Macrodantin

Contraindications

Renal failure (anuria, oliguria, or CrCl <60 mL/min)

Pregnancy at term (38-42 weeks of gestation)

History of hepatic dysfunction/cholestatic jaundice with nitrofurantoin

Neonates (<28 days)

Hypersensitivity

Cautions

Caution in patients with G6PD deficiency (may increase risk for hemolytic anemia)

Avoid long-term use in the elderly (may increase risk for pulmonary toxicity)

Renal impairment

Discontinue if paresthesia or hemolysis develop

Risk of occasional hepatotoxicity and pulmonary toxicity

Protect from light

Peripheral neuropathy may occur; risk may increase in patients diagnosed with anemia, diabetes, vitamin B deficiency, or electrolyte imbalance (use caution)

Acute/chronic pulmonary reactions (eg., cough, interstitial pneumonitis or fibrosis) reported

Bacterial superinfections may occur with prolonged treatment

• Macrobid, Macrodantin, and Furadantin are the brands available for nitrofurantoin in the US.
• The brand names Ivadantin and Furalan have been discontinued in the US.

Yes

Serious side effects have been reported with Macrodantin. See "Precautions" section.

Common side effects of Macrodantin include the following:

• diarrhea
• upset stomach
• dizziness
• drowsiness
• constipation
• vomiting

This is not a complete list of Macrodantin side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Antacids containing magnesium such as aluminum hydroxide or magnesium hydroxide (Mylanta)
• Uricosuric drugs such as probenecid (Benemid)

This is not a complete list of Macrodantin drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Macrodantin including the following:

• Lung problems (pulmonary hypersensitivity reactions). Tell your healthcare provider right away if you have some or all of the following symptoms:
  • malaise
  • dyspnea
  • cough
• Liver problems
• Peripheral neuropathy (nerve problems)
• Clostridium difficile- associated diarrhea

Macrodantin can cause drowsiness. Do not drive or operate heavy machinery until you know how Macrodantin affects you.

Do not take Macrodantin if you:

• are known hypersensitivity/allergy to Macrodantin or to any of its ingredients
• significant impairment of renal function
• pregnant patients at term (38-42 weeks gestation) as well as  during labor and delivery
• in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with Macrodantin

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Upset stomach or throwing up.
• Loose stools (diarrhea).
• Gas.
• This medicine may change the color of the urine to brown. This is normal and not harmful.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Rx Only

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

Macrodantin (nitrofurantoin macrocrystals) is a synthetic chemical of controlled crystal size. It is a stable, yellow, crystalline compound. Macrodantin is an antibacterial agent for specific urinary tract infections. It is available in 25 mg, 50 mg, and 100 mg capsules for oral administration.

1-[[(5-nitro-2-furanyl)methylene] amino]-2,4-imidazolidinedione

Inactive Ingredients:  Each capsule contains edible black ink, gelatin, lactose, starch, talc, titanium dioxide, and may contain FD&C Yellow No. 6 and D&C Yellow No. 10.

1.) Clinical and Laboratory Standards Institute. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard-Eighth Edition. CLSI document M07-A8 [ISBN 1-56238-689-1]. Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2009.

2.) Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard-Tenth Edition. CLSI document M02-A 10 [ISBN 1-56238-688-3]. Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2009.

3.) Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Susceptibility Testing; Nineteenth Informational Supplement. CLSI document M100-S19 [ISBN 1-56238-716-2]. Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2010.

Made in USA

Distributed by:
Almatica Pharma, Inc.
Pine Brook, NJ 07058 USA

To report SUSPECTED ADVERSE REACTIONS, contact Alvogen, Inc. at 1-866-770-3024 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Rev: 03/2013

PI286-04

NDC 52427-286-01 Rx Only

25 mg

Macrodantin®
(nitrofurantoin macrocrystals)

URINARY TRACT
ANTIBACTERIAL

100 Capsules

Almatica®

NDC 52427-287-01 Rx Only

50 mg

Macrodantin®
(nitrofurantoin macrocrystals)

URINARY TRACT
ANTIBACTERIAL

100 Capsules

Almatica®

NDC 52427-288-01 Rx Only

100 mg

Macrodantin®
(nitrofurantoin macrocrystals)

URINARY TRACT
ANTIBACTERIAL

100 Capsules

Almatica®

You should not take Macrodantin if you are allergic to it, or if you have:

• severe kidney disease;

• a history of jaundice or liver problems caused by taking Macrodantin;

• if you are urinating less than usual or not at all; or

• if you are in the last 2 to 4 weeks of pregnancy.

Do not take Macrodantin if you are in the last 2 to 4 weeks of pregnancy.

To make sure Macrodantin is safe for you, tell your doctor if you have:

• kidney disease;

• anemia;

• diabetes;

• an electrolyte imbalance or vitamin B deficiency;

• glucose-6-phosphate dehydrogenase (G6PD) deficiency; or

• any type of debilitating disease.

FDA pregnancy category B. This medicine is not expected to be harmful to an unborn baby during early pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Nitrofurantoin can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are taking nitrofurantoin.

Macrodantin should not be given to a child younger than 1 month old.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.