Description

APO NITROFURANTOIN is a prescription medication formulated to address uncomplicated lower urinary tract infections (UTIs) such as cystitis and pyelitis. Manufactured by Apotex, it leverages the active ingredient nitrofurantoin, available in both monohydrate and macrocrystal forms, to effectively combat a range of Gram-positive and Gram-negative urinary tract pathogens, including Escherichia coli and Staphylococcus saprophyticus.

Dosage Forms

• Capsules: Available in 50 mg and 100 mg strengths. The 100 mg variant may also come in a slow-release form.
• Oral Suspension: 25 mg/5 mL, designed for individuals who have difficulty swallowing capsules.

Capsule Description

• 50 mg Capsule: Features a yellow opaque cap and a white opaque body, filled with yellow powder.
• 100 mg Capsule: Typically has a yellow opaque cap and body, though some variants have a light gray cap and light brown body, imprinted with 'MYLAN;3422'.

Mechanism of Action

APO NITROFURANTOIN works by inhibiting bacterial DNA, RNA, protein, and cell wall synthesis, becoming bactericidal at therapeutic doses in urine. This makes it highly effective within the urinary tract environment.

Administration Guidelines

• Adults: Typically administered at 50–100 mg four times daily, or 100 mg every 12 hours for extended-release capsules.
• Children: Dosage is weight-based and not recommended for infants under one month.

It is advised to take the medication with food or milk to enhance absorption and minimize stomach upset. The oral suspension should be well-shaken before use.

Contraindications

APO NITROFURANTOIN is contraindicated in individuals with significant renal impairment, certain stages of pregnancy, and those with a history of specific liver conditions or hypersensitivity to the drug.

Precautions

Patients should be aware of potential risks such as peripheral neuropathy, pulmonary reactions, and hepatic reactions. Regular monitoring of renal, pulmonary, and liver functions is recommended during prolonged use.

Drug Interactions

Interactions may occur with antacids containing magnesium trisilicate, uricosuric drugs, and certain other medications, potentially affecting the drug's efficacy and safety.

Adverse Effects

Common side effects include nausea, vomiting, and changes in urine color. Serious but rare effects can involve pulmonary and hepatic toxicity, peripheral neuropathy, and severe allergic reactions.

Storage Instructions

Store below 25°C in a tightly closed, light-resistant container. The oral suspension should not be frozen. The product has a shelf life of up to two years.

Legal Classification

As a Schedule 4 medication in Australia, APO NITROFURANTOIN requires a prescription and should be used strictly as directed by a healthcare professional. Patients are encouraged to complete the full course of therapy to ensure effectiveness.