Riomet

Riomet (metformin hcl) is an oral diabetes medicine used with a proper diet and exercise program and possibly with other medications to control high blood sugar. Riomet is used in patients with type 2 diabetes (non-insulin-dependent diabetes). Riomet is not for treating type 1 diabetes. Riomet is available in generic form. Common side effects of Riomet include nausea, vomiting, stomach upset or pain, diarrhea, gas, weakness, headache, muscle pain, or a metallic taste in the mouth. Go to an emergency department if you experience serious side effects including numb or cold feeling in your arms and legs, trouble breathing, dizziness, light-headedness, tiredness, extreme weakness, or slow or uneven heart rate.

Dosage of Riomet is individualized on the basis of effectiveness and tolerance. The maximum recommended daily dose is 2550 mg (25.5 mL) in adults and 2000 mg (20 mL) in pediatric patients (10-16 years of age). Hyperglycemia (high blood sugar) may result if Riomet is taken with drugs that raise blood sugar, such as: isoniazid, diuretics (water pills), steroids, phenothiazines, thyroid medicines, birth control pills and other hormones, seizure medicines, diet pills, or medicines to treat asthma, colds or allergies. Hypoglycemia (low blood sugar) may result if Riomet is taken with drugs that lower blood sugar, such as: nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin or other salicylates, sulfa drugs, monoamine oxidase inhibitors (MAOIs), beta-blockers, or probenecid. Riomet may also interact with furosemide, nifedipine, cimetidine, ranitidine, amiloride, triamterene, digoxin, morphine, procainamide, quinidine, trimethoprim, or vancomycin. Tell your doctor all medications and supplements you use. During pregnancy, Riomet should be used only when prescribed. Your doctor may prescribe insulin instead during your pregnancy. Riomet can promote ovulation and increase the risk of becoming pregnant. Consult your doctor about birth control while using this medication. This drug passes into breast milk in small amounts. Consult your doctor before breastfeeding.

Our Riomet (metformin hcl) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Riomet Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people using metformin develop lactic acidosis, which can be fatal. Get emergency medical help if you have even mild symptoms such as:

• unusual muscle pain;
• feeling cold;
• trouble breathing;
• feeling dizzy, light-headed, tired, or very weak;
• stomach pain, vomiting; or
• slow or irregular heart rate.

Common side effects may include:

• low blood sugar;
• nausea, upset stomach; or
• diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Riomet (Metformin Hcl)

 

Riomet Professional Information

SIDE EFFECTS

The following adverse reactions are also discussed elsewhere in the labeling:

• Lactic Acidosis [see BOXED WARNING and WARNINGS AND PRECAUTIONS]
• Vitamin B12 Deficiency [see WARNINGS AND PRECAUTIONS]
• Hypoglycemia [see WARNINGS AND PRECAUTIONS]

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In a U.S. clinical trial of metformin HCl tablets in patients with type 2 diabetes mellitus, a total of 141 patients received metformin HCl tablets up to 2,550 mg per day. Adverse reactions reported in greater than 5% of patients treated with metformin HCl tablets and that were more common than in placebo-treated patients, are listed in Table 1.

Table 1: Adverse Reactions from a Clinical Trial of Metformin HCl Tablets Occurring >5% and More Common than Placebo in Patients with Type 2 Diabetes Mellitus

	Metformin HCl Tablets (n =141)	Placebo (n = 145)
Diarrhea	53%	12%
Nausea/V omiting	26%	8%
Flatulence	12%	6%
Asthenia	9%	6%
Indigestion	7%	4%
Abdominal Discomfort	6%	5%
Headache	6%	5%

Diarrhea led to discontinuation of metformin HCl tablets in 6% of patients. Additionally, the following adverse reactions were reported in ≥ 1% to ≤ 5% of patients treated with metformin HCl tablets and were more commonly reported than placebo: abnormal stools, hypoglycemia, myalgia, lightheaded, dyspnea, nail disorder, rash, sweating increased, taste disorder, chest discomfort, chills, flu syndrome, flushing, palpitation.

Pediatric Patients

In clinical trials with metformin HCl tablets in pediatric patients with type 2 diabetes mellitus, the profile of adverse reactions was similar to that observed in adults.

Laboratory Tests

Vitamin B12 Concentrations

In clinical trials of 29-week duration with metformin HCl tablets, a decrease to subnormal levels of previously normal serum vitamin B12 levels was observed in approximately 7% of patients.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of metformin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cholestatic, hepatocellular, and mixed hepatocellular liver injury have been reported with postmarketing use of metformin.

Read the entire FDA prescribing information for Riomet (Metformin Hcl)

&Copy; Riomet Patient Information is supplied by Cerner Multum, Inc. and Riomet Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.