Composition:
Each film coated tablet contains:
Ciprofloxacin Hydrochloride USP equivalent to Ciprofloxacin anhydrous 500 mg
Tinidazole BP 600 mg
Colour:
Quinoline Yellow
Titanium dioxide
Excipients:
Calcium Hydrogen Phosphate BP
Maize Starch BP
Methyl Hydroxybenzoate BP
Propyl Hydroxybenzoate BP
Magnesium Stearate BP
Colloidal Anhydrous Silica BP
Croscarmellose Sodium BP
Sodium Starch Glycolate BP
Hypromellose BP
Lactose BP
Polyethylene Glycol BP
Purified Talc BP
Pharmacological Category:
Shalcip 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.
Tinidazole is a nitroimidazole which has antimicrobial action against microaerophilic protozoa, Giardia lamblia, Entamoeba histolytica and Trichomonas vaginalis, and against obligate anaerobic bacteria.
Pharmacological Action:
Ciprofloxacin exerts its bactericidal effect by inhibiting the A subunit of DNA gyrase, an essential enzyme involved in DNA replication.
Tinidazole acts by damage of DNA strands or inhibition of their synthesis.
Therapeutic Indications:
Shalcip 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, including:
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
Diarrhoeas of mixed bacterial and protozoal origin
Contraindications:
Hypersensitivity to the quinolone group or the nitroimidazole group of compounds.
Patients with a history of blood dyscrasias.
Dosage and Method of Administration:
Shalcip 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.
Adverse Reaction:
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.
Other adverse reactions include:
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
Exacerbation of myasthenia gravis
Warnings & Precautions for Use in Special Populations:
Usage in Pregnancy & Lactation:
Shalcip TZ is not recommended for use in pregnancy.
Nursing Mothers:
Shalcip 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.
Seizures and neuropathy have been reported with tinidazole. Discontinue the drug if abnormal neurologic signs develop.
Vaginal candidiasis may develop with tinidazole and require treatment with an antifungal agent.
Use tinidazole with caution in patients with blood dyscrasias. Tinidazole may produce transient leukopenia and neutropenia.
The drug may cause low blood sugar and mental health related side effects.
Low blood sugar levels, also called hypoglycaemia, can lead to coma.
The mental health side effects are more prominent and more consistent across the systemic fluoroquinolone drug class.
The mental health side effects of the fluoroquinolones are:
Disturbances in attention
Disorientation
Agitation
Nervousness
Memory impairment
Serious disturbances in mental abilities called delirium
This drug may cause low blood sugar and mental health related side effects.
Fluoroquinolones have the potential to cause permanent peripheral neuropathy.
Effects on Ability to Drive and Operate Machinery:
Not applicable.
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.
Symptoms of Over Dosage & Its Treatment:
In the event of acute overdosage, reversible renal toxicity has been reported in some cases.
The stomach should be emptied by inducing vomiting or by gastric lavage.
The patient should be carefully observed and given supportive treatment, including:
Monitoring of renal function.
Administration of magnesium, aluminum, or calcium containing antacids, which can reduce the absorption of ciprofloxacin.
Adequate hydration must be maintained.
Only a small amount of ciprofloxacin (<10%) is removed from the body after hemodialysis or peritoneal dialysis.
There is no specific antidote for the treatment of overdosage with tinidazole; therefore, treatment should be symptomatic and supportive.
Gastric lavage may be helpful.
Hemodialysis can be considered because approximately 43% of the amount present in the body is eliminated during a 6-hour hemodialysis session.
Storage Condition:
Do not store above 30°C.
Protect from sunlight.
Keep out of reach of children.
Presentation:
Shalcip TZ
Blister pack of 10 tablets.
PPB Reg. No.: H2014/CTD1007/241
Publication Date: 28-01-2025
Manufactured by / Fabriqué par / Fabricado por:
SHALINA LABORATORIES PVT. LTD.
96, Maker Chambers VI,
Nariman Point,
Mumbai - India.
At:
Plot No. E-2 & E-3,
M.I.D.C. Jejuri,
Tal: Purandar,
Dist: Pune,
Maharashtra - India.
EFP 20601158-00 037