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Orin

Loratadine
Oral Suspension 5 mg/5 ml Allopathic Non-sedating antihistamines

Indications

Urticaria

Indication detailsView
Loratadine tablet provides fast, effective relief from the symptoms of seasonal allergic rhinitis, perennial allergic rhinitis and skin allergies including chronic urticaria. It is also effective in alleviating symptoms of allergic rhinitis such as sneezing, nasal discharge, itching, ocular itching and burning. Nasal and ocular sign and symptoms are relieved rapidly after oral administration. Loratadine tablet is also indicated in idiopathic urticaria. In children over 2 years Loratadine tablet is indicated for the symptomatic relief of seasonal allergic rhinitis and allergic skin conditions such as urticaria, nettlerash.
Therapeutic classView
Non-sedating antihistamines
PharmacologyView
This tablet is a preparation of Loratadine. Loratadine is a non-sedative histamine Hr receptor antagonist with antiallergic properties. Loratadine is a long-acting tricyclic antihistamine with selective peripheral Hi-receptor antagonistic activity and no central sedative or anticholinergic effect. It is rapidly effective and long-lasting, allowing once-a-day administration.
DosageView
Adults and children over 12 years of age: One Loratadine tablet once daily. It is usually administered in the morning or when symptoms require treatment.

Children 2-12 years: Body weight over 30 kg: one Loratadine tablet once daily, below 30 kg: half Loratadine tablet once daily.

Below 2 years of age: Loratadine tablet is not recommended for use below 2 years of age since safety and efficacy has not been established.
Side effectsView
During controlled clinical studies the incidence of adverse events, including sedation and anticholinergic effects observed with 10 mg Loratadine was comparable to that observed with placebo. Studies on the effect of Loratadine on actual driving performance, and on tests of cognitive and psychomotor functioning have shown it to be comparable to placebo.
ContraindicationsView
Loratadine is contraindicated in patients who have shown hypersensitivity or idiosyncrasy to their components.
PrecautionsView
Caution should be taken in patients with liver impairment or renal insufficiency (eGFR <30 ml/min).
InteractionsView
There are no reports of potentially hazardous interactions with other drugs. In contrast to many other histamine H1 receptor antagonists, Loratadine has no potentiating effects when administered concurrently with alcohol, as measured by psychomotor performance studies. Concomitant therapy with drugs that inhibit or are metabolized by hepatic cytochromes P450 3A4 and 2D6 may elevate plasma concentrations of either drug and this mayifesult in adverse effects. Cimetidine inhibits both enzymes while erythromycin or ketoconazole inhibits P450 3A4. These drugs increase loratadine serum concentrations but no adverse effects are reported.
Pregnancy & lactationView
There is no experience of the use of Loratadine in human pregnancy. Therefore its use during pregnancy is not advisable. Loratadine is excreted in breast milk in a very small amount. So nursing mothers are advised not to take the drug.
Overdose effectsView
In adults somnolence, tachycardia and headache have been reported with overdose greater than 10 mg. Extrapyramidal signs and palpitations have been reported in children with overdoses of greater than 10 mg. In the event of overdosage, general symptomatic and supportive measures should be instituted promptly and maintained for as long as necessary. It would seem reasonable to treat patients presenting early after large overdoses with oral activated charcoal. The conscious patients may be induced to vomit or gastric lavage may be performed.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.

Orin

Loratadine
Tablet 10 mg Allopathic Non-sedating antihistamines

Indications

Urticaria

Indication detailsView
Loratadine tablet provides fast, effective relief from the symptoms of seasonal allergic rhinitis, perennial allergic rhinitis and skin allergies including chronic urticaria. It is also effective in alleviating symptoms of allergic rhinitis such as sneezing, nasal discharge, itching, ocular itching and burning. Nasal and ocular sign and symptoms are relieved rapidly after oral administration. Loratadine tablet is also indicated in idiopathic urticaria. In children over 2 years Loratadine tablet is indicated for the symptomatic relief of seasonal allergic rhinitis and allergic skin conditions such as urticaria, nettlerash.
Therapeutic classView
Non-sedating antihistamines
PharmacologyView
This tablet is a preparation of Loratadine. Loratadine is a non-sedative histamine Hr receptor antagonist with antiallergic properties. Loratadine is a long-acting tricyclic antihistamine with selective peripheral Hi-receptor antagonistic activity and no central sedative or anticholinergic effect. It is rapidly effective and long-lasting, allowing once-a-day administration.
DosageView
Adults and children over 12 years of age: One Loratadine tablet once daily. It is usually administered in the morning or when symptoms require treatment.

Children 2-12 years: Body weight over 30 kg: one Loratadine tablet once daily, below 30 kg: half Loratadine tablet once daily.

Below 2 years of age: Loratadine tablet is not recommended for use below 2 years of age since safety and efficacy has not been established.
Side effectsView
During controlled clinical studies the incidence of adverse events, including sedation and anticholinergic effects observed with 10 mg Loratadine was comparable to that observed with placebo. Studies on the effect of Loratadine on actual driving performance, and on tests of cognitive and psychomotor functioning have shown it to be comparable to placebo.
ContraindicationsView
Loratadine is contraindicated in patients who have shown hypersensitivity or idiosyncrasy to their components.
PrecautionsView
Caution should be taken in patients with liver impairment or renal insufficiency (eGFR <30 ml/min).
InteractionsView
There are no reports of potentially hazardous interactions with other drugs. In contrast to many other histamine H1 receptor antagonists, Loratadine has no potentiating effects when administered concurrently with alcohol, as measured by psychomotor performance studies. Concomitant therapy with drugs that inhibit or are metabolized by hepatic cytochromes P450 3A4 and 2D6 may elevate plasma concentrations of either drug and this mayifesult in adverse effects. Cimetidine inhibits both enzymes while erythromycin or ketoconazole inhibits P450 3A4. These drugs increase loratadine serum concentrations but no adverse effects are reported.
Pregnancy & lactationView
There is no experience of the use of Loratadine in human pregnancy. Therefore its use during pregnancy is not advisable. Loratadine is excreted in breast milk in a very small amount. So nursing mothers are advised not to take the drug.
Overdose effectsView
In adults somnolence, tachycardia and headache have been reported with overdose greater than 10 mg. Extrapyramidal signs and palpitations have been reported in children with overdoses of greater than 10 mg. In the event of overdosage, general symptomatic and supportive measures should be instituted promptly and maintained for as long as necessary. It would seem reasonable to treat patients presenting early after large overdoses with oral activated charcoal. The conscious patients may be induced to vomit or gastric lavage may be performed.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.

Orinex

Desloratadine
Tablet 5 mg Allopathic Non-sedating antihistamines

Indications

Watery eye

Indication detailsView
Desloratadine is indicated for the relief of symptoms associated with seasonal and perennial allergic rhinitis, such as sneezing, nasal discharge & itching, congestion or stuffiness, as well as ocular itching, tearing and redness, itching of palate and coughing. Desloratadine is also indicated for the relief of symptoms associated with chronic idiopathic urticaria such as the relief of itching and the size & number of hives.
Therapeutic classView
Non-sedating antihistamines
PharmacologyView
Desloratadine, the major active metabolite of Loratadine, is a non-sedating; long acting tricyclic histamine antagonist with selective H1-receptor histamine antagonist activity. Desloratadine also inhibits histamine release from human mast cell.
DosageView
Pediatric drops:
  • Child 6-11 months of age: 2 ml drops once daily.
  • Child 1-2 years of age: 2.5 ml drops once daily.
Syrup:
  • Child 6-11 months of age: 2 ml once daily.
  • Child 1-5 years of age: 2.5 ml once daily.
  • Child 6-11 years of age: 5 ml once daily.
  • Adults & >12 years of age: 10 ml once daily.
Tablet:
  • Adults and children 12 years of age and over: 1 tablet daily
Side effectsView
Less common side effects may include headache, nausea, fatigue, dizziness, pharyngitis, dyspepsia and myalgia.
ContraindicationsView
Desloratadine is contraindicated in patients having hypersensitivity to this medication or to any of its ingredients or Loratadine.
PrecautionsView
In adult patients with liver or renal impairment: A starting dose of one 5 mg tablet every other day is recommended based on pharmacokinetic data. If the patient has medical or familial history of seizures.
InteractionsView
No clinically relevant drug interactions have been reported.
Pregnancy & lactationView
Pregnancy Category C. The safe use of Desloratadine during pregnancy has not been established. Therefore, Desloratadine is not to be used during pregnancy unless clearly indicated. Desloratadine passes into breast milk, therefore a decision should be made whether to discontinue nursing or to discontinue Desloratadine taking into account the importance of the drug to the mother.
Pediatric usageView
Recommended in the use in children & adolescents.
Overdose effectsView
No clinically relevant adverse effects have been reported.
StorageView
Store in a cool & dry place, protected from light. Store below 30°C. Keep all medicines out of the reach of children.

Orinil

Diazepam
Tablet 5 mg Allopathic Primary anti-epileptic drugs

Indications

Severe anxiety disorders

Indication detailsView
Diazepam is indicated for the short-term treatment of mild to moderate anxiety, excitation, agitation, fear, aggressiveness, etc. Anxiety reactions caused by stressed conditions, anxiety states with somatic expression, acute alcohol withdrawal, status epilepticus, premedication for surgical procedures, febrile convulsions, insomnia of hospitalized patients.
Therapeutic classView
Benzodiazepine sedatives, Centrally acting Skeletal Muscle Relaxants, Primary anti-epileptic drugs
PharmacologyView
Diazepam attaches to the specific site on the GABA receptor and potentiates the effect of GABA, which acts by opening chloride ion channels into cells.

Diazepam is absorbed rapidly and completely after oral administration. Peak Plasma concentration reaches within 15-90 minutes. Mean plasma half-life is 30 hours. Plasma protein binding is 98-99%. Diazepam is metabolized in the liver with only traces of the unchanged drug excreted in urine. A very small proportion of the metabolites is excreted through the bile into the intestine and eliminated with the feces. After rectal administration in suppository form diazepam is significantly absorbed and peak concentration reaches within 1.5-2 hours.
DosageView
Oral:
  • Anxiety: 2 mg thrice daily, increased if necessary to 15-30 mg daily in divided doses. Elderly (or debilitated), half of the adult dose.
  • Insomnia associated with anxiety: 5-15 mg at bedtime.
  • Night terrors and somnambulism in Child: 1-5 mg at bedtime.
IM/slow IV injection (large vein, a rate below 5 mg/minute):
  • For severe acute anxiety, control of acute panic attacks, and acute alcohol withdrawal: 10 mg repeated if necessary after not less than 4 hours.
  • Febrile convulsion in children: Slow IV in a dose of 250 mcg/kg.
Rectal:
  • In case of children- A dose of 500 mcg/kg (maximum 10 mg), repeated if necessary.
Side effectsView
Diazepam is generally well tolerated. Higher doses may cause somnolence, dizziness, light headedness, confusion and ataxia.
ContraindicationsView
Diazepam is contraindicated in myasthenia gravis, pulmonary insufficiency, respiratory depression and hypersensitivity to bezodiazepine.
PrecautionsView
Prolonged use and abrupt withdrawal should be avoided. Diazepam should be used with caution in respiratory disease, muscle weakness, history of drug or alcohol abuse, in hepatic or renal impairment.
InteractionsView
Concomitant intake with alcohol is not recommended. Sedation may be increased due to concomitant use of neuroleptics (antipsychotics), hypnotics, sedative antihistamines and CNS depressants e.g., general anesthetics, narcotic analgesics or antidepressants. Diazepam clearance is increased by concomitant administration of phonobarbitone and is decreased by administration of cimetidine. Omeprazole and isoniazide inhibit diazepam metabolism.
Pregnancy & lactationView
Diazepam and its active metabolites cross the placental barrier and also pass into breast milk. So, it should be avoided if possible during pregnancy and lactation. US FDA pregnancy category D.
Overdose effectsView
Sedation, muscle weakness, profound sleep or paradoxical excitation. In more severe cases symptoms may include ataxia, hypotonia, hypotension, respiratory depression and rarely coma and death.
StorageView
Store in a cool (below 25˚C temperature) and dry place protected from light.

Oriodox

Doxycycline Hydrochloride
Capsule 100 mg Allopathic Tetracycline group of drugs

Indications

Uncomplicated gonorrhoea

Indication detailsView
Doxycycline Hydrochloride is indicated in the following infections caused by susceptible microorganisms:
  • Respiratory tract infections: Pneumonia, influenza, sinusitis, bronchitis, tonsillitis, tracheitis.
  • Gastrointestinal tract infections: Cholera, traveler's diarrhea, shigella dysentery, acute intestinal amebiasis.
  • Chlamydial infections: Lympho-granuloma venereum, psittacosis, trachoma.
  • Sexually transmitted diseases: Non gonococcal urethritis, acute pelvic inflammatory disease, uncomplicated urethral and endocervical or rectal infections, gonorrhoea, syphilis, pyelonephritis, cystitis.
  • Other infections: Impetigo, furunculosis, inclusion conjunctivitis, brucellosis, tularemia, cellulitis, acne and Q-fever.
Therapeutic classView
Tetracycline group of drugs
PharmacologyView
Doxycycline Hydrochloride is a semisynthetic tetracycline antibiotic with broad spectrum activity. It is primarily a bacteriostatic antibiotic. It has a similar spectrum of activity to other tetracyclines but in particular is more active against Staphylococcus aureus and Nocardia. The drug is often active against penicillin-resistant strains of Staphylococcus aureus and against strains of those organisms that are resistant to other Tetracyclines. Certain Gram-negative strains of E. coli, Proteus mirabilis and Klebsiella, which are often resistant to Tetracycline, may be sensitive to Doxycycline. In addition, 70-90% of the various anaerobes are sensitive to Doxycycline and Bacteroides fragilis is more likely to be sensitive to Doxycycline than to other tetracyclines.

Doxycycline is active against most strains of Haemophilus influenzaeand is particularly useful for infections with H. ducreyi, Actinomyces, Brucella and Vibrio cholerae. It is also active against Nocardia, Chlamydia, Mycoplasma and a wide range of Rickettsiae. Doxycycline is active against spirochetes such as Borellia recurrentis, Treponema pallidum and Treponema pertenue. It is also active against Plasmodium falciparum.
DosageView
Usual dose: 200 mg on first day, then 100 mg daily for 7-10 days.
Severe infections (including refractory urinary tract infections): 200 mg daily for 10 days.
Acne: 100 mg daily.
Uncomplicated genital chlamydia, non-gonococcal urethritis: 100 mg twice daily for 7-21 days (14-21 days in pelvic inflammatory disease).
AdministrationView
Capsules should be swallowed whole with plenty of fluid during meals while sitting or standing.
Side effectsView
Nausea, vomiting, diarrhoea, skin rashes, hemolytic anaemia, eosinophilia may be reported.
ContraindicationsView
Doxycycline is contraindicated to the patients who have shown hypersensitivity to any of the tetracyclines. Doxycycline is contraindicated to the children under 8 years of age. It is also contraindicated to pregnant women and to the lactating mothers.
PrecautionsView
The use of drugs of the tetracycline class during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of teeth. Tetracyclines drugs, therefore should not be used in this age group.
InteractionsView
Absorption of tetracyclines is impaired by antacid containing aluminium, calcium or magnesium, and iron containing preparation. Absorption of tetracyclines is also impaired by bismuth salicylate. Barbiturates, carbamazepine and phenytoin decrease half-life of doxycycline. Concurrent use of tetracyclines may render oral contraceptive less effective. Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosages. It is advisable to avoid giving tetracyclines in conjunction with penicillin.
Pregnancy & lactationView
Doxycycline should be avoided in pregnant women, because of the risk of both staining and effect on bone growth in the foetus. Doxycyclines enter breast milk, and mothers taking these drugs should not breastfeed their child.
StorageView
Keep all medicines out of reach of children. Store in a cool and dry place, protected from light.

Orioplex

Vitamin B complex
Syrup Allopathic Specific combined vitamin preparations

Indications

Vitamin B deficiencies

Indication detailsView
Vitamin-B complex is indicated for prophylactic or therapeutic nutritional supplementation in physiologically stressful conditions. These include: Conditions causing depletion, or reduced absorption or bioavailability of essential B-vitamins manifested by glossitis, stomatitis, cheilosis, beriberi Vitamin-B complex is indicated for prophylactic or therapeutic nutritional supplementation in physiologically stressful conditions. These include: Conditions causing depletion, or reduced absorption or bioavailability of essential B-vitamins manifested by glossitis, stomatitis, cheilosis, beriberi
Therapeutic classView
Specific combined vitamin preparations
PharmacologyView
Vitamin-B complex contains the most important members of the vitamin B group in pure form and in therapeutically balanced proportions. The members of the vitamin B group contained in Vitamin-B complex are components of enzyme systems that regulate various stages of carbohydrate, fat and protein metabolism, each of the components playing a specific biological role. Deficiency of B vitamin causes glossitis, stomatitis, cheilosis, polyneuritis, beriberi, pellagra and vascularisation of cornea.
DosageView
Tablet/ capsule: usual recommended dose is 1-2 tablet/capsule 3 times daily or as directed by the physician.

Syrup: 2-3 teaspoonful daily or as directed by the physician.

Injection: It is for intramuscular and intravenous administration. Usual recommended dose is 2 ml daily or as directed by the physician. In addition with Thiamine, Riboflavin, Nicotinamide, Pyridoxine; injectable dosage from contains D-Panthenol 5 mg.
Side effectsView
Adverse reactions have been reported with specific vitamins and minerals, but generally at levels substantially higher than those in Vitamin-B complex. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended level has been associated with gastrointestinal intolerance in some patients.
ContraindicationsView
Vitamin-B complex is contraindicated in patients hypersensitive to any of its components.
InteractionsView
As little as 5 mg pyridoxine daily can decrease the efficacy of levodopa in the treatment of parkinsonism. Therefore, Vitamin-B complex is not recommended for patients undergoing such therapy
Pregnancy & lactationView
It is safe to use Vitamin-B complex in pregnancy and lactation.

Orioplex

Vitamin B complex
Tablet Allopathic Specific combined vitamin preparations

Indications

Vitamin B deficiencies

Indication detailsView
Vitamin-B complex is indicated for prophylactic or therapeutic nutritional supplementation in physiologically stressful conditions. These include: Conditions causing depletion, or reduced absorption or bioavailability of essential B-vitamins manifested by glossitis, stomatitis, cheilosis, beriberi Vitamin-B complex is indicated for prophylactic or therapeutic nutritional supplementation in physiologically stressful conditions. These include: Conditions causing depletion, or reduced absorption or bioavailability of essential B-vitamins manifested by glossitis, stomatitis, cheilosis, beriberi
Therapeutic classView
Specific combined vitamin preparations
PharmacologyView
Vitamin-B complex contains the most important members of the vitamin B group in pure form and in therapeutically balanced proportions. The members of the vitamin B group contained in Vitamin-B complex are components of enzyme systems that regulate various stages of carbohydrate, fat and protein metabolism, each of the components playing a specific biological role. Deficiency of B vitamin causes glossitis, stomatitis, cheilosis, polyneuritis, beriberi, pellagra and vascularisation of cornea.
DosageView
Tablet/ capsule: usual recommended dose is 1-2 tablet/capsule 3 times daily or as directed by the physician.

Syrup: 2-3 teaspoonful daily or as directed by the physician.

Injection: It is for intramuscular and intravenous administration. Usual recommended dose is 2 ml daily or as directed by the physician. In addition with Thiamine, Riboflavin, Nicotinamide, Pyridoxine; injectable dosage from contains D-Panthenol 5 mg.
Side effectsView
Adverse reactions have been reported with specific vitamins and minerals, but generally at levels substantially higher than those in Vitamin-B complex. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended level has been associated with gastrointestinal intolerance in some patients.
ContraindicationsView
Vitamin-B complex is contraindicated in patients hypersensitive to any of its components.
InteractionsView
As little as 5 mg pyridoxine daily can decrease the efficacy of levodopa in the treatment of parkinsonism. Therefore, Vitamin-B complex is not recommended for patients undergoing such therapy
Pregnancy & lactationView
It is safe to use Vitamin-B complex in pregnancy and lactation.

Orioplex-M

Multivitamin & Multimineral
Tablet Allopathic Specific mineral & vitamin combined preparations

Indications

Vitamin deficiency

Indication detailsView
This is indicated for the treatment and/or prevention of vitamin and mineral deficiencies associated with restricted diets, improper food intake, alcoholism and decreased absorption. It is also indicated in patients with increased requirements for vitamins and minerals due to acute and chronic diseases, pregnancy, lactation, menopause, infections, during treatment with antibiotics, convalescence etc. To prevent the occurrence of serious birth defects periconceptional (from three months before conception up to the first trimester of pregnancy) supplementation with this tablet is required.
Therapeutic classView
Multi-vitamin & Multi-mineral combined preparations, Specific mineral & vitamin combined preparations
PharmacologyView
Vitamins and minerals are essential for normal metabolic functions including hematopoiesis. The members of vitamin B-group are components of enzyme system that regulate various stages of carbohydrate, fat and protein metabolism, each of the components playing a specific biological role. Vitamin C is involved in tissue repair and collagen formation. Vitamin A plays an essential role in the function of retina and is essential for growth and differentiation of epithelial tissue. Vitamin E is an antioxidant which preserves essential cellular constituents. Vitamin D is supplemented for prevention and cure of nutritional and metabolic rickets and for treatment of hypoparathyroidism. Iron, Copper, Manganese, Zinc serve as catalysts in enzyme systems which perform vital cellular functions.
DosageView
Orally one tablet daily for adult and children over 5 years of age or as directed by the physicians.
Side effectsView
Side effects have been reported with specific vitamins & minerals, but at level substantially higher than those in this tablet. Iron has been associated with gastrointestinal intolerance in some patients.
ContraindicationsView
This is contraindicated in patients hypersensitive to any of its components. This is not intended for treatment of severe specific deficiencies of vitamins or minerals. It is not recommended for patients undergoing treatment with levodopa as pyridoxine decreases the efficacy of levodopa. During the first trimester of pregnancy, larger doses of vitamin A (more than 10 tablets per day) may be teratogenic.
PrecautionsView
Not intended for treatment of pernicious anemia or other megaloblastic anemia where vitamin B12 is deficient.
Pregnancy & lactationView
During the first trimester of pregnancy, recommended daily dose should not be exceeded. Because larger doses of Vitamin-A (multiple tablets per day) may be teratogenic.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Orizone

Ceftriaxone Sodium
IV Injection 2 gm/vial Allopathic Third generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView
Ceftriaxone is indicated for the treatment of the following major infections:
  • Lower respiratory tract infections
  • Acute Bacterial Otitis Media
  • Skin and skin structure infections
  • Urinary tract infections
  • Gonorrhea
  • Bacterial Septicemia
  • Bone and joint infections
  • Meningitis
  • Prevention of postoperative infections
  • Perioperative prophylaxis of infections associated with surgery
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).
DosageView
Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).
  • Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
  • Uncomplicated gonococcal infections: 250 mg IM as a single dose
  • Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery
Infants and Children (01 month or older): The usual dose is 50 to 75 mg/kg intravenous or intramuscular administration once a day (or in equally divided doses twice a day).
  • Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
  • Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
  • Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day
Duration of therapy: Continue for more than 2 days after signs and symptoms of infection have disappeared. Usual duration is 4 to 14 days; in complicated infections, longer therapy may be required.
AdministrationView
Preparation of Solutions for Intramuscular / Intravenous Injections:
  • For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
  • For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.
The injection should be administered over 2-4 minutes, by Intramuscular or Intravenous injection or by tubing infusion over a period of 30 minutes at concentration between 10 mg/mL and 40 mg/mL. Before starting treatment through Ceftriaxone injection, patient tolerance test should be checked by administration of a test dose. (The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 6 hours at room temperature or 24 hours at 5°C).
Side effectsView
Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.
ContraindicationsView
Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.
PrecautionsView
As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.
InteractionsView
No drug interactions have been reported.
Pregnancy & lactationView
Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.
Pediatric usageView
Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).
Overdose effectsView
There is no specific antidote. Treatment of overdosage should be symptomatic.
StorageView
Vial store in a cool, dry place (below 30° C), away from light & moisture. Keep out of the reach of children.

Orizone

Ceftriaxone Sodium
IV Injection 1 gm/vial Allopathic Third generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView
Ceftriaxone is indicated for the treatment of the following major infections:
  • Lower respiratory tract infections
  • Acute Bacterial Otitis Media
  • Skin and skin structure infections
  • Urinary tract infections
  • Gonorrhea
  • Bacterial Septicemia
  • Bone and joint infections
  • Meningitis
  • Prevention of postoperative infections
  • Perioperative prophylaxis of infections associated with surgery
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).
DosageView
Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).
  • Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
  • Uncomplicated gonococcal infections: 250 mg IM as a single dose
  • Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery
Infants and Children (01 month or older): The usual dose is 50 to 75 mg/kg intravenous or intramuscular administration once a day (or in equally divided doses twice a day).
  • Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
  • Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
  • Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day
Duration of therapy: Continue for more than 2 days after signs and symptoms of infection have disappeared. Usual duration is 4 to 14 days; in complicated infections, longer therapy may be required.
AdministrationView
Preparation of Solutions for Intramuscular / Intravenous Injections:
  • For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
  • For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.
The injection should be administered over 2-4 minutes, by Intramuscular or Intravenous injection or by tubing infusion over a period of 30 minutes at concentration between 10 mg/mL and 40 mg/mL. Before starting treatment through Ceftriaxone injection, patient tolerance test should be checked by administration of a test dose. (The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 6 hours at room temperature or 24 hours at 5°C).
Side effectsView
Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.
ContraindicationsView
Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.
PrecautionsView
As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.
InteractionsView
No drug interactions have been reported.
Pregnancy & lactationView
Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.
Pediatric usageView
Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).
Overdose effectsView
There is no specific antidote. Treatment of overdosage should be symptomatic.
StorageView
Vial store in a cool, dry place (below 30° C), away from light & moisture. Keep out of the reach of children.

Orizone

Ceftriaxone Sodium
IV Injection 500 mg/vial Allopathic Third generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView
Ceftriaxone is indicated for the treatment of the following major infections:
  • Lower respiratory tract infections
  • Acute Bacterial Otitis Media
  • Skin and skin structure infections
  • Urinary tract infections
  • Gonorrhea
  • Bacterial Septicemia
  • Bone and joint infections
  • Meningitis
  • Prevention of postoperative infections
  • Perioperative prophylaxis of infections associated with surgery
Therapeutic classView
Third generation Cephalosporins
PharmacologyView
Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).
DosageView
Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).
  • Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
  • Uncomplicated gonococcal infections: 250 mg IM as a single dose
  • Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery
Infants and Children (01 month or older): The usual dose is 50 to 75 mg/kg intravenous or intramuscular administration once a day (or in equally divided doses twice a day).
  • Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
  • Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
  • Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day
Duration of therapy: Continue for more than 2 days after signs and symptoms of infection have disappeared. Usual duration is 4 to 14 days; in complicated infections, longer therapy may be required.
AdministrationView
Preparation of Solutions for Intramuscular / Intravenous Injections:
  • For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
  • For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.
The injection should be administered over 2-4 minutes, by Intramuscular or Intravenous injection or by tubing infusion over a period of 30 minutes at concentration between 10 mg/mL and 40 mg/mL. Before starting treatment through Ceftriaxone injection, patient tolerance test should be checked by administration of a test dose. (The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 6 hours at room temperature or 24 hours at 5°C).
Side effectsView
Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.
ContraindicationsView
Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.
PrecautionsView
As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.
InteractionsView
No drug interactions have been reported.
Pregnancy & lactationView
Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.
Pediatric usageView
Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).
Overdose effectsView
There is no specific antidote. Treatment of overdosage should be symptomatic.
StorageView
Vial store in a cool, dry place (below 30° C), away from light & moisture. Keep out of the reach of children.

Orlev

Levofloxacin Hemihydrate
Tablet 500 mg Allopathic 4-Quinolone preparations

Indications

Urinary tract infection

Indication detailsView
Levofloxacin is indicated for the treatment of mild, moderate and severe infections caused by susceptible strains of the designated micro-organisms in the condition listed below:
  • Acute maxillary sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.
  • Acute bacterial exacerbation of chronic bronchitis due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.
  • Community-acquired pneumonia due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae.
  • Uncomplicated & complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus.
  • Acute pyelonephritis caused by Escherichia coli.
  • Uncomplicated & complicated skin and soft tissue infections including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to Staphylococcus aureus, Streptococcus pyogenes, Proteus mirabilis or Enterococcus faecalis.
  • Enteric infections caused by Enterobacter sp., Escherichia coli, Campylobacter sp., Vibrio cholerae, Shigella sp., Salmonella sp.
Therapeutic classView
4-Quinolone preparations
PharmacologyView
Levofloxacin is a synthetic, broad-spectrum, third generation fluoroquinolone antibiotic. Chemically, Levofloxacin is a chiral fluorinated carboxyquinolone. Levofloxacin exerts antibacterial action by inhibiting bacterial topoisomerase IV and DNA gyrase, the enzymes required for DNA replication, transcription repair and recombination. It has in vitro activity against a wide range of gm-ve and gm+ve microorganisms.
DosageView
The usual dose of Levofloxacin Tablets is 250 mg or 500 mg or 750 mg administered orally every 24 hours. Levofloxacin tablets can be administered without regard to food. Levofloxacin oral solution should be taken 1 hour before, or  2 hours after eating.

Levofloxacin injection should only be administered by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration. The usual dose of Levofloxacin injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours. Since the Levofloxacin injections are for single-use only, any unused portion should be discarded. Additives or other medications should not be added to Levofloxacin Injection or infused simultaneously through the same intravenous line.

Adults:
  • Acute sinusitis: 500 mg once daily for 10-14 days, or 750 mg once daily for 5 days
  • Exacerbation of chronic bronchitis: 500 mg once daily for 7 days, or 750 mg once daily for 3 days (Uncomplicated), 750 mg once daily for 5 days (Complicated)
  • Community-acquired pneumonia: 500 mg once daily for 7-14 days, or 750 mg once daily for 5 days
  • Uncomplicated urinary-tract infections: 250 mg once daily for 3 days
  • Complicated urinary-tract infections and acute pyelonephritis: 250 mg once daily for 7-10 days
  • Uncomplicated skin and soft-tissue infections: 500 mg once daily for 7-10 days.
  • Complicated skin and soft-tissue infections: 750 mg once daily for 7-14 days.
  • Enteric fever: 500 mg once daily for 7-14 days.
  • Diarrhea, cholera, shigellosis & enteritis: Mild to moderate case: 500 mg (single dose). Moderate to sever case: 500 mg once daily for 3 days
Children:
  • Children 6 months to <5 years: 10 mg/kg every 12 hours.
  • Children >5 years: 10 mg/kg every 24 hours
In each case, sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
AdministrationView
Instructions for the Use of Levofloxacin Infusion-
  • Check the container for minute leaks by squeezing the inner bag firmly. If leaks are found, or if the seal is not intact, discard the solution.
  • Do not use if the solution is cloudy or a precipitate is present.
  • Do not use flexible containers in series connections.
  • Close flow control clamp of administration set.
  • Remove cover from port at bottom of container.
  • Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
  • Suspend container from hanger.
  • Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Levoxin Injection.
  • Open flow control clamp to expel air from set. Close clamp.
  • Regulate rate of administration with flow control clamp.
Side effectsView
Levofloxacin is generally well tolerated. However, a few side-effects can usually be seen. There is a risk of retinal detachment. Other side-effects include: nausea, vomiting, diarrhea, abdominal pain, flatulence and rare occurrence of phototoxicity (0.1%). Side-effects that may be seen very rarely include tremors, depression, anxiety, confusion etc.
ContraindicationsView
Levofloxacin is contraindicated in patients with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents, or any other components of this product.
PrecautionsView
The following measures should be taken during administration of Levofloxacin:
  • Levofloxacin Injection should only be administered by slow intravenous infusion over a period of 60 or 90 minutes depending on the dosage.
  • While administrating Levofloxacin, adequate amount of water should be taken to avoid concentrated form of urine.
  • Dose adjustment should be exercised during Levofloxacin administration in presence of renal insufficiency.
InteractionsView
No quinolone should be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line. Antacids, Iron and Adsorbents reduce absorption of Levofloxacin. NSAID may increase the risk of CNS stimulation. Warfarin may increase the risk of bleeding.
Pregnancy & lactationView
Levofloxacin is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.
Overdose effectsView
Levofloxacin exhibits a low potential for acute toxicity. However, in the events of an acute overdosage, the stomach should be emptied. The patients should be kept under observation and appropriate hydration should be maintained.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Orlev

Levofloxacin Hemihydrate
Tablet 250 mg Allopathic 4-Quinolone preparations

Indications

Urinary tract infection

Indication detailsView
Levofloxacin is indicated for the treatment of mild, moderate and severe infections caused by susceptible strains of the designated micro-organisms in the condition listed below:
  • Acute maxillary sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.
  • Acute bacterial exacerbation of chronic bronchitis due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.
  • Community-acquired pneumonia due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae.
  • Uncomplicated & complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus.
  • Acute pyelonephritis caused by Escherichia coli.
  • Uncomplicated & complicated skin and soft tissue infections including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to Staphylococcus aureus, Streptococcus pyogenes, Proteus mirabilis or Enterococcus faecalis.
  • Enteric infections caused by Enterobacter sp., Escherichia coli, Campylobacter sp., Vibrio cholerae, Shigella sp., Salmonella sp.
Therapeutic classView
4-Quinolone preparations
PharmacologyView
Levofloxacin is a synthetic, broad-spectrum, third generation fluoroquinolone antibiotic. Chemically, Levofloxacin is a chiral fluorinated carboxyquinolone. Levofloxacin exerts antibacterial action by inhibiting bacterial topoisomerase IV and DNA gyrase, the enzymes required for DNA replication, transcription repair and recombination. It has in vitro activity against a wide range of gm-ve and gm+ve microorganisms.
DosageView
The usual dose of Levofloxacin Tablets is 250 mg or 500 mg or 750 mg administered orally every 24 hours. Levofloxacin tablets can be administered without regard to food. Levofloxacin oral solution should be taken 1 hour before, or  2 hours after eating.

Levofloxacin injection should only be administered by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration. The usual dose of Levofloxacin injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours. Since the Levofloxacin injections are for single-use only, any unused portion should be discarded. Additives or other medications should not be added to Levofloxacin Injection or infused simultaneously through the same intravenous line.

Adults:
  • Acute sinusitis: 500 mg once daily for 10-14 days, or 750 mg once daily for 5 days
  • Exacerbation of chronic bronchitis: 500 mg once daily for 7 days, or 750 mg once daily for 3 days (Uncomplicated), 750 mg once daily for 5 days (Complicated)
  • Community-acquired pneumonia: 500 mg once daily for 7-14 days, or 750 mg once daily for 5 days
  • Uncomplicated urinary-tract infections: 250 mg once daily for 3 days
  • Complicated urinary-tract infections and acute pyelonephritis: 250 mg once daily for 7-10 days
  • Uncomplicated skin and soft-tissue infections: 500 mg once daily for 7-10 days.
  • Complicated skin and soft-tissue infections: 750 mg once daily for 7-14 days.
  • Enteric fever: 500 mg once daily for 7-14 days.
  • Diarrhea, cholera, shigellosis & enteritis: Mild to moderate case: 500 mg (single dose). Moderate to sever case: 500 mg once daily for 3 days
Children:
  • Children 6 months to <5 years: 10 mg/kg every 12 hours.
  • Children >5 years: 10 mg/kg every 24 hours
In each case, sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
AdministrationView
Instructions for the Use of Levofloxacin Infusion-
  • Check the container for minute leaks by squeezing the inner bag firmly. If leaks are found, or if the seal is not intact, discard the solution.
  • Do not use if the solution is cloudy or a precipitate is present.
  • Do not use flexible containers in series connections.
  • Close flow control clamp of administration set.
  • Remove cover from port at bottom of container.
  • Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
  • Suspend container from hanger.
  • Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Levoxin Injection.
  • Open flow control clamp to expel air from set. Close clamp.
  • Regulate rate of administration with flow control clamp.
Side effectsView
Levofloxacin is generally well tolerated. However, a few side-effects can usually be seen. There is a risk of retinal detachment. Other side-effects include: nausea, vomiting, diarrhea, abdominal pain, flatulence and rare occurrence of phototoxicity (0.1%). Side-effects that may be seen very rarely include tremors, depression, anxiety, confusion etc.
ContraindicationsView
Levofloxacin is contraindicated in patients with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents, or any other components of this product.
PrecautionsView
The following measures should be taken during administration of Levofloxacin:
  • Levofloxacin Injection should only be administered by slow intravenous infusion over a period of 60 or 90 minutes depending on the dosage.
  • While administrating Levofloxacin, adequate amount of water should be taken to avoid concentrated form of urine.
  • Dose adjustment should be exercised during Levofloxacin administration in presence of renal insufficiency.
InteractionsView
No quinolone should be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line. Antacids, Iron and Adsorbents reduce absorption of Levofloxacin. NSAID may increase the risk of CNS stimulation. Warfarin may increase the risk of bleeding.
Pregnancy & lactationView
Levofloxacin is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.
Overdose effectsView
Levofloxacin exhibits a low potential for acute toxicity. However, in the events of an acute overdosage, the stomach should be emptied. The patients should be kept under observation and appropriate hydration should be maintained.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Orlev

Levofloxacin Hemihydrate
IV Infusion 500 mg/100 ml Allopathic 4-Quinolone preparations

Indications

Urinary tract infection

Indication detailsView
Levofloxacin is indicated for the treatment of mild, moderate and severe infections caused by susceptible strains of the designated micro-organisms in the condition listed below:
  • Acute maxillary sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.
  • Acute bacterial exacerbation of chronic bronchitis due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.
  • Community-acquired pneumonia due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae.
  • Uncomplicated & complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus.
  • Acute pyelonephritis caused by Escherichia coli.
  • Uncomplicated & complicated skin and soft tissue infections including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to Staphylococcus aureus, Streptococcus pyogenes, Proteus mirabilis or Enterococcus faecalis.
  • Enteric infections caused by Enterobacter sp., Escherichia coli, Campylobacter sp., Vibrio cholerae, Shigella sp., Salmonella sp.
Therapeutic classView
4-Quinolone preparations
PharmacologyView
Levofloxacin is a synthetic, broad-spectrum, third generation fluoroquinolone antibiotic. Chemically, Levofloxacin is a chiral fluorinated carboxyquinolone. Levofloxacin exerts antibacterial action by inhibiting bacterial topoisomerase IV and DNA gyrase, the enzymes required for DNA replication, transcription repair and recombination. It has in vitro activity against a wide range of gm-ve and gm+ve microorganisms.
DosageView
The usual dose of Levofloxacin Tablets is 250 mg or 500 mg or 750 mg administered orally every 24 hours. Levofloxacin tablets can be administered without regard to food. Levofloxacin oral solution should be taken 1 hour before, or  2 hours after eating.

Levofloxacin injection should only be administered by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration. The usual dose of Levofloxacin injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours. Since the Levofloxacin injections are for single-use only, any unused portion should be discarded. Additives or other medications should not be added to Levofloxacin Injection or infused simultaneously through the same intravenous line.

Adults:
  • Acute sinusitis: 500 mg once daily for 10-14 days, or 750 mg once daily for 5 days
  • Exacerbation of chronic bronchitis: 500 mg once daily for 7 days, or 750 mg once daily for 3 days (Uncomplicated), 750 mg once daily for 5 days (Complicated)
  • Community-acquired pneumonia: 500 mg once daily for 7-14 days, or 750 mg once daily for 5 days
  • Uncomplicated urinary-tract infections: 250 mg once daily for 3 days
  • Complicated urinary-tract infections and acute pyelonephritis: 250 mg once daily for 7-10 days
  • Uncomplicated skin and soft-tissue infections: 500 mg once daily for 7-10 days.
  • Complicated skin and soft-tissue infections: 750 mg once daily for 7-14 days.
  • Enteric fever: 500 mg once daily for 7-14 days.
  • Diarrhea, cholera, shigellosis & enteritis: Mild to moderate case: 500 mg (single dose). Moderate to sever case: 500 mg once daily for 3 days
Children:
  • Children 6 months to <5 years: 10 mg/kg every 12 hours.
  • Children >5 years: 10 mg/kg every 24 hours
In each case, sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
AdministrationView
Instructions for the Use of Levofloxacin Infusion-
  • Check the container for minute leaks by squeezing the inner bag firmly. If leaks are found, or if the seal is not intact, discard the solution.
  • Do not use if the solution is cloudy or a precipitate is present.
  • Do not use flexible containers in series connections.
  • Close flow control clamp of administration set.
  • Remove cover from port at bottom of container.
  • Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
  • Suspend container from hanger.
  • Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Levoxin Injection.
  • Open flow control clamp to expel air from set. Close clamp.
  • Regulate rate of administration with flow control clamp.
Side effectsView
Levofloxacin is generally well tolerated. However, a few side-effects can usually be seen. There is a risk of retinal detachment. Other side-effects include: nausea, vomiting, diarrhea, abdominal pain, flatulence and rare occurrence of phototoxicity (0.1%). Side-effects that may be seen very rarely include tremors, depression, anxiety, confusion etc.
ContraindicationsView
Levofloxacin is contraindicated in patients with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents, or any other components of this product.
PrecautionsView
The following measures should be taken during administration of Levofloxacin:
  • Levofloxacin Injection should only be administered by slow intravenous infusion over a period of 60 or 90 minutes depending on the dosage.
  • While administrating Levofloxacin, adequate amount of water should be taken to avoid concentrated form of urine.
  • Dose adjustment should be exercised during Levofloxacin administration in presence of renal insufficiency.
InteractionsView
No quinolone should be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line. Antacids, Iron and Adsorbents reduce absorption of Levofloxacin. NSAID may increase the risk of CNS stimulation. Warfarin may increase the risk of bleeding.
Pregnancy & lactationView
Levofloxacin is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.
Overdose effectsView
Levofloxacin exhibits a low potential for acute toxicity. However, in the events of an acute overdosage, the stomach should be emptied. The patients should be kept under observation and appropriate hydration should be maintained.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Orlifit

Orlistat
Capsule 60 mg Allopathic Appetite suppressant drugs/Anti-obesity drugs

Indications

Obesity

Indication detailsView
Adults: Orlistat is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI)>30 kg/m2 and overweight patients (BMI >28 kg/m2 ) with associated risk factors such as type II diabetes, hyperlipidemia and hypertension. Treatment with Orlistat should be discontinued after 12 weeks in patients who have not lost at least 5% of their body weight as measured at the start of drug therapy.

Adolescents (12 years & older): Obese adolescents should be treated with Orlistat only if an adequate reduction of body weight cannot be achieved by means of diet & increased physical activity. Treatment with orlistat should be considered in particular if complications of obesity are present.
Therapeutic classView
Appetite suppressant drugs/Anti-obesity drugs
PharmacologyView
Orlistat is a potent, specific and long-acting lipase inhibitor. It exerts its therapeutic activity in the lumen of the stomach and upper small intestine by forming a covalent bond with the active serine site of gastric and pancreatic lipases. The inactivated enzyme is thus rendered unable to hydrolyze dietary fats in the form of triglycerides into absorbable free fatty acids and monoglycerides. As undigested triglycerides can not be absorbed, a caloric deficit arises which has a positive effect on weight control. Systemic absorption of orlistat is therefore not needed for the activity. At the recommended therapeutic dose of 120 mg three times a day, orlistat inhibit dietary fat absorption by approximately 30%.
DosageView
The recommended dose of Orlistat is one 120 mg capsule to be taken immediately before, during or up to one hour after each main meal. If a meal is missed or contains no fat the dose of Orlistat should be omitted. Doses of Orlistat above 120 mg three times daily have not been shown to provide additional benefits. The effect of Orlistat results in an increase in fecal fat 24-48 hours after dosing. Upon discontinuation of therapy, fecal fat content usually returns to pretreatment levels within 48-72 hours.

The safety & efficacy of Orlistat were investigated in clinical studies lasting up to 4 years. The recommended dose of Orlistat for adolescents is as same as adults.

Special dosage instruction: The tolerability and efficacy of Orlistat have not been studied in elderly patients, or patients with hepatic and/ or renal impairments.
Side effectsView
Common: Undesirable effects of Orlistat are largely gastrointestinal in nature. Common gastrointestinal side effects are oily spotting from the rectum, flatulence, fecal urgency, oily or fatty stool, abdominal discomfort etc.

Rare: Influenza, anxiety. headache, fatigue etc may rarely occur in some patients. Rare cases of hypersensitivity have been reported. Main clinical symptoms are pruritus, exanthema, urticaria, angioedema and anaphylaxis.
ContraindicationsView
Orlistat is contraindicated in patients with chronic malabsorption syndrome, in patients with cholestasis and in patients who are hypersensitive to orlistat or to any of the other ingredients of the capsules.
PrecautionsView
Organic causes of obesity (e.g. hypothyroidism) should be excluded before prescribing Orlistat. Orlistat and cyclosporine should not be coadministered. Cyclosporine should be taken at least 2 hours before or after Orlistat in patients taking both drugs. Cyclosporine level should be measured and frequently monitored.

In clinical trial, the decrease in body weight with Orlistat therapy was less in type II diabetic patients than in non-diabetic patients. Antidiabetic drug treatment should be closely monitored during Orlistat therapy. Because of the improvement in glycemic control, the dose of oral antidiabetics or of insulin may need to be adjusted.

Patients should be advised to adhere to the dietary recommendations. The probability of occurrence of gastrointestinal side effects may increase when Orlistat is taken with a fatty meal. The daily intake of fat should be distributed between three main meals. Patients should be strongly encouraged to take a multivitamin supplement that contains fat soluble vitamins to ensure adequate nutrition because orlistat has been shown to reduce the absorption of some fat soluble vitamins & beta-carotene. In addition, the levels of vitamin D & beta carotene may be low in obese patients compared with non-obese patients.
InteractionsView
No interactions with commonly prescribed medications such as alcohol, digoxin, nifedipine, oral contraceptives, phenytoin, pravastatin, warfarin, or metformin, glibenclamide, fibrates, furosemide, captopril, or atenolol have been observed in studies.
Pregnancy & lactationView
Use in pregnancy & lactation: No clinical data are available on pregnancy exposed to Orlistat. As it is not known whether Orlistat is excreted in breast milk. Orlistat should not be used during breastfeeding.
Overdose effectsView
Single doses of 800 mg Orlistat and multiple doses of up to 400 mg three times a day for 15 days have been studied in normal weight and obese subjects without significant adverse findings.
StorageView
Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.

Orlifit

Orlistat
Capsule 120 mg Allopathic Appetite suppressant drugs/Anti-obesity drugs

Indications

Obesity

Indication detailsView
Adults: Orlistat is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI)>30 kg/m2 and overweight patients (BMI >28 kg/m2 ) with associated risk factors such as type II diabetes, hyperlipidemia and hypertension. Treatment with Orlistat should be discontinued after 12 weeks in patients who have not lost at least 5% of their body weight as measured at the start of drug therapy.

Adolescents (12 years & older): Obese adolescents should be treated with Orlistat only if an adequate reduction of body weight cannot be achieved by means of diet & increased physical activity. Treatment with orlistat should be considered in particular if complications of obesity are present.
Therapeutic classView
Appetite suppressant drugs/Anti-obesity drugs
PharmacologyView
Orlistat is a potent, specific and long-acting lipase inhibitor. It exerts its therapeutic activity in the lumen of the stomach and upper small intestine by forming a covalent bond with the active serine site of gastric and pancreatic lipases. The inactivated enzyme is thus rendered unable to hydrolyze dietary fats in the form of triglycerides into absorbable free fatty acids and monoglycerides. As undigested triglycerides can not be absorbed, a caloric deficit arises which has a positive effect on weight control. Systemic absorption of orlistat is therefore not needed for the activity. At the recommended therapeutic dose of 120 mg three times a day, orlistat inhibit dietary fat absorption by approximately 30%.
DosageView
The recommended dose of Orlistat is one 120 mg capsule to be taken immediately before, during or up to one hour after each main meal. If a meal is missed or contains no fat the dose of Orlistat should be omitted. Doses of Orlistat above 120 mg three times daily have not been shown to provide additional benefits. The effect of Orlistat results in an increase in fecal fat 24-48 hours after dosing. Upon discontinuation of therapy, fecal fat content usually returns to pretreatment levels within 48-72 hours.

The safety & efficacy of Orlistat were investigated in clinical studies lasting up to 4 years. The recommended dose of Orlistat for adolescents is as same as adults.

Special dosage instruction: The tolerability and efficacy of Orlistat have not been studied in elderly patients, or patients with hepatic and/ or renal impairments.
Side effectsView
Common: Undesirable effects of Orlistat are largely gastrointestinal in nature. Common gastrointestinal side effects are oily spotting from the rectum, flatulence, fecal urgency, oily or fatty stool, abdominal discomfort etc.

Rare: Influenza, anxiety. headache, fatigue etc may rarely occur in some patients. Rare cases of hypersensitivity have been reported. Main clinical symptoms are pruritus, exanthema, urticaria, angioedema and anaphylaxis.
ContraindicationsView
Orlistat is contraindicated in patients with chronic malabsorption syndrome, in patients with cholestasis and in patients who are hypersensitive to orlistat or to any of the other ingredients of the capsules.
PrecautionsView
Organic causes of obesity (e.g. hypothyroidism) should be excluded before prescribing Orlistat. Orlistat and cyclosporine should not be coadministered. Cyclosporine should be taken at least 2 hours before or after Orlistat in patients taking both drugs. Cyclosporine level should be measured and frequently monitored.

In clinical trial, the decrease in body weight with Orlistat therapy was less in type II diabetic patients than in non-diabetic patients. Antidiabetic drug treatment should be closely monitored during Orlistat therapy. Because of the improvement in glycemic control, the dose of oral antidiabetics or of insulin may need to be adjusted.

Patients should be advised to adhere to the dietary recommendations. The probability of occurrence of gastrointestinal side effects may increase when Orlistat is taken with a fatty meal. The daily intake of fat should be distributed between three main meals. Patients should be strongly encouraged to take a multivitamin supplement that contains fat soluble vitamins to ensure adequate nutrition because orlistat has been shown to reduce the absorption of some fat soluble vitamins & beta-carotene. In addition, the levels of vitamin D & beta carotene may be low in obese patients compared with non-obese patients.
InteractionsView
No interactions with commonly prescribed medications such as alcohol, digoxin, nifedipine, oral contraceptives, phenytoin, pravastatin, warfarin, or metformin, glibenclamide, fibrates, furosemide, captopril, or atenolol have been observed in studies.
Pregnancy & lactationView
Use in pregnancy & lactation: No clinical data are available on pregnancy exposed to Orlistat. As it is not known whether Orlistat is excreted in breast milk. Orlistat should not be used during breastfeeding.
Overdose effectsView
Single doses of 800 mg Orlistat and multiple doses of up to 400 mg three times a day for 15 days have been studied in normal weight and obese subjects without significant adverse findings.
StorageView
Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.

Orlo

Loratadine
Oral Suspension 5 mg/5 ml Allopathic Non-sedating antihistamines

Indications

Urticaria

Indication detailsView
Loratadine tablet provides fast, effective relief from the symptoms of seasonal allergic rhinitis, perennial allergic rhinitis and skin allergies including chronic urticaria. It is also effective in alleviating symptoms of allergic rhinitis such as sneezing, nasal discharge, itching, ocular itching and burning. Nasal and ocular sign and symptoms are relieved rapidly after oral administration. Loratadine tablet is also indicated in idiopathic urticaria. In children over 2 years Loratadine tablet is indicated for the symptomatic relief of seasonal allergic rhinitis and allergic skin conditions such as urticaria, nettlerash.
Therapeutic classView
Non-sedating antihistamines
PharmacologyView
This tablet is a preparation of Loratadine. Loratadine is a non-sedative histamine Hr receptor antagonist with antiallergic properties. Loratadine is a long-acting tricyclic antihistamine with selective peripheral Hi-receptor antagonistic activity and no central sedative or anticholinergic effect. It is rapidly effective and long-lasting, allowing once-a-day administration.
DosageView
Adults and children over 12 years of age: One Loratadine tablet once daily. It is usually administered in the morning or when symptoms require treatment.

Children 2-12 years: Body weight over 30 kg: one Loratadine tablet once daily, below 30 kg: half Loratadine tablet once daily.

Below 2 years of age: Loratadine tablet is not recommended for use below 2 years of age since safety and efficacy has not been established.
Side effectsView
During controlled clinical studies the incidence of adverse events, including sedation and anticholinergic effects observed with 10 mg Loratadine was comparable to that observed with placebo. Studies on the effect of Loratadine on actual driving performance, and on tests of cognitive and psychomotor functioning have shown it to be comparable to placebo.
ContraindicationsView
Loratadine is contraindicated in patients who have shown hypersensitivity or idiosyncrasy to their components.
PrecautionsView
Caution should be taken in patients with liver impairment or renal insufficiency (eGFR <30 ml/min).
InteractionsView
There are no reports of potentially hazardous interactions with other drugs. In contrast to many other histamine H1 receptor antagonists, Loratadine has no potentiating effects when administered concurrently with alcohol, as measured by psychomotor performance studies. Concomitant therapy with drugs that inhibit or are metabolized by hepatic cytochromes P450 3A4 and 2D6 may elevate plasma concentrations of either drug and this mayifesult in adverse effects. Cimetidine inhibits both enzymes while erythromycin or ketoconazole inhibits P450 3A4. These drugs increase loratadine serum concentrations but no adverse effects are reported.
Pregnancy & lactationView
There is no experience of the use of Loratadine in human pregnancy. Therefore its use during pregnancy is not advisable. Loratadine is excreted in breast milk in a very small amount. So nursing mothers are advised not to take the drug.
Overdose effectsView
In adults somnolence, tachycardia and headache have been reported with overdose greater than 10 mg. Extrapyramidal signs and palpitations have been reported in children with overdoses of greater than 10 mg. In the event of overdosage, general symptomatic and supportive measures should be instituted promptly and maintained for as long as necessary. It would seem reasonable to treat patients presenting early after large overdoses with oral activated charcoal. The conscious patients may be induced to vomit or gastric lavage may be performed.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.

Orlo

Loratadine
Tablet 10 mg Allopathic Non-sedating antihistamines

Indications

Urticaria

Indication detailsView
Loratadine tablet provides fast, effective relief from the symptoms of seasonal allergic rhinitis, perennial allergic rhinitis and skin allergies including chronic urticaria. It is also effective in alleviating symptoms of allergic rhinitis such as sneezing, nasal discharge, itching, ocular itching and burning. Nasal and ocular sign and symptoms are relieved rapidly after oral administration. Loratadine tablet is also indicated in idiopathic urticaria. In children over 2 years Loratadine tablet is indicated for the symptomatic relief of seasonal allergic rhinitis and allergic skin conditions such as urticaria, nettlerash.
Therapeutic classView
Non-sedating antihistamines
PharmacologyView
This tablet is a preparation of Loratadine. Loratadine is a non-sedative histamine Hr receptor antagonist with antiallergic properties. Loratadine is a long-acting tricyclic antihistamine with selective peripheral Hi-receptor antagonistic activity and no central sedative or anticholinergic effect. It is rapidly effective and long-lasting, allowing once-a-day administration.
DosageView
Adults and children over 12 years of age: One Loratadine tablet once daily. It is usually administered in the morning or when symptoms require treatment.

Children 2-12 years: Body weight over 30 kg: one Loratadine tablet once daily, below 30 kg: half Loratadine tablet once daily.

Below 2 years of age: Loratadine tablet is not recommended for use below 2 years of age since safety and efficacy has not been established.
Side effectsView
During controlled clinical studies the incidence of adverse events, including sedation and anticholinergic effects observed with 10 mg Loratadine was comparable to that observed with placebo. Studies on the effect of Loratadine on actual driving performance, and on tests of cognitive and psychomotor functioning have shown it to be comparable to placebo.
ContraindicationsView
Loratadine is contraindicated in patients who have shown hypersensitivity or idiosyncrasy to their components.
PrecautionsView
Caution should be taken in patients with liver impairment or renal insufficiency (eGFR <30 ml/min).
InteractionsView
There are no reports of potentially hazardous interactions with other drugs. In contrast to many other histamine H1 receptor antagonists, Loratadine has no potentiating effects when administered concurrently with alcohol, as measured by psychomotor performance studies. Concomitant therapy with drugs that inhibit or are metabolized by hepatic cytochromes P450 3A4 and 2D6 may elevate plasma concentrations of either drug and this mayifesult in adverse effects. Cimetidine inhibits both enzymes while erythromycin or ketoconazole inhibits P450 3A4. These drugs increase loratadine serum concentrations but no adverse effects are reported.
Pregnancy & lactationView
There is no experience of the use of Loratadine in human pregnancy. Therefore its use during pregnancy is not advisable. Loratadine is excreted in breast milk in a very small amount. So nursing mothers are advised not to take the drug.
Overdose effectsView
In adults somnolence, tachycardia and headache have been reported with overdose greater than 10 mg. Extrapyramidal signs and palpitations have been reported in children with overdoses of greater than 10 mg. In the event of overdosage, general symptomatic and supportive measures should be instituted promptly and maintained for as long as necessary. It would seem reasonable to treat patients presenting early after large overdoses with oral activated charcoal. The conscious patients may be induced to vomit or gastric lavage may be performed.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.

Ormet

Metronidazole
Tablet 400 mg Allopathic Amoebicides

Indications

Vaginal trichomoniasis

Indication detailsView
Metronidazole is indicated in the treatment of following diseases:
  • The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
  • The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
  • In the treatment of urogenital trichomoniasis.
  • Bacterial vaginosis (also known as non-specific vaginitis).
  • All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
  • Giardiasis.
  • Acute ulcerative gingivitis.
  • Anaerobically infected leg ulcers and pressure sores.
  • Acute dental infections due to anaerobic organisms.
  • Antibiotic associated pseudomembranus colitis.
Therapeutic classView
Amoebicides, Anti-diarrhoeal Antiprotozoal
PharmacologyView
Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.
DosageView

Tablet and Suspension:

Trichomoniasis (Adults & Children over 10 yrs)-
  • 200 mg tid or 400 mg bid for 7 days
  • 800 mg in the morning and 1-2 gm at night for 2 days
  • 2 gm as a single dose for 1 days
Trichomoniasis (Children)-
  • Children 7-10 yrs: 100 mg tid
  • Children 3-7 yrs: 100 mg bid
  • Children 1-3 yrs: 50 mg tid
Intestinal amoebiasis (Adults & Children over 10 yrs)- 
  • 800 mg tid for 5 days
Intestinal amoebiasis (Children)-
  • Children 7-10 yrs: 400 mg tid
  • Children 3-7 yrs: 200 mg qid
  • Children 1-3 yrs: 200 mg tid
Extra-intestinal & Asymptomatic amoebiasis (Adults & Children over 10 yrs)-
  • 400-800 mg tid for 5-10 days
Extra-intestinal & Asymptomatic amoebiasis (Children)-
  • Children 7-10 yrs: 200-400 mg tid
  • Children 3-7 yrs: 100-200 mg qid
  • Children 1-3 yrs: 100-200 mg tid
Giardiasis (Adults & Children over 10 yrs)-
  • 2 gm once daily for 3 days
Giardiasis (Children)-
  • Children 7-10 yrs: 1 gm once daily
  • Children 3-7 yrs: 600-800 mg once daily
  • Children 1-3 yrs: 500 mg once daily
Acute ulcerative  gingivitis (Adults & Children over 10 yrs)-
  • 200 mg tid for 3 days
Acute ulcerative  gingivitis (Children)-
  • Children 7-10 yrs: 100 mg tid
  • Children 3-7 yrs: 100 mg bid
  • Children 1-3 yrs: 50 mg tid
Acute dental infections (Adults & Children over 10 yrs)-
  • 200 mg tid for 3-7 days
Bacterial Vaginosis (Adults & Children over 10 yrs)-
  • 400 mg bid for 7 days
  • 2 gm as a single dose for 1 days
Leg ulcers and pressure sores (Adults & Children over 10 yrs)-
  • 400 mg tid for 7 days
Anaerobic infections (Adults & Children over 10 yrs)-
  • 800 mg initially and then 400 mg tid for 7 days
Anaerobic infections (Children)-
  • Children 1-10 yrs: 7.5 mg/kg tid
Surgical prophylaxis (Adults & Children over 10 yrs)-
  • 400 mg tid started 24  hours before  surgery for 1 days
Surgical prophylaxis (Children)-
  • Children 1-10 yrs: 7.5 mg/kg tid

Vaginal Gel:

The recommended dose is one applicator full of Metronidazole gel (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole gel should be administered at bedtime.


Suppository:

Anaerobic Infections-
  • Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
  • Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.
Surgical Prophylaxis-
  • Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
  • Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.


IV Infusion:

Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.
  • Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
  • Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.
Side effectsView
Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.
ContraindicationsView
Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.
PrecautionsView
  • If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
  • Metronidazole should be administered with caution to patients with hepatic encephalopathy.
  • Patients should be warned that metronidazole may darken urine.
InteractionsView
  • Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
  • Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
  • Lithium: Plasma levels of lithium may be increased by metronidazole.
  • Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
  • Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
  • 5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
  • Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.
Pregnancy & lactationView
US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.
Pediatric usageView
Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.

Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).
Overdose effectsView
Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.
StorageView
Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.

Ormet

Metronidazole
Oral Suspension 200 mg/5 ml Allopathic Amoebicides

Indications

Vaginal trichomoniasis

Indication detailsView
Metronidazole is indicated in the treatment of following diseases:
  • The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
  • The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
  • In the treatment of urogenital trichomoniasis.
  • Bacterial vaginosis (also known as non-specific vaginitis).
  • All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
  • Giardiasis.
  • Acute ulcerative gingivitis.
  • Anaerobically infected leg ulcers and pressure sores.
  • Acute dental infections due to anaerobic organisms.
  • Antibiotic associated pseudomembranus colitis.
Therapeutic classView
Amoebicides, Anti-diarrhoeal Antiprotozoal
PharmacologyView
Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.
DosageView

Tablet and Suspension:

Trichomoniasis (Adults & Children over 10 yrs)-
  • 200 mg tid or 400 mg bid for 7 days
  • 800 mg in the morning and 1-2 gm at night for 2 days
  • 2 gm as a single dose for 1 days
Trichomoniasis (Children)-
  • Children 7-10 yrs: 100 mg tid
  • Children 3-7 yrs: 100 mg bid
  • Children 1-3 yrs: 50 mg tid
Intestinal amoebiasis (Adults & Children over 10 yrs)- 
  • 800 mg tid for 5 days
Intestinal amoebiasis (Children)-
  • Children 7-10 yrs: 400 mg tid
  • Children 3-7 yrs: 200 mg qid
  • Children 1-3 yrs: 200 mg tid
Extra-intestinal & Asymptomatic amoebiasis (Adults & Children over 10 yrs)-
  • 400-800 mg tid for 5-10 days
Extra-intestinal & Asymptomatic amoebiasis (Children)-
  • Children 7-10 yrs: 200-400 mg tid
  • Children 3-7 yrs: 100-200 mg qid
  • Children 1-3 yrs: 100-200 mg tid
Giardiasis (Adults & Children over 10 yrs)-
  • 2 gm once daily for 3 days
Giardiasis (Children)-
  • Children 7-10 yrs: 1 gm once daily
  • Children 3-7 yrs: 600-800 mg once daily
  • Children 1-3 yrs: 500 mg once daily
Acute ulcerative  gingivitis (Adults & Children over 10 yrs)-
  • 200 mg tid for 3 days
Acute ulcerative  gingivitis (Children)-
  • Children 7-10 yrs: 100 mg tid
  • Children 3-7 yrs: 100 mg bid
  • Children 1-3 yrs: 50 mg tid
Acute dental infections (Adults & Children over 10 yrs)-
  • 200 mg tid for 3-7 days
Bacterial Vaginosis (Adults & Children over 10 yrs)-
  • 400 mg bid for 7 days
  • 2 gm as a single dose for 1 days
Leg ulcers and pressure sores (Adults & Children over 10 yrs)-
  • 400 mg tid for 7 days
Anaerobic infections (Adults & Children over 10 yrs)-
  • 800 mg initially and then 400 mg tid for 7 days
Anaerobic infections (Children)-
  • Children 1-10 yrs: 7.5 mg/kg tid
Surgical prophylaxis (Adults & Children over 10 yrs)-
  • 400 mg tid started 24  hours before  surgery for 1 days
Surgical prophylaxis (Children)-
  • Children 1-10 yrs: 7.5 mg/kg tid

Vaginal Gel:

The recommended dose is one applicator full of Metronidazole gel (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole gel should be administered at bedtime.


Suppository:

Anaerobic Infections-
  • Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
  • Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.
Surgical Prophylaxis-
  • Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
  • Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.


IV Infusion:

Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.
  • Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
  • Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.
Side effectsView
Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.
ContraindicationsView
Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.
PrecautionsView
  • If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
  • Metronidazole should be administered with caution to patients with hepatic encephalopathy.
  • Patients should be warned that metronidazole may darken urine.
InteractionsView
  • Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
  • Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
  • Lithium: Plasma levels of lithium may be increased by metronidazole.
  • Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
  • Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
  • 5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
  • Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.
Pregnancy & lactationView
US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.
Pediatric usageView
Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.

Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).
Overdose effectsView
Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.
StorageView
Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.