG31.Z	Acute pain, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer capsules orally with water.

For osteoarthritis, the recommended dose is 200 mg once daily or 100 mg twice daily.

For rheumatoid arthritis, administer 100 mg to 200 mg twice daily.

For ankylosing spondylitis, the recommended dose is 200 mg once daily or 100 mg twice daily. If no effect is observed after 6 weeks, consider a trial of 400 mg daily.

For the management of acute pain and primary dysmenorrhea, administer an initial dose of 400 mg, followed by an additional 200 mg dose if needed on the first day. On subsequent days, administer 200 mg twice daily as required.

Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

For elderly patients (65 years and older), patients with a body weight below 50 kg, or those with moderate hepatic impairment, initiate therapy at the lowest recommended dose.

Avoid use in patients with severe renal impairment (creatinine clearance less than 30 ml/min) and severe hepatic impairment.

Do not use in children and adolescents under 18 years of age.

Adverse Reactions

From the cardiovascular system common – peripheral edema; uncommon – exacerbation of arterial hypertension, increased blood pressure, arrhythmia, flushing, palpitations, tachycardia; rare – manifestation of congestive heart failure, ischemic stroke and myocardial infarction.

From the digestive system: common – abdominal pain, diarrhea, dyspepsia, flatulence, dental diseases (post-extraction alveolar osteitis); uncommon – vomiting; rare – gastric and duodenal ulcer, esophageal ulceration, intestinal perforation, pancreatitis, increased activity of liver enzymes; there are reports – gastrointestinal bleeding, hepatitis, liver failure.

From the central and peripheral nervous system common – dizziness, increased muscle tone, insomnia; uncommon – anxiety, drowsiness; rare – confusion, hallucinations, aseptic meningitis.

From the urinary system common – urinary tract infection; there are reports – acute renal failure, interstitial nephritis.

From the respiratory system: common – bronchitis, cough, pharyngitis, rhinitis, sinusitis, upper respiratory tract infections.

Dermatological reactions common – skin itching, skin rash; uncommon – alopecia, urticaria; there are reports – photosensitivity, skin peeling (including in multiform erythema and Stevens-Johnson syndrome), toxic epidermal necrolysis, acute generalized exanthematous pustulosis.

From the hematopoietic system uncommon – anemia, ecchymosis, thrombocytopenia.

From the sensory organs: uncommon – tinnitus, blurred vision; rare – loss of taste, loss of smell.

From the reproductive system there are reports – menstrual cycle disorder.

Allergic reactions rare – angioedema, bullous eruptions; there are reports – anaphylaxis, vasculitis.

From the body as a whole: common – exacerbation of allergic diseases, flu-like syndrome, accidental injuries.

Contraindications

Hypersensitivity to celecoxib; hypersensitivity to other sulfonamide derivatives; complete or incomplete combination of bronchial asthma, recurrent nasal and sinus polyposis, and intolerance to acetylsalicylic acid or other NSAIDs, including other COX-2 inhibitors (including in history); period after coronary artery bypass graft surgery; erosive and ulcerative changes in the gastric or duodenal mucosa in the acute stage, active gastrointestinal bleeding; inflammatory bowel diseases (Crohn’s disease, ulcerative colitis) in the acute phase; chronic heart failure (NYHA functional class II-IV); clinically confirmed coronary artery disease, peripheral arterial disease and cerebrovascular disease in severe stage; uncontrolled arterial hypertension; hemorrhagic stroke; subarachnoid hemorrhage; pregnancy, breastfeeding period; severe hepatic impairment; severe renal impairment (creatinine clearance <30 ml/min), progressive kidney disease, confirmed hyperkalemia; children and adolescents under 18 years of age.

With caution

Gastrointestinal diseases (peptic ulcer of the stomach or duodenum, ulcerative colitis, Crohn’s disease, history of bleeding), presence of Helicobacter pylori infection; fluid retention and edema; moderate hepatic impairment, history of liver disease, hepatic porphyria; chronic renal failure (creatinine clearance 30-60 ml/min); significant decrease in circulating blood volume (including after surgery); cardiovascular diseases, including coronary artery disease, arterial hypertension; cerebrovascular diseases; dyslipidemia/hyperlipidemia; diabetes mellitus; peripheral arterial diseases; in patients who are slow metabolizers or suspected of such condition; severe somatic diseases; long-term use of NSAIDs; simultaneous use with anticoagulants (warfarin), antiplatelet agents (acetylsalicylic acid, clopidogrel), oral corticosteroids (prednisolone), diuretics, selective serotonin reuptake inhibitors (citalopram, fluoxetine, paroxetine, sertraline), digoxin, inhibitors of the CYP2C9 isoenzyme; elderly patients (65 years and older), including those receiving diuretics, debilitated patients with low body weight; tuberculosis; smoking; alcoholism.

Use in Pregnancy and Lactation

Use is contraindicated during pregnancy and breastfeeding.

Use in Hepatic Impairment

Use is contraindicated in severe hepatic impairment.

Use with caution in moderate hepatic impairment, history of liver disease, hepatic porphyria.

Use in Renal Impairment

Use is contraindicated in severe renal impairment (creatinine clearance <30 ml/min), progressive kidney diseases, confirmed hyperkalemia.

Use with caution in chronic renal failure (creatinine clearance 30-60 ml/min).

Pediatric Use

Use is contraindicated in children and adolescents under 18 years of age.

Geriatric Use

In elderly patients with body weight less than 50 kg or with moderate hepatic impairment, treatment should be started with the minimum recommended dose.

Special Precautions

Celecoxib, given its antipyretic effect, may reduce the diagnostic value of such a symptom as fever and affect the diagnosis of infection.

During treatment, it is recommended to monitor blood pressure.

Patients with symptoms and/or signs of liver dysfunction, or those patients in whom liver dysfunction is detected by laboratory methods, should be closely monitored for the development of more severe liver reactions after 2 weeks of celecoxib therapy, and liver parameters should be continuously monitored thereafter. If signs of liver damage appear (skin itching, yellowing of the skin, nausea, vomiting, abdominal pain, dark urine, increased activity of liver transaminases) or systemic manifestations (e.g., eosinophilia, skin rash), the patient should stop taking celecoxib and consult a doctor.

Drug Interactions

With simultaneous use with drugs that inhibit the activity of the CYP2C9 isoenzyme, including fluconazole, a significant increase in the plasma concentration of celecoxib is possible. Antacids (aluminum and magnesium) reduce the absorption of celecoxib by 10%, which does not cause clinically significant effects. With simultaneous use of celecoxib with warfarin, the risk of bleeding increases.

Celecoxib inhibits the activity of the CYP2D6 isoenzyme in vitro, so there is a possibility of drug interaction in vivo with drugs whose metabolism is associated with the CYP2D6 isoenzyme.

Concomitant use of CYP2C9 inducers, such as rifampicin, chlorphenamine, promethazine, cholestyramine, carbamazepine and barbiturates, may reduce plasma concentrations of celecoxib.

With simultaneous administration with warfarin and other anticoagulants (e.g., coumarin drugs), an increase in prothrombin time is possible.

Fluconazole, ketoconazole: with simultaneous use of 200 mg fluconazole once/day, a 2-fold increase in the plasma concentration of celecoxib was noted. This effect is associated with inhibition of celecoxib metabolism by fluconazole via the CYP2C9 isoenzyme.

Inhibition of prostaglandin synthesis under the influence of celecoxib may reduce the antihypertensive effect of ACE inhibitors and/or angiotensin II antagonists. This interaction should be taken into account when using celecoxib concomitantly with ACE inhibitors and/or angiotensin II antagonists.

In elderly patients, dehydrated (including patients receiving diuretic therapy) or patients with impaired renal function, simultaneous use of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors may lead to deterioration of renal function, including possible acute renal failure. Usually these effects are reversible.

It is known that previous NSAIDs in some patients may reduce the natriuretic effect of furosemide and thiazides by reducing renal synthesis of prostaglandins; this should be kept in mind when using celecoxib.

Celecoxib can be used 8-12 days after taking mifepristone, because NSAIDs reduce the effect of drugs of this group.

An increase in plasma lithium concentration by approximately 17% was observed with the combined use of lithium and celecoxib. Patients receiving lithium therapy should be closely monitored when starting or discontinuing celecoxib.

Simultaneous use of celecoxib and other NSAIDs (not containing acetylsalicylic acid) should be avoided.

Celecoxib does not affect the antiplatelet effect of low-dose acetylsalicylic acid. Celecoxib has a weak effect on platelet function, so it cannot be considered as a replacement for acetylsalicylic acid used for the prevention of cardiovascular diseases.

An increase in the plasma level of digoxin is possible with simultaneous use with celecoxib.

Oral antidiabetic drugs: enhancement of the hypoglycemic effect is possible.

Concomitant use with paracetamol increases nephrotoxicity, with methotrexate – hepato- and nephrotoxicity. Simultaneous administration of celecoxib and methotrexate is possible only when using low doses of the latter (monitoring of plasma methotrexate concentration is necessary).

Probenecid reduces the plasma clearance and V_d of celecoxib, increases its plasma concentration and increases T_1/2.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Celecoxib [Jivdhara Pharma, Private Limited (India)]
Capsules 200 mg: 10 pcs.

Marketing Authorization Holder

Jivdhara Pharma, Private Limited (India)

Manufactured By

NPC Scan Biotek, LLC (Russia)

Dosage Form

Celecoxib

Capsules 200 mg: 10 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin size No. 2, white body, dark red cap, capsule contents – white or almost white powder.

	1 caps.
Celecoxib	200 mg

Excipients : lactose monohydrate – 43.15 mg, croscarmellose sodium – 3 mg, sodium lauryl sulfate – 8.1 mg, povidone K30 – 6.75 mg, magnesium stearate – 9 mg.

Capsule body composition: gelatin – 81.4%, methylparaben – 0.8%, propylparaben – 0.2%, sodium lauryl sulfate – 0.1%, water – 14.5%, titanium dioxide – 3%.
Capsule cap composition: gelatin – 82.237%, methylparaben – 0.8%, propylparaben – 0.2%, sodium lauryl sulfate – 0.1%, water – 14.5%, titanium dioxide – 1.2%, azorubine dye – 0.428%, Ponceau 4R dye – 0.535%.

10 pcs. – blisters (1) – cardboard packs.

Celecoxib [Pharmproekt, JSC (Russia)]
Capsules 100 mg: 10, 20, 30, 40, 50, 60, 90, or 100 pcs.
Capsules 200 mg: 10, 20, 30, 40, 50, 60, 90, or 100 pcs.

Marketing Authorization Holder

Pharmproekt, JSC (Russia)

Dosage Forms

	Celecoxib	Capsules 100 mg: 10, 20, 30, 40, 50, 60, 90, or 100 pcs.
		Capsules 200 mg: 10, 20, 30, 40, 50, 60, 90, or 100 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No.3, opaque, white; capsule contents – a mixture of powder and granules, white or almost white.

	1 caps.
Celecoxib	100 mg

Excipients : lactose monohydrate, sodium lauryl sulfate, povidone K30, croscarmellose sodium, magnesium stearate.

Capsule composition: gelatin, titanium dioxide (E171).

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (9) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.

Capsules hard gelatin, size No.1, opaque, white; capsule contents – a mixture of powder and granules, white or almost white.

	1 caps.
Celecoxib	200 mg

Excipients : lactose monohydrate, sodium lauryl sulfate, povidone K30, croscarmellose sodium, magnesium stearate.

Capsule composition: gelatin, titanium dioxide (E171).

Celecoxib Organica [Organika, JSC (Russia)]
Capsules 100 mg: 10, 20, 30, 40, 50, 60, or 100 pcs.
Capsules 200 mg: 10, 20, 30, 40, 50, 60, or 100 pcs.

Marketing Authorization Holder

Organika, JSC (Russia)

Dosage Forms

	Celecoxib Organica	Capsules 100 mg: 10, 20, 30, 40, 50, 60, or 100 pcs.
		Capsules 200 mg: 10, 20, 30, 40, 50, 60, or 100 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin size 0 white or almost white; the capsule contents are a mixture of powder and granules white or almost white or a compacted mass in the form of a column that disintegrates upon light pressure with a glass rod.

	1 caps.
Celecoxib	100 mg

Excipients: lactose monohydrate, microcrystalline cellulose PH101, sodium lauryl sulfate, croscarmellose sodium, magnesium stearate, povidone K25.
Hard gelatin capsule shell titanium dioxide, gelatin.

10 pcs. – contour cell packaging (1) – cardboard packs with an insert.
10 pcs. – contour cell packaging (2) – cardboard packs with an insert.
10 pcs. – contour cell packaging (3) – cardboard packs with an insert.
10 pcs. – contour cell packaging (4) – cardboard packs with an insert.
10 pcs. – contour cell packaging (5) – cardboard packs with an insert.
10 pcs. – contour cell packaging (6) – cardboard packs with an insert.
10 pcs. – contour cell packaging (10) – cardboard packs with an insert.

Capsules hard gelatin size 0 yellow; the capsule contents are a mixture of powder and granules white or almost white or a compacted mass in the form of a column that disintegrates upon light pressure with a glass rod.

	1 caps.
Celecoxib	200 mg

Celecoxib Velpharm [Elzapharm, LLC (Russia)]
Capsules 100 mg: 10, 20, 30, 40, 50, or 100 pcs.
Capsules 200 mg: 10, 20, 30, 40, 50, or 100 pcs.

Marketing Authorization Holder

Elzapharm, LLC (Russia)

Manufactured By

Velpharm, LLC (Russia)

Velpharm-M, LLC (Russia)

Dosage Forms

	Celecoxib Velpharm	Capsules 100 mg: 10, 20, 30, 40, 50, or 100 pcs.
		Capsules 200 mg: 10, 20, 30, 40, 50, or 100 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin size 2 white; contents – white powder.

	1 caps.
Celecoxib	100 mg

Excipients: lactose monohydrate (milk sugar), sodium lauryl sulfate, povidone K30, croscarmellose sodium (primellose), magnesium stearate.

Composition of the gelatin capsule: titanium dioxide, gelatin.

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
40 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.

Capsules hard gelatin size 0 white; contents – white powder.

	1 caps.
Celecoxib	200 mg

Excipients: lactose monohydrate (milk sugar), sodium lauryl sulfate, povidone K30, croscarmellose sodium (primellose), magnesium stearate.

Composition of the gelatin capsule: titanium dioxide, gelatin.

Celecoxib-Teva [Teva Pharmaceutical Industries, Ltd. (Israel)]
Capsules 200 mg: 10 or 30 pcs.

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Watson Pharma, Private Limited (India)

Dosage Form

Celecoxib-Teva

Capsules 200 mg: 10 or 30 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin size 2 with an opaque white cap with a yellow stripe and an opaque white body with a stripe and the inscription “200” on it; capsule contents – a granular white powder.

	1 caps.
Celecoxib	200 mg

Excipients: sodium lauryl sulfate, lactose monohydrate (Pharmatose 200M), crospovidone (type A), povidone (K29-32), lactose monohydrate (SuperTabl 1SD), magnesium stearate.

Gelatin capsule titanium dioxide E171, gelatin, sodium lauryl sulfate, purified water, TekPrint SB-3002 Gold Ink: shellac, anhydrous ethanol, isopropyl alcohol, n-butyl alcohol, propylene glycol, concentrated ammonium hydroxide, iron oxide yellow E172.

10 pcs. – blisters (1) – cardboard packs with an insert.
10 pcs. – blisters (3) – cardboard packs with an insert.

Celecoxib-Vertex [Vertex, JSC (Russia)]
Capsules 100 mg: 10, 20, 30, 40, 50, or 100 pcs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Celecoxib-Vertex

Capsules 100 mg: 10, 20, 30, 40, 50, or 100 pcs.

Dosage Form, Packaging, and Composition

Capsules white, hard, gelatin size 0; capsule contents – a granulated powder or a compacted mass that disintegrates upon light pressure with a glass rod, white or almost white.

	1 caps.
Celecoxib	100 mg

Excipients: lactose monohydrate, sodium lauryl sulfate, povidone (K-30), croscarmellose sodium, magnesium stearate.

Hard gelatin capsules: titanium dioxide, gelatin.

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.

Celecoxib-Vertex [Vertex, JSC (Russia)]
Capsules 200 mg: 10, 20, 30, 40, 50, or 100 pcs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Celecoxib-Vertex

Capsules 200 mg: 10, 20, 30, 40, 50, or 100 pcs.

Dosage Form, Packaging, and Composition

Capsules yellow, hard, gelatin size 0; capsule contents – a granulated powder or a compacted mass that disintegrates upon light pressure with a glass rod, white or almost white.

	1 caps.
Celecoxib	200 mg

Excipients: lactose monohydrate, sodium lauryl sulfate, povidone (K-30), croscarmellose sodium, magnesium stearate.

Hard gelatin capsules: titanium dioxide, iron oxide yellow (ferric oxide), gelatin.

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.

Celecoxib-Vial [Vial, LLC (Russia)]
Capsules 100 mg: 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.

Marketing Authorization Holder

Vial, LLC (Russia)

Manufactured By

Protech Biosystems, Pvt. Ltd. (India)

Dosage Form

Celecoxib-Vial

Capsules 100 mg: 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.

Dosage Form, Packaging, and Composition

Capsules hard, gelatin, size 2, cap – green, body – reddish-orange; capsule contents – white or almost white powder.

	1 caps.
Celecoxib	100 mg

Excipients: anhydrous lactose – 103.33 mg, talc – 10 mg, croscarmellose sodium – 2.67 mg, colloidal silicon dioxide – 2.67 mg, sodium lauryl sulfate – 1.33 mg.

Composition of the capsule cap: brilliant blue dye – 0.135%, quinoline yellow dye – 0.624%, sunset yellow FCF dye – 0.194%, titanium dioxide – 1.875%, methylparaben – 0.8%, propylparaben – 0.2%, sodium lauryl sulfate – 0.1%, gelatin – up to 100%.
Composition of the capsule body: ponceau 4R dye, sunset yellow FCF dye – 1.843%, titanium dioxide – 1.741%, methylparaben – 0.8%, propylparaben – 0.2%, sodium lauryl sulfate – 0.1%, gelatin – up to 100%.

10 pcs. – aluminum/PVC blisters (1) – cardboard packs.
10 pcs. – aluminum/PVC blisters (2) – cardboard packs.
10 pcs. – aluminum/PVC blisters (3) – cardboard packs.
10 pcs. – aluminum/PVC blisters (4) – cardboard packs.
10 pcs. – aluminum/PVC blisters (5) – cardboard packs.
10 pcs. – aluminum/PVC blisters (6) – cardboard packs.
10 pcs. – aluminum/PVC blisters (7) – cardboard packs.
10 pcs. – aluminum/PVC blisters (8) – cardboard packs.
10 pcs. – aluminum/PVC blisters (9) – cardboard packs.
10 pcs. – aluminum/PVC blisters (10) – cardboard packs.
60 pcs. – polymer containers (1) – cardboard packs.

Celecoxib-Vial [Vial, LLC (Russia)]
Capsules 200 mg: 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.

Marketing Authorization Holder

Vial, LLC (Russia)

Manufactured By

Protech Biosystems, Pvt. Ltd. (India)

Dosage Form

Celecoxib-Vial

Capsules 200 mg: 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.

Dosage Form, Packaging, and Composition

Capsules hard, gelatin, size 1, cap – blue, body – almost white; capsule contents – white or almost white powder.

	1 caps.
Celecoxib	200 mg

Excipients: anhydrous lactose – 86.26 mg, talc – 14 mg, croscarmellose sodium – 3.87 mg, colloidal silicon dioxide – 3.87 mg, sodium lauryl sulfate – 2 mg.

Composition of the capsule cap: brilliant blue dye – 0.195%, titanium dioxide – 2.357%, methylparaben – 0.8%, propylparaben – 0.2%, sodium lauryl sulfate – 0.1%, gelatin – up to 100%.
Composition of the capsule body: titanium dioxide – 3%, methylparaben – 0.8%, propylparaben – 0.2%, sodium lauryl sulfate – 0.1%, gelatin – up to 100%.

Medixlife (Author)

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