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Phendrin

Diphenhydramine Hydrochloride

Syrup 10 mg/5 ml Allopathic Sedating Anti-histamine

Indications

Wheezing

Indication detailsView

Diphenhydramine is indicated for the treatment of followings:

Seasonal, perennial, vasomotor rhinitis
Urticaria, angioneurotic oedema, anaphylaxis
Pruiritic conditions
Premedication for emesis and motion sickness
Miscellaneous like meniere's disease and parkinsonism

Therapeutic classView

Sedating Anti-histamine

PharmacologyView

Diphenhydramine is an antihistamine with anticholinergic and sedative effects. It competes with histamine for H1-receptor sites on effector cells in the GI tract, blood vessels and respiratory tract.

DosageView

Adult-

Most allergic conditions: 25-50 mg three times a day with a further 50 mg at night.

Children-

1 to 5 years of age: 5 mg i.e., 2.5 ml of elixir 4 times a day
More than 6 years of age: 10 mg i.e. 5 ml of elixir 4 times a day

Side effectsView

Side effect includes sedation, dizziness, tinnitus, fatigue, ataxia, blurred vision, diplopia, euphoria, and epigastric discomfort.

ContraindicationsView

Known hypersensitivity to Diphenhydramine Hydrochloride, Ammonium chloride is contra-indicated in presence of impaired hepatic or renal function.

PrecautionsView

Caution should be exercised with patients in whom drowsiness is undesirable e.g., drivers, machine operators. Concomitant consumption of alcohol or central nervous system (CNS) depressants will potentiate drowsiness.

InteractionsView

Diphenhydramine administration significantly reduces the absorption of the antituberculous agent para-aminosalicyclic acid (PAS) from the gastrointestinal tract. CNS depressants may potentiate the sedative action of Diphenhydramine. Anticholinergic drugs may potentiate Diphenhydramine’s anticholinergic side effects.

Pregnancy & lactationView

Category B: There are no adequate and well controlled studies in pregnant women using diphenhydramine hydrochloride. Therefore, diphenhydramine hydrochloride should be used in pregnancy only if clearly needed. Diphenhydramine hydrochloride has been reported to be excreted in breast milk and thus, use of diphenhydramine hydrochloride in lactating mother is not recommended.

Overdose effectsView

Symptoms: Impaired consciousness; psychosis, seizures, antimuscarinic symptoms (e.g. mydriasis, tachycardia, tachyarrhythmias), resp failure, rhabdomyolysis; acute delirium with visual and auditory hallucination (topical).

Management: Supportive and symptomatic treatment. Convulsions and marked CNS stimulation may be treated with IV diazepam.

StorageView

Store between 15-30° C. Protect from moisture.

Phenerex

Promethazine Hydrochloride (Injection)

Injection 25 mg/ml Allopathic Sedating Anti-histamine

Indications

Vomiting

Indication detailsView

Promethazine hydrochloride injection is indicated for the following conditions:

Amelioration of allergic reactions to blood or plasma.
In anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled.
For other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated.
For sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused.
Active treatment of motion sickness.
Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.
As an adjunct to analgesics for the control of postoperative pain.
Preoperative, postoperative, and obstetric (during labor) sedation.
Intravenously in special surgical situations, such as repeated bronchoscopy, ophthalmic surgery, and poor-risk patients, with reduced amounts of meperidine or other narcotic analgesic as an adjunct to anesthesia and analgesia.

Therapeutic classView

Anti-emetic drugs, Miscellaneous sedatives & hypnotics, Sedating Anti-histamine

PharmacologyView

Promethazine is a phenothiazine derivative which blocks postsynaptic mesolimbic dopaminergic receptors in the brain. It exhibits strong α-adrenergic blocking effect and depresses the release of hypothalamic and hypophyseal hormones. It competes with histamine for the H1-receptor; muscarinic blocking effect may be responsible for antiemetic activity. It also reduces stimuli to the brainstem reticular system.

Clinical effects are generally apparent within 5 minutes of an intravenous injection and within 20 minutes of an intramuscular injection. Duration of action is four to six hours, although effects may persist up to 12 hours. Promethazine hydrochloride injection is metabolized in the liver, with the sulfoxides of promethazine and N-desmethylpromethazine being the predominant metabolites appearing in the urine. Following intravenous administration in healthy volunteers, the plasma half-life for promethazine has been reported to range from 9 to 16 hours. The mean plasma half-life for promethazine after intramuscular administration in healthy volunteers has been reported to be 9.8±3.4 hours.

DosageView

Allergic Conditions: The average adult dose is 25 mg. This dose may be repeated within two hours if necessary, but continued therapy, if indicated, should be via the oral route as soon as existing circumstances permit. After initiation of treatment, dosage should be adjusted to the smallest amount adequate to relieve symptoms. The average adult dose for amelioration of allergic reactions to blood or plasma is 25 mg.

Sedation: In hospitalized adult patients, nighttime sedation may be achieved by a dose of 25 to 50 mg of Promethazine Hydrochloride injection.

Nausea and Vomiting: For control of nausea and vomiting, the usual adult dose is 12.5 to 25 mg, not to be repeated more frequently than every four hours. When used for control of postoperative nausea and vomiting, the medication may be administered either intramuscularly or intravenously and dosage of analgesics and barbiturates reduced accordingly.

Preoperative and Postoperative Use: As an adjunct to preoperative or postoperative medication, 25 to 50 mg Promethazine Hydrochloride injection in adults may be combined with appropriately reduced doses of analgesics and atropine-like drugs as desired. Dosage of concomitant analgesic or hypnotic medication should be reduced accordingly.

Side effectsView

CNS Effects: Drowsiness is the most prominent CNS effect of the drug. Extrapyramidal reactions may occur with high doses; this is almost always responsive to a reduction in dosage. Other reported reactions include dizziness, lassitude, tinnitus, incoordination, fatigue, blurred vision, euphoria, diplopia, nervousness, insomnia, tremors, convulsive seizures, oculogyric crises, excitation, catatonic-like states, hysteria, and hallucinations.

Cardiovascular Effects: Tachycardia, bradycardia, faintness, dizziness, and increases and decreases in blood pressure have been reported following the use of Promethazine hydrochloride injection. Venous thrombosis at the injection site has been reported.

Gastrointestinal Effects: Nausea and vomiting have been reported, usually in association with surgical procedures and combination drug therapy.

Allergic Reactions: These include urticaria, dermatitis, asthma, and photosensitivity. Angioneurotic edema has been reported.

Other Reported Reactions: Leukopenia and agranulocytosis, usually when promethazine has been used in association with other known marrow-toxic agents, have been reported. Thrombocytopenic purpura and jaundice of the obstructive type have been associated with the use of promethazine. The jaundice is usually reversible on discontinuation of the drug. Subcutaneous injection has resulted in tissue necrosis. Nasal stuffiness may occur. Dry mouth has been reported.

ContraindicationsView

Promethazine hydrochloride injection is contraindicated in comatose states and in patients who have demonstrated an idiosyncrasy or hypersensitivity to promethazine or other phenothiazines. Under no circumstances should Promethazine hydrochloride injection be given by intra-arterial injection due to the likelihood of severe arteriospasm and the possibility of resultant gangrene.

Promethazine hydrochloride injection should not be given by the subcutaneous route; evidence of chemical irritation has been noted, and necrotic lesions have resulted on rare occasions following subcutaneous injection. The preferred parenteral route of administration is by deep intramuscularinjection.

PrecautionsView

General: Drugs having anticholingeric properties should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, and bladder-neck obstruction. Promethazine hydrochloride (promethazine hydrochloride injection) should be used cautiously in persons with cardiovascular disease or impairment of liver function.

Carcinogenesis, Mutagenesis and Impairment of Fertility: Long term animal studies have not been performed to assess the carcinogenic potential of promethazine hydrochloride (promethazine hydrochloride injection), nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility. Promethazine hydrochloride was nonmutagenic in the Ames Salmonella test system.

InteractionsView

CNS Depressants: Promethazine hydrochloride (promethazine hydrochloride injection) may increase, prolong, or intensify the sedative action of central-nervous-system depressants, such as alcohol, sedative-hypnotics (including barbiturates), general anesthetics, narcotics, narcotic analgesics, tranquilizers, etc. When given concomitanty with promethazine hydrochloride (promethazine hydrochloride injection), the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine hydrochloride (promethazine hydrochloride injection) relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain.

Epinephrine: Although reversal of the vasopressor effect of epinephrine has not been reported with promethazine hydrochloride (promethazine hydrochloride injection), it is recommended that epinephrine NOT be used in the case of promethazine hydrochloride (promethazine hydrochloride injection) overdose.

Pregnancy & lactationView

Pregnancy Category C. Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg (approximately 2.1 and 4.2 times the maximum recommended human daily dose) of Promethazine hydrochloride injection . Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats.

There are no adequate and well-controlled studies of Promethazine hydrochloride injection in pregnant women. Because animal reproduction studies are not always predictive of human response, Promethazine hydrochloride injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Pediatric usageView

Pediatric Patients: Promethazine hydrochloride are contraindicated for children under 2 years of age. In pediatric patients 2 years of age and older, the dosage should not exceed half that of the suggested adult dose. As an adjunct to premedication, the suggested dose is 0.5 mg per lb. of body weight in combination with an appropriately reduced dose of narcotic or barbiturate and the appropriate dose of an atropine-like drug. Antiemetics should not be used in vomiting of unknown etiology in pediatric patients

Geriatric Patients (approximately 60 years or older): Since therapeutic requirements for sedative drugs tend to be less in geriatric patients, the dosage should be reduced for these patients.

Overdose effectsView

Signs and symptoms of overdosage range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, and unconsciousness.

Stimulation may be evident, especially in pediatric patients and geriatric patients. Convulsions may rarely occur. A paradoxical reaction has been reported in pediatric patients receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares.

Atropine-like and symptoms: dry mouth, fixed, dilated pupils, flushing, etc., as well as gastrointestinal symptoms, may occur.

Treatment: Treatment of overdosage is essentially symptomatic and supportive. Only in cases of extreme overdosage or individual sensitivity do vital signs, including respiration, pulse, blood pressure, temperature, and EKG, need to be monitored. Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. Diazepam may be used to control convulsions. Acidosis and electrolyte losses should be corrected. Note that any depressant effects of promethazine hydrochloride (promethazine hydrochloride injection) are not reversed by naloxone.

Avoid analeptics, which may cause convulsions. The treatment of choice for resulting hypotension is administration of intravenous fluids, accompanied by repositioning if indicated. In the event that vasopressors are considered for the management of severe hypotension which does not respond to intravenous fluids and repositioning, the administration of levarterenol or phenylephrine should be considered. EPINEPHRINE SHOULD NOT BE USED, since its use in a patient with partial adrenergic blockade may further lower the blood pressure. Extrapyramidal reactions may be treated with anticholinergic antiparkinson agents, diphenhydramine, or barbiturates. Oxygen may also be administered. Limited experience with dialysis indicates that it is not helpful.

StorageView

Store between 15-30° C. Protect from light.

Phenerex

Promethazine Hydrochloride (Injection)

Injection 50 mg/2 ml Allopathic Sedating Anti-histamine

Indications

Vomiting

Indication detailsView

Promethazine hydrochloride injection is indicated for the following conditions:

Amelioration of allergic reactions to blood or plasma.
In anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled.
For other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated.
For sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused.
Active treatment of motion sickness.
Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.
As an adjunct to analgesics for the control of postoperative pain.
Preoperative, postoperative, and obstetric (during labor) sedation.
Intravenously in special surgical situations, such as repeated bronchoscopy, ophthalmic surgery, and poor-risk patients, with reduced amounts of meperidine or other narcotic analgesic as an adjunct to anesthesia and analgesia.

Therapeutic classView

Anti-emetic drugs, Miscellaneous sedatives & hypnotics, Sedating Anti-histamine

PharmacologyView

Promethazine is a phenothiazine derivative which blocks postsynaptic mesolimbic dopaminergic receptors in the brain. It exhibits strong α-adrenergic blocking effect and depresses the release of hypothalamic and hypophyseal hormones. It competes with histamine for the H1-receptor; muscarinic blocking effect may be responsible for antiemetic activity. It also reduces stimuli to the brainstem reticular system.

Clinical effects are generally apparent within 5 minutes of an intravenous injection and within 20 minutes of an intramuscular injection. Duration of action is four to six hours, although effects may persist up to 12 hours. Promethazine hydrochloride injection is metabolized in the liver, with the sulfoxides of promethazine and N-desmethylpromethazine being the predominant metabolites appearing in the urine. Following intravenous administration in healthy volunteers, the plasma half-life for promethazine has been reported to range from 9 to 16 hours. The mean plasma half-life for promethazine after intramuscular administration in healthy volunteers has been reported to be 9.8±3.4 hours.

DosageView

Allergic Conditions: The average adult dose is 25 mg. This dose may be repeated within two hours if necessary, but continued therapy, if indicated, should be via the oral route as soon as existing circumstances permit. After initiation of treatment, dosage should be adjusted to the smallest amount adequate to relieve symptoms. The average adult dose for amelioration of allergic reactions to blood or plasma is 25 mg.

Sedation: In hospitalized adult patients, nighttime sedation may be achieved by a dose of 25 to 50 mg of Promethazine Hydrochloride injection.

Nausea and Vomiting: For control of nausea and vomiting, the usual adult dose is 12.5 to 25 mg, not to be repeated more frequently than every four hours. When used for control of postoperative nausea and vomiting, the medication may be administered either intramuscularly or intravenously and dosage of analgesics and barbiturates reduced accordingly.

Preoperative and Postoperative Use: As an adjunct to preoperative or postoperative medication, 25 to 50 mg Promethazine Hydrochloride injection in adults may be combined with appropriately reduced doses of analgesics and atropine-like drugs as desired. Dosage of concomitant analgesic or hypnotic medication should be reduced accordingly.

Side effectsView

CNS Effects: Drowsiness is the most prominent CNS effect of the drug. Extrapyramidal reactions may occur with high doses; this is almost always responsive to a reduction in dosage. Other reported reactions include dizziness, lassitude, tinnitus, incoordination, fatigue, blurred vision, euphoria, diplopia, nervousness, insomnia, tremors, convulsive seizures, oculogyric crises, excitation, catatonic-like states, hysteria, and hallucinations.

Cardiovascular Effects: Tachycardia, bradycardia, faintness, dizziness, and increases and decreases in blood pressure have been reported following the use of Promethazine hydrochloride injection. Venous thrombosis at the injection site has been reported.

Gastrointestinal Effects: Nausea and vomiting have been reported, usually in association with surgical procedures and combination drug therapy.

Allergic Reactions: These include urticaria, dermatitis, asthma, and photosensitivity. Angioneurotic edema has been reported.

Other Reported Reactions: Leukopenia and agranulocytosis, usually when promethazine has been used in association with other known marrow-toxic agents, have been reported. Thrombocytopenic purpura and jaundice of the obstructive type have been associated with the use of promethazine. The jaundice is usually reversible on discontinuation of the drug. Subcutaneous injection has resulted in tissue necrosis. Nasal stuffiness may occur. Dry mouth has been reported.

ContraindicationsView

Promethazine hydrochloride injection is contraindicated in comatose states and in patients who have demonstrated an idiosyncrasy or hypersensitivity to promethazine or other phenothiazines. Under no circumstances should Promethazine hydrochloride injection be given by intra-arterial injection due to the likelihood of severe arteriospasm and the possibility of resultant gangrene.

Promethazine hydrochloride injection should not be given by the subcutaneous route; evidence of chemical irritation has been noted, and necrotic lesions have resulted on rare occasions following subcutaneous injection. The preferred parenteral route of administration is by deep intramuscularinjection.

PrecautionsView

General: Drugs having anticholingeric properties should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, and bladder-neck obstruction. Promethazine hydrochloride (promethazine hydrochloride injection) should be used cautiously in persons with cardiovascular disease or impairment of liver function.

Carcinogenesis, Mutagenesis and Impairment of Fertility: Long term animal studies have not been performed to assess the carcinogenic potential of promethazine hydrochloride (promethazine hydrochloride injection), nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility. Promethazine hydrochloride was nonmutagenic in the Ames Salmonella test system.

InteractionsView

CNS Depressants: Promethazine hydrochloride (promethazine hydrochloride injection) may increase, prolong, or intensify the sedative action of central-nervous-system depressants, such as alcohol, sedative-hypnotics (including barbiturates), general anesthetics, narcotics, narcotic analgesics, tranquilizers, etc. When given concomitanty with promethazine hydrochloride (promethazine hydrochloride injection), the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine hydrochloride (promethazine hydrochloride injection) relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain.

Epinephrine: Although reversal of the vasopressor effect of epinephrine has not been reported with promethazine hydrochloride (promethazine hydrochloride injection), it is recommended that epinephrine NOT be used in the case of promethazine hydrochloride (promethazine hydrochloride injection) overdose.

Pregnancy & lactationView

Pregnancy Category C. Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg (approximately 2.1 and 4.2 times the maximum recommended human daily dose) of Promethazine hydrochloride injection . Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats.

There are no adequate and well-controlled studies of Promethazine hydrochloride injection in pregnant women. Because animal reproduction studies are not always predictive of human response, Promethazine hydrochloride injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Pediatric usageView

Pediatric Patients: Promethazine hydrochloride are contraindicated for children under 2 years of age. In pediatric patients 2 years of age and older, the dosage should not exceed half that of the suggested adult dose. As an adjunct to premedication, the suggested dose is 0.5 mg per lb. of body weight in combination with an appropriately reduced dose of narcotic or barbiturate and the appropriate dose of an atropine-like drug. Antiemetics should not be used in vomiting of unknown etiology in pediatric patients

Geriatric Patients (approximately 60 years or older): Since therapeutic requirements for sedative drugs tend to be less in geriatric patients, the dosage should be reduced for these patients.

Overdose effectsView

Signs and symptoms of overdosage range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, and unconsciousness.

Stimulation may be evident, especially in pediatric patients and geriatric patients. Convulsions may rarely occur. A paradoxical reaction has been reported in pediatric patients receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares.

Atropine-like and symptoms: dry mouth, fixed, dilated pupils, flushing, etc., as well as gastrointestinal symptoms, may occur.

Treatment: Treatment of overdosage is essentially symptomatic and supportive. Only in cases of extreme overdosage or individual sensitivity do vital signs, including respiration, pulse, blood pressure, temperature, and EKG, need to be monitored. Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. Diazepam may be used to control convulsions. Acidosis and electrolyte losses should be corrected. Note that any depressant effects of promethazine hydrochloride (promethazine hydrochloride injection) are not reversed by naloxone.

Avoid analeptics, which may cause convulsions. The treatment of choice for resulting hypotension is administration of intravenous fluids, accompanied by repositioning if indicated. In the event that vasopressors are considered for the management of severe hypotension which does not respond to intravenous fluids and repositioning, the administration of levarterenol or phenylephrine should be considered. EPINEPHRINE SHOULD NOT BE USED, since its use in a patient with partial adrenergic blockade may further lower the blood pressure. Extrapyramidal reactions may be treated with anticholinergic antiparkinson agents, diphenhydramine, or barbiturates. Oxygen may also be administered. Limited experience with dialysis indicates that it is not helpful.

StorageView

Store between 15-30° C. Protect from light.

Phenerex

Promethazine Hydrochloride

Oral Solution 5 mg/5 ml Allopathic Sedating Anti-histamine

Indications

Vasomotor rhinitis

Indication detailsView

Potent long-acting antihistamine with additional anti-emetic and sedative/calming effects.
Indicated in symptomatic treatment of allergic conditions of the respiratory tract and skin.
Sensitization reactions to drug or foreign proteins, anaphylactic reactions.
For sedation, allergic rhinitis, urticaria and insomnia.
As an adjunct in pre-operative sedation in surgery and obstetrics.
As a paediatric sedative

Therapeutic classView

Anti-emetic drugs, Miscellaneous sedatives & hypnotics, Sedating Anti-histamine

PharmacologyView

Promethazine is a phenothiazine derivative which blocks postsynaptic mesolimbic dopaminergic receptors in the brain. It exhibits strong α-adrenergic blocking effect and depresses the release of hypothalamic and hypophyseal hormones. It competes with histamine for the H1-receptor; muscarinic blocking effect may be responsible for antiemetic activity. It also reduces stimuli to the brainstem reticular system.

Promethazine is well absorbed from the gastrointestinal tract. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although they may persist as long as 12 hours. Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine.

DosageView

Adults: Initial dose one 25 mg tablet at night; may be increased to two or three 25 mg tablets at night if necessary. In allergic conditions more frequently administration, twice or three times daily, may be necessary, starting with one or two 10 mg tablets and increasing as required.

Elderly: No specific dosage recommendations.

Children: They may be treated more conveniently by the elixir containing 5 mg/5 ml.

As an antihistamine in allergy:

Children of 2-5 years: 5-15 mg
Children of 5-10 years: 10-25 mg
In the case where two doses in 24 hours are required, the lower dose stated should be given.

As a sedative:

Children of 2-5 years: 15-20 mg
Children of 5-10 years: 20-25 mg
Given as a single night-time dose

Side effectsView

Nervous system disorders: Frequency Unknown: Neuroleptic Malignant Syndrome the elderly are particularly susceptible to the anticholinergic efects and confusion due to Promethazine, somnolence, dizziness, headaches, extrapyramidal efects including muscle spasm, tic-like movements of the head and face. A very serious and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Stop treatment and call your doctor right away if you have high fever, muscle cramps or stifness, dizziness, very bad headache, fast heartbeat, confusion, agitation, hallucinations, or are sweating a lot.
Immune System Disorders- Frequency unknown: Allergic reactions, including urticaria, rash, pruritus, and anaphylaxis, have been reported.
Skin and Subcutaneous Tissue Disorders- Frequency unknown: Photosensitivity reaction
Metabolism and Nutrition Disorders- Frequency unknown: Anorexia
Gastrointestinal Disorders- Frequency unknown: Epigastric discomfort, dry mouth
Eye Disorders- Frequency unknown: Blurred vision
Blood and Lymphatic System Disorders- Frequency unknown: Blood dyscrasias including hemolytic anemia, agranulocytosis
Renal and Urinary Disorders- Frequency unknown: Urinary retention
Psychiatric Disorders- Frequency unknown: Infants, newborns and premature are susceptible to the anticholinergic efects of promethazine, while other children may display paradoxical hyperexcitability, restlessness, nightmares, disorientation
Cardiac Disorders- Frequency unknown: Palpitations, arrhythmias
Vascular disorders- Frequency unknown: Hypotension
Hepatobiliary disorders- Frequency unknown: Jaundice
General Disorders and Administration Site Conditions- Frequency unknown: Tiredness

Use this drug only as recommended. Do not exceed the recommended dose. There have been case reports of promethazine abuse. Do not take for longer than 10 days.

ContraindicationsView

Promethazine is contraindicated for use in children less than two years of age
Hypersensitivity to promethazine or to any of the excipients.
Phenergan should not be used in patients who are in a coma or suffering from CNS depression of any cause. It must not be given to neonates or premature infants.
Phenergan should be avoided in patients who have been taking monoamine oxidase inhibitors within the previous 14 days

PrecautionsView

The use of promethazine should be avoided in children and adolescents with signs and symptoms suggestive of Reye’s syndrome.
Promethazine may thicken or dry lung secretions and impair expectoration. It should therefore be used with caution in patients with asthma, bronchitis or bronchiectasis.
Use with care in patients with severe coronary artery disease.
Use with care in patients with narrow angle glaucoma.
Use with care in patients with epilepsy.
Use with care in patients with hepatic insufciency.
Use with care in patients with renal insufciency.
Caution should be exercised in patients with bladder neck obstruction.
Caution should be exercised in patients with pyloro-duodenal obstruction.

InteractionsView

Promethazine Hydrochloride may enhance the action of any anticholinergic agent, tricyclic antidepressant, sedative or hypnotic, Alcohol should be avoided during drug treatment.
Phenergan may interfere with immunologic urine pregnancy tests to produce false-positive or false-negative results.
Phenergan should be discontinued at least 72 hours before the start of skin tests using allergen extracts as it may inhibit the cutaneous histamine response thus producing false-negative results.

Pregnancy & lactationView

There is epidemiological evidence for the safety of promethazine in pregnancy and animal studies have shown no hazard, nevertheless, it should not be used in pregnancy unless the physician considers it essential. The use of Phenergan is not recommended in the two weeks prior to delivery in view of the risk of irritability and excitement in the neonate. When promethazine has been given in high doses during late pregnancy, promethazine has caused prolonged neurological disturbances in the infant. Promethazine should be used in pregnancy only if the potential benefts to the patient are weighed against the possible risk to the fetus. Promethazine is excreted in breastmilk. There are risks of neonatal irritability and excitement.

Overdose effectsView

Symptoms of severe over dosage are variable. They are characterised in children by various combinations of excitation, ataxia, incoordination, athetosis and hallucinations, while adults may become drowsy and lapse into coma. Convulsions may occur in both adults and children; coma or excitement may precede their occurrence. Tachycardia may develop. Cardiorespiratory depression is uncommon. If the patient is seen soon enough after ingestion, it should be possible to induce vomiting with ipecacuanha despite the antiemetic efect of promethazine; alternatively, gastric lavage may be used. Treatment is otherwise supportive with attention to maintenance of adequate respiratory and circulatory status. Convulsions should be treated with diazepam or other suitable anticonvulsant.

StorageView

Protect from light. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician

Phenergan

Promethazine Hydrochloride

Tablet 10 mg Allopathic Sedating Anti-histamine

Indications

Vasomotor rhinitis

Indication detailsView

Potent long-acting antihistamine with additional anti-emetic and sedative/calming effects.
Indicated in symptomatic treatment of allergic conditions of the respiratory tract and skin.
Sensitization reactions to drug or foreign proteins, anaphylactic reactions.
For sedation, allergic rhinitis, urticaria and insomnia.
As an adjunct in pre-operative sedation in surgery and obstetrics.
As a paediatric sedative

Therapeutic classView

Anti-emetic drugs, Miscellaneous sedatives & hypnotics, Sedating Anti-histamine

PharmacologyView

Promethazine is a phenothiazine derivative which blocks postsynaptic mesolimbic dopaminergic receptors in the brain. It exhibits strong α-adrenergic blocking effect and depresses the release of hypothalamic and hypophyseal hormones. It competes with histamine for the H1-receptor; muscarinic blocking effect may be responsible for antiemetic activity. It also reduces stimuli to the brainstem reticular system.

Promethazine is well absorbed from the gastrointestinal tract. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although they may persist as long as 12 hours. Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine.

DosageView

Adults: Initial dose one 25 mg tablet at night; may be increased to two or three 25 mg tablets at night if necessary. In allergic conditions more frequently administration, twice or three times daily, may be necessary, starting with one or two 10 mg tablets and increasing as required.

Elderly: No specific dosage recommendations.

Children: They may be treated more conveniently by the elixir containing 5 mg/5 ml.

As an antihistamine in allergy:

Children of 2-5 years: 5-15 mg
Children of 5-10 years: 10-25 mg
In the case where two doses in 24 hours are required, the lower dose stated should be given.

As a sedative:

Children of 2-5 years: 15-20 mg
Children of 5-10 years: 20-25 mg
Given as a single night-time dose

Side effectsView

Nervous system disorders: Frequency Unknown: Neuroleptic Malignant Syndrome the elderly are particularly susceptible to the anticholinergic efects and confusion due to Promethazine, somnolence, dizziness, headaches, extrapyramidal efects including muscle spasm, tic-like movements of the head and face. A very serious and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Stop treatment and call your doctor right away if you have high fever, muscle cramps or stifness, dizziness, very bad headache, fast heartbeat, confusion, agitation, hallucinations, or are sweating a lot.
Immune System Disorders- Frequency unknown: Allergic reactions, including urticaria, rash, pruritus, and anaphylaxis, have been reported.
Skin and Subcutaneous Tissue Disorders- Frequency unknown: Photosensitivity reaction
Metabolism and Nutrition Disorders- Frequency unknown: Anorexia
Gastrointestinal Disorders- Frequency unknown: Epigastric discomfort, dry mouth
Eye Disorders- Frequency unknown: Blurred vision
Blood and Lymphatic System Disorders- Frequency unknown: Blood dyscrasias including hemolytic anemia, agranulocytosis
Renal and Urinary Disorders- Frequency unknown: Urinary retention
Psychiatric Disorders- Frequency unknown: Infants, newborns and premature are susceptible to the anticholinergic efects of promethazine, while other children may display paradoxical hyperexcitability, restlessness, nightmares, disorientation
Cardiac Disorders- Frequency unknown: Palpitations, arrhythmias
Vascular disorders- Frequency unknown: Hypotension
Hepatobiliary disorders- Frequency unknown: Jaundice
General Disorders and Administration Site Conditions- Frequency unknown: Tiredness

Use this drug only as recommended. Do not exceed the recommended dose. There have been case reports of promethazine abuse. Do not take for longer than 10 days.

ContraindicationsView

Promethazine is contraindicated for use in children less than two years of age
Hypersensitivity to promethazine or to any of the excipients.
Phenergan should not be used in patients who are in a coma or suffering from CNS depression of any cause. It must not be given to neonates or premature infants.
Phenergan should be avoided in patients who have been taking monoamine oxidase inhibitors within the previous 14 days

PrecautionsView

The use of promethazine should be avoided in children and adolescents with signs and symptoms suggestive of Reye’s syndrome.
Promethazine may thicken or dry lung secretions and impair expectoration. It should therefore be used with caution in patients with asthma, bronchitis or bronchiectasis.
Use with care in patients with severe coronary artery disease.
Use with care in patients with narrow angle glaucoma.
Use with care in patients with epilepsy.
Use with care in patients with hepatic insufciency.
Use with care in patients with renal insufciency.
Caution should be exercised in patients with bladder neck obstruction.
Caution should be exercised in patients with pyloro-duodenal obstruction.

InteractionsView

Promethazine Hydrochloride may enhance the action of any anticholinergic agent, tricyclic antidepressant, sedative or hypnotic, Alcohol should be avoided during drug treatment.
Phenergan may interfere with immunologic urine pregnancy tests to produce false-positive or false-negative results.
Phenergan should be discontinued at least 72 hours before the start of skin tests using allergen extracts as it may inhibit the cutaneous histamine response thus producing false-negative results.

Pregnancy & lactationView

There is epidemiological evidence for the safety of promethazine in pregnancy and animal studies have shown no hazard, nevertheless, it should not be used in pregnancy unless the physician considers it essential. The use of Phenergan is not recommended in the two weeks prior to delivery in view of the risk of irritability and excitement in the neonate. When promethazine has been given in high doses during late pregnancy, promethazine has caused prolonged neurological disturbances in the infant. Promethazine should be used in pregnancy only if the potential benefts to the patient are weighed against the possible risk to the fetus. Promethazine is excreted in breastmilk. There are risks of neonatal irritability and excitement.

Overdose effectsView

Symptoms of severe over dosage are variable. They are characterised in children by various combinations of excitation, ataxia, incoordination, athetosis and hallucinations, while adults may become drowsy and lapse into coma. Convulsions may occur in both adults and children; coma or excitement may precede their occurrence. Tachycardia may develop. Cardiorespiratory depression is uncommon. If the patient is seen soon enough after ingestion, it should be possible to induce vomiting with ipecacuanha despite the antiemetic efect of promethazine; alternatively, gastric lavage may be used. Treatment is otherwise supportive with attention to maintenance of adequate respiratory and circulatory status. Convulsions should be treated with diazepam or other suitable anticonvulsant.

StorageView

Protect from light. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician

Phenergan

Promethazine Hydrochloride

Oral Solution 5 mg/5 ml Allopathic Sedating Anti-histamine

Indications

Vasomotor rhinitis

Indication detailsView

Potent long-acting antihistamine with additional anti-emetic and sedative/calming effects.
Indicated in symptomatic treatment of allergic conditions of the respiratory tract and skin.
Sensitization reactions to drug or foreign proteins, anaphylactic reactions.
For sedation, allergic rhinitis, urticaria and insomnia.
As an adjunct in pre-operative sedation in surgery and obstetrics.
As a paediatric sedative

Therapeutic classView

Anti-emetic drugs, Miscellaneous sedatives & hypnotics, Sedating Anti-histamine

PharmacologyView

Promethazine is a phenothiazine derivative which blocks postsynaptic mesolimbic dopaminergic receptors in the brain. It exhibits strong α-adrenergic blocking effect and depresses the release of hypothalamic and hypophyseal hormones. It competes with histamine for the H1-receptor; muscarinic blocking effect may be responsible for antiemetic activity. It also reduces stimuli to the brainstem reticular system.

Promethazine is well absorbed from the gastrointestinal tract. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although they may persist as long as 12 hours. Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine.

DosageView

Adults: Initial dose one 25 mg tablet at night; may be increased to two or three 25 mg tablets at night if necessary. In allergic conditions more frequently administration, twice or three times daily, may be necessary, starting with one or two 10 mg tablets and increasing as required.

Elderly: No specific dosage recommendations.

Children: They may be treated more conveniently by the elixir containing 5 mg/5 ml.

As an antihistamine in allergy:

Children of 2-5 years: 5-15 mg
Children of 5-10 years: 10-25 mg
In the case where two doses in 24 hours are required, the lower dose stated should be given.

As a sedative:

Children of 2-5 years: 15-20 mg
Children of 5-10 years: 20-25 mg
Given as a single night-time dose

Side effectsView

Nervous system disorders: Frequency Unknown: Neuroleptic Malignant Syndrome the elderly are particularly susceptible to the anticholinergic efects and confusion due to Promethazine, somnolence, dizziness, headaches, extrapyramidal efects including muscle spasm, tic-like movements of the head and face. A very serious and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Stop treatment and call your doctor right away if you have high fever, muscle cramps or stifness, dizziness, very bad headache, fast heartbeat, confusion, agitation, hallucinations, or are sweating a lot.
Immune System Disorders- Frequency unknown: Allergic reactions, including urticaria, rash, pruritus, and anaphylaxis, have been reported.
Skin and Subcutaneous Tissue Disorders- Frequency unknown: Photosensitivity reaction
Metabolism and Nutrition Disorders- Frequency unknown: Anorexia
Gastrointestinal Disorders- Frequency unknown: Epigastric discomfort, dry mouth
Eye Disorders- Frequency unknown: Blurred vision
Blood and Lymphatic System Disorders- Frequency unknown: Blood dyscrasias including hemolytic anemia, agranulocytosis
Renal and Urinary Disorders- Frequency unknown: Urinary retention
Psychiatric Disorders- Frequency unknown: Infants, newborns and premature are susceptible to the anticholinergic efects of promethazine, while other children may display paradoxical hyperexcitability, restlessness, nightmares, disorientation
Cardiac Disorders- Frequency unknown: Palpitations, arrhythmias
Vascular disorders- Frequency unknown: Hypotension
Hepatobiliary disorders- Frequency unknown: Jaundice
General Disorders and Administration Site Conditions- Frequency unknown: Tiredness

Use this drug only as recommended. Do not exceed the recommended dose. There have been case reports of promethazine abuse. Do not take for longer than 10 days.

ContraindicationsView

Promethazine is contraindicated for use in children less than two years of age
Hypersensitivity to promethazine or to any of the excipients.
Phenergan should not be used in patients who are in a coma or suffering from CNS depression of any cause. It must not be given to neonates or premature infants.
Phenergan should be avoided in patients who have been taking monoamine oxidase inhibitors within the previous 14 days

PrecautionsView

The use of promethazine should be avoided in children and adolescents with signs and symptoms suggestive of Reye’s syndrome.
Promethazine may thicken or dry lung secretions and impair expectoration. It should therefore be used with caution in patients with asthma, bronchitis or bronchiectasis.
Use with care in patients with severe coronary artery disease.
Use with care in patients with narrow angle glaucoma.
Use with care in patients with epilepsy.
Use with care in patients with hepatic insufciency.
Use with care in patients with renal insufciency.
Caution should be exercised in patients with bladder neck obstruction.
Caution should be exercised in patients with pyloro-duodenal obstruction.

InteractionsView

Promethazine Hydrochloride may enhance the action of any anticholinergic agent, tricyclic antidepressant, sedative or hypnotic, Alcohol should be avoided during drug treatment.
Phenergan may interfere with immunologic urine pregnancy tests to produce false-positive or false-negative results.
Phenergan should be discontinued at least 72 hours before the start of skin tests using allergen extracts as it may inhibit the cutaneous histamine response thus producing false-negative results.

Pregnancy & lactationView

There is epidemiological evidence for the safety of promethazine in pregnancy and animal studies have shown no hazard, nevertheless, it should not be used in pregnancy unless the physician considers it essential. The use of Phenergan is not recommended in the two weeks prior to delivery in view of the risk of irritability and excitement in the neonate. When promethazine has been given in high doses during late pregnancy, promethazine has caused prolonged neurological disturbances in the infant. Promethazine should be used in pregnancy only if the potential benefts to the patient are weighed against the possible risk to the fetus. Promethazine is excreted in breastmilk. There are risks of neonatal irritability and excitement.

Overdose effectsView

Symptoms of severe over dosage are variable. They are characterised in children by various combinations of excitation, ataxia, incoordination, athetosis and hallucinations, while adults may become drowsy and lapse into coma. Convulsions may occur in both adults and children; coma or excitement may precede their occurrence. Tachycardia may develop. Cardiorespiratory depression is uncommon. If the patient is seen soon enough after ingestion, it should be possible to induce vomiting with ipecacuanha despite the antiemetic efect of promethazine; alternatively, gastric lavage may be used. Treatment is otherwise supportive with attention to maintenance of adequate respiratory and circulatory status. Convulsions should be treated with diazepam or other suitable anticonvulsant.

StorageView

Protect from light. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician

Phenobarbitone

Phenobarbital

Tablet 30 mg Allopathic Adjunct anti-epileptic drugs

Indications

Tonic-clonic status epilepticus

Indication detailsView

Phenobarbital is indicated for the following conditions:

Sedatives
Hypnotics for the short-term treatment of insomnia
Pre-anesthetics
Long-term anticonvulsants for the treatment of generalized tonic-clonic and cortical local seizures. And, in the emergency control of certain acute convulsive episodes, (those associated with status epilepticus, eclampsia meningitis, tetanus, and toxic reactions to Strychnine or local anesthetics).

Therapeutic classView

Adjunct anti-epileptic drugs, Barbiturates

PharmacologyView

Phenobarbital, the longest-acting barbiturate, is used for its anticonvulsant and sedative-hypnotic properties in the management of all seizure disorders except absence (petit mal). Phenobarbital acts on GABA_A receptors, increasing synaptic inhibition. This has the effect of elevating seizure threshold and reducing the spread of seizure activity from a seizure focus. Phenobarbital may also inhibit calcium channels, resulting in a decrease in excitatory transmitter release. The sedative-hypnotic effects of phenobarbital are likely the result of its effect on the polysynaptic midbrain reticular formation, which controls CNS arousal.

DosageView

Suggested doses of Phenobarbital for specific indications are as follows:

Pediatric Oral Dosage:

Preoperative: 1 mg to 3 mg/kg.
Anticonvulsant: 1 mg to 6 mg/kg per day

Adult Oral Dosage:

Daytime sedative: 30 mg to 120 mg daily in 2 to 3 divided doses.
Bedtime hypnotic: 100 mg to 320 mg.
Anticonvulsant: 50 mg to 100 mg 2 to 3 times daily.

Pediatric Injection Dosage:

15 to 20 mg/kg IV over 10 to 15 min.
Preoperative Sedation:1 to 3 mg/kg IM/IV;
Anticonvulsant: 4 to 6 mg/kg IM/IV per day, for 10 days. Alternatively, use 10 to 15 mg/kg IM/IV per day to reach therapeutic level more quickly. Maxium IV rate 60 mg/min.

Adult Injection Dosage:

Insomnia: 100 to 320 mg IM/IV;
Convulsions: 100 to 320 mg IV. Repeat if needed (maximum, 600 mg per day);
Status Epilepticus: 10 to 20 mg/kg IV. Repeat if needed.

Side effectsView

The most common adverse reaction is somnolence. Other less frequent adverse reactions are agitation, confusion, hyperkinesia, ataxia, CNS depression, nightmares, nervousness, psychiatric disturbance, hallucinations, insomnia, anxiety, dizziness, thinking abnormality, apnea, bradycardia, hypotension, nausea, vomiting and constipation.

ContraindicationsView

Phenobarbital is contraindicated in patients with known Phenobarbital sensitivity or a history of latent porphyria.

PrecautionsView

Tolerance and psychological and physical dependence may occur with continuing use. Phenobarbital should be administered with caution to patients who are mentally depressed, have suicidal tendencies, or a history of drug abuse. In patients with hepatic damage, Phenobarbital should be administered with caution and initially reduced doses.

InteractionsView

The concomitant use of Alcohol or other CNS depressants may produce additive CNS depressant effects.

Pregnancy & lactationView

Pregnancy Category D. Phenobarbital can cause fetal damage when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be in risk of the potential hazard to the fetus. Caution should be taken when Phenobarbital is administered to a nursing woman since small amounts of Phenobarbital are excreted in the milk.

Overdose effectsView

The toxic dose of barbiturates varies considerably. In general, an oral dose of 1 gram of most barbiturates produces serious poisoning in an adult. Death commonly occurs after 2 to 10 grams of ingested barbiturate. Acute overdosage with barbiturates is manifested by CNS and respiratory depression Treatment of overdosage is mainly supportive and immediate hospitalization is necessary.

StorageView

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Phenocept

Mycophenolate Mofetil

Tablet 500 mg Allopathic Immunosuppressant

Indications

Vasculitis

Indication detailsView

Mycophenolate Mofetil in combination with corticosteroids and either ciclosporin or tacrolimus is indicated for-

Prophylaxis of acute organ rejection and treatment of first or refractory organ rejection in patients receiving allogeneic renal transplants.
Prophylaxis of acute organ rejection in patients receiving allogeneic cardiac transplants.
Prophylaxis of acute organ rejection in patients receiving allogeneic hepatic transplants.
Mycophenolate Mofetil is indicated for induction and maintenance therapy of patients with Class III-V lupus nephritis (diagnosed according to International Society of Nephrology/Renal Pathology Society classification.

Therapeutic classView

Immunological Chemotherapy, Immunosuppressant

PharmacologyView

Mechanism of Action: Mycophenolate mofetil is the 2-morpholinoethyl ester of mycophenolic acid (MPA). MPA is a potent, selective, uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), and therefore inhibits the de novo pathway of guanosine nucleotide synthesis. The mechanism by which MPA inhibits the enzymatic activity of IMPDH appears to be related to the ability of MPA to structurally mimic both nicotinamide adenine dinucleotide cofactor and a catalytic water molecule. This prevents the oxidation of IMP to xanthose-5’-monophosphate which is the committed step in de novo guanosine nucleotide biosynthesis. MPA has more potent cytostatic effects on lymphocytes than on other cells because T- and B lymphocytes are critically dependent for their proliferation on de novo synthesis of purines whereas other cell types can utilize salvage pathways.

Pharmacodynamics: Mycophenolic acid, the active metabolite of mycophenolate mofetil, is a non-competitive, reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH). Inhibition of IMPDH blocks the de novo synthesis of guanosine nucleotides which are necessary substrates for DNA and RNA synthesis. Unlike other cell types which can use the salvage pathway, B and T lymphocytes are dependent upon the de novo pathway for the generation of guanosine. Data from in vitro studies indicate that mycophenolic acid and/or mycophenolate mofetil inhibit mixed lymphocyte responses and human peripheral blood lymphocyte proliferation induced by a variety of mitogens and antigens. Mycophenolic acid decreases intracellular pools of guanosine triphosphate (GTP) and deoxyguanosine triphosphate (dGTP) in mitogen-stimulated human peripheral blood monocytes or T lymphocytic cell lines but has no effect on GTP concentrations in human neutrophils.

DosageView

Transplant patients:
Standard dosage for prophylaxis of renal rejection

Adults: A dose of 1 g administered orally twice a day (daily dose of 2 g) is recommended for use in renal transplant patients.
Children (aged 3 months to 18 years): Patients with a body surface area of 1.25 to 1.5 m² may be prescribed Mycophenolate Mofetil Tablets at a dose of 750 mg twice daily (1.5 g daily dose). Patients with a body surface area >1.5 m² may be prescribed Mycophenolate Mofetil tablets at a dose of 1 gm twice daily (2 g daily dose).

Standard dosage for prophylaxis of cardiac rejection-

Adults: A dose of 1.5 g administered orally (over not less than 2 hour) twice a day (daily dose of 3 g) is recommended for use in cardiac transplant patients.
Children: no data are available for pediatric cardiac transplant patients.

Standard dosage for prophylaxis of hepatic rejection-

Adults: A dose of 1.5 g orally twice a day (daily dose of 3 g) is recommended for use in hepatic transplant patients
Children: no data are available for pediatric hepatic transplant patients.

Standard dosage for treatment of first or refractory renal rejection-

Adults: A dose of 1.5 g administered orally twice a day (daily dose of 3 g) is recommended for management of first or refractory rejection.
Children: no data are available for the treatment of first or refractory renal rejection in pediatric renal transplant patients.

Lupus nephritis patients:
Standard Dosage for Induction Therapy-

Adults: A dose of 750 mg-1.5 g administered orally twice a day (daily dose of up to 3 g) is recommended
Children: A dose of 600 mg/m² administered orally twice a day (up to a maximum of 2 g daily) is recommended

Standard Dosage for Maintenance Therapy-

Adults: A dose of 500 mg-1 g administered orally twice a day is recommended
Children: A dose of 300 mg/m² administered orally twice a day is recommended

Mycophenolate Mofetil should be used in combination with corticosteroids. Doses should be introduced gradually and adjusted according to clinical response. Therapeutic drug monitoring could help prevent sub-therapeutic exposure (Cmin≥3.0 mg/L or inter-dose AUC ≥35 h*mg/L).

Side effectsView

The principal adverse reactions associated with the administration of Mycophenolate Mofetil includes diarrhea, leukopenia, sepsis, gastrointestinal candidiasis, urinary tract infection, herpes simplex, vomiting and there is evidence of a higher frequency of certain types of infections eg. opportunistic infections.

ContraindicationsView

Mycophenolic acid is contraindicated in patients with a hypersensitivity to mycophenolic acid, or to any of its excipients. Mycophenolic acid is contraindicated during pregnancy due to its mutagenic and teratogenic potential. Mycophenolic acid is contraindicated in women who are breastfeeding.

PrecautionsView

Mycophenolic acid tablets are used with caution because it-

Can increase new or reactive viral infections. Such infections include latent viral reactivation, such as hepatitis B or hepatitis C reactivation, or infections caused by polyomaviruses.
Can cause blood dyscrasias including pure red cell aplasia (PRCA).
Can cause serious GI tract complications (gastrointestinal bleeding, perforations and ulcers).
May increase the risk of developing lymphomas and other malignancies, particularly of the skin.
Use of live vaccines should be avoided during treatment with Mycophenolic acid.
Patients should not donate blood during therapy.

InteractionsView

Caution should be exercised with concomitant administration of Antacids, Azathioprine, Cyclosporin, Rifampin, Sevelamer, Cholestyramine, Acyclovir, Metronidazole, Hormonal contraceptives as these medicines may decrease Mycophenolic acid concentration.

Pregnancy & lactationView

Mycophenolate Mofetil is contraindicated in pregnancy and during breastfeeding. The safe use of Mycophenolate Mofetil during labor and delivery has not been established.

Pediatric usageView

Geriatric population: Geriatric patients may be at an increased risk of adverse events such as certain infections (including cytomegalovirus tissue invasive disease) and possibly gastrointestinal hemorrhage and pulmonary edema, compared with younger individuals.

Overdose effectsView

In many of these cases no adverse events were reported. It is expected that an overdose of mycophenolate mofetil could possibly result in over suppression of the immune system and increase susceptibility to infections and bone marrow suppression. If neutropenia develops, dosing with Mycophenolate Mofetil should be interrupted or the dose reduced.

StorageView

Store in a cool (below 30°C), dry place and away from light. Keep out of the reach of children.

Phenomark

Chlorpheniramine Maleate

Syrup 2 mg/5 ml Allopathic Sedating Anti-histamine

Indications

Watery eye

Indication detailsView

Chlorpheniramine Maleate is indicated in the following indications-

Urticaria
Sensitivity reactions
Angioneurotic edema
Vasomotor rhinitis
Cough
Common cold
Motion sickness and
Other allergic conditions.

Therapeutic classView

Sedating Anti-histamine

PharmacologyView

Chlorpheniramine Maleate is an alkylamine antihistamine. It is one of the most potent histamine H1-receptor blocking agents which is used as a potent antihistamine. This generally causes less sedation than promethazine. Chlorpheniramine Maleate exerts its effects by blocking H1-receptor competitively.

DosageView

Adult- Usual adult dose is 4 mg every 4-6 hours, maximum 24 mg daily.

Child-

6-12 years: 2 mg every 4-6 hours, maximum 12 mg daily.
2-5 years: 1 mg every 4-6 hours, maximum 6 mg daily.
1-2 years: 1 mg twice daily.

Below 1 year the use of Chlorpheniramine Maleate is not recommended.

Side effectsView

Chlorpheniramine is well-tolerated, but sometimes drowsiness, dizziness, muscular weakness, and gastrointestinal upset may occur.

ContraindicationsView

Chlorpheniramine is contraindicated in patients hypersensitive to this agent, in newborn or premature infants.

PrecautionsView

Chlorpheniramine should be used with caution in patients with glaucoma and prostatic hypertrophy. During therapy with chlorpheniramine, caution should be taken in driving vehicles and operating machinery.

InteractionsView

Chlorphenamine maleate has been reported to be incompatible with calcium chloride, kanamycin sulfate, noradrenaline acid tartrate, pentobarbital sodium, and meglumine adipiodone.

Pregnancy & lactationView

This drug should not be used in lactating mother and in pregnancy especially during the first trimester of pregnancy.

Overdose effectsView

CNS depression (including sedation, apnea, CV collapse), CNS stimulation (including insomnia, hallucination, tremors, convulsions), tinnitus, blurred vision, dizziness, ataxia, hypotension. Stimulation and atropine-like signs and symptoms (including dry mouth, fixed dilated pupils, flushing, hyperthermia, Gl symptoms) are more likely in children.

StorageView

Store in a cool (Below 25°C temperature) and dry place protected from light. Keep out of the reach of children.

Phenoson

Phenobarbital

Tablet 30 mg Allopathic Adjunct anti-epileptic drugs

Indications

Tonic-clonic status epilepticus

Indication detailsView

Phenobarbital is indicated for the following conditions:

Sedatives
Hypnotics for the short-term treatment of insomnia
Pre-anesthetics
Long-term anticonvulsants for the treatment of generalized tonic-clonic and cortical local seizures. And, in the emergency control of certain acute convulsive episodes, (those associated with status epilepticus, eclampsia meningitis, tetanus, and toxic reactions to Strychnine or local anesthetics).

Therapeutic classView

Adjunct anti-epileptic drugs, Barbiturates

PharmacologyView

Phenobarbital, the longest-acting barbiturate, is used for its anticonvulsant and sedative-hypnotic properties in the management of all seizure disorders except absence (petit mal). Phenobarbital acts on GABA_A receptors, increasing synaptic inhibition. This has the effect of elevating seizure threshold and reducing the spread of seizure activity from a seizure focus. Phenobarbital may also inhibit calcium channels, resulting in a decrease in excitatory transmitter release. The sedative-hypnotic effects of phenobarbital are likely the result of its effect on the polysynaptic midbrain reticular formation, which controls CNS arousal.

DosageView

Suggested doses of Phenobarbital for specific indications are as follows:

Pediatric Oral Dosage:

Preoperative: 1 mg to 3 mg/kg.
Anticonvulsant: 1 mg to 6 mg/kg per day

Adult Oral Dosage:

Daytime sedative: 30 mg to 120 mg daily in 2 to 3 divided doses.
Bedtime hypnotic: 100 mg to 320 mg.
Anticonvulsant: 50 mg to 100 mg 2 to 3 times daily.

Pediatric Injection Dosage:

15 to 20 mg/kg IV over 10 to 15 min.
Preoperative Sedation:1 to 3 mg/kg IM/IV;
Anticonvulsant: 4 to 6 mg/kg IM/IV per day, for 10 days. Alternatively, use 10 to 15 mg/kg IM/IV per day to reach therapeutic level more quickly. Maxium IV rate 60 mg/min.

Adult Injection Dosage:

Insomnia: 100 to 320 mg IM/IV;
Convulsions: 100 to 320 mg IV. Repeat if needed (maximum, 600 mg per day);
Status Epilepticus: 10 to 20 mg/kg IV. Repeat if needed.

Side effectsView

The most common adverse reaction is somnolence. Other less frequent adverse reactions are agitation, confusion, hyperkinesia, ataxia, CNS depression, nightmares, nervousness, psychiatric disturbance, hallucinations, insomnia, anxiety, dizziness, thinking abnormality, apnea, bradycardia, hypotension, nausea, vomiting and constipation.

ContraindicationsView

Phenobarbital is contraindicated in patients with known Phenobarbital sensitivity or a history of latent porphyria.

PrecautionsView

Tolerance and psychological and physical dependence may occur with continuing use. Phenobarbital should be administered with caution to patients who are mentally depressed, have suicidal tendencies, or a history of drug abuse. In patients with hepatic damage, Phenobarbital should be administered with caution and initially reduced doses.

InteractionsView

The concomitant use of Alcohol or other CNS depressants may produce additive CNS depressant effects.

Pregnancy & lactationView

Pregnancy Category D. Phenobarbital can cause fetal damage when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be in risk of the potential hazard to the fetus. Caution should be taken when Phenobarbital is administered to a nursing woman since small amounts of Phenobarbital are excreted in the milk.

Overdose effectsView

The toxic dose of barbiturates varies considerably. In general, an oral dose of 1 gram of most barbiturates produces serious poisoning in an adult. Death commonly occurs after 2 to 10 grams of ingested barbiturate. Acute overdosage with barbiturates is manifested by CNS and respiratory depression Treatment of overdosage is mainly supportive and immediate hospitalization is necessary.

StorageView

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Phenoxymethyl

Phenoxymethyl Penicillin [Penicillin V]

Tablet 250 mg Allopathic Benzylpenicillin & Phenoxymethyl penicillin

Indications

Vincent’s infection

Indication detailsView

For the treatment of mild to moderately severe bacterial infections, if these are due to penicillin susceptible pathogens and respond to therapy with oral penicillin, such as:

infections of the ear, nose and throat regions, e.g., tonsillitis, pharyngitis, laryngitis, otitis media, sinusitis.
infections of the lower respiratory tract, e.g., bronchitis and pneumonia, bronchopneumonia.
infections due to beta-hemolytic streptococci of group A, e.g., scarlet fever, erysipelas, rheumatic fever.
skin infections, e.g., pyodermia, furunculosis, phlegmon, erysipeloid, erythema migrans, insofar as the micro-organisms are penicillin-susceptible.
lymphadenitis and lymphangitis of bacterial origin.
infections of the buccal cavity, gums or jaws, e.g., inflammatory infiltrates, delayed dentition stages II and III, antral fistulae, secondary bacterial infection with Gram-positive pathogens following virus-induced gingivitis or stomatitis.

For prophylaxis of scarlet fever; also to prevent recurrences of rheumatic fever. For prophylaxis of infection after dental and oral surgical procedures or dental extractions in certain high risk patients (e.g. with congenital cardiac defects, artificial heart valves, rheumatic endocarditis). In some cases, combination with another appropriate antibiotic may be indicated.

Therapeutic classView

Benzylpenicillin & Phenoxymethyl penicillin

PharmacologyView

Phenoxymethyl penicillin or penicillin V is acid-stable and is absorbed from the upper part of the small intestine. Of different forms of Phenoxymethyl penicillin, the potassium salt of Phenoxymethyl penicillin is best absorbed. This may be given with meals but maximum absorption is achieved when drug is administered orally at least 1 hour before or 2 hours after the meal. Phenoxymethyl penicillin offers a very convenient means of treating Grampositive infections. Phenoxymethyl penicillin has the distinct advantage over penicillin G in resistance to inactivation by gastric acid.

DosageView

The dosage of Phenoxymethyl penicillin should be determined according to the sensitivity of the causative micro-organism and the severity of the infection, and adjusted to the clinical response of the patient.

Adults: 250-500 mg 6 hourly

Children (above 1 year):

125-250 mg 6 hourly
125 mg/5 ml powder for suspension: 1-2 teaspoonful (5-10 ml) 6 hourly
250 mg/5 ml powder for suspension: ½-1 teaspoonful (2.5-5 ml) 6 hourly

Infants (below 1 year):

62.5-125 mg 6 hourly.
125 mg/5 ml powder for suspension: ½-1 teaspoonful (2.5-5 ml) 6 hourly, or as prescribed by the physician.

Phenoxymethyl penicillin is best taken with an empty stomach, preferably at least 1 hour before or 2 hour after meal.

AdministrationView

Phenoxymethyl Penicillin is best taken on an empty stomach, preferably one hour before meals. The tablets are swallowed without chewing with sufficient amounts of liquid. Before each use of this syrup, the bottle has to be shaken vigorously.

Side effectsView

Occasionally, hypersensitivity reactions involving the skin (e.g. urticaria, morbilliform or scarlatiniform rashes, pruritus), eosinophilia or more serious allergic reactions, e.g. drug fever, vasculitis, serum sickness or interstitial nephritis, may develop. Anaphylactic or anaphylactoid reactions accompanied by, e.g- angioneurotic oedema, oedema of the larynx, bronchial spasm and shock may occur.

In the event of signs pointing to anaphylactic/anaphylactoid reactions, the treatment must be terminated immediately. In occasional instances, there may be skin rashes or inflammation of mucous membranes, especially in the region of the mouth (stomatitis); dryness of the mouth and disorders of taste may rarely occur.

The occurrence of severe bullous skin reactions- usually involving the mucosae- has been reported in isolated cases (Stevens-Johnson syndrome, Lyell's syndrome). Gastrointestinal disturbances with, e.g., nausea, vomiting, abdominal pain, loose stools, or diarrhoea may develop.

Diarrhoea may sometimes be a symptom of enterocolitis which may, in some cases, be haemorrhagic. A particular form of enterocolitis that can occur with antibiotics is pseudomembranous colitis (in most cases due to Clostridium diffcile). This must be considered in patients in whom severe, persistent diarrhoea occurs during treatment or in the initial weeks thereafter. Even if pseudomembranous colitis is only suspected, administration of Phenoxymethyl penicillin must be halted immediately. This type of colitis requires immediate and appropriate treatment by a physician. Drugs that inhibit intestinal peristalsis must not be taken in such cases. In isolated cases, particularly after high doses and prolonged administration, changes in blood picture such as reduction in the number of white blood cells (e.g.,leucopenia, granulocytopenia, agranulocytosis), erythrocytes (e.g., due to haemolytic anaemia), thrombocytes, or pancytopenia and myelosuppression may occur. During treatment for spirochaetal infections, Herxheimer's reaction characterized by the occurrence or worsening of general symptoms such as fever, chills, headache, and joint pains may develop. In isolated cases, drug-induced aseptic meningitis may occur.

In extremely rare cases, transient discolouration of the teeth may be seen during treatment with Phenoxymethyl penicillin. Administration of antibiotics, especially if prolonged, may lead to the proliferation of resistant micro organisms.

Beta-lactams predispose the patient to encephalopathy risk (which may include convulsions, confusion, impairment of consciousness, movement disorders), particularly in case of overdose or renal impairment.

ContraindicationsView

Phenoxymethyl Penicillin must not be administered in patients with hypersensitivity to penicillins or any of the excipients of this. Phenoxymethyl Penicillin must not be used to treat patients with severe gastrointestinal disorders accompanied by vomiting and diarrhea.

PrecautionsView

The possibility of cross-allergy between cephalosporins and penicillins must be considered. When treating patients with heart diseases or serious electrolyte disturbances of other origin, the potassium content of Phenoxymethyl Penicillin may have to be considered. Beta-lactams predispose the patient to encephalopathy risk (which may include convulsions, confusion, impairment of consciousness, movement disorders), particularly in case of overdose or renal impairment.

Administration of antibiotics, especially if prolonged, may lead to the proliferation of resistant micro-organisms. The patient's condition must therefore be checked at regular intervals. If a secondary infection occurs, appropriate measures must be taken. In patients with diabetes mellitus, the sugar content of Phenoxymethyl Penicillin syrup must be taken into consideration.

There is no indication of impaired ability to drive, or to operate machinery. Beta-lactams predispose the patient to encephalopathy risk. In the case of adverse reactions such as encephalopathy (which may include convulsions, confusion, impairment of consciousness, movement disorders), the patient should not operate machines or drive a vehicle.

InteractionsView

Food: Concurrent intake of food leads to a reduction in the rate of absorption. Therefore, Phenoxymethyl penicillin is best taken on an empty stomach, preferably one hour before meals, in order to reach the highest possible rate of absorption.

Drug interactions: Concomitant administration of penicillins may lead to increased levels of methotrexate in serum and potentiate its toxic effects. Monitoring of methotrexate serum levels is therefore necessary.

If diarrhoea occurs as a consequence of treatment with Phenoxymethyl penicillin, the absorption of other orally administered drugs may be disturbed and their effcacy may consequently be impaired. If penicillins are combined with bacteriostatic chemotherapeutics or antibiotics (e.g., tetracyclines, chloramphenicol), the activity of penicillins may be attenuated or abolished. Concurrent administration of probenecid inhibits the renal excretion of penicillins. Concurrent use of indomethacin, phenylbutazone, salicylates or sulfinpyrazone may cause elevated and prolonged serum levels of phenoxymethylpenicillin.

Administration of penicillins may cause a transient reduction in plasma concentrations of oestrogens and gestagens. The effectiveness of oral contraceptives is therefore uncertain.

The absorption of Phenoxymethyl penicillin may be reduced where intestinal sterilization with aminoglycosides (e.g. neomycin) has just been performed or is still in progress. Combined use of penicillins and oral anticoagulants (e.g. warfarin) may prolong prothrombin time/INR.

Interference with laboratory and diagnostic tests: Non-enzymatic urine glucose determinations and tests for urobilinogen may give false-positive results.

Pregnancy & lactationView

Phenoxymethylpenicillin crosses the placenta. Given the appropriate indication, this may be used at any time throughout pregnancy. Phenoxymethylpenicillin passes into the breast milk in small amounts. This may be used during lactation; however, diarrhoea and yeast colonization of mucous membranes may occur in the infant.

Overdose effectsView

The toxicity of phenoxymethylpenicillin is low, and it has a broad therapeutic range. When a multiple therapeutic dose is taken orally once only, phenoxymethylpenicillin has no acute toxicity. There is a risk of encephalopathy in cases of administration of beta-lactam antibiotics, particularly in case of overdose or renal impairment. Special measures in the event of overdosage, other than discontinuation of the medication, are not required. Elimination of phenoxymethylpenicillin can be accomplished through haemodialysis.

StorageView

Store in a cool and dry place, protect from light.

Phensilex

Promethazine Hydrochloride

Oral Solution 5 mg/5 ml Allopathic Sedating Anti-histamine

Indications

Vasomotor rhinitis

Indication detailsView

Potent long-acting antihistamine with additional anti-emetic and sedative/calming effects.
Indicated in symptomatic treatment of allergic conditions of the respiratory tract and skin.
Sensitization reactions to drug or foreign proteins, anaphylactic reactions.
For sedation, allergic rhinitis, urticaria and insomnia.
As an adjunct in pre-operative sedation in surgery and obstetrics.
As a paediatric sedative

Therapeutic classView

Anti-emetic drugs, Miscellaneous sedatives & hypnotics, Sedating Anti-histamine

PharmacologyView

Promethazine is a phenothiazine derivative which blocks postsynaptic mesolimbic dopaminergic receptors in the brain. It exhibits strong α-adrenergic blocking effect and depresses the release of hypothalamic and hypophyseal hormones. It competes with histamine for the H1-receptor; muscarinic blocking effect may be responsible for antiemetic activity. It also reduces stimuli to the brainstem reticular system.

Promethazine is well absorbed from the gastrointestinal tract. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although they may persist as long as 12 hours. Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine.

DosageView

Adults: Initial dose one 25 mg tablet at night; may be increased to two or three 25 mg tablets at night if necessary. In allergic conditions more frequently administration, twice or three times daily, may be necessary, starting with one or two 10 mg tablets and increasing as required.

Elderly: No specific dosage recommendations.

Children: They may be treated more conveniently by the elixir containing 5 mg/5 ml.

As an antihistamine in allergy:

Children of 2-5 years: 5-15 mg
Children of 5-10 years: 10-25 mg
In the case where two doses in 24 hours are required, the lower dose stated should be given.

As a sedative:

Children of 2-5 years: 15-20 mg
Children of 5-10 years: 20-25 mg
Given as a single night-time dose

Side effectsView

Nervous system disorders: Frequency Unknown: Neuroleptic Malignant Syndrome the elderly are particularly susceptible to the anticholinergic efects and confusion due to Promethazine, somnolence, dizziness, headaches, extrapyramidal efects including muscle spasm, tic-like movements of the head and face. A very serious and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Stop treatment and call your doctor right away if you have high fever, muscle cramps or stifness, dizziness, very bad headache, fast heartbeat, confusion, agitation, hallucinations, or are sweating a lot.
Immune System Disorders- Frequency unknown: Allergic reactions, including urticaria, rash, pruritus, and anaphylaxis, have been reported.
Skin and Subcutaneous Tissue Disorders- Frequency unknown: Photosensitivity reaction
Metabolism and Nutrition Disorders- Frequency unknown: Anorexia
Gastrointestinal Disorders- Frequency unknown: Epigastric discomfort, dry mouth
Eye Disorders- Frequency unknown: Blurred vision
Blood and Lymphatic System Disorders- Frequency unknown: Blood dyscrasias including hemolytic anemia, agranulocytosis
Renal and Urinary Disorders- Frequency unknown: Urinary retention
Psychiatric Disorders- Frequency unknown: Infants, newborns and premature are susceptible to the anticholinergic efects of promethazine, while other children may display paradoxical hyperexcitability, restlessness, nightmares, disorientation
Cardiac Disorders- Frequency unknown: Palpitations, arrhythmias
Vascular disorders- Frequency unknown: Hypotension
Hepatobiliary disorders- Frequency unknown: Jaundice
General Disorders and Administration Site Conditions- Frequency unknown: Tiredness

Use this drug only as recommended. Do not exceed the recommended dose. There have been case reports of promethazine abuse. Do not take for longer than 10 days.

ContraindicationsView

Promethazine is contraindicated for use in children less than two years of age
Hypersensitivity to promethazine or to any of the excipients.
Phenergan should not be used in patients who are in a coma or suffering from CNS depression of any cause. It must not be given to neonates or premature infants.
Phenergan should be avoided in patients who have been taking monoamine oxidase inhibitors within the previous 14 days

PrecautionsView

The use of promethazine should be avoided in children and adolescents with signs and symptoms suggestive of Reye’s syndrome.
Promethazine may thicken or dry lung secretions and impair expectoration. It should therefore be used with caution in patients with asthma, bronchitis or bronchiectasis.
Use with care in patients with severe coronary artery disease.
Use with care in patients with narrow angle glaucoma.
Use with care in patients with epilepsy.
Use with care in patients with hepatic insufciency.
Use with care in patients with renal insufciency.
Caution should be exercised in patients with bladder neck obstruction.
Caution should be exercised in patients with pyloro-duodenal obstruction.

InteractionsView

Promethazine Hydrochloride may enhance the action of any anticholinergic agent, tricyclic antidepressant, sedative or hypnotic, Alcohol should be avoided during drug treatment.
Phenergan may interfere with immunologic urine pregnancy tests to produce false-positive or false-negative results.
Phenergan should be discontinued at least 72 hours before the start of skin tests using allergen extracts as it may inhibit the cutaneous histamine response thus producing false-negative results.

Pregnancy & lactationView

There is epidemiological evidence for the safety of promethazine in pregnancy and animal studies have shown no hazard, nevertheless, it should not be used in pregnancy unless the physician considers it essential. The use of Phenergan is not recommended in the two weeks prior to delivery in view of the risk of irritability and excitement in the neonate. When promethazine has been given in high doses during late pregnancy, promethazine has caused prolonged neurological disturbances in the infant. Promethazine should be used in pregnancy only if the potential benefts to the patient are weighed against the possible risk to the fetus. Promethazine is excreted in breastmilk. There are risks of neonatal irritability and excitement.

Overdose effectsView

Symptoms of severe over dosage are variable. They are characterised in children by various combinations of excitation, ataxia, incoordination, athetosis and hallucinations, while adults may become drowsy and lapse into coma. Convulsions may occur in both adults and children; coma or excitement may precede their occurrence. Tachycardia may develop. Cardiorespiratory depression is uncommon. If the patient is seen soon enough after ingestion, it should be possible to induce vomiting with ipecacuanha despite the antiemetic efect of promethazine; alternatively, gastric lavage may be used. Treatment is otherwise supportive with attention to maintenance of adequate respiratory and circulatory status. Convulsions should be treated with diazepam or other suitable anticonvulsant.

StorageView

Protect from light. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician

Pheramin

Chlorpheniramine Maleate

Syrup 2 mg/5 ml Allopathic Sedating Anti-histamine

Indications

Watery eye

Indication detailsView

Chlorpheniramine Maleate is indicated in the following indications-

Urticaria
Sensitivity reactions
Angioneurotic edema
Vasomotor rhinitis
Cough
Common cold
Motion sickness and
Other allergic conditions.

Therapeutic classView

Sedating Anti-histamine

PharmacologyView

Chlorpheniramine Maleate is an alkylamine antihistamine. It is one of the most potent histamine H1-receptor blocking agents which is used as a potent antihistamine. This generally causes less sedation than promethazine. Chlorpheniramine Maleate exerts its effects by blocking H1-receptor competitively.

DosageView

Adult- Usual adult dose is 4 mg every 4-6 hours, maximum 24 mg daily.

Child-

6-12 years: 2 mg every 4-6 hours, maximum 12 mg daily.
2-5 years: 1 mg every 4-6 hours, maximum 6 mg daily.
1-2 years: 1 mg twice daily.

Below 1 year the use of Chlorpheniramine Maleate is not recommended.

Side effectsView

Chlorpheniramine is well-tolerated, but sometimes drowsiness, dizziness, muscular weakness, and gastrointestinal upset may occur.

ContraindicationsView

Chlorpheniramine is contraindicated in patients hypersensitive to this agent, in newborn or premature infants.

PrecautionsView

Chlorpheniramine should be used with caution in patients with glaucoma and prostatic hypertrophy. During therapy with chlorpheniramine, caution should be taken in driving vehicles and operating machinery.

InteractionsView

Chlorphenamine maleate has been reported to be incompatible with calcium chloride, kanamycin sulfate, noradrenaline acid tartrate, pentobarbital sodium, and meglumine adipiodone.

Pregnancy & lactationView

This drug should not be used in lactating mother and in pregnancy especially during the first trimester of pregnancy.

Overdose effectsView

CNS depression (including sedation, apnea, CV collapse), CNS stimulation (including insomnia, hallucination, tremors, convulsions), tinnitus, blurred vision, dizziness, ataxia, hypotension. Stimulation and atropine-like signs and symptoms (including dry mouth, fixed dilated pupils, flushing, hyperthermia, Gl symptoms) are more likely in children.

StorageView

Store in a cool (Below 25°C temperature) and dry place protected from light. Keep out of the reach of children.

Pheramin

Chlorpheniramine Maleate

Tablet 4 mg Allopathic Sedating Anti-histamine

Indications

Watery eye

Indication detailsView

Chlorpheniramine Maleate is indicated in the following indications-

Urticaria
Sensitivity reactions
Angioneurotic edema
Vasomotor rhinitis
Cough
Common cold
Motion sickness and
Other allergic conditions.

Therapeutic classView

Sedating Anti-histamine

PharmacologyView

Chlorpheniramine Maleate is an alkylamine antihistamine. It is one of the most potent histamine H1-receptor blocking agents which is used as a potent antihistamine. This generally causes less sedation than promethazine. Chlorpheniramine Maleate exerts its effects by blocking H1-receptor competitively.

DosageView

Adult- Usual adult dose is 4 mg every 4-6 hours, maximum 24 mg daily.

Child-

6-12 years: 2 mg every 4-6 hours, maximum 12 mg daily.
2-5 years: 1 mg every 4-6 hours, maximum 6 mg daily.
1-2 years: 1 mg twice daily.

Below 1 year the use of Chlorpheniramine Maleate is not recommended.

Side effectsView

Chlorpheniramine is well-tolerated, but sometimes drowsiness, dizziness, muscular weakness, and gastrointestinal upset may occur.

ContraindicationsView

Chlorpheniramine is contraindicated in patients hypersensitive to this agent, in newborn or premature infants.

PrecautionsView

Chlorpheniramine should be used with caution in patients with glaucoma and prostatic hypertrophy. During therapy with chlorpheniramine, caution should be taken in driving vehicles and operating machinery.

InteractionsView

Chlorphenamine maleate has been reported to be incompatible with calcium chloride, kanamycin sulfate, noradrenaline acid tartrate, pentobarbital sodium, and meglumine adipiodone.

Pregnancy & lactationView

This drug should not be used in lactating mother and in pregnancy especially during the first trimester of pregnancy.

Overdose effectsView

CNS depression (including sedation, apnea, CV collapse), CNS stimulation (including insomnia, hallucination, tremors, convulsions), tinnitus, blurred vision, dizziness, ataxia, hypotension. Stimulation and atropine-like signs and symptoms (including dry mouth, fixed dilated pupils, flushing, hyperthermia, Gl symptoms) are more likely in children.

StorageView

Store in a cool (Below 25°C temperature) and dry place protected from light. Keep out of the reach of children.

Phidazole

Metronidazole

Oral Suspension 200 mg/5 ml Allopathic Amoebicides

Indications

Vaginal trichomoniasis

Indication detailsView

Metronidazole is indicated in the treatment of following diseases:

The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
In the treatment of urogenital trichomoniasis.
Bacterial vaginosis (also known as non-specific vaginitis).
All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
Giardiasis.
Acute ulcerative gingivitis.
Anaerobically infected leg ulcers and pressure sores.
Acute dental infections due to anaerobic organisms.
Antibiotic associated pseudomembranus colitis.

Therapeutic classView

Amoebicides, Anti-diarrhoeal Antiprotozoal

PharmacologyView

Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.

DosageView

Tablet and Suspension:

Trichomoniasis (Adults & Children over 10 yrs)-

200 mg tid or 400 mg bid for 7 days
800 mg in the morning and 1-2 gm at night for 2 days
2 gm as a single dose for 1 days

Trichomoniasis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Intestinal amoebiasis (Adults & Children over 10 yrs)-

800 mg tid for 5 days

Intestinal amoebiasis (Children)-

Children 7-10 yrs: 400 mg tid
Children 3-7 yrs: 200 mg qid
Children 1-3 yrs: 200 mg tid

Extra-intestinal & Asymptomatic amoebiasis (Adults & Children over 10 yrs)-

400-800 mg tid for 5-10 days

Extra-intestinal & Asymptomatic amoebiasis (Children)-

Children 7-10 yrs: 200-400 mg tid
Children 3-7 yrs: 100-200 mg qid
Children 1-3 yrs: 100-200 mg tid

Giardiasis (Adults & Children over 10 yrs)-

2 gm once daily for 3 days

Giardiasis (Children)-

Children 7-10 yrs: 1 gm once daily
Children 3-7 yrs: 600-800 mg once daily
Children 1-3 yrs: 500 mg once daily

Acute ulcerative gingivitis (Adults & Children over 10 yrs)-

200 mg tid for 3 days

Acute ulcerative gingivitis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Acute dental infections (Adults & Children over 10 yrs)-

200 mg tid for 3-7 days

Bacterial Vaginosis (Adults & Children over 10 yrs)-

400 mg bid for 7 days
2 gm as a single dose for 1 days

Leg ulcers and pressure sores (Adults & Children over 10 yrs)-

400 mg tid for 7 days

Anaerobic infections (Adults & Children over 10 yrs)-

800 mg initially and then 400 mg tid for 7 days

Anaerobic infections (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Surgical prophylaxis (Adults & Children over 10 yrs)-

400 mg tid started 24 hours before surgery for 1 days

Surgical prophylaxis (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Vaginal Gel:

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

Suppository:

Anaerobic Infections-

Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.

Surgical Prophylaxis-

Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.

IV Infusion:

Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.

Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.

Side effectsView

Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.

ContraindicationsView

Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.

PrecautionsView

If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
Metronidazole should be administered with caution to patients with hepatic encephalopathy.
Patients should be warned that metronidazole may darken urine.

InteractionsView

Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
Lithium: Plasma levels of lithium may be increased by metronidazole.
Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.

Pregnancy & lactationView

US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.

Pediatric usageView

Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.

Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).

Overdose effectsView

Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.

StorageView

Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.

Phidazole

Metronidazole

Tablet 400 mg Allopathic Amoebicides

Indications

Vaginal trichomoniasis

Indication detailsView

Metronidazole is indicated in the treatment of following diseases:

The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
In the treatment of urogenital trichomoniasis.
Bacterial vaginosis (also known as non-specific vaginitis).
All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
Giardiasis.
Acute ulcerative gingivitis.
Anaerobically infected leg ulcers and pressure sores.
Acute dental infections due to anaerobic organisms.
Antibiotic associated pseudomembranus colitis.

Therapeutic classView

Amoebicides, Anti-diarrhoeal Antiprotozoal

PharmacologyView

Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.

DosageView

Tablet and Suspension:

Trichomoniasis (Adults & Children over 10 yrs)-

200 mg tid or 400 mg bid for 7 days
800 mg in the morning and 1-2 gm at night for 2 days
2 gm as a single dose for 1 days

Trichomoniasis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Intestinal amoebiasis (Adults & Children over 10 yrs)-

800 mg tid for 5 days

Intestinal amoebiasis (Children)-

Children 7-10 yrs: 400 mg tid
Children 3-7 yrs: 200 mg qid
Children 1-3 yrs: 200 mg tid

Extra-intestinal & Asymptomatic amoebiasis (Adults & Children over 10 yrs)-

400-800 mg tid for 5-10 days

Extra-intestinal & Asymptomatic amoebiasis (Children)-

Children 7-10 yrs: 200-400 mg tid
Children 3-7 yrs: 100-200 mg qid
Children 1-3 yrs: 100-200 mg tid

Giardiasis (Adults & Children over 10 yrs)-

2 gm once daily for 3 days

Giardiasis (Children)-

Children 7-10 yrs: 1 gm once daily
Children 3-7 yrs: 600-800 mg once daily
Children 1-3 yrs: 500 mg once daily

Acute ulcerative gingivitis (Adults & Children over 10 yrs)-

200 mg tid for 3 days

Acute ulcerative gingivitis (Children)-

Children 7-10 yrs: 100 mg tid
Children 3-7 yrs: 100 mg bid
Children 1-3 yrs: 50 mg tid

Acute dental infections (Adults & Children over 10 yrs)-

200 mg tid for 3-7 days

Bacterial Vaginosis (Adults & Children over 10 yrs)-

400 mg bid for 7 days
2 gm as a single dose for 1 days

Leg ulcers and pressure sores (Adults & Children over 10 yrs)-

400 mg tid for 7 days

Anaerobic infections (Adults & Children over 10 yrs)-

800 mg initially and then 400 mg tid for 7 days

Anaerobic infections (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Surgical prophylaxis (Adults & Children over 10 yrs)-

400 mg tid started 24 hours before surgery for 1 days

Surgical prophylaxis (Children)-

Children 1-10 yrs: 7.5 mg/kg tid

Vaginal Gel:

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

Suppository:

Anaerobic Infections-

Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.

Surgical Prophylaxis-

Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.

IV Infusion:

Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.

Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.

Side effectsView

Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.

ContraindicationsView

Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.

PrecautionsView

If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
Metronidazole should be administered with caution to patients with hepatic encephalopathy.
Patients should be warned that metronidazole may darken urine.

InteractionsView

Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
Lithium: Plasma levels of lithium may be increased by metronidazole.
Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.

Pregnancy & lactationView

US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.

Pediatric usageView

Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.

Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).

Overdose effectsView

Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.

StorageView

Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.

Phoenix Azithromycin

Azithromycin Dihydrate

Tablet 500 mg Allopathic

Indication detailsView

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

PharmacologyView

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

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

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

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

DosageView

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

Children:

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

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

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

AdministrationView

Reconstitution procedure of suspension-

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

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

Side effectsView

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

ContraindicationsView

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

PrecautionsView

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

InteractionsView

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

Pregnancy & lactationView

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

Overdose effectsView

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

StorageView

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

Phoenix Calcium

Calcium Carbonate

Tablet 500 mg Allopathic Minerals in bone formation

Indication detailsView

250 mg or 500 mg tablet: This is used for the treatment or prevention of calcium depletion in patients in whom dietary measures are inadequate. Conditions that may be associated with calcium deficiency include hypoparathyroidism, achlorhydria, chronic diarrhea, vitamin D deficiency, steatorrhea, sprue, pregnancy and lactation, menopause, pancreatitis, renal failure, alkalosis, and hyperphosphataemia. Calcium Carbonate is being used increasingly often to treat hyperphosphataemia in chronic renal failure as well as those on continuous ambulatory peritoneal dialysis (CAPD) and haemodialysis. Many patients are unable to tolerate sufficient doses for complete phosphate control and require additional measures such as stringent dietary phosphate restriction or relatively small doses of aluminium hydroxide. Calcium Carbonate containing preparations can provide short-term relief of dyspeptic systems but are no longer recommended for long-term treatment of peptic ulceration.

1000 mg tablet: This is indicated for the management of conditions associated with hyperidity and for fast relief of acid indigestion, heartburn, sour stomach and upset stomach.

Therapeutic classView

Minerals in bone formation, Specific mineral preparations

PharmacologyView

Calcium carbonate reacts with gastric acid to produce a salt and water. For calcium carbonate the postulated chemical reaction is: CaCO₃+2HCl = CaCl₂+H₂O+CO₂. Two grams of calcium carbonate will readily bring 100 ml of hydrochloric acid to a pH above 6. The increase in gastric pH diminishes the activity of pepsin in the gastric secretion. Up to 30% of the oral calcium load may be absorbed.

DosageView

250 mg or 500 mg tablet: Calcium Carbonate is always used orally and when used as an antacid the recommended doses for adults are equivalent to 540-2000 mg Calcium Carbonate per day, doses for children being half of those for adults. As a dietary supplement, such as for the prevention of osteoporosis, 1250-3750 mg Calcium Carbonate (500-1500 mg calcium) daily is recommended in general, but again this will need to be tailored to the individual patient depending on any specific disease such as Calcium deficiency, malabsorption or parathyroid function. In pregnancy and lactation the recommended daily dose of calcium is 1200-1500 mg. In chronic renal failure the doses used vary from 2.5-9.0 gm Calcium Carbonate per day and need to be adjusted according to the individual patient. To maximize effective phosphate binding in this context the Calcium Carbonate should be given with meals.

1000 mg tablet: 2000-3000 mg tablet when symptoms occur; may be repeated hourly if needed or as directed by the physician.

Side effectsView

Orally administered Calcium Carbonate may be irritating to the GI tract. It may also cause constipation. Hypercalcaemia is rarely produced by administration of calcium alone, but may occur when large doses are given to patients with chronic renal failure.

ContraindicationsView

Hypercalcaemia and hyperparathyroidism
Hypercalciuria and nephrolithiasis
Zollinger-Ellison syndrome
Concomitant digoxin therapy (requires careful monitoring of serum calcium level)

When hypercalcaemia occurs, discontinuation of the drug is usually sufficient to return serum calcium concentrations to normal. Calcium salts should be used cautiously in patients with sarcoidosis, renal or cardiac disease, and in patients receiving cardiac glycosides.

InteractionsView

Calcium Carbonate may enhance the cardiac effects of digoxin and other cardiac glycosides, if systemic hypercalcaemia occurs. Calcium Carbonate may interfere with the absorption of concomitantly administered tetracycline preparations and in chronic renal failure modification of vitamin D therapy may be required to avoid hypercalcaemia when Calcium Carbonate is used as the primary phosphate binder.

Pregnancy & lactationView

Calcium containing drugs have been widely used in pregnancy by way of oral calcium supplementation or antacid therapy. Calcium Carbonate can be used in lactating women too.

Pediatric usageView

Use in children: Calcium carbonate has been extensively studied in children and infants with chronic renal failure and is both safe and effective.

Use in elderly: In case of elderly patients with renal failure when calcium carbonate is taken constipation may be troublesome one for this group. For this reason, monitoring of serum calcium and phosphate is of course indicated for elderly patients.

StorageView

Store in a cool, dry place in controlled room temperature.

Phoenix Cetirizine

Cetirizine Hydrochloride

Tablet 10 mg Allopathic Sedating Anti-histamine

Indications

Urticaria

Indication detailsView

It is indicated for the relief of symptoms associated with seasonal & perennial allergic rhinitis. It is also indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria and allergen induced asthma.

Therapeutic classView

Sedating Anti-histamine

PharmacologyView

Cetirizine Hydrochloride is a potent H1 receptor antagonist without any significant anticholinergic and antiserotonic effects. At pharmacologically active dose levels, it has almost no drowsiness effect and does not cause behavioral changes. It inhibits the histamine-mediated early phase of the allergic reaction and also reduces the migration of inflammatory cells and the release of mediators associated with the late phase of the allergic reaction.

Pharmacokinetics: Cetirizine 10 mg achieves peak plasma concentrations of 257 mcg/L within one hour of administration (980 mcg/L in children). Food does not affect the extent of absorption, but it may slightly reduce the rate. Peak blood levels 0.3 micrograms/ml are reached between thirty & sixty minutes after administration of 10 mg dose of Cetirizine. Its plasma half-life is approximately 11 hours. Absorption is very consistent from one subject to the next. Its renal clearance is 30 ml/minute and the excretion half-life is approximately nine hours.

DosageView

Adults and Children 6 years and older: 1 tablet or 2 teaspoonfuls daily (or 1 teaspoonful twice daily).

Children 2-6 years: 1 teaspoonful once daily or 1/2 teaspoonful twice daily.

Children 6 months to 2 years : 1/2 teaspoonful once daily. The dose in children 12-23 months of age can be increased to a maximum dose as 1/2 teaspoonful every 12 hours.

Side effectsView

The most common side effects that occurred more frequently on Cetirizine is somnolence.

ContraindicationsView

It is contraindicated in patients with a history of hypersensitivity to Cetirizine or hydroxyzine.

PrecautionsView

Caution should be exercised when driving a car or operating a heavy machinery.

InteractionsView

No clinically significant drug interactions have been found with Theophylline, Azithromycin, Pseudoephedrine, Ketoconazole or Erythromycin and with other drugs.

Pregnancy & lactationView

US FDA Pregnancy Category of Cetirizine Hydrochloride is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cetirizine Hydrochloride has been shown to be excreted in human milk. So, caution should be exercised when Cetirizine Hydrochloride is administered to a nursing woman.

StorageView

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

Phoenix Ibuprofen

Ibuprofen

Tablet 400 mg Allopathic Drugs for Osteoarthritis

Indications

Yellow fever infection

Indication detailsView

Ibuprofen is indicated in the following indications-

Rheumatoid arthritis
Osteoarthritis
Gouty arthritis
Juvenile polyarthritis
Ankylosing spondylitis
Synovitis
Low back pain
Dysmenorrhoea
Fever
Migraine
Soft tissue injuries
Pain & Inflammation in dental and musculoskeletal origin.

Therapeutic classView

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

PharmacologyView

Ibuprofen has a high level of anti-inflammatory, anti-pyretic, and analgesic activity. The analgesic effects of Ibuprofen are due to both a peripheral and a central effect. Ibuprofen is a potent inhibitor of the enzyme cyclooxygenase, which thus results in a marked reduction in prostaglandin synthesis. Ibuprofen also inhibits the synthesis of some lipo-oxygenase products. Ibuprofen thus quickly relieves pain and stiffness, reduces swelling, and improves the movement of different joints of arthritis sufferers.

DosageView

Adults: The dose is initially, 400 mg 3 times daily. A dose of 2400 mg daily should not be exceeded.

Children:

3-6 months (body-weight over 5 kg): ½ tsp (2.5 ml) 3 times daily; max. 30 mg/kg daily in 3-4 divided doses.
6 months-1 year: ½ tsp (2.5 ml) 3-4 times daily; max. 30 mg/kg daily in 3-4 divided doses.
1-4 years: 1 tsp (5 ml) 3 times daily; max. 30 mg/kg daily in 3-4 divided doses.
4-7 years: 1½ tsp (7.5 ml) 3 times daily; max. 30 mg/kg daily in 3-4 divided doses.
7-10 years: 2 tsp (10 ml) 3 times daily; upto 30 mg/kg (max. 2.4 gm) daily in 3-4 divided doses.
10-12 years: 3 tsp (15 ml) 3 times daily; upto 30 mg/kg (max. 2.4 gm) daily in 3-4 divided doses.

children weighing less than 5 kg: Not recommended for children weighing less than 5 kg.

In juvenile rheumatoid arthritis: up to 30-40 mg/kg of body weight daily in 3-4 divided doses may be taken or as directed by the physician.

Side effectsView

Upset stomach, vomiting, heartburn, nausea may occur.

ContraindicationsView

Ibuprofen is contraindicated in patients who have shown the previous hypersensitivity to Ibuprofen, and in patients with severe or active peptic ulceration.

PrecautionsView

Ibuprofen should be used with caution and the lowest effective doses should be given if there is a history of gastrointestinal hemorrhage or ulcer. Patients on long-term therapy with Ibuprofen require ocular monitoring at regular intervals, as changes in ocular function have been reported. Patients with systemic lupus erythematosus are more likely than others to develop hypersensitivity to Ibuprofen. Ibuprofen should be prescribed with caution in patients with asthma and in patients with a history of hypersensitivity to other nonsteroidal anti-inflammatory agents.

Pregnancy & lactationView

Adverse effects of Ibuprofen on the developing fetus cannot be fully excluded. Ibuprofen should not be used during pregnancy and for nursing mothers unless the potential benefits to the mothers outweigh the potential risks.

StorageView

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