Bio-gem

Uses

Bio-gem is used for the treatment of the following bacterial infections in adults caused by sensitive organisms as follows-

Acute bacterial exacerbation of chronic bronchitis: caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.

Community-acquired pneumonia (of mild to moderate severity): caused by Streptococcus pneumoniae (including multi-drug resistant strains), Haemophilus influenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Klebsiella pneumoniae.

Bio-gem is also used to associated treatment for these conditions: Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB), Bacterial Infections, Community Acquired Pneumonia (CAP), Gonorrhea, Multidrug resistant Streptococcus pneumoniae infection, Bacterial rhinosinusitis

How Bio-gem works

The bactericidal action of gemifloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair, and recombination.

Dosage

Bio-gem dosage

Side Effects

The general adverse events include abdominal pain, diarrhea, headache, nausea, rash and vomiting. Some side effects have been infrequently reported such as fungal overgrowth in body, dizziness and insomnia, urticaria, pruritis and a maculopapular erythmatous skin rash.

Precaution

Precautions: For patients with severe impairment of renal function, alteration of the dosage regimen to 160 mg once daily is necessary. Adequate hydration of patients receiving Bio-gem should be maintained to prevent the formation of a highly concentrated urine and crystalluria. Bio-gem may cause dizziness; if this occurs, patients should not operate an automobile or machinery or engage in activities requiring mental alertness or co-ordination.

Warning: Tendinitis and tendon ruptures may occur in any age group during treatment with quinolones, including Bio-gem, but particularly in elderly patients or when corticosteroids are being co-administered. Bio-gem should be discontinued if tendinitis is suspected or at the first sign of pain or inflammation and the affected limb should be rested. In clinical studies with Bio-gem a small mean increase in QTc interval was observed. Bio-gem should be used with caution in patients predisposed to QTc interval prolongation or in patients taking other medications that are known to prolong the QTc interval. Bio-gem should be used with caution in patients with epilepsy.

Interaction

Bio-gem absorption is significantly reduced when aluminium or magnesium containing antacids and iron salts are concomitantly administered. Bio-gem should be taken at least 2 hours before or 3 hours after these agents. Bio-gem should be taken at least 2 hours before sucralfate administration. No clinically significant interactions have been observed when Bio-gem was co-administered with omeprazole theophylline, digoxin, warfarin and oral contraceptives.

Food Interaction

• Take with or without food. The absorption is unaffected by food.

Bio-gem multivitamins interaction

[Moderate] ADJUST DOSING INTERVAL: Oral preparations that contain magnesium, aluminum, or calcium may significantly decrease the gastrointestinal absorption of quinolone antibiotics.

Absorption may also be reduced by sucralfate, which contains aluminum, as well as other polyvalent cations such as iron and zinc.

The mechanism is chelation of quinolones by polyvalent cations, forming a complex that is poorly absorbed from the gastrointestinal tract.

The bioavailability of ciprofloxacin has been reported to decrease by as much as 90% when administered with antacids containing aluminum or magnesium hydroxide.

When coadministration cannot be avoided, quinolone antibiotics should be dosed either 2 to 4 hours before or 4 to 6 hours after polyvalent cation-containing products to minimize the potential for interaction.

When coadministered with Suprep Bowel Prep (magnesium

Please consult individual product labeling for specific recommendations.

Bio-gem Drug Interaction

Moderate: citric acid / potassium bicarbonate / sodium bicarbonate, citric acid / potassium bicarbonate / sodium bicarbonateMinor: sulfamethoxazole / trimethoprim, sulfamethoxazole / trimethoprimUnknown: 5-hydroxytryptophan, 5-hydroxytryptophan, contained in alcoholic beverages , contained in alcoholic beverages , amoxicillin / clavulanate, amoxicillin / clavulanate, diphenhydramine, diphenhydramine, diphenhydramine, diphenhydramine, acetaminophen, acetaminophen, penicillin v potassium, penicillin v potassium, cholecalciferol, cholecalciferol

Bio-gem Disease Interaction

Major: colitis, CNS disorders, myasthenia gravis, peripheral neuropathy, QT interval prolongation, tendonitisModerate: crystalluria, diabetes, renal dysfunction

Volume of Distribution

• 1.66 to 12.12 L/kg

Elimination Route

Rapidly absorbed from the gastrointestinal tract. The absolute bioavailability averages approximately 71%.

Half Life

7 (± 2) hours

Clearance

• renal cl=11.6+/- 3.9 L/hr [Healthy subjects receiving repeat doses of 320 mg orally]

Elimination Route

Bio-gem and its metabolites are excreted via dual routes of excretion.Following oral administration of gemifloxacin to healthy subjects, a mean (± SD) of 61 ± 9.5% of the dose was excreted in the feces and 36 ± 9.3% in the urine as unchanged drug and metabolites. The mean (± SD) renal clearance following repeat doses of 320 mg was approximately 11.6 ± 3.9 L/hr (range 4.6-6 L/hr), which indicates active secretion is involved in the renal excretion of gemifloxacin.

Pregnancy & Breastfeeding use

Bio-gem should not be used in pregnant or lactating women. The safety and efficacy of Bio-gem in pregnant or lactating women have not been established.

Contraindication

Known hypersensitivity to Bio-gem and other quinolones, Patients who have previously suffered tendon damage with fluoroquinolones. Bio-gem should not be used in children under 18 years of age.

Special Warning

Renal impairment: Dose adjustment in patients with mild/moderate renal impairment is not required. Some modification of dosage is recommended for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:

Creatinine Clearance (>40 ml/min): See usual dosage

Creatinine Clearance (<40 ml/min): 160 mg once daily

Patients on haemodialysis or continuous ambulatory peritoneal dialysis therapy should receive 160 mg once daily

Hepatic impairment: Bio-gem may be given to patients with hepatic impairment, with no requirement for dose adjustment.

Elderly patients: Dose adjustment is not required.

Acute Overdose

No specific antidote is known. Dialysis does not remove Bio-gem sufficiently to be useful in overdose. In the event of acute oral overdosage, the stomach should be emptied by inducing vomiting or by gastric lavage; the patient should be carefully observed, treated symptomatically and adequate hydration should be maintained.

Storage Condition

Store in a cool and dry place, protected from light and moisture. Keep out of reach of children.

Innovators Monograph

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