Ciprofloxacin hydrochloride Tablets 500mg

Ciprofloxacin hydrochloride Tablets 500mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Ciprofloxacin hydrochloride Tablet USP 250mg
• Ciprofloxacin hydrochloride Tablet USP 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Ciprofloxacin Tablets USP 250mg
  Each Film Coated Tablet Contains:
  Ciprofloxacin Hydrochloride USP
  Equivalent to Ciprofloxacin…………………250mg
  Excipients ………………………………q.s.
  Colour: Titanium Dioxide USP NF
• Ciprofloxacin Tablets USP 500mg
  Each Film Coated Tablet Contains:
  Ciprofloxacin Hydrochloride USP
  Equivalent to Ciprofloxacin…………………..500mg
  Excipients…………………………………..q.s.
  Colour: Titanium Dioxide USP

THERAPEUTIC INDICATIONS:

• Ciprofloxacin is used to treat serious infections, or infections when other anitbiotics have not worked. It’s used to treat bacterial infections, such as: chest infections (including pneumonia) skin and bone infections.

CAUTION &  WARNING:

• CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH.
  Read enclosed leaflet before use.
  Keep medicine out of reach of children.
•  WARNING : Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

• Storage: Store at 20° to 25°C (68° to 77°F). Store in cool, dry & dark place Protect from Light & moisture.
• Dosage: As directed by the Physician.

Please read this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others.

• If you experience any side effects, consult your doctor or pharmacist.

1. What is Ciprofloxacin Hydrochloride and what is it used for?

Ciprofloxacin Hydrochloride Tablets 500mg is a prescription antibiotic belonging to the fluoroquinolone class. It is used to treat a wide range of bacterial infections by inhibiting bacterial DNA synthesis.

Indications:

• Urinary tract infections (UTIs), including cystitis and pyelonephritis

• Respiratory tract infections (e.g., bronchitis, pneumonia)

• Skin and soft tissue infections

• Gastrointestinal infections (e.g., infectious diarrhea, typhoid fever)

• Bone and joint infections

• Prostatitis

• Gonorrhea and certain sexually transmitted infections

• Anthrax (inhalational) post-exposure

2. What you need to know before you take Ciprofloxacin

Do NOT take Ciprofloxacin if you:

• Are allergic to ciprofloxacin, other quinolones (e.g., levofloxacin), or any ingredients in the formulation

• Are taking tizanidine (used for muscle spasticity)

• Have a history of tendon rupture related to quinolone use

• Are a child or adolescent (unless advised by your doctor for specific infections)

Warnings and precautions:

Tell your doctor before using Ciprofloxacin if you:

• Have epilepsy or history of seizures

• Suffer from kidney, liver, or heart conditions

• Have myasthenia gravis (muscle weakness)

• Are over 60 or on corticosteroids (increased risk of tendon problems)

• Have or had psychiatric illness

3. Interactions with other medications

Tell your doctor or pharmacist if you are taking or have recently taken:

• Tizanidine – severe drop in blood pressure and drowsiness

• Theophylline – risk of side effects increases

• Antacids, iron, zinc supplements, sucralfate, or calcium-fortified drinks – reduce ciprofloxacin absorption

• Warfarin or other anticoagulants – increased bleeding risk

• NSAIDs – increased risk of seizures

• Clozapine, ropinirole, phenytoin – may alter blood levels of these drugs

• Oral diabetes medications – may increase or decrease blood sugar levels

Wait at least 2 hours before or 6 hours after taking mineral supplements or antacids.

4. How to take Ciprofloxacin Hydrochloride Tablets

Dosage (Adult):

• Typically 500mg twice daily, depending on the type and severity of the infection.

• Duration of therapy: 5–14 days or as prescribed.

Instructions:

• Swallow the tablet whole with water.

• Take with or without food (preferably on an empty stomach for better absorption).

• Maintain adequate hydration during treatment.

• Do not take with dairy products or calcium-fortified juices alone.

If you miss a dose:

Take it as soon as possible. If it’s close to your next dose, skip the missed one. Do not double up.

If you take too much (overdose):

Contact your doctor or go to the nearest hospital. Symptoms may include dizziness, fatigue, seizures, or irregular heartbeat.

5. Possible side effects

Like all medicines, Ciprofloxacin may cause side effects.

Common (1 in 10):

• Nausea, diarrhea, vomiting

• Abdominal pain

• Rash

• Joint pain

Uncommon (1 in 100):

• Fungal superinfection (e.g., thrush)

• Sleep disturbances

• Headache or dizziness

• Abnormal liver function tests

Rare but serious:

• Tendonitis or tendon rupture

• Seizures or tremors

• Severe allergic reactions (anaphylaxis)

• Psychosis or suicidal thoughts

• Photosensitivity (increased skin reaction to sunlight)

Stop taking the medicine and seek immediate medical help if you experience:

• Swelling of face, lips, or throat

• Sudden shortness of breath

• Severe skin rash or peeling

• Yellowing of the eyes or skin

6. How to store Ciprofloxacin Tablets

• Store below 30°C (86°F)

• Protect from moisture and sunlight

• Keep in the original packaging

• Keep out of reach of children

• Do not use after the expiry date

7. Contents of the Pack and Other Information

What Ciprofloxacin Tablets contain:

• Active ingredient: Ciprofloxacin Hydrochloride equivalent to Ciprofloxacin 500mg

• Other ingredients: Microcrystalline cellulose, maize starch, colloidal silicon dioxide, magnesium stearate, and film coating materials

Tablet Description:

• White, film-coated, oblong tablet with breakline

Pack sizes:

• Blister packs of 10, 20, or 100 tablets

8. Manufacturer Information

TAJ PHARMA INDIA LTD.
Plot No.1019, Vill. – Sarigam, G.I.D.C., Road No. 10,
Dist. – Valsad, Gujarat, India 396155
📧 Email: info@tajpharma.com
🌐 Website: www.tajpharma.in

9. Frequently Asked Questions (FAQs)

Q. Can Ciprofloxacin be used during pregnancy?

Not recommended unless absolutely necessary. Inform your doctor if you are pregnant or planning to conceive.

Q. Is Ciprofloxacin safe during breastfeeding?

Small amounts may pass into breast milk. Consult your doctor before use.

Q. Can I drink alcohol while on Ciprofloxacin?

While not strictly contraindicated, alcohol may worsen side effects like dizziness or stomach upset.

Q. Can Ciprofloxacin treat COVID-19?

No, ciprofloxacin is not effective against viral infections like COVID-19.