Nitrofurantoin

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Nitrofurantoin Recall

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Side Effects & Adverse Reactions

For external use only

Discontinue use if irritation and redness develop. If irritation persists for more than 3 days, consult a physician.

When using this product do not get it in the eyes; this product causes eye irritation upon direct contact. In case of eye exposure, rinse thoroughly with water. If eye irritation persists, contact a physician.

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Discontinue use if irritation and redness develop. If irritation persists for more than 3 days, consult a physician.

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

Healthcare Personnel Handwash to decrease transient bacteria on the skin before contact with patients under medical care or treatment.

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History

There is currently no drug history available for this drug.

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Other Information

There are no additional details available for this product.

Sources

Nitrofurantoin Manufacturers

Udl Laboratories, Inc.

Nitrofurantoin | Steris Corporation

Wet skin and spread a small amount on the hands. Wash hands, rinse thoroughly with water, and repeat as necessary between patient contacts.

No Recall
Rebel Distributors Corp

Nitrofurantoin | Rebel Distributors Corp

Nitrofurantoin monohydrate/macrocrystals capsules should be taken with food.

Adults and Pediatric Patients Over 12 Years

One 100 mg capsule every 12 hours for seven days.

No Recall
Blenheim Pharmacal, Inc.

Nitrofurantoin | Blenheim Pharmacal, Inc.

Nitrofurantoin monohydrate/macrocrystals capsules should be taken with food.

Adults and Pediatric Patients Over 12 Years

One 100 mg capsule every 12 hours for seven days.

No Recall
Remedyrepack Inc.

Nitrofurantoin | Remedyrepack Inc.

DOSAGE AND ADMINISTRATION
Nitrofurantoin monohydrate/macrocrystals capsules should be taken with food.

Adults and Pediatric Patients Over 12 Years: One 100 mg capsule every 12 hours for seven days

No Recall
Redpharm Drug Inc.

Nitrofurantoin | Redpharm Drug Inc.

Nitrofurantoin monohydrate/macrocrystals capsules should be taken with food.

Adults and Pediatric Patients Over 12 Years

One 100 mg capsule every 12 hours for seven days.

No Recall
Pd-rx Pharmaceuticals, Inc.

Nitrofurantoin | Pd-rx Pharmaceuticals, Inc.

Nitrofurantoin macrocrystals capsules should be given with food to improve drug absorption and, in some patients, tolerance.

Adults: 50 to 100 mg four times a day – the lower dosage level is recommended for uncomplicated urinary tract infections.

Pediatric Patients: 5 to 7 mg/kg of body weight per 24 hours, given in four divided doses (contraindicated under one month of age).

Therapy should be continued for one week or for at least 3 days after sterility of the urine is obtained. Continued infection indicates the need for reevaluation.

For long-term suppressive therapy in adults, a reduction of dosage to 50 to 100 mg at bedtime may be adequate. For long-term suppressive therapy in pediatric patients, doses as low as 1 mg/kg per 24 hours, given in a single dose or in two divided doses, may be adequate. SEE WARNINGS SECTION REGARDING RISKS ASSOCIATED WITH LONG-TERM THERAPY.

No Recall
Remedyrepack Inc.

Nitrofurantoin | Remedyrepack Inc.

Nitrofurantoin macrocrystals should be given with food to improve drug absorption and, in some patients, tolerance.

Adults
50 to 100 mg four times a day - the lower dosage level is recommended for uncomplicated urinary tract infections.

Pediatric Patients
5 to 7 mg/kg of body weight per 24 hours, given in four divided doses (contraindicated under one month of age).
Therapy should be continued for one week or for at least 3 days after sterility of the urine is obtained. Continued infection indicates the need for reevaluation.
For long-term suppressive therapy in adults, a reduction of dosage to 50 to 100 mg at bedtime may be adequate. For long-term suppressive therapy in pediatric patients, doses as low as 1 mg/kg per 24 hours, given in a single dose or in two divided doses, may be adequate. SEEWARNINGS SECTION REGARDING RISKS ASSOCIATED WITH LONG-TERM THERAPY.

No Recall
Ncs Healthcare Of Ky, Inc Dba Vangard Labs

Nitrofurantoin | Ncs Healthcare Of Ky, Inc Dba Vangard Labs

Nitrofurantoin macrocrystals capsules should be given with food to improve drug absorption and, in some patients, tolerance.

Adults: 50 to 100 mg four times a day – the lower dosage level is recommended for uncomplicated urinary tract infections.

Pediatric Patients: 5 to 7 mg/kg of body weight per 24 hours, given in four divided doses (contraindicated under one month of age).

Therapy should be continued for one week or for at least 3 days after sterility of the urine is obtained. Continued infection indicates the need for reevaluation.

For long-term suppressive therapy in adults, a reduction of dosage to 50 to 100 mg at bedtime may be adequate. For long-term suppressive therapy in pediatric patients, doses as low as 1 mg/kg per 24 hours, given in a single dose or in two divided doses, may be adequate. SEE WARNINGS SECTION REGARDING RISKS ASSOCIATED WITH LONG-TERM THERAPY.

No Recall
Pd-rx Pharmaceuticals, Inc.

Nitrofurantoin | Lupin Pharmaceuticals, Inc.

Use the lowest effective dose for the patient.
2.1 Dosage in Adults
The recommended starting dose is 1 mg. Dosing can be raised to 2 mg or 3 mg if clinically indicated. In some patients, the higher morning blood levels of eszopiclone following use of the 2 mg or 3 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see WARNINGS AND PRECAUTIONS (5.1)]. The total dose of eszopiclone should not exceed 3 mg, once daily immediately before bedtime [see WARNINGS AND PRECAUTIONS (5.6)].
2.2 Geriatric or Debilitated Patients
The total dose of eszopiclone tablets should not exceed 2 mg in elderly or debilitated patients.
2.3 Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4 Inhibitors
In patients with severe hepatic impairment or in patients coadministered eszopiclone with potent CYP3A4 inhibitors, the total dose of eszopiclone tablets should not exceed 2 mg [see WARNING AND PRECAUTIONS (5.7)].
2.4 Use with CNS Depressants
Dosage adjustments may be necessary when eszopiclone tablets are combined with other CNS depressant drugs because of the potentially additive effects [see WARNINGS AND PRECAUTIONS (5.1)].
2.5 Administration with Food
Taking eszopiclone tablets with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone tablets on sleep latency [see CLINICAL PHARMACOLOGY (12.3)].

No Recall
Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

Nitrofurantoin | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

Nitrofurantoin macrocrystals capsules should be given with food to improve drug absorption and, in some patients, tolerance.

Adults: 50 mg to 100 mg four times a day – the lower dosage level is recommended for uncomplicated urinary tract infections.

Pediatric Patients: 5 to 7 mg/kg of body weight per 24 hours, given in four divided doses (contraindicated under one month of age).

Therapy should be continued for one week or for at least 3 days after sterility of the urine is obtained. Continued infection indicates the need for reevaluation.

For long-term suppressive therapy in adults, a reduction of dosage to 50 mg to 100 mg at bedtime may be adequate. For long-term suppressive therapy in pediatric patients, doses as low as 1 mg/kg per 24 hours, given in a single dose or in two divided doses, may be adequate. SEE WARNINGS SECTION REGARDING RISKS ASSOCIATED WITH LONG-TERM THERAPY.

No Recall
Bryant Ranch Prepack

Nitrofurantoin | Bryant Ranch Prepack

Nitrofurantoin monohydrate/macrocrystals capsules should be taken with food.

Adults and Pediatric Patients Over 12 Years

One 100 mg capsule every 12 hours for seven days.

No Recall
Bryant Ranch Prepack

Nitrofurantoin | Bryant Ranch Prepack

Nitrofurantoin monohydrate/macrocrystals capsules should be taken with food.

Adults and Pediatric Patients Over 12 Years

One 100 mg capsule every 12 hours for seven days.

No Recall
A-s Medication Solutions Llc

Nitrofurantoin | A-s Medication Solutions Llc

Nitrofurantoin macrocrystals capsules should be given with food to improve drug absorption and, in some patients, tolerance.

Adults: 50 mg to 100 mg four times a day – the lower dosage level is recommended for uncomplicated urinary tract infections.

Pediatric Patients: 5 to 7 mg/kg of body weight per 24 hours, given in four divided doses (contraindicated under one month of age).

Therapy should be continued for one week or for at least 3 days after sterility of the urine is obtained. Continued infection indicates the need for reevaluation.

For long-term suppressive therapy in adults, a reduction of dosage to 50 mg to 100 mg at bedtime may be adequate. For long-term suppressive therapy in pediatric patients, doses as low as 1 mg/kg per 24 hours, given in a single dose or in two divided doses, may be adequate. SEE WARNINGS SECTION REGARDING RISKS ASSOCIATED WITH LONG-TERM THERAPY.

No Recall
Remedyrepack Inc.

Nitrofurantoin | Remedyrepack Inc.

Nitrofurantoin monohydrate/macrocrystals capsules should be taken with food.

Adults and Pediatric Patients Over 12 Years: One 100 mg capsule every 12 hours for 7 days.

No Recall
American Health Packaging

Nitrofurantoin | American Health Packaging

Nitrofurantoin capsules (monohydrate/macrocrystals)should be taken with food.

Adults and Pediatric Patients Over 12 Years

One 100 mg capsule every 12 hours for seven days.

No Recall
Mylan Pharmaceuticals Inc.

Nitrofurantoin | Mylan Pharmaceuticals Inc.

Nitrofurantoin macrocrystals capsules should be given with food to improve drug absorption and, in some patients, tolerance.

Adults: 50 mg to 100 mg four times a day – the lower dosage level is recommended for uncomplicated urinary tract infections.

Pediatric Patients: 5 to 7 mg/kg of body weight per 24 hours, given in four divided doses (contraindicated under one month of age).

Therapy should be continued for one week or for at least 3 days after sterility of the urine is obtained. Continued infection indicates the need for reevaluation.

For long-term suppressive therapy in adults, a reduction of dosage to 50 mg to 100 mg at bedtime may be adequate. For long-term suppressive therapy in pediatric patients, doses as low as 1 mg/kg per 24 hours, given in a single dose or in two divided doses, may be adequate. SEE WARNINGS SECTION REGARDING RISKS ASSOCIATED WITH LONG-TERM THERAPY.

No Recall
Eon Labs, Inc.

Nitrofurantoin | Eon Labs, Inc.

Nitrofurantoin capsules (monohydrate/macrocrystals)should be taken with food.

Adults and Pediatric Patients Over 12 Years

One 100 mg capsule every 12 hours for seven days.

No Recall
Northwind Pharmaceuticals, Llc

Nitrofurantoin | Northwind Pharmaceuticals, Llc

Nitrofurantoin monohydrate/macrocrystals capsules should be taken with food.

Adults and Pediatric Patients Over 12 Years: One 100 mg capsule every 12 hours for seven days.

No Recall