Malasiya Product

Orgyl Tablets

Orgyl Tablets

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:

Each film coated tablet contains; Ornidazole 500 mg
оrnidazole;
1 tablet contains 500 mg of ornidazole.

Excipients:
microcrystalline cellulose, corn starch, croscarmellose sodium, magnesium stearate, Opadry O3B53217 orange coating.

Orange coloured, film coated, round shaped tablets.

INDICATIONS:
Trichomoniasis (urinogenital infections in male and female caused by Trіchomonas vagіnalіs);
amebiasis (all of intestinal infections caused by Entamoeba hіstolytіca, including amebic dysentery, all of abenteric forms of amebiasis, especially hepatic amoebiasis); lambliasis.
Prophylaxis of infections caused by anaerobic bacteria after colon operations and in gynecology.

DOSAGE:
Trichomoniasis: There are two possible therapeutic regimens: Single-dose therapy ; five-days therapy. The tablets should be taken after meals. (a) Single dose therapy: 3 tablets in the evening (b) Five days therapy: 2 tablets (1 tablet morning and evening) The dosage for children is 25 mg per kg body weight per day, given in a single dose. Amoebiasis: Three days: 3 tablets in one evening dose. Five to ten days: 2 tablets (1 tablet morning and evening) Giardiasis (lambliasis): One to two days: 3 tablets in the evening in one dose Anaerobic Infections: Prophylaxis: 1500 mg orally, 12 hours before surgery the 500 mg 12-hourly for 3 to 5 days postoperatively. a) 3 days for the treatment of patients with amebic dysentery;
b) 5 – 10 days for the treatment of all other amebiasis forms.
Recommended schemes of the preparation dosage:

 Duration of the treatment

Daily dosage

Adults and children over 35 kg

Children below 35kg

а) amebic dysentery
3days

3 tablets as a single dose in the evening.
If body weight is more than 60 kg:
4 tablets (2 tablets in the morning and 2 tablets in the evening).

35 kg – 3 tablets as a single dose;
25 kg – 2 tablets as a single dose;
15 kg – 1 tablet as a single dose;
(it is calculated as 40 mg/kg per 1 kg of BW as a single dose)

b) other amebiasis forms
5–10 days

2 tablets (1 tablet in the morning and 1 tablet in the evening).

35 kg – 2 tablets as a single dose;
20 kg – 1 tablet as a single dose;
(it is calculated as 25 mg/kg per 1 kg of BW as a single dose)

Side effects and drug interactions.

ADVERSE REACTIONS:

Mild side effects such as somnolence, headache and gastrointestinal disturbances like nausea and vomiting may occur. Disturbances of the CNS such as dizziness, tremor, rigidity, poor coordination, seizures, tiredness, vertigo, temporary loss of consciousness and signs of sensory or mixed peripheral neuropathy have been observed in isolated cases. Taste disturbances, abnormal liver function tests and skin reactions have been observed.

Drug interactions:
In contrast to other nitroimidazole derivatives, ordinazole does not inhibit aldehyde dehydrogenase and is therefore not incompatible with alcohol. However, ornidazole potentiates the effect of coumarin type oral anticoagulants. The dosage of the anticoagulant has to be adjusted accordingly. Ornidazole prolongs the muscle-relaxant effect of vecuronium bromide.

Warnings and precautions

Caution should be exercised in patients with diseases of the CNS, e.g., epilepsy or multiple sclerosis. The effect of other medicines can be intensified or impaired. Somnolence, dizziness, tremor, rigidity, poor coordination, seizures, vertigo or temporary loss of consciousness may occur in patients receiving Orgyl. If they occur, such effects may affect tasks requiring alertness including the patient's ability to drive and operate machinery.

Overdosage and Contraindications

Symptoms:
convulsions, depression, peripheral neuritis, and symptoms mentioned in "Side effects" section, but in more severe form. Treatment is symptomatic, specific antidote is unknown, in convulsions – intravenous introduction of diazepam. Gastric lavage or hemodialysis is recommended for ornidazole excretion from the organism.
Ability to influence reaction velocity while driving or operating any other mechanisms.
Orgyl® can influence on ability to drive cars or operate complicated machines, therefore in case of central nervous system side effects appearance (somnolence, rigidity, dizziness, tremor, convulsions, hypotaxia, temporal loss of consciousness) it is necessary to avoid such activity.

CONTRAINDICATIONS:
Hypersensitivity to the preparation components and other nitroimidazole derivates. Patients with CNS affection (epilepsy, cerebral affection, disseminated sclerosis);
pathological blood affection or other hematological anomalies. Periods of pregnancy and lactation. Children age less than 3 years old.

Clinical pharmacology.

PHARMACOLOGICAL PROPERTIES:
After passive absorption into bacterium cell, the nitro group of ornidazole is reduced to amine group by ferredoxin type redox system. The formation of redox intermediate intracellular metabolites is believed to be the key component of microorganism killing for Ornidazole. The drug is active against anaerobic bacteria viz. Peptostreptococcus, Clostridium, B. fragilis, Prevotella, Porphyromonas, Fusobacterium and protozoa viz. E. histolytica, T. vaginalis, G. intestinalis etc. Rationale for combination of ciprofloxacin and ornidazole, Ornidazole which is a new derivative of nitroimidazole series has a longer half-life. It is recommended to be given twice a day. Therefore, it appears appropriate to combine ornidazole and ciprofloxacin as fixed dose combinations. Moreover, FDC will provide broad spectrum of activity as individual drugs are active against different pathogens PHARMACOKINETIC PROPERTIES:
Absorption: Following oral administration ornidazole is rapidly absorbed. Mean absorption is 90%. Peak plasma concentrations are reached within three hours. Distribution: The mean volume of distribution after i.v. administration is 1 litre per kg. Plasma protein binding of ornidazole is about 13%. The active ingredient of Orgyl penetrates the cerebrospinal fluid, the body fluids and the tissues very effectively. Plasma concentrations are within the range considered to be optimal for the various indications (6 to 36 mg/l). After repeated administration of 500 mg or 1000 mg every twelve hours to healthy volunteers, an accumulation factor of 1.5-2.5 calculated. Biotransformation: Ornidazole is mainly metabolised to 2-hydroxymethyl and a-hydroxymethyl metabolites in the liver. Both main metabolites are less active against Trichomonas vaginalis and anaerobic bacteria than the unchanged ornidazole. Elimination
The half-life is about thirteen hours. 85% of a single dose is eliminated within the first five days, most of this being metabolised. 4% of the dose is excreted as unaltered substance in the urine. Pharmacokinetics in Special Populations:
Patients with hepatic impairment:
In patients with liver cirrhosis the elimination half-life is longer (22 versus 14 hours) and clearance lower (35 versus 51 ml/min) than in healthy subjects. The dosing interval should be doubled in patients with severe hepatic impairment. Patients with renal impairment:
The pharmacokinetics of ornidazole are unaltered in renal impairment. Dose adjustment is therefore unnecessary in patients with impaired renal function. Ornidazole is removed by haemodialysis. An additional dose of 500 mg of ornidazole should be administered if the daily dose is 2 g/d, or an additional dose of 250 mg ornidazole if the daily dose is 1 g/d, should therefore be administered before the start of hemodialysis. Neonates and children: The pharmacokinetics of ornidazole in neonates and young children are similar to those in adults
Shelf-life:
3 years.

Storage:
Store below 30°C. Store in cool and dry place. Package:
10 tablets are packed in a Amber PVC blister; 10 blisters are 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