Nateglinide

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Side Effects & Adverse Reactions

FATALITIES ASSOCIATED WITH THE ADMINISTRATION OF SULFONAMIDES, ALTHOUGH RARE, HAVE OCCURRED DUE TO SEVERE REACTIONS, INCLUDING STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, FULMINANT HEPATIC NECROSIS, AGRANULOCYTOSIS, APLASTIC ANEMIA AND OTHER BLOOD DYSCRASIAS.

SULFONAMIDES, INCLUDING SULFONAMIDE-CONTAINING PRODUCTS SUCH AS SULFAMETHOXAZOLE/TRIMETHOPRIM, SHOULD BE DISCONTINUED AT THE FIRST APPEARANCE OF SKIN RASH OR ANY SIGN OF ADVERSE REACTION. In rare instances, a skin rash may be followed by a more severe reaction, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, hepatic necrosis, and serious blood disorders (see PRECAUTIONS). Clinical signs, such as rash, sore throat, fever, arthralgia, pallor, purpura or jaundice may be early indications of serious reactions.

Cough, shortness of breath, and pulmonary infiltrates are hypersensitivity reactions of the respiratory tract that have been reported in association with sulfonamide treatment.

Thrombocytopenia

Sulfamethoxazole/Trimethoprim-induced thrombocytopenia may be an immune-mediated disorder. Severe cases of thrombocytopenia that are fatal or life threatening have been reported. Thrombocytopenia usually resolves within a week upon discontinuation of sulfamethoxazole and trimethoprim.

The sulfonamides should not be used for treatment of group alpha beta-hemolytic streptococcal infections. In an established infection, they will not eradicate the streptococcus and, therefore, will not prevent sequelae such as rheumatic fever.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including sulfamethoxazole and trimethoprim, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Urinary Tract Infections

For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.

Acute Otitis Media

For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim is not indicated for prophylactic or prolonged administration in otitis media at any age.

Acute Exacerbations of Chronic Bronchitis in Adults

For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of a single antimicrobial agent.

Shigellosis

For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated.

Pneumocystis Carinii Pneumonia

For the treatment of documented Pneumocystis carinii pneumonia and for prophylaxis against Pneumocystis carinii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing Pneumocystis carinii pneumonia.

Traveler’s Diarrhea in Adults

For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.

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History

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Other Information

Sulfamethoxazole and Trimethoprim is a synthetic antibacterial combination product available in 800 mg sulfamethoxazole and 160 mg trimethoprim Double Strength tablets and 400 mg sulfamethoxazole and 80 mg trimethoprim tablets for oral administration. Each Double Strength tablet contains 800 mg sulfamethoxazole and 160 mg trimethoprim plus magnesium stearate, pregelatinized starch and sodium starch glycolate. Each tablet contains 400 mg sulfamethoxazole and 80 mg trimethoprim plus magnesium stearate, pregelatinized starch, and sodium starch glycolate. Trimethoprim is 2, 4-diamino-5-(3,4,5 trimethoxybenzyl) pyrimidine: the molecular formula is C 14H 18N 4O 3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and the following structural formula:

Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C10H11N3O3S. It is almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula:

Sources

Nateglinide Manufacturers

Dr. Reddy’s Laboratories Limited

Nateglinide | Blenheim Pharmacal, Inc.

DOSAGE AND ADMINISTRATION

Not recommended for use in pediatric patients less than 2 months of age.

Urinary Tract Infections and Shigellosis in Adults and Pediatric Patients, and Acute Otitis Media in Children

Adults: The usual adult dosage in the treatment of urinary tract infections is 1 sulfamethoxazole and trimethoprim DS (double strength) tablet every 12 hours for 10 to 14 days. An identical daily dosage is used for 5 days in the treatment of shigellosis.
Children: The recommended dose for children with urinary tract infections or acute otitis media is 40 mg/kg sulfamethoxazole and 8 mg/kg trimethoprim per 24 hours, given in two divided doses every 12 hours for 10 days. An identical daily dosage is used for 5 days in the treatment of shigellosis. The following table is a guideline for the attainment of this dosage:

Children 2 months of age and older:

Weight

Dose – every 12 hours

lb

kg

Tablets

22

10

-

44

20

1

66

30

1 ½

88

40

2 or 1 DS tablet

For Patients with Impaired Renal Function

When renal function is impaired, a reduced dosage should be employed using the following table:

Creatinine Clearance (mL/min)

Recommended Dosage Regimen

Above 30

Usual standard regimen

15-30

1/2 the usual regimen

Below 15

Use not recommended

Acute Exacerbations of Chronic Bronchitis in Adults

The usual adult dosage in the treatment of acute exacerbations of chronic bronchitis is 1 sulfamethoxazole and trimethoprim double strength tablet or 2 sulfamethoxazole and trimethoprim tablets every 12 hours for 14 days.

Pneumocystis Carinii Pneumonia

Treatment: Adults and Children:

The recommended dosage for patients with documented Pneumocystis carinii pneumonia is 75 to 100 mg/kg sulfamethoxazole and 15 to 20 mg/kg trimethoprim per 24 hours given in equally divided doses every 6 hours for 14 to 21 days11. The following table is a guideline for the upper limit of this dosage.

Weight

Dose – every 6 hours

lb

kg

Tablets

18

8

-

35

16

1

53

24

1 ½

70

32

2 or 1 DS tablet

88

40

2 ½

106

48

3 or 1 ½ DS tablets

141

64

4 or 2 DS tablets

176

80

5 or 2 ½ DS tablets

For the lower limit dose (75 mg/kg sulfamethoxazole and 15 mg/kg trimethoprim per 24 hours) administer 75% of the dose in the above table.

Prophylaxis

Adults

The recommended dosage for prophylaxis in adults is 1 sulfamethoxazole and trimethoprim DS (double strength) tablet daily 12

Children

For children, the recommended dose is 750 mg/m2/day sulfamethoxazole with 150 mg/m 2/day trimethoprim given orally in equally divided doses twice a day, on 3 consecutive days per week.
The total daily dose should not exceed 1600 mg sulfamethoxazole and 320 mg trimethoprim 13 The following table is a guideline for the attainment of this dosage in children:

Body Surface Area

Dose – every 12 hours

(m2)

Tablets

0.26

-

0.53

½

1.06

1

Traveler’s Diarrhea in Adults

For the treatment of traveler’s diarrhea, the usual adult dosage is 1 sulfamethoxazole and trimethoprim DS (double strength) tablet or 2 sulfamethoxazole and trimethoprim tablets every 12 hours for 5 days.

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Watson Laboratories, Inc.

Nateglinide | Watson Laboratories, Inc.

Nateglinide tablets should be taken 1 to 30 minutes prior to meals.
Monotherapy and Combination with Metformin or a Thiazolidinedione
The recommended starting and maintenance dose of nateglinide tablets, alone or in combination with metformin or a thiazolidinedione, is 120 mg three times daily before meals.

The 60-mg dose of nateglinide tablets, either alone or in combination with metformin or a thiazolidinedione, may be used in patients who are near goal HbA1C when treatment is initiated.
Dosage in Geriatric Patients
No special dose adjustments are usually necessary. However, greater sensitivity of some individuals to nateglinide tablet therapy cannot be ruled out.
Dosage in Renal and Hepatic Impairment
No dosage adjustment is necessary in patients with mild-to-severe renal insufficiency or in patients with mild hepatic insufficiency. Dosing of patients with moderate-to-severe hepatic dysfunction has not been studied. Therefore, nateglinide tablets should be used with caution in patients with moderate-to-severe liver disease (see PRECAUTIONS, Hepatic Impairment).

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Par Pharmaceutical Inc.

Nateglinide | Par Pharmaceutical Inc.

Nateglinide Tablets USP should be taken 1 to 30 minutes prior to meals.
Monotherapy and Combination with Metformin or a Thiazolidinedione
The recommended starting and maintenance dose of nateglinide, alone or in combination with metformin or a thiazolidinedione, is 120 mg three times daily before meals.

The 60 mg dose of nateglinide, either alone or in combination with metformin or a thiazolidinedione, may be used in patients who are near goal HbA1c when treatment is initiated.
Dosage in Geriatric Patients
No special dose adjustments are usually necessary. However, greater sensitivity of some individuals to nateglinide therapy cannot be ruled out.
Dosage in Renal and Hepatic Impairment
No dosage adjustment is necessary in patients with mild-to-severe renal insufficiency or in patients with mild hepatic insufficiency. Dosing of patients with moderate-to-severe hepatic dysfunction has not been studied. Therefore, nateglinide should be used with caution in patients with moderate-to-severe liver disease (see PRECAUTIONS, Hepatic Impairment).

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Physicians Total Care, Inc.

Nateglinide | Physicians Total Care, Inc.

Nateglinide Tablets USP should be taken 1 to 30 minutes prior to meals.
Monotherapy and Combination with Metformin or a Thiazolidinedione
The recommended starting and maintenance dose of nateglinide, alone or in combination with metformin or a thiazolidinedione, is 120 mg three times daily before meals.

The 60 mg dose of nateglinide, either alone or in combination with metformin or a thiazolidinedione, may be used in patients who are near goal HbA1c when treatment is initiated.
Dosage in Geriatric Patients
No special dose adjustments are usually necessary. However, greater sensitivity of some individuals to nateglinide therapy cannot be ruled out.
Dosage in Renal and Hepatic Impairment
No dosage adjustment is necessary in patients with mild-to-severe renal insufficiency or in patients with mild hepatic insufficiency. Dosing of patients with moderate-to-severe hepatic dysfunction has not been studied. Therefore, nateglinide should be used with caution in patients with moderate-to-severe liver disease (see PRECAUTIONS, Hepatic Impairment).

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Ncs Healthcare Of Ky, Inc Dba Vangard Labs

Nateglinide | Ncs Healthcare Of Ky, Inc Dba Vangard Labs

Nateglinide Tablets should be taken 1 to 30 minutes prior to meals.
Monotherapy and Combination with Metformin or a Thiazolidinedione
The recommended starting and maintenance dose of nateglinide, alone or in combination with metformin or a thiazolidinedione, is 120 mg three times daily before meals.

The 60 mg dose of nateglinide, either alone or in combination with metformin or a thiazolidinedione, may be used in patients who are near goal HbA1c when treatment is initiated.
Dosage in Geriatric Patients
No special dose adjustments are usually necessary. However, greater sensitivity of some individuals to nateglinide therapy cannot be ruled out.
Dosage in Renal and Hepatic Impairment
No dosage adjustment is necessary in patients with mild-to-severe renal insufficiency or in patients with mild hepatic insufficiency. Dosing of patients with moderate-to-severe hepatic dysfunction has not been studied. Therefore, nateglinide should be used with caution in patients with moderate-to-severe liver disease (see PRECAUTIONS, Hepatic Impairment).

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American Health Packaging

Nateglinide | American Health Packaging

Nateglinide Tablets USP should be taken 1 to 30 minutes prior to meals.
Monotherapy and Combination with Metformin or a Thiazolidinedione
The recommended starting and maintenance dose of nateglinide, alone or in combination with metformin or a thiazolidinedione, is 120 mg three times daily before meals.

The 60 mg dose of nateglinide, either alone or in combination with metformin or a thiazolidinedione, may be used in patients who are near goal HbA1c when treatment is initiated.
Dosage in Geriatric Patients
No special dose adjustments are usually necessary. However, greater sensitivity of some individuals to nateglinide therapy cannot be ruled out.
Dosage in Renal and Hepatic Impairment
No dosage adjustment is necessary in patients with mild-to-severe renal insufficiency or in patients with mild hepatic insufficiency. Dosing of patients with moderate-to-severe hepatic dysfunction has not been studied. Therefore, nateglinide should be used with caution in patients with moderate-to-severe liver disease (see PRECAUTIONS, Hepatic Impairment).

No Recall