Europe — EMA
Humatin
Humatin paromomycin sulfate is an oral antiprotozoal antibiotic for intestinal amebiasis, giardiasis and visceral leishmaniasis. Learn uses, safety and interactions.
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What is Paromomycin Sulfate?
Humatin is an oral tablet that contains the aminoglycoside antibiotic paromomycin sulfate. It is marketed in the European Union as a prescription product and provides the active ingredient in a tablet form (strength not disclosed) for systemic use. Classified under ATC code A07AA02, Humatin belongs to the antiprotozoal therapeutic class and should be stored at room temperature for the duration of treatment.
What is Paromomycin Sulfate used for?
Humatin is indicated for the treatment of several protozoal infections that affect the gastrointestinal tract and internal organs, and it may also be used in specific prophylactic situations.
- Intestinal amebiasis caused by Entamoeba histolytica. - Giardiasis due to Giardia lamblia infection. - Visceral leishmaniasis (kala‑azar) caused by Leishmania donovani complex. - Prevention of intestinal colonisation in patients at risk of protozoal infection. - Management of chronic carrier state of Entamoeba histolytica. - Adjunct therapy for cutaneous leishmaniasis (off‑label use).
What are the side effects of Paromomycin Sulfate?
Adverse reactions to Humatin are generally related to its aminoglycoside class and may involve the gastrointestinal tract, ear, or kidney.
Common: - Nausea or vomiting. - Diarrhea or abdominal cramps. - Metallic taste in the mouth. - Rash or mild itching. - Headache. - Dizziness. - Abdominal bloating. - Loss of appetite. - Mouth ulcers. - Taste alteration. - Fatigue.
Serious: - Ototoxicity presenting as hearing loss or tinnitus. - Nephrotoxicity with elevated serum creatinine. - Severe allergic reactions such as anaphylaxis. - Persistent vomiting leading to dehydration. - Cardiac arrhythmias. - Elevated liver enzymes. - Seizures. - Severe electrolyte imbalance. - Blood dyscrasias such as neutropenia. - Peripheral neuropathy. - Acute renal failure.
What precautions apply to Paromomycin Sulfate?
When prescribing Humatin, clinicians should evaluate patient history and monitor for conditions that could increase the risk of toxicity or reduce therapeutic benefit.
- Assess renal function before initiating therapy and adjust dose if impairment is present. - Use with caution in patients with pre‑existing hearing loss or vestibular disorders. - Avoid use during the first trimester of pregnancy; category B1 indicates limited data. - Monitor liver enzymes in patients with hepatic disease, as metabolism may be altered. - Counsel patients to report any sudden hearing changes, persistent vomiting, or rash. - Consider drug interactions that may increase nephrotoxicity, such as concurrent NSAIDs. - Discontinue if signs of severe allergic reaction develop.
What does Paromomycin Sulfate interact with?
Humatin can interact with other medicines that affect kidney function, hearing, or drug absorption.
Avoid: - Concomitant use with other aminoglycosides (e.g., gentamicin, amikacin) due to additive ototoxicity and nephrotoxicity. - Co‑administration with loop diuretics (e.g., furosemide) that increase risk of renal injury. - Use with high‑dose penicillins that may compete for intestinal absorption.
Use with caution: - Non‑steroidal anti‑inflammatory drugs (NSAIDs) that may potentiate renal effects. - Loop diuretics at low dose, with close monitoring of renal parameters. - Antacids containing magnesium or aluminum, which can reduce oral bioavailability.
Frequently asked questions
What type of medication is Humatin?+
Which infections can be treated with Humatin?+
How does paromomycin sulfate work against protozoa?+
Is Humatin safe to use during pregnancy?+
What are the most common side effects of Humatin?+
Can Humatin cause hearing problems?+
Do I need kidney function tests while taking Humatin?+
Should I avoid any foods or supplements while on Humatin?+
Is it possible to take Humatin together with other antibiotics?+
What should I do if I experience severe side effects?+
How is Humatin supplied and stored?+
Can Humatin be used in children?+
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