PYLOBACTUS

Tinidazole + Clarithromycin + Lansoprazole is a combination of three medicines: Tinidazole , Clarithromycin and Lansoprazole. Tinidazole is an antibiotic which kills the bacteria and other microorganisms that cause infections by damaging their DNA. Clarithromycin is also an antibiotic. It stops bacterial growth by preventing the synthesis of essential proteins required by the bacteria to carry out vital functions. Together, they treat your infection effectively. Lansoprazole is a proton pump inhibitor (PPI) which reduces the amount of acid in the stomach and prevents acid-related indigestion and ulcers.

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PYLOBACTUS

Lansoprazole, Tinidazole, Clarithromycin Combikit

Composition :

Each combipack kit contains :

A) 2 GASTRO-RESISTANT

LANSOPRAZOLE CAPSULES BP 30 MG Each hard gelatin capsule contains : Lansoprazole BP 30 mg
(As enteric coated pellets)
Excipients Q.S
Approved colours used in empty capsule shell & pellets

B) 2 TINIDAZOLE TABLETS 500 MG

Each film coated tablet contains:
Tinidazole BP 500 mg
Excipients Q.S.
Colour: Tartrazine & Titanium Dioxide BP

C) 2 CLARITHROMYCIN TABLETS BP 250 MG

Each film-coated tablet contains:
Clarithromycin BP 250 mg
Excipients Q.S.
Colour: Titanium Dioxide BP

1.1 Pharmaceuticals form:

Gastro Resistance Lansoprazole capsules BP 30 mg : Capsule

Tinidazole tablets 500 mg : Tablet

Clarithromycin tablets BP 250 mg: Tablet

Therapeutic Indication:

This product is used to treat stomach/ intestinal ulcer caused by the bacteria H. Pylori and to prevent the ulcer from recurring. Treating an ulcer reduces the risk of serious damage to the lining of the stomach/ intestinal (such as bleeding, tearing, blockage). morning and similarly one each in the evening. The duration of therapy recommended is for 7 days.

1.2 Posology And Method Of Administration:

posology

One PYLOKIT pack contains two capsules of lansoprazole (30 mg), two tablets of tinidazole (500 mg) and two tablets of clarithromycin (250 mg). One pack is for one day of treatment. From this specially designed pack, one capsule of lansoprazole, one tablet of tinidazole and one tablet of clarithromycin is to be taken in the orning morning and similarly one each in the evening. The duration of therapy recommended is for 7 days.

1.3 Contraindications & special warnings:

Hypersensitivity to lansoprazole or tinidazole or clarithromycin.

Lansoprazole should not be administered with atazanavir.

During the first trimester of pregnancy.

In Nursing Mothers: Interruption of breasffeeding is recommended during tinidazole therapy and for 3 days following the last dose.

Concomitant Administration of Clarithromycin and Any of the Following Drugs is Contraindicated: Cisapride, pimozide, astemizole, terfenadine, and ergotamine or dihydroergotamine. There have been postmarketing reports of drug interactions when clarithromycin and/or erythromycin are co-administered with cisapride, pimozide, astemizole or terfenadine, resulting in cardiac arrhythmias (QT prolongation, ventricular tachycardia, ventricular fibrillation, and torsades de pointes), most likely due to inhibition of metabolism of these drugs by erythromycin and clarithromycin. Fatalities have been reported.

Tell your doctor if you have ever had:

Liver disease; kidney disease; myasthenia gravis

1.4 Drug interaction:

Lansoprazole

Tinidazole

Clarithromycin

Drugs with pH-Dependent Absorption KineticsPotential Effects of Tinidazole on Other DrugsRitonavir
WarfarinAlcohols, disulfiramDigoxin
TacrolimusLithiumCYP3A
TheophyllinePhenytoin,fosphenytoinCarbamazepine and terfenadine
ClopidogrelCyclosporine, tacrolimusColchicine
MethotrexateFluorouracil:Oral hypoglycemic agents/insulin
CYP3A4 inducers such as phenobarbital, rifampin, phenytoinEfavirenz, nevirapine, rifampicin, rifabutin and rifapentine
CYP3A4 inhibitors such as cimetidine and ketoconazoleSildenafil, tadalafil and vardenafil
Cholestyramine:Tolterodine
OxytetracyclineTriazolobenzodiazepines (e.g. alprazolam, midazolam, triazolam)
Atazanavir
Itraconazole
Saquinavir
Anti-arrhythmics
Ergotamine/dihydroergotamine
Triazolobenziodidiazepines

(such as triazolam and alprazolam)

and related benzodiazepines (such as midazolam)

Oral anticoagulants
HMG-CoA reductase inhibitors

1.5 Pregnancy and lactation:

Pylobactus kit is not recommended in pregnancy.

Consult your doctor or pharmacist if you are breastfeeding.

1.6 Undesirable Effects:

Common side effect Include: Diarrhea, headache, nausea, vomiting, stomach pain, unusual or unpleasant taste in your mouth, constipation, dark colour stools, dry mouth, increased thirst, or vaginal itching, or discharge.

Tell your doctor if you have rare but very serious side effects including: muscel weakness, dark urine, yellowish eye, or skin, easy bruising, or bleeding, signs of infection, or mental/ mood changes.

1.7 Overdose:

In case of overdosage, discontinue medicines, treat symptomatically, and institute supportive measures as required. 2. Pharmacological property:

Lansoprazole is a gastric PPI. It inhibits the final stage of gastric acid formation by inhibiting the activity of H-F/K-E ATPase of the parietal cells in the stomach. The inhibition is dose-dependent and reversible and the effect applies to both basal and stimulated secretion of gastric acid. Lansoprazole is concentrated in the parietal cells and becomes active in their acidic environment, whereupon it reacts with the sulfhydryl group of H+/K+ATPase causing inhibition of the enzymeactivity.

Clarithromycin is an antibiotic belonging to the macrolides antibiotics group. It experts its antibacterial action by selectively binding to the 50s ribosomal subunit of susceptible bacteria preventing translocation of activated amino acid.it inhibits the intracellular protein synthesis of susceptible bacteria.

Tinidazole is an anti-protozoal, antibacterial agent.The nitro-group of tinidazole is reduced by cell extracts of Trichomonas. The free nitro-radical generated as a result of this reduction may be responsible for the anti-protozoal activity. Chemically reduced tinidazole was shown to release nitrites and cause damage to purified bacterial DNA in-vitro. Additionally, the drug caused DNA base changes in bacterial cells and DNA strand breakage in mammalian cells. The mechanism by which tinidazole exhibits activity against Giardiaand Entamoeba species is not known.

2.1 pharmacodynamic and pharmacokinetic properties:

Absorption:

Lansoprazole:

The absorption of lansoprazole is rapid, with the mean Cmax occurring approximately 1.7 hours after oral dosing, and the absolute bioavailability is over 80%. In healthy subjects, the mean (tSD) plasma half-life was 1.5 (±1.0) hours. Both the Cmax and AUC are diminished by about 50 to 70% if lansoprazole is given 30 minutes after food, compared with the fasting condition. There is no significant food effect if lansoprazole is given before meals.

Tinidazole:

After oral administration, tinidazole is rapidly and completely absorbed. A bioavailability study of tinidazole tablets was conducted in adult healthy volunteers. All subjects received a single oral dose of 2 g (four 500 mg tablets) of tinidazole following an overnight fast. Oral administration of four 500 mg tablets of tinidazole under fasted conditions produced a mean peak plasma concentration (Cmax) of 47.7 (±7.5) mcg/mL, with a mean time to peak concentration (Tmax) of 1.6 (±0.7) hours, and a mean area under the plasma concentration-time curve (AUCO-infinity) of 901.6 (± 126.5) mcg.hr/mL at 72 hours. The elimination half-life (T1A) was 13.2 (±1.4) hours. Mean plasma levels decreased to 14.3 mcg/mL at 24 hours, 3.8 mcg/mL at 48 hours, and 0.8 mcg/mL at 72 hours following administration. Steady-state conditions are reached in 2% to 3 days of multi-day dosing. Administration of tinidazole tablets with food resulted in a delay in the Tmax of approximately 2 hours and a decline in the Cmax of approximately 10%, compared with fasted conditions. However, administration of tinidazole with food did not affect AUC or T% in this study. In healthy volunteers, administration of crushed tinidazole tablets in artificial cherry syrup, after an overnight fast, had no effect on any pharmacokinetic parameter as compared with tablets swallowed whole under fasted conditions.

Clarithromycin:

Clarithromycin is rapidly and well absorbed from gastro intestinal tract after oral administrator of clarithromycin tablet. The microbiologically active metabollite 14- hydroxiclarithromycin is formed by first pass metabolism. Clarithromycin may be given without regard to meals as food does not effect the extent of Sioavaililility of clarithromycin tablet.

Distribution:

Lansoprazole is 97% bound to plasma proteins. Plasma protein binding is constant over the concentration range of 0.05 to 5.0 mcg/mL.

Tinidazole is distributed into virtually all tissues and body fluids, and also crosses the blood-brain barrier. The apparent volume of distribution is about 50 liters. Plasma protein binding of tinidazole is 12%. Tinidazole crosses the placental barrier and is secreted in breast milk.

When clarithromycin 500 mg is given three times daily the clarithromycin plasma concentration are increased with respect to the 500 mg twice daily dosage, clarithromycin provides tissue concentration that are several times higher than the circulating drugs level.

Elimination:

Following single-dose oral administration of lansoprazole, virtually no unchanged lansoprazole was excreted in the urine. In one study, after a single oral dose of 14C­lansoprazole, approximately one-third of the administered radiation was excreted in the urine and two-thirds was recovered in the feces. This implies a significant biliary excretion of the lansoprazole metabolites.

The plasma half-life of tinidazole is approximately 12 to 14 hours. Tinidazole is excreted by the liver and the kidneys. Tinidazole is excreted in the urine mainly as unchanged drug (approximately 20 to 25% of the administered dose). Approximately 12% of the drug is excreted in the feces.

The pharmacokinetics of clarithromycin are no linear. At 500 mg b.i.d. daily dosing urinary excreation is greater than the 14- hydroxyclarithromycin is the major urinary metabolite and account for 10-15% of the dose. Most of the remainder of the dose is eliminated in the faecess, primarily via the bile 5-10% of the parent drug is recovered from faeces.

3. special precaution for storage:

Store below 30°C. Protect from light and moisture.

Keep the medicine out of reach of children.

Presentation:

One day therapy: 1 Kit contains:

  1. Gastro Resistant Lansoprazole capsules BP 30 mg 2. Tinidazole tablets 500 mg
  2. Clarithromycin tablets BP 250 mg

7-day therapy: 7 X 1 kit

Marketed by:

PYXUS PHARMACEUTICALS PVT. LTD.

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