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EC number: 214-230-6 | CAS number: 1115-70-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- other: Pharmacological Dose in Humans
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see Remark
- Remarks:
- Metformin hydrochloride is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose by decreasing hepatic glucose production and intestinal absorption of glucose, and improving insulin sensitivity via increased peripheral glucose uptake and utilization (FDA, 2008). The pharmacological activity of Metformin hydrochloride leads to the lowest therapeutic dose of 500 mg/day.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2001
Materials and methods
- Type of study / information:
- Data from clinical studies in humans.
- Endpoint addressed:
- repeated dose toxicity: oral
Test guideline
- Guideline:
- other: Guidelines for clinical studies
Test material
- Reference substance name:
- Metformin hydrochloride
- EC Number:
- 214-230-6
- EC Name:
- Metformin hydrochloride
- Cas Number:
- 1115-70-4
- Molecular formula:
- C4H11N5.ClH
- IUPAC Name:
- N,N-dimethylimidodicarbonimidic diamide hydrochloride
- Test material form:
- solid: bulk
- Remarks:
- migrated information: powder
Constituent 1
Method
- Ethical approval:
- confirmed, but no further information available
- Details on study design:
- The lowest therapeutic dose of Metformin hydrochloride was investigated based on data from the literature and own expertise.
Results and discussion
- Results:
- Metformin hydrochloride is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose by decreasing hepatic glucose production and intestinal absorption of glucose, and improving insulin sensitivity via increased peripheral glucose uptake and utilization (FDA, 2008). The pharmacological activity of Metformin hydrochloride leads to the lowest therapeutic dose of 500 mg/day.
Any other information on results incl. tables
From Product information of Metformin hydrochloride:
The usual starting dose is 500 mg or 850 mg metformin hydrochloride 2 or 3 times daily given during or after meals.
After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. A slow increase of dose may improve gastrointestinal tolerability.
In patients receiving a high metformin hydrochloride dose (2 to 3 grams per day), it is possible to replace two Glucophage 500 mg film-coated tablets with one Glucophage 1000 mg film-coated tablet. The maximum recommended dose of metformin hydrochloride is 3 g daily, taken as 3 divided doses.
Applicant's summary and conclusion
- Conclusions:
- The minimum pharmacological dose of metformin in humans is 500 mg
- Executive summary:
Metformin hydrochloride is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose by decreasing hepatic glucose production and intestinal absorption of glucose, and improving insulin sensitivity via increased peripheral glucose uptake and utilization (FDA, 2008). The pharmacological activity of Metformin hydrochloride leads to the lowest therapeutic dose of 500 mg/day.
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