Vietnam 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:
1. Bacterial vaginosis (non-specific vaginitis).
2. Trichomoniasis. Genitourinary infections in women and men due to Trichomonas vaginalis.
3.Amoebiasis. All intestinal infections due to Entamoeba histolytica, including amoebic dysentery. All extraintestinal forms of amoebiasis, especially amoebic liver abscess.
4. Giardiasis (lambliasis).
5. Infections due to anaerobic bacteria. Treatment of infections such as septicaemia, meningitis,
peritonitis, postoperative wound infections, puerperal sepsis, septic abortion, and endometritis, with demonstrated or suspected involvement of susceptible bacteria (see Properties and Effects).
6. Prophylaxis during surgical interventions, particularly those involving the colon, and in gynaecological operations.

When you should consult your doctor?

You should consult your doctor if you experience any of the following:

Ornidazole is contraindicated in patients hypersensitive to ornidazole and other nitroimidazoles. Nitroimidazoles and also ornidazole are considered safe drugs as only minor side effects have been observed. The most frequent side effects are an unpleasant taste, nausea, vomiting, abdominal discomfort and diarrhea. Serious side effects such as seizures and peripheral neuropathy are very rarely encountered in conventional doses. Side effects may occur more frequently following large, single doses but were reported to subside rapidly. The acute oral LD50 of ornidazole in rats is 1.780 mg/kg. Reported LD50 value for mice is 1.420 mg/kg orally. Ornidazole administrated orally in mice at a dose level of 400 mg/kg/day for 13 weeks did not produce any toxicity except weight loss.
Nitroimidazoles are generally considered mutagenic chemicals. The nitrogen group present in nitroimidazole derivatives is considered responsible for the mutagenicity of these compounds. In a study, mutagenicity was observed with Klebsiella pneumoniae and Salmonella typhimurium TA.
Ornidazole was revealed to be mutagenic in Salmonella typhimurium, but negative results have been observed in other tests, such as micronucleus in mice and chromosome aberrations. Long-term carcinogenicity studies were also conducted with ornidazole (high dose 400 mg/kg/day) by administering in rats for two years. At the end of this study no carcinogenicity was recorded for Ornidazole.
Like other nitroimidazoles, ornidazole is widely distributed in the body, cross the placenta and appears in breast milk. When administered during pregnancy, no teratogenic effect was observed with ornidazole in mice, rats and rabbits. Local and systemic tolerability of ornidazole was excellent in humans when used in pregnancy, and patients showed complete remission without premature delivery. Children born to the trial patients showed normal initial development and their growth was normal. There was no evidence of ornidazole accumulation, and the pharmacokinetic parameters were very similar to those seen in healthy subjects. Therefore, dosage regimen requires no adjustment during pregnancy.
Ornidazole has the advantage of fewer side effects in rats in which species its antifertility action has been documented It has contraceptive properties in male, but not female, rats. It produces infertility by inhibiting epididymal sperm motility in terms of decreased sperm velocity. These effects are rapidly reversible after the cessation of treatment. Ornidazole, the therapeutic use of which is quite distinct from the treatment of chronic alcoholism, may produce a disulfiram-like reaction with alcohol (flushing of the face and neck, palpitations, dizzi ness, nausea, etc.) in some cases. The mechanism of this reaction is thought to be related with an inhibition of acetaldehyde dehydrogenase. Patients should be warned against the possibility of interactions with alcohol.
Besides interaction with alcohol, ornidazole potentiates the effect of coumarin-type oral anticoagulants. The dosage of the anticoagulant has to be adjusted accordingly. Ornidazole also prolongs the musclerelaxant effect of vecuronium bromide.

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?

Hypersensitivity for medication components.
Orgyl is contraindicated for patients with CNS affection, epilepsy, during the periods of pregnancy and lactation and for children under 1 year old.

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

In cases of overdosage the symptoms mentioned under Undesirable Effects occur in more severe form. No specific antidote is known. The administration of diazepam is recommended if cramps occur.

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:

STORAGE CONDITION
Store at below 30°C.
DOSAGE FORMS AND PACKAGING AVAILABLE
10 tablets are in a blister; 10 such blister is in a carton box along with pack insert.

NAME AND ADDRESS OF MANUFACTURER
Kusum Healthcare Private Limited
SP 289 (A), RIICO Industrial Area
Chopanki, Bhiwadi, India
DATE OF REVISION OF PACKAGE INSERT
Not Applicable

Drug Description

COMPOSITION
Each film coated tablet contains;
Ornidazole 500 mg

ADDITONAL INGREDIENTS:
Excipients:
Microcrystalline cellulose, maize starch, croscarmellose sodium, magnesium stearate, purified water, opadry 03B53217 orange.

Indications and dosage.

INDICATIONS
1. Bacterial vaginosis (non-specific vaginitis).
2. Trichomoniasis. Genitourinary infections in women and men due to Trichomonas vaginalis.
3.Amoebiasis. All intestinal infections due to Entamoeba histolytica, including amoebic dysentery. All extraintestinal forms of amoebiasis, especially amoebic liver abscess.
4. Giardiasis (lambliasis).
5. Infections due to anaerobic bacteria. Treatment of infections such as septicaemia, meningitis,
peritonitis, postoperative wound infections, puerperal sepsis, septic abortion, and endometritis, with demonstrated or suspected involvement of susceptible bacteria (see Properties and Effects).
6. Prophylaxis during surgical interventions, particularly those involving the colon, and in gynaecological operations.

RECOMMENDED DOSE:
Oral
Amoebic Dysentery Adult:
1.5 as a single daily dose for three days. Alternatively for patients > 60 kg: 1 g bid for three days

Child:
40 mg/kg daily.
Giardiasis
Adult:
1-1.5g as a single dose for 1-2 days.

Child:
30-40 mg/kg daily.

Trichomoniasis
Adult:
1.5g as a single dose or 0.5 g bid for 5 days. Treat sexual partners concominantly.

Amoebiasis
Adult:
0.5 g bid for 5-10 days.
Child:
25 mg/kg as a single dose for 5-10 days The tablets must always be taken after meals.

In all cases, the sexual partner should also be treated using the same oral dosage so as to avoid reinfection.
MODE OF ADMINISTRATION
The tablets must always be taken after meals.
In all cases, the sexual partner should also be treated using the same oral dosage so as to avoid reinfection.

Side effects and drug interactions.

UNDESIRABLE EFFECTS
Ornidazole is contraindicated in patients hypersensitive to ornidazole and other nitroimidazoles. Nitroimidazoles and also ornidazole are considered safe drugs as only minor side effects have been observed. The most frequent side effects are an unpleasant taste, nausea, vomiting, abdominal discomfort and diarrhea. Serious side effects such as seizures and peripheral neuropathy are very rarely encountered in conventional doses. Side effects may occur more frequently following large, single doses but were reported to subside rapidly. The acute oral LD50 of ornidazole in rats is 1.780 mg/kg. Reported LD50 value for mice is 1.420 mg/kg orally. Ornidazole administrated orally in mice at a dose level of 400 mg/kg/day for 13 weeks did not produce any toxicity except weight loss.
Nitroimidazoles are generally considered mutagenic chemicals. The nitrogen group present in nitroimidazole derivatives is considered responsible for the mutagenicity of these compounds. In a study, mutagenicity was observed with Klebsiella pneumoniae and Salmonella typhimurium TA.
Ornidazole was revealed to be mutagenic in Salmonella typhimurium, but negative results have been observed in other tests, such as micronucleus in mice and chromosome aberrations. Long-term carcinogenicity studies were also conducted with ornidazole (high dose 400 mg/kg/day) by administering in rats for two years. At the end of this study no carcinogenicity was recorded for Ornidazole.
Like other nitroimidazoles, ornidazole is widely distributed in the body, cross the placenta and appears in breast milk. When administered during pregnancy, no teratogenic effect was observed with ornidazole in mice, rats and rabbits. Local and systemic tolerability of ornidazole was excellent in humans when used in pregnancy, and patients showed complete remission without premature delivery. Children born to the trial patients showed normal initial development and their growth was normal. There was no evidence of ornidazole accumulation, and the pharmacokinetic parameters were very similar to those seen in healthy subjects. Therefore, dosage regimen requires no adjustment during pregnancy.
Ornidazole has the advantage of fewer side effects in rats in which species its antifertility action has been documented It has contraceptive properties in male, but not female, rats. It produces infertility by inhibiting epididymal sperm motility in terms of decreased sperm velocity. These effects are rapidly reversible after the cessation of treatment. Ornidazole, the therapeutic use of which is quite distinct from the treatment of chronic alcoholism, may produce a disulfiram-like reaction with alcohol (flushing of the face and neck, palpitations, dizzi ness, nausea, etc.) in some cases. The mechanism of this reaction is thought to be related with an inhibition of acetaldehyde dehydrogenase. Patients should be warned against the possibility of interactions with alcohol.
Besides interaction with alcohol, ornidazole potentiates the effect of coumarin-type oral anticoagulants. The dosage of the anticoagulant has to be adjusted accordingly. Ornidazole also prolongs the musclerelaxant effect of vecuronium bromide.
ADVERSE DRUG REACTIONS:
*"Inform doctors about unexpected reactions after using drugs."

INTERACTIONS WITH OTHER MEDICAMENTS
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

PREGNANCY AND LACTATION:
Extensive studies in various species have revealed no sign of any teratogenic or foetotoxic action of Orgyl. However, no controlled studies have been carried out in pregnant women. As a matter of principle, Orgyl should not be prescribed in early pregnancy or to nursing mothers except when absolutely necessary.

WARNING 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.
Children:
There are no data relatively medication administration in children under 1 year old.

Special indications:
During the treatment of Trichomoniasis it is necessary to treat both of the partners.

Overdosage and Contraindications

OVERDOSE AND TREATMENT
In cases of overdosage the symptoms mentioned under Undesirable Effects occur in more severe form. No specific antidote is known. The administration of diazepam is recommended if cramps occur.

CONTRAINDICATION
Hypersensitivity for medication components.
Orgyl is contraindicated for patients with CNS affection, epilepsy, during the periods of pregnancy and lactation and for children under 1 year old.

Clinical pharmacology.

PHARMACEUTICAL FORM: Film-coated Tablets
PHARMACOTHERAPEUTIC GROUP: Antimicrobial

PHARMACOLOGICAL PROPERTIES:
PHARMACODYNAMIC PROPERTIES:
After passive absorption into bacterium cell, the nitro group of ornidazole is reduced to amine group by ferrodoxin 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, Porphyronomas, 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
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 is 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 or ornidazole in neonates and young children are similar to those in adults.

CERTIFICATES

KEEP IN TOUCH

Kusum Healthcare Pvt Ltd

Regd. Office: D-158A, Okhla Industrial Area

Phase-1, New Delhi-110020, India

Tel: 011-41005147, 40514919

Fax: +91-11-40527575

Email: kusumhealth@kusumhealthcare.com

CIN: U65929DL1997PTC085780

Friend Link: Adidas Stan Smith Adidas Ultra Boost Adidas Yeezy 350 Boost Nike Air Jordan Nike Air Max 2017 Nike LeBron 14 Friend Link: Adidas NMD Runner PK Air Jordan XXXI Nike Kwazi Friend Link: Nike Roshe LD 1000 Nike Air Presto Ultra Flyknit Nike Air Max 90 Fireflies Adidas J Wall 3 Nike Flyknit Max Nike Air Max Zoom 90 Friend Link: Adidas Originals NMD Adidas Yeezy Boost 550 Adidas Tubular Schuhe Adidas Originals Pride Pack Adidas Originals Stan Smith W Adidas Originals ZX 500 Adidas Climacool Boat Lace MBT Baridi Women