Composition
Ciplox-TZ-H Tablets
Each film-coated tablet contains....
Ciprofloxacin Hydrochloride
IP equivalent to Ciprofloxacin 500 mg and
Ciprofloxacin IP 250 mg and
Tinidazole IP 300 mg
Ciplox-TZ
Tablets
Each film coated tablet contains ....
Ciprofloxacin Hydrochloride IP equivalent to Ciprofloxacin
500 mg and
Tinidazole IP 600 mg
Description
Ciplox-TZ Tablets
is a fixed dose combination of ciprofloxacin hydrochloride
and tinidazole. Ciprofloxacin is a fluorinated 4-quinolone
anti-bacterial agent with a broad spectrum of activity.
It exerts its bactericidal effect by inhibiting the
A subunit of DNA gyrase, an essential enzyme involved
in DNA replication.
Tinidazole is a nitroimidazole which has antimicrobial
action against microaerophilic Protozoa, Giardia lamblia,
Entamoeba histolytica and Trichomonas vaginalis and
against obligate anaerobic bacteria. It acts by damage
of DNA strands or inhibition of their synthesis.
Indications
Ciplox-TZ is indicated
for the treatment of a wide variety of infections
caused by susceptible gram-positive and gram-negative
organisms along with anaerobes and protozoa.
-
Surgical
prophylaxis and surgical wound infections
-
Gynaecological
infections including prophylaxis in gynaecological
surgeries
-
Respiratory
Tract infections like lung abscess, aspiration pneumonia,
empyema and bronchiectasis
-
ENT infections
like chronic sinusitis, chronic suppurative otitis
media, cholesteatoma and mastoiditis.
-
Orofacial
and Dental infections
-
Dermatological
infections like cellulitis, breast and other cutaneous
abscesses, gangrene, diabetic and decubitus ulcers
-
Intra-abdominal
infections and diarrhoeas of mixed bacterial and
protozoal origin.
Dosage
and Administration
Ciplox-TZ should be taken one
hour before or two hours after meals with a glass of
water.
Adults: One tablet twice
a day.
IN
IMPAIRED RENAL FUNCTION
If creatinine clearance is less than 20 ml/min, half
the recommended dosage may be administered.
Contraindications
Hypersensitivity to the quinolone group or the nitroimidazole
group of compounds and the those patients with a history
of blood dyscrasias.
|
|
Warnings and Precautions
DRUG INTERACTIONS
Theophylline:
Serum concentration and elimination half-life of theophylline
may be increased when it is used concurrently with ciprofloxacin.
Antacids: Antacids containing magnesium hydroxide
and/or aluminium hydroxide may interfere with the absorption
of ciprofloxacin, resulting in lower serum and urine
levels
.
Anticoagulants: Prolongation of bleeding time
has been reported during concomitant administration
of ciprofloxacin and anticoagulants.
Cyclosporin: Transient increases in serum creatinine
have been seen following concomitant administration
of cyclosporin and ciprofloxacin.
Caffeine: Ciprofloxacin may interfere with the
metabolism of caffeine resulting in reduced clearance
of caffeine.
Alcohol: Disulfiram-like antabuse reaction may
occur due to Tinidazole.
PREGNANCY
Ciplox-TZ is not recommended
for use in pregnancy.
NURSING
MOTHERS
Ciplox-TZ is not recommended
for use in nursing mothers.
PAEDIATRIC
USE
As with other drugs of this class,
ciprofloxacin has been shown to cause arthropathy in
weight-bearing joints of immature animals. Hence ciprofloxacin
is usually not recommended for use in children.
PAEDIATRIC USE
As with other drugs of this class
of quinolones, ciprofloxacin has been shown to cause
arthropathy in weight-bearing joints of immature animals.
Hence the drug is usually not recommended for use in
children.
Side
Effects
CNS stimulation: Ciprofloxacin
should be used with caution in patients with CNS disorders
such as severe cerebral arteriosclerosis or epilepsy.
Crystalluria: Inadequate intake of water, when on ciprofloxacin,
can cause crystalluria.
Phototoxicity: Moderate to severe phototoxicity has
been observed in patients who are exposed to direct
sunlight with some members of the quinolone class of
drugs.
Metallic taste, mild nausea, headache, vomiting, anorexia,
abdominal pain, furry tongue, pruritus, photosensitivity,
vasculitis, skin rash, dizziness, vertigo, incoordination,
insomnia, tremor, convulsion, paraesthesia, blurred
vision, eosinophilia, leucopenia, myalgia, tendinitis
and exacerbation of myasthenia gravis.
Presentation
Ciplox-TZ Blister
pack of 10 tablets
Ciplox-TZ-H Blister
pack of 10 tablets
|
