Paromomycin

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

Paromomycin is an antibiotic that fights bacteria.

Paromomycin is used to treat certain intestinal infections. Paromomycin is also used to treat certain liver problems.

Paromomycin may also be used for purposes not listed here.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

• If you have an allergy to paromomycin or any other part of paromomycin.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have a bowel block.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take paromomycin with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Prescribing Paromomycin Sulfate Capsules in the absence of a proven or strongly suspected bacterial infection or a prophylacticindication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

The use of this antibiotic, as with other antibiotics, may result in an overgrowth of nonsusceptible organisms, including fungi. Constant observation of the patientis essential. If new infections caused by nonsusceptible organisms appear during therapy, appropriate measures should be taken. The drug should be used with caution in individuals with ulcerative lesions of the bowel to avoid renal toxicity through inadvertent absorption.

Information for Patients

Patients should be counseled that antibacterial drugs including Paromomycin Sulfate Capsules should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Paromomycin Sulfate Capsules is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1)  decrease the effectiveness of the immediate treatment and (2)  increase the likelihood that bacteria will develop resistance and will not be treatable by Paromomycin Sulfate Capsules or other antibacterial drugs in the future.

Pediatric Use

See DOSAGE AND ADMINISTRATION section.

Intestinal amebiasis: Adults and Pediatric Patients: Usual dose25 to 35 mg/kg body weight daily, administered in three doses with meals, for five to ten days.

Management of hepatic coma:

Adults: Usual dose4 g daily in divided doses, given at regular intervals for five to six days.

Paromomycin Sulfate Capsules, USP each contain Paromomycin sulfate equivalent to 250 mg Paromomycin, are supplied as follows:

NDC 23155-038-01: Bottles of 100

The capsule is Dark Blue Opaque /White Opaque, imprinted with “HP 38” in black ink on the cap and on the body.

STORAGE

Store at 20°-25°C (68°-77°F)  [See USP controlled Room Temperature]

Protect from moisture.

Preserve in tight containers as defined in the USP.

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

Manufactured for:

Heritage Pharmaceuticals Inc.
Eatontown, NJ 07724
1.866.901.DRUG (3784)

MF # 0241-02
Issued: 10/13

25 to 35 mg/kg/day orally in 3 divided doses with meals for 7 days (unlabeled use).

1 g orally every 15 minutes for 4 doses (unlabeled use). Paromomycin is not the treatment of choice.

<18 years: 25 to 35 mg/kg/day orally in 3 divided doses with meals for 5 to 10 days. Should be used following a course of metronidazole for the treatment of mild to severe, symptomatic disease. Paromomycin is not effective in extraintestinal amebiasis.

25 to 35 mg/kg/day orally in 3 divided doses with meals for 10 to 14 days (investigational). Has occasionally been used for up to 4 to 6 weeks or longer in AIDS patients.

<18 years: 11 mg/kg orally every 15 minutes for 4 doses (unlabeled use).