Prandin

What Is Prandin?

Prandin (repaglinide) is an oral diabetes medicine in the meglitinide class used together with diet and exercise to treat type 2 (non-insulin dependent) diabetes. Other diabetes medicines are sometimes used in combination with Prandin.

What Are Side Effects of Prandin?

Common side effects of Prandin include:

• weight gain,
• diarrhea,
• nausea,
• joint pain,
• back pain,
• headache,
• runny or stuffy nose,
• sneezing,
• cough,
• cold or flu symptoms,
• dizziness,
• blurred vision, or
• temporary hair loss.

Prandin can cause low blood sugar (hypoglycemia) especially if you are taking other medicines for diabetes. Talk to your doctor if you have symptoms of low blood sugar including chills, cold sweat, dizziness, drowsiness, shaking, fast heartbeat, weakness, headache, fainting, tingling of the hands or feet, or hunger.

Dosage for Prandin

The usual starting dose of Prandin ranges from 0.5 mg to 2 mg taken with each meal. Dosing adjustments are determined by blood glucose response. Hyperglycemia (high blood sugar) may result if you take Prandin with drugs that raise blood sugar, such as: isoniazid, diuretics (water pills), steroids, phenothiazines, thyroid medicine, birth control pills and other hormones, seizure medicines, and diet pills, or medicines to treat asthma, colds or allergies.

What Drugs, Substances, or Supplements Interact with Prandin?

Hypoglycemia (low blood sugar) may result if you take Prandin with drugs that lower blood sugar, such as: probenecid, blood thinners, non-steroidal anti-inflammatory drugs (NSAIDs), aspirin or other salicylates, sulfa drugs, monoamine oxidase inhibitors (MAOIs), or beta-blockers.

It may also interact with cyclosporine, St. John's wort, antibiotics, antifungal medications, barbiturates, heart or blood pressure medications, HIV/AIDS medicines, rifamycins, or seizure medication. Tell your doctor all medications you are taking.

Prandin During Pregnancy or Breastfeeding

During pregnancy Prandin should be used only when prescribed. Your doctor may change your diabetes treatment during your pregnancy. It is not known whether this drug passes into breast milk and the effect on a nursing infant is unknown. Breastfeeding while using this drug is not recommended.

Additional Information

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

 

Prandin Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

• pale or yellowed skin, dark colored urine, fever, confusion or weakness; or
• pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting.

Common side effects may include:

• low blood sugar;
• nausea, diarrhea;
• headache, back pain;
• joint pain; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

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 Prandin (Repaglinide)

 

Prandin Professional Information

SIDE EFFECTS

The following serious adverse reaction is also described elsewhere in the labeling: Hypoglycemia [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying designs, the adverse reaction rates reported in one clinical trial may not be easily compared to those rates reported in another clinical trial, and may not reflect the rates actually observed in clinical practice.

PRANDIN has been administered to 2931 individuals during clinical trials. Approximately 1500 of these individuals with type 2 diabetes have been treated for at least 3 months, 1000 for at least 6 months, and 800 for at least 1 year. The majority of these individuals (1228) received PRANDIN in one of five 1-year, active-controlled trials. Over one year, 13% of PRANDIN patients were discontinued due to adverse reactions. The most common adverse reactions leading to withdrawal were hyperglycemia, hypoglycemia, and related symptoms.

Table 1 lists the common adverse reactions for PRANDIN patients compared to placebo in trials 12 to 24 weeks duration.

Table 1: Adverse Reactions (%) occurring ≥ 2% in PRANDIN Treated Patients from Pool of 12 to 24 Week Placebo Controlled Trials*

	PRANDIN N=352	Placebo N=108
Upper Respiratory Infection	16	8
Headache	11	10
Sinusitis	6	2
Arthralgia	6	3
Nausea	5	5
Diarrhea	5	2
Back Pain	5	4
Rhinitis	3	3
Constipation	3	2
Vomiting	3	3
Paresthesia	3	3
Chest pain	3	1
Bronchitis	2	1
Dyspepsia	2	2
Urinary tract infection	2	1
Tooth disorder	2	0
Allergy	2	0
*See trial descriptions in Clinical Trials

Hypoglycemia

In clinical trials with PRANDIN, hypoglycemia is the most commonly observed adverse reaction. Mild or moderate hypoglycemia occurred in 31% of PRANDIN treated patients and 7% of placebo treated patients [see WARNINGS AND PRECAUTIONS).

Hypoglycemia was reported in 16% of 1228 PRANDIN patients, 20% of 417 glyburide patients, and 19% of 81 glipizide patients in 1year controlled trials. Of PRANDIN-treated patients with symptomatic hypoglycemia, none developed coma or required hospitalization.

In a 24-week placebo controlled trial, patients who were naive to oral hypoglycemic agent therapy and patients with a HbA1c below 8% at baseline had a higher frequency of hypoglycemia.

Weight Gain

There was no average gain in body weight when patients previously treated with oral hypoglycemic agents were switched to PRANDIN. The average weight gain in patients treated with PRANDIN and not previously treated with sulfonylurea drugs was 3.3%.

Cardiovascular Events

The incidence of total serious cardiovascular adverse events, including ischemia, was higher for PRANDIN (51/1228 or 4%) than for sulfonylurea drugs (13/498 or 3%) in controlled comparator clinical trials.

Table 2: Summary of Serious Cardiovascular Events in Trials Comparing PRANDIN to Sulfonylureas (% of total patients with events)

	PRANDIN	SU*
Total Exposed	1228	498
Serious CV Events	4%	3%
Cardiac Ischemic Events	2%	2%
Deaths due to CV Events	0.5%	0.4%
*: glyburide and glipizide

Seven controlled clinical trials included PRANDIN combination therapy with NPH-insulin (n=431), insulin formulations alone (n=388) or other combinations (sulfonylurea plus NPH-insulin or PRANDIN plus metformin) (n=120). There were six serious adverse events of myocardial ischemia in patients treated with PRANDIN plus NPH-insulin from two studies, and one event in patients using insulin formulations alone from another study [see WARNINGS AND PRECAUTIONS].

Combination Therapy With Thiazolidinediones

Hypoglycemia

During 24-week treatment clinical trials of PRANDIN-rosiglitazone or PRANDIN-pioglitazone combination therapy (a total of 250 patients in combination therapy), hypoglycemia (blood glucose < 50 mg/dL) occurred in 7% of patients in combination therapy compared to 7% for PRANDIN monotherapy, and 2% for thiazolidinedione monotherapy.

Peripheral Edema And Heart Failure

Peripheral edema was reported in 12 out of 250 (4.8%) PRANDIN-thiazolidinedione combination therapy patients and 3 out of 124 (2.4%) thiazolidinedione monotherapy patients, with no cases reported in these trials for PRANDIN monotherapy. There were reports in 2 of 250 patients (0.8%) treated with PRANDIN-thiazolidinedione therapy of episodes of edema with congestive heart failure. Both patients had a prior history of coronary artery disease and recovered after treatment with diuretic agents. No comparable cases in the monotherapy treatment groups were reported.

Weight Gain

Mean weight increases associated with combination, PRANDIN and pioglitazone therapy were 5.5 kg, 0.3 kg, and 2.0 kg respectively. Mean weight increases associated with combination, PRANDIN and rosiglitazone therapy were 4.5 kg, 1.3 kg, and 3.3 kg respectively.

Infrequent Adverse Events (<1% of Patients)

Less common adverse clinical or laboratory events observed in clinical trials included elevated liver enzymes, thrombocytopenia, leukopenia, and anaphylactoid reactions.

Postmarketing Experience

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

• Alopecia
• Hemolytic anemia
• Pancreatitis
• Stevens-JohnsonSyndrome
• Severe hepatic dysfunction including jaundice and hepatitis

Read the entire FDA prescribing information for Prandin (Repaglinide)