Malasiya Product

Emilar Jelly

Emilar Jelly

Why you have been prescribed this medicine?

You have been prescribed this medicine if you have any of the following:

When you should consult your doctor?

You should consult your doctor if you experience any of the following:
Usually the preparation is well tolerated. During a long-term usage of high doses there can be possible follow side effects:

GIT:
nausea, vomiting, heartburn, diarrhea.

CNS:
hyperexcitability of CNS, headache.

Urinary system:
formation of urinary, cystine and oxalate concernments.
Skin and subcutaneous tissue: allergic reactions.

Blood system:
It can cause erythrocyte hemolysis in patients with insufficiency of glucose-6-phosphatdehydrogenase of hematocytes.

What to do if you miss a dose?

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise take it as soon as you remember and then go back to taking it as you would normally.

Things you MUST NOT DO while on this medicine?

Ascozin® increases salicylates (increases a risk of crystalluria), ethynilestradiol, benzylpenicillin and tetracyclines concentrations in blood, and decreases per oral contraceptives concentration in blood. It reduces anticoagulation effect of coumarin derivatives. It improves iron drugs absorption in intestine. It increases general clearance of ethyl alcohol. Quinolone drugs, calcium chloride, salicylate, corticosteroid decrease vitamin C reserve when used for a long term. Corticosteroids (cortisone and prednisolone), which are administered in concrete diseases (arthritis, bronchial astma etc), also reduce vitamin C and zinc levels.
Concurrent usage of ascorbic acid and deferoxamine enhances tissue toxicity of iron, especially in cardiac muscle that can cause decompensation of blood circulatory system. It can be used only in 2 hours after deferoxamine injection. A long-term administration of high doses in patients, who are treated by disulfiram, inhibits disulfamide-alcohol reaction.
High doses of the preparation decrease efficacy of tricyclic depressants.

What to do if you accidentally take too much (overdose) of the medicine?

Symptoms:
nausea, vomiting, intestine spasm, diarrhea; it is possible allergic reaction, kidney dysfunction, blood pressure increase, hyperexcitability of CNS, sleep disturbance.

Treatment:
It is symptomatic.

Is it safe in pregnancy and breast-feeding?

Tell your doctor immediately if you become pregnant while taking this medication. For safety of any drug during pregnancy or breastfeeding – please consult your doctor.

Storage Conditions:

Store in a dry, protected from light place at a temperature not more than 25° C.
Keep it out of reach of children.

Drug Description

COMPOSITION:

Emilar Jelly contains: Chlorhexidine Gluconate 0.5%w/w Preservative: Methyl Paraben 0.05%.

Indications and dosage.

INDICATIONS:
Emilar Jelly lubricates condoms and is for personal lubrication when vaginal dryness causes discomfort. It also eases insertion of rectal thermometers and tampons.

DOSAGE:
Squeeze tube to obtain desired amount. Emilar Jelly can be applied directly on to condom or skin. Reapply as needed. Close after use.


Indications

Daily dose

Number of uses per day

Treatment duration

Acute sinusitis

500 mg

1 time

10 – 14 days

Exacerbation of chronic bronchitis

250 – 500 mg*

1 time

7-10 days

Outhospital pneumonia

500-1000 mg

1-2 times

7-14 days

Non-complicated urinary tract infection

200 mg

1 time

3 days

Prostatitis

500 mg

1 time

28 days

Complicated urinary tract infection, including pyelonephritis

200 mg

1 time

7-10 days

Infections of skin and soft tissues

500-1000 mg

1-2 times

7-14 days


Septicemia/bacteriemia

500-1000 mg

1-2 times

10-14 days

Intraabdominal infections*

500 mg

1 time

7-14 days


* In combination with antibiotics with an action on anaerobic causative agent. Dosage for patients with kidney function disorders and creatinine clearance less than 50 ml/min:



Creatinine clearance

Dosage regimen (in accordance with infection severity)

50-20 ml/min

initial dose: 250 mg
next doses: 125 mg/24 h

initial dose: 500 mg
next doses: 250 mg/24 h

initial dose: 500 mg
next doses: 250 mg/12 h

19-10 ml/min

initial dose: 250 mg
next doses: 125 mg/48 h

initial dose: 500 mg
next doses: 125 mg/24 h

initial dose: 500 mg
next doses: 125 mg/12 h

<10 ml/min (also in hemodialysis and CAPD¹)

initial dose: 250 mg
next doses: 125 mg/48 h

initial dose: 500 mg
next doses: 125 mg/24 h

initial dose: 500 mg
next doses: 125 mg/24 h


After hemodialysis or chronic ambulatory peritoneal dialysis (CAPD) additional doses are not required.

Dosage for patients with liver function disorders:
Dosage adjustment is not necessary because Levofloxacin is insignificantly metabolised in liver.

Dosage for elderly patients:
If there is no kidney function disorders it is not necessary dose adjustment.


Side effects and drug interactions.

ADVERSE REACTIONS:

*“Inform doctors about unexpected reactions after using drugs.”

Warnings and precautions

For external use only. If Emilar Jelly comes into contact with the eyes, wash out promptly and thoroughly with water.

Overdosage and Contraindications

Overdose:

Symptoms:
mental confusion, dizziness, impairment of consciousness and convulsive attacks, nausea, tunica mucous erosion, QT-interval lengthening.

Treatment:
the therapy is symptomatic. In cases of overdose it is necessary to examine properly a patient, including ECG. In cases of evident overdose gastric lavage is administered. Antacids are used for mucous coat of stomach protection. Hemodialysis, including peritoneal dialysis or CAPD, is non-effective for Levofloxacin excretion from the organism. There are no any specific antidotes.

Influence on velocity reactions while driving motor transport and operating other mechanisms:
Patients, who drive motor transport, operate other machines and mechanisms, should take into account possible unsuspected effects of central nervous system (dizziness, somnolence, mental confusion, visual and hearing impairment, movement disturbance during walking, also while walking).

Clinical pharmacology.

PHARMACOLOGICAL PROPERTIES:

Pharmacodynamics:
Levofloxacin has a wide spectrum of antibacterial action. Bactericidal effect is provided due to inhibition of bacterial enzyme of DNK-gyrase, which is of topoisomerase type II, by Levofloxacin. The result of this inhibition is impossibility of bacterial DNK transfer from "relaxation" condition to "over involuted condition" that, by-turn, render further bacterial cells division (fissiparity) impossible. Activity spectrum of Levofloxacin includes gram-positive and gram-negative bacteria, including non-fermentative bacteria. Following microorganisms are sensitive to the preparation:

- gram-positive aerobes:
Staphylococcus aureus methi-S, Staphylococcus haemolyticus methi-S, Staphylococcus saprophyticus, Streptococci group C, G, Streptococcus agalactiae, Streptococcus pneumoniae peni – i/S/R, Streptococcus pyogenes;

- gram-negative aerobes:

Acinetobacter baumannii, Citrobacter freundii, Eikenella corrodens, Enterobacter agglomerans, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae ampi-S/R, Haemophilus para-influenzae, Klebsiella oxytoca, Klebsiella pneumoniae, Moraxella catarrhalis +/-, Morganella morganii, Pasteurella multocida, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Pseudomonas aeruginosa, Serratia marcescens;

- anaerobes:
Bacteroides fragilis, Clostridium perfringens, Peptostreptococcus;

- others:
Chlamydia pneumoniae, Chlamydia psittaci, Legionella pneumophila, Mycoplasma pneumoniae, Ureaplasma, H.pylori.

Inconstantly sensitive to the preparation action:
- gram-positive aerobes : Staphylococcus haemolyticus methi-R;
- gram-negative aerobes: Burkholderia cepacia;
- anaerobes – Bacteroides ovatus, Bacteroides thetaiotamicron, Bacteroides vulgaris, Clostridium difficile.
Resistant to the preparation action:
gram-positive aerobes: Staphylococcus aureus methi-R. Like another fluoroquinolones Levofloxacin is non-active about spirochete.

Pharmacokinetics:
Absorption:
In per oral use Levofloxacin is quickly and nearly fully absorbed with plasma concentration peak, which is observed in 1 hour after intake. Absolute bioavailability is nearly 100%. Levofloxacin is liable to liner pharmacokinetics in diapason from 50 to 600 mg. Meal has some influence on its absorption.
Distribution:
Approximately 30-40% of Levofloxacin binds with serum protein. Cumulative effect of Levofloxacin in dosage of 500 mg 1 time per day does not have clinical meaning and can be neglected. There is an insignificant but foreseen its cumulation in dosage of 500 mg 2 times per day. Stable distribution indexes are reached within 3 days. Distribution in tissues and liquids of organism:
Distribution in bronchial mucosa and liquid secretion from bronchial epithelium: Maximal concentration of Levofloxacin in bronchial mucosa and liquid secretion from bronchial epithelium in dose more than 500 mg per os was 8.3 and 10.8 mg/ml, correspondingly. Distribution in lungs tissue: Maximal concentration of Levofloxacin in lungs tissue in dose more than 500 mg per os was 11.3 mg/ml and was reached within 4 – 6 hours after use. Concentration in lungs constantly exceeded those one in plasma. Distribution in bladder fluid: Maximal concentration of Levofloxacin in bladder fluid after intake of 500 mf 1 – 2 times per day was 4 and 6.7 mg/ml, correspondingly. Distribution in cerebrospinal fluid: Levofloxacin is poorly penetrates into cerebrospinal fluid. Concentration in urine: Average Levofloxacin concentration during 8 – 12 hours after 150 mg, 300 mg or 500 mg single dose per os was 44 mg/ml, 91 mg/ml and 200 mg/ml, correspondingly.

Metabolism: Levofloxacin is insignificanly metabolised, its metabolites are desmethyl-levofloxacin and N-oxide Levofloxacin. These metabolites are less than 5% of the preparation, which is excreted with urine.

Excretion:
After per oral use Levofloxacin is rather slowly excreted from plasma (half-life period is 6-8 h). It is excreted mainly through kidney (more than 85% of injected dose). There is no difference between pharmacokinetics of Levofloxacin in intravenous and per oral administration. PHARMACEUTICAL CHARACTERISTICS: General physic-chemical properties: film coated capsule-shaped pink tablets with etching "500" or "750" on one side.

Shelf-life: 3 years.

Storage:
Store in a dry, protected from light place at a temperature not more than 25° C. Keep it out of reach of children. Package:
or 10 tablets are in a blister; 1 blister is in a carton box.

Conditions of supply: By prescription.

CERTIFICATES

KEEP IN TOUCH

Kusum Healthcare
D-158A, OKHLA,INDUSTRIAL AREA,
PHASE-I, NEW DELHI,
Pin 110020
INDIA
Tel: 011-41005147, 011-40514919
Fax: +91-11-40527575

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