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    Pelsone

    Econazole Nitrate + Triamcinolone Acetonide
    Cream 1%+0.1% Allopathic Triamcinolone & Combined preparations

    Indications

    Tinea corporis (ringworm)

    Indication detailsView
    Econazole Nitrate & Triamcinolone Acetonide indicated for the treatment of:
    • Eczematous Mycoses
    • Psoriasis
    • Tinea Pedis (Athlete’s foot)
    • Tinea Corporis (Ring worm)
    • Tinea Cruris (Jock itch)
    • Inflammatory Intertrigo
    • Diaper Dermatitis
    Onychomycoses- for the treatment of onychomycoses, local therapy with Econazole/Triamcinolone cream, combined with an oral antimycotic, is recommended.
    Therapeutic classView
    Triamcinolone & Combined preparations
    DosageView
    Adults: This cream should be applied sparingly to the skin lesion no more than 2 times daily, preferably once in the morning and once in the evening. This cream should not be applied with an occlusive dressing, or to large areas of skin on the body. The duration of treatment with this cream should continue until the inflammatory symptoms subside but not longer than 2 weeks; after 2 weeks of therapy with this cream, continue therapy as needed with a preparation containing econazole or econazole nitrate alone.

    Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight. Caution should be exercised.
    Side effectsView
    Rarely, transient local mild irritation, itching & redness may occur immediately after application. Econazole has the minimal allergenic effect and is well tolerated, even by delicate skin. Adrenal suppression on long term continuous topical steroid therapy may occur, particularly in infants or children, or when occlusive dressings are applied. It should be noted that an infant's napkin may act as an occlusive dressing.
    ContraindicationsView
    This Cream is contraindicated-
    • In individuals who have shown hypersensitivity to any of its ingredients.
    • Like any other dermatological preparation containing corticosteroids, this Cream is contraindicated in specific skin conditions such as tuberculous, varicella, herpes simplex or other viral infections of the skin, or fresh vaccination sites.
    • Decubitus ulcers: Viral, bacterial or fungal skin infections (e.g. tuberculosis of the skin, syphilis of the skin, herpes simplex, herpes zoster, chickenpox).
    • Rosacea and rosacea-like dermatitis.
    PrecautionsView
    • For external use only. This Cream is not for ophthalmic or oral use.
    • If a reaction suggesting hypersensitivity or chemical irritation should occur, use of the medication should be discontinued.
    • Corticosteroids applied to the skin can be absorbed in sufficient amounts to produce systemic effects, including adrenal suppression. Systemic absorption may be increased by various factors such as application over a large skin surface area, application to damaged skin, application under occlusive skin dressings and prolonged duration of therapy.
    • Topical corticosteroids are associated with skin thinning and atrophy, striae, telangiectasis and purpura.
    • Topical corticosteroids may lead to increased risk of dermatological superinfection or opportunistic infection.
    Children: Increased caution is required when treating children. Compared to adults, the nature of a child's skin and the larger skin surface area relative to body weight may lead to an increased absorption of the corticosteroid via the child's skin. This cream should be used in children only for short periods of time (less than 2 weeks) and on small areas (less than 10% of body surface area).

    Visual disturbance may be associated with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR).
    InteractionsView
    Econazole: compound metabolized by CYP3A4/2C9 oral anticoagulants (warfarin & acenocoumarol).

    Triamcinolone: lowering of plasma salicylates levels. Increased risk of Gl bleeding and ulceration with NSAIDs. Antagonised blood glucose-lowering effects of the antidiabetics. Increased risk of Hyperkalemia with amphotericin B, beta-blockers, potassium-depleting diuretics, theophylline. Increased clearance of the triamcinolone with ciclosporin, carbamazepine, phenytoin, barbiturate, rifampicin.
    Pregnancy & lactationView
    Pregnancy: Not the Econazole but the Triamcinolone Acetonide crosses the placenta and topical administration of corticosteroids during pregnancy can cause abnormalities of foetal development. The relevance of this finding to human beings has not been established. However, topical steroids in large amounts or for prolonged periods
    should not be used in pregnancy.

    Lactation: Negligible amount of econazole and to some extent Triamcinolone may be excreted in small amounts in breast milk. So this cream should not be prescribed to the lactating mother or if prescribed lactation should be withheld during treatment.
    Overdose effectsView
    This Cream is for cutaneous application only. Corticosteroids applied to the skin, including triamcinolone, can be absorbed in sufficient amounts to produce systemic effects. In the event of accidental ingestion, treat symptomatically. If this cream is accidentally applied to the eyes, wash with clean water or saline and seek medical attention if symptoms persist.
    StorageView
    Store in a cool (below 30°C) and dry place, away from light. Keep out of the reach of children.

    Pelverin

    Alverine Citrate
    Tablet 60 mg Allopathic Anticholinergics

    Indications

    Spasm

    Indication detailsView
    Alverine Citrate is indicated in-
    • Irritable Bowel Syndrome
    • Bowel movement disturbances caused by small sacs or pouches in the wall of the gut (diverticular disease)
    • Abdominal pain associated with menstrual periods (Primary dysmenorrhea)
    • Relief of other conditions associated with spasm of involuntary muscle
    Therapeutic classView
    Anticholinergics
    PharmacologyView
    Alverine Citrate is a smooth muscle relaxant. Smooth muscle is a type of muscle that is not under voluntary control; it is the muscle present in places such as the gut and uterus. Alverine Citrate acts directly on the muscle in the gut, causing it to relax. This prevents the muscle spasm which occur in the gut in conditions such as irritable bowel syndrome and diverticular disease. Alverine Citrate also relaxes the smooth muscle in the uterus. It is therefore also used to treat painful menstruation, which is caused by muscle spasm in the uterus (dysmenorrhea).
    DosageView
    Adult: Orally: 60-120 mg 1-3 times daily.
    Side effectsView
    Possible side effects may include nausea, headache, dizziness, itching, rash and allergic reactions.
    ContraindicationsView
    Paralytic ileus or known hypersensitivity to any of the ingredients.
    PrecautionsView
    Avoid Alverine Citrate in patients with intestinal obstruction or paralytic ileus.
    InteractionsView
    There are no drug interactions reported with this medicine.
    Pregnancy & lactationView
    Although no teratogenic effects have been reported, use during pregnancy or lactation is not recommended as evidence of safety in preclinical studies are limited.
    Pediatric usageView
    Children under 12 years: Not recommended
    Overdose effectsView
    Can produce hypotension and atropine like-toxic effects. Management for overdose is as like as atropine poisoning with continuation of supportive therapy for hypotension.
    StorageView
    Store in a cool and dry place, away from light. Keep all medicines out of the reach of children. Store below 25°C temperature.

    Pemast

    Pemirolast Potassium
    Ophthalmic Solution 0.10% Allopathic Ophthalmic Non-Steroid drugs

    Indications

    Conjunctivitis

    Indication detailsView
    Pemirolast ophthalmic solution is indicated for the prevention of itching of the eye due to allergic conjunctivitis.
    Therapeutic classView
    Ophthalmic Non-Steroid drugs
    PharmacologyView
    Pemirolast binds to the histamine H1 receptor. This blocks the action of endogenous histamine, which subsequently leads to temporary relief of the negative symptoms brought on by histamine. Pemirolast has also been observed to inhibit antigen-stimulated calcium ion influx into mast cells through the blockage of calcium channels. Pemirolast inhibits the chemotaxis of eosinophils into ocular tissue, and prevents inflammatory mediator release from human eosinophils.
    DosageView
    Adult: 1 to 2 drops in each affected eye four times daily.

    Pediatric Use: Safety and effectiveness in pediatric patients below the age of 3 years have not been established.
    Side effectsView
    Burning of eye, dry eye, ocular discomfort, non ocular allergy, sinusitis, headache and sneezing or nasal congestion.
    ContraindicationsView
    Pemirolast ophthalmic solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients of this product.
    PrecautionsView
    To prevent contaminating the dropper tip and solution, do not touch the eyelids or surrounding areas with  the dropper tip. Keep the bottle tightly closed when not in use Patients should be advised not to wear contact lens if their eye is red Pemirolast should not be used to treat contact lens related irritation Patients should wait 10 minutes after applying Pemirolast before they insert contact lenses
    Pregnancy & lactationView
    Pregnancy: There are no adequate and well-controlled studies in pregnant women. Pemirolast ophthalmic solution should be used during pregnancy only if the benefit outweighs the risk.

    Lactation: It is not known whether Pemirolast Potassium is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Pemirolast ophthalmic solution is administered to a nursing woman.
    StorageView
    Store at 15-25° C. Keep out of reach of children. Do not use more than 4 weeks after opening

    Pemeta

    Pemetrexed
    IV Infusion 100 mg/vial Allopathic Cytotoxic Chemotherapy

    Indications

    Non-small cell lung cancer

    Indication detailsView
    Pemetrexed is indicated for:
    • Initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC) in combination with cisplatin.
    • Maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy, as a single agent.
    • Treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy, as a single agent.
    Therapeutic classView
    Cytotoxic Chemotherapy
    PharmacologyView
    Pemetrexed is a thymidylate synthase inhibitor. It works by inhibiting thymidylate synthase, dihydrofolate reductase, glycinamide ribonucleotide formyltransferase and aminoimidazole carboxamide ribonucleotide formyltransferase, the enzymes involved in folate metabolism and DNA synthesis, thus inhibiting purine and thymidine nucleotide and protein synthesis.
    DosageView
    Recommended Dosage And Schedule For Non-Squamous NSCLC:
    • The recommended dose of Pemetrexed in combination with cisplatin for initial treatment of NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m² as an intravenous infusion over 10 minutes administered prior to cisplatin on Day 1 of each 21-day cycle for up to six cycles in the absence of disease progression or unacceptable toxicity.
    • The recommended dose of Pemetrexed for maintenance treatment of NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m² as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity after four cycles of platinum-based first-line chemotherapy.
    • The recommended dose of Pemetrexed for treatment of recurrent NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m² as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
    Recommended Dosage And Schedule For Mesothelioma: The recommended dose of Pemetrexed, administered in combination with cisplatin, in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m² as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
    Side effectsView
    The following adverse reactions are discussed in greater detail in other sections of the labeling:
    • Myelosuppression
    • Renal failure
    • Bullous and exfoliative skin toxicity 
    • Interstitial pneumonitis
    • Radiation recall
    ContraindicationsView
    Pemetrexed is contraindicated in patients with a history of severe hypersensitivity reaction to pemetrexed
    PrecautionsView
    Monitor CBC. Premedication with folate and vitamin B12 are recommended as prophylaxis against haematological and GI toxicity during treatment. Pre-treatment with a corticosteroid also reduces the incidence and severity of skin reactions. Caution when used in renal or hepatic impairment. Not recommended for use in pregnancy and lactation.
    InteractionsView
    High doses of NSAIDs and aspirin may reduce the elimination of pemetrexed; avoid usage 2 days (5 days for longer-acting NSAIDs) before, during and 2 days after treatment with pemetrexed in patients with impaired renal function. Additive GI side effects when used with SSRIs, acetylcholinesterase inhibitors, aripiprazole or ziprasidone. Additive sedation when used with psychotropics. Concurrent use with nephrotoxic drugs (e.g. aminoglycosides, loop diuretics, platinum compounds and ciclosporin) may decrease pemetrexed clearance, thus increasing the risk of toxicity. Clearance may be reduced when used with drugs that are cleared by tubular secretion e.g. probenecid and penicillin.
    Pregnancy & lactationView
    Pregnancy Category D. There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

    Lactation: Advise women not to breastfeed during treatment with Pemetrexed and for 1 week after the final dose
    Pediatric usageView
    Renal Impairment: Pemetrexed dosing recommendations are provided for patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater. There is no recommended dose for patients whose creatinine clearance is less than 45 mL/min

    Pediatric Use: The safety and effectiveness of Pemetrexed in pediatric patients have not been established. 

    Geriatric Use: Of the 3,946 patients enrolled in clinical studies of Pemetrexed, 34% were 65 and over and 4% were 75 and over. No overall differences in effectiveness were observed between these patients and younger patients. The incidences of Grade 3-4 anemia, fatigue, thrombocytopenia, hypertension, and neutropenia were higher in patients 65 years of age and older as compared to younger patients: in at least one of five randomized clinical trials.
    Overdose effectsView
    No drugs are approved for the treatment of Pemetrexed overdose. Based on animal studies, administration of leucovorin may mitigate the toxicities of Pemetrexed overdosage. It is not known whether pemetrexed is dialyzable.
    StorageView
    Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)

    Pemetor

    Pemetrexed
    IV Infusion 500 mg/vial Allopathic Cytotoxic Chemotherapy

    Indications

    Non-small cell lung cancer

    Indication detailsView
    Pemetrexed is indicated for:
    • Initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC) in combination with cisplatin.
    • Maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy, as a single agent.
    • Treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy, as a single agent.
    Therapeutic classView
    Cytotoxic Chemotherapy
    PharmacologyView
    Pemetrexed is a thymidylate synthase inhibitor. It works by inhibiting thymidylate synthase, dihydrofolate reductase, glycinamide ribonucleotide formyltransferase and aminoimidazole carboxamide ribonucleotide formyltransferase, the enzymes involved in folate metabolism and DNA synthesis, thus inhibiting purine and thymidine nucleotide and protein synthesis.
    DosageView
    Recommended Dosage And Schedule For Non-Squamous NSCLC:
    • The recommended dose of Pemetrexed in combination with cisplatin for initial treatment of NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m² as an intravenous infusion over 10 minutes administered prior to cisplatin on Day 1 of each 21-day cycle for up to six cycles in the absence of disease progression or unacceptable toxicity.
    • The recommended dose of Pemetrexed for maintenance treatment of NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m² as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity after four cycles of platinum-based first-line chemotherapy.
    • The recommended dose of Pemetrexed for treatment of recurrent NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m² as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
    Recommended Dosage And Schedule For Mesothelioma: The recommended dose of Pemetrexed, administered in combination with cisplatin, in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m² as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
    Side effectsView
    The following adverse reactions are discussed in greater detail in other sections of the labeling:
    • Myelosuppression
    • Renal failure
    • Bullous and exfoliative skin toxicity 
    • Interstitial pneumonitis
    • Radiation recall
    ContraindicationsView
    Pemetrexed is contraindicated in patients with a history of severe hypersensitivity reaction to pemetrexed
    PrecautionsView
    Monitor CBC. Premedication with folate and vitamin B12 are recommended as prophylaxis against haematological and GI toxicity during treatment. Pre-treatment with a corticosteroid also reduces the incidence and severity of skin reactions. Caution when used in renal or hepatic impairment. Not recommended for use in pregnancy and lactation.
    InteractionsView
    High doses of NSAIDs and aspirin may reduce the elimination of pemetrexed; avoid usage 2 days (5 days for longer-acting NSAIDs) before, during and 2 days after treatment with pemetrexed in patients with impaired renal function. Additive GI side effects when used with SSRIs, acetylcholinesterase inhibitors, aripiprazole or ziprasidone. Additive sedation when used with psychotropics. Concurrent use with nephrotoxic drugs (e.g. aminoglycosides, loop diuretics, platinum compounds and ciclosporin) may decrease pemetrexed clearance, thus increasing the risk of toxicity. Clearance may be reduced when used with drugs that are cleared by tubular secretion e.g. probenecid and penicillin.
    Pregnancy & lactationView
    Pregnancy Category D. There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

    Lactation: Advise women not to breastfeed during treatment with Pemetrexed and for 1 week after the final dose
    Pediatric usageView
    Renal Impairment: Pemetrexed dosing recommendations are provided for patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater. There is no recommended dose for patients whose creatinine clearance is less than 45 mL/min

    Pediatric Use: The safety and effectiveness of Pemetrexed in pediatric patients have not been established. 

    Geriatric Use: Of the 3,946 patients enrolled in clinical studies of Pemetrexed, 34% were 65 and over and 4% were 75 and over. No overall differences in effectiveness were observed between these patients and younger patients. The incidences of Grade 3-4 anemia, fatigue, thrombocytopenia, hypertension, and neutropenia were higher in patients 65 years of age and older as compared to younger patients: in at least one of five randomized clinical trials.
    Overdose effectsView
    No drugs are approved for the treatment of Pemetrexed overdose. Based on animal studies, administration of leucovorin may mitigate the toxicities of Pemetrexed overdosage. It is not known whether pemetrexed is dialyzable.
    StorageView
    Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)

    Pemetor

    Pemetrexed
    IV Infusion 100 mg/vial Allopathic Cytotoxic Chemotherapy

    Indications

    Non-small cell lung cancer

    Indication detailsView
    Pemetrexed is indicated for:
    • Initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC) in combination with cisplatin.
    • Maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy, as a single agent.
    • Treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy, as a single agent.
    Therapeutic classView
    Cytotoxic Chemotherapy
    PharmacologyView
    Pemetrexed is a thymidylate synthase inhibitor. It works by inhibiting thymidylate synthase, dihydrofolate reductase, glycinamide ribonucleotide formyltransferase and aminoimidazole carboxamide ribonucleotide formyltransferase, the enzymes involved in folate metabolism and DNA synthesis, thus inhibiting purine and thymidine nucleotide and protein synthesis.
    DosageView
    Recommended Dosage And Schedule For Non-Squamous NSCLC:
    • The recommended dose of Pemetrexed in combination with cisplatin for initial treatment of NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m² as an intravenous infusion over 10 minutes administered prior to cisplatin on Day 1 of each 21-day cycle for up to six cycles in the absence of disease progression or unacceptable toxicity.
    • The recommended dose of Pemetrexed for maintenance treatment of NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m² as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity after four cycles of platinum-based first-line chemotherapy.
    • The recommended dose of Pemetrexed for treatment of recurrent NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m² as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
    Recommended Dosage And Schedule For Mesothelioma: The recommended dose of Pemetrexed, administered in combination with cisplatin, in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m² as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
    Side effectsView
    The following adverse reactions are discussed in greater detail in other sections of the labeling:
    • Myelosuppression
    • Renal failure
    • Bullous and exfoliative skin toxicity 
    • Interstitial pneumonitis
    • Radiation recall
    ContraindicationsView
    Pemetrexed is contraindicated in patients with a history of severe hypersensitivity reaction to pemetrexed
    PrecautionsView
    Monitor CBC. Premedication with folate and vitamin B12 are recommended as prophylaxis against haematological and GI toxicity during treatment. Pre-treatment with a corticosteroid also reduces the incidence and severity of skin reactions. Caution when used in renal or hepatic impairment. Not recommended for use in pregnancy and lactation.
    InteractionsView
    High doses of NSAIDs and aspirin may reduce the elimination of pemetrexed; avoid usage 2 days (5 days for longer-acting NSAIDs) before, during and 2 days after treatment with pemetrexed in patients with impaired renal function. Additive GI side effects when used with SSRIs, acetylcholinesterase inhibitors, aripiprazole or ziprasidone. Additive sedation when used with psychotropics. Concurrent use with nephrotoxic drugs (e.g. aminoglycosides, loop diuretics, platinum compounds and ciclosporin) may decrease pemetrexed clearance, thus increasing the risk of toxicity. Clearance may be reduced when used with drugs that are cleared by tubular secretion e.g. probenecid and penicillin.
    Pregnancy & lactationView
    Pregnancy Category D. There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

    Lactation: Advise women not to breastfeed during treatment with Pemetrexed and for 1 week after the final dose
    Pediatric usageView
    Renal Impairment: Pemetrexed dosing recommendations are provided for patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater. There is no recommended dose for patients whose creatinine clearance is less than 45 mL/min

    Pediatric Use: The safety and effectiveness of Pemetrexed in pediatric patients have not been established. 

    Geriatric Use: Of the 3,946 patients enrolled in clinical studies of Pemetrexed, 34% were 65 and over and 4% were 75 and over. No overall differences in effectiveness were observed between these patients and younger patients. The incidences of Grade 3-4 anemia, fatigue, thrombocytopenia, hypertension, and neutropenia were higher in patients 65 years of age and older as compared to younger patients: in at least one of five randomized clinical trials.
    Overdose effectsView
    No drugs are approved for the treatment of Pemetrexed overdose. Based on animal studies, administration of leucovorin may mitigate the toxicities of Pemetrexed overdosage. It is not known whether pemetrexed is dialyzable.
    StorageView
    Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)

    Pemetrex

    Pemetrexed
    IV Infusion 500 mg/vial Allopathic Cytotoxic Chemotherapy

    Indications

    Non-small cell lung cancer

    Indication detailsView
    Pemetrexed is indicated for:
    • Initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC) in combination with cisplatin.
    • Maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy, as a single agent.
    • Treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy, as a single agent.
    Therapeutic classView
    Cytotoxic Chemotherapy
    PharmacologyView
    Pemetrexed is a thymidylate synthase inhibitor. It works by inhibiting thymidylate synthase, dihydrofolate reductase, glycinamide ribonucleotide formyltransferase and aminoimidazole carboxamide ribonucleotide formyltransferase, the enzymes involved in folate metabolism and DNA synthesis, thus inhibiting purine and thymidine nucleotide and protein synthesis.
    DosageView
    Recommended Dosage And Schedule For Non-Squamous NSCLC:
    • The recommended dose of Pemetrexed in combination with cisplatin for initial treatment of NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m² as an intravenous infusion over 10 minutes administered prior to cisplatin on Day 1 of each 21-day cycle for up to six cycles in the absence of disease progression or unacceptable toxicity.
    • The recommended dose of Pemetrexed for maintenance treatment of NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m² as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity after four cycles of platinum-based first-line chemotherapy.
    • The recommended dose of Pemetrexed for treatment of recurrent NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m² as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
    Recommended Dosage And Schedule For Mesothelioma: The recommended dose of Pemetrexed, administered in combination with cisplatin, in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m² as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
    Side effectsView
    The following adverse reactions are discussed in greater detail in other sections of the labeling:
    • Myelosuppression
    • Renal failure
    • Bullous and exfoliative skin toxicity 
    • Interstitial pneumonitis
    • Radiation recall
    ContraindicationsView
    Pemetrexed is contraindicated in patients with a history of severe hypersensitivity reaction to pemetrexed
    PrecautionsView
    Monitor CBC. Premedication with folate and vitamin B12 are recommended as prophylaxis against haematological and GI toxicity during treatment. Pre-treatment with a corticosteroid also reduces the incidence and severity of skin reactions. Caution when used in renal or hepatic impairment. Not recommended for use in pregnancy and lactation.
    InteractionsView
    High doses of NSAIDs and aspirin may reduce the elimination of pemetrexed; avoid usage 2 days (5 days for longer-acting NSAIDs) before, during and 2 days after treatment with pemetrexed in patients with impaired renal function. Additive GI side effects when used with SSRIs, acetylcholinesterase inhibitors, aripiprazole or ziprasidone. Additive sedation when used with psychotropics. Concurrent use with nephrotoxic drugs (e.g. aminoglycosides, loop diuretics, platinum compounds and ciclosporin) may decrease pemetrexed clearance, thus increasing the risk of toxicity. Clearance may be reduced when used with drugs that are cleared by tubular secretion e.g. probenecid and penicillin.
    Pregnancy & lactationView
    Pregnancy Category D. There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

    Lactation: Advise women not to breastfeed during treatment with Pemetrexed and for 1 week after the final dose
    Pediatric usageView
    Renal Impairment: Pemetrexed dosing recommendations are provided for patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater. There is no recommended dose for patients whose creatinine clearance is less than 45 mL/min

    Pediatric Use: The safety and effectiveness of Pemetrexed in pediatric patients have not been established. 

    Geriatric Use: Of the 3,946 patients enrolled in clinical studies of Pemetrexed, 34% were 65 and over and 4% were 75 and over. No overall differences in effectiveness were observed between these patients and younger patients. The incidences of Grade 3-4 anemia, fatigue, thrombocytopenia, hypertension, and neutropenia were higher in patients 65 years of age and older as compared to younger patients: in at least one of five randomized clinical trials.
    Overdose effectsView
    No drugs are approved for the treatment of Pemetrexed overdose. Based on animal studies, administration of leucovorin may mitigate the toxicities of Pemetrexed overdosage. It is not known whether pemetrexed is dialyzable.
    StorageView
    Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)

    Pemetrex

    Pemetrexed
    IV Infusion 100 mg/vial Allopathic Cytotoxic Chemotherapy

    Indications

    Non-small cell lung cancer

    Indication detailsView
    Pemetrexed is indicated for:
    • Initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC) in combination with cisplatin.
    • Maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy, as a single agent.
    • Treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy, as a single agent.
    Therapeutic classView
    Cytotoxic Chemotherapy
    PharmacologyView
    Pemetrexed is a thymidylate synthase inhibitor. It works by inhibiting thymidylate synthase, dihydrofolate reductase, glycinamide ribonucleotide formyltransferase and aminoimidazole carboxamide ribonucleotide formyltransferase, the enzymes involved in folate metabolism and DNA synthesis, thus inhibiting purine and thymidine nucleotide and protein synthesis.
    DosageView
    Recommended Dosage And Schedule For Non-Squamous NSCLC:
    • The recommended dose of Pemetrexed in combination with cisplatin for initial treatment of NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m² as an intravenous infusion over 10 minutes administered prior to cisplatin on Day 1 of each 21-day cycle for up to six cycles in the absence of disease progression or unacceptable toxicity.
    • The recommended dose of Pemetrexed for maintenance treatment of NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m² as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity after four cycles of platinum-based first-line chemotherapy.
    • The recommended dose of Pemetrexed for treatment of recurrent NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m² as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
    Recommended Dosage And Schedule For Mesothelioma: The recommended dose of Pemetrexed, administered in combination with cisplatin, in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m² as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
    Side effectsView
    The following adverse reactions are discussed in greater detail in other sections of the labeling:
    • Myelosuppression
    • Renal failure
    • Bullous and exfoliative skin toxicity 
    • Interstitial pneumonitis
    • Radiation recall
    ContraindicationsView
    Pemetrexed is contraindicated in patients with a history of severe hypersensitivity reaction to pemetrexed
    PrecautionsView
    Monitor CBC. Premedication with folate and vitamin B12 are recommended as prophylaxis against haematological and GI toxicity during treatment. Pre-treatment with a corticosteroid also reduces the incidence and severity of skin reactions. Caution when used in renal or hepatic impairment. Not recommended for use in pregnancy and lactation.
    InteractionsView
    High doses of NSAIDs and aspirin may reduce the elimination of pemetrexed; avoid usage 2 days (5 days for longer-acting NSAIDs) before, during and 2 days after treatment with pemetrexed in patients with impaired renal function. Additive GI side effects when used with SSRIs, acetylcholinesterase inhibitors, aripiprazole or ziprasidone. Additive sedation when used with psychotropics. Concurrent use with nephrotoxic drugs (e.g. aminoglycosides, loop diuretics, platinum compounds and ciclosporin) may decrease pemetrexed clearance, thus increasing the risk of toxicity. Clearance may be reduced when used with drugs that are cleared by tubular secretion e.g. probenecid and penicillin.
    Pregnancy & lactationView
    Pregnancy Category D. There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

    Lactation: Advise women not to breastfeed during treatment with Pemetrexed and for 1 week after the final dose
    Pediatric usageView
    Renal Impairment: Pemetrexed dosing recommendations are provided for patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater. There is no recommended dose for patients whose creatinine clearance is less than 45 mL/min

    Pediatric Use: The safety and effectiveness of Pemetrexed in pediatric patients have not been established. 

    Geriatric Use: Of the 3,946 patients enrolled in clinical studies of Pemetrexed, 34% were 65 and over and 4% were 75 and over. No overall differences in effectiveness were observed between these patients and younger patients. The incidences of Grade 3-4 anemia, fatigue, thrombocytopenia, hypertension, and neutropenia were higher in patients 65 years of age and older as compared to younger patients: in at least one of five randomized clinical trials.
    Overdose effectsView
    No drugs are approved for the treatment of Pemetrexed overdose. Based on animal studies, administration of leucovorin may mitigate the toxicities of Pemetrexed overdosage. It is not known whether pemetrexed is dialyzable.
    StorageView
    Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)

    Pemox

    Amoxicillin Trihydrate
    Pediatric Drops 125 mg/1.25 ml Allopathic Broad spectrum penicillins

    Indications

    Skin and skin sructure infections

    Indication detailsView
    Amoxicillin is indicated in the treatment of infections due to susceptible ß-lactamase negative strains of microorganisms. These infections include
    • Ear, nose and throat infections (i.e. otitis media, sinusitis, tonsillitis, pharyngitis, laryngitis)
    • Lower respiratory tract infections (i.e. pneumonia, acute and chronic bronchitis lung abscess, empyema, bronchiectasis)
    • Skin and soft tissue infections (i.e. cellulitis, carbuncles, furunculosis, infected wounds, abscess)
    • Genito-urinary tract infections (i.e. pyelonephritis, cystitis and urethritis)
    • Venereal disease (i.e. acute uncomplicated gonorrhoea)
    • In dental abscess, it is used as short-term therapy.
    • It is also indicated in combination with Clarithromycin and Lansoprazole (as triple therapy), for the treatment of patients with H. pylori infection and duodenal ulcer disease and to reduce the risk of duodenal ulcer recurrence.
    Therapeutic classView
    Broad spectrum penicillins
    PharmacologyView
    Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.
    DosageView
    Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.

    Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
    • Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
    • Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
    • Pneumonia: Recommended dose is 500-1000 mg three times daily.
    • Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
    • Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
    • Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
    • In renal impairment: it may be necessary to reduce the total daily dosage.
    AdministrationView
    Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.
    Side effectsView
    Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.
    ContraindicationsView
    Amoxicillin is contraindicated in penicillin hypersensitive patients.
    PrecautionsView
    The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.
    InteractionsView
    Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
    Pregnancy & lactationView
    US FDA pregnancy category of Amoxicillin 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. Amoxicillin has been shown to be excreted in human milk. So, caution should be exercised when Amoxicillin is administered to a lactating mother.
    ReconstitutionView
    Amoxycillin 500 mg Injection:
    • Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
    • Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.
    StorageView
    Keep in a dry place away from light and heat. Keep out of the reach of children.

    Pemox

    Amoxicillin Trihydrate
    Powder for Suspension 125 mg/5 ml Allopathic Broad spectrum penicillins

    Indications

    Skin and skin sructure infections

    Indication detailsView
    Amoxicillin is indicated in the treatment of infections due to susceptible ß-lactamase negative strains of microorganisms. These infections include
    • Ear, nose and throat infections (i.e. otitis media, sinusitis, tonsillitis, pharyngitis, laryngitis)
    • Lower respiratory tract infections (i.e. pneumonia, acute and chronic bronchitis lung abscess, empyema, bronchiectasis)
    • Skin and soft tissue infections (i.e. cellulitis, carbuncles, furunculosis, infected wounds, abscess)
    • Genito-urinary tract infections (i.e. pyelonephritis, cystitis and urethritis)
    • Venereal disease (i.e. acute uncomplicated gonorrhoea)
    • In dental abscess, it is used as short-term therapy.
    • It is also indicated in combination with Clarithromycin and Lansoprazole (as triple therapy), for the treatment of patients with H. pylori infection and duodenal ulcer disease and to reduce the risk of duodenal ulcer recurrence.
    Therapeutic classView
    Broad spectrum penicillins
    PharmacologyView
    Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.
    DosageView
    Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.

    Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
    • Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
    • Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
    • Pneumonia: Recommended dose is 500-1000 mg three times daily.
    • Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
    • Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
    • Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
    • In renal impairment: it may be necessary to reduce the total daily dosage.
    AdministrationView
    Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.
    Side effectsView
    Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.
    ContraindicationsView
    Amoxicillin is contraindicated in penicillin hypersensitive patients.
    PrecautionsView
    The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.
    InteractionsView
    Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
    Pregnancy & lactationView
    US FDA pregnancy category of Amoxicillin 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. Amoxicillin has been shown to be excreted in human milk. So, caution should be exercised when Amoxicillin is administered to a lactating mother.
    ReconstitutionView
    Amoxycillin 500 mg Injection:
    • Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
    • Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.
    StorageView
    Keep in a dry place away from light and heat. Keep out of the reach of children.

    Pemox

    Amoxicillin Trihydrate
    Capsule 500 mg Allopathic Broad spectrum penicillins

    Indications

    Skin and skin sructure infections

    Indication detailsView
    Amoxicillin is indicated in the treatment of infections due to susceptible ß-lactamase negative strains of microorganisms. These infections include
    • Ear, nose and throat infections (i.e. otitis media, sinusitis, tonsillitis, pharyngitis, laryngitis)
    • Lower respiratory tract infections (i.e. pneumonia, acute and chronic bronchitis lung abscess, empyema, bronchiectasis)
    • Skin and soft tissue infections (i.e. cellulitis, carbuncles, furunculosis, infected wounds, abscess)
    • Genito-urinary tract infections (i.e. pyelonephritis, cystitis and urethritis)
    • Venereal disease (i.e. acute uncomplicated gonorrhoea)
    • In dental abscess, it is used as short-term therapy.
    • It is also indicated in combination with Clarithromycin and Lansoprazole (as triple therapy), for the treatment of patients with H. pylori infection and duodenal ulcer disease and to reduce the risk of duodenal ulcer recurrence.
    Therapeutic classView
    Broad spectrum penicillins
    PharmacologyView
    Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.
    DosageView
    Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.

    Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.
    • Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
    • Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
    • Pneumonia: Recommended dose is 500-1000 mg three times daily.
    • Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
    • Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
    • Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
    • In renal impairment: it may be necessary to reduce the total daily dosage.
    AdministrationView
    Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.
    Side effectsView
    Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.
    ContraindicationsView
    Amoxicillin is contraindicated in penicillin hypersensitive patients.
    PrecautionsView
    The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.
    InteractionsView
    Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
    Pregnancy & lactationView
    US FDA pregnancy category of Amoxicillin 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. Amoxicillin has been shown to be excreted in human milk. So, caution should be exercised when Amoxicillin is administered to a lactating mother.
    ReconstitutionView
    Amoxycillin 500 mg Injection:
    • Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
    • Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.
    StorageView
    Keep in a dry place away from light and heat. Keep out of the reach of children.

    Pemro

    Pembrolizumab
    IV Infusion 100 mg/4 ml Allopathic Immunosuppressant

    Indications

    Melanoma

    Indication detailsView
    Pembrolizumab is a programmed death receptor-1 (PD-1)-blocking antibody indicated:

    Melanoma:
    • for the treatment of patients with unresectable or metastatic melanoma.
    • for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.
    Non-Small Cell Lung Cancer (NSCLC):
    • in combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations.
    • in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, as first-line treatment of patients with metastatic squamous NSCLC.
    • as a single agent for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is: stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.
    • as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Pembrolizumab.
    Small Cell Lung Cancer (SCLC): for the treatment of patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.

    Head and Neck Squamous Cell Cancer (HNSCC):
    • in combination with platinum and FU for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC.
    • as a single agent for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test.
    • as a single agent for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.
    Classical Hodgkin Lymphoma (cHL): for the treatment of adult and pediatric patients with refractory cHL, or who have relapsed after 3 or more prior lines of therapy.

    Primary Mediastinal Large B-Cell Lymphoma (PMBCL): for the treatment of adult and pediatric patients with refractory PMBCL, or who have relapsed after 2 or more prior lines of therapy. 

    Urothelial Carcinoma:
    • for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [Combined Positive Score (CPS) ≥10] as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.
    • for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
    • for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
    Microsatellite Instability-High Cancer: for the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient. solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

    Gastric Cancer: for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, with disease progression on or after 2 or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy.

    Esophageal Cancer: for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 [Combined Positive Score (CPS) ≥10] as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

    Cervical Cancer: for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test.

    Hepatocellular Carcinoma (HCC): for the treatment of patients with HCC who have been previously treated with sorafenib.

    Merkel Cell Carcinoma (MCC): for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma.

    Renal Cell Carcinoma (RCC): in combination with axitinib, for the first-line treatment of patients with advanced RCC.

    Endometrial Carcinoma: in combination with lenvatinib, for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation.
    Therapeutic classView
    Immunological Chemotherapy, Immunosuppressant
    PharmacologyView
    Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. In syngeneic mouse tumor models, blocking PD-1 activity resulted in decreased tumor growth.
    DosageView
    • Melanoma: 200 mg every 3 weeks
    • NSCLC: 200 mg every 3 weeks
    • SCLC: 200 mg every 3 weeks
    • HNSCC: 200 mg every 3 weeks
    • cHL or PMBCL: 200 mg every 3 weeks for adults; 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics
    • Urothelial Carcinoma: 200 mg every 3 weeks
    • MSI-H Cancer: 200 mg every 3 weeks for adults and 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics
    • Gastric Cancer: 200 mg every 3 weeks
    • Esophageal Cancer: 200 mg every 3 weeks
    • Cervical Cancer: 200 mg every 3 weeks
    • HCC: 200 mg every 3 weeks
    • MCC: 200 mg every 3 weeks for adults; 2 mg/kg (up to 200 mg) every 3 weeks for pediatrics
    • RCC: 200 mg every 3 weeks with axitinib 5 mg orally twice daily
    • Endometrial Carcinoma: 200 mg every 3 weeks with lenvatinib 20 mg orally once daily for tumors that are not MSI-H or dMMR.
    Administer Pembrolizumab as an intravenous infusion over 30 minutes.
    Side effectsView
    Most common adverse reactions (reported in ≥20% of patients) were:

    Pembrolizumab as a single agent: fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, and abdominal pain.

    Pembrolizumab in combination with chemotherapy: fatigue/asthenia, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, dyspnea, pyrexia, alopecia, peripheral neuropathy, mucosal inflammation, and stomatitis.

    Pembrolizumab in combination with axitinib: diarrhea, fatigue/asthenia, hypertension, hepatotoxicity, hypothyroidism, decreased appetite, palmar-plantar erythrodysesthesia, nausea, stomatitis/mucosal inflammation, dysphonia, rash, cough, and constipation.

    Pembrolizumab in combination with lenvatinib: fatigue, hypertension, musculoskeletal pain, diarrhea, decreased appetite, hypothyroidism, nausea, stomatitis, vomiting, decreased weight, abdominal pain, headache, constipation, urinary tract infection, dysphonia, hemorrhagic events, hypomagnesemia, palmar-plantar erythrodysesthesia, dyspnea, cough, and rash.
    ContraindicationsView
    None.
    PrecautionsView
    Immune-mediated pneumonitis: Withhold for moderate, and permanently discontinue for severe, life-threatening or recurrent moderate pneumonitis.

    Immune-mediated colitis: Withhold for moderate or severe, and permanently discontinue for life-threatening colitis.

    Immune-mediated hepatitis (Pembrolizumab) and hepatotoxicity (Pembrolizumab in combination with axitinib): Monitor for changes in hepatic function. Based on severity of liver enzyme elevations, withhold or discontinue Pembrolizumab, axitinib, or Pembrolizumab and axitinib. Consider corticosteroid therapy.

    Immune-mediated endocrinopathies:
    • Adrenal insufficiency: Withhold for moderate and withhold or permanently discontinue for severe or life-threatening adrenal insufficiency.
    • Hypophysitis: Withhold for moderate and withhold or permanently discontinue for severe or life-threatening hypophysitis.
    • Thyroid disorders: Monitor for changes in thyroid function. Withhold or permanently discontinue for severe or life-threatening hyperthyroidism.
    • Type 1 diabetes mellitus: Monitor for hyperglycemia. Withhold Pembrolizumab in cases of severe hyperglycemia.
    Immune-mediated nephritis: Monitor for changes in renal function. Withhold for moderate, and permanently discontinue for severe or life-threatening nephritis.

    Immune-mediated skin adverse reactions including, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN): Withhold for severe and permanently discontinue for life-threatening skin reactions.

    Other immune-mediated adverse reactions: In organ transplant recipients, consider the benefit of treatment with Pembrolizumab versus the risk of possible organ rejection.

    Infusion-related reactions: Stop infusion and permanently discontinue Pembrolizumab for severe or life-threatening infusion reactions.

    Complications of allogeneic HSCT: Allogeneic HSCT after treatment with Pembrolizumab: Monitor for hepatic veno-occlusive disease, grade 3-4 acute GVHD including hyperacute GVHD, steroid-requiring febrile syndrome, and other immune-mediated adverse reactions. Transplant-related mortality has occurred. Allogeneic HSCT prior to treatment with Pembrolizumab: In patients with a history of allogeneic HSCT, consider the benefit of treatment with Pembrolizumab versus the risk of GVHD.

    Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.

    Embryo-Fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective method of contraception.
    Pregnancy & lactationView
    Based on its mechanism of action, Pembrolizumab can cause fetal harm when administered to a pregnant woman. There are no available human data informing the risk of embryo-fetal toxicity. There are no data on the presence of pembrolizumab in either animal or human milk or its effects on the breastfed child or on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with Pembrolizumab and for 4 months after the final dose.
    Pediatric usageView
    The safety and effectiveness of Pembrolizumab in pediatric patients have not been established. No overall differences in safety or effectiveness were observed between elderly patients and younger patients.
    StorageView
    Store vials under refrigeration at 2°C to 8°C.

    Pen-G

    Benzyl Penicillin
    Injection 10 lac unit/vial Allopathic Benzylpenicillin & Phenoxymethyl penicillin

    Indications

    Syphilis

    Indication detailsView
    For use in the treatment of severe infections caused by penicillin G-susceptible microorganisms when rapid and high penicillin levels are required such as in the treatment of septicemia, meningitis, pericarditis, endocarditis and severe pneumonia.
    Therapeutic classView
    Benzylpenicillin & Phenoxymethyl penicillin
    PharmacologyView
    Benzylpenicillin has a bactericidal action against gram positive bacteria, gram negative cocci, some other gram negative cross-linking stage of peptidoglycan production through binding and inactivation of transpeptidases on the inner surface of the bacterial cell membrane thus inhibiting bacterial cell wall synthesis. It is inhibited by penicillinase and other β-lactamases.
    DosageView
    Adult:

    Oral: Susceptible infections: 125-312 mg 4-6 hrly.
    IM/IV: Susceptible infections: 0.6-3.6 g/day in 4-6 divided doses.
    IV:
    • Bacterial endocarditis: 7.2-12 g/day in divided doses.
    • Intrapartum prophylaxis against group B Streptoccocal infection in neonates Initial: 3 g, followed by 1.5 g 4 hrly until delivery.
    • Meningococcal meningitis; Pneumococcal meningitis: 2.4 g 4 hrly. Max: 18 g/day in meningococcal meningitis.

    Child:

    IV: Meningococcal meningitis, Pneumococcal meningitis: 
    • Newborn infants: 100 mg/kg daily in 2 divided doses;
    • 1-4 wk: 150 mg/kg daily in 3 divided doses;
    • >1 mth to 12 yr: 180-300 mg/kg daily in 4-6 divided doses.
    Parenteral: susceptible infections: 
    • Newborn infants: 50 mg/kg daily in 2 divided doses;
    • 1-4 wk: 75 mg/kg daily in 3 divided doses;
    • >1 mth to 12 yr: 100 mg/kg daily in divided doses, not exceeding 4 g/day.
    AdministrationView
    Should be taken on an empty stomach. Take with a full glass of water on an empty stomach 1 hr before or 2 hr after meals. Do not take acidic beverages within 1 hr of a dose.
    Side effectsView
    Nausea, vomiting, stomatitis, black or hairy tongue, rash, fever, serum-like sickness, convulsions, interstitial nephritis, haemolytic anaemia, granulocytopenia, agranulocytosis, leucopenia, thrombocytopenia
    ContraindicationsView
    Hypersensitivity to benzylpenicillin and other penicillins.
    PrecautionsView
    Patient with history of allergy esp β-lactam allergy and/or asthma, seizure disorder. Diabetic patients. Renal impairment. Pregnancy and lactation.
    InteractionsView
    May increase the risk of methotrexate toxicity. Increased plasma concentration with probenecid. Antagonism of bactericidal effect with bacteriostatic antibacterials (e.g. erythromycin, tetracyclines).
    Pregnancy & lactationView
    Pregnancy category B. Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect that was not confirmed in controlled studies in women in the 1st trimester.

    Lactation: Monitor electrolyte, hepatic, renal, cardiac and haematologic function; signs and symptoms of anaphylaxis during 1st dose.
    Overdose effectsView
    Symptoms: Agitation, confusion, asterixis, hallucinations, stupor, coma, multifocal myoclonus, seizures and encephalopathy, hyperkalaemia.

    Management: Symptomatic and supportive treatment.
    ReconstitutionView
    Loosen the powder, then, hold the vial horizontally and rotate it while slowly directing the stream of diluent against the wall of the vial. Shake the vial vigorously after all the diluent has been added. Depending on the route of admin, reconstitute with sterile water for inj, NaCl 0.9% inj or dextrose 5% inj.
    StorageView
    Store between 20-25°C. Reconstituted soln: Store between 2-8°C.

    Pen-G

    Benzyl Penicillin
    Injection 5 lac unit/vial Allopathic Benzylpenicillin & Phenoxymethyl penicillin

    Indications

    Syphilis

    Indication detailsView
    For use in the treatment of severe infections caused by penicillin G-susceptible microorganisms when rapid and high penicillin levels are required such as in the treatment of septicemia, meningitis, pericarditis, endocarditis and severe pneumonia.
    Therapeutic classView
    Benzylpenicillin & Phenoxymethyl penicillin
    PharmacologyView
    Benzylpenicillin has a bactericidal action against gram positive bacteria, gram negative cocci, some other gram negative cross-linking stage of peptidoglycan production through binding and inactivation of transpeptidases on the inner surface of the bacterial cell membrane thus inhibiting bacterial cell wall synthesis. It is inhibited by penicillinase and other β-lactamases.
    DosageView
    Adult:

    Oral: Susceptible infections: 125-312 mg 4-6 hrly.
    IM/IV: Susceptible infections: 0.6-3.6 g/day in 4-6 divided doses.
    IV:
    • Bacterial endocarditis: 7.2-12 g/day in divided doses.
    • Intrapartum prophylaxis against group B Streptoccocal infection in neonates Initial: 3 g, followed by 1.5 g 4 hrly until delivery.
    • Meningococcal meningitis; Pneumococcal meningitis: 2.4 g 4 hrly. Max: 18 g/day in meningococcal meningitis.

    Child:

    IV: Meningococcal meningitis, Pneumococcal meningitis: 
    • Newborn infants: 100 mg/kg daily in 2 divided doses;
    • 1-4 wk: 150 mg/kg daily in 3 divided doses;
    • >1 mth to 12 yr: 180-300 mg/kg daily in 4-6 divided doses.
    Parenteral: susceptible infections: 
    • Newborn infants: 50 mg/kg daily in 2 divided doses;
    • 1-4 wk: 75 mg/kg daily in 3 divided doses;
    • >1 mth to 12 yr: 100 mg/kg daily in divided doses, not exceeding 4 g/day.
    AdministrationView
    Should be taken on an empty stomach. Take with a full glass of water on an empty stomach 1 hr before or 2 hr after meals. Do not take acidic beverages within 1 hr of a dose.
    Side effectsView
    Nausea, vomiting, stomatitis, black or hairy tongue, rash, fever, serum-like sickness, convulsions, interstitial nephritis, haemolytic anaemia, granulocytopenia, agranulocytosis, leucopenia, thrombocytopenia
    ContraindicationsView
    Hypersensitivity to benzylpenicillin and other penicillins.
    PrecautionsView
    Patient with history of allergy esp β-lactam allergy and/or asthma, seizure disorder. Diabetic patients. Renal impairment. Pregnancy and lactation.
    InteractionsView
    May increase the risk of methotrexate toxicity. Increased plasma concentration with probenecid. Antagonism of bactericidal effect with bacteriostatic antibacterials (e.g. erythromycin, tetracyclines).
    Pregnancy & lactationView
    Pregnancy category B. Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect that was not confirmed in controlled studies in women in the 1st trimester.

    Lactation: Monitor electrolyte, hepatic, renal, cardiac and haematologic function; signs and symptoms of anaphylaxis during 1st dose.
    Overdose effectsView
    Symptoms: Agitation, confusion, asterixis, hallucinations, stupor, coma, multifocal myoclonus, seizures and encephalopathy, hyperkalaemia.

    Management: Symptomatic and supportive treatment.
    ReconstitutionView
    Loosen the powder, then, hold the vial horizontally and rotate it while slowly directing the stream of diluent against the wall of the vial. Shake the vial vigorously after all the diluent has been added. Depending on the route of admin, reconstitute with sterile water for inj, NaCl 0.9% inj or dextrose 5% inj.
    StorageView
    Store between 20-25°C. Reconstituted soln: Store between 2-8°C.

    Penac

    Diclofenac Sodium
    Tablet 50 mg Allopathic Drugs for Osteoarthritis

    Indications

    Tendonitis

    Indication detailsView
    Rheumatology: Inflammatory and degenerative forms of rheumatism, chronic involutive, polyarthritis, ankylosing spondylarthritis, osteoarthritis, spondylarthroses, acute gout, peri-articular rheumatic disorders.

    Surgery and Traumatology: Sprain, bruises, dislocations, fractures, softtissue injuries, surgical interventions.

    Obstetrics and Gynecology: Primary dysmenorrhoea, episiotomy, adnexitis, endometritis, parametritis, salpingitis, and mastitis.

    Otorhinolaryngology: As pre-operative medication for the prevention of pain, inflammation, and swelling.

    Dentistry: Post-operative and post-traumatic pain, inflammation, and swelling.

    Other indications: For the prevention of pain and treatment of inflammation and swelling of patients operated in the urogenital tract, renal and biliary colic.
    Therapeutic classView
    Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
    PharmacologyView
    Dilofenac Sodium is a potent non-steroidal anti-inflammatory drug (NSAID) with pronounced anti-rheumatic, anti-inflammatory, analgesic and antipyretic properties. It has also some uricosuric effect. Diclofenac exerts its effect by inhibiting prostaglandin biosynthesis which plays a major role in causing inflammation, pain and fever. Diclofenac is rapidly and completely absorbed from the gastro-intestinal tract when taken with or after meal. Peak plasma concentrations are reached within an average of 2 hours after ingestion of it. At therapeutic concentrations, it is 99.7% bound to plasma proteins. Diclofenac is metabolized in the liver and undergoes first pass metabolism.
    DosageView
    Diclofenac FC Tablet: Adults: 75-150 mg daily in 2 to 3 divided doses, preferably after food. Dose should be reduced in long term use.

    Diclofenac SR Tablet:
    • Adult: 1 tablet daily, taken whole with liquid, preferably at meal times. If necessary, the daily dose can be increased to 150 mg by supplementation with conventional tablets.
    • Children: 1-3 mg of diclofenac/kg body wt. daily in divided doses.
    • Elderly patients: In elderly or debilitated patients, the lowest effective dosage is recommended, although the pharmacokinetics of diclofenac sodium is not impaired to any clinically relevant extent in elderly patients.
    Diclofenac Dispersible Tablet:
    • Adults: The recommended daily dosage is 2-3 tablets and the maximum daily dose is 150 mg. In milder cases, 2 tablets of Diclofenac DT per day are sufficient. Diclofenac DT should preferably be taken before meals.
    • Children: Diclofenac is not recommended in children for other indications except juvenile rheumatoid arthritis where the recommended dose is 1-3 mg/kg body weight. Diclofenac DT is to be dropped into a half-glass of water and the liquid is to be stirred to aid dispersion before swallowing. There is no information on the use of Diclofenac DT for more than 03 months.
    Diclofenac TR Capsule: One capsule daily. Diclofenac TR should be taken preferably after mealtimes.

    Diclofenac Suppository: For adults: 50 mg suppository 2-3 times daily. Maximum daily dose is 150 mg.

    Diclofenac injection: For adults the usual dose is 1 ampoule daily. In serious cases this dose may be increased up to 2 ampoules daily.

    Diclofenac Gel: For external use only. Depending on the size of area to be treated, 2-4 g of Diclofenac gel should be applied to the skin 3-4 times daily. To the affected area gel should be rubbed in lightly. This gel may also be given in addition to further treatment with other dosage forms of Diclofenac.
    Side effectsView
    Diclofenac Sodium is generally well tolerated. Adverse effects are mild, rare and transient. At the starting of the treatment, however, patients may be sometimes complaining of epigastric pain, eructation, nausea and diarrhea or dizziness or headache. These effects are usually mild in nature. Peripheral edema and skin reactions, such as rash and eczema have also been encountered. Diclofenac Sodium Gel may cause local irritation and reddening of the skin and skin rash.
    ContraindicationsView
    Contraindicated to the patients hypersensitive to any ingredient of the products. Peptic ulcer, hypersensitivity to Diclofenac like other non-steroid anti-inflammatory agents, Diclofenac is also contra-indicated in asthmatic patient in whom attack with asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or by other drugs with prostaglandin synthetase inhibitor. This Gel should not be used under occlusive airtight dressings.
    PrecautionsView
    In rare instances where peptic ulceration or gastrointestinal bleeding occurs in patients under treatment with Diclofenac. In patients with advanced age should be kept under close observation. Diclofenac Sodium Gel should not be allowed to come in contact with the eyes or mucus membranes, after application the hands should be washed properly and not to be taken by mouth.
    Pregnancy & lactationView
    During pregnancy, Diclofenac should be employed only for compelling reasons. The lowest effective dose should be used. These types of drugs are not recommended during the first trimester of pregnancy. In view of insufficient clinical data, Diclofenac Sodium Gel is not recommended during pregnancy. A very insignificant quantity of Diclofenac may be detected in breast milk but no undesirable effects on the infant to be expected.
    StorageView
    Store in a cool and dry place, protected from light. Store below 30°C. Keep out of the reach of children.

    Penac TR

    Diclofenac Sodium
    Capsule (Timed Release) 100 mg Allopathic Drugs for Osteoarthritis

    Indications

    Tendonitis

    Indication detailsView
    Rheumatology: Inflammatory and degenerative forms of rheumatism, chronic involutive, polyarthritis, ankylosing spondylarthritis, osteoarthritis, spondylarthroses, acute gout, peri-articular rheumatic disorders.

    Surgery and Traumatology: Sprain, bruises, dislocations, fractures, softtissue injuries, surgical interventions.

    Obstetrics and Gynecology: Primary dysmenorrhoea, episiotomy, adnexitis, endometritis, parametritis, salpingitis, and mastitis.

    Otorhinolaryngology: As pre-operative medication for the prevention of pain, inflammation, and swelling.

    Dentistry: Post-operative and post-traumatic pain, inflammation, and swelling.

    Other indications: For the prevention of pain and treatment of inflammation and swelling of patients operated in the urogenital tract, renal and biliary colic.
    Therapeutic classView
    Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
    PharmacologyView
    Dilofenac Sodium is a potent non-steroidal anti-inflammatory drug (NSAID) with pronounced anti-rheumatic, anti-inflammatory, analgesic and antipyretic properties. It has also some uricosuric effect. Diclofenac exerts its effect by inhibiting prostaglandin biosynthesis which plays a major role in causing inflammation, pain and fever. Diclofenac is rapidly and completely absorbed from the gastro-intestinal tract when taken with or after meal. Peak plasma concentrations are reached within an average of 2 hours after ingestion of it. At therapeutic concentrations, it is 99.7% bound to plasma proteins. Diclofenac is metabolized in the liver and undergoes first pass metabolism.
    DosageView
    Diclofenac FC Tablet: Adults: 75-150 mg daily in 2 to 3 divided doses, preferably after food. Dose should be reduced in long term use.

    Diclofenac SR Tablet:
    • Adult: 1 tablet daily, taken whole with liquid, preferably at meal times. If necessary, the daily dose can be increased to 150 mg by supplementation with conventional tablets.
    • Children: 1-3 mg of diclofenac/kg body wt. daily in divided doses.
    • Elderly patients: In elderly or debilitated patients, the lowest effective dosage is recommended, although the pharmacokinetics of diclofenac sodium is not impaired to any clinically relevant extent in elderly patients.
    Diclofenac Dispersible Tablet:
    • Adults: The recommended daily dosage is 2-3 tablets and the maximum daily dose is 150 mg. In milder cases, 2 tablets of Diclofenac DT per day are sufficient. Diclofenac DT should preferably be taken before meals.
    • Children: Diclofenac is not recommended in children for other indications except juvenile rheumatoid arthritis where the recommended dose is 1-3 mg/kg body weight. Diclofenac DT is to be dropped into a half-glass of water and the liquid is to be stirred to aid dispersion before swallowing. There is no information on the use of Diclofenac DT for more than 03 months.
    Diclofenac TR Capsule: One capsule daily. Diclofenac TR should be taken preferably after mealtimes.

    Diclofenac Suppository: For adults: 50 mg suppository 2-3 times daily. Maximum daily dose is 150 mg.

    Diclofenac injection: For adults the usual dose is 1 ampoule daily. In serious cases this dose may be increased up to 2 ampoules daily.

    Diclofenac Gel: For external use only. Depending on the size of area to be treated, 2-4 g of Diclofenac gel should be applied to the skin 3-4 times daily. To the affected area gel should be rubbed in lightly. This gel may also be given in addition to further treatment with other dosage forms of Diclofenac.
    Side effectsView
    Diclofenac Sodium is generally well tolerated. Adverse effects are mild, rare and transient. At the starting of the treatment, however, patients may be sometimes complaining of epigastric pain, eructation, nausea and diarrhea or dizziness or headache. These effects are usually mild in nature. Peripheral edema and skin reactions, such as rash and eczema have also been encountered. Diclofenac Sodium Gel may cause local irritation and reddening of the skin and skin rash.
    ContraindicationsView
    Contraindicated to the patients hypersensitive to any ingredient of the products. Peptic ulcer, hypersensitivity to Diclofenac like other non-steroid anti-inflammatory agents, Diclofenac is also contra-indicated in asthmatic patient in whom attack with asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or by other drugs with prostaglandin synthetase inhibitor. This Gel should not be used under occlusive airtight dressings.
    PrecautionsView
    In rare instances where peptic ulceration or gastrointestinal bleeding occurs in patients under treatment with Diclofenac. In patients with advanced age should be kept under close observation. Diclofenac Sodium Gel should not be allowed to come in contact with the eyes or mucus membranes, after application the hands should be washed properly and not to be taken by mouth.
    Pregnancy & lactationView
    During pregnancy, Diclofenac should be employed only for compelling reasons. The lowest effective dose should be used. These types of drugs are not recommended during the first trimester of pregnancy. In view of insufficient clinical data, Diclofenac Sodium Gel is not recommended during pregnancy. A very insignificant quantity of Diclofenac may be detected in breast milk but no undesirable effects on the infant to be expected.
    StorageView
    Store in a cool and dry place, protected from light. Store below 30°C. Keep out of the reach of children.

    Penac-AC

    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.

    Penalox

    Azithromycin Dihydrate
    Powder for Suspension 200 mg/5 ml 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.

    Penalox

    Azithromycin Dihydrate
    Capsule 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.

    Penamin

    Chlorpheniramine Maleate
    Tablet 4 mg Allopathic Sedating Anti-histamine

    Indications

    Watery eye

    Indication detailsView
    Chlorpheniramine Maleate is indicated in the following indications-
    • Urticaria
    • Sensitivity reactions
    • Angioneurotic edema
    • Vasomotor rhinitis
    • Cough
    • Common cold
    • Motion sickness and
    • Other allergic conditions.
    Therapeutic classView
    Sedating Anti-histamine
    PharmacologyView
    Chlorpheniramine Maleate is an alkylamine antihistamine. It is one of the most potent histamine H1-receptor blocking agents which is used as a potent antihistamine. This generally causes less sedation than promethazine. Chlorpheniramine Maleate exerts its effects by blocking H1-receptor competitively.
    DosageView
    Adult- Usual adult dose is 4 mg every 4-6 hours, maximum 24 mg daily.

    Child-
    • 6-12 years: 2 mg every 4-6 hours, maximum 12 mg daily.
    • 2-5 years: 1 mg every 4-6 hours, maximum 6 mg daily.
    • 1-2 years: 1 mg twice daily.
    Below 1 year the use of Chlorpheniramine Maleate is not recommended.
    Side effectsView
    Chlorpheniramine is well-tolerated, but sometimes drowsiness, dizziness, muscular weakness, and gastrointestinal upset may occur.
    ContraindicationsView
    Chlorpheniramine is contraindicated in patients hypersensitive to this agent, in newborn or premature infants.
    PrecautionsView
    Chlorpheniramine should be used with caution in patients with glaucoma and prostatic hypertrophy. During therapy with chlorpheniramine, caution should be taken in driving vehicles and operating machinery.
    InteractionsView
    Chlorphenamine maleate has been reported to be incompatible with calcium chloride, kanamycin sulfate, noradrenaline acid tartrate, pentobarbital sodium, and meglumine adipiodone.
    Pregnancy & lactationView
    This drug should not be used in lactating mother and in pregnancy especially during the first trimester of pregnancy.
    Overdose effectsView
    CNS depression (including sedation, apnea, CV collapse), CNS stimulation (including insomnia, hallucination, tremors, convulsions), tinnitus, blurred vision, dizziness, ataxia, hypotension. Stimulation and atropine-like signs and symptoms (including dry mouth, fixed dilated pupils, flushing, hyperthermia, Gl symptoms) are more likely in children.
    StorageView
    Store in a cool (Below 25°C temperature) and dry place protected from light. Keep out of the reach of children.