Metformin Hydrochloride (Riomet Er)

Trade Name : RIOMET ER

Sun Pharmaceutical Industries Inc.

FOR SUSPENSION, EXTENDED RELEASE

Strength 500 mg/5mL

METFORMIN HYDROCHLORIDE Biguanide [EPC],Biguanides [CS]

Delivery Process

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 Metformin Hydrochloride (Riomet Er) which is also known as RIOMET ER and Manufactured by Sun Pharmaceutical Industries Inc.. It is available in strength of 500 mg/5mL per ml. Read more

Metformin Hydrochloride (Riomet Er) 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!

About GNH

No data

WARNING: LACTIC ACIDOSIS
See full prescribing information for complete boxed warning.

Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Symptoms included malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Laboratory abnormalities included elevated blood lactate levels, anion gap acidosis, increased lactate/pyruvate ratio; and metformin plasma levels generally > 5 mcg/mL. (5.1)
Risk factors include renal impairment, concomitant use of certain drugs, age u2265 65 years old, radiological studies with contrast, surgery and other procedures, hypoxic states, excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the Full Prescribing Information. (5.1)
If lactic acidosis is suspected, discontinue RIOMET ER and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended. (5.1)

RIOMET ER is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.
RIOMET ER is a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. (1)

Adult Dosage
Pediatric Dosage
Renal Impairment
Discontinuation for Iodinated Contrast Imaging Procedures:
Reconstitution Instructions for the Pharmacist:

For extended-release oral suspension: 47.31 grams of metformin HCl as white to off-white pellets and white to off-white diluent for reconstitution in 473 mL bottle pack
The reconstituted suspension is 500 mg/5 mL appearing as white to off-white suspension containing white to off-white pellets
For extended-release oral suspension: 47.31 grams of metformin HCl for reconstitution in 473 mL bottle pack. The reconstituted suspension is 500 mg/5 mL (3)

RIOMET ER is contraindicated in patients with:

No data

Lactic acidosis:
Vitamin B deficiency:
Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues:

The following adverse reactions are also discussed elsewhere in the labeling:
The most common adverse reactions (> 5.0%) are diarrhea, nausea/vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or n

Table 3 presents clinically significant drug interactions with RIOMET ER.
Table 3: Clinically Significant Drug Interactions with RIOMET ER

No data

Overdose of metformin HCl has occurred, including ingestion of amounts greater than 50 grams. Hypoglycemia was reported in approximately 10% of cases, but no causal association with metformin hydrochloride has been established. Lactic acidosis has been reported in approximately 32% of metformin overdose cases . Metformin is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions. Therefore, hemodialysis may be useful for removal of accumulated drug from patients in whom metformin overdosage is suspected.

RIOMET ER (metformin hydrochloride for extended-release oral suspension) is a biguanide. The chemical name of metformin hydrochloride is ,-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below:
Metformin hydrochloride, USP is a white crystalline powder with a molecular formula of CHNu2022HCl and a molecular weight of 165.62. It is freely soluble in water, slightly soluble in alcohol; practically insoluble in acetone and in methylene chloride. The pK of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride, USP is 6.37 to 6.53.
RIOMET ER is available as follows:
Following reconstitution, the volume of the oral suspension is 473.12 mL (16 oz.) containing 500 mg/5mL metformin HCl equivalent to 389.95 mg metformin base.
The oral suspension include the following inactive ingredients: carboxymethyl cellulose sodium, colloidal silicon dioxide, dibutyl sebacate, ethyl cellulose, hypromellose, magnesium stearate, methyl paraben, microcrystalline cellulose, propyl paraben, sucralose, strawberry flavor Type FL # 28082 (flavoring ingredients, propylene glycol and glycerin) xanthan gum and xylitol.

No data

Long-term carcinogenicity studies have been performed in rats (dosing duration of 104 weeks) and mice (dosing duration of 91 weeks) at doses up to and including 900 mg/kg/day and 1500 mg/kg/day, respectively. These doses are both approximately 3 times the maximum recommended human daily dose of 2,550 mg based on body surface area comparisons. No evidence of carcinogenicity with metformin was found in either male or female mice. Similarly, there was no tumorigenic potential observed with metformin in male rats. There was, however, an increased incidence of benign stromal uterine polyps in female rats treated with 900 mg/kg/day.
There was no evidence of a mutagenic potential of metformin in the following tests: Ames test (), gene mutation test (mouse lymphoma cells), or chromosomal aberrations test (human lymphocytes). Results in the mouse micronucleus test were also negative.
Fertility of male or female rats was unaffected by metformin when administered at doses as high as 600 mg/kg/day, which is approximately 2 times the maximum recommended human daily dose of 2,550 mg based on body surface area comparisons.

No data

No data

No data

RIOMET (ree oh met) ER
(metformin hydrochloride)
for extended-release oral suspension
What is the most important information I should know about RIOMET ER?
RIOMET ER can cause serious side effects including:
Lactic acidosis. Metformin hydrochloride, the medicine in RIOMET ER, can cause a rare, but serious side effect called lactic acidosis (a buildup of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital.
Stop taking RIOMET ER and call your healthcare provider right away if you get any of the following symptoms of lactic acidosis:
You have a higher chance for getting lactic acidosis if you:
Tell your healthcare provider if you have any of the problems in the list above.
Tell your healthcare provider that you are taking RIOMET ER before you have surgery or x-ray tests. Your healthcare provider may need to stop RIOMET ER for a while if you have surgery or certain x-ray tests.
RIOMET ER can have other serious side effects. See n
What is RIOMET ER?
It is not known if RIOMET ER is safe and effective in children under 10 years of age.
Do not take RIOMET ER if you:
Before taking RIOMET ER, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take,
RIOMET ER may affect the way other medicines work, and other medicines may affect how RIOMET ER works.
How should I take RIOMET ER?
If you take too much RIOMET ER, call your healthcare provider, or go to the nearest hospital emergency room right away.
What should I avoid while taking RIOMET ER?
Do not drink a lot of alcoholic drinks while taking RIOMET ER. This means you should not binge drink for short periods, and you should not drink a lot of alcohol on a regular basis. Alcohol can increase your chance of getting lactic acidosis. Also, donu2019t drink alcohol at the same time you take RIOMET ER because it can speed up how fast the medicine gets into your body.
What are the possible side effects of RIOMET ER?
RIOMET ER may cause serious side effects, including:
These are not all the possible side effects of RIOMET ER. Call your doctor for medical advice about side effects. n
Keep RIOMET ER and all medicines out of the reach of children.
You can ask your pharmacist or healthcare provider for information about RIOMET ER that is written for health professionals.
For more information call 1-800-818-4555.
This Patient Information has been approved by the U.S. Food and Drug Administration. 08/2019

RIOMET (ree oh met) ER
(metformin hydrochloride)
for extended-release oral suspension
Read this Instructions for Use for RIOMET ER before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.
Important information: n- See Figure A
Figure A
Step 1. n- See Figure B.
Figure B
Step 2. n- push down and turn
Push down and turn the cap in the direction of the arrow as shown in .
Figure C
Step 3. n- See Figure D
Figure D
Step 4n- See Figure E
Figure E
Step 5n- water only
Step 6.
How to store RIOMET ER
Manufactured by:
Sun Pharmaceutical Industries Limited
MOHALI, INDIA
Distributed by:
Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512
FDA-01
This Instructions for Use has been approved by the U.S. Food and Drug Administration. 08/2019

Contains Drug Pellets
NDC 10631-019-17
RIOMET ERu2122
(metformin hydrochloride for extended-release oral suspension)
500 mg per 5 mL
(when reconstituted with Drug Diluent Bottle)
Attention Pharmacist: Drug Pellets be mixed INTO the accompanying Drug Diluent Bottle
Drug Diluent Bottle for RIOMET ERu2122
NDC 10631-019-17
Attention Pharmacist: Reconstitute with Drug Pellet Bottle prior to dispensing
RIOMET ERu2122
(metformin hydrochloride for extended-release oral suspension)
500 mg per 5 mL
(when reconstituted)
PHARMACIST: Dispense the enclosed Instructions for Use to each patient
SHAKE WELL FOR AT LEAST 10 SECONDS BEFORE EACH USE
For Oral Use Only
Rx only

NDC 10631-019-17
RIOMET ERu2122
(metformin hydrochloride for extended-release oral suspension)
500 mg per 5 mL
(when reconstituted)
PHARMACIST: Dispense the enclosed Instructions for Use to each patient
For Oral Use Only
Pharmacist: Riomet ER must be reconstituted with the enclosed diluent prior to dispensing. See side panel for instructions.
Rx only

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

Clinical Trials Supply

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

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

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

71245 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?

Get Price

Metformin Hydrochloride (Riomet Er)

Trade Name : RIOMET ER

FOR SUSPENSION, EXTENDED RELEASE

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

Metformin Hydrochloride (Riomet Er)

Trade Name : RIOMET ER

FOR SUSPENSION, EXTENDED RELEASE

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

Can’t find what
you’re looking for?