“We use cookies on this website to enhance your user experience and to personalise content. By clicking any link or continuing to use our Website you agree to our cookies as per our Privacy Policy. Read More” Ok, I agree

Amoxicillin And Clavulanate Potassium (Amoxicillin And Clavulanate Potassium)

Trade Name : Amoxicillin and Clavulanate Potassium

Teva Pharmaceuticals USA, Inc.

POWDER, FOR SUSPENSION

Strength 60042.9 mg/5mLmg/5mL

AMOXICILLIN; CLAVULANATE POTASSIUM Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]

Delivery Process

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

We’ll Get in Touch

Once we review your request, we’ll send you an estimated price for the medicine within 2-5 days.

Confirmation and Payment

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Amoxicillin And Clavulanate Potassium (Amoxicillin And Clavulanate Potassium) which is also known as Amoxicillin and Clavulanate Potassium and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 600; 42.9 mg/5mL; mg/5mL per ml. Read more

Amoxicillin And Clavulanate Potassium (Amoxicillin And Clavulanate Potassium) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Inquire directly from our website and get 5% off on any medicine!

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more

About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more
  • No data
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension USP and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.Amoxicillin and clavulanate potassium for oral suspension USP, 600 mg/42.9 mg per 5 mL is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to (penicillin MICs u2264 2 mcg/mL), (including beta-lactamaseu2013producing strains), or (including beta-lactamaseu2013producing strains) characterized by the following risk factors:
  • [see CLINICAL PHARMACOLOGY, Microbiology ()]
  • NOTE: n- S. pneumoniaen- S. pneumoniaen- Sn- pneumoniae
  • Amoxicillin and clavulanate potassium for oral suspension USP, 600 mg/42.9 mg per 5 mL is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to (penicillin MICs u2264 2 mcg/mL), (including beta-lactamaseu2013producing strains), or (including beta-lactamase-producing strains) characterized by the following risk factors ():
  • antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years or younger 2) daycare attendance
  • Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL does not contain the same amount of clavulanic acid (as the potassium salt) as any of the other suspensions of amoxicillin and clavulanate potassium.. Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL contains 42.9 mg of clavulanic acid per 5 mL, whereas the amoxicillin and clavulanate potassium, 200 mg/28.5 mg per 5 mL suspension contains 28.5 mg of clavulanic acid per 5 mL and the 400 mg/57 mg per 5 mL suspension contains 57 mg of clavulanic acid per 5 mL. Therefore, the amoxicillin and clavulanate potassium 200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL suspensions should not be substituted for amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL as they are not interchangeable.
  • Pediatric Patients less than 40 kg: 90 mg/kg/day divided every 12 hours, administered for 10 days. ()
  • Powder for Oral Suspension:
  • u2022 Each 5 mL of reconstituted orange-flavored suspension contains 600 mg amoxicillin trihydrate and 42.9 mg clavulanic acid as the potassium salt.
  • 600 mg/42.9 mg per 5 mL. ()
  • No data
  • History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL or to other beta-lactams (e.g., penicillins or cephalosporins). ()
  • History of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL. (4.2)
  • No data
  • Serious (including fatal) hypersensitivity reactions: Discontinue amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL if a reaction occurs. ()
  • Hepatic dysfunction and cholestatic jaundice: Discontinue if signs/symptoms of hepatitis occur. Monitor liver function tests in patients with hepatic impairment. ()
  • Clostridium difficile
  • Patients with mononucleosis who receive amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL develop skin rash. Avoid amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL use in these patients. (n
  • The most frequently reported adverse reactions were diaper rash (4%), diarrhea (3%), vomiting (2%), candidiasis (1%), and rash (1%). ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 oru00a0
  • No data
  • Coadministration with probenecid is not recommended. ()
  • Concomitant use of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL with oral anticoagulants may increase the prolongation of prothrombin time. ()
  • Coadministration with allopurinol increases the risk of rash. ()
  • Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL may reduce efficacy of oral contraceptives. ()
  • No data
  • Pediatric 3 months to 12 years old: Modify dose according to weight. (, )
  • Adults and pediatric patients weighing more than 40 kg: The safety and effectiveness of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL has not been established. ()
  • Following overdosage, patients have experienced primarily gastrointestinal symptoms including stomach and abdominal pain, vomiting, and diarrhea. Rash, hyperactivity, or drowsiness has also been observed in a small number of patients.
  • In the case of overdosage, discontinue amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, treat symptomatically, and institute supportive measures as required. If the overdosage is very recent and there is no contraindication, an attempt at emesis or other means of removal of drug from the stomach may be performed. A prospective study of 51 pediatric patients at a poison control center suggested that overdosage of less than 250 mg/kg of amoxicillin is not associated with significant clinical symptoms and does not require gastric emptying.n
  • Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with amoxicillin.
  • Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin overdosage in adult and pediatric patients. In case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin crystalluria.
  • Renal impairment appears to be reversible with cessation of drug administration. High blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of both amoxicillin and clavulanate. Both amoxicillin and clavulanate are removed from the circulation by hemodialysis.
  • Amoxicillin and Clavulanate Potassium for Oral Suspension USP is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. Chemically, amoxicillin is (2,56)-6-[()-(-)-2-amino-2-(-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0] heptane-2-carboxylic acid trihydrate and may be represented structurally as:
  • CHNOS u2022 3HO M.W. 419.46
  • Clavulanic acid is produced by the fermentation of . It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of beta-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated beta-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. Chemically, clavulanate potassium is potassium ()-(2,5)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as:
  • CHKNO M.W. 237.25
  • Inactive Ingredients: n- [see Warnings and Precautions (5.6)]
  • Each 5 mL of reconstituted Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg per 5 mL contains 600 mg amoxicillin as the trihydrate and 42.9 mg clavulanic acid as the potassium salt (clavulanate potassium). The potassium content per 5 mL is 0.23 mEq.
  • No data
  • Long-term studies in animals have not been performed to evaluate carcinogenic potential. Amoxicillin and clavulanate potassium (4:1 ratio formulation of amoxicillin:clavulanate) was non-mutagenic in the Ames bacterial mutation assay, and the yeast gene conversion assay. Amoxicillin and clavulanate potassium was weakly positive in the mouse lymphoma assay, but the trend toward increased mutation frequencies in this assay occurred at concentrations that were also associated with decreased cell survival. Amoxicillin and clavulanate potassium was negative in the mouse micronucleus test, and in the dominant lethal assay in mice. Potassium clavulanate alone was tested in the Ames bacterial mutation assay and in the mouse micronucleus test, and was negative in each of these assays.
  • Amoxicillin and clavulanate potassium (2:1 ratio formulation of amoxicillin:clavulanate) at oral doses of up to 1,200 mg/kg/day was found to have no effect on fertility and reproductive performance in rats. Based on body surface area (assuming a 20 kg child), this dose of amoxicillin is approximately 2 times the recommended clinical amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL dose of 90/6.4 mg/kg/day. For clavulanate, the dose multiple is approximately 15 times higher than the recommended clinical daily dose, also based on body surface area.
  • Two clinical studies were conducted in pediatric patients with acute otitis media. A non-comparative, open-label study assessed the bacteriologic and clinical efficacy of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL (90 mg/6.4 mg/kg/day, divided every 12 hours) for 10 days in 521 pediatric patients (3 to 50 months) with acute otitis media. The primary objective was to assess bacteriological response in children with acute otitis media due to with amoxicillin/clavulanic acid MICs of 4 mcg/mL. The study sought the enrollment of patients with the following risk factors: Failure of antibacterial therapy for acute otitis media in the previous 3 months, history of recurrent episodes of acute otitis media, 2 years or younger, or daycare attendance. Prior to receiving amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, all patients had tympanocentesis to obtain middle ear fluid for bacteriological evaluation. Patients from whom (alone or in combination with other bacteria) was isolated had a second tympanocentesis 4 to 6 days after the start of therapy. Clinical assessments were planned for all patients during treatment (4 to 6 days after starting therapy), as well as 2 to 4 days post-treatment and 15 to 18 days post-treatment. Bacteriological success was defined as the absence of the pretreatment pathogen from the on-therapy tympanocentesis specimen. Clinical success was defined as improvement or resolution of signs and symptoms. Clinical failure was defined as lack of improvement or worsening of signs and/or symptoms at any time following at least 72 hours of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL; patients who received an additional systemic antibacterial drug for otitis media after 3 days of therapy were considered clinical failures. Bacteriological eradication on therapy (day 4 to 6 visit) in the per protocol population is summarized in the following table:
  • Clinical assessments were made in the per protocol population 2 to 4 days post-therapy and 15 to 18 days post-therapy. Patients who responded to therapy 2 to 4 days post-therapy were followed for 15 to 18 days post-therapy to assess them for acute otitis media. Nonresponders at 2 to 4 days post-therapy were considered failures at the latter timepoint.
  • In the intent-to-treat analysis, overall clinical outcomes at 2 to 4 days and 15 to 18 days post-treatment in patients with with penicillin MIC = 2 mcg/mL and 4 mcg/mL were 29/41 (71%) and 17/41 (42%), respectively.
  • No data
  • How Supplied
  • The color of the dry powder for Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg per 5 mL is white to off-white powder.
  • Each 5 mL of reconstituted orange-flavored suspension contains 600 mg amoxicillin trihydrate and 42.9 mg clavulanic acid as the potassium salt.
  • It is available in bottles of 75 mL (NDC 0093-8675-78, 125 mL (NDC 0093-8675-75, and 200 mL (NDC 0093-8675-74.n n Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days. Store dry powder at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature]. Dispense in original container. Keep tightly closed.n KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • Take amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL every 12 hours with a meal or snack to reduce the possibility of gastrointestinal upset. If diarrhea develops and is severe or lasts more than 2 or 3 days, call your doctor.
  • Counsel patients that diarrhea is a common problem caused by antibacterial drugs which usually ends when the antibacterial drug is discontinued. Sometimes after starting treatment with antibacterial drugs, patient can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken the last dose of the antibacterial drug. If this occurs, patients should contact their physician as soon as possible.
  • Keep suspension refrigerated. Shake well before using. When dosing a child with the suspension (liquid) of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, use a dosing spoon or medicine dropper. Be sure to rinse the spoon or dropper after each use. Bottles of suspension of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL may contain more liquid than required. Follow your doctoru2019s instructions about the amount to use and the days of treatment your child requires. Discard any unused medicine.
  • Teva Canada Limited
  • Toronto, Canada M1B 2K9
  • Manufactured For:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. I 8/2018
  • No data

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Desogestrel And Ethinyl Estradiol (Emoquette)

Manufacturer: REMEDYREPACK INC.

Presentation: KIT

Strength:

Pack Size:

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET

Strength: 2.5; .025 mg/1; mg/1

Pack Size:

Fluoxetine Hydrochloride (Fluoxetine)

Fluoxetine Hydrochloride (Fluoxetine)

Manufacturer: REMEDYREPACK INC.

Presentation: CAPSULE

Strength: 40 mg/1

Pack Size:

Metoprolol Succinate (Metoprolol Succinate)

Metoprolol Succinate (Metoprolol Succinate)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET, EXTENDED RELEASE

Strength: 25 mg/1

Pack Size:

Losartan Potassium (Losartan Potassium)

Losartan Potassium (Losartan Potassium)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET, FILM COATED

Strength: 25 mg/1

Pack Size:

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

Read More

Name Patient Supply

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

Read More

Validated Cold Chain Shipment

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

Read More

Clinical Trials Supply

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

Read More

Pharmaceutical Contract Manufacturing

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

Read More

Pricing

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

Read More

Disclaimer

Please see the Legal Notice for detailed terms and disclaimers. The Legal Notice governs the use of this Website and by accessing and using this Website you agree to be bound by and accept the Legal Notice.

Browse from other international pharmaceuticals

General

64020 Products

GNH India Brings to over 64036 Product SKUs from India all at 1 place with easy access and global deliveries.

US NDC

71246 Products

GNH India Brings to over 71252 Product SKUs from India all at 1 place with easy access and global deliveries.

Canadian DIN

51046 Products

GNH India Brings to over 51047 Product SKUs from India all at 1 place with easy access and global deliveries.

Swiss Drugs

150 Products

GNH India Brings to over 150 Product SKUs from India all at 1 place with easy access and global deliveries.

NZ Drugs

13296 Products

GNH Brings to over 13298 Product SKUs from India all at 1 place with easy access and global deliveries.

FAQ

Check out our delivery process

Can’t find what
you’re looking for?

Contact US
Get Price

Are you an existing customer or a vendor of GNH India? Log in here to

View your Transaction
COMPANY
SERVICES
QUICK LINKS
CONTACT US
Registered Office Address:

Unit # G- 14, 15, 16, 17, Ground Floor, Prabhadevi Industrial Estate, Enterprises Industrial Premises, 408, Veer Sawarkar Road, Prabhadevi,
Mumbai 400025 India

US Office Address:

GNH Pharmaceuticals USA LLC,
Suite E # 499, 1235 EAST BLVD,
Charlotte, NC, 28203, U.S.A
TEL: +1 704 557 0412

Pharmexcil
DB
FIEO-2016
SiteLock

Copyright © 2024 GNHIndia .com. All Rights Reserved. Please read Legal Notice for further details.

Disclaimer: Product names, logos, brands and other trademarks featured or referred to are the property of their respective trademark holders.