MACROBID Capsule (2020)

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1. Description

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Macrobid and other antibacterial drugs, Macrobid should be used only to treat or prevent infections that are proven ...

2. Clinical Pharmacology

Each Macrobid capsule contains two forms of nitrofurantoin. Twenty-five percent is macrocrystalline nitrofurantoin, which has slower dissolution and absorption than nitrofurantoin monohydrate. The remaining ...

3. Indications and Usage

Macrobid is indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus ...

4. 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 ...

5. Warnings

Pulmonary reactions ACUTE, SUBACUTE, OR CHRONIC PULMONARY REACTIONS HAVE BEEN OBSERVED IN PATIENTS TREATED WITH NITROFURANTOIN. IF THESE REACTIONS OCCUR, MACROBID SHOULD BE DISCONTINUED AND APPROPRIATE ...

6.1. General

Prescribing Macrobid 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 ...

6.2. Information for Patients

Patients should be advised to take Macrobid with food (ideally breakfast and dinner) to further enhance tolerance and improve drug absorption. Patients should be instructed to complete the full course ...

6.4. 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 ...

6.5. 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 Benedicts and Fehlings solutions but not with the glucose enzymatic ...

6.6. 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 ...

6.7. 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 ...

6.8. Labor and Delivery

See CONTRAINDICATIONS.

6.9. 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 ...

6.10. Pediatric Use

Macrobid is contraindicated in infants below the age of one month (See CONTRAINDICATIONS). Safety and effectiveness in pediatric patients below the age of twelve years have not been established.

6.11. Geriatric Use

Clinical studies of Macrobid 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 ...

7. Adverse Reactions

In clinical trials of Macrobid, the most frequent clinical adverse events that were reported as possibly or probably drug-related were nausea (8%), headache (6%), and flatulence (1.5%). Additional clinical ...

9. Overdosage

Occasional incidents of acute overdosage of nitrofurantoin have not resulted in any specific symptoms other than vomiting. Induction of emesis is recommended. There is no specific antidote, but a high ...

10. Dosage and Administration

Macrobid capsules should be taken with food. Adults and Pediatric Patients Over 12 Years: One 100 mg capsule every 12 hours for seven days.

11. How Supplied

Macrobid is available as 100 mg opaque black and yellow capsules imprinted Macrobid on one half and 52427-285 on the other. NDC 52427-285-01 bottle of 100 Distributed by: Almatica Pharma, Inc., Morristown, ...

12. Storage and Handling

Store at controlled room temperature (59°F to 86°F or 15°C to 30°C).

13. Clinical Studies

Controlled clinical trials comparing Macrobid 100 mg p.o. q12h and Macrodantin 50 mg p.o. q6h in the treatment of acute uncomplicated urinary tract infections demonstrated approximately 75% microbiologic ...