NITROFURANTOIN capsule

United States - English - NLM (National Library of Medicine)

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Active ingredient:
NITROFURANTOIN (UNII: 927AH8112L) (NITROFURANTOIN - UNII:927AH8112L)
Available from:
NuCare Pharmaceuticals,Inc.
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Nitrofurantoin capsules (macrocrystals) are specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci , Staphylococcus aureus , and certain susceptible strains of Klebsiella and Enterobacter species. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin capsules (macrocrystals) and other antibacterial drugs, nitrofurantoin capsules (macrocrystals) 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. Nitrofurantoi
Product summary:
100 mg opaque, yellow capsule imprinted in black ink with WATSON on the cap and 5781 on the body. NDC 68071-5050-7 Bottles of 14 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured by: Watson Pharma Private Limited Verna, Salcette Goa 403722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Rev. A 10/2018
Authorization status:
Abbreviated New Drug Application
Authorization number:
68071-5050-7

NITROFURANTOIN- nitrofurantoin capsule

NuCare Pharmaceuticals,Inc.

----------

Nitrofurantoin

Nitrofurantoin Capsules USP (Macrocrystals)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin

(macrocrystals) and other antibacterial drugs, nitrofurantoin (macrocrystals) should be used only to treat

or prevent infections that are proven or strongly suspected to be caused by bacteria.

DESCRIPTION:

Nitrofurantoin, USP (macrocrystals) is a synthetic chemical of controlled crystal size. It is a stable,

yellow, crystalline compound. Nitrofurantoin, USP (macrocrystals) is an antibacterial agent for specific

urinary tract infections. It is available in 25 mg, 50 mg, and 100 mg capsules for oral administration.

Inactive Ingredients: Each capsule contains D&C Yellow # 10, FD&C Blue # 1, FD&C Blue # 2,

FD&C Red # 40, gelatin, iron oxide black, lactose anhydrous, magnesium stearate, pregelatinized corn

starch, sodium lauryl sulfate, talc and titanium dioxide. The 50 mg and 100 mg capsules also contain

FD&C Yellow No. 6.

CLINICAL PHARMACOLOGY:

Nitrofurantoin (macrocrystals) is a larger crystal form of nitrofurantoin. The absorption of

nitrofurantoin (macrocrystals) is slower and its excretion somewhat less when compared to

nitrofurantoin. Blood concentrations at therapeutic dosage are usually low. It is highly soluble in urine,

to which it may impart a brown color.

Following a dose regimen of 100 mg four times a day for 7 days, average urinary drug recoveries (0 to

24 hours) on day 1 and day 7 were 37.9% and 35.0%.

Unlike many drugs, the presence of food or agents delaying gastric emptying can increase the

bioavailability of nitrofurantoin (macrocrystals), presumably by allowing better dissolution in gastric

juices.

MICROBIOLOGY

Nitrofurantoin is a nitrofuran antimicrobial agent with activity against certain Gram-positive and Gram-

negative bacteria.

Mechanism of Action

The mechanism of the antimicrobial action of nitrofurantoin is unusual among antibacterials.

The mechanism of the antimicrobial action of nitrofurantoin is unusual among antibacterials.

Nitrofurantoin is reduced by bacterial flavoproteins to reactive intermediates which inactivate or alter

bacterial ribosomal proteins and other acromolecules. As a result of such inactivations, the vital

biochemical processes of protein synthesis, aerobic energy metabolism, DNA synthesis, RNA

synthesis, and cell wall synthesis are inhibited. Nitrofurantoin is bactericidal in urine at therapeutic

doses. The broad-based nature of this mode of action may explain the lack of acquired bacterial

resistance to nitrofurantoin, as the necessary multiple and simultaneous mutations of the target

macromolecules would likely be lethal to the bacteria.

Interactions with Other Antibiotics

Antagonism has been demonstrated in vitro between nitrofurantoin and quinolone antimicrobials. The

clinical significance of this finding is unknown.

Development of Resistance

Development of resistance to nitrofurantoin has not been a significant problem since its introduction in

1953. Cross-resistance with antibiotics and sulfonamides has not been observed, and transferable

resistance is, at most, a very rare phenomenon.

Nitrofurantoin has been shown to be active against most strains of the following bacteria both in vitro

and in clinical infections (see Indications and Usage):

Aerobic and facultative Gram-positive microorganisms:

Staphylococcus aureus

Enterococci (e.g. Enterococcus faecalis)

Aerobic and facultative Gram-negative microorganisms:

Escherichia coli

NOTE: While nitrofurantoin has excellent activity against Enterococcus faecalis, the majority of

Enterococcus faecium isolates are not susceptible to nitrofurantoin.

At least 90 percent of the following microorganisms exhibit an in vitro minimum inhibitory

concentration (MIC) less than or equal to the susceptible breakpoint for nitrofurantoin. However, the

efficacy of nitrofurantoin in treating clinical infections due to these microorganisms has not been

established in adequate and well-controlled trials.

Aerobic and facultative Gram-positive microorganisms:

Coagulase-negative staphylococci (including Staphylococcus epidermidis and Staphylococcus

saprophyticus)

Streptococcus agalactiae

Group D streptococci

Viridans group streptococci

Aerobic and facultative Gram-negative microorganisms:

Citrobacter amalonaticus

Citrobacter diversus

Citrobacter freundii

Klebsiella oxytoca

Klebsiella ozaenae

NOTE: Some strains of Enterobacter species and Klebsiella species are resistant to nitrofurantoin.

Susceptibility Testing:

For specific information regarding susceptibility test interpretive criteria and associated test methods

and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.

INDICATIONS AND USAGE:

Nitrofurantoin capsules (macrocrystals) are specifically indicated for the treatment of urinary tract

infections when due to susceptible strains of Escherichia coli, enterococci , Staphylococcus aureus, and

certain susceptible strains of Klebsiella and Enterobacter species.

Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin

capsules (macrocrystals) and other antibacterial drugs, nitrofurantoin capsules (macrocrystals) 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.

Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary

tract infections. Consequently, many patients who are treated with nitrofurantoin capsules

(macrocrystals) are predisposed to persistence or reappearance of bacteriuria. Urine specimens for

culture and susceptibility testing should be obtained before and after completion of therapy. If

persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin capsules

(macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In

considering the use of nitrofurantoin capsules (macrocrystals), lower eradication rates should be

balanced against the increased potential for systemic toxicity and for the development of antimicrobial

resistance when agents with broader tissue distribution are utilized.

CONTRAINDICATIONS:

Anuria, oliguria, or significant impairment of renal function (creatinine clearance under 60 mL per

minute or clinically significant elevated serum creatinine) are contraindications. Treatment of this type

of patient carries an increased risk of toxicity because of impaired excretion of the drug.

Because of the possibility of hemolytic anemia due to immature erythrocyte enzyme systems

(glutathione instability), the drug is contraindicated in pregnant patients at term (38 to 42 weeks'

gestation), during labor and delivery, or when the onset of labor is imminent. For the same reason, the

drug is contraindicated in neonates under one month of age.

Nitrofurantoin capsules (macrocrystals) are contraindicated in patients with a previous history of

cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin.

Nitrofurantoin capsules (macrocrystals) are also contraindicated in those patients with known

hypersensitivity to nitrofurantoin.

WARNINGS:

Pulmonary reactions:

ACUTE, SUBACUTE, OR CHRONIC PULMONARY REACTIONS HAVE BEEN OBSERVED

IN PATIENTS TREATED WITH NITROFURANTOIN. IF THESE REACTIONS OCCUR,

NITROFURANTOIN (MACROCRYSTALS) SHOULD BE DISCONTINUED AND

APPROPRIATE MEASURES TAKEN. REPORTS HAVE CITED PULMONARY REACTIONS

AS A CONTRIBUTING CAUSE OF DEATH. CHRONIC PULMONARY REACTIONS

(DIFFUSE INTERSTITIAL PNEUMONITIS OR PULMONARY FIBROSIS, OR BOTH) CAN

DEVELOP INSIDIOUSLY. THESE REACTIONS OCCUR RARELY AND GENERALLY IN

PATIENTS RECEIVING THERAPY FOR SIX MONTHS OR LONGER. CLOSE

MONITORING OF THE PULMONARY CONDITION OF PATIENTS RECEIVING LONG-

TERM THERAPY IS WARRANTED AND REQUIRES THAT THE BENEFITS OF THERAPY

BE WEIGHED AGAINST POTENTIAL RISKS ( SEE RESPIRATORY REACTIONS).

Hepatotoxicity:

Hepatic reactions, including hepatitis, cholestatic jaundice, chronic active hepatitis, and hepatic

necrosis, occur rarely. Fatalities have been reported. The onset of chronic active hepatitis may be

insidious, and patients should be monitored periodically for changes in biochemical tests that would

indicate liver injury. If hepatitis occurs, the drug should be withdrawn immediately and appropriate

measures should be taken.

Neuropathy:

Peripheral neuropathy, which may become severe or irreversible, has occurred. Fatalities have been

reported. Conditions such as renal impairment (creatinine clearance under 60 mL per minute or

clinically significant elevated serum creatinine), anemia, diabetes mellitus, electrolyte imbalance,

vitamin B deficiency, and debilitating disease may enhance the occurrence of peripheral neuropathy.

Patients receiving long-term therapy should be monitored periodically for changes in renal function.

Optic neuritis has been reported rarely in postmarketing experience with nitrofurantoin formulations.

Hemolytic anemia:

Cases of hemolytic anemia of the primaquine-sensitivity type have been induced by nitrofurantoin.

Hemolysis appears to be linked to a glucose-6-phosphate dehydrogenase deficiency in the red blood

cells of the affected patients. This deficiency is found in 10 percent of Blacks and a small percentage of

ethnic groups of Mediterranean and Near-Eastern origin. Hemolysis is an indication for discontinuing

nitrofurantoin (macrocrystals); hemolysis ceases when the drug is withdrawn.

Clostridium difficile-associated diarrhea:

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial

agents, including nitrofurantoin, 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.

PRECAUTIONS:

Information for Patients:

Patients should be advised to take nitrofurantoin (macrocrystals) with food to further enhance tolerance

and improve drug absorption. Patients should be instructed to complete the full course of therapy;

however, they should be advised to contact their physician if any unusual symptoms occur during

therapy.

Many patients who cannot tolerate microcrystalline nitrofurantoin are able to take nitrofurantoin

(macrocrystals) without nausea.

Patients should be advised not to use antacid preparations containing magnesium trisilicate while taking

nitrofurantoin (macrocrystals).

Patients should be counseled that antibacterial drugs including nitrofurantoin (macrocrystals) should

only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).

When nitrofurantoin (macrocrystals) is prescribed to treat a bacterial infection, patients should be told

that although it is common to feel better early in the course of therapy, the medication should be taken

exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the

effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop

resistance and will not be treatable by nitrofurantoin (macrocrystals) or other antibacterial drugs in the

future.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is

discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody

stools (with or without stomach cramps and fever) even as late as two or more months after having taken

the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

General:

Prescribing nitrofurantoin (macrocrystals) in the absence of a proven or strongly suspected bacterial

infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk

of the development of drug-resistant bacteria.

Drug Interactions:

Antacids containing magnesium trisilicate, when administered concomitantly with nitrofurantoin, reduce

both the rate and extent of absorption. The mechanism for this interaction probably is adsorption of

nitrofurantoin onto the surface of magnesium trisilicate.

Uricosuric drugs, such as probenecid and sulfinpyrazone, can inhibit renal tubular secretion of

nitrofurantoin. The resulting increase in nitrofurantoin serum levels may increase toxicity, and the

decreased urinary levels could lessen its efficacy as a urinary tract antibacterial.

Drug/Laboratory Test Interactions:

As a result of the presence of nitrofurantoin, a false-positive reaction for glucose in the urine may

occur. This has been observed with Benedict's and Fehling's solutions but not with the glucose

enzymatic test.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Nitrofurantoin was not carcinogenic when fed to female Holtzman rats for 44.5 weeks or to female

Sprague-Dawley rats for 75 weeks. Two chronic rodent bioassays utilizing male and female Sprague-

Dawley rats and two chronic bioassays in Swiss mice and in BDF

mice revealed no evidence of

carcinogenicity.

Nitrofurantoin presented evidence of carcinogenic activity in female B6C3F

mice as shown by

increased incidences of tubular adenomas, benign mixed tumors, and granulosa cell tumors of the ovary.

In male F344/N rats, there were increased incidences of uncommon kidney tubular cell neoplasms,

osteosarcomas of the bone, and neoplasms of the subcutaneous tissue. In one study involving

subcutaneous administration of 75 mg/kg nitrofurantoin to pregnant female mice, lung papillary

adenomas of unknown significance were observed in the F1 generation.

Nitrofurantoin has been shown to induce point mutations in certain strains of Salmonella typhimurium and

forward mutations in L5178Y mouse lymphoma cells. Nitrofurantoin induced increased numbers of

sister chromatid exchanges and chromosomal aberrations in Chinese hamster ovary cells but not in

human cells in culture. Results of the sex-linked recessive lethal assay in Drosophila were negative

after administration of nitrofurantoin by feeding or by injection. Nitrofurantoin did not induce heritable

mutation in the rodent models examined.

The significance of the carcinogenicity and mutagenicity findings relative to the therapeutic use of

nitrofurantoin in humans is unknown.

The administration of high doses of nitrofurantoin to rats causes temporary spermatogenic arrest; this is

reversible on discontinuing the drug. Doses of 10 mg/kg/day or greater in healthy human males may, in

certain unpredictable instances, produce a slight to moderate spermatogenic arrest with a decrease in

sperm count.

Pregnancy:

Teratogenic effects:

Pregnancy Category B. Several reproduction studies have been performed in rabbits and rats at doses up

to six times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due

to nitrofurantoin. In a single published study conducted in mice at 68 times the human dose (based on

mg/kg administered to the dam), growth retardation and a low incidence of minor and common

malformations were observed. However, at 25 times the human dose, fetal malformations were not

observed; the relevance of these findings to humans is uncertain. There are, however, no adequate and

well-controlled studies in pregnant women. Because animal reproduction studies are not always

predictive of human response, this drug should be used during pregnancy only if clearly needed.

Non-teratogenic effects:

Nitrofurantoin has been shown in one published transplacental carcinogenicity study to induce lung

papillary adenomas in the F1 generation mice at doses 19 times the human dose on a mg/kg basis. The

relationship of this finding to potential human carcinogenesis is presently unknown. Because of the

uncertainty regarding the human implications of these animal data, this drug should be used during

pregnancy only if clearly needed.

Labor and Delivery:

See CONTRAINDICATIONS.

Nursing Mothers:

Nitrofurantoin has been detected in human breast milk in trace amounts. Because of the potential for

serious adverse reactions from nitrofurantoin in nursing infants under one month of age, a decision

should be made whether to discontinue nursing or to discontinue the drug, taking into account the

importance of the drug to the mother (see CONTRAINDICATIONS).

Pediatric Use:

Nitrofurantoin (macrocrystals) is contraindicated in infants below the age of one month (see

CONTRAINDICATIONS).

Geriatric Use:

Clinical studies of nitrofurantoin (macrocrystals) did not include sufficient numbers of subjects aged 65

and over to determine whether they respond differently from younger subjects. Other reported clinical

experience has not identified differences in responses between the elderly and younger patients.

Spontaneous reports suggest a higher proportion of pulmonary reactions, including fatalities, in elderly

patients; these differences appear to be related to the higher proportion of elderly patients receiving

long-term nitrofurantoin therapy. As in younger patients, chronic pulmonary reactions generally are

observed in patients receiving therapy for six months or longer (see WARNINGS). Spontaneous

reports also suggest an increased proportion of severe hepatic reactions, including fatalities, in elderly

patients (see WARNINGS).

In general, the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant

disease or other drug therapy should be considered when prescribing nitrofurantoin (macrocrystals).

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug

may be greater in patients with impaired renal function. Anuria, oliguria, or significant impairment of

renal function (creatinine clearance under 60 mL per minute or clinically significant elevated serum

creatinine) are contraindications (see CONTRAINDICATIONS). Because elderly patients are more

likely to have decreased renal function, care should be taken in dose selection, and it may be useful to

monitor renal function.

ADVERSE REACTIONS:

Res piratory:

CHRONIC, SUBACUTE, OR ACUTE PULMONARY HYPERSENSITIVITY REACTIONS

MAY OCCUR.

CHRONIC PULMONARY REACTIONS OCCUR GENERALLY IN PATIENTS WHO HAVE

RECEIVED CONTINUOUS TREATMENT FOR SIX MONTHS OR LONGER. MALAISE,

DYSPNEA ON EXERTION, COUGH, AND ALTERED PULMONARY FUNCTION ARE

COMMON MANIFESTATIONS WHICH CAN OCCUR INSIDIOUSLY. RADIOLOGIC AND

HISTOLOGIC FINDINGS OF DIFFUSE INTERSTITIAL PNEUMONITIS OR FIBROSIS, OR

BOTH, ARE ALSO COMMON MANIFESTATIONS OF THE CHRONIC PULMONARY

REACTION. FEVER IS RARELY PROMINENT.

THE SEVERITY OF CHRONIC PULMONARY REACTIONS AND THEIR DEGREE OF

RESOLUTION APPEAR TO BE RELATED TO THE DURATION OF THERAPY AFTER

THE FIRST CLINICAL SIGNS APPEAR. PULMONARY FUNCTION MAY BE IMPAIRED

PERMANENTLY, EVEN AFTER CESSATION OF THERAPY. THE RISK IS GREATER

WHEN CHRONIC PULMONARY REACTIONS ARE NOT RECOGNIZED EARLY.

In subacute pulmonary reactions, fever and eosinophilia occur less often than in the acute form. Upon

cessation of therapy, recovery may require several months. If the symptoms are not recognized as being

drug-related and nitrofurantoin therapy is not stopped, the symptoms may become more severe.

Acute pulmonary reactions are commonly manifested by fever, chills, cough, chest pain, dyspnea,

pulmonary infiltration with consolidation or pleural effusion on x-ray, and eosinophilia. Acute reactions

usually occur within the first week of treatment and are reversible with cessation of therapy. Resolution

often is dramatic (see WARNINGS).

Changes in EKG (e.g., non-specific ST/T wave changes, bundle branch block) have been reported in

association with pulmonary reactions.

Cyanosis has been reported rarely.

Hepatic:

Hepatic reactions, including hepatitis, cholestatic jaundice, chronic active hepatitis, and hepatic

necrosis, occur rarely (see WARNINGS).

Neurologic:

Peripheral neuropathy, which may become severe or irreversible, has occurred. Fatalities have been

reported. Conditions such as renal impairment (creatinine clearance under 60 mL per minute or

clinically significant elevated serum creatinine), anemia, diabetes mellitus, electrolyte imbalance,

vitamin B deficiency, and debilitating diseases may increase the possibility of peripheral neuropathy

(see WARNINGS).

Asthenia, vertigo, nystagmus, dizziness, headache, and drowsiness also have been reported with the use

of nitrofurantoin.

Benign intracranial hypertension (pseudotumor cerebri), confusion, depression, optic neuritis, and

psychotic reactions have been reported rarely. Bulging fontanels, as a sign of benign intracranial

hypertension in infants, have been reported rarely.

Dermatologic:

Exfoliative dermatitis and erythema multiforme (including Stevens-Johnson syndrome) have been

reported rarely. Transient alopecia also has been reported.

Allergic:

A lupus-like syndrome associated with pulmonary reactions to nitrofurantoin has been reported. Also,

angioedema; maculopapular, erythematous, or eczematous eruptions; pruritus; urticaria; anaphylaxis;

arthralgia; myalgia; drug fever; chills; and vasculitis (sometimes associated with pulmonary reactions)

have been reported. Hypersensitivity reactions represent the most frequent spontaneously-reported

adverse events in worldwide postmarketing experience with nitrofurantoin formulations.

Gas trointes tinal:

Nausea, emesis, and anorexia occur most often. Abdominal pain and diarrhea are less common

gastrointestinal reactions. These dose-related reactions can be minimized by reduction of dosage.

Sialadenitis and pancreatitis have been reported. There have been sporadic reports of

pseudomembranous colitis with the use of nitrofurantoin. The onset of pseudomembranous colitis

symptoms may occur during or after antimicrobial treatment (see WARNINGS).

Hematologic:

Cyanosis secondary to methemoglobinemia has been reported rarely.

Mis cellaneous :

As with other antimicrobial agents, superinfections caused by resistant organisms, e.g., Pseudomonas

species or Candida species, can occur.

Laboratory Adverse Events:

The following laboratory adverse events have been reported with the use of nitrofurantoin: increased

AST (SGOT), increased ALT (SGPT), decreased hemoglobin, increased serum phosphorus,

eosinophilia, glucose-6-phosphate dehydrogenase deficiency anemia (see WARNINGS),

agranulocytosis, leukopenia, granulocytopenia, hemolytic anemia, thrombocytopenia, megaloblastic

anemia. In most cases, these hematologic abnormalities resolved following cessation of therapy.

Aplastic anemia has been reported rarely.

OVERDOSAGE:

Occasional incidents of acute overdosage of Nitrofurantoin (Macrocrystals) have not resulted in any

specific symptoms other than vomiting. Induction of emesis is recommended. There is no specific

antidote, but a high fluid intake should be maintained to promote urinary excretion of the drug. It is

dialyzable.

DOSAGE AND ADMINISTRATION:

Nitrofurantoin capsules (macrocrystals) 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 50-100 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.

HOW SUPPLIED:

100 mg opaque, yellow capsule imprinted in black ink with WATSON on the cap and 5781 on the body.

NDC 68071-5050-7 Bottles of 14

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Manufactured by:

Watson Pharma Private Limited

Verna, Salcette Goa 403722 INDIA

Distributed by:

Actavis Pharma, Inc.

Parsippany, NJ 07054 USA

To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-

800-FDA-1088 or www.fda.gov/medwatch.

Rev. A 10/2018

PRINCIPAL DISPLAY PANEL - 100 mg

NITROFURANTOIN

nitrofurantoin capsule

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 8 0 71-50 50 (NDC:0 59 1-36 8 6 )

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

NITRO FURANTO IN (UNII: 9 27AH8 112L) (NITROFURANTOIN - UNII:9 27AH8 112L)

NITROFURANTOIN

10 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

FD&C BLUE NO . 2 (UNII: L0 6 K8 R7DQK)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

GELATIN (UNII: 2G8 6 QN327L)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

ANHYDRO US LACTO SE (UNII: 3SY5LH9 PMK)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

STARCH, CO RN (UNII: O8 232NY3SJ)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

Product Characteristics

Color

yello w (o paque)

S core

no sco re

S hap e

CAPSULE

S iz e

18 mm

Flavor

Imprint Code

Wa tso n;578 1

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 0 71-50 50 -7

14 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 9 /0 5/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 9 10 9 5

10 /0 1/20 15

NuCare Pharmaceuticals,Inc.

Labeler -

NuCare Pharmaceuticals,Inc. (010632300)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

NuCare Pharmaceuticals,Inc.

0 10 6 3230 0

re pa c k(6 8 0 71-50 50 )

Revised: 9/2019

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