Amoxicillin (Amoxicillin)

Trade Name : Amoxicillin

Sandoz Inc

CAPSULE

Strength 250 mg/1

AMOXICILLIN Penicillin-class Antibacterial [EPC],Penicillins [CS]

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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 (Amoxicillin) which is also known as Amoxicillin and Manufactured by Sandoz Inc. It is available in strength of 250 mg/1 per ml. Read more

Amoxicillin (Amoxicillin) 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.

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About GNH

No data

No data

Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. ()

H. pylori

No data

2.1n- 2.2n- 2.3
H. pylori

Capsules:
Each amoxicillin capsule, with yellow opaque cap and body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The 250 mg capsule is imprinted AMOX 250 on one side and GG 848 on the other side; the 500 mg capsule is imprinted AMOX 500 on one side and GG 849 on the other side.
Tablets: n- .
Each film coated tablet contains 500 mg or 875 mg amoxicillin as the trihydrate. The tablets are oval-shaped and white to yellowish. The 500 mg tablet is unscored, embossed GG-961 on one side and 500 on the other side. The 875 mg tablet is scored and embossed GG-962 on one side and 875 on the other side.
For Oral Suspension:
Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate.

Amoxicillin is contraindicated in patients who have experienced a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin or to other u03b2-lactam antibiotics (e.g., penicillins and cephalosporins).

u2022
4

No data

Clostridium difficile

The following are discussed in more detail in other sections of the labeling:
The most common adverse reactions (> 1%) observed in clinical trials of amoxicillin capsules, tablets or oral suspension were diarrhea, rash, vomiting, and nausea. ()
To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc., at 1-800-525-8747 or FDA at 1-800-FDA-1088 or n

No data

No data

u2022
8.4

In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures as required. A prospective study of 51 pediatric patients at a poison-control center suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms.
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 amoxicillin. Amoxicillin may be removed from circulation by hemodialysis.

Formulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms.
Chemically, it is (2,5,6)-6-[(R)-(-)-2-amino-2-(-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4- thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:
The amoxicillin molecular formula is CHNOS u2022 3HO, and the molecular weight is 419.45.
Amoxicillin Capsules, USP:
Each amoxicillin capsule, with yellow opaque cap and body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The 250 mg capsule is imprinted AMOX 250 on one side and GG 848 on the other side; the 500 mg capsule is imprinted AMOX 500 on one side and GG 849 on the other side. Inactive ingredients: Capsule shells - yellow ferric oxide, titanium dioxide, gelatin, black ferric oxide, shellac, propylene glycol, potassium hydroxide and ammonium hydroxide; Capsule contents - cellulose microcrystalline and magnesium stearate.
Meets USP Dissolution Test 2.
Amoxicillin Tablets, USP:
Each film coated tablet contains 500 mg or 875 mg amoxicillin as the trihydrate. The tablets are oval-shaped and white to yellowish. The 500 mg tablet is unscored, embossed GG-961 on one side and 500 on the other side. The 875 mg tablet is scored and embossed GG-962 on one side and 875 on the other side. In addition each amoxicillin tablet contains these inactive ingredients: colloidal silicon dioxide, crospovidone, ethylcellulose aqueous dispersion, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, triethyl citrate, and titanium dioxide.
Amoxicillin for Oral Suspension, USP:
Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate. Each 5 mL of the 125 mg, 200 mg, 250 mg, and 400 mg reconstituted suspension contains 0.30 mEq (6.95 mg) of sodium.
Amoxicillin trihydrate for oral suspension 125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL and 400 mg/5 mL are fruity flavored pink suspensions. Inactive ingredients: anhydrous citric acid, colloidal silicon dioxide, flavorings: raspberry, strawberry, refrachessement, FD&C Red 40, sodium benzoate, sodium citrate, sucrose, and xantham gum.

No data

Long-term studies in animals have not been performed to evaluate carcinogenic potential. Studies to detect mutagenic potential of amoxicillin alone have not been conducted; however, the following information is available from tests on a 4:1 mixture of amoxicillin and clavulanate potassium. Amoxicillin and clavulanate potassium was nonmutagenic 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 doses 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. In a multi-generation reproduction study in rats, no impairment of fertility or other adverse reproductive effects were seen at doses up to 500 mg/kg (approximately 2 times the 3 g human dose based on body surface area).

Randomized, double-blind clinical studies performed in the United States in patients with and duodenal ulcer disease (defined as an active ulcer or history of an ulcer within 1 year) evaluated the efficacy of lansoprazole in combination with amoxicillin capsules and clarithromycin tablets as triple 14-day therapy, or in combination with amoxicillin capsules as dual 14-day therapy, for the eradication of . Based on the results of these studies, the safety and efficacy of 2 different eradication regimens were established: Amoxicillin 1 gram twice daily/clarithromycin 500 mg twice daily/lansoprazole 30 mg twice daily (see Table 6). Amoxicillin 1 gram three times daily/lansoprazole 30 mg three times daily (see Table 7).
All treatments were for 14 days. eradication was defined as 2 negative tests (culture and histology) at 4 to 6 weeks following the end of treatment. Triple therapy was shown to be more effective than all possible dual therapy combinations. Dual therapy was shown to be more effective than both monotherapies. Eradication of has been shown to reduce the risk of duodenal ulcer recurrence.

No data

Amoxicillin Capsules, USP,
250 mg:
NDC 0781-2020-76............................................ bottles of 30 u00d7 12's
NDC 0781-2020-01.................................................... bottles of 100
NDC 0781-2020-05.................................................... bottles of 500
500 mg:
NDC 0781-2613-76............................................ bottles of 30 u00d7 12's
NDC 0781-2613-01.................................................... bottles of 100
NDC 0781-2613-05.................................................... bottles of 500
Amoxicillin Tablets, USP
500 mg:
NDC 0781-5060-20...................................................... bottles of 20
NDC 0781-5060-01.................................................... bottles of 100
875 mg:
NDC 0781-5061-20...................................................... bottles of 20
NDC 0781-5061-01.................................................... bottles of 100
Amoxicillin for Oral Suspension, USP:
125 mg/5 mL
NDC 0781-6039-58...................................................... 80 mL bottle
NDC 0781-6039-46.................................................... 100 mL bottle
NDC 0781-6039-55.................................................... 150 mL bottle
200 mg/5 mL
NDC 0781-6156-52...................................................... 50 mL bottle
NDC 0781-6156-57...................................................... 75 mL bottle
NDC 0781-6156-46.................................................... 100 mL bottle
250 mg/5 mL
NDC 0781-6041-58...................................................... 80 mL bottle
NDC 0781-6041-46.................................................... 100 mL bottle
NDC 0781-6041-55.................................................... 150 mL bottle
400 mg/5 mL
NDC 0781-6157-52...................................................... 50 mL bottle
NDC 0781-6157-57...................................................... 75 mL bottle
NDC 0781-6157-46.................................................... 100 mL bottle
Store capsules, tablets and unreconstituted powder for oral suspension at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature].

Information for Patients
CLINITESTu00ae is a registered trademark of Miles, Inc.
CLINISTIXu00ae is a registered trademark of Bayer Corporation.
CLOtestu00ae is a registered trademark of Kimberly-Clark Corporation.
46176378
12-2015M
Manufactured in Austria by Sandoz GmbH for
Sandoz Inc., Princeton, NJ 08540
Product of Spain

NDC 0781-2020-01
Amoxicillin
Capsules, USP
250 mg
Rx Only
100 Capsules
SANDOZ

NDC 0781-2613-01
Amoxicillin
Capsules, USP
500 mg
Rx Only
100 Capsules
SANDOZ

NDC 0781-5060-20
Amoxicillin
Tablets, USP
500 mg
Rx Only
20 Tablets
SANDOZ

NDC 0781-5061-20
Amoxicillin
Tablets, USP
875 mg
Rx Only
20 Tablets
SANDOZ

NDC 0781-6039-58
Amoxicillin for
Oral Suspension, USP
125 mg/5 mL
Rx Only
When reconstituted, each 5 mL
(1 teaspoonful) will contain
amoxicillin trihydrate equivalent
to 125 mg amoxicillin.
80 mL
(when reconstituted)
SANDOZ

NDC 0781-6156-52
Amoxicillin for
Oral Suspension, USP
200 mg/5 mL
Rx Only
When reconstituted, each 5 mL
(1 teaspoonful) will contain amoxicillin
trihydrate equivalent to 200 mg
amoxicillin.
50 mL (when reconstituted)
SANDOZ

NDC 0781-6041-58
Amoxicillin for
Oral Suspension, USP
250 mg/5 mL
Rx Only
When reconstituted, each 5 mL
(1 teaspoonful) will contain
amoxicillin trihydrate equivalent
to 250 mg amoxicillin.
80 mL
(when reconstituted)
SANDOZ

NDC 0781-6157-52
Amoxicillin for
Oral Suspension, USP
400 mg/5 mL
Rx Only
When reconstituted, each 5 mL
(1 teaspoonful) will contain amoxicillin
trihydrate equivalent to 400 mg
amoxicillin.
50 mL (when reconstituted)
SANDOZ

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GNH Provides Contract Manufacturing services for: Generic Medicines with following

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Amoxicillin (Amoxicillin)

Trade Name : Amoxicillin

CAPSULE

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

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Amoxicillin (Amoxicillin)

Trade Name : Amoxicillin

CAPSULE

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

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

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

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