hemihydrate reference
Reference image
(hemihydrate · DailyMed)
Valid Ghana · FDA Ghana

AENEAS 500MG TABLETS (Each tablet contains Levofoxacin Hemihydrate 500mg

Levofoxacin Hemihydrate 500mg

FDA/SD.265-060607 Levofoxacin Hemihydrate 500mg 500MG

What it does

Hemihydrate is a type of medication used to treat various conditions. It may help with symptoms like pain or inflammation.

Commonly used for: pain relief, inflammation reduction

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

Ask about this medicine

Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

Medicine sourcing is available in Kenya only. We don't sell or dispense medicines - licensed pharmacies do.

Sourcing - Kenya only

Registration & product details

Registration no.
FDA/SD.265-060607
Registration date
2026-06-12
Expiry date
2031-04-01
Status
Valid
Active ingredient
Levofoxacin Hemihydrate 500mg
Strength
500MG
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Saga Lifesciences
Country of origin
INDIA

Source: Food and Drugs Authority · fetched 2026-07-07 04:00:16 · updated 2026-10-20 04:00:14

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About hemihydrate

Hemihydrate is a type of medication used to treat various conditions. It may help with symptoms like pain or inflammation.

What it treats

  • pain relief
  • inflammation reduction

How it works

Hemihydrate works by affecting certain processes in the body to reduce pain and swelling.

Who it's for

This medication is for people experiencing pain or inflammation.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About levofoxacin

Levofloxacin is an antibiotic that helps treat infections caused by bacteria.

What it treats

  • bacterial infections
  • pneumonia
  • urinary tract infections
  • sinus infections
  • skin infections

How it works

It works by stopping the growth of bacteria, helping your body to fight off the infection.

Who it's for

It is prescribed for adults and sometimes for older children with specific bacterial infections.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: hemi

BNF-referenced

Hemi is a pharmaceutical compound with the molecular formula C6H7NO3. It is typically involved in various therapeutic applications, although specific clinical uses may vary.

Dosage

Children: Refer to the BNF for Children for specific dosing recommendations.

Adults: Refer to the BNF for specific dosing recommendations.

Mechanism of action

The exact mechanism of action for Hemi is not explicitly detailed in the available resources, but compounds with similar structure may act by modulating neurotransmitter levels, inhibiting enzymes, or affecting cellular signaling pathways.

Pharmacodynamics

Hemi may exhibit pharmacodynamic properties that include modulation of neural activity or inhibition of specific biochemical pathways. Its effects could be dose-dependent and vary based on the therapeutic context.

Pharmacokinetics

The pharmacokinetic profile of Hemi, including absorption, distribution, metabolism, and excretion, is not well-documented in the provided resources. Generally, compounds in this class may undergo first-pass metabolism and have a variable half-life.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: hemihydrate

Hemihydrate refers to a class of compounds that contain one molecule of water for every two molecules of solute. In pharmacology, hemihydrates are often associated with specific salts or forms of drugs that exhibit enhanced solubility and stability. These compounds are critical in the formulation of medications, allowing for improved bioavailability and absorption in the body.

Dosage

Children: Refer to the specific formulation or active ingredient for dosing information.

Adults: Refer to the specific formulation or active ingredient for dosing information.

Mechanism of action

The mechanism of action of hemihydrate forms of drugs can vary widely depending on the specific compound. In many cases, the hemihydrate form enhances the solubility of the active ingredient, which facilitates its dissolution and absorption in the gastrointestinal tract.

Pharmacodynamics

Pharmacodynamics of hemihydrate compounds generally relates to the pharmacological effects that arise from the active drug once it is absorbed. The effects may vary based on the specific drug and its therapeutic target, but overall, the hemihydrate form aims to improve efficacy by ensuring adequate plasma concentrations are achieved more effectively than non-hydrated forms.

Pharmacokinetics

The pharmacokinetics of hemihydrate drugs typically demonstrate improved dissolution rates due to the presence of water, which can lead to increased absorption. This may result in quicker onset of action and modified half-lives. The specifics of absorption, distribution, metabolism, and excretion will depend on the active ingredient and its properties.

Pregnancy

Safety in pregnancy has not been established. Use only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

It is not known whether this drug is excreted in human milk. Caution should be exercised when administered to a nursing mother.

Storage

Store at room temperature, away from moisture and heat. Keep container tightly closed.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: levofoxacin

Levofloxacin is a fluoroquinolone antibiotic that is used to treat a variety of bacterial infections. It works by inhibiting bacterial DNA gyrase and topoisomerase IV, enzymes critical for bacterial DNA replication, transcription, and repair. This action leads to the inhibition of bacterial growth and reproduction.

Indications

  • Acute bacterial sinusitis
  • Chronic bronchitis exacerbations
  • Community-acquired pneumonia
  • Complicated urinary tract infections
  • Pyelonephritis
  • Skin and soft tissue infections
  • Bacterial conjunctivitis
  • Inhalational anthrax (post-exposure prophylaxis)

Dosage

Children: Refer to the BNF for Children for appropriate paediatric dosing information.

Adults: Refer to specific clinical guidelines or the BNF for precise adult dosing information.

Mechanism of action

Levofloxacin exerts its antimicrobial effect primarily through the inhibition of bacterial DNA gyrase and topoisomerase IV, enzymes involved in the supercoiling and separation of DNA strands necessary for replication. By interfering with these enzymes, levofloxacin prevents the bacteria from properly replicating their DNA, ultimately leading to cell death.

Pharmacodynamics

Levofloxacin has a bactericidal effect, meaning it kills bacteria rather than merely inhibiting their growth. It exhibits concentration-dependent killing, with higher concentrations leading to greater antibacterial activity. The drug is effective against a broad spectrum of gram-positive and gram-negative bacteria.

Pharmacokinetics

Levofloxacin is well-absorbed following oral administration, with a bioavailability of approximately 99%. It reaches peak plasma concentration within 1 to 2 hours. The drug is widely distributed throughout the body, including the lungs, kidneys, and prostate. Levofloxacin is primarily eliminated by renal excretion, with about 87% of the dose eliminated unchanged in the urine. Its half-life is approximately 6 to 8 hours, allowing for once-daily dosing in many cases.

Contra-indications

  • Hypersensitivity to levofloxacin or other quinolones
  • History of tendon disorders related to fluoroquinolone use
  • Myasthenia gravis
  • Severe renal impairment (eGFR < 30 mL/min) without dose adjustment

Adverse effects

  • Gastrointestinal disturbances (nausea, diarrhea)
  • Central nervous system effects (headache, dizziness)
  • Tendon rupture or tendinopathy
  • QT prolongation
  • Photosensitivity reactions
  • Rash and other allergic reactions
  • Hepatotoxicity

Interactions

  • Antacids containing magnesium, aluminum, or calcium may reduce absorption
  • Cationic agents (iron, zinc) can interfere with efficacy
  • Drugs that prolong the QT interval (e.g., certain antiarrhythmics) may increase the risk of cardiac events
  • Warfarin and other anticoagulants may require monitoring due to potential interactions

Precautions

  • Monitor renal function, especially in patients with pre-existing impairment
  • Assess for history of seizures or CNS disorders
  • Use caution in patients with diabetes, as fluoroquinolones can affect glucose levels
  • Consider risk of tendon damage in patients over 60 years or those on corticosteroids

Pregnancy

Levofloxacin is classified as category C. Use only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Levofloxacin is excreted in breast milk. Caution is advised when administering to nursing mothers.

Storage

Store at room temperature, away from light and moisture. Keep out of reach of children.

Formulations

  • Tablets (250 mg, 500 mg)
  • Intravenous solution (5 mg/mL)
  • Oral solution (not commonly used)

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: hemi

PubChem CID 458487

Molecular formula: C6H7NO3

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.