Macrodantin Side Effects

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Answer the side-effect intent for macrodantin without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is Macrodantin?

Macrodantin contains the active ingredient Nitrofurantoin.

• Active ingredient — Nitrofurantoin
• Registration number — 55/18.5/0207; 55/18.5/0208
• Registration holder — AUROGEN SA (PTY) LTD

It is approved for:

• UNITRO contain a medicine called nitrofurantoin
• This belongs to a group of antibacterial medicine
• UNITRO is used to treat and prevent the recurrence of specific uncomplicated lower urinary tract infections like pyelonephritis, pyelitis (inflammation of the kidney and/ pelvis or its part by the result of bacterial infection) and cystitis (inflammation of the urinary bladder)

Common side effects of Macrodantin

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Frequency unknown side effects

• Superinfections (Fungi or resistant organisms caused infections)
• Granulocytopenia (loss of neutrophils in circulating blood)
• Leukopenia (lowered white blood cell count)
• Megaloblastic anemia (many large immature and dysfunctional red blood cells)
• Thrombocytopenia (deficiency of platelets in the blood)
• Aplastic anemia (deficiency of all types of blood cells in blood)
• Haemolytic anemia (abnormal breakdown of red blood cells)
• A variety of skin rashes or reactions have occurred in some patients
• Flaking skin
• a red rash or fever accompanied by rapid heart rate
• Severe rash with blistering
• Feeling sick (nausea)
• Depression
• Confusion
• Psychiatric reactions
• Headache
• Loose stools
• Loss of appetite
• Stomach ache
• Vomiting
• Dizziness
• Drowsiness
• Blood cells have been affected in some patients. This may result in bruising, delayed clotting of the blood
• Sore throat
• Fever
• Anaemia
• A susceptibility to colds or persistent cold
• Other reactions may include inflammation of salivary glands (causing facial pains)
• Inflammation of the pancreas (causing severe abdominal pain) Joint pains
• Short-term hair loss
• Urinary infection by germs which are not sensitive to Nitrofurantoin Capsules
• Inflammation of small blood vessel walls
• Skin lesions
• Liver inflammation due to turn of immune system against liver cells
• Inflammation of kidney tissue surrounding tubules
• Renal impairment
• Stevens – Johnson syndrome (a serious systemic (body- wide) allergic reaction with a characteristic rash involving the skin and mucous membranes, including the inside of the mouth, conjunctiva, and genital areas). The symptoms of this condition are fever, body aches, red rash, cough, blisters and sores on the skin and on mucus membranes of the mouth, throat, eyes, genitals, and anus, peeling skin, drooling (because closing the mouth is painful), eyes sealed shut (due to blisters and swelling)

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• If you are allergic or sensitive to UNITRO or any of the ingredients of UNITRO
• If your kidney completely failure to produce urine or produce a small amount of urine
• If you are a pregnant
• Do not administer if your baby is below one year
• If you have deficiency of glucose 6-phosphate Dehydrogenase or nursing a baby with this deficiency. (It is a hereditary condition in which red blood cells break down (haemolysis) when the body is exposed to certain foods, drugs, infections or stress. It occurs when a person is missing or has low levels of the enzyme glucose-6- phosphate dehydrogenase)

Use with care, and tell your doctor, if

• A course of therapy should not exceed 14 days
• If your doctor suggest to take repeated doses, it should be separated by rest periods
• If you are older age patient
• If you are asthma patient (a respiratory condition marked by attacks of spasm in the bronchi of the lungs, causing difficulty in breathing.), because pulmonary function monitoring is required for prolonged therapy
• If you observe any abnormal paleness or lack of colour of the skin, yellowish skin, eyes, and mouth (jaundice), dark- coloured urine, fever, weakness, dizziness or confusion tell your doctor
• These are symptom of haemolysis (destruction of red blood cells), the UNITRO should be discontinued
• If you are a pulmonary (lung) disease patient or experience any lung related condition, treatment should be discontinued and your doctor should be consulted immediately
• If you are liver impairment patient
• If you are neurological disorder (disorder pertaining to the nervous system) patient. Tell your doctor, if you have any of the following conditions:
• If you are suffering from anaemia (deficiency of red blood cells)
• If you are suffering from diabetes mellitus (elevated blood glucose levels in the blood)
• If you are electrolyte imbalance patient
• If you are vitamin B deficient patient

Pregnancy and breastfeeding

• – If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine
• As far as it is known Nitrofurantoin Capsules may be used in pregnancy
• – However, it should not be used during labour or delivery because there is a possibility that use at this stage may affect the baby
• If you want to breast feed, please consult your doctor first
• If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking UNITRO
• Driving and using machinery: Nitrofurantoin can cause dizziness and drowsiness

Interactions and medicines to check

The approved leaflet names these interactions.

• Combination of UNITRO and quinolone antibiotic produces opposite mechanisms, so this co-administration is not recommended (levofloxacin, ciprofloxacin, moxifloxacin), also fluoroquinolones increase the nalidixic acid
• The antibacterial activity of UNITRO is decreased by carbonic anhydrase inhibitors (acetazolamide, methazolamide etc.)
• Probenecid or sulfinpyrazone (anti gout medicines) reduces the UNITRO excretion
• Antacid medicine i.e., magnesium trisilicate reduces the absorption of UNITRO
• Antibacterial medicines, like Nitrofurantoin, make the oral typhoid fever vaccine ineffective
• False positive results or incorrect high reading can occur with urinary glucose tests based on the reduction of copper sulphate, such as Benedict’s reagent and Clinitest (Ames)

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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