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Acunac

Bromfenac Sodium
Ophthalmic Solution 0.09% Allopathic Ophthalmic Non-Steroid drugs

Indications

Postoperative ocular inflammation

Indication detailsView
Bromfenac is indicated for the treatment of postoperative inflammation and the reduction of ocular pain in patients who have undergone cataract extraction
Therapeutic classView
Ophthalmic Non-Steroid drugs
PharmacologyView
Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID). The mechanism of anti-inflammatory activity is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase 1 and 2. Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed in animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilation, increased vascular permeability, leukocytosis and increased intraocular pressure.
DosageView
Adults: 1 drop to the problem eye 2 times a day; treatment should start 24 hours after surgery and should continue for 2 weeks

Children: Use and dose must be determined by the doctor.

Pediatric Use: Safety and efficacy in pediatric patients below the age of 18 have not been established yet.
Side effectsView
The most commonly reported adverse reactions following use of Bromfenac after cataract surgery include: abnormal sensation in eye, conjunctival hyperemia, eye irritation (including burning/stinging), eye pain, eye pruritus, eye redness, headache and iritis. These events were reported in 2-7% of patients
ContraindicationsView
Bromfenac ophthalmic solution is contraindicated in patients with known hypersensitivity to any ingredients of the formulation.
PrecautionsView
All topical NSAIDs may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. It is recommended that Bromfenac ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time. Bromfenac ophthalmic solution should not be administered while wearing contact lenses.

Bromfenac ophthalmic solution contains Sodium Sulfite, a compound that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
Pregnancy & lactationView
Pregnancy Category C. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when Bromfenac ophthalmic solution is administered to a nursing mother.
StorageView
Keep out of the reach of children. Store in a cool, dry place, away from heat and direct light.  Do not use more than 4 weeks after opening.

Acupain

Ketorolac Tromethamine
Tablet 10 mg Allopathic Drugs used for Rheumatoid Arthritis

Indications

Soft tissue inflammation

Indication detailsView
Ketorolac Tromethamine is indicated for the short-term management of moderate to severe acute post-operative pain.
Therapeutic classView
Drugs used for Rheumatoid Arthritis, Non-Opioid Analgesics
PharmacologyView
Ketorolac Tromethamine is a potent analgesic of the non-steroidal anti-inflammatory drugs (NSAIDs). It acts by inhibiting the cyclooxygenase enzyme system and hence inhibits the prostaglandin synthesis. It demonstrates a minimal anti-inflammatory effect at its analgesic dose.
DosageView

Tablet-

Recommended dose is 10 mg every 4-6 hours. It should be used short-term only (up to 7 days) and are not recommended for chronic use. Doses exceeding 40 mg/day is not recommended.

Injection-

Ketorolac injection may be used as a single or multiple doses, on a regular or when necessary schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. When administering Ketorolac injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins within 30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.

Single-Dose Treatment-
IM Dosing (Adult):
  • Patients <65 years of age: One dose of 60 mg.
  • Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 30 mg.
IV Dosing (Adult):
  • Patients <65 years of age: One dose of 30 mg.
  • Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 15 mg.
IV or IM Dosing (2 to 16 years of age):
  • IM Dosing: One dose of 1 mg/kg up to a maximum of 30 mg.
  • IV Dosing: One dose of 0.5 mg/kg up to a maximum of 15 mg.
Multiple-Dose Treatment (IV or IM)-
  • Patients <65 years of age: The recommended dose is 30 mg Ketorolac injection every 6 hours. The maximum daily dose should not exceed 120 mg. Patients >65 years of age, renally impaired patients and patients less than 50 kg: The recommended dose is 15 mg Ketorolac injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg. For breakthrough pain, do not increase the dose or the frequency of Ketorolac Tromethamine.
  • Conversion from Parenteral to Oral Therapy: Ketorolac tablets may be used either as monotherapy or as follow-on therapy to parenteral Ketorolac. When Ketorolac tablets are used as a follow-on therapy to parenteral Ketorolac, the total combined daily dose of ketorolac (oral + parenteral) should not exceed 120 mg in younger adult patients or 60 mg in elderly patients on the day the change of formulation is made. On subsequent days, oral dosing should not exceed the recommended daily maximum of 40 mg. Ketorolac IM should be replaced by Ketorolac tablet as soon as feasible. The total duration of combined parenteral and oral treatment should not exceed 5 days.
Side effectsView
Commonly occurring side effects are nausea, vomiting, gastro-intestinal bleeding, melana, peptic ulcer, pancreatitis, anxiety, drowsiness, headache, excessive thirst, fatigue, bradycardia, hypertension, palpitation, chest pain, infertility in female and pulmonary edema.
ContraindicationsView
Ketorolac is contraindicated in patients having hypersensitivity to this drug or other NSAIDs. It should not be used in children under 16 years of age. lt is also contraindicated as prophylactic analgesic before surgery.
PrecautionsView
Caution should be exercised in patients over the age of 65 years. Caution should also be taken in patients with active or suspected peptic ulcer or gastrointestinal bleeding or asthma and liver dysfunction.
InteractionsView
Other NSAIDs or aspirin: Increase the side effects of ketorolac Tromethamine.
Anti-coagulants: Enhance anti-coagulant effect.
Beta Blocker: Reduce the anti-hypertensive effect .
ACE Inhibitors: Increase the risk of renal impairment.
Methotrexate: Enhance the toxicity of methotrexate.
Pregnancy & lactationView
US FDA Pregnancy category of Ketorolac Tromethamine is C. So, Ketorolac Tromethamine should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.

Acupain

Ketorolac Tromethamine
IM/IV Injection 30 mg/ml Allopathic Drugs used for Rheumatoid Arthritis

Indications

Soft tissue inflammation

Indication detailsView
Ketorolac Tromethamine is indicated for the short-term management of moderate to severe acute post-operative pain.
Therapeutic classView
Drugs used for Rheumatoid Arthritis, Non-Opioid Analgesics
PharmacologyView
Ketorolac Tromethamine is a potent analgesic of the non-steroidal anti-inflammatory drugs (NSAIDs). It acts by inhibiting the cyclooxygenase enzyme system and hence inhibits the prostaglandin synthesis. It demonstrates a minimal anti-inflammatory effect at its analgesic dose.
DosageView

Tablet-

Recommended dose is 10 mg every 4-6 hours. It should be used short-term only (up to 7 days) and are not recommended for chronic use. Doses exceeding 40 mg/day is not recommended.

Injection-

Ketorolac injection may be used as a single or multiple doses, on a regular or when necessary schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. When administering Ketorolac injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins within 30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.

Single-Dose Treatment-
IM Dosing (Adult):
  • Patients <65 years of age: One dose of 60 mg.
  • Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 30 mg.
IV Dosing (Adult):
  • Patients <65 years of age: One dose of 30 mg.
  • Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 15 mg.
IV or IM Dosing (2 to 16 years of age):
  • IM Dosing: One dose of 1 mg/kg up to a maximum of 30 mg.
  • IV Dosing: One dose of 0.5 mg/kg up to a maximum of 15 mg.
Multiple-Dose Treatment (IV or IM)-
  • Patients <65 years of age: The recommended dose is 30 mg Ketorolac injection every 6 hours. The maximum daily dose should not exceed 120 mg. Patients >65 years of age, renally impaired patients and patients less than 50 kg: The recommended dose is 15 mg Ketorolac injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg. For breakthrough pain, do not increase the dose or the frequency of Ketorolac Tromethamine.
  • Conversion from Parenteral to Oral Therapy: Ketorolac tablets may be used either as monotherapy or as follow-on therapy to parenteral Ketorolac. When Ketorolac tablets are used as a follow-on therapy to parenteral Ketorolac, the total combined daily dose of ketorolac (oral + parenteral) should not exceed 120 mg in younger adult patients or 60 mg in elderly patients on the day the change of formulation is made. On subsequent days, oral dosing should not exceed the recommended daily maximum of 40 mg. Ketorolac IM should be replaced by Ketorolac tablet as soon as feasible. The total duration of combined parenteral and oral treatment should not exceed 5 days.
Side effectsView
Commonly occurring side effects are nausea, vomiting, gastro-intestinal bleeding, melana, peptic ulcer, pancreatitis, anxiety, drowsiness, headache, excessive thirst, fatigue, bradycardia, hypertension, palpitation, chest pain, infertility in female and pulmonary edema.
ContraindicationsView
Ketorolac is contraindicated in patients having hypersensitivity to this drug or other NSAIDs. It should not be used in children under 16 years of age. lt is also contraindicated as prophylactic analgesic before surgery.
PrecautionsView
Caution should be exercised in patients over the age of 65 years. Caution should also be taken in patients with active or suspected peptic ulcer or gastrointestinal bleeding or asthma and liver dysfunction.
InteractionsView
Other NSAIDs or aspirin: Increase the side effects of ketorolac Tromethamine.
Anti-coagulants: Enhance anti-coagulant effect.
Beta Blocker: Reduce the anti-hypertensive effect .
ACE Inhibitors: Increase the risk of renal impairment.
Methotrexate: Enhance the toxicity of methotrexate.
Pregnancy & lactationView
US FDA Pregnancy category of Ketorolac Tromethamine is C. So, Ketorolac Tromethamine should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.

Acuren

Hydrochlorothiazide
Tablet 25 mg Allopathic Thiazide diuretics & related drugs

Indications

Oedema

Indication detailsView
Edema associated with congestive heart failure, hepatic cirrhosis, premenstrual tension and oedema due to various forms of renal dysfunction (i.e. nephrotic syndrome, acute glomerulonephritis, chronic renal failure). Hypertension, either alone or as an adjunct to other antihypertensive drugs.
Therapeutic classView
Thiazide diuretics & related drugs
PharmacologyView
Thiazides such as hydrochlorothiazide promote water loss from the body (diuretics). They inhibit Na+/Cl- reabsorption from the distal convoluted tubules in the kidneys. Thiazides also cause loss of potassium and an increase in serum uric acid. Thiazides are often used to treat hypertension, but their hypotensive effects are not necessarily due to their diuretic activity. Thiazides have been shown to prevent hypertension-related morbidity and mortality although the mechanism is not fully understood. Thiazides cause vasodilation by activating calcium-activated potassium channels (large conductance) in vascular smooth muscles and inhibiting various carbonic anhydrases in vascular tissue.
DosageView
Edema: initially 25 to 50 mg daily, reduced for maintenance if possible; maximum 100 mg daily.

Hypertension: 25 mg daily, increased to 50 mg daily if necessary.

Elderly: in some patients, especially the elderly an initial dose of 12.5 mg daily may be sufficient.

Children: An initial dose for children has been 1 to 2 mg per kg body-weight in 2 divided doses. Infants under 6 months may need doses up to 3 mg per kg daily.
Side effectsView
Gastro-intestinal system: Anorexia, gastric irritation, nausea, vomiting, cramps, diarrhoea, constipation, jaundice (intrahepatic cholestatic jaundice), pancreatitis, salivary gland inflammation.

Central nervous system: Dizziness, vertigo, paraesthesiae, headache, yellow vision.

Heamatological: Leucopenia, agranulocytosis, thrombocytopenia, aplastic anaemia, haemolytic anaemia.

Cardiovascular: Hypotension, including orthostatic hypotension.

Hypersensitivity: Purpura, photosensitivity, rash, urticaria, necrotising angiitis (vasculitis, cutaneous vasculitis), fever, respiratiory distress including pneumonitis and pulmonary oedema, anaphylactic reactions, toxic epidermal necrolysis.

Metabolic: Hyperglycaemia, glycosuria, hyperuricaema, electrolyte imbalance including hyponatraemia and hypokalaemia.

Renal: Renal dysfunction, interstitial nephritis, renal failure.

Other: Muscle spasm, weakness, restlessness, transient blurred vision, impotence. Whenever side-effects are moderate to severe, thiazide dosage should be reduced or therapy was withdrawn.
ContraindicationsView
Anuria, hypersensitivity to Hydrochlorothiazide or to other sulphonamide-derived drugs, severe renal or hepatic failure, Addison’s disease, hypercalcemia, concurrent lithium therapy.
PrecautionsView
Patients should be carefully monitored for signs of fluid and electrolyte imbalance (hyponatraemia, hypochloraemic alkalosis, hypokalaemia and hypomagnesaemia). It is particularly important to make serum and urine electrolyte determinations when the patient is vomiting excessively or receiving parenteral fluids. Warning signs or symptoms of fluid and electrolyte imbalance include: dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, seizures, confusion, muscle pains or cramps, muscle fatigue, hypotension, oliguria, tachycardia, and gastro-intestinal disturbances such as nausea and vomiting. Hypokalaemia may develop, especially with brisk diuresis, when severe cirrhosis is present, or after prolonged therapy. Hypokalaemia can sensitise or exaggerate the response of the heart to the toxic effects of digitalis (e.g. increased ventricular irritability). Sensitivity reactions may occur in patients with or without history of allergy or bronchial asthma. Hypokalaemia may be avoided or treated in the adult by concurrent use of amiloride hydrochloride, a potassium conserving agent. It may also be avoided by giving potassium chloride or foods with a high potassium content. Diuretic-induced hyponatraemia is usually mild and asymptomatic. Dilutional hyponatraemia may occur in oedematous patients in hot weather; and, except in rare instances when hyponatraemia is life-threatening, appropriate therapy is water restriction rather than administration of salt. Thiazides may decrease serum protein bound iodine levels without signs of thyroid disturbances. Thiazides may decrease urinary calcium excretion, and may also cause intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism. Thiazides should be discontinued before carrying out tests for parathyroid function. When creatinine clearance falls below 30ml/min, thiazide diuretics become ineffective. Uraemia may be precipitated or increased by chlorothiazide. Cumulative effects of the drug may develop in patients with impaired renal function. If increasing uraemia and oliguria occur during treatment of renal disease, Hydrochlorothiazide should be discontinued. Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma. Hyperuricaemia may occur, or gout may be precipitated, in certain patients receiving thiazide therapy. Thaizide therapy may impair glucose tolerance. Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy. The possibility of exacerbation or activation of systemic lupus erythematosus has been reported. Latent diabetes may become manifest during thiazide administration.
InteractionsView
Alcohol, barbiturates or narcotics: Co-administration may potentiate orthostatic hypotension. Oral and parenteral antidiabetic drugs may require adjustment of dosage with concurrent use. Other antihypertensive drugs may have an additive effect. Discontinuation of diuretic therapy 2-3 days before the initiation of treatment with an ACE inhibitor may reduce the likelihood of first-dose hypotension. The antihypertensive effect of the drug may be enhanced in the post-sympathectomy patient.

Cholestyramine and colestipol resin: Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resin. Single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85% and 43%, respectively. Corticosteroids or ACTH may intensify any Thiazide-induced electrolyte depletion, particularly hypokalaemia. Pressor amines such as adrenaline may show decreased arterial responsiveness when used with hydrochlorothiazide, but this reaction is not enough to preclude their therapeutic usefulness. Non-depolarising muscle relaxants such as tubocurarine may possibly interact with Hydrochlorothiazide to increase muscle relaxation. Non-steroidal anti-inflammatory drugs may attenuate the diuretic and antihypertensive effects of diuretics.

Drug/laboratory tests: Because thiazides may affect calcium metabolism, Hydrochlorothiazide may interfere with tests for parathyroid function.
Pregnancy & lactationView
Use in pregnancy: Thiazides cross the placental barrier and appear in cord blood. The use of Hydrochlorothiazide when pregnancy is present or suspected requires, therefore, that the benefits of the drug be weighed against possible hazards to the fetus. These hazards include fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions, which have occurred in the adult. The routine use of diuretics in otherwise healthy pregnant women with or without mild oedema is not recommended, because their use may be associated with hypovolaemia, increased blood viscosity and decreased placental perfusion.

Use in breastfeeding mothers: Thiazides appear in breast milk. If use of the drug is deemed essential, the patient should stop breast-feeding.
Overdose effectsView
The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalaemia, hypochloraemia, hyponatraemia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalaemia may accentuate cardiac arrhythmias. In the event of overdosage, symptomatic and supportive measures should be employed. If ingestion is recent, emesis should be induced or gastric lavage performed. Dehydration, electrolyte imbalance, hepatic coma and hypotension should be corrected by established methods. If required, give oxygen or artificial respiration for respiratory impairment.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Acuren

Hydrochlorothiazide
Tablet 50 mg Allopathic Thiazide diuretics & related drugs

Indications

Oedema

Indication detailsView
Edema associated with congestive heart failure, hepatic cirrhosis, premenstrual tension and oedema due to various forms of renal dysfunction (i.e. nephrotic syndrome, acute glomerulonephritis, chronic renal failure). Hypertension, either alone or as an adjunct to other antihypertensive drugs.
Therapeutic classView
Thiazide diuretics & related drugs
PharmacologyView
Thiazides such as hydrochlorothiazide promote water loss from the body (diuretics). They inhibit Na+/Cl- reabsorption from the distal convoluted tubules in the kidneys. Thiazides also cause loss of potassium and an increase in serum uric acid. Thiazides are often used to treat hypertension, but their hypotensive effects are not necessarily due to their diuretic activity. Thiazides have been shown to prevent hypertension-related morbidity and mortality although the mechanism is not fully understood. Thiazides cause vasodilation by activating calcium-activated potassium channels (large conductance) in vascular smooth muscles and inhibiting various carbonic anhydrases in vascular tissue.
DosageView
Edema: initially 25 to 50 mg daily, reduced for maintenance if possible; maximum 100 mg daily.

Hypertension: 25 mg daily, increased to 50 mg daily if necessary.

Elderly: in some patients, especially the elderly an initial dose of 12.5 mg daily may be sufficient.

Children: An initial dose for children has been 1 to 2 mg per kg body-weight in 2 divided doses. Infants under 6 months may need doses up to 3 mg per kg daily.
Side effectsView
Gastro-intestinal system: Anorexia, gastric irritation, nausea, vomiting, cramps, diarrhoea, constipation, jaundice (intrahepatic cholestatic jaundice), pancreatitis, salivary gland inflammation.

Central nervous system: Dizziness, vertigo, paraesthesiae, headache, yellow vision.

Heamatological: Leucopenia, agranulocytosis, thrombocytopenia, aplastic anaemia, haemolytic anaemia.

Cardiovascular: Hypotension, including orthostatic hypotension.

Hypersensitivity: Purpura, photosensitivity, rash, urticaria, necrotising angiitis (vasculitis, cutaneous vasculitis), fever, respiratiory distress including pneumonitis and pulmonary oedema, anaphylactic reactions, toxic epidermal necrolysis.

Metabolic: Hyperglycaemia, glycosuria, hyperuricaema, electrolyte imbalance including hyponatraemia and hypokalaemia.

Renal: Renal dysfunction, interstitial nephritis, renal failure.

Other: Muscle spasm, weakness, restlessness, transient blurred vision, impotence. Whenever side-effects are moderate to severe, thiazide dosage should be reduced or therapy was withdrawn.
ContraindicationsView
Anuria, hypersensitivity to Hydrochlorothiazide or to other sulphonamide-derived drugs, severe renal or hepatic failure, Addison’s disease, hypercalcemia, concurrent lithium therapy.
PrecautionsView
Patients should be carefully monitored for signs of fluid and electrolyte imbalance (hyponatraemia, hypochloraemic alkalosis, hypokalaemia and hypomagnesaemia). It is particularly important to make serum and urine electrolyte determinations when the patient is vomiting excessively or receiving parenteral fluids. Warning signs or symptoms of fluid and electrolyte imbalance include: dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, seizures, confusion, muscle pains or cramps, muscle fatigue, hypotension, oliguria, tachycardia, and gastro-intestinal disturbances such as nausea and vomiting. Hypokalaemia may develop, especially with brisk diuresis, when severe cirrhosis is present, or after prolonged therapy. Hypokalaemia can sensitise or exaggerate the response of the heart to the toxic effects of digitalis (e.g. increased ventricular irritability). Sensitivity reactions may occur in patients with or without history of allergy or bronchial asthma. Hypokalaemia may be avoided or treated in the adult by concurrent use of amiloride hydrochloride, a potassium conserving agent. It may also be avoided by giving potassium chloride or foods with a high potassium content. Diuretic-induced hyponatraemia is usually mild and asymptomatic. Dilutional hyponatraemia may occur in oedematous patients in hot weather; and, except in rare instances when hyponatraemia is life-threatening, appropriate therapy is water restriction rather than administration of salt. Thiazides may decrease serum protein bound iodine levels without signs of thyroid disturbances. Thiazides may decrease urinary calcium excretion, and may also cause intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism. Thiazides should be discontinued before carrying out tests for parathyroid function. When creatinine clearance falls below 30ml/min, thiazide diuretics become ineffective. Uraemia may be precipitated or increased by chlorothiazide. Cumulative effects of the drug may develop in patients with impaired renal function. If increasing uraemia and oliguria occur during treatment of renal disease, Hydrochlorothiazide should be discontinued. Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma. Hyperuricaemia may occur, or gout may be precipitated, in certain patients receiving thiazide therapy. Thaizide therapy may impair glucose tolerance. Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy. The possibility of exacerbation or activation of systemic lupus erythematosus has been reported. Latent diabetes may become manifest during thiazide administration.
InteractionsView
Alcohol, barbiturates or narcotics: Co-administration may potentiate orthostatic hypotension. Oral and parenteral antidiabetic drugs may require adjustment of dosage with concurrent use. Other antihypertensive drugs may have an additive effect. Discontinuation of diuretic therapy 2-3 days before the initiation of treatment with an ACE inhibitor may reduce the likelihood of first-dose hypotension. The antihypertensive effect of the drug may be enhanced in the post-sympathectomy patient.

Cholestyramine and colestipol resin: Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resin. Single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85% and 43%, respectively. Corticosteroids or ACTH may intensify any Thiazide-induced electrolyte depletion, particularly hypokalaemia. Pressor amines such as adrenaline may show decreased arterial responsiveness when used with hydrochlorothiazide, but this reaction is not enough to preclude their therapeutic usefulness. Non-depolarising muscle relaxants such as tubocurarine may possibly interact with Hydrochlorothiazide to increase muscle relaxation. Non-steroidal anti-inflammatory drugs may attenuate the diuretic and antihypertensive effects of diuretics.

Drug/laboratory tests: Because thiazides may affect calcium metabolism, Hydrochlorothiazide may interfere with tests for parathyroid function.
Pregnancy & lactationView
Use in pregnancy: Thiazides cross the placental barrier and appear in cord blood. The use of Hydrochlorothiazide when pregnancy is present or suspected requires, therefore, that the benefits of the drug be weighed against possible hazards to the fetus. These hazards include fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions, which have occurred in the adult. The routine use of diuretics in otherwise healthy pregnant women with or without mild oedema is not recommended, because their use may be associated with hypovolaemia, increased blood viscosity and decreased placental perfusion.

Use in breastfeeding mothers: Thiazides appear in breast milk. If use of the drug is deemed essential, the patient should stop breast-feeding.
Overdose effectsView
The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalaemia, hypochloraemia, hyponatraemia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalaemia may accentuate cardiac arrhythmias. In the event of overdosage, symptomatic and supportive measures should be employed. If ingestion is recent, emesis should be induced or gastric lavage performed. Dehydration, electrolyte imbalance, hepatic coma and hypotension should be corrected by established methods. If required, give oxygen or artificial respiration for respiratory impairment.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Acusan

Losartan Potassium
Tablet 50 mg Allopathic Angiotensin-ll receptor blocker

Indications

Stroke

Indication detailsView
Hypertension: Losartan Potassium is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents (eg. thiazide diuretics).

Renal Protection in Type-2 Diabetic Patients with Proteinuria: Losartan Potassium is indicated to delay the progression of renal disease in hypertensive type-2 diabetics with proteinuria, defined as urinary albumin to creatinine ratio >300 mg/g.
Therapeutic classView
Angiotensin-ll receptor blocker
PharmacologyView
Losartan Potassium is the first non-peptide orally active angiotensin II receptor blocker. It binds to the AT1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland, kidneys and the heart) and reduces several important biological actions including vasoconstriction and the release of aldosterone responsible for hypertension.
DosageView
The usual starting and maintenance dose is 50 mg once daily for most patients. If the antihypertensive effect using 50 mg once daily is inadequate, 25 mg twice daily is recommended prior to increasing the dose. For patients with intravascular volume-depletion (e.g., those treated with high-dose diuretics), a starting dose of 25 mg once daily should be considered. Losartan Potassium can be administered once or twice daily. The total daily dose ranges from 25 mg to 100 mg.
Side effectsView
The side effects with the use of Losartan Potassium are mild and transient in nature. The most common side effects are dizziness, diarrhea, nasal congestion, cough, upper respiratory infection. Other side effects are fatigue, oedema, abdominal pain, chest pain, nausea, headache & pharyngitis.
ContraindicationsView
Losartan Potassium is contraindicated in pregnant women and in patients who are hypersensitive to any component of this product. Losartan Potassium should not be administered with Aliskiren in patients with diabetes.
PrecautionsView
Use of Losartan Potassium during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. In patients who are intravascularly volume-depleted (e.g., those treated with high-dose diuretics), symptomatic hypotension may occur. Plasma concentration of Losartan Potassium is significantly increased in cirrhotic patients. Changes in renal function including renal failure have been reported in renal impaired patient.
InteractionsView
Rifampicin and fluconazole reduce levels of active metabolite of Losartan Potassium. Concomitant use of Losartan Potassium and hydrochlorothiazide may lead to potentiation of the antihypertensive effects. Concomitant use of potassium-sparing diuretics (eg, spironolactone, triamterene, amiloride), potassium supplements or salt substitutes containing potassium may lead to increases in serum potassium. The antihypertensive effect of losartan may be attenuated by the non-steroidal anti-inflammatory drug indomethacin. The use of ACE-inhibitor, angiotensin receptor antagonist, an anti-inflammatory drug and a thiazide diuretic at the same time increases the risk of renal impairment.
Pregnancy & lactationView
Pregnancy Category D. The risk to the fetus increases if Losartan Potassium is administered during the second or third trimesters of pregnancy. It is not known whether Losartan Potassium is excreted in human milk, as many drugs are excreted in human milk and because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
StorageView
keep in a dry place away from light and heat. Keep out of the reach of children.

Acusan Plus

Losartan Potassium + Hydrochlorothiazide
Tablet 50 mg+12.5 mg Allopathic Combined antihypertensive preparations

Indications

Stroke

Indication detailsView
This is indicated for the treatment of hypertension. It is also indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy.
Therapeutic classView
Combined antihypertensive preparations
PharmacologyView
Angiotensin II formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE), is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Losartan and its principal active metabolite block the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g. vascular smooth muscle, adrenal gland). In vitro binding studies indicate that losartan is a reversible, competitive inhibitor of the AT1 receptor. Neither Losartan nor its active metabolite inhibits ACE (kinase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin); nor do they bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of Sodium and Chloride in approximately equivalent amounts. Indirectly, the diuretic action of Hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in Aldosterone secretion, increases in urinary Potassium loss, and decreases in serum Potassium. The renin-aldosterone link is mediated by angiotensin II, so co-administration of an angiotensin II receptor antagonist tends to reverse the Potassium loss associated with these diuretics.
DosageView
Hypertension-
  • The usual starting dose of 50/12.5 is one tablet once daily.
  • For patients who do not respond adequately to one tablet the dosage may be increased to 100/25 once daily.
  • A patient whose blood pressure is not adequately controlled with Losartan 100 mg monotherapy may be switched to this combination 100/12.5 once daily.
  • In hypertensive patients with left ventricular hypertrophy initial dose is 50/12.5, if additional blood pressure reduction is needed, 100/12.5 may be given, followed by 100/25 if required. The maximum dose is 100/25 once daily.
  • In general, the antihypertensive effect is attained within three weeks after initiation of therapy.
  • No initial dosage adjustment of 50/12.5 is necessary for elderly patients. But maximum dose of 100/25 once daily dose should not be used as initial therapy in elderly patients.
Severe Hypertension:
  • The starting dose for initial treatment of severe hypertension is one tablet of 50/12.5 once daily.
  • For patients who do not respond adequately to this dose after 2 to 4 weeks of therapy, the dosage may be increased to 100/25 once daily. The maximum dose is one tablet of 100/25 once daily.
AdministrationView
This preparation may be administered with other antihypertensive agents. This may be administered with or without food.
Side effectsView
Side-effects are usually mild. Symptomatic hypotension including dizziness may occur, particularly in patients with intravascular volume depletion (e.g. those taking high-dose diuretics). Hyperkalaemia occurs occasionally; angioedema has also been reported with some angiotensin-II receptor antagonists. Vertigo; less commonly gastro-intestinal disturbances, angina, palpitation, oedema, dyspnoea, headache, sleep disorders, malaise, urticaria, pruritus, rash; rarely hepatitis, atrial fibrillation, cerebrovascular accident, syncope, paraesthesia; also reported pancreatitis, anaphylaxis, cough, depression, erectile dysfunction, anaemia, thrombocytopenia, hyponatraemia, arthralgia, myalgia, renal impairment, rhabdomyolysis, tinnitus, photosensitivity, and vasculitis (including Henoch-Schonlein purpura)
ContraindicationsView
The combination of Losartan and Hydrochlorothiazide is contraindicated in patients who are hypersensitive to any component of this product. Because of the Hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.
PrecautionsView
  • Hypersensitivity: Angiooedema
  • Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals
  • Hypokalemia may rarely develop, especially with brisk diuresis, when severe cirrhosis is present, or after prolonged therapy
  • Impaired renal function and
  • Symptomatic hypotension
InteractionsView
Losartan Potassium: No significant drug-drug pharmacokinetic interactions have been found in interaction studies with Hydrochlorothiazide, Digoxin, Warfarin, Cimetidine and Phenobarbital. As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics (e.g. Spironolactone, Triamterene, Amiloride), potassium supplements, or salt substitutes containing potassium may lead to increase in serum potassium. As with other antihypertensive agents, the antihypertensive effect of Losartan may be blunted by the non-steroidal anti-inflammatory drug Indomethacin.

Hydrochlorothiazide: When administered concurrently, the following drugs may interact with Thiazide diuretics: alcohol, barbiturates, or narcotics-potentiation of orthostatic hypotension may occur.

Antidiabetic drugs (oral agents and Insulin): dosage adjustment of the antidiabetic drug may be required.

Other antihypertensive drugs: additive effect or potentiation.

Cholestyramine and colestipol resins: absorption of Hydrochlorothiazide is impaired in the presence of anionic exchange resins
Pregnancy & lactationView
Angiotensin-II receptor antagonists should be avoided in pregnancy unless essential. They may adversely affect fetal and neonatal blood pressure control and renal function; skull defects and oligohy dramnios have also been reported. Information on the use of angiotensin-II receptor antagonists in breastfeeding is limited. They are not recommended in breastfeeding and alternative treatment options, with better-established safety information during breastfeeding, are available.
Pediatric usageView
Use in Patients with Renal Impairment: The usual regimens of therapy with 50/12.5 may be followed as long as the patient's creatinine clearance is >30 ml/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides. In that case, hydrochlorothiazide is not recommended.

Use in Patients with Hepatic Impairment: The combination of Losartan and Hydrochlorothiazide is not recommended for titration in patients with hepatic impairment because the appropriate 25 mg starting dose of Losartan cannot be given.

Use in pediatric patients: The safety and effectiveness in pediatric patients have not been established.
Overdose effectsView
Losartan Potassium: Limited data are available in regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Neither losartan nor its metabolite can be removed by hemodialysis.

Hydrochlorothiazide: The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia, may accentuate cardiac arrhythmias. The degree to which Hydrochlorothiazide is removed by hemodialysis has not been established.
StorageView
Do not store above 30°C. Keep out of the reach of children.

Acyvir

Acyclovir (Ophthalmic)
Ophthalmic Ointment 3% Allopathic Ophthalmic Anti-viral Products

Indications

Neonatal Conjunctivitis

Indication detailsView
Acyclovir is indicated for the treatment of Herpes simplex keratitis.
Therapeutic classView
Ophthalmic Anti-viral Products
PharmacologyView
Acyclovir is an antiviral agent which is highly active in vitro against Herpes simplex (HSV) types I and II and Varicella zoster viruses, but its toxicity to mammalian cells is low. Acyclovir is phosphorylated to the active compound Acyclovir triphosphate after entry into herpes infected cell. The ­first step in this process requires the presence of the viral-coded thymidine kinase. Acyclovir triphosphate acts as an inhibitor of and substrate for the herpes specifi­ed DNA polymerase preventing further viral DNA synthesis without affecting normal cellular processes.
DosageView
The dosage for all age groups is the same. A 10 mm ribbon of the ointment should be placed inside the lower conjunctival sac ­five times a day at approximately four hourly intervals. Treatment should continue for at least 3 days after healing
Side effectsView
Very common: Superfi­cial punctate keratopathy. This did not necessitate an early termination of therapy and healed without apparent sequelae. Common: Transient mild stinging of the eye occurring immediately following application, conjunctivitis. Rare: Blepharitis.
ContraindicationsView
Acyclovir is contraindicated in patients known to be hypersensitive to Acyclovir or Valacyclovir
PrecautionsView
The recommended dosage, frequency of applications, and length of treatment should not be exceeded.
InteractionsView
No clinically signi­ficant interactions have been identi­fied.
Pregnancy & lactationView
Pregnancy category B. There are no adequate and well-controlled studies of Acyclovir in pregnant women. It is not known whether topically applied Acyclovir is excreted in breast milk.
Overdose effectsView
No adverse effects would be expected if the entire contents of the tube containing 90 mg Acyclovir were ingested orally.
StorageView
Store in a cool and dry place. Keep away from light. Keep out of reach of children. Do not touch the tip of the tube since this may contaminate the product. After one month of the opening do not use the medicine of tube.

Acyvir

Acyclovir (Injection)
IV Infusion 500 mg/vial Allopathic Herpes simplex & Varicella-zoster virus infections

Indications

Varicella zoster (chickenpox)

Indication detailsView
Acyclovir intravenous infusion is indicated for the treatment of-
  • Acute clinical manifestations of Herpes simplex virus in immunocompromised patients
  • Severe primary or non-primary genital herpes in immune competent patients
  • Varicella zoster virus infection in immunocompromised patients
  • Herpes zoster (shingles) in immune competent patients who show very severe acute local or systemic manifestations of the disease
  • Herpes simplex encephalitis
Therapeutic classView
Herpes simplex & Varicella-zoster virus infections
PharmacologyView
Acyclovir exerts its antiviral e­ects on Herpes simplex virus and Varicella zoster virus by interfering with DNA synthesis and inhibiting viral replication. In cells infected with Herpes virus, the antiviral activity of Acyclovir appears to depend principally on the intracellular conversion of the drug to Acyclovir Triphosphate. Acyclovir is converted to Acyclovir Monophosphate principally via virus coded thymidine kinase, the monophosphate is phosphorylated to diphosphate via cellular guanylate kinase and then via other cellular enzymes to the Triphosphate, which is the pharmacologically active form of the drug.
DosageView
  • Herpes simplex infection: For normal or immunocompromised immune status: 5 mg/kg every 8 hours
  • Very severe Herpes zoster infection (shingles): For normal immune status: 5 mg/kg every 8 hours
  • Varicella zoster infection: For immunocompromised immune status: 10 mg/kg every 8 hours
  • Herpes simplex encephalitis: For normal or immunocompromised immune status: 10 mg/kg every 8 hours
Each dose should be administered by slow intravenous infusion over a one-hour period.
AdministrationView
It is recommended that Acyclovir IV Injection for Intravenous Infusion should be administered for five to seven days in the treatment of most infections and for at least ten days in the treatment of Herpes simplex encephalitis.

Acyclovir IV Injection after reconstitution may be injected directly into a vein over one hour by a controlled-rate infusion pump or be further diluted for administration by infusion. For intravenous infusion each vial of Acyclovir IV Injection should be reconstituted and then, wholly or in part according to the dosage required, added to and mixed with at least 50 mL-100 ml infusion solution. A maximum of 250 mg & 500 mg of Acyclovir may be added to 50 ml & 100 ml infusion solution respectively. After addition of Acyclovir IV Injection to an infusion solution the mixture should be shaken to ensure thorough mixing. Acyclovir IV Injection when diluted in accordance with the above schedule will give an Acyclovir concentration not greater than 0.5% w/v.

Acyclovir IV Injection is known to be compatible with the following infusion fluids and stable for up to 12 hours at room temperature (below 25°C) when diluted to a concentration not greater than 0.5% w/v Acyclovir.
  • Sodium Chloride Intravenous Infusion BP (0.45% and 0.9% w/v)
  • Sodium Chloride (0.18% w/v) and Glucose (4% w/v) Intravenous Infusion
  • Sodium Chloride (0.45% w/v) and Glucose (2.5% w/v) Intravenous Infusion
  • Compound Sodium Lactate Intravenous Infusion BP (Hartmann's Solution)
Acyclovir IV Injection for Intravenous Infusion contains no preservative. Reconstitution and dilution should therefore be carried out immediately before use and any unused solution should be discarded. The solution should not be refrigerated.
Side effectsView
Some infrequent adverse reactions are lethargy, obtundation, tremors, confusion, hallucinations, agitation, somnolence, psychosis, convulsions and coma, phlebitis, nausea, vomiting, reversible increases in liver-related enzymes, pruritus, urticaria, rashes, increases in blood urea and creatinine. Local inflammatory reactions may occur if Acyclovir IV Infusion is inadvertently infused into extracellular tissues.
ContraindicationsView
Acyclovir IV Injection is contraindicated in patients known to be hypersensitive to Acyclovir or Valacyclovir.
PrecautionsView
Acyclovir IV injection is intended for intravenous infusion only and should not be used through any other route. Reconstituted Acyclovir IV Infusion has a pH of approximately 11.0 and should not be administered by mouth. Acyclovir IV injection as infusion must be given over a period of at least one hour in order to avoid renal tubular damage. It should not be administered as a bolus injection. Acyclovir IV infusion must be accompanied by adequate hydration. Since maximum urine concentration occurs within the first few hours following infusion, particular attention should be given to establish sufficient urine ‑ow during that period. Concomitant use of other nephrotoxic drugs, pre-existing renal disease and dehydration increase the risk of further renal impairment by Acyclovir. As Acyclovir has been associated with reversible encephalopathic changes, it should be used with caution in patients with neurological abnormalities, significant hypoxia or serious renal, hepatic or electrolyte abnormalities.
InteractionsView
Co-administration of probenecid with Acyclovir has been shown to increase the mean Acyclovir half-life and the area under the concentration time curve. Urinary excretion and renal clearance correspondingly reduced. In patients over 60 years of age concurrent use of diuretics increases plasma levels of Acyclovir very significantly.
Pregnancy & lactationView
Pregnancy category B. There have been no adequate and well controlled studies concerning the safety of Acyclovir in pregnant women. It should not be used during pregnancy unless the benefits to the patient clearly outweigh the potential risks to the fetus. Acyclovir should only be administered to nursing mothers if the benefits to the mother outweigh the potential risks to the baby. There is no experience of the effect of Acyclovir on human fertility.
Pediatric usageView
Pediatric use: The dose of Acyclovir IV injection in children aged 1-12 years should be calculated on the basis of body surface area. Children in this age group with Herpes simplex infections (except Herpes simplex encephalitis) or Varicella zoster infections should be given Acyclovir IV Infusion in doses of 250 mg/m2 (equivalent to 5 mg/kg in adults). Immunocompromised children in this age group with Varicella zoster virus infection or with Herpes simplex encephalitis should be given Acyclovir IV Infusion in doses of 500 mg/m2 (equivalent to 10 mg/kg in adults). Children with impaired renal function require an appropriately modified dose, according to the degree of impairment.
 
Geriatric use: No data are available on this age group. However, as creatinine clearance is often low in the elderly, special attention should be given to dosage reduction.

In patients with renal impairment: Acyclovir should be administered with caution since the drug is excreted through the kidneys. The following modifications in dosage are suggested:
  • CrCl: 25-50 ml/min: 5 or 10 mg/kg every 12 hours
  • CrCl: 10-25 ml/min: 5 or 10 mg/kg every 24 hours
  • CrCl: 0-10 ml/min: 2.5 or 5 mg/kg every 24 hours and after dialysis.
Overdose effectsView
Overdosage of intravenous Acyclovir has resulted in elevations of serum creatinine, blood urea nitrogen and subsequent renal failure. Neurological effects including confusion, hallucinations, agitation, seizures and coma have been described in association with over dosage. Adequate hydration is essential to reduce the possibility of crystal formation in the urine. Hemodialysis significantly enhances the removal of Acyclovir from the blood and may, therefore, be considered an option in the management of overdose of Acyclovir.
Duration of treatmentView
It is recommended that Acyclovir IV Injection for Intravenous Infusion should be administered for five to seven days in the treatment of most infections and for at least ten days in the treatment of Herpes simplex encephalitis.
ReconstitutionView
Each 250 mg vial of Acyclovir IV Injection should be reconstituted by the addition of 10 ml of either Water for Injection or Sodium Chloride Intravenous Infusion (0.9% w/v). This provides a solution containing 25 mg Acyclovir per ml.

Each 500 mg vial of Acyclovir IV Injection should be reconstituted by the addition of 10 ml of either Water for Injection or Sodium Chloride Intravenous Infusion (0.9% w/v). This provides a solution containing 50 mg Acyclovir per ml.
StorageView
Store at 15°C to 25°C. Protected from light and moisture. Keep the medicine out of the reach of children.

Acyvir

Acyclovir (Injection)
IV Infusion 250 mg/vial Allopathic Herpes simplex & Varicella-zoster virus infections

Indications

Varicella zoster (chickenpox)

Indication detailsView
Acyclovir intravenous infusion is indicated for the treatment of-
  • Acute clinical manifestations of Herpes simplex virus in immunocompromised patients
  • Severe primary or non-primary genital herpes in immune competent patients
  • Varicella zoster virus infection in immunocompromised patients
  • Herpes zoster (shingles) in immune competent patients who show very severe acute local or systemic manifestations of the disease
  • Herpes simplex encephalitis
Therapeutic classView
Herpes simplex & Varicella-zoster virus infections
PharmacologyView
Acyclovir exerts its antiviral e­ects on Herpes simplex virus and Varicella zoster virus by interfering with DNA synthesis and inhibiting viral replication. In cells infected with Herpes virus, the antiviral activity of Acyclovir appears to depend principally on the intracellular conversion of the drug to Acyclovir Triphosphate. Acyclovir is converted to Acyclovir Monophosphate principally via virus coded thymidine kinase, the monophosphate is phosphorylated to diphosphate via cellular guanylate kinase and then via other cellular enzymes to the Triphosphate, which is the pharmacologically active form of the drug.
DosageView
  • Herpes simplex infection: For normal or immunocompromised immune status: 5 mg/kg every 8 hours
  • Very severe Herpes zoster infection (shingles): For normal immune status: 5 mg/kg every 8 hours
  • Varicella zoster infection: For immunocompromised immune status: 10 mg/kg every 8 hours
  • Herpes simplex encephalitis: For normal or immunocompromised immune status: 10 mg/kg every 8 hours
Each dose should be administered by slow intravenous infusion over a one-hour period.
AdministrationView
It is recommended that Acyclovir IV Injection for Intravenous Infusion should be administered for five to seven days in the treatment of most infections and for at least ten days in the treatment of Herpes simplex encephalitis.

Acyclovir IV Injection after reconstitution may be injected directly into a vein over one hour by a controlled-rate infusion pump or be further diluted for administration by infusion. For intravenous infusion each vial of Acyclovir IV Injection should be reconstituted and then, wholly or in part according to the dosage required, added to and mixed with at least 50 mL-100 ml infusion solution. A maximum of 250 mg & 500 mg of Acyclovir may be added to 50 ml & 100 ml infusion solution respectively. After addition of Acyclovir IV Injection to an infusion solution the mixture should be shaken to ensure thorough mixing. Acyclovir IV Injection when diluted in accordance with the above schedule will give an Acyclovir concentration not greater than 0.5% w/v.

Acyclovir IV Injection is known to be compatible with the following infusion fluids and stable for up to 12 hours at room temperature (below 25°C) when diluted to a concentration not greater than 0.5% w/v Acyclovir.
  • Sodium Chloride Intravenous Infusion BP (0.45% and 0.9% w/v)
  • Sodium Chloride (0.18% w/v) and Glucose (4% w/v) Intravenous Infusion
  • Sodium Chloride (0.45% w/v) and Glucose (2.5% w/v) Intravenous Infusion
  • Compound Sodium Lactate Intravenous Infusion BP (Hartmann's Solution)
Acyclovir IV Injection for Intravenous Infusion contains no preservative. Reconstitution and dilution should therefore be carried out immediately before use and any unused solution should be discarded. The solution should not be refrigerated.
Side effectsView
Some infrequent adverse reactions are lethargy, obtundation, tremors, confusion, hallucinations, agitation, somnolence, psychosis, convulsions and coma, phlebitis, nausea, vomiting, reversible increases in liver-related enzymes, pruritus, urticaria, rashes, increases in blood urea and creatinine. Local inflammatory reactions may occur if Acyclovir IV Infusion is inadvertently infused into extracellular tissues.
ContraindicationsView
Acyclovir IV Injection is contraindicated in patients known to be hypersensitive to Acyclovir or Valacyclovir.
PrecautionsView
Acyclovir IV injection is intended for intravenous infusion only and should not be used through any other route. Reconstituted Acyclovir IV Infusion has a pH of approximately 11.0 and should not be administered by mouth. Acyclovir IV injection as infusion must be given over a period of at least one hour in order to avoid renal tubular damage. It should not be administered as a bolus injection. Acyclovir IV infusion must be accompanied by adequate hydration. Since maximum urine concentration occurs within the first few hours following infusion, particular attention should be given to establish sufficient urine ‑ow during that period. Concomitant use of other nephrotoxic drugs, pre-existing renal disease and dehydration increase the risk of further renal impairment by Acyclovir. As Acyclovir has been associated with reversible encephalopathic changes, it should be used with caution in patients with neurological abnormalities, significant hypoxia or serious renal, hepatic or electrolyte abnormalities.
InteractionsView
Co-administration of probenecid with Acyclovir has been shown to increase the mean Acyclovir half-life and the area under the concentration time curve. Urinary excretion and renal clearance correspondingly reduced. In patients over 60 years of age concurrent use of diuretics increases plasma levels of Acyclovir very significantly.
Pregnancy & lactationView
Pregnancy category B. There have been no adequate and well controlled studies concerning the safety of Acyclovir in pregnant women. It should not be used during pregnancy unless the benefits to the patient clearly outweigh the potential risks to the fetus. Acyclovir should only be administered to nursing mothers if the benefits to the mother outweigh the potential risks to the baby. There is no experience of the effect of Acyclovir on human fertility.
Pediatric usageView
Pediatric use: The dose of Acyclovir IV injection in children aged 1-12 years should be calculated on the basis of body surface area. Children in this age group with Herpes simplex infections (except Herpes simplex encephalitis) or Varicella zoster infections should be given Acyclovir IV Infusion in doses of 250 mg/m2 (equivalent to 5 mg/kg in adults). Immunocompromised children in this age group with Varicella zoster virus infection or with Herpes simplex encephalitis should be given Acyclovir IV Infusion in doses of 500 mg/m2 (equivalent to 10 mg/kg in adults). Children with impaired renal function require an appropriately modified dose, according to the degree of impairment.
 
Geriatric use: No data are available on this age group. However, as creatinine clearance is often low in the elderly, special attention should be given to dosage reduction.

In patients with renal impairment: Acyclovir should be administered with caution since the drug is excreted through the kidneys. The following modifications in dosage are suggested:
  • CrCl: 25-50 ml/min: 5 or 10 mg/kg every 12 hours
  • CrCl: 10-25 ml/min: 5 or 10 mg/kg every 24 hours
  • CrCl: 0-10 ml/min: 2.5 or 5 mg/kg every 24 hours and after dialysis.
Overdose effectsView
Overdosage of intravenous Acyclovir has resulted in elevations of serum creatinine, blood urea nitrogen and subsequent renal failure. Neurological effects including confusion, hallucinations, agitation, seizures and coma have been described in association with over dosage. Adequate hydration is essential to reduce the possibility of crystal formation in the urine. Hemodialysis significantly enhances the removal of Acyclovir from the blood and may, therefore, be considered an option in the management of overdose of Acyclovir.
Duration of treatmentView
It is recommended that Acyclovir IV Injection for Intravenous Infusion should be administered for five to seven days in the treatment of most infections and for at least ten days in the treatment of Herpes simplex encephalitis.
ReconstitutionView
Each 250 mg vial of Acyclovir IV Injection should be reconstituted by the addition of 10 ml of either Water for Injection or Sodium Chloride Intravenous Infusion (0.9% w/v). This provides a solution containing 25 mg Acyclovir per ml.

Each 500 mg vial of Acyclovir IV Injection should be reconstituted by the addition of 10 ml of either Water for Injection or Sodium Chloride Intravenous Infusion (0.9% w/v). This provides a solution containing 50 mg Acyclovir per ml.
StorageView
Store at 15°C to 25°C. Protected from light and moisture. Keep the medicine out of the reach of children.

Ad-All

Iron + Folic Acid + Vitamin B Complex + Vitamine C + Zinc Sulfate
Capsule Allopathic Iron & Vitamin Combined preparations

Indications

Vitamin deficiency

Indication detailsView
This is indicated for the treatment and prophylaxis of Zinc, Iron, Folic Acid, B-vitamins and Vitamin-C deficiency especially during pregnancy and lactation.
Therapeutic classView
Iron & Vitamin Combined preparations
PharmacologyView
Zinc sulfate precipitates protein and this is responsible for the astringent and weak antiseptic activity of Zn sulfate. It also produces mild vasodilation. Zinc sulfate can also be used orally or systemically as a zinc supplement. 220 mg of zinc sulfate (heptahydrate) contains 50 mg of elemental zinc.

Iron
 is an essential mineral, with several important roles in the body. For example, it helps to make red blood cells, which carry oxygen around the body. A lack of iron can lead to iron deficiency anaemia. Liver is a good source of iron, don't eat it if you are pregnant. This is because it is also rich in vitamin A which, in large amounts, can harm your unborn baby.

Folic acid is essential for the production of certain coenzymes in many metabolic systems such as purine and pyrimidine synthesis. It is also essential in the synthesis and maintenance of nucleoprotein in erythropoesis. It also promotes WBC and platelet production in folate-deficiency anaemia.

Nicotinamide is a vitamin B3 derivative. It is incorporated into coenzymes nicotinamide adenine dinucleotide (NAD) and nicotinamide adenine dinucleotide phosphate (NADP), which are involved in multiple cellular metabolic pathways.

Vitamin C
is necessary for collagen formation and tissue repair; plays a role in oxidation/reduction reactions as well as other metabolic pathways including synthesis of catecholamines, carnitine, and steroids; also plays a role in conversion of folic acid to folinic acid.

Vitamin B complex: The building blocks for good health come from a variety of foods, even if they are from the same family of nutrients. Such is the case with vitamin B, a key player in maintaining cell health and keeping you energized.

Not all types of vitamin B do the same thing. Additionally, the different types of vitamin B all come from different types of foods.

Vitamin B deficiencies can lead to health problems. Sometimes a doctor will prescribe a supplement when they think you’re not getting enough.
DosageView
One capsule daily. In more severe cases, 2 capsules a day may be required or as directed by the physician.
Side effectsView
Generally well tolerated. However, a few allergic reactions may be seen.
ContraindicationsView
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
PrecautionsView
Care should be taken in patients who may develop iron overload, such as those with haemochromatosis, haemolytic anaemia or red cell aplasia. Iron chelates with tetracycline and absorption may be impaired.
Pregnancy & lactationView
Recommended.
Overdose effectsView
Accidental overdose of iron containing products is a leading cause of fatal poisoning in children below 6 years. Avoid higher doses if you have liver disease or haemochromatosis; excess can cause bloody diarrhea, vomiting, acidosis, darkened stools, abdominal pain. Symptoms may clear in a few hours.

Riboflavin is reported to be completely safe and no toxic symptoms have been reported so far. Higher doses of Nicotinamide may cause vomiting, diarrhea. Sensory neuropathy was observed in individuals consuming more than 200 mg Pyridoxine for very long periods. No case of Folic acid overdodage has been reported.

Acute ingestion of Ascorbic acid, even of massive doses, is unlikely to cause significant effects.

Zinc toxicity has been seen in both acute and chronic forms. Ingestion of 150 to 450 mg of zinc per day have been associated with low copper status, altered iron function, reduced immune function, and reduced levels of high-density lipoproteins. So, Zinc at its RDA dosages dose not cause any significant effect.
StorageView
Store in a dry place below 25 °C. Protect from light.

Adaben Duo

Adapalene + Benzoyl peroxide
Gel 0.1%+2.5% Allopathic Topical retinoid and related preparations

Indications

Acne vulgaris

Indication detailsView
Adapalene & Benzoyl peroxide gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
Therapeutic classView
Topical retinoid and related preparations
PharmacologyView
Adapalene & Benzoyl peroxide gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. Adapalene binds to specific retinoic acid nuclear receptors but does not bind to cytosolic receptor protein. Biochemical and pharmacological profile studies have demonstrated that Adapalene is a modulator of cellular differentiation, keratinization and inflammatory processes. Adapalene binds with specific retinoic acid nuclear receptors that normalize the differentiation of follicular epithelial cells resulting in decreased microcomedone formation. Benzoyl peroxide is an oxidizing agent with bacteriocidal and keratolytic effects.
DosageView
Apply a thin film of Adapalene & Benzoyl peroxide gel to affected areas of the face and/or trunk once daily after washing. Use a pea-sized amount for each area of the face (e.g., forehead, chin, each cheek). Avoid the eyes, lips and mucous membranes. Adapalene & Benzoyl peroxide is not for oral, ophthalmic, or intravaginal use.

Pediatric use: The safety and effectiveness of Adapalene and Benzoyl peroxide gel in pediatric patients under the age of 12 years have not been established.
Side effectsView
Erythema, scaling, dryness, and stinging/ burning may occur. Most commonly reported adverse events are dry skin, contact dermatitis, application site burning, application site irritation, and skin irritation.
ContraindicationsView
Should not be administered to individuals who are hypersensitive to any of its component.
PrecautionsView
Avoid exposure to sunlight and sunlamps. Wear sunscreen when sun exposure cannot be avoided.
InteractionsView
Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. No formal drug-drug interaction studies were conducted.
Pregnancy & lactationView
There are no well-controlled trials in pregnant women treated with Adapalene and Benzoyl peroxide. Animal reproduction studies have not been conducted with the combination gel or Benzoyl peroxide. Furthermore, such studies are not always predictive of human response; therefore, this preparation should be used during pregnancy only if the potential benefit justifies the risk to the fetus. It is not known whether Adapalene or Benzoyl peroxide is excreted in human milk following use. Caution should be exercised when administered to a nursing woman.
StorageView
Store in a cool (below 25°C) and dry place protected from light and moisture. Keep out of the reach of children. Keep the tube tightly closed after use.

Adafil

Tadalafil
Tablet 10 mg Allopathic Drugs for Erectile Dysfunction

Indications

Pulmonary arterial hypertension

Indication detailsView
Tadalafil is indicated in-
  • Erectile Dysfunction (ED)
  • Benign Prostatic Hyperplasia (BPH)
  • Both Erectile Dysfunction and signs and symptoms of Benign Prostatic Hyperplasia
Therapeutic classView
Drugs for Erectile Dysfunction
PharmacologyView
Tadalafil is a selective phosphodiesterase type 5 (PDE5) inhibitor. Inhibition of PDE5 increases cGMP in smooth muscle cells. cGMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum, causing penile erection. PDE5 also is present in smooth muscles of the prostate and bladder wall. Inhibiting PDE5 increases cGMP concentrations leading to relaxation of smooth muscle in the prostate and bladder. Smooth muscle relaxation may improve blood flow to the urinary tract and widen the opening of the bladder neck, resulting in improved voiding.
DosageView

Erectile Dysfunction: For most patients the recommended starting dose is 10 mg. The dose may be increased to 20 mg or decreased to 5 mg based on requirement. The maximum dosing frequency is once daily. Tadalafil is effective for up to 36 hours.

Benign prostatic hyperplasia: The recommended dose is 5 mg taken at the same time every day.

Combined Erectile Dysfunction and Benign prostatic hyperplasia: The recommended dose is 5 mg at the same time every day.

Side effectsView
Headache, Dyspepsia, Back pain, Myalgia, Nasal pharyngitis, Nasal congestion are common side effects. Change in Color Vision, Sudden vision loss, Hearing loss, Stevens-Johnson Syndrome, Exfoliative dermatitis, Angina, Stroke, Myocardial infarction, Severe hypotension, Tachycardia may also occur rarely.
ContraindicationsView
  • Use of Nitrates (for example, Nitroglycerine, Isosorbide): may increase hypotensive effects of Nitrates
  • Hypersensitivity reactions to Tadalafil
PrecautionsView
Angina, renal impairment, hepatic impairment, bleeding concomitant with Nitrates, Alpha Blockers, Alcohol, CYP3A4 Inhibitors (for example, Ritonavir, Ketoconazole, Itraconazole), other PDE5 inhibitors precaution should be taken in all these conditions.
InteractionsView
May interact with Nitrates for example, Isosorbide, Nitroglycerin, Alpha adrenergic blockers, Antihypertensives, Alcohol, Antacids (magnesuim hydroxide/aluminum hydroxide), Ketoconazole, Ritonavir, Erythromycin, Itraconazole, Grapefruit juice, other HIV protease inhibitors, Rifampin, Carbamazepine, Phenytoin & Phenobarbital.
Pregnancy & lactationView
Tadalafil has been assigned to pregnancy category B by the USFDA. Tadalafil is only recommended for use during pregnancy when benefit outweighs risk. There are no data on the excretion of Tadalafil in human milk. Caution should be used when administering tadalafil to nursing women.
StorageView
Keep in a dry place, away from light and heat. Keep out of the reach of children.

Adafil

Tadalafil
Tablet 20 mg Allopathic Drugs for Erectile Dysfunction

Indications

Pulmonary arterial hypertension

Indication detailsView
Tadalafil is indicated in-
  • Erectile Dysfunction (ED)
  • Benign Prostatic Hyperplasia (BPH)
  • Both Erectile Dysfunction and signs and symptoms of Benign Prostatic Hyperplasia
Therapeutic classView
Drugs for Erectile Dysfunction
PharmacologyView
Tadalafil is a selective phosphodiesterase type 5 (PDE5) inhibitor. Inhibition of PDE5 increases cGMP in smooth muscle cells. cGMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum, causing penile erection. PDE5 also is present in smooth muscles of the prostate and bladder wall. Inhibiting PDE5 increases cGMP concentrations leading to relaxation of smooth muscle in the prostate and bladder. Smooth muscle relaxation may improve blood flow to the urinary tract and widen the opening of the bladder neck, resulting in improved voiding.
DosageView

Erectile Dysfunction: For most patients the recommended starting dose is 10 mg. The dose may be increased to 20 mg or decreased to 5 mg based on requirement. The maximum dosing frequency is once daily. Tadalafil is effective for up to 36 hours.

Benign prostatic hyperplasia: The recommended dose is 5 mg taken at the same time every day.

Combined Erectile Dysfunction and Benign prostatic hyperplasia: The recommended dose is 5 mg at the same time every day.

Side effectsView
Headache, Dyspepsia, Back pain, Myalgia, Nasal pharyngitis, Nasal congestion are common side effects. Change in Color Vision, Sudden vision loss, Hearing loss, Stevens-Johnson Syndrome, Exfoliative dermatitis, Angina, Stroke, Myocardial infarction, Severe hypotension, Tachycardia may also occur rarely.
ContraindicationsView
  • Use of Nitrates (for example, Nitroglycerine, Isosorbide): may increase hypotensive effects of Nitrates
  • Hypersensitivity reactions to Tadalafil
PrecautionsView
Angina, renal impairment, hepatic impairment, bleeding concomitant with Nitrates, Alpha Blockers, Alcohol, CYP3A4 Inhibitors (for example, Ritonavir, Ketoconazole, Itraconazole), other PDE5 inhibitors precaution should be taken in all these conditions.
InteractionsView
May interact with Nitrates for example, Isosorbide, Nitroglycerin, Alpha adrenergic blockers, Antihypertensives, Alcohol, Antacids (magnesuim hydroxide/aluminum hydroxide), Ketoconazole, Ritonavir, Erythromycin, Itraconazole, Grapefruit juice, other HIV protease inhibitors, Rifampin, Carbamazepine, Phenytoin & Phenobarbital.
Pregnancy & lactationView
Tadalafil has been assigned to pregnancy category B by the USFDA. Tadalafil is only recommended for use during pregnancy when benefit outweighs risk. There are no data on the excretion of Tadalafil in human milk. Caution should be used when administering tadalafil to nursing women.
StorageView
Keep in a dry place, away from light and heat. Keep out of the reach of children.

Adagel Plus

Adapalene + Benzoyl peroxide
Gel 0.1%+2.5% Allopathic Topical retinoid and related preparations

Indications

Acne vulgaris

Indication detailsView
Adapalene & Benzoyl peroxide gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
Therapeutic classView
Topical retinoid and related preparations
PharmacologyView
Adapalene & Benzoyl peroxide gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. Adapalene binds to specific retinoic acid nuclear receptors but does not bind to cytosolic receptor protein. Biochemical and pharmacological profile studies have demonstrated that Adapalene is a modulator of cellular differentiation, keratinization and inflammatory processes. Adapalene binds with specific retinoic acid nuclear receptors that normalize the differentiation of follicular epithelial cells resulting in decreased microcomedone formation. Benzoyl peroxide is an oxidizing agent with bacteriocidal and keratolytic effects.
DosageView
Apply a thin film of Adapalene & Benzoyl peroxide gel to affected areas of the face and/or trunk once daily after washing. Use a pea-sized amount for each area of the face (e.g., forehead, chin, each cheek). Avoid the eyes, lips and mucous membranes. Adapalene & Benzoyl peroxide is not for oral, ophthalmic, or intravaginal use.

Pediatric use: The safety and effectiveness of Adapalene and Benzoyl peroxide gel in pediatric patients under the age of 12 years have not been established.
Side effectsView
Erythema, scaling, dryness, and stinging/ burning may occur. Most commonly reported adverse events are dry skin, contact dermatitis, application site burning, application site irritation, and skin irritation.
ContraindicationsView
Should not be administered to individuals who are hypersensitive to any of its component.
PrecautionsView
Avoid exposure to sunlight and sunlamps. Wear sunscreen when sun exposure cannot be avoided.
InteractionsView
Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. No formal drug-drug interaction studies were conducted.
Pregnancy & lactationView
There are no well-controlled trials in pregnant women treated with Adapalene and Benzoyl peroxide. Animal reproduction studies have not been conducted with the combination gel or Benzoyl peroxide. Furthermore, such studies are not always predictive of human response; therefore, this preparation should be used during pregnancy only if the potential benefit justifies the risk to the fetus. It is not known whether Adapalene or Benzoyl peroxide is excreted in human milk following use. Caution should be exercised when administered to a nursing woman.
StorageView
Store in a cool (below 25°C) and dry place protected from light and moisture. Keep out of the reach of children. Keep the tube tightly closed after use.

Adair

Roflumilast
Tablet 500 mcg Allopathic Antihistamines anti-allergies & hypo-sensitisation

Indications

COPD

Indication detailsView
Roflumilast is indicated:
  • As add-on therapy to bronchodilator treatment.
  • For the maintenance treatment of severe Chronic Obstructive Pulmonary Disease (COPD) associated with chronic bronchitis (i.e. patients with a history of chronic cough and sputum) in adult patients with a history of frequent exacerbations.
Roflumilast should not be used as a rescue medication.
Therapeutic classView
Antihistamines anti-allergies & hypo-sensitisation
PharmacologyView
Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor which, due to its selective inhibition of the PDE4 isoenzyme, has potential antiinflammatory and antimodulatory effects in the pulmonary system. It is thought that the increased levels of intracellular cyclic AMP are responsible for the therapeutic actions of Roflumilast.
DosageView
The recommended dosage for patients with COPD is one 500 mcg tablet daily, with or without food.
Side effectsView
General disorders: Fatigue.
Metabolism and nutrition disorders: Decreased appetite, Weight decreased.
Musculoskeletal and connective tissue disorders: Back pain, muscle spasms.
Nervous system disorders: Dizziness, Headache, Tremor.
Psychiatric disorders: Anxiety, Depression, Insomnia.
ContraindicationsView
Hypersensitivity to Roflumilast or to any of the excipients. Moderate to severe liver impairment.
PrecautionsView
Not as emergency treatment for relief of acute brochospasm. Monitor body wt regularly. Severe immunological disease, severe acute infections, cancers (except basal cell carcinoma) or patients on immunosuppressants; CHF (NYHA grades III & IV). History of depression associated with suicidal ideation or behavior. Galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption. Hepatic impairment. Pregnancy & lactation.
InteractionsView
A major step in Roflumilast metabolism is the N-oxidation of Roflumilast to Roflumilast N-oxide by CYP3A4 and CYP1A2. Therefore, the use of strong cytochrome P450 enzyme inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin) with Roflumilast is not recommended. The co-administration of Roflumilast with CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously (e.g., erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine) may increase Roflumilast systemic exposure and may result in increased adverse reactions. The co-administration of Roflumilast with oral contraceptives containing gestodene and ethinyl estradiol may increase roflumilast systemic exposure and may result in increased side effects.
Pregnancy & lactationView
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Roflumilast should not be used during pregnancy & lactation.
Pediatric usageView
Geriatrics ( 65 years of age): There were no overall differences in safety and effectiveness of Roflumilast in the elderly compared to younger patients with COPD. Therefore, no dose adjustment is necessary.

Pediatrics (<18 years of age): Safety and effectiveness of Roflumilast in children and adolescents below 18 years of age have not been established.

Hepatic Impairment: Roflumilast is not recommended for use in patients with moderate or severe liver impairment.

Renal impairment: No dosage adjustment is necessary for patients with renal impairment
Overdose effectsView
No case of overdose has been reported in clinical studies with Roflumilast. However, during the Phase I studies of Roflumilast, at an increased rate after a single oral dose of 2500 mcg and a single dose of 5000 mcg,

The following symptoms were observed: headache, gastrointestinal disorders, dizziness, palpitations, lightheadedness, clamminess and arterial hypotension.

Missed Dose: Patients should be advised that if they forget to take a tablet at the usual time, they should take the tablet as soon as they remember or continue on the next day with the next tablet at the usual time. Patients should not take a double dose to make up for a forgotten dose.
StorageView
Store below 30° C, keep away from light, moisture. Keep out of the reach of children.

Adalimab

Adalimumab
SC Injection 40 mg/0.8 ml Allopathic Immunosuppressant

Indications

Ulcerative colitis

Indication detailsView
Adalimumab is a tumor necrosis factor (TNF) blocker indicated for treatment of:
  • Rheumatoid Arthritis (RA): Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA
  • Juvenile Idiopathic Arthritis (JIA): Reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older
  • Psoriatic Arthritis (PsA): Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA
  • Ankylosing Spondylitis (AS): Reducing signs and symptoms in adult patients with active AS
  • Adult Crohn’s Disease (CD): Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. Reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab
  • Pediatric Crohn’s Disease: Reducing signs and symptoms and inducing and maintaining clinical remission in patients 6 years of age and older with moderately to severely active Crohn’s disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate
  • Ulcerative Colitis (UC): Inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP). The effectiveness of Adalimumab has not been established in patients who have lost response to or were intolerant to TNF blockers
  • Plaque Psoriasis (Ps): The treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy and when other systemic therapies are medically less appropriate
  • Hidradenitis Suppurative (HS): The treatment of moderate to severe hidradenitis suppurativa
Therapeutic classView
Disease-modifying antirheumatic drugs (DMARDs), Immunosuppressant
PharmacologyView
Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human tumor necrosis factor (TNF). Adalimumab binds specifically to TNF-alpha and blocks its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab also lyses surface TNF expressing cells in vitro in the presence of complement. TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Elevated levels of TNF are found in the synovial fluid of patients with Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis and play an important role in both the pathologic inflammation and the joint destruction that are hallmarks of these diseases. Increased levels of TNF are also found in psoriasis plaques. In Plaque Psoriasis, treatment with Adalimumab may reduce the epidermal thickness and infiltration of inflammatory cells.
DosageView
Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis: 40 mg every other week Some patients with RA not receiving methotrexate may benefit from increasing the frequency to 40 mg every week.

Juvenile Idiopathic Arthritis:
  • 10 kg to <15 kg: 10 mg every other week
  • 15 kg to < 30 kg: 20 mg every other week
  • ≥ 30 kg: 40 mg every other week
Adult Crohn's Disease and Ulcerative Colitis:
  • Initial dose (Day 1): 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days).
  • Second dose two weeks later (Day 15): 80 mg.
  • Two weeks later (Day 29): Maintenance dose of 40 mg every other week.
  • For patients with Ulcerative Colitis only: Adalimumab should only be continued in patients who have shown evidence of clinical remission by eight weeks (Day 57) of therapy.
Pediatric Crohn’s Disease:
  • 17 kg to < 40 kg: Initial dose (Day 1): 80 mg (two 40 mg injections in one day) , Second dose two weeks later (Day 15): 40 mg , Two weeks later (Day 29): Maintenance dose of 20 mg every other week.
  • ≥ 40 kg: Initial dose (Day 1): 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days) , Second dose two weeks later (Day 15): 80 mg (two 40 mg injections in one day) , Two weeks later (Day 29): Maintenance dose of 40 mg every other week.
Plaque Psoriasis:
  • 80 mg initial dose, followed by 40 mg every other week starting one week after initial dose.
  • Hidradenitis Suppurativa: Initial dose (Day 1): 160 mg (given as four 40 mg injection on Day 1 or as two 40 mg injections per day on Days 1 and 2, Second dose two weeks later (Day 15): 80 mg (two 40 mg injections in one day), Third (Day 29) and subsequent doses: 40 mg every week.
AdministrationView
Administered by subcutaneous injection.
Side effectsView
The most common adverse reaction with Adalimumab was injection site reactions (erythema and/or itching, hemorrhage, pain or swelling). The most common adverse reactions leading to discontinuation of Adalimumab in rheumatoid arthritis were clinical flare reaction, rash and pneumonia.
  • Other adverse reactions of Adalimumab includes- Gastrointestinal disorders: Diverticulitis, large bowel perforations including perforations associated with diverticulitis and appendiceal perforations associated with appendicitis, pancreatitis.
  • General disorders and administration site conditions: Pyrexia.
  • Hepato-biliary disorders: Liver failure, hepatitis.
  • Immune system disorders: Sarcoidosis.
  • Neoplasms benign, malignant and unspecified (including cysts and polyps): Merkel Cell Carcinoma (neuroendocrine carcinoma of the skin). 
  • Nervous system disorders: Demyelinating disorders (e.g., optic neuritis, Guillain-Barré syndrome).
  • Cerebrovascular accident Respiratory disorders: Interstitial lung disease, including pulmonary fibrosis.
  • Pulmonary embolism Skin reactions: Stevens Johnson Syndrome, cutaneous vasculitis, erythema multiforme, new or worsening psoriasis (all sub-types including pustular and palmoplantar), alopecia.
  • Vascular disorders: Systemic vasculitis, deep vein thrombosis.
ContraindicationsView
Adalimumab should not be administered to patients with known hypersensitivity to Adalimumab or any of its components.
PrecautionsView
  • Serious infections: Adalimumab should not be started during an active infection. If an infection develops, should be carefully monitored and if infection becomes serious Adalimumab should be stopped.
  • Invasive fungal infections: For patients who develop a systemic illness on Adalimumab, empiric antifungal therapy should be considered for those who reside or travel to regions where mycoses are endemic
  • Malignancies: Incidence of malignancies was greater in Adalimumab-treated patients than in controls
  • Anaphylaxis or serious allergic reactions may occur Hepatitis B virus reactivation: HBV carriers should be monitored during and several months after therapy. If reactivation occurs, Adalimumab should be stopped and antiviral therapy should be started
  • Demyelinating disease: Exacerbation or new onset, may occur Cytopenias, pancytopenia: Patients should be advised to seek immediate medical attention if symptoms develop, and should be considered stopping Adalimumab
  • Heart failure: Worsening or new onset, may occur
  • Lupus-like syndrome: Adalimumab should be stopped if syndrome develops
InteractionsView
Abatacept: Increased risk of serious infection
Anakinra: Increased risk of serious infection
Live vaccines: Adalimumab use should be avoided
Pregnancy & lactationView
Pregnancy Category B. Adequate and well controlled studies with Adalimumab have not been conducted in pregnant women. Adalimumab is an IgG1 monoclonal antibody and IgG1 is actively transferred across the placenta during the third trimester of pregnancy. Limited data from published literature indicate that Adalimumab is present in low levels in human milk and is not likely to be absorbed by a breastfed infant. However, no data is available on the absorption of Adalimumab from breast milk in newborn or preterm infants. Caution should be exercised when Adalimumab is administered to a nursing woman.
Pediatric usageView
Pediatric Use: Safety and efficacy of Adalimumab in pediatric patients for uses other than polyarticular juvenile idiopathic arthritis (JIA) and pediatric Crohn’s disease have not been established.

Geriatric Use: A total of 519 patients 65 years of age and older, including 107 patients 75 years and older, received Adalimumab in clinical studies. No overall difference in effectiveness was observed between these subjects and younger subjects. The frequency of serious infection and malignancy among Adalimumab treated subjects over age 65 was higher than for those under age 65. Because there is a higher incidence of infections and malignancies in the elderly population in general, caution should be used when treating the elderly.
Overdose effectsView
The maximum tolerated dose of Adalimumab has not been established in humans. Multiple doses up to 10 mg/kg have been administered to patients in clinical trials without evidence of dose-limiting toxicities. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.
StorageView
Do not use beyond the expiration date on the container. Adalimumab must be refrigerated at 2-8° C. Do not freeze. Protect the pre-filled syringe from exposure to light. Store in original carton until time of administration.

Adam 33

Prednisolone
Tablet 5 mg Allopathic Glucocorticoids

Indications

Wiskott-Aldrich syndrome

Indication detailsView
Rheumatic Disorders: Psoriatic arthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis.

Endocrine Disorders: Primary or secondary adrenocortical insufficiency, congenital adrenal hyperplasia, nonsuppurative thyroiditis, hypercalcemia associated with cancer.

Dermatologic Diseases: Pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme, exfoliative dermatitis, mycosis fungoides, severe psoriasis.

Allergic States: Seasonal or perennial allergic rhinitis, bronchial asthma, contact dermatitis, atopic dermatitis, serum sickness, drug hypersensitivity reactions.

Respiratory Diseases: Symptomatic sarcoidosis, berylliosis, fulminating, aspiration pneumonitis.

Hematologic Disorders: Idiopathic thrombocytopenic purpura, secondary thrombocytopenia, acquired (autoimmune) hemolytic anemia, erythroblastopenia (RBC anemia).

Edematous States: To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.

Gastrointestinal Diseases: Ulcerative colitis, regional enteritis.
Therapeutic classView
Glucocorticoids
PharmacologyView
Prednisolone is a synthetic adrenocortical drug with predominantly glucocorticoid properties. Prednisolone directly inhibits the action of the Phospholipase A2 enzyme which is responsible for the production of different inflammatory mediators like Leukotrienes, SRS-A, Prostaglandins etc. Prednisolone is rapidly and well absorbed from the Gl tract following oral administration. Prednisolone is 70- 90% protein-bound in the plasma and it is eliminated from the plasma with a half-life of 2 to 4 hours. It is metabolized mainly in the liver and excreted in the urine.
DosageView
Adult-
Nephrotic Syndrome:
  • Initial: 2 mg/kg/day (maximum 80 mg/day) in divided doses 3 to 4 times/day until urine is protein free for 3 consecutive days (maximum: 28 days); followed by 1 to 1.5 mg/kg/dose given every other day for 4 weeks.
  • Maintenance dose: 0.5 to 1 mg/kg/ dose given every other day for 3 to 6 months.
Anti-inflammatory: 5 to 60 mg per day in divided doses 1 to 4 times/day.

Acute Asthma: 40-60 mg/day PO in single daily dose or divided q12 hr for 3-10 days.

Allergic Conditions:
  • Day 1: 10 mg PO before breakfast, 5 mg after lunch and after dinner, and 10 mg at bedtime.
  • Day 2: 5 mg PO before breakfast, after lunch, and after dinner and 10 mg at bedtime.
  • Day 3: 5 mg PO before breakfast, after lunch, after dinner, and at bedtime.
  • Day 4: 5 mg PO before breakfast, after lunch, and at bedtime.
  • Day 5: 5 mg PO before breakfast and at bedtime.
  • Day 6: 5 mg PO before breakfast.

Pediatric-
Asthma:
  • 1 year: Acute: 10 mg orally every 12 hours. Maintenance: 10 mg orally every other day.
  • 1 to 4 years: Acute: 20 mg orally every 12 hours. Maintenance: 20 mg orally every other day.
  • 5 to 12 years: Acute: 30 mg orally every 12 hours. Maintenance: 30 mg orally every other day.
  • 12 years: Acute: 40 mg orally every 12 hours. Maintenance: 40 mg orally every other day.
Anti-inflammatory: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.

Immunosuppression: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.
Side effectsView
Common side effects include increased appetite, indigestion, nervousness or restlessness. Less frequent or rare side effects are darkening or lightening of skin color, dizziness or lightheadedness, flushing of face or cheeks, hiccups, increased sweating, the sensation of spinning.
ContraindicationsView
Systemic infections unless specific anti-infective therapy is employed. Hypersensitivity to any ingredient. Ocular herpes simplex because of possible perforation.
PrecautionsView
Precaution has to be taken in diabetes, hypertension, Psychological disturbances, osteoporosis, post-menopausal women, pregnancy and in chronic nephritis. Long-term use of Prednisolone can cause Cushing's habitus, hyperglycemia, muscular weakness, increased susceptibility to infection, delayed wound healing, and psychiatric disturbances.
InteractionsView
The efficacy of prednisolone is reduced by Aminoglutethimide, Antacids, Barbiturates, Carbamazepine, Griseofulvin, Mitotane, Phenylbutazone, Phenytoin, Primidone and Rifampin. Prednisolone reduces the amount of potassium in the blood. Digitalis can cause Cardiac arrhythmias if hypokalemia occurs. Immunization should be done very carefully.
Pregnancy & lactationView
This medicine is not recommended for use during pregnancy unless considered essential by your doctor. It should only be used if the expected benefit to the mother is greater than any possible risk to the foetus. Corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production or cause other unwanted effects.
Overdose effectsView
Adverse effects related to prednisone normally develop only after prolonged use of doses in excess of the normal physiological requirement. Treatment is symptomatic and where possible the prednisone dose should be reduced gradually.
StorageView
Store in a cool and dry place, protected from light. Keep out of the reach of the children.

Adam 33

Prednisolone
Tablet 20 mg Allopathic Glucocorticoids

Indications

Wiskott-Aldrich syndrome

Indication detailsView
Rheumatic Disorders: Psoriatic arthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis.

Endocrine Disorders: Primary or secondary adrenocortical insufficiency, congenital adrenal hyperplasia, nonsuppurative thyroiditis, hypercalcemia associated with cancer.

Dermatologic Diseases: Pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme, exfoliative dermatitis, mycosis fungoides, severe psoriasis.

Allergic States: Seasonal or perennial allergic rhinitis, bronchial asthma, contact dermatitis, atopic dermatitis, serum sickness, drug hypersensitivity reactions.

Respiratory Diseases: Symptomatic sarcoidosis, berylliosis, fulminating, aspiration pneumonitis.

Hematologic Disorders: Idiopathic thrombocytopenic purpura, secondary thrombocytopenia, acquired (autoimmune) hemolytic anemia, erythroblastopenia (RBC anemia).

Edematous States: To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.

Gastrointestinal Diseases: Ulcerative colitis, regional enteritis.
Therapeutic classView
Glucocorticoids
PharmacologyView
Prednisolone is a synthetic adrenocortical drug with predominantly glucocorticoid properties. Prednisolone directly inhibits the action of the Phospholipase A2 enzyme which is responsible for the production of different inflammatory mediators like Leukotrienes, SRS-A, Prostaglandins etc. Prednisolone is rapidly and well absorbed from the Gl tract following oral administration. Prednisolone is 70- 90% protein-bound in the plasma and it is eliminated from the plasma with a half-life of 2 to 4 hours. It is metabolized mainly in the liver and excreted in the urine.
DosageView
Adult-
Nephrotic Syndrome:
  • Initial: 2 mg/kg/day (maximum 80 mg/day) in divided doses 3 to 4 times/day until urine is protein free for 3 consecutive days (maximum: 28 days); followed by 1 to 1.5 mg/kg/dose given every other day for 4 weeks.
  • Maintenance dose: 0.5 to 1 mg/kg/ dose given every other day for 3 to 6 months.
Anti-inflammatory: 5 to 60 mg per day in divided doses 1 to 4 times/day.

Acute Asthma: 40-60 mg/day PO in single daily dose or divided q12 hr for 3-10 days.

Allergic Conditions:
  • Day 1: 10 mg PO before breakfast, 5 mg after lunch and after dinner, and 10 mg at bedtime.
  • Day 2: 5 mg PO before breakfast, after lunch, and after dinner and 10 mg at bedtime.
  • Day 3: 5 mg PO before breakfast, after lunch, after dinner, and at bedtime.
  • Day 4: 5 mg PO before breakfast, after lunch, and at bedtime.
  • Day 5: 5 mg PO before breakfast and at bedtime.
  • Day 6: 5 mg PO before breakfast.

Pediatric-
Asthma:
  • 1 year: Acute: 10 mg orally every 12 hours. Maintenance: 10 mg orally every other day.
  • 1 to 4 years: Acute: 20 mg orally every 12 hours. Maintenance: 20 mg orally every other day.
  • 5 to 12 years: Acute: 30 mg orally every 12 hours. Maintenance: 30 mg orally every other day.
  • 12 years: Acute: 40 mg orally every 12 hours. Maintenance: 40 mg orally every other day.
Anti-inflammatory: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.

Immunosuppression: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.
Side effectsView
Common side effects include increased appetite, indigestion, nervousness or restlessness. Less frequent or rare side effects are darkening or lightening of skin color, dizziness or lightheadedness, flushing of face or cheeks, hiccups, increased sweating, the sensation of spinning.
ContraindicationsView
Systemic infections unless specific anti-infective therapy is employed. Hypersensitivity to any ingredient. Ocular herpes simplex because of possible perforation.
PrecautionsView
Precaution has to be taken in diabetes, hypertension, Psychological disturbances, osteoporosis, post-menopausal women, pregnancy and in chronic nephritis. Long-term use of Prednisolone can cause Cushing's habitus, hyperglycemia, muscular weakness, increased susceptibility to infection, delayed wound healing, and psychiatric disturbances.
InteractionsView
The efficacy of prednisolone is reduced by Aminoglutethimide, Antacids, Barbiturates, Carbamazepine, Griseofulvin, Mitotane, Phenylbutazone, Phenytoin, Primidone and Rifampin. Prednisolone reduces the amount of potassium in the blood. Digitalis can cause Cardiac arrhythmias if hypokalemia occurs. Immunization should be done very carefully.
Pregnancy & lactationView
This medicine is not recommended for use during pregnancy unless considered essential by your doctor. It should only be used if the expected benefit to the mother is greater than any possible risk to the foetus. Corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production or cause other unwanted effects.
Overdose effectsView
Adverse effects related to prednisone normally develop only after prolonged use of doses in excess of the normal physiological requirement. Treatment is symptomatic and where possible the prednisone dose should be reduced gradually.
StorageView
Store in a cool and dry place, protected from light. Keep out of the reach of the children.

Adapel

Adapalene
Cream 0.10% Allopathic Topical retinoid and related preparations

Indications

Keratosis pilaris

Indication detailsView
Adapalene cream or gel is indicated for topical treatment of acne vulgaris.
Therapeutic classView
Topical retinoid and related preparations
PharmacologyView
Adapalene acts on retinoid receptors that are commonly found in the skin of face, back and chest. Biochemical and pharmacological studies have demonstrated that Adapalene is a modulator of cellular differentiation, keratinization, and inflammatory processes, all of that represent important features in the pathology of acne vulgaris. Adapalene binds with specific retinoic acid nuclear receptors that normalize the differentiation of follicular epithelial cells resulting in decreased microcomedone formation. Absorption of Adapalene through human skin is low.
DosageView
Adapalene 0.1%: It should be applied to the affected areas of skin, once daily at night-time.
Adapalene 0.3%: It should be applied to the entire face and any other affected areas of the skin, once daily in the evening.

Children below 12 years of age: Safety and effectiveness in children below 12 years of age have not been established.
AdministrationView
A thin film of gel or cream should be applied to the skin areas where lesions present, using enough to cover the entire affected areas lightly.
Side effectsView
Erythema, scaling, dryness, pruritus, burning sensation, skin irritation, stinging unburn, acne flares, etc. are commonly seen during the first month of therapy but usually lessen with continued use of the medication.
ContraindicationsView
Adapalene should not be administered to individuals who are hypersensitive to Adapalene or any of its components.
PrecautionsView
Adapalene should not be applied to cuts, abrasions, eczematous or sunburned skin.
InteractionsView
Concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, products with high concentrations of alcohol, astringents, spices or lime) should be approached with caution. Exercise particular caution in using preparations containing sulfur, resorcinol or salicylic acid in combination with Adapalene. If any of these preparations have been used, it is advisable not to start therapy with Adapalene until the effects of such preparations in skin have subsided. If combined use of both medications is important, it is better to use in two different times.
Pregnancy & lactationView
Use Adapalene during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in breast milk. Exercise caution when administering Adapalene to a nursing mother.
StorageView
Store in a cool (below 25°C) and dry place protected from light and moisture. Keep out of the reach of children. Keep the tube tightly closed after use.