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Arixon

Ceftriaxone Sodium

IM 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.

Arixon

Ceftriaxone Sodium

IV Injection 250 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.

Arixon

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.

Arizith

Azithromycin Dihydrate

Tablet 500 mg Allopathic

Indication detailsView

Azithromycin is indicated for infections (caused by susceptible organisms) in lower respiratory tract infections including bronchitis and pneumonia, in upper respiratory tract infections including sinusitis and pharyngitis/tonsillitis, in otitis media, and in skin and soft tissue infections. In sexually transmitted diseases in men and women, Azithromycin is indicated in the treatment of non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis.

PharmacologyView

Azithromycin is acid-stable and can therefore be taken orally with no need of protection from gastric acids. It is readily absorbed; its absorption is greater on an empty stomach. Time to peak concentration in adults is 2.1 to 3.2 hours for oral dosage forms. Due to the high concentration in phagocytes, azithromycin is actively transported to the site of infection. During active phagocytosis, large concentrations of azithromycin are released. The concentration of azithromycin in the tissues can be over 50 times higher than in plasma. This is due to ion trapping and the high lipid solubility.

Azithromycin's half-life allows a large single dose to be administered and yet maintain bacteriostatic levels in the infected tissue for several days. Following a single 500 mg dose, plasma concentrations of azithromycin declined in a polyphasic pattern with a mean apparent plasma clearance of 630 mL/min and a terminal elimination half life of 68 hours. The prolonged terminal half-life is thought to be due to extensive uptake and subsequent release of drug from tissues. Biliary excretion of azithromycin, predominantly unchanged, is a major route of elimination. Over the course of a week, approximately 6% of the administered dose appears as unchanged drug in urine.

Microbiology: Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections:

Aerobic and facultative gram-positive microorganisms: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes
Aerobic and facultative gram-negative microorganisms: Haemophilus ducreyi, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae
Other microorganisms: Chlamydia pneumoniae, Chlamydia trachomatis , Mycoplasma pneumoniae , Betalactamase production should have no effect on azithromycin activity.
Aerobic and facultative gram-positive microorganisms: Streptococci (Groups C,F,G), Viridans group streptococci
Aerobic and facultative gram-negative microorganisms: Bordetella pertussis, Legionella pneumophila
Anaerobic microorganisms: Peptostreptococcus species, Prevotella bivia

DosageView

Oral-
Adult: 500 mg once daily orally for 3 days or 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days. For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 gm given as a single dose or 500 mg once on day 1, followed by 250 mg once daily for next 2 days may also be given.

Children:

10 mg/kg body weight once daily for 3 days for child over 6 months
200 mg (1 teaspoonful) for 3 days if body weight is 15-25 kg
300 mg (1½ teaspoonfuls) for 3 days if body weight is 26-35 kg; 400 mg (2 teaspoonfuls) for 3 days if body weight is 36-45 kg.
In typhoid fever, 500 mg (2½ teaspoonfuls) once daily for 7-10 days is given.

Azithromycin Injection (For IV Infusion only): The recommended dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is:

500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7 to 10-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
The recommended dose of Azithromycin for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin.
Safety and effectiveness of azithromycin for injection in children or adolescents under 16 years have not been established.

AdministrationView

Reconstitution procedure of suspension-

Step 01: Shake the bottle well to loosen the powder.
Step 02: Add boiled and cooled water up to the water mark of the bottle label.
Step 03: Shake until powder is completely mixed with water.

Azithromycin should be taken at least 1 hour before or 2 hours after meal.

Side effectsView

Azithromycin is well tolerated with a low incidence of side effects. The side effects include nausea, vomiting, abdominal discomfort (pain/cramps), flatulence, diarrhoea, headache, dizziness, and skin rashes and are reversible upon discontinuation of therapy.

ContraindicationsView

Azithromycin is contraindicated in patients hypersensitive to Azithromycin or any other macrolide antibiotic. Co-administration of ergot derivatives and Azithromycin is contraindicated. Azithromycin is contraindicated in patients with hepatic diseases.

PrecautionsView

As with any antibiotic, observation for signs of superinfection with non-susceptible organisms, including fungi, is recommended. No dose adjustment is needed in patients with renal impairment.

InteractionsView

Azithromycin absorption is reduced in presence of food and antacid. In patients receiving ergot alkaloids Azithromycin should be avoided because of the possibility of ergotism resulting from interaction of Azithromycin with the cytochrome P-450 system. As macrolides increase the plasma concentration of digoxin and cyclosporin, caution should be exercised while co-administration. There have been no drug interactions between Azithromycin and Warfarin, Theophylline, Carbamazepine, Methylprednisolone or Cimetidine.

Pregnancy & lactationView

Pregnancy Category of Azithromycin is B. Animal reproduction studies have demonstrated that Azithromycin has no evidence of harm to the fetus. There are no adequate and well controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, Azithromycin should be used during pregnancy only if adequate alternatives are not available. It is not known whether Azithromycin is secreted in breast milk. So, caution should be exercised when Azithromycin is administered to nursing women.

Overdose effectsView

There is no data on overdosage with Azithromycin. Typical symptoms of overdosage with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhoea. Gastric lavage and general supportive measures are indicated.

StorageView

Keep in a dry place away from light and heat. Keep out of the reach of children.

Arjunacard

Arjunarista

Syrup Herbal Herbal and Nutraceuticals

Indications

Asthma

Indication detailsView

Arjunarista is indicated for the prevention & treatment of

Cardiac palpitation
Cardiopathy
Cardiac asthma
Physical debility

Therapeutic classView

Herbal and Nutraceuticals

PharmacologyView

Terminalia arjuna: It contains tannins, beta-sitosterol, arjunolic acid, flavonoids, triterpenoids, and saponins. It is cardiotonic and diuretic. It is used in cardiac palpitation, cardiopathy, physical debility, high blood pressure, asthma, bronchitis and hyperhydrosis.

Vitis vinifera: It contains tannins ( proanthocyanidins), flavonoids, tartaric acid, malic acid, citric acid, oxalic acid which shows positive effects against peripheral venous insufficiency. It has anti- oxidant, ischemia preventive and anti-atherosclerotic effect.

Madhuca indica: It contains glycoside, saponin, sapogenin, beta sitosterol and sterol glycoside. It is used in constipation, tonsillitis and pharyngitis.

Woodfordia fruticosa: It contains ellagic acid, beta sitosterol and octacosanol. It has cooling, stimulant and astringent effect. It is used in disorders of mucous membrane.

DosageView

Adult: 2-4 teaspoonful 2-3 times daily after meal.
Children: 1-2 teaspoonful 2-3 times daily after meal.

Side effectsView

There is no significant side effect.

ContraindicationsView

There is no absolute contraindication.

StorageView

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

Arkid

Aravindasav

Syrup Herbal Herbal and Nutraceuticals

Indications

Malnutrition

Indication detailsView

This insindicated in-

Malnutrition
Indigestion
Immune deficiency
Dysentery
Worm

Therapeutic classView

Herbal and Nutraceuticals

PharmacologyView

Roktoutpol (Nymphaea lotus): It has bioflavonodis, glucose, fructose, sucrose, galacturonic acid and amino acids. It is used as a key to good health. Its rhizomes are cooling, sweet, tonic and used in diarrhea, dysentery, dyspepsia and general debility. It is also used internally in the treatment of gastrointestinal disorders and jaundice.

Draksha (Vitis vinifera): It contains sugar, gum, tannin, tartaric, citric, racemic and malic acids, chlorides of potassium and sodium, iron, albumin etc. It is used as demulcent, diuretic, laxative, stomachic and tonic. It is also used in dyspepsia.

Dhaiful (Woodfordia fruticosa): It has cooling and anthelmintic properties. It is stimulant & astringent. It is used in dysentery, disorders of mucous membrane. It is also used in headache and fever.

Haritaki (Terminalia chebula): It contains chebulin, tanic acid, gallic acid, resin etc. Chebulin exhibited antispasmodic action on smooth muscle. It is digestive, antiseptic and carminative. It promotes digestive power. It is also used in diarrhea, dysentery, colic and enlarged spleen and liver.

Amalaki (Phyllanthus emblica): It is a rich dietary source of vitamin C, minerals, flavonoids, amino acids and also contains a wide variety of phenolic compounds such as tannins, phyllembelic acid, phyllemblin, mucic acid and emblico. It balances stomach acids and enhances food absorption. It also increases body immunity and nourishes the brain and mental function. It is used medicinally for the treatment of diarrhea.

DosageView

6 month above to 5 years of children: 1/2 -1 tea-spoonful 2 times daily.
5 years above of children: 1-2 tea-spoonful 2 times daily.

Side effectsView

No side effect in the above mentioned therapeutic doses.

ContraindicationsView

There is no evidence available on contraindication but it may happen in-patient who is hypersensitive to any of its ingredients.

StorageView

There is no evidence available on contraindication but it may happen in-patient who is hypersensitive to any of its ingredients.

Arlin

Linezolid

IV Infusion 2 mg/ml Allopathic Macrolides

Indications

Uncomplicated pneumococcal pneumonia

Indication detailsView

Vancomycin-Resistant Enterococcus faecium infections including cases with concurrent bacteremia.

Nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant strains) or Streptococcus pneumoniae (including multi-drug resistant strains). Combination therapy may be clinically indicated if the documented or presumptive pathogens include Gram-negative organism.

Complicated skin and skin structure infections, including diabetic foot infections (without concomitant osteomyelitis) caused by Staphylococcus aureus (methicillin-susceptible and methicillin-resistant strains), Streptococcus pyogenes or Streptococcus agalactiae.

Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible only) or Streptococcus pyogenes.

Community-acquired pneumonia caused by Streptococcus pneumoniae (including multi-drug resistant strains) including cases with concurrent bacteremia or Staphylococcus aureus (methicillin-susceptible strains only).

Therapeutic classView

Macrolides

PharmacologyView

Linezolid is a synthetic, antibacterial agent belonging to a new class of antibiotics, the oxazolidinones, with in vitro activity against Gram positive aerobic bacteria, some Gram positive anaerobic bacteria and certain Gram negative bacteria. It selectively inhibits bacterial protein synthesis via a mechanism of action different from that of other antibacterial agents. Linezolid binds to the 23S ribosomal RNA of the 50S subunit of the bacterial ribosome and prevents the formation of a functional 70S initiation complex which is an essential component of the bacterial translation process. The results of time-kill studies have shown Linezolid to be bacteriostatic against enterococci and staphylococci. For streptococci, Linezolid was found to be bactericidal for the majority of strains.

DosageView

Patients who commence treatment on the parenteral formulation may be switched to oral presentation when clinically indicated. In such circumstances, no dose adjustment is required as Linezolid has an oral bioavailability of approximately 100%. The injection should be administered over a period of 30 to 120 minutes. The film-coated tablets or oral suspension may be taken with or without food.

Complicated skin and skin structure infections, Community-acquired pneumonia, including concurrent bacteremia-

Pediatric Patients (Birth through 11 Years of Age): 10 mg/kg IV or oral t.i.d.
Adults and Adolescents (12 Years and Older): 600 mg IV or oral b.i.d.
Recommended Duration of Treatment (consecutive days): 10 to 14

Nosocomial pneumonia, Vancomycin-resistant Enterococcus faecium infections including concurrent bacteremia-

Pediatric Patients (Birth through 11 Years of Age): 10 mg/kg IV or oral t.i.d.
Adults and Adolescents (12 Years and Older): 600 mg IV or oral b.i.d.
Recommended Duration of Treatment (consecutive days): 14 to 28

Uncomplicated skin and skin structure infections-

Pediatric Patients (Birth through 11 Years of Age): <5 yrs: 10 mg/kg oral t.i.d. 5-11 yrs: 10 mg/kg oral b.i.d
Adults and Adolescents (12 Years and Older): Adults: 400 mg oral b.i.d. Adolescents: 600 mg oral b.i.d
Recommended Duration of Treatment (consecutive days): 10 to 14

Neonates <7 days: Most pre-term neonates <7 days of age (gestational age <34 weeks) have lower systemic Linezolid clearance values and larger AUC values than many full-term neonates and older infants. These neonates should be initiated with a dosing regimen of 10 mg/kg every 12 hours. Consideration may be given to the use of 10 mg/kg in every eight hours regimen in neonates with a sub-optimal clinical response. All neonatal patients should receive 10 mg/kg t.i.d. by 7 days of life.

AdministrationView

Reconstitution of Oral Suspension: Shake the bottle to loosen powder. Add 75 ml (with the help of given cup) of boiled and cooled water to the dry mixture in the bottle. For the ease of preparation, add water to the bottle in two portions. Shake well after each addition until all the powder is in suspension.

Note: Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place. Use within 21 days after constitution.

Intravenous Administration: Linezolid IV Injection is supplied in single-use, ready-to-use infusion bottles. Linezolid IV Injection should be administered by intravenous infusion over a period of 30 to 120 minutes. The intravenous infusion bottles should not be used in series connections. Additives should not be introduced into this solution. The infusion bottles should be stored at room temperature and protected from freezing. Linezolid IV Injection may exhibit a yellow color that can intensify over time without adversely affecting potency.

Side effectsView

Most of the adverse events reported with Linezolid were mild to moderate in intensity. The most common adverse events in patients treated with Linezolid were diarrhea, headache and nausea. Other adverse events includes oral moniliasis, vaginal moniliasis, hypertension, dyspepsia, localized abdominal pain, pruritus, and tongue discoloration.

ContraindicationsView

Linezolid formulations are contraindicated for using in patients who have known hypersensitivity to Linezolid or any of the other product components. Linezolid should not be used in patients taking any medicinal product which inhibits monoamine oxidases A or B (e.g. Phenelzine, Isocarboxazid) or within two weeks of taking any such medicinal product. Linezolid should not be administered to patients with uncontrolled hypertension, pheochromocytoma, thyrotoxicosis, carcinoid syndrome and/or patients taking directly and indirectly acting sympathomimetic agents (e.g. Pseudoephedrine), vasopressive agents (e.g. Epinephrine, Norepinephrine), dopaminergic agents (e.g. Dopamine, Dobutamine), serotonin re-uptake inhibitors, tricyclic antidepressants, serotonin 5-HT1 receptor agonists (triptans), meperidine or buspirone.

PrecautionsView

Patients who develop recurrent nausea or vomiting, unexplained acidosis or low bicarbonate level while receiving Linezolid should receive immediate medical evaluation. Where administration of Linezolid and concomitant serotonergic agents are clinically appropriate, patients should be closely observed for signs and symptoms of serotonin syndrome such as cognitive dysfunction, hyperpyrexia, hyperreflexia and incoordination. If signs or symptoms occur, physicians should consider discontinuation of either one or both agents. If the concomitant serotonergic agent is withdrawn, discontinuation symptoms can be observed. If patients experience symptoms of visual impairment, such as changes in visual acuity, changes in color vision, blurred vision or visual field defect, prompt ophthalmic evaluation is recommended. Convulsions have been reported in patients when treated with Linezolid. In some of these cases, a history of seizures or risk factors for seizures was reported.

InteractionsView

Monoamine Oxidase Inhibition: Linezolid is a reversible and nonselective inhibitor of monoamine oxidase. Therefore, Linezolid has the potential for interaction with adrenergic and serotonergic agents.

Adrenergic Agents: Some individuals receiving Linezolid may experience a reversible enhancement of the pressor response to indirect-acting sympathomimetic agents, vasopressor or dopaminergic agents. Initial doses of adrenergic agents such as dopamine or epinephrine should be reduced and titrated to achieve the desired response.

Serotonergic Agents: Physicians should be alert to the possible signs and symptoms of serotonergic syndrome in patients receiving concomitant Linezolid and serotonergic agents.

Pregnancy & lactationView

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Linezolid should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Linezolid is excreted in human milk. Because many drugs are excreted in human milk. Caution should be exercised when Linezolid is administered to a nursing woman.

Overdose effectsView

No cases of overdose have been reported. Symptomatic and supportive care is advised together with maintenance of glomerular filtration. Approximately 30% of a Linezolid dose is removed during 3 hours of haemodialysis. No data are available for the removal of Linezolid by peritoneal dialysis or haemoperfusion.

StorageView

Linezolid formulations should be stored at room temperature (15°C-30°C), away from light and moisture. All medicines should be kept away from children.

Arlin

Linezolid

Tablet 400 mg Allopathic Macrolides

Indications

Uncomplicated pneumococcal pneumonia

Indication detailsView

Vancomycin-Resistant Enterococcus faecium infections including cases with concurrent bacteremia.

Nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant strains) or Streptococcus pneumoniae (including multi-drug resistant strains). Combination therapy may be clinically indicated if the documented or presumptive pathogens include Gram-negative organism.

Complicated skin and skin structure infections, including diabetic foot infections (without concomitant osteomyelitis) caused by Staphylococcus aureus (methicillin-susceptible and methicillin-resistant strains), Streptococcus pyogenes or Streptococcus agalactiae.

Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible only) or Streptococcus pyogenes.

Community-acquired pneumonia caused by Streptococcus pneumoniae (including multi-drug resistant strains) including cases with concurrent bacteremia or Staphylococcus aureus (methicillin-susceptible strains only).

Therapeutic classView

Macrolides

PharmacologyView

Linezolid is a synthetic, antibacterial agent belonging to a new class of antibiotics, the oxazolidinones, with in vitro activity against Gram positive aerobic bacteria, some Gram positive anaerobic bacteria and certain Gram negative bacteria. It selectively inhibits bacterial protein synthesis via a mechanism of action different from that of other antibacterial agents. Linezolid binds to the 23S ribosomal RNA of the 50S subunit of the bacterial ribosome and prevents the formation of a functional 70S initiation complex which is an essential component of the bacterial translation process. The results of time-kill studies have shown Linezolid to be bacteriostatic against enterococci and staphylococci. For streptococci, Linezolid was found to be bactericidal for the majority of strains.

DosageView

Patients who commence treatment on the parenteral formulation may be switched to oral presentation when clinically indicated. In such circumstances, no dose adjustment is required as Linezolid has an oral bioavailability of approximately 100%. The injection should be administered over a period of 30 to 120 minutes. The film-coated tablets or oral suspension may be taken with or without food.

Complicated skin and skin structure infections, Community-acquired pneumonia, including concurrent bacteremia-

Pediatric Patients (Birth through 11 Years of Age): 10 mg/kg IV or oral t.i.d.
Adults and Adolescents (12 Years and Older): 600 mg IV or oral b.i.d.
Recommended Duration of Treatment (consecutive days): 10 to 14

Nosocomial pneumonia, Vancomycin-resistant Enterococcus faecium infections including concurrent bacteremia-

Pediatric Patients (Birth through 11 Years of Age): 10 mg/kg IV or oral t.i.d.
Adults and Adolescents (12 Years and Older): 600 mg IV or oral b.i.d.
Recommended Duration of Treatment (consecutive days): 14 to 28

Uncomplicated skin and skin structure infections-

Pediatric Patients (Birth through 11 Years of Age): <5 yrs: 10 mg/kg oral t.i.d. 5-11 yrs: 10 mg/kg oral b.i.d
Adults and Adolescents (12 Years and Older): Adults: 400 mg oral b.i.d. Adolescents: 600 mg oral b.i.d
Recommended Duration of Treatment (consecutive days): 10 to 14

Neonates <7 days: Most pre-term neonates <7 days of age (gestational age <34 weeks) have lower systemic Linezolid clearance values and larger AUC values than many full-term neonates and older infants. These neonates should be initiated with a dosing regimen of 10 mg/kg every 12 hours. Consideration may be given to the use of 10 mg/kg in every eight hours regimen in neonates with a sub-optimal clinical response. All neonatal patients should receive 10 mg/kg t.i.d. by 7 days of life.

AdministrationView

Reconstitution of Oral Suspension: Shake the bottle to loosen powder. Add 75 ml (with the help of given cup) of boiled and cooled water to the dry mixture in the bottle. For the ease of preparation, add water to the bottle in two portions. Shake well after each addition until all the powder is in suspension.

Note: Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place. Use within 21 days after constitution.

Intravenous Administration: Linezolid IV Injection is supplied in single-use, ready-to-use infusion bottles. Linezolid IV Injection should be administered by intravenous infusion over a period of 30 to 120 minutes. The intravenous infusion bottles should not be used in series connections. Additives should not be introduced into this solution. The infusion bottles should be stored at room temperature and protected from freezing. Linezolid IV Injection may exhibit a yellow color that can intensify over time without adversely affecting potency.

Side effectsView

Most of the adverse events reported with Linezolid were mild to moderate in intensity. The most common adverse events in patients treated with Linezolid were diarrhea, headache and nausea. Other adverse events includes oral moniliasis, vaginal moniliasis, hypertension, dyspepsia, localized abdominal pain, pruritus, and tongue discoloration.

ContraindicationsView

Linezolid formulations are contraindicated for using in patients who have known hypersensitivity to Linezolid or any of the other product components. Linezolid should not be used in patients taking any medicinal product which inhibits monoamine oxidases A or B (e.g. Phenelzine, Isocarboxazid) or within two weeks of taking any such medicinal product. Linezolid should not be administered to patients with uncontrolled hypertension, pheochromocytoma, thyrotoxicosis, carcinoid syndrome and/or patients taking directly and indirectly acting sympathomimetic agents (e.g. Pseudoephedrine), vasopressive agents (e.g. Epinephrine, Norepinephrine), dopaminergic agents (e.g. Dopamine, Dobutamine), serotonin re-uptake inhibitors, tricyclic antidepressants, serotonin 5-HT1 receptor agonists (triptans), meperidine or buspirone.

PrecautionsView

Patients who develop recurrent nausea or vomiting, unexplained acidosis or low bicarbonate level while receiving Linezolid should receive immediate medical evaluation. Where administration of Linezolid and concomitant serotonergic agents are clinically appropriate, patients should be closely observed for signs and symptoms of serotonin syndrome such as cognitive dysfunction, hyperpyrexia, hyperreflexia and incoordination. If signs or symptoms occur, physicians should consider discontinuation of either one or both agents. If the concomitant serotonergic agent is withdrawn, discontinuation symptoms can be observed. If patients experience symptoms of visual impairment, such as changes in visual acuity, changes in color vision, blurred vision or visual field defect, prompt ophthalmic evaluation is recommended. Convulsions have been reported in patients when treated with Linezolid. In some of these cases, a history of seizures or risk factors for seizures was reported.

InteractionsView

Monoamine Oxidase Inhibition: Linezolid is a reversible and nonselective inhibitor of monoamine oxidase. Therefore, Linezolid has the potential for interaction with adrenergic and serotonergic agents.

Adrenergic Agents: Some individuals receiving Linezolid may experience a reversible enhancement of the pressor response to indirect-acting sympathomimetic agents, vasopressor or dopaminergic agents. Initial doses of adrenergic agents such as dopamine or epinephrine should be reduced and titrated to achieve the desired response.

Serotonergic Agents: Physicians should be alert to the possible signs and symptoms of serotonergic syndrome in patients receiving concomitant Linezolid and serotonergic agents.

Pregnancy & lactationView

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Linezolid should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Linezolid is excreted in human milk. Because many drugs are excreted in human milk. Caution should be exercised when Linezolid is administered to a nursing woman.

Overdose effectsView

No cases of overdose have been reported. Symptomatic and supportive care is advised together with maintenance of glomerular filtration. Approximately 30% of a Linezolid dose is removed during 3 hours of haemodialysis. No data are available for the removal of Linezolid by peritoneal dialysis or haemoperfusion.

StorageView

Linezolid formulations should be stored at room temperature (15°C-30°C), away from light and moisture. All medicines should be kept away from children.

Arlin

Linezolid

Powder for Suspension 100 mg/5 ml Allopathic Macrolides

Indications

Uncomplicated pneumococcal pneumonia

Indication detailsView

Vancomycin-Resistant Enterococcus faecium infections including cases with concurrent bacteremia.

Nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant strains) or Streptococcus pneumoniae (including multi-drug resistant strains). Combination therapy may be clinically indicated if the documented or presumptive pathogens include Gram-negative organism.

Complicated skin and skin structure infections, including diabetic foot infections (without concomitant osteomyelitis) caused by Staphylococcus aureus (methicillin-susceptible and methicillin-resistant strains), Streptococcus pyogenes or Streptococcus agalactiae.

Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible only) or Streptococcus pyogenes.

Community-acquired pneumonia caused by Streptococcus pneumoniae (including multi-drug resistant strains) including cases with concurrent bacteremia or Staphylococcus aureus (methicillin-susceptible strains only).

Therapeutic classView

Macrolides

PharmacologyView

Linezolid is a synthetic, antibacterial agent belonging to a new class of antibiotics, the oxazolidinones, with in vitro activity against Gram positive aerobic bacteria, some Gram positive anaerobic bacteria and certain Gram negative bacteria. It selectively inhibits bacterial protein synthesis via a mechanism of action different from that of other antibacterial agents. Linezolid binds to the 23S ribosomal RNA of the 50S subunit of the bacterial ribosome and prevents the formation of a functional 70S initiation complex which is an essential component of the bacterial translation process. The results of time-kill studies have shown Linezolid to be bacteriostatic against enterococci and staphylococci. For streptococci, Linezolid was found to be bactericidal for the majority of strains.

DosageView

Patients who commence treatment on the parenteral formulation may be switched to oral presentation when clinically indicated. In such circumstances, no dose adjustment is required as Linezolid has an oral bioavailability of approximately 100%. The injection should be administered over a period of 30 to 120 minutes. The film-coated tablets or oral suspension may be taken with or without food.

Complicated skin and skin structure infections, Community-acquired pneumonia, including concurrent bacteremia-

Pediatric Patients (Birth through 11 Years of Age): 10 mg/kg IV or oral t.i.d.
Adults and Adolescents (12 Years and Older): 600 mg IV or oral b.i.d.
Recommended Duration of Treatment (consecutive days): 10 to 14

Nosocomial pneumonia, Vancomycin-resistant Enterococcus faecium infections including concurrent bacteremia-

Pediatric Patients (Birth through 11 Years of Age): 10 mg/kg IV or oral t.i.d.
Adults and Adolescents (12 Years and Older): 600 mg IV or oral b.i.d.
Recommended Duration of Treatment (consecutive days): 14 to 28

Uncomplicated skin and skin structure infections-

Pediatric Patients (Birth through 11 Years of Age): <5 yrs: 10 mg/kg oral t.i.d. 5-11 yrs: 10 mg/kg oral b.i.d
Adults and Adolescents (12 Years and Older): Adults: 400 mg oral b.i.d. Adolescents: 600 mg oral b.i.d
Recommended Duration of Treatment (consecutive days): 10 to 14

Neonates <7 days: Most pre-term neonates <7 days of age (gestational age <34 weeks) have lower systemic Linezolid clearance values and larger AUC values than many full-term neonates and older infants. These neonates should be initiated with a dosing regimen of 10 mg/kg every 12 hours. Consideration may be given to the use of 10 mg/kg in every eight hours regimen in neonates with a sub-optimal clinical response. All neonatal patients should receive 10 mg/kg t.i.d. by 7 days of life.

AdministrationView

Reconstitution of Oral Suspension: Shake the bottle to loosen powder. Add 75 ml (with the help of given cup) of boiled and cooled water to the dry mixture in the bottle. For the ease of preparation, add water to the bottle in two portions. Shake well after each addition until all the powder is in suspension.

Note: Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place. Use within 21 days after constitution.

Intravenous Administration: Linezolid IV Injection is supplied in single-use, ready-to-use infusion bottles. Linezolid IV Injection should be administered by intravenous infusion over a period of 30 to 120 minutes. The intravenous infusion bottles should not be used in series connections. Additives should not be introduced into this solution. The infusion bottles should be stored at room temperature and protected from freezing. Linezolid IV Injection may exhibit a yellow color that can intensify over time without adversely affecting potency.

Side effectsView

Most of the adverse events reported with Linezolid were mild to moderate in intensity. The most common adverse events in patients treated with Linezolid were diarrhea, headache and nausea. Other adverse events includes oral moniliasis, vaginal moniliasis, hypertension, dyspepsia, localized abdominal pain, pruritus, and tongue discoloration.

ContraindicationsView

Linezolid formulations are contraindicated for using in patients who have known hypersensitivity to Linezolid or any of the other product components. Linezolid should not be used in patients taking any medicinal product which inhibits monoamine oxidases A or B (e.g. Phenelzine, Isocarboxazid) or within two weeks of taking any such medicinal product. Linezolid should not be administered to patients with uncontrolled hypertension, pheochromocytoma, thyrotoxicosis, carcinoid syndrome and/or patients taking directly and indirectly acting sympathomimetic agents (e.g. Pseudoephedrine), vasopressive agents (e.g. Epinephrine, Norepinephrine), dopaminergic agents (e.g. Dopamine, Dobutamine), serotonin re-uptake inhibitors, tricyclic antidepressants, serotonin 5-HT1 receptor agonists (triptans), meperidine or buspirone.

PrecautionsView

Patients who develop recurrent nausea or vomiting, unexplained acidosis or low bicarbonate level while receiving Linezolid should receive immediate medical evaluation. Where administration of Linezolid and concomitant serotonergic agents are clinically appropriate, patients should be closely observed for signs and symptoms of serotonin syndrome such as cognitive dysfunction, hyperpyrexia, hyperreflexia and incoordination. If signs or symptoms occur, physicians should consider discontinuation of either one or both agents. If the concomitant serotonergic agent is withdrawn, discontinuation symptoms can be observed. If patients experience symptoms of visual impairment, such as changes in visual acuity, changes in color vision, blurred vision or visual field defect, prompt ophthalmic evaluation is recommended. Convulsions have been reported in patients when treated with Linezolid. In some of these cases, a history of seizures or risk factors for seizures was reported.

InteractionsView

Monoamine Oxidase Inhibition: Linezolid is a reversible and nonselective inhibitor of monoamine oxidase. Therefore, Linezolid has the potential for interaction with adrenergic and serotonergic agents.

Adrenergic Agents: Some individuals receiving Linezolid may experience a reversible enhancement of the pressor response to indirect-acting sympathomimetic agents, vasopressor or dopaminergic agents. Initial doses of adrenergic agents such as dopamine or epinephrine should be reduced and titrated to achieve the desired response.

Serotonergic Agents: Physicians should be alert to the possible signs and symptoms of serotonergic syndrome in patients receiving concomitant Linezolid and serotonergic agents.

Pregnancy & lactationView

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Linezolid should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Linezolid is excreted in human milk. Because many drugs are excreted in human milk. Caution should be exercised when Linezolid is administered to a nursing woman.

Overdose effectsView

No cases of overdose have been reported. Symptomatic and supportive care is advised together with maintenance of glomerular filtration. Approximately 30% of a Linezolid dose is removed during 3 hours of haemodialysis. No data are available for the removal of Linezolid by peritoneal dialysis or haemoperfusion.

StorageView

Linezolid formulations should be stored at room temperature (15°C-30°C), away from light and moisture. All medicines should be kept away from children.

Arlin

Linezolid

Tablet 600 mg Allopathic Macrolides

Indications

Uncomplicated pneumococcal pneumonia

Indication detailsView

Vancomycin-Resistant Enterococcus faecium infections including cases with concurrent bacteremia.

Nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant strains) or Streptococcus pneumoniae (including multi-drug resistant strains). Combination therapy may be clinically indicated if the documented or presumptive pathogens include Gram-negative organism.

Complicated skin and skin structure infections, including diabetic foot infections (without concomitant osteomyelitis) caused by Staphylococcus aureus (methicillin-susceptible and methicillin-resistant strains), Streptococcus pyogenes or Streptococcus agalactiae.

Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible only) or Streptococcus pyogenes.

Community-acquired pneumonia caused by Streptococcus pneumoniae (including multi-drug resistant strains) including cases with concurrent bacteremia or Staphylococcus aureus (methicillin-susceptible strains only).

Therapeutic classView

Macrolides

PharmacologyView

Linezolid is a synthetic, antibacterial agent belonging to a new class of antibiotics, the oxazolidinones, with in vitro activity against Gram positive aerobic bacteria, some Gram positive anaerobic bacteria and certain Gram negative bacteria. It selectively inhibits bacterial protein synthesis via a mechanism of action different from that of other antibacterial agents. Linezolid binds to the 23S ribosomal RNA of the 50S subunit of the bacterial ribosome and prevents the formation of a functional 70S initiation complex which is an essential component of the bacterial translation process. The results of time-kill studies have shown Linezolid to be bacteriostatic against enterococci and staphylococci. For streptococci, Linezolid was found to be bactericidal for the majority of strains.

DosageView

Patients who commence treatment on the parenteral formulation may be switched to oral presentation when clinically indicated. In such circumstances, no dose adjustment is required as Linezolid has an oral bioavailability of approximately 100%. The injection should be administered over a period of 30 to 120 minutes. The film-coated tablets or oral suspension may be taken with or without food.

Complicated skin and skin structure infections, Community-acquired pneumonia, including concurrent bacteremia-

Pediatric Patients (Birth through 11 Years of Age): 10 mg/kg IV or oral t.i.d.
Adults and Adolescents (12 Years and Older): 600 mg IV or oral b.i.d.
Recommended Duration of Treatment (consecutive days): 10 to 14

Nosocomial pneumonia, Vancomycin-resistant Enterococcus faecium infections including concurrent bacteremia-

Pediatric Patients (Birth through 11 Years of Age): 10 mg/kg IV or oral t.i.d.
Adults and Adolescents (12 Years and Older): 600 mg IV or oral b.i.d.
Recommended Duration of Treatment (consecutive days): 14 to 28

Uncomplicated skin and skin structure infections-

Pediatric Patients (Birth through 11 Years of Age): <5 yrs: 10 mg/kg oral t.i.d. 5-11 yrs: 10 mg/kg oral b.i.d
Adults and Adolescents (12 Years and Older): Adults: 400 mg oral b.i.d. Adolescents: 600 mg oral b.i.d
Recommended Duration of Treatment (consecutive days): 10 to 14

Neonates <7 days: Most pre-term neonates <7 days of age (gestational age <34 weeks) have lower systemic Linezolid clearance values and larger AUC values than many full-term neonates and older infants. These neonates should be initiated with a dosing regimen of 10 mg/kg every 12 hours. Consideration may be given to the use of 10 mg/kg in every eight hours regimen in neonates with a sub-optimal clinical response. All neonatal patients should receive 10 mg/kg t.i.d. by 7 days of life.

AdministrationView

Reconstitution of Oral Suspension: Shake the bottle to loosen powder. Add 75 ml (with the help of given cup) of boiled and cooled water to the dry mixture in the bottle. For the ease of preparation, add water to the bottle in two portions. Shake well after each addition until all the powder is in suspension.

Note: Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place. Use within 21 days after constitution.

Intravenous Administration: Linezolid IV Injection is supplied in single-use, ready-to-use infusion bottles. Linezolid IV Injection should be administered by intravenous infusion over a period of 30 to 120 minutes. The intravenous infusion bottles should not be used in series connections. Additives should not be introduced into this solution. The infusion bottles should be stored at room temperature and protected from freezing. Linezolid IV Injection may exhibit a yellow color that can intensify over time without adversely affecting potency.

Side effectsView

Most of the adverse events reported with Linezolid were mild to moderate in intensity. The most common adverse events in patients treated with Linezolid were diarrhea, headache and nausea. Other adverse events includes oral moniliasis, vaginal moniliasis, hypertension, dyspepsia, localized abdominal pain, pruritus, and tongue discoloration.

ContraindicationsView

Linezolid formulations are contraindicated for using in patients who have known hypersensitivity to Linezolid or any of the other product components. Linezolid should not be used in patients taking any medicinal product which inhibits monoamine oxidases A or B (e.g. Phenelzine, Isocarboxazid) or within two weeks of taking any such medicinal product. Linezolid should not be administered to patients with uncontrolled hypertension, pheochromocytoma, thyrotoxicosis, carcinoid syndrome and/or patients taking directly and indirectly acting sympathomimetic agents (e.g. Pseudoephedrine), vasopressive agents (e.g. Epinephrine, Norepinephrine), dopaminergic agents (e.g. Dopamine, Dobutamine), serotonin re-uptake inhibitors, tricyclic antidepressants, serotonin 5-HT1 receptor agonists (triptans), meperidine or buspirone.

PrecautionsView

Patients who develop recurrent nausea or vomiting, unexplained acidosis or low bicarbonate level while receiving Linezolid should receive immediate medical evaluation. Where administration of Linezolid and concomitant serotonergic agents are clinically appropriate, patients should be closely observed for signs and symptoms of serotonin syndrome such as cognitive dysfunction, hyperpyrexia, hyperreflexia and incoordination. If signs or symptoms occur, physicians should consider discontinuation of either one or both agents. If the concomitant serotonergic agent is withdrawn, discontinuation symptoms can be observed. If patients experience symptoms of visual impairment, such as changes in visual acuity, changes in color vision, blurred vision or visual field defect, prompt ophthalmic evaluation is recommended. Convulsions have been reported in patients when treated with Linezolid. In some of these cases, a history of seizures or risk factors for seizures was reported.

InteractionsView

Monoamine Oxidase Inhibition: Linezolid is a reversible and nonselective inhibitor of monoamine oxidase. Therefore, Linezolid has the potential for interaction with adrenergic and serotonergic agents.

Adrenergic Agents: Some individuals receiving Linezolid may experience a reversible enhancement of the pressor response to indirect-acting sympathomimetic agents, vasopressor or dopaminergic agents. Initial doses of adrenergic agents such as dopamine or epinephrine should be reduced and titrated to achieve the desired response.

Serotonergic Agents: Physicians should be alert to the possible signs and symptoms of serotonergic syndrome in patients receiving concomitant Linezolid and serotonergic agents.

Pregnancy & lactationView

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Linezolid should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Linezolid is excreted in human milk. Because many drugs are excreted in human milk. Caution should be exercised when Linezolid is administered to a nursing woman.

Overdose effectsView

No cases of overdose have been reported. Symptomatic and supportive care is advised together with maintenance of glomerular filtration. Approximately 30% of a Linezolid dose is removed during 3 hours of haemodialysis. No data are available for the removal of Linezolid by peritoneal dialysis or haemoperfusion.

StorageView

Linezolid formulations should be stored at room temperature (15°C-30°C), away from light and moisture. All medicines should be kept away from children.

Armoda

Armodafinil

Tablet 250 mg Allopathic CNS stimulant drugs

Indications

Shift work disorder (SWD)

Indication detailsView

Armodafinil is indicated to improve wakefulness in adult patients with-

Obstructive sleep apnea (OSA)
Narcolepsy
Shift work disorder (SWD)

Therapeutic classView

CNS stimulant drugs

PharmacologyView

Armodafinil is an indirect dopamine receptor agonist. This is the R-enantiomer of Modafinil which is a 1:1 mixture of the R- and S-enantiomers. Armodafinil binds to the dopamine transporter and inhibits dopamine reuptake. As a result, increases neuronal activity in the hypothalamus, enhances activity in hypothalamic wakefulness center (TMN, tuberomammillary nucleus) within the hypothalamic sleep wake switch.

DosageView

Adults:

Obstructive Sleep Apnea (OSA) & Narcolepsy: 150 mg to 250 mg as a single dose in the morning.
Shift Work Disorder (SWD): 150 mg as a single dose approximately 1 hour prior to the start of work shift.

Children: Safety and effectiveness in pediatric patients less than 17 years of age have not been established.

Elderly: In elderly patients, elimination of Armodafinil and its metabolites may be reduced as a consequence of aging. Therefore, consideration should be given to the use of lower doses and close monitoring in this population.

Side effectsView

The most common side effects of Armodafinil are serious rash, including Stevens-Johnson syndrome, angioedema and anaphylaxis reactions, multi-organ hypersensitivity reactions, persistent sleepiness, psychiatric symptoms and some cardiovascular events.

ContraindicationsView

Contraindicated in patients with known hypersensitivity to Armodafinil or any of theexcipients of this product

PrecautionsView

Patients should be cautioned about operating an automobile or other hazardous machinery until it is reasonably certain that Armodafinil therapy will not adversely affect their ability to engage in such activities. Caution should be taken in treating patients with a history of psychosis, depression or mania. Discontinuation of treatment should be considered if psychiatric symptoms develop. Increased monitoring of heart rate and blood pressure should be exercised. Caution should be exercised when prescribing Armodafinil to patients with known cardiovascular disease.

InteractionsView

The clearance of drugs that are substrates for CYP3A4 or CYP3A5 (e.g., steroidal contraceptives, Cyclosporine, Midazolam and Triazolam) may be increased by Armodafinil which results in lower systemic exposure. Dosage adjustment of these drugs should be considered when used concomitantly with Armodafinil.

Elimination of drugs that are substrates for CYP2C19 (e.g., Phenytoin, Diazepam, Propranolol, Omeprazole and Clomipramine) may be prolonged by Armodafinil which results in higher systemic exposure. Dosage adjustment of these drugs should be considered when used concomitantly with Armodafinil.

More frequent monitoring of prothrombin times/ International normalized ratio (INR) should be considered whenever Armodafinil is co-administered with Warfarin.

Caution should be used when concomitantly administering MAO inhibitors and Armodafinil.

Pregnancy & lactationView

Pregnancy: There are no adequate and well controlled studies of Armodafinil in pregnant women. Armodafinil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation: It is not known whether Armodafinil or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Armodafinil is administered to a nursing woman.

Pediatric usageView

Patients with hepatic impairment: In patients with severe hepatic impairment, Armodafinil should be administered at a reduced dose.

Patients with renal impairment:There is inadequate information to determine safety and efficacy of dosing in patients with severe renal impairment.

Overdose effectsView

There were no overdoses reported in the Armodafinil clinical studies. Symptoms of Armodafinil overdose are likely to be similar to those of Modafinil which included excitation or agitation, insomnia and slight or moderate elevations in hemodynamic parameters. There is no specific antidote for Armodafinil overdose. However, if overdose occurs, it should be managed with primary supportive care.

StorageView

Store in a cool (below 25°C) and dry place protected from light.

Armoda

Armodafinil

Tablet 150 mg Allopathic CNS stimulant drugs

Indications

Shift work disorder (SWD)

Indication detailsView

Armodafinil is indicated to improve wakefulness in adult patients with-

Obstructive sleep apnea (OSA)
Narcolepsy
Shift work disorder (SWD)

Therapeutic classView

CNS stimulant drugs

PharmacologyView

Armodafinil is an indirect dopamine receptor agonist. This is the R-enantiomer of Modafinil which is a 1:1 mixture of the R- and S-enantiomers. Armodafinil binds to the dopamine transporter and inhibits dopamine reuptake. As a result, increases neuronal activity in the hypothalamus, enhances activity in hypothalamic wakefulness center (TMN, tuberomammillary nucleus) within the hypothalamic sleep wake switch.

DosageView

Adults:

Obstructive Sleep Apnea (OSA) & Narcolepsy: 150 mg to 250 mg as a single dose in the morning.
Shift Work Disorder (SWD): 150 mg as a single dose approximately 1 hour prior to the start of work shift.

Children: Safety and effectiveness in pediatric patients less than 17 years of age have not been established.

Elderly: In elderly patients, elimination of Armodafinil and its metabolites may be reduced as a consequence of aging. Therefore, consideration should be given to the use of lower doses and close monitoring in this population.

Side effectsView

The most common side effects of Armodafinil are serious rash, including Stevens-Johnson syndrome, angioedema and anaphylaxis reactions, multi-organ hypersensitivity reactions, persistent sleepiness, psychiatric symptoms and some cardiovascular events.

ContraindicationsView

Contraindicated in patients with known hypersensitivity to Armodafinil or any of theexcipients of this product

PrecautionsView

Patients should be cautioned about operating an automobile or other hazardous machinery until it is reasonably certain that Armodafinil therapy will not adversely affect their ability to engage in such activities. Caution should be taken in treating patients with a history of psychosis, depression or mania. Discontinuation of treatment should be considered if psychiatric symptoms develop. Increased monitoring of heart rate and blood pressure should be exercised. Caution should be exercised when prescribing Armodafinil to patients with known cardiovascular disease.

InteractionsView

The clearance of drugs that are substrates for CYP3A4 or CYP3A5 (e.g., steroidal contraceptives, Cyclosporine, Midazolam and Triazolam) may be increased by Armodafinil which results in lower systemic exposure. Dosage adjustment of these drugs should be considered when used concomitantly with Armodafinil.

Elimination of drugs that are substrates for CYP2C19 (e.g., Phenytoin, Diazepam, Propranolol, Omeprazole and Clomipramine) may be prolonged by Armodafinil which results in higher systemic exposure. Dosage adjustment of these drugs should be considered when used concomitantly with Armodafinil.

More frequent monitoring of prothrombin times/ International normalized ratio (INR) should be considered whenever Armodafinil is co-administered with Warfarin.

Caution should be used when concomitantly administering MAO inhibitors and Armodafinil.

Pregnancy & lactationView

Pregnancy: There are no adequate and well controlled studies of Armodafinil in pregnant women. Armodafinil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation: It is not known whether Armodafinil or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Armodafinil is administered to a nursing woman.

Pediatric usageView

Patients with hepatic impairment: In patients with severe hepatic impairment, Armodafinil should be administered at a reduced dose.

Patients with renal impairment:There is inadequate information to determine safety and efficacy of dosing in patients with severe renal impairment.

Overdose effectsView

There were no overdoses reported in the Armodafinil clinical studies. Symptoms of Armodafinil overdose are likely to be similar to those of Modafinil which included excitation or agitation, insomnia and slight or moderate elevations in hemodynamic parameters. There is no specific antidote for Armodafinil overdose. However, if overdose occurs, it should be managed with primary supportive care.

StorageView

Store in a cool (below 25°C) and dry place protected from light.

Arnac

Aceclofenac

Tablet 100 mg Allopathic Drugs for Osteoarthritis

Indications

Spondylitis

Indication detailsView

Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, toothache, trauma and lumbago.

Therapeutic classView

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

PharmacologyView

Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.

DosageView

Extended release tablet: The recommended dose in adults is one 200 mg Aceclofenac tablet daily or as prescribed by the physician.
Film coated tablet: The recommended dose in adults is 100 mg, twice daily.

Side effectsView

Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.

ContraindicationsView

Aceclofenac is contraindicated in patients with known hypersensitivity to it or in whom aspirin or NSAIDs precipitate attacks of asthma.

PrecautionsView

Caution should be exercised to patients with active or suspected peptic ulcer or gastro-intestinal bleeding moderate to severe hepatic impairment and cardiac or renal impairment. Caution should also be exercised in patients suffering from dizziness or urticaria.

InteractionsView

No significant drug interactions has not been observed but close monitoring of patients is required when it is used with:

Lithium and Digoxin: may increase plasma concentration of lithium and digoxin.
Diuretics: may interact the activity of diuretics.
Anticoagulants: may enhance the activity of anticoagulant.
Methotrexate: may increase the plasma level of methotrexate.

Pregnancy & lactationView

The use of Aceclofenac should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

Pediatric usageView

There are no clinical data on the use of Aceclofenac in children.

StorageView

keep in a dry place away from light and heat. Keep out of the reach of children.

Arnigen

Sacubitril + Valsartan

Tablet 49 mg+51 mg Allopathic

Indication detailsView

This is indicated:

To reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class ll-IV) and reduced ejection fraction.
For the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older.
This is usually administered in conjunction with other heart failure therapies, in place of an angiotensin-converting enzyme inhibitor (ACEi) or other ARB.

PharmacologyView

This tablet contains a neprilysin inhibitor, sacubitril, and an angiotensin receptor blocker, valsartan. This tablet inhibits neprilysin (neutral endopeptidase; NEP) via LBQ657, the active metabolite of the prodrug sacubitril, and blocks the angiotensin II type-1 (AT1 ) receptor via valsartan. The cardiovascular and renal effects of this tablet in heart failure patients are attributed to the increased levels of peptides that are degraded by neprilysin, such as natriuretic peptides, by LBQ657, and the simultaneous inhibition of the effects of angiotensin II by valsartan. Valsartan inhibits the effects of angiotensin II by selectively blocking the AT1 receptor, and also inhibits angiotensin II-dependent aldosterone release.

DosageView

Adult Heart Failure: The recommended starting dose is 49/51 mg orally twice daily. Double the dose after 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.

Reduce the starting dose to 24/26 mg twice daily for:

Patients not currently taking an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB) or previously taking a low dose of these agents.
Patients with severe renal impairment.
Patients with moderate hepatic impairment.

Pediatric Heart Failure: Refer to Table 1 for the recommended dose for pediatric patients aged one year and older. Take the recommended dose orally twice daily. Adjust pediatric patient doses every 2 weeks, as tolerated by the patient.

Recommended Dose Titration-

Pediatric Patients Less than 40 kg:

Starting: 1.6 mg/kg
Second: 2.3 mg/kg
Final: 3.1 mg/kg

Pediatric Patients At least 40 kg, less than 50 kg:

Starting: 24/26 mg
Second: 49/51 mg
Final: 49/51 mg

Pediatric Patients At least 50 kg:

Starting: 49/51 mg
Second: 72/78 mg
Final: 97/103 mg

Side effectsView

The most common side effects are Angioedema, Hypotension, Impaired Renal Function, Hyperkalemia, Cough, Dizziness.

ContraindicationsView

This combination is contraindicated:

In patients with hypersensitivity to any component
In patients with a history of angioedema related to previous ACE inhibitor or ARB therapy
With concomitant use of ACE inhibitors. Do not administer within 36 hours of switching from or to an ACE inhibitor
With concomitant use of aliskiren in patients with diabetes

PrecautionsView

This tablet may cause angioedema and must not be used in patients with a known history of angioedema related to previous ACEi or ARB therapy and in patients with hereditary angioedema.

This tablet lowers blood pressure and may cause symptomatic hypotension. Closely monitor serum creatinine, and down-titrate or interrupt this tablet in patients who develop a clinically significant decrease in renal function. In patients with renal artery stenosis, monitor renal function.

Monitor serum potassium periodically and treat appropriately, especially in patients with risk factors for hyperkalemia such as severe renal impairment, diabetes, hypoaldosteronism, or a high potassium diet. Dosage reduction or interruption of this tablet may be required.

InteractionsView

Dual Blockade of the Renin-Angiotensin-Aldosterone System: Should not be used with an ACEi, aliskiren in patients with diabetes, and use with an ARB should be avoided.
Potassium-sparing Diuretics: Serum potassium level may be increased.
NSAIDs: Risk of renal impairment may be increased.
Lithium: Increased risk of lithium toxicity.

Pregnancy & lactationView

Pediatric Use: Safety and effectiveness have not been established in pediatric patients less than 1 year of age.

Geriatric Use: No relevant pharmacokinetic differences have been observed in elderly (>65 years) or very elderly (>75 years) patients compared to the overall population.

Hepatic Impairment: No dose adjustment is required when administering this tablet to patients with mild hepatic impairment (Child-Pugh A classification). This tablet is not recommended in patients with severe hepatic impairment, as no studies have been conducted in these patients.

Renal Impairment: No dose adjustment is required in patients with mild (eGFR 60 to 90 ml/min/1.73 m2) to moderate (eGFR 30 to 60 ml/min/1.73 m2) renal impairment. The recommended starting dose in patients with severe renal impairment (eGFR <30 ml/min/1.73 m2) is 24/26 mg twice daily.

Pediatric usageView

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: No relevant pharmacokinetic differences have been observed in elderly (≥65 years) or very elderly (≥75 years) patients compared to the overall population

Renal Impairment:

Severe: A starting dose of 24/26 mg twice-daily is recommended for patients with severe renal impairment (eGFR <30 mL/min/1.73 m²). Double the dose of Sacubitril & Valsartan every 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.
Mild or moderate: No starting dose adjustment is needed for mild or moderate renal impairment.

Hepatic Impairment:

Moderate: A starting dose of 24/26 mg twice-daily is recommended for patients with moderate hepatic impairment (Child-Pugh B classification). Double the dose of Sacubitril & Valsartan every 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.
Mild: No starting dose adjustment is needed for mild hepatic impairment.
Severe: Use in patients with severe hepatic impairment is not recommended.

Overdose effectsView

Limited data are available with regard to overdosage in human subjects with this tablet. In healthy volunteers, a single dose of this tablet 583 mg sacubitril/617 mg valsartan, and multiple doses of 437 mg sacubitril/463 mg valsartan (14 days) have been studied and were well tolerated. Hypotension is the most likely result of overdosage due to the blood-pressure-lowering effects of this tablet. Symptomatic treatment should be provided. This tablet is unlikely to be removed by hemodialysis because of high protein binding.

StorageView

Keep in a dry place and store below 30°C. Protect from moisture and keep out of the reach of children.

Arnigen

Sacubitril + Valsartan

Tablet 24 mg+26 mg Allopathic

Indication detailsView

This is indicated:

To reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class ll-IV) and reduced ejection fraction.
For the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older.
This is usually administered in conjunction with other heart failure therapies, in place of an angiotensin-converting enzyme inhibitor (ACEi) or other ARB.

PharmacologyView

This tablet contains a neprilysin inhibitor, sacubitril, and an angiotensin receptor blocker, valsartan. This tablet inhibits neprilysin (neutral endopeptidase; NEP) via LBQ657, the active metabolite of the prodrug sacubitril, and blocks the angiotensin II type-1 (AT1 ) receptor via valsartan. The cardiovascular and renal effects of this tablet in heart failure patients are attributed to the increased levels of peptides that are degraded by neprilysin, such as natriuretic peptides, by LBQ657, and the simultaneous inhibition of the effects of angiotensin II by valsartan. Valsartan inhibits the effects of angiotensin II by selectively blocking the AT1 receptor, and also inhibits angiotensin II-dependent aldosterone release.

DosageView

Adult Heart Failure: The recommended starting dose is 49/51 mg orally twice daily. Double the dose after 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.

Reduce the starting dose to 24/26 mg twice daily for:

Patients not currently taking an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB) or previously taking a low dose of these agents.
Patients with severe renal impairment.
Patients with moderate hepatic impairment.

Pediatric Heart Failure: Refer to Table 1 for the recommended dose for pediatric patients aged one year and older. Take the recommended dose orally twice daily. Adjust pediatric patient doses every 2 weeks, as tolerated by the patient.

Recommended Dose Titration-

Pediatric Patients Less than 40 kg:

Starting: 1.6 mg/kg
Second: 2.3 mg/kg
Final: 3.1 mg/kg

Pediatric Patients At least 40 kg, less than 50 kg:

Starting: 24/26 mg
Second: 49/51 mg
Final: 49/51 mg

Pediatric Patients At least 50 kg:

Starting: 49/51 mg
Second: 72/78 mg
Final: 97/103 mg

Side effectsView

The most common side effects are Angioedema, Hypotension, Impaired Renal Function, Hyperkalemia, Cough, Dizziness.

ContraindicationsView

This combination is contraindicated:

In patients with hypersensitivity to any component
In patients with a history of angioedema related to previous ACE inhibitor or ARB therapy
With concomitant use of ACE inhibitors. Do not administer within 36 hours of switching from or to an ACE inhibitor
With concomitant use of aliskiren in patients with diabetes

PrecautionsView

This tablet may cause angioedema and must not be used in patients with a known history of angioedema related to previous ACEi or ARB therapy and in patients with hereditary angioedema.

This tablet lowers blood pressure and may cause symptomatic hypotension. Closely monitor serum creatinine, and down-titrate or interrupt this tablet in patients who develop a clinically significant decrease in renal function. In patients with renal artery stenosis, monitor renal function.

Monitor serum potassium periodically and treat appropriately, especially in patients with risk factors for hyperkalemia such as severe renal impairment, diabetes, hypoaldosteronism, or a high potassium diet. Dosage reduction or interruption of this tablet may be required.

InteractionsView

Dual Blockade of the Renin-Angiotensin-Aldosterone System: Should not be used with an ACEi, aliskiren in patients with diabetes, and use with an ARB should be avoided.
Potassium-sparing Diuretics: Serum potassium level may be increased.
NSAIDs: Risk of renal impairment may be increased.
Lithium: Increased risk of lithium toxicity.

Pregnancy & lactationView

Pediatric Use: Safety and effectiveness have not been established in pediatric patients less than 1 year of age.

Geriatric Use: No relevant pharmacokinetic differences have been observed in elderly (>65 years) or very elderly (>75 years) patients compared to the overall population.

Hepatic Impairment: No dose adjustment is required when administering this tablet to patients with mild hepatic impairment (Child-Pugh A classification). This tablet is not recommended in patients with severe hepatic impairment, as no studies have been conducted in these patients.

Renal Impairment: No dose adjustment is required in patients with mild (eGFR 60 to 90 ml/min/1.73 m2) to moderate (eGFR 30 to 60 ml/min/1.73 m2) renal impairment. The recommended starting dose in patients with severe renal impairment (eGFR <30 ml/min/1.73 m2) is 24/26 mg twice daily.

Pediatric usageView

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: No relevant pharmacokinetic differences have been observed in elderly (≥65 years) or very elderly (≥75 years) patients compared to the overall population

Renal Impairment:

Severe: A starting dose of 24/26 mg twice-daily is recommended for patients with severe renal impairment (eGFR <30 mL/min/1.73 m²). Double the dose of Sacubitril & Valsartan every 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.
Mild or moderate: No starting dose adjustment is needed for mild or moderate renal impairment.

Hepatic Impairment:

Moderate: A starting dose of 24/26 mg twice-daily is recommended for patients with moderate hepatic impairment (Child-Pugh B classification). Double the dose of Sacubitril & Valsartan every 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.
Mild: No starting dose adjustment is needed for mild hepatic impairment.
Severe: Use in patients with severe hepatic impairment is not recommended.

Overdose effectsView

Limited data are available with regard to overdosage in human subjects with this tablet. In healthy volunteers, a single dose of this tablet 583 mg sacubitril/617 mg valsartan, and multiple doses of 437 mg sacubitril/463 mg valsartan (14 days) have been studied and were well tolerated. Hypotension is the most likely result of overdosage due to the blood-pressure-lowering effects of this tablet. Symptomatic treatment should be provided. This tablet is unlikely to be removed by hemodialysis because of high protein binding.

StorageView

Keep in a dry place and store below 30°C. Protect from moisture and keep out of the reach of children.

Arnigen

Sacubitril + Valsartan

Tablet 97 mg+103 mg Allopathic

Indication detailsView

This is indicated:

To reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class ll-IV) and reduced ejection fraction.
For the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older.
This is usually administered in conjunction with other heart failure therapies, in place of an angiotensin-converting enzyme inhibitor (ACEi) or other ARB.

PharmacologyView

This tablet contains a neprilysin inhibitor, sacubitril, and an angiotensin receptor blocker, valsartan. This tablet inhibits neprilysin (neutral endopeptidase; NEP) via LBQ657, the active metabolite of the prodrug sacubitril, and blocks the angiotensin II type-1 (AT1 ) receptor via valsartan. The cardiovascular and renal effects of this tablet in heart failure patients are attributed to the increased levels of peptides that are degraded by neprilysin, such as natriuretic peptides, by LBQ657, and the simultaneous inhibition of the effects of angiotensin II by valsartan. Valsartan inhibits the effects of angiotensin II by selectively blocking the AT1 receptor, and also inhibits angiotensin II-dependent aldosterone release.

DosageView

Adult Heart Failure: The recommended starting dose is 49/51 mg orally twice daily. Double the dose after 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.

Reduce the starting dose to 24/26 mg twice daily for:

Patients not currently taking an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB) or previously taking a low dose of these agents.
Patients with severe renal impairment.
Patients with moderate hepatic impairment.

Pediatric Heart Failure: Refer to Table 1 for the recommended dose for pediatric patients aged one year and older. Take the recommended dose orally twice daily. Adjust pediatric patient doses every 2 weeks, as tolerated by the patient.

Recommended Dose Titration-

Pediatric Patients Less than 40 kg:

Starting: 1.6 mg/kg
Second: 2.3 mg/kg
Final: 3.1 mg/kg

Pediatric Patients At least 40 kg, less than 50 kg:

Starting: 24/26 mg
Second: 49/51 mg
Final: 49/51 mg

Pediatric Patients At least 50 kg:

Starting: 49/51 mg
Second: 72/78 mg
Final: 97/103 mg

Side effectsView

The most common side effects are Angioedema, Hypotension, Impaired Renal Function, Hyperkalemia, Cough, Dizziness.

ContraindicationsView

This combination is contraindicated:

In patients with hypersensitivity to any component
In patients with a history of angioedema related to previous ACE inhibitor or ARB therapy
With concomitant use of ACE inhibitors. Do not administer within 36 hours of switching from or to an ACE inhibitor
With concomitant use of aliskiren in patients with diabetes

PrecautionsView

This tablet may cause angioedema and must not be used in patients with a known history of angioedema related to previous ACEi or ARB therapy and in patients with hereditary angioedema.

This tablet lowers blood pressure and may cause symptomatic hypotension. Closely monitor serum creatinine, and down-titrate or interrupt this tablet in patients who develop a clinically significant decrease in renal function. In patients with renal artery stenosis, monitor renal function.

Monitor serum potassium periodically and treat appropriately, especially in patients with risk factors for hyperkalemia such as severe renal impairment, diabetes, hypoaldosteronism, or a high potassium diet. Dosage reduction or interruption of this tablet may be required.

InteractionsView

Dual Blockade of the Renin-Angiotensin-Aldosterone System: Should not be used with an ACEi, aliskiren in patients with diabetes, and use with an ARB should be avoided.
Potassium-sparing Diuretics: Serum potassium level may be increased.
NSAIDs: Risk of renal impairment may be increased.
Lithium: Increased risk of lithium toxicity.

Pregnancy & lactationView

Pediatric Use: Safety and effectiveness have not been established in pediatric patients less than 1 year of age.

Geriatric Use: No relevant pharmacokinetic differences have been observed in elderly (>65 years) or very elderly (>75 years) patients compared to the overall population.

Hepatic Impairment: No dose adjustment is required when administering this tablet to patients with mild hepatic impairment (Child-Pugh A classification). This tablet is not recommended in patients with severe hepatic impairment, as no studies have been conducted in these patients.

Renal Impairment: No dose adjustment is required in patients with mild (eGFR 60 to 90 ml/min/1.73 m2) to moderate (eGFR 30 to 60 ml/min/1.73 m2) renal impairment. The recommended starting dose in patients with severe renal impairment (eGFR <30 ml/min/1.73 m2) is 24/26 mg twice daily.

Pediatric usageView

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: No relevant pharmacokinetic differences have been observed in elderly (≥65 years) or very elderly (≥75 years) patients compared to the overall population

Renal Impairment:

Severe: A starting dose of 24/26 mg twice-daily is recommended for patients with severe renal impairment (eGFR <30 mL/min/1.73 m²). Double the dose of Sacubitril & Valsartan every 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.
Mild or moderate: No starting dose adjustment is needed for mild or moderate renal impairment.

Hepatic Impairment:

Moderate: A starting dose of 24/26 mg twice-daily is recommended for patients with moderate hepatic impairment (Child-Pugh B classification). Double the dose of Sacubitril & Valsartan every 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.
Mild: No starting dose adjustment is needed for mild hepatic impairment.
Severe: Use in patients with severe hepatic impairment is not recommended.

Overdose effectsView

Limited data are available with regard to overdosage in human subjects with this tablet. In healthy volunteers, a single dose of this tablet 583 mg sacubitril/617 mg valsartan, and multiple doses of 437 mg sacubitril/463 mg valsartan (14 days) have been studied and were well tolerated. Hypotension is the most likely result of overdosage due to the blood-pressure-lowering effects of this tablet. Symptomatic treatment should be provided. This tablet is unlikely to be removed by hemodialysis because of high protein binding.

StorageView

Keep in a dry place and store below 30°C. Protect from moisture and keep out of the reach of children.

Arocaine-A DC

Articaine Hydrochloride + Epinephrine

Injection 4%+0.001% Allopathic Local & Surface anesthesia

Indications

Local anaesthesia

Indication detailsView

Articaine and Epinephrine is an amide local anesthetic containing a vasoconstrictor indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures.

Therapeutic classView

Local & Surface anesthesia

PharmacologyView

Articaine is an amide local anesthetic. Local anesthetics block the generation and conduction of nerve impulses, presumably by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse and by reducing the rate of rise of the action potential. In general, the progression of anesthesia is related to the diameter, myelination, and conduction velocity of the affected nerve fibers. Epinephrine is a vasoconstrictor added to articaine to slow absorption into the general circulation and thus prolong maintenance of an active tissue concentration.

DosageView

Below are the recommended volumes and concentrations of articaine-epinephrine for various types of anesthetic procedures. The dosages suggested below are for normal healthy adults, administered by submucosal infiltration and/or nerve block.

Infiltration: 0.5 mL to 2.5 mL or 20 mg to 100 mg of articaine
Nerve block: 0.5 mL to 3.4 mL or 20 mg to 136 mg of articaine
Oral surgery: 1.0 mL to 5.1 mL or 40 mg to 204 mg of articaine.

For normal healthy adults, the maximum dose of articaine administered by submucosal infiltration and/or nerve block should not exceed 7 mg/kg of body weight.

Side effectsView

Common side effects include Pain, headache, facial edema, gingivitis, paresthesia, infection. Other side effects include pain, headache, positive blood aspiration into syringe, swelling, face edema, infection, neck pain, abdominal pain, ear pain, taste perversion, and accidental injury have been reported

Gastrointestinal side effects including nausea and emesis, gingivitis, constipation, diarrhea, dyspepsia, glossitis, gum hemorrhage, mouth ulceration, nausea, stomatitis, tongue edema, tooth disorder, and vomiting have been reported.

Musculoskeletal side effects including trismus, arthralgia, myalgia, back pain, and osteomyelitis have been reported.

General side effects including sleepiness, malaise, and asthenia have been reported.

Nervous system side effects including paresthesia, numbness and tingling, dizziness, dry mouth, facial paralysis, hyperesthesia, increased salivation, nervousness, neuropathy, paresthesia, somnolence, and exacerbation of Kearns-Sayre syndrome have been reported.

Cardiovascular side effects including palpitation, hemorrhage, migraine, syncope, tachycardia, and elevated blood pressure have been reported.

Respiratory side effects including pharyngitis, rhinitis, sinus pain, and sinus congestion have been reported.

ContraindicationsView

Articaine HCl and Epinephrine is contraindicated in patients who are hypersensitive to products containing sulfites. Products containing sulfites may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people

InteractionsView

The administration of local anesthetic solutions containing epinephrine to patients receiving monoamine oxidase inhibitors, nonselective beta-adrenergic antagonists or tricyclic antidepressants may produce severe, prolonged hypertension. Phenothiazines and butyrophenones may reduce or reverse the pressor effect of epinephrine. Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful patient monitoring is essential

Pregnancy & lactationView

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women with articaine with epinephrine. This should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: It is not known whether Articaine and Epinephrine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this combination is administered to a nursing woman.

Pediatric usageView

Pediatric Use: Safety of doses greater than 7 mg/kg of articaine in pediatric patients has not been established. Dosages in pediatric patients should be reduced, commensurate with age, body weight, and physical condition.

Renal or Hepatic Insufficiency: No studies have been performed with articaine and epinephrine in renal and hepatic impaired patient.

Arocef

Cefadroxil Monohydrate

Powder for Suspension 125 mg/5 ml Allopathic First generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView

It is indicated for the treatment of upper respiratory tract infections (pharyngitis and tonsillitis) caused by Streptococcus pyogenes (group-A beta-hemolytic Streptococci) and Streptococcus pneumoniae; urinary tract infections caused by E. coli, Proteus mirabilis, and Klebsiella species and skin & soft tissue infections caused by Staphylococci (including penicillinase producing bacteria) and Streptococci.

Therapeutic classView

First generation Cephalosporins

PharmacologyView

Cefadroxil inhibits bacterial cell wall synthesis by binding to 1 or more of the penicillin-binding proteins (PBPs) which in turn inhibit the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis and arresting cell wall assembly resulting in bacterial cell death.

DosageView

Adult:

Pharyngitis and Tonsillitis: 1 g per day in one or two divided doses.
Urinary Tract Infections: 1 or 2 g per day in one or two divided doses.
Skin and Skin Structure Infections: 1 g per day in one or two divided doses.

Children: 30 mg/kg daily in divided doses every 12 hours.

It may be taken with meals or on empty stomach. Administration with food may be helpful in diminishing potential gastrointestinal complaints.

Side effectsView

Generally Cefadroxil is well tolerated. However, the most commonly reported side effects are gastrointestinal disturbances and hypersensitivity phenomena.

ContraindicationsView

Cefadroxil is contraindicated in patients with a history of hypersensitivity to Cefadroxil or any of the ingredients of it.

PrecautionsView

Use of this antibiotic may cause pseudomembranous colitis; so caution should be taken during diagnosis in patients who develop diarrhea in association with Cefadroxil therapy.

InteractionsView

There is no significant drug interaction with other drugs.

Pregnancy & lactationView

US FDA pregnancy category of Cefadroxil 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. Cefadroxil have been shown to be excreted in human milk. So, caution should be exercised when Cefadroxil is administered during lactation.

StorageView

Keep in a dry place away from light and heat. Keep out of the reach of children.

Arocef

Cefadroxil Monohydrate

Capsule 500 mg Allopathic First generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView

It is indicated for the treatment of upper respiratory tract infections (pharyngitis and tonsillitis) caused by Streptococcus pyogenes (group-A beta-hemolytic Streptococci) and Streptococcus pneumoniae; urinary tract infections caused by E. coli, Proteus mirabilis, and Klebsiella species and skin & soft tissue infections caused by Staphylococci (including penicillinase producing bacteria) and Streptococci.

Therapeutic classView

First generation Cephalosporins

PharmacologyView

Cefadroxil inhibits bacterial cell wall synthesis by binding to 1 or more of the penicillin-binding proteins (PBPs) which in turn inhibit the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis and arresting cell wall assembly resulting in bacterial cell death.

DosageView

Adult:

Pharyngitis and Tonsillitis: 1 g per day in one or two divided doses.
Urinary Tract Infections: 1 or 2 g per day in one or two divided doses.
Skin and Skin Structure Infections: 1 g per day in one or two divided doses.

Children: 30 mg/kg daily in divided doses every 12 hours.

It may be taken with meals or on empty stomach. Administration with food may be helpful in diminishing potential gastrointestinal complaints.

Side effectsView

Generally Cefadroxil is well tolerated. However, the most commonly reported side effects are gastrointestinal disturbances and hypersensitivity phenomena.

ContraindicationsView

Cefadroxil is contraindicated in patients with a history of hypersensitivity to Cefadroxil or any of the ingredients of it.

PrecautionsView

Use of this antibiotic may cause pseudomembranous colitis; so caution should be taken during diagnosis in patients who develop diarrhea in association with Cefadroxil therapy.

InteractionsView

There is no significant drug interaction with other drugs.

Pregnancy & lactationView

US FDA pregnancy category of Cefadroxil 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. Cefadroxil have been shown to be excreted in human milk. So, caution should be exercised when Cefadroxil is administered during lactation.

StorageView

Keep in a dry place away from light and heat. Keep out of the reach of children.

Arodex

Anastrozole

Tablet 1 mg Allopathic Hormonal Chemotherapy

Indications

Ovulation induction

Indication detailsView

Anastrozole is indicated in-

Treatment of early breast cancer in hormone receptor positive post-menopausal women.
Adjuvant treatment of early breast cancer in hormone receptor positive
postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen.
Reduction in the incidence of contralateral breast cancers in post menopausal women receiving Anastrozole as adjuvant treatment for early breast cancer.
Treatment of advanced breast cancer in post-menopausal women.

Therapeutic classView

Hormonal Chemotherapy

PharmacologyView

Anastrazole exerts its anti-estrogenic effects via selective and competitive inhibition of the aromatase enzyme found predominantly in the adrenal glands, liver, and fatty tissues. Many breast cancers are hormone receptor-positive, meaning their growth is stimulated and/or maintained by the presence of hormones such as estrogen or progesterone. In postmenopausal women, estrogen is primarily derived from the conversion of adrenally-produced androgens into estrogens by the aromatase enzyme- by competitively inhibiting the biosynthesis of estrogen at these enzymes, anastrozole effectively suppresses circulating estrogen levels and, subsequently, the growth of hormone receptor-positive tumours.

DosageView

Adults Including the Elderly: One tablet (1 mg) to be taken orally once a day.
Children: The use of Anastrozole is not recommended in children, as efficacy has not been established
Renal Impairment: No dose change is recommended.
Hepatic Impairment: No dose change is recommended.

Side effectsView

Very common side effects: Hot flushes, asthenia, joint stiffness, arthritis, headache, nausea, rash etc. Common side effects: Hair thinning, allergic reactions, diarrhea, vomiting, somnolence etc.

PrecautionsView

Anastrozole is not recommended for use in children or in pre-menopausal women as safety and efficacy have not been established in these groups of patients.

Anastrozole has not been investigated in patients with severe hepatic or severe renal impairment. The potential risk/benefit to such patients should be carefully considered before administration of Anastrozole.
As Anastrozole lowers circulating estrogen levels, it may cause a reduction in bone mineral density with a possible consequent increased risk of fracture.

InteractionsView

Tamoxifen and/or other therapies containing estrogen should not be co-administered with Anastrozole.

Pregnancy & lactationView

Anastrozole must not be administered during pregnancy or lactation.

Overdose effectsView

There is limited clinical experience of overdose of Anastrozole. There are no reports where a patient has taken a dose in excess of 60 mg. No toxicity was observed and no clinically relevant adverse effects have been seen.

StorageView

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