MACRODANTIN Capsule (2017)

Βιβλιογραφική αναφορά

Συγγραφείς

Almatica Pharma Inc.

Λέξεις κλειδιά

52427-286 52427-287 52427-288

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

1. Description

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 ...

2. Clinical Pharmacology

Macrodantin is a larger crystal form of Furadantin (nitrofurantoin). The absorption of Macrodantin is slower and its excretion somewhat less when compared to Furadantin. Blood concentrations at therapeutic ...

3. Indications and Usage

Macrodantin is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible ...

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, MACRODANTIN SHOULD BE DISCONTINUED AND ...

6.1. General

Prescribing Macrodantin 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 Macrodantin with food to further enhance tolerance and improve drug absorption. Patients should be instructed to complete the full course of therapy; however, they should ...

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 6 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

Macrodantin is contraindicated in infants below the age of one month (see CONTRAINDICATIONS).

6.11. Geriatric Use

Clinical studies of Macrodantin 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

Respiratory: CHRONIC, SUBACUTE, OR ACUTE PULMONARY HYPERSENSITIVITY REACTIONS MAY OCCUR. CHRONIC PULMONARY REACTIONS OCCUR GENERALLY IN PATIENTS WHO HAVE RECEIVED CONTINUOUS TREATMENT ...

9. Overdosage

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

10. Dosage and Administration

Macrodantin 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 ...

11. How Supplied

Macrodantin is available as follows: 25 mg opaque, white capsule imprinted with MACRODANTIN 25 mg and 52427-286. NDC 52427-286-01 bottle of 100 50 mg opaque, yellow and white capsule imprinted ...

12. Storage and Handling

Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.