Paromomycin Sulfate

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Overview

What is Paromomycin Sulfate?

Paromomycin sulfate is a broad spectrum antibiotic produced by var.. It is a white, amorphous, stable, water-soluble product. Paromomycin sulfate is designated chemically as -2, 6-Diamino-2, 6-dideoxy-β -L-idopyranosyl-(1→3)--β -D-ribofuranosyl-(1→5)--[2-amino-2-deoxy-α -D-glucopyranosyl-(1→4)]-2-deoxystreptamine sulfate (salt). The molecular formula is CHNO•xHSO, with a molecular weight of 615.64 (base).

Its structural formula is:

Each capsule, for oral administration, contains paromomycin sulfate equivalent to 250 mg paromomycin. Each capsule also contains the following inactive ingredients: FD&C Blue # 1, D&C Red # 28, FD&C Red # 40, gelatin and titanium dioxide. The imprinting ink for the 250 mg capsule contains D&C yellow #10, FD&C blue # 1, FD&C blue # 2, FD&C red # 40, iron oxide black, pharmaceutical shellac glaze, and propylene glycol.

What does Paromomycin Sulfate look like?

What are the available doses of Paromomycin Sulfate?

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What should I talk to my health care provider before I take Paromomycin Sulfate?

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How should I use Paromomycin Sulfate?

Paromomycin sulfate is indicated for intestinal amebiasis–acute and chronic (NOTE-It is not effective in extraintestinal amebiasis); management of hepatic coma–as adjunctive therapy.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Paromomycin Sulfate Capsules and other antibacterial drugs, Paromomycin Sulfate Capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Intestinal amebiasis:

Management of hepatic coma:

Adults: Usual dose—4 g daily in divided doses, given at regular intervals for five to six days.

What interacts with Paromomycin Sulfate?

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What are the warnings of Paromomycin Sulfate?

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What are the precautions of Paromomycin Sulfate?

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What are the side effects of Paromomycin Sulfate?

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What should I look out for while using Paromomycin Sulfate?

Paromomycin sulfate is contraindicated in individuals with a history of previous hypersensitivity reactions to it. It is also contraindicated in intestinal obstruction.

What might happen if I take too much Paromomycin Sulfate?

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How should I store and handle Paromomycin Sulfate?

Store gabapentin capsules and tablets at 20° to 25°C (68° to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Paromomycin Sulfate Capsules, USP each contain paromomycin sulfate equivalent to 250 mg paromomycin, are supplied as follows:NDC 23155-038-01: Bottles of 100The capsule is Dark Blue Opaque /White Opaque, imprinted with "HP 38" in black ink on the cap and on the body.STORAGEStore 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-1088Manufactured for:Heritage Pharmaceuticals Inc.MF # 0241-02Issued: 10/13Paromomycin Sulfate Capsules, USP each contain paromomycin sulfate equivalent to 250 mg paromomycin, are supplied as follows:NDC 23155-038-01: Bottles of 100The capsule is Dark Blue Opaque /White Opaque, imprinted with "HP 38" in black ink on the cap and on the body.STORAGEStore 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-1088Manufactured for:Heritage Pharmaceuticals Inc.MF # 0241-02Issued: 10/13Paromomycin Sulfate Capsules, USP each contain paromomycin sulfate equivalent to 250 mg paromomycin, are supplied as follows:NDC 23155-038-01: Bottles of 100The capsule is Dark Blue Opaque /White Opaque, imprinted with "HP 38" in black ink on the cap and on the body.STORAGEStore 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-1088Manufactured for:Heritage Pharmaceuticals Inc.MF # 0241-02Issued: 10/13Paromomycin Sulfate Capsules, USP each contain paromomycin sulfate equivalent to 250 mg paromomycin, are supplied as follows:NDC 23155-038-01: Bottles of 100The capsule is Dark Blue Opaque /White Opaque, imprinted with "HP 38" in black ink on the cap and on the body.STORAGEStore 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-1088Manufactured for:Heritage Pharmaceuticals Inc.MF # 0241-02Issued: 10/13Paromomycin Sulfate Capsules, USP each contain paromomycin sulfate equivalent to 250 mg paromomycin, are supplied as follows:NDC 23155-038-01: Bottles of 100The capsule is Dark Blue Opaque /White Opaque, imprinted with "HP 38" in black ink on the cap and on the body.STORAGEStore 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-1088Manufactured for:Heritage Pharmaceuticals Inc.MF # 0241-02Issued: 10/13Paromomycin Sulfate Capsules, USP each contain paromomycin sulfate equivalent to 250 mg paromomycin, are supplied as follows:NDC 23155-038-01: Bottles of 100The capsule is Dark Blue Opaque /White Opaque, imprinted with "HP 38" in black ink on the cap and on the body.STORAGEStore 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-1088Manufactured for:Heritage Pharmaceuticals Inc.MF # 0241-02Issued: 10/13Paromomycin Sulfate Capsules, USP each contain paromomycin sulfate equivalent to 250 mg paromomycin, are supplied as follows:NDC 23155-038-01: Bottles of 100The capsule is Dark Blue Opaque /White Opaque, imprinted with "HP 38" in black ink on the cap and on the body.STORAGEStore 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-1088Manufactured for:Heritage Pharmaceuticals Inc.MF # 0241-02Issued: 10/13Paromomycin Sulfate Capsules, USP each contain paromomycin sulfate equivalent to 250 mg paromomycin, are supplied as follows:NDC 23155-038-01: Bottles of 100The capsule is Dark Blue Opaque /White Opaque, imprinted with "HP 38" in black ink on the cap and on the body.STORAGEStore 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-1088Manufactured for:Heritage Pharmaceuticals Inc.MF # 0241-02Issued: 10/13Paromomycin Sulfate Capsules, USP each contain paromomycin sulfate equivalent to 250 mg paromomycin, are supplied as follows:NDC 23155-038-01: Bottles of 100The capsule is Dark Blue Opaque /White Opaque, imprinted with "HP 38" in black ink on the cap and on the body.STORAGEStore 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-1088Manufactured for:Heritage Pharmaceuticals Inc.MF # 0241-02Issued: 10/13Paromomycin Sulfate Capsules, USP each contain paromomycin sulfate equivalent to 250 mg paromomycin, are supplied as follows:NDC 23155-038-01: Bottles of 100The capsule is Dark Blue Opaque /White Opaque, imprinted with "HP 38" in black ink on the cap and on the body.STORAGEStore 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-1088Manufactured for:Heritage Pharmaceuticals Inc.MF # 0241-02Issued: 10/13Paromomycin Sulfate Capsules, USP each contain paromomycin sulfate equivalent to 250 mg paromomycin, are supplied as follows:NDC 23155-038-01: Bottles of 100The capsule is Dark Blue Opaque /White Opaque, imprinted with "HP 38" in black ink on the cap and on the body.STORAGEStore 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-1088Manufactured for:Heritage Pharmaceuticals Inc.MF # 0241-02Issued: 10/13

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Clinical Information

Chemical Structure

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Clinical Pharmacology

The and antibacterial action of paromomycin closely parallels that of neomycin. It is poorly absorbed after oral administration, with almost 100% of the drug recoverable in the stool.

Non-Clinical Toxicology

Paromomycin sulfate is contraindicated in individuals with a history of previous hypersensitivity reactions to it. It is also contraindicated in intestinal obstruction.

As with other drugs, the potential for interaction by a variety of mechanisms (e.g., pharmacodynamic, pharmacokinetic inhibition or enhancement, etc.) is a possibility (see ).

Monoamine Oxidase Inhibitors

Drugs Affecting Hepatic Metabolism

PhenytoinIn healthy male patients (n=18), phenytoin (200 mg daily) increased mirtazapine (30 mg daily) clearance about 2-fold, resulting in a decrease in average plasma mirtazapine concentrations of 45%. Mirtazapine did not significantly affect the pharmacokinetics of phenytoin.

CarbamazepineIn healthy male patients (n=24), carbamazepine (400 mg twice daily) increased mirtazapine (15 mg twice daily) clearance about 2-fold, resulting in a decrease in average plasma mirtazapine concentrations of 60%.

When phenytoin, carbamazepine, or another inducer of hepatic metabolism (such as rifampicin) is added to mirtazapine therapy, the mirtazapine dose may have to be increased. If treatment with such a medicinal product is discontinued, it may be necessary to reduce the mirtazapine dose.

Ketoconazole: In healthy, male, Caucasian patients (n=24), coadministration of the potent CYP3A4 inhibitor ketoconazole (200 mg twice daily for 6.5 days) increased the peak plasma levels and the AUC of a single 30 mg dose of mirtazapine by approximately 40% and 50%, respectively.

Caution should be exercised when coadministering mirtazapine with potent CYP3A4 inhibitors, HIV protease inhibitors, azole antifungals, erythromycin, or nefazodone.

Paroxetine: In an interaction study in healthy, CYP2D6 extensive metabolizer patients (n=24), mirtazapine (30 mg/day), at steady state, did not cause relevant changes in the pharmacokinetics of steady state paroxetine (40 mg/day), a CYP2D6 inhibitor.

Other Drug-Drug Interactions

Warfarin: In healthy male subjects (n=16), mirtazapine (30 mg daily), at steady state, caused a small (0.2) but statistically significant increase in the International Normalized Ratio (INR) in subjects treated with warfarin. As at a higher dose of mirtazapine, a more pronounced effect can not be excluded, it is advisable to monitor the INR in case of concomitant treatment of warfarin with mirtazapine.

Lithium: No relevant clinical effects or significant changes in pharmacokinetics have been observed in healthy male subjects on concurrent treatment with subtherapeutic levels of lithium (600 mg/day for 10 days) at steady state and a single 30 mg dose of mirtazapine. The effects of higher doses of lithium on the pharmacokinetics of mirtazapine are unknown.

Risperidone: In an , nonrandomized, interaction study, subjects (n=6) in need of treatment with an antipsychotic and antidepressant drug, showed that mirtazapine (30 mg daily) at steady state did not influence the pharmacokinetics of risperidone (up to 3 mg twice daily).

Alcohol

Diazepam

QTc-Prolonging Drugs

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.

Nausea, abdominal cramps, and diarrhea have been reported inpatients on doses over 3 g daily.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Review

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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