Novidat DS 400 mg / 100 mL IV Injection (Ciprofloxacin) — 1 Vial

Description

Novidat DS is an intravenous antibiotic preparation delivering 400 mg of ciprofloxacin in a 100 mL solution, intended for infusion. It’s used to treat a variety of serious bacterial infections when oral therapy is not feasible, or in hospitalized patients. 

Ingredients

• Active ingredient: Ciprofloxacin (400 mg)

• Excipients / vehicle: A suitable sterile aqueous medium and buffering agents per formulation (as per manufacturer leaflet)

Drug Class

• Fluoroquinolone antibiotic (second generation) 

Dosage Form

• Intravenous (IV) infusion solution

• 100 mL vial containing 400 mg ciprofloxacin ready for infusion

Uses / Indications

Novidat DS is indicated for treatment of infections caused by susceptible bacteria, including:

• Lower respiratory tract infections (e.g. pneumonia)

• Urinary tract infections (complicated, acute pyelonephritis) 

• Skin and soft tissue infections 

• Other systemic and hospital-acquired infections when fluoroquinolone therapy is appropriate 

Dosage

• The usual IV dose is 400 mg every 12 hours (or as per local guidelines / susceptibility). 

• Infuse over 60 minutes to reduce risk of local irritation or adverse effects.

• Dose adjustments may be needed in renal impairment.

• Duration depends on infection type and patient response (often 7–14 days or longer in complicated cases).

In Case of Overdose

• Symptoms: GI distress (nausea, vomiting), CNS effects (dizziness, confusion, seizures), possible cardiac arrhythmias.

• Management: Supportive treatment, monitoring, and possibly removal via dialysis (some clearance possible) under supervision.

• Watch for renal function, electrolytes, and neurological status.

Missed Dose

• If an infusion is missed, administer as soon as feasible, unless it is very close to the next scheduled infusion.

• Do not double the dose.

How To Use / Administration Instructions

1. Inspect the vial for clarity and absence of particulate matter.

2. Use aseptic technique to prepare infusion set.

3. Administer intravenous infusion over about 60 minutes through a suitable IV line.

4. Ensure compatibility with other IV drugs—avoid mixing with incompatible medications.

5. Monitor patient vital signs during infusion for allergic or adverse reactions.

When Not to Use / Contraindications

• Known hypersensitivity to ciprofloxacin or other fluoroquinolones

• History of tendon disorders related to fluoroquinolones

• Myasthenia gravis (may exacerbate muscle weakness)

• Children, adolescents, or pregnant women unless benefit outweighs risk (some restrictions apply)

• Avoid use in patients with severe hepatic or renal impairment unless dose adjusted

Side Effects / Adverse Reactions

Common / less serious:

• Nausea, diarrhea, vomiting

• Headache, dizziness

• Local vein irritation at infusion site

• Rash, pruritus

Serious / less common:

• Tendonitis or tendon rupture (e.g. Achilles tendon)

• QT prolongation, cardiac arrhythmias

• CNS effects: seizures, confusion, hallucinations

• Hepatotoxicity

• Clostridioides difficile–associated diarrhea

• Hypersensitivity reactions including anaphylaxis

Precautions & Warnings

• Monitor renal and hepatic function, electrolytes, and ECG in at-risk patients

• Use caution in patients with known QT prolongation or on QT-prolonging drugs

• Avoid use of concomitant nonsteroidal anti-inflammatory drugs (NSAIDs) which may intensify CNS effects

• Avoid in patients at high risk of tendon disorders (elderly, corticosteroid users)

• Inform patients to report signs of tendon pain, swelling, or rupture immediately

• Use caution in CNS disorders or history of seizures

Drug Interactions

• Theophylline: may raise theophylline levels (monitor)

• Warfarin / oral anticoagulants: may enhance anticoagulant effect (monitor INR)

• Antiarrhythmics, antipsychotics: additive QT prolongation risk

• Iron, magnesium, calcium, zinc, sucralfate: interfere with absorption if coadministered orally (less relevant for IV)

• NSAIDs / corticosteroids: may increase risk of CNS side effects like seizures

Storage / Disposal

• Store vials at 20–25 °C (or as specified by manufacturer)

• Protect from light and freezing

• Use once opened; discard any unused portion per hospital/clinic policy

• Dispose of vials and infusion sets in medical sharps and waste containers

Control Drug / Prescription Status

• Prescription-only medicine

• Administered in clinical / hospital settings only under supervision

Quick Tips

• Novidat DS is a fluoroquinolone IV option for serious bacterial infections when oral therapy is not suitable

• Infuse slowly (≈1 hour) to reduce adverse reactions

• Always check for tendon pain or signs of allergic reaction during therapy

• Adjust dose in renal dysfunction and monitor ECG in high-risk patients

• Encourage hydration to protect kidneys