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Celecoxib 200 Mg Capsules

Celecoxib 200 Mg Capsules

Product Description

Posology

As the cardiovascular (CV) risks of celecoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis (see sections 4.3, 4.4, 4.8 and 5.1).

Osteoarthritis

The usual recommended daily dose is 200 mg taken once daily or in two divided doses. In some patients, with insufficient relief from symptoms, an increased dose of 200 mg twice daily may increase efficacy. In the absence of an increase in therapeutic benefit after two weeks, other therapeutic options should be considered.

Rheumatoid arthritis

The initial recommended daily dose is 200 mg taken in two divided doses. The dose may, if needed, later be increased to 200 mg twice daily. In the absence of an increase in therapeutic benefit after two weeks, other therapeutic options should be considered.

Ankylosing spondylitis

The recommended daily dose is 200 mg taken once daily or in two divided doses. In a few patients, with insufficient relief from symptoms, an increased dose of 400 mg once daily or in two divided doses may increase efficacy. In the absence of an increase in therapeutic benefit after two weeks, other therapeutic options should be considered.

The maximum recommended daily dose is 400 mg for all indications.

Special populations

Elderly

As in younger adults, 200 mg per day should be used initially. The dose may, if needed, later be increased to 200 mg twice daily. Particular caution should be exercised in elderly with a body weight less than 50 kg (see sections 4.4 and 5.2).

Paediatric population

Celecoxib is not indicated for use in children.

CYP2C9 poor metabolisers

Patients who are known, or suspected to be CYP2C9 poor metabolisers based on genotyping or previous history/experience with other CYP2C9 substrates should be administered celecoxib with caution as the risk of dose-dependent adverse effects is increased. Consider reducing the dose to half the lowest recommended dose (see section 5.2).

Hepatic impairment

Treatment should be initiated at half the recommended dose in patients with established moderate liver impairment with a serumalbumin of 25-35 g/l. Experience in such patients is limited to cirrhotic patients (see sections 4.3, 4.4 and 5.2).

Renal impairment

Experience with celecoxib in patients with mild or moderate renal impairment is limited, therefore such patients should be treated with caution (see sections 4.3, 4.4 and 5.2).

Method of administration

Oral use

Celecoxib may be taken with or without food. For patients who have difficulty swallowing Capsules, the contents of a celecoxib capsule can be added to applesauce, rice gruel, yogurt or mashed banana. To do so, the entire capsule contents must be carefully emptied onto a level teaspoon of cool or room temperature applesauce, rice gruel, yogurt or mashed banana and should be ingested immediately with 240 ml of water. The sprinkled capsule contents on applesauce, rice gruel or yogurt are stable for up to 6 hours under refrigerated conditions (2-8°C). The sprinkled capsule contents on mashed banana should not be stored under refrigerated conditions and should be ingested immediately.

NINGBO VOICE BIOCHEMIC CO. LTD

 

Since 2015, NINGBO VOICE BIOCHEMIC CO. LTD. is a professional company to offer one-package service for Contract Manufacturing; international pharmaceutical registration, processing quality controlling and shipment. All the FPP (Finished Pharmaceutical Products ); APIs (Active Pharmaceutical Ingredients); Chemicals (Pharmaceutical Intermediates ); Veterinary Pharmaceuticals supplied by us meet requirements of Standard GMP and current BP,USP version.


Ningbo Voice Bioquímica Empresa. Es una empresa profesional de ofrecer un paquete de servicio para International Farmacéutica registro, procesamiento, control de calidad y envío.
Podemos suministrar productos farmacéuticos cualificados (FPPs, APIs, productos de cuidado de la salud) de acuerdo a la norma GMP y actual BP, USP version.


Ningbo Voice Biochemic Entreprise. est une compagnie professionnelle offre un service d'enregistrement international forfait pour le contrôle de la qualité pharmaceutique, traitement, et l'expédition. Nous fournir des produits pharmaceutiques (FPPs, APIs, des produits de soins de santé) selon la norme GMP et BP, USP version.



Your kindly purchase enquiry or Contract Manufacturing proposal would be highly appreciated.

Address:No. 298,West Zhongshan Rd.. Ningbo, Zhejiang, P. R. China , 315000

E-Mail: info@pharma-voice.com / medicren@hotmail,com

Attn: Dr. Medic Ren ( General Manager, Pharmacist)

Tel/Fax: 0086 574 87330957; Mobile:13806670686 ; 17702506716



Company Info

  • Company Name: NINGBO VOICE BIOCHEMIC CO. LTD
  • Representative: Quan Sheng Ren
  • Product/Service: Oncology Anticarcinogenic , Antipyretic Analgesics , Antiparasitic & Antimycotic , Digestive System Drug , Neural System Remedy , Respiratory System Remedy
  • Capital (Million US $): 200000RMB
  • Year Established: 2015
  • Export Percentage: 61% - 70%
  • Contact Person: Mr. Medic Ren
  • Tel: 86-574-87330957
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